Split (3)

train · 29.5k rows

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[ 0 ]	59	NA	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to learn how the body responds to different amounts of vitamin K in the diet in order to understand the roles that vitamin K may have in the body. We also need to determine if older adults need more or less vitamin K in their diet compared to younger adults in order to maintain normal body stores of vitamin K.	Vitamin K has a role in bone health, but little is known about vitamin K metabolism in aging and in maintenance of bone mass. The limited understanding of vitamin K metabolism impedes the establishment of dietary recommendations for vitamin K, and the interpretation of results from clinical trials on vitamin K supplementation and bone health of women in a narrow age group. This study is the first to assess the role of dietary and other factors that influence the response to vitamin K status and bone turnover to vitamin K depletion and repletion in adults. This study also compares the absorption efficiency and body retention of vitamin K relative to current vitamin K status. Men and women \[21 younger (18-40y) and 21 older (55+y)\] will participate in a 62-d metabolic study, with a 5d run-in period, followed by a 28d dietary vitamin K restriction period (10 ug/d), and ending with a 28d dietary vitamin K supplementation period (500 ug/d). Coagulation times will be monitored during the dietary restriction period. Serial measurements of vitamin K status markers and of bone turnover markers will show the response of vitamin K to dietary manipulation for both age groups under identically controlled dietary conditions. Deuterium-labeled vitamin K in collards will be used to compare the absorption of vitamin K during a vitamin K-deplete state to that of a vitamin K-replete state. Vitamin K is transported in triglyceride-rich lipoproteins, which may vary among individuals due to differences in adiposity and lipid homeostasis. Therefore, measurement of body composition by Dual Energy X-Ray Absorptiometry (DXA) and plasma lipids will provide insight into the role of lipids in absorption and transport of vitamin K. The findings of this study are critical for the interpretation of the epidemiologic and clinical data used to determine the protective role vitamin K may have in chronic disease prevention.	Aging Osteoporosis	Vitamin K metabolism Bone health Metabolism	null	1	arm 1: 28 day diet low vitamin K, 28 day diet high vitamin K	[ 0 ]	1	[ 0 ]	intervention 1: phylloquinone (vitamin K1) 500 mcg daily in third month	intervention 1: Vitamin K	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	42	NCT00336232	1COMPLETED	2009-07-01	2006-05-01	Tufts University	7OTHER	false	false	false	null	0
[ 3 ]	157	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.	PROCRIT (Epoetin alfa) is a brand of recombinant human erythropoietin (rHuEPO). Erythropoietin is a hormone produced in the kidney. Its function is to stimulate the production of red blood cells in the bone marrow. Many patients with Chronic Kidney Disease (CKD) do not produce enough erythropoietin and thus develop anemia (a reduction in red blood cell levels). This can cause them to feel tired. PROCRIT (Epoetin alfa) is approved by the United States Food and Drug Administration (FDA) for the treatment of anemia (low red blood cell count) in patients with CKD (not on dialysis). The approved dosing frequency for PROCRIT (Epoetin alfa) in patients with CKD is one injection three times per week. Although PROCRIT (Epoetin alfa) is approved by the FDA for the treatment of certain types of anemia at different dosing schedules, the dosing schedules that will be used in this study are investigational in CKD. An investigational use is one that is currently not approved by the FDA. This is an open-label, randomized (patients are assigned different treatments based on chance), multi-center, controlled study of patients with anemia of Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. Approximately 156 patients with CKD, not on dialysis, who have not received an erythropoietin receptor agonist (a drug that stimulates red blood cell production) for eight weeks immediately prior to screening (Week -1) and who have a hemoglobin (Hb, a measure of the number of red blood cells), less than 11 g/dL at screening will be eligible to participate. Patients will be evaluated for eligibility during a one-week screening phase. Eligible patients will be randomized in a 3:1 ratio to a PROCRIT (Epoetin alfa) group or to the control group for a period of 26 weeks. Randomization is done through a computer that randomly assigns the subject by chance (like rolling dice) to one of two groups (No one can choose the group to which they will be assigned.). They will have a 3 to 1 chance of being assigned to Group 1 versus Group 2, which means that out of every 4 patients entering the study 3 will receive PROCRIT (Epoetin alfa) and 1 will not. Group 1 -will receive PROCRIT (Epoetin alfa) 20,000 Units (U) every 2 weeks until the hemoglobin reaches 11.0 g/dL or higher and remains at this level for two measurements in a row. At Week 6 or thereafter, the 20,000 Unit dose may be adjusted upward or downward as required to obtain the two consecutive hemoglobin measurements. Once the two consecutive measurements have been achieved, PROCRIT (Epoetin alfa) will be given every 4 weeks (Q4W) at double the previous dose to obtain a target hemoglobin of up to 12.0 g/dL. There will be no conversion to Q4W before Week 6 or after Week 18. If the hemoglobin drops, patients may go back to receiving PROCRIT (Epoetin alfa) every 2-weeks. If the hemoglobin rises above 12.0 g/dL, patients will not receive another dose of PROCRIT (Epoetin alfa) until the Hg level is below 12.0 g/dL. If the hemoglobin rises rapidly, patients will not receive another dose of PROCRIT (Epoetin alfa) until the rise is 1 g/dL or less in a 2-week period. The maximum amount of PROCRIT (Epoetin alfa) that this group can receive is 60,000 Units over a 4-week period. All doses of PROCRIT (Epoetin alfa) are injected under the skin (subcutaneous). Group 2 - will not receive any PROCRIT (Epoetin alfa). This group will continue to receive the care that they are now receiving from their physician and the physician will review all lab results. Since a lack of iron could interfere with the ability of patients to make red blood cells, patients in both groups will have iron levels checked at the screening visit and during the study. Based on the results of iron tests, the study doctor may prescribe an oral (by mouth) or intravenous (injection) iron supplement during the study. If the need for iron supplementation is determined, patients will receive iron supplementation no matter which group they are in. Every two weeks a study visit will be performed. At each visit, blood pressure and heart rate will be checked, and blood will be drawn for all patients and sent to the central laboratory for complete blood count (CBC). The Hb by CBC will be used for efficacy analysis ( to measure the effectiveness of the study drug in increasing the hemoglobin level). Hb testing by HemoCue will be performed every two weeks on-site for PROCRIT (Epoetin alfa) group patients, for the purpose of real-time dosing decisions. (HemoCue is the brand name of a portable hemoglobin test that uses a drop of blood to obtain immediate hemoglobin measurements). PROCRIT (Epoetin alfa) will be administered at a dose based on the HemoCue Hb measurement. Full hematology panel, serum chemistry, and iron status will be assessed at intervals throughout the study by a central laboratory. The number of units of packed red blood cells (PRBC) transfused, pre-transfusion Hb level, and the reasons for transfusion will be collected. Hemoglobin response will also be measured. A patient exhibiting a hemoglobin response will have two consecutive Hb measurements at least 1 g/dL greater than baseline any time during the study or have two consecutive Hb measurements \>= 11.0 g/dL at any time during the study. Falls, activities of daily living (ADLs), and mobility will be assessed during the study. Clinical laboratory results, blood pressure and heart rate, and the incidence and severity of adverse events will be monitored during the study. The study hypothesis is that the mean Hb change from baseline to the end of study will be significantly higher in the PROCRIT (Epoetin alfa) group over the control group. Group 1 patients will receive a maximum of 13 doses of PROCRIT (Epoetin alfa) by subcutaneous injection (under the skin) for up to 26 weeks. Dosage is based on the hemoglobin measurement done at each visit. Doses will be started at an every 2-week interval and may be increased to every four weeks. The maximum dose that can be given is 60,000 Units of PROCRIT (Epoetin alfa) over a 4-week period. Any PROCRIT (Epoetin alfa) dose over 40,000 Units will be administered in two separate injections.	Renal Failure , Chronic Anemia	Long Term Care Facilities subcutaneous injections PROCRIT Epoetin alfa Anemia	null	2	arm 1: None arm 2: Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks intervention 2: None	intervention 1: Epoetin Alfa intervention 2: Standard of care	0	null	157	NCT00337935	1COMPLETED	2009-07-01	2006-07-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	-0
[ 3 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	To test the effect of the research study drug, inhaled fluticasone on lung function in exercising patients with Chronic Obstructive Pulmonary Disease (COPD).	null	Chronic Obstructive Pulmonary Disease (COPD)		null	2	arm 1: Arm 1: drug, crossing over to Pbo comparator arm 2: Arm 2: Pbo comparator, crossing over to drug	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: fluticasone 250 µg/inhalation, 2 inhalations bid. 14 Days of treatment. intervention 2: Placebo /inhalation, 2 inhalations bid. 14 Days of treatment.	intervention 1: Fluticasone intervention 2: Comparator: Placebo	0	null	24	NCT00387036	6TERMINATED	2009-07-01	2006-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	39	NON_RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	true	0ALL	false	This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.	Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure to a traumatic event. PTSD symptoms may include emotional numbness, loss of interest in activities that were once enjoyable, irritability, and sleep problems. Medication therapy, behavioral therapy, and a combination of both therapies are among the available treatment options for people with PTSD. Cognitive behavioral therapy (CBT), a type of talking therapy that has been shown to be effective in treating PTSD, teaches patients how to alter their thinking to, in turn, improve how they feel. A selective serotonin reuptake inhibitor (SSRI) is a type of medication that has also been effective in treating PTSD. Information about the comparative physiological effects of each of these treatments on people with PTSD is needed. This study will evaluate which parts of the brain are affected by CBT treatment versus SSRI treatment in people with PTSD. Participants with and without PTSD will be enrolled in this 12-week, open label study. Following a screening visit to determine eligibility, participants with PTSD will be offered a choice of either CBT or SSRI treatment. Those participants who choose CBT will attend 16 therapy sessions. The first phase of therapy will focus on the development of emotional and interpersonal regulation skills. The second phase will use a modified form of prolonged exposure therapy, which has been effective in reducing symptoms of PTSD. Participants who elect to receive medication will take sertraline, an SSRI that has been safe and effective in treating PTSD. These participants will attend 12 treatment sessions. Pre- and post-treatment fear response will be assessed in all participants using fMRI scans to measure brain responses and using saliva samples to test cortisol levels. All participants will also self-administer saliva samples at various points during the 3 days prior to fMRI scanning. Other outcomes will be assessed throughout the study using questionnaires. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00648375	Post-Traumatic Stress Disorder	PTSD Trauma Sexual Abuse Sexual Assault	null	3	arm 1: Participants assigned to the control condition will receive no treatment arm 2: Participants will receive treatment with sertraline arm 3: Participants will receive cognitive behavioral therapy	[ 4, 1, 1 ]	2	[ 0, 5 ]	intervention 1: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks intervention 2: CBT consists of sixteen 1-hour sessions during a period of 12 weeks.	intervention 1: Sertraline intervention 2: Cognitive behavioral therapy (CBT)	1	New York \| New York \| United States \| -74.00597 \| 40.71427	15	NCT00391430	6TERMINATED	2009-07-01	2005-05-01	NYU Langone Health	7OTHER	false	false	false	null	0
[ 2, 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by joint swelling, pain, stiffness, damage, and ultimately loss of joint function. Scientists estimate that about 1.3 million people (0.6 percent) of the U.S. adult population have RA. Current therapies target the immune system early in the disease process before joint damage occurs, and include drugs such as methotrexate (MTX) and tumor necrosis factor (TNF)-blocking agents. Rituximab is a disease-modifying antirheumatic drug (DMARD) recently approved by the FDA for use in combination with MTX for treatment of moderately to severely active RA in patients who have had an inadequate response to TNF-blocking agents, in an effort to try to slow the course of the disease. This study will examine the effects of rituximab on the immune response and disease activity in participants with early RA who have not been treated with any disease-modifying agent. In addition, the safety and tolerability of rituximab in this population will be examined.	RA is an inflammatory disease that causes pain, swelling, stiffness, and loss of function in the joints. It occurs when the immune system, which normally defends the body from invading organisms, turns its attack against the membrane lining the joints. RA is commonly managed by DMARDs initiated early in the disease process, before irreversible joint damage occurs. The most common DMARD prescribed in the United States is MTX; this drug is well tolerated and has better efficacy compared to other DMARDs, but is inadequate in providing lasting improvement in individuals with RA. In patients with an inadequate response to MTX alone, the use of biologic agents, including TNF-blocking agents in combination with MTX, has become a standard therapeutic approach. Rituximab (anti-CD20) is a man-made antibody used to treat certain types of cancer. The drug blocks the CD20 antigen found on the surface of B cells and is known to deplete B cells when administered intravenously. Previous research suggests B-cell activity is important in pathogenesis of RA, so B-cell depletion may decrease inflammation and other symptoms of RA. Rituximab has recently been approved by the FDA for use in combination with MTX for treatment of patients with moderately to severely active RA who have had an inadequate response to TNF-blocking agents. This study will examine the effects of rituximab on the immune response and disease activity in patients with early active RA who have not been treated with any disease-modifying agent. Levels of B and T cells and other markers of disease activity will be monitored during the study. The safety and tolerability of rituximab in this DMARD-naive population will be examined. The expected duration of this study is 2.5 years. All participants will receive two intravenous infusions of rituximab in an outpatient setting at study entry and Week 2. Throughout the study, participants will receive MTX, systemic corticosteroids, and folic or folinic acid. MTX dosing will be re-evaluated by disease activity scores every month until Month 6 and again at Months 8, 10, and 12. Systemic corticosteroid doses will be modified based on the participant's health while in the study. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) is permitted, but NSAID doses should not be changed during the study, if at all possible. NSAIDs will not be provided by this study. There will be a maximum of 2 screening visits before study treatment, a baseline visit (Day 0), and 11 study visits. A physical exam, assessment for adverse events, and blood collection will occur at all study visits. Kidney and liver function tests and rheumatologic evaluations will occur at most study visits; participants will also be asked to complete a questionnaire on their health at most study visits. Arthroscopy (knee biopsy) on the more inflamed knee will occur at baseline and Month 3. Participants will be contacted by telephone the day after each arthroscopy and rituximab infusion.	Rheumatoid Arthritis	Autoimmune disease Biologic response modifiers Disease-modifying antirheumatic drugs (DMARDS) Immune system Rheumatoid arthritis (RA) Rituximab (anti-CD20 monoclonal antibodies)	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.	intervention 1: Rituximab	1	Denver \| Colorado \| United States \| -104.9847 \| 39.73915	4	NCT00396812	6TERMINATED	2009-07-01	2006-11-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0
[ 4 ]	109	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	Patients received one injection with incobotulinumtoxinA (Xeomin) or placebo at baseline. Thereafter, all patients who entered the Open-Label Extension Period (OLEX) received up to five injection sessions of incobotulinumtoxinA (Xeomin) during the OLEX period.	null	Blepharospasm		null	2	arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to 50 Units per eye; Open-Label Extension Period: up to 5 injections, up to 50 Units per eye per injection session; Mode of administration: intramuscular injection arm 2: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, up to 50 Units per eye; Mode of administration: intramuscular injection intervention 2: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium chloride (NaCl), placebo volume corresponding to up to 50 Units per eye; Mode of administration: intramuscular injection	intervention 1: incobotulinumtoxinA (Xeomin) intervention 2: Placebo	2	Houston \| Texas \| United States \| -95.36327 \| 29.76328 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269	108	NCT00406367	1COMPLETED	2009-07-01	2006-10-01	Merz Pharmaceuticals GmbH	4INDUSTRY	false	false	false	null	0
[ 4 ]	564	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	Science News (October 2004) called vitamin D deficiency a "silent epidemic" in America, with no group unaffected. Using new guidelines of optimal vitamin D levels, more than 90% of African American women now suffer from vitamin D deficiency. Deficiency during pregnancy has profound effects on the developing fetus. Other systems besides bones are affected by vitamin D deficiency, including an increased risk of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, type I diabetes, and certain cancers. This study proposes to examine and manage vitamin D levels in more than one thousand women in an underserved population in South Carolina. The women will be from the patient population seeking OB/GYN and Pediatric services through Eau Claire Cooperative Health Centers, Inc. (ECCHC), a network of ten clinics in three counties in the center of the state approximately 70 miles from Charleston, SC. ECCHC is one of approximately 1000 community health centers supported through Health and Human Services' (HHS) Health Resources and Services Administration's (HRSA), Bureau of Primary Health Care. The research objectives for this project will be managed through the Pediatric Nutritional Sciences Research Center of the Children's Research Institute at the Medical University of South Carolina, Charleston, SC, in collaboration with ECCHC. The research aims will evaluate vitamin D levels and possible contributing factors to the levels in pregnant women. Women who present to ECCHC within the first trimester of pregnancy will be randomized to one of two doses of vitamin D supplementation shown to be effective in other groups. Each pregnant mother will begin supplementation during the 12th week of pregnancy and will be followed closely throughout pregnancy for one year to determine the effectiveness of supplementation on vitamin D status, overall health of mother, and of her infant following delivery. We expect to observe severe vitamin D deficiency in a considerable percentage of the mothers and their infants who receive care at ECCHC, especially those individuals with darker pigmentation. When the extent of vitamin D deficiency within each racial/ethnic group is better defined and their supplementation requirements identified, we will be better able to establish guidelines for supplementation and health maintenance, and set policy recommendations for the dietary recommended intake of vitamin D. Those women and their infants identified as deficient in vitamin D will be important in establishing community health care policies for vitamin D surveillance and supplementation strategies. The results will allow us to implement specific dietary and/or medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally.	With avoidance of sunlight exposure due to lifestyle changes and concerns regarding skin cancer and the resultant widespread use of sunscreen, very few Americans are meeting their needs for vitamin D either through skin photosynthesis or dietary intake. A study published by the Centers for Disease Control (CDC) and our laboratory at the Medical University of South Carolina (MUSC) revealed that 42% of African American women in their childbearing years exhibited a deficiency of D vitamin (hypovitaminosis D) (1). Using new guidelines of optimal vitamin D levels, more than 90% of African American women now suffer from vitamin D deficiency (2). Science News (October 2004) called vitamin D deficiency a "silent epidemic" in America, with no group unaffected (3). Deficiency during pregnancy has profound effects on the developing fetus. Vitamin D deficiency affects other systems besides bones: it is associated with later, lifelong sequelae, with notable increased risk of autoimmune diseases such as rheumatoid arthritis (4), multiple sclerosis (5,6), type I diabetes (7,8), and certain cancers (7,9-14). Prevention and intervention studies only recently have been undertaken (3). A reexamination of dietary vitamin D requirements of various vulnerable populations in the U.S. is desperately needed (2,3). As a representative community with a diverse population, Eau Claire Cooperative Health Centers in South Carolina (ECCHC) serves a large percentage of African American as well as Caucasian and Hispanic women and children considered to be at high risk for vitamin D deficiency. ECCHC has eight clinics providing 1o care services to patients with special emphasis on Pediatric and OB/GYN services. Defining the prevalence of vitamin D deficiency in this patient population and the optimal vitamin D supplementation strategies for these women and their infants will become the prototype for recommendations applicable to other communities throughout the U.S. In Specific Aim 1, the vitamin D status of a cross-sectional sample of 1000 pregnant women presenting at ECCHC for their prenatal care will be determined by measuring serum calcium, phosphorus, intact parathyroid hormone (iPTH), 25(OH)D, the nutritional marker of vitamin D as a function of ethnicity. Maternal health characteristics, skin pigmentation (using reflectance spectrophotometry), dietary characteristics (using an established food frequency questionnaire), and lifestyle profiles (using standardized questionnaires) will be ascertained as well. Any deficiency noted will lead to specific recommendations for vitamin D supplementation by the research team, with standardized strategies to monitor status following initiation of supplementation in Specific Aim 2. Based on extensive preliminary data, a supplementation regimen will be implemented and its efficacy in achieving optimal vitamin D status in these women tested in Aim 2: women within three racial groups (African American, Hispanic and Caucasian) will be stratified into two groups by their initial 25(OH)D level: Group 1, \<32 ng/mL (less than optimal vitamin D status) and Group 2, ≥32 ng/mL (optimal vitamin D status). Based on our ongoing NIH study of pregnant women, each group will be randomized to receive one of two doses starting at 13 weeks' gestation: 2,000 or 4,000 IU vitamin D3/day after a universal one-month 2,000 IU/day dosing run-in period at 12 weeks' balanced by race/ethnicity. The randomization schema allows determination of both efficacy and safety for those deficient and those replete at entry into the study as a function of race/ethnicity and season. Anticipated Results and Future Studies: We expect to observe vitamin D deficiency in a considerable percentage of the mothers and their newborn infants who receive care at ECCHC, especially those individuals with darker pigmentation. In Aims 1 \& 2, by determining the prevalence of vitamin D deficiency with each racial/ethnic group, we will establish guidelines for supplementation and health maintenance, and policy recommendations for the dietary recommended intake of vitamin D in the U.S. The results will allow us to implement specific dietary and/or medical interventions aimed at correcting hypovitaminosis D in the population in this study and other similar populations being served by the more than 1000 community health centers nationally.	Vitamin D Deficiency Pregnancy	vitamin D cholecalciferol pregnant women	null	2	arm 1: Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery. arm 2: Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day intervention 2: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3 intervention 3: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation.	intervention 1: cholecalciferol (vitamin D3) intervention 2: cholecalciferol intervention 3: cholecalciferol	1	Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071	265	NCT00412087	1COMPLETED	2009-07-01	2007-01-01	Medical University of South Carolina	7OTHER	false	false	false	null	0
