Split (3)

train · 29.5k rows

FEATURE_phases list	FEATURE_enrollmentCount int64	FEATURE_allocation string	FEATURE_interventionModel string	FEATURE_primaryPurpose class label	FEATURE_masking class label	FEATURE_healthyVolunteers bool	FEATURE_sex class label	FEATURE_oversightHasDmc bool	FEATURE_briefSummary string	FEATURE_detailedDescription string	FEATURE_conditions string	FEATURE_conditionsKeywords string	FEATURE_protocolPdfText string	FEATURE_numArms int64	FEATURE_armDescriptions string	FEATURE_armGroupTypes list	FEATURE_numInterventions int64	FEATURE_interventionTypes list	FEATURE_interventionDescriptions string	FEATURE_interventionNames string	FEATURE_numLocations int64	FEATURE_locationDetails string	LABEL_ct_level_ade_population int64	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_Intentional overdose int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent f...	Isradipine safety profile Isradipine, FDA approved for treatment of hypertension since 1990, has a well established data on its efficacy and safety in the hypertensive population (see package insert, Appendix 3). The side effect profile of isradipine is related to the primary mechanism of action of the agent as a vasod...	Parkinson's Disease	Parkinson's disease Isradipine Neuroprotection	null	1	arm 1: Dynacirc CR (Isradipine) will start at 5mg dose and increased in increments of 5mg every 2 weeks	[ 0 ]	1	[ 0 ]	intervention 1: Dynacirc CR is given by the recommended schedule for titration. Subjects start on a 5mg dose and are increased in increments of 5mg every 2 weeks provided that the subjects do not have significant adverse events or symptomatic orthostatic hypotension.	intervention 1: Dynacirc CR (Isradipine)	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	31	0	0	0	NCT00753636	1COMPLETED	2010-02-01	2008-04-01	Northwestern University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	49	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	Plaque induced gingivitis	null	Gingivitis		null	2	arm 1: Triclosan/Copolymer/fluoride toothpaste arm 2: sodium monofluorophosphate toothpaste	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Twice daily usage intervention 2: Twice daily usage	intervention 1: Triclosan/Copolymer/fluoride toothpaste intervention 2: Sodium monofluorophosphate toothpaste	1	Greenville \| North Carolina \| United States \| -77.36635 \| 35.61266	49	0	0	0	NCT00762528	1COMPLETED	2010-02-01	2009-02-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	63	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney. LCP-Tacro is a tabl...	This study was a randomized, parallel-group, open label, multicenter study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets and Prograf capsules in the first 2 weeks after kidney transplantation. In addition the study compared the efficacy and safety of LCP...	Kidney Failure Renal Failure	Kidney Transplantation Immunosuppression Tacrolimus Prograf	null	2	arm 1: The initial dose starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg), will be administered orally in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for th...	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: The initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK main...	intervention 1: Tacrolimus (Tacro™) intervention 2: Prograf	1	Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711	63	0	0	0	NCT00765661	1COMPLETED	2010-02-01	2008-09-01	Veloxis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	122	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).	null	Staphylococcal Infection		null	3	arm 1: None arm 2: None arm 3: None	[ 0, 1, 0 ]	3	[ 0, 0, 0 ]	intervention 1: MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) intervention 2: vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days intervention 3: MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicem...	intervention 1: Daptomycin 4 mg/kg intervention 2: Comparator: vancomycin intervention 3: Daptomycin 6 mg/kg	0	null	122	0	0	0	NCT00770341	1COMPLETED	2010-02-01	2008-09-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	35	RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks follo...	null	Non-Small Cell Lung Cancer		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: iv 9mg/kg weekly intervention 2: 150mg oral daily	intervention 1: RG1507 intervention 2: erlotinib [Tarceva]	16	Santa Monica \| California \| United States \| -118.49138 \| 34.01949 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Hickory \| Nor...	34	0	0	0	NCT00773383	6TERMINATED	2010-02-01	2008-11-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	2	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.	null	Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease		null	1	arm 1: Single arm open label IV Infliximab given at weeks 1,2,14,22	[ 0 ]	1	[ 0 ]	intervention 1: IV drug given at weeks 1,2,14,22	intervention 1: Infliximab	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	2	0	0	0	NCT00791557	1COMPLETED	2010-02-01	2008-10-01	University Hospitals Cleveland Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	563	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.	null	Chronic Obstructive Pulmonary Disease (COPD)	COPD indacaterol long-acting β2-agonist adults	null	3	arm 1: Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was availabl...	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 3: Placebo to indacaterol was supplied in powder-filled capsules with a single-...	intervention 1: Indacaterol 150 µg intervention 2: Indacaterol 300 μg intervention 3: Placebo to indacaterol	15	Adelaide \| N/A \| Australia \| 138.59863 \| -34.92866 Clayton \| N/A \| Australia \| 145.11667 \| -37.91667 Daw Park \| N/A \| Australia \| 138.58407 \| -34.98975 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Changsha \| N/A \| China \| 112.97087 \| 28.19874 Chongqing \| N/A \| China \| 106.55771 \| 29.56026 Fuzhou \| N/A \| China \| 119.3061...	561	0	0	0	NCT00792805	1COMPLETED	2010-02-01	2008-11-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	143	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.	null	Type 2 Diabetes Mellitus		null	2	arm 1: None arm 2: None	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks. intervention 2: Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepir...	intervention 1: MK-0941 intervention 2: Glimepiride intervention 3: Metformin	0	null	143	0	0	0	NCT00792935	1COMPLETED	2010-02-01	2009-01-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	3	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients receive transfusions of plasma, the liquid part of blood, from healthy donors. This study will examine the effectiveness of an antibody...	TTP is a disorder that causes blood clots to form in the small blood vessels throughout the body. If the clots in fact block the blood vessels, blood flow is restricted to various organs, including the brain, kidneys, and heart. This can lead to neurological problems, stroke, abnormal kidney function, and heart problem...	Thrombotic Thrombocytopenic Purpura	TTP Rituximab Plasma Exchange	null	2	arm 1: Participants will receive rituximab in addition to plasma exchange and corticosteroids. arm 2: Participants will receive plasma exchange and corticosteroids.	[ 0, 1 ]	3	[ 0, 3, 0 ]	intervention 1: Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses intervention 2: Target volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have imp...	intervention 1: Rituximab intervention 2: Plasma exchange intervention 3: Corticosteroids	23	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Iowa City \| Iowa \| United States \| -91.53017 \| 41.66113 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Baltimore \| Maryland \| Uni...	0	0	0	0	NCT00799773	6TERMINATED	2010-02-01	2009-04-01	Carelon Research	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	375	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The Primary objective of this study is to test whether LY2196044 can reduce the number of heavy drinking days per month in people with alcohol dependence. Each subject will undergo a screening and assessment period (including medication washout) prior to randomization into a 16 week double blind treatment period.	null	Alcohol Dependence		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks intervention 2: once daily, orally, 16 weeks	intervention 1: LY2196044 intervention 2: placebo	17	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lafayette \| Indiana \| United States \| -86.87529 \| 40.4167 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Belmont \| Massachusetts \| United States \| -71.17867 \| 42.39593 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Omaha \| Nebraska ...	375	0	0	0	NCT00804570	1COMPLETED	2010-02-01	2008-11-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.	When a person exercises at a high intensity or starts a new exercise program, muscle soreness will develop. Muscle soreness that peaks between 24-72 hours after exercise and diminishes in 5-7 days is characterized as delayed onset muscle soreness (DOMS). DOMS is associated with the eccentric phase of exercise, where th...	Muscle Damage Muscle Inflammation		null	2	arm 1: Lovaza, 3 grams/day for 65 days arm 2: Wheat Germ Oil, 3 grams/day for 65 days	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Lovaza, 3 grams per day for 65 days intervention 2: Wheat germ oil, 3 grams/day for 65 days	intervention 1: Lovaza (omega-3-acid ethyl esters) intervention 2: Wheat Germ Oil	1	Kalamazoo \| Michigan \| United States \| -85.58723 \| 42.29171	20	0	0	0	NCT00805870	1COMPLETED	2010-02-01	2009-03-01	Western Michigan University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	390	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	2MALE	false	This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.	null	Erectile Dysfunction	ED Erectile Dysfunction Dysfunction Diabetic Erectile	null	3	arm 1: None arm 2: None arm 3: None	[ 2, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: 30 minutes orally prior to initiation of sexual activity intervention 2: 30 minutes orally prior to initiation of sexual activity intervention 3: 30 minutes orally prior to initiation of sexual activity	intervention 1: placebo intervention 2: avanafil intervention 3: avanafil	39	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Homewood \| Alabama \| United States \| -86.80082 \| 33.47177 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| Califor...	388	0	0	0	NCT00809471	1COMPLETED	2010-02-01	2008-12-01	VIVUS LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	10	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents	The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2)...	Fatigue Chemotherapy Side Effects	Cancer Fatigue Taxanes	null	2	arm 1: * 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents arm 2: * placebo * taxane chemotherapy treatment alone or in combination with other agents	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: * 150 mg/day armodafinil * concurrent with one cycle of taxane chemotherapy alone or in combination with other agents * patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherap...	intervention 1: Armodafinil 150 mg/day intervention 2: Placebo,	29	Muscle Shoals \| Alabama \| United States \| -87.66753 \| 34.74481 Burbank \| California \| United States \| -118.30897 \| 34.18084 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 La Verne \| California \| United States \| -117.76784 \| 34.10084 Riverside \| California \| United States \| -117.39616 \| 33.95335 Sa...	10	0	0	0	NCT00825227	6TERMINATED	2010-02-01	2008-12-01	Cephalon	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	33	NON_RANDOMIZED	SINGLE_GROUP	2DIAGNOSTIC	0NONE	false	0ALL	false	The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.	Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.	