phases
list | enrollmentCount
int64 | allocation
string | interventionModel
string | primaryPurpose
class label | masking
class label | healthyVolunteers
bool | sex
class label | oversightHasDmc
bool | briefSummary
string | detailedDescription
string | conditions
string | conditionsKeywords
string | protocolPdfText
string | numArms
int64 | armDescriptions
string | armGroupTypes
list | numInterventions
int64 | interventionTypes
list | interventionDescriptions
string | interventionNames
string | numLocations
int64 | locationDetails
string | target
int64 | nctid
string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
5
] | 51
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| null |
Phase 4 commitment pharmacokinetic study to determine systemic exposure to adapalene.
|
Multi-center, double-blind, randomized, parallel group study enrolling male or female subjects with acne vulgaris.
Screening will take place within 14 days prior to Baseline. At the Baseline visit, and at each study day up to Day 30, a trained nurse or technician will apply 2 grams of study medication (either Differin® Gel, 0.3% or Differin® Gel, 0.1%) to the face, upper part of chest, and upper part of back of the subjects. To ensure maximal usage conditions, 2 grams study medication will be applied once daily to a total body surface area of approximately 1000 cm², which is equivalent to 2 mg/cm2.
Subjects will arrive at the clinic the night before on visit days (Day 1, Day 15 and Day 30) when PK blood samples will be drawn. Subjects will be discharged from the clinic on Day 2 and Day 16 following the 24-hour post-dose blood sample, and on Day 31 after the 36-hour post-dose blood samples.
Cutaneous safety (local tolerability assessments) will be assessed, by recording erythema, scaling, dryness, and stinging/burning sensation as separate scores on the face, upper part of the chest, and upper part of the back using a 4-point scale (0 = None to 3 = Severe). Local tolerability assessments will be performed weekly on Day 1, 8, 15, 22 and Day 30, prior application of study medication.
Efficacy will be evaluated by Inflammatory and Non-inflammatory lesion counts on the face performed at Screening, Baseline (Day 1), and on Day 30.
Subjects will have routine laboratory tests (fasting hematology, blood chemistry) performed at Screening and at Day 30 visits.
Blood samples for determination of adapalene plasma concentrations will be drawn on Day 1, Day 15, and Day 30 before the morning study medication application (pre-dose) and 1, 2, 4, 6, 8, 10, 12, 16 and 24 hours after application of study medication; and additionally after the last study medication application (Day 31, 32, 33) at 32, 36, 48 and 72 hours post-dose.
The adapalene plasma concentrations will be determined by a high performance liquid chromatography (HPLC) and fluorescence detection method.
|
Acne Vulgaris
|
Acne vulgaris Differin Adapalene
| null | 2
|
arm 1: Gel, 0.3%, 2g, once daily for 30 days arm 2: Gel, 0.1%, 2g, once daily for 30 days
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Gel, 0.3%, 2g, once daily for 30 days intervention 2: Gel, 0.1%, 2g, once daily for 30 days
|
intervention 1: Adapalene intervention 2: Adapalene
| 2
|
Austin | Texas | United States | -97.74306 | 30.26715
College Station | Texas | United States | -96.33441 | 30.62798
| 0
|
NCT00660985
|
[
3
] | 100
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 3TRIPLE
| false
| 0ALL
| null |
This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia
| null |
Schizophrenia
| null | 4
|
arm 1: AZD0328 low dose arm 2: AZD0328 Optimal dose arm 3: AZD0328 High dose arm 4: Placebo Comparator
|
[
0,
0,
0,
2
] | 2
|
[
0,
0
] |
intervention 1: None intervention 2: None
|
intervention 1: AZD0328 intervention 2: Placebo
| 2
|
Garden Grove | California | United States | -117.94145 | 33.77391
Glendale | California | United States | -118.25508 | 34.14251
| 0
|
NCT00669903
|
|
[
2,
3
] | 104
|
RANDOMIZED
|
PARALLEL
| 7BASIC_SCIENCE
| 2DOUBLE
| false
| 0ALL
| false
|
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.
| null |
Rheumatoid Arthritis
|
Rheumatoid Arthritis
| null | 12
|
arm 1: AIN457A 0.3 mg/kg was administered intravenously as a single dose. arm 2: AIN457A 1.0 mg/kg was administered intravenously as a single dose. arm 3: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 4: AIN457A 10.0 mg/kg was administered intravenously as a single dose. arm 5: Placebo to AIN457A was administered intravenously as a single dose. arm 6: AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 7: AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 8: AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 9: Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. arm 10: AIN457A 3.0 mg/kg was administered intravenously as a single dose. arm 11: AIN457A 10 mg/kg was administered intravenously as a single dose. arm 12: Placebo to AIN457A was administered intravenously as a single dose.
|
[
0,
0,
0,
0,
2,
0,
0,
0,
2,
0,
0,
2
] | 2
|
[
2,
0
] |
intervention 1: AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A. intervention 2: Placebo to AIN457
|
intervention 1: AIN457 intervention 2: Placebo
| 24
|
Anniston | Alabama | United States | -85.83163 | 33.65983
Tucson | Arizona | United States | -110.92648 | 32.22174
Largo | Florida | United States | -82.78842 | 27.90979
Ocala | Florida | United States | -82.14009 | 29.1872
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Port Orange | Florida | United States | -80.99561 | 29.13832
Madisonville | Kentucky | United States | -87.49889 | 37.3281
St Louis | Missouri | United States | -90.19789 | 38.62727
Omaha | Nebraska | United States | -95.94043 | 41.25626
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Bend | Oregon | United States | -121.31531 | 44.05817
Duncansville | Pennsylvania | United States | -78.4339 | 40.42341
Brussels | N/A | Belgium | 4.34878 | 50.85045
Merksem | N/A | Belgium | 4.44903 | 51.24623
Bad Nauheim | N/A | Germany | 8.73859 | 50.36463
Erlangen | N/A | Germany | 11.00783 | 49.59099
München | N/A | Germany | 13.31243 | 51.60698
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425
Singapore | Singapore | Singapore | 103.85007 | 1.28967
Singapore | Singapore | Singapore | 103.85007 | 1.28967
A Coruña | Galicia | Spain | -8.396 | 43.37135
Santiago de Compostela | Galicia | Spain | -8.54569 | 42.88052
Guadalajara | N/A | Spain | -3.16185 | 40.62862
| 0
|
NCT00669942
|
[
3
] | 90
|
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 who are currently on metformin monotherapy.
| null |
Type 2 Diabetes Mellitus
|
GLP-1, incretin, type 2 diabetes
| null | 3
|
arm 1: Twice-a-week dose of 1.5 mg CJC-1134-PC arm 2: Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo arm 3: Twice-a-week placebo for CJC-1134-PC
|
[
0,
0,
2
] | 2
|
[
0,
0
] |
intervention 1: twice-a-week intervention 2: twice-a-week
|
intervention 1: 1.5 mg or 2.0 mg CJC-1134-PC intervention 2: Placebo
| 1
|
Montreal | Quebec | Canada | -73.58781 | 45.50884
| 0
|
NCT00674466
|
[
5
] | 7
|
NON_RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month
| null |
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder
|
Schizophrenia Integrated Care Quetiapine
| null | 2
|
arm 1: Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion arm 2: Oral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
|
[
0,
0
] | 2
|
[
0,
10
] |
intervention 1: 400-800 mg, oral, bid intervention 2: Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.
|
intervention 1: Quetiapine XR intervention 2: Integrated Care Program (ICP)
| 8
|
München | Bavaria | Germany | 13.46314 | 48.69668
Oranienburg | Brandenburg | Germany | 13.24197 | 52.75577
Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073
Lüneburg | Lower Saxony | Germany | 10.41409 | 53.2509
Oldenburg | Lower Saxony | Germany | 8.21467 | 53.14118
Chemnitz | Saxony | Germany | 12.92922 | 50.8357
Berlin | State of Berlin | Germany | 13.41053 | 52.52437
Stolberg | N/A | Germany | 6.22595 | 50.77368
| 0
|
NCT00681629
|
[
5
] | 7
|
NA
|
SINGLE_GROUP
| 2DIAGNOSTIC
| 0NONE
| false
| 0ALL
| false
|
Subjects will be given 3 infusions of infliximab according to the label at week 0, 2, and 6. Subjects will be followed for a maximum of 18 weeks or until relapse. This study will assess the ability of the Power Doppler Ultrasonography (PDUS) to be a reliable marker of enthesitis response and relapse in subjects treated with infliximab.
| null |
Spondylitis, Ankylosing SpA
| null | 1
|
arm 1: Infliximab infusions: 5 mg/kg at weeks 0, 2, and 6.
|
[
0
] | 2
|
[
3,
0
] |
intervention 1: PDUS scored for each enthesitis every 2 weeks for 24 weeks. intervention 2: * 5 mg/kg
* IV
* Frequency : weeks 0,2,6
|
intervention 1: PDUS intervention 2: Infliximab
| 0
| null | 0
|
NCT00686894
|
|
[
3
] | 61
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| null |
The primary objective of this study is to assess the efficacy and safety of an extended-release (ER) formulation of pramipexole in comparison with placebo for the treatment of fibromyalgia.
The objective of the open-label phase is to assess the safety profile and effect of Pramipexole (PPX) extended-release (ER) in fibromyalgia patients over a 24-week period.
| null |
Fibromyalgia
| null | 2
|
arm 1: 0.75 mg to 4.5 mg tablets of Pramipexole ER, once daily in the evening arm 2: Placebo tablets, once daily in the evening
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: None intervention 2: None
|
intervention 1: pramipexole ER intervention 2: placebo
| 42
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Arcadia | California | United States | -118.03534 | 34.13973
Los Angeles | California | United States | -118.24368 | 34.05223
Santa Ana | California | United States | -117.86783 | 33.74557
Englewood | Colorado | United States | -104.98776 | 39.64777
Danbury | Connecticut | United States | -73.45401 | 41.39482
DeLand | Florida | United States | -81.30312 | 29.02832
Fort Myers | Florida | United States | -81.84059 | 26.62168
Orlando | Florida | United States | -81.37924 | 28.53834
Palm Beach Gardens | Florida | United States | -80.13865 | 26.82339
Sunrise | Florida | United States | -80.1131 | 26.13397
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Lexington | Kentucky | United States | -84.47772 | 37.98869
Newton | Massachusetts | United States | -71.20922 | 42.33704
Lansing | Michigan | United States | -84.55553 | 42.73253
Flowood | Mississippi | United States | -90.13898 | 32.30959
Picayune | Mississippi | United States | -89.67788 | 30.52556
Kansas City | Missouri | United States | -94.57857 | 39.09973
Billings | Montana | United States | -108.50069 | 45.78329
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Albany | New York | United States | -73.75623 | 42.65258
New York | New York | United States | -74.00597 | 40.71427
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Fargo | North Dakota | United States | -96.7898 | 46.87719
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Columbus | Ohio | United States | -82.99879 | 39.96118
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Medford | Oregon | United States | -122.87559 | 42.32652
Portland | Oregon | United States | -122.67621 | 45.52345
Duncansville | Pennsylvania | United States | -78.4339 | 40.42341
Warwick | Rhode Island | United States | -71.41617 | 41.7001
Austin | Texas | United States | -97.74306 | 30.26715
San Antonio | Texas | United States | -98.49363 | 29.42412
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Renton | Washington | United States | -122.21707 | 47.48288
Seattle | Washington | United States | -122.33207 | 47.60621
Spokane | Washington | United States | -117.42908 | 47.65966
| 0
|
NCT00689052
|
|
[
4
] | 10
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| null |
This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months. After that, subjects who have completed the study will be eligible to enroll in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-318).
| null |
Epilepsy
| null | 2
|
arm 1: None arm 2: None
|
[
1,
2
] | 2
|
[
0,
0
] |
intervention 1: 50-400 mg capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks) intervention 2: 50-400 mg Zonisamide Placebo capsules once daily in the evening orally.
Maximum study duration 28 weeks comprising:
Baseline Period (Week -8 to Week 0): no treatment
Titration Period (Week 0 to Week 4): 50 mg Zonisamide Placebo daily titrated weekly until 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) 400 mg Zonisamide Placebo (or 350 mg in the event of dose limiting adverse events)
Down Titration Period (4 Weeks)
|
intervention 1: Zonisamide intervention 2: Placebo
| 72
|
Chatswood | New South Wales | Australia | 151.18333 | -33.8
Randwick | New South Wales | Australia | 151.24895 | -33.91439
Heidelburg | Victoria | Australia | N/A | N/A
Melbourne | Victoria | Australia | 144.96332 | -37.814
Split | HR | Croatia | 16.43915 | 43.50891
Zagreb | HR | Croatia | 15.97798 | 45.81444
Zagreb | HR | Croatia | 15.97798 | 45.81444
Kralove | N/A | Czechia | N/A | N/A
Kroměříž | N/A | Czechia | 17.39312 | 49.29785
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Ostrava | N/A | Czechia | 18.28204 | 49.83465
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Rychnov nad Kněžnou | N/A | Czechia | 16.27488 | 50.16284
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tartu | N/A | Estonia | 26.72509 | 58.38062
Kuopio | N/A | Finland | 27.67703 | 62.89238
Oulu | N/A | Finland | 25.46816 | 65.01236
Berlin | N/A | Germany | 13.41053 | 52.52437
Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959
Marburg | N/A | Germany | 8.77069 | 50.80904
München | N/A | Germany | 13.31243 | 51.60698
Ulm | N/A | Germany | 9.99155 | 48.39841
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Gyula | N/A | Hungary | 21.28333 | 46.65
Kecskemét | N/A | Hungary | 19.69128 | 46.90618
Szombathely | N/A | Hungary | 16.62155 | 47.23088
Veszprém | N/A | Hungary | 17.91149 | 47.09327
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Vilnius | N/A | Lithuania | 25.2798 | 54.68916
Bialystok | N/A | Poland | 23.16433 | 53.13333
Gdansk | N/A | Poland | 18.64912 | 54.35227
Katowice | N/A | Poland | 19.02754 | 50.25841
Krakow | N/A | Poland | 19.93658 | 50.06143
Lodz | N/A | Poland | 19.47395 | 51.77058
Poznan | N/A | Poland | 16.92993 | 52.40692
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.76667
Lasi | N/A | Romania | N/A | N/A
Lasi | N/A | Romania | N/A | N/A
Tg Mures | N/A | Romania | N/A | N/A
Krasnoyarsk | N/A | Russia | 92.90765 | 56.02668
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
Novosibirsk | N/A | Russia | 82.94339 | 55.03442
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Smolensk | N/A | Russia | 32.04371 | 54.77944
Smolensk | N/A | Russia | 32.04371 | 54.77944
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Belgrade | N/A | Serbia | 20.46513 | 44.80401
Belgrade | N/A | Serbia | 20.46513 | 44.80401
Kragujevac | N/A | Serbia | 20.91667 | 44.01667
Niš | N/A | Serbia | 21.90333 | 43.32472
Dnipropetrovsk | N/A | Ukraine | 35.04066 | 48.46664
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Lviv | N/A | Ukraine | 24.02324 | 49.83826
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639
| 0
|
NCT00693017
|
|
[
4
] | 126
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
| null |
Cataract
|
Cataract extraction with intraocular lens implantation
| null | 2
|
arm 1: Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily arm 2: Placebo, Dosed 1 Drop Daily
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution
|
intervention 1: bromfenac ophthalmic solution intervention 2: placebo
| 1
|
Irvine | California | United States | -117.82311 | 33.66946
| 0
|
NCT00703781
|
[
3
] | 121
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| null |
The objective of this study is to investigate the effect of BI 1356 on 24-h glucose control and various pharmacodynamic parameters in type 2 diabetic patients with inadequate glycaemic control.
| null |
Diabetes Mellitus, Type 2
| null | 3
|
arm 1: Patients received placebo matching 5mg linagliptin and placebo matching 100mg sitagliptin. arm 2: Patients received 5mg linagliptin, and placebo matching 100mg sitagliptin. arm 3: Patients received 100mg sitagliptin, and placebo matching 5mg linagliptin.
|
[
2,
0,
1
] | 6
|
[
0,
0,
0,
0,
0,
0
] |
intervention 1: once daily for 28 days intervention 2: once daily for 28 days intervention 3: 100 mg once daily for 28 days intervention 4: once daily for 28 days intervention 5: once daily for 28 days intervention 6: 5mg once daily for 28 days
|
intervention 1: Placebo (linagliptin) intervention 2: Placebo (linagliptin) intervention 3: Sitagliptin intervention 4: Placebo (sitagliptin) intervention 5: Placebo (sitagliptin) intervention 6: Linagliptin
| 3
|
Berlin | N/A | Germany | 13.41053 | 52.52437
Mainz | N/A | Germany | 8.2791 | 49.98419
Neuss | N/A | Germany | 6.68504 | 51.19807
| 0
|
NCT00716092
|
|
[
5
] | 30
|
NON_RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| true
| 0ALL
| false
|
The purpose of this study is to assess whether a dosing adjustment is needed in patients with renal impairment.