[ 3 ]	53	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately 50 patients who qualified for tumor response population.	null	Gastric Cancer		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 700 milligrams/meters squared (mg/m2), intravenous (IV), every 21 days x 6 cycles intervention 2: 75 mg/m2, IV, every 21 days x 6 cycles	intervention 1: pemetrexed intervention 2: cisplatin	6	Barnaul \| N/A \| Russia \| 83.7456 \| 53.3598 Ivanovo \| N/A \| Russia \| 40.97139 \| 56.99719 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Stavropol \| N/A \| Russia \| 41.9734 \| 45.0428	53	NCT00415168	1COMPLETED	2009-07-01	2006-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	6	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.	The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.	Breast Neoplasms		null	1	arm 1: sunitinib + exemestane	[ 0 ]	2	[ 0, 0 ]	intervention 1: 25 mg, oral, daily dosing intervention 2: 37.5 mg, oral, continuous dosing, daily	intervention 1: exemestane intervention 2: sunitinib malate	3	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	6	NCT00417885	6TERMINATED	2009-07-01	2007-06-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of the study is to determine the best dose of Vitamin D to give to hip fracture patients to achieve the optimal therapeutic level.	Low Vitamin D levels can cause faster bone loss and increase the risk of having a fracture. Patients who experience a hip fracture have low levels of Vitamin D. It is not clear how much Vitamin D must be taken in order to reach this optimal level. Serum 25-hydroxyvitamin D3 (25-OHD) concentrations are the recognized functional status indicator for vitamin D. Although there is no clear consensus, vitamin D 'insufficiency' has been considered in the range of 25- 75/80 nmol/L. Patients with acute hip fracture are at high risk for a recurrent hip fracture or other fragility fractures (and falls) and are a group who should be targeted for osteoporosis treatment (i.e. Bisphosphonate or other antiresorptive). Before fracture patients start on a bisphosphonate, however, an important consideration is whether 25-OHD levels are at a therapeutic level (\>75 nmol/l and less than 150-200 nmol/L). Case-control studies indicate that older people who experience a hip fracture have lower serum concentrations of 25-OHD than do those without a fracture. In cross-sectional studies, the majority of patients with hip fracture are considered to have insufficient vitamin D levels. Although the benefits of supplementing patients with at least 800 to 1000 IU/day Vitamin D3 may be recognized, there is little information available to guide physicians regarding the appropriate management of hip fracture patients who may be severely Vitamin D deficient, particularly in acute hip fracture patients. Few studies have examined whether high dose vitamin D (i.e. 50,000 IU or greater/week) offers an advantage over smaller, routinely prescribed doses (i.e. 800 or 1000 IU), particularly in hip fracture patients. The purpose of this study is to determine the number of hip fracture patients reaching an optimal level of vitamin D comparing between three different Vitamin D dose strategies: A. 50,000 D2 oral bolus followed by 800 IU D3 daily B. 100,000 D2 oral bolus followed by 800 IU D3 daily C. 800 IU D3 daily The Vitamin D strategies will be administered over 3-months in acute hip fracture patients. The proportion of patients reaching an optimal level of 25-OHD (\>75 nmol/L) will be determined. Secondary measures include the Timed Up and Go test, and 2 Minute Walk Test to compare the effects of the Vitamin D supplementation strategies on functional and muscle strength scales.	Hip Fracture	Vitamin D Hip fracture Optimal level Deficiency Functional muscle strength	null	3	arm 1: 50 000 IU Vitamin D2 arm 2: 100 000 IU Vitamin D2 arm 3: Placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 50 000 IU vitamin D2, one time bolus dose intervention 2: 100 000 IU vitamin D2, one time bolus dose intervention 3: Placebo, 1 time bolus dose	intervention 1: Vitamin D2 intervention 2: Vitamin D2 intervention 3: Placebo	0	null	64	NCT00424619	1COMPLETED	2009-07-01	2007-10-01	McMaster University	7OTHER	false	false	false	null	0
[ 3 ]	4	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.	Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.	Churg-Strauss Syndrome	Antineutrophil cytoplasmic antibody associated vasculitis Glomerulonephritis Rituximab	null	1	arm 1: 375 mg/m\^2/week for 4 weeks	[ 0 ]	2	[ 0, 0 ]	intervention 1: Patients received 4 weekly doses of rituximab 375 mg/m\^2. intervention 2: Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months	intervention 1: Rituximab intervention 2: Prednisone	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	3	NCT00424749	6TERMINATED	2009-07-01	2007-06-01	Fernando Fervenza	7OTHER	false	false	false	null	0
[ 3, 4 ]	255	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration	null	Macular Degeneration Choroidal Neovascularization	Age-related macular degeneration AMD Choroidal neovascularization Verteporfin Ranibizumab	null	2	arm 1: Verteporfin (6 mg/m\^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). arm 2: Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of the infusion. intervention 2: Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection intervention 3: As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.	intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab intervention 3: Placebo	12	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Regensburg \| N/A \| Germany \| 12.10161 \| 49.01513 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Florence \| N/A \| Italy \| 11.24626 \| 43.77925 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Geneva \| N/A \| Switzerland \| 6.14569 \| 46.20222 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095	255	NCT00433017	6TERMINATED	2009-07-01	2007-05-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 5 ]	151	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.	null	Major Depressive Disorder Idiopathic Parkinson Disease		null	1	arm 1: Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks	[ 0 ]	1	[ 0 ]	intervention 1: Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks	intervention 1: Duloxetine hydrochloride	13	Ancona \| N/A \| Italy \| 13.5103 \| 43.60717 Brescia \| N/A \| Italy \| 10.21472 \| 45.53558 Catania \| N/A \| Italy \| 15.07041 \| 37.49223 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Lido di Camaiore \| N/A \| Italy \| 10.2269 \| 43.90012 Messina \| N/A \| Italy \| 15.55256 \| 38.19394 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Pozzilli \| N/A \| Italy \| 14.06252 \| 41.51142 Rome \| N/A \| Italy \| 12.51133 \| 41.89193 Torino \| N/A \| Italy \| 11.99138 \| 44.88856	151	NCT00437125	1COMPLETED	2009-07-01	2007-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	180	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.	null	Asthma		null	2	arm 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) arm 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. intervention 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.	intervention 1: mometasone furoate dry powder inhaler intervention 2: Budesonide DPI	0	null	180	NCT00442117	1COMPLETED	2009-07-01	2007-06-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 4 ]	3,002	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.	Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications	Thrombosis, Venous	superficial vein thrombosis superficial thrombophlebitis fondaparinux deep vein thrombosis venous thromboembolism treatment thrombosis	null	2	arm 1: None arm 2: None	[ 1, 2 ]	1	[ 0 ]	intervention 1: Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day	intervention 1: Fondaparinux 2.5mg or placebo	227	Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Říčany \| N/A \| Czechia \| 14.65427 \| 49.99168 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Saku \| N/A \| Estonia \| 24.66382 \| 59.30354 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Abbeville \| N/A \| France \| 1.83547 \| 50.10521 Alès \| N/A \| France \| 4.08082 \| 44.12489 Amiens \| N/A \| France \| 2.3 \| 49.9 Annecy \| N/A \| France \| 6.12565 \| 45.90878 Annonay \| N/A \| France \| 4.6707 \| 45.23992 Arras \| N/A \| France \| 2.78186 \| 50.29301 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Brest \| N/A \| France \| -4.48628 \| 48.39029 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nice \| N/A \| France \| 7.26608 \| 43.70313 Nîmes \| N/A \| France \| 4.35788 \| 43.83665 Saint-Aubin-sur-Scie \| N/A \| France \| 1.06823 \| 49.87162 Saint-Priest-en-Jarez \| N/A \| France \| 4.37678 \| 45.4739 Tarbes \| N/A \| France \| 0.07139 \| 43.23407 Toulon \| N/A \| France \| 5.92836 \| 43.12442 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Valenciennes \| N/A \| France \| 3.52506 \| 50.35909 Villeurbanne \| N/A \| France \| 4.8795 \| 45.76601 Baesweiler \| Baden-Wurttemberg \| Germany \| N/A \| N/A Freiburg im Breisgau \| Baden-Wurttemberg \| Germany \| 7.85222 \| 47.9959 Heidelberg \| Baden-Wurttemberg \| Germany \| 8.69079 \| 49.40768 Karlsbad \| Baden-Wurttemberg \| Germany \| N/A \| N/A Karlsruhe \| Baden-Wurttemberg \| Germany \| 8.40444 \| 49.00937 Lauffen am Neckar \| Baden-Wurttemberg \| Germany \| 9.14567 \| 49.0734 Augsburg \| Bavaria \| Germany \| 10.89851 \| 48.37154 Großheirath \| Bavaria \| Germany \| 10.9505 \| 50.17603 Hemau \| Bavaria \| Germany \| 11.78195 \| 49.05399 Munich \| Bavaria \| Germany \| 11.57549 \| 48.13743 Munich \| Bavaria \| Germany \| 11.57549 \| 48.13743 Munich \| Bavaria \| Germany \| 11.57549 \| 48.13743 Mühldorf \| Bavaria \| Germany \| 12.52155 \| 48.2467 Nördlingen \| Bavaria \| Germany \| 10.48868 \| 48.85122 Nuremberg \| Bavaria \| Germany \| 11.07752 \| 49.45421 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Dahlwitz-Hoppegarten \| Brandenburg \| Germany \| 13.66667 \| 52.51667 Potsdam \| Brandenburg \| Germany \| 13.06566 \| 52.39886 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Darmstadt \| Hesse \| Germany \| 8.65027 \| 49.87167 Eschwege \| Hesse \| Germany \| 10.05329 \| 51.18386 Frankfurt am Main \| Hesse \| Germany \| 8.68417 \| 50.11552 Wiesbaden \| Hesse \| Germany \| 8.24932 \| 50.08258 Bad Bevensen \| Lower Saxony \| Germany \| 10.58129 \| 53.07923 Leer \| Lower Saxony \| Germany \| 7.461 \| 53.23157 Osnabrück \| Lower Saxony \| Germany \| 8.0498 \| 52.27264 Rostock \| Mecklenburg-Vorpommern \| Germany \| 12.14049 \| 54.0887 Cologne \| North Rhine-Westphalia \| Germany \| 6.95 \| 50.93333 Kettwig \| North Rhine-Westphalia \| Germany \| 6.94416 \| 51.36908 Koeln-Junkersdorf \| North Rhine-Westphalia \| Germany \| N/A \| N/A Mönchengladbach \| North Rhine-Westphalia \| Germany \| 6.44172 \| 51.18539 Neuss \| North Rhine-Westphalia \| Germany \| 6.68504 \| 51.19807 Oberhausen \| North Rhine-Westphalia \| Germany \| 6.8625 \| 51.47805 Waldbröl \| North Rhine-Westphalia \| Germany \| 7.61688 \| 50.87576 Wuppertal \| North Rhine-Westphalia \| Germany \| 7.14816 \| 51.25627 Frankenthal \| Rhineland-Palatinate \| Germany \| 8.35357 \| 49.53414 Ludwigshafen am Rhein \| Rhineland-Palatinate \| Germany \| 8.44641 \| 49.48121 Neustadt \| Rhineland-Palatinate \| Germany \| 8.25949 \| 50.00837 Neunkirchen \| Saarland \| Germany \| 7.18045 \| 49.34449 Chemnitz \| Saxony \| Germany \| 12.92922 \| 50.8357 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Kirchberg \| Saxony \| Germany \| 12.52449 \| 50.6219 Leipzig \| Saxony \| Germany \| 12.37129 \| 51.33962 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Altenburg \| Thuringia \| Germany \| 12.43684 \| 50.98763 Jena \| Thuringia \| Germany \| 11.5899 \| 50.92878 Nordhausen \| Thuringia \| Germany \| 10.7957 \| 51.5018 Alexandroupoli \| N/A \| Greece \| 25.87644 \| 40.84995 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Heraklion \| N/A \| Greece \| 25.14341 \| 35.32787 Larissa \| N/A \| Greece \| 22.41761 \| 39.63689 Melissia Athens \| N/A \| Greece \| N/A \| N/A Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Békéscsaba \| N/A \| Hungary \| 21.1 \| 46.68333 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Esztergom \| N/A \| Hungary \| 18.74148 \| 47.7928 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Kaposvár \| N/A \| Hungary \| 17.8 \| 46.36667 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Nyiregyháza \| N/A \| Hungary \| N/A \| N/A Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szikszó \| N/A \| Hungary \| 20.93333 \| 48.2 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Ashkelon \| N/A \| Israel \| 34.57149 \| 31.66926 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Safed \| N/A \| Israel \| 35.496 \| 32.96465 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Chieti Scalo \| Abruzzo \| Italy \| N/A \| N/A Napoli \| Campania \| Italy \| 14.5195 \| 40.87618 Piacenza \| Emilia-Romagna \| Italy \| 9.69342 \| 45.05242 Reggio Emilia \| Emilia-Romagna \| Italy \| 10.63125 \| 44.69825 Rimini \| Emilia-Romagna \| Italy \| 12.56528 \| 44.05755 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Milan \| Lombardy \| Italy \| 9.18951 \| 45.46427 Pavia \| Lombardy \| Italy \| 9.15917 \| 45.19205 Palermo \| Sicily \| Italy \| 13.3636 \| 38.1166 Florence \| Tuscany \| Italy \| 11.24626 \| 43.77925 Padua \| Veneto \| Italy \| 11.88586 \| 45.40797 Venezia \| Veneto \| Italy \| 11.46482 \| 45.60496 Daugavpils \| N/A \| Latvia \| 26.53333 \| 55.88333 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Alkmaar \| N/A \| Netherlands \| 4.74861 \| 52.63167 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Amsterdam \| N/A \| Netherlands \| 4.88969 \| 52.37403 Maastricht \| N/A \| Netherlands \| 5.68889 \| 50.84833 The Hague \| N/A \| Netherlands \| 4.29861 \| 52.07667 Weerselo \| N/A \| Netherlands \| 6.85694 \| 52.35167 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Gniewkowo \| N/A \| Poland \| 18.40785 \| 52.89461 Grudziądz \| N/A \| Poland \| 18.75366 \| 53.48411 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Arkhangelsk \| N/A \| Russia \| 40.55291 \| 64.54717 Barnaul \| N/A \| Russia \| 83.7456 \| 53.3598 Irkutsk \| N/A \| Russia \| 104.29585 \| 52.29795 Kemerovo \| N/A \| Russia \| 86.08333 \| 55.33333 Kursk \| N/A \| Russia \| 36.18712 \| 51.73758 Lipetsk \| N/A \| Russia \| 39.57076 \| 52.60311 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Perm \| N/A \| Russia \| 56.25017 \| 58.01046 Perm \| N/A \| Russia \| 56.25017 \| 58.01046 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Ryazan \| N/A \| Russia \| 39.6916 \| 54.6269 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburgh \| N/A \| Russia \| N/A \| N/A Samara \| N/A \| Russia \| 50.15 \| 53.20007 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Stavropol \| N/A \| Russia \| 41.9734 \| 45.0428 Tomsk \| N/A \| Russia \| 84.98204 \| 56.50032 Tomsk \| N/A \| Russia \| 84.98204 \| 56.50032 Tyumen \| N/A \| Russia \| 65.52722 \| 57.15222 Ufa \| N/A \| Russia \| 55.96779 \| 54.74306 Voronezh \| N/A \| Russia \| 39.1843 \| 51.67204 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Bardejov \| N/A \| Slovakia \| 21.27271 \| 49.29175 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Košice \| N/A \| Slovakia \| 21.25808 \| 48.71395 Košice \| N/A \| Slovakia \| 21.25808 \| 48.71395 Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839 Žilina \| N/A \| Slovakia \| 18.73941 \| 49.22315 Ávila \| N/A \| Spain \| -4.69951 \| 40.65724 Boadilla Del Monte (Madrid) \| N/A \| Spain \| -3.87835 \| 40.405 Cartagena (Murcia) \| N/A \| Spain \| -0.98397 \| 37.60197 Getafe \| N/A \| Spain \| -3.73295 \| 40.30571 Gijón \| N/A \| Spain \| -5.66152 \| 43.53573 L'Hospitalet de Llobregat \| N/A \| Spain \| 2.10028 \| 41.35967 Marid \| N/A \| Spain \| N/A \| N/A Mataró \| N/A \| Spain \| 2.4445 \| 41.54211 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Sabadell (Barcelona) \| N/A \| Spain \| 2.10942 \| 41.54329 Sant Joan d'Alacant \| N/A \| Spain \| -0.43623 \| 38.40148 Segovia \| N/A \| Spain \| -4.11839 \| 40.94808 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Valladolid \| N/A \| Spain \| -4.72372 \| 41.65518 Zamora \| N/A \| Spain \| -5.74456 \| 41.50633 Bern \| N/A \| Switzerland \| 7.44744 \| 46.94809 Bruderholz \| N/A \| Switzerland \| 7.59902 \| 47.5296 Fribourg \| N/A \| Switzerland \| 7.15128 \| 46.80237 Geneva \| N/A \| Switzerland \| 6.14569 \| 46.20222 Lausanne \| N/A \| Switzerland \| 6.63282 \| 46.516 Lucerne \| N/A \| Switzerland \| 8.30635 \| 47.05048 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Dnipropetrovsk \| N/A \| Ukraine \| 35.04066 \| 48.46664 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Ivano-Frankivsk \| N/A \| Ukraine \| 24.71248 \| 48.92312 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Sevastopol \| N/A \| Ukraine \| 33.52134 \| 44.60795 Uzhhorod \| N/A \| Ukraine \| 22.2947 \| 48.6242 Vinnitsa \| N/A \| Ukraine \| 37.71861 \| 49.84639 Zaporizhzhya \| N/A \| Ukraine \| 35.11714 \| 47.85167 Zaporizhzhya \| N/A \| Ukraine \| 35.11714 \| 47.85167 Zaporizhzhya \| N/A \| Ukraine \| 35.11714 \| 47.85167	2,987	NCT00443053	1COMPLETED	2009-07-01	2007-03-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 4 ]	399	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.	null	Attention Deficit Hyperactivity Disorder		null	2	arm 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension arm 2: Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension intervention 2: Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension	intervention 1: Atomoxetine intervention 2: Other standard therapy for ADHD	35	Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Hoboken \| N/A \| Belgium \| 4.34844 \| 51.17611 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Amiens \| N/A \| France \| 2.3 \| 49.9 Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Tours \| N/A \| France \| 0.70398 \| 47.39484 Westside \| Galway \| Ireland \| N/A \| N/A Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Messina \| N/A \| Italy \| 15.55256 \| 38.19394 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 S.Vito Tagliamento \| N/A \| Italy \| N/A \| N/A San Donà di Piave \| N/A \| Italy \| 12.5681 \| 45.63019 Insurgentes Cuicuilco \| N/A \| Mexico \| -99.18332 \| 19.30701 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Roma Sur \| N/A \| Mexico \| -99.16265 \| 19.40582 Bergen \| N/A \| Norway \| 5.32415 \| 60.39299 Fredrikstad \| N/A \| Norway \| 10.9298 \| 59.2181 Alicante \| N/A \| Spain \| -0.48149 \| 38.34517 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Donostia / San Sebastian \| N/A \| Spain \| -1.97499 \| 43.31283 Espluges de Llobregat \| N/A \| Spain \| N/A \| N/A Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Pamplona \| N/A \| Spain \| -1.64323 \| 42.81687 Sabadell \| N/A \| Spain \| 2.10942 \| 41.54329 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Adana \| N/A \| Turkey (Türkiye) \| 35.32531 \| 36.98615 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Basildon \| Essex \| United Kingdom \| 0.45782 \| 51.56844 Wigan \| Lancashire \| United Kingdom \| -2.63706 \| 53.54296 Sheffield \| South Yorkshire \| United Kingdom \| -1.4659 \| 53.38297	398	NCT00447278	1COMPLETED	2009-07-01	2007-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	21	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.	OBJECTIVES: Primary * Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol. Secondary * Determine the toxicity of this regimen in these patients. * Determine the response rate in patients treated with this regimen. * Determine the time to PSA progression and measurable disease progression in patients treated with this regimen. * Determine time to death from all causes in patients treated with this regimen. * Correlate levels of serum estradiol, serum cathepsin B, and bone turnover markers with PSA response in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive transdermal estradiol continuously (patches changed every 7 days) until the PSA level rises. Patients whose PSA increases above baseline or PSA decreases \< 10% after 4 weeks of estradiol therapy or whose serum PSA reduction is \< 50% after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy. These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1. Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.	Prostate Cancer	adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer	null	0	null	null	2	[ 0, 0 ]	intervention 1: Transdermal estradiol given 0.2mg/day for duration of study. intervention 2: Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2	intervention 1: transdermal estradiol intervention 2: paclitaxel poliglumex	2	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Portland \| Oregon \| United States \| -122.67621 \| 45.52345	21	NCT00459810	6TERMINATED	2009-07-01	2007-02-01	OHSU Knight Cancer Institute	7OTHER	false	false	false	null	0
[ 3 ]	12	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	false	This is a residential study that looks at the effects of buprenorphine in persons who abuse but are not dependent on opioids. Animal studies show that very high doses of buprenorphine produce less effects than mid-range doses. This suggests that buprenorphine can be a very safe medication. However, no studies in humans have tested higher doses in a similar way. The goal of this study is to show the effects of single doses of buprenorphine, across a range of doses, in persons who are not physically dependent on opioids (but do abuse opioids).	Preclinical studies have demonstrated for a variety of measures that buprenorphine has a bell-shaped dose response curve. However, human studies with buprenorphine have not shown such an effect, although controlled studies have generally not tested higher acute doses of buprenorphine. Current clinical recommendations generally place an upper limit of daily buprenorphine dosing at 32 mg of sublingual tablets, although considerably higher acute doses have been administered to humans (primarily in clinical studies of less than daily dosing). Determining the relationship between higher doses of buprenorphine in humans and effects produced would be valuable; it would be scientifically interesting to demonstrate a bell-shaped curve in humans, and it would help guide clinical practice (for example, with respect to dosing, safety, and side effect considerations. The purpose of this study is to characterize the dose response curve for buprenorphine in humans, utilizing acute single doses of parenteral buprenorphine.	Opioid-related Disorders	Opioid addiction Opioid dependence Buprenorphine	null	8	arm 1: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 2: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 3: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 4: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 5: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 6: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 7: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine). arm 8: All participants are randomly assigned to receive an order of the 8 study drugs/doses (placebo, 2 doses of morphine, 5 doses of buprenorphine).	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Intramuscular, doses (8, 16, 32, 48, 60 mg) are blind; administered up to 1-2 times per week. intervention 2: Intramuscular; up to 1-2 times per week; doses (15, 30 mg) double blind intervention 3: Intramuscular; double blind; once per week	intervention 1: Buprenorphine intervention 2: Morphine intervention 3: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	36	NCT00460239	1COMPLETED	2009-07-01	2007-01-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 5 ]	40	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.	null	Rheumatoid Arthritis		null	1	arm 1: Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate greater than or equal to (≥) 5 mg/week, PO, folate greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.	[ 0 ]	4	[ 0, 0, 0, 7 ]	intervention 1: 1000 mg i.v. on Days 1 and 15 intervention 2: 10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24 intervention 3: ≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24 intervention 4: ≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24	intervention 1: rituximab intervention 2: Methotrexate intervention 3: Corticosteroid or NSAID intervention 4: Folate	4	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	40	NCT00462345	1COMPLETED	2009-07-01	2007-06-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	298	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.	null	Parkinson's Disease Psychosis	Parkinson's disease, psychotic disorders	null	3	arm 1: Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks arm 2: Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks arm 3: Placebo tablet, once daily by mouth, 6 weeks	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg, tablet, once daily by mouth, 6 weeks intervention 2: 40 mg, tablet, once daily by mouth, 6 weeks intervention 3: tablet, once daily by mouth, 6 weeks	intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Placebo	78	Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Carson \| California \| United States \| -118.28202 \| 33.83141 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Irvine \| California \| United States \| -117.82311 \| 33.66946 Sunnyvale \| California \| United States \| -122.03635 \| 37.36883 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Fairfield \| Connecticut \| United States \| -73.26373 \| 41.14121 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pompano Beach \| Florida \| United States \| -80.12477 \| 26.23786 Port Charlotte \| Florida \| United States \| -82.09064 \| 26.97617 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Scarborough \| Maine \| United States \| -70.32172 \| 43.57814 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Southfield \| Michigan \| United States \| -83.22187 \| 42.47337 Traverse City \| Michigan \| United States \| -85.62063 \| 44.76306 Toms River \| New Jersey \| United States \| -74.19792 \| 39.95373 Kingston \| New York \| United States \| -73.99736 \| 41.92704 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Brentwood \| Tennessee \| United States \| -86.78278 \| 36.03312 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Kirkland \| Washington \| United States \| -122.20874 \| 47.68149 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Hyderabad \| N/A \| India \| 78.45636 \| 17.38405 Karnataka \| N/A \| India \| N/A \| N/A Mangalore \| N/A \| India \| 74.85603 \| 12.91723 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 New Dalhi \| N/A \| India \| N/A \| N/A Pune \| N/A \| India \| 73.85535 \| 18.51957 Pune \| N/A \| India \| 73.85535 \| 18.51957 Tamil Nadu \| N/A \| India \| N/A \| N/A Tamil Nadu \| N/A \| India \| N/A \| N/A Visakhapatnam \| N/A \| India \| 83.20161 \| 17.68009 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Kirov \| N/A \| Russia \| 49.66007 \| 58.59665 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Luhansk \| N/A \| Ukraine \| 39.30553 \| 48.56814 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Vinnytsia \| N/A \| Ukraine \| 28.46871 \| 49.2322 Barnsley \| N/A \| United Kingdom \| -1.48333 \| 53.55 Blackburn \| N/A \| United Kingdom \| -2.48333 \| 53.75 Brighton \| N/A \| United Kingdom \| -0.13947 \| 50.82838 Dorset \| N/A \| United Kingdom \| N/A \| N/A London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328 North Shields \| N/A \| United Kingdom \| -1.44925 \| 55.01646 Salford \| N/A \| United Kingdom \| -2.29042 \| 53.48771	295	NCT00477672	1COMPLETED	2009-07-01	2007-06-01	ACADIA Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.	null	Osteoporosis	postmenopausal women with primary osteoporosis	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Once daily subcutaneous injection in the abdomen by self administration intervention 2: The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water	intervention 1: Full Length Parathyroid Hormone, PTH(1-84) intervention 2: Strontium Ranelate	1	Roskilde \| N/A \| Denmark \| 12.08035 \| 55.64152	80	NCT00479037	1COMPLETED	2009-07-01	2007-04-01	Nycomed	4INDUSTRY	false	false	false	null	0