Renal Artery Stenosis	Renal artery stenosis Contrast agent MRA	null	2	arm 1: Each subject will receive one injection of Dotarem 0.2 ml/kg. arm 2: Each subject undergo a TOF MRA	[ 0, 5 ]	2	[ 0, 10 ]	intervention 1: Each subject will receive one injection of Dotarem 0.2 ml/kg intervention 2: Each subject will undergo a TOF MRA	intervention 1: Gadoterate meglumine (Dotarem) intervention 2: Time of Flight Magnetic Resonance Angiography	1	Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533	64	0	0	0	NCT00845702	6TERMINATED	2010-02-01	2009-04-01	Guerbet	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	82	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.	Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesa...	Hypotension	spinal anesthesia cesarean section	null	2	arm 1: colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. arm 2: crystalloid administration; The patients received 1.5 L...	[ 0, 1 ]	3	[ 10, 10, 0 ]	intervention 1: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. intervention 2: The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. intervention 3: A phenylephrine infusion will be start...	intervention 1: Colloid administration intervention 2: Crystalloid administration intervention 3: phenylephrine infusion	1	Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592	82	0	0	0	NCT00846651	1COMPLETED	2010-02-01	2009-02-01	Milton S. Hershey Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	1	RANDOMIZED	SINGLE_GROUP	0TREATMENT	2DOUBLE	true	1FEMALE	false	The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.	Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.	Overactive Bladder	Overactive Bladder Incontinence Solifenacin Women Postoperative	null	2	arm 1: Placebo Orally 9 weeks once daily. arm 2: Solifenacin Orally 9 weeks once daily.	[ 2, 0 ]	2	[ 0, 10 ]	intervention 1: Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks. intervention 2: Take orally once daily for 9 weeks.	intervention 1: Solifenacin intervention 2: Placebo	1	Weston \| Florida \| United States \| -80.39977 \| 26.10037	1	0	0	0	NCT00852696	6TERMINATED	2010-02-01	2008-02-01	Cleveland Clinic Florida	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	225	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	true	This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Ind...	null	Acute Gout Flare	Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout Flare	null	3	arm 1: Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). arm 2: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin o...	[ 1, 1, 1 ]	4	[ 0, 0, 10, 10 ]	intervention 1: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline). intervention 2: Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). intervention 3: Placebo (for Indomethacin) orally TID for 12 days. interve...	intervention 1: Rilonacept intervention 2: Indomethacin intervention 3: Placebo (for Indomethacin) intervention 4: Placebo (for Rilonacept)	44	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Mesa \| Arizona \| United States \| -111.82264 \| 33.42227 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Sierra Vista \| Arizona \| United States \| -110.30369 \| 31.55454 Burbank \| California \| Un...	225	0	0	0	NCT00855920	1COMPLETED	2010-02-01	2009-03-01	Regeneron Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 4 ]	326	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.	The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.	Scalp Seborrheic Dermatitis		null	4	arm 1: Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) arm 2: Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) arm 3: Clobetasol propionate shampoo 0.05% (2/week) arm 4: Ketoconazole shampoo 2% (2/week)	[ 0, 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Association: clobetasol propionate shampoo \& ketoconazole shampoo intervention 2: Association: clobetasol propionate shampoo \& ketoconazole shampoo intervention 3: Monotherapy with clobetasol propionate shampoo intervention 4: Monotherpay ketoconazole shampoo (2/week)	intervention 1: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) intervention 2: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) intervention 3: clobetasol propionate shampoo (2/week) intervention 4: ketoconazole shampoo (2/week)	18	Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Geel \| N/A \| Belgium \| 4.98917 \| 51.16557 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Mons \| N/A \| Belgium \| 3.95229 \| 50.45413 Paris \| N/A \| France \| 2.3488 \| 48.85341 Berlin \| N/A \| Germany...	326	0	0	0	NCT00862654	1COMPLETED	2010-02-01	2009-03-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0
[ 1 ]	22	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	4QUADRUPLE	true	0ALL	true	Phytosterols and ezetimibe each reduce intestinal cholesterol absorption by 30-55% but appear to have different mechanisms of action. The investigators' hypothesis is that phytosterols and ezetimibe given together will block cholesterol absorption in an additive fashion. In a randomized, placebo-controlled crossover tr...	The investigators will perform a randomized, placebo-controlled crossover feeding study in 25 subjects with greater than ideal levels of LDL cholesterol who do not require anti-cholesterol drug treatment. Subjects will consume a baseline diet provided by a feeding center that is deficient in phytosterols for three peri...	Hypercholesterolemia Coronary Heart Disease	Phytosterols Ezetimibe Cholesterol Excretion Cholesterol Absorption Diet Mass Spectrometry Deuterium	null	6	arm 1: The order of treatments is A (phytosterols + ezetimibe), B (double placebo), and C (active ezetimibe and phytosterol placebo). arm 2: The order of treatments is B (double placebo), C (active ezetimibe and phytosterol placebo), and A (phytosterols + ezetimibe). arm 3: The order of treatments is B (double placebo)...	[ 0, 0, 0, 0, 0, 0 ]	3	[ 0, 10, 10 ]	intervention 1: Subjects will undergo three diet periods of 21 days each separated by 7 day washouts. Food will be supplied by a metabolic kitchen and will consist of a phytosterol-deficient baseline diet. During each period subjects will receive either phytosterol esters or placebo and ezetimibe or placebo. interventi...	intervention 1: Ezetimibe intervention 2: Phytosterols + ezetimibe intervention 3: Placebo	1	Logan \| Utah \| United States \| -111.83439 \| 41.73549	66	0	0	0	NCT00863265	1COMPLETED	2010-02-01	2009-06-01	Washington University School of Medicine	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	416	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once dail...	null	Depressive Disorder	Immediate-release formulation of paroxetine (paroxetine IR) HAM-D (17 items) Controlled-release formulation of paroxetine (paroxetine CR)	null	3	arm 1: controlled-release (CR) of paroxetine 12.5 to 50mg/day arm 2: Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm arm 3: matched placebo to both paroxetine CR and paroxetine IR	[ 0, 5, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: 1 or 2 tablets once a day intervention 2: 1 tablet once a day intervention 3: 1 or 2 tablets once a day intervention 4: 1 or 2 tablets once a day intervention 5: 1 or 2 tablets once a day intervention 6: 1 or 2 tablets once a day	intervention 1: paroxetine IR 10mg tablet intervention 2: paroxetine IR 20mg tablet intervention 3: matched placebo to paroxetine IR 10mg or 20mg intervention 4: Paroxetine CR 12.5mg tablet intervention 5: Paroxetine CR 25mg tablet intervention 6: matched placebo to paroxetine CR 12.5mg or 25mg	67	Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Aichi \| N/A \| Japan \| 130.62158 \| 32.51879 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.41667 \| 33.6 Fukuoka \| N/A \| Japan \| 130.4...	660	0	0	0	NCT00866294	1COMPLETED	2010-02-01	2009-04-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 3 ]	87	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021.	null	Diabetes Mellitus, Type 2	Diabetes Mellitus, Type 2	null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 2, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 4 capsules by mouth taken once daily for 12 weeks intervention 2: 4 capsules by mouth once daily for 12 weeks	intervention 1: LY2409021 intervention 2: Placebo	19	Buena Park \| California \| United States \| -117.99812 \| 33.86751 Huntington Park \| California \| United States \| -118.22507 \| 33.98168 Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Fort Lauderdale \| Florida \| United States \| -80.14338 \| 26.12231 Jupiter \| Florida \| United States \| -80.09421 \| 26.9...	85	0	0	0	NCT00871572	1COMPLETED	2010-02-01	2009-03-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,142	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).	null	Chronic Obstructive Pulmonary Disease (COPD)	chronic obstructive pulmonary disease COPD indacaterol tiotropium bronchodilation	null	2	arm 1: Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Dai...	[ 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was sup...	intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol	176	Anniston \| Alabama \| United States \| -85.83163 \| 33.65983 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Phoenix \| Arizona \| United Stat...	1,142	0	0	0	NCT00877383	1COMPLETED	2010-02-01	2009-04-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	98	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post...	null	Nausea and Vomiting, Postoperative		null	2	arm 1: The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). arm 2: The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishab...	intervention 1: Ondansetron intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	98	0	0	0	NCT00878228	1COMPLETED	2010-02-01	2009-04-01	Hospital for Special Surgery, New York	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	512	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.	Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if...	Migraine Disorders	COL-144 acute treatment migraine	null	5	arm 1: 50 mg lasmiditan administered orally (PO) arm 2: 100 mg lasmiditan administered orally (PO) arm 3: 200 mg lasmiditan administered orally (PO) arm 4: 400 mg lasmiditan administered orally (PO) arm 5: Placebo administered orally (PO)	[ 0, 0, 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours. ...	intervention 1: Lasmiditan intervention 2: Placebo	39	Montegnée \| Liege \| Belgium \| 5.51411 \| 50.64576 Hasselt \| Limburg \| Belgium \| 5.33781 \| 50.93106 Leuven \| Vlaams-Brabant \| Belgium \| 4.70093 \| 50.87959 Bruges \| West-Vlaanderen \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Helsinki \| Etelä-Suomi...	390	0	0	0	NCT00883051	1COMPLETED	2010-02-01	2009-07-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	166	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.	null	Type 2 Diabetes Mellitus		null	2	arm 1: None arm 2: None	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Tablets, Oral, 2.5 mg, Twice daily, 12 weeks intervention 2: Tablets, Oral, Placebo, Twice daily, 12 weeks	intervention 1: Saxagliptin plus metformin IR intervention 2: Placebo plus metformin IR	41	Concord \| California \| United States \| -122.03107 \| 37.97798 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Lomita \| California \| United States \| -118.31507 \| 33.79224 San Diego \| California \| United States \| -117.16472 \| 32.71571 Altamonte Springs \| Florida \| United States \| -81.36562 \| 28.66111 ...	160	0	0	0	NCT00885378	1COMPLETED	2010-02-01	2009-05-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	247	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).	In this multicenter, randomized, double-blind, placebo-controlled study, the efficacy and safety of imiquimod 3.75% cream following cryosurgery to treat clinically typical visible or palpable AK lesions on the face was compared with that of placebo cream. Based on a 1:1 randomization, approximately 120 subjects applied...	