| null |
Human Immunodeficiency Virus (HIV) Infection
|
maraviroc, pharmacokinetics, renal impairment
| null | 5
|
arm 1: Subjects with Normal Renal Function (Creatinine Clearance \> 80mL/min) (I) Maraviroc single dose, followed by (II) Maraviroc + Saquinavir/Ritonavir arm 2: Subjects with Mild Renal Impairment (Creatinine Clearance \>50 and ≤80 mL/min) arm 3: Subjects with Moderate Renal Impairment (Creatinine Clearance ≥30 and ≤50 mL/min) arm 4: Subjects with Severe Renal Impairment (Creatinine Clearance \<30 mL/min) arm 5: Subjects with End Stage Renal Impairment receiving Hemodialysis(Creatinine Clearance \<30 mL/min) (I) Maraviroc single dose one hour following completion of hemodialysis, followed by (II) Maraviroc single dose three hours prior to start of hemodialysis
|
[
0,
0,
0,
0,
0
] | 13
|
[
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] |
intervention 1: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 2: Maraviroc 150 mg tablet twice daily x 7 days intervention 3: Ritonavir 100 mg capsule twice daily x 7 days intervention 4: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 5: Maraviroc 150 mg tablet once daily x 7 days intervention 6: Ritonavir 100 mg capsule twice daily x 7 days intervention 7: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 8: Maraviroc 150 mg tablet once every 48 hours x 7 days intervention 9: Ritonavir 100 mg capsule twice daily x 7 days intervention 10: Saquinavir 1000 mg (500 mg x 2 tablets) twice daily x 7 days intervention 11: Maraviroc 300 mg (150 mg x 2 tablets) x single dose intervention 12: Maraviroc 300 mg (150 mg x 2 tablets) x single dose one hour following completion of hemodialysis intervention 13: Maraviroc 300 mg (150 mg x 2 tablets) x single dose three hours prior to start of hemodialysis
|
intervention 1: Maraviroc intervention 2: Maraviroc intervention 3: Ritonavir intervention 4: Saquinavir intervention 5: Maraviroc intervention 6: Ritonavir intervention 7: Saquinavir intervention 8: Maraviroc intervention 9: Ritonavir intervention 10: Saquinavir intervention 11: Maraviroc intervention 12: Maraviroc intervention 13: Maraviroc
| 2
|
Berlin | N/A | Germany | 13.41053 | 52.52437
München | N/A | Germany | 13.31243 | 51.60698
| 0
|
NCT00717067
|
[
3
] | 92
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
* Multi-Center
* Randomized
* Open-Label Study of single agent IMO-2055
* Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
|
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly subcutaneous (SC) injections in two patient populations, treatment naïve or previously treated patients. Each dose group (treatment naive or previously treated) will be randomized to receive one of the 2 doses being studied.
|
Renal Cell Carcinoma
|
renal cell renal carcinoma metastatic recurrent treatment naive
| null | 4
|
arm 1: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 2: Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg arm 3: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg arm 4: Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg
|
[
1,
1,
1,
1
] | 1
|
[
0
] |
intervention 1: immunostimulatory oligonucleotide
|
intervention 1: IMO-2055
| 1
|
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
| 0
|
NCT00729053
|
[
4
] | 351
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
| null |
Allergic Rhinitis
| null | 2
|
arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
|
intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray
| 0
| null | 0
|
NCT00732381
|
|
[
4
] | 776
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)
|
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be rated, reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
|
Seasonal Allergic Rhinitis
| null | 4
|
arm 1: nasal spray arm 2: nasal spray arm 3: nasal spray arm 4: nasal spray
|
[
0,
1,
1,
2
] | 4
|
[
0,
0,
0,
0
] |
intervention 1: azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID intervention 2: azelastine Hcl 548 mcg one spray per nostril BID intervention 3: fluticasone propionate 200 mcg one spray per nostril BID intervention 4: placebo one spray per nostril BID
|
intervention 1: azelastine HCl/fluticasone propionate intervention 2: azelastine Hcl intervention 3: fluticasone propionate intervention 4: placebo
| 39
|
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Encinitas | California | United States | -117.29198 | 33.03699
Fountain Valley | California | United States | -117.95367 | 33.70918
Fresno | California | United States | -119.77237 | 36.74773
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Mission Viejo | California | United States | -117.672 | 33.60002
San Diego | California | United States | -117.16472 | 32.71571
Stockton | California | United States | -121.29078 | 37.9577
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Denver | Colorado | United States | -104.9847 | 39.73915
Atlanta | Georgia | United States | -84.38798 | 33.749
Stockbridge | Georgia | United States | -84.23381 | 33.54428
Stockbridge | Georgia | United States | -84.23381 | 33.54428
Normal | Illinois | United States | -88.99063 | 40.5142
Overland Park | Kansas | United States | -94.67079 | 38.98223
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Plymouth | Minnesota | United States | -93.45551 | 45.01052
St Louis | Missouri | United States | -90.19789 | 38.62727
Papillion | Nebraska | United States | -96.04224 | 41.15444
Ocean City | New Jersey | United States | -74.5746 | 39.27762
Skillman | New Jersey | United States | -74.7146 | 40.42011
Warren Township | New Jersey | United States | -74.51803 | 40.60822
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Collegeville | Pennsylvania | United States | -75.45157 | 40.18566
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Upland | Pennsylvania | United States | -75.38269 | 39.85261
Charleston | South Carolina | United States | -79.93275 | 32.77632
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
New Braunfels | Texas | United States | -98.12445 | 29.703
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Draper | Utah | United States | -111.86382 | 40.52467
| 0
|
NCT00740792
|
|
[
5
] | 211
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| true
| 0ALL
| false
|
This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.
| null |
Pain
|
Dental pain analgesia
| null | 3
|
arm 1: None arm 2: None arm 3: None
|
[
2,
1,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: 2 placebo gels capsules delivered as a single dose. intervention 2: 2 marketed ibuprofen gels intervention 3: 2 marketed ibuprofen gels
|
intervention 1: placebo intervention 2: ibuprofen Formulation 1 intervention 3: ibuprofen Formulation 2
| 1
|
Salt Lake City | Utah | United States | -111.89105 | 40.76078
| 0
|
NCT00740857
|
[
5
] | 15
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
This purpose of this study is to understand the differences between people who have a good response to deferasirox (exjade) compared to people who have a poor response to this medication when used for transfusion-dependent iron overload.
The hypothesis is that patients with poor responses have physiologic barriers to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.
|
The purpose of this trial is to examine three potential mechanisms of inadequate response to Exjade® in patients with transfusion dependent iron overload including patients with thalassemia syndromes, sickle cell disease and bone marrow failure.
Hypothesis: Patients have physiologic barriers to adequately respond to deferasirox that may include absorption, pharmacokinetics of drug metabolism, hepatic clearance and/or genetic factors.
Study objectives Primary objective
* To evaluate three potential mechanisms for inadequate response to deferasirox in a small cohort of patients with hemoglobinopathies.
* Oral pharmacokinetics measured with Cmax and AUC following standard dose deferasirox.
* Hepatobiliary excretory function
* Accessibility of chelatable iron pool by deferoxamine challenge Secondary objective(s)
* To identify risk factors that can predict adequate response including demographics, disease status, presence and severity of liver disease, trough levels of deferasirox at outpatient visits and pharmacogenomics.
* To investigate usefulness of potential surrogate measures of response including serum deferasirox levels, Hepatobiliary Iminodiacetic Acid (HIDA)nuclear medicine scan to evaluate hepatic excretory function and urinary iron excretion by deferoxamine challenge.
This is an investigator-initiated, pilot-scale, open-label physiological assessment of patients who respond poorly to deferasirox compared with patients who respond well. We plan to study 2 groups of patients: a)10 patients who have demonstrated poor responses and b) 5 control patients with good responses as defined further in the protocol. The study has two parts.
Part I: Both groups of patients will have inpatient physiological assessments with a dose of 35mg/kg of deferasirox.
Part II: Inadequate responders eligible to continue on deferasirox will continue on a dose of 35 mg/kg for three months during which time serial pharmacokinetic levels will be studied. The control patients will resume their previous clinically appropriate dosing (likely less than 35 mg/kg) and for three months have serial pharmacokinetic levels drawn as well.
The study will begin with an outpatient screening visit when demographics and historical information as well as a physical examination will be obtained and reviewed for eligibility. At that visit patients will be able to sign informed consent. Shortly thereafter patients will be admitted to the GCRC at Children's Hospital Boston for part I of the study, a 2-3 day stay during which PK and nuclear medicine studies will be performed as well as the deferoxamine urinary iron excretion challenge. Patients who are eligible will continue on to part II of the study, and for 3 months and will be monitored for compliance, PK and ferritin changes on appropriate deferasirox doses.
|
Transfusion-dependent Hemachromatosis Thalassemia Major Sickle Cell Disease
|
Thalassemia Iron Chelation
| null | 1
|
arm 1: All patients received the same interventions of deferoxamine challenge, deferasirox dose with pharmacokinetic monitoring and HIDA scan. Then we compared responses between patients who were known to be slow responders to deferasirox and those who were known to be rapid responders (chelated well).
|
[
0
] | 3
|
[
0,
0,
4
] |
intervention 1: After a 3-day washout period from all chelation, all patients have a 12 hour infusion of 50mg/kg of deferoxamine with urine collection and pre and post blood sampling to assess iron and Total Iron Binding Capacity (TIBC) by atomic absorption. intervention 2: After a 3-day washout period from all chelation, patients had a desferal challenge which was followed by a single dose of deferasirox, 35mg/kg orally with blood sampling taken pre-deferasirox and at intervals for 24 hours after the dose. intervention 3: All patients had a HIDA scan to assess physiologic liver clearance capacity.
|
intervention 1: Deferoxamine intervention 2: Deferasirox intervention 3: HIDA
| 1
|
Boston | Massachusetts | United States | -71.05977 | 42.35843
| 0
|
NCT00749515
|
[
4
] | 497
|
NON_RANDOMIZED
|
SINGLE_GROUP
| null | 0NONE
| false
| 0ALL
| false
|
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
|
Issues on adverse event data are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the results section.
\- General Educational Development (GED)
|
Pain
|
Non-prescription
| null | 1
|
arm 1: subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever
|
[
0
] | 1
|
[
0
] |
intervention 1: Consumer use of Extended Release Naproxen Sodium
|
intervention 1: Naproxen Sodium ER (BAYH6689)
| 24
|
Anaheim | California | United States | -117.9145 | 33.83529
Oceanside | California | United States | -117.37948 | 33.19587
San Dimas | California | United States | -117.80673 | 34.10668
Overland Park | Kansas | United States | -94.67079 | 38.98223
Anoka | Minnesota | United States | -93.38718 | 45.19774
Blaine | Minnesota | United States | -93.23495 | 45.1608
Elk River | Minnesota | United States | -93.56718 | 45.30385
Saint Francis | Minnesota | United States | -93.3594 | 45.38691
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483
Belton | Missouri | United States | -94.5319 | 38.81195
Saint Joseph | Missouri | United States | -94.84663 | 39.76861
Savannah | Missouri | United States | -94.83025 | 39.94166
Cary | North Carolina | United States | -78.78112 | 35.79154
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Bountiful | Utah | United States | -111.88077 | 40.88939
Ogden | Utah | United States | -111.97383 | 41.223
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Syracuse | Utah | United States | -112.06467 | 41.08939
West Jordan | Utah | United States | -111.9391 | 40.60967
Kenmore | Washington | United States | -122.24401 | 47.75732
Seattle | Washington | United States | -122.33207 | 47.60621
Snohomish | Washington | United States | -122.09818 | 47.91288
| 0
|
NCT00751400
|
[
4
] | 386
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 1SINGLE
| false
| 0ALL
| false
|
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
| null |
Colon Cancer
|
colonoscopy screening
| null | 2
|
arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy
|
intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation
| 12
|
Anaheim | California | United States | -117.9145 | 33.83529
Orange | California | United States | -117.85311 | 33.78779
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Jackson | Mississippi | United States | -90.18481 | 32.29876
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Portland | Oregon | United States | -122.67621 | 45.52345
Franklin | Tennessee | United States | -86.86889 | 35.92506
Germantown | Tennessee | United States | -89.81009 | 35.08676
Nashville | Tennessee | United States | -86.78444 | 36.16589
Houston | Texas | United States | -95.36327 | 29.76328
Charlottesville | Virginia | United States | -78.47668 | 38.02931
Bellevue | Washington | United States | -122.20068 | 47.61038
| 0
|
NCT00756548
|
[
4
] | 394
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 1SINGLE
| false
| 0ALL
| false
|
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.
| null |
Colon Cancer
|
Colonoscopy screening
| null | 2
|
arm 1: multi-dose preparation for oral administration prior to colonoscopy arm 2: multi-dose preparation for oral administration prior to colonoscopy
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: multi-dose preparation for oral administration prior to colonoscopy intervention 2: multi-dose preparation for oral administration prior to colonoscopy
|
intervention 1: BLI850 intervention 2: polyethylene glycol 3350 based bowel preparation
| 12
|
Mobile | Alabama | United States | -88.04305 | 30.69436
Jupiter | Florida | United States | -80.09421 | 26.93422
Miami | Florida | United States | -80.19366 | 25.77427
New Smyrna Beach | Florida | United States | -80.927 | 29.02582
Roswell | Georgia | United States | -84.36159 | 34.02316
Monroe | Louisiana | United States | -92.1193 | 32.50931
Laurel | Maryland | United States | -76.84831 | 39.09928
Great Neck | New York | United States | -73.72846 | 40.80066
Harrisburg | North Carolina | United States | -80.65784 | 35.32395
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Lancaster | Pennsylvania | United States | -76.30551 | 40.03788
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
| 0
|
NCT00756977
|
[
3,
4
] | 50
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The aim of the study is to evaluate the efficacy of methotrexate to improve physical capacity in patients with symptomatic ischemic heart failure.
|
Recent studies have showed the importance of proinflammatory mediators in the heart failure. However, there is a lack of benefit of therapies that tried to neutralize these mediators.
Methotrexate has adenosine-mediated anti-inflammatory effects in rheumatoid arthritis and psoriasis. Methotrexate limits infarct size via this adenosine-dependent mechanisms in heart of dogs (J Cardiovasc Pharmacol. 2004 Apr;43(4):574-9). A recent trial showed that this drug reduced proinflammatory mediators in patients with heart failure (Am Heart J. 2006 Jan;151(1):62-8).
These data suggest that methotrexate may improve physical capacity in patients ischemic heart failure reducing inflammation, but a randomized clinical trial is necessary to prove it.
|
Heart Failure Myocardial Ischemia
|
Heart Failure Myocardial Ischemia Methotrexate Inflammation Anti-Inflammatory Agents Inflammation Mediators
| null | 2
|
arm 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks. arm 2: Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.
All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks. intervention 2: Patients receiving conventional treatment to heart failure who will receive placebo oral plus folic acid 5mg oral once a week for 12 weeks.
All patients will have evaluated at the baseline and after 12 weeks: physical capacity by the 6-minutes walk test, quality of life by the Brazilian edition SF-36 and inflammatory marker by C-reactive protein. They also will be tested for ALT, AST, blood cell count, creatinine, and prothrombin time at baseline, after 6 weeks and after 12 weeks.
|
intervention 1: Methotrexate intervention 2: Placebo
| 1
|
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
| 0
|
NCT00759811
|
[
4
] | 461
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.
|
In Japan, low-dose aspirin is one of the commonly prescribed drugs for inhibiting thrombosis and thrombus formation after angina, myocardial infarction, ischemic cerebrovascular disease, coronary artery by-pass surgery and percutaneous transluminal coronary angioplasty in patients. While low-dose aspirin is effective in these cases, its use sometimes causes gastric and duodenal ulcers which can lead to gastrointestinal bleeding, and in worse cases may lead to death.
The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily low dose aspirin therapy.
|
Stomach Ulcer Duodenal Ulcer
|
Curling Ulcer Gastric Ulcer Aspirin Acetylsalicylic Acid Drug Therapy
| null | 2
|
arm 1: None arm 2: None
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months. intervention 2: Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
|
intervention 1: Lansoprazole intervention 2: Gefarnate
| 65
|
Matsudo-shi | Chiba | Japan | N/A | N/A
Yotsukaido-shi | Chiba | Japan | N/A | N/A
Imabari | Ehime | Japan | 133.00023 | 34.07001
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Fukui-shi | Fukui | Japan | 136.22257 | 36.06443
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6
Onga-gun | Fukuoka | Japan | N/A | N/A
Gifu | Gifu | Japan | 136.76039 | 35.42291
Fujioka-shi | Gunma | Japan | N/A | N/A
Maebashi | Gunma | Japan | 139.08333 | 36.4
Higashihiroshima-shi | Hiroshima | Japan | N/A | N/A
Hiroshima | Hiroshima | Japan | 132.45 | 34.4
Kure-shi | Hiroshima | Japan | N/A | N/A
Asahikawa-shi | Hokkaido | Japan | N/A | N/A
Hakodate-shi | Hokkaido | Japan | N/A | N/A
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Nishinomiya-shi | Hyōgo | Japan | N/A | N/A
Higashiibaraki-gun | Ibaraki | Japan | N/A | N/A
Hitachi-Naka | Ibaraki | Japan | 140.53479 | 36.39659
Inashiki-gun | Ibaraki | Japan | N/A | N/A
Namegata-shi | Ibaraki | Japan | N/A | N/A
Tsuchiura-shi | Ibaraki | Japan | N/A | N/A
Yuuki-shi | Ibaraki | Japan | N/A | N/A
Hakusan-shi | Ishikawa-ken | Japan | N/A | N/A
Kanazawa | Ishikawa-ken | Japan | 136.61667 | 36.6
Komatsu-shi | Ishikawa-ken | Japan | N/A | N/A
Takamatsu | Kagawa-ken | Japan | 134.05 | 34.33333
Fujisawa-shi | Kanagawa | Japan | N/A | N/A
Kawasaki-shi | Kanagawa | Japan | N/A | N/A
Yamato-shi | Kanagawa | Japan | N/A | N/A
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Yokosuka-shi | Kanagawa | Japan | N/A | N/A
Kochi | Kochi | Japan | 133.53333 | 33.55
Kumamoto | Kumamoto | Japan | 130.69181 | 32.80589
Kyoto | Kyoto | Japan | 135.75385 | 35.02107
Matsusaka-shi | Mie-ken | Japan | N/A | N/A
Shima-shi | Mie-ken | Japan | N/A | N/A
Tsu | Mie-ken | Japan | 136.51667 | 34.73333
Sendai | Miyagi | Japan | 140.86667 | 38.26667
Ebino-shi | Miyazaki | Japan | N/A | N/A
Miyazaki | Miyazaki | Japan | 131.41667 | 31.91667
Jōetsu | Niigata | Japan | 138.23642 | 37.14828
Niigata | Niigata | Japan | 139.04125 | 37.92259
Beppu-shi | Ooita | Japan | N/A | N/A
Ōita | Ooita | Japan | 131.6 | 33.23333
Ibaraki-shi | Osaka | Japan | N/A | N/A
Matsubara-shi | Osaka | Japan | N/A | N/A
Osaka | Osaka | Japan | 135.50107 | 34.69379
Takatsuki-shi | Osaka | Japan | N/A | N/A
Hanyuu-shi | Saitama | Japan | N/A | N/A
Ōtsu | Shiga | Japan | 135.86667 | 35.0
Hamada-shi | Shimane | Japan | N/A | N/A
Sunto-gun | Shizuoka | Japan | N/A | N/A
Shimotsuke-shi | Tochigi | Japan | N/A | N/A
Chiyoda-ku | Tokyo | Japan | N/A | N/A
Chuuo-ku | Tokyo | Japan | N/A | N/A
Hachioji-shi | Tokyo | Japan | N/A | N/A
Kiyose-shi | Tokyo | Japan | N/A | N/A
Minato-ku | Tokyo | Japan | N/A | N/A
Shinagawa-ku | Tokyo | Japan | N/A | N/A
Shinjuku-ku | Tokyo | Japan | N/A | N/A
Toshima-ku | Tokyo | Japan | N/A | N/A
Higashitagawa-gun | Yamagata | Japan | N/A | N/A
Iwakuni-shi | Yamaguchi | Japan | N/A | N/A
Shimonoseki-shi | Yamaguchi | Japan | N/A | N/A
| 0
|
NCT00762359
|
[
3
] | 411
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 3TRIPLE
| true
| 0ALL
| false
|
The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.
|
Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.
Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.
The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.
|
Common Cold
|
cold, common rhinovirus
| null | 2
|
arm 1: None arm 2: None
|
[
2,
0
] | 2
|
[
0,
0
] |
intervention 1: * topical product
* apply 2 pumps
* apply at least every 4 hours or after hand washing intervention 2: * topical
* apply 2 pumps
* apply at least every 4 hours or after hand washing
|
intervention 1: 3804-250A intervention 2: 3804-291
| 2
|
Paramus | New Jersey | United States | -74.07542 | 40.94454
Charlottesville | Virginia | United States | -78.47668 | 38.02931
| 0
|
NCT00762476
|
[
5
] | 102
|
RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 2DOUBLE
| true
| 0ALL
| false
|
To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.
| null |
Allergic Rhinitis
|
rhinitis
| null | 1
|
arm 1: Olopatadine 0.6% / Azelastine 137 mcg
|
[
0
] | 1
|
[
0
] |
intervention 1: single dose; 2 sprays per nostril
|
intervention 1: Olopatadine 0.6% / Azelastine 137 mcg
| 1
|
Fort Worth | Texas | United States | -97.32085 | 32.72541
| 0
|
NCT00772304
|
[
2
] | 22
|
RANDOMIZED
|
CROSSOVER
| 2DIAGNOSTIC
| 2DOUBLE
| false
| 0ALL
| false
|
This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.
| null |
Osteoarthritis
| null | 6
|
arm 1: Participants were treated with Placebo for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 2: Participants were treated with Naproxen for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 3: Participants were treated with Ultracet for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 4: Participants were treated with Placebo for 3 days in Treatment Period 1, Ultracet for 3 days in Treatment Period 2, and Naproxen for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 5: Participants were treated with Naproxen for 3 days in Treatment Period 1, Placebo for 3 days in Treatment Period 2, and Ultracet for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break. arm 6: Participants were treated with Ultracet for 3 days in Treatment Period 1, Naproxen for 3 days in Treatment Period 2, and Placebo for 3 days in Treatment Period 3. The treatment periods were separated by a 4-6 day break.
|
[
0,
0,
0,
0,
0,
0
] | 3
|
[
0,
0,
0
] |
intervention 1: Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. intervention 2: Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period. intervention 3: Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
|
intervention 1: Naproxen intervention 2: Placebo intervention 3: Ultracet
| 0
| null | 0
|
NCT00772967
|
|
[
0
] | 26
|
NON_RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| true
| 0ALL
| false
|
Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called "sitagliptin") the investigators could reverse these defects.
| null |
Obesity
|
pre-diabetes isotopes insulin secretion insulin action GLP-1 simple obesity impaired fasting glucose
| null | 2
|
arm 1: Treatment of people with impaired fasting glucose with Januvia (sitagliptin phosphate) arm 2: Treatment of people with normal glucose tolerance with Januvia (sitagliptin phosphate)
|
[
0,
0
] | 1
|
[
0
] |
intervention 1: Januvia 100 mg po qd x 28 days for all subjects after baseline measures made
|
intervention 1: Sitagliptin Phosphate
| 1
|
Aurora | Colorado | United States | -104.83192 | 39.72943
| 0
|
NCT00795275
|
[
0
] | 100
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
Current therapeutic options for ureteral stones include active intervention as well as conservative "watch and wait" approaches. Endoscopic treatment of ureteral stones has a high success rate and reliably results in immediate stone removal However, surgical as well as anaesthetic risks are not negligible and serious complications are possible. For many patients, a conservative treatment is an appealing option. Watchful waiting, however, not always results in stone clearance and may be associated with recurrent renal colics.
The therapeutic potential of alpha-blockers for ureteral stone disease has been investigated prompted by the detection of alpha-receptors in ureteral smooth muscle cells. Blocking of such receptors, which are predominantly located in the distal part of the ureter results in relaxation of the ureteral wall and modulation of peristaltic activity. This mechanism has been proposed to facilitate stone passage for ureteral calculi.
Numerous clinical trials have revealed a significant improvement of the stone expulsion rate using the alpha-blocker tamsulosin. Most of these studies were randomised but none were performed in a double-blind and placebo-controlled fashion. Therefore, the objective of this trial was to evaluate the efficacy of medical expulsive therapy with tamsulosin in a randomised, double-blind, placebo-controlled setting.
| null |
Ureteral Calculi
|
Adrenergic alpha antagonists drug therapy tamsulosin ureter
| null | 2
|
arm 1: Tamsulosin treatment arm 2: Placebo treatment
|
[
1,
2
] | 2
|
[
0,
0
] |
intervention 1: 0.4 mg Tamsulosin once daily for 21 days intervention 2: One placebo pill per day for 21 days or until stone expulsion
|
intervention 1: Tamsulosin intervention 2: Placebo
| 1
|
Zurich | N/A | Switzerland | 8.55 | 47.36667
| 0
|
NCT00831701
|
[
2
] | 20
|
RANDOMIZED
|
CROSSOVER
| 0TREATMENT
| 0NONE
| true
| 1FEMALE
| true
|
The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).
| null |
Partial Epilepsy
|
Partial Epilepsy Eslicarbazepine acetate Combined oral contraceptive Pharmacokinetics Tolerability
| null | 2
|
arm 1: A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®). arm 2: 15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.
|
[
5,
0
] | 2
|
[
0,
0
] |
intervention 1: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.
Microginon®: single oral dose on day 14 of treatment period intervention 2: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)
|
intervention 1: eslicarbazepine acetate and Microginon® intervention 2: Microginon®
| 1
|
Porto | N/A | Portugal | -8.61099 | 41.14961
| 0
|
NCT00898560
|
[
0
] | 33
|
RANDOMIZED
|
PARALLEL
| 7BASIC_SCIENCE
| 0NONE
| true
| 1FEMALE
| false
|
The purpose of this research study is to gain a better understanding of the changes that may occur in the breast when a woman uses an oral contraceptive (birth control pill). Some research indicates that women who use birth control pills with lower amounts of progestin (a hormone in the birth control pill) may have lower breast cell growth than women who use birth control pills with a higher amount of progestin; this research will examine that in detail.
| null |
Oral Contraceptive
|
Oral Contraceptives Breast Tissue
| null | 2
|
arm 1: Ortho-Novum® 1/35 is an oral contraceptive that contains more progestin. arm 2: Ovcon Fe® is an oral contraceptive that contains less progestin.
|
[
1,
1
] | 2
|
[
0,
0
] |
intervention 1: None intervention 2: None
|
intervention 1: Oral Contraceptive: Ortho-Novum® 1/35 intervention 2: Oral Contraceptive: Ovcon Fe®
| 1
|
Los Angeles | California | United States | -118.24368 | 34.05223
| 0
|
NCT00972439
|
[
3
] | 557
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.
| null |
Painful Diabetic Neuropathy
|
pain diabetes neuropathy
| null | 6
|
arm 1: ESL 400 mg twice daily (BID) arm 2: ESL 800 mg once-daily (QD) arm 3: Eslicarbazepine 600 mg twice daily arm 4: Eslicarbazepine acetate 1200 mg once daily arm 5: Eslicarbazepine acetate 800 mg twice daily arm 6: Placebo
|
[
0,
0,
0,
0,
0,
2
] | 2
|
[
0,
0
] |
intervention 1: Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period. intervention 2: oral route
|
intervention 1: Eslicarbazepine acetate intervention 2: Placebo
| 0
| null | 0
|
NCT00980746
|
[
4
] | 288
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.
|
In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory drug (NSAID) or paracetamol or a weak opioid. This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who previously did not receive any strong opioids. The drug class of opioid analgesics can broadly be classified into strong and weak. Weak opioids (for example tramadol, codeine, dihydrocodeine and tilidine) are useful for mild to moderate pain and the strong opioids (for example morphine, fentanyl and hydromorphone) are useful for moderate to severe pain of different origin. OROS hydromorphone is an opioid, which is available in a prolonged-release tablet in different dosage strengths. The primary aim of the study is to test the efficacy of OROS hydromorphone against placebo at an individual dose sufficient to control the pain and to establish the usefulness of a new low-dose formulation of OROS hydromorphone (4 mg hydromorphone per tablet) for initiating the treatment and for dose titration. The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured. The safety of the treatment will be recorded by measuring blood pressure, heart rate, and respiratory rate.This clinical trial is a placebo-controlled trial, meaning that one group of patients will receive the drug to be tested (OROS hydromorphone) while the control group receives an optically identical tablet with no active ingredient, a so-called placebo. A total number of 270 patients will be enrolled in this clinical trial and assigned to one of two treatment arms at an equal ratio (i.e. 135 patients per treatment). Patients will be randomly assigned to one of the two treatment arms, like flipping a coin to decide which treatment they will receive. Neither the patient nor the doctor will know to which of the two treatment arms the patient is assigned to and neither the patient nor the doctor can influence the assignment to the treatment arm. During the whole treatment period paracetamol will be allowed to be taken as needed in case of pain. Medical history and physical exam will be conducted during the screening visit, followed in 1 week by the baseline visit where after completing several questionnaires assessing pain, physical functioning quality of life and sleep quality, the patient will be assigned to one of two treatment groups. After starting the study treatment the patient will visit the doctor 7 times: at week 1, 2, 3, 4, 8, 12, 16 and at a follow-up visit after the end of the treatment period at week 16. At week 16 questionnaires will again be completed and the results will be compared to the baseline findings. 4, 8, 12, 16, 24 or 32 mg of OROS hydromorphone tablets or matching placebo tablets taken for 16 weeks. All tablets are taken by mouth at the same time each day in the morning. Tablets have to be swallowed whole without chewing or crushing. After completion of the treatment duration (or at early withdrawal), the study medication is gradually tapered down over a maximum of 6 days.
|
Pain Osteoarthritis, Hip Osteoarthritis, Knee
|
Osteoarthritis Strong pain killer Strong opioid Low starting dose Fewer side effects Physical functioning Pain control Quality of life Sleep quality
| null | 2
|
arm 1: OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks arm 2: Placebo placebo tablet once daily for 16 weeks
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: 4 to 32 mg taken orally once daily for 16 weeks intervention 2: placebo tablet once daily for 16 weeks
|
intervention 1: OROS hydromorphone HCl intervention 2: Placebo
| 12
|
Klatovy | N/A | Czechia | 13.29505 | 49.39552
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Pelhøimov | N/A | Czechia | N/A | N/A
Prague | N/A | Czechia | 14.42076 | 50.08804
Roudnice nad Labem | N/A | Czechia | 14.26175 | 50.42528
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.76667
Iași | N/A | Romania | 27.6 | 47.16667
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Hlohovec | N/A | Slovakia | 17.8031 | 48.43174
Piešťany | N/A | Slovakia | 17.82591 | 48.59479
London | N/A | United Kingdom | -0.12574 | 51.50853
| 0
|
NCT00980798
|
[
5
] | 18
|
RANDOMIZED
|
CROSSOVER
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
Chronic Obstructive Pulmonary Disease (COPD) is a major worldwide problem.Steroids inhalers are now an established treatment for COPD. Inhaled steroids can have a number of bad effects including suppression of the adrenal glands because of absorption. A previous study in patients with COPD.
C-reactive Protein (CRP) is a peptide produced in the liver in response to inflammation. Elevated circulating levels of CRP are associated with heart conditions. High levels of CRP have also been found in patients with COPD. In some studies, steroid inhalers have reduced CRP levels, and that of other inflammatory mediators, in patients with COPD. It is unknown whether this reflects a reduction in lung inflammation or an effect of systemically absorbed corticosteroid.
It is proposed to investigate the link between inhaled corticosteroid and serum CRP, lung inflammation (measured by exhaled nitric oxide) and systemic absorption of steroids.
| null |
COPD
| null | 2
|
arm 1: FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks. After a washout period of 2 weeks, they then received FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. arm 2: FP matched placebo pMDI one puff twice daily for two weeks then FP four puffs twice daily for two weeks. After a washout period of 2 weeks, they then received FP 250μg per actuation pMDI one puff twice daily (total daily dose 500μg) for two weeks then FP 250μg per actuation pMDI four puffs twice daily (total daily dose 2000μg) for two weeks.
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: None intervention 2: None
|
intervention 1: Fluticasone propionate intervention 2: Placebo
| 0
| null | 0
|
NCT00995475
|
|
[
5
] | 18
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 4QUADRUPLE
| true
| 1FEMALE
| true
|
In the United States, the majority of first-trimester surgical abortions are performed in outpatient clinics that utilize a wide variety of oral and intravenous regimens for pain control. The specific aim of this study is to evaluate the equivalency of intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg) for first-trimester surgical abortions. The investigators hypothesize that oral moderate sedation and intravenous moderate sedation will be equivalent in controlling pain as measured by a difference of +/- 10 on a 100-point (range 0-100) visual analog pain scale.
|
Approximately 50% of pregnancies in the United States are unintended and about 50% of these end in an induced abortion. In 2000, approximately 1.31 million abortions were performed in the United States, approximately 88% of which were less than 12 weeks gestational age. There has been a movement toward performing elective abortions in the ambulatory care setting; however this can provide a dilemma in terms of the procedural anesthesia. In fact, general anesthesia for induced abortions has been associated with an increased incidence of complications and death.5
The paracervical block (PCB) alone has been shown to reduce pain from cervical dilation and tenaculum placement. Slower injection and greater volume have been associated with greater pain control, possibly related to an effect on tissue distension as well as to nerve blockade.6,7,8 However, women's perception of pain continues to be significant with PCB alone.
A majority of high-volume first trimester providers (abortion clinics) offer intravenous moderate sedation. However, many individual practitioners are limited in their ability to provide outpatient moderate sedation, and research has shown mixed results about its efficacy. There continues to be a dilemma in terms of what constitutes optimal anesthesia for first trimester abortions to maximize pain control and minimize side effects and duration of hospital/clinic stay for the patients. A randomized, double blind, placebo controlled trial of intravenous fentanyl (50-100 mcg) with local anesthesia versus placebo and local anesthesia alone in 368 participants found that fentanyl, when compared with placebo, reduced the pain of first trimester abortion by 1.0 point on an 11-point verbal numerical scale. The investigators concluded that this pain reduction was of questionable clinical significance and less than what study participants desired (2.0 points). Another randomized, double blind, placebo controlled study in 100 participants compared local anesthesia alone to local anesthesia with intravenous fentanyl (25mcg) and midazolam (2mg) for first trimester suction curettage. There was no statistically significant difference in pain scores between the groups. However, patients who received intravenous sedation reported increased satisfaction with their abortion procedure.11
There is some evidence of good pain control with oral and sublingual analgesia. Preliminary data from a study performed at the UCSF Mt. Zion Women's Options Clinic between 11/04 and 12/05 (Meckstroth H10873-25519) of 120 women undergoing first trimester abortions who received sublingual lorazepam, ibuprofen, and cervical block revealed that 84.5% of patients reported their pain as acceptable during the procedure with 4.8% considering their pain level unacceptable and 10.7% unsure.
Considering barriers to abortion access, developing an adequate medication regimen that does not require the monitoring and expense of moderate sedation could be very helpful in encouraging more providers to offer abortion. . Given that many patients pay directly for abortions, increasing the cost of services can be prohibitive for many women. Oral medications may also be more appealing to patients seeking sedation but who are fearful of needles. We hope to demonstrate that pain will be adequately controlled with sublingual lorazepam and oral ibuprofen- ideal medications for the clinic setting.
Currently, the standard of care in the SFGH Women's Option Center is moderate sedation with IV fentanyl and midazolam. We will conduct a randomized control trial to evaluate moderate sedation vs. sublingual lorazepam, oral ibuprofen, and hydrocodone/acetaminophen to assess pain control and satisfaction in patients undergoing first trimester abortions. Both groups will receive local cervical block analgesia.
