Split (3)

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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	LABEL_sum_dosing_errors int64	LABEL_dosing_error_rate float32	LABEL_wilson_label 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_count_Accidental overdose int64	METADATA_count_Drug administration error int64	METADATA_count_Intentional overdose int64	METADATA_count_Medication error int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 0 ]	1,518	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).	null	Staphylococcal Infections	Methicillin resistance Infection control Staphylococcus aureus Cross infection Epidemiology Chlorhexidine	null	2	arm 1: Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation. arm 2: Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation.	[ 1, 1 ]	3	[ 10, 0, 10 ]	intervention 1: Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU. intervention 2: CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study. intervention 3: All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.	intervention 1: Nasal swabs for MRSA culture intervention 2: Chlorhexidine gluconate intervention 3: Contact isolation	1	Newark \| Delaware \| United States \| -75.74966 \| 39.68372	1,518	0	0	0	NCT00779246	1COMPLETED	2009-07-01	2008-06-01	Christiana Care Health Services	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	96	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.	null	Schizophrenia	Acute schizophrenia PANSS	null	1	arm 1: Seroquel XR 400-800mg	[ 0 ]	1	[ 0 ]	intervention 1: oral, once daily, flexible dose	intervention 1: Quetiapine Fumarate XR	7	Ansan \| Gyeonggi-do \| South Korea \| 127.55845 \| 37.21795 Gwangju \| Gyeonggi-do \| South Korea \| 127.25722 \| 37.41 Bugok \| Gyeongsangnam-do \| South Korea \| N/A \| N/A Masan \| Gyeongsangnam-do \| South Korea \| 128.44938 \| 35.35728 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Pusan \| N/A \| South Korea \| 128.3681 \| 36.3809 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	94	0	0	0	NCT00779506	1COMPLETED	2009-07-01	2008-11-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	597	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare bowel function/constipation that occurs during tapentadol treatment with that occuring during oxycodone treatment, as measured by the frequency of spontaneous bowel movements per week. The frequency of spontaneous bowel movements will be determined from a Bowel Function Patient Diary completed by the enrolled sujbects.	Chronic pain from end-stage degenerative joint disease is often moderate to severe in intensity and results in a relatively constant level of pain requiring continuous pain relief medication. Despite available pain relief medications, 60% to 80% of subjects suffering from chronic pain are currently inadequately treated. Opioid pain medications are central to the effective treatment of moderate to severe pain. However, opioid therapy is frequently complicated by side effects. Constipation is one of the most commonly reported side effects and most debilitating. An opioid medication that provides pain relief with a reduced incidence of constipation symptoms would improve the capability of subjects to stay on medication to achieve the long-term relief they need. This is a randomized, double-blind, placebo- and active-controlled, parallel-arm, multicenter study with 4 treatment groups of subjects who have moderate to severe chronic pain from end-stage degenerative joint disease of the hip or knee and who are candidates for primary total or partial joint replacement. The study consists of 3 periods: a pretreatment period (a 14-day screening for study eligibility and a 7-day washout of any previously taken opioid medication), a double-blind treatment period (a 14-day IR treatment phase followed by a 28-day ER treatment phase), and a follow-up period (1 study-site visit within 4 days after the last dose of study drug is taken and 1 telephone contact within 10 to 14 days after the last dose of study drug is taken). On Day 1 of the IR treatment phase, patients will be randomly assigned to 1 of 4 possible treatment groups to receive 50 mg CG5503 IR, 75 mg CG5503 IR, 10 mg oxycodone IR, or placebo daily every 4 to 6 hours. At the beginning of the ER treatment phase, patients' study drugs will be transitioned to the ER form (by conversion from the IR to approximate equivalent total daily doses of the ER form) of their randomly assigned study drug of tapentadol ER, oxycodone CR, or placebo. The ER study drugs will be taken every 12 hours b.i.d. Dosages will be adjustable, with the study site personnel oversight, to ensure adequate pain relief is provided. Beginning with the washout period, patients will be given hand-held computer diaries in which to record their pain intensity, pain relief, bowel movement information, and answer questions on any nausea or vomiting that may occur. In addition, patients will write down the times and dosages of all medications they take during the study in a medication diary. Safety and tolerability will be assessed using physical examination, monitoring of adverse events, clinical and laboratory measures, and 12 lead ECG results. The first study hypothesis is that both tapentadol IR dosages are more effective than placebo in relieving pain based on the SPID score recorded by the patients over the first 5 days of the study. The second study hypothesis is that the Bowel Function Patient Diary results for both tapentadol IR dosages demonstrate improved tolerability compared to oxycodone IR 10 mg, based on the number of spontaneous bowel movements per week over the first 2 weeks of the study. In the IR treatment phase, each patient will take CG5503 IR 50 mg, CG5503 IR 75 mg, oxycodone IR 10 mg, or placebo orally every 4 to 6 hours for 14 days. In the ER treatment phase, dosages of the IR treatment groups will be converted to approximately equivalent dosages of the ER form of the assigned study drug: tapentadol ER, oxycodone CR, or placebo. Dosages may range from 100 to 500 mg/day of tapentadol ER and 20 to 60 mg/day of oxycodone CR taken orally 2x daily for 28 days.	Joint Diseases Arthritis Osteoarthritis	Pain medication Arthritis Joint pain Analgesia Analgesics tapentadol CG5503 Nucynta	null	7	arm 1: Tapentadol IR (CG5503) 50mg for 14 days arm 2: Tapentadol IR (CG5503) 75mg for 14 days arm 3: oxycodone IR 10mg for 14 days arm 4: placebo 1 capsule for 14 days arm 5: Tapentadol ER (CG5503) flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) arm 6: oxycodone CR flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) arm 7: placebo Tablets and capsules 2 x a day for 28 days	[ 0, 0, 1, 2, 0, 1, 2 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: flexible dose tablets and capsules 2 x a day for 28 days (20-60mg/day) intervention 2: 10mg for 14 days intervention 3: flexible dose tablets and capsules 2 x a day for 28 days (100-500mg/day) intervention 4: 50mg for 14 days intervention 5: 75mg for 14 days intervention 6: 1 capsule for 14 days intervention 7: Tablets and capsules 2 x a day for 28 days	intervention 1: oxycodone CR intervention 2: oxycodone IR intervention 3: Tapentadol ER (CG5503) intervention 4: Tapentadol IR (CG5503) intervention 5: Tapentadol IR (CG5503) intervention 6: placebo intervention 7: placebo	0	null	1,059	0	0	0	NCT00784277	1COMPLETED	2009-07-01	2008-10-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	6	NON_RANDOMIZED	PARALLEL	null	0NONE	true	1FEMALE	false	PK and safety profile of Proellex® in females with various stages of impaired renal function	The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function	Renal Impairment	Renal impairment	null	3	arm 1: 50 mg Proellex single dose Female subjects with mild renal impairment function. arm 2: 50 mg Proellex, Female subjects with moderate renal impairment function. arm 3: 50 mg Proellex, Female subjects with normal renal function.	[ 1, 1, 1 ]	1	[ 0 ]	intervention 1: Single dose	intervention 1: 50 mg Proellex	4	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064	0	0	0	0	NCT00787618	6TERMINATED	2009-07-01	2008-10-01	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	106	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	null	The purpose of this study is to determine the effectiveness of an oral medication called gabapentin in reducing pain after Photorefractive Keratectomy (PRK) eye surgery and to assess the frequency of use of rescue medication interventions, defined as non-steroidal anti-inflammatory (NSAID) eye drops and oral narcotic medication.	null	Postoperative Pain	Gabapentin PRK pain	null	2	arm 1: oral medication arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Gabapentin 300 mg taken by mouth thrice daily for 7 days intervention 2: placebo (sugar pill) taken by mouth thrice daily for 7 days	intervention 1: Gabapentin intervention 2: placebo	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	106	0	0	0	NCT00793910	1COMPLETED	2009-07-01	2008-07-01	Walter Reed Army Medical Center	1FED	false	false	false	null	0	0	0	0	0	0
[ 3 ]	47	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This is a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric patients with hematologic malignancies at high risk for transplant related mortality with standard transplantation. Patients qualify based on organ system dysfunction, active but stable infection, history of previous transplant or late stage disease. We plan to enroll 45 patients through the Pediatric Blood and Marrow Transplant Consortium (PBMTC) and anticipate that the outcome of the trial will pave the way for phase II or III disease specific protocols addressing efficacy of the approach compared to standard transplant approaches in better risk patients.	Summary/Proposal: Reduced Intensity Hematopoietic Cell Transplantation for High-Risk Relapsed Pediatric Hematologic Malignancies and Patients Ineligible for Standard Transplantation We propose a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric patients with hematologic malignancies at high risk for transplant related mortality with standard transplantation. Patients qualify based on organ system dysfunction, active but stable infection, history of previous transplant, or late stage disease. We plan to enroll 45 patients through the Pediatric Blood and Marrow transplant Consortium (PBMTC) and anticipate that the outcome of the trial will pave the way for phase II or III disease specific protocols addressing efficacy of the approach compared to standard transplant approaches in better risk patients. Hypothesis High risk pediatric hematologic malignancy patients ineligible for standard myeloablative HCT undergoing reduced intensity conditioning (RIC) HCT can achieve a sustained engraftment rate \> 90% with a 100day TRM \< 30% using either bone marrow or PBSC from related or unrelated donors. High risk pediatric patients undergoing RIC-HCT using related or unrelated cord blood can achieve a sustained engraftment rate \>80% and a 100d TRM \<30%. Rationale for Reduced Intensity Approaches in High Risk Patients There are a number patient-specific risk factors associated with increased transplant related mortality. They can be broadly placed into three categories: pretransplant organ system dysfunction, active infections at the time of transplant, and degree of pretransplant therapy (previous transplants, third or subsequent remission, etc.). The primary objective of this study is to determine the likelihood of achieving sustained donor engraftment using reduced intensity conditioning (fludarabine/busulfan/ATG) followed by hematopoietic cell transplantation (HCT) with either cord blood, bone marrow or peripheral blood stem cells (PBMTC) in pediatric patients with hematopoietic malignancies who are at high risk of transplant related mortality (TRM) with myeloablative HCT. Patients qualify based on organ system dysfunction, active but stable infection, history of previous transplant or late stage disease. We plan to enroll 45 patients through the Pediatric Blood and Marrow Transplant Consortium (PBMTC) and anticipate that the outcome of the trial will pave the way for phase II or III disease specific protocols addressing efficacy of the approach compared to standard transplant approaches in better risk patients. Study procedures Patients receive their conditioning regimen consisting of fludarabine, busulfan, and ATG and then receive their stem cell transplant. Patients receive immunosuppression consisting of cyclosporine and mycophenolate mofetil. Patients with persistent or progressive disease may receive donor lymphocyte infusion off protocol.	Acute Leukaemia Chronic Disease Leukemia Myelodysplasia Lymphoma	cancer Hematologic Malignancies Hematopoietic Cell Transplantation	null	3	arm 1: Bone Marrow Peripheral Blood Stem Cell (BM PBSC) from a donor related to the participant/recipient arm 2: Bone Marrow Peripheral Blood Stem Cell (BM PBSC) from a donor unrelated to the participant/recipient arm 3: Blood Cord donated from a donor unrelated to the participant/recipient	[ 1, 1, 1 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: This drug is a bifunctional alkylating agent. Busulfan is highly toxic to noncycling or slowly-cycling cells. Pharmacokinetic studies of the IV formulation in pediatrics have shown that using a dose of 0.8mg/kg IV q6 hours most patients will achieve AUC levels between 800 and 1300 uM/min, representing steady state levels between 600-900ug/ml. The manufacturer recommends higher doses, 1.1mg/kg for children less than 12kg. Because this is a reduced intensity study and infants on the study will be very heavily pretreated we will use the lower dose of 0.8mg/kg q6 hours for a total of 8 doses for all patients. intervention 2: Thymoglobulin will be administered at a dose of 2.5 mg/kg recipient body weight intravenously on each of 4 successive mornings (Days -4, -3,-2,-1) for patients receiving unrelated grafts and at a dose of 2.5mg/kg as a single dose on d-1 for patients receiving related marrow grafts. ATG is infused over a minimum of 4 hours, but is generally better tolerated over 6-8 hours. Suggested premedications are acetaminophen (10 mg/kg/dose), diphenhydramine (1 mg/kg/dose), and methylprednisolone. The methylprednisolone should be given at a dose of 1mg/kg 30 minutes prior to the ATG, with another 1mg /kg four hours into the infusion (total 2mg/kg/d). Patients are observed continuously for possible allergic reactions throughout the infusion. intervention 3: Administration and Dosage: Fludarabine will be administered at a dose of 30 mg/m2 in 100 ml of D5W intravenously over one hour on each of six consecutive days -10 through -5 for unrelated grafts or d-7 through d-2 for related grafts. Fludarabine is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-beta-D-arabinofuranosyladenine. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. The half-life of 2-fluoro-ara-A is approximately 10 hours. The mean total plasma clearance is 8.9 L/hr/m2 and the mean volume of distribution is 98 L/m2. Approximately 23% is excreted unchanged. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. intervention 4: Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung. The effectiveness of cyclosporine results from specific and reversible inhibition of immunocompetent lymphocytes in the G 0 - and G 1 -phase of the cell cycle. Administration and Dosage: Cyclosporin start on day -3 initially at a dose of 2.5mg/kg IV q12 hours or 3mg/kg/dose (neoral equivalent) PO q12 hours targeting suggested troughs of 250 to 350 ng/ml. Continuous infusion cyclosporin may be allowed per institutional preference. 3x daily dosing may be used for younger children to achieve therapeutic levels. PBMTC Protocol #ONC0313 19 Continuous infusion cyclosporin may be allowed per institutional preference. intervention 5: MMF is a potent, selective, uncompetitive, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA. Administration and Dosage: Initial dosage will be IV or PO with switch to PO when tolerated. Starting doses will be 15 mg/kg/day bid (total dose 30mg/kg/d, IV same as PO dose) beginning day 0 with the first dose given approximately 4-6 hours after the stem cell infusion. This dose will stop on day +30 for patients receiving matched sibling BM/PBSC and UCB grafts, but will continue until day +40 and then taper at approximately 11%/wk over 8 weeks until patients are off at day +96.	intervention 1: Busulfan intervention 2: Anti-Thymocyte Globulin intervention 3: Fludarabine intervention 4: Cyclosporine intervention 5: Mycophenolate mofetil	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	47	0	0	0	NCT00795132	1COMPLETED	2009-07-01	2004-04-01	University of Utah	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	45	NA	SINGLE_GROUP	1PREVENTION	4QUADRUPLE	true	1FEMALE	true	This study is designed to determine the ED90 for an infusion of phenylephrine to prevent spinal induced low blood pressure in parturients presenting for an elective cesarean delivery. The up-down methodology (UDM) is commonly used study method to determine the dose of a drug that causes the desired effect in over 90% of the subjects to whom it given. For example: the investigators want to know what is the best dose of phenylephrine (from a range of commonly used doses) to prevent a drop in blood pressure during cesarean delivery ninety times out of one hundred when it is given at that dose. The ED90 is the effective dose at which 90% of subjects will have a "positive" response to a phenylephrine infusion, i.e. no drop in blood pressure. The investigators hypothesize that the ED90 will be between 40 - 60 mcg/min. The primary outcome measure is the ED90 for phenylephrine infusions that prevents a drop in blood pressure in women undergoing cesarean delivery.	null	Spinal Induced Hypotension in Cesarean Delivery		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Up-down, biased coin design	intervention 1: Phenylephrine infusion	0	null	40	0	0	0	NCT00796328	6TERMINATED	2009-07-01	2008-11-01	IWK Health Centre	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).	This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects. Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.	Chronic Obstructive Pulmonary Disease (COPD)	COPD pulmonary inhalation	null	5	arm 1: Represents Dose A in the Dosing Sequence assignments. arm 2: Represents Dose B arm 3: Represents Dose C arm 4: Represents Dose D arm 5: Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment.	[ 2, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. intervention 2: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 3: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 4: Trospium inhalation powder containing 400 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. intervention 5: Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler.	intervention 1: Placebo intervention 2: TrIP-2D intervention 3: TrIP-2SS intervention 4: TrIP-2D intervention 5: TrIP-2SS + Foradil	1	Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957	144	0	0	0	NCT00801684	1COMPLETED	2009-07-01	2009-02-01	Alkermes, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	78	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time; explores what the body does to the drug) of tapentadol prolonged release (JNS024PR, PR) in participants with moderate to severe cancer (abnormal tissue that grows and spreads in the body until it kills) pain.	This is a Phase 2 open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), non-comparative, optional dose-titration study of tapentadol PR in Japanese participants with cancer pain. This study will consist of Screening period (3 to 7 days), Dose adjustment period (3 to 14 days), Fixed dose period (5 days) and Follow-up period (7 days). Tapentadol PR will be administered orally (taken by mouth; to be swallowed) twice daily before meal. For participants previously using opioids, the initial dose of tapentadol PR will be selected depending on the daily dose of opioid at the completion of Screening period. For opioid-naive (moderate to severe cancer pain that is not controlled adequately with non-opioid medications) participants, the initial dose of tapentadol PR will be 25 milligram (mg) twice daily. Participants will receive the same dose of tapentadol PR for the first 2 days of the dose adjustment period and from Day 3, the dose can be titrated as per the Investigator's discretion up to Day 14. After that participants will receive fixed dose regimen for 5 days at the same dose as that used at the end of the dose adjustment period. Efficacy will primarily be evaluated by sustained pain control for the 5 day fixed dose phase. Participants' safety will be monitored throughout the study.	Pain Cancer	Pain Cancer Tapentadol	null	2	arm 1: Opioid-naive participants are defined as those who had moderate to severe cancer pain that is not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in the maintenance period. Treatment will be initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose will be increased or decreased as per Investigator's discretion up to Day 14. Maximum dose limit will be 500 mg per day. Participants will then be assigned to the treatment in the maintenance period (15-19 days). The maintenance period is duration between the first dose and the final assessment in the maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period. arm 2: Opioid-switching participants are defined as those who had moderate to severe cancer pain that is controlled sufficiently with opioid therapy. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) is duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR is selected according to daily dose of opioid (morphine sustained release \[SR\] preparation, oxycodone hydrochloride \[HCl\] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily is given depending on daily dose of opioid at completion of Screening period. Maximum dose limit is 500 mg per day. Participants will then be assigned to treatment in maintenance period (15-19 days). Maintenance period is defined as duration between first dose and final assessment in maintenance period. Participants will receive tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Tapentadol PR tablets will be administered orally twice daily initiated at dose of 25 mg. Dose will be adjusted as per Investigator's discretion. Maximum dose limit is 500 mg per day. Total duration of treatment is 19 days.	intervention 1: Tapentadol PR	21	Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chikushino-shi \| N/A \| Japan \| 130.5156 \| 33.49631 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Himeji \| N/A \| Japan \| 134.7 \| 34.81667 Hirosaki \| N/A \| Japan \| 140.4725 \| 40.59306 Ichinomiya \| N/A \| Japan \| 136.8 \| 35.3 Ikeda \| N/A \| Japan \| 135.4298 \| 34.82208 Iwakuni \| N/A \| Japan \| 132.22 \| 34.16297 Kobe \| N/A \| Japan \| 135.183 \| 34.6913 Kochi \| N/A \| Japan \| 133.53333 \| 33.55 Kyoto \| N/A \| Japan \| 135.75385 \| 35.02107 Nishinomiya \| N/A \| Japan \| 135.33199 \| 34.71562 Ohta \| N/A \| Japan \| N/A \| N/A Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Sapporo \| N/A \| Japan \| 141.35 \| 43.06667 Sasebo \| N/A \| Japan \| 129.72502 \| 33.16834 Shizuoka \| N/A \| Japan \| 138.38333 \| 34.98333 Sonogishukugō \| N/A \| Japan \| 129.91964 \| 33.03689 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Toyonaka \| N/A \| Japan \| 135.46932 \| 34.78244 Utsunomiya \| N/A \| Japan \| 139.88333 \| 36.56667	78	0	0	0	NCT00805142	1COMPLETED	2009-07-01	2008-11-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	190	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	H8R-MC-HJAQ is a Phase 2, parallel, double-blind, randomized study comparing LY686017 with placebo in a 12-week trial that includes Medical Management. This study is an outpatient study in which approximately 180 alcohol dependent subjects will be enrolled. Subjects will be randomized in a 1:1 fashion to LY686017 or placebo, and will receive once daily dosing for twelve weeks.	null	Alcohol Dependence	Alcoholic	null	2	arm 1: None arm 2: None	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 50 milligrams (mg) daily by oral route for 12 weeks intervention 2: Daily by oral route for 12 weeks	intervention 1: LY686017 intervention 2: Placebo	21	Oceanside \| California \| United States \| -117.37948 \| 33.19587 San Diego \| California \| United States \| -117.16472 \| 32.71571 Deerfield Beach \| Florida \| United States \| -80.09977 \| 26.31841 North Miami \| Florida \| United States \| -80.18671 \| 25.89009 Naperville \| Illinois \| United States \| -88.14729 \| 41.78586 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Havertown \| Pennsylvania \| United States \| -75.30852 \| 39.98095 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 DeSoto \| Texas \| United States \| -96.85695 \| 32.58986 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Kirkland \| Washington \| United States \| -122.20874 \| 47.68149 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	183	0	0	0	NCT00805441	1COMPLETED	2009-07-01	2008-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	41	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies.	null	Chronic Hepatitis C (HCV)	Hepatitis C, HCV, treatment-naive	null	4	arm 1: Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 2: Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 3: Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. arm 4: Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: oral dose, active or placebo	intervention 1: IDX184	0	null	41	0	0	0	NCT00807001	1COMPLETED	2009-07-01	2008-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	A Phase II study of temsirolimus in combination with standard chemotherapy (irinotecan; cyclophosphamide, doxorubicin and etoposide (CAE); cisplatin and etoposide (HiPE) and topotecan (TPT) followed by and additional six courses of induction chemotherapy and then intensification with autologous hematopoietic stem cell transplantation. The first five courses of induction chemotherapy will also evaluate the feasibility of combining weekly temsirolimus with these standard chemotherapy combinations. This will be followed by 16 months of oral maintenance therapy with eight months of 13-cis-retinoic acid and then eight months of oral topotecan.	All children will receive fixed doses of intravenous temsirolimus (50 mg/m2 weekly 6 times ) concomitantly with two courses of fixed dosages of irinotecan (20 mg/m2 intravenously daily 5 times ,2 days off, repeated daily 5 times .If these initial dosages are not tolerable then subsequent patients will be given a reduced dosage of temsirolimus (25 mg/m2 weekly 6 times) with 20 mg/m2 of irinotecan.If this dosage combination is not tolerable, the irinotecan dosage will be decreased to 15 mg/m2 .If this dosage combination is not tolerable then further enrollment to the initial six week treatment will be terminated.The second course of irinotecan will begin on day 22 and response will be determined after six weeks (two courses). Resection of primary tumor will be attempted after this initial therapy, whenever possible. Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide, doxorubicin, etoposide, topotecan, and cisplatin (Block 2). The first cohort of 17 patients will receive Block 2 with temsirolimus (50mg/m2) for all three courses, weekly 2 times. If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus (25mg/m2).	Neuroblastoma	Neuroblastoma	null	1	arm 1: Fixed doses of IV temsirolimus concomitantly with two courses of fixed dosages of irinotecan, 2 days off, repeated daily 5 times.If initial dosages are not tolerable, subsequent patients will be given a reduced dosage of temsirolimus with irinotecan.If this dosage combination is not tolerable,irinotecan dosage will be decreased.If this dosage combination is not tolerable.Further enrollment to initial six week treatment will be terminated.Second course of irinotecan will begin on day 22, response will be determined after six weeks. Resection of primary tumor will be attempted after initial therapy.Following initial treatment children will undergo alternating courses of induction chemotherapy with cyclophosphamide,doxorubicin,etoposide,topotecan, and cisplatin.First cohort of 17 patients will receive Block 2 with temsirolimus for all three courses, weekly 2 times.If this is not tolerated subsequent patients will receive Block 2 chemotherapy with reduced dosages of temsirolimus.	[ 0 ]	11	[ 0, 0, 3, 0, 0, 0, 0, 0, 3, 4, 0 ]	intervention 1: Temsirolimus intervention 2: Irinotecan intervention 3: Surgical Resection of Primary Tumor intervention 4: Cyclophosphamide intervention 5: Doxorubicin intervention 6: Etoposide intervention 7: Cisplatin intervention 8: Topotecan intervention 9: Peripheral Blood Stem Cell Harvest intervention 10: Radiation Therapy intervention 11: 13-cis-retinoic acid	intervention 1: Temsirolimus intervention 2: Irinotecan intervention 3: Surgical Resection of Primary Tumor intervention 4: Cyclophosphamide intervention 5: Doxorubicin intervention 6: Etoposide intervention 7: Cisplatin intervention 8: Topotecan intervention 9: PBSC intervention 10: Radiation Therapy intervention 11: 13-cis-retinoic acid	1	Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953	4	0	0	0	NCT00808899	6TERMINATED	2009-07-01	2008-12-01	St. Jude Children's Research Hospital	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	451	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To evaluate the efficacy and safety of the valsartan/aliskiren combination compared to valsartan alone in patients with Stage 2 hypertension.	