Actinic Keratosis	actinic keratosis skin disease	null	2	arm 1: placebo cream in 250mg/packet, up to 2 packets applied daily arm 2: Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period intervention 2: cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period	intervention 1: imiquimod cream intervention 2: placebo cream	18	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Saint Petersberg \| Florida \| United States \| N/A \| N/A West Palm Beach \| Florida \| United States \| -80.05337 \| 26.71534 Newnan \| Georgia \| United States \| -84.79966 \| 33.38067 Skokie \| Illinoi...	247	0	0	0	NCT00894647	1COMPLETED	2010-02-01	2009-05-01	Graceway Pharmaceuticals, LLC	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 0 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.	The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even h...	Shift-Work Sleep Disorder	Shift-work SWSD eszopiclone MWT shiftworkers	null	2	arm 1: Treatment with eszopiclone arm 2: Treatment with matching placebo	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) intervention 2: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)	intervention 1: eszopiclone intervention 2: matching placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	48	0	0	0	NCT00900159	1COMPLETED	2010-02-01	2009-05-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	13	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically...	null	Adverse Effects	lidocaine pre-medication mammography pain safety	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water	intervention 1: 4% lidocaine gel	1	Boise \| Idaho \| United States \| -116.20345 \| 43.6135	10	0	0	0	NCT00925353	1COMPLETED	2010-02-01	2010-01-01	Mountain States Tumor and Medical Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	357	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.	The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neithe...	Attention Deficit Disorder With Hyperactivity	Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl CONCERTA® (OROS MPH)	null	2	arm 1: OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks arm 2: Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks intervention 2: Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks intervention 3: Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks intervention 4: Optimal Patient Dose (placebo to match 18 mg - 72 mg) ...	intervention 1: OROS MPH intervention 2: Placebo intervention 3: OROS MPH Tablets intervention 4: Placebo Tablets	0	null	349	0	0	0	NCT00937040	1COMPLETED	2010-02-01	2009-07-01	Ortho-McNeil Janssen Scientific Affairs, LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	true	0ALL	true	This protocol describes a study to gain experience in the use of Clevidipine for perioperative blood pressure control in patients undergoing craniotomy for brain tumor or epilepsy focus resection. The purpose of this study is to establish the efficacy of Clevidipine for intraoperative blood pressure control in patients...	Clevidipine, a recently introduced, short-acting, vascular-selective calcium antagonist, could be a potentially useful adjuvant for neurosurgical cases. It decreases arterial blood pressure by reducing systemic vascular resistance with no effect on venous capacitance vessels (7). Clevidipine was successfully used for t...	Hypertension Brain Tumor Epilepsy	Hypertension Neurosurgery bloodpressure control brain tumor resection epilepsy focus resection	null	1	arm 1: 21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia	[ 0 ]	1	[ 0 ]	intervention 1: Clevidipine (0.5 mg/ml in 20 % lipid solution) will be administered via peripheral vein using syringe pump; drug infusion will be initiated at 5 mg/hr (10ml/h) and titrated to effect up to a maximum rate of 32 mg/hr when SBP exceeds 130 mm Hg. The anesthesiologist will be allowed to administer the alter...	intervention 1: Clevidipine	1	New York \| New York \| United States \| -74.00597 \| 40.71427	22	0	0	0	NCT00952081	1COMPLETED	2010-02-01	2009-07-01	NYU Langone Health	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	8	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calc...	null	Diastolic Dysfunction	Separation Cardiopulmonary bypass Calcium chloride	null	2	arm 1: Calcium chloride, 10mg/kg arm 2: Normal saline	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes intervention 2: Normal saline, 50cc delivered over 5 minutes	intervention 1: Calcium Chloride intervention 2: Placebo	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	8	0	0	0	NCT00955266	6TERMINATED	2010-02-01	2009-07-01	Brigham and Women's Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	15	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; ...	This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; ...	Hypertriglyceridemia	hypertriglyceridemia Omega-3 Fatty Acids Lipoprotein Statin Lovaza	null	1	arm 1: Lovaza was given as the only agent; there was no comparator agent or arm	[ 0 ]	1	[ 0 ]	intervention 1: 1 gram gel capsule 4 capsules per day for 8 weeks	intervention 1: Lovaza	1	Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997	15	0	0	0	NCT00959842	1COMPLETED	2010-02-01	2009-09-01	Sanford Research	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	195	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to: * its individual components (Brinz and Brim), and * the concomitant administration of Brinz and Brim (Brinz+Brim).	This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medicat...	Open-Angle Glaucoma Ocular Hypertension	Open-Angle Glaucoma Ocular Hypertension Brinzolamide Brimonidine Intraocular Pressure	null	4	arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug. arm 2: Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in...	[ 0, 1, 1, 1 ]	4	[ 0, 0, 0, 10 ]	intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used as placebo	intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide ophthalmic suspension, 1% intervention 3: Brimonidine tartrate ophthalmic solution, 0.2% intervention 4: Vehicle	0	null	170	0	0	0	NCT00961649	6TERMINATED	2010-02-01	2009-10-01	Alcon Research	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	36	RANDOMIZED	CROSSOVER	null	2DOUBLE	false	0ALL	false	Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).	The main purpose for this study is to determine whether dimebon exhibits abuse potential.	Alzheimer's Disease Huntington's Disease	oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety	null	6	arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None	[ 0, 0, 0, 2, 1, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Oral tablet; 20 mg dimebon, single dose intervention 2: Oral tablet; 40 mg dimebon, single dose intervention 3: Oral tablet; 60 mg dimebon, single dose intervention 4: Oral tablet or capsule; placebo, single dose intervention 5: Oral capsule; 1 mg alprazolam, single dose intervention 6: Oral capsule; 3 ...	intervention 1: dimebon intervention 2: dimebon intervention 3: dimebon intervention 4: placebo intervention 5: alprazolam intervention 6: alprazolam	0	null	195	0	0	0	NCT00975481	1COMPLETED	2010-02-01	2009-10-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	203	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.	null	Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy	immunotherapy	null	3	arm 1: Matching placebo tablet sublingual, once daily arm 2: 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily arm 3: 12 Amb a 1-U in an AIT, sublingual, once daily	[ 2, 0, 0 ]	3	[ 0, 2, 2 ]	intervention 1: Placebo sublingual tablet, once daily intervention 2: Allergy immunotherapy tablet (sublingual) intervention 3: Allergy immunotherapy tablet (sublingual)	intervention 1: Placebo intervention 2: SCH 39641 intervention 3: SCH 39641	0	null	196	0	0	0	NCT00978029	1COMPLETED	2010-02-01	2009-11-01	ALK-Abelló A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	47	NA	SINGLE_GROUP	null	0NONE	true	1FEMALE	false	The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.	null	Chronic Hepatitis C		null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: Tablets, Oral, 60 mg, once daily, 10 days intervention 2: Tablets, Oral, once daily, 78 days	intervention 1: BMS-790052 intervention 2: Ortho Tri-Cyclen®	3	Tempe \| Arizona \| United States \| -111.90931 \| 33.41477 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Saint-Laurent \| Quebec \| Canada \| -73.66585 \| 45.50008	116	0	0	0	NCT00983957	1COMPLETED	2010-02-01	2009-10-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The optimal insulin therapy in T2DM is controversial and its impact on nonalcoholic fatty liver disease (NAFLD) has not been systematically studied before, and in particular, never when using the new insulin formulations detemir (Levemir®) or aspart (Novolog®). This study is to determine the effect on hepatic steatosis...	The control of hyperglycemia in T2DM ameliorates the metabolic abnormalities of T2DM but whether this improves hepatic steatosis has not been examined carefully with the use of improved insulin formulations (long-acting insulins detemir or glargine, alone or combined with pre-meal short-acting insulins). Most research ...	Type 2 Diabetes	Type 2 diabetes mellitus Insulin therapy Detemir (Levemir) Aspart (Novolog) Hepatic steatosis	null	2	arm 1: Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir). arm 2: After baseline evaluations, insulin detemir will be given at be...	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. intervention 2: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart b...	intervention 1: Long-acting bedtime insulin detemir (Levemir) intervention 2: Insulin detemir and pre-meal insulin aspart.	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	52	0	0	0	NCT00998335	1COMPLETED	2010-02-01	2007-06-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	24	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary aim of the study is to determine the impact on hepatic steatosis of replacing premeal rapid-acting insulin for exenatide (Byetta) while maintaining bedtime long-acting detemir (Levemir) insulin in well-controlled patients with type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD). Se...	Type 2 diabetes mellitus (T2DM) is a major public health problem in the United States with \~2/3 of Americans that are overweight or frankly obese. Less well recognized is that obesity and T2DM are fueling another "silent epidemic": non-alcoholic fatty liver disease (NAFLD). In NAFLD, hepatic fat accumulation ranges fr...	Nonalcoholic Fatty Liver Disease Type 2 Diabetes Mellitus		null	1	arm 1: Patients with T2DM well-controlled on an intensified insulin regimen for the previous 6 months by the will have their insulin aspart discontinued and replaced for exenatide twice daily while continuing the bedtime detemir insulin. Safety and efficacy parameters will be measured before and after 6 months of treat...	[ 0 ]	1	[ 0 ]	intervention 1: The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined...	intervention 1: Exenatide	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	20	0	0	0	NCT01006889	1COMPLETED	2010-02-01	2008-01-01	University of Florida	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	218	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate efficacy and safety of fentanyl in opioid-naive participants with osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stuff) or low back pain who cannot obtain a sufficient analgesic effect by the treatment of non-opioid analge...	This is a multi-center (conducted in more than one center), double-blind (neither the participant nor the physician knows the assigned study drug), randomized (participants assigned study drug by chance), withdrawal study in opioid-naive participants with osteoarthritis or low back pain. The study will consist of titra...	Chronic Pain Osteoarthritis Low Back Pain	Chronic pain Osteoarthritis Low back pain Fentanyl JNS020QD Patch, transdermal Opioid analgesics	null	3	arm 1: One-day adhesive transdermal patch containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which will be increased by 12.5 mcg/hr at one time based on the medical examination of numbe...	