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_Multiple drug overdose intentional int64	METADATA_count_Overdose int64	METADATA_wilson_lower_bound float32
[ 3 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be an effective way to kill more tumor cells. PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical cancer, or ovarian epithelial cancer.	OBJECTIVES: Primary * To evaluate the efficacy of the CerviPrep™ device in delivering topical gemcitabine hydrochloride to the cervix Secondary * To document any side effects directly attributed to local administration of gemcitabine hydrochloride. OUTLINE: Patients undergo application of topical gemcitabine hydrochloride directly to the cervix using the CerviPrep™ drug delivery device during routine hysterectomy. Uterine vein and peripheral blood samples are obtained periodically to measure local and peripheral gemcitabine hydrochloride concentration levels in the blood. Local gemcitabine hydrochloride concentration levels are also measured in uterine tissue samples obtained from the surgical specimen after hysterectomy. Patients complete a self-reported symptom diary for the first 7 days after surgery for assessment of local and systemic side effects associated with topical administration of gemcitabine hydrochloride. After completion of study therapy, patients are followed at 2-4 weeks.	Cervical Cancer Endometrial Cancer Ovarian Cancer	recurrent cervical cancer cervical cancer endometrial carcinoma ovarian epithelial cancer recurrent ovarian epithelial cancer recurrent endometrial carcinoma	null	1	arm 1: CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.	[ 0 ]	2	[ 0, 3 ]	intervention 1: Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device. intervention 2: hysterectomy	intervention 1: topical gemcitabine hydrochloride intervention 2: therapeutic conventional surgery	1	Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997	18	0	0	0	NCT00610740	1COMPLETED	2008-04-01	2006-07-01	Masonic Cancer Center, University of Minnesota	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	16	RANDOMIZED	CROSSOVER	0TREATMENT	3TRIPLE	true	1FEMALE	false	The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the mild to moderate cognitive disturbances frequently experienced by women during the menopause transition. In addition, we seek to determine, using the Brown Attention Deficit Disorder Scale (BADDS), whether and to what degree peri- and early post-menopausal women experience cognitive disturbances which overlap with the impairments of executive function characteristic of adults with attention deficit disorder (ADHD).	Decline in cognitive function, and in particular memory, is a frequent complaint for which menopausal women seek clinical intervention. While there is a wealth of preclinical evidence demonstrating the neuroprotective and cognitive enhancing role of estradiol (Wise et al., 1999; Jezierski \& Sohrabji, 2001), recent publicity from the Women's Health Initiative Study has made gynecologists and menopausal women concerned about using estrogen therapy (ET) to address their cognitive complaints as well as other symptoms of menopause (WHI Writing Group, 2002). Decades of data suggesting that estrogen enhances cognitive function in women undergoing surgical or natural menopause (Sherwin et al., 1998) has been all but forgotten in the wake of the results of the WHI. Further, recent findings from a naturalistic study suggesting that having used estrogen replacement therapy for three years before the mean age of 70 years significantly reduced the risk of Alzheimer's Disease (AD; Zandi et al., 2002) did not receive sufficient attention in the lay press or in scientific circles to allay concerns. Most recently, conjugated equine estrogen plus medroxyprogesterone acetate (PremPro®) use daily is associated with a small increased risk for dementia (Schumaker et al., 2003). Now that clinicians and women have become hesitant to utilize ET, they find themselves between the proverbial rock and a hard place as there have been no studies demonstrating efficacy of any other agent in the treatment of mild to moderate cognitive difficulties in healthy non-demented menopausal women. Thus, it is timely and crucial to investigate other pharmacologic strategies aimed at improving cognitive function in this population. Interestingly, many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with ADHD (Warga, 1999; Brown, 2000). That ATX has demonstrated efficacy in the treatment of ADHD provides a compelling rationale for investigating the treatment of menopause-related declines in memory and cognitive function. Thus, this will be the first double-blind, placebo-controlled, cross-over clinical trial to obtain preliminary data for the efficacy of ATX in the treatment of mild to moderate cognitive disturbances in menopause aged women. Women who are in the early menopause have been chosen for this study as clinical and preclinical data suggest that long periods of hypoestrogenism may be associated with poorer response to intervention with ET. Therefore, we believe that this population may be more likely to respond to treatment with ATX than women who have been postmenopausal for many years.	Menopause Cognitive Disturbances	Menopause Cognition	null	2	arm 1: Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects undergo assessments of cognition, mood, and menopausal symptoms prior to randomization, after 6 weeks in the first treatment condition (ATX or PBO) and then finally after the second 6-week period of the alternate treatment condition. Subjects are monitored every other week to assess medication compliance and side effects. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B. arm 2: Subjects were enrolled into a double-blind, placebo-controlled cross over study where they will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks or placebo (PBO) for 6 weeks, followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. Subjects undergo assessments of cognition, mood, and menopausal symptoms prior to randomization, after 6 weeks in the first treatment condition (ATX or PBO) and then finally after the second 6-week period of the alternate treatment condition. Subjects are monitored every other week to assess medication compliance and side effects. Subjects will be instructed to take one capsule of ATX 40mg/d or placebo per day. If tolerated, the number of pills of ATX will be increased to 2 per day at the end of Week 1 of both Trials A and B. Subjects will remain on two capsules per day for the remaining 5 weeks of Trials A and B.	[ 1, 2 ]	2	[ 0, 0 ]	intervention 1: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week. intervention 2: Subjects will receive placebo equivalent for 6 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.	intervention 1: atomoxetine intervention 2: placebo	1	New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815	32	0	0	0	NCT00611533	1COMPLETED	2008-04-01	2004-05-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	117	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	0NONE	false	0ALL	null	To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.	null	Relapsing Multiple Sclerosis		null	2	arm 1: None arm 2: None	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected intervention 2: Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.	intervention 1: Rebif New Formulation + prophylactic Ibuprofen intervention 2: Rebif New Formulation + ibuprofen PRN	2	Paris \| N/A \| France \| 2.3488 \| 48.85341 Munich \| N/A \| Germany \| 11.57549 \| 48.13743	116	0	0	0	NCT00619307	1COMPLETED	2008-04-01	2007-07-01	Merck KGaA, Darmstadt, Germany	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	24	RANDOMIZED	CROSSOVER	7BASIC_SCIENCE	0NONE	true	1FEMALE	false	This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).	null	Osteoporosis		null	3	arm 1: Oral Tablet arm 2: Oral Tablet arm 3: Nasal Spray	[ 0, 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Single dose of a nasal spray or one of two doses of tablets, randomized to visits 2, 3, and 4. intervention 2: 0.15 mgs recombinant salmon calcitonin, single oral dose intervention 3: 0.2mgs recombinant salmon calcitonin, single oral tablet intervention 4: 200 IU recombinant salmon calcitonin, single intranasal spray	intervention 1: Recombinant Salmon Calcitonin (rsCT) intervention 2: Oral Tablet intervention 3: Oral Tablet intervention 4: Nasal Spray	1	Springfield \| Missouri \| United States \| -93.29824 \| 37.21533	24	0	0	0	NCT00620854	1COMPLETED	2008-04-01	2008-02-01	Tarsa Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections	null	Infectious Skin Diseases Bacterial Skin Diseases Staphylococcal Skin Infections Streptococcal Infections Abscess		null	3	arm 1: Radezolid 450 mg PO QD arm 2: Radezolid 450 mg PO BID arm 3: Linezolid 600 mg PO BID	[ 0, 0, 1 ]	3	[ 0, 0, 0 ]	intervention 1: 450mg PO QD intervention 2: 450mg PO BID intervention 3: 600mg PO BID	intervention 1: Radezolid intervention 2: Radezolid intervention 3: Linezolid	19	Montgomery \| Alabama \| United States \| -86.29997 \| 32.36681 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pasadena \| California \| United States \| -118.14452 \| 34.14778 Sylmar \| California \| United States \| -118.44925 \| 34.30778 Atlantis \| Florida \| United States \| -80.10088 \| 26.5909 Columbus \| Georgia \| United States \| -84.98771 \| 32.46098 Hinesville \| Georgia \| United States \| -81.59595 \| 31.84688 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Keego Harbor \| Michigan \| United States \| -83.34382 \| 42.60809 Butte \| Montana \| United States \| -112.53474 \| 46.00382 Jamaica \| New York \| United States \| -73.80569 \| 40.69149 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Akron \| Ohio \| United States \| -81.51901 \| 41.08144 Downington \| Pennsylvania \| United States \| N/A \| N/A Warminster \| Pennsylvania \| United States \| -75.09962 \| 40.20678 McKenzie \| Tennessee \| United States \| -88.51866 \| 36.13256 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	146	0	0	0	NCT00646958	1COMPLETED	2008-04-01	2007-12-01	Melinta Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	607	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)	This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day Placebo Lead-In Period (Day -7 to Day 1), subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray. Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the TOSS symptoms of itchy eyes, watery eyes and eye redness, and the symptom of postnasal drip twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the adult RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject reported adverse events (AEs), nasal examinations, and vital signs assessments.	Seasonal Allergic Rhinitis		null	4	arm 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray arm 2: azelastine Hcl 548 mcg nasal spray arm 3: fluticasone propionate 200 mcg nasal spray arm 4: placebo nasal spray	[ 0, 1, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day intervention 2: azelastine Hcl nasal spray one spray per nostril two times a day intervention 3: fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day intervention 4: placebo nasal spray one spray per nostril two times a day	intervention 1: MP29-02 intervention 2: azelastine Hcl intervention 3: fluticasone propionate intervention 4: placebo	7	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 \| -98.49363 \| 29.42412 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Waco \| Texas \| United States \| -97.14667 \| 31.54933	607	0	0	0	NCT00660517	1COMPLETED	2008-04-01	2007-12-01	Meda Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	536	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.	null	Seasonal Allergic Rhinitis		null	2	arm 1: Placebo arm 2: 0.15% Azelastine Hydrochloride	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride 822 mcg	intervention 1: Placebo intervention 2: 0.15% Azelastine Hydrochloride	6	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 Waco \| Texas \| United States \| -97.14667 \| 31.54933	532	0	0	0	NCT00660829	1COMPLETED	2008-04-01	2007-12-01	Meda Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	60	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.	Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources \[sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)\] using an in situ caries model.	Healthy Subjects Partial Denture Wearers Caries	remineralization enamel fluoride caries in situ	null	5	arm 1: Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 2: Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 3: Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 4: Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. arm 5: Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.	[ 1, 0, 1, 1, 2 ]	2	[ 0, 0 ]	intervention 1: Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F intervention 2: Fluoride free toothpaste (0 ppm F)	intervention 1: Sodium fluoride toothpaste intervention 2: Placebo toothpaste	0	null	275	0	0	0	NCT00708123	1COMPLETED	2008-04-01	2007-11-01	GlaxoSmithKline	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	250	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.	Same as above.	Plaque Psoriasis		null	2	arm 1: clobetasol propionate spray 0.05% arm 2: clobetasol propionate ointment 0.05%	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Apply twice daily intervention 2: Apply twice daily	intervention 1: clobetasol propionate spray intervention 2: clobetasol propionate ointment	6	Fremont \| California \| United States \| -121.98857 \| 37.54827 Vallejo \| California \| United States \| -122.25664 \| 38.10409 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Fridley \| Minnesota \| United States \| -93.26328 \| 45.08608 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Dallas \| Texas \| United States \| -96.80667 \| 32.78306	245	0	0	0	NCT00733954	1COMPLETED	2008-04-01	2007-08-01	Galderma R&D	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	25	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.	The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.	Gingival Diseases		null	3	arm 1: None arm 2: None arm 3: None	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Brush twice daily intervention 2: Half mouth toothbrushing twice daily for 4 days intervention 3: Mouth rinsing twice a day for 4 days	intervention 1: Fluoride intervention 2: Triclosan/Fluoride intervention 3: Chlorhexidine Gluconate	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	25	0	0	0	NCT00759187	1COMPLETED	2008-04-01	2008-01-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	39	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	0ALL	false	To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.	null	Gingival Diseases		null	2	arm 1: Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes. arm 2: fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Brush twice daily for 6 weeks intervention 2: Brush twice daily	intervention 1: Fluoride intervention 2: Fluoride, triclosan	1	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	39	0	0	0	NCT00763048	1COMPLETED	2008-04-01	2008-03-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	111	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	To evaluate the Intraocular Pressure (IOP) lowering efficacy and safety of Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.	To evaluate the IOP lowering efficacy and safety fo Travoprost 0.004% compared to Timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The study structure is a parallel design. The patients will receive treatment for 12 weeks.	Glaucoma	Glaucoma	null	2	arm 1: Travoprost 0.004% arm 2: Timolol 0.5%	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Travoprost at 9 AM + Placebo \& 9 PM intervention 2: Timolol in each eye, twice daily at 9 AM \& 9 PM	intervention 1: Travoprost 0.004% Ophthalmic Solution (Travatan) intervention 2: Timolol 0.5% Ophthalmic Solution (Timoptic)	1	Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541	111	0	0	0	NCT00763061	1COMPLETED	2008-04-01	2006-05-01	Alcon Research	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	98	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).	null	Healthy	certolizumab pegol Cimzia bioequivalence Comparison Bioequivalence Study	null	2	arm 1: pre-filled syringe (reference) arm 2: Auto-injection device (test)	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections intervention 2: Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections	intervention 1: Certolizumab pegol intervention 2: Certolizumab pegol	1	Rennes \| N/A \| France \| -1.67429 \| 48.11198	98	0	0	0	NCT00845663	1COMPLETED	2008-04-01	2007-10-01	UCB Pharma	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	54	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.	A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy metal work removal. Subjects will be randomized into two groups: the first group will have an anesthetic pain pump device supplemented with oral analgesia and the second group will only receive oral analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects in both groups will receive oral analgesia according to their pain requirements. The amount of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4 day period. Subjects will have their pain score assessed daily with the use of the Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction with post-operative pain management will be assessed at the end of the study with the use of the Parent Total Quality Pain Management questionnaire.	Cerebral Palsy	Pain Pain management Cerebral Palsy	null	2	arm 1: Group 1 will receive oral analgesic only arm 2: Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: per clinical standard of care intervention 2: per clinical standard of care	intervention 1: oral analgesic intervention 2: intravenous analgesic per pump	1	Aurora \| Colorado \| United States \| -104.83192 \| 39.72943	37	0	0	0	NCT00884650	1COMPLETED	2008-04-01	2005-06-01	University of Colorado, Denver	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	234	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.	This is an open-label (all people know the identity of the intervention), multi-center (study conducted in more than 1 center), prospective (study following participants forward in time) study comparing the American College of Rheumatology (ACR) scores of participants with moderate RA (defined as having a score greater than 3.2, but less than 5.1 on the Disease Activity Score 28 \[DAS 28\]) to those participants with severe RA (defined as having a score greater than 5.1 on the DAS 28 score) disease while being treated with infliximab and MTX. DAS evaluates RA activity by several parameters including the number of swollen and tender joints and the participant's own assessment of their pain. Participants will receive infliximab 3 milligram (mg) per kilogram (kg) intravenous infusion (drug given into a vein) (over no less than 2 hours) at Weeks 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 Weeks. Participants will have a follow-up visit on Week 26. Efficacy will primarily be assessed by the percentage of participants obtaining ACR20, ACR50 and ACR70 response at Week 26. Participants' safety will be assessed throughout the study.	Arthritis, Rheumatoid	Arthritis, Rheumatoid Infliximab Methotrexate	null	2	arm 1: Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activity score \[DAS\] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX IN a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks. arm 2: Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (mg/week) equal to the dose used before participation in the study) for 22 weeks.	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22. intervention 2: MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.	intervention 1: Infliximab intervention 2: Methotrexate	0	null	234	0	0	0	NCT00896168	1COMPLETED	2008-04-01	2007-06-01	Xian-Janssen Pharmaceutical Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	98	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.	null	Dental Plaque		null	3	arm 1: Winterfresh Gel arm 2: Positive control (Total toothpaste) arm 3: test toothpaste	[ 2, 1, 0 ]	3	[ 0, 0, 10 ]	intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily	intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Metal salt	1	Cedar Knolls \| New Jersey \| United States \| -74.44876 \| 40.82204	102	0	0	0	NCT00926029	1COMPLETED	2008-04-01	2008-01-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	158	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors. The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.	null	Carcinoma	Sorafenib Advanced Solid Tumors Maximum tolerated dose Carboplatin and paclitaxel chemotherapy combination	null	5	arm 1: Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 2: Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 3: Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 4: Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD). arm 5: Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion. Treatment were planned until primary completion date (PCD). 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib until 18 Sep 2008.	[ 0, 0, 0, 0, 0 ]	5	[ 0, 0, 0, 0, 0 ]	intervention 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet) intervention 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet) intervention 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet) intervention 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) intervention 5: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion	intervention 1: Sorafenib 100 mg (50-mg tablet) intervention 2: Sorafenib 200 mg (50-mg tablet) intervention 3: Sorafenib 400 mg (50-mg tablet) intervention 4: Sorafenib 400 mg (200-mg tablet) intervention 5: Sorafenib 400 mg (Expansion)	3	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	158	0	0	0	NCT00941863	1COMPLETED	2008-04-01	2002-07-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the utility of screening tools in large samples of adult patients with SUD in inpatient treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult patients being treated for a co-morbid SUD in a residential treatment facility (RTF). The primary objective of the study was to assess the efficacy of atomoxetine in adults with an SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the safety and tolerability of atomoxetine in this population.	Phase 1: Patients with SUD who were either newly admitted (abstinent for \<1 week) or in treatment in the RTF (abstinent \<3 months) were administered the Adult ADHD Self-Report Scale Symptom Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(\>= 4 out 6 significant items) were then administered the Adult Clinician Diagnostic Scale (ACDS) v.1.2 to establish a diagnosis of ADHD and the Predictive Value Positive (PVP) in this population. Phase II (Treatment): Participants who screened positive for ADHD on the ACDS were given informed consent and baseline evaluations for inclusion. Those meeting inclusion/exclusion criteria were treated with atomoxetine starting at 25 mg/day. The dose was adjusted based on clinical response and tolerability over a 4-week period up to 120 mg/day and held constant for the final six weeks of the trial.	Attention Deficit Hyperactivity Disorder	ADHD Substance Use Disorder Residential Treatment Facility	null	1	arm 1: Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 120 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side-effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a \>=30% reduction in total AISRS scores from baseline.	[ 0 ]	1	[ 0 ]	intervention 1: In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant at the optimized level for the final 6 weeks of the trial.	intervention 1: Atomoxetine	0	null	18	0	0	0	NCT00953862	1COMPLETED	2008-04-01	2005-07-01	NYU Langone Health	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	22	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	true	0ALL	false	Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse	Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.	Dental Plaque		null	3	arm 1: negative control toothpaste arm 2: positive control toothpaste (Total toothpaste) arm 3: positive control oral rinse	[ 2, 1, 1 ]	3	[ 0, 0, 0 ]	intervention 1: Brush half mouth twice daily for four days. intervention 2: Brush twice daily intervention 3: Rinse mouth twice a day	intervention 1: Fluoride intervention 2: Triclosan, fluoride intervention 3: Chlorhexidine Gluconate	1	Paramus \| New Jersey \| United States \| -74.07542 \| 40.94454	66	0	0	0	NCT01024738	1COMPLETED	2008-04-01	2008-03-01	Colgate Palmolive	4INDUSTRY	false	false	false	null	0	0	0	0
[ 0 ]	50	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	Celiac disease is a condition in which the small intestine is damaged by gluten, the storage protein of wheat and similar proteins in barley and rye. The disease can cause different symptoms such as diarrhea, bloating, abdominal pain and weight loss. The majority of patients respond to a gluten-free diet. However some patients (5-30%) have persistent symptoms and are considered to be poor responders to the diet. Bacterial overgrowth in the small intestine accounts for some of the refractory patients. This study seeks to determine if antibiotic therapy with rifaximin relieves the symptoms of patients who are poorly responsive to a gluten-free diet and whether this impacts their breath test results.	A symptom questionnaire will be administered at study initiation, 2 weeks and 12 weeks. Patients will undergo a breath test which involves drinking a sugar (lactulose) solution and breathing into a machine. This technique will identify the presence of bacteria in the small intestine. They will be randomly selected to receive either an antibiotic (rifaximin) or placebo three times a day for 10 days to treat their bacterial overgrowth.	Celiac Disease	Gastrointestinal Symptom Rating Scale (GSRS) Poorly responsive Refractory Small intestine bacterial overgrowth Breath test	null	2	arm 1: Antibiotic ,Rifaximin 400mg, given 3 times a day for 10 days. arm 2: Placebo pills given 3 times a day for 10 days.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Rifaximin 400mg orally three times a day for 10 days total intervention 2: Placebo orally three times a day for 10 days total	intervention 1: Rifaximin intervention 2: Placebo	1	New York \| New York \| United States \| -74.00597 \| 40.71427	41	0	0	0	NCT01137955	1COMPLETED	2008-04-01	2006-10-01	Columbia University	7OTHER	false	false	false	null	0	0	0	0
