sssohrab/ct-dosing-errors-benchmark · Datasets at Hugging Face

[ 4 ]

1,326

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of the study is to determine if cladribine tablets are a safe and effective treatment for relapsing-remitting multiple sclerosis (RRMS).

This is a randomized, double-blind, three-arm, placebo-controlled, multi-center study. The study includes a pre-study evaluation period (up to 28 days prior to the start of treatment); an initial treatment period from Week 1 to 48; and a re-treatment period during Week 49 to 96. During the initial treatment period (Week 1 to 48), eligible subjects are equally randomized by a central randomization system to receive either a) cladribine at a low dose (0.875 milligram per kilogram per course \[mg/kg/course\] for two courses plus placebo for two courses); b) cladribine at a high dose (0.875 mg/kg/course for four courses); or c) placebo (four courses). During the re-treatment period (Weeks 49 to 96), subjects received either a) cladribine at a low dose (0.875 mg/kg/course for two courses); or b) placebo (two courses). For all randomized subjects, there is a rescue option of treatment with Rebif® (interferon beta-1a 44 microgram (mcg) given subcutaneously three times a week), if the subject experienced more than one qualifying relapse, and/or experienced a sustained increase in their EDSS score of greater than or equal to (\>=) 1 point, or \>=1.5 points if baseline EDSS score is 0, (over a period of three months or greater), during a calendar year beginning at Week 24. To maintain the blind, there is a treating physician who view clinical laboratory results and assess adverse events and safety information, and an independent blinded evaluating physician who will perform neurological exams. A central neuroradiology center, also blinded to treatment, will assess magnetic resonance imaging (MRI) evaluations.

Multiple Sclerosis, Relapsing-Remitting

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Cladribine tablet will be administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks. intervention 2: Cladribine tablet will be administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 48, and 52 and placebo matched to cladribine tablet will be administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks. intervention 3: Placebo matched to cladribine tablet will be administered over a course of 4 or 5 consecutive days of 28-day period at Weeks 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.

intervention 1: Cladribine 5.25 mg/kg intervention 2: Cladribine 3.5 mg/kg intervention 3: Placebo

0

null

1

NCT00213135

[ 5 ]

390

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.

null

Diabetes Mellitus, Type 2

null

3

arm 1: Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) arm 2: Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%) arm 3: Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Insulin glargine administered subcutaneously once daily. intervention 2: Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c \>6.5%)

intervention 1: Insulin Glargine intervention 2: Insulin Glulisine

1

Bridgewater | New Jersey | United States | -74.64815 | 40.60079

1

NCT00283049

[ 4 ]

365

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this trial is to understand if saxagliptin is more effective than placebo as a treatment for type 2 diabetic subjects who are not controlled with diet and exercise

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (rescue medication) added onto their blinded study medication

Diabetes

null

5

arm 1: PLUS open-label metformin (as needed as rescue medication) arm 2: PLUS open-label metformin (as needed as rescue medication) arm 3: PLUS open-label metformin (as needed as rescue medication) arm 4: PLUS open-label metformin (as needed as rescue medication) arm 5: PLUS open-label metformin (as needed as rescue medication)

[ 0, 0, 0, 0, 2 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT) intervention 5: Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2000 mg, as needed (12 months LT)

intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Saxagliptin intervention 4: Saxagliptin intervention 5: Placebo intervention 6: metformin

74

1

NCT00316082

[ 4 ]

490

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Anemia

null

2

arm 1: Eligible participants with anemia in CKD who were on hemodialysis will receive methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) IV once every month up to 52 weeks. The starting dose of MIRCERA which will be administered during the treatment period will depend on the dose of darbepoetin alfa administered during screening period i.e., 120, 200 and 360 mcg for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively. arm 2: Eligible participants with anemia in CKD who were on hemodialysis will receive darbepoetin alfa (Aranesp) IV once every two weeks up to 26 weeks and darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: As prescribed, iv. intervention 2: 120, 200 or 360 micrograms iv / month, starting dose

intervention 1: Darbepoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]

88

Adelaide | N/A | Australia | 138.59863 | -34.92866 Clayton | N/A | Australia | 145.11667 | -37.91667 Gosford | N/A | Australia | 151.34399 | -33.4244 Parkville | N/A | Australia | 144.95 | -37.78333 Woolloongabba | N/A | Australia | 153.03655 | -27.48855 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 Brussels | N/A | Belgium | 4.34878 | 50.85045 Roeselare | N/A | Belgium | 3.12269 | 50.94653 Calgary | Alberta | Canada | -114.08529 | 51.05011 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Kitchener | Ontario | Canada | -80.5112 | 43.42537 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Toronto | Ontario | Canada | -79.39864 | 43.70643 Greenfield Park | Quebec | Canada | -73.46223 | 45.48649 Trois-Rivières | Quebec | Canada | -72.5477 | 46.34515 Aalborg | N/A | Denmark | 9.9187 | 57.048 Hillerød | N/A | Denmark | 12.30081 | 55.92791 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Auch | N/A | France | 0.58856 | 43.64561 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne | N/A | France | -1.3194 | 46.79346 Castelnau-le-Lez | N/A | France | 3.90137 | 43.63605 Cergy-Pontoise | N/A | France | 2.07805 | 49.03894 Chamalières | N/A | France | 3.06703 | 45.77364 Dijon | N/A | France | 5.01667 | 47.31667 Fleury-Mérogis | N/A | France | 2.36378 | 48.6373 Hérouville-Saint-Clair | N/A | France | -0.30653 | 49.21088 La Tronche | N/A | France | 5.74629 | 45.20507 Lyon | N/A | France | 4.84671 | 45.74846 Montpellier | N/A | France | 3.87635 | 43.61093 Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Reims | N/A | France | 4.02853 | 49.26526 Rennes | N/A | France | -1.67429 | 48.11198 Saint-Brieuc | N/A | France | -2.76838 | 48.51513 Saint-Herblain | N/A | France | -1.651 | 47.21154 Saint-Ouen | N/A | France | 2.33339 | 48.90654 Villeurbanne | N/A | France | 4.8795 | 45.76601 Bad Hersfeld | N/A | Germany | 9.70891 | 50.87197 Bonn | N/A | Germany | 7.09549 | 50.73438 Dortmund | N/A | Germany | 7.466 | 51.51494 München | N/A | Germany | 13.31243 | 51.60698 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226 Bologna | N/A | Italy | 11.33875 | 44.49381 Como | N/A | Italy | 9.0832 | 45.80819 Genova | N/A | Italy | 11.87211 | 45.21604 Lecco | N/A | Italy | 9.39704 | 45.85589 Modena | N/A | Italy | 10.92539 | 44.64783 Pavia | N/A | Italy | 9.15917 | 45.19205 Prato | N/A | Italy | 11.09699 | 43.8805 Venezia | N/A | Italy | 11.17365 | 44.42329 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Dordrecht | N/A | Netherlands | 4.67361 | 51.81 Leiria | N/A | Portugal | -8.80705 | 39.74362 Alicante | N/A | Spain | -0.48149 | 38.34517 Badalona | N/A | Spain | 2.24741 | 41.45004 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bilbao | N/A | Spain | -2.92528 | 43.26271 Córdoba | N/A | Spain | -4.77275 | 37.89155 León | N/A | Spain | -5.57032 | 42.60003 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Ourense | N/A | Spain | -7.86407 | 42.33669 Santander | N/A | Spain | -3.80444 | 43.46472 Vigo | N/A | Spain | -8.72264 | 42.23282 Vigo | N/A | Spain | -8.72264 | 42.23282 Aarau | N/A | Switzerland | 8.04422 | 47.39254 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Canterbury | N/A | United Kingdom | 1.07992 | 51.27904 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Truro | N/A | United Kingdom | -5.05436 | 50.26526

1

NCT00394953

[ 3 ]

765

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly \[QW\]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.

The study was conducted in 2 parts. Part 1 of the study had 5 arms using weight based ribavirin 800-1400 mg/day and compared: * PegIntron and ribavirin for 48 weeks (Arm 1 - Control) * PegIntron, ribavirin, and boceprevir for 28 weeks (Arm 2) * Lead-in with PegIntron and ribavirin for 4 weeks followed by PegIntron, ribavirin and boceprevir for 24 weeks (Arm 3) * PegIntron, ribavirin and boceprevir for 48 weeks (Arm 4) * Lead-in with PegIntron and ribavirin for 4 weeks, followed by PegIntron, ribavirin and boceprevir for 44 weeks (Arm 5) Participants from Arm 1 receiving PegIntron and ribavirin that were HCV positive after 24 weeks of treatment had the option to receive boceprevir in combination with PegIntron and ribavirin for an additional 24 weeks. All participants from Arm 1 that started boceprevir after Week 24 formed the crossover arm (Arm 8). Part 2 of the study assessed the safety and efficacy of low dose ribavirin (400-1000 mg/day) and compared: * PegIntron, ribavirin (800-1400 mg/day) and boceprevir for 48 weeks (Arm 6) * PegIntron, low-dose ribavirin (400-1000 mg/day) and boceprevir for 48 weeks (Arm 7) Follow-up for all participants was up to 72 weeks after randomization.

Chronic Hepatitis C

null

8

arm 1: Participants treated with PegIntron (1.5 μg/kg, once weekly \[QW\]) and Ribavirin (800 to 1400 mg/day) for 48 weeks. Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron (1.5 μg/kg, QW), Ribavirin (800 to 1400 mg/day), and boceprevir (800 mg three times daily \[TID\]) for 24 additional weeks. The participants that crossed over to receive boceprevir formed Arm 8. The total treatment duration was up to 54 weeks. arm 2: Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks. arm 3: Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks. arm 4: Participants receiving boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks. arm 5: Participants receiving a lead-in treatment with PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks, followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks. arm 6: Participants receiving PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks during Part II of the study. Part II was initiated after participants were fully enrolled for Part I. arm 7: Participants receiving PegIntron (1.5 μg/kg QW), low-dose ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks (Arm 7) during Part II of the study. Part II was initiated after participants were fully enrolled for Part I. arm 8: Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), and ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.

[ 1, 0, 0, 0, 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 200 mg capsules taken as 800 mg orally three times daily (TID) intervention 2: 1.5 μg/kg subcutaneously (SC) once weekly (QW) intervention 3: 200 mg capsules in doses of 800 to 1400 mg/day (based on weight) taken orally divided twice daily intervention 4: 200 mg capsules in doses of 400 to 1000 mg/day (based on weight) taken orally divided twice daily

intervention 1: boceprevir (SCH 503034) intervention 2: peginterferon-alfa 2b (PegIntron) intervention 3: ribavirin intervention 4: ribavirin (low-dose)

0

null

1

NCT00423670

[ 4 ]

517

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The general aim of this trial is to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for Unified Parkinsons Disease Rating Scale Parts II and III combined), safety, and tolerability of pramipexole ER, in daily doses from 0.375 milligram to 4.5 milligram once a day, in comparison to placebo, in Levodopa combined with a Dopa-Decarboxylase-inhibitor treated Parkinson patients with advanced Parkinsons Disease and motor fluctuations. In addition, a numerical comparison of the efficacy of pramipexole extended release versus pramipexole immediate release will be done. The efficacy of pramipexole immediate release will also be compared to placebo, for assay sensitivity.

null

Parkinson Disease

null

3

arm 1: None arm 2: None arm 3: None

[ 5, 5, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo

76

Linz | N/A | Austria | 14.28611 | 48.30639 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Rakovník | N/A | Czechia | 13.7334 | 50.1037 Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284 Valašské Meziříčí | N/A | Czechia | 17.97113 | 49.47181 Győr | N/A | Hungary | 17.63512 | 47.68333 Kecskemét | N/A | Hungary | 19.69128 | 46.90618 Szeged | N/A | Hungary | 20.14824 | 46.253 Veszprém | N/A | Hungary | 17.91149 | 47.09327 Bangalore | N/A | India | 77.59369 | 12.97194 Chennai | N/A | India | 80.27847 | 13.08784 Delhi | N/A | India | 77.23149 | 28.65195 Hyderabad | N/A | India | 78.45636 | 17.38405 Indore | N/A | India | 75.8333 | 22.71792 Karnataka | N/A | India | N/A | N/A Pune | N/A | India | 73.85535 | 18.51957 Catania | N/A | Italy | 15.07041 | 37.49223 Catanzaro | N/A | Italy | 16.60086 | 38.88247 Chieti | N/A | Italy | 14.16494 | 42.34827 Grosseto | N/A | Italy | 11.10941 | 42.76296 Napoli | N/A | Italy | 14.5195 | 40.87618 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Makati City | N/A | Philippines | 121.03269 | 14.55027 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Pasig | N/A | Philippines | 121.0614 | 14.58691 Quezon | N/A | Philippines | 125.09889 | 7.73028 Quezon | N/A | Philippines | 125.09889 | 7.73028 Gdansk | N/A | Poland | 18.64912 | 54.35227 Krakow | N/A | Poland | 19.93658 | 50.06143 Warsaw | N/A | Poland | 21.01178 | 52.22977 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 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Dubnica nad Váhom | N/A | Slovakia | 18.16634 | 48.95981 Trnava | N/A | Slovakia | 17.58723 | 48.37741 Gyeonggi-do | N/A | South Korea | 126.76917 | 37.58944 Kyeonggi-do | N/A | South Korea | N/A | N/A Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Alcorcon (Madrid) | N/A | Spain | -3.82487 | 40.34582 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 San Cugat Del Valles (Barcelona) | N/A | Spain | N/A | N/A Tarrasa (Barcelona) | N/A | Spain | N/A | N/A Malmo | N/A | Sweden | 13.00073 | 55.60587 Nyköping | N/A | Sweden | 17.00788 | 58.753 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664 Kharkiv | N/A | Ukraine | 36.25475 | 49.98177 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167 Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167 Barnsley | N/A | United Kingdom | -1.48333 | 53.55 Blackburn | N/A | United Kingdom | -2.48333 | 53.75 London | N/A | United Kingdom | -0.12574 | 51.50853 Norwich | N/A | United Kingdom | 1.29834 | 52.62783 Salford | N/A | United Kingdom | -2.29042 | 53.48771

1

NCT00466167

[ 4 ]

1,075

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Acne Vulgaris

Acne Vulgaris Adapalene

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks intervention 2: Adapalene Lotion Vehicle will be applied topically to the face, once a day, for 12 weeks

intervention 1: Adapalene lotion 0.1% intervention 2: Adapalene Lotion Vehicle

34

1

NCT00598832

[ 3 ]

808

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The study seeks to determine the optimal dose of the Aclidinium/Formoterol combination for investigation in Phase III clinical trials

Dose-finding clinical trial, to assess the efficacy, safety and pharmacokinetics of three different doses of formoterol combined with the inhaled anticholinergic aclidinium bromide, aclidinium bromide monotherapy and formoterol monotherapy

Chronic Obstructive Pulmonary Disease (COPD)

Bronchitis Chronic Emphysema Smokers or ex-Smokers

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 0, 0, 0, 2, 2, 2 ]

2

[ 0, 0 ]

intervention 1: once daily intervention 2: once daily

intervention 1: Aclidinium bromide and formoterol intervention 2: Aclidinium bromide and formoterol placebo

9

Taichung | N/A | Australia | N/A | N/A Taipei | N/A | Australia | N/A | N/A Moscow | N/A | Czechia | N/A | N/A Saint Petersburg | N/A | Poland | N/A | N/A St-Petersburg | N/A | Poland | N/A | N/A Moscow | N/A | Russia | 37.61556 | 55.75222 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

1

NCT00626522

[ 4 ]

600

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine the efficacy and safety of once daily vortioxetine (Lu AA21004) in adults with major depressive disorder.

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took vortioxetine. The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need): * Vortioxetine 5 mg * Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient. All participants were asked to take one capsule at the same time each day throughout the study. This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 94 days. Participants made 8 visits to the clinic, and were contacted by telephone 1 week, 2 weeks, and 4 weeks after the last dose of study drug for a follow-up assessment.

Major Depressive Disorder

Major Depressive Disorder Depression Drug Therapy Major Depressive Episode

null

2

arm 1: Vortioxetine placebo-matching capsules, orally, once daily for up to 6 weeks. arm 2: Vortioxetine 5 mg, encapsulated tablet, orally, once daily for up to 6 weeks.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Encapsulated immediate-release tablets. intervention 2: Vortioxetine placebo-matching capsules.

intervention 1: Vortioxetine intervention 2: Placebo

33

1

NCT00672958

[ 3 ]

10

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

OBJECTIVES: I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

PROTOCOL OUTLINE: Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Osteoporosis

arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease

null

1

arm 1: Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.

[ 0 ]

1

[ 0 ]

intervention 1: Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

intervention 1: Alendronate

1

Charleston | South Carolina | United States | -79.93275 | 32.77632

0

NCT00010439

[ 4 ]

53

RANDOMIZED

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

2MALE

true

RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

OBJECTIVES: * Compare bone loss in patients receiving long-term androgen deprivation therapy for stage III or IV prostate cancer when treated with supportive care with vs without zoledronate. * Compare the percentage change in lumbar spine and hip bone density in patients treated with these regimens. * Compare markers of bone formation and resorption in patients treated with these regimens. * Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures, spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated with these regimens. * Compare the incidence of new or progressive bone metastatic disease in patients treated with these regimens. * Compare the survival rate of patients treated with these regimens. OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. * Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study.

Osteoporosis Prostate Cancer

osteoporosis stage III prostate cancer stage IV prostate cancer

null

2

arm 1: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months in the absence of toxicity. arm 2: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.

[ 0, 1 ]

3

[ 7, 0, 0 ]

intervention 1: Given orally intervention 2: Given orally intervention 3: Given IV

intervention 1: cholecalciferol intervention 2: calcium gluconate intervention 3: zoledronic acid

3

0

NCT00058188

[ 3 ]

70

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

null

This phase II trial is to see if combining bevacizumab with low-dose cyclophosphamide works in treating patients with ovarian epithelial or primary peritoneal cancer that has come back or spread to other parts of the body. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with cyclophosphamide may kill more tumor cells.