[ 0, 0, 2 ]	2	[ 0, 0 ]	intervention 1: One-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper arm or thigh and replaced every day. intervention 2: Placebo patch indistinguishable from one-day adhesive transdermal patch containing fentanyl 12.5 to 50 mcg/hr applied to chest, abdomen, upper ar...	intervention 1: Fentanyl intervention 2: Placebo	59	Aki \| N/A \| Japan \| 133.9 \| 33.5 Akō \| N/A \| Japan \| 137.25 \| 35.55 Amagasaki \| N/A \| Japan \| 135.41667 \| 34.71667 Anan \| N/A \| Japan \| 134.65 \| 33.91667 Annaka \| N/A \| Japan \| 138.89585 \| 36.33011 Chiba \| N/A \| Japan \| 140.11667 \| 35.6 Chiisagata \| N/A \| Japan \| N/A \| N/A Fuchū \| N/A \| Japan \| 139.48216 \| 35.67452 Fuk...	368	0	0	0	NCT01008618	1COMPLETED	2010-02-01	2009-01-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	671	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind ...	This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. This study will consist of a Screening Period, followed by a Single-Blind Placebo Run-in period. The Double-blind Treatment period (14±2 days) will begin at randomization/Day 1 and consist of an interim visit 7±1 days after rando...	Seasonal Allergic Rhinitis	Mountain Cedar	null	3	arm 1: 160 μg once daily arm 2: 80 μg once daily arm 3: Placebo	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Ciclesonide HFA Nasal Aerosol 160 μg once daily intervention 2: Ciclesonide HFA Nasal Aerosol 80 μg once daily intervention 3: Placebo HFA Nasal Aerosol once daily	intervention 1: Ciclesonide HFA 160 μg intervention 2: Ciclesonide HFA 80 μg intervention 3: Placebo	7	Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 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...	671	0	0	0	NCT01010971	1COMPLETED	2010-02-01	2009-12-01	Sumitomo Pharma America, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KO...	null	Post Operative Anterior Chamber Inflammation (Flare)		null	2	arm 1: bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. arm 2: Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days. intervention 2: Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively	intervention 1: Ketorolac Tromethamine 0.45% intervention 2: Bromfenac 0.09%	1	Wilkes-Barre \| Pennsylvania \| United States \| -75.88131 \| 41.24591	50	0	0	0	NCT01023724	1COMPLETED	2010-02-01	2009-12-01	Bucci Laser Vision Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	49	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.	In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and a...	Opioid Abuse	Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence	null	5	arm 1: 8x oxycodone/niacin 5/0mg tablets arm 2: 8x oxycodone/niacin 10/0mg tablets arm 3: 8x oxycodone/niacin 5/30mg tablets arm 4: 8x oxycodone/niacin 10/60mg tablets arm 5: Placebo	[ 1, 1, 0, 0, 2 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses intervention 2: 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses intervention 3: 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses intervention...	intervention 1: 40/0mg taken first intervention 2: 80/0mg taken first intervention 3: 40/240mg taken first intervention 4: 80/480mg taken first intervention 5: 0/0mg taken first	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	245	0	0	0	NCT01030406	1COMPLETED	2010-02-01	2010-01-01	Acura Pharmaceuticals Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.	null	Skin Manifestations		null	2	arm 1: Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks arm 2: Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks intervention 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks	intervention 1: adapalene cream 0.1% and adapalene lotion 0.1% intervention 2: adapalene lotion 0.1%	1	Colorado Springs \| Colorado \| United States \| -104.82136 \| 38.83388	138	0	0	0	NCT01046396	1COMPLETED	2010-02-01	2010-01-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	75	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.	null	Skin Manifestations		null	2	arm 1: Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks arm 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks intervention 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks	intervention 1: adapalene cream 0.1% intervention 2: adapalene lotion 0.1%	1	Carrollton \| Texas \| United States \| -96.89028 \| 32.95373	150	0	0	0	NCT01046565	1COMPLETED	2010-02-01	2010-01-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	48	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	This is a single-center, randomized, double blind, placebo-controlled study evaluating the effects of placebo, codeine, methylnaltrexone and codeine with methylnaltrexone on gastrointestinal motility and colonic transit of solids in healthy human subjects. The hypotheses are: 1. Methylnaltrexone administered subcutan...	Methodology Following the initial screening visit (visit 1), participants will be randomized to study medication, either 0.30mg/kg methylnaltrexone subcutaneously or placebo once daily and 30 mg codeine orally or placebo taken four times daily for a total of five days. Participants will be randomly assigned to study m...	Gastric Motility Disorder	Methylnaltrexone Codeine Gastrointestinal motility Colonic transit	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: 0.30 mg/kg subcutaneous injection daily intervention 2: 30 mg taken orally four times daily for 5 days intervention 3: Methylnaltrexone 0.30 mg/kg by subcutaneous injection once daily and codeine 30 mg taken orally four times daily for 5 days intervention 4: Placebo subcutaneous injection once daily and...	intervention 1: Methylnaltrexone only intervention 2: Codeine only intervention 3: Methylnaltrexone + codeine intervention 4: Placebo + placebo	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	48	0	0	0	NCT01055704	1COMPLETED	2010-02-01	2009-11-01	Mayo Clinic	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	42	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	2MALE	null	The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.	null	Insomnia	Insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)	null	2	arm 1: None arm 2: None	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Group A Period I, Group B Period II: Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting \>=10 hours. Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration...	intervention 1: Eszopiclone 3 mg intervention 2: Eszopiclone 1 mg	1	Sumida City \| Tokyo \| Japan \| 139.82085 \| 35.73289	111	0	0	0	NCT01055834	1COMPLETED	2010-02-01	2010-01-01	Eisai Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	265	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract ...	null	Infection	Cough assessment in upper respiratory infection guaifenesin honey	null	3	arm 1: Placebo arm 2: Guaifenesin arm 3: Buckwheat Honey	[ 2, 0, 0 ]	3	[ 0, 0, 10 ]	intervention 1: One placebo tablet administered orally as a single dose intervention 2: One 400 mg immediate release tablet administered orally as a single dose intervention 3: 10 mL administered orally as a single dose	intervention 1: Placebo intervention 2: Guaifenesin intervention 3: Buckwheat Honey	2	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869	265	0	0	0	NCT01062256	1COMPLETED	2010-02-01	2010-01-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	false	The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD. The investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Oi...	The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost...	Atopic Dermatitis	Atopic Dermatitis Wake Forest Dermatology Skin Over-the-counter Moisturizer Children	null	3	arm 1: Aquaphor Healing Ointment three times daily to atopic dermatitis arm 2: Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis arm 3: EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis	[ 0, 1, 1 ]	3	[ 0, 10, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Atopiclair Nonsteroidal Cream intervention 2: Aquaphor Healing Ointment intervention 3: EpiCeram	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	39	0	0	0	NCT01093469	1COMPLETED	2010-02-01	2009-09-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	96	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	true	Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use...	This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has bee...	Rotator Cuff Tear		null	3	arm 1: The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline. arm 2: The control group patients will receive no continuous infusion catheter. arm 3: Study group patients will receive a subacromial continuous standa...	[ 2, 4, 0 ]	2	[ 0, 0 ]	intervention 1: Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour. intervention 2: The placebo group will receive the same subacromial infusion catheter however, t...	intervention 1: 0.5% bupivacaine intervention 2: Normal Saline	1	Orlando \| Florida \| United States \| -81.37924 \| 28.53834	96	0	0	0	NCT01126593	1COMPLETED	2010-02-01	2008-12-01	Orlando Health, Inc.	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	37	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.	Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized c...	Posttraumatic Stress Disorder	PTSD anxiety disorders trauma	null	2	arm 1: Paroxetine and Prolonged Exposure Therapy arm 2: Placebo pill plus Prolonged Exposure Therapy	[ 0, 2 ]	2	[ 0, 5 ]	intervention 1: Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks intervention 2: Weekly for 10 weeks	intervention 1: Paroxetine intervention 2: Prolonged Exposure Therapy	1	New York \| New York \| United States \| -74.00597 \| 40.71427	37	0	0	0	NCT01130103	1COMPLETED	2010-02-01	2004-03-01	Research Foundation for Mental Hygiene, Inc.	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	null	0NONE	true	0ALL	null	This open label, randomized, three-period crossover study will evaluate the effect of co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine or Tamiflu plus rimantadine in random order, wi...	null	Healthy Volunteer		null	3	arm 1: None arm 2: None arm 3: None	[ 1, 1, 0 ]	2	[ 0, 0 ]	intervention 1: multiple oral doses intervention 2: multiple oral doses	intervention 1: oseltamivir [Tamiflu] intervention 2: rimantadine	1	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648	67	0	0	0	NCT01172847	1COMPLETED	2010-02-01	2009-08-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	716	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	true	The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.	null	Venous Thromboembolism	anticoagulant venus thromboembolism thrombosis thromboembolism embolism and thrombosis deep vein thrombosis DU-176b Edoxaban factor Xa total knee arthroplasty Enoxaparin sodium	null	2	arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery. arm 2: enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: edoxaban intervention 2: enoxaparin sodium	3	Osaka \| N/A \| Japan \| 135.50107 \| 34.69379 Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626	703	0	0	0	NCT01181102	1COMPLETED	2010-02-01	2009-03-01	Daiichi Sankyo Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	92	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	false	The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.	null	Venous Thromboembolism	Anticoagulants Enoxaparin sodium venous thromboembolism. thromboembolism Thrombosis deep vein thrombosis DU-176b Edoxaban factor Xa hip fracture surgery embolism	null	2	arm 1: DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery arm 2: Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: DU-176b (edoxaban) intervention 2: Enoxaparin sodium 20mg	1	Osaka \| N/A \| Japan \| 135.50107 \| 34.69379	88	0	0	0	NCT01181141	1COMPLETED	2010-02-01	2008-10-01	Daiichi Sankyo Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	34	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	false	The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. The investigators hypothesis for these studies is that vitamin D supplementation enhances exercise-induced increases in strength and lean mass, potentially thro...	