[ 3, 4 ]	230	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.	Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies. To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.	Type 2 Diabetes Mellitus	Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy	null	3	arm 1: None arm 2: None arm 3: None	[ 1, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 2: Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks. intervention 3: Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.	intervention 1: Alogliptin and voglibose intervention 2: Alogliptin and voglibose intervention 3: Voglibose	0	null	230	0	0	0	NCT01263483	1COMPLETED	2008-04-01	2007-01-01	Takeda	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	56	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).	This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.	Schizophrenia	Schizophrenia Paliperidone Palmitate JNS010	null	4	arm 1: Paliperidone palmitate 50 milligram (mg) intramuscular (into the muscle) injection on Days 1, 8, 36 and 64. arm 2: Paliperidone palmitate 100 mg intramuscular injection on Days 1, 8, 36 and 64. arm 3: Paliperidone palmitate 150 mg intramuscular injection on Days 1, 8, 36 and 64. arm 4: Paliperidone palmitate 150 mg intramuscular injection on Day 1 and paliperidone palmitate 50 mg intramuscular injection on Days 8, 36 and 64.	[ 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.	intervention 1: Paliperidone palmitate	1	Ichikawa \| N/A \| Japan \| 139.9065 \| 35.73413	56	0	0	0	NCT01606254	1COMPLETED	2008-04-01	2007-01-01	Janssen Pharmaceutical K.K.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	174	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The primary objective of this study is to investigate efficacy and safety of SPM 962 in advanced Parkinson's Disease (PD) patients in a multi-center, placebo-controlled study following once-daily multiple transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg (12 weeks of dose titration/maintenance period). Recommended maintenance dose range is also to be investigated with distribution of the maintenance dose and accumulated response rate of efficacy.	null	Parkinson's Disease	SPM 962 rotigotine Parkinson's disease concomitant use of L-dopa	null	2	arm 1: SPM 962 transdermal patch arm 2: Placebo transdermal patch	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day intervention 2: Placebo transdermal patch	intervention 1: SPM 962 intervention 2: Placebo	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	174	0	0	0	NCT01628848	1COMPLETED	2008-04-01	2006-08-01	Otsuka Pharmaceutical Co., Ltd.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	56	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	3TRIPLE	false	0ALL	true	The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.	The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is \>6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of \<6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.	Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma	Tympanomastoid Surgery Cochlear Implant Mastoidectomy Cholesteatoma Pediatrics Clonidine Bupivacaine Greater Auricular Nerve Block Regional Anesthesia	null	2	arm 1: This is our standard of care concentration arm 2: These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.	[ 4, 0 ]	1	[ 0 ]	intervention 1: Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine	intervention 1: 0.25% Bupivacaine + Clonidine	1	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003	56	0	0	0	NCT01638052	1COMPLETED	2008-04-01	2006-02-01	Ann & Robert H Lurie Children's Hospital of Chicago	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	14	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The purpose of this post marketing study is to determine the plasma concentration of bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug enters and leaves the blood and tissues over time) properties in the Taiwanese population. It will also provide expanded access (expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a participant with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options) to bortezomib for the same group of participants with multiple myeloma (cancer of the types of cells normally found in bone marrow).	This is an open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who have received at least 2 previous lines of therapy (medicine or medical care given to a participant for a disease or condition) and are refractory (not responding to treatment) to or have relapsed (the return of a medical problem) after their last therapy. Eligible participants will receive bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles. Blood samples for PK assessment will be collected on specified time points of Day 1, Day 8, and Day 11 of Cycle 1. Efficacy of the participants will primarily be evaluated by recording 'response to treatment' and 'Karnofsky Performance Status'. Participants' safety will be monitored throughout the study.	Multiple Myeloma	Multiple Myeloma Bortezomib Velcade	null	1	arm 1: Bortezomib 1.3 milligram (mg) per meter square (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.	[ 0 ]	1	[ 0 ]	intervention 1: Bortezomib 1.3 mg per (m\^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.	intervention 1: Bortezomib	0	null	14	0	0	0	NCT01801436	1COMPLETED	2008-04-01	2006-12-01	Johnson & Johnson Taiwan Ltd	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	18	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	null	This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.	null	Breast Cancer		null	1	arm 1: None	[ 0 ]	3	[ 0, 0, 0 ]	intervention 1: 15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles intervention 2: 75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles intervention 3: 950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks	intervention 1: bevacizumab [Avastin] intervention 2: docetaxel intervention 3: capecitabine [Xeloda]	1	Salzburg \| N/A \| Austria \| 13.04399 \| 47.79941	18	0	0	0	NCT02005549	1COMPLETED	2008-04-01	2006-02-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	40	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.	null	Colorectal Cancer		null	1	arm 1: Participants will receive IV bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks in combination with standard of care chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.	[ 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor. intervention 2: Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study. intervention 3: Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study. intervention 4: Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.	intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Oxaliplatin	8	Chai Yi \| N/A \| Taiwan \| N/A \| N/A Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 Kaohsiung City \| N/A \| Taiwan \| 120.31333 \| 22.61626 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Taichung \| N/A \| Taiwan \| 120.6839 \| 24.1469 Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Tainan City \| N/A \| Taiwan \| 120.21333 \| 22.99083 Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	40	0	0	0	NCT02582970	1COMPLETED	2008-04-01	2005-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	12	NON_RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	false	2MALE	false	Determine the serum pharmacokinetic profile for two oral formulations of T-esters (one TE and one TU) administered once -(QD) and twice-daily (BID) to hypogonadal men.	Five period cross-over study in which subjects received a single day of dosing in each period. Dosing was either QD or BID with one of two T esters (T-enanthate (TE) or T-undecanoate (TU)). Dosing was within 5 minutes of meals (breakfast and for BID dosing dinner). There was a minimum of a 5-day washout between periods. Subjects were hypogonadal men.	Hypogonadism	testosterone male hypogonadism low testosterone	null	2	arm 1: Period 2 - 200 mg T (as TU) QD Period 3 - 200 mg T (as TU) BID (100 mg/dose) Period 4 - 400 mg T (as TU) BID (200 mg/dose) arm 2: Period 1 - 400 mg T (as TE) QD Period 5 - 800 mg T (as TE) BID (400 mg/dose)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Single-day dose as QD or BID for 3 of 5 crossover periods intervention 2: Single-day dose for 2 of 5 crossover periods	intervention 1: Testosterone undecanoate intervention 2: Testosterone enanthate	2	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	60	0	0	0	NCT02697188	1COMPLETED	2008-04-01	2007-11-01	Clarus Therapeutics, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	11	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of moxetumomab pasudotox in relapsed or refractory participants with chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or Small Lymphocytic Lymphoma (SLL).	This was a multicenter, Phase 1, standard 3+3 dose-escalation study to evaluate the safety and anti-neoplastic activity of CAT-8015 in relapsed or refractory participants with CLL, PLL, or SLL. Participants in the initial dose cohort were to receive CAT-8015 at a dose of 5 microgram per kilogram (mcg/kg) CAT-8015, increasing to 10 mcg/kg in the second dose cohort, and then increasing by 10 mcg/kg increments in subsequent cohorts (that is, to doses of 20, 30, 40, 50, 60 mcg/kg, etc) until a maximum tolerated dose (MTD) was identified. Following identification of the MTD, the MTD cohort was to be expanded to 16 participants.	Leukemia, Lymphoma, Chronic Lymphocytic Leukemia, Prolymphocytic Leukemia, Small Lymphocytic Lymphoma, Moxetumomab Pasudotox	Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Small Lymphocytic Lymphoma Moxetumomab pasudotox	null	3	arm 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. arm 2: Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. arm 3: Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	[ 0, 0, 0 ]	3	[ 0, 0, 0 ]	intervention 1: Participants received a single intravenous infusion of 5 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. intervention 2: Participants received a single intravenous infusion of 10 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible. intervention 3: Participants received a single intravenous infusion of 20 mcg/kg moxetumomab pasudotox (CAT-8015) on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until progressive disease (PD) or until otherwise they become ineligible.	intervention 1: CAT-8015 5 mcg/kg intervention 2: CAT-8015 10 mcg/kg intervention 3: CAT-8015 20 mcg/kg	3	Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058	11	0	0	0	NCT00587457	6TERMINATED	2008-04-07	2007-03-07	MedImmune LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	207	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.	null	Migraine		null	2	arm 1: Active Drug arm 2: Matching Pbo Comparator	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack intervention 2: Matching placebo; one dose, treatment of a single migraine attack	intervention 1: Comparator: rizatriptan benzoate intervention 2: Comparator: Placebo	0	null	188	0	0	0	NCT00516737	1COMPLETED	2008-04-08	2007-10-03	Organon and Co	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	24	RANDOMIZED	CROSSOVER	0TREATMENT	2DOUBLE	false	0ALL	null	Study to understand the effects of migraine treatments on blood pressure in participants with migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmHg.	null	Migraine Disorders		null	4	arm 1: Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A); Period 2: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 3: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D); Period 4: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B). Each dosing period is separated by a 5-day washout. arm 2: Participants receive the following: Period 1: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 2: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D): Period 3: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C); Period 4:single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A). Each dosing period is separated by a 5-day washout. arm 3: Participants receive the following: Period 1 :single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C), Period 2: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 3: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treatment A): Period 4: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D). Each dosing period is separated by a 5-day washout. arm 4: Participants receive the following: Period 1: single oral dose of sumatriptan placebo/telcagepant placebo (Treatment D), Period 2: single oral dose of 100 mg sumatriptan/600 mg telcagepant (Treament A); Period 3: single oral dose of 100 mg sumatriptan/telcagepant placebo (Treatment B); Period 4: single oral dose of sumatriptan placebo/600 mg telcagepant (Treatment C). Each dosing period is separated by a 5-day washout.	[ 0, 0, 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Single oral dose of 2 x 300 mg capsules. intervention 2: single oral dose of 100 mg sumatriptan intervention 3: single oral dose intervention 4: single oral dose of 2 MK-0974 placebo capsules	intervention 1: telcagepant potassium intervention 2: sumatriptan intervention 3: sumatriptan placebo intervention 4: telcagepant potassium placebo	0	null	96	0	0	0	NCT00701389	1COMPLETED	2008-04-10	2007-11-20	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	0	0	0
[ 2 ]	12	RANDOMIZED	CROSSOVER	0TREATMENT	0NONE	true	1FEMALE	false	An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.	This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.	Healthy	PK Pharmacokinetics	null	3	arm 1: Single dose of Proellex 25 mg formulation A, fed arm 2: Single dose of Proellex 25 mg formulation B, fed arm 3: Single dose of Proellex 25 mg formulation B, fasted	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: One Proellex 25 mg formulation A capsule intervention 2: One 25 mg Proellex capsule formulation B administered both fed and fasted	intervention 1: Proellex 25 mg formulation A intervention 2: Proellex 25 mg formulation B	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	36	0	0	0	NCT00620503	1COMPLETED	2008-04-30	2008-02-29	Repros Therapeutics Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	719	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	null	This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.	null	Post-Menopausal Osteoporosis		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 150mg po monthly for 3 years intervention 2: 100mg po monthly for 3 years	intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva]	31	Loma Linda \| California \| United States \| -117.26115 \| 34.04835 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Livingston \| New Jersey \| United States \| -74.31487 \| 40.79593 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Merksem \| N/A \| Belgium \| 4.44903 \| 51.24623 São Paulo \| N/A \| Brazil \| -46.63611 \| -23.5475 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Ballerup Municipality \| N/A \| Denmark \| 12.36328 \| 55.73165 Vejle \| N/A \| Denmark \| 9.5357 \| 55.70927 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Balatonfüred \| N/A \| Hungary \| 17.87187 \| 46.96188 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Kiskunhalas \| N/A \| Hungary \| 19.48479 \| 46.43402 Zalaegerszeg \| N/A \| Hungary \| 16.84389 \| 46.84 Siena \| N/A \| Italy \| 11.33064 \| 43.31822 León \| N/A \| Mexico \| -113.78333 \| 28.51667 Obregón \| N/A \| Mexico \| -109.63445 \| 26.82768 Haugesund \| N/A \| Norway \| 5.268 \| 59.41378 Stavanger \| N/A \| Norway \| 5.73332 \| 58.97005 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Southampton \| N/A \| United Kingdom \| -1.40428 \| 50.90395	719	1	0.001391	1	NCT00081653	1COMPLETED	2008-05-01	2004-05-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	1	0.000246
[ 5 ]	948	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.	null	Hepatitis C, Chronic		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 0, 0, 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: 1000/1200mg po daily for 72 weeks intervention 2: 1000/1200mg po daily for 48 weeks intervention 3: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 60 weeks intervention 4: 360 micrograms sc weekly for 12 weeks, followed by 180 micrograms sc weekly for 36 weeks. intervention 5: 180 micrograms sc weekly for 72 weeks intervention 6: 180 micrograms sc weekly for 48 weeks	intervention 1: Ribavirin intervention 2: Ribavirin intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys] intervention 5: peginterferon alfa-2a [Pegasys] intervention 6: peginterferon alfa-2a [Pegasys]	104	Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pasadena \| California \| United States \| -118.14452 \| 34.14778 San Diego \| California \| United States \| -117.16472 \| 32.71571 Ukiah \| California \| United States \| -123.20778 \| 39.15017 Farmington \| Connecticut \| United States \| -72.83204 \| 41.71982 Bradenton \| Florida \| United States \| -82.57482 \| 27.49893 Hollywood \| Florida \| United States \| -80.14949 \| 26.0112 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Florham Park \| New Jersey \| United States \| -74.38821 \| 40.78788 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 Williamsville \| New York \| United States \| -78.73781 \| 42.96395 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Cranston \| Rhode Island \| United States \| -71.43728 \| 41.77982 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Rio de Janeiro \| N/A \| Brazil \| -43.18223 \| -22.90642 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Clichy \| N/A \| France \| 2.30952 \| 48.90018 Créteil \| N/A \| France \| 2.46569 \| 48.79266 Lille \| N/A \| France \| 3.05858 \| 50.63297 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Marseille \| N/A \| France \| 5.38107 \| 43.29695 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Bochum \| N/A \| Germany \| 7.21648 \| 51.48165 Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Erlangen \| N/A \| Germany \| 11.00783 \| 49.59099 Frankfurt am Main \| N/A \| Germany \| 8.68417 \| 50.11552 Freiburg im Breisgau \| N/A \| Germany \| 7.85222 \| 47.9959 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Homburg/saar \| N/A \| Germany \| N/A \| N/A Kassel \| N/A \| Germany \| 9.5 \| 51.31667 Kiel \| N/A \| Germany \| 10.13489 \| 54.32133 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 München \| N/A \| Germany \| 13.31243 \| 51.60698 Oberhausen \| N/A \| Germany \| 6.8625 \| 51.47805 Würzburg \| N/A \| Germany \| 9.95121 \| 49.79391 Alexandroupoli \| N/A \| Greece \| 25.87644 \| 40.84995 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Athens \| N/A \| Greece \| 23.72784 \| 37.98376 Thessaloniki \| N/A \| Greece \| 22.93086 \| 40.64361 Bari \| N/A \| Italy \| 16.86982 \| 41.12066 Bologna \| N/A \| Italy \| 11.33875 \| 44.49381 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Palermo \| N/A \| Italy \| 13.3636 \| 38.1166 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Lisbon \| N/A \| Portugal \| -9.1498 \| 38.72509 Alicante \| N/A \| Spain \| -0.48149 \| 38.34517 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Granada \| N/A \| Spain \| -3.60667 \| 37.18817 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Santander \| N/A \| Spain \| -3.80444 \| 43.46472 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Huddinge \| N/A \| Sweden \| 17.98192 \| 59.23705 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Zurich \| N/A \| Switzerland \| 8.55 \| 47.36667 Ankara \| N/A \| Turkey (Türkiye) \| 32.85427 \| 39.91987 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Istanbul \| N/A \| Turkey (Türkiye) \| 28.94966 \| 41.01384 Izmir \| N/A \| Turkey (Türkiye) \| 27.13838 \| 38.41273 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142	942	1	0.001062	1	NCT00087646	1COMPLETED	2008-05-01	2003-09-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	1	0.000187
[ 4 ]	11,506	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.	null	Hypertension	cardiovascular morbidity cardiovascular mortality benazepril amlodipine high risk population	null	2	arm 1: Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \< 140/\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg. arm 2: Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \< 140/\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg.	[ 0, 1 ]	6	[ 0, 0, 0, 0, 0, 0 ]	intervention 1: Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily. intervention 2: Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily. intervention 3: Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure. intervention 4: Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily. intervention 5: Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily. intervention 6: Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.	intervention 1: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1 intervention 2: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2 intervention 3: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter intervention 4: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1 intervention 5: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2 intervention 6: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter	5	East Hanover \| New Jersey \| United States \| -74.36487 \| 40.8201 Denmark \| N/A \| Denmark \| N/A \| N/A Finland \| N/A \| Finland \| N/A \| N/A Norway \| N/A \| Norway \| N/A \| N/A Sweden \| N/A \| Sweden \| N/A \| N/A	11,497	1	0.000087	0	NCT00170950	6TERMINATED	2008-05-01	2003-10-01	Novartis	4INDUSTRY	false	false	false	null	0	0	1	0.000015
[ 3 ]	78	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	The study consisted of two parts. In Part 1 the study enrolled 38 patients (Step 1 Simon 2 step design) after which Step 2 was opened and the total enrollment target for the study (n=63) was exceeded due to a rapid enrollment (78 patients were entered). Part 2 of the study did not open due to the final overall insufficiency of efficacy observed in 78 patients. Sunitinib (SU011248) was administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg with provision for dose reduction based on tolerability. All patients received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met. After discontinuation of treatment, patients were followed up in order to collect information on further antineoplastic therapy and survival.	null	Stomach Neoplasms		null	1	arm 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed	[ 0 ]	1	[ 0 ]	intervention 1: 50mg daily, taken by mouth for 28 days followed by 2 weeks of drug free period was one cycle. Cycles were repeated until progression of disease or unacceptable toxicity was observed	intervention 1: Sunitinib	18	Nanjing \| Jiangsu \| China \| 118.77778 \| 32.06167 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Guangzhou \| N/A \| China \| 113.25 \| 23.11667 Hong Kong \| N/A \| Hong Kong \| 114.17469 \| 22.27832 Shatin \| N/A \| Hong Kong \| 114.18333 \| 22.38333 Ancona \| N/A \| Italy \| 13.5103 \| 43.60717 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Kashiwa \| Chiba \| Japan \| 139.97732 \| 35.86224 Suntougun \| Shizuoka \| Japan \| N/A \| N/A Chuo-ku \| Tokyo \| Japan \| N/A \| N/A Porto \| N/A \| Portugal \| -8.61099 \| 41.14961 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Kwei-Shan \| Taoyuan \| Taiwan \| N/A \| N/A Taipei \| N/A \| Taiwan \| 121.52639 \| 25.05306	78	1	0.012821	1	NCT00226811	1COMPLETED	2008-05-01	2006-01-01	Pfizer	4INDUSTRY	false	false	false	null	0	0	1	0.002267
[ 4 ]	1,428	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	This is a controlled, randomized, parallel-groups, open-label, multinational study designed to evaluate the efficacy and safety of PEG-Intron® (pegylated interferon alfa-2b) plus Rebetol® (ribavirin) in subjects with chronic hepatitis C. It is designed to evaluate whether 72 weeks of treatment with PEG-Intron plus Rebetol is more effective than 48 weeks of treatment in subjects with Genotype 1 chronic hepatitis C who exhibit a slow response to treatment.	null	Hepatitis C, Chronic		null	2	arm 1: Slow responders (defined as being polymerase chain reaction \[PCR\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48. arm 2: Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks intervention 2: 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks. 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks	intervention 1: Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) intervention 2: Combination of pegylated interferon alfa-2b and ribavirin	0	null	1,427	1	0.000701	1	NCT00265395	1COMPLETED	2008-05-01	2004-12-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	0	1	0	0.000124
[ 4 ]	3,608	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	true	The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.	null	Deep Vein Thrombosis Pulmonary Embolism	Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery	null	2	arm 1: \+ placebo arm 2: \+ placebo	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period intervention 2: Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period	intervention 1: Enoxaparin + Placebo intervention 2: Apixaban + Placebo	107	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Tuscaloosa \| Alabama \| United States \| -87.56917 \| 33.20984 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Englewood \| Colorado \| United States \| -104.98776 \| 39.64777 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Bay Pines \| Florida \| United States \| -82.77816 \| 27.81419 Brandon \| Florida \| United States \| -82.28592 \| 27.9378 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Orange City \| Florida \| United States \| -81.29867 \| 28.94888 Winter Park \| Florida \| United States \| -81.33924 \| 28.6 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 Lubbock \| Texas \| United States \| -101.85517 \| 33.57786 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Buenos Aires \| Buenos Aires \| Argentina \| N/A \| N/A Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Capital Federal \| Buenos Aires \| Argentina \| N/A \| N/A Córdoba \| Córdoba Province \| Argentina \| -64.18853 \| -31.40648 Garran \| Australian Capital Territory \| Australia \| 149.10846 \| -35.34206 Camperdown \| New South Wales \| Australia \| 151.17642 \| -33.88965 Caringbah \| New South Wales \| Australia \| 151.12468 \| -34.03534 Lismore \| New South Wales \| Australia \| 153.2773 \| -28.81354 Gold Coast \| Queensland \| Australia \| 153.43088 \| -28.00029 Adelaide \| South Australia \| Australia \| 138.59863 \| -34.92866 Bedford Park \| South Australia \| Australia \| 138.56815 \| -35.02204 Box Hill \| Victoria \| Australia \| 145.12545 \| -37.81887 Windsor \| Victoria \| Australia \| 144.99241 \| -37.85344 Perth \| Western Australia \| Australia \| 115.8614 \| -31.95224 Curitiba \| Paraná \| Brazil \| -49.27306 \| -25.42778 Porto Alegre \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Porto Alegre, Rs \| Rio Grande do Sul \| Brazil \| -51.23019 \| -30.03283 Campinas \| São Paulo \| Brazil \| -47.06083 \| -22.90556 São Paulo \| São Paulo \| Brazil \| -46.63611 \| -23.5475 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Ajax \| Ontario \| Canada \| -79.03288 \| 43.85012 Burlington \| Ontario \| Canada \| -79.83713 \| 43.38621 Cambridge \| Ontario \| Canada \| -80.31269 \| 43.3601 Chatham \| Ontario \| Canada \| -82.18494 \| 42.41224 Dartmouth \| Ontario \| Canada \| N/A \| N/A Guelph \| Ontario \| Canada \| -80.25599 \| 43.54594 Lindsay \| Ontario \| Canada \| -78.73286 \| 44.35012 Newmarket \| Ontario \| Canada \| -79.46631 \| 44.05011 Niagara Falls \| Ontario \| Canada \| -79.06627 \| 43.10012 Sarnia \| Ontario \| Canada \| -82.40407 \| 42.97866 Scarborough Village \| Ontario \| Canada \| -79.22124 \| 43.73899 Scarborough Village \| Ontario \| Canada \| -79.22124 \| 43.73899 St. Catharines \| Ontario \| Canada \| -79.24267 \| 43.17126 Stratford \| Ontario \| Canada \| -80.94972 \| 43.36679 Waterloo \| Ontario \| Canada \| -80.51639 \| 43.4668 Windsor \| Ontario \| Canada \| -83.01654 \| 42.30008 Charlottetown \| Prince Edward Island \| Canada \| -63.1256 \| 46.23459 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Hørsholm \| N/A \| Denmark \| 12.50111 \| 55.88098 Kopenhamn S \| N/A \| Denmark \| N/A \| N/A Kecskemét \| N/A \| Hungary \| 19.69128 \| 46.90618 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szolnok \| N/A \| Hungary \| 20.2 \| 47.18333 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Beersheba \| N/A \| Israel \| 34.7913 \| 31.25181 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Holon \| N/A \| Israel \| 34.77918 \| 32.01034 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Rehovot \| N/A \| Israel \| 34.81199 \| 31.89421 Ẕerifin \| N/A \| Israel \| 34.84852 \| 31.95731 Chihuahua City \| Chihuahua \| Mexico \| -106.08889 \| 28.63528 Tijuana \| Estado de Baja California \| Mexico \| -117.00371 \| 32.5027 Guadalajara \| Jalisco \| Mexico \| -103.34749 \| 20.67738 Df \| Mexico City \| Mexico \| N/A \| N/A Df \| Mexico City \| Mexico \| N/A \| N/A Df \| Mexico City \| Mexico \| N/A \| N/A Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Monterrey \| Nuevo León \| Mexico \| -100.31721 \| 25.68435 Ciudad Madero \| Tamaulipas \| Mexico \| -97.83665 \| 22.2475 Jalapa \| Veracruz \| Mexico \| -95.03708 \| 18.06832 Mérida \| Yucatán \| Mexico \| -89.62318 \| 20.967 Mérida \| Yucatán \| Mexico \| -89.62318 \| 20.967 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Adana \| N/A \| Turkey (Türkiye) \| 35.32531 \| 36.98615 Bursa \| N/A \| Turkey (Türkiye) \| 29.06013 \| 40.19559 Mersin \| N/A \| Turkey (Türkiye) \| 34.63886 \| 36.81196 Trabzon \| N/A \| Turkey (Türkiye) \| 39.72694 \| 41.005	3,184	5	0.00157	1	NCT00371683	1COMPLETED	2008-05-01	2006-11-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	1	0	4	0.000671