OBJECTIVES: Primary I. Determine the time to progression in patients with recurrent ovarian epithelial or primary peritoneal cancer treated with bevacizumab and low-dose cyclophosphamide. Secondary I. Determine the response rate in patients treated with this regimen. II. Determine the toxicity of this regimen in these patients. III. Determine molecular correlates for response and outcomes in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study within 1-2 years.

Primary Peritoneal Carcinoma Recurrent Ovarian Carcinoma Stage IV Ovarian Cancer

null

1

arm 1: Patients receive bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

[ 0 ]

3

[ 2, 0, 10 ]

intervention 1: Given IV intervention 2: Given PO intervention 3: Correlative studies

intervention 1: Bevacizumab intervention 2: Cyclophosphamide intervention 3: Laboratory Biomarker Analysis

1

Duarte | California | United States | -117.97729 | 34.13945

0

NCT00072566

[ 2, 3 ]

174

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

true

The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

null

Breast Neoplasms

metastatic breast cancer

null

2

arm 1: Docetaxel + Placebo arm 2: Docetaxel + AG-013736

[ 5, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 5 mg twice daily \[bid\] continuous dosing intervention 2: Standard of care drug administration intervention 3: 5mg twice daily \[bid\] continuous dosing intervention 4: Standard of care drug administration

intervention 1: Placebo intervention 2: Docetaxel intervention 3: AG-013736 (axitinib) intervention 4: Docetaxel

54

0

NCT00076024

[ 3 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the safety and effectiveness of combination therapy with peginterferon alpha-2a and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. Peginterferon alpha with ribavirin is the therapy of choice for people with HCV alone. Peginterferon alpha-2a is a compound that results from attaching a polyethylene glycol molecule to interferon alpha-2a. This compound stays in the blood longer than unmodified interferon alpha-2a, causing a higher blood concentration and thus maintaining greater activity against the hepatitis C virus. HIV-infected patients 18 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2-1/2 year study. Candidates are screened with a medical history and physical examination, blood and urine tests, eye examination, chest x-ray, electrocardiogram (EKG), liver ultrasound, and pregnancy test in women who are able to become pregnant. If a recent liver biopsy is not available, this test is done to determine the type and severity of liver disease. The patient is given a sedative before the procedure. Then, the skin in the area over the biopsy site is numbed with a local anesthetic and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. Participants begin treatment with injections under the skin of peginterferon alpha-2a and ribavirin pills by mouth on study day 0. Peginterferon is given either once or twice a week for 4 weeks and then once a week for 44 weeks. Ribavirin is given daily. In addition, patients continue to take all other medications prescribed by their doctor. Clinic visits are scheduled for the following procedures: * Days 1, 3, 4, 7, 10 and weeks 2, 3, and 4 - Blood tests for safety measures and to measure blood levels of HIV and HCV. * Weeks 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection. In addition, eye examinations are done every 3 months, and pregnancy and thyroid function tests are done several times during the treatment period. * Week 48 or end of treatment - Treatment stops after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients return to the clinic for a chest x-ray, EKG, blood tests, and abdominal ultrasound. Patients are hospitalized for a repeat liver biopsy. * Weeks 52, 56, 64 and 72 - Blood and urine tests to determine the side effects of treatment and its effect on the HCV infection, and a urine pregnancy test in women.

Hepatitis C infection occurs in one-third of all HIV-infected individuals. Liver disease has become more significant among patients coinfected with HIV and HCV. Several studies have shown that coinfected individuals develop earlier and more severe liver disease. Pegylated interferon alpha with ribavirin has become the therapy of choice among people with HCV alone. This is a randomized controlled study to address the safety and efficacy of a 4 week induction therapy consisting of twice-weekly pegylated interferon alpha-2a and daily ribavirin on HIV-1 and hepatitis C coinfected individuals. Twenty-two patients who are infected with both HIV and HCV and who also have evidence of chronic hepatitis will be randomized to receive peginterferon alpha-2a either twice weekly or once weekly for four weeks. They will then continue with standard weekly peginterferon for 44 more weeks. The patients will receive standard daily dose of ribavirin during the entire 48 weeks. These patients will be monitored for peginterferon level, HCV viral load, HIV viral load and CD4 counts and undergo a baseline liver biopsy and another at the end of 72 weeks. The results of the study will enable us to better delineate the efficacy of twice weekly peginterferon induction therapy in suppressing the hepatitis C virus in the first 4 weeks of the therapy. Since viral suppression for hepatitis C in the early phase of the combination treatment has predictive values for long term eradication of the virus, a therapy that improves early viral suppression may improve the long term cure rate. This will be especially important given the current low cure rate of HCV among HIV coinfected individuals.

Hepatitis C HIV Infections

Pegasys Ribavirin Early Virological Response Hepatitis C HIV

null

2

arm 1: Pegylated interferon alfa -2a STANDARD DOSE Pegasys 180ug/week arm 2: Double dose pegylated interferon with weight based Ribavirin

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: pegylated interferon alfa -2a 180ug/twice weekly and weight based ribavirin for 4 weeks then pegylated interferon alfa -2a 180ug/ weekly for the remainder of the treatment intervention 2: pegylated interferon alfa -2a 180ug weekly and weight based ribavirin for duration of the treatment

intervention 1: Double dose pegylated interferon with weight based Ribavirin intervention 2: standard dose pegylated interferon alfa -2a and ribavirin

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00085917

[ 3 ]

16

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.

OBJECTIVES: Primary * Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan. Secondary * Determine the duration of response in patients treated with this regimen. * Determine the tolerance to and toxicity of this regimen in these patients. * Determine the median and progression-free survival of patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.

Bladder Cancer

transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer stage IV bladder cancer

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: gemcitabine hydrochloride intervention 2: irinotecan hydrochloride

1

Charleston | South Carolina | United States | -79.93275 | 32.77632

0

NCT00089128

[ 3 ]

23

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing multiple myeloma.

PRIMARY OJBECTIVES: I. Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in patients with monoclonal gammopathy of undetermined significance or smoldering myeloma. SECONDARY OBJECTIVES: I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of monoclonal gammopathy (monoclonal gammopathy of undetermined significance vs smoldering myeloma). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive celecoxib orally (PO) twice daily (BID) for 6 months in the absence of unacceptable toxicity or progression to malignancy. ARM II: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. After completion of study treatment, patients are followed at 1, 6, and 12 months.

Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma

null

2

arm 1: Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. arm 2: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

[ 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

intervention 1: celecoxib intervention 2: placebo intervention 3: laboratory biomarker analysis

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00099047

[ 3 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.

OBJECTIVES: Primary * Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan. Secondary * Determine the safety and tolerability of this drug in these patients. OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Head and Neck Cancer

thyroid gland medullary carcinoma recurrent thyroid cancer

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: irinotecan hydrochloride

2

0

NCT00100828

[ 3 ]

10

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.

Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath. Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.

Pulmonary Disease, Chronic Obstructive Emphysema

Chronic Obstructive Pulmonary Disease Emphysema Phosphodiesterase inhibitors Sildenafil Exercise testing Quality of life

null

2

arm 1: Sildenafil first, followed by washout, followed by placebo arm 2: Placebo first, followed by washout, followed by Sildenafil

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: sildenafil citrate 25 mg by mouth thrice daily (po tid) intervention 2: 25 mg po tid

intervention 1: sildenafil citrate intervention 2: Placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00104637

[ 4 ]

602

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

The following abbreviations were used in the Adverse Event section: * international normalized ratio (inr) * Common Terminology Criteria for Adverse Events (ctcae) * Not Otherwise Specified (nos) * Gastrointestinal (gi) * Central nervous system (cns) * Absolute Neutrophil Count (anc) * Alanine aminotransferase (ALT) * Aspartate aminotransferase (AST) * Creatine phosphokinase (cpk) * Gammaglutamyltransferase (ggt) * Genitourinary (gu) * Atrioventricular (av)

Carcinoma, Hepatocellular

Liver Cancer Cancer

null

2

arm 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study. arm 2: Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. intervention 2: Sorafenib-matching placebo tablets were orally administered twice daily (bid).

intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo

178

0

NCT00105443

[ 5 ]

131

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

2MALE

true

The purpose of the study is to compare the safety and effectiveness of Prograf in the prevention of erectile dysfunction in men after a radical prostatectomy.

The purpose of the study is to compare the safety and efficacy of Prograf versus placebo in the prevention of erectile dysfunction in men after a bilateral nerve-sparing radical prostatectomy.

Erectile Dysfunction Prostate Cancer

Treatment effectiveness Treatment efficacy Investigational, Therapies Immunosuppressant Erectile dysfunction Prostatectomy

null

2

arm 1: Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up. arm 2: Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: oral intervention 2: oral

intervention 1: Tacrolimus intervention 2: Placebo

6

0

NCT00106392

[ 3 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is being done to test a drug called etanercept (Enbrel®). Etanercept has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate to severe plaque psoriasis (PsO), for use in reducing the signs and symptoms of moderately to severely active rheumatoid arthritis (RA) in adults and children, and psoriatic arthritis (PsA) and ankylosing spondylitis (AS) in adults. It is available by prescription for the treatment of PsO, RA, PsA, and AS. Etanercept is approved for injection under the skin at a dose of 50 mg per week in patients with psoriasis. The purpose of this study is to determine whether etanercept is safe and effective for the treatment of hidradenitis. Another purpose of this study is to determine the impact of etanercept treatment of hidradenitis on skin related to quality of life. The skin lesions typically associated with hidradenitis are thought to be partly due to a blockage that occurs in sweat glands, called apocrine ducts, which become inflamed and eventually destroyed. A protein found in the body called tumor necrosis factor alpha, or TNF- α, is a hormone that causes this inflammation or swelling. The study drug, etanercept, blocks the action of TNF- α. By blocking the action of TNF-α, etanercept may provide a reduction in the signs and symptoms of hidradenitis. This study will take place at the University of Pennsylvania and will involve up to 21 participants ages 18 and up. Approximately 21 subjects will participate at the University of Pennsylvania. Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years.

Purpose: The primary objective of this study is to determine the safety and estimate the efficacy of etanercept for the treatment of hidradenitis suppurativa. The secondary objective of this study is to determine the impact of etanercept treatment of hidradenitis suppurativa on skin related quality of life. Duration: Each patient will participate in this study for a maximum of 6 months. The study consists of a screening visit, baseline assessment visit (Day 1), a treatment period (Week 2 - Week 14), and a one month follow-up visit (Week 18 visit). The total duration of the study will be approximately 2 years. Subject Recruitment and Selection: It is planned that enrollment will be 12-21 patients. Background: Hidradenitis suppurativa is a physically, psychologically, and socially disabling disease characterized by inflammatory, cystic papules and nodules affecting the underarms, groin, perineum, and breasts. Lesions can become erosive and often develop deep abscesses and sinus tracts and drain foul smelling pus. Left untreated, hidradenitis can result in permanent scarring. In the most severe cases, characterized by chronic ulceration and granulation, there may be an increased risk of aggressive squamous cell carcinoma. Current treatment of hidradenitis consists of intra-lesional injections of steroids, topical and/or systemic antibiotics, hormonal therapy, and isotretinoin. For many patients with severe hidradenitis (stage II and III), these therapies are often ineffective. Patients with stage II and III hidradenitis often require surgical excision of the affected area (a highly morbid procedure) to control the disease. Unfortunately, for most patients with hidradenitis, existing therapies are ineffective and there is an unmet medical need for therapies that control this disabling and destructive disease. The pathophysiology of hidradenitis is unknown. The leading hypothesis is that occlusion of apocrine ducts leads to severe dilatation, apocrine gland inflammation, with ensuing bacterial growth and neutrophilic infiltration and destruction of the duct. The importance of the immune dysregulation in hidradenitis is further demonstrated by its association in many individuals with inflammatory bowel disease. The pathologic immune reaction to follicular occlusion in hidradenitis suggests a strong rationale for the use of treatments that may neutralize this inflammatory reaction. In fact, the existing standard treatment of hidradenitis is intra-lesional injections of steroids, in the effort to minimize the destructive nature of the immune response. Medications that are broadly immuno-suppressive, such as cyclosporine, have also been used to successfully treat hidradenitis, but are limited by organ toxicity. This rationale is further supported by case reports of dramatic and rapid (e.g. within days) improvement in hidradenitis treated with infliximab, a monoclonal antibody that blocks TNF-alpha. Etanercept is a TNF-alpha inhibitor currently FDA approved to treat various inflammatory disorders including rheumatoid arthritis, psoriatic arthritis and psoriasis. By inhibiting TNF-alpha, etanercept stops the inflammatory cascade by binding directly to circulating TNF-alpha and inhibiting its binding to cell surface receptors. Etanercept has been used in over 200,000 patients world wide for more than 5 years and has a well established safety record. The most common adverse effect of etanercept is injection site reaction which is typically mild and self-limited. Currently, laboratory monitoring for patients being treated with etanercept is not recommended according to its label since the drug has not been associated with a significant incidence of laboratory abnormalities. The well established safety profile of etanercept and its potent role in suppressing pathologic immune responses through TNF-inhibition make it a promising agent for the treatment of hidradenitis suppurativa. In this phase II clinical trial, we will determine preliminary evidence of safety and estimate the efficacy of etanercept in the treatment of hidradenitis. This study will provide critical preliminary data for planning larger pivotal trials. Research Design: This is a phase II, open label, two-stage clinical trial of etanercept for the treatment of hidradenitis. This design is a widely accepted method for early investigations of safety and efficacy of medications for new indications. Etanercept 50 mg will be administered subcutaneously once a week for 12 weeks in an open label manner. At week 12, the etanercept dose will be tapered to 25 mg subcutaneously once a week for 2 weeks. This is an 18 week study. Subjects will be screened to determine eligibility. Day -95 to -3 will be a screening period which will allow washout of concurrent therapies if necessary. Potential Risks: Etanercept was generally well tolerated in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Adverse events that were reported in at least 3% of all patients with higher incidence in patients treated with etanercept than placebo are: * Injection site reaction; * Infection; * Headache; * Nausea; * Rhinitis; * Dizziness; * Pharyngitis; * Cough; * Asthenia; * Abdominal pain; * Rash; * Peripheral edema; * Respiratory disorder; * Dyspepsia; * Sinusitis; * Vomiting; * Mouth ulcer; * Alopecia Potential Benefits: No direct benefits from participation in the study can be guaranteed. The study medication will be provided by the Financial Sponsor at no charge.

Hidradenitis Suppurativa

clinical trial; efficacy; etanercept; hidradenitis suppurativa; quality of life; safety; tnf

null

1

arm 1: Open-label treatment with etanercept 50 mg/week subcutaneous injection

[ 0 ]

1

[ 0 ]

intervention 1: etanercept 50 mg/week subcutaneous injection

intervention 1: etanercept

0

null

0

NCT00107991

[ 3 ]

16

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To study if decitabine can help to control Myelodysplastic Syndrome (MDS) in patients who have failed on therapy with azacytidine, the current standard of therapy.

Methylation is a change that occurs to Deoxyribonucleic acid (DNA) that affects gene usage in human cells. Abnormal methylation is very common in leukemias, which is a related disease to MDS. Decitabine is a new drug that blocks DNA methylation. Researchers want to find out if blocking methylation will help control MDS. Before you can start treatment on this study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, routine blood tests (between 4-6 tablespoons), and a bone marrow aspirate. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test. If you are found to be eligible to take part in this study, you will receive decitabine by vein over one hour, once a day, for 5 days (1 course). If this is not possible due to complications, you will receive the drug as an injection under the skin twice a day for 5 days (1 course). Treatment will be given every 4 to 8 weeks depending on how well your blood counts recover. After completing 8-12 weeks of therapy, response will be evaluated. If the response to treatment is good, treatment with decitabine will continue. Decitabine treatment may be continued for up to 12 courses, or as long as it is judged best to control the leukemia. During this study, you will need to visit your doctor periodically for physical exams and measurement of vital signs. The frequency of doctor visits will vary depending on your physical condition, but will be required at least once a month. Blood tests (about 2 teaspoons) will be done about every week during the first 6-8 weeks of treatment, then every 1 to 2 weeks for the length of the study. The blood samples will be used for routine lab tests. Every 1-3 courses, bone marrow samples will also be taken to check cells related to the disease before, during (every 1-3 courses), and after completion of this study. You will be taken off study if the disease gets worse or intolerable side effects occur. This is an investigational study. Decitabine is not yet Food and Drug Administration (FDA)approved. It will be provided free of charge by MGI Pharma. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia

Myelodysplastic Syndrome Chronic Myelomonocytic Leukemia Azacytidine Failure Decitabine

null

1

arm 1: 20 mg/m2 by vein (IV) over 1 hour daily x 5 days.

[ 0 ]

1

[ 0 ]

intervention 1: 20 mg/m2 IV over 1 hour daily x 5 days.

intervention 1: Decitabine

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00113321

[ 3 ]

183

RANDOMIZED

SINGLE_GROUP

1PREVENTION

2DOUBLE

false

0ALL

false

The purpose of this clinical research study is to learn whether Abatacept can treat and prevent lupus flares; specifically, in patients with active lupus flares in at least one of three organ systems: skin (discoid lesions); inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints (arthritis). All participants will receive prednisone or prednisone-equivalent treatment in combination with study medication. The safety of this treatment will also be studied.

null

Systemic Lupus Erythematosus

SLE

null

3

arm 1: Double Blind Period arm 2: Double Blind Period arm 3: Open Label

[ 1, 2, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months intervention 2: Injectable, intravenous, 0 mg, every 28 days, 12 months intervention 3: Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months intervention 4: Injectable, intravenous, 10 mg/kg, every 28 days

intervention 1: Abatacept intervention 2: Placebo intervention 3: Prednisone intervention 4: Abatacept

52

0

NCT00119678

[ 5 ]

1,091

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

null

Atopic Dermatitis

Atopic, dermatitis, asthma, children, modification Atopic dermatitis/atopy

null

2

arm 1: Pimecrolimus arm 2: Corticosteroid

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Pimecrolimus cream 1 % intervention 2: conventional corticosteroid-based treatment

intervention 1: Pimecrolimus intervention 2: Corticosteroid

36

0

NCT00124709

[ 4 ]

143

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.

null

Multiple Myeloma Stage I

Multiple Myeloma Stage I Zoledronic acid Progression

null

2

arm 1: Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily. arm 2: No treatment with study medication.