[ 3 ]	61	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	This treatment study is targeted specifically for those who want to stop using marijuana. We want to find out if patients who are dependent on marijuana and want to stop using are helped by a combination of the drug dronabinol and six sessions of individual therapy (BRENDA). Dronabinol is a pill form of the active ingredient in marijuana (THC). Currently, dronabinol is approved for the treatment of nausea in people receiving cancer chemotherapy and as an appetite stimulant in people with AIDS. In some studies, dronabinol reduced the amount of psychological and physical discomfort experienced when people stopped using marijuana. One purpose of our study is to see if people who are on dronabinol have fewer problems with psychological and physical discomfort than those who are on a placebo. In addition to treatment, this research trial will also be measuring the reactions of subjects to drug-related cues, and also to computer-presented tasks unrelated to drug use. We may examine whether the response to these cues/tasks either predicts treatment outcome, or is affected by your treatment. This information may also help us to understand the ways in which chronic drug use causes changes in our subjects' mental functioning and how those changes respond to treatment. In addition to participation in the treatment research trial, some subjects may be asked to undergo a brain scan in an MRI. The purpose of the brain scan research project is to measure brain reactions with a non-invasive, non-radioactive imaging technique known as fMRI (functional magnetic resonance imaging) in marijuana subjects before and after treatment with the medication dronabinol or with an inactive substance (placebo).	1\. Background: Cannabis is the most widely used illicit drug in the U.S. According to the 2004 U.S. The 2004 NSDUH estimates there are 3.2 million daily or almost daily marijuana smokers in the United States. Recent reports have estimated that 1.5% of the US population meets DSM-IV diagnostic criteria for cannabis abuse or dependence, with the sharpest increases among young black men and women and young Hispanic men (2). Cannabis users commonly endorse adverse psychosocial and medical effects from their cannabis use, which include dysphoria, loss of control over use, cognitive impairment, and strained social relationships. In humans, the cannabis withdrawal syndrome is a constellation of affective and behavioral symptoms that occur within 24 to 48 hours after abrupt cessation of marijuana use with a gradual return to baseline after 1-2 weeks. A recent review of the literature on cannabis withdrawal identified consistent reports of anxiety, irritability, physical discomfort, insomnia, and appetite suppression to be associated with abrupt cessation of cannabis use in heavy users across controlled inpatient and outpatient trials. The agonist dronabinol (Marinol) has shown promise in the prevention of cannabis withdrawal in human lab studies and its reported amelioration of anxiety, misery, insomnia, drug craving and appetite suppression from abrupt cannabis cessation provides the rationale for its use as an agent to prevent cannabis withdrawal in an outpatient, treatment seeking population(9). Dronabinol has also been used as a brief "maintenance" treatment in a cannabis self-administration study in humans. Currently, dronabinol is indicated for treatment of AIDS-related anorexia and nausea associated with cancer chemotherapy. Two principle aims of our proposal are therefore to gain familiarity with cannabis withdrawal in a naturalistic outpatient treatment setting and compare an agonist therapy to placebo to attenuate cannabis withdrawal and enhance treatment outcome. The general pattern of low rates of total abstinence and lack of significant differences between high intensity psychotherapy treatment vs. low intensity and voucher-based treatment holds across all psychosocial treatment studies. In keeping with prior evidence supporting the relative efficacy of brief interventions for cannabis dependence, the current proposal will apply a well-established brief medicalized psychotherapy known as B.R.E.N.D.A. for the treatment of cannabis dependence. To date, studies evaluating cannabis patients have primarily focused on identifying neurotoxic drug effects such as impaired learning, memory, attention and executive function. We propose to more fully examine the behaviors with relevance to addiction vulnerability and relapse. Such behaviors include but are not limited to poor inhibition, high risk-taking, positive affective bias toward drug stimuli, poor affect regulation, and poor decision-making. We plan to utilize standardized tasks and questionnaires to objectively characterize dimensions of these addiction relevant behaviors in cannabis patients and to examine the effect of cannabis withdrawal and dronabinol treatment on these behavioral measures. We will also correlate brain differences (structural and functional) with behavioral measures in cannabis dependent patients before and after treatment with dronabinol as compared to placebo. The search for effective treatment of addictive disorders is limited by our incomplete knowledge about the brain substrates critical for addiction and for addiction recovery. The recent use of PET and fMRI has allowed researchers to examine connections between brain activity and vulnerability to addiction and relapse. In marijuana users, PET and fMRI techniques have been used to study regional brain volumes, blood flow, metabolism. However, understanding cue induced craving is more immediately relevant to treatment and relapse prevention in cannabis addiction since cannabis users have a high rate of relapse compared to those found for other drugs of abuse. In addiction, cues that have been consistently associated with drug reward can trigger craving for the drug. Clinically, the craving for the drug is sufficiently compelling in many cases to precipitate a relapse despite significant effort on the patient's part to maintain abstinence and despite significant negative consequences. Although PET and fMRI techniques have been successfully used to study cue induced craving in other drugs of abuse (e.g. cocaine) leading to greater understanding of the mechanism of relapse (limbic activation in response to drug cues), these techniques have not been utilized in cannabis patients. Several preliminary studies used patient self-report to demonstrate cue induced craving in cannabis patients. We propose to utilize physiological measures and functional neuroimaging to objectively demonstrate cue-induced craving in cannabis dependent subjects and to identify the brain substrates that mediate this craving. Similarly, dronabinol reduced self-reported drug craving in one recent human laboratory study. We propose to examine whether dronabinol will change physiological measures and brain activation in response to drug cues. 2\. Study objectives: 1. To evaluate the cannabis withdrawal syndrome in a naturalistic outpatient setting as one possible cause for the low rates of total abstinence seen in our trial and all other clinical trials of adult cannabis dependence. 1. Primary Hypothesis: Subjective ratings of cannabis withdrawal can be assessed reliably in an outpatient treatment setting. 2. Secondary Hypothesis: Subjects with high subjective ratings of cannabis withdrawal will have lower rates of abstinence regardless of treatment group (dronabinol vs. placebo). 2. To determine the feasibility and efficacy of a three-week trial of a cannabinoid agonist medication under double blind placebo controlled conditions to treat cannabis withdrawal. 1. Primary Hypothesis: Dronabinol can be used safely at a dosage of 10mg qid (four times per day) as an outpatient treatment for cannabis withdrawal 2. Secondary Hypothesis: Dronabinol will perform better than placebo in attenuating the symptoms of cannabis withdrawal. 3. To determine the feasibility and efficacy of providing brief psychotherapy (BRENDA) to patients seeking treatment for cannabis dependence. 1. Primary Hypothesis: Six sessions of BRENDA therapy can be applied to the treatment of cannabis dependence. 2. Secondary Hypothesis: Six-sessions of BRENDA therapy for cannabis dependence is an adequate "dose" of individual therapy for subjects motivated to stop smoking marijuana. 4. To characterize the neurocognitive aspects (e.g. attention, working memory, impulsivity, decision making, risk-taking, affective bias/drug preference, reward and punishment sensitivity, affect regulation) of cannabis dependence, cannabis withdrawal and dronabinol effects by utilizing a battery of tasks, questionnaires and interviews. 1. Primary Hypothesis: Poor performance on neurocognitive tasks and questionnaires will be correlated with duration and amount of cannabis use. 2. Secondary Hypothesis: Cannabis withdrawal will be correlated with impaired performance on neurocognitive tasks and questionnaires. Dronabinol treatment will reduce this impairment on tasks of affect regulation and affective bias/drug preference compared to placebo. 5. To objectively demonstrate cue-induced craving in cannabis dependent patients and to determine whether baseline measures of our cannabis patients' brain vulnerabilities (of structure, and of function; e.g., resting perfusion) can predict both brain and behavioral outcomes. 1. Primary Hypothesis: Cue-induced craving will be positively correlated with changes in physiological measures and increased amygdalar activation and negatively correlated with prefrontal activation in cannabis dependent patients during cannabis discontinuation, and dronabinol treatment will reduce the intensity of cue- induced physiological changes and brain activation compared to placebo. 2. Secondary Hypotheses: Measures of prefrontal cortex gray matter and resting perfusion in prefrontal cortex, cingulate cortex and amygdala will be positively correlated with performance on neurocognitive tasks and questionnaires as well as treatment outcome. 3\. Location: This is a single site study. All patient recruitment and data collection will occur at the Treatment Research Center at the University of Pennsylvania, 3900 Chestnut Street, Philadelphia, PA 19104, except for the Neuroimaging which will take place at the HUP6 fMRI in the basement of the Hospital of the University of Pennsylvania, 34th and Spruce Streets, Philadelphia, PA 19104. STUDY DESIGN 4\. Research design \& methodology: This is a Phase 2 double blind placebo controlled trial. We will recruit 60 cannabis dependent subjects and treat them with the combination of dronabinol 10mg QID (four times per day) and BRENDA or placebo qid (four times per day) and BRENDA to reduce their consumption of cannabis. Subjects will be 60 men and women with current DSM-IV diagnosis of cannabis dependence. All patients will receive six sessions of BRENDA at visits 1, 3, 6, 9, 11, and 12. The study length for each patient will be one week for screening and baseline self-report and neurocognitive battery measures. Patients who qualify will be offered an opportunity to participate in the fMRI portion of the study with baseline fMRI obtained in the first week prior to starting medications and second fMRI obtained during week two of medications. This is followed by 3 weeks of medication and, after completing medications, three additional weekly visits (two for BRENDA and one for final assessment). 5\. Duration: Each subject will participate in a 7 week treatment trial with the following schedule of visits: STUDY VISITS Week 1 (Baseline Measures): Week 2 - 4 (Medication Treatment): Weeks 5-6 (Medication Washout) Week 7 (Final Visit): We anticipate that we will require two years to complete data collection with 60 subjects and will require one year for data analysis. Thus, the proposed study will be completed in approximately three years. SUBJECT SELECTION \& WITHDRAWAL	Marijuana Dependence	Marijuana Addiction Substance Withdrawal Syndrome Clinical Trial Dronabinol Behavioral Therapy Adults Neuroimaging Neuropsychological Testing Neurocognitive Testing Behavioral Probes	null	2	arm 1: Dronabinol+ BRENDA therapy arm 2: Placebo+BRENDA therapy	[ 1, 2 ]	3	[ 0, 5, 0 ]	intervention 1: 10mg capsules taken 4 times daily for 2 weeks and then tapered over 1 week intervention 2: weekly therapy sessions for 6 weeks intervention 3: 4 capsules daily for 2 weeks followed by a 1 week taper	intervention 1: Dronabinol intervention 2: BRENDA therapy intervention 3: Placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	61	NCT00480441	1COMPLETED	2009-07-01	2006-08-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 3 ]	94	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel together with vorinostat is more effective than giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung cancer	PRIMARY OBJECTIVES: I. To compare the response rate associated with the combination of vorinostat, carboplatin, paclitaxel versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC. SECONDARY OBJECTIVES: I. To determine the time to progression and overall survival for the two regimens. II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel for patients with advanced NSCLC. III. To understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood, archived tumor tissue, and paired biopsies in consenting patients. OUTLINE: This is a multicenter, randomized study. Patients are stratified according to gender and brain metastasis (present vs absent). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral vorinostat (SAHA) once daily on days 1-14 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Arm II: Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l. In both arms, treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.	Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer		null	2	arm 1: Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3. arm 2: Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.	[ 0, 1 ]	5	[ 0, 0, 0, 10, 10 ]	intervention 1: Given PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given PO intervention 5: Correlative studies	intervention 1: vorinostat intervention 2: paclitaxel intervention 3: carboplatin intervention 4: placebo intervention 5: laboratory biomarker analysis	1	Duarte \| California \| United States \| -117.97729 \| 34.13945	93	NCT00481078	1COMPLETED	2009-07-01	2007-05-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	null	RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.	OBJECTIVES: Primary * Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel. Secondary * Determine the time to PSA recurrence in patients receiving this treatment. * Determine the time to metastatic disease in patients receiving this treatment. * Determine the time to androgen independent state in patients receiving this treatment. * Determine the time to death from any cause in patients receiving this treatment. OUTLINE: This is an open label study. Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression. After completion of study therapy, patients are followed periodically for up to 5 years. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.	Prostate Cancer	adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer	null	0	null	null	1	[ 0 ]	intervention 1: Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.	intervention 1: docetaxel	2	Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	3	NCT00482274	6TERMINATED	2009-07-01	2007-05-01	OHSU Knight Cancer Institute	7OTHER	false	false	false	null	0
[ 2 ]	47	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML). For enrollment information see the Central Contact information below	null	Acute Myelogenous Leukemia	Phase I Phase II acute myelogenous leukemia AML cancer	null	0	null	null	1	[ 0 ]	intervention 1: intravenous infusion administered on days 1, 2 and 3	intervention 1: AZD4877	4	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	9	NCT00486265	6TERMINATED	2009-07-01	2007-07-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).	null	Myelodysplastic Syndromes Blood Disease Bone Marrow Disease		null	2	arm 1: vorinostat 400 mg arm 2: vorinostat 200 mg	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles. intervention 2: vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.	intervention 1: vorinostat intervention 2: vorinostat	0	null	21	NCT00486720	6TERMINATED	2009-07-01	2007-06-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	226	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The purpose of the study is * Find out if patients receiving Sorafenib will live longer * Find out if Sorafenib has any effect on patient reported outcomes * Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases * Determine the pharmacokinetics (PK) in patients with liver cancer	null	Carcinoma, Hepatocellular		null	2	arm 1: Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment. arm 2: Placebo tablets matching in appearance were orally administered bid (twice daily).	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: multikinase inhibitor; Sorafenib 400 mg (orally) twice daily intervention 2: Matching placebo (orally) twice daily	intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo	23	Hefei \| Anhui \| China \| 117.28083 \| 31.86389 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Dalian \| Liaoning \| China \| 121.60222 \| 38.91222 Dalian \| Liaoning \| China \| 121.60222 \| 38.91222 Hangzhou \| Zhejiang \| China \| 120.16142 \| 30.29365 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Chongqing \| N/A \| China \| 106.55771 \| 29.56026 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Tianjin \| N/A \| China \| 117.17667 \| 39.14222 Seoul \| Seoul Teugbyeolsi \| South Korea \| 126.9784 \| 37.566 Daegu \| N/A \| South Korea \| 128.59111 \| 35.87028 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Changhua \| N/A \| Taiwan \| 120.5512 \| 24.0692 Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Taoyuan District \| N/A \| Taiwan \| 121.3187 \| 24.9896	230	NCT00492752	1COMPLETED	2009-07-01	2005-10-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,027	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.	Currently, in the US, Asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. A once daily dose is potentially beneficial to patients and physicians alike. This study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? This study will confirm whether there are benefits to once daily dosing beyond increased convenience. In order to understand how the QD regimen compares to BID in a "real life" practice setting, the patient will remain on the total daily dose of Asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a QD or BID regimen. This is an investigator-blinded study.	Ulcerative Colitis		null	2	arm 1: an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day) arm 2: an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks intervention 2: Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks	intervention 1: Mesalamine Once-Daily intervention 2: Mesalamine Twice-Daily	245	Athens \| Alabama \| United States \| -86.97219 \| 34.80243 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Dothan \| Alabama \| United States \| -85.39049 \| 31.22323 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tuscon \| Arizona \| United States \| N/A \| N/A Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Lowell \| Arkansas \| United States \| -94.13076 \| 36.25535 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Chico \| California \| United States \| -121.83748 \| 39.72849 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Folsom \| California \| United States \| -121.17606 \| 38.67796 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Lancaster \| California \| United States \| -118.13674 \| 34.69804 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Madera \| California \| United States \| -120.06072 \| 36.96134 Merced \| California \| United States \| -120.48297 \| 37.30216 Mission Hills \| California \| United States \| -120.43683 \| 34.68609 Monterey \| California \| United States \| -121.89468 \| 36.60024 Murrieta \| California \| United States \| -117.21392 \| 33.55391 Oakland \| California \| United States \| -122.2708 \| 37.80437 Orange \| California \| United States \| -117.85311 \| 33.78779 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 San Carlos \| California \| United States \| -122.26052 \| 37.50716 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Torrance \| California \| United States \| -118.34063 \| 33.83585 Torrance \| California \| United States \| -118.34063 \| 33.83585 Upland \| California \| United States \| -117.64839 \| 34.09751 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Golden \| Colorado \| United States \| -105.2211 \| 39.75554 Lafayette \| Colorado \| United States \| -105.08971 \| 39.9936 Pueblo \| Colorado \| United States \| -104.60914 \| 38.25445 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Meriden \| Connecticut \| United States \| -72.80704 \| 41.53815 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Norwalk \| Connecticut \| United States \| -73.4079 \| 41.1176 Torrington \| Connecticut \| United States \| -73.12122 \| 41.80065 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Largo \| Florida \| United States \| -82.78842 \| 27.90979 Maitland \| Florida \| United States \| -81.36312 \| 28.62778 Naples \| Florida \| United States \| -81.79596 \| 26.14234 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 North Miami Beach \| Florida \| United States \| -80.16255 \| 25.93315 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Palm Harbor \| Florida \| United States \| -82.76371 \| 28.07807 Port Orange \| Florida \| United States \| -80.99561 \| 29.13832 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Trinity \| Florida \| United States \| -82.68177 \| 28.18085 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Zephyrhills \| Florida \| United States \| -82.18119 \| 28.23362 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Berwyn \| Illinois \| United States \| -87.79367 \| 41.85059 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Elgin \| Illinois \| United States \| -88.28119 \| 42.03725 Highland Park \| Illinois \| United States \| -87.80034 \| 42.18169 Hoffman Estates \| Illinois \| United States \| -88.0798 \| 42.04281 Homewood \| Illinois \| United States \| -87.6656 \| 41.55726 Lake Barrington \| Illinois \| United States \| -88.15258 \| 42.21252 Oak Lawn \| Illinois \| United States \| -87.75811 \| 41.71087 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Urbana \| Illinois \| United States \| -88.20727 \| 40.11059 Anderson \| Indiana \| United States \| -85.68025 \| 40.10532 Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Clive \| Iowa \| United States \| -93.72411 \| 41.60304 Davenport \| Iowa \| United States \| -90.57764 \| 41.52364 Waterloo \| Iowa \| United States \| -92.34296 \| 42.49276 Pratt \| Kansas \| United States \| -98.73759 \| 37.64391 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Whichita \| Kansas \| United States \| N/A \| N/A Bowling Green \| Kentucky \| United States \| -86.4436 \| 36.99032 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Alexandria \| Louisiana \| United States \| -92.44514 \| 31.31129 Lafayette \| Louisiana \| United States \| -92.01984 \| 30.22409 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Monroe \| Louisiana \| United States \| -92.1193 \| 32.50931 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Bangor \| Maine \| United States \| -68.77265 \| 44.79884 Chevy Chase \| Maryland \| United States \| -77.07115 \| 39.00287 College Park \| Maryland \| United States \| -76.93692 \| 38.98067 Greenbelt \| Maryland \| United States \| -76.87553 \| 39.00455 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Hollywood \| Maryland \| United States \| -76.5858 \| 39.07511 Lutherville \| Maryland \| United States \| -76.62608 \| 39.42122 Reisterstown \| Maryland \| United States \| -76.8319 \| 39.46976 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Braintree \| Massachusetts \| United States \| -71.00215 \| 42.20384 Southbridge \| Massachusetts \| United States \| -72.03341 \| 42.0751 Chesterfield \| Michigan \| United States \| -82.84242 \| 42.66281 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 West Bloomfied \| Michigan \| United States \| N/A \| N/A Wyoming \| Michigan \| United States \| -85.70531 \| 42.91336 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Tupelo \| Mississippi \| United States \| -88.70464 \| 34.25807 Cape Girardeau \| Missouri \| United States \| -89.51815 \| 37.30588 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 Mexico \| Missouri \| United States \| -91.88295 \| 39.16976 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Somersworth \| New Hampshire \| United States \| -70.86534 \| 43.26175 Camden \| New Jersey \| United States \| -75.11962 \| 39.92595 Cedar Knolls \| New Jersey \| United States \| -74.44876 \| 40.82204 Egg Harbor \| New Jersey \| United States \| -74.60361 \| 39.38646 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Ocean City \| New Jersey \| United States \| -74.5746 \| 39.27762 South Plainfield \| New Jersey \| United States \| -74.41154 \| 40.57927 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Babylon \| New York \| United States \| -73.32568 \| 40.69566 Binghamton \| New York \| United States \| -75.91797 \| 42.09869 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Cheektowaga \| New York \| United States \| -78.75475 \| 42.90339 Cortland \| New York \| United States \| -76.18048 \| 42.60118 Forest Hills \| New York \| United States \| -73.85014 \| 40.71621 Garden City \| New York \| United States \| -73.6343 \| 40.72677 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Lake Success \| New York \| United States \| -73.71763 \| 40.77066 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Pittsford \| New York \| United States \| -77.515 \| 43.09062 Port Jefferson Station \| New York \| United States \| -73.04733 \| 40.92538 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Boone \| North Carolina \| United States \| -81.67455 \| 36.21679 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Jacksonville \| North Carolina \| United States \| -77.43024 \| 34.75405 Kinston \| North Carolina \| United States \| -77.58164 \| 35.26266 Morganton \| North Carolina \| United States \| -81.68482 \| 35.74541 Mount Airy \| North Carolina \| United States \| -80.60729 \| 36.4993 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Pinehurst \| North Carolina \| United States \| -79.46948 \| 35.19543 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Mentor \| Ohio \| United States \| -81.33955 \| 41.66616 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Westlake \| Ohio \| United States \| -81.91792 \| 41.45532 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 Beaver Falls \| Pennsylvania \| United States \| -80.31923 \| 40.75201 Clairton \| Pennsylvania \| United States \| -79.88171 \| 40.29229 Indiana \| Pennsylvania \| United States \| -79.15253 \| 40.62146 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Phoenixville \| Pennsylvania \| United States \| -75.51491 \| 40.13038 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Sewickley \| Pennsylvania \| United States \| -80.1845 \| 40.53646 Souderton \| Pennsylvania \| United States \| -75.32518 \| 40.31177 Uniontown \| Pennsylvania \| United States \| -79.71643 \| 39.90008 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Morristown \| Tennessee \| United States \| -83.29489 \| 36.21398 Amarillo \| Texas \| United States \| -101.8313 \| 35.222 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Greenville \| Texas \| United States \| -96.11081 \| 33.13845 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lewisville \| Texas \| United States \| -96.99417 \| 33.04623 Longview \| Texas \| United States \| -94.74049 \| 32.5007 Odessa \| Texas \| United States \| -102.36764 \| 31.84568 Pasadena \| Texas \| United States \| -95.2091 \| 29.69106 Plano \| Texas \| United States \| -96.69889 \| 33.01984 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 West Valley City \| Utah \| United States \| -112.00105 \| 40.69161 Alexandria \| Virginia \| United States \| -77.04692 \| 38.80484 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Fairfax \| Virginia \| United States \| -77.30637 \| 38.84622 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Winchester \| Virginia \| United States \| -78.16333 \| 39.18566 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Wenatchee \| Washington \| United States \| -120.31035 \| 47.42346 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Monroe \| Wisconsin \| United States \| -89.63845 \| 42.60112 Abbotsford \| British Columbia \| Canada \| -122.25257 \| 49.05798 Guelph \| Ontario \| Canada \| -80.25599 \| 43.54594 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Ponce \| N/A \| Puerto Rico \| -66.62398 \| 18.01031 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	1,023	NCT00505778	1COMPLETED	2009-07-01	2007-07-01	Warner Chilcott	4INDUSTRY	false	false	false	null	0
[ 3 ]	28	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures. The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo.	The Fontan physiology is the end result of staged reconstruction of the heart and the major blood vessels in patients who have a single ventricle. After completion of the reconstruction, the great veins which usually bring blood back to the heart are connected directly to the pulmonary arteries, allowing blood from the body to bypass the heart and flow directly into the lungs. In this system, blood flow through the lungs is passive (not pumped) and the efficiency of flow through the cardiovascular system is related to the resistance to blood flow in the vessels of the lungs. There are two potential problems that arise in this scenario, as a result of the resistance to blood flow in the vessels of the lungs. First, the amount of blood flow returning to the heart from the lungs may not be sufficient to allow the heart to function at maximum efficiency, compromising the heart's ability to keep up with the demands of the body. Second, if the resistance to blood flow in the lungs is high, pressure may be transmitted back into the great veins themselves and secondarily into the organs of the body causing mild, or sometimes significant, organ dysfunction. Not all patients with the Fontan physiology develop these problems, but we know that even in patients without obvious problems, the ability to keep up with an increased metabolic demand, as during exercise, in compromised. Improving the efficiency of blood flow through the lungs should improve the return of blood to the heart and thereby diminish the pressure transmitted back to the vessels which passively deliver blood to the lungs. We believe that this change may manifest as diminished symptoms in those patients with known difficulties, or may allow for an increased ability to walk, run, or participate in sports in those without any overt symptoms. Most importantly, we speculate that improved efficiency of flow through the lungs, and the resulting improved cardiac output (blood flow through the body) will make patients more energetic and will make them feel better. Sildenafil is an oral medication that has been used to treat patients with pulmonary hypertension, a disease in which there is abnormally elevated pressure in the vessels of the lung. In this disease, the resistance in the lungs is abnormally high, severely limiting the ability of the heart to keep up with the demands of the body. Sildenafil lowers the resistance in the vessels of the lungs and has been shown to improve exercise performance in patients with this disease. We believe that Sildenafil may have a similar benefit for our patients after Fontan operation in whom cardiac output is also limited by resistance of the blood vessels in the lungs. In our study, we will compare the exercise capacity, echocardiographic measures of cardiac function, and the overall quality of life in patients with the Fontan before and after a six-week period of sildenafil administration. As a control, the same group of patients will take a placebo for a six-week period, also with before and after testing. We hypothesize that oral sildenafil will result in significant improvements in exercise capacity, energy levels, and echocardiographic measures of cardiac function and output in our study participants. We are hopeful that the findings of this investigation will directly help children and young adults with Fontan physiology.	Hypoplastic Left Heart Syndrome Tricuspid Atresia	Other Single Ventricle Anatomy Hypoplastic Left Heart Syndrome Tricuspid Atresia	null	2	arm 1: Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks. arm 2: Placebo will be given for six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: One 20 mg capsule of sildenafil will be taken by mouth three times-a-day. intervention 2: One placebo capsule will be taken by mouth three times-a-day.	intervention 1: Sildenafil intervention 2: Placebo	0	null	55	NCT00507819	1COMPLETED	2009-07-01	2007-12-01	Children's Hospital of Philadelphia	7OTHER	false	false	false	null	0
[ 3 ]	279	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.	null	Knee Osteoarthritis	Osteoarthritis Knee CRx-102 prednisolone dipyridamole CombinatoRx WOMAC	null	5	arm 1: 2.7 mg prednisolone plus 90 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 2: 2.7 mg prednisolone plus 180 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 3: 2.7 mg prednisolone plus 360 mg dipyridamole Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 4: 2.7 mg prednisolone Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. arm 5: Placebo Subjects were dose twice daily through day 98.	[ 0, 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: CRx-102 dose 1 intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 dose 2 intervention 5: CRx-102 dose 3	intervention 1: CRx-102 (2.7/90) intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 (2.7/180) intervention 5: CRx-102 (2.7/360)	58	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tuscon \| Arizona \| United States \| N/A \| N/A Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Upland \| California \| United States \| -117.64839 \| 34.09751 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Kissimee \| Florida \| United States \| N/A \| N/A Largo \| Florida \| United States \| -82.78842 \| 27.90979 Longwood \| Florida \| United States \| -81.3384 \| 28.70305 Palm Harbor \| Florida \| United States \| -82.76371 \| 28.07807 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Covington \| Louisiana \| United States \| -90.10042 \| 30.47549 Towson \| Maryland \| United States \| -76.60191 \| 39.4015 Brockton \| Massachusetts \| United States \| -71.01838 \| 42.08343 Haverhill \| Massachusetts \| United States \| -71.07728 \| 42.7762 Peabody \| Massachusetts \| United States \| -70.92866 \| 42.52787 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Bingham Farms \| Michigan \| United States \| -83.27326 \| 42.51587 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Haddon Heights \| New Jersey \| United States \| -75.06462 \| 39.87734 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 New York \| New York \| United States \| -74.00597 \| 40.71427 Plainview \| New York \| United States \| -73.46735 \| 40.77649 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Mayfield Village \| Ohio \| United States \| N/A \| N/A Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Duncansville \| Pennsylvania \| United States \| -78.4339 \| 40.42341 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Cumberland \| Rhode Island \| United States \| -71.43284 \| 41.96677 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Bountiful \| Utah \| United States \| -111.88077 \| 40.88939 Sandy City \| Utah \| United States \| -111.8841 \| 40.59161 Roanoke \| Virginia \| United States \| -79.94143 \| 37.27097 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537	279	NCT00521989	6TERMINATED	2009-07-01	2007-08-01	Zalicus	4INDUSTRY	false	false	false	null	0
[ 5 ]	214	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This is a 12 month randomized, open-label, parallel-group study to obtain data on the frequency and variability of exacerbations in severe and very severe Chronic Obstructive Pulmonary Disease (COPD) patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage III and IV) receiving salmeterol xinafoate and fluticasone propionate either in fixed combination (SFC) or from separate inhalers (Sal/FP) with standard therapy. 200 subjects will be enrolled in approximately 30 study centres in Germany. Data on health care utilisation will be collected to compare direct costs associated with COPD in these two groups. Baseline data will be collected for all subjects at Visit 1 and eligible subjects will be randomized to receive either SFC 50/500 µg bid (twice daily) as fixed combination or Sal 50 µg bid (twice daily) and FP 500 µg bid (twice daily) concurrently over 52 weeks. Subjects will return for study visits every two to three months until week 52. Additional telephone calls will be made between scheduled visits every 4 weeks. Assessments will include monitoring of frequency of exacerbations, health care utilisation (including emergency visits and hospitalizations) and rescue medication, lung function, drug compliance, health-related quality of life (SGRQ = St George's Respiratory Questionnaire) and safety.	A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination (SFC50/500 µg bid) or separately (SAL 50 µg and FP 500 µg bid) via Diskus inhalers on the course of the disease and frequency of exacerbations in subjects with severe and very severe COPD ( GOLD stage III+IV)	Pulmonary Disease, Chronic Obstructive	Severe and very severe COPD (GOLD stage III / IV) exacerbations health care utilisation Chronic Obstructive Pulmonary Disease (COPD) quality of life compliance salmeterol/fluticasone combination	null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: comparator intervention 2: comparator	intervention 1: Salmeterol / Fluticasone (50/500 µg) BID fixed combination intervention 2: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers	23	Bruchsal \| Baden-Wurttemberg \| Germany \| 8.59804 \| 49.12426 Heidelberg \| Baden-Wurttemberg \| Germany \| 8.69079 \| 49.40768 Mannheim \| Baden-Wurttemberg \| Germany \| 8.46694 \| 49.4891 Wiesloch \| Baden-Wurttemberg \| Germany \| 8.69846 \| 49.29504 Cottbus \| Brandenburg \| Germany \| 14.32888 \| 51.75769 Neuruppin \| Brandenburg \| Germany \| 12.80311 \| 52.92815 Potsdam \| Brandenburg \| Germany \| 13.06566 \| 52.39886 Hamburg \| City state of Hamburg \| Germany \| 9.99302 \| 53.55073 Eschwege \| Hesse \| Germany \| 10.05329 \| 51.18386 Gelnhausen \| Hesse \| Germany \| 9.18742 \| 50.20164 Kassel \| Hesse \| Germany \| 9.5 \| 51.31667 Marburg \| Hesse \| Germany \| 8.77069 \| 50.80904 Wiesbaden \| Hesse \| Germany \| 8.24932 \| 50.08258 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Bochum \| North Rhine-Westphalia \| Germany \| 7.21648 \| 51.48165 Gütersloh \| North Rhine-Westphalia \| Germany \| 8.37853 \| 51.90693 Saarbrücken \| Saarland \| Germany \| 7.00982 \| 49.23262 Annaberg \| Saxony \| Germany \| 13.00507 \| 50.57864 Leipzig \| Saxony \| Germany \| 12.37129 \| 51.33962 Radebeul \| Saxony \| Germany \| 13.66047 \| 51.10654 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Schmölln \| Thuringia \| Germany \| 12.35339 \| 50.89678	213	NCT00527826	1COMPLETED	2009-07-01	2007-11-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	178	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.	null	Hypertension With Metabolic Syndrome	Hypertension Metabolic Syndrome Dual combination therapy Triple combination therapy Aliskiren Direct Renin inhibitor	null	3	arm 1: 6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. arm 2: 6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. arm 3: 6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. intervention 2: aliskiren 150-300 mg tablets. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. intervention 3: ramipril 5-10 mg capsules. Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.	intervention 1: Amlodipine intervention 2: Aliskiren intervention 3: Ramipril	1	Cambridge \| N/A \| United Kingdom \| 0.11667 \| 52.2	178	NCT00542269	6TERMINATED	2009-07-01	2008-03-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 0 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Bipolar disorder is a common and often chronic and debilitating mental illness. The depressive phase of bipolar disorder contributes the largest portion of the disorder, and treatment resistant bipolar depression represents a significant public health problem. Recent research has suggested that bipolar depression is associated with elevated brain glutamate activity. We hypothesize that riluzole, a drug approved for ALS which inhibits glutamate activity, will lead to clinical improvement in patients with bipolar depression.	We hypothesize that riluzole will lead to significant reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D). Additionally, improvement in depressive symptoms will be associated with reduced glutamate levels in the anterior cingulate cortex, but not parieto-occipital cortex, both at day two and day 42.	Bipolar Depression	Bipolar depression	null	1	arm 1: Riluzole 50 mg twice daily for 2 weeks, increased to riluzole 50 mg in the morning and 100 mg in the evening for 1 week if tolerated, with a further increase to riluzole 100 mg twice daily if tolerated for 3 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: 50 mg twice daily for 2 weeks 50 mg in the morning and 100 mg in the evening for 1 week 100 mg twice daily for 3 weeks	intervention 1: Riluzole	1	Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593	14	NCT00544544	1COMPLETED	2009-07-01	2007-06-01	Mclean Hospital	7OTHER	false	false	false	null	0
[ 0 ]	55	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	1FEMALE	true	Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.	Women with recurrent BV will be randomly assigned to standard care of metronidazole vs metronidazole plus vaginal acidifying gel. Symptoms and presence of BV will be measured at followup.	Bacterial Vaginosis	bacterial vaginosis vaginal acidifying gel recurrence	null	2	arm 1: Receive metronidazole plus vaginal gel arm 2: Oral Metronidazole antibiotic therapy alone	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: placement of vaginal acidifying gel into vagina to restore "normal" vaginal pH. intervention 2: oral metronidazole therapy alone	intervention 1: Vaginal acidifying gel (RepHresh) intervention 2: Metronidazole control	1	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838	54	NCT00545181	1COMPLETED	2009-07-01	2007-09-01	Indiana University School of Medicine	7OTHER	false	false	false	null	0
[ 4 ]	513	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure	null	Anemia		null	2	arm 1: Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. arm 2: SMC for IDA (as determined by the Investigator) for treating CKD related anemia.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	513	NCT00548691	1COMPLETED	2009-07-01	2007-10-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	2,018	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.	null	Anemia		null	2	arm 1: Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) arm 2: Varied as determined by the Investigator	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC)	1	Norristown \| Pennsylvania \| United States \| -75.3399 \| 40.1215	2,018	NCT00548860	1COMPLETED	2009-07-01	2007-10-01	American Regent, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	67	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.	null	Endometriosis	Endometriosis Pelvic pain Oral progesterone blocker	null	3	arm 1: Placebo once daily arm 2: Proellex 25 mg once daily arm 3: Proellex 50 mg once daily	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 1 capsule daily for 4 months intervention 2: 1 capsule daily for 4 months intervention 3: 2 capsules daily for 4 months	intervention 1: Proellex 25 mg intervention 2: Placebo intervention 3: Proellex 50 mg	17	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Ramon \| California \| United States \| -121.97802 \| 37.77993 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Dubuque \| Iowa \| United States \| -90.66457 \| 42.50056 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Miamisburg \| Ohio \| United States \| -84.28661 \| 39.64284 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Gaffney \| South Carolina \| United States \| -81.64982 \| 35.07179 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	67	NCT00556075	6TERMINATED	2009-07-01	2007-11-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study assesses the efficacy and safety of Viokase® 16 for the correction of steatorrhea (malabsorption of dietary fats) in patients with a history of exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatectomy. This study is sponsored by Aptalis Pharma (formerly Axcan).	This study is a Phase III, multicenter, randomized, double-blind, parallel, placebo-controlled study, to assess the efficacy and safety of Viokase® 16 for the correction of steatorrhea in patients with EPI due to CP or pancreatectomy. The study will include the following phases: screening phase (up to 10 days), wash-out phase (6 to 7 days), randomization phase (up to 10 days), and treatment phase (6 to 7 days). In screening phase, patients will undergo screening procedures prior to entry into the study. In wash-out phase, stool collection will be performed to allow determination of the baseline CFA. In randomization phase, patients who qualify for the Treatment Phase (that is, patients who have a CFA% below 80%) will be randomized in the study. In the treatment phase, patients will be randomized in a 2:1 ratio (Viokase® 16 or Placebo). In treatment phase, stool collection period will be performed to allow determination of the CFA% that will serve to assess the efficacy of Viokase® 16 for the correction of steatorrhea. Follow-up procedures will be scheduled 7 to 10 days after discharge. Patients who do not show abnormal findings, adverse events or concomitant medications during the treatment phase will be assessed via follow-up telephone call. Patients who show abnormal findings (physical examination, vital signs, clinical laboratory tests, adverse events, concomitant medications) during the treatment phase will complete a follow-up visit.	Exocrine Pancreatic Insufficiency Chronic Pancreatitis Pancreatectomy		null	2	arm 1: None arm 2: None	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. intervention 2: Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. intervention 3: Patients on PPI during Screening will continue their usual PPI therapy throughout the study. intervention 4: Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.	intervention 1: Viokase® 16 intervention 2: Placebo intervention 3: Proton pump inhibitor (PPI) intervention 4: Omeprazole	18	Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Lévis \| Quebec \| Canada \| -71.17793 \| 46.80326 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Sosnowiec \| N/A \| Poland \| 19.10385 \| 50.28682 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Brastislava \| N/A \| Slovakia \| N/A \| N/A Bratilslava \| N/A \| Slovakia \| N/A \| N/A Nitra \| N/A \| Slovakia \| 18.08453 \| 48.30763 Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839	50	NCT00559364	1COMPLETED	2009-07-01	2007-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 3 ]	70	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To determine the safety and efficacy of sub-antimicrobial dose COL-101 in the treatment of patients who have both blepharitis and facial rosacea	null	Blepharitis Meibomianitis Dry Eye		null	2	arm 1: COL-101 arm 2: Sugar capsule	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 40mg, once per day for 84 days intervention 2: sugar capsule	intervention 1: COL-101 (doxycycline, USP) capsules intervention 2: placebo	8	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lynbrook \| New York \| United States \| -73.6718 \| 40.65483 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Layton \| Utah \| United States \| -111.97105 \| 41.06022	70	NCT00560703	1COMPLETED	2009-07-01	2007-11-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 5 ]	102	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.	Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.	Osteoarthritis of the Knee	osteoarthritis knee arthroplasty local infiltration analgesia TKA epidural analgesia operation surgery	null	3	arm 1: Local infiltration analgesia with ropivacaine and adrenaline and intravenous ketorolac and morphine arm 2: Local infiltration analgesia with ropivacaine, adrenaline and ketorolac and morphine arm 3: standard continuous epidural analgesia	[ 0, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: intraoperative and 1. postoperative day intervention 2: intraoperative LIA (IV and IA) and continuous EDA intervention 3: intraoperative and 1. postoperative day intervention 4: intraoperative intervention 5: continuous postoperatively intervention 6: continuous postoperatively	intervention 1: ropivacaine intervention 2: adrenaline intervention 3: ketorolac intervention 4: morphine intervention 5: fentanyl intervention 6: bupivacaine	1	Rud \| N/A \| Norway \| 11.63333 \| 60.43333	99	NCT00562627	1COMPLETED	2009-07-01	2007-11-01	Asker & Baerum Hospital	7OTHER	false	false	false	null	0
