Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	METADATA_nctId string	METADATA_overallStatus class label	METADATA_completionDate date32	METADATA_startDate date32	METADATA_leadSponsorName string	METADATA_leadSponsorClass class label	METADATA_hasProtocol bool	METADATA_hasSap bool	METADATA_hasIcf bool	METADATA_protocolPdfLinks string	METADATA_wilson_lower_bound float32
[ 5 ]	136	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).	This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.	Partial Seizures	Lyrica Epilepsies - Partial	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 150 to 600 mg/day during 21 weeks	intervention 1: Pregabalin	8	Mexico \| D. F. \| Mexico \| -98.43784 \| 18.88011 Acapulco de Juárez \| Guerrero \| Mexico \| -99.90891 \| 16.84942 Morelia \| Michoacán \| Mexico \| -101.18443 \| 19.70078 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Aguascalientes \| N/A \| Mexico \| -102.2843 \| 21.88262 Chihuahua City \| N/A \| Mexico \| -106.08889 \| 28.63528 Estado de México \| N/A \| Mexico \| -90.88107 \| 18.01981	136	NCT00407797	6TERMINATED	2009-08-01	2007-03-01	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	52	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer. Despite the efforts in front-line therapy, second-line protocols have not yet been established in randomized clinical trials for those patients. Although many patients are still in good performance status and present with low tumor burden after failure of first-line chemotherapy, they may clearly benefit from second-line treatment. Increasingly more metachronic metastatic patients are urging for new platinum-free therapeutic options due to the fast-growing use of (neo-) adjuvant platin-based protocols. So far, only sparse data on chemotherapy are available after failure of platin-based protocols. Nearly only irinotecan-containing combinations have properly been analyzed, and produced excellent response rates and survival times of up to 30% and 7.6 months, respectively. However, irinotecan has not been approved yet for this indication. In addition, as irinotecan-containing regimens have been submitted for approval for first-line therapy, second-line regimens in irinotecan-refractory patients have not been evaluated in any trial. Thus, there is an urgent need to establish new second-line treatment options for both, cisplatinum- or irinotecan-combination refractory patients with advanced or metastatic gastric cancer. Sunitinib inhibits the receptor tyrosine kinases (RTKs) involved in tumor proliferation and angiogenesis, specifically the VEGFR, PDGFR, KIT, FLT-3, and RET. The VEGF pathway has been shown to be a significant factor in metastatic gastric cancer. In gastric carcinoma cells, VEGF ligands and its receptors are definitely involved in the process of tumor progression. KDR and FLT-1 are expressed widely and VEGF stimulated KDR-positive tumor cell growth directly. The ligand VEGF-C has also been shown to be involved in progression of human gastric carcinoma, particularly via lymphangiogenesis. In addition, peritoneal metastases of some cancers such as gastric cancers were largely dependent on VEGF. Therefore, patients with chemo-refractory metastatic gastric cancer might benefit from VEGFR inhibitory therapy with sunitinib.	null	Gastric Adenocarcinoma Barrett Esophagus	Adenocarcinoma of esophagogastric junction Adenocarcinoma of lower esophagus (Barrett carcinoma)	null	0	null	null	1	[ 0 ]	intervention 1: Capsules of 50, 25 or 12,5 mg. Dosage 50 mg, 37.5 mg or 25 mg once daily until progression of disease or untolerable side effects	intervention 1: Sunitinib-Malate	12	Heidelberg \| Baden-Würtemberg \| Germany \| 8.69079 \| 49.40768 Tübingen \| Baden-Würtemberg \| Germany \| 9.05222 \| 48.52266 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Cologne \| North Rhine-Westphalia \| Germany \| 6.95 \| 50.93333 Essen \| North Rhine-Westphalia \| Germany \| 7.01228 \| 51.45657 Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 Homburg/Saar \| Saarland \| Germany \| N/A \| N/A Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Magdeburg \| Saxony-Anhalt \| Germany \| 11.62916 \| 52.12773 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333	52	NCT00411151	1COMPLETED	2009-08-01	2006-12-01	Johannes Gutenberg University Mainz	7OTHER	false	false	false	null	0
[ 3 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to assess the effects of the treatment combination of the commercially available chemotherapy drugs, docetaxel and liposomal doxorubicin, and a blood thinner Enoxaparin on pancreatic cancer. The main goal of the study is to find out if this combination chemotherapy and enoxaparin increases the number of individuals whose tumors shrink.	The objective of the study is to determine the safety and efficacy of the combination of docetaxel and liposomal doxorubicin chemotherapy combined with enoxaparin in patients with advanced pancreatic cancer. Docetaxel (TAXOTERE) belongs to the group of anticancer drugs called mitotic inhibitors. Liposomal doxorubicin (Doxil) is an anthracycline, and is thought to prevent nucleic acid synthesis that is needed to make DNA. Enoxaparin (Lovenox) is an anticoagulant. We are interested in combining chemotherapy with the blood thinner enoxaparin because there is a scientific link between blood clotting and malignancy. This research is being done to improve on currently available chemotherapy treatments for advanced pancreatic cancer. The main goal of the study is to find out if this combination chemotherapy and enoxaparin increases the number of individuals whose tumors shrink. Another purpose of this study is to find out how this study treatment effects blood clotting levels in individuals. We will also determine the incidence of elevated D-dimer and the effect of this regimen on the level of D-dimer, and collect safety data on this regimen.	Pancreatic Cancer	Pancreatic Docetaxel Doxorubicin Enoxaparin	null	1	arm 1: Docetaxel 75 mg/m\^2 + Doxil 30 mg/m\^2 + Enoxaparin 1.5 mg/kg	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Docetaxel intervention 2: Liposomal Doxorubicin intervention 3: Enoxaparin	1	Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113	2	NCT00426127	6TERMINATED	2009-08-01	2006-11-01	University of Iowa	7OTHER	false	false	false	null	0
[ 0 ]	9	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives: 1. To determine the feasibility and toxicity of employing purine-analog based conditioning for allogeneic donor stem cell transplantation in patients with severe aplastic anemia (AA). 2. To determine the engraftment kinetics and degree of chimerism that can be achieved with this strategy.	Before treatment starts, patients will have their bone marrow checked and will have lung, heart, and kidney tests. Patients in this study will receive the drugs fludarabine, cyclophosphamide, and antithymocyte globulin by vein through a previously inserted plastic catheter that extends into the large chest vein. Fludarabine will be given daily for four days, cyclophosphamide will given daily for four days, and antithymocyte globulin will be given daily for four days (three days for related donor transplants). Two days after the last dose of cyclophosphamide, donor marrow or stem cells will be infused through a catheter (thin plastic tube). Drugs will be given to lower the chance of an allergic reaction to the stem cells. Patients will also get shots of filgrastim (a drug that helps white blood cell growth) and antibiotics by mouth. The blood cell counts will fall to low levels during the first 2 weeks when patients may need transfusions of red blood cells and platelets. The chemotherapy will be given in the hospital. After the infusion of stem cells, patients will be monitored in the hospital. They will later be closely followed as outpatients and will be required to remain in the Houston area for about three months after the transplant. Drugs (cyclosporine and methotrexate) to lower the chance of graft-versus-host disease will be given. Cyclosporine will be given as a continuous infusion starting 2 days before transplantation. Methotrexate will be given through the catheter on Days 1, 3, 6 and 11 after transplantation. Cyclosporine will be given as pills when the patient is able to swallow. Cyclosporine will be continued for no less than 6 months after transplantation after which it will be gradually stopped. The drug tacrolimus may be used instead of cyclosporine. Blood, urine, bone marrow, and x-ray exams will be done as needed to monitor the results of bone marrow transplantation. Patients may require blood and platelet transfusions. Blood tests will be done daily while hospitalized and several times a week until the blood counts recover. Bone marrow aspiration and biopsies will be performed before the transplant, when the donated cells show signs of engraftment, and at other times during the next 1 to 3 years. They will be done to evaluate the growth of the transplant marrow, possible recurrence of malignancy, and recovery of immunity. If this treatment proves unsuccessful in more than three of the first ten patients, the study will be stopped. This is an investigational study. The FDA has approved all of the drugs in this study for other indications. Up to 30 patients will be treated on this study. All will be enrolled at M.D. Anderson.	Aplastic Anemia	Severe Aplastic Anemia Bone Marrow Failure Stem Cell Transplantation Fludarabine Cyclophosphamide Antithymocyte Globulin SAA ATG Cytoxan Neosar Fludarabine Phosphate Thymoglobulin	null	1	arm 1: Fludarabine 30 mg/m\^2/day by vein (IV), Cyclophosphamide IV 300 mg/m\^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 30 mg/m\^2 by vein daily over 30 minutes intervention 2: 300 mg/m\^2 by vein daily over 2 hours intervention 3: 3.75 mg/kg by vein daily over 4 hours	intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Antithymocyte Globulin	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	9	NCT00427336	1COMPLETED	2009-08-01	2000-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 4 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	1FEMALE	false	The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity. Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation. The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.	-Introduction The Polycystic Ovarian Syndrome (PCOS) is a frequent endocrine among women in reproductive ages, with a prevalence of 10%. In 2003, a consensus among the European and American Society of Human Reproduction (ESRHE and ASRM) defined that PCOS is a ovarian disfunction which present at least 2 out of 3 criteria: oligomenorrhea or anovulation; clinical or laboratorial signs of hyperandrogenism and polycystic ovaries on ultrasound; other causes, such as congenital adrenal hyperplasia, androgen secretory tumors, Cushing syndrome and hyperprolactinemia must be rule out. Patients with PCOS who desire to became pregnant need, in their majority, induction of ovulation. Traditionally, clomiphene citrate, an estrogen receptor agonist, is the most used drug for this type of anovulation. The mechanism of action of clomiphene is related to a negative feedback to the endogenous estrogen, resulting in a higher amplitude of gonadotrophin surges, i.e., luteinizing hormone(LH) and follicle stimulating hormone(FSH). Nevertheless, recent studies have been shown that clomiphene citrate has a deleterious effect in the endometrium. The markers of uterine receptivity, among them, the integrin beta3 subunit, has its expression diminished, which implicate in a reduced fecundation rate. The raloxifene is a selective estrogen receptor modulator. It has an agonist and antagonist activity over different organs. The daily therapy with raloxifene increase bone density, reduce cholesterol serum concentrations (LDL) and do not stimulate the endometrium in post-menopausal women (Delmas PD et al., 1997). Recent studies have shown that this drug is safe in healthy pre-menopausal women (Baker VL et al., 1998). A daily dosi of 100mg per 28 days, beginning on the 3rd day of the cycle, has shown that FSH and LH levels were not affected when compared to controls during the menstrual cycle. However, women who had received 100mg of raloxifene had a 31% increase in their FSH serum levels during the follicular phase, when compared to controls. An increase to 200mg did not increase FSH levels (Baker VL et al, 1998). Furthermore, it has been shown that raloxifene significantly increase the in vitro expression of αvβ3 integrin, suggesting a beneficial effect over the endometrium in relation to clomiphene (Lessey BA, personal communication, 2006). -Objective To compare the ovulation rate between raloxifene and clomiphene among women with polycystic ovarian syndrome. To identify the endometrial alterations compatible with ovulations, i.e., secretory endometrium, through endometrial biopsy between the women who used raloxifene or clomiphene. -Patients and Methods Patients with the diagnosis of polycystic ovarian syndrome (because of infertility or hirsutism) who had a consultation at outpatient clinic of Hospital de Clínicas de Porto Alegre will be invited to participate in the study, after signing the informed consent. A standard interview will be performed. In the first consultation, the laboratorial exams will reviewed: total testosterone, 17 OH-progesterone, fasting glucose, TSH, prolactin. After the interview, the patient will be randomized for one of the treatments: 100mg of clomiphene or 100mg of raloxifene from day 3 of the menstrual cycle, for 5 days. Menstruation will be induced with 10mg of oral medroxyprogesterone per 10 days. On day 10, urinary LH will be collected daily along with endovaginal ultrasound for assessing follicular development. On post-ovulatory day 8\~10, progesterone levels will be measured from blood. An endometrial biopsy on day 8\~10 post-ovulation will be performed in those patients who do not wish to became pregnant. The endometrial biopsy will divided into 2 parts and kept in liquid nitrogen and formol for immunohistochemistry and histological analysis respectively. Sample size and statistical analysis Ethical aspects	Polycystic Ovary Syndrome	Polycystic Ovary Syndrome clomiphene citrate Raloxifene	null	2	arm 1: Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle arm 2: Use of 100mg of raloxifene during days 5-9 of the menstrual cycle	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 100mg PO on days 5-9 of the menstrual cycle intervention 2: 100mg PO on days 5-9 of the menstrual cycle	intervention 1: clomiphene citrate intervention 2: raloxifene	1	Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283	82	NCT00427700	1COMPLETED	2009-08-01	2008-08-01	Hospital de Clinicas de Porto Alegre	7OTHER	false	false	false	null	0
[ 3 ]	41	NON_RANDOMIZED	null	0TREATMENT	0NONE	false	0ALL	null	The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.	null	Breast Neoplasms		null	1	arm 1: BIBW 2992 (Afatinib) once daily until progression	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: BIBW 2992	12	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Bournemouth \| N/A \| United Kingdom \| -1.8795 \| 50.72048 Crownhill, Plymouth \| N/A \| United Kingdom \| N/A \| N/A Guildford \| N/A \| United Kingdom \| -0.57427 \| 51.23536 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Poole \| N/A \| United Kingdom \| -1.98458 \| 50.71429 Truro \| N/A \| United Kingdom \| -5.05436 \| 50.26526	41	NCT00431067	1COMPLETED	2009-08-01	2006-09-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0
[ 2 ]	28	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.	The prevalence of asthma has dramatically increased in many parts of the world. Currently, there is no effective way to prevent development of allergic rhinitis and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and tolerability of a sublingual cockroach extract given to people with perennial allergic rhinitis. Participants in this study will include people both with and without asthma. Participation in this study will last a little more than 2 weeks. Participants will be stratified by age (oldest to youngest age group) and degree of cockroach sensitivity. Each age group will be enrolled after the previous group's safety data have been reviewed. At study entry (Day 0), participants will receive a dose of placebo and then up to seven incremental doses of cockroach extract at 15-minute intervals while observed by the clinic nurse. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached. At the Principal Investigator's discretion, participants who were able to achieve the maximum study dose will be invited to continue onto the 2-week treatment course of the study. These participants will return on Days 1 and 2 to the clinic to self-administer the maximum study dose of cockroach extract. After self-administering the maximum study dose, participants will be observed by the clinic nurse for 30 minutes. On Days 3 through 14, participants will take the maximum study dose of cockroach extract daily at home. Participants will be asked to keep a diary and record signs or symptoms experienced after taking each dose. Skin tests, breathing tests, and blood collection will occur at study screening. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical exam/fitness assessment will be done at study screening, study entry, and the final visit. Unused extract will be collected at the final visit from participants who entered the 2-week treatment course of the study. The reference for this study is SCSS (Sublingual Cockroach Safety Study) in the provided citation: Wood RA, Togias A, Wildfire J et al. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52. PubMed ID: 24184147).	Allergy Asthma	Perennial Allergic Rhinitis Asthma Sublingual Immunotherapy (SLIT)	null	1	arm 1: Glycerinated German Cockroach Allergenic Extract	[ 0 ]	2	[ 0, 0 ]	intervention 1: Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters \[mL\], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose \[0.42 mL, 1:10 wt/vol\] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route. intervention 2: Placebo was administered only as the first dose (e.g., representing no Glycerinated German Cockroach bioequivalent allergy units) during the initial 1-day, 8-dose escalation, otherwise referred to as the Preliminary Dosing Visit. Refer to the Glycerinated German cockroach allergenic extract treatment for more details. Route of administration: sublingual-oral route.	intervention 1: Glycerinated German cockroach allergenic extract intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	28	NCT00434421	1COMPLETED	2009-08-01	2007-02-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0
[ 4 ]	1,723	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	To determine if long-term treatment with Flibanserin is safe and to monitor the effectiveness of Flibanserin in Women with HSDD that have already completed a previous study (511.70/71/.74/.75/.105) with Flibanserin.	null	Sexual Dysfunctions, Psychological		null	1	arm 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.	[ 0 ]	1	[ 0 ]	intervention 1: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.	intervention 1: Flibanserin	196	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Little Rock \| Alaska \| United States \| N/A \| N/A Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fair Oaks \| California \| United States \| -121.27217 \| 38.64463 Irvine \| California \| United States \| -117.82311 \| 33.66946 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Sacramento \| California \| United States \| -121.4944 \| 38.58157 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 Stanford \| California \| United States \| -122.16608 \| 37.42411 Tarzana \| California \| United States \| -118.55397 \| 34.17334 Torrance \| California \| United States \| -118.34063 \| 33.83585 Vista \| California \| United States \| -117.24254 \| 33.20004 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Groton \| Connecticut \| United States \| -72.07841 \| 41.3501 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 New London \| Connecticut \| United States \| -72.09952 \| 41.35565 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Fort Meyers \| Florida \| United States \| N/A \| N/A Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Gainsville \| Florida \| United States \| N/A \| N/A Hudson \| Florida \| United States \| -82.69343 \| 28.36445 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Stuart \| Florida \| United States \| -80.25283 \| 27.19755 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Sandy Springs \| Georgia \| United States \| -84.37854 \| 33.92427 Champaign \| Illinois \| United States \| -88.24338 \| 40.11642 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Lafayette \| Louisiana \| United States \| -92.01984 \| 30.22409 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 New Orlean \| Louisiana \| United States \| N/A \| N/A Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Brighton \| Massachusetts \| United States \| -71.15644 \| 42.3501 Haverhill \| Massachusetts \| United States \| -71.07728 \| 42.7762 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Bingham Farms \| Michigan \| United States \| -83.27326 \| 42.51587 Bingham Farms \| Michigan \| United States \| -83.27326 \| 42.51587 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Chaska \| Minnesota \| United States \| -93.60218 \| 44.78941 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Albequerque \| New Mexico \| United States \| N/A \| N/A Endwell \| New York \| United States \| -76.02103 \| 42.11285 Poughkeepsie \| New York \| United States \| -73.92097 \| 41.70037 Purchase \| New York \| United States \| -73.71457 \| 41.04093 Rochester \| New York \| United States \| -77.61556 \| 43.15478 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medfod \| Oregon \| United States \| N/A \| N/A Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Jenkintown \| Pennsylvania \| United States \| -75.12517 \| 40.09594 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 West Reading \| Pennsylvania \| United States \| -75.94743 \| 40.3337 Wilkes-Barre \| Pennsylvania \| United States \| -75.88131 \| 41.24591 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Anderson \| South Carolina \| United States \| -82.65013 \| 34.50344 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 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 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Sandy City \| Utah \| United States \| -111.8841 \| 40.59161 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Renton \| Washington \| United States \| -122.21707 \| 47.48288 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Middleton \| Wisconsin \| United States \| -89.50429 \| 43.09722 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Coquitlam \| British Columbia \| Canada \| -122.78217 \| 49.2846 North Vancouver \| British Columbia \| Canada \| -123.06934 \| 49.31636 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Woodstock \| New Brunswick \| Canada \| -67.58377 \| 46.15796 Mount Pearl \| Newfoundland and Labrador \| Canada \| -52.78135 \| 47.51659 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Barrie \| Ontario \| Canada \| -79.66634 \| 44.40011 Burlington \| Ontario \| Canada \| -79.83713 \| 43.38621 London \| Ontario \| Canada \| -81.23304 \| 42.98339 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238	1,723	NCT00441558	6TERMINATED	2009-08-01	2007-02-01	Sprout Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	60	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).	Varicose veins are extremely common, affecting up to 25% of the western adult population. While in their early stages they are little more than a sometimes-painful aesthetic problem, progression is inevitable and some will progress to more severe and largely irreversible problems of chronic venous insufficiency (CVI) and, finally, venous leg ulcer. At present, no system has been proven to identify those that will progress and while varicose veins are not the only cause of CVI, in approximately 50% of patients with leg ulcers, superficial varicose veins are the only causal factor identified. The cost of management of simple varicose veins is relatively small in comparison with the long-term management of CVI and leg ulcers. Many patients progress to develop leg ulcers without having received primary treatment for their varicose veins. The current management of major varicose veins includes maintenance by compression stockings, injection sclerotherapy with liquid sclerosants, and superficial vein surgery. The disadvantages to surgery include the use of general anesthesia, incisions resulting in possible scars, a painful recovery period with significant functional down time and historically high rates of recurrence. Sclerotherapy has been performed since 1851 with the advent of hypodermic needles. The two surfactant sclerosants most widely used are sodium tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph Eur, Aethoxyskerol®). Sotradecol is the only FDA-approved sclerosant. With the advent of duplex ultrasound scanning, the technique of echo-guided sclerotherapy has widened the possibilities for sclerotherapy of large veins but the liquid sclerosants available are rapidly deactivated and diluted by blood frequently resulting in unsatisfactory outcomes. Because the microfoam delivers sclerosant more efficiently to the venous endothelium, it is believed that lower concentrations of polidocanol (Varisolve)can be used when compared with liquid sclerosant. BTG International Ltd is developing sclerosant microfoam technology based on polidocanol (PD)(Varisolve) into a pharmaceutical product. The presence of bubbles in the heart has been a concern as bubbles may pass from the right heart to the left through a patent foramen ovale (PFO) or other right-to-left shunt. Once in the systemic circulation, some bubbles inevitably pass into the cerebral circulation where their theoretical potential for causing damage due to occlusion of vessels is recognized yet ill defined. Therefore this study is to determine whether patients with bubbles detected in the middle cerebral artery (MCA) during the Varisolve® procedure experience any sub-clinical, safety-related events such as abnormalities on brain MRI, neurological examination, cardiac markers or other symptoms or signs.	Varicose Veins	PFO Patent Foramen Ovale Right-to-Left Shunt Sclerotherapy	null	1	arm 1: Polidocanol (1%) Microfoam (Varisolve)	[ 0 ]	2	[ 0, 3 ]	intervention 1: Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein. intervention 2: Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.	intervention 1: Polidocanol (1%) Microfoam (Varisolve) intervention 2: Endovenous Microfoam Occlusion	7	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038	60	NCT00442364	1COMPLETED	2009-08-01	2007-03-01	Boston Scientific Corporation	4INDUSTRY	false	false	false	null	0
[ 3 ]	56	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This phase II trial is studying how well giving erlotinib together with sorafenib works in treating patients with progressive or recurrent glioblastoma multiforme. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving erlotinib together with sorafenib may kill more tumor cells.	PRIMARY OBJECTIVES: I. The primary objective of this trial is to estimate the overall survival rate associated with this combined regimen in treating adult patients with recurrent glioblastoma multiforme. SECONDARY OBJECTIVES: I. To assess and estimate the toxicities. II. Tumor response rate. III. To estimate 6-month progression free survival. IV. To describe the pharmacokinetics of this route of administration. V. For the Molecular Targeted Combinations Correlative (MTC2) Study Initiative: To determine the relationship between tumor and blood biomarkers and clinical outcome of patients treated with the combination of targeted agents. OUTLINE: This is a multicenter, open-label, phase II study. Patients receive oral erlotinib hydrochloride once daily and oral sorafenib tosylate twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Tumor tissue and blood samples are collected prior to beginning treatment. Samples are analyzed by immunohistochemistry, gene expression, and DNA mutation and genomic analyses of the epidermal growth factor receptor, ras-raf-ERK, and PI3K-Akt-mTOR pathways to identify markers that correlate with patient outcomes. Blood samples are also collected on day 15 of course 1 for pharmacokinetic studies. Samples are analyzed by reversed-phase isocratic high-performance liquid chromatography with electrospray ionization mass spectrometry to determine the concentration of erlotinib hydrochloride and sorafenib tosylate and its known metabolites. After completion of study therapy, patients are followed every 2 months.	Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor		null	1	arm 1: Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Other: pharmacological study	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: 150mg Given orally once daily intervention 2: 400mg Given orally twice daily intervention 3: Correlative studies	intervention 1: erlotinib hydrochloride intervention 2: sorafenib tosylate intervention 3: pharmacological study	9	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	56	NCT00445588	1COMPLETED	2009-08-01	2007-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0