[ 0, 4 ]

2

[ 0, 7 ]

intervention 1: Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg\*hr/l). intervention 2: Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.

intervention 1: Zoledronic acid intervention 2: Calcium / Vitamin D

1

Berlin | N/A | Germany | 13.41053 | 52.52437

0

NCT00171925

[ 4 ]

475

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

true

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

null

Breast Cancer Breast Neoplasms Cancer of the Breast

null

2

arm 1: None arm 2: None

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression intervention 2: 75 mg/m2, intravenous (IV), every 21 days until disease progression intervention 3: 1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

intervention 1: gemcitabine intervention 2: docetaxel intervention 3: capecitabine

65

0

NCT00191152

[ 2 ]

19

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.

null

Advanced Solid Tumors Neoplasms

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression intervention 2: rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2

intervention 1: ixabepilone intervention 2: Rifampin

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00207090

[ 3 ]

61

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).

null

Macular Degeneration

Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 1 drop per dosed eye per protocol.

intervention 1: pegaptanib sodium

12

0

NCT00239928

[ 5 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether treatment with valganciclovir decreases T cell activation levels among HIV-infected patients with asymptomatic cytomegalovirus (CMV) co-infection, potentially improving immune responses to antiretroviral therapy.

null

HIV Infections Cytomegalovirus Infections

HIV CMV T Cell activation Valganciclovir

null

2

arm 1: 900mg PO qd arm 2: 900mg PO qd

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone. intervention 2: Placebo designed to resemble Valganciclovir

intervention 1: Valganciclovir intervention 2: Placebo

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00264290

[ 3 ]

6

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the anti-tumor activity of 852A when used to treat certain hematologic malignancies not responding to standard treatment.

852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Non-Hodgkin's Lymphoma Hodgkin's Lymphoma Multiple Myeloma Chronic Lymphocytic Leukemia

Leukemia Lymphoma Myeloma Hematology 852A IRM Oncology

null

1

arm 1: Patients receiving at least one dose of 852A.

[ 0 ]

1

[ 0 ]

intervention 1: Subcutaneous injection 0.6 mg/m2 2 times/week/12 weeks, may increase by 0.2 mg/m2 up to 1.2 mg/m2.

intervention 1: 852A

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00276159

[ 3, 4 ]

114

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study is being conducted to assess the impact of minocycline on the progression of symptoms of HD. The study will also assess whether it is reasonable to continue with further study of minocycline in HD. We will measure the effect of minocycline on HD by measuring the change in Huntington's disease symptoms.

The DOMINO study is a randomized, double-blind, multi-center, futility study of minocycline in patients with HD. Subjects will be randomized (3:1) to one of the two study arms: (1) the group that receives active minocycline (100 mg po b.i.d.), and (2) the group that receives placebo. Subjects will be enrolled over an approximate six-month period and remain on blinded study drug for 18 months. The primary analysis will involve a comparison of the change over time in TFC between the minocycline group and a fixed value determined from historical control data. A placebo group will also be included to facilitate blinding and to permit a descriptive assessment of the validity of the assumed change over time in historical controls.

Huntington Disease

Study of Minocycline in Huntington's Disease

null

2

arm 1: Minocycline (3:1 randomization) 100 mg capsules taken by mouth twice daily, 200 mg per day total for 18 months treatment duration. arm 2: Sugar pill manufactured to mimic minocycline, 1 capsule taken by mouth twice daily for 18 months treatment duration.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Minocycline: Oral; minocycline 100 mg capsules administered twice a day with the morning and evening meal (\~ 8 hours apart) intervention 2: Matching placebo 1 capsule twice daily, 18 months treatment duration.

intervention 1: minocycline intervention 2: Matching placebo

12

0

NCT00277355

[ 2 ]

27

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.

null

Cancer: Solid Tumors

Cancer, solid tumors

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.

intervention 1: E7080

1

Tokyo | Tokyo | Japan | 139.69171 | 35.6895

0

NCT00280397

[ 4 ]

35

null

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to: * Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS * Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS

null

Clinically Isolated Syndrome

null

2

arm 1: None arm 2: None

[ 0, 5 ]

2

[ 0, 10 ]

intervention 1: 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks intervention 2: No treatment for 96 weeks

intervention 1: Rebif® intervention 2: No Treatment

1

Windsor, Barrie, Hamilton, Mississauga | Ontario | Canada | N/A | N/A

0

NCT00287079

[ 4 ]

344

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis.

This is a Phase 3, randomized, double-blind, placebo-controlled, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). Approximately 320 patients at approximately 50 centers will be randomly assigned (1:1) to receive pirfenidone 2403 milligrams or placebo equivalent administered in divided doses three times per day (TID) with food. The primary outcome variable will be the absolute change in percent predicted Forced Vital Capacity from Baseline to Week 72. Patients will be randomized by geographic region. Patients will receive blinded study treatment from the time of randomization until the last patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will periodically review safety and efficacy data to ensure patient safety. After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥ 10% absolute decrease in percent predicted Forced Vital Capacity or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted idiopathic pulmonary fibrosis therapies in addition to their blinded study drug. Permitted idiopathic pulmonary therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).

Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune

null

2

arm 1: 2403 mg/day pirfenidone dose group. arm 2: Placebo equivalent.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study. intervention 2: Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.

intervention 1: Pirfenidone intervention 2: Placebo

1

Brisbane | California | United States | -122.39997 | 37.68077

0

NCT00287729

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study will estimate overall response rate of pemetrexed in poor risk patients with advanced, metastatic, or recurrent squamous cell carcinoma of the head and neck.

Rationale: Patients with advanced stage head and neck cancer, especially those with disease in the hypopharynx, oropharynx, or oral cavity, and poor performance status defined through clinical testing, are often not eligible for clinical trials and treated with best supportive care. The possibility of developing a well-tolerated chemotherapy regimen in these patients may lead to an equivalent benefit and better palliation. The current study offers the chemotherapy drug pemetrexed to patients with advanced head and neck cancer. Researchers consider this agent to have some anti-tumor efficacy against a variety of site-specific cancers, including head and neck cancer with a response rate that is similar to other single chemotherapy drugs. In addition, previous research indicates that toxicities associated with pemetrexed have been reduced when patients are given folic acid and B12 vitamin supplementation. Along with pemetrexed, the current study provides study participants with both folic acid and B12. Purpose: The primary objective of this study is to evaluate tumor response, including complete and partial remission, and toxicities from pemetrexed in patients with advanced head and neck cancer. Secondary objectives of this study include measurements of time to tumor progression, survival, and patient quality of life. Treatment: Study participants will be given pemetrexed through intravenous infusions. Pemetrexed will be administered once every three weeks. This schedule of pemetrexed once every three weeks will be repeated up to six times. Study participants will also be provided with both folic acid and B12 vitamin supplementation before, during, and after study treatments with pemetrexed. Vitamin supplementation is considered critical and compliance must be followed closely. Several tests and exams will be given throughout the study to monitor patients. Treatments will be discontinued due to disease growth and unacceptable side effects.

Head and Neck Cancer

head and neck cancer

null

1

arm 1: pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles

[ 0 ]

1

[ 0 ]

intervention 1: 500 mg/m2 IV every 3 weeks for 6 cycles

intervention 1: Pemetrexed

1

Columbus | Ohio | United States | -82.99879 | 39.96118

0

NCT00293579

[ 4 ]

746

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This trial is conducted in North America (the United States of America (USA) and Mexico). The trial is designed to evaluate the effects of treatment with liraglutide versus glimepiride in subjects with type 2 diabetes. The trial is a 52-week randomised, double-blind trial period plus a 52-week open-label extension (week 104) followed by an additional 156-week continued open-label extension. The total duration of the treatment period is planned to be 260 weeks (5 years).

null

Diabetes Diabetes Mellitus, Type 2

null

4

arm 1: Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195). arm 2: Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195). arm 3: Glimepiride 8 mg once daily + liraglutide placebo 200 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195). arm 4: Glimepiride 8 mg once daily + liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195).

[ 0, 0, 1, 1 ]

6

[ 0, 0, 0, 0, 0, 0 ]

intervention 1: 1.8 mg for s.c. (under the skin) injection intervention 2: 8 mg capsule intervention 3: 1.2 mg for s.c. (under the skin) injection intervention 4: Glimepiride placebo, 8mg capsule intervention 5: Liraglutide placebo, 200 mcl intervention 6: Liraglutide placebo, 300 mcl

intervention 1: liraglutide intervention 2: glimepiride intervention 3: liraglutide intervention 4: placebo intervention 5: placebo intervention 6: placebo

117

0

NCT00294723

[ 3 ]

41

NA

SINGLE_GROUP

0TREATMENT

1SINGLE

false

0ALL

null

Background: * CD4+ cells are white blood cells that regulate the immune system by controlling the strength and quality of the immune response. * CD25+ cells are a subset of CD4+ cells that suppress or prevent immune responses. * RFT-5-dgA is an immunotoxin (substance that kills specific cells in the immune system) that kills CD25+ cells. * In mouse studies, RFT-5-dgA showed anti-tumor activity in animals studies. Objective: To determine whether the immune system of patients with metastatic melanoma (melanoma that has spread beyond the original site) can cause tumors to shrink if the patients are given RFT-5-dgA to remove their CD25+ cells. Eligibility: Patients 18 years of age and older with metastatic melanoma whose disease has progressed after receiving standard treatment. Design: * Patients receive RFT-5-dgA through a vein every other day for a total of 3 doses (one treatment course). Patients have routine blood tests during the week of treatment. * Four to 5 weeks after the last dose, patients are evaluated with a physical examination, blood tests and scans and x-rays to evaluate their tumor. * Patients whose tumor has shrunk or remained stable may be offered additional treatment with RFT-5-dgA up to a total of four courses. * Patients undergo leukapheresis or have several tubes of blood drawn from a vein to determine the effects of RFT-5-dgA on the immune system. This is done before the first dose of RFT-5-dgA, after the first three doses, and possibly during subsequent treatment courses in those patients who receive additional treatment. For leukapheresis, blood is collected through a needle in an arm vein and flows through a catheter into a machine that separates it into its components by spinning. The white cells are extracted and the rest of the blood is returned through another needle in the other arm.

Background: * RFT5-dgA is an immunotoxin comprised of the IL-2Ra-specific murine IgG1 antibody RFT5 linked to deglycosylated ricin A chain (dgA) via the sterically hindered heterobifunctional disulfide linker SMPT (4-succinimidyl-oxycarbonyl-a-methyl-a-(2-pyridyldithio)-toluene). * RFT5-dgA is a recombinant immunotoxin that selectively targets CD25 expressing cells in vivo. Further, treatment of human PBMC with RFT5-dgA in vitro results in the preferential depletion of CD25+ Treg cells. * Depletion of Treg cells can enhance tumor protection to tumor-associated antigens expressed as self antigens and the RFT5-dgA immunotoxin had potent antitumor effects in SCID mice xenografted with L540 cells which express CD25. * The MTD established in the phase I trial of RFT5-dgA was 15mg/m(2)/course IV. Objectives: * The primary objective is to determine whether objective clinical responses can be obtained in patients with metastatic melanoma following administration of RFT5-dgA. * Secondary objectives will determine whether changes occur in levels of CD4+CD25+ regulatory T cells (Treg cells) in peripheral blood from before to after treatment and evaluate the toxicity profile of patients treated on this trial. Eligibility: * Patients greater than 18 years of age with measurable metastatic melanoma, an expected survival greater than three months, who have progressed after receiving standard therapy will be included. * Standard clinical laboratory values must be normal for study inclusion and patients may not be pregnant, breast-feeding or require anticoagulation. * Patients must be willing to undergo leukapheresis. * Patients with active infections, other major medical disorders, HAMA levels greater than 1 ug/mL, or who have had prior radiotherapy or who have extensive lung disease will be excluded. Design: * Patients will receive 3 mg/m(2) RFT5-dgA intravenously every other day for a total of 3 doses (one course). * Four to five weeks after the last dose, patients will undergo tumor evaluation, evaluation of changes in T-regulatory cells (CD4+CD25+cells and Foxp3 expression), and toxicity assessment. * One additional course may be administered to patients with stable disease or partial or complete response. * Up to 41 evaluable patients may be accrued to determine whether theRFT5-dgA can produce a modest response rate targeted to be 20 percent (p1=0.20) * Enrollment reflects the anticipated enrollment. Actual enrollment is unknown due to no longer having access to the data as records were destroyed

Metastatic Melanoma

Clinical Response Stage IV Melanoma Immunotoxin T Regulatory Cells CD25+ Cells Metastatic Melanoma

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: RFT5pdgA

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00314093

[ 4 ]

1,091

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).

null

Diabetes Diabetes Mellitus, Type 2

null

5

arm 1: Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 2: Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 3: Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day arm 4: Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo arm 5: Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo

[ 0, 0, 0, 1, 1 ]

7

[ 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: 0.6 mg for s.c. (under the skin) injection. intervention 2: 1.5-2.0 g tablets intervention 3: 4 mg tablets intervention 4: Glimepiride placebo 1 mg and 2 mg tablets intervention 5: Liraglutide placebo 1-3 mL for s.c. (under the skin) injection intervention 6: 1.2 mg for s.c. (under the skin) injection intervention 7: 1.8 mg for s.c. (under the skin) injection

intervention 1: liraglutide intervention 2: metformin intervention 3: glimepiride intervention 4: placebo intervention 5: placebo intervention 6: liraglutide intervention 7: liraglutide