null	Stage 2 Hypertension	Hypertension, aliskiren and valsartan	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks intervention 2: Valsartan (160mg) for 2 weeks followed by forced titration to Valsartan (320mg) for the remaining 6 weeks	intervention 1: Valsartan/aliskiren intervention 2: Valsartan	1	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201	451	0	0	0	NCT00809926	1COMPLETED	2009-07-01	2009-01-01	Novartis	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	12	NON_RANDOMIZED	SINGLE_GROUP	7BASIC_SCIENCE	0NONE	true	0ALL	false	The purpose of this study is to evaluate the effects of a chronic co-medication of efavirenz on pharmacokinetics and sterol-lowering effects of ezetimibe at steady-state in healthy subjects genotyped for ABCB1, ABCC2, CYP2B6 and UGT1A1.	null	Pharmacokinetics Drug Interactions Pharmacodynamics Intestinal Transporter Expression		null	1	arm 1: A study with a duration of 34 days with 4 periods (= 4 pharmakokinetics) on 12 healthy subjects.	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: administration of 1 tablet/day Ezetrol (10 mg ezetimibe) on study day 6-15 and a pharmakokinetic on study day 15 (0-24 h blood sampling, 0-24 h urine sampling and 5 d feces sampling (study day 11-15)) intervention 2: administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) on study day 16-20 and 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 16 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 16-20) intervention 3: administration of 1 tablet/day Ezetrol(R) (10 mg ezetimibe) and 2 capsules/day Sustiva(R) (2x200 mg efavirenz) on study day 21-30 and with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) on study day 30 and feces sampling on study day 26-30) intervention 4: administration of 2 capsules Sustiva(R) (2x200 mg efavirenz) on study day 1 with a pharmakokinetic (0-120 h blood sampling, urine sampling (24 h intervals) and feces sampling on study days 1-5)	intervention 1: Ezetrol (ezetimibe) multiple dose intervention 2: Ezetrol (ezetimibe) multiple dose and Sustiva (efavirenz) single dose intervention 3: Ezetrol (ezetimibe) and Sustiva (efavirenz) multiple dose intervention 4: Sustiva (efavirenz) single dose	1	Greifswald \| N/A \| Germany \| 13.40244 \| 54.08905	60	0	0	0	NCT00810303	1COMPLETED	2009-07-01	2009-03-01	University Medicine Greifswald	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin	null	Type 2 Diabetes	Type II Diabetes	null	2	arm 1: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days arm 2: Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Subjects will be treated with tolerable dose twice daily for another 24 days. intervention 2: Subjects will be treated with tolerable dose twice daily for another 24 days.	intervention 1: AZD1656 intervention 2: Placebo	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	27	0	0	0	NCT00817778	1COMPLETED	2009-07-01	2009-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	32	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of activated recombinant human coagulation factor VII analogue (NN1731, vatreptacog alfa (activated)) in healthy Japanese male subjects. In addition, the pharmacokinetics of NN1731 will be examined	null	Congenital Bleeding Disorder Healthy		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 0 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: One single dose is injected i.v. over 2 minutes to 6 subjects, 5 mcg/kg intervention 2: One single dose is injected i.v. over 2 minutes to 6 subjects, 10 mcg/kg intervention 3: One single dose is injected i.v. over 2 minutes to 6 subjects, 20 mcg/kg intervention 4: One single dose is injected i.v. over 2 minutes to 6 subjects, 30 mcg/kg intervention 5: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 5 mcg/kg intervention 6: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 10 mcg/kg intervention 7: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 20 mcg/kg intervention 8: Single dose is injected i.v. over 2 minutes to 2 subjects per dose level: 30 mcg/kg	intervention 1: vatreptacog alfa (activated) intervention 2: vatreptacog alfa (activated) intervention 3: vatreptacog alfa (activated) intervention 4: vatreptacog alfa (activated) intervention 5: placebo intervention 6: placebo intervention 7: placebo intervention 8: placebo	1	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	32	0	0	0	NCT00822185	1COMPLETED	2009-07-01	2009-01-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	35	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	There are still no established protocols for maintenance therapy with intravenous or oral vitamin D preparations after the iPTH target has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols, i.e., oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 ug/day (higher-dose group) or at a dose of 0.25 ug/day (lower-dose group), in patients with secondary hyperparathyroidism who responded to initial maxacalcitol therapy, resulting in the control of iPTH to \< 150 pg/mL.	Chronic kidney disease (CKD) causes various bone mineral disorders, which have recently been named CKD mineral and bone disorder (CKD-MBD). CKD-MBD presents a spectrum of skeletal abnormalities ranging from high bone turnover state such as osteitis fibrosa, which is seen with SHPT, to states of low bone turnover, which includes osteomalacia and adynamic bone disease. This disease not only increases the risk of cardiovascular disease and mortality, but also increases the risk of fracture. Therefore, it is important to correct the serum inorganic phosphorus (Pi), calcium (Ca) and parathyroid hormone (PTH) levels in dialysis patients, to achieve both appropriate bone turnover and to improve mortality. The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that the target range of iPTH level for vitamin D therapy should be set at 150-300 pg/mL. In Japan, the mortality risk was significantly lower in the group of patients with iPTH levels \< 120 pg/mL than in the standard group set at 180 pg/mL \< iPTH \< 360 pg/mL, and lowest in the group of patients with 60 pg/mL \< iPTH \< 120 pg/mL . Based on these findings, Japanese guideline recommend that the target range of iPTH should be set at 60-180 pg/mL . The efficacies of various oral and intravenous vitamin D preparations for treating SHPT in hemodialysis patients have been reported. and oral or intravenous vitamin D pulse therapy has been clinically applied, especially for patients with severe SHPT. Up to now, the effectiveness of an oral daily alfacalcidol on SHPT has been confirmed at the dose of 0.25-0.5 μg /day (average 0.364μg /day), 0.5 μg /day, and 1.0 μg /day. The effective dose of OCT has also been verified, and furthermore, it has also been reported that intravenous vitamin D was more effective than oral vitamin D for suppressing PTH secretion. Accordingly, at present intravenous vitamin D therapy is the standard treatment for SHPT, and there are established protocols with regard to dosage and administration. However, no protocols have been established for maintenance therapy using intravenous or oral vitamin D preparations after the control of iPTH target range has been achieved. Therefore, the present study compared the efficacy of two maintenance therapy protocols for patients with SHPT who responded to initial OCT therapy, resulting in the control of iPTH to \<150pg/mL. One was oral administration of alfacalcidol (an oral vitamin D preparation) at a dose of 1.0 μg/day (higher-dose group) and the other was at a dose of 0.25 μg/day (lower-dose group), both of which are clinically effective doses for HD patients with SHPT.	Secondary Hyperparathyroidism		null	2	arm 1: Alfacalcidol 1.0 μg capsule by mouth, every day for 6 months arm 2: Alfacalcidol 0.25 μg capsule by mouth, every day for 6 months	[ 5, 5 ]	2	[ 0, 0 ]	intervention 1: We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 1.0 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy. intervention 2: We compared the efficacy of two protocols for maintenance therapy, which were oral administration of alfacalcidol at a dose of 0.25 μg/day in patients whose iPTH level was controlled to \< 150 pg/mL by initial maxacalcitol therapy.	intervention 1: 1.0 μg/day Alfacalcidol intervention 2: 0.25 μg/day Alfacalcidol	1	Kumamoto \| Kumamoto \| Japan \| 130.69181 \| 32.80589	23	0	0	0	NCT00828347	1COMPLETED	2009-07-01	2008-01-01	Kumamoto University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	25	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma patients.	null	Asthma	Asthma Symbicort Turbuhaler	null	2	arm 1: Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days arm 2: Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 160/4.5μg for 3 days intervention 2: 0.4 mg for 3 days	intervention 1: Symbicort Turbuhaler intervention 2: Terbutaline Turbuhaler	2	Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	48	0	0	0	NCT00837967	1COMPLETED	2009-07-01	2009-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	47	null	CROSSOVER	0TREATMENT	null	false	0ALL	null	The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily administration and 2 dosages for administration twice daily.	null	Pulmonary Disease, Chronic Obstructive		null	0	null	null	1	[ 0 ]	intervention 1: None	intervention 1: BI 1744 CL	5	Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Hasselt \| N/A \| Belgium \| 5.33781 \| 50.93106 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Heerlen \| N/A \| Netherlands \| 5.98154 \| 50.88365	186	0	0	0	NCT00846768	1COMPLETED	2009-07-01	2009-02-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.	This was a Phase 2a, blinded, randomized, placebo-controlled clinical trial in hepatitis C virus (HCV)-infected adults with 2 planned sequential evaluations, Part 1 and Part 2. The study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-333 or placebo monotherapy, followed by 26 days of ABT-333 or placebo with pegylated interferon a-2a (pegIFN) and ribavirin (RBV) combination therapy. Review of safety and efficacy in Part 1 of the study showed similar response rates across ABT-333 doses so Part 2 of the study was not performed. The study also assessed emergence of resistant HCV in conjunction with kinetics of viral load decay and rebound in treatment-naïve, HCV-infected participants.	Chronic Hepatitis C Virus Infection		null	4	arm 1: Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 2: Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 3: Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day. arm 4: Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.	[ 0, 0, 0, 2 ]	4	[ 0, 10, 0, 0 ]	intervention 1: 50 mg capsules intervention 2: Capsule intervention 3: Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly intervention 4: 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day	intervention 1: ABT-333 intervention 2: Placebo for ABT-333 intervention 3: Pegylated interferon intervention 4: Ribavirin	8	Anaheim \| California \| United States \| -117.9145 \| 33.83529 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Santurce \| N/A \| Puerto Rico \| -67.14018 \| 18.19523	30	0	0	0	NCT00851890	1COMPLETED	2009-07-01	2009-03-01	AbbVie (prior sponsor, Abbott)	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	207	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	Subjects with moderate papulopustular rosacea will be treated either with azelaic acid 15% gel topically plus an anti-inflammatory dose of doxycyline (40mg) daily or with metronidazole 1% gel topically once daily plus an anti-inflammatory dose of doxycycline (40mg) over at total of twelve weeks to determine the rapidity of improvement, and the length of time to reach 25%, 50% and 75% clearing compared to baseline.	The change in inflammatory lesion count will be assessed at each post-baseline visit by an analysis of variance model (ANOVA) with factors treatment and center, but not including treatment-by-center interaction. Investigator's Global Assessment (IGA) of papulopustular rosacea (static score): 0 - Clear (Virtually no rosacea ie, no papules and/or pustules; no or residual erythema; no or mild to moderate degree of telangiectasia may be present); 1 - Minimal (Rare papules and/or pustules; residual to mild erythema; mild to moderate degree of telangiectasia may be present); 2 - Mild (Few papules and/or pustules; mild erythema; mild to moderate degree of telangiectasia may be present); 3 - Mild to moderate (Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate degree of telangiectasia may be present); 4 - Moderate (Pronounced number of papules and/or pustules; moderate erythema; mild to moderate degree of telangiectasia may be present); 5 - Moderate to severe (Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia may be present); 6 - Severe (Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe degree of telangiectasia may be present).	Papulopustular Rosacea	Rosacea	null	2	arm 1: Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks arm 2: Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Participants received topical azelaic acid gel 15% twice daily for 12 weeks intervention 2: Participants received topical metronidazole 1% gel once daily for 12 weeks intervention 3: Participants received systemic doxycycline 40 mg once daily for 12 week	intervention 1: Azelaic acid (Finacea, BAY39-6251) intervention 2: Metronidazole (Metrogel) intervention 3: Doxycycline (Oracea)	17	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Warren \| Michigan \| United States \| -83.01304 \| 42.49044 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Henderson \| Nevada \| United States \| -114.98194 \| 36.0397 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Stony Brook \| New York \| United States \| -73.14094 \| 40.92565 Mason \| Ohio \| United States \| -84.30994 \| 39.36006 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Austin \| Texas \| United States \| -97.74306 \| 30.26715 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 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681	207	0	0	0	NCT00855595	1COMPLETED	2009-07-01	2009-02-01	LEO Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 0 ]	135	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your surgeon will know which group you are in.	All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Post-operative pain was assessed by a visual analog scale (VAS) and post-operative narcotic use was calculated in intravenous morphine equivalents.	Pain		null	2	arm 1: No suppository given arm 2: B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)	[ 4, 0 ]	1	[ 0 ]	intervention 1: belladonna 16.2 mg and opium 60 mg suppository	intervention 1: belladonna 16.2 mg and opium 60 mg suppository	1	Seattle \| Washington \| United States \| -122.33207 \| 47.60621	99	0	0	0	NCT00863928	1COMPLETED	2009-07-01	2008-10-01	Benaroya Research Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	17	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study is for patients with pancreatic cancer that has grown and/or spread after having previously received the standard chemotherapy drug called gemcitabine. In this study a drug called pemetrexed is being tested. This drug is approved by the FDA for use in lung cancer and mesothelioma. The purpose of this study is to see if pemetrexed keeps pancreas cancer that has grown and/or spread after gemcitabine from growing. Subjects will receive pemetrexed IV once every 21 days until disease progression or unacceptable side effects occur.	This is an open label Phase II trial using pemetrexed as second-line treatment in patients with advanced pancreatic cancer progressing within six months of prior gemcitabine-based therapy. Subjects will receive pemetrexed 500 mg/m2 IV every 21 days until disease progression or unacceptable toxicity.	Pancreas Cancer	pancreas metastatic recurrent	null	1	arm 1: pemetrexed	[ 0 ]	1	[ 0 ]	intervention 1: pemetrexed 500 mg/m2 IV day 1 of each 21 day cycle until disease progression or unacceptable toxicity for a maximum of 8 cycles	intervention 1: pemetrexed	1	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	15	0	0	0	NCT00864513	6TERMINATED	2009-07-01	2007-10-01	Georgetown University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	30	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.	null	Chronic Obstructive Pulmonary Disease (COPD)	COPD Antimuscarinic	null	3	arm 1: Aclidinium bromide 400 μg twice-daily by inhalation arm 2: Tiotropium 18 μg once-daily by inhalation arm 3: Placebo	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 15 days. intervention 2: Tiotropium 18 μg once-daily via inhalation by Handihaler® dry powder inhaler: 1 puff in the morning for 15 days. intervention 3: Inhaled placebo: 1 puff in the morning (placebo to tiotropium) or in the morning and evening (placebo to aclidnium) for 15 days.	intervention 1: Aclidinium bromide 400 μg bid intervention 2: Tiotropium 18 μg once-daily intervention 3: Placebo	2	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667	87	0	0	0	NCT00868231	1COMPLETED	2009-07-01	2009-03-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	204	RANDOMIZED	PARALLEL	1PREVENTION	1SINGLE	true	0ALL	false	To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.	null	Upper Gastrointestinal Mucosal Damage	To evaluate the acute gastrointestinal safety of PL-2100.	null	2	arm 1: PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. arm 2: Immediate release 325mg aspirin	[ 0, 1 ]	1	[ 0 ]	intervention 1: 325mg once a day for 7 days	intervention 1: acetylsalicylic acid	6	Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Altoona \| Pennsylvania \| United States \| -78.39474 \| 40.51868 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328	204	0	0	0	NCT00872534	1COMPLETED	2009-07-01	2009-01-01	PLx Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	24	RANDOMIZED	PARALLEL	9OTHER	1SINGLE	false	0ALL	false	The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.	null	Psoriasis Vulgaris		null	6	arm 1: LEO 29102 2.5 mg/g cream applied topically twice daily for 4 weeks arm 2: LEO 29102 cream vehicle applied topically twice daily for 4 weeks. arm 3: Betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. arm 4: LEO 29102 2.5 mg/g plus calcipotriol 50mcg/g cream applied topically twice daily for 4 weeks. arm 5: LEO 29102 2.5 mg/g plus betamethasone 0.5 mg/g (as dipropionate) cream applied topically twice daily for 4 weeks. arm 6: Daivobet® ointment, combination of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) applied topically twice daily for 4 weeks.	[ 0, 2, 0, 0, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None	intervention 1: LEO 29102 cream intervention 2: LEO 29102 Cream Vehicle intervention 3: Betamethasone Dipropionate Cream intervention 4: LEO 29102 Plus Calcipotriol Cream intervention 5: LEO 29102 Plus Betamethasone Dipropionate intervention 6: Daivobet® Ointment	1	Saint-Quentin-en-Yvelines \| N/A \| France \| 2.01891 \| 48.77186	24	0	0	0	NCT00875277	1COMPLETED	2009-07-01	2009-04-01	LEO Pharma	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	241	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with osteoarthritis of the knee and at what dose. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.	null	Pain	Phase II Pain	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: oral, during 4 weeks intervention 2: oral, during 4 weeks intervention 3: Oral, during 4 weeks	intervention 1: AZD1386 intervention 2: AZD1386 intervention 3: Placebo	41	Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Bay Roberts \| Newfoundland and Labrador \| Canada \| -53.26478 \| 47.59989 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Brampton \| Ontario \| Canada \| -79.76633 \| 43.68341 Etobicoke \| Ontario \| Canada \| -79.56985 \| 43.64415 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 St. Catharines \| Ontario \| Canada \| -79.24267 \| 43.17126 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Saint Romuald \| Quebec \| Canada \| -71.23921 \| 46.75818 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Hyvinkää \| N/A \| Finland \| 24.8606 \| 60.63195 Lahti \| N/A \| Finland \| 25.66151 \| 60.98267 Riihimäki \| N/A \| Finland \| 24.77726 \| 60.73769 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Vantaa \| N/A \| Finland \| 25.04099 \| 60.29414 Békéscsaba \| N/A \| Hungary \| 21.1 \| 46.68333 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Veszprém \| N/A \| Hungary \| 17.91149 \| 47.09327 Japan \| N/A \| Japan \| N/A \| N/A Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Elblag \| N/A \| Poland \| 19.40884 \| 54.1522 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Toru \| N/A \| Poland \| N/A \| N/A Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Brastislava \| N/A \| Slovakia \| N/A \| N/A Komárno \| N/A \| Slovakia \| 18.12263 \| 47.76356 Liptovský Hrádok \| N/A \| Slovakia \| 19.72335 \| 49.03962 Poprad \| N/A \| Slovakia \| 20.29798 \| 49.06144 Považská Bystrica \| N/A \| Slovakia \| 18.42169 \| 49.12153 Rimavská Sobota \| N/A \| Slovakia \| 20.02239 \| 48.38284 Žiar nad Hronom \| N/A \| Slovakia \| 18.84958 \| 48.59184 Žilina \| N/A \| Slovakia \| 18.73941 \| 49.22315	240	0	0	0	NCT00878501	6TERMINATED	2009-07-01	2009-03-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	1,791	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).	This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray. Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments	Seasonal Allergic Rhinitis		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 1, 1, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Placebo intervention 2: azelastine hydrochloride 548 mg intervention 3: fluticasone propionate 200 mcg intervention 4: azelastine hydrochloride 548 mcg/fluticasone propionate 200 mcg	intervention 1: Placebo intervention 2: azelastineHcl intervention 3: fluticasone propionate intervention 4: azelastine Hcl/fluticasone propionate	45	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Encinitas \| California \| United States \| -117.29198 \| 33.03699 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Stockton \| California \| United States \| -121.29078 \| 37.9577 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Normal \| Illinois \| United States \| -88.99063 \| 40.5142 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Papillion \| Nebraska \| United States \| -96.04224 \| 41.15444 Ocean City \| New Jersey \| United States \| -74.5746 \| 39.27762 Skillman \| New Jersey \| United States \| -74.7146 \| 40.42011 Warren Township \| New Jersey \| United States \| -74.51803 \| 40.60822 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Collegeville \| Pennsylvania \| United States \| -75.45157 \| 40.18566 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 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 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Draper \| Utah \| United States \| -111.86382 \| 40.52467 Seattle \| Washington \| United States \| -122.33207 \| 47.60621	1,798	0	0	0	NCT00883168	1COMPLETED	2009-07-01	2009-04-01	Meda Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	true	0ALL	false	The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.	null	Healthy Volunteers	Healthy Volunteers	null	4	arm 1: Inhaled PT001 18 μg arm 2: Inhaled PT005 2.4 μg arm 3: Inhaled PT003 (PT001 18 μg / 2.4 μg PT005) arm 4: PT001 18 μg + PT005 2.4 μg	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Inhaled PT001, single dose intervention 2: Inhaled PT005, single dose intervention 3: Inhaled PT003, single dose intervention 4: Inhaled PT001 + PT005, single dose	intervention 1: PT001 intervention 2: PT005 intervention 3: PT003 intervention 4: PT001 + PT005	1	Herston \| Queensland \| Australia \| 153.01852 \| -27.44453	59	0	0	0	NCT00893971	1COMPLETED	2009-07-01	2009-05-01	Pearl Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	30	NA	SINGLE_GROUP	9OTHER	0NONE	false	0ALL	false	The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.	null	P Acnes Colonization		null	1	arm 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily	[ 0 ]	1	[ 0 ]	intervention 1: Apply once daily	intervention 1: Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)	1	Broomall \| Pennsylvania \| United States \| -75.35658 \| 39.9815	30	0	0	0	NCT00907101	1COMPLETED	2009-07-01	2009-06-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	52	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product	This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, a topical antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product. The subjects will be entered into a 2-week treatment phase. The once-daily applications for the study medication will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays. A blinded expert grader will rate comparative product tolerance on each week day (excluding Saturdays and Sundays) during the study before study product is applied. Subject questionnaires will be completed along with collection of all adverse events.	Acne Vulgaris	Acne	null	2	arm 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide (BPO). arm 2: Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide (BPO) and adapalene	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide gel. This contains a topical antibiotic and benzoyl peroxide gel. intervention 2: Once-daily applications, to the randomized side of the face either left or right,benzoyl peroxide and adapalene gel	intervention 1: Clindamycin and benzoyl peroxide intervention 2: benzoyl peroxide 2.5% and adapalene 0.1% gel	1	Broomall \| Pennsylvania \| United States \| -75.35658 \| 39.9815	52	0	0	0	NCT00926367	1COMPLETED	2009-07-01	2009-05-01	Stiefel, a GSK Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	60	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.	This was a trial of healthy adults to compare the effects of oral lubiprostone, 24 microgram per day and placebo for three days, on sensation and contractions of the colon using validated methods. On days 1 and 2, participants took the study medication with their breakfast and recorded the time. On day 2 starting at 4:00 pm, participants started a polyethylene glycol-based bowel preparation to cleanse the colon. After overnight bowl preparation, participants reported fasting to the study center at 7:00 am on day 3. Colonic sensorimotor functions were assessed by an endoscopically placed barostat-manometric assembly. After 30 minutes of rest following tube placement, fasting colonic tone, colonic compliance and colonic sensation were tested. The last dose of medication was ingested and 1 hour later the same colonic functions, as well as colonic response to a standardized meal of a 1,000-kilocalorie chocolate milkshake were assessed. The participant was able to leave the study center in the afternoon, after a meal had been ingested (if desired). Details on colonic tube placement: A flexible sigmoidoscopy was performed to evaluate the left side of the colon and to place a Teflon-coated guide wire beyond the splenic flexure. The colon was deflated as the sigmoidoscope was removed and a barostat catheter (constructed at Mayo Clinic, Rochester, MN) with six manometric point sensors and a polyethylene balloon was introduced into the colon over the guide wire. The barostat catheter was positioned in the mid-descending or upper sigmoid colon with the aid of fluoroscopy. The final position of the barostatically controlled balloon was confirmed by fluoroscopy. After the colonic tube placement, participants rested for 30 min. The catheter was connected to a rigid piston barostat machine. After transient inflation of the barostat bag to a volume of 75 ml to ensure it was unfolded, it was deflated. Thereafter, it was inflated in 2 mm Hg increments to baseline operating pressure, which was defined as 2 mm Hg above the minimal distension pressure at which respiratory excursions were clearly recorded by the barostat tracing.	Healthy	lubiprostone colon motility sensation	null	2	arm 1: Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days. arm 2: Subjects randomized to this arm received placebo medication for three days.	[ 1, 2 ]	3	[ 0, 0, 10 ]	intervention 1: Lubiprostone 24 micrograms, one dose daily for three days in 30 subjects intervention 2: Placebo medication given for three days intervention 3: Polyethylene glycol-based bowel preparation	intervention 1: lubiprostone intervention 2: Placebo intervention 3: Bowel preparation	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	54	0	0	0	NCT00953043	1COMPLETED	2009-07-01	2007-09-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	40	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	This is a phase II, open label, randomized-controlled pilot study designed to study both the efficacy and safety of salsalate in decreasing endothelial cell dysfunction, systemic inflammation, and insulin resistance in HIV-infected adults. The investigators hypothesis is that salsalate will reduce inflammation and therefore endothelial cell activation and insulin resistance. The sample size will be 40, with an equal number of people being randomized to one of two groups. The first arm will be randomized to salsalate therapy. The second arm will act as a control group. The study duration will be 13 weeks.	null	HIV Endothelial Dysfunction Inflammation Insulin Resistance	HIV Endothelial dysfunction Inflammation Insulin resistance	null	2	arm 1: None arm 2: None	[ 1, 4 ]	1	[ 0 ]	intervention 1: Salsalate 2 grams orally twice a day for 13 weeks. This is the maximum dosage. During the initial 9 days of the study salsalate dose will be titrated to reach this goal dosage.	intervention 1: Salsalate	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	40	0	0	0	NCT01046682	1COMPLETED	2009-07-01	2009-01-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This open, multicentric, randomized, controlled study is planned to evaluate the correlation between gene expression, spontaneous catch-up growth and therapeutic response to Saizen in SGA children.	