The study was designed to assess the effects of vitamin D supplementation during exercise training on body composition, muscle function, and glucose tolerance. It was a double-blind, randomized, placebo-controlled, clinical trial with participants randomized into either a 4,000 IU/day vitamin D or placebo group and all...	Obesity Insulin Resistance Inflammation	25-hydroxyvitamin D Parathyroid hormone Lean mass Muscular strength Glucose tolerance	null	2	arm 1: Participants in this arm consumed a 4000 IU vitamin D supplement daily for 12 weeks while participating in a resistance exercise training program. arm 2: Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.	[ 0, 2 ]	2	[ 7, 0 ]	intervention 1: 4000 IU of vitamin D per day for 12 weeks. intervention 2: Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.	intervention 1: Vitamin D intervention 2: Placebo	1	West Lafayette \| Indiana \| United States \| -86.90807 \| 40.42587	0	0	0	0	NCT01199926	1COMPLETED	2010-02-01	2008-08-01	Purdue University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	100	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who...	This is an open-label, multicenter study designed to establish the safety and efficacy of adalimumab in the treatment of moderate to severely active rheumatoid arthritis. A total of 100 subjects with inadequate preexisting standard anti-rheumatic therapy were enrolled at 5 sites in Russia.	Rheumatoid Arthritis	Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis	null	1	arm 1: Adalimumab / pre-filled syringe 40 mg/0.8 ml	[ 0 ]	1	[ 0 ]	intervention 1: Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.	intervention 1: adalimumab	5	Kazan' \| N/A \| Russia \| 49.12214 \| 55.78874 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863	100	0	0	0	NCT01231321	1COMPLETED	2010-02-01	2007-12-01	Abbott	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	104	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This is a prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.	Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period. OBJECTIVES * To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of s...	Diabetic Neuropathies Polyneuropathies	Polyneuropathy Diabetes Mellitus Diabetic peripheral neuropathy	null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses...	intervention 1: F0434 intervention 2: Gabapentin	1	Pachuca \| Hidalgo \| Mexico \| -98.73329 \| 20.11697	75	0	0	0	NCT01263132	1COMPLETED	2010-02-01	2008-02-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	60	NA	SINGLE_GROUP	null	0NONE	false	0ALL	false	Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and occurs all year around. It's caused by allergy to the aerosolised droppings of house dust mites and pet skin flakes (dander). Occasiona...	Rationale Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and occurs all year around. It's caused by allergy to the aerosolised droppings of house dust mites and pet skin flakes (dander)....	Rhinitis, Allergic, Perennial	AVY-REG00108VN	null	1	arm 1: 50 adult patients with Perennial Allergic Rhinities treated with Avamys.	[ 0 ]	1	[ 0 ]	intervention 1: At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray 110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the device into each nostril on...	intervention 1: Avamys aqueous nasal spray 110mcg	1	Hà Nội \| N/A \| Vietnam \| 106.02292 \| 20.47366	56	0	0	0	NCT01270958	1COMPLETED	2010-02-01	2009-08-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	91	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	Study of safety of Saizen® in children born with serious intra-uterine growth retardation (IUGR) treated to final height. An open, phase III study involving 17 centers in France. The study enrolled children who have completed 3 or 2 years of treatment and at least one year of post treatment observation in the Sponsor ...	null	Children Born With Serious Intra-uterine Growth Retardation	Intra-uterine growth retardation (IUGR) Saizen Recombinant human growth hormone (r-hGH) Final height Bone age SGA (Small for Gestational Age)	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 5 ]	3	[ 0, 0, 10 ]	intervention 1: Continuous or intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc). intervention 2: Observed until the first signs of puberty and then continuous treatment with r-hGH 0.067 mg/kg/day sc or observed without treatment. interventi...	intervention 1: Saizen® A intervention 2: Saizen® B intervention 3: Observation only	0	null	91	0	0	0	NCT01400698	1COMPLETED	2010-02-01	1998-11-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	30	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	false	Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less...	Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed...	Diaphragm Paralysis	bupivacaine concentration interscalene nerve block diaphragm function diaphragm weakness	null	2	arm 1: interscalene nerve block with 0.25% bupivacaine arm 2: interscalene nerve block with 0.125% bupivacaine	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: interscalene nerve block performed with 20 ml of 0.25% bupivacaine intervention 2: interscalene block with 20 ml of 0.125% bupivacaine	intervention 1: interscalene nerve block with 0.25% bupivacaine intervention 2: interscalene block with 0.125% bupivacaine	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	28	0	0	0	NCT01429584	1COMPLETED	2010-02-01	2008-05-01	University of Utah	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	126	NON_RANDOMIZED	PARALLEL	1PREVENTION	0NONE	false	0ALL	true	Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmaco...	null	Epilepsy Post-traumatic Epilepsy	Post-Traumatic epilepsy Traumatic brain injury Epilepsy prevention Levetiracetam	null	2	arm 1: 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following hea...	[ 1, 4 ]	1	[ 0 ]	intervention 1: 55 mg/kg/day given in 2 divided doses 12 hours apart	intervention 1: Levetiracetam	2	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511	66	0	0	0	NCT01463033	1COMPLETED	2010-02-01	2005-04-01	Pavel Klein	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	18	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	0ALL	false	To investigate the pharmacokinetics of levodopa when administered concomitantly with BIA 9-1067 or 1 hour after.	Single-centre, open-label, randomized, gender-balanced, crossover study with four consecutive single-dose treatment periods.	Parkinson Disease	Parkinson Disease BIA 9-1067	null	4	arm 1: Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25 arm 2: Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100...	[ 0, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: 50 mg of BIA 9-1067 (single-dose) intervention 2: immediate-release levodopa/carbidopa 100/25 (single-dose).	intervention 1: BIA 9-1067 intervention 2: Sinemet® 100/25 mg	1	Mount Royal \| Quebec \| Canada \| -73.64918 \| 45.51675	69	0	0	0	NCT01533077	1COMPLETED	2010-02-01	2009-03-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	10	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to investigate the effect of BIA 9-1067 on the levodopa pharmacokinetics when administered in combination with immediate release levodopa/carbidopa or levodopa/benserazide in Parkinson's Disease (PD) patients.	This was a three-centre, double-blind, randomised, placebo-controlled, crossover study with four consecutive single-dose treatment periods in PD patients treated with immediate release 100 mg/25 mg levodopa/carbidopa or 100 mg/25 mg levodopa/benserazide	Parkinson's Disease	Parkinson's Disease BIA 9-1067	null	4	arm 1: Treatment Sequence A Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half arm 2: Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 P...	[ 0, 0, 0, 0 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: BIA 9-1067 - 25 mg single-dose intervention 2: BIA 9-1067 - 50 mg single-dose intervention 3: BIA 9-1067 - 100 mg single-dose intervention 4: single-dose intervention 5: Levodopa 100 mg Carbidopa 25 mg intervention 6: Levodopa 100 mg Benzerazide 25 mg	intervention 1: BIA 9-1067 intervention 2: BIA 9-1067 intervention 3: BIA 9-1067 intervention 4: Placebo intervention 5: Levodopa/Carbidopa intervention 6: Levodopa/Benzerazide	3	Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Kyiv \| N/A \| Ukraine \| 30.5238 \| 50.45466	39	0	0	0	NCT01568034	1COMPLETED	2010-02-01	2009-04-01	Bial - Portela C S.A.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	130	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The primary objective of this study is to investigate safety of SPM 962 in advanced PD patients in a multi-center, open-label, non-controlled study following once-daily multiple transdermal doses of SPM962 within a range of 4.5 to 36.0 mg (maximum treatment period: 54 weeks). Efficacy is also to be exploratory investig...	null	Parkinson's Disease	SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day	intervention 1: SPM 962	7	Chubu Region \| N/A \| Japan \| N/A \| N/A Hokkaido Region \| N/A \| Japan \| N/A \| N/A Kanto Region \| N/A \| Japan \| N/A \| N/A Kinki Region \| N/A \| Japan \| N/A \| N/A Kyushu Region \| N/A \| Japan \| N/A \| N/A Shikoku Region \| N/A \| Japan \| N/A \| N/A Tohoku Region \| N/A \| Japan \| N/A \| N/A	130	0	0	0	NCT01631812	1COMPLETED	2010-02-01	2006-12-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	253	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.	null	Diabetic Macular Edema		null	2	arm 1: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria. arm 2: Initial sham injection with up to 1 additional treatment based on re-treatment criteria...	[ 0, 3 ]	3	[ 0, 0, 3 ]	intervention 1: Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. intervention 2: Initial sham injection with up to 1 additional treatment based on re-treatment criteria. intervention 3: Initial laser photocoagulation with up to 3 additional treatme...	intervention 1: Dexamethasone intervention 2: Sham injection intervention 3: Laser Photocoagulation	2	Artesia \| California \| United States \| -118.08312 \| 33.86585 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359	252	0	0	0	NCT00464685	1COMPLETED	2010-02-08	2007-05-01	Allergan	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	197	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The primary objective of this pilot study is to assess effects of Hyoscine Butylbromide (HBB) 20 mg in comparison to placebo, when used as needed, as measured by the subject's assessment of intensity of abdominal pain associated with cramping (APC) in the treatment of two episodes.	null	Abdominal Pain		null	2	arm 1: Patient to receive 1-5 tablets containing 20mg HBB per Abdominal pain associated with cramping (APC) episode arm 2: patient to receive a tablet identical to those containing HBB and take 1-5 tablets per episode	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: 1-5 tablets per episode intervention 2: Active drug, one to five tablets per episode	intervention 1: Placebo intervention 2: HBB 20 mg	19	Westlake Village \| California \| United States \| -118.80565 \| 34.14584 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Jupiter \| Florida \| United States \| -80.09421 \| 26.93422 Rockford \| Illinois \| United States \| -89.094 \| 42.27113 Indianapolis \| Indian...	175	0	0	0	NCT00932737	1COMPLETED	2010-02-08	2009-06-09	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	99	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the st...	This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phas...	