190

Ciudad Autonoma de Bs As | N/A | Argentina | N/A | N/A Ciudad Autónoma de Bs As | N/A | Argentina | N/A | N/A Ciudad Autónoma de BsAs | N/A | Argentina | N/A | N/A Junín | N/A | Argentina | -60.94644 | -34.59391 Broadmeadow | New South Wales | Australia | 151.72849 | -32.92371 Penrith | New South Wales | Australia | 150.7 | -33.75 St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Daw Park | South Australia | Australia | 138.58407 | -34.98975 East Ringwood | Victoria | Australia | N/A | N/A Fremantle | Western Australia | Australia | 115.74557 | -32.05632 Adelaide | N/A | Australia | 138.59863 | -34.92866 Adelaide | N/A | Australia | 138.59863 | -34.92866 Auckland | N/A | Australia | N/A | N/A Bankstown | N/A | Australia | 151.03333 | -33.91667 Box Hill | N/A | Australia | 145.12545 | -37.81887 Cairns | N/A | Australia | 145.76613 | -16.92366 Camperdown | N/A | Australia | 151.17642 | -33.88965 Christchurch | N/A | Australia | N/A | N/A Clayton | N/A | Australia | 145.11667 | -37.91667 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Garran | N/A | Australia | 149.10846 | -35.34206 Hornsby | N/A | Australia | 151.09931 | -33.70244 Malvern | N/A | Australia | 145.02811 | -37.86259 Perth | N/A | Australia | 115.8614 | -31.95224 Westmead | N/A | Australia | 150.98768 | -33.80383 Woodville | N/A | Australia | 138.54291 | -34.877 Arlon | N/A | Belgium | 5.81667 | 49.68333 Bonheiden | N/A | Belgium | 4.54714 | 51.02261 Ghent | N/A | Belgium | 3.71667 | 51.05 Huy | N/A | Belgium | 5.23284 | 50.51894 La Louvière | N/A | Belgium | 4.18785 | 50.48657 Leuven | N/A | Belgium | 4.70093 | 50.87959 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Zagreb | N/A | Croatia | 15.97798 | 45.81444 Aalborg | N/A | Denmark | 9.9187 | 57.048 Århus C | N/A | Denmark | N/A | N/A Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Frederiksberg | N/A | Denmark | 12.53463 | 55.67938 Herlev | N/A | Denmark | 12.43998 | 55.72366 Hjørring | N/A | Denmark | 9.98229 | 57.46417 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 København S | N/A | Denmark | 12.5978 | 55.65059 Odense | N/A | Denmark | 10.38831 | 55.39594 Viborg | N/A | Denmark | 9.40201 | 56.45319 Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Bad Heilbrunn | N/A | Germany | 11.45934 | 47.74671 Bad Kreuznach | N/A | Germany | 7.86713 | 49.8414 Bad Lauterberg im Harz | N/A | Germany | 10.47031 | 51.63272 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Bad Neuenahr-Ahrweiler | N/A | Germany | 7.1113 | 50.54322 Beckum | N/A | Germany | 8.04075 | 51.75571 Bensheim | N/A | Germany | 8.61839 | 49.68369 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Darmstadt | N/A | Germany | 8.65027 | 49.87167 Diez | N/A | Germany | 8.00735 | 50.37419 Dormagen | N/A | Germany | 6.83167 | 51.09683 Dresden | N/A | Germany | 13.73832 | 51.05089 Dresden | N/A | Germany | 13.73832 | 51.05089 Flensburg | N/A | Germany | 9.43722 | 54.78805 Großheirath | N/A | Germany | 10.9505 | 50.17603 Halle | N/A | Germany | 11.97947 | 51.48158 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Kutenholz-Mulsum | N/A | Germany | N/A | N/A Ludwigshafen | N/A | Germany | 9.06138 | 47.81663 Marburg | N/A | Germany | 8.77069 | 50.80904 Münster | N/A | Germany | 7.62571 | 51.96236 Neuwied | N/A | Germany | 7.47057 | 50.4336 Oberhausen | N/A | Germany | 6.8625 | 51.47805 Pirna | N/A | Germany | 13.93702 | 50.95843 Pohlheim | N/A | Germany | N/A | N/A Regensburg | N/A | Germany | 12.10161 | 49.01513 Rehlingen-Siersburg | N/A | Germany | 6.68439 | 49.37565 Saaldorf | N/A | Germany | 12.92834 | 47.86873 Saarbrücken | N/A | Germany | 7.00982 | 49.23262 Saint Ingbert | N/A | Germany | N/A | N/A Speyer | N/A | Germany | 8.43111 | 49.32083 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Sulzbach-Rosenberg | N/A | Germany | 11.74598 | 49.50126 Tübingen | N/A | Germany | 9.05222 | 48.52266 Viersen | N/A | Germany | 6.39441 | 51.25435 Völklingen | N/A | Germany | 6.85873 | 49.25162 Würzburg | N/A | Germany | 9.95121 | 49.79391 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Gyula | N/A | Hungary | 21.28333 | 46.65 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Pécs | N/A | Hungary | 18.23083 | 46.0725 Szekszárd | N/A | Hungary | 18.70905 | 46.35014 Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84 Hyderabad | Andhra Pradesh | India | N/A | N/A Kochi | Kerala | India | 76.26022 | 9.93988 Mumbai | Maharashtra | India | 72.88261 | 19.07283 Chennai | Tamil Nadu | India | 80.27847 | 13.08784 Bangalore | N/A | India | 77.59369 | 12.97194 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Waterford | N/A | Ireland | -7.11194 | 52.25833 Bari | N/A | Italy | 16.86982 | 41.12066 Catania | N/A | Italy | 15.07041 | 37.49223 Florence | N/A | Italy | 11.24626 | 43.77925 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Monza | N/A | Italy | 9.27246 | 45.58005 Orbassano | N/A | Italy | 7.53813 | 45.00547 Padua | N/A | Italy | 11.88586 | 45.40797 Palermo | N/A | Italy | 13.3636 | 38.1166 Rimini | N/A | Italy | 12.56528 | 44.05755 Roma | N/A | Italy | 11.10642 | 44.99364 Sassari | N/A | Italy | 8.55552 | 40.72586 Torino | N/A | Italy | 11.99138 | 44.88856 Verona | N/A | Italy | 10.9938 | 45.43854 Apeldoorn | N/A | Netherlands | 5.96944 | 52.21 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Sliedrecht | N/A | Netherlands | 4.77639 | 51.82083 Bekkestua | N/A | Norway | N/A | N/A Bergen | N/A | Norway | 5.32415 | 60.39299 Elverum | N/A | Norway | 11.56231 | 60.88191 Gjøvik | N/A | Norway | 10.69155 | 60.79574 Hamar | N/A | Norway | 11.06798 | 60.7945 Kongsberg | N/A | Norway | 9.65017 | 59.66858 Kongsvinger | N/A | Norway | 11.99772 | 60.19049 Stavanger | N/A | Norway | 5.73332 | 58.97005 Tromsø | N/A | Norway | 18.95508 | 69.6489 Trondheim | N/A | Norway | 10.39506 | 63.43049 Cluj-Napoca | Cluj | Romania | 23.6 | 46.76667 Constanța | N/A | Romania | 28.63432 | 44.18073 Iași | N/A | Romania | 27.6 | 47.16667 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 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Moldava nad Bodvou | N/A | Slovakia | 20.99957 | 48.61428 Prešov | N/A | Slovakia | 21.23393 | 48.99839 Trenčín | N/A | Slovakia | 18.04436 | 48.89452 Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Durban | KwaZulu-Natal | South Africa | 31.0292 | -29.8579 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Benoni | N/A | South Africa | 28.32078 | -26.18848 A Coruña | N/A | Spain | -8.396 | 43.37135 Alcázar de San Juan | N/A | Spain | -3.20827 | 39.39011 Almería | N/A | Spain | -2.45974 | 36.83814 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bilbao | N/A | Spain | -2.92528 | 43.26271 Cadiz | N/A | Spain | -6.2891 | 36.52672 Girona | N/A | Spain | 2.82493 | 41.98311 Granada | N/A | Spain | -3.60667 | 37.18817 Málaga | N/A | Spain | -4.42034 | 36.72016 Mérida | N/A | Spain | -6.34366 | 38.91611 San Cristóbal de La Laguna | N/A | Spain | -16.32014 | 28.4853 San Juan | N/A | Spain | -1.16667 | 39.53333 Santa Cruz de Tenerife | N/A | Spain | -16.25462 | 28.46824 Santander | N/A | Spain | -3.80444 | 43.46472 Seville | N/A | Spain | -5.97317 | 37.38283 Falun | N/A | Sweden | 15.62597 | 60.60357 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Linköping | N/A | Sweden | 15.62157 | 58.41086 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Umeå | N/A | Sweden | 20.25972 | 63.82842 Abergavenny | N/A | United Kingdom | -3.01743 | 51.82098 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Berkshire | N/A | United Kingdom | N/A | N/A Cardiff | N/A | United Kingdom | -3.18 | 51.48 Coventry | N/A | United Kingdom | -1.51217 | 52.40656 Dundee | N/A | United Kingdom | -2.97489 | 56.46913 East Horsley | N/A | United Kingdom | -0.43207 | 51.27358 Frome | N/A | United Kingdom | -2.32211 | 51.22834 Llanelli | N/A | United Kingdom | -4.16191 | 51.68195 Oxford | N/A | United Kingdom | -1.25596 | 51.75222 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Sunbury-on-Thames | N/A | United Kingdom | -0.41817 | 51.40424

0

NCT00318461

[ 0 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The objective of this study is to compare the safety and efficacy of Myfortic with CellCept in liver transplant patients. Myfortic and CellCept are both immunosuppressive (anti-rejection) drugs. CellCept is commonly used after liver transplantation but gastrointestinal (GI) side effects are very common, sometimes necessitating in its discontinuation. Myfortic is a new drug similar to CellCept, except it is enteric-coated. Our hypothesis is that Myfortic has less GI side effects than CellCept and also has comparable effectiveness to CellCept.

This is a prospective, randomized, double-blinded, single center, safety and efficacy study comparing Myfortic with CellCept used after liver transplantation. Patients with biopsy-proven acute cellular rejection, renal insufficiency (i.e. acute or chronic renal failure requiring hemodialysis or patients with creatinine clearance \< 50 ml/min), or calcineurin inhibitor-induced neurotoxicity (defined as the presence of neurologic symptoms such as tremors, altered mental status, seizures, etc) will be randomized to start on either Myfortic (720 mg po bid) or CellCept (1 gm po bid). In those patients with calcineurin-induced neurotoxicity or nephrotoxicity, tacrolimus or cyclosporine doses will also be reduced to maintain serum trough levels of 4-8 mg/dl or 100-200 mg/dl, respectively. Comparison: Thirty patients will be enrolled and randomized in this two-armed, double-blinded study- half of the patients will receive Myfortic and the other half, CellCept.

Immunosuppression

Liver transplantation mycophenolate mofetil gastrointestinal adverse effects

null

2

arm 1: Subjects in the Myfortic arm will receive Myfortic 360mg or 720 mg BID for 90 days arm 2: Subjects in the CellCept arm will receive CellCept 500mg or 1000mg BID for 90 days

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Myfortic 360mg or 720 mg BID for 90 days intervention 2: CellCept 500mg or 1000mg BID for 90 days

intervention 1: Myfortic intervention 2: CellCept

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00336817

[ 0 ]

29

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The objective of this study is to determine the tolerability and safety of Myfortic in liver transplant patients. Patients receiving CellCept who have GI side effects will have CellCept discontinued and changed to Myfortic (Myfortic is a new drug similar to CellCept, except it is enteric-coated). Our hypothesis is that Myfortic has less GI side effects and will, therefore, be tolerated better than CellCept and also that Myfortic will have a comparable effectiveness to CellCept.

This is a prospective, single center, open-label, safety and tolerability study on the use of Myfortic after liver transplantation. Adult liver transplant patients who are experiencing GI symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) attributable to CellCept are eligible to enter the study. CellCept will be discontinued and replaced with Myfortic. The duration of the study will be 3 months, and during this time, we will assess the incidence and severity of GI adverse events, the incidence and severity of bone marrow suppression (leukopenia), and the incidence of cytomegalovirus (CMV) infection or disease in patients receiving Myfortic.

Immunosuppression

Liver transplantation mycophenolate mofetil gastrointestinal adverse effects

null

1

arm 1: All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

[ 0 ]

1

[ 0 ]

intervention 1: Myfortic 360mg or 720 mg BID for 90 days.

intervention 1: Myfortic

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00336895

[ 4 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and 5-fluorouracil). Patients randomized to the XELOX arm will receive Avastin (7.5mg/kg iv) on Day 1 of each 3 week cycle; patients randomized to the FOLFOX-4 arm will receive Avastin (5mg/kg iv) on Day 1 of each 2 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

null

Colorectal Cancer

null

2

arm 1: None arm 2: None

[ 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle intervention 2: As prescribed intervention 3: 5mg/kg iv on day 1 of each 2 week cycle intervention 4: As prescribed

intervention 1: bevacizumab [Avastin] intervention 2: XELOX intervention 3: bevacizumab [Avastin] intervention 4: FOLFOX-4

7

Box Hill | N/A | Australia | 145.12545 | -37.81887 Fitzroy | N/A | Australia | 144.97833 | -37.79839 Sydney | N/A | Australia | 151.20732 | -33.86785 Brampton | Ontario | Canada | -79.76633 | 43.68341 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Toronto | Ontario | Canada | -79.39864 | 43.70643 Christchurch | N/A | New Zealand | 172.63333 | -43.53333

0

NCT00349336

[ 4 ]

226

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is being conducted to determine the effectiveness of a lower monotherapy dose of lamotrigine than that currently approved.

The study consists of a Treatment phase, where efficacy is determined and a Continuation phase for extended safety information. The Continuation phase is open to all Treatment phase participants and those who did not qualify for treatment because of an insufficient number of seizures during the Baseline phase.

Epilepsy, Partial

epilepsy lamotrigine Lamictal monotherapy

null

2

arm 1: 300 mg/day treatment arm 2: 250 mg/day treatment

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 300 mg/day intervention 2: 250 mg/day

intervention 1: lamotrigine, 300 mg/day intervention 2: lamotrigine, 250 mg/day

103

0

NCT00355082

[ 4 ]

599

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.

null

Human Immunodeficiency Virus Infections

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: LPV/r 800/200 mg once-daily (QD) tablet intervention 2: LPV/r 400/100 mg twice-daily (BID) tablet

intervention 1: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) intervention 2: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)

1

Abbott Park | Illinois | United States | N/A | N/A

0

NCT00358917

[ 5 ]

3

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.

This study would be the first prospective, placebo-controlled study to our knowledge of any pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid anxiety) in patients with bipolar disorder. Our hypotheses are: 1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms significantly more than placebo in patients with bipolar disorder who have a full or subsyndromal diagnosis of generalized anxiety disorder (GAD). 2. Ziprasidone will be well tolerated in patients with generalized anxiety based on the incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on a lack of worsening of bipolar depression, mania or hypomania compared to placebo. 3. Treatment with ziprasidone will have a significantly greater positive impact on measures of quality of life and resilience than placebo.

Generalized Anxiety Disorder Bipolar Disorder

Bipolar Disorder Generalized Anxiety Disorder Double-blind Placebo-controlled Ziprasidone

null

2

arm 1: Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer response for some anxiety symptoms. arm 2: Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks. intervention 2: Placebo administered daily for 8 weeks

intervention 1: Ziprasidone intervention 2: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00374543

[ 4 ]

26

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP.

null

Follicular Lymphoma Lymphoma, Follicular

null

2

arm 1: Participants will receive standard R-CVP followed by Zevalin Therapeutic Regimen (Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin). arm 2: Participants will receive standard R-CVP.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Day 1: 250 mg/m2 Rituxan followed by 5 mCi 111In Zevalin. Day 7: 250 mg/m2 Rituxan followed by 0.4 mCi/kg Zevalin intervention 2: Standard R-CVP

intervention 1: Zevalin Therapeutic Regimen intervention 2: R-CVP

6

0

NCT00384111

[ 3 ]

106

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

2MALE

true

The purpose of this study is to assess the safety and efficacy of siltuximab administered in combination with mitoxantrone and prednisone in participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body) (HRPC).

This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study to evaluate the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where participants will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at a dose of 12 milligram per square meter (mg/m\^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m\^2). Siltuximab will be administered at a dose of 6 mg/kilogram intravenously as a 2-hour infusion, starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone. The duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week 12 after the first study agent dosing, then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression. Tumor (a mass in a specific area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria. There will be short-term follow-up visits (conducted monthly for 2 months), followed by long-term follow-up visits (conducted once every 3 months). Participants' safety will also be monitored throughout the study.

Cancer, Prostate

Cancer Prostate IL-6 Mitoxantrone Metastatic prostate cancer

null

3

arm 1: In Part 1, mitoxantrone 12 milligram per square meter (mg/m\^2) will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kilogram (mg/kg) intravenously as a 2 hour-infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. arm 2: In Part 2, mitoxantrone 12 mg/m\^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone. arm 3: In Part 2, mitoxantrone 12 mg/m\^2 will be given intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Mitoxantrone 12 mg/m\^2 intravenously as a 30 minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m\^2) intervention 2: Siltuximab 6 mg/kg intravenously as a 2 hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year intervention 3: Prednisone 5 mg orally twice daily

intervention 1: Mitoxantrone intervention 2: Siltuximab intervention 3: Prednisone

34

Norwalk | Connecticut | United States | -73.4079 | 41.1176 Port Saint Lucie | Florida | United States | -80.35033 | 27.29393 Atlanta | Georgia | United States | -84.38798 | 33.749 Shreveport | Louisiana | United States | -93.75018 | 32.52515 Baltimore | Maryland | United States | -76.61219 | 39.29038 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Charleston | South Carolina | United States | -79.93275 | 32.77632 North Charleston | South Carolina | United States | -79.97481 | 32.85462 Milwaukee | Wisconsin | United States | -87.90647 | 43.0389 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Sankt Veit an der Glan | N/A | Austria | 14.36028 | 46.76806 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Aalst | N/A | Belgium | 4.0355 | 50.93604 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brasschaat | N/A | Belgium | 4.49182 | 51.2912 Brussels | N/A | Belgium | 4.34878 | 50.85045 Roeselare | N/A | Belgium | 3.12269 | 50.94653 Sint-Niklaas | N/A | Belgium | 4.1437 | 51.16509 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Caen | N/A | France | -0.35912 | 49.18585 Le Mans | N/A | France | 0.20251 | 48.0021 Lyon | N/A | France | 4.84671 | 45.74846 Villejuif | N/A | France | 2.35992 | 48.7939 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Kassel | N/A | Germany | 9.5 | 51.31667 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 London | N/A | United Kingdom | -0.12574 | 51.50853 Sutton | N/A | United Kingdom | -0.2 | 51.35

0

NCT00385827

[ 3 ]

12

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Background: The p53 gene normally suppresses tumor growth, but when it is mutated, or damaged, tumors can grow unchecked. In cancers where the p53 gene has mutated, an increased level of p53(overexpression of p53) can be measured in the tumor. Objectives To determine whether advanced cancers that overexpress p53 can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-p53 protein. Eligibility Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) Patient's tumor overexpresses p53 Patient's leukocyte antigen type is HLA-A 0201 Design Patients undergo the following procedures: Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-p53 protein is inserted into the cells using an inactivated (harmless)virus in a process called transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) for 1 week to suppress the immune system so that the patients immune cells do not interfere with the treatment. Treatment with anti-p53 cells. Patients receive an IV infusion of the transduced cells containing anti-p53 protein, followed by infusions of a drug called IL-2, which helps boost the effectiveness of the transduced white cells. Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). Patients are evaluated with laboratory tests and imaging tests, such as computed tomography (CT) scans 4 to 6 weeks after treatment and then once a month 3 to 4 months to determine the response to treatment. Patients have blood tests at 1, 3, 6 and 12 months and then annually for the next 10 years.