This open, multicentric, randomized, controlled study was planned to identify genes activated by hGH in SGA children responders to treatment (making it possible in the near future to better identify SGA children likely to benefit from hGH treatment). Furthermore, the study would hopefully allow to verify which genes were responsible of spontaneous catch-up growth in children with diagnosis of SGA at birth but above the third percentile for height at the age of 24 months, and if these genes were the same activated by hGH during the treatment in participants responders. Sixty children born at term (i.e. after the 37th completed week of gestation) and with a diagnosis of SGA (defined as a length less than tenth percentile according to the Italian reference table published by Bertini and Fabris) were planned to be enrolled in the study. Forty participants (group A) were still less than third percentile for height (according to the Tanner reference table) at the age of 24 months, the remaining 20 (group B) being more than or equal to third percentile (thus showing a spontaneous catch-up growth). Group A was randomized to receive Saizen at the daily dose of 0.067 mg/kg (Group A1) or no treatment (Group A2) for two years. All participants were to undergo full clinical examination and blood chemistry at baseline visit and visit after 1,6,12,18 and 24 months for a period of two years. Gene expression analysis using the Clontech Atlas Human Array was performed in all participants at baseline and after one year in order to identify the possible correlation between catch-up growth (either spontaneous or drug-induced) and expression of some genes. OBJECTIVES Primary objective: * To evaluate the correlation between gene expression profiling and catch-up growth (either spontaneous or drug induced after one year of treatment) in SGA children. Secondary Objectives: * To evaluate the percentage of participants not treated who show a spontaneous catch-up growth during the two years of observation. * To assess the safety and tolerability of early treatment with Saizen	Infant, Small for Gestational Age	Infant, small for gestational age Growth hormone Saizen	null	3	arm 1: Participants were allocated to Group A if were still third percentile for height (according to the Tanner reference table) at the age of 4-6 years. Group A would be then randomized to receive Saizen at the daily dose of 0.035 milligram (mg)/kilogram (kg) (Group A1) or no treatment (Group A2) for two years. arm 2: Participants were allocated to Group A if were still third percentile for height (according to the Tanner reference table) at the age of 4-6 years. Group A would be then randomized to receive no treatment (Group A2) for two years. arm 3: Participants were allocated to Group B being third percentile (thus showing a spontaneous catch-up growth).	[ 0, 4, 4 ]	1	[ 0 ]	intervention 1: Recombinant human GH were administered subcutaneously (s.c) at the daily dose of 0.067 mg/kg of body weight to Group A1.	intervention 1: Recombinant human growth hormone (r-hGH)	1	Roma \| N/A \| Italy \| 11.10642 \| 44.99364	22	0	0	0	NCT01067352	6TERMINATED	2009-07-01	2004-02-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	20	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously\[IV\]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.	null	Malignant Melanoma		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: 15 mg/kg intravenously on day 1 of every 3 week cycle intervention 2: 100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles	intervention 1: bevacizumab [Avastin] intervention 2: fotemustine	4	Florence \| N/A \| Italy \| 11.24626 \| 43.77925 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Torino \| N/A \| Italy \| 11.99138 \| 44.88856	20	0	0	0	NCT01069627	1COMPLETED	2009-07-01	2006-12-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	125	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.	null	Epilepsy		null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day. intervention 2: Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.	intervention 1: zonisamide low dose group intervention 2: zonisamide high dose group	11	Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	125	0	0	0	NCT01127165	1COMPLETED	2009-07-01	2006-03-01	Eisai Korea Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	168	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This expanded access study will assess the safety and efficacy of intravenous bevacizumab (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.	null	Colorectal Cancer		null	1	arm 1: Bevacizumab will be administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen. intervention 2: Fluoropyrimidine-based chemotherapy administered according to standard of care.	intervention 1: Bevacizumab intervention 2: Fluoropyrimidine-based Chemotherapy	28	Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.92083 Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.92083 Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.92083 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Brasília \| N/A \| Brazil \| -47.92972 \| -15.77972 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Caxias do Sul \| N/A \| Brazil \| -51.17944 \| -29.16806 Curitiba \| N/A \| Brazil \| -49.27306 \| -25.42778 Curitiba \| N/A \| Brazil \| -49.27306 \| -25.42778 Fortaleza \| N/A \| Brazil \| -38.54306 \| -3.71722 Ijuí \| N/A \| Brazil \| -53.91472 \| -28.38778 João Pessoa \| N/A \| Brazil \| -34.86306 \| -7.115 Porto Alegre \| N/A \| Brazil \| -51.23019 \| -30.03283 Porto Alegre \| N/A \| Brazil \| -51.23019 \| -30.03283 Recife \| N/A \| Brazil \| -34.88111 \| -8.05389 Ribeirão Preto \| N/A \| Brazil \| -47.81028 \| -21.1775 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Salvador \| N/A \| Brazil \| -38.49096 \| -12.97563 Salvador \| N/A \| Brazil \| -38.49096 \| -12.97563 Salvador \| N/A \| Brazil \| -38.49096 \| -12.97563 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475	162	0	0	0	NCT01169558	1COMPLETED	2009-07-01	2006-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 1 ]	95	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	1FEMALE	true	The purpose of this research study is to determine whether melatonin taken every night can affect blood levels of estrogen or IGF (insulin-growth factor levels). Both IGF and estrogen are normally produced in the body and may influence breast cancer risk. Melatonin is also naturally produced in the body. Laboratory studies have shown that melatonin may decrease cancer growth and influence estrogen and IGF levels. Melatonin's effects on sleep, hot flashes, and mood will also be measured.	If you agree to participate in this study you will be asked to undergo a blood test to find out if you are eligible. Approximately 2 tablespoons of blood will be drawn. The blood test will check your health and menopausal status. This test will aslo be used to help measure any additional effects of the study drug on your body. If you have had a blood test recently, it may or may not have to be repeated. If these tests show that you are eligible to participate in the research study, you will begin the study. If you do not meet the eligibility criteria, you will not be able to participate. Because no one knows which of the study options is best, and all of the options are considered likely to work, you will be "randomized" into one of the study groups: melatonin or placebo. Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in. You will have an equal chance of being placed in either group. Neither you nor the research doctor will know what group you are in. You will not know the identity of your study treatment until after the final research analysis has taken place. Once this has happened, you will be mailed a letter from the principal research doctor telling you which study drug you received while on study. You will be given a study drug and it will either contain melatonin or placebo (pills with no medical effect). You will take one tablet by mouth every night as close to 9:00 pm as possible. You should not make up missed doses. You will be given enough study drug to last 4 months. You will also be given a study medication-dosing calendar to write down times you took the study drug for each month you are taking the study drug. Before taking the study drug, you will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. At this visit, you will also be asked to complete a questionnaire that will take approximately 15 minutes. A member of the research study staff will check in by telephone once a month to monitor your experiences on the research study. You may also contact a member of the research study staff at any time if you have any questions or concerns. You should tell your research doctor if you are currently taking black cohosh, flaxseed or soy in pill or supplement form, as it may affect your participation in this research study. After you have completed approximately 4 months of study drug, you will return to clinic to see a member of the research study staff. At this visit you will have the following tests and procedures: You will have blood tests to look at the level of estrogen and IGF in your blood. Approximately 2 tablespoons of blood will be drawn. You must return your study medication-dosing calendar and all of your pill bottles at the end of the research study to a member of the research study staff. You wil also be asked to complete a questionnaire that will take about 15 minutes.	Breast Cancer		null	2	arm 1: Taken orally, once per day, at/around 9:00pm arm 2: Taken orally, once per day, at/around 9:00pm	[ 1, 2 ]	1	[ 0 ]	intervention 1: Melatonin vs. Placebo	intervention 1: Melatonin 3 mg	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	95	0	0	0	NCT01805089	1COMPLETED	2009-07-01	2006-10-01	Dana-Farber Cancer Institute	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	20	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.	Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin single-dose was to be administered alone.	Parkinson's Disease (PD)	Parkinson's disease (PD) BIA 9-1067 Opicapone	null	2	arm 1: Period 1: BIA 9-1067 + warfarin Period 2: warfarin arm 2: Period 1: warfarin Period 2: BIA 9-1067 + warfarin	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: BIA 9-1067 25 mg intervention 2: Warfarin 25 mg	intervention 1: BIA 9-1067 intervention 2: Warfarin	1	S. Mamede Do Coronado \| Trofa \| Portugal \| N/A \| N/A	40	0	0	0	NCT02169440	1COMPLETED	2009-07-01	2009-06-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	10	NON_RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	null	Dr. MacIntyre and his colleagues are studying inhaled medications in asthma. There are two new medications that have been approved by the United States Food and Drug Administration (FDA): levalbuterol and formoterol. Both of these drugs are similar to standard asthma bronchodilator drugs but offer theoretical advantages in terms of fewer side effects. There are also newer devices to deliver these medications into the lungs: breath actuated nebulizers (BANs) and non-static chambers (Aerochamber-max) that can be used with metered dose inhalers (MDIs or "puffers"). The purpose of this study is to deliver these new medications using several different devices and measuring lung function, heart rate, and sensations of breathlessness.	Patients will be studied on five separate mornings. The duration of the study and frequency of the visits will be solely dependant on the subject availability. Each subject will receive all 5 treatments in the same order.	Asthma	asthma	null	5	arm 1: 0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer arm 2: 0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer arm 3: levalbuterol metered dose inhaler 2 puffs arm 4: levalbuterol MDI + aerochamber max without pause 2 puffs arm 5: levalbuterol MDI + aerochamber max with 2 second pause 2 puffs	[ 1, 1, 1, 1, 1 ]	6	[ 0, 0, 10, 1, 1, 0 ]	intervention 1: 0.5 ml. levalbuterol intervention 2: 0.5ml saline intervention 3: None intervention 4: None intervention 5: None intervention 6: None	intervention 1: levalbuterol intervention 2: saline intervention 3: levalbuterol MDI intervention 4: breath actuated nebulizer intervention 5: aerochamber max intervention 6: ipratroprium	0	null	10	0	0	0	NCT02170532	1COMPLETED	2009-07-01	2007-07-01	Duke University	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	12	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The study assessed the safety and ability of several doses of an orally inhaled medicine \[ie, Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.	In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.	Chronic Obstructive Pulmonary Disease	Emphysema Chronic bronchitis COPD Chronic Obstructive Pulmonary Disease	null	7	arm 1: Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily arm 5: Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily arm 6: Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily arm 7: Placebo 0.5 mL via jet nebulizer, once daily	[ 0, 0, 0, 0, 0, 0, 2 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 25 μg oral inhalation via eFlow Nebulizer, once daily intervention 2: 75 μg oral inhalation via eFlow Nebulizer, once daily intervention 3: 200 μg oral inhalation via eFlow Nebulizer, once daily intervention 4: 200 μg oral inhalation via inhalation via jet nebulizer, once daily intervention 5: 500 μg oral inhalation via eFlow nebulizer, once daily intervention 6: 1000 μg oral inhalation via eFlow nebulizer, once daily intervention 7: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily	intervention 1: Glycopyrrolate Inhalation Solution 25mg intervention 2: Glycopyrrolate Inhalation Solution 75mg intervention 3: Glycopyrrolate Inhalation Solution 200mg intervention 4: Glycopyrrolate Inhalation Solution 200mg Jet intervention 5: Glycopyrrolate Inhalation Solution 500mg intervention 6: Glycopyrrolate Inhalation Solution1000mg intervention 7: Placebo	0	null	42	0	0	0	NCT02951312	1COMPLETED	2009-07-01	2009-05-01	Sunovion Respiratory Development Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	628	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This study was a proof-of-efficacy, dose finding study of LCI699 in participants with mild-to-moderate uncomplicated essential hypertension in order to assess the blood pressure (BP) lowering effect, safety and tolerability of LCI699 as compared to placebo and eplerenone.	null	Essential Hypertension	Essential hypertension Phase 2 study Antihypertensive agent	null	17	arm 1: Participants received LCI699 0.25 mg capsules, orally, once daily (QD), with or without food for up to 8 weeks. arm 2: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 3: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 8 weeks. arm 4: Participants received LCI699 0.5 mg capsules, orally, twice daily (BID), with or without food for up to 8 weeks. arm 5: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 8 weeks. arm 6: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 8 weeks. arm 7: Participants received LCI699 0.25 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 8: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 9: Participants received LCI699 0.5 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 10: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 11: Participants received LCI699 1 mg capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 12: Participants received LCI699 matching placebo capsules, orally, QD, with or without food for up to 1 week (Week 8 to Week 9). arm 13: Participants received LCI699 0.5 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 14: Participants received LCI699 matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 15: Participants received eplerenone 50 mg capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 16: Participants received eplerenone matching placebo capsules, orally, BID, with or without food for up to 1 week (Week 8 to Week 9). arm 17: Participants received LCI699-matching placebo or eplerenone-matching placebo, capsules, orally, QD or BID, with or without food for up to 1 week (Week 8 to Week 9).	[ 0, 0, 0, 0, 1, 2, 0, 2, 0, 2, 0, 2, 0, 2, 1, 2, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: LCI699 oral capsules intervention 2: Eplerenone oral capsules intervention 3: LCI699-matching placebo oral capsules intervention 4: Eplerenone-matching placebo oral capsules	intervention 1: LCI699 intervention 2: Eplerenone intervention 3: LCI699-matching Placebo intervention 4: Eplerenone-matching Placebo	1	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201	997	0	0	0	NCT00758524	1COMPLETED	2009-07-02	2008-09-11	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	38	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	null	This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.	null	Healthy	Healthy volunteers	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets intervention 2: CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets. intervention 3: SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).	intervention 1: SPD503 intervention 2: Concerta intervention 3: SPD503 + Concerta	1	Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593	112	0	0	0	NCT00901576	1COMPLETED	2009-07-06	2009-05-18	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	49	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	Eligible patients must receive Caelyx plus Cyclophosphamide plus Herceptin for 6 cycles that will be administered every 4 weeks.	Sample size calculation will be done by means of Simon's method in 2 stages for phase II studies and will be based on the principal aim of the study (evaluation of the rate of objective response). The hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. In this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. The total number of patients to including in the study would be 44. The results will be significant if they find at least 20 objective responses. Assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.	Breast Cancer	HER2 positive breast cancer Metastatic breast cancer	null	1	arm 1: Caelyx (Liposomal Doxorubicin) 50 mg/m2 every 4 weeks for 6 cycles, Cyclophosphamide 600 mg/m2 every 4 weeks for 6 cycles, Trastuzumab weekly for 24 weeks, at dose of 2mg/kg (day 1 loading dose of 4mg/kg)	[ 5 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Liposomal Doxorubicin intervention 2: Cyclophosphamide intervention 3: Trastuzumab	12	Badalona \| Barcelona \| Spain \| 2.24741 \| 41.45004 Alcorcón \| Madrid \| Spain \| -3.82487 \| 40.34582 A Coruña \| N/A \| Spain \| -8.396 \| 43.37135 A Coruña \| N/A \| Spain \| -8.396 \| 43.37135 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Cadiz \| N/A \| Spain \| -6.2891 \| 36.52672 Castelló \| N/A \| Spain \| 0.84856 \| 41.01149 Jaén \| N/A \| Spain \| -3.79028 \| 37.76922 Lugo \| N/A \| Spain \| -7.55602 \| 43.00992 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Santa Cruz de Tenerife \| N/A \| Spain \| -16.25462 \| 28.46824	48	0	0	0	NCT00258960	1COMPLETED	2009-07-14	2006-02-15	Spanish Breast Cancer Research Group	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	47	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	false	This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.	This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction. Subjects will be invited to complete a screening visit, during which time exercise induced bronchoconstriction must be demonstrated, defined as a decrease between 20-40% in FEV1 compared to baseline immediately following exercise challenge. Eligible subjects will complete a randomized, double-blind, five-way crossover study. Subjects will be randomized to a single dose of either 10 mg, 50 mg, 100 mg, 200 mg GSK2190915, or placebo during each treatment period. Each treatment period will last 2 days and will include various assessments following exercise challenge at 2, 9.5, and 24 hours post dose. A minimum 7 day washout between treatment periods will be required. Regardless if a subject completes or prematurely withdraws from the study, a follow up visit will be completed 7-21 days following last dose.	Asthma	Asthma, Exercise Induced Asthma, Exercise Induced Bronchospasm	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 2, 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915. intervention 2: This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single dose of 10 mg, 50 mg, 100 mg, or 200 mg GSK2190915, compared to a placebo control.	intervention 1: Placebo intervention 2: GSK2190915	6	Denver \| Colorado \| United States \| -104.9847 \| 39.73915 North Dartmouth \| Massachusetts \| United States \| -70.97032 \| 41.63899 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Orangeburg \| South Carolina \| United States \| -80.85565 \| 33.49182 El Paso \| Texas \| United States \| -106.48693 \| 31.75872	226	0	0	0	NCT00812929	1COMPLETED	2009-07-15	2008-12-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0	0	-0
[ 2 ]	30	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	0ALL	false	Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin	null	Healthy Subjects		null	3	arm 1: Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 2: Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast arm 3: Organ-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 2: Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water intervention 3: Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water	intervention 1: Vicks Cough Syrup for Chesty Coughs intervention 2: Robitussin Extra Strength Chest Congestion intervention 3: Organ-I- NR tablet	0	null	85	0	0	0	NCT03643575	1COMPLETED	2009-07-16	2009-06-30	Reckitt Benckiser Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine whether daptomycin at a higher dose given during the last 30 minutes of a dialysis session is equal to a lower dose of daptomycin given after a dialysis session.	null	End-stage Renal Disease Renal Failure Chronic Requiring Hemodialysis	End-stage renal disease hemodialysis chronic renal failure	null	2	arm 1: 9 mg/kg of daptomycin administered during the last 30 minutes of a hemodialysis session. arm 2: Post dialysis dosing	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: intradialytic: 9 mg/kg during the last 30 minutes of dialysis intervention 2: 6 mg/kg administered after a hemodialysis session	intervention 1: daptomycin intervention 2: daptomycin	2	Cypress \| California \| United States \| -118.03729 \| 33.81696 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	15	0	0	0	NCT00882557	1COMPLETED	2009-07-17	2009-04-29	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	302	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort	null	Abdominal Pain		null	2	arm 1: None arm 2: None	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Hyoscine Butylbromide - Tablet intervention 2: Hyoscine Butylbromide - Capsule intervention 3: Placebo	0	null	288	0	0	0	NCT02242305	1COMPLETED	2009-07-20	2008-11-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 2 ]	12	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	2DOUBLE	true	2MALE	false	This study will evaluate the effect of a single dose of sitagliptin on glucose dependent insulin secretion using a meal tolerance test (MTT) during a hyperglycemic clamp (HCG) procedure.	null	Type 2 Diabetes Mellitus		null	3	arm 1: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 2: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods arm 3: Sitagliptin in 2 of 3 treatment periods and Placebo in 1 of 3 treatment periods	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Single oral dose of sitagliptin 100 mg (2 x 50 mg) tablets followed by the hyperglycemic clamp procedure and meal tolerance test. intervention 2: Single oral dose of 2 tablets placebo to sitagliptin followed by the hyperglycemic clamp procedure and meal tolerance test.	intervention 1: sitagliptin intervention 2: Comparator: Placebo	0	null	24	0	0	0	NCT00888238	1COMPLETED	2009-07-21	2009-05-12	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	147	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this trial is to establish superiority of the once-daily Tiotropium plus Salmeterol Inhalation Powder in daytime lung function response and non-inferiority in night-time lung function response over the comparator treatments inhaled in their established dose regimens when administered for 6-week periods to patients with chronic obstructive pulmonary disease (COPD). The main secondary objective is to evaluate the safety of the Tiotropium plus Salmeterol Inhalation Powder versus the comparator treatments.	null	Pulmonary Disease, Chronic Obstructive		null	4	arm 1: 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)/ 18 µg Tiotropium (Tio18GEL) / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (T18GEL) plus 50 µg Salmeterol MDPI (S\_DPI) BID arm 2: 18 µg Tiotropium (Tio18GEL) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 50 µg Salmeterol MDPI (Salm50DPI) arm 3: 50 µg Salmeterol MDPI (Salm50DPI) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) / 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 18 µg Tiotropium (Tio18GEL) arm 4: 18 µg Tiotropium (T18GEL) + 50 µg Salmeterol MDPI (S\_DPI) BID / 50 µg Salmeterol MDPI (Salm50DPI) / 18 µg Tiotropium (Tio18GEL) / 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE)	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 18 µg Tiotropium (Tio18GEL) inhalation powder intervention 2: 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) intervention 3: 18 µg Tiotropium (T18GEL) inhalation powder plus 50 µg Salmeterol MDPI (S\_DPI) twice daily (BID) intervention 4: Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder	intervention 1: Tiotropium (Tio18GEL) intervention 2: Salmeterol MDPI (Salm50DPI) intervention 3: Tiotropium (T18GEL) + Salmeterol MDPI (S_DPI) intervention 4: Tiotropium/Salmeterol (T+S_PE)	12	Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Cottbus \| N/A \| Germany \| 14.32888 \| 51.75769 Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 Rodgau-Dudenhofen \| N/A \| Germany \| N/A \| N/A Rüdersdorf \| N/A \| Germany \| 13.78631 \| 52.46927 Schwerin \| N/A \| Germany \| 11.41316 \| 53.62937 Wiesbaden \| N/A \| Germany \| 8.24932 \| 50.08258 Wiesloch \| N/A \| Germany \| 8.69846 \| 49.29504	682	0	0	0	NCT00662792	1COMPLETED	2009-07-22	2008-04-15	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	81	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.	null	Psoriasis	chronic plaque psoriasis topical treatment	null	8	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None	[ 0, 0, 0, 0, 0, 0, 2, 2 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: Topical treatment once daily for 28 days intervention 2: Topical treatment once daily for 28 days intervention 3: Topical treatment once daily for 28 days intervention 4: Topical treatment twice daily for 28 days intervention 5: Topical treatment twice daily for 28 days intervention 6: Topical treatment twice daily for 28 days intervention 7: Topical treatment once daily for 28 days intervention 8: Topical treatment twice daily for 28 days	intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: Placebo Vehicle intervention 8: Placebo Vehicle	20	Irvine \| California \| United States \| -117.82311 \| 33.66946 San Diego \| California \| United States \| -117.16472 \| 32.71571 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 High Point \| North Carolina \| United States \| -80.00532 \| 35.95569 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Surrey \| British Columbia \| Canada \| -122.82509 \| 49.10635 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228	81	0	0	0	NCT00678561	1COMPLETED	2009-07-24	2008-10-13	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	169	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 temozolomide together with sorafenib may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different schedules of temozolomide when given together with sorafenib to compare how well they work in treating patients with metastatic or unresectable melanoma.	OBJECTIVES: Primary * To measure the progression-free survival of patients with metastatic or unresectable melanoma with no brain metastasis or no prior treatment with temozolomide (TMZ) treated with sorafenib tosylate in combination with two different schedules (extended daily dosing vs standard dosing) of TMZ. * To measure the progression-free survival of patients with or without brain metastasis and prior treatment with TMZ treated with sorafenib in combination with extended daily dosing of TMZ. * To measure the progression-free survival of patients with brain metastasis and no prior treatment with TMZ treated with sorafenib in combination with standard dosing TMZ. * To estimate the median time to progression in all patients. * To quantify the number and percent of patients who have stable disease after 6 months of treatment (failure to progress). * To choose the optimal combination dosing regimen for further study. Secondary * To estimate and define the objective response rate in these patients. * To characterize the duration of objective responses in these patients. * To estimate the incidence of new symptomatic brain metastasis in these patients. * To measure overall survival of these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior brain metastases (yes vs no) and prior treatment with temozolomide (TMZ) (yes vs no). Patients with no prior brain metastases who did not receive prior treatment with TMZ are randomized to 1 of 2 treatment arms. These patients are further stratified according to prior treatment with sorafenib tosylate (yes vs no). Patients with or without prior brain metastases who received prior treatment with TMZ are assigned to arm I. Patients with prior brain metastases who did not receive prior treatment with TMZ are assigned to arm II. * Arm I: Patients receive oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. * Arm II: Patients receive sorafenib tosylate as in arm I and oral TMZ once daily on days 1-5 and 29-33. In both arms, courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.	