[ 4 ]	426	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	null	The purpose of this study is to determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.	null	Atrophy Vaginal Diseases	Urogenital atrophy Menopausal symptoms Vulvar and vaginal atrophy in postmenopausal women Vaginal atrophy	null	2	arm 1: Ospemifene will be taken orally, once daily, in the morning, with food for 52 weeks. arm 2: Placebo will be taken once daily, in the morning, with food for 52 weeks.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg/day (QD) dose of ospemifene (1 tablet) will be taken for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52). Dosing will be oral and the ospemifene 60 mg tablet will be taken once daily, in the morning, with food. intervention 2: Dosing will be oral and placebo will be taken once daily, in the morning, with food for 52 weeks - from Visit 2 (Randomization, Day 1) to Visit 6 (End of Therapy or Early Discontinuation, Week 52)	intervention 1: Ospemifene 60 mg intervention 2: Placebo	0	null	426	NCT00566982	1COMPLETED	2009-07-01	2007-10-01	Shionogi	4INDUSTRY	false	false	false	null	0
[ 5 ]	26	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.	Because the opiate antagonists appear to be effective in the treatment of pathological gambling (PG), it is reasonable to ask whether acamprosate (calcium acetylhomotaurine; Campral), also FDA approved for the treatment of alcoholism, can be used effectively to treat PG. Acamprosate is not an opioid antagonist; rather, it is assumed that its therapeutic effects are due to actions on GABA receptors. Acamprosate is structurally related to 1-glutamic, which is an excitatory neurotransmitter. It has been proposed that acamprosate decreases the effects of the naturally-occuring excitatory neurotransmitter glutamate in the body. Because chronic alcohol consumption disrupts this system, and the changes last many months after alcohol ingestion is stopped, it is possible that acamprosate restores the glutamate system towards normal. Regardless, acamprosate decreases the pleasant "high" associated with alcohol consumption, and thus decreases the frequency of relapse during abstinence. We hypothesize that acamprosate will have similar actions in persons with PG.	Pathological Gambling	acamprosate, impulse-control disorders	null	1	arm 1: Open Label. At visit 2, all participants were started on Acamprosate, 1,998 mg divided into 3 equal doses.	[ 0 ]	1	[ 0 ]	intervention 1: Two 333mg tablets taken three times daily.	intervention 1: acamprosate	0	null	28	NCT00571103	1COMPLETED	2009-07-01	2007-10-01	University of Iowa	7OTHER	false	false	false	null	0
[ 5 ]	64	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.	We performed a 6-week, 4-group, parallel, randomized, double-blind, double-dummy, clinical trial in 60 patients with perennial allergic rhinitis. After an initial screening with an allergy questionnaire and skin puncture testing to confirm an allergic response to a perennial allergen (cat, dog, dust mite, indoor mold), qualified individuals were randomized into 1 of 4 treatment groups. The 4 groups received the following treatments: placebo, OXY (0.05%, 2 puffs in each nostril every evening), FF nasal spray (110 mg per day), and FF nasal spray plus OXY (FF/OXY). All participants received 2 nasal sprays at night, with 1 spray containing FF or its placebo, the other oxymetazoline or its placebo. The nasal sprays were labeled with participant code numbers, and the investigator assigned participants in a sequential randomized fashion to a study code number in blocks of 4. Dropouts were replaced until 60 subjects were randomized. Replacement subjects were assigned the next sequential treatment. Thus, the number of subjects in each group was not exactly 15. Eligible participants completed the Rhinitis Quality of Life Questionnaire (RQLQ) and underwent measurement of nasal volume by acoustic rhinometry before starting the study. Participants were instructed to keep a diary of daily symptoms, nasal peak inspiratory flow (NPIF) meter readings, and medication use during the study; no rescue medications were allowed. The severity of sneezing, rhinorrhea, nasal congestion, and other symptoms was recorded in the morning (reflective of symptoms overnight) and evening (reflective of daytime symptoms) on a 0 to 3 scale. Intake of the study medication was performed once daily, at night, after recording of symptoms and NPIF values. Subjects returned to the nasal laboratory every 2 weeks for a total of 4 weeks for review of the symptom diaries, replacement of medications, performance of acoustic rhinometry, and completion of the RQLQ. After the fourth week, participants stopped treatment, returned medication, and continued with the clinical trial for 2 additional weeks. During this time, they maintained symptom diaries and NPIF measurements twice daily. At the end of the 2-week period, participants returned to the nasal laboratory to perform a final acoustic rhinometry, complete an RQLQ survey, and return the diaries.	Allergic Rhinitis		null	4	arm 1: Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm arm 2: Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm arm 3: Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm arm 4: Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm	[ 2, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 2 puffs of each nasal spray in each nostril in the pm intervention 2: 2 puffs of each nasal spray in each nostril in the pm intervention 3: 2 puffs of each nasal spray in each nostril in the pm intervention 4: 2 puffs of each nasal spray in each nostril in the pm	intervention 1: Fluticasone furoate intervention 2: Placebo Fluticasone furoate intervention 3: Oxymetazoline intervention 4: Placebo Oxymetazoline	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	64	NCT00584987	1COMPLETED	2009-07-01	2007-06-01	University of Chicago	7OTHER	false	false	false	null	0
[ 3 ]	8	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can induce effective innate and adaptive anti-GIST immunity, which can eradicate imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with imatinib-sensitive GIST, leading to improved response rate and remission duration.	null	Gastrointestinal Stromal Tumors Cancer Brain Solid Tumors	Gastrointestinal stromal tumors Imatinib Peginterferon α-2b Immunotherapy Targeted therapy	null	1	arm 1: All participants enrolled in the study.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible. intervention 2: Continue imatinib until progression.	intervention 1: Peginterferon-alpha 2b (PegIFNa2b); intervention 2: Imatinib	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	0	NCT00585221	6TERMINATED	2009-07-01	2007-07-01	University of Utah	7OTHER	false	false	false	null	0
[ 0 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.	Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. However, few studies have focused on the prevention or treatment of coronary artery disease (CAD) in CKD patients. The development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. The broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with CKD. Thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes. To address this hypothesis the following Specific Aims are proposed: 1. To determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with CKD (creatinine clearance ≤ 60 ml/ min, but not on dialysis) 2. To determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with CKD 3. To determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with CKD	Chronic Kidney Disease	Kidney Failure, Chronic Renal Insufficiency, Chronic Proteinuria Albuminuria	null	2	arm 1: Placebo 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity. arm 2: Pioglitazone 30 mg daily for 6 months, nitroglycerin was given to check the brachial reactivity.	[ 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Pioglitazone 30 mg daily for 6 months intervention 2: Placebo 30 mg daily for 6 months intervention 3: 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication to check the brachial reactivity.	intervention 1: Pioglitazone intervention 2: Placebo intervention 3: Nitroglycerin	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	36	NCT00586261	6TERMINATED	2009-07-01	2006-03-01	Mayo Clinic	7OTHER	false	false	false	null	0
[ 3 ]	105	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	null	This study will evaluate the efficacy and safety of two vaginal products compared with that of placebo to determine if the two products are better than placebo in the relief of vaginal discomfort.	null	Vulvodynia		null	3	arm 1: None arm 2: None arm 3: None	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: semi solid, twice weekly, 4 months intervention 2: semi solid, twice weekly for 4 months intervention 3: semi solid, twice weekly for 4 months	intervention 1: Lidocaine/Diphenhydramine intervention 2: lidocaine intervention 3: placebo	48	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Searcy \| Arkansas \| United States \| -91.73625 \| 35.25064 Dinuba \| California \| United States \| -119.38707 \| 36.54328 San Diego \| California \| United States \| -117.16472 \| 32.71571 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Hudson \| Florida \| United States \| -82.69343 \| 28.36445 Largo \| Florida \| United States \| -82.78842 \| 27.90979 Paw Paw \| Florida \| United States \| N/A \| N/A Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Champaign \| Illinois \| United States \| -88.24338 \| 40.11642 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Gallipolis \| Ohio \| United States \| -82.20237 \| 38.8098 Miamisburg \| Ohio \| United States \| -84.28661 \| 39.64284 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Allentown \| Pennsylvania \| United States \| -75.49018 \| 40.60843 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Jackson \| Tennessee \| United States \| -88.81395 \| 35.61452 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Irving \| Texas \| United States \| -96.94889 \| 32.81402 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Sandy City \| Utah \| United States \| -111.8841 \| 40.59161 Coquitlam \| British Columbia \| Canada \| -122.78217 \| 49.2846 North Vancouver \| British Columbia \| Canada \| -123.06934 \| 49.31636 White Rock \| British Columbia \| Canada \| -122.79507 \| 49.02049 Mount Pearl \| Newfoundland and Labrador \| Canada \| -52.78135 \| 47.51659 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008	105	NCT00590590	1COMPLETED	2009-07-01	2007-10-01	Lumara Health, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	17	NA	SINGLE_GROUP	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this research is to determine if patients who receive phenytoin (also commonly known as Dilantin) before taking corticosteroids will show less memory impairment and hypomanic symptoms (feelings of agitation, overexcitement or hyperactivity) than those receiving placebo (an inactive substance). This research also seeks to determine if patients taking phenytoin before corticosteroids show more activity in the area of the brain involved with memory than those receiving placebo. This research is being done because increased levels of cortisol (the body's natural corticosteroid) in the body are frequently associated with forgetfulness, and interventions that may prevent or reverse this effect are of great importance.	Introduction and aims: Stress and corticosteroid exposure are associated with changes in the human and animal hippocampus. In animals, phenytoin prevents dendritic changes in the hippocampus secondary to corticosterone. We propose to use functional magnetic resonance imaging (fMRI) to explore the effects of 3-days of exposure to placebo, hydrocortisone, phenytoin and hydrocortisone plus phenytoin on hippocampal activation. If phenytoin attenuates the effects of hydrocortisone, we will use this model system to explore other potential neuroprotective agents CONCISE SUMMARY OF PROJECT: Sixteen healthy participants will, in a one-hour imaging session, receive a structural magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS) and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant will receive placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant will receive each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory will be assessed. The figure in Appendix I illustrates the study design. All participants will complete a University of Texas (UT) Southwestern (UTSW) Institutional Review Board (IRB) approved informed consent process and give written consent to participate prior to study entry. At the first screening visit, demographic information and a complete medical and psychiatric history will be obtained. The Structured Clinical Interview for DSM-IV (SCID) (First et al 1995) will be used to rule out exclusionary psychiatric illnesses. Mood will be assessed with the Hamilton Rating Scale for Depression (HRSD), Young Mania Rating Scale (YMRS), and Activation (ACT) subscale of the ISS. Cognition will be assessed with the Rey Auditory Verbal Learning Test (RAVLT) (declarative memory-hippocampus), Digit Span Backwards, and two computer tests - the Sternberg Memory Task (SMT, declarative memory-hippocampus) (Sternberg 1969), and Running Memory Continuous Performance Task (RMCPT, working memory-prefrontal cortex) (Baddeley 1986). Alternative versions of the tests will be used throughout the study to minimize any learning effects. For subjects who successfully pass the screening, fMRI sessions will be scheduled, and they will be asked to return 4 days prior to their first scan. If subjects feel uncomfortable answering any questions on the questionnaires during their screening visit, they can refuse to do so, and they will be removed from the study. If any psychological disorders are diagnosed at this stage (e.g., mood disorders such as depression), subjects will be removed from the study and referred either to Parkland hospital or to a private psychiatrist based on their insurance coverage for further evaluations and treatment. If at a later stage any abnormalities are uncovered through imaging, subjects will be notified immediately. Subjects will be provided with a referral to either Parkland Hospital or a different facility based on their insurance coverage. With the subject's consent, we will also notify their primary physician. Pregnancy tests will be obtained for females at baseline and prior to the start of each new medication cycle to ensure that no pregnant women are participating in the study (5 times total during the study). One day prior to each study drug course, mood will be assessed with HRSD, YMRS, and ACT subscale of Internal State Scale, and cognition will be assessed with the Sternberg Memory Task. Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The doses were selected to achieve a low therapeutic blood level of phenytoin and stress level of cortisol. Newcomer et al. (1999) used this dose of hydrocortisone in healthy controls. The imaging will be performed at approximately 1300 hours. Imaging will be performed after each three day exposure to study medications. Mood assessments and the SMT will be conducted at baseline and prior to and after each course of study medication (day medication course begins and on the day of the neuroimaging). The SMT has a large number of equivalent versions and thus can be administered numerous times. By administering prior to each exposure to study drug we can determine whether or not memory will, as expected, have returned to baseline after each washout period. Other cognitive testing including the RAVLT, Digits Backwards, and RMCPT will be performed after each course of study medication. Cognitive testing is not performed prior to receiving the study medication to avoid multiple testing over a short period of time which is unnecessary given the baseline and placebo data which can be used for comparison. Monitoring study drug levels: Blood will be drawn at baseline (approximately 1400 hours) to assess cortisol levels. Blood will be drawn after each scan (approximately 1400 hours) to assess cortisol and phenytoin levels and to ensure adherence to the medications. We anticipate an increase in cortisol levels following administration of cortisol compared to baseline in subjects taking cortisol, and that therapeutic levels of phenytoin for seizures (10 to 20 mg/l) will be achieved.	Healthy	Phenytoin Dilantin Corticosteroid Neuroprotection Mania Cognition Mood Memory Hydrocortisone Healthy Controls MRI hippocampal activation	null	1	arm 1: This study has one arm due to a crossover design. All 17 subjects received 4 treatments: placebo then placebo, phenytoin then placebo, placebo then hydrocortisone, and phenytoin then hydrocortisone. Each treatment was randomly assigned and had a unique sequence out of 24 possible sequences.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Three days prior to imaging, participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). intervention 2: Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The doses were selected to achieve a low therapeutic blood level of phenytoin and stress level of cortisol. Newcomer et al. (1999) used this dose of hydrocortisone in healthy controls. The imaging will be performed at approximately 1300 hours. intervention 3: Participants take two capsules of placebo 100 mg at 0900 hours and 2100 hours for a total of 3 days with the last dose at 0900 hours on the day of imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating placebo), participants will being taking 4 tablets containing placebo (20 mg) also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total).	intervention 1: Phenytoin (brand name Dilantin) intervention 2: Hydrocortisone intervention 3: Placebo	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	61	NCT00591006	1COMPLETED	2009-07-01	2008-01-01	University of Texas Southwestern Medical Center	7OTHER	false	false	false	null	0
[ 5 ]	176	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will examine two questions: 1. Whether insulin treatment of high blood sugar in patients with diabetes while they are in the emergency room will improve how quickly they recover from illness if they need to be hospitalized. 2. Whether immediately beginning long lasting insulin detemir in patients with diabetes when they are admitted to hospital from the emergency room will improve how quickly they recover from the illness which necessitated hospitalization.	null	Type 2 Diabetes Mellitus		null	2	arm 1: these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating. arm 2: these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.	[ 1, 4 ]	2	[ 0, 0 ]	intervention 1: insulin aspart: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating. intervention 2: insulin detemir: insulin aspart will be given every 2 hours dosed from 0.05 to 0.15 units per kg weight to patients with a prior history of diabetes if blood glucose is more than 200 mg/dl in the ER. If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.If subjects are admitted to hospital then they will receive insulin detemir 0.3 units/kg daily and insulin aspart 0.1 units/kg per meal if they are eating.	intervention 1: insulin aspart intervention 2: insulin detemir	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	176	NCT00591227	1COMPLETED	2009-07-01	2008-05-01	Rush University Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Respiratory recurrent papilloma (RRP) is one of the most common benign tumors. Surgical removal is the current management for RRP, but it is a very traumatic procedure, and often leads to permanent voice dysfunction. In this study, we will develop a new, combined RRP treatment with a pulsed dye laser (PDL) and Celebrex. We will determine if Celebrex, a newly developed inhibitor of cyclooxygenase (COX)-2, can provide a long-term inhibitory effect on RRP, therefore preventing RRP from recurring. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP.	RRP and its surgeries usually involves the vocal cords or other regions of the larynx, thereby, resulting in a poor voice. Our previous studies have shown the efficacy and safety of a microvascular targeting technique (MVT) for RRP treatment using the 585 nm PDL. This technique provides a less traumatic alternative to surgery. However, postoperative recurrence of lesions still remains a problem because of microvascular regrowth. This study is a continuation of our effort to develop a new and less traumatic treatment for RRP. In this study, we will develop a new, combined RRP treatment with PDL and Celebrex. We will determine if Celebrex, a newly developed inhibitor of COX-2, can provide a long-term inhibitory effect on RRP through its anti-angiogenic activity and the synergic effect produced with the laser therapy. The hypothesis is that postoperative administration of Celebrex will provide a long-term inhibitory effect on microvascular regrowth and on COX-2 enzyme, thereby, preventing RRP from recurring after the PDL therapy. Our specific aim in this study is to determine the synergic effect between PDL and Celebrex and long-term efficacy of Celecoxib in preventing postoperative RRP recurrence. We will compare this new combined strategy with traditional treatments in 30 adult patients. This is the first time to combined this new laser MVT technique with a COX-2 inhibitor for microvascular targeting therapy of RRP. This combined strategy, if successful in this proposed study, will provide a new and ideal "voice-preserving" therapy for RRP that will deliver long-term efficacy in managing RRP and will be safe and convenient enough for use in out-patient treatment.	Laryngeal Papilloma	Papilloma pulsed dye laser Celebrex voice	null	2	arm 1: endoscopic treatment with once-time PDL radiation at 6.0-8.0 J on laryngeal papilloma, followed by oral taking of 9-month Celebrex (100mg, BID), in 15 subjects arm 2: once-time and routine surgery, with either of carbon dioxide (CO2) laser radiation at 10.0-20.0 W or "cold" surgery with microinstruments, in 15 subjects	[ 0, 1 ]	3	[ 0, 1, 3 ]	intervention 1: oral taking of Celebrex (100 mg, BID) for 9 months intervention 2: once time radiation on laryngeal papilloma with PDL , at 6.0-8.0 J intervention 3: once-time surgery to remove laryngeal papilloma	intervention 1: Celebrex intervention 2: PDL intervention 3: CO2 laser or microsurgery	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	10	NCT00592319	6TERMINATED	2009-07-01	2005-05-01	Boston University	7OTHER	false	false	false	null	0
[ 3 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will test the combination of clofarabine, cytarabine, and thymoglobulin as a non-myeloablative conditioning regimen for patients with myelodysplastic syndromes or acute myeloid leukemia undergoing allogeneic stem cell transplant.	Current reduced intensity conditioning regimens have been able to decrease TRM (treatment related mortality) but suffer from increased rates of disease relapse. Disease burden at transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens employ fludarabine and busulfan with various adjutants, but these agents are not part of the usual armamentarium used versus leukemia and have questionable anti-leukemic activity. By substituting clofarabine and cytarabine, a combination with proven anti-leukemic activity in the relapsed and refractory setting as well as activity versus MDS, as the back bone of the regimen we hope overcome residual disease and improve post-transplant relapse rates. Furthermore the principal toxicity of this regimen is myelosuppression, which should be abrogated by the infusion of stem cells. Thymoglobulin is included due to its minimal contribution to toxicity but significant benefits in engraftment, and controlling acute and chronic GVHD, which are major contributors to TRM and disease specific activity in MDS.	Myelodysplastic Syndromes Acute Myeloid Leukemia	Conditioning regimens Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Allogeneic Stem Cell Transplantation Nonmyeloablative conditioning Clofarabine Cytarabine Anti-thymocyte globulin	null	1	arm 1: * Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2 * Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine. * Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2. * Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.	[ 0 ]	4	[ 0, 0, 0, 3 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None	intervention 1: Clofarabine intervention 2: Cytarabine intervention 3: Thymoglobulin intervention 4: Stem cell infusion	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	7	NCT00593645	6TERMINATED	2009-07-01	2007-11-01	Washington University School of Medicine	7OTHER	false	false	false	null	0