[ 3 ]	235	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this study is to compare hemoglobin response rates between two PROCRIT (epoetin alfa) doses and ARANESP (darbepoetin alfa) in anemic cancer patients receiving chemotherapy	This is an open-label (both the physician and the patient know which treatment is being provided), multi-center study of up to 16 weeks duration in which 450 patients will be randomly assigned (patients are assigned to a specific study group by chance) to one of three treatment groups in a 1:1:1 ratio. Patients will receive PROCRIT (epoetin alfa) 80,000 Units injected subcutaneously (under the skin) once every three weeks or 120,000 Units injected under the skin once every three weeks or ARANESP (darbepoetin alfa) 500 mcg injected under the skin once every three weeks for up to 13 weeks. PROCRIT (epoetin alfa) 80,000 Units and 120,000 Units given once every three weeks are doses and schedules that are not approved for use in the United States and are under investigation, while the ARANESP dose and schedule are approved for use in the United States. Adult patients with specific types of cancer (confirmed non-myeloid malignancy) who are scheduled to receive cyclic chemotherapy for a minimum of 12 weeks during the study and who meet all other eligibility criteria will be enrolled. This study will be conducted in approximately 80 study sites located in the United States. The study hypothesis is that a dosing regimen of PROCRIT (Epoetin alfa) 80,000 Units or 120,000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once every three weeks with respect to the mean hemoglobin (Hb) change from baseline to Study Week 7 in anemic cancer patients receiving chemotherapy. Hemoglobin levels will be monitored throughout the study on a weekly basis and before each drug dose is administered. Drug dosing will be adjusted (ie, held, reduced, resumed at a lower dose) as needed to maintain hemoglobin values within desired ranges. The maximum dose of PROCRIT (Epoetin alfa) allowed in this study is 120,000 Units every three weeks (Q3W) and the maximum dose of ARANESP (darbepoetin) is 500 mcg Q3W. Safety evaluations will be conducted throughout the study and will consist of assessment of laboratory tests, vital signs, physical examinations. The occurrence and severity of adverse events, including thrombovascular events will be evaluated throughout the study.Periodic data monitoring of the study by an external Independent Data Monitoring Committee (IDMC) will be performed. The main responsibility of the IDMC is to conduct ongoing monitoring of safety and to report any irregularities back to the Sponsor along with recommendations regarding continuation of the study. Each patient will be assigned to one of three dosing schedules. All schedules will be administered by way of subcutaneous (under the skin) injection once every three weeks over a period of 13 weeks. The three dosing schedules are as follows: PROCRIT (epoetin alfa) 80,000 Units, PROCRIT (epoetin alfa) 120,000 Units or ARANESP (darbepoetin alfa) 500 mcg	Neoplasms Anemia Cancer	Anemia Cancer Chemotherapy-Induced Anemia Epoetin alfa Darbepoetin alfa	null	3	arm 1: epoetin alfa (PROCRIT) 120,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks arm 2: epoetin alfa (PROCRIT) 80,000 Units injected subcutaneously once every 3 weeks for up to 13 weeks arm 3: darbepoetin alfa (ARANESP) 500 mcg injected subcutaneously the skin once every 3 weeks for up to 13 weeks	[ 0, 0, 1 ]	2	[ 0, 0 ]	intervention 1: 80,000 Units and 120,000 Units of epoetin alfa (PROCRIT) injected subcutaneously once every 3 weeks for up to 13 weeks intervention 2: 500 mcg of darbepoetin alfa (ARANESP) injected subcutaneously the skin once every 3 weeks for up to 13 weeks	intervention 1: epoetin alfa intervention 2: darbepoetin alfa	76	Glendale \| Arizona \| United States \| -112.18599 \| 33.53865 Jonesboro \| Arkansas \| United States \| -90.70428 \| 35.8423 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Anaheim \| California \| United States \| -117.9145 \| 33.83529 Bakersfield \| California \| United States \| -119.01871 \| 35.37329 Corona \| California \| United States \| -117.56644 \| 33.87529 Fountain Valley \| California \| United States \| -117.95367 \| 33.70918 Fullerton \| California \| United States \| -117.92534 \| 33.87029 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Irvine \| California \| United States \| -117.82311 \| 33.66946 La Jolla \| California \| United States \| -117.2742 \| 32.84727 La Verne \| California \| United States \| -117.76784 \| 34.10084 Lancaster \| California \| United States \| -118.13674 \| 34.69804 Long Beach \| California \| United States \| -118.18923 \| 33.76696 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Northridge \| California \| United States \| -118.53675 \| 34.22834 Orange \| California \| United States \| -117.85311 \| 33.78779 Rancho Mirage \| California \| United States \| -116.41279 \| 33.73974 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Norwich \| Connecticut \| United States \| -72.07591 \| 41.52426 Gainsville \| Florida \| United States \| N/A \| N/A Kissimmee \| Florida \| United States \| -81.41667 \| 28.30468 Lecanto \| Florida \| United States \| -82.4876 \| 28.85165 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Athens \| Georgia \| United States \| -83.37794 \| 33.96095 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Griffin \| Georgia \| United States \| -84.26409 \| 33.24678 Centralia \| Illinois \| United States \| -89.1334 \| 38.52505 Gurnee \| Illinois \| United States \| -87.90202 \| 42.3703 North Chicago \| Illinois \| United States \| -87.84118 \| 42.32558 Olympia Fields \| Illinois \| United States \| -87.67421 \| 41.51337 Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114 Springfield \| Illinois \| United States \| -89.64371 \| 39.80172 New Albany \| Indiana \| United States \| -85.82413 \| 38.28562 Hutchinson \| Kansas \| United States \| -97.92977 \| 38.06084 Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417 Paducah \| Kentucky \| United States \| -88.60005 \| 37.08339 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Free Soil \| Michigan \| United States \| -86.21675 \| 44.10695 Lansing \| Michigan \| United States \| -84.55553 \| 42.73253 Southfield \| Michigan \| United States \| -83.22187 \| 42.47337 Tupelo \| Mississippi \| United States \| -88.70464 \| 34.25807 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Omaha \| Nebraska \| United States \| -95.94043 \| 41.25626 Englewood \| New Jersey \| United States \| -73.97264 \| 40.89288 Clifton Springs \| New York \| United States \| -77.13998 \| 42.96173 Lake Success \| New York \| United States \| -73.71763 \| 40.77066 Asheville \| North Carolina \| United States \| -82.55402 \| 35.60095 Wilmington \| North Carolina \| United States \| -77.94604 \| 34.23556 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Canton \| Ohio \| United States \| -81.37845 \| 40.79895 Lancaster \| Pennsylvania \| United States \| -76.30551 \| 40.03788 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pottsville \| Pennsylvania \| United States \| -76.1955 \| 40.68565 Aiken \| South Carolina \| United States \| -81.71955 \| 33.56042 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Mt. Pleasant \| South Carolina \| United States \| -79.86259 \| 32.79407 North Charleston \| South Carolina \| United States \| -79.97481 \| 32.85462 Sumter \| South Carolina \| United States \| -80.34147 \| 33.92044 Johnson City \| Tennessee \| United States \| -82.35347 \| 36.31344 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 El Paso \| Texas \| United States \| -106.48693 \| 31.75872 Galveston \| Texas \| United States \| -94.7977 \| 29.30135 Grapevine \| Texas \| United States \| -97.07807 \| 32.93429 Houston \| Texas \| United States \| -95.36327 \| 29.76328 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Chesapeake \| Virginia \| United States \| -76.27494 \| 36.81904 Newport News \| Virginia \| United States \| -76.42975 \| 36.98038 Woodbridge \| Virginia \| United States \| -77.2497 \| 38.65817 Vancouver \| Washington \| United States \| -122.66149 \| 45.63873 Walla Walla \| Washington \| United States \| -118.34302 \| 46.06458 Morgantown \| West Virginia \| United States \| -79.9559 \| 39.62953	227	1	0.004405	1	NCT00386152	6TERMINATED	2008-05-01	2006-11-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	1	0	0	0.000778
[ 3 ]	342	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).	null	Diabetes Mellitus, Type 2		null	6	arm 1: MK0893 tablets totaling 80 mg once daily. arm 2: MK0893 tablets totaling 60 mg once daily. arm 3: MK0893 40 mg tablet once daily. arm 4: MK0893 20 mg tablet once daily. arm 5: Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. arm 6: PLA tablets. 12 week treatment period.	[ 0, 0, 0, 0, 1, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose. intervention 2: Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks. intervention 3: Dose-matched placebo tablets to MK0893; taken orally once daily. intervention 4: Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.	intervention 1: MK0893 intervention 2: Metformin intervention 3: Placebo to MK0893 intervention 4: Placebo to Metformin	0	null	342	9	0.026316	1	NCT00479466	6TERMINATED	2008-05-01	2007-07-01	Merck Sharp & Dohme LLC	4INDUSTRY	false	false	false	null	9	0	0	0.013905
[ 3 ]	12	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.	OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease). * To determine the safety and tolerance of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy. OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued to this study.	Visual Pathway Glioma	visual pathway glioma not amenable to standard therapy visual pathway glioma not responding to standard therapy	null	1	arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.	[ 0 ]	1	[ 0 ]	intervention 1: Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).	intervention 1: Antineoplaston therapy (Atengenal + Astugenal)	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	12	0	0	0	NCT00003477	1COMPLETED	2008-05-01	1996-06-01	Burzynski Research Institute	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	26	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells. PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.	OBJECTIVES: * Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b. * Determine the toxicity of this regimen in these patients. * Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies. OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.) Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.) During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.) Patients are followed at 30 days after the last treatment. PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.	Kidney Cancer	stage IV renal cell cancer recurrent renal cell cancer	null	1	arm 1: Weekly ATRA-IV with recombinant interferon alfa	[ 0 ]	2	[ 2, 0 ]	intervention 1: None intervention 2: None	intervention 1: recombinant interferon alfa intervention 2: tretinoin liposome	2	New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427	26	0	0	0	NCT00003656	1COMPLETED	2008-05-01	1999-01-01	Weill Medical College of Cornell University	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	186	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.	PRIMARY OBJECTIVES: I. To determine whether oral administration of the carboxyaminoimidazole (CAI) is more effective than placebo in prolonging the overall survival in patients with non-small cell lung cancer stage III or stage IV non-small cell lung cancer who have been stable or had tumor regression following chemotherapy. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of oral CAI following chemotherapy. II. To determine whether CAI prolongs time-to-disease progression relative to a placebo. III. To evaluate whether a substantive effect in quality of life (QOL) can be detected between the CAI and placebo groups using the FACT-L and the UNISCALE. IV. To document the response rate to CAI in patients with measurable or evaluable disease. TERTIARY OBJECTIVES: I. To evaluate genotypes at GSH-related loci as predictors of overall survival. OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to timing of first-line therapy (prior to registration vs after registration), disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating center. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral carboxyamidotriazole daily. ARM II: Patients receive oral placebo daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then monthly during study. Patients are followed every 3 months for 5 years.	Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer		null	2	arm 1: Patients receive oral carboxyamidotriazole daily. arm 2: Patients receive oral placebo daily	[ 0, 2 ]	4	[ 0, 10, 3, 10 ]	intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Correlative studies	intervention 1: carboxyamidotriazole intervention 2: placebo intervention 3: quality-of-life assessment intervention 4: laboratory biomarker analysis	1	Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163	182	0	0	0	NCT00003869	1COMPLETED	2008-05-01	1999-04-01	National Cancer Institute (NCI)	0NIH	false	false	false	null	0	0	0	0
[ 3 ]	34	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin or leuprolide may stop the adrenal glands from producing androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, hormone therapy, and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving chemotherapy together with hormone therapy and radiation therapy in treating patients with locally advanced prostate cancer.	OBJECTIVES: * Determine the feasibility and safety of paclitaxel, estramustine, carboplatin, and androgen ablation followed by radiotherapy in patients with poor-prognosis locally advanced prostate cancer. * Determine the progression-free survival and time to prostate specific antigen failure in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 1 hour once weekly; oral estramustine three times a day, five days a week; and carboplatin IV over 1 hour once monthly. Treatment repeats every 4 weeks for 4 courses. Patients also receive gonadotropin-releasing hormonal therapy comprising either goserelin subcutaneously or leuprolide intramuscularly once monthly. Treatment repeats every 4 weeks for 6 courses. After the completion of chemotherapy, patients undergo radiotherapy once daily on weeks 17-24. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 1.5 years.	Prostate Cancer	adenocarcinoma of the prostate stage III prostate cancer	null	1	arm 1: Patients with localized high-risk prostate cancer were treated with 4 cycles (16 weeks) of continuous weekly paclitaxel at 80 mg/m\^2 intravenously with estramustine at 280 mg orally 3 times a day for 5 days a week and carboplatin (area under the curve of 6) on Day 1 of every cycle followed by 3-dimensional conformal or intensity-modulated radiotherapy (total dose of 77.4 gray \[Gy\] in 1.8-Gy fractions). All patients received androgen deprivation therapy with either goserelin acetate at 3.6 mg subcutaneously or leuprolide acetate at 7.5 mg intramuscularly monthly for 6 months starting at Day 1 of therapy.	[ 0 ]	5	[ 0, 0, 0, 4, 0 ]	intervention 1: AUC=6 week one of each 4 week cycle intervention 2: 2 tablets tid PO 5 of 7 days per week each 4 week cycle intervention 3: 80 mg/sq m IV infusion over 1 hour weekly for ea 4 week cycle intervention 4: 77.4 Gy in 1.8 Gy fractions intervention 5: 7.5 mg IM injection once every 4 weeks for 6 months	intervention 1: carboplatin intervention 2: estramustine intervention 3: paclitaxel intervention 4: radiation therapy intervention 5: leuprolide or goserelin acetate	23	Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Worcester \| Massachusetts \| United States \| -71.80229 \| 42.26259 Chesterfield \| Missouri \| United States \| -90.57707 \| 38.66311 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 New York \| New York \| United States \| -74.00597 \| 40.71427 Oswego \| New York \| United States \| -76.5105 \| 43.45535 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Syracuse \| New York \| United States \| -76.14742 \| 43.04812 Goldsboro \| North Carolina \| United States \| -77.99277 \| 35.38488 Goldsboro \| North Carolina \| United States \| -77.99277 \| 35.38488 Kinston \| North Carolina \| United States \| -77.58164 \| 35.26266 Wilson \| North Carolina \| United States \| -77.91554 \| 35.72127 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Danville \| Virginia \| United States \| -79.39502 \| 36.58597	29	0	0	0	NCT00016913	1COMPLETED	2008-05-01	2001-05-01	Alliance for Clinical Trials in Oncology	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	41	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.	OBJECTIVES: * Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma. * Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients. * Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients. * Determine the pharmacodynamics of this drug in these patients. * Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients. * Correlate changes in biological measurements with indices of outcome in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.	Kidney Cancer	recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer	null	1	arm 1: None	[ 0 ]	1	[ 0 ]	intervention 1: OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.	intervention 1: OSI-774	1	San Antonio \| Texas \| United States \| -98.49363 \| 29.42412	41	0	0	0	NCT00045487	1COMPLETED	2008-05-01	2002-06-01	The University of Texas Health Science Center at San Antonio	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	271	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	false	The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.	This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.	Liposarcoma Leiomyosarcoma	Trabectedin Yondelis ET-743 Ecteinascidin Anthracycline Ifosfamide Dexamethasone Intravenous Cancer Malignant Metastatic	null	2	arm 1: Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. arm 2: Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.	[ 0, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. intervention 2: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. intervention 3: Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. intervention 4: Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.	intervention 1: Yondelis intervention 2: Yondelis intervention 3: Dexamethasone intervention 4: Dexamethasone	39	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Aurora \| Colorado \| United States \| -104.83192 \| 39.72943 Coeur d'Alene \| Idaho \| United States \| -116.78047 \| 47.67768 Park Ridge \| Illinois \| United States \| -87.84062 \| 42.01114 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Louisville \| Kentucky \| United States \| -85.75941 \| 38.25424 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 Rochester \| Minnesota \| United States \| -92.4699 \| 44.02163 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 New York \| New York \| United States \| -74.00597 \| 40.71427 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 East Melbourne \| N/A \| Australia \| 144.9879 \| -37.81667 Newcastle \| N/A \| Australia \| 151.7801 \| -32.92953 Perth \| N/A \| Australia \| 115.8614 \| -31.95224 Woodville \| N/A \| Australia \| 138.54291 \| -34.877 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Edmonton \| N/A \| Canada \| -113.46871 \| 53.55014 Lyon \| N/A \| France \| 4.84671 \| 45.74846 Villejuif \| N/A \| France \| 2.35992 \| 48.7939 Düsseldorf \| N/A \| Germany \| 6.77616 \| 51.22172 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Obninsk \| N/A \| Russia \| 36.61238 \| 55.10993 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Samara \| N/A \| Russia \| 50.15 \| 53.20007 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391	260	0	0	0	NCT00060944	1COMPLETED	2008-05-01	2003-05-01	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	150	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	false	0ALL	true	This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks.	Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine. Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.	Social Anxiety Disorder	Social Phobia	null	2	arm 1: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. arm 2: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.	[ 0, 0 ]	2	[ 0, 5 ]	intervention 1: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. intervention 2: CBT will consist of 16 weekly treatment sessions.	intervention 1: Paroxetine intervention 2: Cognitive behavioral therapy (CBT)	2	New York \| New York \| United States \| -74.00597 \| 40.71427 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	61	0	0	0	NCT00074802	1COMPLETED	2008-05-01	2003-12-01	Temple University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	49	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	0NONE	false	1FEMALE	true	RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy. PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.	OBJECTIVES: Primary * Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy. Secondary * Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug. * Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug. * Determine quality of life of patients treated with this drug. * Determine disease-free and overall survival of patients treated with this drug. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 35 years vs 35 to 39 years vs \> 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide \[6 courses\] OR fluorouracil, doxorubicin, and cyclophosphamide \[6 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] followed by a taxane \[4 courses\]); and hormone receptor status (estrogen receptor \[ER\]- AND progesterone receptor \[PR\]-negative vs ER- OR PR-positive). * Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy. * Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years. Patients are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.	Breast Cancer Hormone Changes Drug Toxicity	drug/agent toxicity by tissue/organ hormone changes stage I breast cancer stage II breast cancer	null	2	arm 1: GnRH analogue (triptorelin) during chemotherapy arm 2: No GnRH analogue (triptorelin) during chemotherapy	[ 0, 4 ]	1	[ 0 ]	intervention 1: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection	intervention 1: triptorelin	9	Oakland \| California \| United States \| -122.2708 \| 37.80437 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Springfield \| Missouri \| United States \| -93.29824 \| 37.21533 Fargo \| North Dakota \| United States \| -96.7898 \| 46.87719 Temple \| Texas \| United States \| -97.34278 \| 31.09823 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288	49	0	0	0	NCT00090844	6TERMINATED	2008-05-01	2004-07-01	University of South Florida	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	77	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).	Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria: * Abdominal obesity (waist measurement \>39.8 inches in men, \>34.4 inches in women) * Elevated triglycerides (\>150 mg/dl) * Low HDL or "good" cholesterol (\<40 mg/dl in men or \<50 mg/dl in women) * Elevated blood pressure (\>130/85) or treatment for high blood pressure * Elevated fasting blood sugar (\>100 mg/dl) Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function. This study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams. Taking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.	Obesity Hypertension Hypercholesterolemia Hyperglycemia	Metabolic Syndrome triglycerides HDL LDL High Blood Pressure High Cholesterol High Blood Sugar	null	2	arm 1: placebo arm 2: Metformin 850 mg twice daily	[ 2, 0 ]	2	[ 0, 0 ]	intervention 1: 850mg tablet once a day for one month, then twice a day for 3 months intervention 2: placebo tablet once a day for one month, then twice a day for 3 months	intervention 1: Metformin intervention 2: Placebo	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	77	0	0	0	NCT00105066	1COMPLETED	2008-05-01	2004-01-01	National Institute on Aging (NIA)	0NIH	false	false	false	null	0	0	0	-0