Depressive Disorder	anti-depressant Severe Depression Efficacy Major Depressive Disorder Major Depressive Episode	null	2	arm 1: Parallel Group - High Dose Arm, Low Dose Arm arm 2: Parallel Group	[ 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Developed for the treatment of Major Depressive Disorder intervention 2: Developed for the treatment of Major Depressive Disorder intervention 3: Developed for the treatment of Major Depressive Disorder	intervention 1: GSK163090 1 mg intervention 2: GSK163090 Placebo intervention 3: GSK163090 3 mg	15	Kemerovo \| N/A \| Russia \| 86.08333 \| 55.33333 Lipetsk Region \| N/A \| Russia \| N/A \| N/A Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Nizhny Novgorod \| N/A \| Russia \| 44.00205 \| 56.32867 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Ru...	99	0	0	0	NCT00896363	1COMPLETED	2010-02-09	2009-04-23	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	3	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, a...	3.2 Study Design/Type 1. Patient meeting inclusion/exclusion criteria is enrolled up to 24 hours after admission for a vasoocclusive episode. 2. Prior to onset of ketamine infusion, the following information is collected: 1. Demographic information (age, gender, SCD genotype, past history of SCD-related complicati...	Sickle Cell Disease	ketamine vasoocclusive pain	null	1	arm 1: This group will receive ketamine	[ 0 ]	1	[ 0 ]	intervention 1: Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr. Dosing Regimen: * Patients begin the ketamine infusion at 0.05 mg/kg/hr. * 4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if: ...	intervention 1: ketamine	2	Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371	3	0	0	0	NCT00595530	6TERMINATED	2010-02-12	2008-03-04	Connecticut Children's Medical Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	29	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already rec...	null	Rheumatoid Arthritis		null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: 8mg/kg iv every 4 weeks for 24 weeks	intervention 1: tocilizumab [RoActemra/Actemra]	4	City of Muntinlupa \| N/A \| Philippines \| 121.0475 \| 14.39028 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 San Fernando City \| N/A \| Philippines \| 120.68445 \| 15.03425	29	0	0	0	NCT00848120	1COMPLETED	2010-02-13	2008-12-31	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	259	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The current study is a 52-week safety study in elderly outpatients with chronic primary insomnia randomized to treatment with 1.5 mg or 3.0 mg of esmirtazapine (Org 50081, SCH 900265, MK-8265) to investigate the safety and tolerability of long-term treatment with esmirtazapine in elderly patients.	Insomnia is a common complaint or disorder throughout the world. About one third of the population in the industrial countries reports difficulty initiating or maintaining sleep, resulting in a non-refreshing or non-restorative sleep. The majority of the insomniacs suffer chronically from their complaints. The maleic ...	Sleep Initiation and Maintenance Disorder; Elderly Mental Disorder Dyssomnias Sleep Disorders Sleep Disorder, Intrinsic	elderly randomized double blind	null	2	arm 1: Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks arm 2: Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks	[ 0, 0 ]	1	[ 0 ]	intervention 1: One tablet daily	intervention 1: Esmirtazapine	0	null	259	0	0	0	NCT00561574	1COMPLETED	2010-02-14	2008-01-09	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	795	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.	The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in th...	Rhinitis, Allergic, Seasonal	Rhinitis Seasonal Allergic Rhinitis Mometasone Furoate Equivalence Hay fever	null	3	arm 1: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. arm 3: Placebo nasal spray admi...	[ 0, 1, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 2: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. intervention 3: Placebo nasal spray administered once daily (4 actuations) for 14 days.	intervention 1: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) intervention 2: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray intervention 3: Placebo	8	Austin \| Texas \| United States \| -97.74306 \| 30.26715 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Kerrville \| Texas \| United States \| -99.14032 \| 30.04743 Live Oak \| Texas \| United States \| -98.3364 \| 29.56523 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 San Antonio \| Texas \| United States \| -98...	795	0	0	0	NCT01038427	1COMPLETED	2010-02-16	2009-12-02	Sandoz	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	48	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	false	A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.	null	Breast Cancer		null	2	arm 1: Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes. arm 2: Single dose of dalotuzumab 20 mg/kg infused intravenously over 60-120 minutes.	[ 0, 0 ]	1	[ 0 ]	intervention 1: Single intravenous infusion	intervention 1: dalotuzumab (MK0646)	0	null	45	0	0	0	NCT00759785	1COMPLETED	2010-02-17	2008-09-30	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	230	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.	null	Dry Eye	Dry Eye ophthalmic delivery	null	4	arm 1: Placebo Ophthalmic Solution arm 2: Lifitegrast arm 3: Lifitegrast arm 4: Lifitegrast	[ 2, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Ophthalmic Solution intervention 2: Ophthalmic Solution	intervention 1: Lifitegrast intervention 2: Placebo	5	Waterbury \| Connecticut \| United States \| -73.0515 \| 41.55815 Lewiston \| Maine \| United States \| -70.21478 \| 44.10035 Andover \| Massachusetts \| United States \| -71.137 \| 42.65843 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953	230	0	0	0	NCT00926185	1COMPLETED	2010-02-18	2009-08-03	Shire	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	27	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used...	An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.	Chronic Pain	Opioid tolerant Pediatric Male 6-17 years of age Female 6-17 years of age Pain Non malignant Malignant	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period. Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications	intervention 1: Oxymorphone ER	13	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Stanford \| California \| United States \| -122.16608 \| 37.42411 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.8951...	51	0	0	0	NCT00765856	6TERMINATED	2010-02-22	2008-11-17	Endo Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	619	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia. The study will also evaluate t...	null	Primary Hypercholesterolemia Mixed Hyperlipidemia		null	6	arm 1: Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 2: Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks arm 3: Participants receive SCH 900271 5 mg ...	[ 0, 0, 0, 0, 0, 2 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks intervention 2: oral tablets; SCH 900271 10 mg taken once daily for 8 weeks intervention 3: oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks intervention 4: oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks intervention...	intervention 1: SCH 900271 15mg intervention 2: SCH 900271 intervention 3: SCH 900271 intervention 4: SCH 900271 intervention 5: SCH 900271 intervention 6: Placebo	0	null	618	0	0	0	NCT00941603	1COMPLETED	2010-02-22	2009-06-29	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	174	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	false	This study is designed to evaluate the safety and beneficial effects of elagolix (NBI-56418) compared to placebo and leuprorelin (an approved endometriosis therapy) over a three month period followed by an additional three months of treatment on elagolix.	The study followed a parallel-group design in which participants were randomized (1:1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (q.d.); 250 mg elagolix q.d.; placebo; or leuprorelin acetate depot injection 3.75 mg (monthly). Blinding was achieved using a ...	Endometriosis	bone mineral density,endometriosis,pelvic pain	null	4	arm 1: Participants received placebo tablets once a day and placebo intramuscular injection once a month for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) for 12 weeks. arm 2: Participants received elagolix 150 mg tablets once a day and p...	[ 2, 0, 0, 5 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Leuprorelin acetate depot injection 3.75 mg administered as an intramuscular injection intervention 2: Elagolix tablets administered orally intervention 3: Placebo tablet administered orally intervention 4: Saline solution administered as an intramuscular injection	intervention 1: Leuprorelin Acetate Depot intervention 2: Elagolix intervention 3: Placebo to Elagolix intervention 4: Placebo to Leuprorelin Acetate	0	null	259	0	0	0	NCT00797225	1COMPLETED	2010-02-24	2008-11-26	AbbVie	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	11	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy...	OBJECTIVES: Primary * Determine the feasibility of a new intensification regimen comprising cisplatin and paclitaxel in combination with radiotherapy and surgery in patients with resectable advanced squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx. Secondary * Assess the disease-free interval ...	Head and Neck Cancer	stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the or...	null	1	arm 1: PREOPERATIVE:Patients receive cisplatin IV over 2 hours three times weekly in week 1 once daily(QD),5 days a week, in weeks 1-2. SURGERY:Patients undergo triple endoscopy and biopsy with submandibular gland transfer in week 3. INTRAOPERATIVE: Patients also undergo Intensity-Modulated Radiation Therapy (IMRT) E...	[ 0 ]	4	[ 0, 0, 4, 3 ]	intervention 1: Patients will receive Cisplatin (30 mg/m2 i.v.) daily x 3 days in week 1. intervention 2: Patients will receive Paclitaxel (45 mg/m2i.v.) infusion over 3 hours during weeks 7,8,9,10 intervention 3: Patients will receive Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation to tumor and in...	intervention 1: Cisplatin intervention 2: Paclitaxel intervention 3: Intensity-Modulated Radiation Therapy (IMRT) External Beam Radiation intervention 4: Triple endoscopy and biopsy	1	Columbus \| Ohio \| United States \| -82.99879 \| 39.96118	11	0	0	0	NCT00566540	6TERMINATED	2010-02-25	2007-12-11	Ohio State University Comprehensive Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 2 ]	32	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.	null	Renal Impairment	Betrixaban Renal impairment Healthy Kidney dysfunction	null	4	arm 1: Healthy subjects matched to the renal impairment groups arm 2: Patients with mild renal impairment arm 3: Patients with moderate renal impairment arm 4: Patients with severe renal impairment	[ 1, 0, 0, 0 ]	1	[ 0 ]	intervention 1: 80 mg betrixaban qd for 8 days	intervention 1: Betrixaban	1	Munich \| N/A \| Germany \| 11.57549 \| 48.13743	32	0	0	0	NCT00999336	1COMPLETED	2010-02-28	2009-07-31	Portola Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	340	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.	null	Seasonal Allergic Rhinitis Hay Fever		null	2	arm 1: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks. intervention 2: Placebo nasal aerosol administered each morning for two weeks.	intervention 1: Beclomethasone dipropionate intervention 2: Placebo Nasal Aerosol	4	Austin \| Texas \| United States \| -97.74306 \| 30.26715 New Braunfels \| Texas \| United States \| -98.12445 \| 29.703 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Waco \| Texas \| United States \| -97.14667 \| 31.54933	338	0	0	0	NCT01024608	1COMPLETED	2010-02-28	2009-12-31	Teva Branded Pharmaceutical Products R&D, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	1,225	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumon...	null	Methicillin Resistant Staphylococcus Aureus (MRSA)	Staphylococcal pneumonia Methicillin-resistant staphylococcal pneumonia healthcare-associated pneumonia	null	2	arm 1: Subjects receiving linezolid for the treatment phase of the study arm 2: Subjects receiving vancomycin for the treatment phase of the study	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion. intervention 2: Subjects to receive vancomycin 15mg/kg IV (Intravenous) ...	intervention 1: linezolid (Zyvox) intervention 2: vancomycin	177	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Montgomery \| Alabama ...	1,184	1	0.000845	1	NCT00084266	1COMPLETED	2010-03-01	2004-10-01	Pfizer	4INDUSTRY	false	false	false	null	0	1	0	0.000149