[ 2 ]	12	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To evaluate the clinically recommended dose of AG-013736 (Axitinib) in Japanese patients by reviewing the safety of AG-013736 (Axitinib) following single and multiple dosing.	null	Carcinoma	Safety PK Biomarker	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: AG-013736 5mg twice daily \[BID\]	intervention 1: Axitinib (AG-013736)	1	Kashiwa \| Chiba \| Japan \| 139.97732 \| 35.86224	12	NCT00447005	1COMPLETED	2009-08-01	2007-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 3 ]	137	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.	null	Influenza	influenza flu	null	3	arm 1: Peramivir 200 mg administered intravenously once daily for 5 days (5 doses) arm 2: Peramivir 400 mg administered intravenously once daily for 5 days (5 doses) arm 3: Oseltamivir 75 mg oral suspension administered orally twice daily for 5 days (10 doses)	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment intervention 2: Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 ml) intervention 3: Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)	intervention 1: Peramivir 200 mg intervention 2: Peramivir 400 mg intervention 3: Oseltamivir	83	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Orange \| California \| United States \| -117.85311 \| 33.78779 Orange \| California \| United States \| -117.85311 \| 33.78779 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Jose \| California \| United States \| -121.89496 \| 37.33939 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Natchitoches \| Louisiana \| United States \| -93.08627 \| 31.76072 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Neptune City \| New Jersey \| United States \| -74.02792 \| 40.20011 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salem \| Virginia \| United States \| -80.05476 \| 37.29347 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Marshfield \| Wisconsin \| United States \| -90.1718 \| 44.66885 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Randwick \| New South Wales \| Australia \| 151.24895 \| -33.91439 Wentworthville \| New South Wales \| Australia \| 150.96785 \| -33.80652 Cairns \| Queensland \| Australia \| 145.76613 \| -16.92366 South Brisbane \| Queensland \| Australia \| 153.02049 \| -27.48034 Southport \| Queensland \| Australia \| 153.39796 \| -27.96724 Woolloongabba \| Queensland \| Australia \| 153.03655 \| -27.48855 Daw Park \| South Australia \| Australia \| 138.58407 \| -34.98975 Parkville \| Victoria \| Australia \| 144.95 \| -37.78333 Nedlands \| Western Australia \| Australia \| 115.8073 \| -31.98184 Kelowna \| British Columbia \| Canada \| -119.48568 \| 49.88307 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Chicoutimi \| Quebec \| Canada \| -71.06369 \| 48.41963 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Rimouski \| Quebec \| Canada \| -68.52396 \| 48.44879 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Shatin - New Territories \| N/A \| Hong Kong \| N/A \| N/A Christchurch \| N/A \| New Zealand \| 172.63333 \| -43.53333 Hamilton \| N/A \| New Zealand \| 175.28333 \| -37.78333 Tauranga \| N/A \| New Zealand \| 176.16667 \| -37.68611 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Port Elizabeth \| E. Cape \| South Africa \| 25.61494 \| -33.96109 Bloemfontein \| Free State \| South Africa \| 26.214 \| -29.12107 Benoni \| Gauteng \| South Africa \| 28.32078 \| -26.18848 Cape Town \| Gauteng \| South Africa \| N/A \| N/A Johannesburg \| Gauteng \| South Africa \| 28.04363 \| -26.20227 Krugersdorp \| Gauteng \| South Africa \| 27.77515 \| -26.08577 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Soweto \| Gauteng \| South Africa \| 27.85849 \| -26.26781 Durban \| KZ-Natal \| South Africa \| 31.0292 \| -29.8579 Mbombela \| Mpumalanga \| South Africa \| 30.96935 \| -25.47512 Worcester \| W Cape \| South Africa \| 19.44852 \| -33.64651 Cape Town \| WC \| South Africa \| 18.42322 \| -33.92584	137	NCT00453999	1COMPLETED	2009-08-01	2007-07-01	BioCryst Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	420	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	1FEMALE	false	The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety	The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles. The trial is sponsored by Bayer Yakuhin, Ltd.	Dysmenorrhea	Dysmenorrhea Intracyclic bleeding Drospirenone (DRSP) Ethinylestradiol	null	2	arm 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) arm 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles) intervention 2: 1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)	intervention 1: DRSP 3 mg/EE 20 µg (13 cycles) intervention 2: DRSP 3 mg/EE 30 µg (6 cycles)	26	Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Nagoya \| Aichi-ken \| Japan \| 136.90641 \| 35.18147 Maebashi \| Gunma \| Japan \| 139.08333 \| 36.4 Takasaki \| Gunma \| Japan \| 139.01667 \| 36.33333 Kobe \| Hyōgo \| Japan \| 135.183 \| 34.6913 Nishinomiya \| Hyōgo \| Japan \| 135.33199 \| 34.71562 Yamato \| Kanagawa \| Japan \| 139.45101 \| 35.47276 Yokohama \| Kanagawa \| Japan \| 139.65 \| 35.43333 Sendai \| Miyagi \| Japan \| 140.86667 \| 38.26667 Sendai \| Miyagi \| Japan \| 140.86667 \| 38.26667 Sendai \| Miyagi \| Japan \| 140.86667 \| 38.26667 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Toyonaka \| Osaka \| Japan \| 135.46932 \| 34.78244 Chuo-ku \| Tokyo \| Japan \| N/A \| N/A Hachiōji \| Tokyo \| Japan \| 139.32389 \| 35.65583 Machida \| Tokyo \| Japan \| 139.45083 \| 35.54028 Musashino \| Tokyo \| Japan \| 139.55944 \| 35.70611 Ōta-ku \| Tokyo \| Japan \| 139.71605 \| 35.56126 Setagaya-ku \| Tokyo \| Japan \| N/A \| N/A Setagaya-ku \| Tokyo \| Japan \| N/A \| N/A Shibuya-ku \| Tokyo \| Japan \| N/A \| N/A Shinagawa-ku \| Tokyo \| Japan \| N/A \| N/A Suginami-ku \| Tokyo \| Japan \| N/A \| N/A Toshima-ku \| Tokyo \| Japan \| N/A \| N/A	420	NCT00461305	1COMPLETED	2009-08-01	2007-02-01	Bayer	4INDUSTRY	false	false	false	null	0
[ 0 ]	100	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas	The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place. Fibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.	Pleural Effusion Associated With Pulmonary Infection Bacterial Pleural Effusion Other Than Tuberculosis	parapneumonic pleural effusion empyema TPA (Activase, Alteplase)	null	2	arm 1: Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted. arm 2: If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days intervention 2: Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days	intervention 1: Alteplase intervention 2: Placebo	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	90	NCT00468104	1COMPLETED	2009-08-01	2004-04-01	Midwest Pulmonary and Critical Care	7OTHER	false	false	false	null	0
[ 2, 3 ]	27	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	RATIONALE: Drugs used in chemotherapy, such as ABT-751, 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 I/II trial is studying the side effects and best dose of ABT-751 and to see how well it works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.	OBJECTIVES: Primary * Evaluate the safety and efficacy of ABT-751 in patients with androgen-independent, hormone-refractory metastatic prostate cancer and determine the maximum tolerated dose (MTD) and optimal phase II dose of this drug in these patients. Secondary * Determine the objective response rate (partial and complete response) in patients with measurable disease treated with this drug. * Evaluate the effect of this drug on prostate-specific antigen (PSA) response in patients with nonmeasurable disease. * Determine the time to tumor progression in patients treated with this drug. * Determine survival of patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. * Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ABT-751 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 50 additional patients may be treated at the recommended phase II dose (RPTD) which is the dose level at the maximally administered dose. * Phase II: Patients receive ABT-751 at the MTD determined in phase I. After completion of study treatment, patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.	Prostate Cancer	adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer	null	1	arm 1: Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 twice daily	[ 0 ]	1	[ 0 ]	intervention 1: Phase I: Cohort \\| Number of Patients \\|Dose (mg) ABT-751 (BID) * -1 \\| 3-6 \\|100 mg BID * 1 \\| 3-6 \\|125 mg BID * 2 \\| 3-6 \\|150 mg BID * 3 \\| 3-6 \\|175 mg BID * 4 \\| 3-6 \\|200 mg BID Phase II: Patients receive ABT-751 at 125mg po BID for 7 days on, 7 days off (X2) for a 28 day cycle	intervention 1: ABT-751	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	27	NCT00471718	6TERMINATED	2009-08-01	2004-01-01	Vanderbilt-Ingram Cancer Center	7OTHER	false	false	false	null	0
[ 2 ]	5	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Purpose : This study will determine whether MK-0657, a selective NR2B Antagonist, can quickly improve symptoms of depressed mood, psychomotor retardation, poor motivation and reduced enjoyment of things in patients with major depression. MK-0657 decreases the activity of a brain receptor called NMDA, which the chemical glutamate binds to, possibly inducing a rapid antidepressant response. People between 18 and 55 years of age who have major depression of at least 4 weeks' duration and have not been helped by two antidepressants approved for major depression may be eligible for this study. Women who are able to have children are excluded. Participants are admitted to the NIH Clinical Center for two study phases, as follows. Phase I (1 to 2 weeks): Patients are tapered off their current medications. Phase II (7 weeks): Patients are randomly assigned to take either MK-0657 or placebo (look-alike capsules with no active ingredient) by mouth for 12 days. At some point during the second part this phase, patients who had been taking MK-0657 are switched over to placebo and those who had been taking placebo are switched to MK-0657. Participants undergo the following procedures during the study:Physical examination twice (at the beginning and at the end of the study) Electrocardiogram (ECG) four times Blood tests about six times Rating scales up to 28 times to assess the effects of MK-0657 on mood and thinking Blood pressure measurements three times a day. Study examines the effectiveness of a new medication, targeting a system called glutamate, will improve depression when compared with placebo.	Even though there are many antidepressant drugs for clinical use, clinical trials indicate that 30% to 40% of patients with major depression fail to respond to first-line antidepressant treatments despite adequate dosage, duration, and compliance. Furthermore, these medications may take weeks to months to achieve their full effects and in the meantime, patients continue to suffer from their symptoms and be at risk of self-harm as well as harm to their personal and professional lives. Thus, there is a clear need to develop novel and improved therapeutics for treatment-resistant major depression that have a rapid onset of action. Recent preclinical studies suggest that antidepressants may exert delayed indirect effects on the glutamatergic system, specifically on the NMDA receptor complex. A recent study by our group found that a single intravenous dose of the non-competitive NMDA antagonist ketamine produced a rapid, robust and relatively sustained antidepressant effect in patients with treatment-resistant major depression. Together, these data suggest that the NMDA receptor may play an important role in the mechanism of antidepressant action. Unfortunately, ketamine's psychotomimetic effects preclude its use as a chronic antidepressant; these side effects probably are a result of ketamine's effects on multiple NMDA subunits. Thus, studying selective NMDA subunit antagonists in depression is a reasonable next step. The NR2B subunit stands as a prime candidate to test in depression. Preclinical data by our group indicates that the NR2B subunit is involved in the mechanism of antidepressant action as indicated by changes in phosphorylation of serine residues in the learned helplessness model of depression and with chronic treatment with imipramine. In addition, we found that the NR2B antagonist R0 25-6981 has antidepressant-like properties in the forced swim test. We propose to examine whether the selective NR2B antagonist (MK-0657) produces rapid antidepressant effects in patients with treatment-resistant major depression but without causing psychotomimetic effects. Male and female patients, ages 18 to 55 years, with a diagnosis of major depression (without psychotic features), will be recruited for this study. This study consists of the double-blind crossover administration of either the NR2B antagonist MK-0657 (4-8 mg/day) or placebo. The specific aim of this study is to assess the efficacy of 12 days of a selective NR2B antagonist (MK-0657, 4-8 mg/day given orally) compared with placebo in improving overall depressive symptomatology in patients with treatment-resistant major depression. Our primary hypothesis is that subjects with treatment-resistant major depression who are randomized to a selective NR2B antagonist (MK-0657) will have a more rapid and superior response compared to when they are randomized to placebo. This is a proof of concept and treatment study. Approximately, 27 subjects will be randomized; the accrual ceiling for this protocol is 60 subjects.	Major Depression	NMDA Receptor Depression Treatment Unipolar Depression Treatment Resistant Glutamatergic Depression Major Depression	null	2	arm 1: Double-blind crossover administration of placebo then MK-0657 (4-8 mg/day) arm 2: Double-blind crossover administration of MK-0657 (4-8 mg/day) then placebo	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Daily double-blind administration of the NR2B antagonist MK-0657 (4-8 mg/day) intervention 2: Daily double-blind administration of placebo	intervention 1: MK-0657 intervention 2: Placebo	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	10	NCT00472576	1COMPLETED	2009-08-01	2007-05-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0
[ 0 ]	78	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	Among patients with stable coronary artery disease (CAD), it is not clear if the pleiotropic effects of cholesterol reduction differ between high-dose simvastatin alone and combined ezetimibe/simvastatin. The investigators sought to compare the anti-inflammatory and anti-platelet effects of ezetimibe 10 mg / simvastatin 20 mg (E10/S20) to simvastatin 80 mg (S80).	Introduction Among patients with coronary artery disease (CAD), a robust evidence base supports the beneficial effects of statin therapy on mortality and other adverse cardiovascular outcomes . Recently, two large trials , have demonstrated that compared to standard dose statin therapy, high statin doses reduced Low-density lipoprotein-C (LDL-C) to extremely low levels and decreased coronary events, even in patients with normal levels of Low-density lipoprotein-C (LDL-C). Subsequently, recent guidelines have suggested an Low-density lipoprotein-C (LDL-C) treatment goal of \<70 mg/dL in patients with coronary artery disease (CAD). Achieving such low Low-density lipoprotein-C (LDL-C) levels frequently demands an intensive Low-density lipoprotein-C (LDL-C) reduction, often above 50%. Ezetimibe, an intestinal cholesterol absorption inhibitor, can be used as an additional therapy if statin monotherapy fails to reduce Low-density lipoprotein-C (LDL-C) below the treatment goal. Furthermore, anti-inflammatory and antithrombotic pleiotropic effects of statins might explain, at least in part, the large benefits demonstrated in randomized trials , . For example, in hypercholesterolemic patients treated with statins, a decrease in inflammation-associated markers such as the C-reactive protein (CRP) has been described , although it is debated whether this effect is clearly independent of Low-density lipoprotein-C (LDL-C). Moreover, although inhibition of platelets by statin therapy is a well established effect , , it has not yet been clarified whether platelet inhibition by statin therapy depends on the reduction of Low-density lipoprotein-C (LDL-C) or on the inhibition of intracellular signal pathways accompanied by disaggregating effects. Two alternative pharmacologic strategies are equally effective in reducing Low-density lipoprotein-C (LDL-C): high-dose statin alone and combined treatment with ezetimibe plus moderate-dose statin . It is not known whether these two strategies have different cholesterol-independent pleiotropic effects on inflammation and platelets. We therefore compared the anti-inflammatory and antiplatelet effects of two intensive pharmacologic strategies to reduce cholesterol: 80 mg of simvastatin (S80) versus 10 mg ezetimibe/ 20 mg of simvastatin (E10/S20). Anti-inflammatory effects were assessed by performing serial measurements of the following biomarkers: C-Reactive Protein (CRP), monocyte chemoattractant protein (MCP)-1, oxidized Low-density lipoprotein-C (oxLDL), soluble intercellular adhesion molecule (sICAM)-1. Platelet aggregation was also compared between the two strategies.	Stable Angina	angina atherosclerosis simvastatin ezetimibe inflammation	null	2	arm 1: Patients were treated with simvastatin 80 mg for 6 weeks arm 2: Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Simvastatin 80 mg/day, single dose, for 6 weeks. intervention 2: Ezetimibe 10 mg / Simvastatin 20 mg Patients were treated with daily Ezetimibe 10 mg / Simvastatin 20 mg for 6 weeks	intervention 1: Simvastatin 80 mg/day for 6 weeks intervention 2: Ezetimibe 10 mg / Simvastatin 20 mg	1	São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475	78	NCT00474123	1COMPLETED	2009-08-01	2006-01-01	University of Sao Paulo	7OTHER	false	false	false	null	0
[ 4 ]	150	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This was a multicenter, open-label, single-arm phase 3B study of the combination lenalidomide plus pulse high-dose dexamethasone. This study (CC-5013-MM-019) was set up and executed primarily as an expanded access program in Germany. Screening procedures were to take place within 28 days prior to Cycle 1 Day 1 (baseline) with the exception of hematology assessments that were to be performed within 14 days prior to Cycle 1 Day 1. Randomization, blinding, and stratification were not applied in this open-label single-arm study. Eligible subjects given open-label treatment and received treatment with lenalidomide plus high-dose dexamethasone in 28-day cycles. Lenalidomide (hard capsules) was to be administered orally (PO) at a dose of 25 mg daily (QD) for the first 21 days of each 28-day cycle. According to the protocol, accrual of subjects to the study was to be terminated within 2 months of commercial availability of lenalidomide for this indication in Germany. Upon discontinuation from study, minimal information was collected in order to identify when disease progressed.	null	Relapsed or Refractory Multiple Myeloma	CC-5013 Revlimid Lenalidomide Celgene Multiple Myeloma	null	1	arm 1: Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression. intervention 2: Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4 (approximately months 1-4). Beginning cycle 5 (approximately month 5) dexamethasone is reduced to 40 mg daily for days 1-4 every 28 days.	intervention 1: Lenalidomide intervention 2: dexamethasone	48	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Braunschweig \| N/A \| Germany \| 10.52673 \| 52.26594 Burg \| N/A \| Germany \| 14.14856 \| 51.83448 Chemnitz \| N/A \| Germany \| 12.92922 \| 50.8357 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Frankfurt (Oder) \| N/A \| Germany \| 14.55062 \| 52.34714 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Göttingen \| N/A \| Germany \| 9.93228 \| 51.53443 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 Karlsruhe \| N/A \| Germany \| 8.40444 \| 49.00937 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Koblenz \| N/A \| Germany \| 7.57883 \| 50.35357 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 Mönchengladbach \| N/A \| Germany \| 6.44172 \| 51.18539 München \| N/A \| Germany \| 13.31243 \| 51.60698 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Potsdam \| N/A \| Germany \| 13.06566 \| 52.39886 Regensburg \| N/A \| Germany \| 12.10161 \| 49.01513 Rostock \| N/A \| Germany \| 12.14049 \| 54.0887 Saarbrücken \| N/A \| Germany \| 7.00982 \| 49.23262 Saarbrücken \| N/A \| Germany \| 7.00982 \| 49.23262 Siegen \| N/A \| Germany \| 8.02431 \| 50.87481 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232 Trier \| N/A \| Germany \| 6.63935 \| 49.75565 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Ulm \| N/A \| Germany \| 9.99155 \| 48.39841 Wuppertal \| N/A \| Germany \| 7.14816 \| 51.25627 Würselen \| N/A \| Germany \| 6.1347 \| 50.81809 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391	144	NCT00478777	1COMPLETED	2009-08-01	2007-03-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0
[ 3 ]	138	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty	This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind, dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of bupivacaine HCl.	Postoperative Pain	pain postoperative total knee arthroplasty analgesia	null	2	arm 1: Bupivacaine HCl (Marcaine 0.25% with epinephrine 1:200,000) arm 2: SKY0402 at various dosage levels. Single administration.	[ 1, 5 ]	2	[ 0, 0 ]	intervention 1: 150 mg Bupivacaine HCl intervention 2: 600 mg SKY0402 (study drug)	intervention 1: Bupivacaine HCl intervention 2: SKY0402	9	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Davis \| California \| United States \| -121.74052 \| 38.54491 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 New York \| New York \| United States \| -74.00597 \| 40.71427 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Kladno \| N/A \| Czechia \| 14.10285 \| 50.14734 Třebíč \| N/A \| Czechia \| 15.88166 \| 49.21492	138	NCT00485693	1COMPLETED	2009-08-01	2007-06-01	Pacira Pharmaceuticals, Inc	4INDUSTRY	false	false	false	null	0
[ 3 ]	73	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Mixed states in bipolar disorder have long been recognized. Over a century ago, it was argued that mixed states were the most common episodes in manic-depressive illness. A mixed state is defined as a person who is experiencing symptoms of both depression and mania. Currently, a person must have depression plus 3 or more manic symptoms for the episode to be diagnosed mixed. Using this narrow view, less than 10% of episodes in patients with bipolar disorder would meet criteria for a mixed episode. A broader view requires that the person have at least 2 manic symptoms. Using this broader view, data suggest that about 50% of episodes in bipolar disorder would be diagnosable as mixed states. Studies suggest that the majority of persons with a depressive mixed state have bipolar disorder type II. Many people who have a mixed state will also have major depression. Even with such high potential rates of mixed episodes in both bipolar disorder and major depression, there have been few studies addressing the issue. The purpose of this study is to look at how effective Geodon is in treating the depressive mixed state in people with bipolar or major depression. This will be the first clinical trial that is both double-blind and randomized.	We plan on enrolling 25 subjects from each of the four sites. After signing a consent form, subjects will be screened and asked to have a physical and specific safety labs done to make sure they can safely participate in the study. After the screening visit, subjects will be randomly, like a flip of a coin, placed into one of two groups. One group will get the study drug, Geodon. The other group will get placebo, a sugar pill. Neither the doctor nor subject will know in which group the subject has been placed. Subjects will see the doctor once a week for 6 weeks. During each visit, we will check and treat any side effects. We will ask questions about mood and go through a number of rating scales and assessments that will look at mood and symptoms. Subjects will also fill out questionnaires at each visit to assess their moods and see how the study is going. At the final visit, subjects will have the same physical exam and lab tests done as in the initial visit.	Bipolar Disorder Bipolar Depression Depression	Bipolar Disorder Major Depression Clinical pharmacology Clinical Trial	null	2	arm 1: Participants were instructed by a physician to take a study drug daily. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received sugar pills. arm 2: Participants were instructed by a physician to take a study drug daily. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone. Participants were not informed whether they were receiving sugar pills or Geodon. Participants in this study arm received Geodon.	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: ziprasidone, geodon. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks. intervention 2: Placebo, sugar pill arm. Dosing instructions began at 40 mg/day and were increased by increments of 20-40 mg weekly weekly based on target symptoms and tolerability with a target range of 80-160 mg/d of ziprasidone for 6 weeks.	intervention 1: ziprasidone (Geodon) intervention 2: placebo	4	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Cambridge \| Massachusetts \| United States \| -71.10561 \| 42.3751 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403	73	NCT00490542	1COMPLETED	2009-08-01	2006-12-01	Tufts Medical Center	7OTHER	false	false	false	null	0