[ 4 ]	165	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.	null	Type 2 Diabetes Mellitus	diabetes exenatide metformin thiazolidinedione Byetta Amylin Lilly	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: subcutaneous injection, 5 mcg or 10 mcg, twice a day (BID) intervention 2: subcutaneous injection, volume equivalent to 5 mcg or 10 mcg of active drug, twice a day	intervention 1: exenatide intervention 2: placebo	25	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Concord \| California \| United States \| -122.03107 \| 37.97798 Fresno \| California \| United States \| -119.77237 \| 36.74773 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Mogadore \| Ohio \| United States \| -81.39789 \| 41.04645 Corvallis \| Oregon \| United States \| -123.26204 \| 44.56457 New Westminster \| British Columbia \| Canada \| -122.91092 \| 49.20678 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Ajax \| Ontario \| Canada \| -79.03288 \| 43.85012 Cambridge \| Ontario \| Canada \| -80.31269 \| 43.3601 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Chihuahua City \| Chihuahua \| Mexico \| -106.08889 \| 28.63528 Celaya \| Guanajuato \| Mexico \| -100.8157 \| 20.52353 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Baia Mare \| N/A \| Romania \| 23.56808 \| 47.65729 Brasov \| N/A \| Romania \| 25.60613 \| 45.64861 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Dolj \| N/A \| Romania \| N/A \| N/A Iași \| N/A \| Romania \| 27.6 \| 47.16667 Suceava \| N/A \| Romania \| 26.25 \| 47.63333 Johannesburg \| N/A \| South Africa \| 28.04363 \| -26.20227 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486	165	NCT00603239	1COMPLETED	2009-07-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	-0
[ 4 ]	71	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This two arm study will compare the efficacy and safety of subcutaneous Mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. Patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of Mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.	null	Anemia		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: As prescribed intervention 2: 120, 200 or 360 micrograms sc 4-weekly (starting dose)	intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]	21	Alicante \| Alicante \| Spain \| -0.48149 \| 38.34517 Badajoz \| Badajoz \| Spain \| -6.97061 \| 38.87789 Badalona \| Barcelona \| Spain \| 2.24741 \| 41.45004 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 L'Hospitalet de Llobregat \| Barcelona \| Spain \| 2.10028 \| 41.35967 Santander \| Cantabria \| Spain \| -3.80444 \| 43.46472 Ciudad Real \| Ciudad Real \| Spain \| -3.92907 \| 38.98626 Córdoba \| Cordoba \| Spain \| -4.77275 \| 37.89155 Granada \| Granada \| Spain \| -3.60667 \| 37.18817 A Coruña \| La Coruña \| Spain \| -8.396 \| 43.37135 Santiago de Compostela \| La Coruña \| Spain \| -8.54569 \| 42.88052 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Madrid \| Madrid \| Spain \| -3.70256 \| 40.4165 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Valladolid \| Valladolid \| Spain \| -4.72372 \| 41.65518 Barakaldo \| Vizcaya \| Spain \| -2.98813 \| 43.29639 Galdakao \| Vizcaya \| Spain \| -2.8429 \| 43.23073	71	NCT00605345	1COMPLETED	2009-07-01	2007-12-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 5 ]	21	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Patients with Type 2 diabetes and severe insulin resistance with very large insulin requirements who have failed all previous insulin regimens using non-concentrated forms of insulin (U100 insulin formulations) will receive 5X concentrated insulin (U500 regular insulin)infused via insulin pump.	Patients with Type 2 diabetes who have severe insulin resistance and very large insulin requirements (over 1.4 units of insulin /kg/day) often fail insulin regimens with persistent poor blood glucose control when standard U-100 insulin formulations are used. This is due in part to poor absorption of the large insulin volumes required using these less concentrated standard insulin preparations. The hypothesis that using a concentrated form of insulin called U-500 Regular insulin and delivering it by infusion via insulin pump will lower the volume of insulin required and therefore improve insulin absorption, which will lead to improved blood glucose control, will be tested.	Type 2 Diabetes Insulin Resistance	Type 2 diabetes Insulin Resistance Continuous Subcutaneous Insulin Infusion U-500 Insulin Omnipod	null	1	arm 1: All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.	[ 0 ]	1	[ 0 ]	intervention 1: U-500 insulin (concentrated insulin) will be infused continuously subcutaneously using a disposable insulin pump called an Omnipod; the insulin infusion dosage will be individualized to each subject's needs	intervention 1: U-500 Insulin delivered by Omnipod (disposable insulin pump)	1	Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095	21	NCT00606034	1COMPLETED	2009-07-01	2007-12-01	Mountain Diabetes and Endocrine Center	7OTHER	false	false	false	null	0
[ 2 ]	34	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is a dose-finding study; therefore, there is no hypothesis testing	null	Neoplasms		null	2	arm 1: Schedule A (CP-870,893 administration schedule) arm 2: Schedule B (CP-870,893 administration schedule)	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 3 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg) intervention 2: Paclitaxel is administered intravenously on day 1 of a 21-day cycle at a dose of 175 mg/m\^2. Carboplatin is administered intravenously on day 1 of a 21-day cycle at AUC 6. CP-870,893 is administered intravenously on DAY 8 of a 21-day cycle in escalating doses (0.1 mg/kg and 0.2 mg/kg)	intervention 1: Paclitaxel + Carboplatin + CP-870,893 intervention 2: Paclitaxel + Carboplatin + CP-870,893	4	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	32	NCT00607048	1COMPLETED	2009-07-01	2007-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 3 ]	13	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).	An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine for the treatment of autoimmune hepatitis (AIH). Patients with histologically confirmed chronic hepatitis who fulfill criteria established by the International Autoimmune Hepatitis Group (IAIHG) and Inclusion and Exclusion criteria will be enrolled after having signed an informed consent document. Up to 60 patients will be randomized (1:1) to receive treatment with LCP-Tacro + prednisone vs. azathioprine (AZA) + prednisone. * LCP-Tacro will be started at 2 mg once daily (q.d.) with weekly measurement of tacrolimus whole blood trough levels and adjustment of the daily dose of LCP-Tacro to achieve target tacrolimus levels of 3 - 6 ng/mL. Patients with histological evidence of cirrhosis and a Model for End-Stage Liver Disease (MELD) score ≤ 8 will commence LCP-Tacro at a fixed dose of 1 mg once daily, with subsequent dosage adjustments to maintain tacrolimus trough levels at 3 - 6 ng/mL. * AZA will be started at 50 - 100 mg (approximately 1 mg/kg) once daily (q.d.). Patients will also commence treatment with prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.	Autoimmune Hepatitis	Autoimmune hepatitis Chronic active hepatitis	null	2	arm 1: LCP-Tacro tablets(1,2,and 5mg tacrolimus)+ prednisone tablets(5mg) arm 2: Azathioprine tablets(50mg)+ prednisone tablets(5mg)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: LCP-Tacro(tacrolimus)tablets starting at 2 mg once daily, then adjusted to achieve and maintain target whole blood tacrolimus levels of 3 - 6 ng/mL, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6. intervention 2: Azathioprine tablets 50 - 100 mg (approximately 1 mg/kg) once daily, plus prednisone 30 mg/day for one week, then 20 mg/day for one week, then 15 mg/day for two weeks, then 10 mg/day through Month 6.	intervention 1: LCP-Tacro (tacrolimus) intervention 2: Azathioprine	12	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 New York \| New York \| United States \| -74.00597 \| 40.71427 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269	13	NCT00608894	6TERMINATED	2009-07-01	2007-12-01	Veloxis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	70	RANDOMIZED	SINGLE_GROUP	0TREATMENT	3TRIPLE	false	0ALL	true	This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.	null	Severe Sepsis	Sepsis septic shock Systemic Inflammatory Response Syndrome	null	6	arm 1: AZD9773: single infusion of 50 units/kg arm 2: AZD9773: single infusion of 250 units/kg arm 3: AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs arm 4: AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs arm 5: AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs arm 6: Placebo	[ 0, 0, 0, 0, 0, 2 ]	2	[ 0, 10 ]	intervention 1: intravenous infusions intervention 2: Placebo	intervention 1: AZD9773 (CytoFab) intervention 2: Placebo	26	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Bay Pines \| Florida \| United States \| -82.77816 \| 27.81419 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Oak Park \| Illinois \| United States \| -87.7845 \| 41.88503 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Hazard \| Kentucky \| United States \| -83.19323 \| 37.24954 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Camden \| New Jersey \| United States \| -75.11962 \| 39.92595 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Houston \| Texas \| United States \| -95.36327 \| 29.76328	70	NCT00615017	1COMPLETED	2009-07-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3 ]	96	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is evaluate the difference between two doses of gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, on pain associated with post-herpetic neuralgia.	The primary purpose of study PXN110527 was to investigate the efficacy of a high (3600mg/day) dose versus a low (1200mg/day) dose of GEn in subjects with post-herpetic neuralgia (PHN) who have a history of an inadequate response to gabapentin treatment. The study is a cross-over design. Prior to screening subjects are required to have a demonstrated history of an inadequate response (as determined by the investigator) to at least 1800 mg/day of gabapentin. Prior history of treatment with gabapentin includes current treatment at 1800mg/day (2 weeks) or prior treatment with ≥1800mg/day (4 weeks). Subjects could also have been treated with pregabalin monotherapy (150-300mg/day, ≥4 weeks) and had an inadequate response. Subjects are treated with gabapentin 1800mg/day during the Baseline Period and are randomized if during the Basleline Period they are compliant with gabapentin treatment and have a 24-hour average pain intensity score ≥4.0 based on an 11-point pain intensity numerical rating scale (PI-NRS). Subjects are then randomized to receive gabapentin enacarbil (either 1200mg/day or 3600mg/day in a 1:1 ratio) for Treatment Period 1 (28 days). Followed by a dose of 2400mg/day for 4 days and the alternate fixed dose (either 3600 mg/day or 1200 mg/day) for Treatment Period 2 (28 days).	Neuralgia, Postherpetic	Post-herpetic neuralgia(PHN) Neuropathic pain	null	2	arm 1: gabapentin enacarbil 1200mg/day, 4 weeks treatment in either the first or second treatment period arm 2: gabapentin enacarbil 3600mg/day, 4 weeks treatment in either the first or second treatment period	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1200mg/day gabapentin enacarbil intervention 2: 3600mg/day gabapentin enacarbil	intervention 1: GEn 1200mg/day intervention 2: GEn 3600mg/day	53	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Oxnard \| California \| United States \| -119.17705 \| 34.1975 Roseville \| California \| United States \| -121.28801 \| 38.75212 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Chipley \| Florida \| United States \| -85.53854 \| 30.78186 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Marianna \| Florida \| United States \| -85.22687 \| 30.77436 Miami Springs \| Florida \| United States \| -80.2895 \| 25.82232 Naranja \| Florida \| United States \| -80.42283 \| 25.51816 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 New York \| New York \| United States \| -74.00597 \| 40.71427 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Greensburg \| Pennsylvania \| United States \| -79.53893 \| 40.30146 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Longview \| Texas \| United States \| -94.74049 \| 32.5007 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Weber City \| Virginia \| United States \| -78.28389 \| 37.75514 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Yakima \| Washington \| United States \| -120.5059 \| 46.60207 Schönau \| Baden-Wurttemberg \| Germany \| 8.47243 \| 49.54353 Hüttenberg \| Hesse \| Germany \| 8.62189 \| 50.51453 Wiesbaden \| Hesse \| Germany \| 8.24932 \| 50.08258 Achim \| Lower Saxony \| Germany \| 9.0263 \| 53.01416 Bochum \| North Rhine-Westphalia \| Germany \| 7.21648 \| 51.48165 Hattingen \| North Rhine-Westphalia \| Germany \| 7.18557 \| 51.39894 Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Leipzg \| Saxony \| Germany \| N/A \| N/A Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437	526	NCT00617461	1COMPLETED	2009-07-01	2008-03-01	XenoPort, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	1,060	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	false	The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®	null	Cardiovascular Disease	DEFINITY Safety Survelliance	null	1	arm 1: Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography	[ 5 ]	1	[ 0 ]	intervention 1: DEFINITY may be injected by either an intravenous or bolus injection or infusion. Dosage as per standard clinical practice and Package Insert	intervention 1: DEFINITY®	16	San Diego \| California \| United States \| -117.16472 \| 32.71571 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 York \| Pennsylvania \| United States \| -76.72774 \| 39.9626 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Houston \| Texas \| United States \| -95.36327 \| 29.76328	1,053	NCT00625365	1COMPLETED	2009-07-01	2008-02-01	Lantheus Medical Imaging	4INDUSTRY	false	false	false	null	0
[ 4 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Palmoplantar psoriasis is a variant of psoriasis affecting palms and soles. It is one of the most debilitating variants of psoriasis which very often interferes with daily activities and with the ability to work. This type of psoriasis is very difficult to treat as topicals have difficulty penetrating the thick epidermis of palms and soles and are therefore not very effective. The response to standard agents (methotrexate, cyclosporine and acitretin) is also usually limited. A number of these patients have very severe hand and feet disease with mild to no involvement elsewhere on the body. Given the efficacy of infliximab in psoriasis, the purpose of this study is to evaluate if infliximab is safe and if it will improve severity and quality of life in patients with palmoplantar psoriasis, a debilitating variant of psoriasis.	A total of 24 patients with non-pustular palmoplantar psoriasis affecting at least 10% of the combined palms and soles area and with a modified palmoplantar pustulosis area severity index (m-PPPASI) of at least 8 will be recruited. Patients will be randomized (1:1) to receive either infliximab 5 mg/kg or placebo (normal saline) on weeks 0, 2 and 6. Patients assigned to placebo during the first 3 infusions will receive infliximab 5 mg/kg at weeks 14, 16 and 20 and placebo again at week 22 while patients who were assigned to receive infliximab during the first 3 infusions will receive infliximab at week 14 and placebo at week 16 and week 20 as well as infliximab for the last infusion at week 22. The primary endpoint will be at week 14. Patients will come back to the clinic at week 26 for a final efficacy and safety assessment. Efficacy will be evaluated by assessing psoriasis plaque severity on palms and soles (physician's global assessment PGA), percentage of palms and soles area affected by psoriasis (palmoplantar surface area - PPSA) as well as m-PPPASI (modified palmoplantar pustulosis area and severity index). Quality of life will be evaluated at every visit by performing the dermatology life quality index DLQI. Safety will be evaluated by repeating chemistry and haematology laboratories at regular visits as well as by physical examinations and assessment of adverse events.	Palmoplantar Psoriasis	Palmoplantar psoriasis Infliximab	null	2	arm 1: Placebo at weeks 0, 2, 6 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period. arm 2: Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Patients receive placebo on weeks 0, 2 and 6. They receive infliximab 5mg/kg at weeks 14, 16 and 20. intervention 2: Patients in infliximab group receive infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22. Patients in placebo then infliximab group receive placebo at weeks 0, 2, 6, then receive infliximab at weeks 14, 16 and 20.	intervention 1: Placebo intervention 2: Infliximab	5	London \| Ontario \| Canada \| -81.23304 \| 42.98339 Markham \| Ontario \| Canada \| -79.2663 \| 43.86682 Laval \| Quebec \| Canada \| -73.692 \| 45.56995 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228	24	NCT00629772	1COMPLETED	2009-07-01	2007-03-01	Innovaderm Research Inc.	7OTHER	false	false	false	null	0
[ 5 ]	273	RANDOMIZED	PARALLEL	9OTHER	0NONE	true	1FEMALE	false	The ACCEPT study is a Phase IV trial in which women are randomized to either the NuvaRing® vaginal contraceptive ring or a low dose oral contraceptive to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students.	For many women, college is a time of great change that affects one's social and behavioral practices, including sexual behavior. The first part of the NuvaRing ® Acceptability study is an online survey, developed in conjunction with the University of Illinois's Survey Research Laboratory, which examines women's attitudes and beliefs regarding various methods of birth control. The second part of the study is a comparison trial in which the women are randomized to either the NuvaRing ® vaginal contraceptive ring or a low dose oral contraceptive. The women are followed for three months to assess compliance, side effects, overall acceptability and intent to continue use of the method. Ultimately, we would like college women to be well informed about various methods of contraception available to them and to choose the contraceptive method that best suits their lifestyle.	Birth Control Compliance	Contraception, Compliance, Acceptability	null	2	arm 1: Contraceptive vaginal ring (NuvaRing) arm 2: Oral contraceptive pill (Ortho Tri-cyclen Lo)	[ 1, 1 ]	2	[ 0, 1 ]	intervention 1: Low dose oral contraceptive intervention 2: Contraceptive vaginal ring	intervention 1: Ortho Tri-cyclen Lo intervention 2: NuvaRing	3	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	273	NCT00635570	1COMPLETED	2009-07-01	2008-07-01	University of Chicago	7OTHER	false	false	false	null	0
[ 4 ]	514	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.	null	Type 2 Diabetes Mellitus	diabetes exenatide once weekly Byetta sitagliptin Januvia thiazolidinedione Amylin Lilly Pioglitazone	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: subcutaneous injection, 2.0mg, once a week intervention 2: oral tablet, 100mg, once a day intervention 3: oral tablet, 45mg, once a day intervention 4: oral tablet, once a day intervention 5: subcutaneous injection, once a week	intervention 1: exenatide once weekly intervention 2: sitagliptin intervention 3: pioglitazone intervention 4: placebo tablet intervention 5: placebo once weekly	62	Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Artesia \| California \| United States \| -118.08312 \| 33.86585 Concord \| California \| United States \| -122.03107 \| 37.97798 Encino \| California \| United States \| -118.50119 \| 34.15917 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 La Mesa \| California \| United States \| -117.02308 \| 32.76783 Orange \| California \| United States \| -117.85311 \| 33.78779 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Whittier \| California \| United States \| -118.03284 \| 33.97918 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Melbourne \| Florida \| United States \| -80.60811 \| 28.08363 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Avon \| Indiana \| United States \| -86.39972 \| 39.76282 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Oxon Hill \| Maryland \| United States \| -76.9897 \| 38.80345 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Chelsea \| Michigan \| United States \| -84.02181 \| 42.31807 Ypsilanti \| Michigan \| United States \| -83.61299 \| 42.24115 Saint Louis Park \| Minnesota \| United States \| -93.34801 \| 44.9483 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 New Windsor \| New York \| United States \| -74.02375 \| 41.47676 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Statesville \| North Carolina \| United States \| -80.8873 \| 35.78264 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Athens \| Ohio \| United States \| -82.10126 \| 39.32924 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Olympia \| Washington \| United States \| -122.90169 \| 47.04491 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Indore \| N/A \| India \| 75.8333 \| 22.71792 Karnāl \| N/A \| India \| 76.98448 \| 29.69197 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Pune \| N/A \| India \| 73.85535 \| 18.51957 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Zapopan \| Jalisco \| Mexico \| -103.38742 \| 20.72111 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 Cuernavaca \| Morelos \| Mexico \| -99.23075 \| 18.9261 Monterrey \| NuevoLeon \| Mexico \| -100.31721 \| 25.68435 Toluca \| State of Mexico \| Mexico \| -99.65324 \| 19.28786	491	NCT00637273	1COMPLETED	2009-07-01	2008-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	-0
[ 5 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.	null	Dysphonia	horseness	null	2	arm 1: Lansoprazole and dietary control arm 2: Dietary control and placebo	[ 1, 2 ]	2	[ 0, 10 ]	intervention 1: Lansoprazole 30 mg taken by mouth daily for 3 months intervention 2: placebo taken by mouth daily for 3 months	intervention 1: Lansoprazole intervention 2: Placebo	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	9	NCT00637416	6TERMINATED	2009-07-01	2008-03-01	University of Kansas Medical Center	7OTHER	false	false	false	null	0
[ 4 ]	782	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares	null	Psoriasis Vulgaris		null	3	arm 1: Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks arm 2: Tacalcitol once daily for up to 8 weeks arm 3: Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Once daily application for up to 8 weeks intervention 2: Once daily application for up to 8 weeks intervention 3: Once daily application for up to 8 weeks	intervention 1: Calcipotriol plus hydrocortisone ointment vehicle intervention 2: Tacalcitol Ointment intervention 3: Calcipotriol plus hydrocortisone ointment	3	Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Nice \| N/A \| France \| 7.26608 \| 43.70313 Dundee \| N/A \| United Kingdom \| -2.97489 \| 56.46913	739	NCT00640822	1COMPLETED	2009-07-01	2008-02-01	LEO Pharma	4INDUSTRY	false	false	false	null	0
[ 4 ]	188	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.	null	Anemia		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 120, 200 or 360 micrograms iv monthly (starting dose)	intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]	24	Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Český Krumlov \| N/A \| Czechia \| 14.31521 \| 48.81091 Děčín \| N/A \| Czechia \| 14.21478 \| 50.78215 Havířov \| N/A \| Czechia \| 18.43688 \| 49.77984 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Jihlava \| N/A \| Czechia \| 15.59124 \| 49.3961 Karlovy Vary \| N/A \| Czechia \| 12.87117 \| 50.23271 Kolin III \| N/A \| Czechia \| N/A \| N/A Liberec \| N/A \| Czechia \| 15.05619 \| 50.76711 Nový Jičín \| N/A \| Czechia \| 18.01028 \| 49.59438 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Písek \| N/A \| Czechia \| 14.1475 \| 49.3088 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Strakonice \| N/A \| Czechia \| 13.90237 \| 49.26141 Šumperk \| N/A \| Czechia \| 16.97061 \| 49.96528 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Třebíč \| N/A \| Czechia \| 15.88166 \| 49.21492 Ústí nad Labem \| N/A \| Czechia \| 14.03227 \| 50.6607 Znojmo \| N/A \| Czechia \| 16.0488 \| 48.8555	188	NCT00642850	1COMPLETED	2009-07-01	2007-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0
[ 4 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The study is designed to compare the effects of nebivolol (10, 20, 40mg/day) with another beta blocker, extended-release metoprolol, at a range of doses. Its purpose is to study the mechanism of action of nebivolol on forearm blood flow, nitric oxide availability and other biomarkers.	null	Hypertension	Hypertension Blood pressure Nebivolol Bystolic (TM) Metoprolol ER (TM)	null	2	arm 1: Nebivolol arm 2: Metoprolol ER (TM)	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: nebivolol 10mg, 20mg, 40mg daily dosage, oral administration intervention 2: Metoprolol ER 100mg, 200mg, 400mg, daily dosage, oral administration	intervention 1: Nebivolol intervention 2: Metoprolol ER (TM)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	12	NCT00648895	1COMPLETED	2009-07-01	2007-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 3 ]	201	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.	null	Rheumatoid Arthritis		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: multiple dose, single schedule intervention 2: matching placebo	intervention 1: ARRY-438162, MEK inhibitor; oral intervention 2: Placebo; oral	35	Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 San Juan \| N/A \| Argentina \| -68.52568 \| -31.53726 San Miguel de Tucumán \| N/A \| Argentina \| -65.21051 \| -26.81601 Santa Fe \| N/A \| Argentina \| -60.70868 \| -31.64881 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Mezőkövesd \| N/A \| Hungary \| 20.58333 \| 47.81667 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szolnok \| N/A \| Hungary \| 20.2 \| 47.18333 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Arequipa \| N/A \| Peru \| -71.53747 \| -16.39899 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Elblag \| N/A \| Poland \| 19.40884 \| 54.1522 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Târgu Mureş \| N/A \| Romania \| 24.55747 \| 46.54245 Timișoara \| N/A \| Romania \| 21.22571 \| 45.75372	198	NCT00650767	1COMPLETED	2009-07-01	2008-03-01	Array Biopharma, now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	173	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.	null	Hypercholesterolemia		null	1	arm 1: Patients with intermediate or high risk dyslipidemia will be enrolled to receive treatment with Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks	[ 0 ]	1	[ 0 ]	intervention 1: Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.	intervention 1: ezetimibe (+) simvastatin	0	null	173	NCT00654628	1COMPLETED	2009-07-01	2007-08-01	Organon and Co	4INDUSTRY	false	false	false	null	0