The proposed study is a randomized, double-blind, controlled trial to be conducted at the San Francisco General Hospital (SFGH) Women's Options Center evaluating the equivalency of intravenous moderate sedation (fentanyl 100 mcg plus midazolam 2 mg) vs oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetominophen 5/500 mg, and ibuprofen 800 mg) for first trimester surgical abortions.
The study participants will be derived from the SFGH Women's Options Center. On average, the SFGH Women's Options Center performs about 2200 abortions per year, of which 50% are in the first trimester, and intravenous moderate sedation is currently the standard pain control regimen, utilized in nearly 100% of procedures. In the SFGH's sister clinic at Mt. Zion and at Planned Parenthood Golden Gate and its affiliates, various regimes of oral analgesia/anxiolysis are utilized instead. Both are considered standard of care for early abortion both locally and nationally.
|
Undesired Intrauterine Pregnancy First Trimester Pregnancy
|
abortion uterine aspiration pain control
| null | 2
|
arm 1: None arm 2: None
|
[
1,
1
] | 1
|
[
0
] |
intervention 1: Intravenous moderate sedation (fentanyl 100 mcg and midazolam 2 mg) versus oral analgesia/anxiolysis (lorazepam 2 mg sublingual, hydrocodone/acetaminophen 5/500 mg, and ibuprofen 800 mg)
|
intervention 1: Intravenous moderate sedation versus oral medication
| 1
|
San Francisco | California | United States | -122.41942 | 37.77493
| 0
|
NCT01011634
|
[
2
] | 58
|
RANDOMIZED
|
CROSSOVER
| null | 0NONE
| true
| 0ALL
| false
|
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted state.
|
Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in the relief of moderate to severe malignant and non-malignant pain.
|
Healthy
|
Healthy subjects Opioid Healthy volunteers
| null | 2
|
arm 1: Reformulated OXY 80 mg (Totowa) x 1 dose arm 2: Reformulated OXY 80 mg (Wilson) x 1 dose
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food. intervention 2: Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.
|
intervention 1: Reformulated OXY (Totowa) (oxycodone HCl) intervention 2: Reformulated OXY (Wilson) (oxycodone HCl)
| 1
|
Honolulu | Hawaii | United States | -157.85833 | 21.30694
| 0
|
NCT01101321
|
[
0
] | 84
|
RANDOMIZED
|
CROSSOVER
| 7BASIC_SCIENCE
| 2DOUBLE
| false
| 0ALL
| false
|
The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.
|
The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.
|
Tobacco Dependence
|
Smoking Cessation Nicotine
| null | 3
|
arm 1: An experimental 2 mg nicotine product coded "STD" arm 2: An experimental 2 mg nicotine product coded "STE" arm 3: A comparative 2 mg marketed nicotine product called Nicorette Microtab
|
[
0,
0,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: 2 mg Single-dose of experimental nicotine product coded "STD" intervention 2: 2 mg Single-dose of experimental nicotine product coded "STE" intervention 3: A comparative 2 mg Single-dose of marketed tablet
|
intervention 1: Code STD intervention 2: Code STE intervention 3: Nicorette Microtab
| 1
|
Lund | N/A | Sweden | 13.19321 | 55.70584
| 0
|
NCT01238640
|
[
5
] | 35
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The purpose of this study is to evaluate the efficacy and safety of Transdermal therapeutic system (TTS) fentanyl patches (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in knee osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become painful and stiff) participants with moderate to severe pain.
|
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, "unblinded"), single-arm, prospective study (study following participants forward in time) of TTS-fentanyl matrix form in knee osteoarthritis participants. The study consists of 3 phases: a screening phase, an open label treatment phase consisting of 2 periods, and an evaluation phase. The first patch will be applied on the first day of treatment phase by the investigator, and sufficient patches until Day 30 will be provided to the participant with the instructions to apply the patch. The TTS-fentanyl dose will normally be increased, if needed by 12.5 microgram per hour taking into account the daily dose of supplemental paracetamol required by the participant. Efficacy with regard to pain control will be recorded principally by the participant via questionnaires in a daily diary. This record will be used to support more detailed assessments at study visits on Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Participants' safety will be monitored.
|
Osteoarthritis, Knee
|
Osteoarthritis, Knee Transdermal therapeutic system (TTS) fentanyl Durogesic
| null | 1
|
arm 1: Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
|
[
0
] | 1
|
[
0
] |
intervention 1: None
|
intervention 1: TTS-fentanyl
| 1
|
Bangkok | N/A | Thailand | 100.50144 | 13.75398
| 0
|
NCT01742897
|
[
2
] | 16
|
RANDOMIZED
|
CROSSOVER
| 0TREATMENT
| 2DOUBLE
| true
| 2MALE
| false
|
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)
| null |
Parkinson's Disease (PD)
|
Parkinson's disease (PD) Opicapone Bia 9-1067
| null | 4
|
arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
Every period with concomitant single oral administration of Prolopa® 100-25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
Every period with concomitant single oral administration of Prolopa® 100-25 arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
Every period with concomitant single oral administration of Prolopa® 100-25 arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
Every period with concomitant single oral administration of Prolopa® 100-25
|
[
0,
0,
0,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: None intervention 2: None intervention 3: levodopa/benserazide 100/25 mg
|
intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Prolopa®
| 1
|
Mount Royal | Quebec | Canada | -73.64918 | 45.51675
| 0
|
NCT02169895
|
[
2
] | 47
|
RANDOMIZED
|
CROSSOVER
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| null |
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.
The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium bromide when administered as fixed dose combination or as single-agent therapy.
| null |
Pulmonary Disease, Chronic Obstructive
| null | 3
|
arm 1: None arm 2: None arm 3: None
|
[
0,
1,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: None intervention 2: None intervention 3: None
|
intervention 1: BI 1744 CL intervention 2: BI 1744 CL/Tiotropium FDC intervention 3: Tiotropium
| 0
| null | 0
|
NCT02231177
|
|
[
3
] | 253
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The purpose of the study is to assess the efficacy and safety of a range of doses of SCH 420814 (preladenant) when used together with a stable dose of L-dopa/dopa decarboxylase inhibitor to treat Parkinson's disease. In this study, we will be comparing 3 doses (1 mg, 2 mg, and 5 mg taken twice a day) of preladenant with placebo (sugar pill). Following an Interim Analysis (temporary hold for new enrollment-ongoing subjects will continue on treatment) to review drug safety, a new dose group of 10 mg (taken twice a day) may be added.
Approximately 160 participants will be randomized in this study in approximately 22 study centers worldwide for the first part of this study. Following the Interim Analysis, 40 new participants may be added, for a total of 200 participants. The study is double blind, which means neither you nor your study doctor will know whether you are receiving the study medication or placebo.
| null |
Parkinson Disease Movement Disorders Central Nervous System Diseases Neurodegenerative Diseases Brain Diseases
| null | 5
|
arm 1: Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period. arm 2: Participants received preladenant 2 mg BID during the 12-week treatment period. arm 3: Participants received preladenant 5 mg BID during the 12-week treatment period. arm 4: Participants received preladenant 10 mg BID during the 12-week treatment period. arm 5: Participants received preladenant matching placebo BID during the 12-week treatment period.
|
[
0,
0,
0,
0,
2
] | 7
|
[
0,
0,
0,
0,
0,
0,
0
] |
intervention 1: 1 mg BID capsules intervention 2: 2 mg BID capsules intervention 3: 5 mg BID capsules intervention 4: 10 mg BID capsules intervention 5: BID capsules intervention 6: Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa). intervention 7: Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O-methyl transferase (COMT) inhibitor entacapone.
|
intervention 1: Preladenant intervention 2: Preladenant intervention 3: Preladenant intervention 4: Preladenant intervention 5: Placebo intervention 6: L-dopa intervention 7: Other Parkinson's Disease treatments
| 0
| null | 1
|
NCT00406029
|
|
[
2
] | 50
|
NON_RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.
|
The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escalated. In Part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded cohort to explore safety and efficacy of dalotuzumab.
|
Advanced Solid Tumors
| null | 7
|
arm 1: Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 2: Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 3: Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 4: Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 5: Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 6: Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months. arm 7: Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
|
[
0,
0,
0,
0,
0,
0,
0
] | 1
|
[
0
] |
intervention 1: Administered as an IV infusion over one to two hours
|
intervention 1: dalotuzumab
| 0
| null | 0
|
NCT00635778
|
|
[
4
] | 435
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The objectives of this study are to assess the safety and efficacy of treatment with pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone 1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.
|
This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately 400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either 2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone administered in divided doses three times per day (TID) with food. 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 FVC or a ≥ 15% absolute decrease in percent predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted IPF therapies in addition to their blinded study drug. Permitted IPF therapies include corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).
|
Idiopathic Pulmonary Fibrosis
|
Idiopathic Pulmonary Fibrosis Lung Pirfenidone InterMune
| null | 3
|
arm 1: Active arm 1, 2403 mg/day pirfenidone dose group. arm 2: Active arm 2, 1197 mg/day pirfenidone. arm 3: Placebo equivalent.
|
[
1,
1,
2
] | 2
|
[
0,
0
] |
intervention 1: 1197 or 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
|
NCT00287716
|
[
3
] | 156
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.
| null |
Pulmonary Disease, Chronic Obstructive
|
Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Pulmonary Disease Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease COPD COAD
| null | 3
|
arm 1: Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening arm 2: Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening arm 3: Formoterol fumarate 12 µg twice-daily (BID)
|
[
0,
0,
1
] | 4
|
[
0,
0,
0,
0
] |
intervention 1: Inhaled aclidinium bromide 200 µg/formoterol fumarate 12 µg fixed-dose combination once-daily in the morning intervention 2: Inhaled formoterol fumarate 12 µg twice-daily (BID) intervention 3: Inhaled placebo to formoterol fumarate once-daily in the evening intervention 4: Inhaled formoterol fumarate 12 μg once-daily in the evening
|
intervention 1: Once-daily aclidinium/formoterol intervention 2: Twice-daily formoterol fumarate intervention 3: Placebo to formoterol fumarate intervention 4: Once-daily formoterol fumarate
| 40
|
Tucson | Arizona | United States | -110.92648 | 32.22174
Tucson | Arizona | United States | -110.92648 | 32.22174
Fullerton | California | United States | -117.92534 | 33.87029
Lakewood | California | United States | -118.13396 | 33.85363
Rancho Mirage | California | United States | -116.41279 | 33.73974
Redlands | California | United States | -117.18254 | 34.05557
San Diego | California | United States | -117.16472 | 32.71571
San Jose | California | United States | -121.89496 | 37.33939
Stockton | California | United States | -121.29078 | 37.9577
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Hartford | Connecticut | United States | -72.68509 | 41.76371
New Britain | Connecticut | United States | -72.77954 | 41.66121
Waterbury | Connecticut | United States | -73.0515 | 41.55815
DeLand | Florida | United States | -81.30312 | 29.02832
Panama City | Florida | United States | -85.65983 | 30.15946
Tamarac | Florida | United States | -80.24977 | 26.21286
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Austell | Georgia | United States | -84.63438 | 33.81261
Blue Ridge | Georgia | United States | -84.32409 | 34.86397
Bowling Green | Kentucky | United States | -86.4436 | 36.99032
Hazard | Kentucky | United States | -83.19323 | 37.24954
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899
Rochester | Minnesota | United States | -92.4699 | 44.02163
Florissant | Missouri | United States | -90.32261 | 38.78922
Saint Charles | Missouri | United States | -90.48123 | 38.78394
St Louis | Missouri | United States | -90.19789 | 38.62727
Albany | New York | United States | -73.75623 | 42.65258
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Columbus | Ohio | United States | -82.99879 | 39.96118
Medford | Oregon | United States | -122.87559 | 42.32652
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
East Providence | Rhode Island | United States | -71.37005 | 41.81371
Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Dallas | Texas | United States | -96.80667 | 32.78306
McKinney | Texas | United States | -96.61527 | 33.19762
Midvale | Utah | United States | -111.89994 | 40.61106
Richmond | Virginia | United States | -77.46026 | 37.55376
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
| 0
|
NCT00706914
|
[
4
] | 848
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 2DOUBLE
| false
| 0ALL
| null |
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
| null |
Chemotherapy-Induced Nausea and Vomiting
| null | 2
|
arm 1: Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. arm 2: Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
|
[
5,
5
] | 6
|
[
0,
0,
0,
0,
0,
0
] |
intervention 1: aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. intervention 2: Ondansetron 8 mg capsule Three day treatment period. intervention 3: dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. intervention 4: fosaprepitant dimeglumine 115 mg intervention 5: dexamethasone 12mg Pbo tablets. intervention 6: Aprepitant 80 mg \& 125 mg Pbo capsules.
|
intervention 1: aprepitant intervention 2: Comparator: ondansetron intervention 3: Comparator: dexamethasone intervention 4: Comparator: fosaprepitant dimeglumine intervention 5: Comparator; Placebo (unspecified) intervention 6: Comparator; Placebo (unspecified)
| 0
| null | 0
|
NCT00337727
|
|
[
3
] | 252
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 1FEMALE
| false
|
This study is designed to assess the effects of elagolix versus subcutaneous depot medroxyprogesterone acetate (DMPA-SC; also known as depo-provera) on bone mineral density (BMD) during treatment for 24 weeks with a subsequent 24-week post-treatment period.
| null |
Endometriosis
| null | 3
|
arm 1: Participants received elagolix 75 mg orally twice a day (BID) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 2: Participants received elagolix 150 mg orally once a day (QD) for 24 weeks and placebo to DMPA-SC by subcutaneous injection at weeks 1 and 12. arm 3: Participants received placebo to elagolix orally once a day for 24 weeks and DMPA-SC 104 mg by subcutaneous injection at weeks 1 and 12.
|
[
0,
0,
1
] | 4
|
[
0,
0,
0,
0
] |
intervention 1: Provided as tablets for oral administration intervention 2: Provided for subcutaneous injection in a prefilled syringe, 104 mg/0.65 mL per syringe. intervention 3: Matching placebo tablets for oral administration intervention 4: Matching placebo for subcutaneous injection in a pre-filled syringe
|
intervention 1: Elagolix intervention 2: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) intervention 3: Placebo to Elagolix intervention 4: Placebo to DMPA-SC
| 0
| null | 0
|
NCT00437658
|
|
[
3
] | 84
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
| null |
Oesophagitis, Eosinophilic
|
eosinophilic mepolizumab esophagitis
| null | 3
|
arm 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 2: Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8. arm 3: Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
|
[
0,
0,
0
] | 1
|
[
0
] |
intervention 1: Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
|
intervention 1: mepolizumab
| 29
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
San Diego | California | United States | -117.16472 | 32.71571
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Springfield | Illinois | United States | -89.64371 | 39.80172
Evansville | Indiana | United States | -87.55585 | 37.97476
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Southfield | Michigan | United States | -83.22187 | 42.47337
Troy | Michigan | United States | -83.14993 | 42.60559
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Kansas City | Missouri | United States | -94.57857 | 39.09973
St Louis | Missouri | United States | -90.19789 | 38.62727
New York | New York | United States | -74.00597 | 40.71427
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Norfolk | Virginia | United States | -76.28522 | 36.84681
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Brisbane | Queensland | Australia | 153.02809 | -27.46794
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Kingston | Ontario | Canada | -76.48098 | 44.22976
London | Ontario | Canada | -81.23304 | 42.98339
Montreal | Quebec | Canada | -73.58781 | 45.50884
Liverpool | N/A | United Kingdom | -2.97794 | 53.41058
London | N/A | United Kingdom | -0.12574 | 51.50853
Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
Watford | N/A | United Kingdom | -0.39602 | 51.65531
| 0
|
NCT00358449
|
[
3
] | 11
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects
| null |
Head and Neck Cancer
| null | 1
|
arm 1: None
|
[
0
] | 1
|
[
0
] |
intervention 1: Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
|
intervention 1: Paclitaxel
| 9
|
Kashiwa-shi | Chiba | Japan | N/A | N/A
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667
Yokohama | Kanagawa | Japan | 139.65 | 35.43333
Osaka | Osaka | Japan | 135.50107 | 34.69379
Sunto-gun | Shizuoka | Japan | N/A | N/A
Meguro-ku | Tokyo | Japan | N/A | N/A
Kanagawa | N/A | Japan | 139.91667 | 37.58333
Tochigi | N/A | Japan | 139.73333 | 36.38333
| 0
|
NCT00971867
|
|
[
3
] | 159
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 3TRIPLE
| false
| 0ALL
| true
|
To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study.
| null |
Osteoarthritis, Knee
|
PF-04136309 CCR2 osteoarthritic pain knee phase 2 placebo multicenter double-blind placebo-controlled
| null | 2
|
arm 1: None arm 2: None
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: 125 mg capsules. Dose will be 4 capsules BID for 2 weeks for a total of 500 mg for each dosing interval. intervention 2: Placebo will be matched to PF-04136309. Dose, frequency, and duration same as PF-04136309.