[ 3 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	true	This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.	Primary Objective: To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR. Secondary Objective: To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1. To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum. Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy. Additionally, given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth, it is felt that testing in the "early" androgen independent state is warranted. This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden.	Prostate Cancer		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Sandostatin 30mg intramuscular every 28 days	intervention 1: Sandostatin	1	San Francisco \| California \| United States \| -122.41942 \| 37.77493	13	NCT00510224	6TERMINATED	2009-08-01	2007-07-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 3 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This study will define the safety and efficacy of Everolimus (RAD001) administered daily in patients with glioblastoma multiforme (GBM)	This was a multicenter, open label, randomized study of RAD001 dosed daily in patients with recurrent GBM. The study was conducted with 2 parallel groups of patients. Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection, and Group 2 was to enroll patients who were not scheduled for surgery. Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups (0, 5 or 10 mg/day RAD001 for 7 days). All patients in Group 2 were to receive a fixed daily dose of 10 mg/day oral RAD001.	Glioblastoma Multiforme	Glioblastoma Multiforme, GBM, RAD001, RAD	null	4	arm 1: Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity. arm 2: Participants scheduled to undergo salvage surgical resection received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. arm 3: Participants scheduled to undergo salvage surgical resection received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity. arm 4: Participants scheduled to undergo salvage surgical resection received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.	[ 0, 0, 0, 1 ]	2	[ 0, 3 ]	intervention 1: Tablets taken once a day with a full glass of water. intervention 2: Salvage surgical resection	intervention 1: Everolimus intervention 2: Surgery	8	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	41	NCT00515086	6TERMINATED	2009-08-01	2007-08-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	22	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.	null	Idiopathic Thrombocytopenic Purpura Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)	Immune (Idiopathic) Thrombocytopenic Purpura Pediatric Idiopathic Thrombocytopenic Purpura	null	2	arm 1: 5 thrombocytopenic (as defined per protocol) subjects arm 2: 15 thrombocytopenic (as defined per protocol) subjects	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. intervention 2: Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts.	intervention 1: Placebo intervention 2: AMG 531	0	null	22	NCT00515203	1COMPLETED	2009-08-01	2007-07-01	Amgen	4INDUSTRY	false	false	false	null	0
[ 5 ]	88	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.	null	Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State	Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 300 mg quetiapine fumarate tablets for oral use. Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.	intervention 1: Quetiapine 600mg	7	Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 San Pedro Garza García \| Nuevo León \| Mexico \| -100.40651 \| 25.6604 San Luis Potosí City \| San Luis Potosí \| Mexico \| -100.97135 \| 22.15234 Mérida \| Yucatán \| Mexico \| -89.62318 \| 20.967 Durango \| N/A \| Mexico \| -104.65756 \| 24.02032	88	NCT00521365	1COMPLETED	2009-08-01	2008-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 4 ]	662	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	false	The study is designed to investigate the safety of the investigational product for the lining of the uterus (endometrium).	null	Postmenopause	Postmenopausal Symptoms e.g. Hot flushes Sweating episodes Vaginal dryness	null	2	arm 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). arm 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: One capsule \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 13 cycles (28 days per cycle). intervention 2: One capsule \[0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)\] per day taken orally for 13 cycles (28 days per cycle).	intervention 1: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.5mg NETA / 1.0mg E2 (Activella)	59	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Greenwood Village \| Colorado \| United States \| -104.95081 \| 39.61721 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Amite \| Louisiana \| United States \| -90.50898 \| 30.72657 Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Lanús Oeste \| Buenos Aires \| Argentina \| -58.40056 \| -34.70377 San Isidro \| Buenos Aires \| Argentina \| -58.52111 \| -34.46971 Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61315 Buenos Aires \| Ciudad Auton. de Buenos Aires \| Argentina \| -58.37723 \| -34.61315 Mödling \| Lower Austria \| Austria \| 16.28921 \| 48.08605 Wiener Neustadt \| Lower Austria \| Austria \| 16.23196 \| 47.80485 Fürstenfeld \| Styria \| Austria \| 16.08333 \| 47.05 Wörgl \| Tyrol \| Austria \| 12.06174 \| 47.48906 Bregenz \| Vorarlberg \| Austria \| 9.7471 \| 47.50311 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Klagenfurt \| N/A \| Austria \| 14.30528 \| 46.62472 Mürzzuschlag \| N/A \| Austria \| 15.67226 \| 47.6066 Sankt Pölten \| N/A \| Austria \| 15.63333 \| 48.2 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Zeltweg \| N/A \| Austria \| 14.75 \| 47.18333 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 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Ballerup Municipality \| N/A \| Denmark \| 12.36328 \| 55.73165 Vejle \| N/A \| Denmark \| 9.5357 \| 55.70927 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Modena \| N/A \| Italy \| 10.92539 \| 44.64783 Novara \| N/A \| Italy \| 8.62118 \| 45.44694 Parma \| N/A \| Italy \| 10.32618 \| 44.79935 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Sassari \| N/A \| Italy \| 8.55552 \| 40.72586 Siena \| N/A \| Italy \| 11.33064 \| 43.31822 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 México, D.F. \| N/A \| Mexico \| -103.57339 \| 22.76088 Monterrey \| N/A \| Mexico \| -100.31721 \| 25.68435 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moskva \| N/A \| Russia \| 32.16579 \| 56.91775 Moskva \| N/A \| Russia \| 32.16579 \| 56.91775 Moskva \| N/A \| Russia \| 32.16579 \| 56.91775	661	NCT00522873	1COMPLETED	2009-08-01	2007-08-01	Bayer	4INDUSTRY	false	false	false	null	-0
[ 3 ]	166	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.	This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram \[mg\] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon \[Peg-IFN\]-alfa-2a and ribavirin \[RBV\] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.	Chronic Hepatitis C	Chronic Hepatitis C Genotype 1 Telaprevir Treatment-naïve VX-950-C208 VX-950-TiDP24-C208	null	4	arm 1: Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. arm 2: Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. arm 3: Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. arm 4: Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.	[ 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Oval tablets containing 375 mg of telaprevir for oral administration. intervention 2: Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe. intervention 3: Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen. intervention 4: Tablets containing 200 mg RBV for oral administration. intervention 5: Capsules containing 200 mg RBV for oral administration.	intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a intervention 3: Peg-IFN-alfa-2b intervention 4: Ribavirin (RBV) tablet intervention 5: Ribavirin (RBV) capsule	24	Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Angers \| N/A \| France \| -0.55202 \| 47.47156 Clichy \| N/A \| France \| 2.30952 \| 48.90018 Grenoble \| N/A \| France \| 5.71479 \| 45.17869 Lille \| N/A \| France \| 3.05858 \| 50.63297 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Vandœuvre-lès-Nancy \| N/A \| France \| 6.17114 \| 48.66115 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Leiden \| N/A \| Netherlands \| 4.49306 \| 52.15833 Nijmegen \| N/A \| Netherlands \| 5.85278 \| 51.8425 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391	161	NCT00528528	1COMPLETED	2009-08-01	2007-10-01	Tibotec BVBA	4INDUSTRY	false	false	false	null	0
[ 3 ]	44	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.	SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." SCD is caused by an abnormal type of hemoglobin, which is a protein inside red blood cells that carries oxygen. HbSC is a form of SCD that is characterized by the presence of dense red blood cells. People with HbSC usually develop less severe SCD symptoms than people with the more common form of the disease. There are limited treatment approaches aimed specifically at modifying the abnormal state of red blood cells. Also, few combination therapy treatments have been studied. The medication hydroxyurea is currently used to prevent sickle cell crises and to decrease the need for blood transfusions. The dietary supplement magnesium has not been widely studied as a treatment for SCD, but it may prevent dehydration, which may decrease the frequency of sickle cell crises. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of sickle cell crises in people with HbSC. This 1-year study will enroll people with HbSC. Participants will be randomly assigned to one of the following four treatment groups: * Group 1 participants will receive placebo pills and placebo liquid. * Group 2 participants will receive hydroxyurea pills and placebo liquid. * Group 3 participants will receive placebo pills and magnesium pidolate liquid. * Group 4 participants will receive hydroxyurea pills and magnesium pidolate liquid. Participants will receive the hydroxyurea or placebo pills once a day and the magnesium pidolate or placebo liquid twice a day for 11 months. Study visits will occur every 2 weeks during the first 2 months of the study, once a month for the following 9 months, and then at Year 1. At each visit, a physical exam and blood collection will occur. Selected visits will also include urine collection and a pregnancy test for female participants. Throughout the study, participants will record their study medication use in a daily diary.	Hemoglobin SC Disease	Sickle Cell Disease Vaso-occlusive Event Painful Crises Acute Chest Syndrome	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 1, 1, 1 ]	3	[ 0, 0, 10 ]	intervention 1: HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months) intervention 2: HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months) intervention 3: HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)	intervention 1: Hydroxyurea intervention 2: Magnesium Pidolate intervention 3: Placebo Pills and Placebo Liquid	19	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Oakland \| California \| United States \| -122.2708 \| 37.80437 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	44	NCT00532883	6TERMINATED	2009-08-01	2007-01-01	St. Jude Children's Research Hospital	7OTHER	false	false	false	null	0
[ 5 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a randomized, open- label, parallel group, phase IV, multicentre study. The total number of patients expected to be recruited is 40. These randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic NSCLC. Patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. The study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. The target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. At study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). Patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. An independent committee will be appointed to perform a blinded review of all patient scans. Any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. If selected screening evaluations are done within 7 days of Day 1, Cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on Day 1 unless the investigator believes that they are likely to have significantly changed. Any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease	null	Carcinoma, Non-Small-Cell Lung	Non-Small Cell Lung Cancer Locally Advanced or Metastatic NSCL Cancer	null	2	arm 1: docetaxel arm 2: Gefitinib (IRESSA)	[ 1, 0 ]	3	[ 0, 3, 0 ]	intervention 1: 250 mg oral intervention 2: performed at screening and every 6 weeks intervention 3: 60mg/m2 intravenous infusion	intervention 1: Gefitinib intervention 2: CT or MRI intervention 3: Docetaxel	1	Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	14	NCT00536107	6TERMINATED	2009-08-01	2007-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	426	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level	null	Type 2 Diabetes Mellitus		null	2	arm 1: Insulin lispro low mixture (1, 2 or 3 daily injections) arm 2: Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required. intervention 2: Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks intervention 3: Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.	intervention 1: Insulin lispro low mixture intervention 2: Insulin glargine intervention 3: Insulin lispro	25	Daw Park \| South Australia \| Australia \| 138.58407 \| -34.98975 East Ringwood \| Victoria \| Australia \| N/A \| N/A Nedlands \| Western Australia \| Australia \| 115.8073 \| -31.98184 Belém \| N/A \| Brazil \| -48.50444 \| -1.45583 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Curitiba \| N/A \| Brazil \| -49.27306 \| -25.42778 Fortaleza \| N/A \| Brazil \| -38.54306 \| -3.71722 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Aligarh \| N/A \| India \| 78.07464 \| 27.88145 Bangalore \| N/A \| India \| 77.59369 \| 12.97194 Coimbatore \| N/A \| India \| 76.96612 \| 11.00555 Mumbai \| N/A \| India \| 72.88261 \| 19.07283 Trivandrum \| N/A \| India \| 76.94924 \| 8.4855 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Monterrey \| N/A \| Mexico \| -100.31721 \| 25.68435 Kyunggi-Do \| N/A \| South Korea \| N/A \| N/A Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	423	NCT00548808	1COMPLETED	2009-08-01	2007-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary: * To determine if treatment with Haelan (fermented soy product) can decrease the severity of poor appetite measured using a visual analog scale (VAS) of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days. * To determine if treatment with Haelan can decrease the severity of nausea, fatigue, and improve patients' overall sense of well being measured using a VAS of 0 to 100 mm (0 mm = best, 100 mm = worst) at week 4 +/- 5 days. * To determine if treatment with Haelan can increase patient's calorie intake, albumin, pre-albumin, anthropometric measure, lean body mass (measured by bio-impedence analysis), and weight at week 4+/- 5 days. * To determine if treatment with Haelan can decrease patient's Functional assessment of anorexia/cachexia therapy subscales or (FAACT) and the Functional Assessment of Chronic Illness Therapy with fatigue subscales (FACIT-F) at week 4+/- 5 days. * To assess the feasibility of accrual, and adherence to the Haelan consumption. Secondary: * Determine the plasma isoflavone activity, 12-MTA and 13-MTA of these patients. * Correlate the biologic modulation of peripheral blood lymphocyte NF-kB by Haelan with primary outcome in these patients. * To determine if treatment with Haelan can increase patient's functional status at week 4+/- 5 days.	Individuals who have cancer-related malnutrition have also been found to have a higher risk of complications and are less able to tolerate the side effects of conventional therapies such as chemotherapy, radiation, and surgery. Haelan is a soy-based liquid (beverage). It contains large amount of isoflavones. Isoflavones inhibit "nuclear factor-kappa B," which may lead to prevention of weight loss. If you are eligible to take part in this study, you will then be given 2 fluid ounces of Haelan, as a taste test. If you are not able to tolerate the taste of Haelan, you will not be eligible for this study. If you are able to pass the taste test and you are a woman who is able to have children, you will be asked to have a pregnancy test 24 hours prior to registration to Part B. Then only if you test negative for the pregnancy test will you be considered eligible for this study. If you are a female patient and refuse to practice accepted methods of contraceptives during the study, you will not be eligible for this study. If you are still eligible for this study, you will have about 6 teaspoons of blood drawn, for baseline routine tests. Your height and weight will be measured. You will be instructed by a research nurse to recall your one day food intake before starting treatment. You will be asked about any medications you are taking (especially any appetite stimulants, such as megestrol, corticosteroid, and marinol), including the dose and when you take them. If you are able to tolerate the taste of Haelan, you will be instructed to drink 4 ounces of Haelan soy beverage 2 times a day, on an empty stomach, for 8 weeks. You may add water, stevia, honey or artificial sweeteners into Haelan prior to drinking it to improve the tolerance of Haelan. If you are unable to tolerate 4 ounces of Haelan twice a day after 2 attempts, the dose will be reduced to 2 ounces twice a day. If you are still not able to tolerate it after 2 attempts, the dose will be reduced again to 1 ounce twice a day. If you still cannot tolerate drinking this Haelan dose after 2 more attempts, the dose will be reduced again to 1 ounce daily. If you cannot tolerate at least 1 ounce a day for 5 consecutive days, you will be taken off this study. If you vomit within half hour of taking the Haelan, you should try at least 2 more times to drink at least 1 ounce of Haelan on the same day. If unsuccessful, please record that you were not able to take the Haelan on that day. If you cannot tolerate at least 1 ounce of Haelan a day for 5 days in a row, you will be taken off this study. If you are able to pass the taste test and if you are a female with child-bearing potential you will be asked to have a pregnancy test 24 hours prior to registration to Part B . You will be asked to write down how many ounces of Haelan you are able to drink at each dose and each day, in a study-drug diary. You will be asked to write down the side effect of Haelan daily. You will be asked to write down the side effect of Haelan daily. You will have about 6 teaspoons of blood drawn for routine clinical tests, for protein level and kidney function at Week 4 +/- 5 days. You will also be asked to complete 3 questionnaires that have questions about any appetite, nausea, and fatigue you experience and your overall sense of well being. These questionnaires will take about 15 minutes to complete. You will be given several tests to measure your weight, skin-fold thickness and body composition. You will be given 2 functional tests, which involves timing how long it takes for you to get up from a chair to walk and timing how long it takes for you to walk 50 feet at your fastest speed. These tests will take about 30 minutes to complete. The questionnaires, measurement of your weight, skin-fold thickness and body composition, and functional tests will be done before treatment starts and on a visit day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days. You will also be instructed by a research nurse to record your food intake, for one day in day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days. During this study, you will have several tests performed to check for safety and effectiveness. Every 2 weeks, you will be asked if you are experiencing any side effects, either related or not related to the treatment. You will be asked about any medications you are taking, including the dose levels and when you take them. You will be asked to bring the Haelan intake diary back to clinic on the study visits between day 10 +/- 5 days, week 4 +/- 5 days, week 6 +/- 5 days, so the study staff can record how many ounces of Haelan you have taken every day. At the end of Haelan soy beverage treatment (week 8 +/- 5 days), you will be asked to return to the clinic for a end-of-treatment visit. You will have blood drawn (about 6 teaspoons) for routine clinic tests to detect for protein level and kidney function. Your study-drug diary will be checked, and you will again be given the questionnaires. Measurement of your weight, skin-fold thickness and body composition, and functional tests will be given. You will be asked about any medications you are taking, including the dose levels and when you take them. You will also be asked to provide the research nurse with the record of one day food intake at 8 weeks +/- 5 days. The one day food intake record should be finished before coming in for your clinic visit, as long as it is the recording of the 8th week food intake. However, if the 8th-week clinic visit is on the first day of the 8th week, you can continue to record your food intake after the visit, and then return it to the research nurse at a later time. For this record, you need to write down what type of food you eat, and the estimated portion (for example: rice, 2 ounces; slice of apple pie, 1/8 of a pie). If you are currently taking megestrol, any corticosteroid, mirtazapine, metoclopramide, or dronabinol and you change your dose while on study, you will be taken off study. Also, if you were not on them before but you start taking any of the above listed drugs while on this study, you will be taken off study. This is an investigational study. About 32 people will take part in this study. All will be enrolled at M. D. Anderson.	Anorexia Weight Loss Cachexia	Solid Tumors Cancer-Associated Anorexia Weight Loss Haelan Fermented Soy Product Nutrition Cachexia	null	1	arm 1: 4 oz Haelan orally twice daily for 8 weeks	[ 5 ]	1	[ 0 ]	intervention 1: 4 oz orally twice daily for 8 Weeks	intervention 1: Haelan	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	4	NCT00558558	6TERMINATED	2009-08-01	2007-10-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0
[ 0 ]	31	RANDOMIZED	PARALLEL	6HEALTH_SERVICES_RESEARCH	2DOUBLE	false	0ALL	true	Cocaine addiction continues to be an important public health problem in the US with a significant cost to the individual and society. Among substance abusers, cocaine use has been recognized as a significant problem especially in methadone-maintenance patients. In several studies, rates of cocaine use have been reported to range from 30 to over 60 percent of those in methadone maintenance programs (Condelli et al. 1991; Hunt et al. 1984; Kidorf and Stitzer 1993; Kosten et al. 1988). In these patients, cocaine use seems to be a predictor of poor clinical outcome (Hartel et al. 1995; Kosten et al. 1987a). The development of effective pharmacotherapies for cocaine use disorders, especially in the opioid-dependent population is of great importance. Unfortunately, such effective pharmacotherapies do not exist. 1. To determine the safety and tolerability of varenicline in cocaine-using methadone-stabilized subjects. 2. To determine if varenicline is efficacious in reducing cocaine-use in methadone-stabilized subjects.	For this pilot study, we hope to recruit a total of 40 subjects, with 20 subjects in the varenicline group, and 20 into the placebo-control group. Assuming significant findings, these data will enable us to estimate a possible effect size for carrying-out a larger study. For preliminary analysis as a prelude to planning larger controlled studies, we will clinically require an effect size of 20% differences in the rates of cocaine positive urines or of self-reported cocaine use between the active medication and placebo groups. We will not adjust for these multiple comparisons to the placebo group since this is a pilot study, and use two-tailed significance level of 0.05 when we employ repeated measures analysis of variance (ANOVA) or Hierarchical Linear Modeling (HLM,see below) for statistical analysis over the 16-week study period. An Amendment was made and a new Updated consent form to include new FDA findings for study medication Varenicline." Varenicline may also cause changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior." Currently we have 30 subjects who have completed this study. This study is suspended due to these new concerns, Department of Veterans Affairs and the P.I. James Poling agreed. Study has been published. (April 2011)	Cocaine Dependence Nicotine Dependence	varenicline	null	2	arm 1: None arm 2: Placebo is compared to active drug varenicline	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Varenicline up to 2 mg a day intervention 2: Placebo	intervention 1: Varenicline intervention 2: Sugar pill or Placebo	1	West Haven \| Connecticut \| United States \| -72.94705 \| 41.27065	29	NCT00567320	1COMPLETED	2009-08-01	2007-03-01	Yale University	7OTHER	false	false	false	null	0
[ 2, 3 ]	46	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.	The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.	Alcoholism	N-acetylcysteine Alcoholism Treatment	null	2	arm 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. arm 2: Patients will take oral placebo (identical matching placebo) during the study period.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. intervention 2: Patients will take oral placebo (identical matching placebo) during the study period.	intervention 1: N-acetylcysteine intervention 2: Placebo	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	44	NCT00568087	1COMPLETED	2009-08-01	2007-12-01	Minneapolis Veterans Affairs Medical Center	1FED	false	false	false	null	0
[ 4 ]	375	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)	This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg \[Fioricet\]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T = TREXIMET®; P = Placebo; B = Butalbital-containing Combination Medication) . Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization visit, and (4) a Final visit. The Final visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. These two replicate studies were amended while ongoing to allow for the reporting of pooled data only.	Migraine Disorders Migraine, Acute	Migraine, acute Migraine Butalbital-containing Combination Medication (BCM) Naproxen sodium Sumatriptan succinate TREXIMET®	null	6	arm 1: TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) arm 2: TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) arm 3: BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) arm 4: BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) arm 5: placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) arm 6: placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)	[ 5, 5, 5, 5, 5, 5 ]	3	[ 0, 0, 0 ]	intervention 1: Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) intervention 2: butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\] intervention 3: placebo	intervention 1: TREXIMET® intervention 2: Butalbital-containing Combination Medications (BCM) intervention 3: placebo	107	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Gilbert \| Arizona \| United States \| -111.78903 \| 33.35283 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Irvine \| California \| United States \| -117.82311 \| 33.66946 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Northridge \| California \| United States \| -118.53675 \| 34.22834 Riverside \| California \| United States \| -117.39616 \| 33.95335 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Sherman Oaks \| California \| United States \| -118.44925 \| 34.15112 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 East Hartford \| Connecticut \| United States \| -72.61203 \| 41.78232 New Britain \| Connecticut \| United States \| -72.77954 \| 41.66121 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Daytona Beach \| Florida \| United States \| -81.02283 \| 29.21081 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Plantation \| Florida \| United States \| -80.23184 \| 26.13421 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Rome \| Georgia \| United States \| -85.16467 \| 34.25704 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Suwanee \| Georgia \| United States \| -84.0713 \| 34.05149 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Biddeford \| Maine \| United States \| -70.45338 \| 43.49258 Pikesville \| Maryland \| United States \| -76.72247 \| 39.37427 Brockton \| Massachusetts \| United States \| -71.01838 \| 42.08343 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171 Hattiesburg \| Mississippi \| United States \| -89.29034 \| 31.32712 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Cherry Hill \| New Jersey \| United States \| -75.03073 \| 39.93484 Ridgewood \| New Jersey \| United States \| -74.11653 \| 40.97926 Stratford \| New Jersey \| United States \| -75.01545 \| 39.82678 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Albany \| New York \| United States \| -73.75623 \| 42.65258 Albany \| New York \| United States \| -73.75623 \| 42.65258 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Mount Vernon \| New York \| United States \| -73.83708 \| 40.9126 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Orchard Park \| New York \| United States \| -78.74392 \| 42.76756 Schenectady \| New York \| United States \| -73.93957 \| 42.81424 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Valley Stream \| New York \| United States \| -73.70846 \| 40.66427 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Minot \| North Dakota \| United States \| -101.29627 \| 48.23251 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Greensburg \| Pennsylvania \| United States \| -79.53893 \| 40.30146 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Beaufort \| South Carolina \| United States \| -80.66993 \| 32.4317 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Columbia \| Tennessee \| United States \| -87.03528 \| 35.61507 Cordova \| Tennessee \| United States \| -89.7762 \| 35.15565 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 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 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293	1,203	NCT00573170	1COMPLETED	2009-08-01	2008-02-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	128	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment	null	Non-diabetic Nephropathy With Hypertension	Candesartan Cilexetil Non-diabetic Nephropathy hypertension urine protein creatinine ratio	null	3	arm 1: Candesartan Cilexetil arm 2: Candesartan Cilexetil arm 3: Candesartan Cilexetil	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 8 mg oral once daily dose intervention 2: 16 mg oral once daily dose intervention 3: 32 mg oral once daily dose	intervention 1: Candesartan Cilexetil intervention 2: Candesartan Cilexetil intervention 3: Candesartan Cilexetil 32mg	1	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	128	NCT00573430	1COMPLETED	2009-08-01	2007-12-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 2, 3 ]	7	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection	null	Bacteria Infection Respiratory Tract Infections	Ureaplasma Bronchopulmonary dysplasia very low birthweight	null	2	arm 1: Early treatment with azithromycin arm 2: Expectant (usual) management	[ 0, 4 ]	1	[ 0 ]	intervention 1: 10 mg/kg IV per dose given for 10 days	intervention 1: Azithromycin	1	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066	7	NCT00599053	6TERMINATED	2009-08-01	2007-05-01	University of Alabama at Birmingham	7OTHER	false	false	false	null	0