Background: Human peripheral blood lymphocytes (PBL's) can be engineered to express alpha T-cell receptor that recognizes an human leukocyte antigen serotype witin HLA-A A serotype group) HLA-A2. 1 restricted epitope derived from the p53 protein. We constructed a single retroviral vector that contains both alpha and existent chains and can mediate genetic transfer of this TCR with high efficacy (less than 30%) without the need to perform any selection. In co-cultures with HLA-A2 and p53 double positive tumors including melanoma, hepatoma, sarcoma, small-cell lung cancer, esophageal and breast tumors, p53-TCR transduced T cells secreted significant amount of IFN-(but no significant secretion was observed in control co-cultures with either HLA-A2+/p53- or HLA-A2-p53+cell lines. Additional secretion of cytokines (IL-2, IL-4, IL-10,granulocyte macrophage stimulating factor (GM-CSF),tumor necrosis factor alpha (TNFalpha)) and chemokines (regulated upon activation, normal T cell expressed and secreted (RANTES), macrophage inflammatory protein 1 alpha (MIP-1 alpha)) was also observed in co-cultures with HLA-A2+/p53+tumor lines. p53-TCR transduced PBL could efficiently kill HLA-A2, 1/p53 expressing tumors (H2087, MDA-MB 231, Saos2/143, BE-3). In addition, we also tested for specific lysis of normal tissues by p53-TCR transduced cells and there was little or no lysis of the normal fibroblasts, renal epithelia cells, resting or activated normal PBLs compared to control HLA\_A2+/p53+H2087 tumor. Objectives: Primary objective: Determine of the administration of anti-p53 TCR-engineered peripheral blood lymphocytes and aldesleukin to patients following a nonmyeloablative but lymphoid depleting preparative regimen will result in clinical tumor regression in patients with metastatic cancer overexpressing p53. Secondary objectives: Determine the in vivo survival of TCR gene-engineered cells. Determine the toxicity profile of this treatment regimen. Eligibility: Patients who are HLA A0201 and 18 years of age or older must have metastatic cancer whose tumors overexpress p53; previously received and have been a non-responder or recurred to standard care for metastatic disease; biopsy available to evaluate p53 expression; normal values for basic laboratory values; Patients may not have: concurrent major medical illnesses; any form of primary or secondary immunodeficiency; severe hypersensitivity to any of the agents used in this study; contraindications for high dose aldesleukin administration. Design: PBMC, obtained by leukapheresis (approximately 5 x 10\^9 cells) will be cultured in the presence of anti-CD3 Muromonab-CD3( OKT3) and IL-2 in order to stimulate T-cell growth. Transduction is initiated by exposure of approximately 10\^8 to 5 x 10\^8 cells to supernatant containing the anti-p53 TCR retroviral vector. These transduced cells will be expanded and tested for their anti-tumor activity. Patients will receive a nonmyeloablative but lymphocyte depleting preparative regiment consisting of cyclophosphamide and fludarabine followed by intravenous infusion of in vitro tumor reactive, TCR gene-transduced PBL plus IV aldesleukin (720,000IU/kg q8h for a maximum of 15 doses). Patients will undergo complete evaluation of tumor with physical examination, CT of the chest, abdomen and pelvis and clinical laboratory evaluation four to six weeks after treatment and then monthly for approximately 3 to 4 months or until off study criteria are met. Patients will be entered into two cohorts based on histology: cohort 1 will include patients with metastatic melanoma or renal cell cancer, cohort 2 will include patients with other types of metastatic cancer. For each of the 2 strata evaluated, the study will be conducted using a phase II optimal design where initially 21 evaluable patients will be enrolled. For each of these two arms of the trial, if 0 or 1 of the 21 patients experiences a clinical response, then no further patients will be enrolled but if 2 or more of the first 21 evaluable patients enrolled have a clinical response, then accrual will continue until a total of 41 evaluable patients have been enrolled in that stratum. For both strata, the objective will be to determine if the combination of high dose aldesleukin, lymphocyte depleting chemotherapy, and anti-p53 TCR-gene engineered lymphocytes is able to be associated with a clinical response rate that can rule out 5% (p0=0.05) in favor of a modest 20% PR + CR rate (p1=0.20).

Anti-p53 TCR-Gene

Tumor Regression In Vivo Cell Survival Toxicity Profile Metastatic Renal Cell Cancer Cancer Metastatic Cancer

null

2

arm 1: Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes). arm 2: None

[ 0, 0 ]

5

[ 2, 2, 2, 0, 0 ]

intervention 1: Peripheral blood lymphocytes are harvested by lymphapheresis and engineered to express a T cell receptor that binds to P53. intervention 2: 720,000 IU/kg intravenously over 15 minutes every 8 hours for up to 5 days intervention 3: Beginning on day 1 or 2, administered subcutaneously at a dose of 5 mcg/kg/day (not to exceed 300 mcg/day); continue daily until neutrophil count \> 1.0 x 10\^9/L x 3 days or \> 5.0 x 10\^9/L. intervention 4: 60 mg/kg/day x 2 days intravenously in 250ml dextrose 5% in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour. intervention 5: 25 mg/m2/day intravenously piggyback (IVPB) daily over 30 minutes for 5 days.

intervention 1: anti-protein 53 or tumor protein 53 (p53) T-cell receptor transduced peripheral blood lymphocytes intervention 2: aldesleukin intervention 3: filgrastim intervention 4: cyclophosphamide intervention 5: fludarabine phosphate

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00393029

[ 3 ]

16

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

The study consisted of: * A 30-day screening phase prior to Day 1 * Day 1 registration and pre-treatment paracentesis * Aflibercept administration within 1-day of registration * Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration * A 60-day post-treatment follow-up phase During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation: * Participant (or legal representative) chose to withdraw from treatment * The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being * Participant had intercurrent illness that prevented further administration of investigational product (IP) * Participant had more than 2 IP dose reductions * Participant had unacceptable adverse events (AEs) * Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina * Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation

Ovarian Neoplasms

Ovarian cancer malignant ascites angiogenesis angiogenesis inhibition VEGF-Trap fusion recombinant protein

null

1

arm 1: Participants with advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) treated with Aflibercept every 2 weeks until a criterion for treatment discontinuation was met

[ 0 ]

1

[ 0 ]

intervention 1: 4.0 mg/kg administered intravenously (IV) once every 2 weeks

intervention 1: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

3

Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Milan | N/A | Italy | 12.59836 | 42.78235 Bromma | N/A | Sweden | 17.94 | 59.34

0

NCT00396591

[ 3 ]

58

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).

null

Idiopathic Parkinson's Disease

null

2

arm 1: Intracerebral administration of CERE-120 arm 2: Sham Neurosurgery

[ 0, 3 ]

2

[ 0, 3 ]

intervention 1: CERE-120 5.4 x 10\^11 vg intervention 2: Bilateral partial thickness burr holes placed, no intraparenchymal injections

intervention 1: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) intervention 2: Sham Surgery

9

0

NCT00400634

[ 5 ]

80

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

true

The investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (AF) following esophagectomy surgery. Their specific aims are to: Determine the effectiveness of amiodarone for the prevention of AF following esophagectomy surgery; Determine the influence of the prevention of AF following esophagectomy surgery on post-surgical duration of stay in the Intensive Care Unit ICU)and duration of post-surgical hospital stay; and Determine the safety of amiodarone for the prevention of AF following esophagectomy surgery.

Thousands of patients undergo major esophagectomy surgery in the United States each year, during which all or a portion of the esophagus is removed. A major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (AF), which develops in up to 40% of patients undergoing these procedures. AF is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). The average time to occurrence of post-surgical AF is 2-3 days following surgery. AF occurring following esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. Further, the risk of death following esophagectomy is significantly higher in patients who develop AF compared with those who do not. Therefore, the occurrence of this irregular heartbeat following esophagectomy is associated with severe, potentially life-threatening consequences. Prevention of this irregular heartbeat in these patients may therefore be very important. Amiodarone is a medication that is known to be effective for prevention and treatment of AF that occurs in patients who have not undergone surgery. In addition, amiodarone has been shown to be effective for prevention of AF following open-chest heart surgery. However, the use of medications for prevention of AF following esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of AF in this population. In addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

Atrial Fibrillation Esophagectomy

Amiodarone Atrial fibrillation Surgical procedures, thoracic

null

2

arm 1: Intravenous amiodarone arm 2: Control

[ 0, 5 ]

2

[ 0, 10 ]

intervention 1: Intravenous amiodarone continuous infusion x 4 days intervention 2: No amiodarone

intervention 1: Amiodarone intervention 2: Control

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00420017

[ 4 ]

722

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

true

0ALL

false

This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.

null

Asthma

Glucocorticosteroids Dry Powder Inhaler Bronchodilator Metered-Dose Inhaler

null

2

arm 1: Mometasone furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily. arm 2: Fluticasone propionate/salmeterol (F/SC) 250/50 mcg BID

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks. intervention 2: Fluticasone propionate 250 mcg and salmeterol 50 mcg fixed dose combination dry powder inhaler taken twice daily for 52 weeks.

intervention 1: Mometasone furoate/formoterol (MF/F) MDI intervention 2: Fluticasone propionate/salmeterol (F/SC) DPI

0

null

0

NCT00424008

[ 3 ]

66

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This open-label, repeat dosing study, TRA108057, will evaluate the efficacy, safety and tolerability of eltrombopag, when administered in a repeat, cyclic dosing schedule. The study will describe the effect of repeated (3 cycles), intermittent dosing of eltrombopag on the pharmacodynamics and durability of eltrombopag response as measured by the peripheral platelet counts. For more information or to see if you qualify, please visit: http://www.itpstudy.com/gov

null

Purpura, Thrombocytopaenic, Idiopathic

idiopathic thrombocytopenic purpura ITP thrombocytopenia platelets

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: experimental

intervention 1: eltrombopag

3

0

NCT00424177

[ 4 ]

336

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

1FEMALE

false

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

null

Menopause Postmenopausal Vaginal Atrophy

null

1

arm 1: One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks

[ 0 ]

1

[ 0 ]

intervention 1: Tablets, administered intravaginally twice weekly

intervention 1: estradiol, 10 mcg

42

Brno | N/A | Czechia | 16.60796 | 49.19522 Brno | N/A | Czechia | 16.60796 | 49.19522 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Århus N | N/A | Denmark | N/A | N/A Glostrup Municipality | N/A | Denmark | 12.40377 | 55.6666 Herlev | N/A | Denmark | 12.43998 | 55.72366 Hillerød | N/A | Denmark | 12.30081 | 55.92791 Roskilde | N/A | Denmark | 12.08035 | 55.64152 Virum | N/A | Denmark | 12.45103 | 55.79488 Espoo | N/A | Finland | 24.6522 | 60.2052 Kuopio | N/A | Finland | 27.67703 | 62.89238 Oulu | N/A | Finland | 25.46816 | 65.01236 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Évry | N/A | France | 2.44049 | 48.6328 Nantes | N/A | France | -1.55336 | 47.21725 Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Pécs | N/A | Hungary | 18.23083 | 46.0725 Szeged | N/A | Hungary | 20.14824 | 46.253 Drammen | N/A | Norway | 10.20449 | 59.74389 Hamar | N/A | Norway | 11.06798 | 60.7945 Larvik | N/A | Norway | 10.03517 | 59.05328 Oslo | N/A | Norway | 10.74609 | 59.91273 Sandvika | N/A | Norway | 13.59125 | 64.46377 Ski | N/A | Norway | 10.83576 | 59.71949 Stavanger | N/A | Norway | 5.73332 | 58.97005 Stavanger | N/A | Norway | 5.73332 | 58.97005 Trondheim | N/A | Norway | 10.39506 | 63.43049 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Linköping | N/A | Sweden | 15.62157 | 58.41086 Malmo | N/A | Sweden | 13.00073 | 55.60587 Norrköping | N/A | Sweden | 16.1826 | 58.59419 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00431132

[ 5 ]

27

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme. Patients were randomized to either continue Pulmozyme or have therapy withdrawn for 2 weeks (placebo group). Patients must have had stable CF symptoms without any change in therapy for 2 weeks prior to enrollment in order to participate.

null

Cystic Fibrosis

Lung disease CF Pulmozyme

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 2.5 mg inhalation dose twice daily for 14±2 days intervention 2: 2.5 mg inhalation dose twice daily for 14±2 days

intervention 1: Dornase alfa intervention 2: placebo

40

0

NCT00434278

[ 3, 4 ]

282

RANDOMIZED

FACTORIAL

0TREATMENT

3TRIPLE

false

0ALL

true

Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.

Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema, enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury. Because beta-2 agonists have been shown to reduce permeability induced lung injury, it is anticipated that the severity of lung injury will be reduced by aerosolized beta-2 agonist therapy. The therapy may work by enhancing resolution of pulmonary edema by upregulating alveolar epithelial fluid transport mechanisms that will in turn enhance the clearance of alveolar edema. A reduction in the severity of lung injury and the quantity of alveolar edema should result in earlier extubation and more ventilator free days, improved pulmonary oxygen uptake, and improved lung compliance. Study design: phase II/III prospective, randomized double-blind, placebo controlled trial. * In Phase II, patients will be treated with aerosolized albuterol 5.0 mg vs. normal saline (n=40-50)administered every 4 hours for 10 days following randomization or until 24 hours following extubation, whichever occurs first. The protocol stipulates that the 5.0 mg dose will be reduced to 2.5 mg if patients exceed defined heart rate limits. * In Phase III, the 5.0 mg dose will be used unless there is evidence that this dose has an unacceptable safety profile or dose reductions for tachycardia occur in a large fraction of patients. In that case, a lower dose of 2.5 mg will be used. * Patients will be followed for 90 days or until discharge from the hospital to home with unassisted breathing whichever occurs first.

Respiratory Distress Syndrome, Adult

Acute Lung Injury Acute Respiratory Distress Syndrome Albuterol Aerosolized Critical Care Ventilator

null

2

arm 1: None arm 2: None

[ 1, 2 ]

3

[ 0, 3, 0 ]

intervention 1: Albuterol sulfate, USP, solution for inhalation will be diluted as follows: * The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution. * The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first. intervention 2: The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3 intervention 3: Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative. A high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle). The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.

intervention 1: Albuterol Sulfate intervention 2: Mini-Bronchoalveolar Lavage (BAL) intervention 3: Placebo

40

0

NCT00434993

[ 5 ]

265

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

null

0ALL

null

To evaluate the potential effects of artemether- lumefantrine on the auditory function

null

Malaria Falciparum

Malaria hearing co-artemether auditory Plasmodium falciparum marsh fever Plasmodium infections remittent fever paludism artemether artemisinins benflumetol lumefantrine

null

3

arm 1: Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight. arm 2: Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight. arm 3: Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.

[ 0, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Artesunate-mefloquine intervention 2: Atovaquone-proguanil intervention 3: Artemether-lumefantrine

1

Tumaco | N/A | Colombia | -78.79275 | 1.79112

0

NCT00444106

[ 4 ]

735

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

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.

Vasomotor Symptoms Hot Flashes

Vasomotor symptom relief Postmenopausal women Severe to Moderate Vasomotor symptoms

null

4

arm 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). arm 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). arm 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One tablet \[0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 2: One tablet \[0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)\] per day taken orally for 3 cycles (28 days per cycle). intervention 3: One tablet \[17β-estradiol (E2 0.3mg)\] per day taken orally for 3 cycles (28 days per cycle). intervention 4: Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

intervention 1: 0.5mg DRSP / 0.5mg E2 (BAY86-4891) intervention 2: 0.25mg DRSP / 0.5mg E2 (BAY86-4891) intervention 3: Estradiol (E2 0.3mg) intervention 4: Placebo

76

0

NCT00446199

[ 3 ]

18

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

null

Herpes Simplex

Infants, Herpes simplex infection

null

1

arm 1: Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.

[ 0 ]

1

[ 0 ]

intervention 1: Administered orally as a single individualized dose between 25-200 mg based on body weight.

intervention 1: famciclovir

6

0

NCT00448227

[ 3 ]

10

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

OBJECTIVES: Primary * Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors. Secondary * Determine the safety of this drug in these patients. * Determine the time to tumor response and duration of tumor response in patients treated with this drug. OUTLINE: This is a open-label study. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 28 days and then periodically thereafter.

Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor

recurrent ovarian germ cell tumor stage IV ovarian germ cell tumor ovarian choriocarcinoma ovarian immature teratoma ovarian mature teratoma recurrent malignant testicular germ cell tumor testicular choriocarcinoma testicular seminoma testicular yolk sac tumor ovarian dysgerminoma ovarian embryonal carcinoma ovarian yolk sac tumor ovarian monodermal and highly specialized teratoma ovarian polyembryoma stage III malignant testicular germ cell tumor ovarian mixed germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and seminoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular embryonal carcinoma and seminoma testicular embryonal carcinoma and teratoma with seminoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor with seminoma testicular embryonal carcinoma and yolk sac tumor testicular yolk sac tumor and teratoma with seminoma testicular yolk sac tumor and teratoma testicular embryonal carcinoma recurrent extragonadal non-seminomatous germ cell tumor recurrent extragonadal seminoma stage IV extragonadal non-seminomatous germ cell tumor stage IV extragonadal seminoma recurrent extragonadal germ cell tumor testicular immature teratoma testicular mature teratoma adult teratoma

null

1

arm 1: The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: sunitinib malate

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00453310

[ 0 ]

102

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of this study is to scientifically evaluate two different management strategies for perforated appendicitis. The hypothesis is that early discharge with oral antibiotic therapy may result in a dramatic decrease in medical care expenses for the patient. The primary outcome variable between the two strategies is abscess rate.

This will be a single institution, prospective, randomized clinical trial involving patients who present to the hospital with perforated appendicitis. This will be a definitive study. Power calculation was based on abscess rate in the previous prospective, randomized study we just finished. Our current rate is 18%, or just under one-fifth of the patients. A doubling of this rate to 36% would place just over one third of the patients at risk which would be unacceptable. Using a delta of 0.18 with alpha of 0.05 and power of 0.8, the sample size is 74 patients in each arm. Therefore we will anticipate enrolling 150. Subjects will be those children who undergo a laparoscopic appendectomy as part of their routine care. Perforation will be defined as an identifiable hole in the appendix or stool in the abdomen. The control group will receive current standard care: ceftriaxone 50mg/kg once a day (maximum dose = 2 grams) and metronidazole 30mg/kg once a day (maximum dose = 1 gram) with once a day dosing for both. The length of antibiotic therapy will be a minimum of 5 days. At that time, if they have been afebrile for at least 24 hours, a white blood cell (WBC) count will be obtained, and if that is within normal limits, the antibiotics will be discontinued and the patient will be discharged. If the WBC is elevated, they will receive another 2 days before recheck, if still elevated, they receive another 3 days and a CT Scan is obtained. If, after 5 days of therapy, the patient remains febrile, therapy will continue until afebrile before a WBC check is performed. This is all our current standard management. The experimental group will receive the same combination of antibiotics while in the hospital. When the patient is tolerating a regular diet, on oral pain medication and has been afebrile for over 12 hours, they will be discharged on oral antibiotics to complete a course of 7 days. The home antibiotic regimen will be ampicillin/clavulanic acid (Augmentin®). Augmentin® dose will be 40mg/kg twice a day. They will be asked to bring their pill containers with them to clinic where we will quantify medication compliance. Given the purpose of this study is the comparison of oral antibiotics to intravenous antibiotics, an allergy to one of the above medications will not be considered an exclusion criteria. In such cases the patient will be treated with an alternative that offers the same spectrum of coverage, but will be included in the study.