|
intervention 1: PF-04136309 intervention 2: Placebo
| 22
|
DeLand | Florida | United States | -81.30312 | 29.02832
South Miami | Florida | United States | -80.29338 | 25.7076
South Miami | Florida | United States | -80.29338 | 25.7076
Overland Park | Kansas | United States | -94.67079 | 38.98223
Overland Park | Kansas | United States | -94.67079 | 38.98223
Madisonville | Kentucky | United States | -87.49889 | 37.3281
Chesterfield | Missouri | United States | -90.57707 | 38.66311
City of Saint Peters | Missouri | United States | -90.62651 | 38.80033
Creve Coeur | Missouri | United States | -90.42262 | 38.66089
New York | New York | United States | -74.00597 | 40.71427
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Warwick | Rhode Island | United States | -71.41617 | 41.7001
Warwick | Rhode Island | United States | -71.41617 | 41.7001
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Arlington | Virginia | United States | -77.10428 | 38.88101
Arlington | Virginia | United States | -77.10428 | 38.88101
Clarksburg | West Virginia | United States | -80.34453 | 39.28065
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
| 0
|
NCT00689273
|
[
4
] | 680
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects
| null |
Bipolar Disorder
| null | 3
|
arm 1: None arm 2: None arm 3: None
|
[
2,
0,
0
] | 3
|
[
0,
0,
0
] |
intervention 1: Placebo with mood stabilizer (either lithium or divalproex) intervention 2: Flexible dosing, 20-40mg BID, with a mood stabilizer (either lithium or divalproex) intervention 3: Flexible dosing, 60-80mg BID, with a mood stabilizer (either lithium or divalproex)
|
intervention 1: Placebo intervention 2: Ziprasidone intervention 3: Ziprasidone
| 66
|
Dothan | Alabama | United States | -85.39049 | 31.22323
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Cerritos | California | United States | -118.06479 | 33.85835
Costa Mesa | California | United States | -117.91867 | 33.64113
Escondido | California | United States | -117.08642 | 33.11921
Glendale | California | United States | -118.25508 | 34.14251
Huntington Beach | California | United States | -117.99923 | 33.6603
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
National City | California | United States | -117.0992 | 32.67811
Oceanside | California | United States | -117.37948 | 33.19587
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
Torrance | California | United States | -118.34063 | 33.83585
Hartford | Connecticut | United States | -72.68509 | 41.76371
New Britain | Connecticut | United States | -72.77954 | 41.66121
DeLand | Florida | United States | -81.30312 | 29.02832
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Gainesville | Florida | United States | -82.32483 | 29.65163
Hollywood | Florida | United States | -80.14949 | 26.0112
Jacksonville | Florida | United States | -81.65565 | 30.33218
Lauderhill | Florida | United States | -80.21338 | 26.14036
North Miami | Florida | United States | -80.18671 | 25.89009
Atlanta | Georgia | United States | -84.38798 | 33.749
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Des Plaines | Illinois | United States | -87.8834 | 42.03336
Hoffman Estates | Illinois | United States | -88.0798 | 42.04281
Hoffman Estates | Illinois | United States | -88.0798 | 42.04281
Schaumburg | Illinois | United States | -88.08341 | 42.03336
Greenwood | Indiana | United States | -86.10665 | 39.61366
Prairie Village | Kansas | United States | -94.63357 | 38.99167
Glen Burnie | Maryland | United States | -76.62469 | 39.16261
Flowood | Mississippi | United States | -90.13898 | 32.30959
Kansas City | Missouri | United States | -94.57857 | 39.09973
Saint Charles | Missouri | United States | -90.48123 | 38.78394
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Clementon | New Jersey | United States | -74.98294 | 39.8115
Princeton | New Jersey | United States | -74.65905 | 40.34872
Amityville | New York | United States | -73.41707 | 40.67899
Buffalo | New York | United States | -78.87837 | 42.88645
Cedarhurst | New York | United States | -73.7243 | 40.62288
Elmsford | New York | United States | -73.82013 | 41.0551
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cleveland | Ohio | United States | -81.69541 | 41.4995
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston | South Carolina | United States | -79.93275 | 32.77632
Dallas | Texas | United States | -96.80667 | 32.78306
Irving | Texas | United States | -96.94889 | 32.81402
Plano | Texas | United States | -96.69889 | 33.01984
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Richmond | Virginia | United States | -77.46026 | 37.55376
Richmond | Virginia | United States | -77.46026 | 37.55376
Bellevue | Washington | United States | -122.20068 | 47.61038
Kirkland | Washington | United States | -122.20874 | 47.68149
| 1
|
NCT00312494
|
|
[
3
] | 61
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine
| null |
Metastatic Pancreatic Cancer
| null | 2
|
arm 1: Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. All medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab. arm 2: Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
|
[
0,
1
] | 4
|
[
2,
2,
0,
2
] |
intervention 1: I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1 intervention 2: 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. intervention 3: 1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. intervention 4: I.V.infusions of 250 mg/m2 (over 60 minutes) weekly
|
intervention 1: cetuximab intervention 2: bevacizumab intervention 3: gemcitabine intervention 4: cetuximab
| 16
|
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
San Francisco | California | United States | -122.41942 | 37.77493
Stamford | Connecticut | United States | -73.53873 | 41.05343
Miami | Florida | United States | -80.19366 | 25.77427
Orlando | Florida | United States | -81.37924 | 28.53834
Orlando | Florida | United States | -81.37924 | 28.53834
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Marietta | Georgia | United States | -84.54993 | 33.9526
Metairie | Louisiana | United States | -90.15285 | 29.98409
Billings | Montana | United States | -108.50069 | 45.78329
Concord | North Carolina | United States | -80.58158 | 35.40888
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston | South Carolina | United States | -79.93275 | 32.77632
Arlington | Texas | United States | -97.10807 | 32.73569
Dallas | Texas | United States | -96.80667 | 32.78306
| 1
|
NCT00326911
|
|
[
4
] | 1,306
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| true
|
The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone
|
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 pioglitazone (rescue medication) added onto their blinded study medication
|
Diabetes
| null | 4
|
arm 1: PLUS open-label pioglitazone (as needed as rescue medication) arm 2: PLUS open-label pioglitazone (as needed as rescue medication) arm 3: PLUS open-label pioglitazone (as needed as rescue medication) arm 4: PLUS open-label pioglitazone (as needed as rescue medication)
|
[
0,
0,
0,
1
] | 5
|
[
0,
0,
0,
0,
0
] |
intervention 1: Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT) intervention 2: Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT) intervention 3: Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT) intervention 4: Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 15-45 mg, as needed (12 months LT)
|
intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Metformin intervention 4: Placebo intervention 5: pioglitazone
| 211
|
Concord | California | United States | -122.03107 | 37.97798
Encinitas | California | United States | -117.29198 | 33.03699
Orange | California | United States | -117.85311 | 33.78779
Santa Monica | California | United States | -118.49138 | 34.01949
Spring Valley | California | United States | -116.99892 | 32.74477
Stockton | California | United States | -121.29078 | 37.9577
Coral Gables | Florida | United States | -80.26838 | 25.72149
Gainesville | Florida | United States | -82.32483 | 29.65163
Kissimmee | Florida | United States | -81.41667 | 28.30468
Marianna | Florida | United States | -85.22687 | 30.77436
Miami | Florida | United States | -80.19366 | 25.77427
Perry | Georgia | United States | -83.73157 | 32.45821
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Vernon Hills | Illinois | United States | -87.97952 | 42.21947
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Wichita | Kansas | United States | -97.33754 | 37.69224
Excelsior Springs | Missouri | United States | -94.22606 | 39.33917
North Las Vegas | Nevada | United States | -115.1175 | 36.19886
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Durham | North Carolina | United States | -78.89862 | 35.99403
Morehead City | North Carolina | United States | -76.72604 | 34.72294
Bellbrook | Ohio | United States | -84.07077 | 39.63562
Massillon | Ohio | United States | -81.52151 | 40.79672
Mentor | Ohio | United States | -81.33955 | 41.66616
Newark | Ohio | United States | -82.40126 | 40.05812
Uniontown | Pennsylvania | United States | -79.71643 | 39.90008
East Providence | Rhode Island | United States | -71.37005 | 41.81371
Greer | South Carolina | United States | -82.22706 | 34.93873
Fayetteville | Tennessee | United States | -86.57055 | 35.15203
Memphis | Tennessee | United States | -90.04898 | 35.14953
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Irving | Texas | United States | -96.94889 | 32.81402
Midland | Texas | United States | -102.07791 | 31.99735
New Braunfels | Texas | United States | -98.12445 | 29.703
Pearland | Texas | United States | -95.28605 | 29.56357
Rosenberg | Texas | United States | -95.80856 | 29.55718
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Falls Church | Virginia | United States | -77.17109 | 38.88233
Salem | Virginia | United States | -80.05476 | 37.29347
Spokane | Washington | United States | -117.42908 | 47.65966
Belgrano | Buenos Aires | Argentina | N/A | N/A
Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Chacabuco | Buenos Aires | Argentina | -60.47124 | -34.64203
La Plata | Buenos Aires | Argentina | -57.95442 | -34.92126
Morón | Buenos Aires | Argentina | -58.62205 | -34.65118
San Martín | Buenos Aires | Argentina | -57.75317 | -35.02575
San Pedro | Buenos Aires | Argentina | -59.66633 | -33.67918
Zárate | Buenos Aires | Argentina | -59.02423 | -34.09584
Mendoza | Mendoza Province | Argentina | -68.84582 | -32.88946
Salta | Salta Province | Argentina | -65.41999 | -24.80645
Salta | Salta Province | Argentina | -65.41999 | -24.80645
San Juan | San Juan Province | Argentina | -68.52568 | -31.53726
Rosario | Santa Fe Province | Argentina | -60.63932 | -32.94682
Lanus Este | Tucumán Province | Argentina | N/A | N/A
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Fortaleza | Ceará | Brazil | -38.54306 | -3.71722
Fortaleza | Ceará | Brazil | -38.54306 | -3.71722
Goiânia | Goiás | Brazil | -49.25389 | -16.67861
Belém | Pará | Brazil | -48.50444 | -1.45583
Recife | Pernambuco | Brazil | -34.88111 | -8.05389
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Campinas | São Paulo | Brazil | -47.06083 | -22.90556
Marília | São Paulo | Brazil | -49.94583 | -22.21389
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704
Bad | N/A | Germany | 9.83333 | 47.63333
Dresden | N/A | Germany | 13.73832 | 51.05089
Dresden | N/A | Germany | 13.73832 | 51.05089
Duisburg | N/A | Germany | 6.76516 | 51.43247
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Künzing | N/A | Germany | 13.08333 | 48.66667
Ludwigshafen | N/A | Germany | 9.06138 | 47.81663
Magdeburg | N/A | Germany | 11.62916 | 52.12773
Mainz | N/A | Germany | 8.2791 | 49.98419
Mannheim | N/A | Germany | 8.46694 | 49.4891
Saarbrücken | N/A | Germany | 7.00982 | 49.23262
Vellmar | N/A | Germany | 9.47974 | 51.35806
Wangen | N/A | Germany | 9.83247 | 47.6895
Eger | N/A | Hungary | 20.37329 | 47.90265
Érd | N/A | Hungary | 18.91361 | 47.39489
Gyula | N/A | Hungary | 21.28333 | 46.65
Szentes | N/A | Hungary | 20.2608 | 46.65834
Szigetvár | N/A | Hungary | 17.80554 | 46.04865
Panjagutta, Hyderabad | Andhra Pradesh | India | N/A | N/A
Vasanth Nagar | Bangalore | India | 77.59444 | 12.99182
Bangalore | Karnataka | India | 77.59369 | 12.97194
Pune | Maharashtra | India | 73.85535 | 18.51957
Kandivili West | Mumbai | India | N/A | N/A
Sarita Vihar | New Delhi | India | N/A | N/A
Chennai | Tamil Nadu | India | 80.27847 | 13.08784
Bangalore | N/A | India | 77.59369 | 12.97194
Chennai | N/A | India | 80.27847 | 13.08784
Haryāna | N/A | India | 76.98056 | 29.61611
Rajasthan | N/A | India | N/A | N/A
Rajasthan | N/A | India | N/A | N/A
Vellore, Tamilnadu | N/A | India | 79.13255 | 12.9184
Catania | N/A | Italy | 15.07041 | 37.49223
Genova | N/A | Italy | 11.87211 | 45.21604
Milan | N/A | Italy | 12.59836 | 42.78235
Perugia | N/A | Italy | 12.38878 | 43.1122
Ravenna | N/A | Italy | 12.20121 | 44.41344
Aguascalientes | Aguascalientes | Mexico | -102.2843 | 21.88262
Aguascalientes | Aguascalientes | Mexico | -102.2843 | 21.88262
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Cuernavaca | Morelos | Mexico | -99.23075 | 18.9261
Garza García | Nuevo León | Mexico | -99.81754 | 25.18305
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
Mérida | Yucatán | Mexico | -89.62318 | 20.967
Cebu City | N/A | Philippines | 123.89071 | 10.31672
Iloilo City | N/A | Philippines | 122.56444 | 10.69694
Manila | N/A | Philippines | 120.9822 | 14.6042
Marikina City | N/A | Philippines | 121.1133 | 14.6481
Pasig | N/A | Philippines | 121.0614 | 14.58691
Quezon City | N/A | Philippines | 121.0509 | 14.6488
Gniewkowo | N/A | Poland | 18.40785 | 52.89461
Gorzów Wielkopolski | N/A | Poland | 15.22878 | 52.73679
Izabelin | N/A | Poland | 20.81729 | 52.29992
Krakow | N/A | Poland | 19.93658 | 50.06143
Lublin | N/A | Poland | 22.56667 | 51.25
Michalow-Regionow | N/A | Poland | N/A | N/A
Warsaw | N/A | Poland | 21.01178 | 52.22977
Wroclaw | N/A | Poland | 17.03333 | 51.1
Zabrze | N/A | Poland | 18.78576 | 50.32492
Carolina | N/A | Puerto Rico | -65.95739 | 18.38078
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Rio Pieoras | N/A | Puerto Rico | N/A | N/A
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
Kemerovo | Russia | Russia | 86.08333 | 55.33333
Moscow | Russia | Russia | 37.61556 | 55.75222
Moscow | Russia | Russia | 37.61556 | 55.75222
Moscow | Russia | Russia | 37.61556 | 55.75222
Nizhny Novgorod | Russia | Russia | 44.00205 | 56.32867
Izhevsk | N/A | Russia | 53.20448 | 56.84976
Kirov | N/A | Russia | 49.66007 | 58.59665
Krasnodar | N/A | Russia | 38.97603 | 45.04484
Krasnodar | N/A | Russia | 38.97603 | 45.04484
Kursk | N/A | Russia | 36.18712 | 51.73758
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Nizhny Novgorod | N/A | Russia | 44.00205 | 56.32867
Novosibirsk | N/A | Russia | 82.94339 | 55.03442
Novosibirsk | N/A | Russia | 82.94339 | 55.03442
Perm | N/A | Russia | 56.25017 | 58.01046
Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135
Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135
Saint Peterburg | N/A | Russia | N/A | N/A
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saratov | N/A | Russia | 46.00861 | 51.54056
Saratov | N/A | Russia | 46.00861 | 51.54056
Saratov | N/A | Russia | 46.00861 | 51.54056
Saratov | N/A | Russia | 46.00861 | 51.54056
Smolensk | N/A | Russia | 32.04371 | 54.77944
Tuymen | N/A | Russia | N/A | N/A
Vladimir | N/A | Russia | 40.39658 | 56.13655
Volgograd | N/A | Russia | 44.50183 | 48.71939
Volgograd | N/A | Russia | 44.50183 | 48.71939
Yaroslaval | N/A | Russia | N/A | N/A
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Dniepropetrovsk | N/A | Ukraine | N/A | N/A
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Lutsk | N/A | Ukraine | 25.35024 | 50.75784
Lviv | N/A | Ukraine | 24.02324 | 49.83826
Lviv | N/A | Ukraine | 24.02324 | 49.83826
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Ternopil | N/A | Ukraine | 25.59067 | 49.55404
| 1
|
NCT00327015
|
|
[
3
] | 65
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.
|
CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine. The two drugs are present inside the liposome in a fixed 1:1 molar ratio. CPX-1 was developed as a means of delivering and preserving a fixed 1:1 molar ratio of the two drugs. This ratio was found in vitro and in vivo models of cancer to have synergistic anti-cancer activity and preservation and delivery of this ratio is important because other ratios of these two drugs have been found to be antagonistic or only additive. Both floxuridine and irinotecan HCl are active chemotherapeutic agents, each approved for clinical use in the United States and Canada for colorectal cancer. Current practice routinely administers 5- fluorouracil with irinotecan in combination regimens in first or second line treatment without the means of preserving the synergistic ratio.
|
Colorectal Neoplasms
|
Colorectal cancer Colorectal carcinoma Colonic cancer Rectal cancer
| null | 1
|
arm 1: None
|
[
0
] | 1
|
[
0
] |
intervention 1: CPX-1 Liposome Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs irinotecan HCl and floxuridine.
|
intervention 1: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
| 13
|
Greenbrae | California | United States | -122.5247 | 37.94854
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Coral Springs | Florida | United States | -80.2706 | 26.27119
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Savannah | Georgia | United States | -81.09983 | 32.08354
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Canton | Ohio | United States | -81.37845 | 40.79895
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Columbia | South Carolina | United States | -81.03481 | 34.00071
Nashville | Tennessee | United States | -86.78444 | 36.16589
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Montreal | Quebec | Canada | -73.58781 | 45.50884
| 1
|
NCT00361842
|
[
4
] | 429
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
|
This is a multi-center, open-label (doctors and patients know which drug is being administered), Phase IIIb clinical trial to evaluate differences in effectiveness, safety, and tolerability of darunavir/ritonavir by sex and/or race over a 48-week treatment period. This study will be conducted in HIV positive women and men who have been treated previously with antiretroviral therapy. This study will enroll 70% women and will be conducted in the U.S., Puerto Rico, Mexico and Canada in approximately 420 patients who will receive darunavir 600 mg and ritonavir 100 mg twice daily. The primary objective of this study is to determine the percentage of patients who achieve virologic response, defined as a viral load (VL) of \<50 copies/mL at week 48. Secondary study objectives include comparisons of endpoints between women and men as well as race across multiple parameters including but not limited to change in CD4 count from baseline to week 48, time to loss of virologic response (TLOVR), changes in metabolic parameters (blood chemistry), etc.