[ 5 ]	24	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	0NONE	false	0ALL	false	The purpose of this research is to find out how a nasal spray (fluticasone furoate), sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain cells within a child's adenoids. We hypothesize that intranasal steroids lead to an upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will result in a local reduction in inflammation and edema explaining the improvement in OSAS.	The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.	Childhood Obstructive Sleep Apnea Syndrome (OSAS)		null	2	arm 1: 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy arm 2: None	[ 1, 4 ]	1	[ 0 ]	intervention 1: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy	intervention 1: fluticasone furoate	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	24	NCT00603044	1COMPLETED	2009-08-01	2008-01-01	University of Chicago	7OTHER	false	false	false	null	0
[ 4 ]	4,008	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to assess the weight loss effect of lorcaserin during and at the end of 1 year of treatment in overweight and obese patients.	Randomized, double-blind, placebo-controlled, parallel-group assessment of the effects of lorcaserin hydrochloride during 52 weeks of administration to overweight or obese male and female volunteers aged 18 to 65 years inclusive.	Obesity	Obesity Weight loss lorcaserin APD356 BLOSSOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena	null	3	arm 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening arm 2: Lorcaserin 10 mg tablet each morning and evening arm 3: Matching placebo tablet each morning and evening	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks. intervention 2: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks. intervention 3: Matching placebo tablet each morning and evening for a duration of 52 weeks.	intervention 1: Lorcaserin 10 mg once daily (QD) intervention 2: Lorcaserin 10 mg twice a day (BID) intervention 3: Matching Placebo	1	San Diego \| California \| United States \| -117.16472 \| 32.71571	4,004	NCT00603902	1COMPLETED	2009-08-01	2008-01-01	Eisai Inc.	4INDUSTRY	false	false	false	null	-0
[ 4 ]	252	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	We are performing a prospective, randomized, controlled trial of dopamine versus norepinephrine for septic shock. The trial will enroll patients with suspected or documented site of infection and having 2 out of the three SIRS criteria. Patients will also be receiving standard of care, early-goal directed therapy including but not limited to fluid resuscitation, appropriate and early antibiotics, source control and evaluation for drotrecogin alpha where deemed appropriate, while being supported for septic shock.	Research Question/Hypothesis: The initial selection of the vasopressor norepinephrine in comparison to dopamine will result in a decrease in mortality for patients in septic shock. Study Design/Source Population: This trial is a single-center, prospective, randomized, open-label comparison of dopamine versus norepinephrine as initial vasopressor for patients presenting with septic shock. The study takes place at Rush University Medical Center, a 600 bed facility. Patients are transferred to our medical intensive care unit from the emergency room (ER), general medical floors, and from outside hospitals. Patients were eligible if they were greater than 18 years of age, and presented with a diagnosis of SIRS plus a suspected or documented source of infection. Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic etiologies of their vasodilatory shock or another etiology of their SIRS. Patients in the medical intensive care unit presenting with septic shock were randomized to receive either dopamine or norepinephrine as the first-line vasopressors for septic shock. Randomization was based upon whether the patient presented on an odd or even day of the week. For example, if the patient had presented on the third then they would be randomized to dopamine and if they had presented to the ICU on the fourth then they would be randomized to the norepinephrine treatment arm. The study investigators accept that the randomization scheme is not truly randomized, however a patient presenting with sepsis is not dependent on the day of the week. For example, the timeline for a patient to present with sepsis is unpredictable and the therapy for septic shock is started immediately upon their diagnosis, therefore the selection of a vasoactive agent (norepinephrine or dopamine) is really determined by the date of the patient's presentation, rather than the investigator. All patients were treated according to recommendations by the Surviving Sepsis Campaign (early-goal directed therapy including fluid resuscitation, early and appropriate antimicrobial therapy, strict glycemic control, and consideration of steroid replacement for patients with relative adrenal insufficiency). Patients presenting with hemodynamic instability are first treated with initial fluid resuscitation which encompasses either 500ml to 1000ml of crystalloid or 300ml to 500ml of colloid, depending on a clinician's preference. The administration and titration of vasopressors was directed to achieve a mean arterial pressure ≥ 60 mmHg or a systolic pressure ≥ 90 mmHg. If the predetermined maximum dose was reached for the initial vasopressor, then an addition of vasopressin at a continuous dose of 0.04 units/min was initiated. Patients who still required hemodynamic support were then started on an infusion of phenylephrine. The primary endpoint was all-cause 28-day mortality. Secondary endpoints included length of stay in the intensive care unit, organ dysfunction/failure, and the occurrence of dysrhythmia's. The study was approved by the Institutional Review Board (IRB) for human experimentation. Data to be collected includes baseline characteristics, laboratory parameters, microbiology, APACHE II score, occurrence of dysrhythmia's, and survival. Definition of Outcome: Primary outcome- All cause 28 day mortality Secondary outcome- Length of stay in the ICU (days), organ dysfunction/failure (MODS and SOFA scores), and the occurrence of dysrhythmia's between dopamine or norepinephrine (sinus tachycardia \> 20% increase in heart rate from baseline or the presence of an abnormal atrial or ventricular rhythm based on EKG) Definition of Exposure: Therapy with either dopamine or norepinephrine than they will be followed for primary and secondary outcomes until vasopressor therapy in no longer required for hemodynamic support. Statistical Analysis: The primary outcome variable will be survival. The exposure variable will be whether the patient received dopamine or norepinephrine for hemodynamic support in the setting of septic shock. The primary outcome of survival will be compared both via a Chi-square test and utilizing the time-to-event model of the Kaplan-Meier test. We anticipate similar mortality rates between the two vasopressor treatment groups. We will analyze the baseline demographics of the two treatment groups. Comparison of baseline categorical and continuous data will be completed using a Chi-square and t-test, respectively. If there appears to be an imbalance in the baseline characteristics then the confounding variables will be addressed by utilizing a Cox-proportional Hazards model in the final analysis. The occurrence of the secondary outcomes of length of stay and organ dysfunction/failure will be analyzed using a t-test. The main secondary outcome to be evaluated was the occurrence of dysrhythmia's. The dysrhythmia's will be compared in both groups utilizing a Chi-square test. One particular confounding variable for this secondary endpoint is the patient's prior cardiac history, which should be balanced based upon randomization of vasopressor therapy. Unfortunately, septic shock has an expected mortality of approximately 40-60%. We are looking for 20% reduction in mortality rate which would require an n=252 for our sample size to achieve a power of 80%. The results will aid clinicians who treat patient with septic shock in their selection of initial vasopressor agents. The external validity of our study is limited since this is a single-center evaluation and a high proportion of our patients have underlying malignancy and/or immunocompromised co-morbid conditions, and this could increase our 28 day mortality in comparison to other institutions; however this strengthens our internal validity. Two potential ways to overcome these limitations are to perform sub-group analysis and/or a Gray's survival analysis.7	Septic Shock	sepsis septic shock	null	2	arm 1: Patients that get Dopamine as an infusion for hypotension arm 2: Patients that get norepinephrine as an infusion for hypotension	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Dopamine 5-20 mcg/kg/min to pre-determined max of 20 intervention 2: Norepinephrine 5-20 mcg/min, to a pre-determined max of 20	intervention 1: Dopamine intervention 2: Norepinephrine	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	252	NCT00604019	1COMPLETED	2009-08-01	2003-03-01	Rush University Medical Center	7OTHER	false	false	false	null	0
[ 2 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this research study is to determine the best dose of the combination of two approved drugs, intravenous topotecan and oral erlotinib.	The primary objectives of this trial include: * To determine the maximum tolerated dosage (MTD) of intravenous topotecan when given in combination with oral erlotinib. * To define the dosage-limiting toxicities (DLT) of this combination. * To evaluate the pharmacokinetic (PK) parameters of intravenous topotecan with and without erlotinib The secondary objectives include: * To evaluate the pharmacodynamic effect of the topotecan and erlotinib combination * To evaluate for any correlations between the presence of CYP3A4/5 polymorphisms and topotecan / erlotinib disposition and to measure the frequency of MDR1 and BCRP in peripheral blood samples and correlate these results with topotecan pharmacokinetics * To measure the frequency of UGT genotypes in peripheral blood samples * To evaluate the objective response rate using the RECIST criteria.	Metastatic Solid Tumor		null	1	arm 1: All subjects receive treatment with intravenous topotecan and oral erlotinib.	[ 0 ]	2	[ 0, 0 ]	intervention 1: All subjects receive treatment with intravenous topotecan and oral erlotinib. intervention 2: All subjects receive treatment with intravenous topotecan and oral erlotinib.	intervention 1: Topotecan intervention 2: Erlotinib	1	Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953	29	NCT00611468	1COMPLETED	2009-08-01	2006-06-01	Accelerated Community Oncology Research Network	7OTHER	false	false	false	null	0
[ 5 ]	1,139	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by the time they are two years old. Active disease is concentrated in children and occurs sporadically in adults. Infection is more widespread. It is anticipated that 25% of the children will be blinded by this disease if they live to be 60 years of age. The blindness rates are higher in women, presumably because of their closer contact with children who can infect them and add to damage from infections the women had while young. This proposal is to better define how azithromycin in community-based treatment can be used to eliminate blinding trachoma. We will also take the opportunity to join these field studies with genetic epidemiologic studies to better understand the dynamic epidemiology of Chlamydia trachomatis infection in a trachoma endemic area. The empiric data generated from the treatment/follow-up studies, together with the information on sources and spread patterns from genetic epidemiology will be used to generate more robust models to guide future treatment/re-treatment protocols. We propose to conduct a randomized, community based trial in the Maradi region of Niger to test the hypothesis that two community wide azithromycin treatments, spaced one month apart, are significantly more effective in reducing ocular C. trachomatis infection and trachoma at one year compared to a single mass azithromycin treatment.	Population We will take advantage of the ongoing work in the ten villages currently being studied in Kornaka West. They have never had mass treatment with azithromycin, and the baseline trachoma and infection rates are greater than 20%. The final survey for that current study will occur in January, 2008. Within villages, we will use the updated complete village census lists generated in the January 2008 survey. The children for that survey were randomly selected from the baseline census to provide a sample of approximately 50-60 children in the village ages 0 to five years. They are now a cohort of children ages 2 to 7 years. We propose to add approximately 15 children ages 0-2 from the updated census list for a total of 65-70 children per village. Sample We propose to re-randomize the villages, stratified by baseline trachoma rates and former intervention, into treatment intervention (2 rounds of mass treatment) and control (one round of mass treatment) arms. The villages will be balanced by baseline trachoma rates and the original randomization to water and sanitation interventions. Within villages, we propose to use the same sample of children ages 2-7 years and add a random sample of 15 children ages 0 to 2 years. It will also be important to determine the effect of the two mass drug administration arms on infection in adults, so we propose to randomly select one adult from each household where there is an index child. If the adult is out of the village at the time of the survey, then the next randomly assigned adult will be selected for the study. Statistical plan including sample size justification and interim data analysis We intend to analyze the data starting by determining comparability of sample children and adults in intervention and control villages. Village characteristics, household characteristics, and age and gender distributions will be compared by intervention and control status. Importantly, baseline assessment of trachoma, and C. trachomatis infection, will be used to assure comparability. Variables that differ will be used as potentially confounding factors. We will determine the change from baseline to one month and one year in the trachoma prevalence and prevalence of C. trachomatis in the sentinel sample, stratified by children and adults. We will compare the average prevalence in the intervention villages compared to the control villages, by way of preserving the unit of randomization. We will then use logistic regression models to predict trachoma/infection at each time point, adjusting for clustering within villages and other confounding factors. Coverage of mass treatment will also be included as a predictor of trachoma/infection. We use our sample of children to estimate power, as they are the risk group with highest rates of infection and trachoma. With our sample size of 350 children per group, we have 80% power (at α=0.5) to detect a 15% difference in decline in active trachoma or infection, assuming modest village level clustering. We will sample 140 subjects per village (70 children plus one randomly selected adult from the same household) for a total of 1400 subjects. Subjects will be sampled at baseline, one-month post-treatment, and at one-year post-treatment. Prior to the surveys, a training program will take place to accomplish the following objectives for the survey team: * All persons who will be grading trachoma are standardized against a senior grader, with reliability of kappa=0.65 for TF and for TI, at least. Consistency across graders is essential so that differences are not attributable to grader variations. In any case, all graders must work in all villages, so that the effect of variation by grader does not confound the effect of variation by village. * All persons who will be taking or assisting with laboratory specimens are trained in proper techniques for taking and storing specimens in the field. * Proper completion of the survey form, "Examen Oculaire" for each child and adult in the sample, and the completion of the census list on treatment receipt for all persons in the village The Baseline survey for trachoma in the sample of children and adults will take place prior to any antibiotic intervention. The surveys will consist of the following steps: 1. Prior to the survey in the village, a member of the team will alert the village leadership that the survey team is coming, that mass treatment for all members of the community, as part of the Niger Trachoma Control Program will be part of the survey. 2. The day of the baseline survey, all members of the household will be asked to stay in their concession for the examination and mass treatment, which is done house to house. As they come, the name will be checked on the list of those in the sample survey, and those who are in need of treatment only. If the person in the house is part of the trachoma survey, a form is prepared and a single specimen label filled out for the examiner and the laboratory technician. The label consists of the type of visit (b=baseline, 1=one month, 2=one year) and the full study identification number of the sample person: (village number)-(concession number)-(person number). Thus, during the baseline survey, a person who lives in village number 2, in concession number A-034 and who is on the census list as person 16 would have a study identification number of 02-A-034-16, and a label for the vial of B-02-A-034-16 3. The trachoma grader will be everting the eyelids. Therefore, his fingers are the primary source of contamination for the laboratory specimen. He will change gloves between each exam (or wash his gloves with soap and water) between each child, even children in the same house and even if the child does not appear to have trachoma. This is because about 20% of children without trachoma can still have infection with C. trachomatis (sub-clinical infection). The trachoma grader, wearing 2.5X loupes and using a torche (or in sunlight), will assess the trachoma status of the tarsal plate, using the WHO Simplified grading scheme. The assistant will first evert the right eyelid, grade the tarsal plate, then evert the left eyelid and grade the trachoma status of the tarsal plate. A scribe will record the trachoma assessment on the "Examen Oculaire" form. 4. While the left eyelid is still everted, the laboratory technician, following careful procedures described in the training manual, will roll the swab three times across the tarsal plate to obtain a specimen. The swab must not touch anything other than the tarsal plate. The lab technician can also not touch anything other than the swab and the vial. Once the swab has been taken, it is inserted in an open NUC vial, broken off, and the NUC vial is closed. The sealed vial is labeled with a pre-printed label and placed in a cold box with ice packs while in the field. The scribe will record that the specimen has been taken, or any reason why it was not taken. 5. At this point, the sample person is eligible for azithromycin, which is administered at 20mg/kg. A height stick will be used to estimate dose. For children younger than 2 months, topical tetracycline will be used for 4-6 weeks. The form is reviewed for completeness, and stored safely for eventual data entry. Please note: The first azithromycin treatment in each study arm is administered as part of Niger's trachoma control program; only the second azithromycin treatment is provided to Arm 2 as part of the experimental protocol 6. The concession is then checked to see if all members of the sample have been examined and a swab obtained. If so, the remainder of the concession is treated with azithromycin in accordance with program guidelines. 7. The second treatment team assigned to the village will be providing azithromycin treatment to households who do NOT have anyone in the sample, in order to expedite treatment of the entire village. 8. At the end of each day in the field, all specimens are transferred to a freezer in World Vision in Maradi, awaiting return to the freezer in Niamey. During the drive to Niamey, specimens must be kept frozen as well, with ice packs. 9. The data entry clerk will enter the survey form into the "baseline" database if the survey is the baseline survey, or the "one month" or "one year" database, depending on the follow-up survey. The data entry clerk will also enter the data on those who received treatment at baseline, and at two months into the treatment data base. The same sample of children and adults will be surveyed for trachoma and infection at one month post the last treatment, and at one year. No additional persons will be added to the sample to replace any who have died or moved away, as we will not have baseline data for any replacements. The procedures for the one month and one year follow up surveys are exactly the same as for the baseline survey, except the following: the laboratory label is changed from a "B" to a "1" or a "2" as the first part of the label, and the survey forms are entered into the one month or one year data bases. All positive specimens will have the major outer membrane gene amplified and sequenced. The genovars will be mapped for location within villages and families and then their distribution will be followed over time, after treatment to provide a better understanding of the epidemiology of the infection. Results of the study will be used as data input for the generation of mathematical models to predict whether community-wide retreatment (or alternate strategies) will be needed, and the optimal timing for such retreatment.	Trachoma Chlamydia Trachomatis	Trachoma Chlamydia trachomatis	null	2	arm 1: Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive an initial treatment with 1 gm oral dose of Azithromycin; receive a second 1 gm oral dose of Azithromycin at Day 30; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360. arm 2: Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); be treated at Day 30 with the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children \> 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 \& Day 30 for a total of 2 doses. intervention 2: 1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children \> 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given at Day 30 for a total of 1 dose.	intervention 1: Azithromcyin intervention 2: Azithromycin	2	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Niamey \| N/A \| Niger \| 2.1098 \| 13.51366	1,139	NCT00618449	1COMPLETED	2009-08-01	2008-01-01	University of California, San Francisco	7OTHER	false	false	false	null	0
[ 2, 3 ]	171	RANDOMIZED	FACTORIAL	1PREVENTION	1SINGLE	true	1FEMALE	false	Osteoporosis is a major health problem in postmenopausal women. Our long-term goal is to develop a new alternative treatment that include a dietary supplement (green tea extract) and a mind-body exercise (Tai Chi) for lessening bone loss in postmenopausal women with low bone mass. A combination of dietary supplement and moderate intensity exercise now becomes a new alternative treatment in reducing bone loss in postmenopausal women with low bone mass, due to the possible stronger effects of the combination than individual treatments. Objective: To test a CAM intervention including green tea polyphenol (GTP) and Tai Chi (TC) exercise for feasibility, and to quantitatively assess their individual and conjugate effects on postmenopausal women with osteopenia. Hypotheses: (1) 24 weeks of GTP supplement, TC exercise, and their combination will benefit bone remodeling as measured by bone biomarkers and muscle strength/physical function in postmenopausal women with osteopenia compared to those receiving placebo only, and (2) the changes in bone biomarkers associated with bone remodeling will be correlated with the changes in oxidative stress.	This is a 24-week, randomized, and placebo-controlled intervention trial to investigate the effects of green tea polyphenols (GTP) and Tai Chi (TC) on relevant primary and secondary endpoints in postmenopausal women with osteopenia. Women at least 2 years after menopause, with osteopenia, will be recruited primarily from local senior independent/assisted living facilities, municipal senior community centers, and obstetrics and gynecology clinics. After screening, qualified participants will be matched for age and will be randomly assigned to one of the four treatment groups: placebo, GTP, placebo+TC, and GTP+TC. During the 24-week intervention, all participants will be provided with calcium and vitamin D daily. The participants in the placebo group will receive medicinal starch for 24 weeks. The GTP participants will receive GTP for 24 weeks. The placebo+TC participants will receive both placebo and TC treatments for 24 weeks. The GTP+TC participants will receive both GTP and TC treatments for 24 weeks. Participants will receive the primary and secondary outcome measures at baseline, 4, 12, and 24 weeks. The primary outcome measures are concentrations of bone biomarkers. The secondary outcome measure is a biomarker of oxidative stress DNA damage. Additional secondary outcome is muscle strength/physical function. Investigators evaluating the endpoints will be blinded to intervention allocation.	Osteoporosis	postmenopausal, bone, dietary supplement, mind-body exercise	null	4	arm 1: 24 weeks of placebo. arm 2: 24 weeks of green tea polyphenols arm 3: 24 weeks of placebo plus Tai Chi exercise. arm 4: 24 weeks of green tea polyphenols plus Tai Chi exercise.	[ 2, 1, 1, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 500 mg medicinal starch pills daily intervention 2: 500 mg green tea polyphenols daily intervention 3: 500 mg medicinal starch daily and Tai Chi (3x/week) for 24 weeks intervention 4: 500 mg GTP daily plus TC exercise (3x/week) for 24 weeks	intervention 1: Placebo intervention 2: Green Tea Polyphenols (GTP) intervention 3: Placebo+Tai Chi (TC) intervention 4: GTP+TC	1	Lubbock \| Texas \| United States \| -101.85517 \| 33.57786	150	NCT00625391	1COMPLETED	2009-08-01	2008-02-01	Texas Tech University Health Sciences Center	7OTHER	false	false	false	null	0