[ 4 ]	12,064	RANDOMIZED	FACTORIAL	1PREVENTION	4QUADRUPLE	false	0ALL	true	SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064 patients with myocardial infarction (MI) prior to study entry which aims to demonstrate whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid 2 mg + vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in vascular disease.	In observational studies, lower blood cholesterol concentrations are associated with lower coronary risk, without any clear threshold below which lower levels are not associated with lower risk. Cholesterol reduction with statins reduces such risk but there is uncertainty about whether greater reductions with more intensive statin therapy will produce greater benefits. Elevated blood homocysteine levels appear to be an independent marker of cardiovascular risk, but it is unknown whether taking vitamins to reduce homocysteine concentrations will translate into cardiovascular benefit. 12,064 survivors of myocardial infarction have been randomised in a 2x2 factorial design to more intensive versus standard cholesterol-lowering treatment, using 80 mg or 20 mg daily simvastatin, and separately to homocysteine-lowering with folic acid plus vitamin B12 or matching placebo. Follow-up will continue until there are at least 2800 confirmed major vascular events (MVE), defined as non-fatal myocardial infarction, coronary death, stroke or arterial revascularisation. The primary outcome is the incidence of first MVE during the scheduled treatment period. SEARCH should provide reliable evidence of the effectiveness and safety of more intensive cholesterol-lowering for the reduction of major vascular events in a high-risk population, and of the effects of homocysteine-lowering with folic acid plus vitamin B12.	Cardiovascular Disease	Myocardial infarction Coronary heart disease Cholesterol Stroke	null	4	arm 1: Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily arm 2: Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily arm 3: Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily arm 4: Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily	[ 1, 1, 1, 1 ]	4	[ 0, 7, 0, 0 ]	intervention 1: Simvastatin 20 mg tablet once daily intervention 2: Folic acid 2 mg + vitamin B12 1 mg tablet once daily intervention 3: Simvastatin 80 mg tablet once daily intervention 4: Placebo vitamin B12/folic acid tablet once daily	intervention 1: Simvastatin 20 mg daily intervention 2: Folic acid 2 mg + vitamin B12 1 mg daily intervention 3: Simvastatin 80 mg daily intervention 4: Placebo	1	Oxford \| Oxon \| United Kingdom \| -1.25596 \| 51.75222	24,128	0	0	0	NCT00124072	1COMPLETED	2008-05-01	1998-07-01	University of Oxford	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	6	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	This study will examine the safety and effectiveness of a monoclonal antibody called humanized anti-Tac (HAT, also called daclizumab) to treat children and adolescents with uveitis (chronic inflammatory eye disease) associated with juvenile idiopathic arthritis (JIA). Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. The HAT antibody is designed to prevent a specific chemical interaction needed for immune cells to produce inflammation. Current treatments for uveitis include steroids and immune-suppressing drugs. These treatments do not always work or they may cause significant side effects. This study will determine whether daclizumab can improve uveitis in children and reduce the need for other medicines. Patients between 6 and 18 years of age with active non-infectious JIA-associated uveitis requiring treatment with anti-inflammatory medications as often as three times a day or more may be eligible for this study. Each candidate is screened with a medical history, physical examination, blood tests, eye examination, and the following specialized tests: * Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating the presence of inflammation. * Optical coherence tomography to measure retinal thickness. The eyes are examined through a machine that produces cross-sectional pictures of the retina. These measures are repeated during the study to determine changes, if any, in retinal thickening. * Stereoscopic color fundus photography to examine the back of the eye. The pupils are dilated with eye drops to examine and photograph the back of the eye. Upon entering the study, participants receive a 90-minute infusion of daclizumab through a catheter (plastic tube) placed in an arm vein. They return to the clinic after 14 days and again after 28 days for repeat eye examinations, blood tests, and daclizumab infusions. Four weeks after the third infusion, patients are examined for response to treatment. Those who have benefited from daclizumab may continue receiving monthly infusions of the drug for up to one year. A blood test and eye examination are done at the time of each infusion. Patients whose disease has remained active 12 weeks after the first infusion are taken off the study and treated with other medications.	Pediatric uveitis represents 5-10 % of all patients with uveitis. Uveitis refers to intraocular inflammatory diseases. The most common type of non-infectious pediatric uveitis, associated with a systemic disease, is JIA-associated chronic, anterior uveitis. Therapeutic considerations for pediatric uveitis are often very challenging. Current therapeutic modalities include corticosteroids and other immunosuppressive agents. These modalities are not always effective at controlling the disease. In addition they can also be associated with a higher rate of ocular side effects. To further add to this challenge, pediatric uveitis has a higher rate of ocular complications, even with the current therapies. Consequently, an effective treatment with a safer side effect profile is highly desirable. Daclizumab is a humanized monoclonal antibody directed against the high affinity interleukin-2 (IL-2) receptor CD25 or Tac subunit. The IL-2 receptor system plays a central role in mediating immune responses. Blocking this system impedes immune responses and can inhibit local inflammatory responses, including uveitis. Pilot studies using intravenous or subcutaneous daclizumab treatments suggest that daclizumab treatments at 2 mg/kg every 2-4 weeks for quiescent uveitis may effectively replace the other immunosuppressive medications in a majority of cases. Because we have little experience using daclizumab for active uveitis in a pediatric population, this feasibility study will enroll seven study participants that would normally be treated with systemic, high-dose corticosteroids or other cytotoxic, systemic immunosuppressive medications. Since daclizumab for other indications can be tolerated with repeated dosing at 8-10 mg/kg, we will administer daclizumab to reach high serum levels with a pair of doses at 8 mg/kg and 4 mg/kg two weeks apart. The primary objective of this study is to collect preliminary information on the utility of acute daclizumab therapy on active ocular inflammation in a pediatric population. The primary outcome is resolution of active disease defined as a two step reduction in the anterior chamber cell scale from baseline. Safety assessment will be made at 28 days and efficacy assessment at 8 weeks after the initial daclizumab injection. Secondary outcomes will include fluorescein retinal vascular leakage, cystoid macular edema, vitreous haze and visual acuity. In addition all adverse events will be collected regardless of possible relation to daclizumab. Participants who do not meet the safety end point at day 28 will be permitted to continue IV daclizumab maintenance treatments beginning at Day 28 with 2 mg/kg every 4 weeks. An efficacy assessment will be made at 8 weeks, and patients who show a 2 step reduction in their intraocular inflammation, and has not met the safety end point, will continue daclizumab treatment with 2mg/kg every 4 weeks for a total of 52 weeks in the study. At any time during the follow-up period, if a participant loses greater than 3 lines of visual acuity from baseline study, or meet the safety end point, treatments will be discontinued. The primary objective of this feasibility study is to gain preliminary information regarding the safety and possible efficacy of daclizumab to treat active uveitis, associated with JIA. The primary focus of this feasibility study is a short or acute response trial to relatively high-dose daclizumab infusions to observe if the anterior cell and flare associate with active JIA-associated uveitis can be promptly reduced. In order to qualify for enrollment, each participant must meet all of the inclusion criteria and not meet any of the exclusion criteria. This study will enroll seven participants at the National Eye Institute (NEI) who currently have active JIA-associated active uveitis. Enrollment is expected to take approximately three months. The two induction treatments will be completed within 14 days, with the primary safety evaluation at Day 14 and Day 28 and primary efficacy assessment at 12 weeks. An induction regimen of intravenous (IV) daclizumab at 8 mg/kg is given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint has not been met. An efficacy assessment will be made at 12 weeks, and patients who show a 2-step reduction in their intraocular inflammation, and has not met the safety endpoint, will continue with daclizumab therapy. Meeting the safety failure criterion or having a serious adverse affect attributable to the daclizumab therapy will be cause for termination from further daclizumab study treatments. Continuing follow-up and standard-of-care alternative treatments with a potentially reduced visit schedule will be provided through the duration of the trial if daclizumab treatments are suspended. After the trial, participants may seek other standard-of-care treatments from their own physician or ophthalmologist or they may be eligible to enroll in other research trials if these are available. Participants who show a 2-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, will have the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks in the study.	Anterior Uveitis Arthritis, Juvenile Idiopathic Iritis Immunosuppression	Anterior Uveitis Arthritis, Juvenile Idiopathic Daclizumab Iritis Immunosuppression Chronic Inflammatory Eye-Disease Juvenile Idiopathic Arthritis	null	1	arm 1: IV daclizumab	[ 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Daclizumab	1	Bethesda \| Maryland \| United States \| -77.10026 \| 38.98067	6	0	0	0	NCT00130637	1COMPLETED	2008-05-01	2005-08-01	National Eye Institute (NEI)	0NIH	false	false	false	null	0	0	0	0
[ 5 ]	36	RANDOMIZED	PARALLEL	0TREATMENT	1SINGLE	true	1FEMALE	true	This study will determine the effects of St. John's wort, a common herbal remedy, on metabolism of the female contraceptive hormone levonorgestrel.	In the last decade, St. John's wort has become one of the most commonly used botanicals. Levonorgestrel is a form of progesterone, a female hormone involved in conception. It can be given as both a pill and an injection and is used for contraception and for the treatment of endometriosis. However, evidence suggests that St. John's wort may reduce the effectiveness of the contraceptive hormone levonorgestrel. This study will determine whether interactions between St. John's wort and levonorgestrel reduce the effectiveness of the hormone. This study will also determine whether a higher dose of levonorgestrel will override the effects of St. John's wort. All participants will receive a single dose of levonorgestrel between Days 9 and 12 of their first menstrual cycle after entering this study. Blood and urine collection will occur immediately after the levonorgestrel is given and every week until participants' next menstrual cycle to determine the levels of reproductive hormones in participants' bodies. At the beginning of participants' next menstrual cycle, they will be randomly assigned to one of four groups and receive either St. John's wort or placebo for 6 weeks. Group 1 will receive a placebo; Groups 2 and 3 will receive a standard dose of St. John's wort (900 mg per day); and Group 4 will receive an increased dose of St. John's wort (1500 mg per day). After 6 weeks, Groups 1, 2, and 4 will receive 150 mcg levonorgestrel; and Group 3 will receive 225 mcg levonorgestrel. Blood and urine collection will occur immediately after levonorgestrel is given and every week until participants' next menstrual cycle.	Contraception	Menstruation Complementary Therapies Pharmacokinetics Hypericum St. John's wort Levonorgestrel Women	null	4	arm 1: This group had baseline pharmacokinetic studies after an oral dose of levonorgestrel (LNG) 1.5 mg, then took a placebo herb daily for 4-6 weeks, during which time pharmacokinetic studies were repeated after an oral dose of LNG 1.5 mg arm 2: This group had baseline pharmacokinetic studies after an oral dose of levonorgestrel (LNG) 1.5 mg, then took St. John's Wort (SJW) 900 mg a Day orally for 4-6 weeks, during which time pharmacokinetic studies were repeated after an oral dose of LNG 1.5 mg arm 3: This group had baseline pharmacokinetic studies after an oral dose of levonorgestrel (LNG) 1.5 mg, then took a St. Johns's Wort 300 mg capsules three times daily for 4-6 weeks, during which time pharmacokinetic studies were repeated after an oral dose of LNG 2.25 mg arm 4: This group had baseline pharmacokinetic studies after an oral dose of levonorgestrel (LNG) 1.5 mg, then took a St. Johns's Wort 300 mg capsules five times daily for 4-6 weeks, during which time pharmacokinetic studies were repeated after an oral dose of LNG 1.5 mg	[ 2, 1, 1, 1 ]	3	[ 7, 7, 0 ]	intervention 1: Placebo herb three times daily (ground cellulose) for 4-6 weeks intervention 2: St. John's Wort (Hypericum perforatum) orally or 4-6 weeks intervention 3: Levonorgestrel in a single oral dose	intervention 1: Placebo Control (Placebo Herb) intervention 2: St. John's Wort intervention 3: Levonorgestrel	1	Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078	36	0	0	0	NCT00131885	1COMPLETED	2008-05-01	2005-08-01	University of Utah	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	43	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	true	0ALL	true	This study will assess the effectiveness of taking propranolol soon after a traumatizing incident in reducing the incidence and severity of posttraumatic stress disorder in acutely traumatized individuals.	Posttraumatic Stress Disorder (PTSD) is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will assess the effect of post-trauma propranolol on reducing the incidence and severity of PTSD. The study will also evaluate propranolol's effectiveness as a preventive measure against subsequent PTSD symptoms. Participants in this double-blind study will be recruited upon admission to the Massachusetts General Hospital Emergency Department after exposure to a psychologically traumatic event. Baseline psychometric and psychobiologic measurements will be collected. Within 6 hours following the traumatic event, participants will be randomly assigned to receive either 40 mg of short-acting propranolol or placebo and 60 mg of either long-acting propranolol or placebo. For the next 10 days, participants will receive 120 mg of either long-acting propranolol or placebo twice daily. A 9-day medication tapering will follow. Participants will undergo psychophysiologic, psychodiagnostic, and psychometric testing for PTSD 1 and 3 months following the traumatic event.	Post-Traumatic Stress Disorder	Post-Traumatic Stress Disorder Prevention Propranolol Psychophysiology	null	2	arm 1: Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days. arm 2: Following the occurrence of an acute psychologically traumatic event, an initial dose of placebo-matching short-acting propranolol 40 mg orally then one hour later, placebo-matching long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of placebo-matching long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Propranolol short-acting or long-acting capsule intervention 2: Placebo-matching propranolol short-acting or long-acting capsule	intervention 1: Propranolol intervention 2: Placebo	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843	41	0	0	0	NCT00158262	1COMPLETED	2008-05-01	2004-09-01	Massachusetts General Hospital	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	233	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters.	Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. Deferasirox (Exjade, ICL670) is an oral chelator with high iron-binding potency and selectivity. This extension study aimed at collecting efficacy and safety data during 2 years of treatment with deferasirox in the extension study or until deferasirox became commercially available in the countries where the centers were located, whichever came first. The population comprised of β-thalassemia patients with transfusional hemosiderosis who could not be satisfactorily treated with deferoxamine or deferiprone.	Beta-thalassemia Major Hemosiderosis Iron Overload Rare Anemia	Transfusional hemosiderosis Beta-thalassemia major Deferasirox iron overload rare anemia iron overload due to transfusion	null	1	arm 1: Deferasirox was given orally once daily (10 to 20 mg/kg) to participants 2 years and older based on participant's body weight.	[ 0 ]	1	[ 0 ]	intervention 1: Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.	intervention 1: Deferasirox	5	Cairo \| N/A \| Egypt \| 31.24967 \| 30.06263 Beirut \| N/A \| Lebanon \| 35.50157 \| 33.89332 Muscat \| N/A \| Oman \| 58.40778 \| 23.58413 Riyadh \| N/A \| Saudi Arabia \| 46.72185 \| 24.68773 Damascus \| N/A \| Syria \| 36.29128 \| 33.5102	231	0	0	0	NCT00171301	1COMPLETED	2008-05-01	2005-06-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	10	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving licorice root extract together with docetaxel may be an effective treatment for prostate cancer. PURPOSE: This phase II trial is studying the side effects and how well giving licorice root extract together with docetaxel works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.	OBJECTIVES: Primary * Determine the efficacy and toxicity of licorice root extract in combination with docetaxel in patients with hormone-refractory metastatic prostate cancer. Secondary * Determine the ability of licorice root extract to alter surrogate markers of estrogen activity and cytotoxicity in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral licorice root extract 3 times a day on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.	Prostate Cancer	adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer	null	1	arm 1: None	[ 0 ]	2	[ 7, 0 ]	intervention 1: Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle. intervention 2: All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.	intervention 1: licorice root extract intervention 2: docetaxel	1	New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622	10	0	0	0	NCT00176631	6TERMINATED	2008-05-01	2007-09-01	Rutgers, The State University of New Jersey	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	69	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	true	0ALL	true	This study will compare the symptoms, experiences, and laboratory sleep characteristics of young adults with and without insomnia.	The overall aim of this research study is to compare the symptoms, experiences and laboratory sleep characteristics of young adults with and without insomnia. Insomnia is a pattern of difficulty falling asleep, staying asleep or feeling poorly rested despite an adequate amount of time for sleep, which occurs nearly every night for one month or longer. For those with insomnia, we will look at the effects of an intervention with one of two medications (escitalopram or zolpidem) or an inactive pill (placebo). This intervention will be followed by re-evaluation of symptoms, experiences and laboratory sleep characteristics. The three hypotheses being investigated are: compared to control subjects, those with insomnia will demonstrate affective disturbance and heightened arousal; the different medications will have different degrees of effect on the two dimensions being measured (affective disturbance and heightened arousal); and PET scans will reveal different patterns of activity in the brains of groups of people with insomnia. We will specifically focus on the syndrome of Primary Insomnia (PI), defined by DSM-IV as insomnia that lasts for at least one month and causes significant impairment or distress. PI excludes insomnia that occurs exclusively during the course of another sleep, mental, substance-induced, or medical disorder. Insomnia is a significant public health problem because of its prevalence, morbidity, and the risk it poses for the development of subsequent mental disorders, particularly depressive and anxiety disorders. Understanding the psychobiology of primary insomnia is a critical step toward addressing questions regarding its relationships with mood and anxiety disorders. Our model of insomnia builds on two major concepts running through previous insomnia research, affective disturbance and heightened arousal, as driving factors for the sleep-wake disturbances that define PI. Implicit in this model is that individuals with PI have different degrees of each dysfunction, which accounts for their heterogeneity of clinical symptoms. Contemporary theories of affect structure suggest that these two dimensions may be orthogonal in pure form, but are nevertheless related in clinical conditions characterized by mixed anxiety-depression, such as PI. Measures of affective disturbance and arousal in this study will include questionnaires, diary-based assessments, and physiological measures. Pharmacological treatment probes may help to further distinguish the roles of affective disturbance and heightened arousal in insomnia. We will use a benzodiazepine receptor agonist (BzRA), zolpidem, and an antidepressant, escitalopram. BzRA potentiate the effects of GABA (1), but have minimal direct activity at any other receptor types. They are efficacious treatments for insomnia (2-4), but have little effect on mood. We chose zolpidem because it is relatively specific for hypnotic versus anxiolytic or other actions (5), because it is the most widely-prescribed BzRA hypnotic, and because it is well-tolerated (6). Clinically-effective doses of even "nonsedating" antidepressants can also improve symptoms in PI (7), suggesting that direct sedation is not their only mechanism for improving insomnia. We chose escitalopram because it is neither strongly alerting nor sedating in clinical and polysomnographic studies. This "sleep-neutral" profile will allow us to use it for its effects on affective disturbance, rather than its nonspecific sedating properties. Escitalopram's specific effect on serotonin reuptake blockade and its lack of affinity for Bz receptors distinguish it from zolpidem as a pharmacologic probe. Functional neuroimaging studies in wakefulness and sleep may also help to identify the substrate of affective disturbance and heightened arousal in insomnia. Affective disturbance in the form of MDD is associated with alterations in both regional deactivation patterns during NREM sleep, and regional activation patterns during REM sleep. These observations suggest that a sleep-wake functional neuroimaging paradigm in insomnia patients, in conjunction with behavioral measures, may help to identify which brain systems mediate heightened arousal and affective disturbance, and how these systems interact.	Sleep Disorders	Primary Insomnia Insomnia Placebo-Controlled Double-Blind Polysomnography PET Studies Escitalopram Zolpidem	null	3	arm 1: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred. arm 2: The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used. arm 3: A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or \>). The dose was decreased to 5 mg if side effects occurred. intervention 2: The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used. intervention 3: A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.	intervention 1: Zolpidem intervention 2: Escitalopram intervention 3: Placebo	1	Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062	69	0	0	0	NCT00177216	1COMPLETED	2008-05-01	2002-02-01	University of Pittsburgh	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	468	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study). Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.	The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc.. Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.	Multiple Sclerosis		null	2	arm 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase arm 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)	[ 0, 0 ]	2	[ 0, 0 ]	intervention 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase intervention 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)	intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046)	94	Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Liège \| N/A \| Belgium \| 5.56749 \| 50.63373 Calgary \| Alberta \| Canada \| -114.08529 \| 51.05011 Vancouver \| British Columbia \| Canada \| -123.11934 \| 49.24966 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Ottawa \| Ontario \| Canada \| -75.69812 \| 45.41117 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Hradec Králové \| N/A \| Czechia \| 15.83277 \| 50.20923 Ostrava \| N/A \| Czechia \| 18.28204 \| 49.83465 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Glostrup Municipality \| N/A \| Denmark \| 12.40377 \| 55.6666 Helsinki \| N/A \| Finland \| 24.93545 \| 60.16952 Kuopio \| N/A \| Finland \| 27.67703 \| 62.89238 Oulu \| N/A \| Finland \| 25.46816 \| 65.01236 Seinäjoki \| N/A \| Finland \| 22.82822 \| 62.79446 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Rennes \| Brittany Region \| France \| -1.67429 \| 48.11198 Bordeaux \| Gironde \| France \| -0.5805 \| 44.84044 Clermont-Ferrand \| N/A \| France \| 3.08682 \| 45.77969 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Lille \| N/A \| France \| 3.05858 \| 50.63297 Nancy \| N/A \| France \| 6.18496 \| 48.68439 Nice \| N/A \| France \| 7.26608 \| 43.70313 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Ulm \| Baden-Wurttemberg \| Germany \| 9.99155 \| 48.39841 München \| Bavaria \| Germany \| 13.46314 \| 48.69668 Regensburg \| Bavaria \| Germany \| 12.10161 \| 49.01513 Würzburg \| Bavaria \| Germany \| 9.95121 \| 49.79391 Hennigsdorf \| Brandenburg \| Germany \| 13.20419 \| 52.63598 Giessen \| Hesse \| Germany \| 8.67554 \| 50.58727 Marburg \| Hesse \| Germany \| 8.77069 \| 50.80904 Offenbach \| Hesse \| Germany \| 8.76647 \| 50.10061 Braunschweig \| Lower Saxony \| Germany \| 10.52673 \| 52.26594 Göttingen \| Lower Saxony \| Germany \| 9.93228 \| 51.53443 Greifswald \| Mecklenburg-Vorpommern \| Germany \| 13.40244 \| 54.08905 Cologne \| North Rhine-Westphalia \| Germany \| 6.95 \| 50.93333 Düsseldorf \| North Rhine-Westphalia \| Germany \| 6.77616 \| 51.22172 Düsseldorf \| North Rhine-Westphalia \| Germany \| 6.77616 \| 51.22172 Münster \| North Rhine-Westphalia \| Germany \| 7.62571 \| 51.96236 Mainz \| Rhineland-Palatinate \| Germany \| 8.2791 \| 49.98419 Homburg \| Saarland \| Germany \| 7.33867 \| 49.32637 Halle \| Saxony-Anhalt \| Germany \| 11.97947 \| 51.48158 Magdeburg \| Saxony-Anhalt \| Germany \| 11.62916 \| 52.12773 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Erfurt \| Thuringia \| Germany \| 11.03283 \| 50.9787 Szeged \| Csongrád megye \| Hungary \| 20.14824 \| 46.253 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Haifa \| Israel \| Israel \| 34.99928 \| 32.81303 Tel Litwinsky \| Israel \| Israel \| 34.84588 \| 32.05096 Gallarate \| Varese \| Italy \| 8.79164 \| 45.66019 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Torino \| N/A \| Italy \| 11.99138 \| 44.88856 Sittard \| N/A \| Netherlands \| 5.86944 \| 50.99833 Tilburg \| N/A \| Netherlands \| 5.0913 \| 51.55551 Bergen \| N/A \| Norway \| 5.32415 \| 60.39299 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Coimbra \| N/A \| Portugal \| -8.41955 \| 40.20564 Ljubljana \| N/A \| Slovenia \| 14.50513 \| 46.05108 L'Hospitalet de Llobregat \| Barcelona \| Spain \| 2.10028 \| 41.35967 Barakaldo \| Vizcaya \| Spain \| -2.98813 \| 43.29639 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Valencia \| N/A \| Spain \| -0.37966 \| 39.47391 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Basel \| Canton of Basel-City \| Switzerland \| 7.57327 \| 47.55839 Sankt Gallen \| N/A \| Switzerland \| 9.37477 \| 47.42391 Dundee \| Scotland \| United Kingdom \| -2.97489 \| 56.46913 Aberdeen \| N/A \| United Kingdom \| -2.09814 \| 57.14369 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Sheffield \| N/A \| United Kingdom \| -1.4659 \| 53.38297	468	0	0	0	NCT00185211	1COMPLETED	2008-05-01	2002-08-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	394	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	1FEMALE	false	The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.	The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.	Menopause		null	1	arm 1: Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.	[ 0 ]	1	[ 0 ]	intervention 1: LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.	intervention 1: LNG IUS	12	Ghent \| N/A \| Belgium \| 3.71667 \| 51.05 Huy \| N/A \| Belgium \| 5.23284 \| 50.51894 Espoo \| N/A \| Finland \| 24.6522 \| 60.2052 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Heerlen \| N/A \| Netherlands \| 5.98154 \| 50.88365 Venlo \| N/A \| Netherlands \| 6.16806 \| 51.37 Zaandam \| N/A \| Netherlands \| 4.82643 \| 52.43854 Zwijndrecht \| N/A \| Netherlands \| 4.63333 \| 51.8175 Cambridge \| Cambridgeshire \| United Kingdom \| 0.11667 \| 52.2 Poole \| Dorset \| United Kingdom \| -1.98458 \| 50.71429 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328	394	0	0	0	NCT00185458	1COMPLETED	2008-05-01	2000-05-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	139	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	false	The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.	