Perforated Appendicitis

appendicitis, perforation, abscess, treatment

null

2

arm 1: 5 days of IV antibiotics after appendectomy arm 2: home on oral antibiotics to complete 7 days of treatment when tolerating PO's

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 5 days of IV antibiotics (ceftriaxone and metronidazole once a day dosing) intervention 2: Augmentin 40mg/kg BID when tolerating POs to complete 7 days total

intervention 1: 5 days of IV antibiotics (ceftriaxone and metronidazole) intervention 2: Home with oral antibiotics when eating (ampicillin/clavulanic acid)

1

Kansas City | Missouri | United States | -94.57857 | 39.09973

0

NCT00462020

[ 3 ]

230

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome. The effects of rotigotine on pain, sleep, general activity, mood, and quality of life, and the use of rescue medication to treat pain will be assessed.

The overall post-Baseline duration of treatment was 13 weeks. The trial consisted of a 4-week Titration Phase, an 8-week Maintenance Phase, a 1-week De-escalation Phase, and a 2-week Safety Follow-Up Phase. If subjects met the eligibility criteria, they were randomized to receive rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo during the Maintenance Phase. During the 4-week Titration Phase, subjects assigned to rotigotine were titrated at weekly intervals of 2 mg/24 hrs until they reached 4 mg/24 hrs or 8 mg/24 hrs. All subjects who completed the 4-week Titration Phase entered an 8-week Maintenance Phase and were maintained at their randomized dose (rotigotine 4 mg/24 hrs, rotigotine 8 mg/24 hrs, or placebo). No dose adjustment was allowed during the Maintenance Phase. The Treatment Phase was defined as the combined Titration and Maintenance Phases.

Fibromyalgia Syndrome

Fibromyalgia Syndrome Rotigotine Neupro

null

3

arm 1: Placebo arm 2: 4 mg/24 hrs arm 3: 8 mg/24 hrs

[ 2, 0, 0 ]

3

[ 0, 0, 10 ]

intervention 1: Titration by Week 4 to two 20 cm2 patches (one placebo patch and one 4 mg/24 hrs patch) intervention 2: Titration by Week 4 to two 20 cm2 patches (both are 4 mg/24 hrs patches) intervention 3: Titration by Week 4 to two 20 cm2 placebo patches. At all weeks, placebo patches are matched in size and appearance to active patches.

intervention 1: Rotigotine intervention 2: Rotigotine intervention 3: Placebo

35

0

NCT00464737

[ 3 ]

147

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy. Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.

null

Partial Epilepsy Catamenial Epilepsy

Partial onset seizures Complex-partial seizures Anticonvulsant Partial seizures Catamenial epilepsy

null

2

arm 1: active study drug arm 2: placebo

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Oral suspension 200-500 mg 3x/day intervention 2: non-active placebo

intervention 1: Ganaxolone intervention 2: Placebo

27

0

NCT00465517

[ 3 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cetuximab together with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with celecoxib works in treating patients with metastatic colorectal cancer or colorectal cancer that cannot be removed by surgery.

OBJECTIVES: Primary * Determine the time to progression in patients with unresectable or metastatic colorectal cancer treated with cetuximab and celecoxib. Secondary * Determine the response rate, median survival, and 1-year survival rate of patients treated with this regimen. * Determine the toxicity profile of this regimen in these patients. * Determine the feasibility of testing urinary PGE-M in patients treated with this regimen. * Determine the feasibility of testing serum transforming growth factor-α and amphiregulin in patients treated with this regimen. * Determine the effects of this regimen on the EGFR pathway in tumor cells (i.e., phosphorylated EGFr, phosphorylated AKT, activated mitogen-activated protein kinase). * Determine the effects of this regimen on the cyclooxygenase-2 pathway in tumor cells by measuring PGE-2 levels. OUTLINE: Patients receive cetuximab IV over 1-2 hours once weekly and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Serum and urine samples are collected at baseline, after week 1, and every other course thereafter for evaluation of PGE-2 by mass spectrometry, cyclooxygenase-2 activity, and phospho-EGFR levels by western blot analysis and immunohistochemistry. Samples are also analyzed for TGF-α and amphiregulin proteomics. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Colorectal Cancer

recurrent colon cancer stage IV colon cancer recurrent rectal cancer stage IV rectal cancer

null

1

arm 1: None

[ 0 ]

6

[ 2, 0, 6, 10, 10, 10 ]

intervention 1: 400 mg/m2 iv week 1, then 250 mg/m2 weekly thereafter, starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol. intervention 2: 200 mg po BID starting on day 1 and continuing until progressive disease, excessive toxicity or removal from study for other reasons listed in the protocol. intervention 3: Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. We will use LC-MS-MS or MALDITOF mass spectrometry. intervention 4: phospho-EGFR levels using western blots of tissue extracts and immunohistochemistry on frozen and (if no other option available, paraffinembedded tissue sections). intervention 5: Serum samples obtained as above will be analyzed by proteomic analysis in order to determine biomarkers of treatment response and toxicity prediction. intervention 6: We will use LC-MS-MS or MALDITOF mass spectrometry. Before any tissues are received, the drug of interest is evaluated via MALDI mass spectrometry on a MDS/Sciex QStar QqTOF mass spectrometer.

intervention 1: cetuximab intervention 2: celecoxib intervention 3: proteomic profiling intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis intervention 6: mass spectrometry

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00466505

[ 5 ]

265

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

null

Alzheimer's Disease

memantine Alzheimer's Disease communication

null

2

arm 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks arm 2: Placebo oral administration twice daily for 12 weeks

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Memantine 20mg (10mg twice daily) oral administration for 12 weeks intervention 2: Placebo oral administration twice daily for 12 weeks

intervention 1: Memantine intervention 2: placebo

25

0

NCT00469456

[ 5 ]

228

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.

null

Attention Deficit Hyperactivity Disorder

null

1

arm 1: 0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.

intervention 1: Atomoxetine

8

Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222 Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Neihu Taipei | N/A | Taiwan | N/A | N/A Niao Sung Hsiang | N/A | Taiwan | N/A | N/A Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896

0

NCT00471354

[ 2, 3 ]

54

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

true

The purpose of this study is to determine the maximum tolerated dose and evaluate the safety, tolerability, and activity at the recommended dose (maximum tolerated dose \[MTD\]) of abiraterone acetate (also known as CB7630) in participants with hormone refractory prostate (gland that makes fluid that aids movement of sperm) cancer (HRPC).

This is an open-label (all people know the identity of the intervention) study to evaluate the safety, tolerability, and recommended dose of abiraterone acetate taken orally (by mouth), once daily in participants with HRPC. The study will consist of a dose escalation stage (Phase 1) that will be conducted to determine the MTD of abiraterone and an activity evaluation stage (Phase 2) to evaluate the activity of abiraterone in participants with HRPC. Escalated doses of abiraterone (starting at 250 milligram \[mg\] up to a maximum of 2000 mg) will be given for 28-day treatment periods to determine the MTD. Participants will be given MTD of abiraterone for up to 12 cycles (28 day each) in Phase 2 of the study. Participants' safety will be monitored throughout the study.

Prostatic Neoplasms

Abiraterone acetate CB7630 Prostatic neoplasms Hormone refractory prostate cancer Castration resistant prostate cancer Castration refractory prostate cancer

null

1

arm 1: Abiraterone acetate 250 mg up to a maximum of 2000 mg capsules will be given orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants will receive MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg will be given orally (If participants have disease progression) daily up to 12 cycles.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Abiraterone 250 mg (1 capsule) up to 2000 mg (8 capsules) once daily, each dose will be tested in sequential order for 28 days to determine the MTD. intervention 2: Abiraterone acetate MTD orally for 12 cycles (28 day each). intervention 3: Dexamethasone 0.5 mg orally will be given (If participants have disease progression) daily up to 12 cycles.

intervention 1: Abiraterone acetate intervention 2: Abiraterone acetate MTD intervention 3: Dexamethasone

1

Sutton | N/A | United Kingdom | -0.2 | 51.35

0

NCT00473512

[ 4 ]

79

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

null

Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients. Secondary : 1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients. 2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

null

Renal Transplant

null

0

null

1

[ 0 ]

intervention 1: (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

intervention 1: Sirolimus (Rapamune®)

9

Deagu | N/A | South Korea | N/A | N/A Deagu | N/A | South Korea | N/A | N/A Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Suwon | N/A | South Korea | 127.00889 | 37.29111

0

NCT00478608

[ 3 ]

397

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to assess if the study drug, Vardenafil (approved by Health Authorities is available on the market for treatment of erectile dysfunction) has an effect on bladder function and micturition frequency. The study drug is to be taken in the form of tablets twice a day, one tablet in the morning and one tablet in the evening. A non-active treatment (placebo), a sugar pill, will be used as a comparator to see if the new study drug works better than no drug. The timing of visits for the study is as follows: the 1st visit (screening visit) at beginning of run-in-assessment with qualifying tests for patients: electrocardiogram (ECG), safety laboratory and residual urine (by ultrasonography: a non-invasive examination using ultrasound for the assessment of the bladder). 2nd visit (randomization visit). During visit this should be performed: urodynamic measurements (filling cystometry and pressure flow investigations), ECG and safety laboratory. 3rd visit (safety visit) takes place at two up to three weeks of randomized treatment. 4th visit (final visit)-following test should be done: urodynamic measurements (filling cystometry and pressure flow investigations), ECG, safety laboratory and residual urine (by ultrasonography); A phone call 24 hours after visit 4 to assess any SAEs.

null

Overactive Bladder Detrusor Overactivity

null

2

arm 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks arm 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks intervention 2: vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks

intervention 1: Vardenafil HCl (Levitra, BAY38-9456) intervention 2: Placebo

55

0

NCT00478881

[ 4 ]

539

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The objectives of this trial conducted in early Parkinson's Disease (PD) patients are to determine the efficacy (as measured by the change from baseline to the end of the maintenance phase in the total score for the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III combined), safety, and tolerability of Pramipexole Extended Release (ER) (in daily doses from 0.375mg to 4.5mg q.d.) in comparison to placebo, and to test for non-inferiority between the two formulations (ER and IR) of pramipexole. In addition, the efficacy of Pramipexole Immediate Release (IR) will be compared to placebo, for assay sensitivity

null

Early Parkinson Disease (Early PD)

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None

intervention 1: Pramipexol Extended Release intervention 2: Pramipexol Immediate Release intervention 3: Placebo

95

Gilbert | Arizona | United States | -111.78903 | 33.35283 Sun City | Arizona | United States | -112.27182 | 33.59754 La Jolla | California | United States | -117.2742 | 32.84727 Oxnard | California | United States | -119.17705 | 34.1975 Danbury | Connecticut | United States | -73.45401 | 41.39482 Boca Raton | Florida | United States | -80.0831 | 26.35869 Augusta | Georgia | United States | -81.97484 | 33.47097 Chicago | Illinois | United States | -87.65005 | 41.85003 Kansas City | Kansas | United States | -94.62746 | 39.11417 Elkridge | Maryland | United States | -76.71358 | 39.21261 Southfield | Michigan | United States | -83.22187 | 42.47337 Hattiesburg | Mississippi | United States | -89.29034 | 31.32712 Commack | New York | United States | -73.29289 | 40.84288 Dallas | Texas | United States | -96.80667 | 32.78306 Midvale | Utah | United States | -111.89994 | 40.61106 Burlington | Vermont | United States | -73.21207 | 44.47588 Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Santa Fe | N/A | Argentina | -60.70868 | -31.64881 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Vienna | N/A | Austria | 16.37208 | 48.20849 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284 Hyvinkää | N/A | Finland | 24.86667 | 60.63333 Oulu | N/A | Finland | 25.46816 | 65.01236 Tampere | N/A | Finland | 23.78712 | 61.49911 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bochum | N/A | Germany | 7.21648 | 51.48165 Bremerhaven | N/A | Germany | 8.57553 | 53.55357 Dresden | N/A | Germany | 13.73832 | 51.05089 Göttingen | N/A | Germany | 9.93228 | 51.53443 Kassel | N/A | Germany | 9.5 | 51.31667 Leipzig | N/A | Germany | 12.37129 | 51.33962 Marburg | N/A | Germany | 8.77069 | 50.80904 Eger | N/A | Hungary | 20.37329 | 47.90265 Győr | N/A | Hungary | 17.63512 | 47.68333 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Sopron | N/A | Hungary | 16.59049 | 47.68501 Szeged | N/A | Hungary | 20.14824 | 46.253 Szeged | N/A | Hungary | 20.14824 | 46.253 Szombathely | N/A | Hungary | 16.62155 | 47.23088 Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84 Chennai | N/A | India | 80.27847 | 13.08784 Hyderabad | N/A | India | 78.45636 | 17.38405 Hyderabad | N/A | India | 78.45636 | 17.38405 Karnataka | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A Maharashtra | N/A | India | N/A | N/A New Delhi | N/A | India | 77.2148 | 28.62137 New Delhi | N/A | India | 77.2148 | 28.62137 Pune | N/A | India | 73.85535 | 18.51957 Aomori, Aomori | N/A | Japan | N/A | N/A Bunkyo-ku, Tokyo | N/A | Japan | N/A | N/A Fuchu, Tokyo | N/A | Japan | N/A | N/A Fujisawa, Kanagawa | N/A | Japan | N/A | N/A Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Iwamizawa,Hokkaido | N/A | Japan | 141.75972 | 43.20028 Kodaira, Tokyo | N/A | Japan | N/A | N/A Kyoto, Kyoto | N/A | Japan | N/A | N/A Morioka, Iwate | N/A | Japan | N/A | N/A Okayama, Okayama | N/A | Japan | N/A | N/A Ota-ku, Tokyo | N/A | Japan | N/A | N/A Sagamihara, Kanagawa | N/A | Japan | N/A | N/A Shimogyo-ku, Kyoto, Kyoto | N/A | Japan | N/A | N/A Shiroishi, Miyagi | N/A | Japan | N/A | N/A Takamatsu, Kagawa | N/A | Japan | N/A | N/A Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Terengganu | N/A | Malaysia | 103.1408 | 5.3302 Pulau Pinang | N/A | Malaysia | 102.56667 | 3.55 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 Dubnica nad Váhom | N/A | Slovakia | 18.16634 | 48.95981 Trnava | N/A | Slovakia | 17.58723 | 48.37741 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242 Vinnytzya | N/A | Ukraine | N/A | N/A Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167 Zaporizhzhya | N/A | Ukraine | 35.11714 | 47.85167

0

NCT00479401

[ 4 ]

310

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The objective of the study is to assess the continued safety of the daily coadministration of ABT-335 in combination with rosuvastatin calcium, simvastatin or atorvastatin calcium.

null

Mixed Dyslipidemia

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Oral coadministration of ABT-335 (135 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 2: Oral coadministration of rosuvastatin calcium (20 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 3: Oral coadministration of simvastatin (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study intervention 4: Oral coadministration of atorvastatin calcium (40 mg) once daily, beginning in either the 12-week double-blind study or the previous 52-week open-label year 1 study and continuing in 52-week year 2 study

intervention 1: ABT-335 intervention 2: rosuvastatin calcium intervention 3: simvastatin intervention 4: atorvastatin calcium

1

Abbott Park | Illinois | United States | N/A | N/A

0

NCT00491530

[ 2 ]

75

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.

A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Pain Fever

null

2

arm 1: Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject arm 2: Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h)

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age) Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen intervention 2: This study will investigate two doses (12.5 milligrams/kilogram (mg/kg) and 15 milligrams/kilogram) based on weight administered every four hours (q4h), every six hours (q6h), or every eight hours (q8h) (depending on age) Neonates: 12.5 mg/kg q6h IV acetaminophen Neonates: 15 mg/kg q8h IV acetaminophen Infants: 12.5 mg/kg q4h IV acetaminophen Infants: 15 mg/kg q6h IV acetaminophen Children: 12.5 mg/kg q4h IV acetaminophen Children: 15 mg/kg q6h IV acetaminophen Adolescents: 12.5 mg/kg q4h IV acetaminophen Adolescents: 15 mg/kg q6h IV acetaminophen

intervention 1: IV Acetaminophen intervention 2: IV Acetaminophen

5

0

NCT00493246

[ 3 ]

185

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.

Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.

Pneumonia Bacterial Pneumonia Ventilator-Associated Pneumonia Infections, Nosocomial

Pneumonia Lung Infection Bacterial Infection Hospital-Acquired Infection Ventilator Infection Antibiotic Therapy

null

1

arm 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

[ 0 ]

1

[ 0 ]

intervention 1: 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

intervention 1: doripenem

40

0

NCT00502801

[ 3 ]

200

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Primary Objectives: 1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose adjusted to yield a blood drug level with a median daily area under the plasma concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given intravenously over three hours once daily for four (4) days, in combination with Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndromes. 2. To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS) patients undergoing treatment with this regimen. Data regarding engraftment, toxicity, relapse rate, long-term (disease-free) outcome, and overall survival will be collected. 3. To determine the safety profile of this regimen when utilized as preparation for allogeneic transplantation. 4. To describe the plasma pharmacokinetics of busulfan when administered intravenously in this regimen.