[ 0 ]	8	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	1SINGLE	false	0ALL	true	Inhaled medications are often used to treat lung diseases such as cystic fibrosis. We are performing this study to determine whether inhaled medications dissolved in surfactant-based solutions will distribute more evenly throughout the lungs when compared to standard saline-based solutions. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. This study will use a special nuclear medicine test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol.	Cystic fibrosis (CF) is an inherited chronic disease that affects the lungs and digestive system of about 30,000 children and adults in the United States (70,000 worldwide). The lungs of a person with cystic fibrosis often contain thick sticky mucus that can clog the lungs and lead to life-threatening lung infections. A major milestone in the treatment of CF was the development of an inhaled form of an antibiotic drug called tobramycin. For an inhaled antibiotic to work it must be delivered to all infected parts of the lung. Many studies have shown that blockages in the lungs, like those found in CF patients, can prevent inhaled medicines from reaching all parts of the lungs. Usually aerosolized medications are dissolved in saline or water. Most of these medications could be dissolved in surfactant solutions and aerosolized. Soaps are common examples of surfactants. Surfactants may have the ability to spread medication over the inside surface of the lungs similar to the way dish soap spreads over water. We think that inhaling medication that is in a surfactant-based liquid will result in more medication reaching partially blocked parts of the lung. We further believe that the normal movements of the lung associated with breathing will further spread surfactant-based aerosol medications, and contribute to even more even drug distribution over longer periods of time. A surfactant-based inhaled antibiotic would have the potential to reach more sites of infection in the lung, possibly getting rid of infection all together. This study will use a special test called an aerosol deposition scan to compare how a drug spreads in the lung using a surfactant-based aerosol compared to a saline-based aerosol. The study includes one screening and two testing visits.	Cystic Fibrosis	cystic fibrosis surfactant aerosol inhaled drug inhaled antibiotic	null	2	arm 1: Subjects inhaled calfactant then isotonic saline arm 2: Subjects inhaled isotonic saline then calfactant	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: single inhaled dose by nebulizer intervention 2: single inhaled dose by nebulizer	intervention 1: calfactant intervention 2: isotonic saline	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	16	NCT00628134	1COMPLETED	2009-08-01	2008-03-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 2 ]	20	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.	null	Osteosarcoma Leukemia Lymphoma	high dose methotrexate Voraxaze leucovorin delayed elimination methotrexate toxicity rescue renal insufficiency	null	2	arm 1: High-dose methotrexate, leucovorin, and Voraxaze arm 2: High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: single intravenous dose intervention 2: standard of care, leucovorin every 6 hours	intervention 1: glucarpidase, high-dose methotrexate, leucovorin intervention 2: high-dose methotrexate, leucovorin	25	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Oakland \| California \| United States \| -122.2708 \| 37.80437 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Evanston \| Illinois \| United States \| -87.69006 \| 42.04114 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Columbia \| Missouri \| United States \| -92.33407 \| 38.95171 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	20	NCT00634504	1COMPLETED	2009-08-01	2008-05-01	BTG International Inc.	7OTHER	false	false	false	null	0
[ 4 ]	994	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this clinical research study is to learn if initiating treatment with BMS-51248 (Dapagliflozin) in combination with metformin XR can improve diabetes control in patients with Type 2 Diabetes who do not receive any pharmacological treatment for diabetes, when compared to initial treatment with monotherapy dapagliflozin or metformin XR. The safety of this treatment will also be studied	null	Type 2 Diabetes		null	3	arm 1: Dapagliflozin (5 mg) + Metformin XR (up to 2000 mg) arm 2: Dapagliflozin (5 mg) arm 3: Metformin XR (500 mg up to 2000 mg)	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: Tablets, Oral, Once daily, 24 weeks intervention 2: Tablets, Oral, Once daily, 24 weeks	intervention 1: Dapagliflozin intervention 2: Metformin XR	99	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Haleyville \| Alabama \| United States \| -87.62141 \| 34.22649 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Concord \| California \| United States \| -122.03107 \| 37.97798 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Fresno \| California \| United States \| -119.77237 \| 36.74773 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Kissimmee \| Florida \| United States \| -81.41667 \| 28.30468 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Perry \| Georgia \| United States \| -83.73157 \| 32.45821 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Vernon Hills \| Illinois \| United States \| -87.97952 \| 42.21947 Rolling Fork \| Mississippi \| United States \| -90.87816 \| 32.90652 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Kingston \| New York \| United States \| -73.99736 \| 41.92704 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Canal Fulton \| Ohio \| United States \| -81.59762 \| 40.88978 Kettering \| Ohio \| United States \| -84.16883 \| 39.6895 Newark \| Ohio \| United States \| -82.40126 \| 40.05812 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Yukon \| Oklahoma \| United States \| -97.76254 \| 35.50672 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Fleetwood \| Pennsylvania \| United States \| -75.81798 \| 40.45398 Shippensburg \| Pennsylvania \| United States \| -77.52026 \| 40.05065 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Fayetteville \| Tennessee \| United States \| -86.57055 \| 35.15203 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Midland \| Texas \| United States \| -102.07791 \| 31.99735 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 Pearland \| Texas \| United States \| -95.28605 \| 29.56357 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Pachuca \| Hidelgo \| Mexico \| -98.73329 \| 20.11697 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Mexico City \| Mexico City \| Mexico \| -99.12766 \| 19.42847 Morelia \| Michioacan \| Mexico \| -101.18443 \| 19.70078 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Monterrey, Nl \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Tampico \| Tamaulipas \| Mexico \| -97.87777 \| 22.28519 Mérida \| Yucatán \| Mexico \| -89.62318 \| 20.967 Aguascalientes \| N/A \| Mexico \| -102.2843 \| 21.88262 Durango \| N/A \| Mexico \| -104.65756 \| 24.02032 Veracruz \| N/A \| Mexico \| -96.1429 \| 19.18095 Cebu City \| N/A \| Philippines \| 123.89071 \| 10.31672 Jaro Iloilo City \| N/A \| Philippines \| N/A \| N/A Las Piñas \| N/A \| Philippines \| 120.98278 \| 14.45056 Marikina City \| N/A \| Philippines \| 121.1133 \| 14.6481 Pasig \| N/A \| Philippines \| 121.0614 \| 14.58691 Quezon City \| N/A \| Philippines \| 121.0509 \| 14.6488 Villa Fontana \| Carolina \| Puerto Rico \| -65.9735 \| 18.40439 Ponce \| N/A \| Puerto Rico \| -66.62398 \| 18.01031 Ponce \| N/A \| Puerto Rico \| -66.62398 \| 18.01031 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633 Arkhangelsk \| N/A \| Russia \| 40.55291 \| 64.54717 Dzerzhinskiy \| N/A \| Russia \| 37.8443 \| 55.62868 Kemerovo \| N/A \| Russia \| 86.08333 \| 55.33333 Moscov \| N/A \| Russia \| N/A \| N/A Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Nizhny Novgorod \| N/A \| Russia \| 44.00205 \| 56.32867 Novosibirsk \| N/A \| Russia \| 82.94339 \| 55.03442 Novosibirsk \| N/A \| Russia \| 82.94339 \| 55.03442 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Volgograd \| N/A \| Russia \| 44.50183 \| 48.71939 Voronezh \| N/A \| Russia \| 39.1843 \| 51.67204 Yaroslav \| N/A \| Russia \| N/A \| N/A Guri-si \| Gyeonggi-do \| South Korea \| 127.1394 \| 37.5986 Seoul \| Nowon-Gu \| South Korea \| 126.9784 \| 37.566 Bucheon-si \| N/A \| South Korea \| 126.78306 \| 37.49889 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Sungnam-Si, Gyeonggi-Do \| N/A \| South Korea \| 126.76917 \| 37.58944 Dnipro \| N/A \| Ukraine \| 35.04066 \| 48.46664 Donetsk \| N/A \| Ukraine \| 37.80224 \| 48.023 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Odesa \| N/A \| Ukraine \| 30.74383 \| 46.48572 Vinnytsia \| N/A \| Ukraine \| 28.46871 \| 49.2322 Zhytomyr \| N/A \| Ukraine \| 28.67913 \| 50.26235	598	NCT00643851	1COMPLETED	2009-08-01	2008-06-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 0 ]	11	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	true	0ALL	false	This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.	This is a double blind crossover study of fenofibrate vs. placebo in healthy volunteers. The null hypothesis is that over a four week period, fenofibrate (160mg/day orally) is equivalent to placebo in terms of relative changes in cytokines ENA-78 and MCP-1 over a four week periods, separated by a four week washout. ENA-78 is a marker of inflammation. See http://en.wikipedia.org/wiki/CXCL5 for more details.	Healthy	Healthy Volunteers	null	2	arm 1: 4 weeks of drug at 160 mg orally per day, 4 week washout, then 4 weeks of placebo arm 2: 4 weeks of placebo then 4 week washout then 4 weeks of Fenofibrate at 160 mg/day orally.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo capsule daily for 4 weeks intervention 2: 160 mg/day orally for 4 weeks	intervention 1: Fenofibrate capsule daily for 4 weeks intervention 2: Fenofibrate	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	22	NCT00644592	6TERMINATED	2009-08-01	2008-03-01	University of Florida	7OTHER	false	false	false	null	0
[ 3 ]	14	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may help the natural killer cells kill more tumor cells. PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.	OBJECTIVES: Primary * To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell product following a preparative regimen comprising cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer. Secondary * To characterize the quantitative and qualitative toxicities of this treatment regimen. * To estimate disease response (complete or partial response) or clinical benefit (stable disease for \> 6 months) as measured by Response Evaluation Criteria in Solid Tumours (RECIST) criteria. * To estimate time to progression and overall survival. * To estimate the association between clinical response and donor/recipient KIR ligand matching status. Tertiary * To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK cells and its effect on the immune system. OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell infusion. * Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0. Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin subcutaneously (SC) 3 times a week for 6 doses. Patients achieving any initial response (complete or partial response) or a clinical benefit (stable disease for \> 6 months) who progress after 6 months may receive 1 re-treatment course as above. Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3 months post NK cell infusion for cytokine measurements, immunophenotyping, functional analyses, and testing for persistence of donor cells. After completion of study treatment, patients are followed periodically for at least 1 year.	Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	recurrent ovarian epithelial cancer recurrent ovarian germ cell tumor stage IV ovarian epithelial cancer stage IV ovarian germ cell tumor fallopian tube cancer peritoneal cavity cancer	null	2	arm 1: This group includes patients that received all chemotherapy, infusion of natural killer (NK) cells and total body irradiation per protocol. 1\. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m\^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m\^2 on Days 6 through 2 preceding NK cell infusion. 4. Radiation: total-body irradiation 200 cGy Day 1 preceding NK cell infusion. 5. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 \* 10\^7/kg. 6. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0. arm 2: This group includes patients that received chemotherapy and infusion of natural killer cells, but did not receive total body irradiation. 1\. Allopurinol 300 mg by mouth daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post NK cell infusion. 2. Cyclophosphamide 60 mg/m\^2 on Days 4 and 5 preceding NK cell infusion. 3. Fludarabine phosphate 25 mg/m\^2 on Days 6 through 2 preceding NK cell infusion. 4. Allogeneic natural killer cells- Given day 0 - dose of 1.5-8.0 \* 10\^7/kg. 5. Aldesleukin 10 million units 3 times/week for a total of 6 doses beginning Day 0.	[ 0, 0 ]	6	[ 2, 0, 0, 4, 2, 2 ]	intervention 1: All patients are to receive allopurinol 300 mg PO daily (unless known allergy) before beginning chemotherapy and continuing through day 14 post natural killer cell infusion. intervention 2: 60 mg/m\^2 on Days 4 and 5 preceding natural killer cell infusion. intervention 3: 25 mg/m\^2 on Days 6 through 2 preceding natural killer cell infusion. intervention 4: 200 cGy Day 1 preceding natural killer cell infusion. intervention 5: Given day 0 - dose of 1.5-8.0 \* 10\^7/kg intervention 6: 10 MU 3 times/week for a total of 6 doses beginning Day 0	intervention 1: Allopurinol intervention 2: Cyclophosphamide intervention 3: Fludarabine phosphate intervention 4: total-body irradiation intervention 5: Allogeneic natural killer cells intervention 6: Aldesleukin	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	14	NCT00652899	6TERMINATED	2009-08-01	2008-03-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0
[ 4 ]	153	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	To assess the long term safety, tolerability and efficacy of fesoterodine in patients with OAB.	null	Overactive Bladder		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 4 mg tablets OD for 4 weeks, then either 4 mg or 8 mg tablets OD for 48 weeks	intervention 1: fesoterodine fumarate	12	Inegeku, Chibashi \| Chiba \| Japan \| 140.11667 \| 35.6 Akashi-shi \| Hyōgo \| Japan \| N/A \| N/A Amagasaki-shi \| Hyōgo \| Japan \| N/A \| N/A Chuou-ku, Koube-shi \| Hyōgo \| Japan \| 135.183 \| 34.6913 Kaibara-cho, Tanba-shi \| Hyōgo \| Japan \| N/A \| N/A Nishinomiya-shi \| Hyōgo \| Japan \| N/A \| N/A Kawasakishi \| Kanagawa \| Japan \| N/A \| N/A Sagamihara-shi \| Kanagawa \| Japan \| N/A \| N/A Nara \| Nara \| Japan \| 135.80485 \| 34.68505 Osaka \| Osaka \| Japan \| 135.50107 \| 34.69379 Edogawa-ku \| Tokyo \| Japan \| N/A \| N/A Shibuya-ku \| Tokyo \| Japan \| N/A \| N/A	304	NCT00658684	1COMPLETED	2009-08-01	2008-02-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 0 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar I disorder and improve psychiatric and functional outcomes. To accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. The study will be divided in three steps: Screening, Baseline Period (cross taper to aripiprazole, up to 2 months in duration), Months 1-3 (continued aripiprazole treatment). Subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). Brief clinical assessments will be conducted at each visit. More thorough assessments will be conducted at Baseline, Week 2, and Month 3.	null	Bipolar Disorder Metabolic Syndrome	bipolar disorder sedation overweight Abilify medication	null	1	arm 1: Aripiprazole	[ 0 ]	1	[ 0 ]	intervention 1: All subjects will be assessed at baseline and then switched from their current antimanic agent to aripiprazole. Arpipirazole will be titrated from a starting dose of 5 mg/day up to a target dose of 15 mg/day over a period of up to 2 months (approximately 8 weeks). Concomitant medication will not be changed unless medically necessary. If a subject is taking an antipsychotic in addition to divalproex, aripiprazole will replace the antipsychotic.	intervention 1: Aripiprazole	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	3	NCT00665444	6TERMINATED	2009-08-01	2008-04-01	University of Pittsburgh	7OTHER	false	false	false	null	0
[ 3 ]	230	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.	null	Idiopathic Restless Legs Syndrome	SPM 962 rotigotine Idiopathic Restless Legs Syndrome RLS	null	4	arm 1: inactive placebo arm 2: 2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets arm 3: 4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet arm 4: 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets	[ 2, 0, 0, 0 ]	1	[ 0 ]	intervention 1: transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks	intervention 1: SPM 962	8	Chubu Region \| N/A \| Japan \| N/A \| N/A Chugoku Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/A	230	NCT00666965	1COMPLETED	2009-08-01	2008-06-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0
[ 4 ]	440	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study aims at evaluating efficacy and safety of quadruple therapy (bismuth, metronidazole, tetracycline and omeprazole: OBMT) vs triple therapy (amoxicillin, clarithromycin and omeprazole: OAC) in H. Pylori eradication. It is hypothesized that quadruple therapy will be comparable in efficacy to triple therapy. Subjects with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 6 and 10 follow-up visits, a urea breath test (UBT) will be performed to confirm eradication.	The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 30 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations. Treatment: Subjects assigned to OAC will be treated for 7 days. Those assigned to Pylera will be treated for 10 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 8 and 14. Follow-up: includes two visits. approximately one and two months post-treatment. Eradication of H. Pylori will be confirmed through UBT, and resistance will be evaluated in case of treatment failure. These subjects will undergo an endoscopy.	Helicobacter Infections	H. Pylori Quadruple therapy Eradication rate Multinational trial Resistance to antibiotics Subjects with confirmed Helicobacter Pylori infection	null	2	arm 1: Triple therapy, given for 7 days at a dose of omeprazole 20 mg twice daily, amoxicillin 500 mg 2 capsules twice daily, and clarithromycin 500 mg 1 tablet twice daily arm 2: OBMT (Pylera), consisting of a 3 in 1 capsule, made of bismuth subcitrate potassium 120 mg, metronidazole 125 mg, and tetracycline 125 mg, administered as 3 capsules 4 times daily. Omeprazole 20 mg is administered twice daily.	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Triple therapy given for 7 days at a dose of omeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID intervention 2: Pylera is a three in one capsule containing bismuth subcitrate potassium 120 mg, metronidazole 125 mg and tetracycline 125 mg given as 3 capsules QID, with omeprazole 20 mg BID.	intervention 1: Omeprazole, amoxicillin, clarithromycin intervention 2: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole	1	Bath \| N/A \| United Kingdom \| -2.36172 \| 51.3751	438	NCT00669955	1COMPLETED	2009-08-01	2008-06-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 4 ]	528	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	Benign Prostatic Hyperplasia (BPH) is the most common hyperplastic disease occuring in human males over the age of 50 which increases in prevalence with age and 40% of males reported moderate or severe urinary symptoms of prostatism by the age of 50 to 80. The purpose of this study is to collect safety and efficacy data for this dosage regimen of cetrorelix pamoate. For this study, study medication (Cetrorelix pamoate) is administered by injection in the buttocks (Intramuscular).	null	Benign Prostatic Hypertrophy	Cetrorelix BPH	null	1	arm 1: Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.	[ 0 ]	1	[ 0 ]	intervention 1: Cetrorelix Pamoate IM, 52 mg week 0, 26 mg week 2,	intervention 1: Cetrorelix Pamoate	69	Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Tarzana \| California \| United States \| -118.55397 \| 34.17334 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Middlebury \| Connecticut \| United States \| -73.12761 \| 41.52787 Trumbull \| Connecticut \| United States \| -73.20067 \| 41.24287 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Lake Worth \| Florida \| United States \| -80.07231 \| 26.61708 Naples \| Florida \| United States \| -81.79596 \| 26.14234 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Sandy Springs \| Georgia \| United States \| -84.37854 \| 33.92427 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Newburgh \| Indiana \| United States \| -87.40529 \| 37.94449 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Bel Air \| Maryland \| United States \| -76.34829 \| 39.53594 Greenbelt \| Maryland \| United States \| -76.87553 \| 39.00455 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Woodlane \| New Jersey \| United States \| -74.80155 \| 40.01178 Albany \| New York \| United States \| -73.75623 \| 42.65258 Albany \| New York \| United States \| -73.75623 \| 42.65258 Bay Shore \| New York \| United States \| -73.24539 \| 40.7251 Garden City \| New York \| United States \| -73.6343 \| 40.72677 Jackson Heights \| New York \| United States \| -73.88541 \| 40.75566 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Concord \| North Carolina \| United States \| -80.58158 \| 35.40888 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Bethany \| Oklahoma \| United States \| -97.63226 \| 35.51867 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Warwick \| Rhode Island \| United States \| -71.41617 \| 41.7001 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Myrtle Beach \| South Carolina \| United States \| -78.88669 \| 33.68906 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Virginia Beach \| Virginia \| United States \| -75.97799 \| 36.85293 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Barrie \| Ontario \| Canada \| -79.66634 \| 44.40011 Brampton \| Ontario \| Canada \| -79.76633 \| 43.68341 Brantford \| Ontario \| Canada \| -80.26636 \| 43.1334 Guelph \| Ontario \| Canada \| -80.25599 \| 43.54594 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 North Bay \| Ontario \| Canada \| -79.46633 \| 46.3168 Oakville \| Ontario \| Canada \| -79.68292 \| 43.45011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Scarborough Village \| Ontario \| Canada \| -79.22124 \| 43.73899 Thunder Bay \| Ontario \| Canada \| -89.25018 \| 48.38202 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	528	NCT00670306	1COMPLETED	2009-08-01	2008-03-01	AEterna Zentaris	4INDUSTRY	false	false	false	null	0
[ 0 ]	14	NON_RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	1FEMALE	false	The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with Metformin. Additionally, brain function in women with PCOS will be compared to the brain activity in normal control subjects with regular menstrual cycles.	The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder, is associated with insulin resistance. The effects of insulin resistance on cognition, mood, opioid system and reproductive function in PCOS affected women are investigated in the current study. The identification of reversible changes in brain function and reproductive measures in insulin resistant PCOS patients would likely significantly influence treatment protocols for these young women. 1. Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to normal controls. 2. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women with insulin resistant PCOS.	Polycystic Ovary Syndrome	Polycystic Ovary Syndrome Insulin resistance Metformin Brain function	null	2	arm 1: Control subjects will have 5 visits (screening, oral glucose tolerance test (OGTT), neuropsychological testing, functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) as they will receive no treatment and will not have repeat studies. The baseline values obtained from the control subjects will be compared to the baseline values acquired from the PCOS affected subjects. arm 2: Subjects with Polycystic Ovary Syndrome (PCOS) will be scheduled for 9 visits total: following the screening visit they will go through OGTT, neuro-psychological testing, fMRI and PET scan before and after 4 months of metformin use: 500mg tablets once daily with breakfast for 1 week, then increased to one tablet twice daily with breakfast \& lunch for 1 week, then increased to one tablet three times daily with breakfast, lunch \& dinner.	[ 4, 0 ]	1	[ 0 ]	intervention 1: Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg twice daily (BID), adding a dose after lunch. On the third week, the dose will be increased to 500 mg three times daily (TID), adding a 500 mg tablet after supper. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia.	intervention 1: Metformin	1	Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756	12	NCT00670800	1COMPLETED	2009-08-01	2008-01-01	University of Michigan	7OTHER	false	false	false	null	0
[ 0 ]	7	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this study is to evaluate the role of nutritional Vitamin D deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease	The goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin D deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (ESRD). This study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin D deficiency. After consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin D supplementation. After washout is complete, an blood sample will be obtained for baseline 25(OH)D levels and monocyte isolation for analysis by flow cytometry. Patients will then be started on cholecalciferol 50,000 IU twice weekly for 8 weeks. 25-vitamin D levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. An additional blood sample will be drawn post-therapy for repeat 25(OH)D levels and monocyte isolation for flow cytometry analysis.	End-Stage Renal Disease	Endstage renal disease Vitamin D Monocyte function	null	1	arm 1: Cholecalciferol (Vitamin D)	[ 0 ]	1	[ 0 ]	intervention 1: 50,000 Units PO Twice weekly for 8 weeks	intervention 1: Cholecalciferol	0	null	7	NCT00677534	1COMPLETED	2009-08-01	2008-05-01	University of Kansas	7OTHER	false	false	false	null	0
[ 3 ]	114	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.	Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure. Erythropoiesis stimulating agents (ESAs) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents. Eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. Total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.	Anemia Chronic Renal Failure Chronic Kidney Disease	anemia chronic kidney disease CKD chronic renal failure CRF erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.04 milligram per kilogram (mg/kg); the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL). intervention 2: Participants received peginesatide by intravenous injection once every 4 weeks at the starting dose of 0.08 mg/kg; the dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL. intervention 3: Participants received Epoetin alfa by intravenous injection three times a week at the starting dose of 50 Units/kg. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.	intervention 1: peginesatide intervention 2: peginesatide intervention 3: Epoetin Alfa	11	Irkutsk \| N/A \| Russia \| 104.29585 \| 52.29795 Krasnodar \| N/A \| Russia \| 38.97603 \| 45.04484 Krasnoyarsk \| N/A \| Russia \| 92.90765 \| 56.02668 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Nizhny Novgorod \| N/A \| Russia \| 44.00205 \| 56.32867 Omsk \| N/A \| Russia \| 73.36859 \| 54.99244 Petrozavodsk \| N/A \| Russia \| 34.34691 \| 61.78491 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Tver' \| N/A \| Russia \| 35.90057 \| 56.85836 Volzhsk \| N/A \| Russia \| 48.35931 \| 55.86661	114	NCT00680043	1COMPLETED	2009-08-01	2008-06-01	Affymax	4INDUSTRY	false	false	false	null	0