Melanoma (Skin)	recurrent melanoma stage III melanoma stage IV melanoma	null	4	arm 1: Patients who were temozolomide naive and had no brain metastases received oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. arm 2: Patients who were temozolomide naive and had no brain metastases received sorafenib tosylate as in arm A and oral TMZ once daily on days 1-5 and 29-33. arm 3: Patient with or without treated brain metastases who were treated with prior temozolomide and progressed were treated with oral sorafenib tosylate twice daily on days -7 to 56 of course 1 and on days 1-56 of all subsequent courses. Patients also receive oral TMZ once daily on days 1-42. arm 4: Patients with treated brain metastases were treated with sorafenib tosylate as in arm B and oral TMZ once daily on days 1-5 and 29-33.	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Given orally intervention 2: Given orally	intervention 1: sorafenib tosylate intervention 2: temozolomide	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	169	0	0	0	NCT00602576	1COMPLETED	2009-07-26	2005-01-01	Abramson Cancer Center at Penn Medicine	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	42	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	null	Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.	null	Healthy	Normal, healthy volunteers (for this Phase 1 study)	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. intervention 2: VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. intervention 3: SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.	intervention 1: SPD503 intervention 2: VYVANSE intervention 3: SPD503 and VYVANSE	1	Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593	122	0	0	0	NCT00919867	1COMPLETED	2009-07-30	2009-06-24	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This phase II clinical trial is studying biomarkers and side effects in women receiving chemotherapy and celecoxib for stage II or stage III breast cancer that can be removed by surgery.	OBJECTIVES: * To determine the safety and efficacy of four courses of neoadjuvant chemotherapy comprising docetaxel, capecitabine, and celecoxib followed by doxorubicin hydrochloride, cyclophosphamide, and celecoxib for the treatment of women with resectable stage II or III breast cancer. * To determine the mRNA and protein levels of thyraidylate synthase (TS), thymidine phosphylase (TP), vascular endothelial growth factor (VEGF), Multi-Drug Resistance Protein 1 (MDR-1), cyclooxygenase-2 (COX-2), and matrix metalloproteinase-2 (MMP-2) in tumor tissue prior to and following treatment. * To correlate baseline expression of TS, TP, VEGF, MDR, COX-2, and MMP-2 to tumor response measured by physical exam, breast MRI, breast ultrasound, mammography, and pathologic response. * To determine if polymorphisms in the genes that encode those proteins also correlate with outcome, if a correlation is found between specific molecular markers and clinical outcome. OUTLINE: * Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. * Surgery: Patients undergo definitive surgery (either modified radical mastectomy or lumpectomy combined with axillary node dissection). Patients may also undergo adjuvant radiotherapy and hormonal therapy at the discretion of multidisciplinary breast team. Blood is collected at baseline and examined for genetic polymorphisms associated with functional changes in proteins. Tumor tissue is obtained by needle biopsy at baseline, before the second course of docetaxel/capecitabine/celecoxib, and at surgical resection. Molecular markers and protein expression are assessed by immunohistochemistry using fluorescence-image analysis and real-time reverse-transcriptase PCR. Patients undergo imaging comprising dynamic MRI, ultrasound, and mammogram at baseline and after the first and second 4 courses of chemotherapy.	Breast Cancer	stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer	null	1	arm 1: •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: Patients undergo definitive surgery (either modified radical mastectomy or lumpectomy combined with axillary node dissection). Patients may also undergo adjuvant radiotherapy and hormonal therapy at the discretion of multidisciplinary breast team.	[ 0 ]	19	[ 2, 0, 0, 0, 0, 0, 6, 6, 6, 6, 10, 10, 10, 10, 3, 3, 3, 3, 3 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None intervention 15: None intervention 16: None intervention 17: None intervention 18: None intervention 19: None	intervention 1: filgrastim intervention 2: capecitabine intervention 3: celecoxib intervention 4: cyclophosphamide intervention 5: docetaxel intervention 6: doxorubicin hydrochloride intervention 7: gene expression analysis intervention 8: polymorphism analysis intervention 9: protein expression analysis intervention 10: reverse transcriptase-polymerase chain reaction intervention 11: imaging biomarker analysis intervention 12: immunohistochemistry staining method intervention 13: laboratory biomarker analysis intervention 14: pharmacogenomic studies intervention 15: dynamic contrast-enhanced magnetic resonance imaging intervention 16: needle biopsy intervention 17: neoadjuvant therapy intervention 18: radiomammography intervention 19: ultrasound imaging	1	Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626	3	0	0	0	NCT00665457	6TERMINATED	2009-07-31	2004-04-15	University of Nebraska	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2 ]	41	RANDOMIZED	CROSSOVER	9OTHER	0NONE	true	0ALL	null	To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)	null	Healthy		null	3	arm 1: None arm 2: None arm 3: None	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 2: Lanthanum carbonate (1000 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period. intervention 3: Sevelamer carbonate (2400 mg three times daily with meals for one day) + calcitriol (1.0 microgram) single dose at lunch administered on Day 1 of the study period.	intervention 1: Calcitriol intervention 2: Lanthanum carbonate + Calcitriol intervention 3: Sevelamer carbonate + Calcitriol	1	Cypress \| California \| United States \| -118.03729 \| 33.81696	116	0	0	0	NCT00925704	1COMPLETED	2009-07-31	2009-06-01	Shire	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.	To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25\~27 weeks.	Epilepsy		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day. intervention 2: Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.	intervention 1: zonisamide intervention 2: carbamazepine	12	Bundang \| N/A \| South Korea \| N/A \| N/A Ilsan \| N/A \| South Korea \| 129.43333 \| 35.5 Incheon \| N/A \| South Korea \| 126.70515 \| 37.45646 Jungnam \| N/A \| South Korea \| 128.02522 \| 36.27333 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566	200	0	0	0	NCT01127256	1COMPLETED	2009-07-31	2006-05-31	Eisai Korea Inc.	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	304	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.	CF is an inherited disease that causes mucus to build up in the lungs and digestive tract, which can cause lung infections and digestive problems. It is the most common type of chronic lung disease in children and young adults and may result in early death. There is no cure for this disease. The primary cause of death in individuals with CF is progressive obstructive pulmonary disease associated with chronic Pseudomonas aeruginosa (PA) infection. PA infection can occur early in life and can become highly resistant to antibiotics. Once an individual has been diagnosed with chronic PA infection, it is almost impossible to manage effectively. The need exists for an effective treatment to control and eliminate PA infection. Past research has shown that if PA infection is treated early, there is a greater likelihood that it may be eliminated completely. This study will examine two treatment regimens to compare which is more effective at eliminating PA infection. In the first regimen, participants will receive antibiotic treatment at various times throughout the study, based on findings of PA respiratory cultures obtained on a quarterly basis. In the second regimen, participants will receive antibiotic medications in consistent, quarterly cycles throughout the study. The antibiotic medications used in this study will be ciprofloxacin and inhaled tobramycin, which will be administered with a nebulizer. Both of these medications have been proven effective at treating bacterial lung infections. The overall purpose of this study is to compare the effectiveness of culture-based treatment versus consistent treatment at reducing PA infection in children with CF. This 18-month study will enroll children with CF. For the first 28 days of the study, all participants will receive inhaled tobramycin. For the initial 14 days of this 28-day period, half of the participants will also receive either ciprofloxacin or placebo. If respiratory cultures after three weeks of treatment confirm the presence of PA, participants will receive tobramycin for an additional 28 days. Participants will then be randomly assigned to one of four treatment options: tobramycin and placebo for six consecutive quarterly cycles; tobramycin and ciprofloxacin for six consecutive quarterly cycles; tobramycin and placebo only when PA is found during quarterly respiratory cultures; or tobramycin and ciprofloxacin only when PA is found during quarterly respiratory cultures. At the first study visit, participants will undergo a physical examination, a chest x-ray, and a review of their medical history. Lung function will be measured via spirometry (in children greater than four years of age who are able to perform spirometry), and hearing ability will be measured via audiometry (at selected sites). Blood will be drawn for laboratory tests, and a specimen will be obtained for a respiratory culture. Subsequent study visits will take place at Day 21, Weeks 10, 22, 34, 46, 58, and 70. At each visit, participants will undergo a physical examination and a spirometry test (as appropriate), and a respiratory specimen for PA culture and blood will again be collected. Participants will be required to maintain a medication diary throughout the study, and they will be contacted between visits to review medication adherence and test results.	Cystic Fibrosis Pulmonary Disease, Chronic Obstructive	Lung Diseases Chronic Obstructive Pulmonary Disease	null	4	arm 1: Tobramycin inhalation solution and oral placebo for six consecutive quarterly cycles arm 2: Tobramycin solution for inhalation and oral ciprofloxacin for six consecutive quarterly cycles. arm 3: Tobramycin solution for inhalation and oral placebo administered only when quarterly respiratory cultures are found positive for Pa. arm 4: Tobramycin solution for inhalation and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pa.	[ 2, 1, 2, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa. intervention 2: Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily. intervention 3: Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.	intervention 1: Tobramycin solution for inhalation (TOBI) intervention 2: Oral placebo intervention 3: Oral ciprofloxacin	54	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 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 Wilmington \| Delaware \| United States \| -75.54659 \| 39.74595 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Portland \| Maine \| United States \| -70.2589 \| 43.65737 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Jackson \| Mississippi \| United States \| -90.18481 \| 32.29876 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Long Branch \| New Jersey \| United States \| -73.99236 \| 40.30428 Albany \| New York \| United States \| -73.75623 \| 42.65258 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Valhalla \| New York \| United States \| -73.77513 \| 41.07482 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Charlottesville \| Virginia \| United States \| -78.47668 \| 38.02931 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	304	1	0.003289	1	NCT00097773	1COMPLETED	2009-08-01	2004-09-01	Seattle Children's Hospital	7OTHER	false	false	false	null	0	0	0	0	1	0.000581
[ 4 ]	1,286	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to summarize the safety and tolerability of abatacept during 6 months of combined treatment with one or more of the background non-biologic disease modifying anti-rheumatic drugs (DMARDs) approved for rheumatoid arthritis (RA) in subjects with active RA. Secondary objectives assessed the clinical efficacy of combination treatment, including disease activity, physical function, and quality of life outcomes.	null	Rheumatoid Arthritis		null	3	arm 1: In participants who have had an inadequate efficacy response or intolerance on previous TNF-antagonist therapy (off therapy for at least 2 months), open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 2: In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing \< 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing \> 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion. arm 3: Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months. intervention 2: During the study, subjects continued to receive 1 or more background non-biologic DMARDs (e.g. methotrexate, leflunomide) at the dose level(s) and regimen(s) administered at the time of abatacept treatment onset (Day 1). intervention 3: Any of the anti-TNF therapies (Infliximab, Adalimumab, Etanercept, etc.)administered at the approved label dose for at least 3 months	intervention 1: Abatacept intervention 2: Non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD) intervention 3: Anti-Tumor Necrosing Factor (TNF) Therapy	148	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Paradise Valley \| Arizona \| United States \| -111.94265 \| 33.53115 Peoria \| Arizona \| United States \| -112.23738 \| 33.5806 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Palm Springs \| California \| United States \| -116.54529 \| 33.8303 Palo Alto \| California \| United States \| -122.14302 \| 37.44188 San Diego \| California \| United States \| -117.16472 \| 32.71571 Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Danbury \| Connecticut \| United States \| -73.45401 \| 41.39482 Hamden \| Connecticut \| United States \| -72.89677 \| 41.39593 Trumbull \| Connecticut \| United States \| -73.20067 \| 41.24287 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Largo \| Florida \| United States \| -82.78842 \| 27.90979 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Blue Ridge \| Georgia \| United States \| -84.32409 \| 34.86397 Macon \| Georgia \| United States \| -83.6324 \| 32.84069 Morton Grove \| Illinois \| United States \| -87.78256 \| 42.04059 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Prairie Village \| Kansas \| United States \| -94.63357 \| 38.99167 Bowling Green \| Kentucky \| United States \| -86.4436 \| 36.99032 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Peabody \| Massachusetts \| United States \| -70.92866 \| 42.52787 Springfield \| Massachusetts \| United States \| -72.58981 \| 42.10148 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 East Lansing \| Michigan \| United States \| -84.48387 \| 42.73698 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Lansing \| Michigan \| United States \| -84.55553 \| 42.73253 Petockey \| Michigan \| United States \| N/A \| N/A Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lebanon \| New Hampshire \| United States \| -72.25176 \| 43.64229 Nashua \| New Hampshire \| United States \| -71.46757 \| 42.76537 Cherry Hill \| New Jersey \| United States \| -75.03073 \| 39.93484 Dover \| New Jersey \| United States \| -74.5621 \| 40.88399 Manalapan \| New Jersey \| United States \| -74.39571 \| 40.25733 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Somerset \| New Jersey \| United States \| -74.48849 \| 40.4976 Teaneck \| New Jersey \| United States \| -74.01597 \| 40.8976 Voorhees Township \| New Jersey \| United States \| -74.49062 \| 40.4795 Albany \| New York \| United States \| -73.75623 \| 42.65258 Brooklyn \| New York \| United States \| -73.94958 \| 40.6501 Hewlett \| New York \| United States \| -73.69569 \| 40.64316 Lake Success \| New York \| United States \| -73.71763 \| 40.77066 Mineola \| New York \| United States \| -73.64068 \| 40.74927 New York \| New York \| United States \| -74.00597 \| 40.71427 Olean \| New York \| United States \| -78.42974 \| 42.07756 Orchard Park \| New York \| United States \| -78.74392 \| 42.76756 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Schenectady \| New York \| United States \| -73.93957 \| 42.81424 Smithtown \| New York \| United States \| -73.20067 \| 40.85593 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Beachwood \| Ohio \| United States \| -81.50873 \| 41.4645 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Mayfield Village \| Ohio \| United States \| N/A \| N/A Youngstown \| Ohio \| United States \| -80.64952 \| 41.09978 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Bala-Cynwyd \| Pennsylvania \| United States \| -75.23407 \| 40.00761 Bethlehem \| Pennsylvania \| United States \| -75.37046 \| 40.62593 Camp Hill \| Pennsylvania \| United States \| -76.91997 \| 40.23981 Duncansville \| Pennsylvania \| United States \| -78.4339 \| 40.42341 Erie \| Pennsylvania \| United States \| -80.08506 \| 42.12922 Meadville \| Pennsylvania \| United States \| -80.15145 \| 41.64144 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 Wexford \| Pennsylvania \| United States \| -80.05589 \| 40.62646 Willow Grove \| Pennsylvania \| United States \| -75.11573 \| 40.144 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Myrtle Beach \| South Carolina \| United States \| -78.88669 \| 33.68906 Simpsonville \| South Carolina \| United States \| -82.25428 \| 34.73706 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Hixson \| Tennessee \| United States \| -85.23273 \| 35.14063 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 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 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sugarland \| Texas \| United States \| N/A \| N/A Burke \| Virginia \| United States \| -77.27165 \| 38.79345 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Fairfax \| Virginia \| United States \| -77.30637 \| 38.84622 Salem \| Virginia \| United States \| -80.05476 \| 37.29347 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 Glendale \| Wisconsin \| United States \| -87.93564 \| 43.13529 La Crosse \| Wisconsin \| United States \| -91.23958 \| 43.80136 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Boisguillaume \| N/A \| France \| N/A \| N/A Bordeaux \| N/A \| France \| -0.5805 \| 44.84044 Brest \| N/A \| France \| -4.48628 \| 48.39029 Chambray-lès-Tours \| N/A \| France \| 0.70286 \| 47.33537 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Rennes \| N/A \| France \| -1.67429 \| 48.11198 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Tübingen \| N/A \| Germany \| 9.05222 \| 48.52266 Cork \| Cork \| Ireland \| -8.47061 \| 51.89797 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Distrito Federal \| Mexico City \| Mexico \| N/A \| N/A Alicante \| N/A \| Spain \| -0.48149 \| 38.34517 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Guipuzcoa \| N/A \| Spain \| N/A \| N/A Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Santander \| N/A \| Spain \| -3.80444 \| 43.46472 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Cambridge \| Cambridgeshire \| United Kingdom \| 0.11667 \| 52.2 Manchester \| Greater Manchester \| United Kingdom \| -2.23743 \| 53.48095 Maidstone \| Kent \| United Kingdom \| 0.51667 \| 51.26667 Leeds \| North Yorkshire \| United Kingdom \| -1.54785 \| 53.79648	1,576	1	0.000635	1	NCT00124982	1COMPLETED	2009-08-01	2005-04-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000112
[ 4 ]	708	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).	null	Diabetes Diabetes Mellitus, Type 2		null	3	arm 1: Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen. arm 2: Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen. arm 3: Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.	[ 0, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart intervention 2: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart intervention 3: Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir	intervention 1: biphasic insulin aspart intervention 2: insulin detemir intervention 3: insulin aspart	63	Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Dublin \| N/A \| Ireland \| -6.24889 \| 53.33306 Galway \| N/A \| Ireland \| -9.05095 \| 53.27245 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 Addlestone \| N/A \| United Kingdom \| -0.49353 \| 51.37135 Airdrie \| N/A \| United Kingdom \| -3.98025 \| 55.86602 Ashton-under-Lyne \| N/A \| United Kingdom \| -2.0989 \| 53.48876 Ayr \| N/A \| United Kingdom \| -4.63393 \| 55.46273 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Berkshire \| N/A \| United Kingdom \| N/A \| N/A Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Bournemouth \| N/A \| United Kingdom \| -1.8795 \| 50.72048 Bradford \| N/A \| United Kingdom \| -1.75206 \| 53.79391 Bristol \| N/A \| United Kingdom \| -2.59665 \| 51.45523 Bury St Edmunds \| N/A \| United Kingdom \| 0.71111 \| 52.2463 Cambridge \| N/A \| United Kingdom \| 0.11667 \| 52.2 Colchester \| N/A \| United Kingdom \| 0.90421 \| 51.88921 Coventry \| N/A \| United Kingdom \| -1.51217 \| 52.40656 Crawley \| N/A \| United Kingdom \| -0.18312 \| 51.11303 Derby \| N/A \| United Kingdom \| -1.47663 \| 52.92277 Dundee \| N/A \| United Kingdom \| -2.97489 \| 56.46913 Edinburgh \| N/A \| United Kingdom \| -3.19648 \| 55.95206 Exeter \| N/A \| United Kingdom \| -3.52751 \| 50.7236 Gillingham \| N/A \| United Kingdom \| 0.54863 \| 51.38914 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Guildford \| N/A \| United Kingdom \| -0.57427 \| 51.23536 Haywards Heath \| N/A \| United Kingdom \| -0.10313 \| 50.99769 Headington \| N/A \| United Kingdom \| -1.21974 \| 51.75737 High Wycombe \| N/A \| United Kingdom \| -0.74934 \| 51.62907 Hull \| N/A \| United Kingdom \| -0.33525 \| 53.7446 Kettering \| N/A \| United Kingdom \| -0.72571 \| 52.39836 Leeds \| N/A \| United Kingdom \| -1.54785 \| 53.79648 Leicester \| N/A \| United Kingdom \| -1.13169 \| 52.6386 Leicester \| N/A \| United Kingdom \| -1.13169 \| 52.6386 Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058 Liverpool \| N/A \| United Kingdom \| -2.97794 \| 53.41058 Livingstone \| N/A \| United Kingdom \| N/A \| N/A London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Manchester \| N/A \| United Kingdom \| -2.23743 \| 53.48095 Middlesbrough \| N/A \| United Kingdom \| -1.23483 \| 54.57623 Newcastle \| N/A \| United Kingdom \| -5.88979 \| 54.21804 Newcastle \| N/A \| United Kingdom \| -5.88979 \| 54.21804 Norfolk \| N/A \| United Kingdom \| N/A \| N/A Northampton \| N/A \| United Kingdom \| -0.88333 \| 52.25 Nottingham \| N/A \| United Kingdom \| -1.15047 \| 52.9536 Plymouth \| N/A \| United Kingdom \| -4.14305 \| 50.37153 Rugby \| N/A \| United Kingdom \| -1.26417 \| 52.37092 Sheffield \| N/A \| United Kingdom \| -1.4659 \| 53.38297 Skipton \| N/A \| United Kingdom \| -2.01676 \| 53.96144 Stevenage \| N/A \| United Kingdom \| -0.20256 \| 51.90224 Torquay \| N/A \| United Kingdom \| -3.52522 \| 50.46198 Welwyn Garden City \| N/A \| United Kingdom \| -0.20691 \| 51.80174 Whiston \| N/A \| United Kingdom \| -2.78907 \| 53.41997 Wirral, Merseyside \| N/A \| United Kingdom \| -3.10501 \| 53.37616	708	7	0.009887	1	NCT00184600	1COMPLETED	2009-08-01	2004-11-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	3	0	2	2	0	0.004797
[ 4 ]	919	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	1FEMALE	true	This is a phase III randomized study comparing induction treatments of Gemcitabine and Carboplatin versus Paclitaxel and Carboplatin, with or without consolidation therapy for patients that do not have any evidence of disease after completion of six cycles of induction therapy. Patients with disease after induction therapy will crossover to receive single agent therapy.	This study (Study B9E-US-S302) is a multicenter, comparative, open-label randomized, superiority, trial evaluating Gemcitabine and Carboplatin to the standard of care. Both treatment arms will be given the option to receive elective consolidation therapy of Paclitaxel 135 mg/m\^2 given every 28 days for one year. Patients not achieving a complete response will crossover to the opposite single agent.	Genital Neoplasms, Female Fallopian Tube Neoplasms Ovarian Neoplasms Pelvic Neoplasms Peritoneal Neoplasms		null	2	arm 1: Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles arm 2: Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 1000 mg/m\^2, Intravenously (IV), day 1 and day 8 every (q) 21 days x 6 cycles If anything other than complete response in Paclitaxel arm patients, 1000 mg/m\^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity intervention 2: 175 mg/m\^2, IV, Day 1, q 21 days x 6 cycles If complete response both Paclitaxel and Gemcitabine arms may elect to receive consolidation therapy, 135 mg/m\^2, IV, 3 hours q 28 days x 12 cycles (1 year) If no complete response, then Gemcitabine arm patients may receive 175 mg/m\^2, IV, Day 1, q 21 days until complete response, disease progression or unacceptable toxicity intervention 3: Gemcitabine/Carboplatin AUC 5, IV, Day 1, q 21 days x 6 cycles Paclitaxel/Carboplatin AUC 6, IV, Day 1, q 21 days x 6 cycles	intervention 1: Gemcitabine intervention 2: Paclitaxel intervention 3: Carboplatin	55	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Gatos \| California \| United States \| -121.97468 \| 37.22661 Modesto \| California \| United States \| -120.99688 \| 37.6391 San Diego \| California \| United States \| -117.16472 \| 32.71571 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 South Miami \| Florida \| United States \| -80.29338 \| 25.7076 Sunrise \| Florida \| United States \| -80.1131 \| 26.13397 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Palatine \| Illinois \| United States \| -88.03424 \| 42.1103 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Scarborough \| Maine \| United States \| -70.32172 \| 43.57814 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Duluth \| Minnesota \| United States \| -92.10658 \| 46.78327 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 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 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Reno \| Nevada \| United States \| -119.8138 \| 39.52963 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266 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 Dunmore \| Pennsylvania \| United States \| -75.63241 \| 41.4198 Johnstown \| Pennsylvania \| United States \| -78.92197 \| 40.32674 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Sayre \| Pennsylvania \| United States \| -76.5155 \| 41.97896 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Roanoke \| Virginia \| United States \| -79.94143 \| 37.27097 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	1,327	1	0.000754	1	NCT00191646	1COMPLETED	2009-08-01	2002-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	1	0	0	0	0.000133
[ 4 ]	9,016	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	true	The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.	ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events. Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel: * ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone * ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC). Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.	Atrial Fibrillation Cardiovascular Disease	Atrial fibrillation Cardiovascular disease angiotensin II blocker	null	2	arm 1: 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit arm 2: Matching placebo up to final follow-up visit	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: oral administration (tablets) once daily intervention 2: oral administration (tablets) once daily	intervention 1: Irbesartan intervention 2: placebo	30	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Macquarie Park \| N/A \| Australia \| 151.12757 \| -33.78105 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Diegem \| N/A \| Belgium \| 4.43354 \| 50.89727 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Laval \| N/A \| Canada \| -73.692 \| 45.56995 Santiago \| N/A \| Chile \| -70.64827 \| -33.45694 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Hørsholm \| N/A \| Denmark \| 12.50111 \| 55.88098 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Causeway Bay \| N/A \| Hong Kong \| 114.18515 \| 22.28189 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Kuala Lumpur \| N/A \| Malaysia \| 101.68653 \| 3.1412 Mexico \| N/A \| Mexico \| -98.43784 \| 18.88011 Gouda \| N/A \| Netherlands \| 4.70833 \| 52.01667 Lysaker \| N/A \| Norway \| 10.63545 \| 59.90994 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Porto Salvo \| N/A \| Portugal \| -9.30473 \| 38.72293 Singapore \| N/A \| Singapore \| 103.85007 \| 1.28967 Midrand \| N/A \| South Africa \| 28.118 \| -25.976 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Bromma \| N/A \| Sweden \| 17.94 \| 59.34 Geneva \| N/A \| Switzerland \| 6.14569 \| 46.20222 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306 Guildford Surrey \| N/A \| United Kingdom \| N/A \| N/A	9,016	15	0.001664	1	NCT00249795	1COMPLETED	2009-08-01	2003-06-01	Sanofi	4INDUSTRY	false	false	false	null	3	0	0	0	12	0.001009