null	Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder		null	2	arm 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval. arm 2: placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.	[ 0, 2 ]	4	[ 0, 0, 0, 0 ]	intervention 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) intervention 2: None intervention 3: atomoxetine 1.2 mg/kg/day QD, PO intervention 4: atomoxetine 1.2 - 1.4 mg/kg/day QD, PO	intervention 1: atomoxetine 0.5 mg/kg/day intervention 2: placebo intervention 3: atomoxetine 1.2 mg/kg/day intervention 4: atomoxetine 1.2-1.4 mg/kg/day	12	Alessandria \| N/A \| Italy \| 8.61007 \| 44.90924 Bari \| N/A \| Italy \| 16.86982 \| 41.12066 Cagliari \| N/A \| Italy \| 9.11917 \| 39.23054 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Messina \| N/A \| Italy \| 15.55256 \| 38.19394 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 S. Vito Tagliamento \| N/A \| Italy \| N/A \| N/A Venezia \| N/A \| Italy \| 11.17365 \| 44.42329	139	0	0	0	NCT00192023	1COMPLETED	2008-05-01	2004-10-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	60	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.	Upon determination of eligibility, all patients will be receive: * Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.	Lung Cancer		null	1	arm 1: Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).	[ 0 ]	4	[ 0, 0, 0, 4 ]	intervention 1: 50mg/m2 days 1 \& 8 each 21-day cycle 1 \& 2, 28-day cycle 3 \& 4 intervention 2: AUC 5 intervention 3: 10mg/kg IV every 2 weeks for 10 doses starting week 16 intervention 4: None	intervention 1: Irinotecan intervention 2: Carboplatin intervention 3: Bevacizumab intervention 4: Radiation	0	null	60	0	0	0	NCT00193375	1COMPLETED	2008-05-01	2003-08-01	SCRI Development Innovations, LLC	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	16	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study uses a computerized method of musical instrument digital interface (MIDI) quantification of performance before and after treatment with botulinum toxin type B (Myobloc ®, Solstice Neurosciences). Myobloc is a purified and diluted form of botulinum toxin used medically to relax unwanted muscle spasms and movements. The aim of the study is to determine the feasibility of quantifying change in performance following treatment.	Dystonia represents a group of clinical disorders characterized by various combinations of sustained involuntary muscle contractions, abnormal postures and movements, tremors and pain. Dystonia can occur at rest but is more likely to appear during voluntary activity. Focal dystonia affects one body area and includes blepharospasm, oromandibular dystonia, spasmodic dysphonia, torticollis, and limb dystonia. Focal dystonia typically presents as task-specific muscle spasms or "occupational cramps" in which learned or repetitive motor tasks (such as writing or playing a musical instrument) trigger muscle spasms and interfere with performance while other actions remain normal. Writer's cramp is the most common form of idiopathic limb dystonia \[1-3\] where involuntary muscle activity and abnormal postures affect the arms and hands, but virtually any part of the body may be affected, even the lips when playing a woodwind or brass instrument \[4\]. Patients may develop two focal dystonias but rarely does focal dystonia progress to more generalized forms. As originally defined by Oppenheim \[5\], dystonia refers to the slow, sustained, writhing, contorting movements of dystonia musculorum deformans. Dystonic movements, however, are often rapid \[6\] and this can be a cause for misdiagnosis. Electromyography (EMG) may be helpful in corroborating dystonia, but is not essential for diagnostic purposes. Nerve conduction studies, short and long loop reflexes and analysis of motor units are normal \[7, 8\]. Ballistic movements, which are normally tri-phasic in pattern with alternating agonist-antagonist bursts, may show disrupted patterns with co-contraction of agonist and antagonist muscles and excessively long EMG bursts in dystonia \[3\]. Dystonic spasms are intriguing in that they may be suppressed (or triggered) by sensory input such as postural change, tactile stimuli, alternative movements or even thought processes \[9\]. Studies are revealing that the involuntary muscle spasms may be due, at least in part, to abnormal sensory processing of spindle afferent information \[10-12\]. This may help explain the nature of these sensory "tricks" as well as why the effect of treatment using botulinum toxin usually outlasts the weakness it creates. Though the pathophysiology of musicians' dystonia has yet to be determined fully, the motor learning associated with playing a musical instrument probably results in both functional and structural changes in the brain \[13\]. This plastic reorganization, including the rapid unmasking of existing neural circuitry and the establishment of new connections, is probably fundamental to the accomplishment of skillful playing, but also may result in focal, task-specific dystonia. When musicians get dystonia, their playing abilities can become severely compromised, to the point where they may not be able to perform professionally, and possibly not even teach. While botulinum toxin injections can be highly successful in allowing musicians to perform again, there are no objective methods to evaluate improvement. Subtle dystonic abnormalities in motor control, therefore, particularly when they involve the arms, are difficult to ascertain with a high level of certainty. There are no truly objective measures of arm dystonia, and this is problematic because arm involvement can present so mildly as to go unnoticed by the examiner \[14\]. Furthermore, patients may not complain of mild finger or thumb cramping, arm twisting or shoulder elevation that could signify the presence of dystonia. Clinical rating scales, even those that have been validated, do not detect subtle motor dysfunction or small changes after treatment \[15\] and certainly cannot determine improvement in musical performance. Metabolic imaging studies using positron emission tomography (PET) studies are emerging as helpful ancillary tests, but these are invasive and expensive. Furthermore, while PET studies have implicated that primary dystonia may be associated with relative hypermetabolism in the putamen \[16\], there have been conflicting reports \[17\]. Another major difficulty in the study of musician's dystonias has been lack of objective, quantifiable methods to assess degrees of dystonia severity or measure of treatment effects. Subjective and objective clinical rating scales with varying degrees of sophistication. Some subjective methods that have been used include subjective quantification usually using percentage improvement, also different various subjective rating scales using surveys. This study tests a novel method devised for quantifying change in musical performance based on musical instrument digital interface (MIDI) data that will be able to directly rate or score changes in musical output. MIDI data include information on the note played, the time of onset, note duration, and note loudness. Note duration and loudness will be used in this study. It will be a quantitative, objective computerized evaluation that compares the patients' fine motor skills before and after treatment with Myobloc ®. It will be one of the first quantitative analyses of musical ability of its kind and could significantly impact the way musicians determine the efficacy of botulinum toxin treatment. REFERENCES 1. Nutt JG, Muenter MD, Melton LJ, Aronson A, Kurland LT. Epidemiology of dystonia in Rochester, Minnesota. Adv Neurol 1988; 50: 361-5. 2. Sheehy MP, Marsden CD. Writers' cramp - a focal dystonia. Brain 1982; 105: 461-480. 3. Cohen LG, Hallett M. Hand cramps: clinical features and electromyographic patterns in a focal dystonia. Neurology 1988; 38: 1005-1012. 4. Frucht S, Fahn S, Ford B. French horn embouchure dystonia. Mov Disord 1999; 14: 171-3. 5. Oppenheim H. Uber eine eigenartige Krampfkrankheit des kindlichen und jungendichen Alters (dysbasia lordotica progressiva, dystonia musculorum deformans). Neurologie Centralblatt 1911; 30: 1090-1107. 6. Fahn S. Concept and classification of dystonia. In Fahn, S, Marsden, CD, Caln, DB, ed. Advances in Neurology: Dystonia 2. New York: Raven Press, 1988: 1-8. 7. Rothwell JC, Obeso JA, Day BL, Marsden CD. Pathophysiology of dystonias. In Desmedt, JE, ed. Advances in Neurology: Motor Control Mechanisms in Health and Disease. New York: Raven Press, 1983: 851-863. 8. Marsden CD, Rothwell JC. The physiology of idiopathic dystonia. Can J Neurol Sci 1987; 14: 521-527. 9. Greene PE, Bressman S. Exteroceptive and interoceptive stimuli in dystonia. Mov Disord 1998; 13: 549-51. 10. Tempel L, Perlmutter J. Abnormal vibration-induced cerebral blood flow responses in idiopathic dystonia. Brain 1990; 113: 691-707. 11. Kaji R, Rothwell JC, Katayama M, Tomoko I, Kubori T, Kohara N, Mezaki T, Shibasaki H, Kimura J. Tonic vibration reflex and muscle afferent block in writer's cramp. Ann Neurol 1995; 38: 155-162. 12. Koelman JHTM, Willemse RB, Bour LJ, Hilgevoord AAJ, Speelman JD, Ongerboer de Visser BW. Soleus H-reflex tests in dystonia. Mov Disord 1995; 10: 44-50. 13. Pascual-Leone A. The brain that plays music and is changed by it. Ann N Y Acad Sci 2001; 930: 315-29. 14. Bressman SB, de Leon D, Kramer PL, Ozelius LJ, Brin MF, Greene PE, Fahn S, Breakefield XO, Risch NJ. Dystonia in Ashkenazi Jews: Clinical characterization of a founder mutation. Ann Neurol 1994; 36: 771-777. 15. Burke RE, Fahn S, Marsden CD, Bressman SB, Moskowitz C, Friedman J. Validity and reliability of a rating scale for the primary torsion dystonias. Neurology 1985; 35: 73-77. 16. Eidelberg D, Moeller JR, Ishikawa T, Dhawan V, Spetsieris P, Przedborski S, Fahn S. The metabolic topography of idiopathic torsion dystonia. Brain 1995; 118: 1473-1484. 17. Karbe H, Holthoff VA, Rudolf J, Herholz K, Heiss WD. Positron emission tomography demonstrates frontal cortex and basal ganglia hypometabolism in dystonia. Neurology 1992; 42: 1540-1544. 18. Pullman SL. Limb dystonia: Use of botulinum toxin. In Jankovic, J, Hallett, M, ed. Therapeutic Use of Botulinum Toxin. New York: Marcel Dekker, 1994: 307-321. 19. Medical Research Council Aids to the Examination of the Peripheral Nervous System; Crown: London, 1976. 20. Pullman SL, Greene P, Fahn S, Pedersen SF. Approach to the treatment of limb disorders with botulinum toxin A. Experience with 187 patients. Arch Neurol 1996; 53: 617-24. 21. Cohen LG, Hallett M, Geller BD, Hochberg F. Treatment of focal dystonias of the hand with botulinum toxin injections. J Neurol Neurosurg Psychiatry 1989; 52: 355-363. 22. Trosch RM, Pullman SL. Botulinum toxin A injections for the treatment of hand tremors. Mov Disord 1994; 9: 601-9.	Focal Dystonia	Myloboc Botulinum Toxin Type B Focal Dystonia Musicians Muscle Relaxants Motor Impairments Motor Performance Tremor Abnormal Postures	null	1	arm 1: Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.	[ 0 ]	1	[ 0 ]	intervention 1: Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.	intervention 1: Botulinum toxin, type B	1	New York \| New York \| United States \| -74.00597 \| 40.71427	16	0	0	0	NCT00208091	1COMPLETED	2008-05-01	2003-04-01	Columbia University	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	20	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	African-Americans suffer from increased prevalence of both type 2 diabetes and diabetes complications, reflecting a combination of psychobehavioral factors as well as metabolic dysfunction. In this process, depression may contribute to both the genesis of type 2 diabetes (through impact on neurohormonal activation, inflammatory mediators, and insulin resistance), and difficulties in management (through decreased adherence to diet plans, medication, and scheduled appointments). The preliminary data from the Grady Diabetes Clinic indicates that depression may be common in African-Americans with diabetes, that depression is a factor in non-adherence, and that non-adherence leads to poor glycemic control - a direct cause of diabetes complications. What is not known is: how treatment of depression could lead to both neurohormonal and psychobiological improvement, with improved patient adherence and glycemic control.	To determine the psychobehavioral and neurohormonal mechanisms of effective treatment, the investigator will conduct a randomized, double-blind, placebo-controlled trial in patients with major depression, who will receive either: (i) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + placebo, or (ii) computer-based cognitive behavioral therapy (CBT) program entitled "Beating the Blues" + the SSRI antidepressant escitalopram. The investigator will assess (a) glycemic control (levels of glycated hemoglobin (HbA1c)), in relation to (b) adherence (keeping scheduled return appointments, diet, exercise, and glucose monitoring), (c) depressive symptoms (neurocognitive and neurobehavioral symptoms determined by self- and observer-rated scales), and (d) the four pathways of neurometabolic function. Study visits will occur once a month for 6 months. Should patients report severe environmental stressors (such as marital conflict, loss of family member or job, being exposed to trauma), patients will be offered an intensification of their contact with study personnel, e.g. weekly contact by phone or "in-person" visits to see study personnel at the Grady Diabetes Clinic.	Diabetes Depression		null	2	arm 1: Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months arm 2: Subjects with type 2 diabetes will be randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months	[ 0, 1 ]	3	[ 5, 0, 0 ]	intervention 1: Beating the Blues is a computerized cognitive behavioral therapy. intervention 2: Escitalopram is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It's a 10 mg pill taken once or twice daily for 6 months. intervention 3: A sugar pill taken as one to two tablets daily for 6 months.	intervention 1: Beating the Blues intervention 2: Escitalopram intervention 3: Placebo	1	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749	14	0	0	0	NCT00209170	1COMPLETED	2008-05-01	2004-05-01	Emory University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	22	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	Preoperative induction chemotherapy has been successfully used in a variety of malignancies and provides several advantages over postoperative therapy. Combination of 5-FU/Leucovorin/CPT-11 has demonstrated significantly better response rate than 5-FU/Leucovorin alone. Replacing 5-FU with oral capecitabine in combination with CPT-11 has emerged as a potentially more effective, safe and convenient treatment option for metastatic colorectal cancer. Capecitabine is also well tolerated in concurrent treatment with radiation. Recent data has shown that preoperative radiation appears to be significantly more effective in increasing resectability rates. This trial will investigate the activity of capecitabine and CPT-11 combination in the preoperative setting followed by chemoradiation with capecitabine in locally advanced rectal cancer to improve response and decrease local recurrence. We will also study whether TS, TP, DPD and carboxyesterase expressions correlate with the objective response rate with this chemotherapy and chemoradiation regimen.	OUTLINE: This is a multi-center study. Biopsy per EUS * Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000\* mg/m2 PO BID day 1-14 Repeat every three weeks for two cycles\* For calculated creatinine clearance of 30-50 mL/min or patients \> 70years old, capecitabine starting dose is 825 mg/m2 PO BID Beginning at week 7 or following recovery from chemotherapy: * Pelvic XRT 45 Gy/1.8 Gy/fx/qd+5.4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8 Gy/fx/qd for T4 * Capecitabine 825\* mg/m2 PO BID, 5 days/week, throughout XRT\* For calculated creatinine clearance of 30-50 mL/min or patients \> 70years old, capecitabine starting dose is 650 mg/m2 PO BID * Surgery within 8weeks following chemoradiotherapy * Adjuvant Chemotherapy at investigator's discretion ECOG performance status 0 or 1 Hematopoietic:· * ANC count \>1,500 mm3· * Platelets \> 100,000/mm3· * Hemoglobin \> 9g/dL * Prothrombin time (PT)/INR or PTT \< 1.25 times upper limit of normal; Hepatic:· * Bilirubin \<1.5 times upper limit of normal * Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \<2.5 times the upper limit of normal Renal:· * Adequate renal function by calculated creatinine clearance \> 30 mL/min (by Cockroft and Gault) Cardiovascular:· * No congestive heart failure requiring therapy or NYHA class II or greater or active angina or known myocardial infarction within 12 months prior to study	Rectal Cancer	Rectal Cancer	null	1	arm 1: * Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles * For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid * EUS * Neoadjuvant Chemotherapy * Preoperative Radiation * Surgery * Adjuvant Chemotherapy (at discretion of treating physician)	[ 0 ]	7	[ 0, 0, 3, 0, 3, 3, 3 ]	intervention 1: Capecitabine 1000\* mg/m2 po bid day 1-14; repeat every three weeks for two cycles \For calculated creatinine clearance of 30-50 mL/min or patients \> 70 years old, capecitabine starting dose is 825 mg/m2 po bid intervention 2: Irinotecan 200 mg/m2 IV, day 1 intervention 3: biopsy per EUS intervention 4: Irinotecan 200 mg/m2 IV, day 1 * Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles intervention 5: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4 intervention 6: Surgery within 8 weeks following chemoradiotherapy intervention 7: Adjuvant chemotherapy at investigator's discretion	intervention 1: Capecitabine intervention 2: Irinotecan intervention 3: EUS intervention 4: Neoadjuvant Chemotherapy intervention 5: Preoperative Radiation intervention 6: Surgery intervention 7: Adjuvant Chemotherapy	9	Elkhart \| Indiana \| United States \| -85.97667 \| 41.68199 Fort Wayne \| Indiana \| United States \| -85.12886 \| 41.1306 Goshen \| Indiana \| United States \| -85.83444 \| 41.58227 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Muncie \| Indiana \| United States \| -85.38636 \| 40.19338 New Albany \| Indiana \| United States \| -85.82413 \| 38.28562 South Bend \| Indiana \| United States \| -86.25001 \| 41.68338 Terre Haute \| Indiana \| United States \| -87.41391 \| 39.4667	22	0	0	0	NCT00216086	6TERMINATED	2008-05-01	2005-05-01	Gabi Chiorean, MD	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	24	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.	The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.	Detrusor Hyperreflexia		null	1	arm 1: Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing	[ 0 ]	1	[ 0 ]	intervention 1: 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration	intervention 1: Oxybutynin transdermal system	6	Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328	24	0	0	0	NCT00224029	1COMPLETED	2008-05-01	2004-12-01	Watson Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	27	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	true	0ALL	true	This study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.	Melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. Melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. Clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. Data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. Generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. This study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep. Participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of Week 1 and the end of Week 6. At study entry, participants will be admitted to the General Clinical Research Center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. Participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. During Night 1 at the clinic, participants will have urine samples collected throughout the night. Night 2 will be an adaptation night to allow participants to get used to their surroundings. On Night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. Participants with sleep efficiencies of 80% or higher will complete their study participation. Participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. Participants will have study visits at Weeks 1, 3, and 6 to monitor for adverse events. After 6 weeks, participants will have 2 more overnight clinic visits that will be identical to Nights 2 and 3 from the beginning of the study. Sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. One month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.	Sleep Initiation and Maintenance Disorders	Aged Sleep Insomnia Melatonin Neurobehavioral Manifestations Circadian Rhythms Human Polysomnography Elderly	null	3	arm 1: Melatonin 0.4 mg arm 2: Melatonin 4.0 mg arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: None intervention 2: None intervention 3: None	intervention 1: Melatonin 0.4 mg intervention 2: Melatonin 4.0 mg intervention 3: Placebo	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	27	0	0	0	NCT00230737	1COMPLETED	2008-05-01	2004-10-01	Nalaka Gooneratne	7OTHER	false	false	false	null	0	0	0	0
[ 5 ]	43	RANDOMIZED	CROSSOVER	2DIAGNOSTIC	4QUADRUPLE	true	0ALL	false	The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.	We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.	Healthy	Naltrexone Alcohol	null	4	arm 1: alcohol and active naltrexone arm 2: "sham" alcohol and active naltrexone arm 3: placebo naltrexone and alcohol arm 4: placebo naltrexone and placebo (non-alcoholic) alcohol	[ 0, 1, 2, 2 ]	4	[ 0, 0, 10, 10 ]	intervention 1: 50 mg/day for two days prior to the alcohol challenge session intervention 2: placebo pills intervention 3: 190 proof alcohol prepared to 11% volume mixed with fruit juice. intervention 4: non-alcoholic placebo alcohol	intervention 1: Naltrexone intervention 2: placebo intervention 3: alcohol intervention 4: Sham alcohol	1	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	155	0	0	0	NCT00256451	1COMPLETED	2008-05-01	2005-11-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	17	RANDOMIZED	PARALLEL	9OTHER	4QUADRUPLE	false	0ALL	false	Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people.	Please see the following review articles on this topic: Shoelson SE, Lee J, Goldfine AB. (2006) Inflammation in insulin resistance. J. Clin. Invest. 116, 1793-1801. Goldfine AB, Fonseca V and Shoelson SE (2010) Therapeutic approaches to target inflammation in type 2 diabetes. Clin Chem. 57, 162-167. Donath MY and Shoelson SE (2011) Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 11, 98-107. Goldfine AB and Shoelson SE (2017) Therapeutic approaches targeting inflammation for diabetes and associated cardiovascular risk. J Clin Invest. 127, 83-93.	Insulin Resistance		null	2	arm 1: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the salsalate 4.0 g/d arm. arm 2: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the placebo arm.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Active intervention 2: Placebo for salslate, used only in the third trial	intervention 1: Salsalate intervention 2: Placebo	0	null	17	0	0	0	NCT00258128	1COMPLETED	2008-05-01	2000-01-01	Joslin Diabetes Center	7OTHER	false	false	false	null	0	0	0	0