[ 3 ]	10	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	false	1FEMALE	true	PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.	The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.	Uterine Fibroids	Uterine fibroids Fibroids	null	3	arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Lupron Depot	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Proellex 25 mg, 1 capsule daily for 4 months intervention 2: Proellex 50 mg, 2 capsules daily for 4 months intervention 3: Lupron 3.75 mg monthly intramuscular injections for 4 months	intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Lupron Depot	4	Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Mexico City \| Federal District \| Mexico \| -99.12766 \| 19.42847	0	NCT00683917	6TERMINATED	2009-08-01	2008-05-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	108	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To compare the efficacy and safety of once-nightly insulin glargine versus a single morning injection of glargine or once-nightly NPH insulin in ethnic minority type 2 diabetic patients inadequately controlled on combination oral agents.	Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when used as a once-nightly or morning basal insulin injection in type 2 diabetic patients who are inadequately controlled on combination oral agents has been controversial. Inner city ethnic minority patients with diabetes are a particularly challenging population of diabetic patients to treat. This study investigates whether insulin glargine may be a more effective or safer first-line basal insulin than NPH in this population.	Type 2 Diabetes Mellitus	Glargine Type 2 diabetes Basal insulin	null	3	arm 1: Insulin glargine injected subcutaneously once daily at bedtime arm 2: Insulin glargine injected subcutaneously once daily in the morning arm 3: NPH insulin injected subcutaneously once daily at bedtime	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Insulin glargine at bedtime (dose titrated to maintain 50% of fasting glucose readings \<120 mg/dL) intervention 2: Insulin glargine in AM (dose titrated to maintain 50% of pre-supper glucose readings \<120 mg/dL) intervention 3: NPH insulin at bedtime (dose titrated to maintain 50% of fasting glucoses \<120 mg/dL)	intervention 1: 1- Insulin glargine QHS intervention 2: 2 - Insulin glargine QAM intervention 3: 3 - NPH insulin QHS	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	85	NCT00686712	1COMPLETED	2009-08-01	2003-02-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0
[ 5 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	To compare the efficacy and safety of once-nightly insulin glargine versus twice-daily NPH insulin in ethnic minority type 2 diabetic patients inadequately treated with once-nightly NPH insulin alone.	Insulin glargine has a longer action than compared to NPH insulin, but whether this results in improved control when compared to twice-daily NPH insulin is not known when used in low-income ethnic minority patients. This study investigates whether insulin glargine may be more or less effective and safe than twice-daily NPH insulin in this population.	Type 2 Diabetes Mellitus	Glargine Type 2 diabetes Basal insulin	null	2	arm 1: Insulin glargine injected at bedtime arm 2: NPH insulin injected twice-daily, before breakfast and at bedtime	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Insulin glargine at bedtime substituting for NPH insulin at bedtime intervention 2: Addition of morning NPH to bedtime NPH	intervention 1: Insulin glargine at bedtime instead of NPH intervention 2: NPH twice-daily	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	24	NCT00687453	6TERMINATED	2009-08-01	2003-02-01	Charles Drew University of Medicine and Science	7OTHER	false	false	false	null	0
[ 3 ]	29	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The purpose of this pharmacokinetic study is to determine whether oral testosterone (T) ester formulations can be used effectively to treat men with low testosterone.	Determination of the steady-state serum T pharmacokinetic profiles for two oral formulations of T-esters \[testosterone undecanoate (TU) and TU combined with testosterone enanthate (TE)\] administered bis in die (BID) to 29 hypogonadal adult male subjects. TU was evaluated in total daily doses of 400 and 600 mg equivalents of T given twice daily for 7 or 8 days; TU + TE was evaluated in total daily doses of 600 and 800 mg equivalents of T given twice daily for 7 days. All subjects were enrolled into a single group and proceeded through the four Treatment Periods 1-4 in a sequential manner. In Treatment Period 3 the effect of food on the study-state pharmacokinetics profile of the TU formulation was evaluated.	Hypogonadism	testosterone male hypogonadism low testosterone	null	1	arm 1: Treatment Period 1: Three capsules each containing 100 mg testosterone (T) as testosterone undecanoate (TU), twice daily (BID) for 7 days. Treatment Period 2: Two capsules each containing 200 mg T as TU and testosterone enanthate (TE), BID for 7 days. Treatment Period 3: Two capsules each containing 100 mg T as TU, BID for 8 days. Treatment Period 4: Two capsules each containing 150 mg T as TU and TE, BID for 7 days.	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Three capsules each containing 100 mg testosterone (T) as TU, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. intervention 2: Two capsules each containing 100 mg T as TU and 100 mg T as TE, BID. 400 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days. A 7-14 day washout period occurred between successive Treatment Periods. intervention 3: Two capsules each containing 100 mg T as TU, BID for 8 days. 200 mg T equivalents BID 30 minutes after initiation of meals (breakfast and dinner), except for Day 8 when the morning dose was administered fasting. A 7-14 day washout period occurred between successive Treatment Periods. intervention 4: Two capsules each containing 150 mg T as TU and 150 mg T as TE, BID. 300 mg T equivalents BID 30 minutes after initiation of breakfast and dinner meals for 7 days.	intervention 1: Oral testosterone undecanoate (TU) (300 mg T equivalents/dose) intervention 2: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose) intervention 3: Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food) intervention 4: Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)	4	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	29	NCT00695110	1COMPLETED	2009-08-01	2008-06-01	Clarus Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	56	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.	Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period. Study was terminated by clinical hold.	Uterine Fibroids Anemia	Uterine fibroids Anemia	null	3	arm 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months arm 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months arm 3: Placebo, 2 capsules daily for 3 months	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months	intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo	30	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Leesburg \| Florida \| United States \| -81.87786 \| 28.81082 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 College Park \| Georgia \| United States \| -84.44937 \| 33.65344 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Morrow \| Georgia \| United States \| -84.33937 \| 33.58317 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Silver Spring \| Maryland \| United States \| -77.02609 \| 38.99067 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Englewood \| Ohio \| United States \| -84.30217 \| 39.87756 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Houston \| Texas \| United States \| -95.36327 \| 29.76328 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 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	0	NCT00702702	6TERMINATED	2009-08-01	2008-06-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 3 ]	3	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. High-dose aldesleukin may stimulate lymphocytes to kill tumor cells. Vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. Giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.	OBJECTIVES: Primary * Determine if the administration of anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes, high-dose aldesleukin, and adenovirus p53 dendritic cell (DC) vaccine after a nonmyeloablative, but lymphoid-depleting, preparative regimen will result in clinical tumor regression in patients with metastatic cancer that overexpresses p53. Secondary * Determine the in vivo survival of T-cell receptor (TCR) gene-engineered cells. * Determine the ability of a dendritic cell (DC) vaccine to restimulate TCR gene-engineered cells in vivo. * Determine the toxicity profile of this treatment regimen. OUTLINE: Patients are stratified according to type of metastatic cancer (melanoma or renal cell cancer vs all other cancers). * Peripheral blood mononuclear cell (PBMC) collection: Patients undergo PBMC collection via leukapheresis for the generation of the adenovirus p53 dendritic cell vaccine as well as anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes. * Nonmyeloablative lymphocyte-depleting preparative regimen: Patients receive cyclophosphamide intravenously (IV) over 1 hour on days -7 and -6 and fludarabine phosphate IV over 30 minutes on days -5 to -1. * Peripheral blood lymphocyte infusion: Patients receive anti-p53 TCR gene-engineered peripheral blood lymphocytes IV over 20-30 minutes on day 0. Patients receive filgrastim (growth colony stimulating factor (G-CSF)) subcutaneously (SC) once daily beginning on day 1 or 2 and continuing until blood counts recover. * High-dose aldesleukin: Patients receive high-dose aldesleukin IV over 15 minutes three times daily on days 0-4 for up to 15 doses. * Dendritic cell vaccine: Patients receive adenovirus p53 dendritic cell vaccine SC on days 0, 7, 14, and 28. Patients may receive one re-treatment course as above (nonmyeloablative preparative regimen, peripheral blood lymphocyte infusion, high-dose aldesleukin, and dendritic cell vaccinations) beginning 6-8 weeks after the last dose of high-dose aldesleukin. After completion of study treatment, patients are followed periodically for up to 15 years.	Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific	recurrent renal cell cancer stage IV renal cell cancer recurrent melanoma stage IV melanoma unspecified adult solid tumor, protocol specific	null	2	arm 1: Patients with melanoma and renal cell cancer will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2) arm 2: Patients with other histologies, such as breast cancer, will receive anti-p53 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + dendritic cells (DC) + interleukin-2 (IL-2)	[ 0, 0 ]	6	[ 2, 2, 2, 2, 0, 0 ]	intervention 1: Intravenous (IV) aldesleukin 720,000 IU/kg every 8 hours for a maximum of 15 doses. intervention 2: Intravenous (IV) anti-p53 TCR transduced PBL will be administered at a a dose of 1 x 10\^8 cells to 5 x 10\^10 cells. intervention 3: Ad-p53 DC vaccine, up to 2 x 10\^8 ad-p53 DCs per dose will be administered subcutaneously, divided into 4 injections, one into each of the 4 extremities. Ad-p53 DCs will be administered subcutaneously on day 7 (± 2 days), day 14 (between day 14 and day 18), and day 28 (between day 25 and day 42) post T cell infusion. intervention 4: subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day). intervention 5: 60mg/kg/day (Days-7,-6) intervention 6: 25mg/m\^2 (Days -5, -4, -3, -2, and -1)	intervention 1: aldesleukin intervention 2: anti-p53 T-cell receptor-transduced peripheral blood lymphocytes intervention 3: autologous dendritic cell-adenovirus p53 vaccine intervention 4: filgrastim intervention 5: cyclophosphamide intervention 6: fludarabine phosphate	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	3	NCT00704938	6TERMINATED	2009-08-01	2008-06-01	National Institutes of Health Clinical Center (CC)	0NIH	false	false	false	null	0
[ 2 ]	46	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and to establish what happens to the drug once inside the body. An escalating dose of PG-11047 will be investigated in this study and the maximum tolerated dose of the drug will be established.	This is an open-label phase I, dose-escalation safety study in subjects with refractory solid tumors. The primary objectives of the study are to assess the safety, tolerability, and pharmacokinetics of PG-11047. PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. The planned minimum treatment schedule is 2 cycles (8 weeks) of PG-11047 treatment. Subjects who tolerate treatment may be eligible to receive additional cycles as per investigator's medical judgment. Evaluation of anti-tumor response will be performed every 2 cycles.	Cancer	cancer advanced cancer solid tumors CGC-11047 PG-11047	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).	intervention 1: PG-11047	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	46	NCT00705653	1COMPLETED	2009-08-01	2005-03-01	Progen Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	17	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	2MALE	false	The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.	The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.	Secondary Hypogonadism	Adult Onset Idiopathic Hypothalamic Hypogonadism (AIHH) Secondary hypogonadism Semen volume Sperm count Sperm motility	null	3	arm 1: 1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period arm 2: Testim 1% Gel applied topically for 6 months arm 3: 1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone	[ 0, 1, 0 ]	2	[ 0, 0 ]	intervention 1: 25 mg Androxal capsules, 1 capsule daily for 6 months intervention 2: Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months	intervention 1: 25 mg Androxal intervention 2: Testim 1%	2	New York \| New York \| United States \| -74.00597 \| 40.71427 Purchase \| New York \| United States \| -73.71457 \| 41.04093	17	NCT00706719	1COMPLETED	2009-08-01	2008-06-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	231	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.	null	Glaucoma Ocular Hypertension	Ocular surface health OSDI TFBUT Glaucoma Ocular hypertension Corneal staining	null	2	arm 1: One drop self-administered in the study eye(s) once daily at night for 12 weeks arm 2: One drop self-administered in the study eye(s) once daily at night for 12 weeks	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.	intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)	0	null	231	NCT00708422	1COMPLETED	2009-08-01	2008-07-01	Alcon Research	4INDUSTRY	false	false	false	null	0
[ 4 ]	64	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).	null	Pulmonary Arterial Hypertension	Ventavis iloprost inhaled treatment pulmonary arterial hypertension	null	2	arm 1: Single dose of iloprost (5 µg) on study day 2 followed by single dose of placebo on study day 3 arm 2: Single dose of placebo on study day 2 followed by single dose of iloprost (5 µg) on study day 3	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Single dose of iloprost 5 µg using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc intervention 2: Single dose of matching placebo using I-neb(R) Adaptive Aerosol Delivery (AAD(R)) System power setting 15 disc	intervention 1: iloprost (5 µg) intervention 2: placebo	0	null	64	NCT00709956	1COMPLETED	2009-08-01	2008-07-01	Actelion	4INDUSTRY	false	false	false	null	0
[ 4 ]	160	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.	CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered three times a day using the PARI eFlow® electronic nebulizer, in CF patients with PA and mild lung disease. In this study, participant eligibility was assessed at a screening visit that occurred up to 14 days prior to the baseline visit (Day 0). Those participants who met eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow up visit 14 days after the last dose of the trial drug (Day 42).	Cystic Fibrosis Lung Infection Pseudomonas Aeruginosa	cystic fibrosis pseudomonas aeruginosa lung infection CFQ-R inhaled antibiotic aztreonam lysine	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: AZLI 75 mg three times daily (TID) intervention 2: Placebo three times daily (TID)	40	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Oakland \| California \| United States \| -122.2708 \| 37.80437 Orange \| California \| United States \| -117.85311 \| 33.78779 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Albany \| New York \| United States \| -73.75623 \| 42.65258 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Toledo \| Ohio \| United States \| -83.55521 \| 41.66394 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Westmead \| New South Wales \| Australia \| 150.98768 \| -33.80383 Westmead \| New South Wales \| Australia \| 150.98768 \| -33.80383 Chermside \| Queensland \| Australia \| 153.03062 \| -27.38472 Herston \| Queensland \| Australia \| 153.01852 \| -27.44453 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	157	NCT00712166	1COMPLETED	2009-08-01	2008-05-01	Gilead Sciences	4INDUSTRY	false	false	false	null	-0
[ 3 ]	25	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The investigators propose to investigate if using a combination of medications that may improve cholesterol give additional benefit to that gained from the statin medication, Lipitor. It is recommended that patients who meet certain criteria for risk of heart disease take a statin medication to improve cholesterol and hopefully reduce risk of heart disease. The combination therapy will include Lipitor, Niaspan, and investigational medication (known as ABT335) in a class of drugs called fibrates. We are looking to see if and how these three medications together might improve risk factors for atherosclerosis and influence HDL cholesterol. The study will also look at the safety and any side effects that might be associated with this combination of medications.	Objectives Summary \* To investigate whether the progressive addition of a fibrate and niacin to baseline statin therapy will improve apolipoprotein A-I kinetics, postprandial lipidemia, and postabsorptive lipoproteins and metabolism in adult men and women with atherogenic dyslipidemia. Major Efficacy Aims * Objective 1 is to test the hypothesis that the fibrate ABT335 and extended release (ER) niacin progressively improve apolipoprotein A-I kinetics when added sequentially to baseline therapy with atorvastatin. The key outcomes include the apolipoprotein AI rate of catabolism and rate of production. * Objective 2 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve postprandial lipidemia by oral fat challenge when added sequentially to baseline therapy with atorvastatin. Key outcomes include the incremental area under the curve for triglycerides and high-density lipoprotein cholesterol. * Objective 3 is to test the hypothesis that the fibrate ABT335 and ER niacin progressively improve markers of postabsorptive lipoproteins and metabolism when added sequentially to baseline therapy with atorvastatin. Key outcomes include a. fasting cholesterol efflux, b. HDL cholesterol, apolipoprotein A-I, and enzymes that remodel HDL, c. atherogenic lipoproteins, and d. markers of energy metabolism and e. markers of inflammation. Additional Aims \* Objective 4 is to assess tolerability and adverse events when ABT335 and ER niacin are added sequentially to atorvastatin. Specifically, we will assess changes in hepatobiliary laboratory tests (including incidence of elevation), incidence of symptomatic myalgia, and incidence of flushing. On an exploratory basis, we will enhance the flushing evaluation with objective and subjective measurements of flushing during inpatient visits. Study Design: This is an open-label feasibility study of fixed-sequence addition of lipid-altering medications, in which comparisons are made to the baseline for each subject. Subjects begin a lead-in phase in which they start the study statin (atorvastatin) or switch from previous statin therapy to the study statin. Subjects will wash off other excluded lipid-altering drugs during the lead-in. Subjects return for the first inpatient visit, where they have baseline studies on statin monotherapy. At the end of this visit, subjects are started on fibrate therapy (ABT335). They repeat the studies on dual therapy with statin and fibrate, and then add niacin (ER niacin). To minimize flushing during chronic treatment, they start aspirin 325 mg daily, or titrate to 325 mg if they are taking a lower dose of aspirin (e.g. 81 mg). Finally, they repeat the studies on triple therapy with statin, fibrate, and niacin/aspirin.	Dyslipidemia	Low HDL cholesterol High triglycerides niacin fibrate	null	3	arm 1: atorvastatin 10 mg/day by mouth for a total duration of 4 weeks arm 2: ABT335 135 mg/day by mouth added to atorvastatin for a total duration of at least 8 arm 3: ER niacin titrated up to 2 g/day with aspirin 325 mg/day by mouth added to atorvastatin and ABT335 for 10 weeks	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg QD for 4 weeks intervention 2: 135 mg QD added to atorvastatin for 8 weeks intervention 3: 2000 mg QD added to atorvastatin and ABT335 for 10 weeks	intervention 1: Atorvastatin intervention 2: ABT335 intervention 3: ER Niacin	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	25	NCT00728910	1COMPLETED	2009-08-01	2008-06-01	University of Pennsylvania	7OTHER	false	false	false	null	0
[ 4 ]	919	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	null	The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.	null	Atrophy Vaginal Diseases	Vulvar and vaginal atrophy in postmenopausal women Menopausal symptoms Vaginal atrophy Urogenital atrophy	null	2	arm 1: Subjects will receive a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed. arm 2: Subjects will receive a single, oral dose (1 tablet) of Placebo each morning with food for 12 weeks. All subjects will be provided vaginal lubricant (K-Y® Brand) and should use it as needed.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed intervention 2: oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed	intervention 1: Ospemifene 60 mg intervention 2: Placebo	0	null	919	NCT00729469	1COMPLETED	2009-08-01	2008-07-01	Shionogi	4INDUSTRY	false	false	false	null	0
[ 3 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The study drug which is an inhaled bronchodilator (lung airway relaxant)has been given to both healthy volunteers and to COPD patients before. This study will assess a new formulation of GSK573719. Many drugs are known to deteriorate over time. To make the study medicine less likely to deteriorate in its container, it is mixed with an inactive substance that helps to to maintain the quality of the study medicine. Previous studies have looked at GSK573719 with another inactive substance called Cellobiose Octaacetate (COA). This study will be looking at a new formulation of GSK573719 using Magnesium Stearate (MgSt) as the inactive substance. MgSt itself is not a medicine but is approved as a food ingredient and has also has been approved to be used in a number of marketed medical inhalers. The purpose of this study is to assess the safety and tolerability of compound GSK573719 with Magnesium Stearate for once-daily treatment of COPD(Chronic Obstructive Pulmonary Disease). This drug will be given to 2 groups of 12 people for 7 days. Group 1 will receive 250mcg or placebo and group 2 will receive 1000mcg or placebo. Group 2 will not be dosed until at least 6 people have completed dosing in group 1 without any significant safety concerns. The following safety measures will be assessed including: ECGs, heart rate, blood pressure, blood samples for safety labs, lung function and 24 hour monitoring of the heart. We will also take blood and urine samples to measure medication levels in the body. GlaxoSmithKline will be funding the research and it will be recruiting at Synexus in 7 of their centres in the UK.	null	Pulmonary Disease, Chronic Obstructive	Chronic Obstructive Pulmonary Disease (COPD) Magnesium stearate GSK573719	null	1	arm 1: 7 day repeat dose	[ 0 ]	1	[ 0 ]	intervention 1: 7 day repeat dose	intervention 1: GSK573719	7	Reading \| Berkshire \| United Kingdom \| -0.97113 \| 51.45625 Buckshaw Village, Chorley \| Lancashire \| United Kingdom \| -2.61667 \| 53.65 Waterloo, Liverpool \| Merseyside \| United Kingdom \| N/A \| N/A Clydebank, Glasgow \| N/A \| United Kingdom \| N/A \| N/A Edgbaston, Birmingham \| N/A \| United Kingdom \| N/A \| N/A Llanishen \| N/A \| United Kingdom \| -2.75722 \| 51.72333 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095	38	NCT00732472	1COMPLETED	2009-08-01	2008-10-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0
[ 5 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The effects of none-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase inhibitors (Coxibs) on the formation of bone and fracture healing have been a matter of debate since long. There is, however, limited data in humans and further prospective randomised studies are warranted. Ekman et al studied in a prospective randomised double blind study the effects of celecoxib, a selective cox-II-inhibitor, on pain and bone healing following spine surgery. They found significant effects on reduction of pain and need for opioid analgesics postoperatively but could see no negative effects the numbers of "none-unions" at a 1-year follow up 3. In a similar prospective randomised double-blind study design significant effects in reduction of pain and need for rescue analgesia was seen from the use of celecoxib in the perioperative multi-modal pain strategy for cruciate-ligament reconstruction and no negative effects could bee seen on six month follow-up of the strength of the reconstructed ligament. The aim of the present study is to further study the effects of the perioperative use of etoricoxib, a selective cox-II-inhibitor (Coxibs), in a prospective randomised double-blind study on bone healing, pain and need for rescue analgesia in patients undergoing elective Hallux Valgus surgery with a standardised surgical technique including an osteotomy of metatarsale I and excision of exostosis. Study population 100 American Society of Anesthesiology (ASA) physiological status1-2 patients scheduled for elective hallux valgus (HV) surgery The patients are going to be randomised into 2 groups, 50 patients in each; 1. etoricoxib 90 mg once daily x 5 2. tramadol 100 mg twice daily x 5 First line rescue medication t. paracetamol 1 gr up to 4 gram daily Second line rescue t. oxycodone 10 mg Primary study variables: * X-ray evaluation (computer tomography (CT)-investigation) of bone healing assessed a CT-scan modelling of the osteotomy at twelve weeks after surgery * Number of patients requiring rescue medication * Patient assessment using "brief pain inventory" 24 hours and 2 weeks after surgery Secondary study variables are; * Visual Analogue Scale (VAS) grading Day 1-7 * Compliance to base medication * Need for rescue analgesia Day 1-7 * Adverse Effects * Experience of any emetic symptoms * Experience of any gastrointestinal symptoms * Satisfaction with pain medication Day 20 * Wound dressing Day 20 * Clinical evaluation 17 weeks, final assessment	See brief summary	Postoperative Pain	Day surgery Hallux Valgus Pain Analgesics	null	2	arm 1: Active study drug: Etoricoxib 90 mg once daily arm 2: Tramadol 100 mg slow release twice daily	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 90 mg once daily intervention 2: 100 mg twice daily	intervention 1: etoricoxib intervention 2: tramadol	1	Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938	98	NCT00733421	1COMPLETED	2009-08-01	2008-10-01	Karolinska Institutet	7OTHER	false	false	false	null	0