Within 4 weeks after the Screening Visit (initial visit with investigator to determine eligibility), the Investigator should have received all data required to determine the patient's eligibility and will construct the individual Optimized Background Regimen (OBR) that will be used during the treatment period in combination with darunavir/ritonavir for those patients enrolled in the study. The OBR will consist of additional antiretroviral (ARV) agents that will also be administered during the study chosen by the Investigator and based on resistance testing and prior treatment history. The study Sponsor will provide the following ARV agents, that may be used as options for the OBR: TMC 125 (investigational non-nucleoside reverse transcriptase inhibitor; NNRTI); Truvada (tenofovir/emtricitabine); Viread (tenofovir); Emtriva (emtricitabine); Zidovudine. Other NRTIs (nucleoside reverse transcriptase inhibitors) or NNRTIs may be used at the discretion of the Investigator, but will not be provided by the Sponsor. The Baseline Visit (Day 1) will be followed by a 48-week treatment period during which patients will be evaluated at Weeks 4, 8, 12, 16, 24, 36, 48 and at a final Follow-Up Visit during Week 52. (total of 10 visits from Screening to final visit). At a number of visits throughout the study, blood samples will be obtained to assess defined laboratory values, safety parameters and to determine concentrations of study drugs darunavir, TMC125 (if applicable) and ritonavir). Patients will be assessed for change in CD4 count and HIV-RNA throughout the study. At each visit, vital signs will be assessed and patients will be asked about any untoward medical occurrences and these will be recorded as adverse events (AEs) and/or HIV-related events. Detailed definitions and reporting procedures for AEs will be provided as part of the protocol. Study patients will receive PREZISTA (darunavir) 600 mg boosted with 100 mg of ritonavir orally (by mouth) twice a day in combination with other antiretroviral drugs for 48 weeks.
|
HIV Infectious
|
HIV AIDS Immunodeficiency Virus, Human Females Women PREZISTA darunavir TMC114 Protease Inhibitor
| null | 1
|
arm 1: darunavir 600mg bid for 48 wks,ritonavir 100mg bid for 48 wks
|
[
0
] | 2
|
[
0,
0
] |
intervention 1: 600mg bid for 48 wks intervention 2: 100mg bid for 48 wks
|
intervention 1: darunavir intervention 2: ritonavir
| 46
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
Torrance | California | United States | -118.34063 | 33.83585
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
North Palm Beach | Florida | United States | -80.08199 | 26.81756
Orlando | Florida | United States | -81.37924 | 28.53834
Pensacola | Florida | United States | -87.21691 | 30.42131
Port Saint Lucie | Florida | United States | -80.35033 | 27.29393
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Atlanta | Georgia | United States | -84.38798 | 33.749
Savannah | Georgia | United States | -81.09983 | 32.08354
Chicago | Illinois | United States | -87.65005 | 41.85003
Kansas City | Kansas | United States | -94.62746 | 39.11417
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Detroit | Michigan | United States | -83.04575 | 42.33143
St Louis | Missouri | United States | -90.19789 | 38.62727
Neptune City | New Jersey | United States | -74.02792 | 40.20011
Newark | New Jersey | United States | -74.17237 | 40.73566
New York | New York | United States | -74.00597 | 40.71427
The Bronx | New York | United States | -73.86641 | 40.84985
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Durham | North Carolina | United States | -78.89862 | 35.99403
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United States | -96.80667 | 32.78306
Harlingen | Texas | United States | -97.6961 | 26.19063
Houston | Texas | United States | -95.36327 | 29.76328
Longview | Texas | United States | -94.74049 | 32.5007
San Antonio | Texas | United States | -98.49363 | 29.42412
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Charlottesville | Virginia | United States | -78.47668 | 38.02931
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Toronto | Ontario | Canada | -79.39864 | 43.70643
Montreal | Quebec | Canada | -73.58781 | 45.50884
Ponce | PR | Puerto Rico | -66.62398 | 18.01031
Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745
| 1
|
NCT00381303
|
[
5
] | 8,424
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| null |
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period
| null |
Asthma
|
Asthma
| null | 0
| null | null | 1
|
[
0
] |
intervention 1: None
|
intervention 1: Budesonide/formoterol
| 817
|
Aalst | N/A | Belgium | 4.0355 | 50.93604
Aarschot | N/A | Belgium | 4.83695 | 50.98715
Aatrijken | N/A | Belgium | N/A | N/A
Asse | N/A | Belgium | 4.19836 | 50.91011
Balen | N/A | Belgium | 5.17027 | 51.16837
Bastogne | N/A | Belgium | 5.71844 | 50.00347
Bellaire | N/A | Belgium | 5.66585 | 50.64453
Betrix | N/A | Belgium | N/A | N/A
Binche | N/A | Belgium | 4.16469 | 50.41155
Blankenberge | N/A | Belgium | 3.13227 | 51.31306
Boortmeerbeek | N/A | Belgium | 4.57443 | 50.97929
Bornem | N/A | Belgium | 4.24364 | 51.09716
Boussu | N/A | Belgium | 3.7944 | 50.43417
Bruges | N/A | Belgium | 3.22424 | 51.20892
Brussels | N/A | Belgium | 4.34878 | 50.85045
Buizingen | N/A | Belgium | 4.25278 | 50.74227
Burdinne | N/A | Belgium | 5.07663 | 50.58454
Champion | N/A | Belgium | 4.90385 | 50.4953
Charleroi | N/A | Belgium | 4.44448 | 50.41136
Châtelet | N/A | Belgium | 4.52826 | 50.40338
Chênée | N/A | Belgium | 5.6141 | 50.612
Dendermonde | N/A | Belgium | 4.10106 | 51.02869
Diksmuide | N/A | Belgium | 2.86384 | 51.03248
Drongen | N/A | Belgium | 3.65649 | 51.05067
Duffel | N/A | Belgium | 4.50903 | 51.09554
Edegem | N/A | Belgium | 4.44504 | 51.15662
Eeklo | N/A | Belgium | 3.55654 | 51.18703
Ekeren | N/A | Belgium | 4.41813 | 51.28087
Erembodegem | N/A | Belgium | 4.05041 | 50.91905
Evergem | N/A | Belgium | 3.70976 | 51.11306
Fleurus | N/A | Belgium | 4.55006 | 50.48351
Gembloux | N/A | Belgium | 4.69889 | 50.56149
Genk | N/A | Belgium | 5.50082 | 50.965
Ghent | N/A | Belgium | 3.71667 | 51.05
Gilly | N/A | Belgium | 4.4789 | 50.42449
Graty | N/A | Belgium | 3.99624 | 50.63172
Grivegnée | N/A | Belgium | 5.61101 | 50.62148
Halle | N/A | Belgium | 4.23454 | 50.73385
Ham | N/A | Belgium | 3.45852 | 50.94066
Ham-sur-Heure | N/A | Belgium | 4.38844 | 50.323
Hasselt | N/A | Belgium | 5.33781 | 50.93106
Havinnes | N/A | Belgium | 3.46341 | 50.61658
Heist-op-den-Berg | N/A | Belgium | 4.72827 | 51.07537
Herentals | N/A | Belgium | 4.83248 | 51.17655
Herstal | N/A | Belgium | 5.62346 | 50.66415
Hoboken | N/A | Belgium | 4.34844 | 51.17611
Hoeselt | N/A | Belgium | 5.48767 | 50.84714
Hooglede | N/A | Belgium | 3.08333 | 50.98333
Hornu | N/A | Belgium | 3.82736 | 50.4328
Houthalen-Helchteren | N/A | Belgium | 5.37849 | 51.03216
Huldenberg | N/A | Belgium | 4.5831 | 50.78939
Izegem | N/A | Belgium | 3.21378 | 50.91396
Jambes | N/A | Belgium | 4.87166 | 50.45636
Jodoigne | N/A | Belgium | 4.86914 | 50.72357
Kinrooi | N/A | Belgium | 5.74207 | 51.14543
Kontich | N/A | Belgium | 4.44706 | 51.13213
Kraainem | N/A | Belgium | 4.46946 | 50.86155
La Louvière | N/A | Belgium | 4.18785 | 50.48657
Langdorp | N/A | Belgium | 4.87175 | 50.99561
Lauwe | N/A | Belgium | 3.1869 | 50.79479
Leopoldsburg | N/A | Belgium | 5.25 | 51.11667
Leuven | N/A | Belgium | 4.70093 | 50.87959
Lier | N/A | Belgium | 4.57041 | 51.13128
Liège | N/A | Belgium | 5.56749 | 50.63373
Lommel | N/A | Belgium | 5.31349 | 51.23074
Lovendegem | N/A | Belgium | 3.61298 | 51.10168
Malmedy | N/A | Belgium | 6.02794 | 50.42686
Marchovelette | N/A | Belgium | 4.94059 | 50.52303
Meelbeke | N/A | Belgium | N/A | N/A
Moerkerke | N/A | Belgium | 3.34251 | 51.24547
Mol | N/A | Belgium | 5.11662 | 51.19188
Monceau-sur-Sambre | N/A | Belgium | 4.37668 | 50.41694
Mons | N/A | Belgium | 3.95229 | 50.45413
Montegnée | N/A | Belgium | 5.51411 | 50.64576
Moorsel | N/A | Belgium | 4.09825 | 50.94743
Mouscron | N/A | Belgium | 3.20639 | 50.74497
Namur | N/A | Belgium | 4.86746 | 50.4669
Natoye | N/A | Belgium | 5.058 | 50.34294
Nijlen | N/A | Belgium | 4.67008 | 51.16096
Nivelles | N/A | Belgium | 4.32848 | 50.59833
Oedelem | N/A | Belgium | 3.33762 | 51.17033
Oostkamp | N/A | Belgium | 3.23128 | 51.15432
Oppuurs | N/A | Belgium | 4.24222 | 51.06629
Ostend | N/A | Belgium | 2.927 | 51.21551
Oudenaarde | N/A | Belgium | 3.60891 | 50.85168
Paal | N/A | Belgium | 5.17233 | 51.03988
Peutie | N/A | Belgium | 4.45187 | 50.92998
Poederlee | N/A | Belgium | 4.84034 | 51.22769
Pulle | N/A | Belgium | 4.71434 | 51.20317
Rijkevorsel | N/A | Belgium | 4.76053 | 51.34795
Rixensart | N/A | Belgium | 4.52529 | 50.71229
Rotselaar | N/A | Belgium | 4.71665 | 50.95302
Roux | N/A | Belgium | 4.3917 | 50.44111
Saint Katharina Lombeek | N/A | Belgium | N/A | N/A
Sankt Vith | N/A | Belgium | 6.12724 | 50.28146
Sijsele | N/A | Belgium | 3.31714 | 51.20846
Sint-Genesius-Rode | N/A | Belgium | 4.35754 | 50.74645
Sint-Niklaas | N/A | Belgium | 4.1437 | 51.16509
Steenokkerzeel | N/A | Belgium | 4.50989 | 50.91851
Stekene | N/A | Belgium | 4.03651 | 51.2099
Tavier | N/A | Belgium | 5.47063 | 50.49634
Thieusies | N/A | Belgium | 4.04931 | 50.51525
Tielt | N/A | Belgium | 3.32707 | 50.99931
Tienen | N/A | Belgium | 4.9378 | 50.80745
Tirlt | N/A | Belgium | N/A | N/A
Tongeren | N/A | Belgium | 5.46484 | 50.78054
Tournai | N/A | Belgium | 3.38932 | 50.60715
Tremelo | N/A | Belgium | 4.70807 | 50.99231
Turhout | N/A | Belgium | N/A | N/A
Vedrin | N/A | Belgium | 4.87604 | 50.50273
Villers-Poterie | N/A | Belgium | 4.54885 | 50.35379
Vilvoorde | N/A | Belgium | 4.42938 | 50.92814
Vosselaar | N/A | Belgium | 4.8896 | 51.30856
Wambeek | N/A | Belgium | 4.16169 | 50.85281
Waregem | N/A | Belgium | 3.42756 | 50.88898
Waterloo | N/A | Belgium | 4.3991 | 50.71469
Wetteren | N/A | Belgium | 3.88341 | 51.00526
Wijnegem | N/A | Belgium | 4.51895 | 51.22787
Willebroek | N/A | Belgium | 4.36019 | 51.06041
Wilsele | N/A | Belgium | 4.69769 | 50.89188
Zele | N/A | Belgium | 4.0403 | 51.06566
Zemst | N/A | Belgium | 4.46079 | 50.98318
Zoersel | N/A | Belgium | 4.71296 | 51.26825
Zottegem | N/A | Belgium | 3.81052 | 50.86955
Zwijnaarde | N/A | Belgium | 3.70746 | 51.00077
Espho | N/A | Finland | N/A | N/A
Espoo | N/A | Finland | 24.6522 | 60.2052
Harjavalta | N/A | Finland | 22.13333 | 61.31667
Hämeenlinna | N/A | Finland | 24.46434 | 60.99596
Helsinki | N/A | Finland | 24.93545 | 60.16952
Hyvinkää | N/A | Finland | 24.8606 | 60.63195
Jakobstad | N/A | Finland | 22.70256 | 63.67486
Joensuu | N/A | Finland | 29.76316 | 62.60118
Jokioinen | N/A | Finland | 23.48004 | 60.80162
Kannus | N/A | Finland | 23.9 | 63.9
Kemi | N/A | Finland | 24.56371 | 65.73641
Kereva | N/A | Finland | N/A | N/A
Kokkola | N/A | Finland | 23.13066 | 63.83847
Korpilahti | N/A | Finland | 25.55 | 62.01667
Kotka | N/A | Finland | 26.94582 | 60.4664
Kouvola | N/A | Finland | 26.7 | 60.86667
Kuopio | N/A | Finland | 27.67703 | 62.89238
Kuusankoski | N/A | Finland | 26.62437 | 60.907
Lahti | N/A | Finland | 25.66151 | 60.98267
Lappeenranta | N/A | Finland | 28.18871 | 61.05871
Lapua | N/A | Finland | 23.0088 | 62.96927
Lathi | N/A | Finland | N/A | N/A
Lempäälä | N/A | Finland | 23.75 | 61.31667
Lohja | N/A | Finland | 24.06534 | 60.24859
Mikkeli | N/A | Finland | 27.27227 | 61.68857
Muurame | N/A | Finland | 25.66667 | 62.13333
Nurmij�rvi | N/A | Finland | N/A | N/A
Oulu | N/A | Finland | 25.46816 | 65.01236
Pello | N/A | Finland | 23.96255 | 66.77364
Pieksämäki | N/A | Finland | 27.13333 | 62.3
Pori | N/A | Finland | 21.78333 | 61.48333
Porvoo | N/A | Finland | 25.66507 | 60.39233
Pudasj�rvi | N/A | Finland | N/A | N/A
Pyhäjoki | N/A | Finland | 24.23333 | 64.46667
Riihimäki | N/A | Finland | 24.77726 | 60.73769
Seinäjoki | N/A | Finland | 22.82822 | 62.79446
Suonenjoki | N/A | Finland | 27.13333 | 62.61667
Tamepare | N/A | Finland | N/A | N/A
Tampera | N/A | Finland | N/A | N/A
Turku | N/A | Finland | 22.26869 | 60.45148
Ulvila | N/A | Finland | 21.87103 | 61.42844
Vaajakoksi | N/A | Finland | N/A | N/A
Vantaa | N/A | Finland | 25.04099 | 60.29414
Agen | N/A | France | 0.62055 | 44.20199
Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Ajaccio | N/A | France | 8.73812 | 41.91886
Alès | N/A | France | 4.08082 | 44.12489
Amboise | N/A | France | 0.98266 | 47.41249
Amelie Les Bains Palalda | N/A | France | N/A | N/A
Amiens | N/A | France | 2.3 | 49.9
Angers | N/A | France | -0.55202 | 47.47156
Angoulême | N/A | France | 0.15345 | 45.64997
Annecy | N/A | France | 6.12565 | 45.90878
Annonay | N/A | France | 4.6707 | 45.23992
Antibes | N/A | France | 7.12487 | 43.58127
Arpajon | N/A | France | 2.24672 | 48.58875
Asnières-sur-Seine | N/A | France | 2.28333 | 48.91667
Aubagne | N/A | France | 5.57067 | 43.29276
Aulnay-sous-Bois | N/A | France | 2.49402 | 48.93814
Avignon | N/A | France | 4.80892 | 43.94834
Bastia | N/A | France | 9.45123 | 42.70219
Bayonne | N/A | France | -1.473 | 43.49316
Belfort | N/A | France | 6.85385 | 47.64218
Bernay | N/A | France | 0.59858 | 49.08888
Besançon | N/A | France | 6.01815 | 47.24878
Béthune | N/A | France | 2.64003 | 50.52965