[ 0 ]	25	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.	At the shock trauma center, the management of patients with NSTI is conducted in the following fashion: All new patients with NSTI are admitted to the trauma center through the 12-bed shock trauma admitting area. Full hemodynamic resuscitation is undertaken. The on-call soft-tissue and infection team is mobilized. Standard investigations, radiographic evaluations, and laboratory tests, including gram stain and culture specimens, are obtained. The University of Maryland Medical Systems/shock trauma laboratory is utilized for hematology, biochemical, and bacteriologic studies. Aggressive empiric broad-spectrum antibiotic therapy is instituted. The standard antibiotic therapy for NSTI's at shock trauma includes the following: Gram negative rods: Piperacillin/Tazobactam or quinolones or aztreonam / \+ aminoglycosides Anaerobes: Piperacillin/Tazobactam or Metronidazole or Clindamycin Gram positive cocci (not MRSA/VRE): Piperacillin/Tazobactam or Clindamycin Gram positive cocci (MRSA): Vancomycin Gram positive cocci (VRE): Linezolid For purposes of this study, daptomycin would replace Vancomycin, Linezolid or clindamycin for gram positive coverage. Prior antibiotic therapy, culture data, comorbid conditions, allergy history and other variables may result in institution of a different antibiotic regimen. The patient is taken to the shock trauma operating room for debulking of infected tissue (excision and debridement) and reculturing. Postoperatively, the patient is moved to a critical or intensive care unit for further management and monitoring. When the patient is stable, HBO is begun within 12 hours of arrival. Once the patient is enrolled in the study the following procedures will be followed: Antibiotic Therapy: Once the patient is consented, the antibiotic therapy will be started. The combination regimen will include the following drugs in standard approved dosing. * Gram negative bacteria: Aztreonam or ciprofloxacin / + aminoglycosides\* * Anaerobic bacteria: Metronidzole * Gram positive bacteria: Daptomycin For all patients the recommended dose of Daptomycin will be 6 mgm/kg/day administered over 30 minutes. A pharmacokinetic study performed in obese patients demonstrated that daptomycin could be dosed based on total body weight. No adjustment in daptomycin dose should be required based solely on obesity (12). Any patient who develops a decrease in renal function during the study to the point where his/her creatinine clearance (CrCl) falls below 30 mL/min would have their dose adjusted to 6 mg/kg every 48 hours, the interval recommended by the package insert. This includes patients who go on to require conventional hemodialysis. Since there are no data available on the pharmacokinetics (PK) of daptomycin in patients receiving continuous renal replacement therapy (CRRT), and therefore no recommendation for dosage adjustment, these patients would be removed from the study and initiated on a standard of care regimen . Treatment duration will be 7-14 days. * Aminoglycosides will be added if there is suspicion or documentation of resistant gram negative rods. At various intervals, the following information will be collected or procedures will be followed: (See attached study schedule) Baseline 1. Demographic data - age, gender, weight, height, nursing home residence 2. Number and length of previous hospitalizations in last six months 3. Nature and duration of symptoms 4. Admission status including vital signs, GCS, APACHE, SIRS scores, CBC with diff, CPK, lactate, BUN, creatinine, liver function tests, blood gases if on ventilator, cultures of wound-aerobic and anaerobic. 5. Prior surgery for NSTI - number and dates 6. Comorbid conditions - diabetes, peripheral vascular disease, immunocompromised, etc. 7. Prior antibiotics over last six months - dose/route/type 8. Prior cultures of NSTI, presence of resistant bacteria. 9. Wound size - length, depth in cm. 10. Use of drugs such as HMG-CoA reductase inhibitors At various intervals, the following procedures will be followed:. * GCS, vital signs, CBC, CPK, BUN, creatinine, liver functions, blood gases if ventilated * Wound size in cm * Surgical intervention * Cultures of wound, (both aerobic and anaerobic), blood, super infections. Preferably cultures of the debrided tissue or purulent material will be obtained. If there is no tissue or pus available, only then a deep culture of the wound will be obtained. The culture will be evaluated in the microbiologic lab for gram stain, culture (aerobic and anaerobic if already indicated) and antimicrobiological sensitivity (by standard CLSI (NCCLS) techniques. The organisms in the study will be identified at the genus and species level. * LOS - hospital, ICU * Wound dressing - type * Use of vacuum assisted dressing * Duration of antibiotic therapy * Adverse events * Mortality * Patient will be evaluated clinically on a daily basis by several clinical services (surgery, infectious diseases, critical care, hyperbaric medicine)and safety labs will be obtained every 3-5days. If a patient is failing therapy then based on available microbiological determinants, patient will be changed to an appropriate antibiotic regimen. The End points of the study are as follows: * clinical cure at 7-14 days * clinical failure at any point after 72 hours of treatment * if the patient is clinically cured and there is persistence of initial infective organism in the wound culture, the study would be terminated. However, if the patient is worse then appropriate treatment will be initiated and study drug will be discontinued. * if the patient experiences a serious adverse event related to the study drug, the study drug will be terminated. * if the patient decides to withdraw consent. Clinical Response at the end of treatment (7-14 days) and test of cure (3-28 days) post end of treatment): * Cure: Resolution of clinically significant signs and symptoms\* associated with the infected wound present at the time of study entry and no additional gram-positive antibiotic therapy is needed until the end of treatment visit. * Improved: Partial resolution of clinical signs and symptoms\* of the wound (e.g., although the patient's clinical status has not completely returned to pre-infection baseline, the infectious process has been controlled) and no additional gram-positive antibiotic therapy is needed until the end of treatment visit. * Failure: No response or worsening of clinical signs and symptoms of infection; or new signs and symptoms of infection are present; or additional gram-positive antibiotic therapy is needed until the end of treatment visit. * Unable to Evaluate: Unable to determine response; e.g., no evaluation performed at the time point, or administration of non-study antibiotics effective against a study pathogen. \* Clinically significant signs and symptoms are: * pain out of proportion to clinical findings * tenderness to palpation * elevated temps.\[100.4\] or reduced temps.\[\>96\] * WBC counts \> 12.000/cu.mm * swelling * erythema * induration * pus formation Microbiological Response at End of Treatment and Test of Cure Visit: * Documented Eradicated: The baseline infecting pathogen was absent at end of treatment as determined by a negative culture result. * Presumed Eradicated: The baseline infection was presumed absent at the end of treatment as determined that there was "nothing to culture". * Documented Persistent: The baseline infecting pathogen was present at the end of treatment. Patients will also be monitored for 3 - 28 days post therapy. Analysis Because of the small sample size (25 patients) stated above, this study will serve as a preliminary study to obtain data to evaluate the presence of positive trends in terms of outcome in the patients treated with Daptomycin. If favorable, this would warrant a larger prospective controlled study in which a larger sample size would allow for a more robust statistical analysis. Variables in the initial analysis will include antibiotic days, intensive care unit and hospital length of stay and mortality.	Fasciitis, Necrotizing Severe Necrotizing Skin and Soft Tissue Infections Fournier's Gangrene	severe skin infections	null	1	arm 1: It was a single arm study with higher dose of daptomycin used for patients with severe skin and soft tissue infections.	[ 5 ]	1	[ 0 ]	intervention 1: None	intervention 1: Daptomycin 6mg/kg/day	1	Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038	25	0	0	0	NCT00261807	1COMPLETED	2008-05-01	2005-06-01	University of Maryland, Baltimore	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	18	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.	OBJECTIVES: Primary * Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride. Secondary * Determine the safety and toxic effects of this regimen in these patients. * Determine the time to progression in patients treated with this regimen. * Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen. OUTLINE: This is a multicenter, pilot study. Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.	Lymphoma	recurrent adult Hodgkin lymphoma	null	1	arm 1: None	[ 0 ]	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: bortezomib intervention 2: gemcitabine hydrochloride	2	Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Rochester \| New York \| United States \| -77.61556 \| 43.15478	18	0	0	0	NCT00262860	1COMPLETED	2008-05-01	2005-04-01	University of Rochester	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	130	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	true	The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.	null	Pancreatic Neoplasm		null	2	arm 1: None arm 2: None	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles intervention 2: 1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles	intervention 1: enzastaurin intervention 2: gemcitabine	1	Dallas \| Texas \| United States \| -96.80667 \| 32.78306	121	0	0	0	NCT00267020	1COMPLETED	2008-05-01	2005-12-01	Eli Lilly and Company	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	74	RANDOMIZED	PARALLEL	1PREVENTION	4QUADRUPLE	false	0ALL	false	This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).	Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively. Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA. The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T \& A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.	Sleep Apnea, Obstructive Tonsillectomy Adenoidectomy Postoperative Complications	Obstructive Sleep Apnea (OSA) Tonsillectomy and Adenoidectomy (T&A) Postoperative Complications Recovery	null	2	arm 1: Saline arm 2: Caffeine benzoate	[ 2, 1 ]	2	[ 0, 0 ]	intervention 1: Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. intervention 2: Children in group two will receive an amount of normal saline equal to Caffeine	intervention 1: Caffeine intervention 2: Placebo	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	72	0	0	0	NCT00273754	1COMPLETED	2008-05-01	2003-09-01	The University of Texas Health Science Center, Houston	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	61	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	A conversion study of Mirapex (pramipexole) to Requip (ropinirole) controlled release (CR) in patients with Parkinson's disease to determine the appropriate conversion ratio and side effects related to the drug.	Three different arms will be used in this study. Each of the three cohorts will be treated sequentially. Each participant will be taking Mirapex for PD and will be converted to Requip CR by 1 of 3 conversion factors (mg:mg): 1:3, 1:4 and 1:5 from Mirapex to once a day Requip CR. The first five subjects of each cohort will have their initial dose administered in the clinic and be monitored for orthostatic changes. Assessments of motor function before and after conversion will be done.	Parkinson Disease	PD Parkinson's	null	3	arm 1: Conversion factor of Mirapex to Requip 24-Hour of 1:3. This was a switch study in which the conversion factor was being investigated to assist in the conversion from Mirapex to Requip PR. In this group, the dose of Requip PR was 3 times the dose of Mirapex. arm 2: Conversion factor of Mirapex to Requip 24-Hour of 1:4 arm 3: Conversion factor of Mirapex to Requip 24-Hour of 1:5	[ 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Requip 24-Hour once a day for one month intervention 2: All subjects started the study on Mirapex. They were all then switched to Requip PR based on a conversion factor of 1:3, 1:4 or 1:5.	intervention 1: Requip PR intervention 2: Mirapex	1	Kansas City \| Kansas \| United States \| -94.62746 \| 39.11417	60	0	0	0	NCT00275275	1COMPLETED	2008-05-01	2006-01-01	Rajesh Pahwa, MD	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	10	NON_RANDOMIZED	null	0TREATMENT	0NONE	false	0ALL	true	RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin works as second-line therapy in treating patients with metastatic or recurrent colon cancer.	OBJECTIVES: Primary * Determine the complete response and partial response rates in patients with recurrent or progressive colon cancer treated with gemcitabine hydrochloride and oxaliplatin. Secondary * Determine the overall and failure-free survival of patients treated with the chemotherapy regimen. * Determine the duration of response (complete or partial) in patients treated with this regimen. * Determine the percentage of patients who experience a 50% fall of serum carcinoembryonic antigen levels with a baseline elevation of \> 5 U/mL after receiving this regimen. * Evaluate the toxicity associated with the administration of this regimen in these patients. OUTLINE: This is a non-randomized study. Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 1 year. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.	Colorectal Cancer	adenocarcinoma of the colon recurrent colon cancer stage IV colon cancer	null	0	null	null	2	[ 0, 0 ]	intervention 1: None intervention 2: None	intervention 1: gemcitabine hydrochloride intervention 2: oxaliplatin	1	Miami \| Florida \| United States \| -80.19366 \| 25.77427	10	0	0	0	NCT00276861	6TERMINATED	2008-05-01	2005-09-01	University of Miami	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	849	RANDOMIZED	SINGLE_GROUP	1PREVENTION	2DOUBLE	false	0ALL	true	Most cases of infection of clean-contaminated wounds (wounds without gross spillage of organisms from the gastrointestinal tract) are thought to originate from the skin. Therefore, it is conceivable that application of an optimal antiseptic agent can reduce the rate of surgical wound infections. This trial is to compare the impact of disinfecting the skin with Chloraprep (2%chlorhexidine and 70% isopropyl alcohol) vs. Betadine on the rates of infection of clean-contaminated surgical wounds. The study will also assess the occurrence of adverse effects on the skin from either antiseptic agent and the cost-savings associated with the use of Chloraprep vs Betadine.	This is a prospective, randomized, multicenter clinical trial. All adult patients, who are scheduled for a clean-contaminated surgical procedure of the alimentary, respiratory, reproductive or urinary tract will be asked to participate.	Postoperative Wound Infection	Prevention Antiseptic Preoperative Scrub Postoperative Wound Infection	null	2	arm 1: preoperative skin preparation with povidone-iodine arm 2: preoperative skin preparation with scrub and paint technique	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Preoperative skin preparation with scrub and paint technique intervention 2: preoperative skin preparation with scrub and paint technique	intervention 1: chlorhexidine-alcohol intervention 2: Povidone-Iodine	6	West Roxbury \| Massachusetts \| United States \| -71.1495 \| 42.27926 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	849	0	0	0	NCT00290290	1COMPLETED	2008-05-01	2003-09-01	Baylor College of Medicine	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	190	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.	This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.	Metrorrhagia	Dysfunctional Uterine Bleeding	null	2	arm 1: A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo arm 2: Matching placebo to be taken orally daily	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placeboA blister card consists of 28 pills taken orally once a day for 28 days (one cycle) intervention 2: Matching placebo to be taken orally daily.	intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo	46	Lake Havasu City \| Arizona \| United States \| -114.32245 \| 34.4839 Greenbrae \| California \| United States \| -122.5247 \| 37.94854 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Pacific Palisades \| California \| United States \| -118.52647 \| 34.04806 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 San Diego \| California \| United States \| -117.16472 \| 32.71571 Greenwood Village \| Colorado \| United States \| -104.95081 \| 39.61721 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Aventura \| Florida \| United States \| -80.13921 \| 25.95648 Clearwater \| Florida \| United States \| -82.8001 \| 27.96585 Fort Myers \| Florida \| United States \| -81.84059 \| 26.62168 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Tampa \| Florida \| United States \| -82.45843 \| 27.94752 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Douglasville \| Georgia \| United States \| -84.74771 \| 33.7515 Champaign \| Illinois \| United States \| -88.24338 \| 40.11642 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 New York \| New York \| United States \| -74.00597 \| 40.71427 New Bern \| North Carolina \| United States \| -77.04411 \| 35.10849 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pottstown \| Pennsylvania \| United States \| -75.64963 \| 40.24537 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Watertown \| South Dakota \| United States \| -97.11507 \| 44.89941 Clarksville \| Tennessee \| United States \| -87.35945 \| 36.52977 Corpus Christi \| Texas \| United States \| -97.39638 \| 27.80058 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Plano \| Texas \| United States \| -96.69889 \| 33.01984 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Tacoma \| Washington \| United States \| -122.44429 \| 47.25288 Bathurst \| New Brunswick \| Canada \| -65.65112 \| 47.61814 Kitchener \| Ontario \| Canada \| -80.5112 \| 43.42537 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Québec \| Quebec \| Canada \| -71.21454 \| 46.81228 Shawinigan \| Quebec \| Canada \| -72.74913 \| 46.56675 Sherbrooke \| Quebec \| Canada \| -71.89908 \| 45.40008 Ste-Foy \| Quebec \| Canada \| N/A \| N/A	185	0	0	0	NCT00293059	1COMPLETED	2008-05-01	2005-12-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	7	RANDOMIZED	PARALLEL	4SUPPORTIVE_CARE	2DOUBLE	false	0ALL	true	D-cycloserine may help lessen pain and other symptoms of peripheral neuropathy caused by chemotherapy. It is not yet known whether D-cycloserine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. This randomized, double-blind, placebo-controlled clinical trial was designed to study D-cycloserine at 2 different doses to see how well each works compared to the other and to a placebo in treating cancer patients with peripheral neuropathy caused by chemotherapy.	This is a randomized, double-blind, placebo-controlled study. Initially, patients were randomized to 1 of 2 treatment arms (D-cycloserine 250 mg twice daily or placebo twice daily), and treated for up to 4 weeks in the absence of unacceptable toxicity. Later, the design was changed to randomize patients to 1 of 3 arms as follows: * D-cycloserine 50 mg twice daily for up to 12 weeks * D-cycloserine 200 mg twice daily for up to 12 weeks * Placebo twice daily for up to 12 weeks	Neurotoxicity Pain Breast Cancer	pain neurotoxicity breast cancer	null	5	arm 1: Placebo administered orally twice per day for 4 weeks. arm 2: D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks. arm 3: D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks. arm 4: This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks. arm 5: Placebo administered orally twice per day for 12 weeks.	[ 2, 1, 1, 1, 2 ]	2	[ 0, 10 ]	intervention 1: None intervention 2: None	intervention 1: D-cycloserine intervention 2: Placebo	2	Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305	6	0	0	0	NCT00301080	6TERMINATED	2008-05-01	2006-02-01	Northwestern University	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	72	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	null	The purpose of this study is to evaluate the safety and tolerability of romiplostim in thrombocytopenic patients with low or Intermediate-1 risk MDS. In addition, the study will evaluate the platelet response to romiplostim.	null	Thrombocytopenia MDS Myelodysplastic Syndromes Refractory Cytopenias	MDS Myelodysplastic Syndromes Refractory Cytopenias Thrombocytopenia	null	7	arm 1: Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 2: Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 3: Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 4: Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 5: Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who complete Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase. arm 6: Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who complete Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase. arm 7: Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who complete Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.	[ 0, 0, 0, 0, 0, 0, 0 ]	1	[ 0 ]	intervention 1: None	intervention 1: Romiplostim	0	null	72	0	0	0	NCT00303472	1COMPLETED	2008-05-01	2006-02-01	Amgen	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	200	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	true	The aim of this study was to determine whether long-term (≥ 6 months at the target dose) blockade of ETA receptors using sitaxsentan showed functional benefit in subjects with chronic Heart Failure and an Left Ventricular Ejection Fraction ≥50%.	null	Diastolic Heart Failure		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: sitaxsentan 100 mg (target dose) 0rally once daily. A 10-week Run-In Phase was conducted where dosing commenced at 25 mg daily for 2 weeks, and then was stepped up to 50 mg daily for 2 weeks, to 75 mg daily for 2 weeks and then to 100 mg daily for 2 weeks, with an additional 2-week stabilization period (10 weeks total) to a target study dose of 100 mg daily. During the Run-In Phase, if a subject was not able to tolerate upward dose titration to the target dose of 100 mg, the investigator may have elected to continue at the current dosage or reduce the dosage of sitaxsentan or placebo to the subject's immediate prior dose. During the Maintenance Phase, subjects received the highest titrated dose reached of study drug and continued it through the last day of Week M24 of the Maintenance Phase (14 weeks)- total study drug treatment duration= 6 months intervention 2: placebo identical to the study drug in description, dose and duration	intervention 1: Sitexsentin sodium intervention 2: Placebo	52	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Mobile \| Alabama \| United States \| -88.04305 \| 30.69436 Little Rock \| Alaska \| United States \| N/A \| N/A Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Orange \| California \| United States \| -117.85311 \| 33.78779 Sacramento \| California \| United States \| -121.4944 \| 38.58157 San Diego \| California \| United States \| -117.16472 \| 32.71571 New Haven \| Connecticut \| United States \| -72.92816 \| 41.30815 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Orlando \| Florida \| United States \| -81.37924 \| 28.53834 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Auburn \| Maine \| United States \| -70.23117 \| 44.09785 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Boston \| Massachusetts \| United States \| -71.05977 \| 42.35843 Minneapolis \| Minnesota \| United States \| -93.26384 \| 44.97997 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 St Louis \| Missouri \| United States \| -90.19789 \| 38.62727 Lincoln \| Nebraska \| United States \| -96.66696 \| 40.8 Manchester \| New Hampshire \| United States \| -71.45479 \| 42.99564 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 Troy \| New York \| United States \| -73.69179 \| 42.72841 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Huntersville \| North Carolina \| United States \| -80.84285 \| 35.41069 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Rapid City \| South Dakota \| United States \| -103.23101 \| 44.08054 Germantown \| Tennessee \| United States \| -89.81009 \| 35.08676 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Murray \| Utah \| United States \| -111.88799 \| 40.66689 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Madison \| Wisconsin \| United States \| -89.40123 \| 43.07305 Toronto \| Ontario \| Canada \| -79.39864 \| 43.70643 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884	191	0	0	0	NCT00303498	1COMPLETED	2008-05-01	2006-03-27	Pfizer	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	231	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.	The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.	Metrorrhagia	Dysfunctional uterine bleeding	null	2	arm 1: A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo. arm 2: Matching placebo to be taken orally daily.	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 1 pill per day taken orally over 7 cycles of 28 pills per cycle intervention 2: 1 pill per day taken orally over 7 cycles of 28 pills per cycle	intervention 1: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027) intervention 2: Placebo	36	Ashfield \| New South Wales \| Australia \| 151.12274 \| -33.88834 Subiaco \| Western Australia \| Australia \| 115.8268 \| -31.9485 České Budějovice \| N/A \| Czechia \| 14.47434 \| 48.97447 Pardubice \| N/A \| Czechia \| 15.77659 \| 50.04075 Písek \| N/A \| Czechia \| 14.1475 \| 49.3088 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Espoo \| N/A \| Finland \| 24.6522 \| 60.2052 Lahti \| N/A \| Finland \| 25.66151 \| 60.98267 Tampere \| N/A \| Finland \| 23.78712 \| 61.49911 Turku \| N/A \| Finland \| 22.26869 \| 60.45148 Karlsruhe \| Baden-Wurttemberg \| Germany \| 8.40444 \| 49.00937 Rheinstetten \| Baden-Wurttemberg \| Germany \| 8.30704 \| 48.9685 Hanover \| Lower Saxony \| Germany \| 9.73322 \| 52.37052 Dresden \| Saxony \| Germany \| 13.73832 \| 51.05089 Berlin \| State of Berlin \| Germany \| 13.41053 \| 52.52437 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Komárom \| N/A \| Hungary \| 18.11913 \| 47.74318 Miskolc \| N/A \| Hungary \| 20.77806 \| 48.10306 Enschede \| N/A \| Netherlands \| 6.89583 \| 52.21833 Geleen \| N/A \| Netherlands \| 5.82917 \| 50.97417 Nijmegen \| N/A \| Netherlands \| 5.85278 \| 51.8425 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Poznan \| N/A \| Poland \| 16.92993 \| 52.40692 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Lund \| N/A \| Sweden \| 13.19321 \| 55.70584 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Kiev \| N/A \| Ukraine \| 30.5238 \| 50.45466 Lviv \| N/A \| Ukraine \| 24.02324 \| 49.83826 Cheadle \| Cheshire \| United Kingdom \| -1.98333 \| 52.98333 Luton \| N/A \| United Kingdom \| -0.41748 \| 51.87967 Northwood \| N/A \| United Kingdom \| -0.42454 \| 51.61162	226	0	0	0	NCT00307801	1COMPLETED	2008-05-01	2006-02-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 2 ]	4	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Drugs used in chemotherapy, such as gemcitabine, 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. PURPOSE: This phase I trial is studying the side effects and best dose of pemetrexed when given together with radiation therapy in treating patients with locally advanced pancreatic cancer.	OBJECTIVES: Primary * Determine the maximum tolerated dose of pemetrexed disodium when given in combination with upper abdominal radiotherapy after induction therapy comprising gemcitabine hydrochloride and pemetrexed disodium followed by consolidation therapy with gemcitabine hydrochloride in patients with locally advanced pancreatic cancer. * Determine the quantitative toxicity of this regimen in these patients. Secondary * Determine the quantitative and qualitative dose-limiting toxicities of pemetrexed disodium in combination with upper abdominal radiation therapy. * Evaluate patterns of failure, response, and survival of these patients at 1 year OUTLINE: This is an open-label, nonrandomized, dose-escalation study of pemetrexed disodium. * Induction therapy: Patients receive pemetrexed disodium IV over 10 minutes and gemcitabine hydrochloride IV over 30 minutes on day 1. Treatment repeats every 14 days for 3 courses. Approximately 2 weeks later, patients without disease progression proceed to chemoradiotherapy. * Chemoradiotherapy: Patients receive pemetrexed disodium IV over 10 minutes on days 1, 15, and 29 and undergo radiotherapy once daily 5 days a week for 5 ½ weeks. Approximately 2-3 weeks later, patients without disease progression proceed to consolidation therapy. Cohorts of 3-9 patients receive escalating doses of pemetrexed disodium during chemoradiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which ≤ 20% or ≤ 2 of 9 patients experience dose-limiting toxicity. * Consolidation therapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.	Pancreatic Cancer	stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer	null	1	arm 1: Patients will receive Pemetrexed plus Radiotherapy.	[ 0 ]	2	[ 0, 1 ]	intervention 1: 500 milligrams per meter squared day will be given during weeks 1, 3 and 5 of the radiation (3 total doses of Pemetrexed during the radiation therapy). intervention 2: During the chemoradiation, the radiotherapy will be administered in 1.8 Gy/fractions after completion of the Pemetrexed infusion, and continue daily (Monday through Friday) for 5 1/2 weeks for a total delivered dose of 50.4 Gy (Total of 28 radiation treatments).	intervention 1: pemetrexed disodium intervention 2: Radiotherapy	1	Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986	4	0	0	0	NCT00310050	6TERMINATED	2008-05-01	2005-10-01	Wake Forest University Health Sciences	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	1,741	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	true	The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.	