[ 4 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.	Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.	Uterine Fibroids	Uterine Fibroids	null	3	arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: oral daily dose of placebo	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months intervention 2: Two 25 mg mg capsules of Proellex® orally daily for up to four months intervention 3: Two placebo capsules orally daily for up to four months	intervention 1: Proellex intervention 2: Proellex intervention 3: Placebo	15	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Boynton Beach \| Florida \| United States \| -80.06643 \| 26.52535 Leesburg \| Florida \| United States \| -81.87786 \| 28.81082 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 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 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	0	NCT00735553	6TERMINATED	2009-08-01	2008-08-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 4 ]	560	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine the effectiveness and safety of vortioxetine, once daily (QD), in patients with Major Depressive Disorder.	The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine. The study enrolled 560 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 1 mg * Vortioxetine 5 mg * Vortioxetine 10 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-centre trial was conducted in Europe, Asia, Australia, and South Africa. The overall time to participate in this study was up to 14 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.	Major Depressive Disorder	Depression Depressive Disorder Mood Disorder Mental Disorder Melancholia, Involutional Paraphrenia, Involutional Drug Therapy	null	4	arm 1: Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 3: Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks. arm 4: Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.	[ 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Encapsulated immediate-release vortioxetine tablets intervention 2: Vortioxetine placebo-matching capsules	intervention 1: Vortioxetine intervention 2: Placebo	48	Elizabeth Vale \| N/A \| Australia \| 138.66819 \| -34.74857 Southport \| N/A \| Australia \| 153.39796 \| -27.96724 Litoměřice \| N/A \| Czechia \| 14.1318 \| 50.53348 Lnáře \| N/A \| Czechia \| 13.78406 \| 49.4579 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Bully-les-Mines \| N/A \| France \| 2.72703 \| 50.4438 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Chemnitz \| N/A \| Germany \| 12.92922 \| 50.8357 Dillingen \| N/A \| Germany \| 6.72781 \| 49.35557 Hüttenberg \| N/A \| Germany \| 8.62189 \| 50.51453 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 München \| N/A \| Germany \| 13.31243 \| 51.60698 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Osnabrück \| N/A \| Germany \| 8.0498 \| 52.27264 Rodgau \| N/A \| Germany \| 8.88588 \| 50.02627 Westerstede \| N/A \| Germany \| 7.92737 \| 53.25682 Leipaja \| N/A \| Latvia \| N/A \| N/A Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Sigulda \| N/A \| Latvia \| 24.85953 \| 57.15375 Strenči \| N/A \| Latvia \| 25.68535 \| 57.62574 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Wildervank \| N/A \| Netherlands \| 6.8625 \| 53.08083 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 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 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 Tomsk \| N/A \| Russia \| 84.98204 \| 56.50032 Veliky Novgorod \| N/A \| Russia \| 31.27104 \| 58.52131 Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 Noordheuwel \| N/A \| South Africa \| 27.79223 \| -26.08639 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Bucheon-si \| N/A \| South Korea \| 126.78306 \| 37.49889 Namdong-gu \| N/A \| South Korea \| N/A \| N/A Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Lin-Yan District \| N/A \| Taiwan \| N/A \| N/A Dnipro \| N/A \| Ukraine \| 35.04066 \| 48.46664 Kharkiv \| N/A \| Ukraine \| 36.25475 \| 49.98177 Luhansk \| N/A \| Ukraine \| 39.30553 \| 48.56814 Simferopol \| N/A \| Ukraine \| 34.11079 \| 44.95719 Bath \| N/A \| United Kingdom \| -2.36172 \| 51.3751 Bolton \| N/A \| United Kingdom \| -2.43333 \| 53.58333	559	NCT00735709	1COMPLETED	2009-08-01	2008-08-01	Takeda	4INDUSTRY	false	false	false	null	0
[ 4 ]	175	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.	Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.	Uterine Fibroids	Uterine Fibroids	null	2	arm 1: Proellex 25 mg once daily arm 2: Proellex 50 mg once daily	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle intervention 2: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle	intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg	25	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 San Diego \| California \| United States \| -117.16472 \| 32.71571 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Fall River \| Massachusetts \| United States \| -71.15505 \| 41.70149 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Plano \| Texas \| United States \| -96.69889 \| 33.01984 Menomonee Falls \| Wisconsin \| United States \| -88.11731 \| 43.1789	0	NCT00737282	6TERMINATED	2009-08-01	2008-10-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	20	RANDOMIZED	PARALLEL	null	0NONE	false	0ALL	false	Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate of infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. The investigators hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin preparation solutions. The investigators intend to prospectively study twenty patients undergoing total hip arthroplasty. Patients will be randomized to either a chlorhexidine based or an iodine based skin preparation solution. These solutions are both the current gold standard of clinical care. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the same surgeon in a standardized manner. The site marking will include the surgeon's three initials as per usual routine. Underneath the initials three random initials will be placed with a horizontal line drawn underneath. The preparation of the skin will be performed according to the manufacturer's specifications. Digital photographs will be taken of the skin marking after skin preparation. Photographs of the three random initials will be de-identified and placed in a "Powerpoint" presentation form. Ten orthopaedic surgeons will then read the site markings to identify the random initials and to tell whether the mark looks appropriate to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop to quantitatively measure blackness of the mark.	Abstract: Skin preparation solutions are used to clean the skin of the patient before surgery to decrease the rate if infection. This is particularly important for hip replacement to reduce the risk of prosthetic joint infection. The use of a mark on the skin for site identification has become the standard of care to decrease wrong site surgery. The Joint Commission has mandated site identification as part of the surgical "time-out". This procedure is also mandated by hospital policy. Preliminary work on cadaveric skin shows that the type of skin preparation can erase the mark used for surgical site identification. Erasure of the mark presents the surgeon with difficulty in performing the site identification. Any error or lack of visualization of the site marking could lead to catastrophic wrong site surgery. Our hypothesis is that chlorhexidine based skin preparation solutions erase site marking in comparison to iodine based skin marking solutions. We intend to prospectively study twenty patients undergoing total hip arthroplasty to determine if the site marking is erased by chlorhexidine based skin preparation solutions when compared to iodine based skin preparation solutions. This information is critical to all surgeons who must balance the risk of wound infection versus wrong site surgery. Study Procedures: We intend to study twenty patients of one orthopaedic surgeon (SCM) undergoing total hip replacement in the supine position. Patients must be English speaking and of light skin color to standardize the contrast of the site marking. The study will be discussed with the patient in the clinic setting before the surgical date. Patients will be randomized into either using a chlorhexidine based skin preparation solution (Chloraprep® (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; Enturia Inc., Leawood, KS, USA)), or an iodine based skin preparation solution (Duraprep® (Iodophor 0.7% and isopropyl alcohol 74% w/w; 3M Healthcare, St. Paul, MN, USA)). Patients with allergies to either chlorhexidine or iodine will not be included in the study. These solutions are both the current gold standard of clinical care and are routinely used in the Johns Hopkins Bayview Medical Center. No differences have been shown in infection rates for total hip arthroplasty between these solutions. The site marking will be performed by the surgeon in a standardized manner using the standard marker supplied at the hospital (Sharpie Fine Point Permanent Marker, Sanford Corporation, Oak Brook, IL, USA). All markings will be made in the pre-operative holding area per usual routine. The site marking will be made next to the site of the incision on the anterior thigh. The site marking will include the surgeon's three initials as per usual routine. Underneath the surgeon's initials, three random initials will be placed with a horizontal line drawn underneath. Twenty random three-letter combinations will be pre-generated using MS Excel® (Microsoft Office 2003, Microsoft Corporation, Seattle WA). After patient positioning and prior to skin preparation an extra surgical time-out and site identification will be performed. The preparation of the skin will then be conducted according to the manufacturer's specifications for each skin preparation solution. After skin preparation, the solution will be allowed to dry while the patient is draped. Prior to applying the impermeable drape to the skin, digital photographs will be taken. Specimens will be photographed using a digital still camera (Digital Rebel XTi, Canon U.S.A., Lake Success, NY) with a 100-mm macro lens (EF 100mm f/2.8 USM Macro Lens, Canon U.S.A.), and ring flash (MR-14EX TTL, Canon U.S.A). The camera captures data at 10.1 megapixels and will be set in RAW mode. The shutter speed will be set at 1/60s with an F-stop value of 4.0. The camera was placed at a fixed distance from the skin using a tripod. After photography the impervious drape will be placed and another surgical time-out will be performed. The surgeon, anesthesiologist and nurse must all agree on the surgical site and it must be confirmed with the consent form, the patient records and the radiographs. The study will make no changes in the clinic care of the patient besides the use of an additional time-out and the extra initials and the photograph of the site marking. The surgical procedure will not be altered in any way. Photographs of the three random initials will be de-identified. They will be cropped using Adobe Photoshop CS2® (Adobe, San Jose, CA) so that only the three random initials and the horizontal line are visible. The file will be identified by a study number only. The files will be placed into a digital presentation (Powerpoint, Microsoft Office 2003, Microsoft Corporation, Seattle, WA). Ten orthopaedic surgeons will then read the site markings in random order. The surgeons will be asked to identify the initials and to tell whether the mark looks appropriate for them to perform a surgical timeout. The horizontal line will be digitally analyzed using Adobe Photoshop CS2® to quantitatively measure the mean gray level of the horizontal line using the histogram tool. Regression analysis will be performed to examine the affect of the skin preparation solution on the ability of surgeons to correctly read the initials and their ability to identify the site marking. Drugs/Substances/Devices: Two skin preparation solutions will be used for this study. Both are considered gold standards for skin preparation and are routinely used at the Johns Hopkins Bayview Medical Center. These include: Chlorhexidine based skin preparation solution Chloraprep® (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; Enturia Inc., Leawood, KS, USA) Iodine based skin preparation solution Duraprep® (Iodophor 0.7% and isopropyl alcohol 74% w/w; 3M Healthcare, St. Paul, MN, USA) Study Statistics: Primary Variables: Identification of the random initials by the reviewing orthopaedic surgeons Judgment of reviewing orthopaedic surgeons that the site marking is identifiable for them to perform site identification The mean gray level of the horizontal line Risks: Surgical site infection: The skin preparation of the skin will be conducting using the two standard skin preparation solutions at the Johns Hopkins Bayview Medical Center. The preparation will be performed according to manufacturer's directions for the skin preparation solutions. The risk of infection should not be changed by this study. This study is not meant to investigate the rates of infection using the two preparation solutions. Wrong site surgery: The standard protocol for site identification will be performed for all patients. The surgeon's initials will be identified during the time-out procedure. The time out will be performed by the nurse in the operating room according to the protocol of the Johns Hopkins Bayview Medical Center. The nurse will read the consent form, confirm the site identification mark with the surgeon and the anesthesiologist. The side will be confirmed with the radiographs and the consent form for the procedure. The time out will be performed two times to prevent any possibility of wrong site surgery. This is a technique used by the neurosurgical services where site marking is difficult. The site will be identified both before and after the skin preparation. Extra markings: The patient will have three extra initials and one horizontal line drawn underneath the standard site marking. Site markings are with permanent marker and do take several weeks of washing to be removed. All patients will be informed of the extra markings as part of the study consent form. If patients do not want to have these extra markings, they will not be included into the study. Confidentiality: The data from this study includes only the digital photographs of the site marking. The photographs will have no identifying information and will be only labeled with the study number (one to twenty). All information from this study will be de-identified data that should not pose any confidentiality risks to the patient. Benefits: The benefit of this study will be to give more information about the removal of site markings by skin preparation solutions. While the risk of wrong site surgery is currently low, everything possible must be done to eliminate any potential for this occurring. This study examines the marking used for total hip surgery; the risk of wrong site surgery is higher for those surgeries involving the digits or smaller areas of the body. In these areas, the marking must be perfect. Any elimination of the mark could result in catastrophe. If a mark is not well visible or partially erased, a culture is created where the mark is ignored, creating danger to the patient. If this is occurring with standard skin preparation solutions then either the solutions or the marking must be changed in the future. We hope that this study will help to eliminate any potential for wrong site surgery.	Arthroplasty, Replacement, Hip	Skin preparation Skin marking site marking Site identification	null	2	arm 1: Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA) arm 2: Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Skin preparation of the surgical site per label of the product. The area for surgery will be prepared for 30 seconds intervention 2: Skin preparation of the surgical site per product labeling. The area will be painted with the solution.	intervention 1: CHG 2% w/v and IPA 70% v/v intervention 2: Iodophor 0.7% and IPA 74% w/w	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	20	NCT00739583	1COMPLETED	2009-08-01	2008-08-01	Johns Hopkins University	7OTHER	false	false	false	null	0
[ 5 ]	598	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study will assess if customizing the start dose of rosuvastatin appropriate for the degree of LDL-C reduction required, would achieve LDL-C target of ≤ 2.0 mmol/L quickly with either no titration or just one titration step after 6 weeks of therapy in type 2 diabetic patients previously treated with another statin and not at LDL-C targets.	null	Type 2 Diabetes	diabetes type 2	null	2	arm 1: titrated arm 2: Non-titrated	[ 0, 0 ]	1	[ 0 ]	intervention 1: Oral	intervention 1: Rosuvastatin	84	Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Red Deer \| Alberta \| Canada \| -113.802 \| 52.26682 Spruce Grove \| Alberta \| Canada \| -113.91874 \| 53.53344 St. Albert \| Alberta \| Canada \| -113.63533 \| 53.63344 Chilliwack \| British Columbia \| Canada \| -121.95257 \| 49.16638 Coquitlam \| British Columbia \| Canada \| -122.78217 \| 49.2846 Delta \| British Columbia \| Canada \| -122.9068 \| 49.14399 Kelowna \| British Columbia \| Canada \| -119.48568 \| 49.88307 Maple Ridge \| British Columbia \| Canada \| -122.60193 \| 49.21939 Penticton \| British Columbia \| Canada \| -119.58584 \| 49.48062 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Portage la Prairie \| Manitoba \| Canada \| -98.29263 \| 49.97282 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Bathurst \| New Brunswick \| Canada \| -65.65112 \| 47.61814 Woodstock \| New Brunswick \| Canada \| -67.58377 \| 46.15796 Carbonear \| Newfoundland and Labrador \| Canada \| -53.2272 \| 47.73919 Mount Pearl \| Newfoundland and Labrador \| Canada \| -52.78135 \| 47.51659 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Kentville \| Nova Scotia \| Canada \| -64.49605 \| 45.0771 Pubnico \| Nova Scotia \| Canada \| -65.78215 \| 43.70016 Sydney Mines \| Nova Scotia \| Canada \| -60.21767 \| 46.23669 Truro \| Nova Scotia \| Canada \| -63.26538 \| 45.36685 Aylmer \| Ontario \| Canada \| -80.98302 \| 42.76679 Bolton \| Ontario \| Canada \| -79.73791 \| 43.87952 Chatham \| Ontario \| Canada \| -82.18494 \| 42.41224 Fort Erie \| Ontario \| Canada \| -78.93286 \| 42.90012 Georgetown \| Ontario \| Canada \| -79.91634 \| 43.65011 Greater Sudbury \| Ontario \| Canada \| -80.99001 \| 46.49 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Mississauga \| Ontario \| Canada \| -79.6583 \| 43.5789 Morrisburg \| Ontario \| Canada \| -75.18261 \| 44.9001 Nepean \| Ontario \| Canada \| -75.7225 \| 45.33619 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 North York \| Ontario \| Canada \| N/A \| N/A Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Saint Catherines \| Ontario \| Canada \| N/A \| N/A Scaborough \| Ontario \| Canada \| N/A \| N/A Scarborough Village \| Ontario \| Canada \| -79.22124 \| 43.73899 Smith Falls \| Ontario \| Canada \| N/A \| N/A St. Catharines \| Ontario \| Canada \| -79.24267 \| 43.17126 Thornhill \| Ontario \| Canada \| -79.4163 \| 43.80011 Thorold \| Ontario \| Canada \| -79.19958 \| 43.11682 Thunder Bay \| Ontario \| Canada \| -89.25018 \| 48.38202 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Welland \| Ontario \| Canada \| -79.24958 \| 42.98342 Willowdale \| Ontario \| Canada \| -79.39909 \| 43.76672 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Woodstock \| Ontario \| Canada \| -80.7497 \| 43.13339 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Kensington \| Prince Edward Island \| Canada \| -63.64871 \| 46.43343 Montague \| Prince Edward Island \| Canada \| -62.64866 \| 46.16681 Anjou \| Quebec \| Canada \| -73.54917 \| 45.60008 Dolbeau-Mistassini \| Quebec \| Canada \| -72.23142 \| 48.8786 Drummondville \| Quebec \| Canada \| -72.48241 \| 45.88336 Forestville \| Quebec \| Canada \| -69.08478 \| 48.73808 Gatineau \| Quebec \| Canada \| -75.70164 \| 45.47723 Joliette \| Quebec \| Canada \| -73.4236 \| 46.0164 L'Ile Perrot \| Quebec \| Canada \| -73.9492 \| 45.38338 La Sarre \| Quebec \| Canada \| -79.19964 \| 48.80019 Laval \| Quebec \| Canada \| -73.692 \| 45.56995 Longueuil \| Quebec \| Canada \| -73.46818 \| 45.5152 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Roberval \| Quebec \| Canada \| -72.23244 \| 48.5168 Roxton Pond \| Quebec \| Canada \| -72.66582 \| 45.48338 Saint-bruno-lac-saint-jean \| Quebec \| Canada \| N/A \| N/A Saint-Charles-Borromée \| Quebec \| Canada \| -73.46586 \| 46.05007 Saint-Léonard \| Quebec \| Canada \| -73.59501 \| 45.58773 Saint-Marc-des-Carrieres \| Quebec \| Canada \| -72.0491 \| 46.68335 Saint-Pie \| Quebec \| Canada \| -72.9089 \| 45.50277 Sainte Gedeon-de-beauce \| Quebec \| Canada \| N/A \| N/A Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Thetford-Mines \| Quebec \| Canada \| -71.30539 \| 46.09371 Trois-Rivières \| Quebec \| Canada \| -72.5477 \| 46.34515 Moose Jaw \| Saskatchewan \| Canada \| -105.53445 \| 50.40005 Porcupine Plain \| Saskatchewan \| Canada \| -103.25095 \| 52.6 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Yorkton \| Saskatchewan \| Canada \| -102.46766 \| 51.2167	1,165	NCT00747149	1COMPLETED	2009-08-01	2008-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 5 ]	110	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Study objective is to compare neuropsychiatric adverse events in subjects treated with varenicline or placebo in a controlled setting where both groups are experiencing nicotine withdrawal.	null	Smoking Cessation	nicotine withdrawal, smoking cessation, varenicline	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days) intervention 2: 1 mg tablets twice daily by mouth (after one week of uptitration: 0.5mg once daily for three days, 0.5mg twice daily for four days)	intervention 1: varenicline intervention 2: placebo	2	Austin \| Texas \| United States \| -97.74306 \| 30.26715 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	110	NCT00749944	1COMPLETED	2009-08-01	2008-09-01	Pfizer	4INDUSTRY	false	false	false	null	0
[ 5 ]	51	RANDOMIZED	CROSSOVER	0TREATMENT	1SINGLE	true	0ALL	false	Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.	null	Dry Eye Syndromes		null	2	arm 1: Carboxymethylcellulose and Glycerin arm 2: Polyethylene glycol 400	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: 1 drop in both eyes as needed for 7 days' intervention 2: 1 drop in both eyes as needed for 7 days	intervention 1: Lubricant Eye Drops (Optive™) intervention 2: Lubricating Eye Drops (blink® Tears)	1	Chevy Chase \| Maryland \| United States \| -77.07115 \| 39.00287	51	NCT00756678	1COMPLETED	2009-08-01	2008-09-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	56	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	4QUADRUPLE	false	0ALL	false	The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).	null	Cystic Fibrosis	cystic fibrosis	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 60 mg, oral tablet, twice daily for 28 days intervention 2: Match placebo to 60 mg, oral tablet, twice daily for 28 days	intervention 1: AZD9668 intervention 2: AZD9668 Placebo equivalent	14	Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 München \| N/A \| Germany \| 13.31243 \| 51.60698 Rabka-Zdrój \| N/A \| Poland \| 19.96654 \| 49.60889 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Belfast \| Northern Ireland \| United Kingdom \| -5.92541 \| 54.59682 Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058	55	NCT00757848	1COMPLETED	2009-08-01	2008-10-01	AstraZeneca	4INDUSTRY	false	false	false	null	0
[ 3, 4 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.	The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.	Varicose Veins	Varicose Veins	null	2	arm 1: Varisolve (polidocanol endovenous mircofoam) arm 2: Agitated saline	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2) intervention 2: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session	intervention 1: Varisolve (Polidocanol Endovenous Microfoam) intervention 2: Agitated Saline	5	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 New York \| New York \| United States \| -74.00597 \| 40.71427 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038	77	NCT00758420	1COMPLETED	2009-08-01	2008-10-01	Boston Scientific Corporation	4INDUSTRY	false	false	false	null	-0
[ 4 ]	33	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	To test effectiveness of dentifrice in maintaining periodontal health.	null	Periodontal Disease		null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period. intervention 2: subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.	intervention 1: Triclosan, Fluoride intervention 2: Fluoride	1	Queensland \| N/A \| Australia \| N/A \| N/A	33	NCT00763256	1COMPLETED	2009-08-01	2006-05-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,191	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study evaluated the efficacy (blood pressure lowering effect) and safety of aliskiren/amlodipine/hydrochlorothiazide in patients with moderate to severe hypertension.	null	Hypertension	aliskiren antihypertensive hypertension renin inhibitor moderate-severe hypertension	null	4	arm 1: Patients received an aliskiren 150 mg tablet plus an amlodipine 5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus amlodipine 10 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet and a placebo capsule. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 2: Patients received an aliskiren 150 mg tablet plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to aliskiren 300 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo capsule and a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 3: Patients received an amlodipine 5 mg capsule plus a hydrochlorothiazide 12.5 mg capsule for 4 weeks and then were force titrated up to amlodipine 10 mg plus hydrochlorothiazide 25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received 2 placebo tablets. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed. arm 4: Patients received an aliskiren 150 mg tablet, a HCTZ 12.5 mg capsule and a placebo capsule for the first 3 days of treatment. Amlodipine 5 mg was then added for the remainder of the first 4 weeks of treatment. At the end of 4 weeks, patients were force titrated up to aliskiren / amlodipine / hydrochlorothiazide 300/10/25 mg for the remaining 4 weeks of the study. During the 8 weeks, patients also received a placebo tablet. Patients took a total of 4 pills each day orally with water in the morning at approximately 8:00 am, except on the morning of a study visit when they took their study medications after all visit procedures and assessments had been completed.	[ 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 150 and 300 mg tablets intervention 2: 5 and 10 mg capsules intervention 3: 12.5 and 25 mg capsules intervention 4: tablet intervention 5: capsules	intervention 1: Aliskiren intervention 2: Amlodipine intervention 3: Hydrochlorothiazide (HCTZ) intervention 4: Placebo intervention 5: Placebo	12	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Ottawa \| N/A \| Canada \| -75.69812 \| 45.41117 Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Rome \| N/A \| Italy \| 12.51133 \| 41.89193 Riga \| N/A \| Latvia \| 24.10589 \| 56.946 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987	1,188	NCT00765674	1COMPLETED	2009-08-01	2008-09-01	Novartis	4INDUSTRY	false	false	false	null	-0