[ 2 ]	69	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.	null	HIV Infection	HIV-1 infected pregnant women, either treatment naive or on ATV/RTV combined with ZDV/3TC	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks	intervention 1: Atazanavir + Ritonavir + Combivir	6	West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633 Soweto \| Gauteng \| South Africa \| 27.85849 \| -26.26781 Sunnyside \| Gauteng \| South Africa \| 28.21133 \| -25.75746 Westdene \| Gauteng \| South Africa \| 27.98757 \| -26.17533	81	1	0.012346	1	NCT00326716	1COMPLETED	2009-08-01	2006-06-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.002183
[ 3 ]	486	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time. Note: The protocol was amended to remove the option of shorter infusion durations.	null	Severe Sepsis		null	3	arm 1: 24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours arm 2: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol) arm 3: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)	[ 0, 0, 0 ]	1	[ 0 ]	intervention 1: intravenous	intervention 1: Drotrecogin alfa (activated)	47	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Fresno \| California \| United States \| -119.77237 \| 36.74773 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Stanford \| California \| United States \| -122.16608 \| 37.42411 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Portland \| Maine \| United States \| -70.2589 \| 43.65737 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Greensboro \| North Carolina \| United States \| -79.79198 \| 36.07264 Abington \| Pennsylvania \| United States \| -75.11795 \| 40.12067 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Fleurimont \| Quebec \| Canada \| -71.83796 \| 45.40842 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Angoulême \| N/A \| France \| 0.15345 \| 45.64997 La Roche-sur-Yon \| N/A \| France \| -1.42757 \| 46.66974 Limoges \| N/A \| France \| 1.24759 \| 45.83362 Poitiers \| N/A \| France \| 0.34348 \| 46.58261 Tours \| N/A \| France \| 0.70398 \| 47.39484 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633 Sabadell \| N/A \| Spain \| 2.10942 \| 41.54329 Reading \| Berkshire \| United Kingdom \| -0.97113 \| 51.45625 Brighton \| East Sussex \| United Kingdom \| -0.13947 \| 50.82838 Cottingham \| East Yorkshire \| United Kingdom \| -0.7554 \| 52.50243 London \| Greater London \| United Kingdom \| -0.12574 \| 51.50853 Waterloo \| London \| United Kingdom \| -3.03017 \| 53.47454 Kings Lynn \| Norfolk \| United Kingdom \| 0.39516 \| 52.75172 Birmingham \| West Midlands \| United Kingdom \| -1.89983 \| 52.48142	486	1	0.002058	1	NCT00386425	1COMPLETED	2009-08-01	2006-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000363
[ 4 ]	1,200	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to determine if SYMBICORT® delivered via a pressurized metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.	null	Chronic Obstructive Pulmonary Disease	COPD	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Formoterol Turbuhaler	140	Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Fort Smith \| Arkansas \| United States \| -94.39855 \| 35.38592 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Foothill Ranch \| California \| United States \| -117.66088 \| 33.68641 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Banos \| California \| United States \| -120.84992 \| 37.05828 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 Pismo Beach \| California \| United States \| -120.64128 \| 35.14275 Rancho Cordova \| California \| United States \| -121.30273 \| 38.58907 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Riverside \| California \| United States \| -117.39616 \| 33.95335 Rolling Hills Estates \| California \| United States \| -118.35813 \| 33.78779 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 Sepulveda \| California \| United States \| -118.28285 \| 34.16167 Torrance \| California \| United States \| -118.34063 \| 33.83585 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Stanford \| Connecticut \| United States \| N/A \| N/A DeLand \| Florida \| United States \| -81.30312 \| 29.02832 Opa-locka \| Florida \| United States \| -80.25033 \| 25.90232 Orange City \| Florida \| United States \| -81.29867 \| 28.94888 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Panama City \| Florida \| United States \| -85.65983 \| 30.15946 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Saint Cloud \| Florida \| United States \| -81.28118 \| 28.2489 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Blue Ridge \| Georgia \| United States \| -84.32409 \| 34.86397 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Council Bluffs \| Iowa \| United States \| -95.86083 \| 41.26194 Witchita \| Kansas \| United States \| N/A \| N/A Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Metairie \| Louisiana \| United States \| -90.15285 \| 29.98409 Sunset \| Louisiana \| United States \| -92.06845 \| 30.41131 Bangor \| Maine \| United States \| -68.77265 \| 44.79884 Pittsfield \| Massachusetts \| United States \| -73.24538 \| 42.45008 Waltham \| Massachusetts \| United States \| -71.23561 \| 42.37649 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Florissant \| Missouri \| United States \| -90.32261 \| 38.78922 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Papillion \| Nebraska \| United States \| -96.04224 \| 41.15444 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Springfield \| New Jersey \| United States \| -74.31723 \| 40.70491 Bronxville \| New York \| United States \| -73.83208 \| 40.93815 Elmira \| New York \| United States \| -76.80773 \| 42.0898 Larchmont \| New York \| United States \| -73.7518 \| 40.92788 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Elizabeth City \| North Carolina \| United States \| -76.25105 \| 36.2946 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Chardon \| Ohio \| United States \| -81.14899 \| 41.61422 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Sylvania \| Ohio \| United States \| -83.71299 \| 41.71894 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Beaver \| Pennsylvania \| United States \| -80.30478 \| 40.69534 Bensalem \| Pennsylvania \| United States \| -74.95128 \| 40.10455 Downingtown \| Pennsylvania \| United States \| -75.70327 \| 40.0065 Harrisburg \| Pennsylvania \| United States \| -76.88442 \| 40.2737 Landsdale \| Pennsylvania \| United States \| N/A \| N/A Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Warminster \| Pennsylvania \| United States \| -75.09962 \| 40.20678 Yardley \| Pennsylvania \| United States \| -74.846 \| 40.24566 East Providence \| Rhode Island \| United States \| -71.37005 \| 41.81371 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Gaffney \| South Carolina \| United States \| -81.64982 \| 35.07179 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Prosperity \| South Carolina \| United States \| -81.53316 \| 34.20931 Spartanburg \| South Carolina \| United States \| -81.93205 \| 34.94957 Union \| South Carolina \| United States \| -81.62371 \| 34.71541 Fayetteville \| Tennessee \| United States \| -86.57055 \| 35.15203 Boerne \| Texas \| United States \| -98.73197 \| 29.79466 Houston \| Texas \| United States \| -95.36327 \| 29.76328 McKinney \| Texas \| United States \| -96.61527 \| 33.19762 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Abingdon \| Virginia \| United States \| -81.97735 \| 36.70983 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Mar del Plata \| Buenos Aires \| Argentina \| -57.5562 \| -38.00042 Nueve de Julio \| Buenos Aires \| Argentina \| -60.88463 \| -35.44394 Ramos Mejía \| Buenos Aires \| Argentina \| -58.55318 \| -34.6551 Vicente López \| Buenos Aires \| Argentina \| -58.4737 \| -34.52947 Corrientes \| Corrientes Province \| Argentina \| -58.8344 \| -27.46784 Córdoba \| Córdoba Province \| Argentina \| -64.18853 \| -31.40648 Mendoza \| Mendoza Province \| Argentina \| -68.84582 \| -32.88946 San Juan \| San Juan Province \| Argentina \| -68.52568 \| -31.53726 San Miguel de Tucumán \| Tucumán Province \| Argentina \| -65.21051 \| -26.81601 Fortaleza \| Ceará \| Brazil \| -38.54306 \| -3.71722 Goiânia \| Goiás \| Brazil \| -49.25389 \| -16.67861 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Recife \| Pernambuco \| Brazil \| -34.88111 \| -8.05389 Rio de Janeiro \| Rio de Janeiro \| Brazil \| -43.18223 \| -22.90642 Porta Alegre \| Rio Grande do Sul \| Brazil \| N/A \| N/A Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Florian�polis \| Santa Catarina \| Brazil \| N/A \| N/A Santo André \| São Paulo \| Brazil \| -46.53833 \| -23.66389 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Valparaíso \| Región de Valparaíso \| Chile \| -71.62963 \| -33.036 Rancagua \| Región del Libertador General Bernardo O’Higgins \| Chile \| -70.74053 \| -34.1691 Santiago \| RM \| Chile \| -70.64827 \| -33.45694 Medillin \| Antioquia \| Colombia \| N/A \| N/A Barranquilla \| Atl�ntico \| Colombia \| -74.78132 \| 10.96854 Bogota Dc \| Cundianmarca \| Colombia \| N/A \| N/A Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Lima \| Lima Province \| Peru \| -77.02824 \| -12.04318 Jesus Maria \| Lima region \| Peru \| -77.04495 \| -12.06982 San Borja \| Lima region \| Peru \| -77.01107 \| -12.09841 Surco \| Lima region \| Peru \| -76.44002 \| -11.88401 Belvilee \| Cape Town \| South Africa \| N/A \| N/A Tygerberg \| Cape Town \| South Africa \| N/A \| N/A Port Elizabeth \| E Cape \| South Africa \| 25.61494 \| -33.96109 Korsten \| Port Elizabeth \| South Africa \| 25.57755 \| -33.92228 Groenkloof \| Pretoria \| South Africa \| 25.50906 \| -31.78089 Thaba Tswane \| Pretoria \| South Africa \| N/A \| N/A Cape Town \| South Africa \| South Africa \| 18.42322 \| -33.92584 Durban \| South Africa \| South Africa \| 31.0292 \| -29.8579 Bloemfontein \| N/A \| South Africa \| 26.214 \| -29.12107 Boksburg \| N/A \| South Africa \| 28.25958 \| -26.21197 Centurion \| N/A \| South Africa \| 28.18577 \| -25.85891 eManzimtoti \| N/A \| South Africa \| 30.88527 \| -30.05219 Humansdorp \| N/A \| South Africa \| 24.76912 \| -34.02903 Pretoria \| N/A \| South Africa \| 28.18783 \| -25.74486 Pretoria West \| N/A \| South Africa \| 28.15401 \| -25.74841 Roodepoort \| N/A \| South Africa \| 27.8725 \| -26.1625 Distrito Capital \| Miranda \| Venezuela \| N/A \| N/A	1,218	1	0.000821	1	NCT00419744	1COMPLETED	2009-08-01	2007-01-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000145
[ 4 ]	64	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this trial is to evaluate the dose distribution, effectiveness and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. In this study patients and physicians know the name and the dose of the study drug. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The safety assessments to be conducted throughout this study including the regular monitoring and recording of all Adverse Events and Serious Adverse Events.	This trial is a non-randomised (both patient and physician know the study drug), single arm, open label multicentre study which is aimed to evaluate the dose distribution, efficacy and safety in patients with schizophrenia who are switched from an oral atypical antipsychotic to Paliperidone ER. Newly diagnosed patients will also be included in the study. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. Flexible dosing was chosen to best mimic actual clinical practice.The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase will be 40 weeks. Assessment of efficacy and safety will be performed in Phase A at baseline, 2, 4, 6, 9 and 12 weeks and in Phase B at 20, 28, 36, 44 and 52 weeks. At the first visit, a full psychiatric history, demographic data and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will be performed: descriptions of concomitant medications; hospitalisations for psychiatric reasons; clinical deterioration; Clinical Global Impression - Severity (CGI-S) and Global Assessment of Functioning (GAF) assessments; Community Treatment Order (CTO) status; weight; adherence and adverse event reporting. Physical examinations will be performed periodically. Paliperidone ER OROS will be supplied in 3 mg, 6 mg, and 9 mg tablets for oral administration. In general, the recommended Paliperidone ER dose will be 6 mg once daily, however some patients may require a higher or lower initial dose in the recommended range of 3 to 12 mg once daily. The dose can be adjusted any point during the study, to a maximum dose of 12mg/day. The study duration will be split into two phases. Phase A will be 12 weeks and Phase B which will be an optional follow up phase	Schizophrenia	Schizophrenia Drug Therapy Treatment Outcome	null	1	arm 1: Paliperidone3mg or 6mg or 9mg or 12mg once daily for 52 weeks	[ 0 ]	1	[ 0 ]	intervention 1: 3mg or 6mg or 9mg or 12mg once daily for 52 weeks	intervention 1: Paliperidone	0	null	64	2	0.03125	1	NCT00473434	1COMPLETED	2009-08-01	2007-04-01	Janssen-Cilag Pty Ltd	4INDUSTRY	false	false	false	null	0	0	1	0	1	0.008612
[ 5 ]	593	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.	null	Smoking Cessation		null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 1 mg twice a day for 12 weeks, starting with a 1-week titration period. intervention 2: matching placebo 1 tablet twice a day for 12 weeks	intervention 1: varenicline tartrate (CP-526, 555-18) intervention 2: Placebo	42	Fortaleza \| Ceará \| Brazil \| -38.54306 \| -3.71722 Porto Alegre \| Centro \| Brazil \| -51.23019 \| -30.03283 Juiz de Fora \| Minas Gerais \| Brazil \| -43.35028 \| -21.76417 Botucatu \| São Paulo \| Brazil \| -48.445 \| -22.88583 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Medellín \| Antioquia \| Colombia \| -75.57151 \| 6.245 Barranquilla \| Atlántico \| Colombia \| -74.78132 \| 10.96854 San Pedro \| Provincia de San José \| Costa Rica \| -84.05074 \| 9.92829 Cairo \| Egypt \| Egypt \| 31.24967 \| 30.06263 Amman \| Jordan \| Jordan \| 35.94503 \| 31.95522 Beirut \| Lebanon \| Lebanon \| 35.50157 \| 33.89332 Beirut Lebanon \| Lebanon \| Lebanon \| N/A \| N/A Mexico \| D.f. \| Mexico \| -98.43784 \| 18.88011 Morelia \| Michoacán \| Mexico \| -101.18443 \| 19.70078 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Jeddah \| N/A \| Saudi Arabia \| 39.18624 \| 21.49012 Riyadh \| N/A \| Saudi Arabia \| 46.72185 \| 24.68773 Tygerberg \| Cape Town \| South Africa \| N/A \| N/A Bloemfontein \| Free State \| South Africa \| 26.214 \| -29.12107 Benoni \| Gauteng \| South Africa \| 28.32078 \| -26.18848 Midrand \| Gauteng \| South Africa \| 28.118 \| -25.976 Pretoria \| Gauteng \| South Africa \| 28.18783 \| -25.74486 Soweto \| Johannesburg \| South Africa \| 27.85849 \| -26.26781 Durban \| KwaZulu-Natal \| South Africa \| 31.0292 \| -29.8579 Sydenham, Durban \| KwaZulu-Natal \| South Africa \| N/A \| N/A Hillcrest \| Pretoria \| South Africa \| 26.81485 \| -31.89123 Cape Town \| Western Cape \| South Africa \| 18.42322 \| -33.92584 Paarl, Cape Town \| Western Cape \| South Africa \| N/A \| N/A Durban \| N/A \| South Africa \| 31.0292 \| -29.8579 Lyttelton \| N/A \| South Africa \| 28.2012 \| -25.82988 Dubai \| United Arab Emirates \| United Arab Emirates \| 55.30927 \| 25.07725 Abu Dhabi \| N/A \| United Arab Emirates \| 54.39696 \| 24.45118 Al Ain City \| N/A \| United Arab Emirates \| 55.76056 \| 24.19167 Dubai \| N/A \| United Arab Emirates \| 55.30927 \| 25.07725 Jumeirah/Dubai \| N/A \| United Arab Emirates \| N/A \| N/A Ras Al Khaima \| N/A \| United Arab Emirates \| N/A \| N/A Caracas \| Distrito Federal \| Venezuela \| -66.87919 \| 10.48801 Barquisimeto \| Lara \| Venezuela \| -69.35703 \| 10.0647 Gran Caracas \| Miranda \| Venezuela \| N/A \| N/A Caracas \| N/A \| Venezuela \| -66.87919 \| 10.48801	588	1	0.001701	1	NCT00594204	1COMPLETED	2009-08-01	2008-04-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.0003
[ 3 ]	197	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis.	null	Psoriasis	dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: tablets, 2 mg BID for 12 weeks intervention 2: tablets, 5 mg BID for 12 weeks intervention 3: tablets, 15 mg BID for 12 weeks intervention 4: tablets, BID for 12 weeks	intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo	44	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Oceanside \| California \| United States \| -117.37948 \| 33.19587 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Miami \| Florida \| United States \| -80.19366 \| 25.77427 West Dundee \| Illinois \| United States \| -88.28286 \| 42.09808 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 East Windsor \| New Jersey \| United States \| -74.54043 \| 40.268 Paramus \| New Jersey \| United States \| -74.07542 \| 40.94454 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Lake Oswego \| Oregon \| United States \| -122.67065 \| 45.42067 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Moncton \| New Brunswick \| Canada \| -64.7965 \| 46.09454 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 Barrie \| Ontario \| Canada \| -79.66634 \| 44.40011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 North Bay \| Ontario \| Canada \| -79.46633 \| 46.3168 Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Laval \| Quebec \| Canada \| -73.692 \| 45.56995 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228	197	5	0.025381	1	NCT00678210	1COMPLETED	2009-08-01	2008-07-01	Pfizer	4INDUSTRY	false	false	false	null	1	0	1	2	1	0.010889
[ 4 ]	1,291	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to placebo, valsartan and olmesartan in participants with essential hypertension.	Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled: only about one-third of patients successfully maintain control. A major component of blood pressure regulation is the renin-angiotensin-aldosterone system. This is a system of hormone-mediated feedback interactions that result in the relaxation or constriction of blood vessels in response to various stimuli. Angiotensin II, a polypeptide hormone, is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme as part of the renin-angiotensin-aldosterone system. Angiotensin II is the principal pressor agent of the renin-angiotensin-aldosterone system and has multiple effects on the cardiovascular system and on electrolyte homeostasis. TAK-491 (azilsartan medoxomil) is an angiotensin II type 1 receptor antagonist currently being tested as a treatment for essential hypertension. Study participation is anticipated to be about 10 weeks. Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations, electrocardiograms and ambulatory blood pressure monitoring. Outside of the study center, participants will be required wear an ambulatory blood pressure monitoring device at 24 hour intervals.	Hypertension	Essential Hypertension Cardiovascular Disease High Blood Pressure Drug Therapy	null	5	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None	[ 0, 0, 1, 1, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks. Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks. intervention 2: Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks. Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks. intervention 3: Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks. Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks. intervention 4: Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks. Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks. intervention 5: Matching placebo, orally, once daily for up to six weeks.	intervention 1: Azilsartan medoxomil intervention 2: Azilsartan medoxomil intervention 3: Valsartan intervention 4: Olmesartan intervention 5: Placebo	131	Alabaster \| Alabama \| United States \| -86.81638 \| 33.24428 Ozark \| Alabama \| United States \| -85.64049 \| 31.45906 Green Valley \| Arizona \| United States \| -110.9937 \| 31.85425 Litchfield Park \| Arizona \| United States \| -112.35794 \| 33.49337 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Carmichael \| California \| United States \| -121.32828 \| 38.61713 Chula Vista \| California \| United States \| -117.0842 \| 32.64005 Lincoln \| California \| United States \| -121.29301 \| 38.89156 Mission Viejo \| California \| United States \| -117.672 \| 33.60002 National City \| California \| United States \| -117.0992 \| 32.67811 Pasadena \| California \| United States \| -118.14452 \| 34.14778 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 Dimas \| California \| United States \| -117.80673 \| 34.10668 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Ramon \| California \| United States \| -121.97802 \| 37.77993 Santa Ana \| California \| United States \| -117.86783 \| 33.74557 Vista \| California \| United States \| -117.24254 \| 33.20004 Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Longmont \| Colorado \| United States \| -105.10193 \| 40.16721 Cape Coral \| Florida \| United States \| -81.94953 \| 26.56285 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Largo \| Florida \| United States \| -82.78842 \| 27.90979 Miami \| Florida \| United States \| -80.19366 \| 25.77427 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 New Smyrna Beach \| Florida \| United States \| -80.927 \| 29.02582 Palm Harbor \| Florida \| United States \| -82.76371 \| 28.07807 Tallahassee \| Florida \| United States \| -84.28073 \| 30.43826 Dunwoody \| Georgia \| United States \| -84.33465 \| 33.94621 Roswell \| Georgia \| United States \| -84.36159 \| 34.02316 Arlington Heights \| Illinois \| United States \| -87.98063 \| 42.08836 Belleville \| Illinois \| United States \| -89.98399 \| 38.52005 Champaign \| Illinois \| United States \| -88.24338 \| 40.11642 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Vernon Hills \| Illinois \| United States \| -87.97952 \| 42.21947 Evansville \| Indiana \| United States \| -87.55585 \| 37.97476 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Shawnee \| Kansas \| United States \| -94.72024 \| 39.04167 Biddeford \| Maine \| United States \| -70.45338 \| 43.49258 Norwood \| Maine \| United States \| N/A \| N/A Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Towson \| Maryland \| United States \| -76.60191 \| 39.4015 Brooklyn Center \| Minnesota \| United States \| -93.33273 \| 45.07608 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Jefferson City \| Missouri \| United States \| -92.17352 \| 38.5767 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 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Margate City \| New Jersey \| United States \| -74.50349 \| 39.32789 Glens Falls \| New York \| United States \| -73.64401 \| 43.30952 Great Neck \| New York \| United States \| -73.72846 \| 40.80066 New Hyde Park \| New York \| United States \| -73.68791 \| 40.7351 New Windsor \| New York \| United States \| -74.02375 \| 41.47676 New York \| New York \| United States \| -74.00597 \| 40.71427 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Tulsa \| Oklahoma \| United States \| -95.99277 \| 36.15398 Yukon \| Oklahoma \| United States \| -97.76254 \| 35.50672 Ashland \| Oregon \| United States \| -122.70948 \| 42.19458 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Tipton \| Pennsylvania \| United States \| -78.29585 \| 40.6359 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Murrells Inlet \| South Carolina \| United States \| -79.04143 \| 33.551 North Charleston \| South Carolina \| United States \| -79.97481 \| 32.85462 Cleveland \| Tennessee \| United States \| -84.87661 \| 35.15952 Bedford \| Texas \| United States \| -97.14307 \| 32.84402 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Missouri City \| Texas \| United States \| -95.53772 \| 29.61857 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Sugarland \| Texas \| United States \| N/A \| N/A Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Carlos Paz \| Córdoba Province \| Argentina \| N/A \| N/A Córdoba \| Córdoba Province \| Argentina \| -64.18853 \| -31.40648 Guaymayen \| Mendoza Province \| Argentina \| N/A \| N/A Bahía Blanca \| N/A \| Argentina \| -62.26545 \| -38.7176 Berazategui \| N/A \| Argentina \| -58.21278 \| -34.76531 Buenos Aires \| N/A \| Argentina \| -58.37723 \| -34.61315 Corrientes \| N/A \| Argentina \| -58.8344 \| -27.46784 Haedo Pcia. de Buenos Aires \| N/A \| Argentina \| N/A \| N/A La Plata \| N/A \| Argentina \| -57.95442 \| -34.92126 Ramos Mejía Pcia. de Buenos Aires \| N/A \| Argentina \| N/A \| N/A Rosario \| N/A \| Argentina \| -60.63932 \| -32.94682 Salta \| N/A \| Argentina \| -65.41999 \| -24.80645 San Miguel de Tucumán \| N/A \| Argentina \| -65.21051 \| -26.81601 San Salvador de Jujuy \| N/A \| Argentina \| -65.29342 \| -24.1928 Belo Horizonte \| N/A \| Brazil \| -43.93778 \| -19.92083 Campinas \| N/A \| Brazil \| -47.06083 \| -22.90556 Fortaleza \| N/A \| Brazil \| -38.54306 \| -3.71722 Goiaenia \| N/A \| Brazil \| N/A \| N/A Joildille \| N/A \| Brazil \| N/A \| N/A Porto Alegre \| N/A \| Brazil \| -51.23019 \| -30.03283 Rio Janeiro \| N/A \| Brazil \| N/A \| N/A São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Sorocava \| N/A \| Brazil \| N/A \| N/A Aguascalientes \| Aguascalientes \| Mexico \| -102.2843 \| 21.88262 Chihuahua City \| Chihuahua \| Mexico \| -106.08889 \| 28.63528 Tijuana \| Estado de Baja California \| Mexico \| -117.00371 \| 32.5027 León \| Guanajuato \| Mexico \| -101.67374 \| 21.12908 Guadalajara \| Jalapa \| Mexico \| -103.34749 \| 20.67738 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 San Luis Potosí City \| San Luis Potosí \| Mexico \| -100.97135 \| 22.15234 Xalapa \| Veracruz \| Mexico \| -96.91589 \| 19.53124 Mexico City \| N/A \| Mexico \| -99.12766 \| 19.42847 Querètaro \| N/A \| Mexico \| N/A \| N/A Arequipa \| N/A \| Peru \| -71.53747 \| -16.39899 Cusco \| N/A \| Peru \| -71.96701 \| -13.53188 Huaura \| N/A \| Peru \| -77.59944 \| -11.07 Ica \| N/A \| Peru \| -75.73422 \| -14.07538 Lima \| N/A \| Peru \| -77.02824 \| -12.04318 Trujillo \| N/A \| Peru \| -79.02998 \| -8.11599 Aguas Buenas \| N/A \| Puerto Rico \| -66.10294 \| 18.2569 Carolina \| N/A \| Puerto Rico \| -65.95739 \| 18.38078 Jardines de Loiza \| N/A \| Puerto Rico \| -65.87711 \| 18.428 Orocovis \| N/A \| Puerto Rico \| -66.391 \| 18.2269 Ponce \| N/A \| Puerto Rico \| -66.62398 \| 18.01031 San Juan \| N/A \| Puerto Rico \| -66.10572 \| 18.46633	1,286	1	0.000778	1	NCT00696436	1COMPLETED	2009-08-01	2008-04-01	Takeda	4INDUSTRY	false	false	false	null	0	0	1	0	0	0.000137