Patients who agree to the optional pharmacology procedures #1 will initially receive a therapeutic test dose of busulfan to test the blood levels over time; this information will be used to determine the subsequent high-dose busulfan doses. Patients who do not agree to the optional pharmacology procedure will receive a fixed dose of busulfan as has previously been done for 3 years. Patients in this study will then receive fludarabine through a central venous catheter over one hour, once a day, for four days. High-dose Busulfan will be injected through the catheter over three hours, once a day, for four days, starting immediately after fludarabine. After two days of rest, the allogeneic bone marrow, peripheral blood stem cells or cord blood will then be given intravenously. Patients will receive the drug Granulocyte colony-stimulating factor (G-CSF - Neupogen) as an injection under the skin until their blood counts recover. Patients will remain in the hospital for about 4-6 weeks. After discharge, patients will continue as outpatients in the hospital area until they are able to safely leave the immediate hospital area or for a minimum of 100 days after the transplant. Some patients may need to receive spinal taps with instillation of cytosine arabinoside and hydrocortisone several times over the year after transplantation. This is only for patients with a previous clinical history of leukemic involvement of the brain. This is an investigational study. The FDA has approved the study drugs. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.

Leukemia

Acute Myeloid Leukemia Myelodysplastic Syndromes Busulfan Busulfex Myleran Fludarabine Fludarabine Phosphate Fludara

null

1

arm 1: Once a day for four days, Busulfan 130 mg/m\^2 through intravenous catheter over 3 hours immediately after Fludarabine 40 mg/m\^2 over 1 hour.

[ 0 ]

2

[ 0, 0 ]

intervention 1: 130 mg/m\^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine. intervention 2: 40 mg/m\^2 through a central venous catheter over one hour, once a day, for four days.

intervention 1: Busulfan intervention 2: Fludarabine

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00502905

[ 3 ]

146

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.

This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), multicenter study that will evaluate the safety and tolerability of doripenem (an antibiotic used to treat infections) in patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Approximately 250 patients will be assigned in a 3:1 ratio to receive doripenem or imipenem/cilastatin (188 patients randomized to receive doripenem and 62 patients randomized to receive imipenem/cilastatin). Furthermore, patients who receive doripenem or imipenem/cilastatin will be stratified by disease (VAP or cIAI). Therefore, for reporting purposes, there will be 4 groups: Patients with VAP treated with doripenem, patients with VAP treated with imipenem/cilastatin, patients with cIAI treated with doripenem, and patients with cIAI treated with imipenem/cilastatin. Study drug will be administered intravenously (iv) (through a vein) for 7 to 14 days for patients with VAP and for 5 to 14 days for patients with cIAI. The maximum duration of study drug is 14 days. Vancomycin and/or amikacin may be added to the study drug regimen as adjunctive therapy for those patients who meet study specified criteria. The recommended dosage of vancomycin is 1 g every 12 hours administered by iv infusion. The addition of amikacin is at the discretion of the investigator for patients with VAP (not cIAI) and the recommended dosing regimen for amikacin is 15 mg/kg given iv once a day. Alternative amikacin regimens or other aminoglycoside regimens may be permitted. Safety will be assessed during the study by the monitoring of adverse events, evaluation of laboratory test results, and changes in vital signs. The primary endpoint of this study is to assess the overall incidence of treatment-emergent adverse events (TEAEs) from the initiation of the first infusion of study drug and up to 30 days after the completion of study drug therapy. Treatment-emergent adverse events are defined as adverse events that occur or worsen between the initial infusion of study drug up to 30 days after the last dose of study drug. The hypothesis for this study is that doripenem has a similar safety profile to imipenem. Doripenem (1g at 8-hour intervals over a period of 4 hours) or imipenem/cilastatin (1g at 8-hours over a period of 1 hour) will be administered by intravenous (iv) infusion (delivery of drug slowly into the vein over a period of time). Patients diagnosed with ventilator associated pneumonia (VAP) will be treated for 7 to 14 days and patients with complicated intra-abdominal infections (cIAI) will be treated for 5 to 14 days.

Pneumonia, Ventilator-Associated Pneumonia, Bacterial Pneumonia Abdominal Abscess Bacterial Infections

Doripenem Imipenem Cilastatin Vancomycin DORIBAX, DORIPREX, FINIBAX, DURAPTA, PRIMAXIN, Anti Bacterial Agents Ileus Hospitalized Fever

null

4

arm 1: Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion arm 2: Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion arm 3: Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion arm 4: Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion

[ 0, 1, 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion intervention 2: Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion intervention 3: 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days intervention 4: 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days

intervention 1: Imipenem/cilastatin intervention 2: Imipenem/cilastatin intervention 3: Doripenem intervention 4: Doripenem

0

null

0

NCT00515034

[ 3 ]

53

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

Raltegravir (MK-0518) is an HIV-1 integrase inhibitor with potent in vitro activity against HIV-1 strains including those resistant to currently available antiretroviral drugs. The purpose of this study is to assess the effectiveness of raltegravir in further reducing viral load in HIV infected patients that have already achieved viral suppression below the level of detection of standard viral load assays when added to antiretroviral therapy (ART).

Although ART has reduced the morbidity and mortality from HIV-1 infection, most individuals who stop ART experience rapid viral rebound. Effective ART can suppress viral load to less than 50 copies/ml; however, current treatment regimens cannot completely eliminate the infection. The primary purpose of this study was to assess the ability of the HIV-1 integrase inhibitor, raltegravir, to reduce viral load when added to ART regimens of HIV-1 infected patients who have achieved viral suppression to less than 50 copies/ml. The study lasted 24 weeks. Participants were randomly assigned to one of two arms. Participants in Arm A were administered raltegravir in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects halted raltegravir use and received a placebo until Week 24. Participants in Arm B were administered the placebo in addition to their usual ART regimen from study entry until Week 12. At Week 12, subjects halted the placebo and received raltegravir until Week 24. A real-time polymerase chain reaction (PCR) single copy assay (SCA) capable of detecting 1 copy of HIV RNA was used to assay viral load. The cross-over design allowed assessment of the effect of intensification with raltegravir between the two arms at Weeks 10/12 and every participant enrolled in the study receiving raltegravir for 12 weeks. Primary analysis focused on weeks 10/12 measurement and with no washout period, typical analysis of cross-over design was not intended. All participants had scheduled visits at Weeks 0, 2, 4, 10, 12, 14, 16, 22, and 24. A targeted physical exam occurred at all visits. Blood and urine collection occurred at selected visits. A medical/medication assessment occurred at trial entry. Drug dispensing and an adherence questionnaire occurred at some visits. A pregnancy test occurred at select visits. Participants' background ART medications were not provided by the study.

HIV Infections

Treatment Experienced

null

2

arm 1: 400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks arm 2: Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 400 mg tablet taken orally twice daily intervention 2: 400 mg placebo tablet taken orally twice daily

intervention 1: Raltegravir (MK-0518) intervention 2: Placebo

20

0

NCT00515827

[ 5 ]

201

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.

Currently, treatment of acute symptoms in schizophrenia is less than ideal, up to one-third of patients with schizophrenia do not respond to current treatments, and poor drug tolerability can decrease a patient's ability to remain on treatment. Paliperidone ER doses in the range of 3 mg/day to 12 mg/day have been approved for the treatment of patients with schizophrenia. A lower dosage form of paliperidone ER be efficacious and may reduce the risk of certain adverse effects. This study will evaluate the efficacy of 1 fixed (ie, it does not change during the study) dosage of paliperidone ER (1.5 mg/day) compared with placebo. One fixed dosage of paliperidone ER (6.0 mg/day) will be given to some patients as an active (it has already been shown to have efficacy) control. This is a multicenter, double-blind (neither the patient nor the study-site personnel know which treatment the patient is receiving), randomized (patients are assigned to a treatment group by chance), placebo-controlled (some patients will receive placebo and no active drug), parallel-group (patients in all groups follow the same study design) study in adults who were diagnosed with schizophrenia at least 1 year before screening and who are experiencing an acute episode. The study starts with an up-to-5-day screening phase to find out if the patient is eligible for the study. The screening phase includes a 3- to 5-day washout (the medication dosage is tapered down and finally stopped) of any medications that are being taken by a patient but that are not allowed during the study. A 6-week double-blind treatment phase follows and finishes with an end-of-study visit. A post-study visit to collect additional safety data will be scheduled for 1 week after a patient receives his or her last dose of study drug. The length of the entire study is about 8 weeks. Patients who withdraw from the study before completing the double-blind treatment phase will complete the end-of-study visit procedures at the time they withdraw and the post-study visit 1 week after receiving their last dose of study drug. For all patients leaving the study, the investigator will make every effort to see that they receive adequate continuity of care. At baseline (the visit just before a patient takes the first dose of study drug), all patients will be randomly assigned to 1 of the 3 possible treatment groups to receive paliperidone ER 1.5 mg/day, paliperidone ER 6 mg/day, or placebo once daily for 6 weeks. Patients must be voluntary inpatients at the time of randomization, and they must remain in the hospital for a minimum of 8 days. Efficacy will be measured using the following rating scales: the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression-Severity (CGI-S), the Personal and Social Performance Scale (PSP), and the Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36). Safety will be evaluated using physical examinations, ECGs, clinical laboratory testing (hematology, serum chemistry, and urinalysis), testings for pregnancy, and monitoring for adverse events including extrapyramidal symptoms (EPS) using the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Rating Scale (SAS). The study hypothesis is that Paliperidone ER at 1.5 mg per day will be effective in the treatment of schizophrenia as measured by the change in total PANSS score between baseline and endpoint in comparison with placebo. Oral paliperidone ER 1.5 mg or 6.0 mg tablets or matching oral placebo tablets taken once daily in the morning for 6 weeks.

Schizophrenia

null

3

arm 1: Paliperidone ER 1.5 mg tablet once daily for 6 weeks arm 2: Paliperidone ER 6 mg tablet once daily for 6 weeks arm 3: Placebo Once daily for 6 weeks

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 1.5 mg tablet once daily for 6 weeks intervention 2: Once daily for 6 weeks intervention 3: 6 mg tablet once daily for 6 weeks

intervention 1: Paliperidone ER intervention 2: Placebo intervention 3: Paliperidone ER

20

0

NCT00524043

[ 4 ]

12

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

People with sickle cell disease (SCD) may develop acute chest syndrome (ACS), which is a common and serious lung condition that usually requires hospitalization. Dexamethasone is a medication that may decrease hospitalization time for people with ACS, but it may also bring about new sickle cell pain. This study will evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS.

SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." ACS is a life-threatening, lung-related complication of SCD that can lower the level of oxygen in the blood. Repeat occurrences of ACS can cause lung damage. It is the second most common cause of hospitalizations among people with SCD and accounts for more than 25% of premature deaths in people with SCD. Symptoms of ACS include fever, chest pain, cough, and breathing difficulties. ACS can appear suddenly and often requires immediate hospitalization and treatment, including antibiotics, supplemental oxygen, and blood transfusions. Previous studies have shown that dexamethasone, a type of steroid medication that blocks inflammation, can decrease hospitalization time for people with ACS; however, some participants in these earlier studies were re-hospitalized due to new sickle cell pain. Slowly decreasing the dosage of dexamethasone over a period of time may decrease the chance that new sickle cell pain will occur. The purpose of this study is to evaluate the effectiveness of a dexamethasone regimen that includes a gradual dose reduction at decreasing hospitalization and recovery time in people with SCD and ACS. This study will enroll people with SCD who are hospitalized and have been diagnosed with ACS within the past 24 hours. Participants will be randomly assigned to receive either dexamethasone or placebo on a daily basis for 8 days. Every 2 days the medication dose will be gradually reduced. While in the hospital, participants will receive usual care for ACS, including antibiotics, pain control medication, intravenous fluids, and other needed treatments. Each day, participants will undergo a physical exam, a pain assessment score, a test to measure the oxygen level in the body, blood collection, and, if needed, a chest x-ray. Vital signs and blood pressure measurements will be taken every 4 hours. Study staff will document the amount of pain medication, blood transfusions, oxygen, and breathing treatments participants receive. Upon leaving the hospital, follow-up visits will occur 1 week after participants were originally admitted to the hospital (participants who are still hospitalized at this time will not attend this visit) and 1 month after hospital discharge. At both visits, information on hospital visits for pain treatment and blood transfusions will be collected, and evaluations performed earlier in the study will be repeated. The second visit will also include lung function tests.

Anemia, Sickle Cell

Sickle Cell Disease ACS Acute Chest Syndrome Hgb SS Hgb Sβ0 Dexamethasone

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Individuals meeting entry criteria will be randomized to receive dexamethasone 0.3 mg/kg (12 mg maximum single dose). The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days. intervention 2: Individuals meeting entry criteria will be randomized to receive 0.3 mg/kg (12 mg maximum single dose) of placebo. The study drug will be given by mouth every 12 hours until discharge from the hospital or for a maximum of 4 doses (2 days), whichever occurs first. Thereafter, study drug will be tapered over 6 days for a total duration of therapy not to exceed 8 days.

intervention 1: Dexamethasone intervention 2: Placebo

6

0

NCT00530270

[ 3 ]

35

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study is intended for participants with advanced, not amenable to surgery, or metastatic lung cancer who have not received any prior chemotherapy. The study will be conducted in 2 parts: * Part 1 is intended to evaluate safety of pemetrexed + cisplatin + enzastaurin combination chemotherapy * Part 2 whose main objective is to compare the efficacy of pemetrexed + cisplatin + enzastaurin versus pemetrexed + cisplatin + placebo. Participants to be included in Part 2 are those with Nonsquamous Non-Small Cell Lung Cancer (NSCLC).

null

Lung Cancer

null

2

arm 1: None arm 2: None

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral (po), daily (QD), until disease progression intervention 2: 500 milligrams/square meter (mg/m²), intravenously (IV), every 21 days, for each 21-day cycle intervention 3: 75 mg/m², IV, every 21 days, for each 21-day cycle intervention 4: po, QD

intervention 1: enzastaurin intervention 2: pemetrexed intervention 3: cisplatin intervention 4: placebo

12

Leuven | N/A | Belgium | 4.70093 | 50.87959 Gauting | N/A | Germany | 11.37703 | 48.06919 GroBhansdorf | N/A | Germany | N/A | N/A Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Bergamo | N/A | Italy | 9.66721 | 45.69601 Catania | N/A | Italy | 15.07041 | 37.49223 Padua | N/A | Italy | 11.88586 | 45.40797 Trento | N/A | Italy | 11.12108 | 46.06787 Otwock | N/A | Poland | 21.26129 | 52.10577 Poznan | N/A | Poland | 16.92993 | 52.40692 Bucharest | N/A | Romania | 26.10626 | 44.43225

0

NCT00538681

[ 4 ]

535

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The primary objective of this Phase III clinical study is to demonstrate the efficacy of the fixed combination of pyronaridine artesunate (PA) granule formulation (60:20 mg; pediatric PYRAMAX®) by showing a PCR-corrected adequate clinical and parasitological cure rate (ACPR) of more than 90%. Secondary objectives of this clinical study are to compare the efficacy (non-inferiority) and safety of the PA granule formulation compared to Coartem® (ie, the combination of artemether/lumefantrine \[AL\]) crushed tablets in a paediatric population and to assess the safety of the PA granule formulation.

This is a multi-centre, comparative, randomised, open-label, parallel-group study of the efficacy and safety of a 3-day regimen of a fixed combination of PA (3:1) versus AL in the treatment of acute uncomplicated Plasmodium falciparum mono-infection. The study population will include 534 patients, comprising male and female infants and children (body weight ≥5 and \<25 kg) recruited from study sites in East, Central, and West Africa and South East Asia (max. 150 patients/site). Patients will be randomised in a 2:1 ratio to receive either oral PA (60:20 mg granules) once a day for 3 consecutive days (Days 0, 1, and 2) or AL (20:120 mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2). The study drug will be administered by a Third Party Investigator unblinded to the study treatment, while the Investigator will remain blinded. For PA, the dose range covered by this regimen is 7.0:2.3 mg to 13.3:4.4 mg, 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 ≥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 earlier. The primary efficacy end point for this study is the proportion of subjects with PCR-corrected 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

Falciparum malaria pediatric Coartem artesunate lumefantrine pyronaridine Pyramax

null

2

arm 1: Oral pyronaridine/artesunate (PA, 60:20mg granules) once a day for 3 consecutive days (Days 0, 1, and 2). Posology based on body weight ranges. arm 2: Oral artemether/lumefantrine (AL, 20:120mg crushed tablets) twice a day for 3 consecutive days (Days 0, 1, and 2). Posology based on body weight ranges.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The strength of the granule formulation is 60:20 mg pyronaridine artesunate per sachet. Depending on their body weight, patients will receive between 1 to 3 pyronaridine artesunate sachets per day, for 3 consecutive days The actual dose-range covered by this regimen is 7.0:2.3 mg/kg to 13.3:4.4 mg/kg pyronaridine artesunate, which has shown to be effective and safe in the phase II studies conducted in children and adults. intervention 2: The strength of the tablet is 20 mg artemether and 120 mg lumefantrine. Depending on their body weight, patients will receive either 1 or 2 crushed tablets twice a day (≥5 to \<15 = 1 tablet, 15 to \<25 kg = 2 tablets), for 3 consecutive days.

intervention 1: pyronaridine artesunate intervention 2: arthemeter lumefantrine

8

Ouagadougou | N/A | Burkina Faso | -1.53388 | 12.36566 Abidjan | N/A | Côte d’Ivoire | -4.00167 | 5.35444 Kinshasa | N/A | Democratic Republic of the Congo | 15.31357 | -4.32758 Lambaréné | N/A | Gabon | 10.24055 | -0.7001 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

0

NCT00541385

[ 3 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study will test the safety and efficacy of nitric oxide gas in the treatment of venous leg ulcers

Prospective, single center. Controlled study of a moisture retentive wound dressing and sustained compression with 6 weeks of 8 hour daily nitric oxide treatments.