[ 4 ]	370	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in maintaining remission and renal function. Patients were randomized to receive either MMF (1....	null	Lupus Nephritis		null	4	arm 1: Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24 weeks of the Induction Phase. arm 2: Participants received monthly infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids f...	[ 0, 1, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached. intervention 2: Intravenous cyclophosphamide (IVC) was administered every four weeks (...	intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide intervention 3: Azathioprine intervention 4: Placebo to Azathioprine intervention 5: Placebo to Mycophenolate mofetil intervention 6: Corticosteroid	108	Huntsville \| Alabama \| United States \| -86.58594 \| 34.7304 La Jolla \| California \| United States \| -117.2742 \| 32.84727 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Francisco \| California \| United States \| -122.41942 \| 37.77493 San Leandro \| California \| United States \| -122.15608 \| 37.72493 Tor...	590	2	0.00339	1	NCT00377637	1COMPLETED	2010-03-01	2005-07-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	2	0.00093
[ 5 ]	588	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The primary objectives were: * To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60 * To demonstrate the...	null	Diabetes Mellitus, Type 2		null	3	arm 1: Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. arm 2: Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. arm 3: Premixed insulin (Novolog® Mix 70/30) added to oral agents.	[ 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Subcutaneous injection up to 1 injection per day intervention 2: Subcutaneous injection once-a-day intervention 3: Subcutaneous injection twice-a-day. intervention 4: Subcutaneous injection up to 3 injections per day.	intervention 1: Insulin Glulisine intervention 2: Insulin Glargine intervention 3: Premixed Insulin intervention 4: Insulin Glulisine	1	Bridgewater \| New Jersey \| United States \| -74.64815 \| 40.60079	582	1	0.001718	1	NCT00384085	1COMPLETED	2010-03-01	2006-05-01	Sanofi	4INDUSTRY	false	false	false	null	0	0	1	0.000303
[ 4 ]	768	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	true	The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.	On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in ...	Metastatic Colorectal Cancer	colorectal neoplasms	null	2	arm 1: None arm 2: None	[ 0, 2 ]	8	[ 0, 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days intervention 2: 180mg/m2 iv day 1 every 14 days intervention 3: 200mg/m2 iv; day 1 every 14 days intervention 4: 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free...	intervention 1: 5 fluorouracil intervention 2: irinotecan intervention 3: levo- leucovorin intervention 4: sunitinib intervention 5: 5 fluorouracil intervention 6: irinotecan intervention 7: levo- leucovorin intervention 8: placebo	132	La Plata \| Buenos Aires \| Argentina \| -57.95442 \| -34.92126 Santa Fe \| Santa Fe Province \| Argentina \| -60.70868 \| -31.64881 Wollongong \| New South Wales \| Australia \| 150.89345 \| -34.424 East Bentleigh \| Victoria \| Australia \| N/A \| N/A Frankston \| Victoria \| Australia \| 145.12291 \| -38.14458 Fremantle \| Western Austr...	763	1	0.001311	1	NCT00457691	1COMPLETED	2010-03-01	2007-06-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	1	0.000231
[ 5 ]	154	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	The aim of this clinical trial is to compare the efficacy and safety of ritonavir (RTV)-boosted atazanavir with nevirapine, each on a background of emtricitabine and tenofovir disoproxil fumarate (DF).	null	HIV Infections		null	2	arm 1: after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks arm 2: patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with...	[ 1, 1 ]	7	[ 0, 0, 0, 0, 0, 0, 0 ]	intervention 1: 300 mg QD intervention 2: 300 mg QD intervention 3: 200 mg QD intervention 4: 200 mg QD intervention 5: 200 mg BID intervention 6: 300 mg QD intervention 7: 100 mg QD	intervention 1: tenofovir DF 300 mg QD intervention 2: tenofovir DF 300 mg QD intervention 3: emtricitabine 200 mg QD intervention 4: emtricitabine 200 mg QD intervention 5: Nevirapine 200 mg BID intervention 6: Atazanavir 300 mg intervention 7: Ritonavir 100 mg	19	Beverly Hills \| California \| United States \| -118.40036 \| 34.07362 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Fort Lauderdale \| Florida \| United States \| -80.14338...	152	1	0.006579	1	NCT00552240	1COMPLETED	2010-03-01	2007-09-01	Boehringer Ingelheim	4INDUSTRY	false	false	false	null	0	0	1	0.001162
[ 4 ]	383	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	AMB-320/321-E was designed to provide long-term, controlled monitoring of pulmonary arterial hypertension (PAH) patients treated with ambrisentan (AMB) in order to properly define the adverse event profile associated with this endothelin receptor antagonist (ERA), including the incidence and severity of elevated serum ...	AMB-320 (ARIES-1; NCT00423748) and AMB-321 (ARIES-2; NCT00423202) were 12-week, Phase 3, randomized, double-blind, placebo-controlled, multicenter, efficacy studies of AMB in subjects with PAH. The objectives of these studies were to determine the effect of three doses of AMB (2.5, 5.0, and 10.0 mg) on exercise capacit...	Pulmonary Arterial Hypertension		null	1	arm 1: 2.5, 5 or 10 mg ambrisentan	[ 0 ]	1	[ 0 ]	intervention 1: 2.5, 5.0 or 10.0 mg ambrisentan po, qd, long-term	intervention 1: ambrisentan	22	Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Ciudad Autonoma de Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Mar del Plata \| Buenos Aires \| Argen...	383	2	0.005222	1	NCT00578786	1COMPLETED	2010-03-01	2004-02-01	Gilead Sciences	4INDUSTRY	false	false	false	null	2	0	0	0.001433
[ 4 ]	62	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	false	Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.	null	Epilepsy	Epilepsy; Monotherapy Partial Onset Seizures Adults and Adolescents	null	2	arm 1: 50 mg daily arm 2: 100 mg daily	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg \> 20 mg) for subjects not participating in the follow-up study) intervention 2: 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg \> 50 mg \> 20 mg) for subjects not participating in the follow-up ...	intervention 1: Brivaracetam intervention 2: Brivaracetam	68	Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Garden Grove \| California \| United States \| -117.94145 \| 33.77391 Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Riverside \| California \| United States \| -117.39616 \| 33.9533...	62	1	0.016129	1	NCT00699283	6TERMINATED	2010-03-01	2008-08-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	1	0	0.002853
[ 4 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.	null	Diabetes, Type 1		null	2	arm 1: Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) arm 2: Humalog (insulin lispro) in combination with Lantus (insulin glargine)	[ 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Technosphere Insulin Inhalation Powder 15U or 30U intervention 2: Lantus-injectible supplied as 3mL (300 units) pens intervention 3: Humalog autopen cartridges pre-filled with 3mL (300 units)	intervention 1: Technosphere Insulin intervention 2: Insulin glargine intervention 3: Insulin lispro	22	Huntington Beach \| California \| United States \| -117.99923 \| 33.6603 La Jolla \| California \| United States \| -117.2742 \| 32.84727 San Mateo \| California \| United States \| -122.32553 \| 37.56299 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florid...	130	1	0.007692	1	NCT00700622	6TERMINATED	2010-03-01	2008-05-01	Mannkind Corporation	4INDUSTRY	false	false	false	null	0	1	0	0.001359
[ 4 ]	682	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.	null	Major Depressive Disorder	Major Depressive Disorder	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 10 mg tablet, once daily dosing for 8 weeks intervention 2: 50 mg tablet, once daily dosing for 8 weeks intervention 3: Matching placebo tablets (10 or 50mg). Daily dosing for 10 +/- 4 days during a placebo lead-in period, and then 8 weeks during the double-blind period.	intervention 1: Desvenlafaxine Succinate Sustained-Release 10mg intervention 2: Desvenlafaxine Succinate Sustained-Release 50 mg intervention 3: placebo	24	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Encino \| California \| United States \| -118.50119 \| 34.15917 Newport Beach \| California \| United States \| -117.92895 \| 33.61891 Redlands \| California \| United States \| -117.18254 \| 34.05557 Upland \| California \| United States \| -117.64839 \| 34.09751 Aurora \| Co...	673	1	0.001486	1	NCT00863798	1COMPLETED	2010-03-01	2009-04-01	Wyeth is now a wholly owned subsidiary of Pfizer	4INDUSTRY	false	false	false	null	0	1	0	0.000262
[ 4 ]	1,598	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.	null	Chronic Obstructive Pulmonary Disease	COPD indacaterol beta 2 agonist tiotropium	null	2	arm 1: Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication. arm 2...	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI). intervention 2: Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was provided in pow...	intervention 1: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to tiotropium	212	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Jasper \| Alabama \| United States \| -87.27751 \| 33.83122 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Stockton \| California \| Unite...	1,593	1	0.000628	1	NCT00900731	1COMPLETED	2010-03-01	2009-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	1	0.000111
[ 4 ]	571	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether receiving combined carboplatin and paclitaxel plus continued low-dose paclitaxel is more effective than carboplatin ...	OBJECTIVES: * Compare the progression-free interval and overall survival of patients with early stage ovarian epithelial cancer treated with carboplatin and paclitaxel with or without low-dose paclitaxel. * Assess the frequency and severity of toxic effects of these regimens in these patients. OUTLINE: This is a rand...	Ovarian Cancer	stage I ovarian epithelial cancer stage II ovarian epithelial cancer ovarian undifferentiated adenocarcinoma ovarian mixed epithelial carcinoma ovarian serous cystadenocarcinoma ovarian mucinous cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian clear cell cystadenocarcinoma Brenner tumor	null	2	arm 1: carboplatin, paclitaxel followed by low dose paclitaxel 4 weeks later arm 2: carboplatin, paclitaxel	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: carboplatin intervention 2: paclitaxel	151	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Fayetteville \| Arkansas \| United States \| -94.15743 \| 36.06258 Fayetteville \| Arkansa...	542	0	0	0	NCT00003644	1COMPLETED	2010-03-01	1998-10-01	Gynecologic Oncology Group	5NETWORK	false	false	false	null	0	0	0	0