[ 4 ]	688	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.	The secondary objectives of the study are to compare the effects of the three different treatment regimen as assessed by the following variables and, if applicable, by their changes from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic effect will be assessed by evaluating efficacy data after the first four days (Day 4) of treatment as well as after the first week of treatment (Day 8). These analyses will also be performed in the subgroups of patients with 2 failed previous antidepressants and patients with 1 failure.	Major Depressive Disorder Treatment Resistant Depression	Depression MDD TRD	null	3	arm 1: Selective serotonin reuptake inhibitors (SSRI) or Venlafaxine from previous therapy + add-on treatment with quetiapine XR, 300mg tablet once daily (od). From previous anti-depressant treatment 64% of the patients had SSRI and 35% had Venlafaxine at baseline. arm 2: Selective serotonin reuptake inhibitors (SSRI) or venlafaxine from previous therapy + add-on treatment with lithium, approximately 900mg tablet once daily (od). From previous anti-depressant treatment 67% of the patients had SSRI and 33% had Venlafaxine at baseline. arm 3: Switch from previous treatment with SSRI or venlafaxine to quetiapine XR monotherapy, 300mg tablet once daily (od)	[ 1, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 300 mg once daily (od) intervention 2: 900 mg once daily (od) intervention 3: SSRI - doses within label, Venlafaxine dose up to 225 mg/day	intervention 1: Quetiapine XR intervention 2: Lithium carbonate intervention 3: SSRI/Venlafaxine	106	Garran \| Australian Capital Territory \| Australia \| 149.10846 \| -35.34206 Brisbane \| Queensland \| Australia \| 153.02809 \| -27.46794 Everton Park \| Queensland \| Australia \| 152.9884 \| -27.40732 Townsville \| Queensland \| Australia \| 146.80569 \| -19.26639 Gilberton \| South Australia \| Australia \| 138.6126 \| -34.90051 Clayton \| Victoria \| Australia \| 145.11667 \| -37.91667 Frankston \| Victoria \| Australia \| 145.12291 \| -38.14458 Heidelberg \| Victoria \| Australia \| 145.06667 \| -37.75 Malvern \| Victoria \| Australia \| 145.02811 \| -37.86259 Prahran \| Victoria \| Australia \| 144.99318 \| -37.85114 Richmond \| Victoria \| Australia \| 145.00176 \| -37.81819 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Klagenfurt \| N/A \| Austria \| 14.30528 \| 46.62472 Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Wels \| N/A \| Austria \| 14.03333 \| 48.16667 Wiener Neustadt \| N/A \| Austria \| 16.23196 \| 47.80485 Assebroek \| Belgium \| Belgium \| 3.2623 \| 51.19367 Diest \| Belgium \| Belgium \| 5.05062 \| 50.98923 Liège \| Belgium \| Belgium \| 5.56749 \| 50.63373 Tielt \| N/A \| Belgium \| 3.32707 \| 50.99931 Cerova Koria Village \| Veliko Tarnovo \| Bulgaria \| N/A \| N/A Kardzhali \| N/A \| Bulgaria \| 25.36667 \| 41.65 Pazardzhik \| N/A \| Bulgaria \| 24.33333 \| 42.2 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Esbjerg N \| N/A \| Denmark \| 8.50471 \| 55.53985 Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Odense \| N/A \| Denmark \| 10.38831 \| 55.39594 Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Achim \| N/A \| Germany \| 9.0263 \| 53.01416 Augsburg \| N/A \| Germany \| 10.89851 \| 48.37154 Bad Homburg \| N/A \| Germany \| 8.61816 \| 50.22683 Bad Honnef \| N/A \| Germany \| 7.2278 \| 50.64336 Bad Saarow \| N/A \| Germany \| 14.06667 \| 52.28333 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bielefeld \| N/A \| Germany \| 8.53333 \| 52.03333 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Butzbach \| N/A \| Germany \| 8.67122 \| 50.43395 Chemnitz \| N/A \| Germany \| 12.92922 \| 50.8357 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Düren \| N/A \| Germany \| 6.49299 \| 50.80434 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Ellwangen \| N/A \| Germany \| 10.13173 \| 48.96164 Erbach im Odenwald \| N/A \| Germany \| 8.99402 \| 49.66148 Gelsenkirchen \| N/A \| Germany \| 7.09654 \| 51.50508 Gütersloh \| N/A \| Germany \| 8.37853 \| 51.90693 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Hattingen \| N/A \| Germany \| 7.18557 \| 51.39894 Herborn \| N/A \| Germany \| 8.30369 \| 50.68135 Kassel \| N/A \| Germany \| 9.5 \| 51.31667 Köthen \| N/A \| Germany \| 11.97093 \| 51.75185 Neu-Isenburg \| N/A \| Germany \| 8.69406 \| 50.04832 Neubrandenburg \| N/A \| Germany \| 13.27532 \| 53.56414 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Oldenburg \| N/A \| Germany \| 8.21467 \| 53.14118 Ostfildern \| N/A \| Germany \| 9.24954 \| 48.72704 Schwerin \| N/A \| Germany \| 11.41316 \| 53.62937 Stuttgart \| N/A \| Germany \| 9.17702 \| 48.78232 Westerstede \| N/A \| Germany \| 7.92737 \| 53.25682 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Győr \| N/A \| Hungary \| 17.63512 \| 47.68333 Gyula \| N/A \| Hungary \| 21.28333 \| 46.65 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Brixen \| BZ \| Italy \| 11.65598 \| 46.71503 Bruneck \| BZ \| Italy \| 11.93429 \| 46.79942 Cagliari \| CA \| Italy \| 9.11917 \| 39.23054 Pisa \| PI \| Italy \| 10.4036 \| 43.70853 Roma \| RM \| Italy \| 11.10642 \| 44.99364 Bolzano \| N/A \| Italy \| 11.33982 \| 46.49067 Catania \| N/A \| Italy \| 15.07041 \| 37.49223 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Braga \| N/A \| Portugal \| -8.42005 \| 41.55032 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Santarém \| N/A \| Portugal \| -8.68333 \| 39.23333 Galati \| Galați County \| Romania \| 28.05028 \| 45.43687 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Craiova \| N/A \| Romania \| 23.8 \| 44.31667 Sibiu \| N/A \| Romania \| 24.15 \| 45.8 Bratislava \| N/A \| Slovakia \| 17.10674 \| 48.14816 Krupina \| N/A \| Slovakia \| 19.06474 \| 48.3554 Levice \| N/A \| Slovakia \| 18.60705 \| 48.21563 Liptovský Mikuláš \| N/A \| Slovakia \| 19.62218 \| 49.08061 Michalovce Stranany \| N/A \| Slovakia \| N/A \| N/A Prešov \| N/A \| Slovakia \| 21.23393 \| 48.99839 Rožňava \| N/A \| Slovakia \| 20.53758 \| 48.66009 Zilina-bytcica \| N/A \| Slovakia \| N/A \| N/A Zlaté Moravce \| N/A \| Slovakia \| 18.40063 \| 48.38553 Salamanca \| Castille and León \| Spain \| -5.66388 \| 40.96882 Zamora \| Castille and León \| Spain \| -5.74456 \| 41.50633 Barcelona \| Catalonia \| Spain \| 2.15899 \| 41.38879 Vigo \| Galicia \| Spain \| -8.72264 \| 42.23282 Langreo \| Principality of Asturias \| Spain \| -5.68416 \| 43.29568 Addlestone \| Surrey \| United Kingdom \| -0.49353 \| 51.37135 Winnick \| Warrington \| United Kingdom \| N/A \| N/A Horsham \| West Sussex \| United Kingdom \| -0.32757 \| 51.06314 Coventry \| N/A \| United Kingdom \| -1.51217 \| 52.40656 Glasgow \| N/A \| United Kingdom \| -4.25763 \| 55.86515 Harrow \| N/A \| United Kingdom \| -0.33208 \| 51.57835 Hull \| N/A \| United Kingdom \| -0.33525 \| 53.7446 Winsford \| N/A \| United Kingdom \| -2.52398 \| 53.19146	688	1	0.001453	1	NCT00789854	1COMPLETED	2009-08-01	2008-11-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0	1	0.000257
[ 3 ]	188	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study will test the effectiveness of an experimental treatment for peritoneal cancer involving surgical removal of the tumor, perfusion of the abdomen during surgery with a heated solution of the drug cisplatin, and post-surgery combination chemotherapy in the abdomen with fluorouracil (5-FU) and paclitaxel. Patients with certain peritoneal cancer whose tumors are confined to the abdomen may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, electrocardiogram and possibly bone scan, brain magnetic resonance imaging (MRI), and chest, abdomen and pelvic CT scans. Participants undergo surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. During surgery, after the tumor has been removed, two catheters (thin plastic tubes) are placed in the abdomen. A chemotherapy solution containing the anti-cancer drug cisplatin heated to a temperature of about 108.6 degrees (10 degrees above normal body temperature) is then delivered into the abdomen through one catheter and drained through another. During treatment, a drug called sodium thiosulfate is given through a vein to reduce the risk of side effects of cisplatin, particularly kidney damage. After 90 minutes of bathing the abdomen with this solution, the drug is rinsed from the abdomen and the catheters removed. Another small catheter is then placed and left inside the abdomen with one end coming out through the skin. Seven to 12 days after the operation, the anti-cancer drugs 5-FU and paclitaxel are given through this catheter. After complete recovery from the surgery, the catheter is removed and the patient is discharged from the hospital. Clinic visits are scheduled for periodic follow-up examination, imaging, and tests 3 and 6 months after surgery and every 6 months for up to 5 years as long as the disease does not worsen. Patients whose disease progresses are taken off the study and referred back to their local physician or referred for alternative care or other research studies. Patients are also asked to assess how this therapy affects their general health and well being. This will require filling out two quality-of-life (QOL) questionnaires before surgery and again at each follow-up visit after surgery. Each questionnaire takes about 15 minutes to complete.	Background: Cytoreductive surgery plus aggressive combination intraperitoneal chemotherapy may significantly alter the natural history of peritoneal carcinomatosis. The purpose of this study is to examine the treatment results of continuous hyperthermic peritoneal perfusion (CHPP) with cisplatin plus early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel after cytoreductive surgery for peritoneal carcinomatosis. Objectives: The primary objective of this study is to determine response and survival after continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel. Response can only be assessed by measuring the time to clinical or radiographic recurrence of disease. The secondary objectives include the determination of pharmacokinetics of paclitaxel and 5-FU delivered into the peritoneal cavity and the impact that continuous hyperthermic peritoneal perfusion with cisplatin and early postoperative intraperitoneal dwell therapy with 5-FU and paclitaxel has on patients' health related quality of life. The evaluation of pure populations of tumor and normal mesothelial cells to * determine if signal transduction pathways are distinct in tumor versus normal tissue * to see if specific cell pathways are activated or inhibited as a consequence of therapy. * to validate that this technology can provide informative data about these events as a potential surrogate for clinical benefit from therapy or biological behavior of the tumor. Eligibility: The patient greater than or equal to 30 kg must have histologically proven peritoneal carcinomatosis from one of the following histologies: 1) primary peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); 3) adenocarcinoma of gastrointestinal tract origin (other than low grade mucinous, excluding pancreatic cancer), with disease confined to the peritoneal cavity. Patients may not have had treatment for their disease within the previous 30 days and have recovered from all toxicity. Patients must meet certain safety laboratory criteria and may not have major medical disorders that would place them at unacceptable risk for a major surgical procedure. Patients may not have received prior intraperitoneal platinum therapy. Design: Patients will undergo cytoreductive surgery followed by CHPP with cisplatin. A peritoneal dialysis catheter will be inserted into the peritoneal cavity at the time of laparotomy. In the early postoperative period (day 2 - 10) intraperitoneal dwell chemotherapy with paclitaxel (125 mg/M\^2) and 5-FU (800 mg/M\^2) will be administered. Patients will be seen 4 - 6 weeks after discharge for a physical examination and laboratory screen and QOL evaluation. Tumor marker will be included at this stage. Patients will then be seen every 3 months for the first year after surgery and every 6 months thereafter. At each visit they will undergo physical examination, laboratory screening (including tumor marker) and a CT scan of the chest, abdomen and pelvis and QOL evaluation. The objective of this pilot study is to estimate the ability of peritoneal perfusion to achieve potentially tolerable disease free survival in patients with a variety of tumors. For each class of tumors, an appropriate, distinct median disease free survival will be targeted as the principal endpoint. The trial will be conducted as a set of three single-stage phase II studies, with an early stopping rule for clearly unacceptable outcomes. It is expected that accrual for 59 patients with adenocarcinoma of gastrointestinal origin (other than low grade mucinous), 48 patients with low grade mucinous adenocarcinoma, and 96 patients with primary peritoneal mesothelioma (total accrual of 203) will require approximately 5 -6 years. Results will be assessed by following the time to radiographic or clinical recurrence of disease and survival. Patients will be stratified for entry based on histology. This will include 3 cohorts: 1) peritoneal mesothelioma; 2) low grade mucinous adenocarcinoma (including low grade mucinous neoplasms of borderline malignant potential); and 3) adenocarcinoma of gastrointestinal origin (other than low grade mucinous).	Abdominal Neoplasm Colonic Neoplasm Mesothelioma Peritoneal Neoplasm	Surgery Mesothelioma Pseudomyxoma Colon Cancer Chemotherapy	null	3	arm 1: Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites. arm 2: Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary. arm 3: Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.	[ 0, 0, 0 ]	3	[ 3, 3, 0 ]	intervention 1: Patients will undergo cytoreductive surgery to remove as much tumor as possible. Part of the intestines, pancreas, stomach or the entire spleen may also be removed if they are affected. intervention 2: None intervention 3: Intraperitoneal dwell chemotherapy with a combination of 5-FU and Paclitaxel will be delivered in the early postoperative period (day 7 today 12 after surgery). Patients will be premedicated with hydrocortisone (100 mg/intravenous push (i.v.p.)), diphenhydramine (50 mg i.v.p.) and ranitidine (50 mg i.v.p.) 30 minutes prior to delivering intraperitoneal chemotherapy. One liter of normal saline will be infused containing 5-FU (800 mg/M\^2) and 1 L of normal saline containing paclitaxel (125 mg/M\^2) will be infused over 60 minutes. The chemotherapy solution will be left in the abdominal cavity permanently for slow absorption.	intervention 1: Surgery intervention 2: Continuous hyperthermic peritoneal perfusion (CHPP) with Cisplatin intervention 3: Postoperative dwell with paclitaxel and 5-FU	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	188	0	0	0	NCT00004547	1COMPLETED	2009-08-01	2000-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 3 ]	94	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer .	OBJECTIVES: * Determine the efficacy of irinotecan and docetaxel with or without cetuximab, in terms of objective response rate, in patients with metastatic adenocarcinoma of the pancreas. * Determine the time to progression and overall survival of patients treated with these regimens. * Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm A: Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1, 8, 15, and 22. * Arm B: Patients receive docetaxel and irinotecan as in arm A. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm)	Pancreatic Cancer	pancreatic cancer metastatic pancreatic cancer EGF-r irinotecan docetaxel cetuximab	null	2	arm 1: Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles. arm 2: Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute. On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m². Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks.	[ 1, 0 ]	3	[ 2, 0, 0 ]	intervention 1: Patients received cetuximab intravenous infusions, via infusion pump or syringe pump, once a week for 6 weeks. intervention 2: Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Docetaxel was diluted in 100-150 ml of infusion solution. intervention 3: After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m² once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest.	intervention 1: cetuximab intervention 2: docetaxel intervention 3: irinotecan hydrochloride	0	null	91	0	0	0	NCT00042939	1COMPLETED	2009-08-01	2003-12-09	Eastern Cooperative Oncology Group	5NETWORK	false	false	false	null	0	0	0	0	0	0
[ 3 ]	72	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This phase II trial is studying how well giving tirapazamine together with cisplatin, etoposide, and radiation therapy works in treating patients with limited-stage small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more sensitive to chemotherapy and radiation therapy. Combining chemotherapy and radiation therapy with tirapazamine may kill more tumor cells.	PRIMARY OBJECTIVES: I. To assess overall survival in patients with limited stage small cell lung cancer (SCLC) treated with induction tirapazamine combined with cisplatin, etoposide and high dose thoracic radiotherapy followed by consolidative cisplatin and etoposide. II. To assess time to treatment failure calculated from initiation of step 1, response (confirmed plus unconfirmed, complete plus partial during induction in the subset of patients with measurable disease) and toxicity in this patient population treated with this regimen. III. To investigate in an exploratory manner the association of baseline PAI-1, VEGF, OPN and NDRG1 plasma markers with patient response and survival. OUTLINE: This is a multicenter study. CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks. CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-3 months for 2 years and then every 6 months for 1 year. PROJECTED ACCRUAL: A total of 30-85 patients will be accrued for this study within 17 months.	Limited Stage Small Cell Lung Cancer		null	1	arm 1: CHEMORADIOTHERAPY: Patients receive tirapazamine IV over 1 hour on days 1, 8, 10, 12, 29, 36, 38, and 40; cisplatin IV over 1 hour on days 1, 8, 29, and 36; and etoposide IV over 1 hour on days 1-5 and 29-33. Beginning on day 1 of chemotherapy, patients undergo thoracic radiotherapy once daily 5 days a week for 7 weeks. CONSOLIDATION CHEMOTHERAPY: Within 28 days after completion of radiotherapy, patients with stable or responding disease receive cisplatin IV over 1 hour on days 1 and 22 and etoposide IV over 1 hour on days 1-3 and 22-24. Treatment continues in the absence of disease progression or unacceptable toxicity.	[ 0 ]	5	[ 0, 0, 0, 4, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo radiation therapy intervention 5: Correlative studies	intervention 1: tirapazamine intervention 2: cisplatin intervention 3: etoposide intervention 4: radiation therapy intervention 5: laboratory biomarker analysis	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	107	0	0	0	NCT00066742	1COMPLETED	2009-08-01	2003-09-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 3 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with unresectable or metastatic malignant peripheral nerve sheath tumor.	OBJECTIVES: * Determine response (confirmed, complete, and partial) in patients with unresectable or metastatic malignant peripheral nerve sheath tumor when treated with erlotinib. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Correlate, preliminarily, indicators of epidermal growth factor receptor (EGFR) function (e.g., expression, phosphorylation, or markers of signal transduction downstream of EGFR) with response and progression-free and overall survival in patients treated with this drug. * Determine the feasibility of accruing these patients in the cooperative group setting. OUTLINE: This is a multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a confirmed partial response and become resectable undergo surgical resection (with or without radiotherapy) and then receive 2 additional courses of erlotinib. Patients with responding disease who do not become resectable continue erlotinib as above. Patients achieving a complete response (CR) receive 2 additional courses of erlotinib beyond the CR. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.	Sarcoma	adult neurofibrosarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage II adult soft tissue sarcoma stage IV adult soft tissue sarcoma	null	1	arm 1: Drug: erlotinib hydrochloride Other Names: OSI-774 150 mg per day, daily until disease progression	[ 0 ]	1	[ 0 ]	intervention 1: 150 mg per day, daily until disease progression	intervention 1: erlotinib hydrochloride	101	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Davis \| California \| United States \| -121.74052 \| 38.54491 Martinez \| California \| United States \| -122.13413 \| 38.01937 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Montrose \| Colorado \| United States \| -107.87617 \| 38.47832 Westminster \| Colorado \| United States \| -105.0372 \| 39.83665 Wheat Ridge \| Colorado \| United States \| -105.07721 \| 39.7661 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Austell \| Georgia \| United States \| -84.63438 \| 33.81261 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Lawrenceville \| Georgia \| United States \| -83.98796 \| 33.95621 Marietta \| Georgia \| United States \| -84.54993 \| 33.9526 Riverdale \| Georgia \| United States \| -84.41326 \| 33.57261 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Beech Grove \| Indiana \| United States \| -86.08998 \| 39.72199 Ames \| Iowa \| United States \| -93.61994 \| 42.03471 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Battle Creek \| Michigan \| United States \| -85.17816 \| 42.3173 Big Rapids \| Michigan \| United States \| -85.48366 \| 43.69808 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Holland \| Michigan \| United States \| -86.10893 \| 42.78752 Muskegon \| Michigan \| United States \| -86.24839 \| 43.23418 Petoskey \| Michigan \| United States \| -84.95533 \| 45.37334 Traverse City \| Michigan \| United States \| -85.62063 \| 44.76306 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Helena \| Montana \| United States \| -112.03611 \| 46.59271 Kalispell \| Montana \| United States \| -114.31291 \| 48.19579 Miles City \| Montana \| United States \| -105.84056 \| 46.40834 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Goldsboro \| North Carolina \| United States \| -77.99277 \| 35.38488 Wilson \| North Carolina \| United States \| -77.91554 \| 35.72127 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Independence \| Ohio \| United States \| -81.6379 \| 41.36866 Kettering \| Ohio \| United States \| -84.16883 \| 39.6895 Middletown \| Ohio \| United States \| -84.39828 \| 39.51506 Troy \| Ohio \| United States \| -84.20328 \| 40.0395 Wooster \| Ohio \| United States \| -81.93646 \| 40.80517 Xenia \| Ohio \| United States \| -83.92965 \| 39.68478 Gresham \| Oregon \| United States \| -122.43148 \| 45.49818 Milwaukie \| Oregon \| United States \| -122.63926 \| 45.44623 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Tualatin \| Oregon \| United States \| -122.76399 \| 45.38401 Danville \| Virginia \| United States \| -79.39502 \| 36.58597 Auburn \| Washington \| United States \| -122.22845 \| 47.30732 Bellingham \| Washington \| United States \| -122.48822 \| 48.75955 Bremerton \| Washington \| United States \| -122.63264 \| 47.56732 Centralia \| Washington \| United States \| -122.9543 \| 46.71621 Federal Way \| Washington \| United States \| -122.31262 \| 47.32232 Mount Vernon \| Washington \| United States \| -122.33405 \| 48.42122 Olympia \| Washington \| United States \| -122.90169 \| 47.04491 Olympia \| Washington \| United States \| -122.90169 \| 47.04491 Puyallup \| Washington \| United States \| -122.2929 \| 47.18538 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Sedro-Woolley \| Washington \| United States \| -122.23611 \| 48.50389 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 Wenatchee \| Washington \| United States \| -120.31035 \| 47.42346 Wenatchee \| Washington \| United States \| -120.31035 \| 47.42346 Parkersburg \| West Virginia \| United States \| -81.56151 \| 39.26674 Sheridan \| Wyoming \| United States \| -106.95618 \| 44.79719	20	0	0	0	NCT00068367	1COMPLETED	2009-08-01	2003-12-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null	0	0	0	0	0	0
[ 3 ]	62	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.	PRIMARY OBJECTIVES: I. To assess the efficacy (response rate \& duration of stable disease) of CCI-779 (temsirolimus) given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. II. To assess the adverse events, time to progression and response duration of CCI-779 given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the endometrium. III. To correlate objective tumor response with phosphatase and tensin homolog gene (PTEN) expression in the tumor tissue obtained at diagnosis (primary tumor). IV. To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue. OUTLINE: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.	Endometrial Adenocarcinoma Endometrial Adenosquamous Cell Carcinoma Endometrial Clear Cell Carcinoma Endometrial Papillary Serous Carcinoma Recurrent Endometrial Carcinoma Stage IIIA Endometrial Carcinoma Stage IIIB Endometrial Carcinoma Stage IIIC Endometrial Carcinoma Stage IVA Endometrial Carcinoma Stage IVB Endometrial Carcinoma		null	1	arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given IV intervention 2: Correlative studies	intervention 1: temsirolimus intervention 2: laboratory biomarker analysis	1	Kingston \| Ontario \| Canada \| -76.48098 \| 44.22976	60	0	0	0	NCT00072176	1COMPLETED	2009-08-01	2004-05-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 3 ]	155	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity	null	Stroke Muscle Spasticity Motor Neuron Disease		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 2, 2, 0 ]	intervention 1: botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18 intervention 2: botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18 intervention 3: Saline injection at Day 1, Week 12, Week 18	intervention 1: botulinum toxin Type A intervention 2: botulinum toxin Type A intervention 3: saline	4	Miami \| Florida \| United States \| -80.19366 \| 25.77427 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977	155	0	0	0	NCT00076687	1COMPLETED	2009-08-01	2003-10-01	Allergan	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	11	RANDOMIZED	CROSSOVER	9OTHER	4QUADRUPLE	false	0ALL	true	This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of depression within a matter of hours. Purpose: This study will examine whether the drug yohimbine, given at a specific time during the sleep cycle, produces chemical changes in the brain similar to those that occur with sleep deprivation. It will also see if yohimbine can induce rapid (next day) antidepressant effects in patients with major depression. Total sleep deprivation for 36 hours improves mood in most patients with major depression in a matter of hours, but the response is usually short-lived. Understanding the chemical changes that occur in the body during sleep deprivation may help in the development of a rapidly acting antidepressant.Patients with major depressive disorder between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, electrocardiogram, and blood and urine tests. Participants are hospitalized at the NIH Clinical Center for the study, as follows: Drug-free period: Patients are tapered off their anti-depression medications and remain drug-free for 1 week before beginning study phase 1. Study phase 1: Patients undergo sleep deprivation for 36 hours. Those whose depression improves with sleep deprivation initially and then worsens continue to phase 2. The day after sleep deprivation, patients undergo a lumbar puncture (spinal tap). For this test, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Study phase 2: Patients spend 1 night in the sleep lab. A catheter (plastic tube) is placed in a vein in each arm-one to give yohimbine and the other to draw blood samples. A small monitor cuff is placed on a finger to measure the patient's blood pressure and blood oxygen levels during the night. While asleep, the patient receives a dose of yohimbine or placebo, given over 3 minutes. A lumbar puncture is done the following morning. Patients receive no medications for 6 days, and then the sleep lab procedure is repeated. Patients who received yohimbine in the previous experiment are switched to placebo, and those who were given placebo are switched to yohimbine.	Sleep deprivation is one of the only interventions that have consistently been demonstrated to produce rapid antidepressant effects. The mechanisms by which sleep deprivation brings about rapid antidepressant effects remain to be elucidated. It is noteworthy, however, that recent genomic and proteomic studies have shown that acute sleep deprivation rapidly brings about an upregulation of several mediators of neuronal plasticity, most notably CREB and BDNF. Intriguingly, these are the very same molecules that are upregulated by chronic antidepressants, and are believed to underlie the delayed therapeutic effects of most antidepressants. Additional investigation of the regulation of CREB and BDNF by sleep deprivation has revealed that these changes are critically dependent upon the activation of the noradrenergic system. This is particularly noteworthy, since the locus coeruleus (LC) noradrenergic projection is quiescent only during rapid eye movement sleep (REM), when the target tissues display their greatest sensitivity; indeed, the temporal dissociation between the firing of the LC noradrenergic neurons, and the sensitivity of its postsynaptic targets in the cortex may have considerable relevance for the antidepressant effects of sleep deprivation. In this context, biological rhythms have the capacity to temporally dissociate biochemical processes, and imposing a temporal coincidence on normally dissociated events can have striking and unexpected effects. Thus, it is our hypothesis that activating the normally quiescent noradrenergic system during REM sleep (i.e. when its postsynaptic target system displays its greatest sensitivity) will robustly upregulate CREB and BDNF, thereby bringing about a rapid antidepressant effect. We propose to activate the noradrenergic system during REM sleep by infusing an alpha(2) antagonist, yohimbine. Since it is our hypothesis that activating the noradrenergic system during REM sleep will bring about an antidepressant effect by a similar mechanism as sleep deprivation, we will "enrich" our sample with sleep deprivation responders in this pilot study. Patients, ages 18 to 65 with a diagnosis of major depressive disorder, currently depressed without psychotic features will be recruited into this study. This experimental proof-of-concept study has two Study Phases. Study Phase I consists of total sleep deprivation. Responders to total sleep deprivation who subsequently relapse will enter Study Phase II. Study Phase II is a double-blind crossover administration of either intravenous yohimbine or saline solution during REM sleep. The specific aim of this study is to assess the efficacy of a single dose of intravenous yohimbine hydrochloride (0.125 mg/kg given over 3 minutes) compared with placebo in improving overall depressive symptomatology when administered during REM sleep. Our primary hypothesis is that the intravenous use of an alpha(2) antagonist in patients with major depression during REM sleep will activate the LC and thus increase noradrenergic activity during a time when the LC is normally quiescent- namely REM sleep. If the hypothesis that it is the timing of the activation of the noradrenergic system that is crucial in the antidepressant effect of sleep deprivation is correct then an acute antidepressant effect should be observed in patients despite minimal to no disruption of sleep. Assuming that 10% will drop out of the study, then a minimum of 25 patients is necessary in order to obtain a minimum of 8 patients with major depression who will complete the double-blind crossover phase of the study.	Depression, Involutional Major Depresssion	Yohimbine Sleep Deprivation Depression Mood Disorder Fast Affective Disorder Rapid Onset Major Depression MDD	null	2	arm 1: Participants are randomized to receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep. After 8 days they receive placebo administered over 3 minutes during REM sleep. arm 2: Participants are randomized to receive placebo administered over 3 minutes during REM sleep. After 8 days they receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Participants receive yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep. intervention 2: Participants receive an inactive equivalent of yohimbine 0.125 mg/kg administered over 3 minutes during REM sleep.	intervention 1: Yohimbine hydrochloride intervention 2: Placebo	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	12	0	0	0	NCT00078715	1COMPLETED	2009-08-01	2004-03-01	National Institute of Mental Health (NIMH)	0NIH	false	false	false	null	0	0	0	0	0	0