[ 3 ]	52	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.	Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.	Acute Lung Injury	Acute lung injury Lung resection	null	2	arm 1: Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively arm 2: Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively intervention 2: 0.9% saline 1 litre intravenous over 12 hours pre-operatively	intervention 1: N-acetylcysteine intervention 2: 0.9% saline	1	London \| N/A \| United Kingdom \| -0.12574 \| 51.50853	47	NCT00655928	1COMPLETED	2009-07-01	2007-08-01	Imperial College London	7OTHER	false	false	false	null	0
[ 5 ]	468	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).	The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).	Infertility	Infertility In vitro fertilization Embryo transfer Crinone Intramuscular Progesterone Progesterone support	null	2	arm 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. arm 2: Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy. .	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy. intervention 2: Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.	intervention 1: Crinone 8% Vaginal Gel intervention 2: Intramuscular Progesterone	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	407	NCT00656201	1COMPLETED	2009-07-01	2003-07-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0
[ 4 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.	The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.	Neuromuscular Blockade		null	1	arm 1: IV single bolus dose of 4.0 mg/kg sugammadex	[ 0 ]	2	[ 0, 0 ]	intervention 1: At 15 minutes after administration of rocuronium, an IV single bolus dose of 4.0 mg/kg sugammadex was administered. intervention 2: After achieving stable anesthesia an IV single bolus dose of 0.6 mg/kg rocuronium was administered	intervention 1: sugammadex intervention 2: Rocuronium	0	null	6	NCT00656799	1COMPLETED	2009-07-01	2008-04-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 4 ]	186	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.	In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by which the sentinel lymph node (the first node in a draining basin) is identified intraoperatively and removed. This technique, called sentinel node biopsy, has extremely high negative predictive values for melanoma metastases and breast cancer metastases. The two largest trials for melanoma, Morton, et al (2005) and Rossi, et al (2006), reported false negative rates of 6.3% and 14.7%, respectively. Morton, et al (2006), in perhaps the most mature trial reported to date, showed a false negative rate of 3.4% . There is growing evidence that sentinel node biopsy will have a significant impact on the management of melanoma. Sentinel node biopsy also has extremely high negative predictive values for breast cancer metastases; the false-negative rates range from 0% to 9%. There is growing evidence that sentinel node biopsy will have a significant impact on the management of breast cancer. Although the survival and local recurrence studies have yet to be completed, the technique has emerged into common practice. Lymphatic mapping with a radiopharmaceutical is a nuclear medicine examination which identifies for the surgeon the first lymph node to receive lymphatic flow from the primary tumor site. This node is removed and analyzed for the presence of malignant cells. By locating the lymph node prior to surgery, a small incision can be used to remove the node and a smaller dissection can be employed. The high negative predictive value of the technique seems to provide an accurate staging procedure and may spare patients who are lymph node negative the morbidity of a complete lymph node dissection. Consequently, staging of melanoma by lymph node mapping and biopsy may be equivalent to regional node dissection without the attendant post surgical morbidity. An ideal lymph node imaging agent would exhibit rapid clearance from the injection site, rapid uptake and high retention within the first draining lymph node, and low uptake by the remaining lymph nodes. The ideal agent would also have low radiation absorption; high biological safety; convenient, rapid, and stable technetium-99m labeling; and biochemical purity. Lymphoseek (technetium-99m-labeled diethylenetriamine pentaacetic acid-mannosyl-dextran, \[Tc-99m\]DTPA-mannosyl-dextran) is a radiotracer that accumulates in lymphatic tissue by binding to a mannose-binding protein that resides on the surface of dendritic cells and macrophages. Lymphoseek is a macromolecule consisting of multiple units of DTPA and mannose, each synthetically attached to a 10 kilodalton dextran backbone. The mannose acts as a substrate for the receptor, and the DTPA serves as a chelating agent for labeling with Tc-99m.	Breast Cancer Melanoma	breast cancer lymph nodes melanoma surgery	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Breast Cancer: Intradermal admin of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site OR periareolar administration of Lymphoseek: Inject 0.2-.04 mL in multiple divided doses at the margin of the areola OR subareolar administration of Lymphoseek: Inject 0.2-0.4 in multiple divided injections or a single injection in subareolar area as a subcutaneous injection OR peritumor administration of Lymphoseek: Inject 2.0-4.0 mL in multiple divided injections, intraparenchemally surrounding the tumor or biopsy cavity. For melanoma pts intradermal administration of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site.	intervention 1: Lymphoseek	15	Alexander City \| Alabama \| United States \| -85.95385 \| 32.94401 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Bryn Mawr \| Pennsylvania \| United States \| -80.08672 \| 40.30396 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088	179	NCT00671918	1COMPLETED	2009-07-01	2008-04-01	Navidea Biopharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 5 ]	376	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To compare the efficacy and safety of quetiapine fumarate given as mono-therapy or adjunct therapy to lithium in the treatment of patients with acute mania in bipolar disorder. Patients with a documented clinical diagnosis of bipolar mania according to DSM-IV criteria (296.4X Bipolar I Disorder, Most Recent Episode Manic; 296.0X Bipolar I Disorder, Single Manic Episode) are required to have a YMRS total score of ≥20 at enrolment and randomisation	null	Acute Mania in Bipolar Disorder	Acute Mania Bipolar Disorder Quetiapine Fumarate Lithium	null	2	arm 1: Quetiapine Fumarate - tablets arm 2: Quetiapine Fumarate - tablets and Lithium	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Oral treatment, twice daily. 100 mg/day at Day 1, 200 mg/day at Day 2, 300 mg/day at Day 3, 400 mg/day at Day 4, from 400 mg/day to 600 mg/day before Day 8, from 600 mg/day to 800 thereafter, judged by the investigator. Tablets intervention 2: Oral treatment, twice daily. 250 mg/day to 2000mg/day from Day1 to Day 7, 500mg/day to 2000mg/day thereafter, judged by the investigator.	intervention 1: Quetiapine Fumarate intervention 2: Lithium	16	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Guangzhou \| Guangdong \| China \| 113.25 \| 23.11667 Baoding \| Hebei \| China \| 115.46246 \| 38.87288 Shijiazhuang \| Hebei \| China \| 114.47861 \| 38.04139 Daqing \| Heilongjiang \| China \| 125.0 \| 46.58333 Xinxiang \| Henan \| China \| 113.80151 \| 35.19033 Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Suzhou \| Jiangsu \| China \| 120.59538 \| 31.30408 Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Shanghai \| Shanghai Municipality \| China \| 121.45806 \| 31.22222 Xijing \| Shanxi \| China \| 113.40833 \| 36.74083 Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667 Tianjin \| Tianjin Municipality \| China \| 117.17667 \| 39.14222 Kuming \| Yunnan \| China \| N/A \| N/A Hangzhou \| Zhejiang \| China \| 120.16142 \| 30.29365 Huzhou \| Zhejiang \| China \| 120.0933 \| 30.8703	376	NCT00672490	1COMPLETED	2009-07-01	2008-04-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	530	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.	null	Fibromyalgia		null	2	arm 1: 60-120 mg, oral, every day, 12 weeks arm 2: oral, daily, 12 weeks	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase). intervention 2: oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)	intervention 1: duloxetine hydrochloride intervention 2: placebo	46	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Cromwell \| Connecticut \| United States \| -72.64537 \| 41.5951 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Oak Brook \| Illinois \| United States \| -87.92895 \| 41.83281 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Prairie Village \| Kansas \| United States \| -94.63357 \| 38.99167 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593 Fall River \| Massachusetts \| United States \| -71.15505 \| 41.70149 Newton \| Massachusetts \| United States \| -71.20922 \| 42.33704 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Edison \| New Jersey \| United States \| -74.4121 \| 40.51872 Piscataway \| New Jersey \| United States \| -74.39904 \| 40.49927 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Myrtle Beach \| South Carolina \| United States \| -78.88669 \| 33.68906 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Lake Jackson \| Texas \| United States \| -95.43439 \| 29.03386 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Wichita Falls \| Texas \| United States \| -98.49339 \| 33.91371 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Middleton \| Wisconsin \| United States \| -89.50429 \| 43.09722 Hato Rey \| N/A \| Puerto Rico \| N/A \| N/A Ponce \| N/A \| Puerto Rico \| -66.62398 \| 18.01031 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	530	NCT00673452	1COMPLETED	2009-07-01	2008-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the efficacy of imatinib mesylate in reducing cutaneous thickening and tethering in patients with nephrogenic systemic fibrosis (NSF). The study will also work to assess the safety and tolerability of imatinib mesylate in patients with chronic kidney disease and NSF.	Nephrogenic systemic fibrosis (NSF) is a recently described, extremely debilitating and painful condition that affects individuals with renal failure. Recent reports suggest an association between gadolinium exposure during magnetic resonance (MR) studies and the subsequent development of NSF in patients with chronic renal failure. NSF is characterized by rapidly progressive skin hardening, tethering and hyperpigmentation, predominantly on the extremities. Visceral involvement is rare. Skin biopsies of early NSF lesions demonstrate thickened collagen bundles, mucin deposition, angiogenesis and numerous dermal spindle cells that stain with antibodies to cluster of differentiation 34 (CD34) and procollagen. Cutaneous changes of NSF are present in up to 13% of individuals receiving hemodialysis. Among those patients with clinical evidence of NSF, the principle investigator of this protocol has recently reported that NSF is associated with increased early mortality at 24-months. There is no proven therapy for this devastating disorder. Anecdotal reports have shown modest improvement in joint mobility and decreased skin thickening with extracorporeal photopheresis and pentoxyphylline. Increased transforming growth factor (TGF)-beta1 messenger ribonucleic acid (mRNA) on immunostaining has been observed in skin, fascia and striated muscle. Imatinib mesylate, a tyrosine kinase inhibitor, prevents TGF-beta-induced stimulation of collagen and extracellular matrix protein synthesis as well as mRNA expression by normal fibroblasts. This observation led the principal investigator to evaluate imatinib mesylate 400 milligrams (mg) orally (p.o.) daily for 1 year in two participants with NSF. The result was significant softening of previously hardened skin with increased mobility of skin that previously had been tethered to the underlying fascia. After one month of imatinib mesylate, one of the two participants had a 20 degree reduction of his knee flexion contractures.	Nephrogenic Systemic Fibrosis	Treatment Chronic kidney disease Fibrosing disorders Imatinib mesylate	null	1	arm 1: Imatinib mesylate 400 milligrams (mg) orally once daily for 4 months. Dosage was reduced to 200 mg if the participant developed gastrointestinal intolerance or alopecia.	[ 0 ]	1	[ 0 ]	intervention 1: 400 mg p.o. daily for 4 months. Dosage was reduced to 200 mg if participants develop gastrointestinal intolerance or alopecia.	intervention 1: Imatinib mesylate	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	0	NCT00677092	1COMPLETED	2009-07-01	2007-12-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0
[ 4 ]	934	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.	null	Hypercholesterolemia	HMG-CoA LDL-C CHD	null	3	arm 1: Rosuvastatin 5mg qd arm 2: Rosuvastatin 10mg qd arm 3: Atorvastatin 10mg qd	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: Capsule/Tablet, oral, qd, 6 or 12 weeks intervention 2: Capsule/Tablet, 10mg, oral, qd, 6 weeks	intervention 1: Rosuvastatin intervention 2: Atorvastatin	6	Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Changsha \| Hunan \| China \| 112.97087 \| 28.19874 Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Tianjin \| N/A \| China \| 117.17667 \| 39.14222	436	NCT00683618	1COMPLETED	2009-07-01	2008-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	60	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	1SINGLE	true	0ALL	false	This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.	This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a modified Mayo Clinic Research Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if pregnant. Subjects had 3 infusion studies at least 2 days apart within 3 weeks.	Healthy	CCK infusion Gallbladder ejection fraction Normal volunteers	null	6	arm 1: CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg 60 minutes, with at least 2 days between each infusion arm 2: CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg 30 minutes, with at least 2 days between each infusion arm 3: CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg 60 minutes, with at least 2 days between each infusion arm 4: CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg 15 minutes, with at least 2 days between each infusion arm 5: CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg over 15 minutes, followed by CCK-8 0.02 mg/kg 30 minutes, with at least 2 days between each infusion arm 6: CCK-8 0.02 mg/kg over 60 minutes, followed by CCK-8 0.02 mg/kg over 30 minutes, followed by CCK-8 0.02 mg/kg 15 minutes, with at least 2 days between each infusion	[ 1, 1, 1, 1, 1, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes intervention 2: Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes intervention 3: Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion intervention 4: Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion intervention 5: Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion intervention 6: Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion	intervention 1: Experimental Sequence ABC intervention 2: Experimental Sequence ACB intervention 3: Experimental Sequence BAC intervention 4: Experimental Sequence BCA intervention 5: Experimental Sequence CAB intervention 6: Experimental Sequence CBA	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	60	NCT00685477	1COMPLETED	2009-07-01	2008-05-01	Temple University	7OTHER	false	false	false	null	0
[ 4 ]	243	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.	This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"	Acne	Acne	null	2	arm 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily arm 2: Vehicle Gel once daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Topical Gel to the face, once daily in the evening for 24 weeks. intervention 2: Topical Gel to the face, once daily in the evening for 24 weeks.	intervention 1: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel intervention 2: Vehicle Gel	33	San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Snellville \| Georgia \| United States \| -84.01991 \| 33.85733 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Fort Gratiot \| Michigan \| United States \| N/A \| N/A Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Warren \| Ohio \| United States \| -80.81842 \| 41.23756 Hazleton \| Pennsylvania \| United States \| -75.97465 \| 40.95842 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Arlington \| Texas \| United States \| -97.10807 \| 32.73569 Austin \| Texas \| United States \| -97.74306 \| 30.26715 College Station \| Texas \| United States \| -96.33441 \| 30.62798 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Barrie \| Ontario \| Canada \| -79.66634 \| 44.40011 North Bay \| Ontario \| Canada \| -79.46633 \| 46.3168 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Aibonito \| N/A \| Puerto Rico \| -66.266 \| 18.13996 Carolina \| N/A \| Puerto Rico \| -65.95739 \| 18.38078	243	NCT00687908	1COMPLETED	2009-07-01	2008-11-01	Galderma R&D	4INDUSTRY	false	false	false	null	0
[ 0 ]	31	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	false	0ALL	null	We hope to determine whether Ondansetron, an anti-nausea medication, works to help relieve withdrawal symptoms experienced while the patient is being weaned off opioid medications. This medication has shown anecdotal evidence of being affective for the treatment of withdrawal symptoms and we hope to determine whether this is affective.	null	Substance Withdrawal Syndrome		null	2	arm 1: Placebo - sugar pill arm 2: Ondansetron	[ 2, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Ondansetron and Placebo crossover	1	Stanford \| California \| United States \| -122.16608 \| 37.42411	28	NCT00695864	1COMPLETED	2009-07-01	2008-05-01	Stanford University	7OTHER	false	false	false	null	0
[ 4 ]	5	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.	This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.	Respiratory Depression	Chronic Pain Ventilatory Response to Hypercapnia (VRH)	null	1	arm 1: BEMA Fentanyl	[ 0 ]	1	[ 0 ]	intervention 1: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily	intervention 1: BEMA Fentanyl	0	null	0	NCT00696137	1COMPLETED	2009-07-01	2008-06-01	BioDelivery Sciences International	4INDUSTRY	false	false	false	null	0
[ 5 ]	242	null	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.	null	Depressive Disorder, Major		null	1	arm 1: Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.	[ 0 ]	1	[ 0 ]	intervention 1: Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks. Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.	intervention 1: Duloxetine	2	Guri-si \| N/A \| South Korea \| 127.1394 \| 37.5986 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	241	NCT00696774	1COMPLETED	2009-07-01	2008-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	63	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)	This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. A recently published, landmark study (MTOPS - Medical Therapy of Prostatic Symptoms), co-sponsored by the National Institute of Health and the National Institute of Diabetes, Digestive and Kidney Diseases (NIH-NIDDK), demonstrated that, in selected patients, combination therapy with Doxazosin and Finasteride provided additive symptomatic improvements, reduced the risk of acute urinary retention (AUR) and surgical intervention, and was a more effective treatment for reduction in the overall risk of BPH clinical progression. The aim of this proposed combination study, in a population of patients at high risk of BPH clinical progression, is to investigate whether combination therapy with Dutasteride and Tamsulosin with the subsequent withdrawal of Tamsulosin can maintain superior symptom improvement. At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. We hypothesize that patients may start with a combination of Dutasteride and Tamsulosin and eventually may be able to eliminate the use of Tamsulosin and maintain acceptable urinary symptoms on Dutasteride alone.	Benign Prostatic Hyperplasia	Benign Prostatic Hyperplasia Dutasteride Tamsulosin	null	1	arm 1: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis. Subjects will self-administer the study medication once daily for up to 52 weeks (1 year). Subjects will return to the clinic at 13 week intervals during the treatment period. At each scheduled clinic visit (3, 6, and 9 months), the subjects will be counseled on withdrawal of Tamsulosin. The total study duration for each subject will be up to 52 weeks.	[ 0 ]	1	[ 0 ]	intervention 1: Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.	intervention 1: Tamsulosin	1	Evansville \| Indiana \| United States \| -87.55585 \| 37.97476	63	NCT00701779	1COMPLETED	2009-07-01	2005-09-01	Siami, Paul F., M.D.	7OTHER	false	false	false	null	0
[ 4 ]	155	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product- Testosterone MD-Lotion (cutaneous solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of this product. The study will also assess safety of the product.	null	Hypogonadism		null	1	arm 1: Participants received Testosterone Metered Dose (MD)-Lotion for 120 days. Participants started by receiving 3.0 mL (60 mg) of 2% Testosterone MD-Lotion, and based upon restoration to eugonadal levels, may have had their dose of testosterone adjusted upwards or downwards on Days 45 and 90. Doses could be titrated to one of the following: 1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied daily by 1 dose to the axilla (1.5 mL to one axilla). 3.0 mL (60 mg) of 2% Testosterone MD-Lotion applied daily by 2 doses to the axilla (1.5 mL to each axilla). 4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied daily by 3 doses to the axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla). 6.0 mL (120 mg) of 2% Testosterone MD-Lotion applied daily by 4 doses to the axilla (2 x 1.5 mL to each axilla).	[ 0 ]	1	[ 0 ]	intervention 1: 30 mg to 120 mg administered topically once daily for 120 days	intervention 1: Testosterone MD-Lotion	27	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tuscon \| Arizona \| United States \| N/A \| N/A Burbank \| California \| United States \| -118.30897 \| 34.18084 Torrance \| California \| United States \| -118.34063 \| 33.83585 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Shawnee Mission \| Kansas \| United States \| -94.66583 \| 39.02 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sydney \| New South Wales \| Australia \| 151.20732 \| -33.86785 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Melbourne \| Victoria \| Australia \| 144.96332 \| -37.814 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Nice \| N/A \| France \| 7.26608 \| 43.70313 Nîmes \| N/A \| France \| 4.35788 \| 43.83665 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Barnsley \| N/A \| United Kingdom \| -1.48333 \| 53.55 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328 Swansea \| N/A \| United Kingdom \| -3.94323 \| 51.62079	155	NCT00702650	1COMPLETED	2009-07-01	2008-06-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 5 ]	432	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary goal of this study is to compare efficacy of varenicline to placebo for cessation of use of smokeless tobacco.	null	Tobacco Use Cessation		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period. intervention 2: Subjects will be up-titrated during the first week of treatment in the following manner: 0.5 mg once daily for 3 days followed by 0.5 mg twice daily for 4 days, and then 1 mg twice daily for the following 11 weeks of the treatment period.	intervention 1: Varenicline Tartrate intervention 2: Placebo	16	Florø \| N/A \| Norway \| 5.0328 \| 61.59957 Hafrsfjord \| N/A \| Norway \| N/A \| N/A Hamar \| N/A \| Norway \| 11.06798 \| 60.7945 Hønefoss \| N/A \| Norway \| 10.25647 \| 60.16804 Oslo \| N/A \| Norway \| 10.74609 \| 59.91273 Rådal \| N/A \| Norway \| 5.34554 \| 60.31063 Trondheim \| N/A \| Norway \| 10.39506 \| 63.43049 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Helsingborg \| N/A \| Sweden \| 12.69437 \| 56.04673 Jarfalla \| N/A \| Sweden \| N/A \| N/A Karlstad \| N/A \| Sweden \| 13.50357 \| 59.3793 Örebro \| N/A \| Sweden \| 15.2066 \| 59.27412 Södertälje \| N/A \| Sweden \| 17.62525 \| 59.19554 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Sundsvall \| N/A \| Sweden \| 17.3063 \| 62.39129 Umeå \| N/A \| Sweden \| 20.25972 \| 63.82842	431	NCT00717093	1COMPLETED	2009-07-01	2008-08-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	15	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma	null	Asthma	Bronchodilator	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 0, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets. intervention 2: 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose. intervention 3: 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose intervention 4: 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose. intervention 5: 2 x placebo tablets + placebo oral dispersion, single dose.	intervention 1: PF-04191834 intervention 2: PF-04191834 intervention 3: PF-04191834 intervention 4: zileuton intervention 5: Placebo	4	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	74	NCT00723021	1COMPLETED	2009-07-01	2008-07-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 4 ]	376	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia	null	Schizophrenia	Intramuscular ziprasidone, agitation, efficacy and safety	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days. intervention 2: The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.	