Béziers | N/A | France | 3.21402 | 43.34122
Biganos | N/A | France | -0.97841 | 44.64425
Bois-Guillaume | N/A | France | 1.12219 | 49.4602
Bordeaux | N/A | France | -0.5805 | 44.84044
Bouoin Jallieu | N/A | France | N/A | N/A
Bourges | N/A | France | 2.4 | 47.08333
Brest | N/A | France | -4.48628 | 48.39029
Briey | N/A | France | 5.93975 | 49.2492
Brive-la-Gaillarde | N/A | France | 1.53326 | 45.1589
Cachan | N/A | France | 2.33661 | 48.79632
Caen | N/A | France | -0.35912 | 49.18585
Cagnes-sur-Mer | N/A | France | 7.1479 | 43.66352
Caluire-et-Cuire | N/A | France | 4.8464 | 45.79462
Cambrai | N/A | France | 3.23472 | 50.17596
Carpentras | N/A | France | 5.04813 | 44.05507
Castelnau-le-Lez | N/A | France | 3.90137 | 43.63605
Castres | N/A | France | 2.24088 | 43.60527
Cavaillon | N/A | France | 5.03586 | 43.83125
Challans | N/A | France | -1.87942 | 46.8458
Charleville-Mézières | N/A | France | 4.72487 | 49.7685
Chauny | N/A | France | 3.21857 | 49.61514
Chaville | N/A | France | 2.18864 | 48.80565
Châlons-en-Champagne | N/A | France | 4.36724 | 48.95393
Châteauroux | N/A | France | 1.69362 | 46.81248
Chevillu Larue Cedex | N/A | France | N/A | N/A
Cholet | N/A | France | -0.87974 | 47.05893
Cluses | N/A | France | 6.57497 | 46.06251
Colmar | N/A | France | 7.35584 | 48.08078
Colma | N/A | France | N/A | N/A
Colomiers | N/A | France | 1.33467 | 43.61058
Corbeil-Essonnes | N/A | France | 2.48757 | 48.60603
Créteil | N/A | France | 2.46569 | 48.79266
Denain | N/A | France | 3.3943 | 50.3293
Eaubonne | N/A | France | 2.28249 | 48.99712
Échirolles | N/A | France | 5.71441 | 45.14603
Écully | N/A | France | 4.77758 | 45.77437
Épernay | N/A | France | 3.95922 | 49.04
Épinal | N/A | France | 6.45304 | 48.18324
Étampes | N/A | France | 2.16233 | 48.43507
Férolles-Attilly | N/A | France | 2.63088 | 48.73184
Forbach | N/A | France | 6.89255 | 49.18848
Gentilly | N/A | France | 2.3417 | 48.81294
Gleizé | N/A | France | 4.69708 | 45.98916
Grasse | N/A | France | 6.92537 | 43.65783
Grenoble | N/A | France | 5.71479 | 45.17869
Hagondange | N/A | France | 6.16374 | 49.24879
Hazebrouck | N/A | France | 2.53729 | 50.72374
Herblay-sur-Seine | N/A | France | 2.1699 | 48.98994
Hyères | N/A | France | 6.12857 | 43.12038
Joué-lès-Tours | N/A | France | 0.66513 | 47.34907
Juan-les-Pins | N/A | France | 7.11309 | 43.56945
La Garda | N/A | France | N/A | N/A
La Roche-sur-Yon | N/A | France | -1.42757 | 46.66974
La Rochelle | N/A | France | -1.15222 | 46.16308
La Teste-de-Buch | N/A | France | -1.14513 | 44.63278
Lagny-sur-Marne | N/A | France | 2.71667 | 48.86667
Langon | N/A | France | -0.24986 | 44.55277
Laval | N/A | France | -0.77019 | 48.07247
Le Bouscat | N/A | France | -0.59864 | 44.86488
Le Perreux-sur-Marne | N/A | France | 2.5 | 48.85
Lens | N/A | France | 2.82791 | 50.43302
Les Sbles D Olonne | N/A | France | N/A | N/A
Libourne | N/A | France | -0.24186 | 44.91449
Lille | N/A | France | 3.05858 | 50.63297
Limoges | N/A | France | 1.24759 | 45.83362
Lorient | N/A | France | -3.37177 | 47.74817
Lunel | N/A | France | 4.13611 | 43.67778
Lunéville | N/A | France | 6.49383 | 48.59273
Lyon | N/A | France | 4.84671 | 45.74846
Maisons-Laffitte | N/A | France | 2.14521 | 48.95264
Mandelieu-la-Napoule | N/A | France | 6.93734 | 43.54577
Marmande | N/A | France | 0.16546 | 44.50361
Marseille | N/A | France | 5.38107 | 43.29695
Marselle | N/A | France | N/A | N/A
Martigues | N/A | France | 5.05526 | 43.40735
Maubeuge | N/A | France | 3.97267 | 50.27875
Meaux | N/A | France | 2.87885 | 48.96014
Melun | N/A | France | 2.65356 | 48.5457
Mende | N/A | France | 3.49978 | 44.52161
Menton | N/A | France | 7.50435 | 43.77649
Metz | N/A | France | 6.17269 | 49.11911
Montauban | N/A | France | 1.3542 | 44.01759
Montbéliard | N/A | France | 6.79823 | 47.50957
Montereau-Fault-Yonne | N/A | France | 2.95 | 48.38333
Montferrier-sur-Lez | N/A | France | 3.85686 | 43.66806
Montigny-lès-Metz | N/A | France | 6.15271 | 49.0956
Montpellier | N/A | France | 3.87635 | 43.61093
Montreuil | N/A | France | 2.44322 | 48.86415
Nantes | N/A | France | -1.55336 | 47.21725
Narbonne | N/A | France | 3.00141 | 43.18396
Nevers | N/A | France | 3.159 | 46.98956
Nice | N/A | France | 7.26608 | 43.70313
Niort | N/A | France | -0.45877 | 46.32313
Nîmes | N/A | France | 4.35788 | 43.83665
Obernai | N/A | France | 7.481 | 48.46313
Ollioules | N/A | France | 5.84766 | 43.1399
Oloron-Sainte-Marie | N/A | France | -0.61069 | 43.19441
Orange | N/A | France | 4.81025 | 44.13806
Orléans | N/A | France | 1.90389 | 47.90289
Oyonnax | N/A | France | 5.65727 | 46.25917
Paris | N/A | France | 2.3488 | 48.85341
Pau | N/A | France | -0.35583 | 43.31117
Perpignan | N/A | France | 2.89541 | 42.69764
Pertuis | N/A | France | 5.50291 | 43.69415
Périgueux | N/A | France | 0.71439 | 45.18691
Pézenas | N/A | France | 3.42258 | 43.45997
Poitiers | N/A | France | 0.34348 | 46.58261
Pontault-Combault | N/A | France | 2.60676 | 48.79813
Pontoise | N/A | France | 2.1 | 49.05
Privas | N/A | France | 4.59918 | 44.735
Quimper | N/A | France | -4.09795 | 47.99597
Reims | N/A | France | 4.02853 | 49.26526
Rennes | N/A | France | -1.67429 | 48.11198
Rezé | N/A | France | -1.56885 | 47.19058
Roanne | N/A | France | 4.06802 | 46.03624
Rochefort | N/A | France | -0.96774 | 45.94304
Romans-sur-Isère | N/A | France | 5.06602 | 45.0496
Romorantin-Lanthenay | N/A | France | 1.75 | 47.36667
Rosny-sous-Bois | N/A | France | 2.4991 | 48.87017
Rouen | N/A | France | 1.09932 | 49.44313
Rueil-Malmaison | N/A | France | 2.18967 | 48.8765
Saint Andre Les Verges | N/A | France | N/A | N/A
Saint Orenes de Gameville | N/A | France | N/A | N/A
Saint-Amand-les-Eaux | N/A | France | 3.43076 | 50.44718
Saint-Brieuc | N/A | France | -2.76838 | 48.51513
Saint-Denis | N/A | France | 2.35387 | 48.93564
Saint-Dizier | N/A | France | 4.94892 | 48.63773
Saint-Estève | N/A | France | 2.84152 | 42.7131
Saint-Etienne | N/A | France | 4.39 | 45.43389
Saint-Girons | N/A | France | 1.14587 | 42.98491
Saint-Herblain | N/A | France | -1.651 | 47.21154
Saint-Jean-de-Luz | N/A | France | -1.66267 | 43.38871
Saint-Jean-de-Maurienne | N/A | France | 6.35293 | 45.27534
Saint-Laurent-du-Var | N/A | France | 7.19 | 43.67323
Saint-Quentin | N/A | France | 3.28757 | 49.84889
Saint-Raphaël | N/A | France | 6.7735 | 43.42332
Saintes | N/A | France | -0.63489 | 45.74742
Salon-de-Provence | N/A | France | 5.09478 | 43.64229
Sarlat La Ceneda | N/A | France | N/A | N/A
Schiltigheim | N/A | France | 7.74931 | 48.60749
Sedan | N/A | France | 4.94028 | 49.70187
Sélestat | N/A | France | 7.4489 | 48.26195
Six-Fours-les-Plages | N/A | France | 5.82465 | 43.09174
St-Malo | N/A | France | -2.00877 | 48.64738
St.-Jean | N/A | France | -4.49478 | 48.26473
Ste Feyre | N/A | France | N/A | N/A
Strasbourg | N/A | France | 7.74553 | 48.58392
Tergnier | N/A | France | 3.30107 | 49.65607
Thionville | N/A | France | 6.16044 | 49.35994
Thonon-les-Bains | N/A | France | 6.47985 | 46.37049
Toulon | N/A | France | 5.92836 | 43.12442
Toulouse | N/A | France | 1.44367 | 43.60426
Tours | N/A | France | 0.70398 | 47.39484
Valence | N/A | France | 4.90956 | 44.9256
Vannes | N/A | France | -2.76205 | 47.65688
Verneuil-sur-Seine | N/A | France | 1.9648 | 48.97388
Vienne | N/A | France | 4.87484 | 45.52569
Villebon-sur-Yvette | N/A | France | 2.24019 | 48.70594
Villejuif | N/A | France | 2.35992 | 48.7939
Viooefranche Sur Saone | N/A | France | N/A | N/A
Voiron | N/A | France | 5.5856 | 45.36471
Aachen | N/A | Germany | 6.08342 | 50.77664
Annaberg-Buchholz | N/A | Germany | 13.00627 | 50.57953
Ansbach | N/A | Germany | 10.5931 | 49.30481
Apolda | N/A | Germany | 11.51638 | 51.02624
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704
Auerbach | N/A | Germany | 12.40083 | 50.51155
Augusburg | N/A | Germany | N/A | N/A
Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827
Bad Lippspringe | N/A | Germany | 8.81683 | 51.78333
Bad Naustadt | N/A | Germany | N/A | N/A
Bad Sassendorf | N/A | Germany | 8.16667 | 51.58333
Bergkamen | N/A | Germany | 7.64451 | 51.61633
Bergrheinfeld | N/A | Germany | 10.18089 | 50.01028
Berlin | N/A | Germany | 13.41053 | 52.52437
Bernau | N/A | Germany | 8.0383 | 47.80018
Bernsheim | N/A | Germany | N/A | N/A
Beucha | N/A | Germany | 12.57119 | 51.32214
Bochum | N/A | Germany | 7.21648 | 51.48165
Bockenem | N/A | Germany | 10.13197 | 52.00993
Bogen | N/A | Germany | 12.68955 | 48.91122
Bonn | N/A | Germany | 7.09549 | 50.73438
Borna | N/A | Germany | 12.49639 | 51.12416
Braunschweig | N/A | Germany | 10.52673 | 52.26594
Buchholz | N/A | Germany | 9.56287 | 53.00884
Burgwedel | N/A | Germany | 9.90769 | 53.65148
Chemnitz | N/A | Germany | 12.92922 | 50.8357
Cologne | N/A | Germany | 6.95 | 50.93333
Coswig | N/A | Germany | 13.58312 | 51.13204
Cottbus | N/A | Germany | 14.32888 | 51.75769
Deggendorf | N/A | Germany | 12.96068 | 48.84085
Dillingen | N/A | Germany | 6.72781 | 49.35557
Dortmund | N/A | Germany | 7.466 | 51.51494
Dresden | N/A | Germany | 13.73832 | 51.05089
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Emeden | N/A | Germany | N/A | N/A
Eppelborn | N/A | Germany | 6.96667 | 49.4
Erfurt | N/A | Germany | 11.03283 | 50.9787
Essen | N/A | Germany | 7.01228 | 51.45657
Esslingen am Neckar | N/A | Germany | 9.30473 | 48.73961
Flensburg | N/A | Germany | 9.43722 | 54.78805
Frankfurt | N/A | Germany | 10.53333 | 49.68333
Freiberg | N/A | Germany | 13.33881 | 50.91089
Freital | N/A | Germany | 13.6488 | 51.00166
Fürstenfeldbruck | N/A | Germany | 11.2547 | 48.17904
Fürstenwalde | N/A | Germany | 14.06185 | 52.36067
Fürth | N/A | Germany | 10.98856 | 49.47593
Geesthacht | N/A | Germany | 10.3779 | 53.43575
Geisen | N/A | Germany | N/A | N/A
Gelnhausen | N/A | Germany | 9.18742 | 50.20164
Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508
Greven | N/A | Germany | 7.59396 | 52.09364
Gütersloh | N/A | Germany | 8.37853 | 51.90693
Hagen | N/A | Germany | 7.47168 | 51.36081
Halle | N/A | Germany | 11.97947 | 51.48158
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hanover | N/A | Germany | 9.73322 | 52.37052
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Heilbronn | N/A | Germany | 9.22054 | 49.13995
Hsloch | N/A | Germany | N/A | N/A
Ingolstadt | N/A | Germany | 11.42372 | 48.76508
Kaarst | N/A | Germany | 6.61883 | 51.22929
Karlsruhe | N/A | Germany | 8.40444 | 49.00937
Karlsruhe-Durlach | N/A | Germany | N/A | N/A
Kassel | N/A | Germany | 9.5 | 51.31667
Katzhütte | N/A | Germany | 11.05293 | 50.55191
Kempten | N/A | Germany | 7.93702 | 49.96729
Ketzin | N/A | Germany | 12.8453 | 52.47809
Kiel | N/A | Germany | 10.13489 | 54.32133
Kippenheim | N/A | Germany | 7.8251 | 48.29564
Kirchhain | N/A | Germany | 8.92806 | 50.8272
Krefeld | N/A | Germany | 6.55381 | 51.33645
Laage | N/A | Germany | 12.3494 | 53.92633
Landsberg | N/A | Germany | 12.16076 | 51.52698
Lebach | N/A | Germany | 6.90988 | 49.41122
Leipzig | N/A | Germany | 12.37129 | 51.33962
Lippstadt | N/A | Germany | 8.34482 | 51.67369
Lübeck | N/A | Germany | 10.68729 | 53.86893
Lüdenscheid | N/A | Germany | 7.6273 | 51.21977
Lütjenburg | N/A | Germany | 10.58945 | 54.29188
Magdenburg | N/A | Germany | N/A | N/A
Mainz | N/A | Germany | 8.2791 | 49.98419
Marburg | N/A | Germany | 8.77069 | 50.80904
Marl | N/A | Germany | 7.09038 | 51.65671
Meisen | N/A | Germany | N/A | N/A
Mittelbach | N/A | Germany | 8.04239 | 48.44047
Moers | N/A | Germany | 6.6326 | 51.45342
Mühlhausen | N/A | Germany | 10.45275 | 51.20896
Mülheim | N/A | Germany | 6.87967 | 51.43218
Mülsen | N/A | Germany | 12.56667 | 50.75
München | N/A | Germany | 13.31243 | 51.60698
Neukirchen-Vluyn | N/A | Germany | 6.55194 | 51.44665
Neunkirchen | N/A | Germany | 7.18045 | 49.34449
Neunstadt | N/A | Germany | 10.18244 | 48.94793
Neuss | N/A | Germany | 6.68504 | 51.19807
Niesky | N/A | Germany | 14.82107 | 51.29241
Oranienburg | N/A | Germany | 13.24197 | 52.75577
Oschersleben | N/A | Germany | 11.22898 | 52.03039
Osnabr�ck | N/A | Germany | N/A | N/A
Pirmasens | N/A | Germany | 7.60529 | 49.20145
Potsdam | N/A | Germany | 13.06566 | 52.39886
Potsda | N/A | Germany | N/A | N/A
Rathenow | N/A | Germany | 12.33696 | 52.60659
Ratingen | N/A | Germany | 6.84929 | 51.29724
Recklinghausen | N/A | Germany | 7.19738 | 51.61379
Remscheid | N/A | Germany | 7.1925 | 51.17983
Rodgau | N/A | Germany | 8.88588 | 50.02627
Saarbrücken | N/A | Germany | 7.00982 | 49.23262
Saarlouis | N/A | Germany | 6.75154 | 49.31366
Sangerhausen | N/A | Germany | 11.29533 | 51.47221
Schimiedeberg | N/A | Germany | N/A | N/A
Schwetzingen | N/A | Germany | 8.5823 | 49.38217
Silbitz | N/A | Germany | 12.0 | 50.95
Sindelfingen | N/A | Germany | 9.01667 | 48.7
Solingen | N/A | Germany | 7.0845 | 51.17343
Stade | N/A | Germany | 9.47629 | 53.59337
Steinhagen | N/A | Germany | 8.4 | 52.0
Stockach | N/A | Germany | 9.0091 | 47.85105
Straelen | N/A | Germany | 6.26639 | 51.4419
Stutensee | N/A | Germany | N/A | N/A
Stuttgart | N/A | Germany | 9.17702 | 48.78232
Tiefenbach | N/A | Germany | 12.1 | 48.5
Ueckermünde | N/A | Germany | 14.04473 | 53.73795
Wallerfangen | N/A | Germany | 6.71102 | 49.32749
Wedel | N/A | Germany | 9.69835 | 53.58374
Weimar | N/A | Germany | 11.32903 | 50.9803