[ 3 ]	112	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.	OBJECTIVES: * Determine the response rate (complete and partial, confirmed and unconfirmed) in women with stage IV breast cancer treated with oral cyclophosphamide and oral capecitabine. * Determine the progression-free survival and overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. * Determine the quality of life of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral cyclophosphamide once daily on days 1-14 and oral capecitabine twice daily on days 8-21. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at weeks 7, 13, 19, and 25. After completion of study treatment, patients are followed every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study within 4 years.	Breast Cancer	stage IV breast cancer recurrent breast cancer	null	1	arm 1: cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: capecitabine intervention 2: cyclophosphamide	145	Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Anchorage \| Alaska \| United States \| -149.90028 \| 61.21806 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Castro Valley \| California \| United States \| -122.08635 \| 37.6941 Fremont \| California \| United States \| -121.98857 \| 37.54827 Hayward \| California \| United States \| -122.0808 \| 37.66882 Hayward \| California \| United States \| -122.0808 \| 37.66882 Oakland \| California \| United States \| -122.2708 \| 37.80437 Oakland \| California \| United States \| -122.2708 \| 37.80437 Oakland \| California \| United States \| -122.2708 \| 37.80437 Oakland \| California \| United States \| -122.2708 \| 37.80437 Pleasanton \| California \| United States \| -121.87468 \| 37.66243 Redwood City \| California \| United States \| -122.23635 \| 37.48522 Richmond \| California \| United States \| -122.34775 \| 37.93576 Roseville \| California \| United States \| -121.28801 \| 38.75212 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Sacramento \| California \| United States \| -121.4944 \| 38.58157 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Jose \| California \| United States \| -121.89496 \| 37.33939 San Pablo \| California \| United States \| -122.34553 \| 37.96215 San Rafael \| California \| United States \| -122.53109 \| 37.97353 Santa Clara \| California \| United States \| -121.95524 \| 37.35411 Santa Rosa \| California \| United States \| -122.71443 \| 38.44047 South San Francisco \| California \| United States \| -122.40775 \| 37.65466 Stockton \| California \| United States \| -121.29078 \| 37.9577 Vallejo \| California \| United States \| -122.25664 \| 38.10409 Walnut Creek \| California \| United States \| -122.06496 \| 37.90631 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Edwards \| Colorado \| United States \| -106.5942 \| 39.64499 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Valdosta \| Georgia \| United States \| -83.28032 \| 30.83334 Alton \| Illinois \| United States \| -90.18428 \| 38.8906 Decatur \| Illinois \| United States \| -88.9548 \| 39.84031 Maywood \| Illinois \| United States \| -87.84312 \| 41.8792 Mount Vernon \| Illinois \| United States \| -88.90312 \| 38.31727 Naperville \| Illinois \| United States \| -88.14729 \| 41.78586 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 Chanute \| Kansas \| United States \| -95.4572 \| 37.67921 Dodge City \| Kansas \| United States \| -100.01708 \| 37.7528 El Dorado \| Kansas \| United States \| -96.86225 \| 37.81724 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Kingman \| Kansas \| United States \| -98.11367 \| 37.64585 Liberal \| Kansas \| United States \| -100.921 \| 37.04308 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Parsons \| Kansas \| United States \| -95.26108 \| 37.34034 Pratt \| Kansas \| United States \| -98.73759 \| 37.64391 Salina \| Kansas \| United States \| -97.61142 \| 38.84028 Salina \| Kansas \| United States \| -97.61142 \| 38.84028 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Topeka \| Kansas \| United States \| -95.67804 \| 39.04833 Wellington \| Kansas \| United States \| -97.37171 \| 37.2653 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Wichita \| Kansas \| United States \| -97.33754 \| 37.69224 Winfield \| Kansas \| United States \| -96.99559 \| 37.23975 Methuen \| Massachusetts \| United States \| -71.19089 \| 42.7262 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Lansing \| Michigan \| United States \| -84.55553 \| 42.73253 Mount Clemens \| Michigan \| United States \| -82.87798 \| 42.59726 Royal Oak \| Michigan \| United States \| -83.14465 \| 42.48948 Cape Girardeau \| Missouri \| United States \| -89.51815 \| 37.30588 Gape Girardeau \| Missouri \| United States \| N/A \| N/A Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Billings \| Montana \| United States \| -108.50069 \| 45.78329 Bozeman \| Montana \| United States \| -111.03856 \| 45.67965 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 Great Falls \| Montana \| United States \| -111.30081 \| 47.50024 Helena \| Montana \| United States \| -112.03611 \| 46.59271 Kalispell \| Montana \| United States \| -114.31291 \| 48.19579 Kalispell \| Montana \| United States \| -114.31291 \| 48.19579 Kalispell \| Montana \| United States \| -114.31291 \| 48.19579 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Glens Falls \| New York \| United States \| -73.64401 \| 43.30952 Goldsboro \| North Carolina \| United States \| -77.99277 \| 35.38488 Statesville \| North Carolina \| United States \| -80.8873 \| 35.78264 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Independence \| Ohio \| United States \| -81.6379 \| 41.36866 Mansfield \| Ohio \| United States \| -82.51545 \| 40.75839 Wooster \| Ohio \| United States \| -81.93646 \| 40.80517 Gresham \| Oregon \| United States \| -122.43148 \| 45.49818 Milwaukie \| Oregon \| United States \| -122.63926 \| 45.44623 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Tualatin \| Oregon \| United States \| -122.76399 \| 45.38401 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 American Fork \| Utah \| United States \| -111.79576 \| 40.3769 Cedar City \| Utah \| United States \| -113.06189 \| 37.67748 Logan \| Utah \| United States \| -111.83439 \| 41.73549 Murray \| Utah \| United States \| -111.88799 \| 40.66689 Murray \| Utah \| United States \| -111.88799 \| 40.66689 Ogden \| Utah \| United States \| -111.97383 \| 41.223 Provo \| Utah \| United States \| -111.65853 \| 40.23384 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 St. George \| Utah \| United States \| -113.58412 \| 37.10415 Auburn \| Washington \| United States \| -122.22845 \| 47.30732 Bellingham \| Washington \| United States \| -122.48822 \| 48.75955 Bremerton \| Washington \| United States \| -122.63264 \| 47.56732 Centralia \| Washington \| United States \| -122.9543 \| 46.71621 Federal Way \| Washington \| United States \| -122.31262 \| 47.32232 Mount Vernon \| Washington \| United States \| -122.33405 \| 48.42122 Olympia \| Washington \| United States \| -122.90169 \| 47.04491 Puyallup \| Washington \| United States \| -122.2929 \| 47.18538 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 Wenatchee \| Washington \| United States \| -120.31035 \| 47.42346 Clarksburg \| West Virginia \| United States \| -80.34453 \| 39.28065 Parkersburg \| West Virginia \| United States \| -81.56151 \| 39.26674 Sheridan \| Wyoming \| United States \| -106.95618 \| 44.79719	95	0	0	0	NCT00107276	1COMPLETED	2009-08-01	2005-08-01	SWOG Cancer Research Network	5NETWORK	false	false	false	null	0	0	0	0	0	0
[ 0 ]	42	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Primary Objectives: 1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma. 2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin. 3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.	Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements. In this study, 6 patients at a time will be randomly assigned (as in the toss of a coin) to one of two groups of 3 patients each. One group (Arm A) will receive curcumin alone. The other group (Arm B) will receive curcumin in combination with Bioperine. There is an equal chance of being in either group. While on study you may receive standard supportive care as appropriate. Both of the study agents will be taken by mouth two times a day. Each group will have five dose levels of curcumin, starting with the lowest dose. After 6 patients have been enrolled in the first level (3 in each arm), the next group will be treated at a new dose level. You will always receive the same dose during your treatment, which will continue for at least 12 weeks unless there is evidence that the disease has gotten worse or intolerable side effects occur. You may receive treatment up to one year depending on your response to treatment. You may be treated as outpatient and may receive your treatment at home. You will be asked to return to M. D. Anderson every 4 weeks for evaluation and physical exam. This is an investigational study. A total of up to 30 evaluable patients will take part in the study. All will be enrolled at M. D. Anderson.	Multiple Myeloma	Multiple Myeloma Diferuloylmethane Derivative Curcumin Bioperine	null	2	arm 1: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.). arm 2: Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 2 grams (Capsules) orally in 2 divided doses (a.m., p.m.) intervention 2: 5 mg (Tablets) orally twice daily	intervention 1: Curcumin intervention 2: Bioperine	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	33	0	0	0	NCT00113841	1COMPLETED	2009-08-01	2004-11-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	112	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study was to investigate the use of systemic intracoronary administration of albumin-bound paclitaxel, ABI-007, for the prevention and reduction of restenosis following de novo stenting or following angioplasty for in-stent restenosis.	This study consisted of a Phase I non-randomized dose escalation phase to determine the maximum tolerated dose and a randomized Phase II component to assess preliminary efficacy. Nanoparticle paclitaxel was administered by intracoronary catheter following either successful and uncomplicated stenting of de novo lesions in native coronary arteries or following successful and uncomplicated balloon angioplasty of instent restenosis (ISR) lesions.	Coronary Restenosis	Prevention of Instent Restenosis	null	4	arm 1: Participants received a single dose of 10 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions). arm 2: Participants received a single dose of 22 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). arm 3: Participants received a single dose of 35 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions). arm 4: Participants received a single dose of 45 mg/m\^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Nanoparticle albumin-bound paclitaxel, administered via intracoronary catheter.	intervention 1: Nanoparticle Paclitaxel	0	null	112	0	0	0	NCT00124943	1COMPLETED	2009-08-01	2005-07-01	Celgene Corporation	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	400	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	2MALE	true	The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.	This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.	HIV Infection		null	4	arm 1: participants in this arm start study product immediately upon enrollment arm 2: participants in this arm start study product immediately upon enrollment arm 3: persons in this arm start study product 9 months after enrollment arm 4: participants in this arm start study product nine months after enrollment	[ 1, 2, 1, 2 ]	2	[ 0, 0 ]	intervention 1: study product taken daily intervention 2: study product taken daily	intervention 1: tenofovir disoproxil fumarate intervention 2: placebo	3	San Francisco \| California \| United States \| -122.41942 \| 37.77493 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	373	0	0	0	NCT00131677	1COMPLETED	2009-08-01	2005-02-01	Centers for Disease Control and Prevention	1FED	false	false	false	null	0	0	0	0	0	0
[ 3, 4 ]	321	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are: 1. Twin pregnancy 2. Triplet pregnancy	Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity. In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates. The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth.	Preterm Birth	Preterm Birth Preterm Delivery Multiple gestation 17-alpha-hydroxyprogesterone caproate Progesterone	null	2	arm 1: Test Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. arm 2: Control Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first. intervention 2: Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.	intervention 1: 17-alpha-hydroxyprogesterone caproate injectable intervention 2: Placebo	18	Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Laguna Hills \| California \| United States \| -117.71283 \| 33.61252 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Orange \| California \| United States \| -117.85311 \| 33.78779 San Jose \| California \| United States \| -121.89496 \| 37.33939 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Lonetree \| Colorado \| United States \| -107.17282 \| 37.16806 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Kirkland \| Washington \| United States \| -122.20874 \| 47.68149 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288	321	0	0	0	NCT00163020	1COMPLETED	2009-08-01	2004-11-01	Obstetrix Medical Group	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 5 ]	319	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This study will determine whether adding interpersonal psychotherapy to treatment with the antidepressant escitalopram will be more effective in reducing symptoms of depression than antidepressant medication alone.	The purpose of this research study is to learn if adding psychotherapy (Interpersonal Psychotherapy) to antidepressant medication (escitalopram), will be more effective in reducing lingering symptoms of depression and decreasing the burden of these symptoms, when initial treatment with just antidepressant medication alone has led to only a partial response. Participation in the study will last up to 22 weeks. Because fewer than 50% of elderly depressed patients achieve remission and recovery in response to first-line antidepressant pharmacotherapy, the majority of patients are left with significant symptoms and functional impairment, putting them at risk of chronic, relapsing illness, non-adherence to other medical treatment, suicide, and family caregiver burden. We will recruit and treat 320 patients with unipolar major depression aged 60 and older, using clinical management with escitalopram 10 mg/day for six weeks. Patients who are partial responders to escitalopram plus clinical management will be randomly assigned to 16 weeks of extension therapy with either 20 mg escitalopram plus clinical management or 20 mg escitalopram plus Interpersonal Psychotherapy (IPT, 16 sessions). Changes over time in measures of depressive symptoms, hopelessness, suicidal ideation, disability, and family caregiving burden will be assessed. This study will answer the question of how best to treat partial responders-by simply extending pharmacotherapy at higher doses, or by also adding psychotherapy-to remission and recovery. For information on related studies, please follow these links: http://clinicaltrials.gov/show/NCT00178035 http://clinicaltrials.gov/show/NCT00178074	Depression	Elderly Remission Escitalopram Interpersonal Psychotherapy Psychotherapy Caregiving Late-Life	null	2	arm 1: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT) arm 2: Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management(DCM) without interpersonal psychotherapy (IPT)	[ 0, 1 ]	3	[ 0, 5, 5 ]	intervention 1: Escitalopram 10 mg daily for first 6 weeks, followed by escitalopram 20 mg daily for 16 additional weeks. intervention 2: 16 sessions of interpersonal psychotherapy (IPT) intervention 3: 16 weeks of depression care management(DCM). No psychotherapy will be provided.	intervention 1: Escitalopram intervention 2: Interpersonal Psychotherapy intervention 3: Clinical Monitoring	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	124	0	0	0	NCT00177294	1COMPLETED	2009-08-01	2004-04-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	228	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The study is long-term extension study to evaluate long-term safety and efficacy of Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder (AD/HD).	null	Attention Deficit Hyperactivity Disorder		null	1	arm 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years	[ 0 ]	1	[ 0 ]	intervention 1: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years	intervention 1: Atomoxetine hydrochloride	24	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukui \| N/A \| Japan \| 135.54836 \| 34.84214 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Hokkaido \| N/A \| Japan \| N/A \| N/A Hyōgo \| N/A \| Japan \| 144.43333 \| 43.36667 Ibaraki \| N/A \| Japan \| 135.56828 \| 34.81641 Ishikawa \| N/A \| Japan \| 127.82139 \| 26.42333 Kanagawa \| N/A \| Japan \| 139.91667 \| 37.58333 Kumamoto \| N/A \| Japan \| 130.69181 \| 32.80589 Mie \| N/A \| Japan \| 131.58333 \| 32.96667 Miyagi \| N/A \| Japan \| 128.18236 \| 26.62566 Nagano \| N/A \| Japan \| 138.18333 \| 36.65 Nara \| N/A \| Japan \| 135.80485 \| 34.68505 Okayama \| N/A \| Japan \| 133.93333 \| 34.65 Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Saga \| N/A \| Japan \| 130.3 \| 33.23333 Shiga \| N/A \| Japan \| 138.13005 \| 36.02247 Shizuoka \| N/A \| Japan \| 138.38333 \| 34.98333 Tochigi \| N/A \| Japan \| 139.73333 \| 36.38333 Tokushima \| N/A \| Japan \| 134.56667 \| 34.06667 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Toyama \| N/A \| Japan \| 137.21667 \| 36.7 Wakayama \| N/A \| Japan \| 135.16667 \| 34.23333	228	0	0	0	NCT00191386	1COMPLETED	2009-08-01	2005-05-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 3 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.	Upon determination of eligibility, all patients will be receive: Gemcitabine + Trastuzumab	Breast Cancer		null	1	arm 1: All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Trastuzumab intervention 2: Gemcitabine	intervention 1: Trastuzumab intervention 2: Gemcitabine	0	null	41	0	0	0	NCT00193063	1COMPLETED	2009-08-01	2001-07-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	72	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study is designed to study the role of an active and well-tolerated non-platinum agent, gemcitabine, in a combination regimen with pemetrexed in the first-line treatment of advanced NSCLC. This study will serve to define the role of next generation agents in a new combination regimen in the treatment of advanced NSCLC. This combination regimen may ultimately be important in further expanding treatment options for patients while improving survival, quality of life, and symptom control compared with platinum-based combination regimens - and with acceptable toxicity.	Upon determination of eligibility, patients will be receive: * Pemetrexed + Gemcitabine	Lung Cancer		null	1	arm 1: Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.	[ 0 ]	2	[ 0, 0 ]	intervention 1: 500mg/m2 IV over 10 min, Day 1, prior to gemcitabine intervention 2: 1500mg/m2, 30min IV	intervention 1: Pemetrexed intervention 2: Gemcitabine	1	Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	72	0	0	0	NCT00193414	1COMPLETED	2009-08-01	2005-05-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	true	We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.	Osteoporosis is an uncommon disease in children and early adolescents. Patients have a low bone mineral density, develop fractures with minimal or no trauma, and frequently have a negative family history. The disease results from either diminished bone formation or increased bone removal (resorption). No specific drug therapy has been recommended for juvenile osteoporosis. Alendronate (Fosamax) is effective in inhibiting bone resorption, increasing BMD and reducing fractures in adults with postmenopausal osteoporosis, but have not become established therapies in children. In the present study, we plan to evaluate the safety and efficacy of Alendronate in 20 patients with juvenile osteoporosis in a two-year period. This is a randomized, double-blind, placebo-controlled protocol. In the year-1, 10 patients will be assigned to receive Alendronate and 10 patients placebo. In the year-2, patients will be crossed over to the second arm of the study. Those who received Alendronate in the year-1, will receive placebo in the second year and vice verse. The patients will have 5 visits, the initial screening visit followed by 4 post therapy visits in a six-month interval. Measurements include DXA bone density scan of spine and hip, urinalysis and blood work.	Osteoporosis	Fracture Bone Mineral Density DXA	null	2	arm 1: Crossover study. Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements. Year-2, they will crossover to the second arm of the study. Those who took study medication and supplements in year-1, will take placebo and supplements in the year-2, and those 10 participants who took placebo and supplements in the year-1, will take study medications and supplements in the year-2. arm 2: Year-1, 10 participants will take Alendronate (study medication)and calcium and vitamin D supplement). Another 10 participants will take placebo, calcium and vitamin D. In year-2 they will crossover. Those who took alendronate in the first year, will take Placebo, calcium and vitamin D for 12 months and those who took Placebo in the first year, will take Alendronate, calcium and vitamin D in the second year (12 months).	[ 0, 2 ]	1	[ 0 ]	intervention 1: Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.	intervention 1: Alendronate	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	22	0	0	0	NCT00259857	1COMPLETED	2009-08-01	2003-10-01	Medical University of South Carolina	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	45	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to control CLL in patients who have already received standard therapy. The safety of lenalidomide will also be studied.	Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. Blood (between 2-4 teaspoons) and urine will be collected for routine tests. For patients taking Coumadin, blood will be collected (2-4 teaspoons) to measure anticoagulation in order to closely monitor your clotting ability for the purpose of adjusting your Coumadin dose, if necessary. This blood test is called an INR (International Standard Method to follow anticoagulation). You will have a bone marrow biopsy and aspirate. To collect a bone marrow biopsy and aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. These two collections are performed as one single procedure. You also will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). Women who are able to have children must have a negative urine pregnancy test. If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every morning at about the same time for 28 days. This is considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down depending on how your disease responds and the side effects you experience. During this study, you will have blood samples (about 1 tablespoon each) taken once a week during the Cycle 1 until a stable dose of lenalidomide has been found. You will then have about 1 tablespoon of blood drawn every 2 weeks for an additional cycle and then once a month from then on while you are on study. Blood tests (about 1 tablespoon each) may be done more frequently if the dose of medication needs to be adjusted or if you experience side effects. Every month during the first 3 months, you will have a physical exam to see how you are doing. You will have a physical exam every 3 months from then on. After the first 3 months of treatment, a bone marrow biopsy and aspirate is going to be collected to evaluate your response to the treatment. In participants who continue to receive treatment, a bone marrow biopsy and aspiration are going to be repeated every 6 months during the first year, and then once a year after that while on study. You will be required to return to M. D. Anderson at least once a month, for the first 3 months, and until a stable dose of lenalidomide has been established. Following this, you will be required to return at least every 3 months while taking the medication . Women who are able to have children must have a negative pregnancy test 10-14 days before the start of therapy and a repeat pregnancy test 24 hours before the start of lenalidomide, every week for the first 4 weeks, every 4 weeks if they have regular menstruation, every 2 weeks if their periods are irregular, and 30 days after they stop taking lenalidomide. Only if you have had a hysterectomy or no menstrual periods for at least 24 months in a row, will you not be required to have these pregnancy tests and use birth control. You may continue to receive treatment as long as your disease is responding and no intolerable side effects occur. You will be taken off study if the disease gets worse or intolerable side effects occur. This is an investigational study. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for multiple myeloma. Lenalidomide use in chronic lymphocytic leukemia is considered experimental. Up to 45 patients may take part in this study. All will be enrolled at M. D. Anderson.	Chronic Lymphocytic Leukemia Leukemia	Chronic Lymphocytic Leukemia Lenalidomide Revlimid CLL	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 10 mg/day, orally once a day for 28 days	intervention 1: Lenalidomide	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	44	0	0	0	NCT00267059	1COMPLETED	2009-08-01	2005-12-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	30	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.	null	Acute Ischemic Stroke	Stroke Nonhemorrhagic hypothermia	null	0	null	null	2	[ 0, 3 ]	intervention 1: Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. intervention 2: External or internal cooling for 24 hours and rewarming over 12 hours.	intervention 1: Caffeinol intervention 2: hypothermia	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	30	0	0	0	NCT00299416	1COMPLETED	2009-08-01	2003-02-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 4 ]	895	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine if hypertonic saline with and without dextran can improve overall survival in victims of trauma with shock. Injury and lost blood from trauma can cause your body to be in shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation." The resuscitation fluid most commonly used is "isotonic" or one that is the same concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid (or one more concentrated than the blood) can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids the investigators are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than your blood. Dextran is a sugar solution.	Specific Aim: To determine if prehospital administration of 7.5% hypertonic saline /6% Dextran-70 (HSD) OR 7.5% hypertonic saline alone (HS), compared to current standard therapy with normal saline (NS), as an initial resuscitation fluid, affects survival following traumatic injury with hypovolemic shock. Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. The majority of these deaths result from hypovolemic shock or severe brain injury. Patients in hypovolemic shock develop a state of systemic tissue ischemia then a subsequent reperfusion injury at the time of fluid resuscitation. Conventional resuscitation involves the IV administration of a large volume of isotonic or slightly hypotonic (lactated ringers, LR) solutions beginning in the prehospital setting. Although not conclusive, prior studies have suggested that alternative resuscitation with hypertonic saline (7.5%) solutions may reduce morbidity or mortality in these patients. Furthermore, hypertonic fluids may have specific advantages in the brain-injured patient, as they may aid in the rapid restoration of cerebral perfusion and prevent extravascular fluid sequestration, thereby limiting secondary brain injury. In addition, recent studies have demonstrated that hypertonicity significantly alters the activation of inflammatory cells, an effect that may reduce subsequent organ injury from ischemia-reperfusion and decrease nosocomial infection. The majority of previous clinical trials have focused on the use of HSD. The potential for 7.5% saline alone (HS) to have similar effects has not been well studied. Removal of the dextran component may enhance the anti-inflammatory effects of this solution, which could improve secondary outcomes such as acute respiratory distress syndrome (ARDS), multiple organ failure syndrome (MOFS) and rates of nosocomial infections. This study is a randomized, double-blind, three-arm placebo controlled trial designed to evaluate the clinical outcome of trauma patients with hypovolemic shock, as manifested by prehospital hypotension. Patients will be randomized to a single 250cc IV dose of 7.5% saline in 6% Dextran-70 (HSD), 7.5% saline (HS) or normal saline as the initial fluid for prehospital resuscitation. No additional interventions will occur once the patient is admitted to the hospital. In hospital data collection will last up to 28 days.	