intervention 1: Intramuscular ziprasidone mesylate intervention 2: Intramuscular haloperidol	9	Baoding \| Hebei \| China \| 115.46246 \| 38.87288 Wuhan \| Hubei \| China \| 114.26667 \| 30.58333 Kunming \| Yunnan \| China \| 102.71833 \| 25.03889 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Changsha \| N/A \| China \| 112.97087 \| 28.19874 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Nanjing \| N/A \| China \| 118.77778 \| 32.06167 Xi'an \| N/A \| China \| 108.92861 \| 34.25833	376	NCT00723606	1COMPLETED	2009-07-01	2008-09-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	530	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study was a randomized, parallel group, double-blind, placebo controlled design to compare the efficacy and tolerability of NP101 to a placebo iontophoretic transdermal patch. The primary objective of this study was to assess the proportion of subjects who were headache pain free at two hours after patch activation. Key secondary objectives included: 1. The proportion of subjects who were nausea free at two hours after patch activation. 2. The proportion of subjects who were photophobia free at two hours after patch activation. 3. The proportion of subjects who were phonophobia free at two hours after patch activation.	Subjects stayed in the study until they had treated one migraine headache with a study patch or two months after randomization, whichever occurred first. During a migraine headache, subjects rated their baseline headache pain severity in a Migraine Study Diary using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) and applied the study patch only if their score was 2 or 3 (i.e., qualifying migraine headache). In addition to headache pain severity, subjects also recorded the presence or absence of aura, nausea, phonophobia, and photophobia, as well as the location of their headache (unilateral or bilateral) and whether their headache increased with movement.	Migraine Disorders		null	2	arm 1: NP101 - sumatriptan iontophoretic transdermal patch arm 2: Placebo iontophoretic transdermal patch	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Sumatriptan iontophoretic transdermal patch intervention 2: NP101 Placebo iontophoretic transdermal patch	intervention 1: NP101 - Sumatriptan iontophoretic transdermal patch intervention 2: Placebo	34	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Fairfield \| Connecticut \| United States \| -73.26373 \| 41.14121 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Palm Beach Gardens \| Florida \| United States \| -80.13865 \| 26.82339 Sunrise \| Florida \| United States \| -80.1131 \| 26.13397 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Mount Vernon \| New York \| United States \| -73.83708 \| 40.9126 Plainview \| New York \| United States \| -73.46735 \| 40.77649 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 West Chester \| Ohio \| United States \| -84.40716 \| 39.33172 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Wynnewood \| Pennsylvania \| United States \| -75.27074 \| 40.00289 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Alexandria \| Virginia \| United States \| -77.04692 \| 38.80484 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	469	NCT00724815	1COMPLETED	2009-07-01	2009-01-01	NuPathe Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To evaluate safety, visual acuity outcomes, persistence of choroidal neovascular leakage, and the number of treatments of combination intravitreal bevacizumab and verteporfin photodynamic therapy at standard or reduced fluence level in patients with subfoveal CNV due to age-related macular degeneration.	null	Age Related Macular Degeneration Choroidal Neovascularization Macular Edema	choroidal neovascularization macular degeneration macular edema intravitreal bevacizumab vegf verteporfin PDT	null	2	arm 1: Patients will receive combination verteporfin with photodynamic therapy at reduced fluence \[300mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. arm 2: Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\] followed by intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy.	[ 0, 0 ]	3	[ 0, 1, 1 ]	intervention 1: Patients will receive intravitreal bevacizumab (1.25mg) on same day following photodynamic therapy. intervention 2: Patients will receive combination verteporfin photodynamic therapy with stand fluence \[600mW/cm2\]. intervention 3: Patients will receive combination verteporfin with photodynamic therapy at standard fluence \[600mw/cm2\].	intervention 1: Bevacizumab intervention 2: verteporfin photodynamic therapy reduced fluence intervention 3: verteporfin photodynamic therapy standardfluence	2	Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Santa Barbara \| California \| United States \| -119.69819 \| 34.42083	22	NCT00729846	1COMPLETED	2009-07-01	2006-05-01	California Retina Consultants	7OTHER	false	false	false	null	0
[ 4 ]	650	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	false	0ALL	true	The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.	ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems. Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP. The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.	ERCP Pancreatic Diseases Bile Duct Diseases	ERCP Drotaverine hydrochloride Hyoscine-N-butylbromide	null	2	arm 1: Drotaverine hydrochloride arm 2: Hyoscine-N-butylbromide	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP intervention 2: Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.	intervention 1: Drotaverine hydrochloride intervention 2: Hyoscine-N-butylbromide	4	Fuzhou \| N/A \| China \| 119.30611 \| 26.06139 Hangzhou \| N/A \| China \| 120.16142 \| 30.29365 Harbin \| N/A \| China \| 126.65 \| 45.75 Shanghai \| N/A \| China \| 121.45806 \| 31.22222	638	NCT00731198	1COMPLETED	2009-07-01	2008-08-01	Changhai Hospital	7OTHER	false	false	false	null	0
[ 4 ]	511	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine whether imiquimod creams are effective in treating external genital warts (EGW). The secondary objective of this study is to provide information on recurrence of EGW. Additionally the study will also look at any adverse events associated with the use of the creams. External genital and perianal warts are caused by the infection of human papillomavirus or HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like small flesh-colored, pink, or red growths on or around the external skin of sex organs or perianal area. The warts may look similar to the small parts of a cauliflower or they may be very tiny and difficult to see. They often appear in clusters of three or four, and may grow and spread rapidly. They usually are not painful, although they may cause mild pain, bleeding, and itching.	null	Genital Warts	external genital warts perianal warts condylomata acuminata human papilloma virus HPV types 6 and 11	null	3	arm 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks arm 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks. arm 3: Placebo cream applied daily to wart areas for up to 8 weeks.	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks. intervention 2: 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks intervention 3: Placebo cream applied daily to wart areas for up to 8 weeks	intervention 1: 2.5% imiquimod cream intervention 2: 3.75% imiquimod cream intervention 3: Placebo cream	43	Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Chico \| California \| United States \| -121.83748 \| 39.72849 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Flint \| Michigan \| United States \| -83.68746 \| 43.01253 Saginaw \| Michigan \| United States \| -83.95081 \| 43.41947 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Riverside Park \| New Jersey \| United States \| -74.97461 \| 40.03844 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Jenkintown \| Pennsylvania \| United States \| -75.12517 \| 40.09594 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Clarksville \| Tennessee \| United States \| -87.35945 \| 36.52977 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Annandale \| Virginia \| United States \| -77.19637 \| 38.83039 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	511	NCT00735462	1COMPLETED	2009-07-01	2008-08-01	Graceway Pharmaceuticals, LLC	4INDUSTRY	false	false	false	null	0
[ 3 ]	285	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to examine the efficacy of CX157 60 mg administered three times a day (180 mg daily dose) as compared to placebo in subjects with Major Depressive Disorder (MDD). Secondary objectives are to evaluate the safety and tolerability and steady state pharmacokinetic profile of CX157 in these subjects.	This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multi-center study comparing the efficacy, safety and tolerability of CX157 60mg TID and placebo. This study will be conducted at approximately 12 investigative sites in the US. Subjects with suspected Major Depressive Disorder (MDD) and experiencing a Major Depressive Episode (MDE) who the investigator wishes to consider for enrollment in the study and who provide written informed consent will initially be evaluated by the Inventory of Depressive Symptomatology 30 item -Self Report (IDS-SR30) administered via Interactive Voice Response System (IVRS). Subjects who meet the minimum score of 40 on the IDS-SR30 will proceed with the remaining study related assessments at the Screening visit. Those subjects who meet all inclusion criteria and none of the exclusion criteria will enter a one to two week Screening period to confirm eligibility and to capture Screening data prior to Randomization. At the Randomization visit, all eligibility requirements will be reconfirmed. The subjects who meet all criteria will be randomized to study medication and enter into a six-week treatment period and a subsequent one week Follow-Up period. The total duration of participation for subjects who complete all phases of the study will be approximately 8-9 weeks. During the treatment period, clinic visits will occur at Week 1, Week 2, Week 4, and Week 6. A subsequent clinic visit will occur at the end of the one week Follow-Up period. The clinical site will contact the subjects via telephone at Weeks 3 and 5 to inquire about their wellbeing, query about adverse events and administer the suicidality scale. Eligible subjects will be randomized (1:1) to receive: * CX157 60mg three times a day (TID) for a total daily dose of 180 mg, or * Placebo administered three times a day. Subjects who discontinue from the study for any reason will not be replaced.	Major Depressive Disorder	MDD	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Six capsules administered three times a day for six weeks. intervention 2: Six capsules administered three times a day for six weeks.	intervention 1: CX157 (TriRima) intervention 2: Placebo	14	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Oakbrook Terrace \| Illinois \| United States \| -87.96451 \| 41.85003 Rockville \| Maryland \| United States \| -77.15276 \| 39.084 Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593 Clementon \| New Jersey \| United States \| -74.98294 \| 39.8115 New York \| New York \| United States \| -74.00597 \| 40.71427 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Brown Deer \| Wisconsin \| United States \| -87.96453 \| 43.16334	285	NCT00739908	1COMPLETED	2009-07-01	2008-09-01	CeNeRx BioPharma Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	33	RANDOMIZED	PARALLEL	2DIAGNOSTIC	3TRIPLE	false	0ALL	false	The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.	null	Peripheral Arterial Occlusive Disease		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution intervention 2: ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution	intervention 1: VISIPAQUE 270 intervention 2: Isovue 250	0	null	33	NCT00740207	1COMPLETED	2009-07-01	2008-09-01	Bracco Diagnostics, Inc	4INDUSTRY	false	false	false	null	0
[ 4 ]	301	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of vortioxetine, once daily (QD), in adults with Generalized Anxiety Disorders.	The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat anxiety in adults who have general anxiety disorder (GAD). This study looked at GAD relief in people who took vortioxetine. The study enrolled 301 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 5 mg * Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in Europe. The overall time to participate in this study was up to 13 weeks. Participants made 7 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.	Generalized Anxiety Disorder	Generalized Anxiety Disorder Anxiety Disorders Drug Therapy	null	2	arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Encapsulated vortioxetine immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules	intervention 1: Vortioxetine intervention 2: Placebo	38	Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Viljandi \| N/A \| Estonia \| 25.59 \| 58.36389 Bad Saarow \| N/A \| Germany \| 14.06667 \| 52.28333 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Hüttenberg \| N/A \| Germany \| 8.62189 \| 50.51453 Rodgau \| N/A \| Germany \| 8.88588 \| 50.02627 Schwerin \| N/A \| Germany \| 11.41316 \| 53.62937 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Liepāja \| N/A \| Latvia \| 21.01085 \| 56.50474 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Sigulda \| N/A \| Latvia \| 24.85953 \| 57.15375 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Palanga \| N/A \| Lithuania \| 21.06861 \| 55.9175 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Gorlice \| N/A \| Poland \| 21.16035 \| 49.65563 Leszno \| N/A \| Poland \| 16.57494 \| 51.84034 Skórzewo \| N/A \| Poland \| 17.81889 \| 53.03629 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Tuszyn \| N/A \| Poland \| 19.53009 \| 51.60949 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Oradea \| N/A \| Romania \| 21.91833 \| 47.0458 Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Lipetsk \| N/A \| Russia \| 39.57076 \| 52.60311 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Rostov-on-Don \| N/A \| Russia \| 39.72328 \| 47.23135 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Smolensk \| N/A \| Russia \| 32.04371 \| 54.77944 Stavropol \| N/A \| Russia \| 41.9734 \| 45.0428 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Dnipro \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Liev \| N/A \| Ukraine \| N/A \| N/A Luhansk \| N/A \| Ukraine \| 39.30553 \| 48.56814 Simferopol \| N/A \| Ukraine \| 34.11079 \| 44.95719	300	NCT00744627	1COMPLETED	2009-07-01	2008-09-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 0 ]	3	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	true	Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade. The primary aim of this study is: To obtain pilot safety data on the use of simvastatin in young adults treated for HD. The secondary aims of this study are: To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD. To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD. To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.	With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade. The primary aim of this study is: To obtain pilot safety data on the use of simvastatin in young adults treated for HD. The secondary aims of this study are: To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD. To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD. To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD. We will do this by enrolling patients diagnosed with HD and evaluating the safety of simvastatin as evidenced by laboratory measures	Carotid Artery Disease		null	1	arm 1: Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma	[ 0 ]	1	[ 0 ]	intervention 1: All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40. Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.	intervention 1: Simvastatin	1	New York \| New York \| United States \| -74.00597 \| 40.71427	3	NCT00746603	6TERMINATED	2009-07-01	2008-01-01	Columbia University	7OTHER	false	false	false	null	0
[ 4 ]	136	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.	Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 centers in the United States. Subjects who met all eligibility criteria were randomized to receive a treatment sequence of GEn:placebo or placebo:GEn. Investigational product was taken with food at approximately 5pm. Investigational product was dosed as 600mg/day x3 days followed by 1200mg/day x25 days for each 4-week treatment period. There was a 1-week taper at 600mg after each treatment period followed by a 1-week washout between treatments. Polysomnography (PSG) was used to objectively evaluate changes in sleep and PLMs.	Restless Legs Syndrome Restless Legs Syndrome (RLS)	PSG Restless Legs Syndrome gabapentin enacarbil XP13512 GSK1838262 sleep disturbance RLS polysomnography	null	2	arm 1: GSK1838262 extended release tablets for Treatment Period 1 followed by Placebo for Treatment Period 2 arm 2: Placebo for Treatment Period 1 followed by GSK1838262 for Treatment Period 2	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: GSK1838262 extended release tablets intervention 2: Placebo	intervention 1: GSK1838262 Extended Release Tablets intervention 2: Placebo	24	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Hallandale \| Florida \| United States \| -80.14838 \| 25.9812 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Lenexa \| Kansas \| United States \| -94.73357 \| 38.95362 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Crestview Hills \| Kentucky \| United States \| -84.58494 \| 39.02728 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Chevy Chase \| Maryland \| United States \| -77.07115 \| 39.00287 Brighton \| Massachusetts \| United States \| -71.15644 \| 42.3501 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 West Seneca \| New York \| United States \| -78.79975 \| 42.85006 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dublin \| Ohio \| United States \| -83.11408 \| 40.09923 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Walla Walla \| Washington \| United States \| -118.34302 \| 46.06458	259	NCT00748098	1COMPLETED	2009-07-01	2008-10-01	XenoPort, Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	2	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and myocardial efficiency in patients with heart failure and to confirm that the unique preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with heart failure.	null	Heart Failure		null	2	arm 1: 0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 arm 2: ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr intervention 2: I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr	intervention 1: CK-1827452 intervention 2: CK-1827452	3	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	2	NCT00748579	6TERMINATED	2009-07-01	2008-09-01	Cytokinetics	4INDUSTRY	false	false	false	null	0
[ 5 ]	131	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to determine if a 24 week weight loss program with orlistat 60 mg will produce greater changes in body composition compared to placebo.	Large amounts of VAT (adipose tissue surrounding the viscera of the organs), is known to be associated with increased risk of heart disease and diabetes. Orlistat (tetrahydrolipstatin or THL) inhibits gastrointestinal lipase and reduces the absorption of dietary fat. The purpose of this study is to to determine if a 24 week weight loss program with orlistat 60 mg would produce greater changes in adipose tissue depots (specifically VAT) compared to placebo. This study will use the Echo MRI technology across multiple sites to measure total fat mass. EchoMRI is a non invasive method ideally suited for studies which track changes in human body composition over time, with measuring times of less than 3 minutes and no radiation exposure.	Obesity Overweight	overweight, orlistat, body composition	null	2	arm 1: Orlistat 60 milligram (mg) capsules to be consumed orally with each meal 3 times per day arm 2: Placebo to match Orlistat 60 mg capsules to be consumed orally with each meal 3 times per day.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Weight loss treatment intervention 2: Inactive	intervention 1: Orlistat intervention 2: Placebo	3	Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Gothenburg \| West Gothland \| Sweden \| 11.96679 \| 57.70716	127	NCT00752726	1COMPLETED	2009-07-01	2008-09-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 3 ]	368	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.	null	Asthma	Asthma	null	4	arm 1: AZD1981 50 mg Twice Daily (Bid) arm 2: Placebo arm 3: AZD1981 400 mg Twice Daily (Bid) arm 4: AZD1981 1000 mg Twice Daily (Bid)	[ 0, 2, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Oral tablet, 50 mg twice daily intervention 2: Oral tablet, 400 mg twice daily intervention 3: Oral tablet, 1000 mg twice daily intervention 4: None	intervention 1: AZD1981 intervention 2: AZD1981 intervention 3: AZD1981 intervention 4: Placebo	21	Buenos Aires \| Argentina \| Argentina \| -58.37723 \| -34.61315 Quilmes \| Buenos Aires \| Argentina \| -58.25454 \| -34.72065 Santa Fe \| Santa Fe Province \| Argentina \| -60.70868 \| -31.64881 San Miguel de Tucumán \| Tucumán Province \| Argentina \| -65.21051 \| -26.81601 Porto Alegre \| Brasil \| Brazil \| -51.23019 \| -30.03283 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Santo André \| São Paulo \| Brazil \| -46.53833 \| -23.66389 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Barrio Los Yoses \| Provincia de San José \| Costa Rica \| N/A \| N/A San Francisco de Dos Ríos \| Provincia de San José \| Costa Rica \| -84.05716 \| 9.90947 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Gdalsk \| N/A \| Poland \| N/A \| N/A Kielce \| N/A \| Poland \| 20.62752 \| 50.87033 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznal \| N/A \| Poland \| N/A \| N/A Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Tarnów \| N/A \| Poland \| 20.98698 \| 50.01381 Turek \| N/A \| Poland \| 18.50055 \| 52.01548 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1	368	NCT00758589	1COMPLETED	2009-07-01	2008-09-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	86	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.	null	Glaucoma	Glaucoma	null	2	arm 1: Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months. arm 2: Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: One drop three times a day in both eyes for 3 months intervention 2: One drop three times a day in both eyes for 3 months intervention 3: One drop once a day in both eyes for 3 months	intervention 1: Brinzolamide 1% ophthalmic solution (Azopt) intervention 2: Placebo eye drops intervention 3: Latanoprost 0.005% ophthalmic solution (Xalatan)	1	Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541	86	NCT00759941	1COMPLETED	2009-07-01	2007-10-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 5 ]	8	NA	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	true	The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.	Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.	Coronary Artery Disease		null	1	arm 1: Compare to baseline	[ 5 ]	1	[ 0 ]	intervention 1: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously	intervention 1: dipyridamole	1	Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982	8	NCT00763009	6TERMINATED	2009-07-01	2002-09-01	UConn Health	7OTHER	false	false	false	null	0
[ 4 ]	401	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.	null	Chronic Low Back Pain		null	2	arm 1: Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment arm 2: Patients received placebo by mouth once daily for 12 weeks of double-blind treatment	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg orally once daily for 12 weeks intervention 2: Placebo once daily orally for 12 weeks	intervention 1: Duloxetine intervention 2: Placebo	26	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Cromwell \| Connecticut \| United States \| -72.64537 \| 41.5951 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Brighton \| Massachusetts \| United States \| -71.15644 \| 42.3501 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Sacomã \| N/A \| Brazil \| -46.59817 \| -23.63083 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Aalen \| N/A \| Germany \| 10.0933 \| 48.83777 Alzenau in Unterfranken \| N/A \| Germany \| 9.06455 \| 50.0888 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Ellwangen \| N/A \| Germany \| 10.13173 \| 48.96164 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Rotterdam \| N/A \| Netherlands \| 4.47917 \| 51.9225 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 A Coruña \| N/A \| Spain \| -8.396 \| 43.37135 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Bilboa \| N/A \| Spain \| N/A \| N/A Getafe \| N/A \| Spain \| -3.73295 \| 40.30571 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165	401	NCT00767806	1COMPLETED	2009-07-01	2008-09-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0

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