null	Acute Coronary Syndrome (ACS)		null	4	arm 1: None arm 2: None arm 3: None arm 4: None	[ 1, 0, 2, 0 ]	4	[ 0, 0, 0, 0 ]	intervention 1: Tablets, Oral, 2.5 mg, twice daily, 26 weeks intervention 2: Tablets, Oral, 10 mg, once daily, 26 weeks intervention 3: Tablets, Oral, 0, twice daily, 26 weeks intervention 4: Tablets, Oral 10 mg, twice daily, 26 weeks	intervention 1: Apixaban intervention 2: Apixaban intervention 3: Placebo intervention 4: Apixaban	151	Scottsdale \| Arizona \| United States \| -111.89903 \| 33.50921 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Santa Rosa \| California \| United States \| -122.71443 \| 38.44047 Littleton \| Colorado \| United States \| -105.01665 \| 39.61332 Lakeland \| Florida \| United States \| -81.9498 \| 28.03947 Safety Harbor \| Florida \| United States \| -82.69316 \| 27.99085 Vero Beach \| Florida \| United States \| -80.39727 \| 27.63864 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Covington \| Georgia \| United States \| -83.86018 \| 33.59678 Peoria \| Illinois \| United States \| -89.58899 \| 40.69365 Indianapolis \| Indiana \| United States \| -86.15804 \| 39.76838 Des Moines \| Iowa \| United States \| -93.60911 \| 41.60054 Lexington \| Kentucky \| United States \| -84.47772 \| 37.98869 Troy \| Michigan \| United States \| -83.14993 \| 42.60559 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Gastonia \| North Carolina \| United States \| -81.1873 \| 35.26208 Hickory \| North Carolina \| United States \| -81.3412 \| 35.73319 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Columbus \| Ohio \| United States \| -82.99879 \| 39.96118 Dayton \| Ohio \| United States \| -84.19161 \| 39.75895 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Danville \| Pennsylvania \| United States \| -76.61273 \| 40.96342 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Providence \| Rhode Island \| United States \| -71.41283 \| 41.82399 Kingsport \| Tennessee \| United States \| -82.56182 \| 36.54843 San Antonio \| Texas \| United States \| -98.49363 \| 29.42412 Tyler \| Texas \| United States \| -95.30106 \| 32.35126 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Feldkirch \| N/A \| Austria \| 9.6 \| 47.23306 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Huy \| Luik \| Belgium \| 5.23284 \| 50.51894 Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Antwerp \| N/A \| Belgium \| 4.40026 \| 51.22047 Brasschaat \| N/A \| Belgium \| 4.49182 \| 51.2912 Bruges \| N/A \| Belgium \| 3.22424 \| 51.20892 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Genk \| N/A \| Belgium \| 5.50082 \| 50.965 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Victoria \| British Columbia \| Canada \| -123.35155 \| 48.4359 St. John's \| Newfoundland and Labrador \| Canada \| -52.70931 \| 47.56494 Belleville \| Ontario \| Canada \| -77.38277 \| 44.16682 Chatham \| Ontario \| Canada \| -82.18494 \| 42.41224 Hamilton \| Ontario \| Canada \| -79.84963 \| 43.25011 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Oshawa \| Ontario \| Canada \| -78.84957 \| 43.90012 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Montreal \| Quebec \| Canada \| -73.58781 \| 45.50884 Saint-Charles-Borromée \| Quebec \| Canada \| -73.46586 \| 46.05007 Terrebonne \| Quebec \| Canada \| -73.64732 \| 45.70004 Arhus C \| N/A \| Denmark \| N/A \| N/A Copenhagen \| N/A \| Denmark \| 12.56553 \| 55.67594 Esbjerg \| N/A \| Denmark \| 8.45187 \| 55.47028 Frederiksberg \| N/A \| Denmark \| 12.53463 \| 55.67938 Glostrup Municipality \| N/A \| Denmark \| 12.40377 \| 55.6666 Hellerup \| N/A \| Denmark \| 12.57093 \| 55.73204 Herning \| N/A \| Denmark \| 8.97662 \| 56.13615 Randers \| N/A \| Denmark \| 10.03639 \| 56.4607 Amiens \| N/A \| France \| 2.3 \| 49.9 Cholet \| N/A \| France \| -0.87974 \| 47.05893 Dijon \| N/A \| France \| 5.01667 \| 47.31667 Nantes \| N/A \| France \| -1.55336 \| 47.21725 Paris \| N/A \| France \| 2.3488 \| 48.85341 Pessac \| N/A \| France \| -0.6324 \| 44.80565 Roubaix \| N/A \| France \| 3.17456 \| 50.69421 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Düren \| N/A \| Germany \| 6.49299 \| 50.80434 Halle \| N/A \| Germany \| 11.97947 \| 51.48158 Hanover \| N/A \| Germany \| 9.73322 \| 52.37052 Krefeld \| N/A \| Germany \| 6.55381 \| 51.33645 Langen \| N/A \| Germany \| 8.66852 \| 49.98955 Ludwigshafen \| N/A \| Germany \| 9.06138 \| 47.81663 Witten \| N/A \| Germany \| 7.35258 \| 51.44362 Afula \| N/A \| Israel \| 35.2892 \| 32.60907 Hadera \| N/A \| Israel \| 34.9039 \| 32.44192 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Nazareth \| N/A \| Israel \| 35.29719 \| 32.70087 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Rehovot \| N/A \| Israel \| 34.81199 \| 31.89421 Safed \| N/A \| Israel \| 35.496 \| 32.96465 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Bydgoszcz \| N/A \| Poland \| 18.00762 \| 53.1235 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Katowice \| N/A \| Poland \| 19.02754 \| 50.25841 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Krakow \| N/A \| Poland \| 19.93658 \| 50.06143 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Opole \| N/A \| Poland \| 17.92533 \| 50.67211 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Zielona Góra \| N/A \| Poland \| 15.50643 \| 51.93548 Kemerovo \| N/A \| Russia \| 86.08333 \| 55.33333 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saratov \| N/A \| Russia \| 46.00861 \| 51.54056 Yaroslavl \| N/A \| Russia \| 39.87368 \| 57.62987 Yaroslav \| N/A \| Russia \| N/A \| N/A Baracaldo (Vizcaya) \| N/A \| Spain \| -2.98813 \| 43.29639 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Hospitalet Llobregat Barcelona \| N/A \| Spain \| N/A \| N/A León \| N/A \| Spain \| -5.57032 \| 42.60003 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Oviedo \| N/A \| Spain \| -5.84476 \| 43.36029 Santiago de Compostela \| N/A \| Spain \| -8.54569 \| 42.88052 Seville \| N/A \| Spain \| -5.97317 \| 37.38283 Tarragona \| N/A \| Spain \| 1.24544 \| 41.11905 Valladolid \| N/A \| Spain \| -4.72372 \| 41.65518 Villajoyosa \| N/A \| Spain \| -0.23346 \| 38.50754 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Gothenburg \| N/A \| Sweden \| 11.96679 \| 57.70716 Malmo \| N/A \| Sweden \| 13.00073 \| 55.60587 Örebro \| N/A \| Sweden \| 15.2066 \| 59.27412 Stockholm \| N/A \| Sweden \| 18.06871 \| 59.32938 Sundsvall \| N/A \| Sweden \| 17.3063 \| 62.39129 Uppsala \| N/A \| Sweden \| 17.63889 \| 59.85882 Stockport \| Cheshire \| United Kingdom \| -2.15761 \| 53.40979 Harrow \| Middlesex \| United Kingdom \| -0.33208 \| 51.57835 Edinburgh \| Midlothian \| United Kingdom \| -3.19648 \| 55.95206 Portadown \| Northern Ireland \| United Kingdom \| -6.44434 \| 54.42302 Sheffield \| South Yorkshire \| United Kingdom \| -1.4659 \| 53.38297 York \| Yorkshire \| United Kingdom \| -1.08271 \| 53.95763 Croydon \| N/A \| United Kingdom \| -0.1 \| 51.38333 Leicester \| N/A \| United Kingdom \| -1.13169 \| 52.6386	2,280	0	0	0	NCT00313300	1COMPLETED	2008-05-01	2006-05-01	Bristol-Myers Squibb	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	240	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).	null	Partial Seizures	Epilepsy Partial seizures	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient. intervention 2: Patients in placebo group were titrated with placebo in the same way as in zonisamide group.	intervention 1: Zonisamide intervention 2: Placebo	8	Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Beijing \| Beijing Municipality \| China \| 116.39723 \| 39.9075 Chongqing \| Chongqing Municipality \| China \| 106.55771 \| 29.56026 Shanghai \| Shanghai Municipality \| China \| 121.45806 \| 31.22222 Shanghai \| Shanghai Municipality \| China \| 121.45806 \| 31.22222 XiÆan \| Shanxi \| China \| N/A \| N/A Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667	238	0	0	0	NCT00327717	1COMPLETED	2008-05-01	2006-09-01	Eisai Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	142	RANDOMIZED	PARALLEL	1PREVENTION	3TRIPLE	false	0ALL	true	We propose to test whether intraoperative administration of dexmedetomidine will reduce hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements in patients undergoing carotid endarterectomy.	Remifentanil is an amidopiperidine derivative with unique pharmacokinetic properties. Its steady-state volume of distribution is 30 L (3). Its context-sensitive half life is consistently short (3.2 min), even after prolonged infusion(4). The pharmacokinetic profile of remifentanil is independent of the hepatic (5) and renal function (6). And finally, the recovery profile of remifentanil is excellent with a speedy anesthetic emergence time which is important for a quick and proper neurologic assessment in the early postoperative period. Remifentanil produces good intraoperative hemodynamic control during intense noxious stimulation like laryngoscopy, endotracheal intubation, and during pinning of the head (8). However, side effects of remifentanil include hypotension and bradycardia (15) intraoperatively, along with apnea(16,17) and hyperalgesia(18) postoperatively which is caused by increasing sensitivity to noxious stimuli. Investigations demonstrate different mechanisms of opioid-induced post-infusion anti-analgesia and secondary hyperalgesia (9). Overall remifentanil is a versatile opioid that is being increasingly used in the operating room. DEXMEDETOMIDINE (DEX), an alpha-2 adrenoreceptor agonist, is gaining popularity in neuroanesthesia. It has a desirable neurophysiologic profile including neuroprotective characteristics through its effect on α2A receptor subtypes (10). Its hypnotic effect is mediated through the α2 receptors in the locus ceruleus and its analgesic properties are mediated through an effect on the dorsal horn of the spinal cord (11,12). Since it has sympatholytic and antinociceptive properties, it may improve hemodynamic stability at critical moments of neurosurgical stimulation. Dexmedetomidine reduces anesthetic drug and opioid requirements in the perioperative period (13,14). In addition, dexmedetomidine does not affect evoked potential monitoring, (19) making it a favorable anesthetic adjunct in cases in which neurophysiologic monitoring is being used. In recent years, dexmedetomidine has emerged as an effective drug useful in a wide range of anesthesia related areas. Study Questions We postulate that dexmedetomidine provides better hemodynamic control in the intra- and post-operative periods and reduces PACU analgesic requirements. Primary Hypothesis 1: Intraoperative dexmedetomidine provides better postoperative analgesia than remifentanil, thus reducing PACU opioid requirements. Primary Hypothesis 2: Dexmedetomidine causes fewer hemodynamic perturbations than remifentanil.	Carotid Artery Stenosis	Carotid Endarterectomy patients	null	2	arm 1: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical arm 2: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.	[ 1, 1 ]	2	[ 0, 0 ]	intervention 1: Remifentanil will be infused throughout surgery at a rate of 0.1-0.2 µg/kg/min. Propofol will be titrated to maintain a BIS value as close to 45 as clinically practical intervention 2: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.	intervention 1: Remifentanil intervention 2: Dexmedetomidine	1	Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995	139	0	0	0	NCT00335972	6TERMINATED	2008-05-01	2006-06-01	The Cleveland Clinic	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	843	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	null	To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.	null	Chronic Obstructive Pulmonary Disease (COPD)	COPD Lung function Exacerbations Quality of Life	null	2	arm 1: Aclidinium bromide 200 μg once-daily by inhalation arm 2: Placebo once-daily via inhalation	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Aclidinium bromide 200 μg once-daily via inhalation via the Eklira Genuair® inhaler: 1 puff in the morning for 52 weeks intervention 2: Placebo once-daily via inhalation: 1 puff in the morning for 52 weeks	intervention 1: Aclidinium bromide intervention 2: Placebo	132	Les Escaldes \| N/A \| Andorra \| 1.53414 \| 42.50729 Graz \| N/A \| Austria \| 15.45 \| 47.06667 Innsbruck \| N/A \| Austria \| 11.39454 \| 47.26266 Linz \| N/A \| Austria \| 14.28611 \| 48.30639 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Vienna \| N/A \| Austria \| 16.37208 \| 48.20849 Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Namur \| N/A \| Belgium \| 4.86746 \| 50.4669 Burgas \| N/A \| Bulgaria \| 27.46781 \| 42.50606 Pleven \| N/A \| Bulgaria \| 24.61667 \| 43.41667 Plovdiv \| N/A \| Bulgaria \| 24.75 \| 42.15 Rousse \| N/A \| Bulgaria \| 25.9534 \| 43.84872 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Sofia \| N/A \| Bulgaria \| 23.32415 \| 42.69751 Varna \| N/A \| Bulgaria \| 27.91667 \| 43.21667 Veliko Tarnovo \| N/A \| Bulgaria \| 25.62904 \| 43.08124 Lovosice \| N/A \| Czechia \| 14.05103 \| 50.51504 Neratovice \| N/A \| Czechia \| 14.51759 \| 50.25926 Pilsen \| N/A \| Czechia \| 13.37759 \| 49.74747 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Třemošná \| N/A \| Czechia \| 13.39499 \| 49.81584 Žatec \| N/A \| Czechia \| 13.54577 \| 50.32717 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Århus C \| N/A \| Denmark \| N/A \| N/A Odense C \| N/A \| Denmark \| 10.39538 \| 55.40841 Beuvry \| N/A \| France \| 2.68541 \| 50.51674 Brest \| N/A \| France \| -4.48628 \| 48.39029 Grasse \| N/A \| France \| 6.92537 \| 43.65783 Montpellier \| N/A \| France \| 3.87635 \| 43.61093 Paris \| N/A \| France \| 2.3488 \| 48.85341 Perpignan \| N/A \| France \| 2.89541 \| 42.69764 Rouen \| N/A \| France \| 1.09932 \| 49.44313 Strasbourg \| N/A \| France \| 7.74553 \| 48.58392 Vieux-Condé \| N/A \| France \| 3.56738 \| 50.45944 Bad Wörishofen \| N/A \| Germany \| 10.59666 \| 48.00674 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Berlin-Spandau \| N/A \| Germany \| N/A \| N/A Bonn \| N/A \| Germany \| 7.09549 \| 50.73438 Großhansdorf \| N/A \| Germany \| 10.28333 \| 53.66667 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Jena \| N/A \| Germany \| 11.5899 \| 50.92878 Mainz \| N/A \| Germany \| 8.2791 \| 49.98419 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Debrecen \| N/A \| Hungary \| 21.62444 \| 47.53167 Nyíregyháza \| N/A \| Hungary \| 21.71671 \| 47.95539 Székesfehérvár \| N/A \| Hungary \| 18.41034 \| 47.18995 Szombathely \| N/A \| Hungary \| 16.62155 \| 47.23088 Tatabánya \| N/A \| Hungary \| 18.39325 \| 47.58494 Törökbálint \| N/A \| Hungary \| 18.91356 \| 47.42931 Genova \| N/A \| Italy \| 11.87211 \| 45.21604 Milan \| N/A \| Italy \| 12.59836 \| 42.78235 Modena \| N/A \| Italy \| 10.92539 \| 44.64783 Napoli \| N/A \| Italy \| 14.5195 \| 40.87618 Perugia \| N/A \| Italy \| 12.38878 \| 43.1122 Pordenone \| N/A \| Italy \| 12.66051 \| 45.95689 Breda \| N/A \| Netherlands \| 4.77596 \| 51.58656 Eindhoven \| N/A \| Netherlands \| 5.47778 \| 51.44083 Hengelo \| N/A \| Netherlands \| 6.79306 \| 52.26583 Hoofddorp \| N/A \| Netherlands \| 4.68889 \| 52.3025 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Torun \| N/A \| Poland \| 18.59814 \| 53.01375 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wroclaw \| N/A \| Poland \| 17.03333 \| 51.1 Zabrze \| N/A \| Poland \| 18.78576 \| 50.32492 Zawadzkie \| N/A \| Poland \| 18.48467 \| 50.60503 Brasov \| N/A \| Romania \| 25.60613 \| 45.64861 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Iași \| N/A \| Romania \| 27.6 \| 47.16667 Judetul Brasov \| N/A \| Romania \| N/A \| N/A Palazu Mare \| N/A \| Romania \| 28.60114 \| 44.22902 Târgu Mureş \| N/A \| Romania \| 24.55747 \| 46.54245 Timișoara \| N/A \| Romania \| 21.22571 \| 45.75372 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow \| N/A \| Russia \| 37.61556 \| 55.75222 Moscow Region \| N/A \| Russia \| N/A \| N/A Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Saint Petersburg \| N/A \| Russia \| 30.31413 \| 59.93863 Sochi \| N/A \| Russia \| 39.72477 \| 43.59699 Badalona \| N/A \| Spain \| 2.24741 \| 41.45004 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Barcelona \| N/A \| Spain \| 2.15899 \| 41.38879 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Málaga \| N/A \| Spain \| -4.42034 \| 36.72016 Palma de Mallorca \| N/A \| Spain \| 2.65024 \| 39.56939 Sant Joan d'Alacant \| N/A \| Spain \| -0.43623 \| 38.40148 Terrassa \| N/A \| Spain \| 2.01667 \| 41.56667 Bedford \| N/A \| United Kingdom \| -0.46632 \| 52.13459 Bristol \| N/A \| United Kingdom \| -2.59665 \| 51.45523 Cottingham \| N/A \| United Kingdom \| -0.7554 \| 52.50243 Doncaster \| N/A \| United Kingdom \| -1.13116 \| 53.52285 Exeter \| N/A \| United Kingdom \| -3.52751 \| 50.7236 Hereford \| N/A \| United Kingdom \| -2.71482 \| 52.05684 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 London \| N/A \| United Kingdom \| -0.12574 \| 51.50853 Newcastle upon Tyne \| N/A \| United Kingdom \| -1.61396 \| 54.97328 Peterborough \| N/A \| United Kingdom \| -0.24777 \| 52.57364 Solihull \| N/A \| United Kingdom \| -1.78094 \| 52.41426 Suffolk \| N/A \| United Kingdom \| N/A \| N/A Windsor \| N/A \| United Kingdom \| -0.6 \| 51.48333	843	0	0	0	NCT00363896	1COMPLETED	2008-05-01	2006-07-01	AstraZeneca	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	568	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	true	0ALL	false	This randomized double-blind, placebo-controlled will determine the relative efficacy of standard versus extended transdermal nicotine (TN) therapy for smoking cessation. After completing the eligibility screening, 600 treatment-seeking smokers will be randomized to receive either standard treatment (ST) with TN (21mg x 8 weeks, placebo x 16 weeks) or extended treatment (ET) with TN (21mg x 24 weeks). All participants will receive behavioral counseling. The primary outcome will be biochemically verified abstinence from smoking at the end of treatment (week 24). Secondary outcomes include abstinence at week 28 (4 weeks after treatment is discontinued), and time to failure. We hypothesize that ET will produce significantly higher quit rates than ST; however, the benefit of ET will last only so long as treatment is continued. Support for this hypothesis would indicate that maintenance therapy with TN should be considered.	Please see brief summary.	TOBACCO USE CESSATION		null	2	arm 1: Participants in this treatment arm receive 24 weeks of 21mg nicotine patch in addition to 8 smoking cessation counseling sessions. arm 2: Participants receive 8 weeks of 21mg nicotine patch followed by 16 weeks of placebo patch.	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: 8-weeks of nicotine patch + 16-weeks of placebo intervention 2: 24-weeks of 21mg nicotine patch	intervention 1: Standard Patch Treatment intervention 2: 24-weeks of nicotine patch	2	Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238	568	0	0	0	NCT00364156	1COMPLETED	2008-05-01	2004-06-01	University of Pennsylvania	7OTHER	false	false	false	null	0	0	0	0
[ 2, 3 ]	12	NON_RANDOMIZED	PARALLEL	0TREATMENT	0NONE	true	0ALL	false	To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.	The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate. The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly	Psoriasis		null	4	arm 1: Monotherapy with Raptiva alone arm 2: Combination therapy with both Raptiva and Methotrexate arm 3: Continue Raptiva, discontinue methotrexate arm 4: Continue combination therapy with both Raptiva and Methotrexate	[ 1, 0, 0, 0 ]	2	[ 0, 0 ]	intervention 1: Initial dose 5 mg, then 15 mg per week intervention 2: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg	intervention 1: Methotrexate intervention 2: Raptiva	1	Sacramento \| California \| United States \| -121.4944 \| 38.58157	0	0	0	0	NCT00368654	1COMPLETED	2008-05-01	2007-01-01	University of California, Davis	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	196	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.	null	Menorrhagia Heavy Menstrual Bleeding	Heavy Menstrual Bleeding Menorrhagia	null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: 3900 mg/Day intervention 2: None	intervention 1: Tranexamic acid tablets intervention 2: Placebo tablets	52	Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Carmichael \| California \| United States \| -121.32828 \| 38.61713 San Diego \| California \| United States \| -117.16472 \| 32.71571 Upland \| California \| United States \| -117.64839 \| 34.09751 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Lakewood \| Colorado \| United States \| -105.08137 \| 39.70471 Groton \| Connecticut \| United States \| -72.07841 \| 41.3501 West Hartford \| Connecticut \| United States \| -72.74204 \| 41.76204 Inverness \| Florida \| United States \| -82.33037 \| 28.83582 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Savannah \| Georgia \| United States \| -81.09983 \| 32.08354 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Amite \| Louisiana \| United States \| -90.50898 \| 30.72657 Baton Rouge \| Louisiana \| United States \| -91.18747 \| 30.44332 Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Shreveport \| Louisiana \| United States \| -93.75018 \| 32.52515 Paw Paw \| Michigan \| United States \| -85.89112 \| 42.21782 Scottsbluff \| Nebraska \| United States \| -103.66717 \| 41.86663 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Canfield \| Ohio \| United States \| -80.76091 \| 41.02506 Centerville \| Ohio \| United States \| -84.15938 \| 39.62839 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Norman \| Oklahoma \| United States \| -97.43948 \| 35.22257 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Medford \| Oregon \| United States \| -122.87559 \| 42.32652 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Salem \| Oregon \| United States \| -123.0351 \| 44.9429 Abington \| Pennsylvania \| United States \| -75.11795 \| 40.12067 Jenkintown \| Pennsylvania \| United States \| -75.12517 \| 40.09594 Reading \| Pennsylvania \| United States \| -75.92687 \| 40.33565 Charleston \| South Carolina \| United States \| -79.93275 \| 32.77632 Columbia \| South Carolina \| United States \| -81.03481 \| 34.00071 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Greer \| South Carolina \| United States \| -82.22706 \| 34.93873 Chattanooga \| Tennessee \| United States \| -85.30968 \| 35.04563 Knoxville \| Tennessee \| United States \| -83.92074 \| 35.96064 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Sandy City \| Utah \| United States \| -111.8841 \| 40.59161 Spokane \| Washington \| United States \| -117.42908 \| 47.65966 Charleston \| West Virginia \| United States \| -81.63262 \| 38.34982 Huntington \| West Virginia \| United States \| -82.44515 \| 38.41925 Menomonee Falls \| Wisconsin \| United States \| -88.11731 \| 43.1789	189	0	0	0	NCT00386308	1COMPLETED	2008-05-01	2006-10-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	400	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.	null	Diabetes Diabetes Mellitus, Type 2		null	2	arm 1: Liraglutide 0.9 mg + glibenclamide placebo arm 2: Glibenclamide 1.25-2.5 mg + liraglutide placebo	[ 0, 1 ]	4	[ 0, 0, 0, 0 ]	intervention 1: 0.9 mg/day. Injected s.c. (under the skin) once daily. intervention 2: 1.25-2.5 mg tablet. Given orally once or twice daily. intervention 3: liraglutide placebo. Injected s.c. (under the skin) once daily. intervention 4: glibenclamide placebo. Given orally once or twice daily.	intervention 1: liraglutide intervention 2: glibenclamide intervention 3: placebo intervention 4: placebo	1	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	400	0	0	0	NCT00393718	1COMPLETED	2008-05-01	2006-11-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	264	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide in combination with sulphonylurea agent (SU) compared to SU monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2 diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.	null	Diabetes Diabetes Mellitus, Type 2		null	4	arm 1: Liraglutide 0.6 mg + sulphonylurea arm 2: Liraglutide 0.9 mg + sulphonylurea arm 3: Liraglutide placebo 0.6 mg + sulphonylurea arm 4: Liraglutide placebo 0.9 mg + sulphonylurea	[ 0, 0, 2, 2 ]	3	[ 0, 0, 0 ]	intervention 1: SU agent intervention 2: Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily. intervention 3: Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.	intervention 1: sulfonylurea intervention 2: liraglutide intervention 3: liraglutide	1	Tokyo \| N/A \| Japan \| 139.69171 \| 35.6895	264	0	0	0	NCT00395746	1COMPLETED	2008-05-01	2006-10-01	Novo Nordisk A/S	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	304	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	1FEMALE	true	The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.	null	Menorrhagia Heavy Menstrual Bleeding	Menorrhagia Heavy Menstrual Bleeding	null	3	arm 1: None arm 2: None arm 3: None	[ 0, 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: 3900 mg/Day intervention 2: 1950 mg/Day intervention 3: None	intervention 1: Tranexamic acid tablets intervention 2: Tranexamic acid tablets intervention 3: Placebo tablets	83	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Phoenix \| Arizona \| United States \| -112.07404 \| 33.44838 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Tucson \| Arizona \| United States \| -110.92648 \| 32.22174 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Searcy \| Arkansas \| United States \| -91.73625 \| 35.25064 Los Alamitos \| California \| United States \| -118.07256 \| 33.80307 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 San Diego \| California \| United States \| -117.16472 \| 32.71571 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Groton \| Connecticut \| United States \| -72.07841 \| 41.3501 Gainesville \| Florida \| United States \| -82.32483 \| 29.65163 Jacksonville \| Florida \| United States \| -81.65565 \| 30.33218 Lighthouse PT \| Florida \| United States \| -80.08727 \| 26.27564 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Miami Beach \| Florida \| United States \| -80.13005 \| 25.79065 New Port Richey \| Florida \| United States \| -82.71927 \| 28.24418 Sarasota \| Florida \| United States \| -82.53065 \| 27.33643 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Decatur \| Georgia \| United States \| -84.29631 \| 33.77483 Boise \| Idaho \| United States \| -116.20345 \| 43.6135 Idaho Falls \| Idaho \| United States \| -112.03414 \| 43.46658 Bloomington \| Indiana \| United States \| -86.52639 \| 39.16533 Newton \| Kansas \| United States \| -97.34504 \| 38.04668 Overland Park \| Kansas \| United States \| -94.67079 \| 38.98223 Marrero \| Louisiana \| United States \| -90.10035 \| 29.89937 Baltimore \| Maryland \| United States \| -76.61219 \| 39.29038 Ann Arbor \| Michigan \| United States \| -83.74088 \| 42.27756 Bingham Farms \| Michigan \| United States \| -83.27326 \| 42.51587 Grand Rapids \| Michigan \| United States \| -85.66809 \| 42.96336 Paw Paw \| Michigan \| United States \| -85.89112 \| 42.21782 Saint Clair Shores \| Michigan \| United States \| -82.88881 \| 42.49698 Kansas City \| Missouri \| United States \| -94.57857 \| 39.09973 Missoula \| Montana \| United States \| -113.994 \| 46.87215 McCook \| Nebraska \| United States \| -100.62571 \| 40.20195 Las Vegas \| Nevada \| United States \| -115.13722 \| 36.17497 Lawrenceville \| New Jersey \| United States \| -74.7296 \| 40.29733 Moorestown \| New Jersey \| United States \| -74.94267 \| 39.96706 New Brunswick \| New Jersey \| United States \| -74.45182 \| 40.48622 Albuquerque \| New Mexico \| United States \| -106.65114 \| 35.08449 New York \| New York \| United States \| -74.00597 \| 40.71427 Rochester \| New York \| United States \| -77.61556 \| 43.15478 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Raleigh \| North Carolina \| United States \| -78.63861 \| 35.7721 Winston-Salem \| North Carolina \| United States \| -80.24422 \| 36.09986 Bismarck \| North Dakota \| United States \| -100.78374 \| 46.80833 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Gallipolis \| Ohio \| United States \| -82.20237 \| 38.8098 Zanesville \| Ohio \| United States \| -82.01319 \| 39.94035 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Eugene \| Oregon \| United States \| -123.08675 \| 44.05207 Portland \| Oregon \| United States \| -122.67621 \| 45.52345 Levittown \| Pennsylvania \| United States \| -74.82877 \| 40.15511 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Phoenixville \| Pennsylvania \| United States \| -75.51491 \| 40.13038 Strafford \| Pennsylvania \| United States \| -75.40436 \| 40.05094 Wexford \| Pennsylvania \| United States \| -80.05589 \| 40.62646 Wynnewood \| Pennsylvania \| United States \| -75.27074 \| 40.00289 Greenville \| South Carolina \| United States \| -82.39401 \| 34.85262 Sioux Falls \| South Dakota \| United States \| -96.70033 \| 43.54997 Bristol \| Tennessee \| United States \| -82.18874 \| 36.59511 Clarksville \| Tennessee \| United States \| -87.35945 \| 36.52977 Nashville \| Tennessee \| United States \| -86.78444 \| 36.16589 Austin \| Texas \| United States \| -97.74306 \| 30.26715 Bryan \| Texas \| United States \| -96.36996 \| 30.67436 Fort Worth \| Texas \| United States \| -97.32085 \| 32.72541 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Plano \| Texas \| United States \| -96.69889 \| 33.01984 Temple \| Texas \| United States \| -97.34278 \| 31.09823 The Woodlands \| Texas \| United States \| -95.48938 \| 30.15799 Waco \| Texas \| United States \| -97.14667 \| 31.54933 Webster \| Texas \| United States \| -95.11826 \| 29.53773 Pleasant Grove \| Utah \| United States \| -111.73854 \| 40.36412 Salt Lake City \| Utah \| United States \| -111.89105 \| 40.76078 West Jordan \| Utah \| United States \| -111.9391 \| 40.60967 West Valley City \| Utah \| United States \| -112.00105 \| 40.69161 Burlington \| Vermont \| United States \| -73.21207 \| 44.47588 Norfolk \| Virginia \| United States \| -76.28522 \| 36.84681 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Renton \| Washington \| United States \| -122.21707 \| 47.48288	297	0	0	0	NCT00401193	1COMPLETED	2008-05-01	2006-11-01	Ferring Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	-0