Shock, Traumatic	Trauma Shock	null	3	arm 1: 7.5% hypertonic saline/6% Dextran-70 (HSD) arm 2: 7.5% hypertonic saline (HS) arm 3: 0.9% normal saline	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 250 cc dose given as a one-time intravenous (IV) bolus in the pre-hospital setting. intervention 2: 250 cc dose given as a one-time IV bolus in the pre-hospital setting. intervention 3: 250 cc dose given as a one-time IV bolus in the pre-hospital setting.	intervention 1: 7.5% hypertonic saline/6% Dextran-70 (HSD) intervention 2: 7.5% hypertonic saline (HS) intervention 3: 0.9% normal saline	10	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 San Diego \| California \| United States \| -117.16472 \| 32.71571 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	852	0	0	0	NCT00316017	6TERMINATED	2009-08-01	2006-05-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	288	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.	A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.	Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)	neovascular age related macular degeneration choroidal neovascularization	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Pegaptanib Sodium dosed every 6 weeks in affected eye.	intervention 1: Pegaptanib Sodium 0.3 mg	58	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 Halifax \| Nova Scotia \| Canada \| -63.57688 \| 44.64269 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Olomouc \| N/A \| Czechia \| 17.25175 \| 49.59552 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Glostrup Municipality \| N/A \| Denmark \| 12.40377 \| 55.6666 Kuopio \| Finlad \| Finland \| 27.67703 \| 62.89238 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Nancy \| N/A \| France \| 6.18496 \| 48.68439 Nantes \| N/A \| France \| -1.55336 \| 47.21725 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 Dortmund \| N/A \| Germany \| 7.466 \| 51.51494 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Münster \| N/A \| Germany \| 7.62571 \| 51.96236 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Ancona \| N/A \| Italy \| 13.5103 \| 43.60717 Bari \| N/A \| Italy \| 16.86982 \| 41.12066 Florence \| N/A \| Italy \| 11.24626 \| 43.77925 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Alicante \| Alicante \| Spain \| -0.48149 \| 38.34517 Barcelona \| Barcelona \| Spain \| 2.15899 \| 41.38879 Santiago de Compostela \| La Coruña \| Spain \| -8.54569 \| 42.88052 Valencia \| Valencia \| Spain \| -0.37966 \| 39.47391 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Edinburgh \| Midlothian \| United Kingdom \| -3.19648 \| 55.95206 Aberdeen \| Scotland \| United Kingdom \| -2.09814 \| 57.14369 Belfast \| N/A \| United Kingdom \| -5.92541 \| 54.59682 Bristol \| N/A \| United Kingdom \| -2.59665 \| 51.45523 Leeds \| N/A \| United Kingdom \| -1.54785 \| 53.79648 Southampton \| N/A \| United Kingdom \| -1.40428 \| 50.90395	286	0	0	0	NCT00327470	6TERMINATED	2009-08-01	2006-07-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	111	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The objective of this study is to evaluate the safety of long-term treatment with Phenoptin in subjects with phenylketonuria (PKU) who participated in Phase 3 clinical studies with Phenoptin.	null	Phenylketonuria	PKU	null	0	null	null	1	[ 0 ]	intervention 1: 5-20mg/kg/day orally, dose may be adjusted up or down as needed at the discretion of the investigator in increments of 5mg/kg/day.	intervention 1: sapropterin dihydrochloride	14	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Jose \| California \| United States \| -121.89496 \| 37.33939 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 New York \| New York \| United States \| -74.00597 \| 40.71427 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	111	0	0	0	NCT00332189	1COMPLETED	2009-08-01	2006-07-01	BioMarin Pharmaceutical	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	1,771	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).	null	Asthma		null	3	arm 1: Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period arm 2: Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period arm 3: Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period	[ 1, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period. intervention 2: Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period. intervention 3: Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.	intervention 1: montelukast sodium intervention 2: Comparator: Placebo (unspecified) intervention 3: montelukast sodium	0	null	1,757	0	0	0	NCT00337675	1COMPLETED	2009-08-01	2006-10-01	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0	0	0
[ 4 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	2MALE	false	The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether exercise training combined with testosterone replacement therapy can improve skeletal muscle strength, and lean mass, to a greater degree than exercise training alone.	Decreases in physical abilities, including losses of strength, endurance, balance, and coordination are major causes of disability and loss of independence in older men. Such individuals are at high risk for injurious falls, hospitalization, and use of supportive services. Age-associated testosterone deficiency may contribute to deficits in muscle mass and strength that are common in this patient population. The primary aim of this study is to determine, in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve skeletal muscle mass and skeletal muscle strength, to a greater degree than six months of exercise training alone. Secondary study aims are to determine in hypogonadal older men with physical frailty, whether six months of exercise training combined with testosterone replacement therapy can improve physical function, bone mineral density, and quality of life, to a greater degree than six months of exercise training alone. Comparison: Men age 65 years and older who meet criteria for physical frailty and have a serum testosterone level below 350 ng/dl are randomly assigned to one of two groups: 1) transdermal testosterone replacement therapy + supervised exercise training for six months vs. 2) inactive placebo gel + supervised exercise training for six months.	Physical Frailty Hip Fracture Elective Hip Replacement Hypogonadism	Testosterone Replacement Therapy Physical Frailty Hip Fracture	null	2	arm 1: Transdermal testosterone 1% gel (Androgel) provided as 2.5 gm and/or 5 gm gel packets with dose titration and monthly dose adjustments to achieve and maintain serum total testosterone level between 500-900 mg/dL. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months. arm 2: Inactive topical gel identical in appearance to the active medication, provided in packets identical to the packaging for the active medication. Gel to be applied daily by participants. Participants are blinded to the contents of the gel packets. Participants in this arm also perform supervised exercise training for 6 months.	[ 1, 2 ]	2	[ 0, 5 ]	intervention 1: Transdermal testosterone replacement therapy with Androgel(TM). Daily application of gel at 5 mg, 7.5 gm, or 10 gm for six months. Target serum total testosterone level between 500-900 ng/dl. intervention 2: Supervised exercise training performed on site at academic medical center exercise facility. Exercise training consisted of 2 months of flexibility, balance, treadmill walking, and physical therapy-type exercises, followed by 4 months of progressive resistance training.	intervention 1: Transdermal Testosterone gel (1%) intervention 2: Supervised exercise training	1	St Louis \| Missouri \| United States \| -90.19789 \| 38.62727	25	0	0	0	NCT00345969	1COMPLETED	2009-08-01	2004-11-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	90	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.	Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as intensive care unit (ICU) patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients. This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes. Comparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.	Respiratory Distress Syndrome, Adult Acute Lung Injury Acute Respiratory Distress Syndrome	Respiratory distress syndrome, adult Acute lung injury Acute respiratory distress syndrome ARDS, human Fish oils Fatty Acids, Omega-3 Docosahexaenoic Acids Eicosapentaenoic Acid	null	2	arm 1: Enteral fish oil arm 2: Enteral saline	[ 0, 2 ]	1	[ 0 ]	intervention 1: Liquid fish oil 7.5cc enterally every 6 hours	intervention 1: Fish oil (eicosapentaenoic acid and docosahexanoic acid)	5	Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	90	0	0	0	NCT00351533	1COMPLETED	2009-08-01	2006-07-01	University of Washington	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	true	The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA). The investigators hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.	Community-associated methicillin resistant Staphylococcus Aureus (CA-MRSA) infections have increased significantly over the past decade. Nearly every major region of the country has reported infections with this organism, with some areas reporting a prevalence as high as 80%. Epidemiologic evidence points to the emergence of a new strain of MRSA within the community, with unique genetic and clinical characteristics that differentiate it from traditional hospital-associated MRSA (HA-MRSA). Unlike HA-MRSA, these CA-MRSA are often susceptible in vitro to multiple antibiotic classes (other than penicillins and cephalosporins), and often cause significant, deep-seated abscesses in healthy individuals without any known risk factors for healthcare contact. Prior to awareness of this disease, many clinicians were using penicillin and cephalosporin antibiotics for empiric treatment of cutaneous abscesses, yet widespread treatment failures in the face of increasing CA-MRSA infections did NOT occur. During a one-year retrospective study in pediatric patients at our institution, we found that nearly 50% of CA-MRSA abscesses were treated with "inappropriate" antibiotics by susceptibility profiles without any significant adverse outcomes. Many clinicians are now confronted with the dilemma of whether to change empiric antibiotic therapy to other classes to which CA-MRSA would be expected to be susceptible; the most common choices including clindamycin, trimethoprim-sulfamethoxazole (TMP-SMX), or vancomycin. Unfortunately, each of these antibiotics has problems of its own in terms of increased cost, poor palatability of pediatric liquid formulation, poorer side effect profile, or necessity of IV infusion, and at this time the optimal, empiric antibiotic treatment for presumed CA-MRSA skin and soft tissue infections is unclear. The purpose of this study is to help define the role of antibiotics in the treatment of pediatric skin infections caused by CA-MRSA. We hypothesize that treatment with cephalexin, a penicillin-like antibiotic to which CA-MRSA would be expected to be resistant, does not result in poorer outcomes than treatment with clindamycin, an antibiotic to which CA-MRSA is most often susceptible.	Staphylococcal Infection Abscess Staphylococcal Skin Infection Folliculitis	clinical trial randomized blinded controlled	null	2	arm 1: None arm 2: None	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: clindamycin suspension or tablets, 20mg/kg/day, given by mouth, divided TID, for 7 days intervention 2: cephalexin suspension or tablets, 40mg/kg/day, given by mouth, divided TID, for 7 days	intervention 1: clindamycin intervention 2: cephalexin	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	200	0	0	0	NCT00352612	1COMPLETED	2009-08-01	2006-09-01	Aaron Chen	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 0 ]	1,767	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Approximately 2 million Ontarians are current smokers. While smoking rates have declined over the past 25 years, these rates have remained constant since 2002. The rate of smoking cessation in Ontario has not kept up with the rest of Canada. A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting over the long term. The overall goal of the Stop Smoking Therapy for Ontario Patients (STOP) Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy (NRT) to Ontario smokers. The study will develop an evidence-based protocol for providing NRT, provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models. The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions. This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge. Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking. However, combining pharmacotherapy with behavioural interventions may be more effective than either alone. Therefore, we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone.	According to the US Surgeon General's Report (1988), there are immediate, intermediate and long-term benefits to health from quitting smoking. For example, there is a 50% reduction in coronary heart disease risk in 12 months and the risk of a stroke is reduced to that of a nonsmoker 5-15 years after quitting. (US Surgeon General's Report, 1990, p.vi). In a systematic assessment of the value of clinical preventive services recommended by the US Preventive Services Task Force, smoking cessation treatment for adults was one of the highest-ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease. Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices. For example, cost-effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality (AHRQ) guidelines show costs of $4,113 per life-year saved, in 2001 prices compared to annual mammography for women aged 40 to 49 years, which costs $71,751 in 2001 prices, and hypertension screening for men aged 40 years, which costs $27,117 in 2001 prices. Therefore, smoking cessation services have been referred to as the "gold standard" for comparing the cost effectiveness of other healthcare interventions. Although some studies have shown high costs from increased healthcare utilization in the first year after quitting smoking due to illness (Martinson, 2003), most studies demonstrate that smokers who quit eventually have significantly lower healthcare utilization than continuing smokers (Fishman, 2003; Warner, 2003) Thus, for healthcare organizations such as the Ontario Health Insurance Plan, implementing smoking cessation services will likely result in a relatively quick return on investment. Both the intensity and duration of behavioural interventions are associated with sustained remission in smoking. The addition of pharmacotherapy doubles the odds of quitting successfully. However, many smokers face barriers in accessing pharmacotherapy. The provision of free pharmacotherapy has the potential to help a substantial number of smokers to quit. A study by Curry et al, 1998, evaluated smokers who were willing to sign up for a cessation-support program under various degrees of coverage for either the program or nicotine replacement therapy (NRT). 10% of Smokers with full coverage were likely to attempt to quit as opposed to 2.5% with partial coverage. Therefore, the United States Health \& Human Services guidelines call for the coverage of these medications. Research has shown that coverage for tobacco dependence treatments can enhance not only the rate of quit attempts but also long-term abstinence for smokers (Levy \& Friend, 2002; Schauffler, McMenamin, Olson, Boyce-Smith, Rideout, \& Kamil, 2001). On average, the odds ratio of quitting at one year was 1.6 for those given free NRT. Therefore, some insurers, both public and private, reimburse patients for stop smoking medications. However, a study by Boyle et al 2002, found that simply including the medication in an insurance plan did not increase quit rates or utilization of medications. Adequate precautions must be taken to ensure that free pharmacotherapy is distributed in conjunction with behavioural interventions to be successful and to be used by those smokers most likely to benefit from pharmacotherapy. Pharmacotherapy can be very expensive if provided to all smokers. However, not all smokers want to quit or require medications to quit (McDonald, 2003). Most smokers use about 2-3 weeks of pharmacotherapy when not combined with behavioural interventions (Pierce, 2002). About 0.05% of smokers looking to quit will seek specialized care. Moreover, if we assume that 70% of current tobacco users (Approximately 1.6 million) in Ontario will try to quit in a given year and that 10% ( i.e. 169,000) of these individuals would qualify for and seek reimbursement for 10 weeks of therapy at $30/week, then the total estimated cost will be about $50 million! This is clearly not fundable and therefore a comprehensive strategy combined with some rational use of pharmacotherapy is necessary. Hypotheses: 1. The provision of free NRT will increase quit attempts in Ontario smokers 2. The provision of free NRT will increase long-term quit rates (\>/= 6 months) in Ontario smokers. 3. Smokers who quit smoking using NRT will have reduced health care costs after the first year of treatment.	Smoking	nicotine replacement therapy smoking cessation	null	1	arm 1: Nicotine Replacement Therapy as per monograph \& behavioural intervention	[ 0 ]	2	[ 0, 5 ]	intervention 1: nicotine transdermal patches as per product monograph intervention 2: Smoking cessation counselling and relapse prevention	intervention 1: nicotine replacement therapy intervention 2: behavioural intervention	1	Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643	1,767	0	0	0	NCT00352781	1COMPLETED	2009-08-01	2006-07-01	Centre for Addiction and Mental Health	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 5 ]	642	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking. PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.	OBJECTIVES: Primary * Compare the efficacy of behavioral counseling and nicotine-replacement therapy with either oral nicotine lozenge (NL) or transdermal nicotine patch (NP), in terms of promoting rates of smoking cessation (e.g., continued abstinence), in adult smokers. * Examine the degree to which nicotine replacement therapy (NRT) preference, desire to control NRT dosing, irregular smoking schedules, and desire for oral preoccupation moderates the relative efficacy of NL vs NP in promoting smoking cessation. * Evaluate the impact of the NL on mediators of smoking cessation (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms). Secondary * Compare the rate of compliance with NRT across the 2 treatment arms and examine if compliance rate mediates the effects of NRT on quit rates. * Examine the potential role of genes related to nicotine dependence such as genes related to nicotine metabolism enzymes (e.g., CYP1A1) or genes related to dopamine concentrations (e.g., DRD2). OUTLINE: This is a randomized, open-label, multicenter study. Participants are stratified according to study center. Participants are randomized to 1 of 2 intervention arms. All participants undergo smoking cessation counseling in weeks 1, 3, 5, 7, and 9. Beginning in week 3, participants are asked to quit smoking for 12 weeks (weeks 3-14). * Arm I: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14. * Arm II: Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day). The moderating variables (e.g., nicotine replacement-therapy \[NRT\] preference and the smoker's desire to control NRT dosing) are assessed at baseline. The mediating variables (i.e., reduced craving, diminished withdrawal symptoms, cue reactivity, and increased perceived control over withdrawal symptoms) are assessed at baseline and then at weeks 5, 7, 9, within weeks 14-16, and within weeks 26-28. Continuous abstinence will be measured at week 27. PROJECTED ACCRUAL: A total of 700 participants will be accrued for this study.	Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder	bladder cancer cervical cancer esophageal cancer gastric cancer renal cell carcinoma adult primary liver cancer non-small cell lung cancer small cell lung cancer pancreatic cancer hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal sinus and nasal cavity cancer adult acute myeloid leukemia tongue cancer tobacco use disorder	null	2	arm 1: Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14. arm 2: Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: nicotine lozenge intervention 2: transdermal nicotine patch	intervention 1: nicotine lozenge intervention 2: nicotine patch	10	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Miami Beach \| Florida \| United States \| -80.13005 \| 25.79065 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Mount Holly \| New Jersey \| United States \| -74.78766 \| 39.99289 East Syracuse \| New York \| United States \| -76.07853 \| 43.06534 Manhasset \| New York \| United States \| -73.69957 \| 40.79788 Danville \| Pennsylvania \| United States \| -76.61273 \| 40.96342 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Wynnewood \| Pennsylvania \| United States \| -75.27074 \| 40.00289 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589	642	0	0	0	NCT00365508	1COMPLETED	2009-08-01	2006-02-01	Fox Chase Cancer Center	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 0 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.	The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.	Coronary Heart Disease	coronary heart disease montelukast inflammation	null	2	arm 1: 1 lactose-containing capsule daily for 1 month arm 2: 1 montelukast 10 mg tablet (masked by capsule) daily for 1 month	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: 10 mg tablet (masked by capsule) daily for 1 month intervention 2: 1 lactose-containing capsule daily for 1 month	intervention 1: montelukast intervention 2: Placebo	1	Gainesville \| Florida \| United States \| -82.32483 \| 29.65163	43	0	0	0	NCT00379808	1COMPLETED	2009-08-01	2006-07-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 2, 3 ]	58	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	3TRIPLE	true	0ALL	true	In congestive heart failure, cardiac output is low, blood pressure is high, and the body becomes congested with fluid. In normal people, when there is high blood pressure, the heart muscle cells secrete a hormone that excretes sodium and water in the urine, reducing blood pressure. The action of this hormone is called the natriuretic response. The purpose of this study is to determine if nesiritide can improve an impaired natriuretic response in subjects with asymptomatic systolic heart failure or asymptomatic diastolic heart failure.	The American Heart Association and the American College of Cardiology define stage B heart failure (HF) as asymptomatic subjects with abnormal heart structure/function. With the advancement of cardiac imaging and biomarkers, abnormal heart structure and function can be detected before the development of symptoms. Stage B HF can represent either diastolic or systolic dysfunction and both are at increased risk of adverse cardiac events and development of symptomatic HF. The broad objective of this study is to define the integrated cardiorenal response to acute volume expansion (VE) in humans with presystolic dysfunction (PSD), prediastolic dysfunction (PDD), and normal cardiac function. We hypothesized that there is an impaired cardiorenal endocrine response to acute VE in PSD and PDD which is characterized by the lack of appropriate activation of urinary cGMP and urinary sodium excretion. Further, we hypothesized that PSD, PDD, and normal control subjects would respond similarly to exogenous administration B-type natriuretic peptide (BNP). The natriuretic peptides (NPs) are a family of structurally similar but genetically distinct peptides with vasodilating, natriuretic, renin inhibiting, and lusitropic properties. Acute peptide therapy with brain natriuretic peptide (BNP) infusion has recently been approved by the FDA as a therapeutic strategy for the treatment of acute human decompensated congestive HF. We will determine the effects of acute subcutaneous BNP or placebo administration on the integrated cardiorenal and humoral response to acute sodium load (sodium chloride 0.9% 0.25 ml/kg/min for 1 hour) in three groups of subjects: Group 1 normal controls, Group 2 with PSD, and Group 3 with PDD. Doppler echocardiography and tonometry will be used to measure cardiac and vascular function before and during the sodium load. Renal function studies will assess sodium excretion, renal plasma flow, and glomerular filtration rate at baseline, during, and after the sodium load. Blood will be drawn for humoral analysis including catecholamines, renin, aldosterone, angiotensin II, atrial natriuretic peptide (ANP), BNP, and cyclic guanosine monophosphate (cGMP) at baseline, during, and after the sodium load.	Congestive Heart Failure	heart failure diastolic dysfunction systolic dysfunction preclinical natriuretic peptide B-type natriuretic peptide cyclic guanosine monophosphate	null	2	arm 1: In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. arm 2: In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: The first 10 subjects in each group will receive a dose of 5 ug/kg and the next ten subjects will receive 10 ug/kg. intervention 2: The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. intervention 3: Normal saline 0.9% 0.25 ml/kg/min for 60 minutes	intervention 1: Nesiritide intervention 2: Placebo intervention 3: Saline	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	116	0	0	0	NCT00387621	1COMPLETED	2009-08-01	2006-02-01	Horng Chen	7OTHER	false	false	false	null	0	0	0	0	0	0
[ 3 ]	14	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a study to explore the use of a reduced intensity transplant conditioning regimen. A conditioning regimen is the treatment that is given to prepare a body for the new bone marrow that will be received from a donor. Reduced intensity conditioning uses lower doses of chemotherapy than conventional conditioning regimens. The use of lower doses of drugs and radiation cause fewer side effects. Reduced intensity regimens have been offered to older patients or patients at increased risk for transplant-related side effects and have been shown to be safe and effective. Reduced intensity conditioning regimens are now considered for many patients who are undergoing transplant.	One of the complications of allogeneic stem cell transplant (ASCT) is graft versus host disease (GVHD). This is when the donor cells that are infused attack the body organs. This can cause serious illness and even death. The chance of getting serious life threatening GVHD with conventional transplant conditioning regimens is 25-50% depending on whether the donor bone marrow is from a family member or an unrelated person. The reduced intensity conditioning regimen used in this study involves a drug called pentostatin as well as a reduced dose of radiation and a treatment called photopheresis. This regimen has been successfully used in 106 patients. The incidence of serious GVHD in those patients was much less than expected: 8% for patients getting bone marrow from a family member and 23% for those getting bone marrow from an unrelated person. The pentostatin and radiation parts of this reduced intensity conditioning regimen are similar to other types of reduced intensity regimens, which use drugs similar to pentostatin. The unique part of this regimen compared to others is the use of extracorporeal photopheresis (ECP). While ECP has been used in 106 patients as part of a reduced intensity conditioning regimen, it is unknown whether adding ECP to pentostatin and radiation is what caused the reduced rate of GVHD that was seen in the previous study that was done. The use of ECP as part of a conditioning regimen is investigational. ECP is approved by the U.S. Food and Drug Administration (FDA) for the treatment of cutaneous T-cell lymphoma, but is not approved by the FDA for use prior to ASCT. Because it is not known whether the use of ECP in the reduced intensity conditioning regimen was what caused the low incidence of GVHD, this research study will look at differences in getting GVHD based on whether you receive ECP. Half the patients in this research study will receive ECP as part of their reduced intensity-conditioning regimen and the other half will not. Patients will be randomized (50% chance you will receive ECP and 50% chance you will not). Both groups will receive pentostatin and reduced dose total body irradiation. The primary purpose of this research study is to look at the chance of developing serious GVHD within the first 100 days after transplant within each group.	Hematologic Malignancies	Allogeneic Stem Cell Transplant	null	2	arm 1: Extracorporeal photopheresis, pentostatin and total body irradiation arm 2: Pentostatin and total body irradiation	[ 1, 1 ]	5	[ 3, 0, 4, 0, 4 ]	intervention 1: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen. intervention 2: pentostatin 8mg/m2 over 48 hours by continuous infusion intervention 3: 600cGy TBI in 3 200cGy TBI fractions intervention 4: pentostatin 8mg/m2 over 48 hours by continuous infusion intervention 5: 600cGy TBI in 3 200cGy TBI fractions	intervention 1: extracorporeal photopheresis intervention 2: Pentostatin intervention 3: Total Body Irradiation intervention 4: Pentostatin intervention 5: Total Body Irradiation	3	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	14	0	0	0	NCT00402714	1COMPLETED	2009-08-01	2006-07-01	Yale University	7OTHER	false	false	false	null	0	0	0	0	0	0

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