[ 4 ]	633	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder	null	Chronic Constipation	Constipation Chronic Constipation Linaclotide	null	3	arm 1: Linaclotide 290 micrograms arm 2: Linaclotide 145 micrograms arm 3: Matching placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 2: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study intervention 3: Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study	intervention 1: Linaclotide 290 micrograms intervention 2: Linaclotide 145 micrograms intervention 3: Placebo	108	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Burbank \| California \| United States \| -118.30897 \| 34.18084 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Foothill Ranch \| California \| United States \| -117.66088 \| 33.68641 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Boulder \| Colorado \| United States \| -105.27055 \| 40.01499 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Boca Raton \| Florida \| United States \| -80.0831 \| 26.35869 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Brooksville \| Florida \| United States \| -82.38991 \| 28.55554 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Kissimmee \| Florida \| United States \| -81.41667 \| 28.30468 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Trinity \| Florida \| United States \| -82.68177 \| 28.18085 Zephyrhills \| Florida \| United States \| -82.18119 \| 28.23362 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Stockbridge \| Georgia \| United States \| -84.23381 \| 33.54428 Woodstock \| Georgia \| United States \| -84.51938 \| 34.10149 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Rockford \| Illinois \| United States \| -89.094 \| 42.27113 Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Arkansas City \| Kansas \| United States \| -97.03837 \| 37.06197 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Madisonville \| Kentucky \| United States \| -87.49889 \| 37.3281 Chevy Chase \| Maryland \| United States \| -77.07115 \| 39.00287 Hagerstown \| Maryland \| United States \| -77.71999 \| 39.64176 Lutherville \| Maryland \| United States \| -76.62608 \| 39.42122 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Chaska \| Minnesota \| United States \| -93.60218 \| 44.78941 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Vineland \| New Jersey \| United States \| -75.02573 \| 39.48623 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 Fayetteville \| North Carolina \| United States \| -78.87836 \| 35.05266 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Bensalem \| Pennsylvania \| United States \| -74.95128 \| 40.10455 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lake Jackson \| Texas \| United States \| -95.43439 \| 29.03386 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Christianburg \| Virginia \| United States \| N/A \| N/A Newport News \| Virginia \| United States \| -76.42975 \| 36.98038 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Bellevue \| Washington \| United States \| -122.20068 \| 47.61038 Lakewood \| Washington \| United States \| -122.51846 \| 47.17176 Wenatchee \| Washington \| United States \| -120.31035 \| 47.42346 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Greater Sudbury \| Ontario \| Canada \| -80.99001 \| 46.49 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	633	NCT00765882	1COMPLETED	2009-08-01	2008-09-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 5 ]	256	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).	null	Essential Hypertension ( Mild to Moderate)	Essential Hypertension ( mild to moderate)	null	1	arm 1: All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: Aliskiren 150 or 300 mg intervention 2: Hydrochlorothiazide 12.5 or 25 mg intervention 3: Amlodipine 5 or 10 mg	intervention 1: Aliskiren intervention 2: Hydrochlorothiazide intervention 3: Amlodipine	4	Paris \| N/A \| France \| 2.3488 \| 48.85341 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816	572	NCT00765947	1COMPLETED	2009-08-01	2008-09-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	1,727	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.	null	Herpes Labialis		null	2	arm 1: Acyclovir Lauriad 50mg arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 50 mg muco-adhesive buccal tablets, single application on the gum intervention 2: 50 mg muco-adhesive buccal tablets, single application on the gum	intervention 1: Acyclovir Lauriad intervention 2: Placebo	53	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 San Francisco \| California \| United States \| -122.41942 \| 37.77493 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Meridian \| Idaho \| United States \| -116.39151 \| 43.61211 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Sydney \| N/A \| Australia \| 151.20732 \| -33.86785 Opava \| N/A \| Czechia \| 17.90257 \| 49.93866 Opava \| N/A \| Czechia \| 17.90257 \| 49.93866 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Besançon \| N/A \| France \| 6.01815 \| 47.24878 Martigues \| N/A \| France \| 5.05526 \| 43.40735 Nancy \| N/A \| France \| 6.18496 \| 48.68439 Nice \| N/A \| France \| 7.26608 \| 43.70313 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Saint-Etienne \| N/A \| France \| 4.39 \| 45.43389 Tours \| N/A \| France \| 0.70398 \| 47.39484 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Biberach \| N/A \| Germany \| 8.03333 \| 48.33333 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Oberkirch \| N/A \| Germany \| 8.07864 \| 48.53241 Rodgau-Dudenhofen \| N/A \| Germany \| N/A \| N/A Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Chrzanów \| N/A \| Poland \| 19.40203 \| 50.13546 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Grudziądz \| N/A \| Poland \| 18.75366 \| 53.48411 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Płock \| N/A \| Poland \| 19.70638 \| 52.54682 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Canterbury \| N/A \| United Kingdom \| 1.07992 \| 51.27904 Cardiff \| N/A \| United Kingdom \| -3.18 \| 51.48 East Sussex \| N/A \| United Kingdom \| N/A \| N/A East Sussex \| N/A \| United Kingdom \| N/A \| N/A Saltash \| N/A \| United Kingdom \| -4.22514 \| 50.40959	775	NCT00769314	1COMPLETED	2009-08-01	2007-05-01	Valerio Therapeutics	4INDUSTRY	false	false	false	null	0
[ 4 ]	8	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.	Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.	Uterine Fibroids Anemia	Uterine fibroids Anemia	null	3	arm 1: Proellex 25 mg arm 2: Proellex 50 mg arm 3: Placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months intervention 2: Proellex 50 mg, 2 - 25 mg capsules daily for 3 months intervention 3: Placebo, 2 capsules daily for 3 months	intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg intervention 3: Placebo	7	Toluca \| Estado de Mexico C.P. \| Mexico \| -99.65324 \| 19.28786 Mexico City \| Federal District \| Mexico \| -99.12766 \| 19.42847 Mexico City \| Federal District \| Mexico \| -99.12766 \| 19.42847 Mexico City \| Federal District \| Mexico \| -99.12766 \| 19.42847 San Miguel de Allende \| Guanajuato \| Mexico \| -100.74389 \| 20.91528 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435	0	NCT00785356	6TERMINATED	2009-08-01	2008-10-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	207	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This study will evaluate the long-term efficacy of nebivolol monotherapy in patients with stage 1 or stage 2 hypertension after the withdrawal of active medication.	null	Hypertension	nebivolol Bystolic® Hypertension blood pressure withdrawal	null	2	arm 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration arm 2: Matching placebo tablets, oral administration	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Nebivolol 10 mg, 10-mg Nebivolol nontrade tablets , oral administration Nebivolol 20 mg, 20-mg Nebivolol nontrade tablets , oral administration Nebivolol 40 mg, two 20-mg Nebivolol nontrade tablets , oral administration intervention 2: Matching placebo tablets, oral administration	intervention 1: Nebivolol intervention 2: Placebo	26	Chandler \| Arizona \| United States \| -111.84125 \| 33.30616 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Brooksville \| Florida \| United States \| -82.38991 \| 28.55554 DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Marion \| Ohio \| United States \| -83.12852 \| 40.58867 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 New Tazewell \| Tennessee \| United States \| -83.59963 \| 36.44258 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	476	NCT00785512	1COMPLETED	2009-08-01	2008-11-01	Forest Laboratories	4INDUSTRY	false	false	false	null	0
[ 4 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Thousands of patients die daily from early and late complications of a heart attack (acute myocardial infarction, AMI). Patients surviving AMI remain at high risk of death from adverse cardiac remodeling (dysfunction and enlargement of the heart) leading to heart failure (weakening of the heart). Current interventions proven to reduce adverse remodeling and progression to heart failure include early reperfusion (restoring blood flow to the heart muscle) and long-term use of medicines that block the effects of hormones (such as angiotensin II, norepinephrine and aldosterone) involved in adverse remodeling. Despite these treatments, however, many patients continue to develop heart failure within 1 year of AMI. These patients are at very high risk of death. Numerous changes occur in the hearts of patients after AMI that lead to adverse remodeling. Ischemia (lack of oxygen) and infarction (cell damage) lead to increased interleukin-1 (IL-1) production in the heart. IL-1 plays a critical role in adverse cardiac remodeling by coordinating the inflammatory pathway (leading to wound healing) and apoptotic pathway (leading to cell death). In opposition to IL-1 activity, the human body produces a natural IL-1 receptor antagonist that blocks the effects of IL-1. The drug form of this IL-1 receptor antagonist (anakinra) is currently FDA approved for the treatment of rheumatoid arthritis, an inflammatory disease characterized by excessive IL-1 activity. Experimental studies show that anakinra is able to prevent cardiac remodeling and improve survival in mice after AMI. We hypothesize that anakinra will show similar benefits in human patients by preventing adverse remodeling and heart failure after AMI.	null	ST Segment Elevation Acute Myocardial Infarction	acute myocardial infarction	null	2	arm 1: Anakinra 100 mg given daily by subcutaneous injection for 14 days arm 2: 0.67 ml of NaCl 0.9% solution	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 100 mg daily subcutaneous injection for 14 days intervention 2: 0.67 ml of NaCl 0.9% subcutaneously daily for 14 days	intervention 1: Anakinra intervention 2: Placebo	1	Richmond \| Virginia \| United States \| -77.46026 \| 37.55376	10	NCT00789724	1COMPLETED	2009-08-01	2008-11-01	Virginia Commonwealth University	7OTHER	false	false	false	null	0
[ 4 ]	646	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.	null	Erectile Dysfunction	ED Erectile Dysfunction Dysfunction Erectile	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 30 minutes orally prior to initiation of sexual activity intervention 2: 30 minutes orally prior to initiation of sexual activity intervention 3: 30 minutes orally prior to initiation of sexual activity intervention 4: 30 minutes orally prior to initiation of sexual activity	intervention 1: placebo intervention 2: avanafil intervention 3: avanafil intervention 4: avanafil	41	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Coral Gables \| Florida \| United States \| -80.26838 \| 25.72149 Hialeah \| Florida \| United States \| -80.27811 \| 25.8576 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Pembroke Pines \| Florida \| United States \| -80.22394 \| 26.00315 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Madisonville \| Kentucky \| United States \| -87.49889 \| 37.3281 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Albany \| New York \| United States \| -73.75623 \| 42.65258 New York \| New York \| United States \| -74.00597 \| 40.71427 Cary \| North Carolina \| United States \| -78.78112 \| 35.79154 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Harrisburg \| North Carolina \| United States \| -80.65784 \| 35.32395 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Salisbury \| North Carolina \| United States \| -80.47423 \| 35.67097 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Spring \| Texas \| United States \| -95.41716 \| 30.07994	644	NCT00790751	1COMPLETED	2009-08-01	2008-11-01	VIVUS LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	9	RANDOMIZED	PARALLEL	7BASIC_SCIENCE	2DOUBLE	false	0ALL	false	A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy	null	Inflammation		null	2	arm 1: Ketorolac 0.4% arm 2: Mineral Oil Emollient	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: One drop 4 times a day in the pre-operative eye beginning day 0 for 4 days intervention 2: One drop 4 times a day in the operative eye beginning one day prior to the peripheral iridotomy and continuing until the day of IOL implantation	intervention 1: Ketorolac 0.4% intervention 2: Lubricating Eye Drop	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	9	NCT00791323	1COMPLETED	2009-08-01	2008-11-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 3 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.	null	Acute Gout	Acute flares Gout Anti-interleukin-1β monoclonal antibody Colchicine Triamcinolone acetonide	null	6	arm 1: Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. arm 2: Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. arm 3: Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. arm 4: Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. arm 5: Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. arm 6: Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.	[ 0, 0, 0, 0, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle. intervention 2: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. intervention 3: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. intervention 4: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. intervention 5: Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. intervention 6: Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.	intervention 1: Canakinumab intervention 2: Canakinumab intervention 3: Canakinumab intervention 4: Canakinumab intervention 5: Canakinumab intervention 6: Triamcinolone acetonide	75	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Buena Park \| California \| United States \| -117.99812 \| 33.86751 Oakland \| California \| United States \| -122.2708 \| 37.80437 San Diego \| California \| United States \| -117.16472 \| 32.71571 West Covina \| California \| United States \| -117.93895 \| 34.06862 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Zephyrhills \| Florida \| United States \| -82.18119 \| 28.23362 Rome \| Georgia \| United States \| -85.16467 \| 34.25704 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Monroe \| Louisiana \| United States \| -92.1193 \| 32.50931 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Binghamton \| New York \| United States \| -75.91797 \| 42.09869 Duncansville \| Pennsylvania \| United States \| -78.4339 \| 40.42341 Varnville \| South Carolina \| United States \| -81.07927 \| 32.85044 Hendersonville \| Tennessee \| United States \| -86.62 \| 36.30477 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Milan \| Tennessee \| United States \| -88.75895 \| 35.91979 Mesquite \| Texas \| United States \| -96.59916 \| 32.7668 Newport News \| Virginia \| United States \| -76.42975 \| 36.98038 Rosario \| N/A \| Argentina \| -60.63932 \| -32.94682 Gozée \| N/A \| Belgium \| 4.35273 \| 50.33461 Moncton \| N/A \| Canada \| -64.7965 \| 46.09454 Mount Pearl \| N/A \| Canada \| -52.78135 \| 47.51659 St. John's \| N/A \| Canada \| -52.70931 \| 47.56494 Paris \| N/A \| France \| 2.3488 \| 48.85341 Bad Nauheim \| N/A \| Germany \| 8.73859 \| 50.36463 Bautzen \| N/A \| Germany \| 14.43494 \| 51.18035 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Chemnitz \| N/A \| Germany \| 12.92922 \| 50.8357 Dachau \| N/A \| Germany \| 11.43402 \| 48.26 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Frankfurt \| N/A \| Germany \| 10.53333 \| 49.68333 Georgensgmünd \| N/A \| Germany \| 11.01667 \| 49.18972 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Löhne \| N/A \| Germany \| 8.6922 \| 52.18848 Magdeburg \| N/A \| Germany \| 11.62916 \| 52.12773 Messkirch \| N/A \| Germany \| 9.11479 \| 47.99457 Munich \| N/A \| Germany \| 11.57549 \| 48.13743 Schwabach \| N/A \| Germany \| 11.02346 \| 49.33047 Zerbst \| N/A \| Germany \| 12.08517 \| 51.9662 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Chelyabinsk \| N/A \| Russia \| 61.42915 \| 55.15402 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Tyumen \| N/A \| Russia \| 65.52722 \| 57.15222 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yekaterinburg \| N/A \| Russia \| 60.6122 \| 56.8519 Baden \| N/A \| Switzerland \| 8.30592 \| 47.47333 Basel \| N/A \| Switzerland \| 7.57327 \| 47.55839 Bern \| N/A \| Switzerland \| 7.44744 \| 46.94809 Lausanne \| N/A \| Switzerland \| 6.63282 \| 46.516 Adana \| N/A \| Turkey (Türkiye) \| 35.32531 \| 36.98615 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Antalya \| N/A \| Turkey (Türkiye) \| 30.69556 \| 36.90812 Aydin \| N/A \| Turkey (Türkiye) \| 27.83963 \| 37.84501 Gaziantep \| N/A \| Turkey (Türkiye) \| 37.3825 \| 37.05944 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Manisa \| N/A \| Turkey (Türkiye) \| 27.42647 \| 38.61202 Sihhiye/Ankara \| N/A \| Turkey (Türkiye) \| N/A \| N/A Antrim \| N/A \| United Kingdom \| -6.211 \| 54.7175 Coventry \| N/A \| United Kingdom \| -1.51217 \| 52.40656 Lancashire \| N/A \| United Kingdom \| N/A \| N/A Wellingborough \| N/A \| United Kingdom \| -0.69446 \| 52.30273	200	NCT00798369	1COMPLETED	2009-08-01	2008-11-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 2 ]	105	RANDOMIZED	PARALLEL	5SCREENING	0NONE	false	0ALL	false	This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.	null	Cataract Extraction	Bioavailability	null	3	arm 1: Besifloxacin ophthalmic suspension arm 2: Vigamox (moxifloxacin ophthalmic solution, 0.5%) arm 3: Zymar (gatifloxacin ophthalmic solution, 0.3%)	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 2: Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. intervention 3: Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.	intervention 1: Besifloxacin hydrochloride intervention 2: moxifloxacin hydrochloride intervention 3: gatifloxacin	1	Rockville Centre \| New York \| United States \| -73.64124 \| 40.65871	105	NCT00824070	1COMPLETED	2009-08-01	2009-02-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0
[ 3 ]	366	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Assess the safety and efficacy of Staccato Loxapine in patients with moderate to severe migraine headache with or without aura in an outpatient setting.	This study was designed to compare the safety and pharmacodynamic profiles of concomitant administration of single doses of ADASUVE and intramuscular (IM) lorazepam compared to that of each agent administered alone. Respiratory pharmacodynamics were monitored through recordings of respirations/minute and pulse oximetry. Other pharmacodynamic safety measures included effects on blood pressure, heart rate, sedation, and psychomotor measures of attention, information processing speed, reaction time, and coordination.	Migraine Headache	Migraine headache Loxapine Staccato	null	3	arm 1: Inhaled Staccato Placebo (0 mg) arm 2: Inhaled Staccato Loxapine 1.25 mg, single dose arm 3: Inhaled Staccato Loxapine 2.5 mg, single dose	[ 2, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Inhaled Staccato placebo (0 mg) intervention 2: Inhaled Staccato Loxapine 1.25 mg, single dose intervention 3: Inhaled Staccato Loxapine 1.25 mg, single dose	intervention 1: Inhaled Placebo intervention 2: Inhaled Loxapine 1.25 mg intervention 3: Inhaled Loxapine 2.5 mg	3	Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Mount Vernon \| New York \| United States \| -73.83708 \| 40.9126 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371	366	NCT00825500	1COMPLETED	2009-08-01	2009-01-01	Alexza Pharmaceuticals, Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	100	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This study compares the effectiveness of two topical creams for atopic dermatitis in pediatric subjects. Subjects will be randomly assigned to use one of the two creams twice daily for 6 weeks or until clear.	null	Atopic Dermatitis		null	2	arm 1: EpiCeram Skin Barrier Emulsion arm 2: Desonide Cream 0.05%	[ 1, 1 ]	2	[ 1, 0 ]	intervention 1: topical cream, twice daily, 6 weeks intervention 2: topical cream, twice daily, 6 weeks	intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Desonide Cream 0.05%	5	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Houston \| Texas \| United States \| -95.36327 \| 29.76328	100	NCT00828412	1COMPLETED	2009-08-01	2009-03-01	Promius Pharma, LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	163	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	null	A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris	null	Acne Vulgaris		null	2	arm 1: Dapsone gel 5% and Tretinoin gel 0.025% arm 2: Tretinoin gel 0.025%	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks intervention 2: Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks	intervention 1: Dapsone; Tretinoin intervention 2: Tretinoin	1	Strongsville \| Ohio \| United States \| -81.83569 \| 41.3145	163	NCT00835198	1COMPLETED	2009-08-01	2008-12-01	Allergan	4INDUSTRY	false	false	false	null	0
[ 4 ]	9	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study will evaluate the safety and effectiveness of Conivaptan, a vasopressin antagonist, in the treatment of hyponatremic subjects having symptomatic acute decompensated heart failure (ADHF).	Subjects will be recruited from the Emergency Department. It is expected that subjects will be treated according to the institution's accepted conventional therapy protocol for the treatment of ADHF. Therapy may also include the use of loop diuretics for the relief of pulmonary congestion and maintenance of adequate urine output.	Hyponatremia Acute Decompensated Heart Failure	hyponatremia euvolemic hyponatremia hypervolemic hyponatremia acute decompensated heart failure conivaptan Vaprisol	null	2	arm 1: Matching loading dose and continuous intravenous infusion for 48 hours arm 2: 20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: Premix bag intervention 2: Premix bag	intervention 1: conivaptan intervention 2: placebo	4	Hyderabaad \| N/A \| India \| N/A \| N/A Karnāl \| N/A \| India \| 76.98448 \| 29.69197 New Delhi \| N/A \| India \| 77.2148 \| 28.62137 New Delhi \| N/A \| India \| 77.2148 \| 28.62137	9	NCT00843986	6TERMINATED	2009-08-01	2009-04-01	Cumberland Pharmaceuticals	4INDUSTRY	false	false	false	null	0
[ 3 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to assess the safety and efficacy of MK8245 as monotherapy compared to placebo.	null	Type 2 Diabetes Mellitus		null	3	arm 1: MK8245 arm 2: MK8245 arm 3: Placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 5 mg b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening. intervention 2: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening. intervention 3: All patients will receive placebo capsules 2 weeks prior to treatment period to be taken twice daily. Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.	intervention 1: MK8245 5 mg (twice a day) b.i.d. intervention 2: MK8245 50 mg b.i.d. intervention 3: Placebo	0	null	14	NCT00846391	6TERMINATED	2009-08-01	2008-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0
[ 5 ]	34	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.	This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.	Plaque-Type Psoriasis	Psoriasis	null	2	arm 1: Olux-E (clobetasol propionate 0.05%) foam arm 2: Clobex (clobetasol propionate 0.05%) lotion.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15. intervention 2: Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15	intervention 1: Olux-E Foam intervention 2: Clobex lotion	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	34	NCT00852761	1COMPLETED	2009-08-01	2009-03-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0
[ 3 ]	349	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.	null	Kidney Failure, Chronic	Chronic Kidney Disease Phosphate Binder Phosphate Hyperphosphatemia	null	7	arm 1: Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. arm 2: Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. arm 3: Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. arm 4: Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. arm 5: Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. arm 6: Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. arm 7: Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.	[ 2, 0, 0, 0, 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Placebo intervention 2: Genz-644470 intervention 3: Sevelamer carbonate	53	Alexander City \| Alabama \| United States \| -85.95385 \| 32.94401 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hot Springs \| Arkansas \| United States \| -93.05518 \| 34.5037 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Paramount \| California \| United States \| -118.15979 \| 33.88946 Pembroke Pines \| California \| United States \| N/A \| N/A Porterville \| California \| United States \| -119.01677 \| 36.06523 Riverside \| California \| United States \| -117.39616 \| 33.95335 San Dimas \| California \| United States \| -117.80673 \| 34.10668 Whittier \| California \| United States \| -118.03284 \| 33.97918 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Hudson \| Florida \| United States \| -82.69343 \| 28.36445 Ocala \| Florida \| United States \| -82.14009 \| 29.1872 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Pontiac \| Michigan \| United States \| -83.29105 \| 42.63892 Southfield \| Michigan \| United States \| -83.22187 \| 42.47337 Brookhaven \| Mississippi \| United States \| -90.44065 \| 31.57906 Gulfport \| Mississippi \| United States \| -89.09282 \| 30.36742 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Kearney \| Nebraska \| United States \| -99.08148 \| 40.69946 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Bellmore \| New York \| United States \| -73.52707 \| 40.66871 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 Port Washington \| New York \| United States \| -73.69819 \| 40.82566 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Doylestown \| Pennsylvania \| United States \| -75.12989 \| 40.31011 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Lewistown \| Pennsylvania \| United States \| -77.57138 \| 40.59924 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Orangeburg \| South Carolina \| United States \| -80.85565 \| 33.49182 Sumter \| South Carolina \| United States \| -80.34147 \| 33.92044 Columbia \| Tennessee \| United States \| -87.03528 \| 35.61507 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Alexandria \| Virginia \| United States \| -77.04692 \| 38.80484 Glendale \| Wisconsin \| United States \| -87.93564 \| 43.13529 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	346	NCT00853242	1COMPLETED	2009-08-01	2009-02-01	Genzyme, a Sanofi Company	4INDUSTRY	false	false	false	null	0
[ 4 ]	71	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	true	Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.	Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.	Uterine Fibroids	Uterine Fibroids	null	3	arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: Placebo treatment	[ 1, 1, 2 ]	2	[ 0, 10 ]	intervention 1: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo intervention 2: Placebo	intervention 1: Proellex intervention 2: placebo	17	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Miami \| Florida \| United States \| -80.19366 \| 25.77427 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 College Park \| Georgia \| United States \| -84.44937 \| 33.65344 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Morrow \| Georgia \| United States \| -84.33937 \| 33.58317 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Englewood \| Ohio \| United States \| -84.30217 \| 39.87756 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Houston \| Texas \| United States \| -95.36327 \| 29.76328	0	NCT00853567	6TERMINATED	2009-08-01	2009-02-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0
[ 5 ]	443	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.	null	Hypertension	Hypertension African Americans Aliskiren Amlodipine Systolic blood pressure Diastolic blood pressure Stage II Combination	null	2	arm 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg arm 2: Amlodipine 5mg titrated to 10 mg	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg intervention 2: Amlodipine 5 mg titrated to 10mg	intervention 1: Aliskiren/Amlodipine intervention 2: Amlodipine	9	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Oxon Hill \| Maryland \| United States \| -76.9897 \| 38.80345 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Trenton \| New Jersey \| United States \| -74.74294 \| 40.21705 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Springfield Gardens \| New York \| United States \| -73.76221 \| 40.66312 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Milwaukeee \| Wisconsin \| United States \| N/A \| N/A	443	NCT00853957	1COMPLETED	2009-08-01	2009-02-01	Novartis	4INDUSTRY	false	false	false	null	0
[ 4 ]	172	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	false	0ALL	false	Study of T-PRED(TM) Compared to Pred Forte(R)	This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.	Cataract		null	2	arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution	intervention 1: T-Pred intervention 2: Pred Forte	1	Irvine \| California \| United States \| -117.82311 \| 33.66946	324	NCT00854061	1COMPLETED	2009-08-01	2009-02-01	Bausch & Lomb Incorporated	4INDUSTRY	false	false	false	null	0

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