[ 5 ]	477	RANDOMIZED	PARALLEL	1PREVENTION	2DOUBLE	false	0ALL	null	This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.	null	Influenza		null	2	arm 1: None arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks. intervention 2: Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.	intervention 1: Oseltamivir intervention 2: Placebo	78	Birmingham \| Alabama \| United States \| -86.80249 \| 33.52066 Little Rock \| Arkansas \| United States \| -92.28959 \| 34.74648 Stanford \| California \| United States \| -122.16608 \| 37.42411 Denver \| Colorado \| United States \| -104.9847 \| 39.73915 Hartford \| Connecticut \| United States \| -72.68509 \| 41.76371 Newark \| Delaware \| United States \| -75.74966 \| 39.68372 St. Petersburg \| Florida \| United States \| -82.67927 \| 27.77086 Atlanta \| Georgia \| United States \| -84.38798 \| 33.749 Augusta \| Georgia \| United States \| -81.97484 \| 33.47097 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 New Orleans \| Louisiana \| United States \| -90.07507 \| 29.95465 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Detroit \| Michigan \| United States \| -83.04575 \| 42.33143 Brooklyn Center \| Minnesota \| United States \| -93.33273 \| 45.07608 Missoula \| Montana \| United States \| -113.994 \| 46.87215 Camden \| New Jersey \| United States \| -75.11962 \| 39.92595 Hackensack \| New Jersey \| United States \| -74.04347 \| 40.88593 Livingston \| New Jersey \| United States \| -74.31487 \| 40.79593 Newark \| New Jersey \| United States \| -74.17237 \| 40.73566 Buffalo \| New York \| United States \| -78.87837 \| 42.88645 New York \| New York \| United States \| -74.00597 \| 40.71427 New York \| New York \| United States \| -74.00597 \| 40.71427 Chapel Hill \| North Carolina \| United States \| -79.05584 \| 35.9132 Charlotte \| North Carolina \| United States \| -80.84313 \| 35.22709 Durham \| North Carolina \| United States \| -78.89862 \| 35.99403 Cincinnati \| Ohio \| United States \| -84.51439 \| 39.12711 Cleveland \| Ohio \| United States \| -81.69541 \| 41.4995 Oklahoma City \| Oklahoma \| United States \| -97.51643 \| 35.46756 Hershey \| Pennsylvania \| United States \| -76.65025 \| 40.28592 Philadelphia \| Pennsylvania \| United States \| -75.16362 \| 39.95238 Pittsburgh \| Pennsylvania \| United States \| -79.99589 \| 40.44062 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Aalst \| N/A \| Belgium \| 4.0355 \| 50.93604 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Brussels \| N/A \| Belgium \| 4.34878 \| 50.85045 Edegem \| N/A \| Belgium \| 4.44504 \| 51.15662 Leuven \| N/A \| Belgium \| 4.70093 \| 50.87959 Edmonton \| Alberta \| Canada \| -113.46871 \| 53.55014 Coquitlam \| British Columbia \| Canada \| -122.78217 \| 49.2846 Winnipeg \| Manitoba \| Canada \| -97.14704 \| 49.8844 London \| Ontario \| Canada \| -81.23304 \| 42.98339 Saskatoon \| Saskatchewan \| Canada \| -106.66892 \| 52.13238 Brno \| N/A \| Czechia \| 16.60796 \| 49.19522 Tallinn \| N/A \| Estonia \| 24.75353 \| 59.43696 Tartu \| N/A \| Estonia \| 26.72509 \| 58.38062 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Paris \| N/A \| France \| 2.3488 \| 48.85341 Toulouse \| N/A \| France \| 1.44367 \| 43.60426 Tours \| N/A \| France \| 0.70398 \| 47.39484 Aachen \| N/A \| Germany \| 6.08342 \| 50.77664 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 München \| N/A \| Germany \| 13.31243 \| 51.60698 München \| N/A \| Germany \| 13.31243 \| 51.60698 Budapest \| N/A \| Hungary \| 19.04045 \| 47.49835 Pécs \| N/A \| Hungary \| 18.23083 \| 46.0725 Szeged \| N/A \| Hungary \| 20.14824 \| 46.253 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Ramat Gan \| N/A \| Israel \| 34.81065 \| 32.08227 Padua \| N/A \| Italy \| 11.88586 \| 45.40797 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Roma \| N/A \| Italy \| 11.10642 \| 44.99364 Kaunas \| N/A \| Lithuania \| 23.90961 \| 54.90272 Vilnius \| N/A \| Lithuania \| 25.2798 \| 54.68916 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Lodz \| N/A \| Poland \| 19.47395 \| 51.77058 Szczecin \| N/A \| Poland \| 14.55302 \| 53.42894 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Madrid \| N/A \| Spain \| -3.70256 \| 40.4165 Birmingham \| N/A \| United Kingdom \| -1.89983 \| 52.48142 Edinburgh \| N/A \| United Kingdom \| -3.19648 \| 55.95206	475	0	0	0	NCT00412737	1COMPLETED	2008-05-01	2007-01-01	Hoffmann-La Roche	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	31	NA	SINGLE_GROUP	0TREATMENT	0NONE	false	2MALE	false	The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.	Despite a modest improvement in survival with available chemotherapy treatments, androgen-independent metastatic prostate cancer remains essentially incurable. Several changes in gene function that characterize malignancy have been identified. For example the p53 gene in normal tissue lessens the risk of cancer through growth arrest or cell suicidal programs. Thus the silenced p53 gene present in cancer tissue contributes to the growth of the cancer. In addition when the p53 gene is silenced, a cell survival pathway, controlled by the NF-kB gene, is activated leading increased cell survival. Quinacrine can activate p53 and inhibit NF-kB, thus reestablishing cell suicidal programs and decreasing cell survival in cancer tissue. Moreover, quinacrine is effective against several prostate tumor cell lines in vitro, and has anti-tumor effects against prostate cancer xenografts in mice.	Prostatic Cancer	Cancer of Prostate Prostate Cancer Cancer of the Prostate Neoplasms, Prostate Neoplasms, Prostatic Prostate Neoplasms Prostatic Cancer Androgen-Independent Prostate Cancer	null	1	arm 1: Uncontrolled treatment arm	[ 0 ]	1	[ 0 ]	intervention 1: 100 mg daily	intervention 1: Quinacrine	0	null	31	0	0	0	NCT00417274	1COMPLETED	2008-05-01	2006-12-01	Cleveland BioLabs	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,272	RANDOMIZED	PARALLEL	0TREATMENT	3TRIPLE	false	0ALL	null	The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.	This is a multi-centre, comparative, randomised, (double-blind, double-dummy), parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of PA with that of AL in the treatment of acute, uncomplicated P. falciparum malaria. The study population will include 1269 patients, comprising male and female children (≥20 kg body weight) and adults recruited from study sites in Africa and South East Asia. Patients will be randomised to receive either oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Days 0, 1, and 2) or AL twice a day plus PA-placebo (once a day) for 3 consecutive days (Days 0, 1, and 2) in a 2:1 ratio. The dose range of PA covered by this regimen is 7.2:2.4 mg/kg to 13.8:4.6 mg/kg, respectively, which has been shown to be effective and safe in Phase I and II studies. Posology will be based on body weight ranges for both the PA and AL regimens. Patients will be confined to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later. The primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response (ACPR) on Day 28. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.	Malaria	malaria antimalarial artemisinin based combination therapy (ACT) P. falciparum pyronaridine artesunate (Pyramax)	null	2	arm 1: Pyronaridine artesunate (PA) arm 2: Arthemether lumefantrine (AL)	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Oral PA (180:60mg tablets) once a day plus AL-placebo (twice a day) for 3 consecutive days (Day 0, 1, and 2) intervention 2: AL (20:120mg tablets) twice a day plus PA-placebo (once a day) for 3 consecutive days (Day 0, 1, and 2)	intervention 1: Pyronaridine artesunate intervention 2: Coartem® (artemether lumefantrine)	10	Kinshasa \| N/A \| Democratic Republic of the Congo \| 15.31357 \| -4.32758 Kumasi \| N/A \| Ghana \| -1.62443 \| 6.68848 Maumere \| Nusa Tenggara Timur \| Indonesia \| 122.2111 \| -8.6199 Jayapura \| Special Region of Papua \| Indonesia \| 140.71813 \| -2.53371 Siaya \| N/A \| Kenya \| 34.28806 \| 0.0607 Bamako \| N/A \| Mali \| -7.97522 \| 12.60915 Maputo \| N/A \| Mozambique \| 32.58322 \| -25.96553 Puerto Princesa City \| N/A \| Philippines \| 118.73528 \| 9.73917 Dakar \| Dakar Fann \| Senegal \| -17.44406 \| 14.6937 Fajara \| N/A \| The Gambia \| -16.69639 \| 13.47	1,272	0	0	0	NCT00422084	1COMPLETED	2008-05-01	2007-01-01	Medicines for Malaria Venture	7OTHER	false	false	false	null	0	0	0	0
[ 3 ]	19	NON_RANDOMIZED	SINGLE_GROUP	0TREATMENT	0NONE	false	0ALL	false	Primary Objectives: 1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer. 2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate. 3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.	If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6 will be a rest day; no drugs will be given. The blood stem cell transplant will be given on day 7. Bone marrow from the matched donor may be used instead of blood stem cells, particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the chest to reduce the number of times patients are stuck with a needle. Researchers will collect blood stem cells from your brother or sister or from an unrelated donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose chemotherapy. You will need to have enough stem cells before transplantation. The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help blood counts return to normal after the transplant. G-CSF is given as a shot under the skin, starting the day from transplant and continuing until the white blood cell count is normal. Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it is given, the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6 after transplant. Day 11 of methotrexate is given additionally if a donor is unrelated. Blood transfusions may be needed also. Antithymocyte globulin will be given to patients who receive blood or bone marrow from donors whose cells do exactly match the patients or from unrelated donors. Sometimes the transplanted cells attack the normal cells in the patient's body instead of the cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone will be given by vein or by mouth to fight GVHD is it occurs. Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston area for about 100 days after the transplant. Blood tests will be done daily while the patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography (CT) scans, and/or bone scans will be done during the 100 days. If there are no signs of disease after 100 days, treatment will stop. Patients must return to the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and once a year after that. If disease is till present after 100 days, but the patient does not have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if GVHD occurs, treatment will stop. Before treatment starts, patients will have a complete exam including blood and urine tests. An EKG (heart function test) and a heart scan will be done. Patients will have a dental exam. A test of lung function will be done. A sample of breast tissue will be taken. This is done with a hollow needle while the doctor looks at a CT scan or with a lighted tube placed through a cut in the breast while the patient is under anesthesia. Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2 (HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done. This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the US Food and Drug Administration for use against breast cancer. About 40 patients will take part in the study.	Breast Cancer	Breast Cancer PBPC Transplantation Stem Cell Infusion Fludarabine Melphalan	null	1	arm 1: Intravenous Fludarabine 30 mg/m\^2 daily on days 1-5, and Melphalan 70 mg/m\^2 on days 4 and 5 followed by blood stem cell transplant on day 7.	[ 0 ]	3	[ 0, 0, 3 ]	intervention 1: 30 mg/m\^2 intravenously Daily for 5 Days intervention 2: 70 mg/m\^2 intravenously Daily for 2 Days intervention 3: Stem Cell Infusion on Day 0.	intervention 1: Fludarabine intervention 2: Melphalan intervention 3: Stem Cell Infusion	1	Houston \| Texas \| United States \| -95.36327 \| 29.76328	19	0	0	0	NCT00429572	1COMPLETED	2008-05-01	1998-01-01	M.D. Anderson Cancer Center	7OTHER	false	false	false	null	0	0	0	0
[ 4 ]	148	RANDOMIZED	PARALLEL	0TREATMENT	4QUADRUPLE	false	0ALL	null	IncobotulinumtoxinA (Xeomin) is a botulinum toxin type A preparation free from complexing proteins, i.e. free from proteins other than the active toxin. Injected into the muscle, incobotulinumtoxinA (Xeomin) causes local weakening. Botulinum toxin type A is widely used for treatment of various neurological conditions. This study will investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in the treatment of post-stroke spasticity of the upper limb.	null	Post-stroke Upper Limb Spasticity		null	2	arm 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection arm 2: None	[ 0, 2 ]	2	[ 0, 0 ]	intervention 1: incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), up to five injections in the Open-Label Extension Period, up to 400 units at each injection visit; Mode of administration: intramuscular injection intervention 2: Placebo	intervention 1: IncobotulinumtoxinA (Xeomin) intervention 2: Placebo	3	Czech Republic \| N/A \| Czechia \| N/A \| N/A Hungary \| N/A \| Hungary \| N/A \| N/A Poland \| N/A \| Poland \| N/A \| N/A	148	0	0	0	NCT00432666	1COMPLETED	2008-05-01	2006-06-01	Merz Pharmaceuticals GmbH	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	46	RANDOMIZED	PARALLEL	0TREATMENT	0NONE	false	0ALL	null	This is a multicenter, Phase II, randomized, controlled, open label trial designed to provide a preliminary assessment of the safety and efficacy of sunitinib when combined with bevacizumab and paclitaxel in patients who have not previously received chemotherapy for locally recurrent or metastatic breast cancer.	null	Metastatic Breast Cancer	Avastin MBC Breast Cancer Sutent	null	2	arm 1: None arm 2: None	[ 0, 2 ]	3	[ 0, 0, 0 ]	intervention 1: Intravenous repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose	intervention 1: bevacizumab intervention 2: sunitinib intervention 3: paclitaxel	0	null	46	0	0	0	NCT00434356	6TERMINATED	2008-05-01	2007-03-01	Genentech, Inc.	4INDUSTRY	false	false	false	null	0	0	0	0
[ 5 ]	10	RANDOMIZED	PARALLEL	1PREVENTION	0NONE	null	0ALL	null	The study will evaluate kidney graft function in maintenance renal transplant patients.	null	Kidney Transplantation	Kidney Transplantation Mycophenolic Acid Immunosuppression Cyclosporine	null	2	arm 1: The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME arm 2: Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.	[ 0, 1 ]	1	[ 0 ]	intervention 1: None	intervention 1: Enteric coated mycophenolate sodium (Myfortic®)	1	Bologna \| N/A \| Italy \| 11.33875 \| 44.49381	10	0	0	0	NCT00434590	6TERMINATED	2008-05-01	2007-03-01	Novartis Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	1,004	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	0ALL	false	The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ 40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic BP in hypertensive patients after 8 weeks of double-blind treatment. The study consisted of two sequential phases of 8 weeks duration each: During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate to severe hypertension. During the second phase, patients whose BP proved to be insufficiently controlled by the OM 40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the up-titrated combination. The study was be conducted by qualified and experienced personnel with adherence to GCP, current guidelines on the design of studies in hypertension, the applicable regulatory requirements and the ethical principles based on the Declaration of Helsinki.	Methodology: After the signature of the informed consent, patients were screened for eligibility and eligible patients entered into a pre-randomisation period consisting of a taper-off phase of approximately 1-2 weeks (during which patients treated for hypertension were to discontinue their antihypertensive therapy) followed by a 2-week single-blind placebo run-in phase (Visit 1). After conclusion of the placebo run-in phase (Visit 2), eligible patients were randomised to the double-blind active treatment period which consisted of two phases: First double-blind treatment phase (Phase A, from Randomisation to Week 8): Eligible patients with mean sitting sBP ≥ 160 and ≤ 200 mmHg and dBP ≥ 100 mmHg and ≤ 120 mmHg were randomised in a 1:2 ratio to receive either OM 40 mg or OM/HCTZ 40/12.5 mg for a total of 8 weeks of treatment (Phase A). Study visits were held after 4 and 8 weeks of double-blind active treatment (Visit 3 and 4, respectively). After 8 weeks (Visit 4), patients reaching the BP goal of \< 140/90 mmHg or \< 130/80 mmHg for diabetics were considered as responders. All patients (responders and non-responders) then entered into the titration phase of the study (Phase B): Second double-blind treatment phase/titration phase (Phase B, from Week 8 to Week 16): Treatment assignment in the second part of the study was based on the following criteria: * Responders to Phase A treatment continued to receive the same double-blind treatment for an additional 8 weeks. * Non-responders Phase A treatment had their treatment assigned as follows: * Non-responders to OM 40 mg were treated with OM/HCTZ 40/12.5 mg for an additional 8 weeks. * Non-responders to OM/HCTZ 40/12.5 mg were uptitrated to OM/HCTZ 40/25 mg for an additional 8 weeks. During Phase B of the study, visits were held 12 and 16 weeks after randomisation (Visits 5 and 6, respectively). The study ended at Visit 6 and a final examination was performed. A safety follow-up (SFU) telephone contact was performed 2 weeks after the end of the treatment. An SFU visit was performed if deemed necessary by the investigator. Sphygmomanometer was used for BP measurement throughout the trial. BP was measured at all visits as nearly as possible at the same time of the day as trough readings (24 ± 2 h after last drug intake) after a 10 minute rest period. Three separate sitting BP measurements were taken at least 1 minute apart from each other. The 3 results were then averaged and rounded to a whole integer. Patients with sBP values \> 200 mmHg and/or dBP values \> 120 mmHg at any time during the study were to be discontinued from the study.	Hypertension		null	2	arm 1: Olmesartanmedoxomil (OM)40 mg tablets. arm 2: Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets.	[ 1, 0 ]	2	[ 0, 0 ]	intervention 1: Initially patients were to be treated with Olmesartanmedoxomil (OM)40 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/12.5 mg and responders remained on the previous therapy for further 8 weeks. intervention 2: Initially patients were to be treated with Olmesartanmedoxomil (OM) /Hydrochlorothiazide (HCTZ)40/12.5 mg tablets once daily for 8 weeks. After 8 weeks non-responders were to be uptitrated to OM/HCTZ 40/25 mg and responders remained on the previous therapy for further 8 weeks.	intervention 1: OM 40 intervention 2: OM/HCTZ 40/12.5	65	Rijeka \| N/A \| Croatia \| 14.44241 \| 45.32673 Slavonski Brod \| N/A \| Croatia \| 18.01556 \| 45.16028 Split \| N/A \| Croatia \| 16.43915 \| 43.50891 Varaždin \| N/A \| Croatia \| 16.33778 \| 46.30444 Zadar \| N/A \| Croatia \| 15.22514 \| 44.11578 Zagreb \| N/A \| Croatia \| 15.97798 \| 45.81444 Benátky nad Jizerou \| N/A \| Czechia \| 14.82343 \| 50.29085 Bílovec \| N/A \| Czechia \| 18.01581 \| 49.75639 Brodce \| N/A \| Czechia \| 14.86917 \| 50.33068 Jablonec nad Nisou \| N/A \| Czechia \| 15.17108 \| 50.72431 Mladá Boleslav \| N/A \| Czechia \| 14.90318 \| 50.41135 Prague \| N/A \| Czechia \| 14.42076 \| 50.08804 Rokycany \| N/A \| Czechia \| 13.59459 \| 49.7427 Tábor \| N/A \| Czechia \| 14.6578 \| 49.41441 Teplice \| N/A \| Czechia \| 13.82451 \| 50.6404 Uničov \| N/A \| Czechia \| 17.12144 \| 49.77092 Aalborg \| N/A \| Denmark \| 9.9187 \| 57.048 Ballerup Municipality \| N/A \| Denmark \| 12.36328 \| 55.73165 Vejle \| N/A \| Denmark \| 9.5357 \| 55.70927 Berlin \| N/A \| Germany \| 13.41053 \| 52.52437 Cologne \| N/A \| Germany \| 6.95 \| 50.93333 Dresden \| N/A \| Germany \| 13.73832 \| 51.05089 Einbeck \| N/A \| Germany \| 9.86961 \| 51.82018 Essen \| N/A \| Germany \| 7.01228 \| 51.45657 Giengen an der Brenz \| N/A \| Germany \| 10.24312 \| 48.62219 Großheirath \| N/A \| Germany \| 10.9505 \| 50.17603 Hamburg \| N/A \| Germany \| 9.99302 \| 53.55073 Hanau \| N/A \| Germany \| 8.91418 \| 50.13423 Heidelberg \| N/A \| Germany \| 8.69079 \| 49.40768 Künzing \| N/A \| Germany \| 13.08333 \| 48.66667 Leipzig \| N/A \| Germany \| 12.37129 \| 51.33962 Lollar \| N/A \| Germany \| 8.70495 \| 50.64652 Mannheim \| N/A \| Germany \| 8.46694 \| 49.4891 München \| N/A \| Germany \| 13.31243 \| 51.60698 Nuremberg \| N/A \| Germany \| 11.07752 \| 49.45421 Ashkelon \| N/A \| Israel \| 34.57149 \| 31.66926 Beersheba \| N/A \| Israel \| 34.7913 \| 31.25181 Haifa \| N/A \| Israel \| 34.99928 \| 32.81303 Jerusalem \| N/A \| Israel \| 35.21633 \| 31.76904 Kfar Saba \| N/A \| Israel \| 34.90694 \| 32.175 Nahariya \| N/A \| Israel \| 35.09814 \| 33.00892 Petah Tikva \| N/A \| Israel \| 34.88747 \| 32.08707 Tel Aviv \| N/A \| Israel \| 34.78057 \| 32.08088 Tel Litwinsky \| N/A \| Israel \| 34.84588 \| 32.05096 Busto Arsizio \| N/A \| Italy \| 8.84914 \| 45.61128 Ferrara \| N/A \| Italy \| 11.62057 \| 44.83804 Pavia \| N/A \| Italy \| 9.15917 \| 45.19205 Pisa \| N/A \| Italy \| 10.4036 \| 43.70853 San Daniele del Friuli \| N/A \| Italy \| 13.00726 \| 46.15714 Sassari \| N/A \| Italy \| 8.55552 \| 40.72586 Somma Lombardo \| N/A \| Italy \| 8.70759 \| 45.68213 Venezia \| N/A \| Italy \| 11.17365 \| 44.42329 Bialystok \| N/A \| Poland \| 23.16433 \| 53.13333 Gdansk \| N/A \| Poland \| 18.64912 \| 54.35227 Gdynia \| N/A \| Poland \| 18.53188 \| 54.51889 Lublin \| N/A \| Poland \| 22.56667 \| 51.25 Płock \| N/A \| Poland \| 19.70638 \| 52.54682 Warsaw \| N/A \| Poland \| 21.01178 \| 52.22977 Wąbrzeżno \| N/A \| Poland \| N/A \| N/A Baia Mare \| N/A \| Romania \| 23.56808 \| 47.65729 Brăila \| N/A \| Romania \| 27.97429 \| 45.27152 Bucharest \| N/A \| Romania \| 26.10626 \| 44.43225 Cluj-Napoca \| N/A \| Romania \| 23.6 \| 46.76667 Oradea \| N/A \| Romania \| 21.91833 \| 47.0458 Suceava \| N/A \| Romania \| 26.25 \| 47.63333	1,638	0	0	0	NCT00441350	1COMPLETED	2008-05-01	2007-07-01	Menarini Group	4INDUSTRY	false	false	false	null	0	0	0	0
[ 3 ]	57	RANDOMIZED	CROSSOVER	0TREATMENT	4QUADRUPLE	false	0ALL	true	The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.	Male or female, 4 to 24 months of age (inclusive) with a diagnosis of IS with a 24 hour video EEG (vEEG) recording confirming the diagnosis and previously treated with 3 or fewer antiepileptic drugs (AEDs) are eligible for the study. The subject is able to continue treatment with concomitant AEDs (no more than 2; adrenocorticotropic hormone \[ACTH\], corticosteroids, felbamate, and vigabatrin are not allowed concomitantly). A ketogenic diet is permitted if it can be maintained for the duration of the study. There will be a total of three weekly 24-hr video EEGs (baseline, end of weeks 1 and 2 of treatment). Dosing titration begins the day after each video EEG during the inpatient stay. All subjects will be receiving ganaxolone the day after the second video EEG. A Data Monitoring Board (DMB) will determine whether successive cohorts of subjects can be dosed at an increased dose level; up to a maximum of 6 cohorts.	Infantile Spasms	infantile spasms anticonvulsant pediatric epilepsy West Syndrome epileptic spasms	null	2	arm 1: ganaxolone arm 2: placebo	[ 0, 2 ]	2	[ 0, 10 ]	intervention 1: None intervention 2: None	intervention 1: Ganaxolone intervention 2: Placebo	15	Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Los Angeles \| California \| United States \| -118.24368 \| 34.05223 Washington D.C. \| District of Columbia \| United States \| -77.03637 \| 38.89511 Miami \| Florida \| United States \| -80.19366 \| 25.77427 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Pensacola \| Florida \| United States \| -87.21691 \| 30.42131 Chicago \| Illinois \| United States \| -87.65005 \| 41.85003 Saint Paul \| Minnesota \| United States \| -93.09327 \| 44.94441 The Bronx \| New York \| United States \| -73.86641 \| 40.84985 Memphis \| Tennessee \| United States \| -90.04898 \| 35.14953 Dallas \| Texas \| United States \| -96.80667 \| 32.78306 Houston \| Texas \| United States \| -95.36327 \| 29.76328 Richmond \| Virginia \| United States \| -77.46026 \| 37.55376 Seattle \| Washington \| United States \| -122.33207 \| 47.60621 Milwaukee \| Wisconsin \| United States \| -87.90647 \| 43.0389	56	0	0	0	NCT00441896	1COMPLETED	2008-05-01	2007-01-01	Marinus Pharmaceuticals	4INDUSTRY	false	false	false	null	0	0	0	0
[ 4 ]	460	RANDOMIZED	PARALLEL	0TREATMENT	2DOUBLE	false	1FEMALE	false	To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)	null	Pelvic Inflammatory Disease	Uncomplicated pelvic inflammatory disease	null	2	arm 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days arm 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days	[ 0, 1 ]	2	[ 0, 0 ]	intervention 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days intervention 2: Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days	intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Levofloxacin & Metronidazole	13	Shenyang \| Liaoning \| China \| 123.43278 \| 41.79222 Chengdu \| Sichuan \| China \| 104.06667 \| 30.66667 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Beijing \| N/A \| China \| 116.39723 \| 39.9075 Chongqing \| N/A \| China \| 106.55771 \| 29.56026 Shanghai \| N/A \| China \| 121.45806 \| 31.22222 Jakarta \| N/A \| Indonesia \| 106.84513 \| -6.21462 Karachi \| N/A \| Pakistan \| 67.0104 \| 24.8608 Manila \| N/A \| Philippines \| 120.9822 \| 14.6042 Seoul \| N/A \| South Korea \| 126.9784 \| 37.566 Taipei \| Taiwan \| Taiwan \| 121.52639 \| 25.05306 Taizung \| N/A \| Taiwan \| N/A \| N/A Bangkok \| Bangkok \| Thailand \| 100.50144 \| 13.75398	455	0	0	0	NCT00453349	1COMPLETED	2008-05-01	2007-01-01	Bayer	4INDUSTRY	false	false	false	null	0	0	0	0

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