Venous Ulcers

Nitric Oxide Venous Leg Ulcers

null

3

arm 1: Standard of care - dressings and sustained compression only arm 2: 200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound arm 3: 200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound

[ 4, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound intervention 2: 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound

intervention 1: Nitric Oxide - same dose 6 wks intervention 2: Nitric Oxide modified treatment

1

Richmond | Virginia | United States | -77.46026 | 37.55376

0

NCT00545298

[ 5 ]

781

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

null

Post-Menopausal Osteoporosis

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day). intervention 2: 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva]

39

Gainesville | Georgia | United States | -83.82407 | 34.29788 St Louis | Missouri | United States | -90.19789 | 38.62727 Omaha | Nebraska | United States | -95.94043 | 41.25626 Bismarck | North Dakota | United States | -100.78374 | 46.80833 Fargo | North Dakota | United States | -96.7898 | 46.87719 Madison | Wisconsin | United States | -89.40123 | 43.07305 St Leonards | N/A | Australia | 151.19836 | -33.82344 Sydney | N/A | Australia | 151.20732 | -33.86785 Brussels | N/A | Belgium | 4.34878 | 50.85045 Liège | N/A | Belgium | 5.56749 | 50.63373 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Prague | N/A | Czechia | 14.42076 | 50.08804 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Ballerup Municipality | N/A | Denmark | 12.36328 | 55.73165 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Vejle | N/A | Denmark | 9.5357 | 55.70927 Lyon | N/A | France | 4.84671 | 45.74846 Orléans | N/A | France | 1.90389 | 47.90289 Berlin | N/A | Germany | 13.41053 | 52.52437 Essen | N/A | Germany | 7.01228 | 51.45657 Hamburg | N/A | Germany | 9.99302 | 53.55073 Budapest | N/A | Hungary | 19.04045 | 47.49835 Arenzano | N/A | Italy | 8.68315 | 44.40521 Siena | N/A | Italy | 11.33064 | 43.31822 Valeggio sul Mincio | N/A | Italy | 10.73635 | 45.35333 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Monterrey | N/A | Mexico | -100.31721 | 25.68435 Haugesund | N/A | Norway | 5.268 | 59.41378 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Grudziądz | N/A | Poland | 18.75366 | 53.48411 Krakow | N/A | Poland | 19.93658 | 50.06143 Krakow | N/A | Poland | 19.93658 | 50.06143 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Sommerset West | N/A | South Africa | N/A | N/A Madrid | N/A | Spain | -3.70256 | 40.4165 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369

0

NCT00551174

[ 3 ]

260

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin, ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic Resonance Spectroscopy

The goal within the current development program and this study is to investigate whether lower doses of AEGR-733 can result in significant reductions in LDL-C and TGs while providing fewer gastrointestinal adverse events and less hepatic fat accumulation than seen in studies with higher doses. The potential for atorvastatin, ezetimibe or the PPAR-alpha agonist (fenofibrate) to ameliorate any hepatic fat accumulation will also be investigated. The twelve week dosing schedule allows us to demonstrate the longer term effects of lower doses of MTP-I on hepatic fat accumulation.

Hyperlipidemia

LDL hepatic fat

null

8

arm 1: Placebo arm 2: 2.5 mg AEGR-733 arm 3: 5 mg AEGR-733 arm 4: 7.5 mg AEGR-733 arm 5: 10 mg AEGR-733 arm 6: 5 mg AEGR-733 + 20 mg atorvastatin arm 7: 5 mg AEGR-733 + 145 mg fenofibrate arm 8: 5 mg AEGR-733 + 10 mg ezetimibe

[ 2, 1, 1, 1, 1, 1, 1, 1 ]

8

[ 0, 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: 3 capsules each evening for each 4-week period intervention 2: 3 capsules each evening for each 4-week period intervention 3: 3 capsules each evening for each 4-week period intervention 4: 3 capsules each evening for each 4-week period intervention 5: 3 capsules each evening for each 4-week period intervention 6: 3 capsules each evening for each 4-week period intervention 7: 3 capsules each evening for each 4-week period intervention 8: 3 capsules each evening for each 4-week period

intervention 1: AEGR-733 intervention 2: placebo intervention 3: AEGR-733 intervention 4: AEGR-733 intervention 5: AEGR-733 intervention 6: AEGR-733 and atorvastatin intervention 7: AEGR-733 and fenofibrate intervention 8: AEGR-733 and ezetimibe

15

0

NCT00559962

[ 5 ]

208

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study evaluated the safety and efficacy of 10 cm\^2 rivastigmine patch in patients with Alzheimer Disease (MMSE 10-26). The primary objective was the percentage of patients who stayed on the target size of 10 cm\^2 for at least 8 weeks. This proportion was then compared to historical data of the percentage of patients who could reach a rivastigmine capsule target dose of 12 mg and stay on it at least 8 weeks.

null

Alzheimer's Disease

Alzheimer's Disease Rivastigmine Patch

null

1

arm 1: For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm\^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm\^2 patch, with adjustments as necessary for safety and tolerability.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Rivastigmine 5 and 10 cm^2 patch

1

Munich | N/A | Germany | 11.57549 | 48.13743

0

NCT00561392

[ 4 ]

153

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to provide information regarding the relative effectiveness of three different atomoxetine doses in the treatment of Korean children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)

null

Attention Deficit Hyperactivity Disorder

null

3

arm 1: None arm 2: None arm 3: None

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention 2: Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period intervention 3: Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days

intervention 1: Atomoxetine Hydrochloride intervention 2: Atomoxetine hydrochloride intervention 3: Atomoxetine hydrochloride

3

Bucheon-si | N/A | South Korea | 126.78306 | 37.49889 Incheon | N/A | South Korea | 126.70515 | 37.45646 Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00568685

[ 2, 3 ]

72

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

null

Methamphetamine Dependence, Treatment Seeking

methamphetamine, crystal, treatment

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 2 gr/day (333 mg, TID) intervention 2: matching placebo

intervention 1: Acamprosate intervention 2: placebo

1

New York | New York | United States | -74.00597 | 40.71427

0

NCT00571922

[ 4 ]

181

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

null

Type 2 Diabetes

diabetes exenatide LY2148568 Byetta Lilly Amylin

null

3

arm 1: None arm 2: None arm 3: None

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: subcutaneous injection, 5mcg, twice a day intervention 2: subcutaneous injection, 10mcg, twice a day intervention 3: subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

intervention 1: exenatide intervention 2: exenatide intervention 3: placebo

12

Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukushima | N/A | Japan | 140.46667 | 37.75 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Ibaraki | N/A | Japan | 135.56828 | 34.81641 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Kyoto | N/A | Japan | 135.75385 | 35.02107 Nagano | N/A | Japan | 138.18333 | 36.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Ōita | N/A | Japan | 131.6 | 33.23333 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00577824

[ 4 ]

2,388

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

null

Seasonal Allergic Rhinitis

allergic rhinitis allergies seasonal allergies

null

4

arm 1: Olopatadine HCl 0.6% 1 spray per nostril twice daily arm 2: Vehicle 1 spray per nostril twice daily arm 3: Olopatadine HCl 0.6% 2 sprays per nostril twice daily arm 4: Vehicle 2 sprays per nostril twice daily

[ 0, 2, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Olopatadine HCl 1 or 2 sprays per nostril twice daily intervention 2: Vehicle 1 or 2 sprays per nostril twice daily

intervention 1: Olopatadine Hydrochloride Nasal Spray 0.6% intervention 2: Vehicle

1

Kenilworth | Illinois | United States | -87.71756 | 42.08586

0

NCT00578929

[ 0 ]

15

RANDOMIZED

SINGLE_GROUP

0TREATMENT

1SINGLE

true

0ALL

false

Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups. Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

• All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

Burn

null

2

arm 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change arm 2: receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change intervention 2: .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

intervention 1: Instilled 1% Lidocaine intervention 2: Placebo (0.9% Normal Saline)

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00585325

[ 5 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

To find out if a single dose of Parcopa®, a form of levodopa that dissolves in your mouth, works faster than regular oral levodopa which is swallowed, in fluctuating PD patients.

This is a study to compare orally dissolving levodopa (Parcopa) to the conventional immediate release oral levodopa. This is a single-dose, double-blind, placebo controlled crossover trial in participants with Parkinson disease.

Parkinson's Disease

Parkinson's disease time to "on" delayed on

null

2

arm 1: Parcopa at equivalent dosage to subjects current stable dose arm 2: Carbidopa-levodopa (Sinemet)at subjects current stable dose

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: at subjects current stable dose of comparator intervention 2: at subjects current stable dose

intervention 1: Parcopa intervention 2: carbidopa-levodopa (Sinemet)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00590122

[ 3 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate the safety of IV conivaptan in stable euvolemic or hypervolemic cirrhotic patients, and to characterize the effects of IV conivaptan on the hepatic hemodynamic response in patients with cirrhosis.

null

Liver Cirrhosis

conivaptan Liver Cirrhosis Hypertension, Portal

null

3

arm 1: Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours arm 2: Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours arm 3: Placebo continuous intravenous infusion over 6.5 hours

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: IV intervention 2: IV

intervention 1: conivaptan intervention 2: Placebo

1

Barcelona | N/A | Spain | 2.15899 | 41.38879

0

NCT00592475

[ 4 ]

217

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease.

This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Early-Stage Parkinson's Disease

Rotigotine

null

1

arm 1: Rotigotine

[ 0 ]

1

[ 0 ]

intervention 1: Rotigotine trans-dermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

intervention 1: Rotigotine

42

0

NCT00594165

[ 0 ]

11

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

3TRIPLE

true

0ALL

false

Night shift-workers are often advised to take a prophylactic nap prior to starting the shift in order to improve alertness and performance. However, individuals often report difficulty initiating and maintaining sleep at that time of the day secondary to the alerting influence of the near-24 hour circadian rhythm (biological clock). A sleep-promoting medication may improve the quality of an evening nap and subsequent alertness and performance during a night shift. We will use Ramelteon, a melatonin agonist that is FDA approved for insomnia, in order to test the following hypotheses: 1. ramelteon, compared with placebo, will significantly increase sleep efficiency during a 2-hour nap; 2. sleep inertia, as assessed by neurobehavioral tests and subjective and objective sleepiness assessments will not be significantly increased after ramelteon treatment compared with placebo treatment; and 3. neurobehavioral performance, subjective and objective sleepiness, and subjective mood during a simulated 8-hour night shift will be significantly improved when ramelteon is given prior to a prophylactic nap compared to a prophylactic nap with placebo.

null

Healthy

sleep performance night shift Ramelteon Healthy Individuals

null

2

arm 1: Ramelteon 8 mg will be given once prior to a 2-hour nap arm 2: Placebo will be given once prior to a 2-hour nap

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ramelteon 8 mg tablet by mouth x 1 dose intervention 2: placebo identical in appearance to active experimental drug x 1 dose

intervention 1: Ramelteon intervention 2: placebo

0

null

0

NCT00595075

[ 4 ]

213

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.

• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients Secondary Objectives: * To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment * To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment * To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment * To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment

Acute Pain Fever

Acute pain Fever IV Acetaminophen Analgesic

null

3

arm 1: 1 g q6h IV Acetaminophen arm 2: 650 mg q4h IV Acetaminophen arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

[ 0, 0, 5 ]

1

[ 0 ]

intervention 1: Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.

intervention 1: IV Acetaminophen

14

0

NCT00598559

[ 2 ]

53

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study determined the maximum tolerated dose and safety of SU011248 (sunitinib malate, SUTENT) in combination with FOLFOX \[Leucovorin + Fluorouracil (5-FU) + Oxaliplatin\]. Three different dosing regimens with starting doses of sunitinib at 37.5 mg/day (Schedule 2/2, Schedule 4/2, and Continuous Dosing) were tested in patients with advanced solid tumors, including colorectal cancer.

Study Design: Treatment, Single Group Assignment (7 cohorts), Open Label, Non-Randomized, Safety Study.

Colorectal Neoplasms Neoplasms

advanced solid tumors, colorectal cancer, sunitinib (SUTENT), FOLFOX

null

1

arm 1: SU011248 \[sunitinib\] in combination with FOLFOX; FOLFOX is a chemotherapy regimen that combines oxaliplatin and leucovorin with bolus and infusion 5-FU. The modified FOLFOX 6 (mFOLFOX6) regimen is one of several different regimens of FOLFOX used in clinic, according to different dosages of the 4 drugs. mFOLFOX6 was administered every 2 weeks on Days 1 and 2 of each cycle. 25, 37.5 and 50 mg/day, oral, administered on an outpatient basis in three different dosing regimens: schedule 2/2 (2 weeks on, 2 weeks off), schedule 4/2 (4 weeks on, 2 weeks off), and continuous daily dosing (every day); FOLFOX will be administered every 2 weeks, using the modified FOLFOX 6 (mFOLFOX6) regimen, consisting of: oxaliplatin 85 mg/m2 + leucovorin 400 mg/m2 as a 2-hr IV infusion; 5-FU 400 mg/m2 IV bolus, followed by - 5-FU 2400 mg/m2 as a 46-hr IV infusion

[ 0 ]

7

[ 0, 0, 0, 0, 0, 0, 0 ]

intervention 1: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 2: 50 mg sunitinib + modified FOLFOX6 (Schedule 2/2) intervention 3: 50 mg sunitinib + modified FOLFOX6 ( CRC, only Schedule 2/2) intervention 4: 37.5 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 5: 50 mg sunitinib + modified FOLFOX6 (Schedule 4/2) intervention 6: 37.5 mg sunitinib + modified FOLFOX6 (Continuous Dosing) intervention 7: 25 mg sunitinib + modified FOLFOX6 (Continuous Dosing)

intervention 1: sunitinib + FOLFOX intervention 2: sunitinib + FOLFOX intervention 3: sunitinib + FOLFOX intervention 4: sunitinib + FOLFOX intervention 5: sunitinib + FOLFOX intervention 6: sunitinib + FOLFOX intervention 7: sunitinib + FOLFOX

3

0

NCT00599924

[ 3 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of the study is to determine the long-term safety and efficacy of VI-0521 (phentermine/topiramate) compared to placebo in providing blood sugar control in Type 2 diabetic adults. Continuation of initial 6 month trial.

null

Diabetes

Diabetes Type 2 Diabetes Diabetes Mellitus Metabolic Diseases Glucose Metabolism Disorders Glycemic Control

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: phentermine 15mg/ topiramate controlled release (CR) 92mg, oral capsule, once daily, 28 weeks intervention 2: Oral placebo capsules, once daily, 28 weeks

intervention 1: Phentermine/Topiramate intervention 2: Placebo

9

0

NCT00600067

[ 3 ]

622

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Low-Dose ICS Therapy

Asthma

Adolescents Adults Pharmacokinetics Asthma GW685698X Pharmacogenetics

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: GW685698X intervention 2: placebo

155

0

NCT00603278

[ 4 ]

272

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (COPD) of at least 12 months. The primary purpose of the study was to evaluate the performance of the MF/F MDI integrated dose counter under normal patient handling conditions.

null

Asthma COPD

null

1

arm 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MFF MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

[ 0 ]

1

[ 0 ]

intervention 1: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.

intervention 1: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )

0

null

0

NCT00604500

[ 3 ]

122

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients with type 2 diabetes mellitus who are currently on metformin monotherapy.

null

Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

null

3

arm 1: 12 weekly doses of 1.5 mg CJC-1134-PC arm 2: 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC arm 3: 12 weekly doses of placebo

[ 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1.5 or 2.0 mg CJC-1134-PC intervention 2: Placebo

intervention 1: CJC-1134-PC intervention 2: Placebo

1

Montreal | Quebec | Canada | -73.58781 | 45.50884

0

NCT00638716

[ 3 ]

30

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This clinical trial is designed to evaluate the safety and potential efficacy of Xyrem for the treatment of excessive daytime sleepiness (EDS) and nocturnal sleep disturbance in patients with mild to moderate Parkinson's Disease (PD).

Inclusion required an Epworth Sleepiness Scale (ESS) score greater than 10 and any subjective nocturnal sleep concern, usually insomnia. An acclimation and screening polysomnogram was performed to exclude subjects with sleepdisordered breathing. The following evening, subjects underwent another polysomnogram, followed by an evaluation with the Unified Parkinson Disease Rating Scale (UPDRS) while practically defined off ("off") PD medications, ESS (primary efficacy point), Pittsburgh Sleep Quality Inventory, and Fatigue Severity Scale. Subjects then started sodium oxybate therapy, which was titrated from 3 to 9 g per night in split doses (at bedtime and 4 hours later) across 6 weeks, and returned for subjective sleep assessments. They then returned at 12 weeks after initiating therapy for a third polysomnogram, an offmedication UPDRS evaluation, and subjective sleep assessments. Data are expressed as mean (SD).

Parkinson Disease

excessive daytime somnolence Parkinson disease sleep disturbance

null

1

arm 1: sodium oxybate 4.5 to 9.0 gms per night

[ 0 ]

1

[ 0 ]

intervention 1: 4.5 to 9.0 grams per night

intervention 1: sodium oxybate

0

null

0

NCT00641186

[ 5 ]

328

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will compare the safety and efficacy of once daily dosing of aliskiren to twice daily dosing of aliskiren in patients with moderate hypertension

null

Essential Hypertension

null

2

arm 1: Participants received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening for a total of 10 weeks. arm 2: Participants received Aliskiren 150 mg tablet + Placebo to Aliskiren matching 300 mg tablet daily in the morning and Aliskiren 150 mg tablet daily in the evening for the first 6 weeks then for the next 4 weeks received Aliskiren 300 mg tablet + Placebo to Aliskiren matching 150 mg tablet daily in the morning and Placebo to Aliskiren matching 150 mg tablet daily in the evening.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Aliskiren supplied in 150 mg and 300 mg tablets. intervention 2: Placebo to Aliskiren matching 150 and 300 mg tablets

intervention 1: Aliskiren intervention 2: Placebo to Aliskiren

3

Zanesville | Ohio | United States | -82.01319 | 39.94035 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Valencia | N/A | Spain | -0.37966 | 39.47391

0

NCT00654875