[ 4 ]	589	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This randomized phase III trial is studying carboplatin, paclitaxel, radiation therapy, and thalidomide to see how well they work compared to carboplatin, paclitaxel, and radiation therapy alone in treating patients with newly diagnosed stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways...	OBJECTIVES: I. Compare the survival and time to progression of patients with stage IIIA or IIIB non-small cell lung cancer when treated with carboplatin, paclitaxel, and chemoradiotherapy with or without thalidomide. II. Evaluate the toxicity of the thalidomide-containing regimen and compare response rates of the two...	Lung Cancer	squamous cell lung cancer large cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer	null	2	arm 1: Induction chemotherapy dosing: Paclitaxel, 225 mg/m² (3 hour infusion) Day 1. Carboplatin, area under the plasma drug concentration versus time curve (AUC) =6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 Concurrent chemotherapy / radiotherapy dosing: Paclitaxel, 45 mg/m2, administered weekly...	[ 1, 0 ]	4	[ 0, 0, 0, 4 ]	intervention 1: Induction Chemotherapy dosing: AUC=6.0, 15-30 min IV infusion immediately following paclitaxel, Day 1 and Day 22. Concurrent Chemotherapy / Radiotherapy dosing, AUC=2; 15- 30 minutes IV infusion immediately following paclitaxel; administered weekly during radiotherapy intervention 2: Induction chemother...	intervention 1: carboplatin intervention 2: paclitaxel intervention 3: thalidomide intervention 4: radiation therapy	236	Fort Smith \| Arkansas \| United States \| -94.39855 \| 35.38592 Modesto \| California \| United States \| -120.99688 \| 37.6391 Salinas \| California \| United States \| -121.6555 \| 36.67774 Stanford \| California \| United States \| -122.16608 \| 37.42411 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Boulder \| Colorado ...	577	0	0	0	NCT00004859	6TERMINATED	2010-03-01	2000-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 4 ]	659	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cel...	OBJECTIVES: I. Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel. II. Compare short and long-term toxic effects ...	Endometrial Adenocarcinoma Endometrial Adenosquamous Carcinoma Endometrial Clear Cell Adenocarcinoma Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation Endometrial Serous Adenocarcinoma Stage III Uterine Corpus Cancer		null	2	arm 1: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11. arm 2: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim o...	[ 0, 0 ]	5	[ 0, 0, 2, 2, 0 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Given SC intervention 4: Given SC intervention 5: Given IV	intervention 1: Doxorubicin Hydrochloride intervention 2: Cisplatin intervention 3: Filgrastim intervention 4: Pegfilgrastim intervention 5: Paclitaxel	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	539	0	0	0	NCT00006011	1COMPLETED	2010-03-01	2000-07-01	Gynecologic Oncology Group	5NETWORK	false	false	false	null	0	0	0	0
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making...	OBJECTIVES: I. Determine the response rate and survival in patients with metastatic or unresectable carcinoma of the stomach treated with bryostatin 1 and cisplatin. II. Determine the toxic effects of this regimen in these patients. III. Determine the molecular determinants of response to this regimen in these patien...	Stage III Gastric Cancer Stage IV Gastric Cancer		null	1	arm 1: Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 0, 10 ]	intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies	intervention 1: bryostatin 1 intervention 2: cisplatin intervention 3: laboratory biomarker analysis	1	Los Angeles \| California \| United States \| -118.24368 \| 34.05223	12	0	0	0	NCT00006389	1COMPLETED	2010-03-01	2000-10-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	51	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.	PRIMARY OBJECTIVES: I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: Patients receive ixabepilone IV...	Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer		null	1	arm 1: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.	[ 0 ]	1	[ 0 ]	intervention 1: Given IV	intervention 1: ixabepilone	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	49	0	0	0	NCT00025155	1COMPLETED	2010-03-01	2002-07-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3, 4 ]	266	RANDOMIZED	FACTORIAL	0TREATMENT	0NONE	false	0ALL	null	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken ...	Antiretroviral therapy in children aims to prolong clinical and immunologic health. Currently, there are no data defining a particular highly active antiretroviral therapy (HAART) strategy as the optimal first-line therapy for children. This study evaluated the long-term efficacy of two HAART regimens used as initial t...	HIV Infections	Drug Therapy, Combination HIV Protease Inhibitors Reverse Transcriptase Inhibitors Viral Load Treatment Naive	null	4	arm 1: Two NRTIs plus a PI with a regimen change recommended at when viral load reaches 1000 copies/ml or higher arm 2: 2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 1,000 copies/ml or higher arm 3: 2 NRTIs plus 1 PI with a regimen change recommended when viral load reaches 30,000 copi...	[ 0, 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Accepted NRTIs: abacavir sulfate (ABC), emtricitabine (FTC), emtricitabine/Tenofovir disoproxil fumarate (FTC/TDF), lamivudine (3TC), lamivudine/zidovudine (3TC/AZT), stavudine (d4T), tenofovir disoproxil fumarate (TDF), zalcitabine (ddC), zidovudine (AZT) Prescribed per participant's doctor interventio...	intervention 1: NRTIs (ABC, FTC, FTC/TDF, 3TC, 3TC/AZT, d4T, TDF, ddC, AZT) intervention 2: NNRTIs (EFV, NVP) intervention 3: PIs (AMP, IDV, LPV/r, NFV, SQV, RTV)	31	Alhambra \| California \| United States \| -118.12701 \| 34.09529 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Oakland \| California \| United States \| -122.2708 \| 37.80437 Hart...	263	0	0	0	NCT00039741	1COMPLETED	2010-03-01	2002-08-01	National Institute of Allergy and Infectious Diseases (NIAID)	0NIH	false	false	false	null	0	0	0	0
[ 2, 3 ]	69	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma.	PRIMARY OBJECTIVES: I. To define the safety of gefitinib administered in conjunction with irradiation in children with newly diagnosed non-disseminated diffuse intrinsic brainstem gliomas and newly diagnosed incompletely resected supratentorial malignant gliomas (STMG) not receiving enzyme inducing anticonvulsant drug...	Untreated Childhood Anaplastic Astrocytoma Untreated Childhood Anaplastic Oligodendroglioma Untreated Childhood Brain Stem Glioma Untreated Childhood Giant Cell Glioblastoma Untreated Childhood Glioblastoma Untreated Childhood Gliomatosis Cerebri Untreated Childhood Gliosarcoma Untreated Childhood Oligodendroglioma		null	1	arm 1: Phase I portion: Patients receive oral gefitinib once daily. Treatment repeats every 4 weeks for 13 courses (1 year). Patients also receive standard brain irradiation once daily, 5 days a week, for 6 weeks beginning concurrently with initiation of the first course of gefitinib. Treatment continues in the absence...	[ 0 ]	4	[ 0, 4, 10, 10 ]	intervention 1: Given orally intervention 2: Undergo standard brain irradiation intervention 3: Correlative studies intervention 4: Correlative studies	intervention 1: gefitinib intervention 2: radiation therapy intervention 3: pharmacological study intervention 4: laboratory biomarker analysis	1	Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953	69	0	0	0	NCT00042991	1COMPLETED	2010-03-01	2002-07-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	35	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Phase II trial to study the effectiveness of combining oxaliplatin with paclitaxel in treating patients who have locally recurrent or metastatic cervical cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor ...	PRIMARY OBJECTIVES: I. To determine the objective response rates for the combination of paclitaxel and oxaliplatin in patients with metastatic or locally recurrent cervical cancer. II. To determine the toxicities and recovery from toxicities of patients with cervical cancer receiving paclitaxel and oxaliplatin. OUTL...	Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma Recurrent Cervical Carcinoma Stage IVA Cervical Cancer Stage IVB Cervical Cancer		null	1	arm 1: Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 0 ]	intervention 1: Given IV intervention 2: Given IV	intervention 1: Paclitaxel intervention 2: Oxaliplatin	1	The Bronx \| New York \| United States \| -73.86641 \| 40.84985	32	0	0	0	NCT00057863	1COMPLETED	2010-03-01	2003-01-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. This phase II trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.	PRIMARY OBJECTIVES: I. To determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with STI571 who have failed one chemotherapy regimen for metastatic disease. II. To assess the toxicities of STI571 in these patients. III. To obtain preliminary da...	Recurrent Gastric Cancer Stage IV Gastric Cancer		null	1	arm 1: Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.	[ 0 ]	2	[ 0, 10 ]	intervention 1: Given orally intervention 2: Correlative studies	intervention 1: imatinib mesylate intervention 2: laboratory biomarker analysis	1	Duarte \| California \| United States \| -117.97729 \| 34.13945	17	0	0	0	NCT00068380	1COMPLETED	2010-03-01	2004-03-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	17	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma.	PRIMARY OBJECTIVES: I. To assess the anti-tumor activity of UCN-01 (7-hydroxystaurosporine) in metastatic melanoma, as determined by the response rate. II. To assess the clinical and laboratory toxicities of UCN-01. III. To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycl...	Recurrent Melanoma Stage IV Melanoma		null	1	arm 1: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	[ 0 ]	3	[ 0, 10, 10 ]	intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies	intervention 1: 7-hydroxystaurosporine intervention 2: laboratory biomarker analysis intervention 3: pharmacological study	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	17	0	0	0	NCT00072189	6TERMINATED	2010-03-01	2003-11-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	470	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	1FEMALE	null	This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline. Patients were randomized to receive either 1250 mg/m\...	null	Breast Cancer		null	2	arm 1: 1250 mg/m\^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m\^2 intravenous on day 1 of each 3 week cycle. arm 2: 825 mg/m\^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg...	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: 825 mg/m\^2 or 1250 mg/m2 orally twice a day on days 1 to 14 of each 3 week cycle. intervention 2: 75 mg/m\^2 intravenous on day 1 of each 3 week cycle	intervention 1: capecitabine (Xeloda®) intervention 2: docetaxel (Taxotere®)	94	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Hoover \| Alabama \| United States \| -86.81138 \| 33.40539 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Berkeley \| California \| United States \| -122.27275 \| 37.87159 Poway \| California \| United States \| -117.03586 \| 32.96282 Boca Raton \| Florida \| Uni...	465	0	0	0	NCT00077857	1COMPLETED	2010-03-01	2003-07-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2...	OBJECTIVES: Primary * Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma. Secondary * Determine duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patien...	Kidney Cancer	stage IV renal cell cancer	null	1	arm 1: None	[ 0 ]	3	[ 2, 2, 0 ]	intervention 1: Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. intervention 2: GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle intervention 3: 200mg daily by mouth	intervention 1: PEG-interferon alfa-2b intervention 2: GM-CSF intervention 3: thalidomide	1	Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632	0	0	0	0	NCT00090870	6TERMINATED	2010-03-01	2002-04-01	Medical University of South Carolina	7OTHER	false	false	false	null	0	0	0	0

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