Wesseling | N/A | Germany | 6.9747 | 50.82709
Weyhe | N/A | Germany | 8.66667 | 52.96667
Wilhelmshaven | N/A | Germany | 8.11253 | 53.52998
Wunstorf | N/A | Germany | 9.43585 | 52.42377
Wuppertal | N/A | Germany | 7.14816 | 51.25627
Alexandroupolos | N/A | Greece | N/A | N/A
Athens | N/A | Greece | 23.72784 | 37.98376
Crete | N/A | Greece | N/A | N/A
Kavala | N/A | Greece | 24.40687 | 40.93959
Larissa | N/A | Greece | 22.41761 | 39.63689
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Reykjavik | N/A | Iceland | -21.89541 | 64.13548
Bautry | N/A | Ireland | N/A | N/A
Beaumont Park | N/A | Ireland | N/A | N/A
Bishopstown | N/A | Ireland | -8.54449 | 51.87326
Blaemy | N/A | Ireland | N/A | N/A
Blanchardstown | N/A | Ireland | -6.37556 | 53.38806
Canigtwohill | N/A | Ireland | N/A | N/A
Carlow Town | N/A | Ireland | N/A | N/A
Carrigaline | N/A | Ireland | -8.39861 | 51.81167
Clonakilty | N/A | Ireland | -8.87056 | 51.62306
Douglas East | N/A | Ireland | N/A | N/A
Drogheda | N/A | Ireland | -6.34778 | 53.71889
Dublin | N/A | Ireland | -6.24889 | 53.33306
Gorey | N/A | Ireland | -6.2925 | 52.67472
Headford | N/A | Ireland | -9.1 | 53.46667
Kilfinanen | N/A | Ireland | N/A | N/A
Kilmallock | N/A | Ireland | -8.57722 | 52.4
Kinvarra | N/A | Ireland | -8.93361 | 53.13944
Macroom | N/A | Ireland | -8.96968 | 51.90663
Mallow | N/A | Ireland | -8.63333 | 52.13333
Maynooth | N/A | Ireland | -6.59361 | 53.385
Mullingar | N/A | Ireland | -7.3385 | 53.52466
Naas | N/A | Ireland | -6.66694 | 53.21583
Phibsborough | N/A | Ireland | -6.28366 | 53.35834
Wexfoord | N/A | Ireland | N/A | N/A
Acquaviva Della Fonti | N/A | Italy | N/A | N/A
Alba | N/A | Italy | 8.0347 | 44.6999
Alessandria | N/A | Italy | 8.61007 | 44.90924
Arezzo | N/A | Italy | 11.88068 | 43.46276
Ascoli Piceno | N/A | Italy | 13.57395 | 42.85351
Avellino | N/A | Italy | 14.79103 | 40.91494
Bari | N/A | Italy | 16.86982 | 41.12066
Benevento | N/A | Italy | 14.77816 | 41.1307
Bergamo | N/A | Italy | 9.66721 | 45.69601
Bologna | N/A | Italy | 11.33875 | 44.49381
Brescia | N/A | Italy | 10.21472 | 45.53558
Busto Arsizio | N/A | Italy | 8.84914 | 45.61128
Cagliari | N/A | Italy | 9.11917 | 39.23054
Cantanzaro | N/A | Italy | N/A | N/A
Caserta | N/A | Italy | 14.33231 | 41.07262
Catania | N/A | Italy | 15.07041 | 37.49223
Catanzaro | N/A | Italy | 16.60086 | 38.88247
Cattinara | N/A | Italy | 13.82792 | 45.63472
Cava de' Tirreni | N/A | Italy | 14.70773 | 40.69954
Chieti | N/A | Italy | 14.16494 | 42.34827
Cittadella | N/A | Italy | 11.78453 | 45.64523
Como | N/A | Italy | 9.0832 | 45.80819
Coppito | N/A | Italy | 13.34358 | 42.3673
Crema | N/A | Italy | 9.68176 | 45.36264
Cuneo | N/A | Italy | 7.54828 | 44.39071
Fano | N/A | Italy | 13.01665 | 43.84052
Ferrara | N/A | Italy | 11.62057 | 44.83804
Florence | N/A | Italy | 11.24626 | 43.77925
Foggia | N/A | Italy | 15.55188 | 41.45845
Genova | N/A | Italy | 11.87211 | 45.21604
Iesi | N/A | Italy | 13.24368 | 43.52142
Latina | N/A | Italy | 12.9043 | 41.46614
Lecco | N/A | Italy | 9.39704 | 45.85589
Livorno | N/A | Italy | 10.32615 | 43.54427
Lugo | N/A | Italy | 11.91094 | 44.42137
Lungro | N/A | Italy | 16.12586 | 39.73772
Macerata | N/A | Italy | 13.45293 | 43.29789
Matera | N/A | Italy | 16.60463 | 40.66599
Mercatino San Severiono | N/A | Italy | N/A | N/A
Messina | N/A | Italy | 15.55256 | 38.19394
Milan | N/A | Italy | 12.59836 | 42.78235
Modena | N/A | Italy | 10.92539 | 44.64783
Monza | N/A | Italy | 9.27246 | 45.58005
Napoli | N/A | Italy | 14.5195 | 40.87618
Novara | N/A | Italy | 8.62118 | 45.44694
Orbassano | N/A | Italy | 7.53813 | 45.00547
Padua | N/A | Italy | 11.88586 | 45.40797
Palermo | N/A | Italy | 13.3636 | 38.1166
Parma | N/A | Italy | 10.32618 | 44.79935
Pavia | N/A | Italy | 9.15917 | 45.19205
Perugia | N/A | Italy | 12.38878 | 43.1122
Pesaro | N/A | Italy | 12.9164 | 43.90921
Pescara | N/A | Italy | 14.20283 | 42.4584
Pietra Ligure | N/A | Italy | 8.28206 | 44.1492
Pisa | N/A | Italy | 10.4036 | 43.70853
Pordenone | N/A | Italy | 12.66051 | 45.95689
Prato | N/A | Italy | 11.09699 | 43.8805
Reggio Calabria | N/A | Italy | 15.66129 | 38.11047
Reggio Emilia | N/A | Italy | 10.63125 | 44.69825
Rocca Priora | N/A | Italy | 12.76577 | 41.76585
Roma | N/A | Italy | 11.10642 | 44.99364
Rovigo | N/A | Italy | 11.79022 | 45.06982
Rozzano | N/A | Italy | 9.1559 | 45.38193
San Pietro Vernotico | N/A | Italy | 17.99752 | 40.4889
Sarzana | N/A | Italy | 9.9622 | 44.11178
Sassari | N/A | Italy | 8.55552 | 40.72586
Sesto San Giovanni | N/A | Italy | 9.22585 | 45.53329
Siena | N/A | Italy | 11.33064 | 43.31822
Syracuse | N/A | Italy | 15.28664 | 37.07542
Terni | N/A | Italy | 12.64329 | 42.56335
Torino | N/A | Italy | 11.99138 | 44.88856
Torrette | N/A | Italy | 15.01974 | 40.53485
Trapani | N/A | Italy | 12.53617 | 38.0176
Verona | N/A | Italy | 10.9938 | 45.43854
Vicenza | N/A | Italy | 11.5475 | 45.54672
Vimercate | N/A | Italy | 9.36801 | 45.61545
's-Hertogenbosch | N/A | Netherlands | 5.30417 | 51.69917
Beek En | N/A | Netherlands | N/A | N/A
Beerzerveld | N/A | Netherlands | 6.57361 | 52.49333
Bennebroek | N/A | Netherlands | 4.59861 | 52.32083
Deurne | N/A | Netherlands | 5.79722 | 51.46
Dordrecht | N/A | Netherlands | 4.67361 | 51.81
Echt | N/A | Netherlands | 5.87361 | 51.10583
Ermelo | N/A | Netherlands | 5.62222 | 52.29833
Fen Haag | N/A | Netherlands | N/A | N/A
Hoogvliet | N/A | Netherlands | 4.3625 | 51.86333
Hoogwoud | N/A | Netherlands | 4.93889 | 52.71583
Lieshout | N/A | Netherlands | 5.59479 | 51.52036
Losser | N/A | Netherlands | 7.00417 | 52.26083
Nijmegen | N/A | Netherlands | 5.85278 | 51.8425
Oude Pekela | N/A | Netherlands | 7.00972 | 53.10417
Poortvliet | N/A | Netherlands | 4.14306 | 51.54417
Rijswijk | N/A | Netherlands | 4.32501 | 52.03634
Roelofarends | N/A | Netherlands | N/A | N/A
Soerendonk | N/A | Netherlands | 5.575 | 51.30083
Spijkenisse | N/A | Netherlands | 4.32917 | 51.845
The Hague | N/A | Netherlands | 4.29861 | 52.07667
Voerendaal | N/A | Netherlands | 5.92978 | 50.88327
Weerselo | N/A | Netherlands | 6.85694 | 52.35167
Wildevank | N/A | Netherlands | N/A | N/A
Woerden | N/A | Netherlands | 4.88333 | 52.085
Zaandam | N/A | Netherlands | 4.82643 | 52.43854
Zutphen | N/A | Netherlands | 6.20139 | 52.13833
Bergen | N/A | Norway | 5.32415 | 60.39299
B�verbru | N/A | Norway | N/A | N/A
Elverum | N/A | Norway | 11.56231 | 60.88191
Fevik | N/A | Norway | 8.67601 | 58.3782
Fredrikstad | N/A | Norway | 10.9298 | 59.2181
Larvik | N/A | Norway | 10.03517 | 59.05328
Løvenstad | N/A | Norway | 11.02525 | 59.93857
Oslo | N/A | Norway | 10.74609 | 59.91273
Rådal | N/A | Norway | 5.34554 | 60.31063
Røa | N/A | Norway | 10.64378 | 59.9465
Ski | N/A | Norway | 10.83576 | 59.71949
Ulstet | N/A | Norway | N/A | N/A
Kazan’ | N/A | Russia | 49.12214 | 55.78874
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
A Coruña | N/A | Spain | -8.396 | 43.37135
Alcalá de Henares | N/A | Spain | -3.35996 | 40.48205
Alcorcón | N/A | Spain | -3.82487 | 40.34582
Alicante Orihuela | N/A | Spain | N/A | N/A
Alicante. Elda | N/A | Spain | N/A | N/A
Andújar | N/A | Spain | -4.05077 | 38.03922
Avilés | N/A | Spain | -5.92483 | 43.55473
Badajoz | N/A | Spain | -6.97061 | 38.87789
Bailbao | N/A | Spain | N/A | N/A
Barakaldi/Vizcaya | N/A | Spain | N/A | N/A
Barakaldo Bizkaia | N/A | Spain | N/A | N/A
Barcelona | N/A | Spain | 2.15899 | 41.38879
Burgos | N/A | Spain | -3.70184 | 42.34106
Cadiz | N/A | Spain | -6.2891 | 36.52672
Castellon | N/A | Spain | -0.04935 | 39.98567
Cáceres | N/A | Spain | -6.37224 | 39.47649
Elche Alicante | N/A | Spain | N/A | N/A
Ferrol | N/A | Spain | -8.23293 | 43.48451
Fuenlabrada | N/A | Spain | -3.79415 | 40.28419
Gandia | N/A | Spain | -0.18333 | 38.96667
Getafe | N/A | Spain | -3.73295 | 40.30571
Gijón | N/A | Spain | -5.66152 | 43.53573
Girona | N/A | Spain | 2.82493 | 41.98311
Granada | N/A | Spain | -3.60667 | 37.18817
Huelva | N/A | Spain | -6.94004 | 37.26638
Huercal Overa | N/A | Spain | -1.943 | 37.38918
Jaén | N/A | Spain | -3.79028 | 37.76922
Laredo | N/A | Spain | -3.41613 | 43.4098
Leganés | N/A | Spain | -3.7635 | 40.32718
Lugo | N/A | Spain | -7.55602 | 43.00992
Madrid | N/A | Spain | -3.70256 | 40.4165
Manacor | N/A | Spain | 3.20955 | 39.56964
Marbella | N/A | Spain | -4.88583 | 36.51543
Málaga | N/A | Spain | -4.42034 | 36.72016
Mérida | N/A | Spain | -6.34366 | 38.91611
Mostoles Madrid | N/A | Spain | N/A | N/A
Murcia | N/A | Spain | -1.13004 | 37.98704
Ourense | N/A | Spain | -7.86407 | 42.33669
Oviedo | N/A | Spain | -5.84476 | 43.36029
Palencia | N/A | Spain | -4.52406 | 42.00955
Palma Mallorca | N/A | Spain | N/A | N/A
Pamplona | N/A | Spain | -1.64323 | 42.81687
Ponferrada | N/A | Spain | -6.59619 | 42.54664
Pontevedra | N/A | Spain | -8.64435 | 42.431
Requena | N/A | Spain | -1.10044 | 39.48834
Ronda | N/A | Spain | -5.16709 | 36.74231
Sagunto | N/A | Spain | -0.26667 | 39.68333
Salamanca | N/A | Spain | -3.67975 | 40.42972
San Zebastian | N/A | Spain | N/A | N/A
Santa Cruz D E Tenerife | N/A | Spain | N/A | N/A
Santander | N/A | Spain | -3.80444 | 43.46472
Segovia | N/A | Spain | -4.11839 | 40.94808
Seville | N/A | Spain | -5.97317 | 37.38283
Valencia | N/A | Spain | -0.37966 | 39.47391
Valladolid | N/A | Spain | -4.72372 | 41.65518
Viadecans | N/A | Spain | N/A | N/A
Vigo | N/A | Spain | -8.72264 | 42.23282
Vitoria-Gasteiz | N/A | Spain | -2.67268 | 42.84998
Vizcaya | N/A | Spain | N/A | N/A
Zaragoza | N/A | Spain | -0.87734 | 41.65606
Zaroma | N/A | Spain | N/A | N/A
Arvidsjaur | N/A | Sweden | 19.16682 | 65.59033
Åkersberga | N/A | Sweden | 18.29967 | 59.47944
Bromma | N/A | Sweden | 17.94 | 59.34
Eskilstuna | N/A | Sweden | 16.5077 | 59.36661
Gävle | N/A | Sweden | 17.14174 | 60.67452
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Grängesberg | N/A | Sweden | 15.00784 | 60.07465
Hesingborg | N/A | Sweden | N/A | N/A
Jarfalla | N/A | Sweden | N/A | N/A
Karskrona | N/A | Sweden | N/A | N/A
Kil | N/A | Sweden | 13.31277 | 59.50234
Laholm | N/A | Sweden | 13.04371 | 56.51207
Limhamn | N/A | Sweden | 12.95 | 55.58333
Linköping | N/A | Sweden | 15.62157 | 58.41086
Ludvika | N/A | Sweden | 15.18776 | 60.14959
Luleå | N/A | Sweden | 22.15465 | 65.58415
Malmo | N/A | Sweden | 13.00073 | 55.60587
Nacka | N/A | Sweden | 18.16372 | 59.31053
Örebro | N/A | Sweden | 15.2066 | 59.27412
Piteå | N/A | Sweden | 21.47944 | 65.31717
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Torsås | N/A | Sweden | 15.99844 | 56.41251
Tyreso | N/A | Sweden | N/A | N/A
Uppsala | N/A | Sweden | 17.63889 | 59.85882
Vastra Fr�lunda | N/A | Sweden | N/A | N/A
Vaxjo | N/A | Sweden | 14.80906 | 56.87767
Vännäs | N/A | Sweden | 19.75712 | 63.90676
Värnamo | N/A | Sweden | 14.04001 | 57.18604
Vinslöv | N/A | Sweden | 13.91667 | 56.1
Airdrie | N/A | United Kingdom | -3.98025 | 55.86602
Aldershot | N/A | United Kingdom | -0.76389 | 51.24827
Aylesbury | N/A | United Kingdom | -0.81458 | 51.81665
Ayrchire | N/A | United Kingdom | N/A | N/A
Barry | N/A | United Kingdom | -3.2838 | 51.39979
Basildon | N/A | United Kingdom | 0.45782 | 51.56844
Bath | N/A | United Kingdom | -2.36172 | 51.3751
Belfast | N/A | United Kingdom | -5.92541 | 54.59682
Bellshill | N/A | United Kingdom | -4.01667 | 55.81667
Bexhill-on-Sea | N/A | United Kingdom | 0.47095 | 50.85023
Blackburn | N/A | United Kingdom | -2.48333 | 53.75
Blantyre | N/A | United Kingdom | -4.09485 | 55.79634
Bolton | N/A | United Kingdom | -2.43333 | 53.58333
Borehamwood | N/A | United Kingdom | -0.27762 | 51.65468
Box | N/A | United Kingdom | -2.24556 | 51.41472
Bracknell | N/A | United Kingdom | -0.75054 | 51.41363
Bradford-on-Avon | N/A | United Kingdom | -2.25065 | 51.34772
Burbage | N/A | United Kingdom | -1.67087 | 51.35184
Bury Saint Edmonds | N/A | United Kingdom | N/A | N/A
Canterbury | N/A | United Kingdom | 1.07992 | 51.27904
Cardiff | N/A | United Kingdom | -3.18 | 51.48
Chesterfield | N/A | United Kingdom | -1.41667 | 53.25
Chippenham | N/A | United Kingdom | -2.12472 | 51.46
Coatbridge | N/A | United Kingdom | -4.02469 | 55.86216
Cookstown | N/A | United Kingdom | -6.74595 | 54.64305
Corsham | N/A | United Kingdom | -2.18437 | 51.43433
Coventry | N/A | United Kingdom | -1.51217 | 52.40656
Crawley | N/A | United Kingdom | -0.18312 | 51.11303
Crowthorne | N/A | United Kingdom | -0.79219 | 51.37027
Cumbernauld | N/A | United Kingdom | -3.99051 | 55.94685
Darlington | N/A | United Kingdom | -1.55039 | 54.52429
Doncaste | N/A | United Kingdom | N/A | N/A
Dumbarton | N/A | United Kingdom | -4.57061 | 55.94433
Dumfries | N/A | United Kingdom | -3.61139 | 55.06959
East Kilbride | N/A | United Kingdom | -4.17669 | 55.76412
Ecclwsfield | N/A | United Kingdom | N/A | N/A
Ely | N/A | United Kingdom | 0.26196 | 52.39964
Fowey | N/A | United Kingdom | -4.6386 | 50.33634
Frome | N/A | United Kingdom | -2.32211 | 51.22834
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
Greenock | N/A | United Kingdom | -4.76121 | 55.94838
Hamilton | N/A | United Kingdom | -4.03333 | 55.76667
Headcorn | N/A | United Kingdom | 0.62433 | 51.16966
High Valleyfield | N/A | United Kingdom | -3.59913 | 56.06357
Huntington | N/A | United Kingdom | -1.05 | 54.0
Kirkintilloch | N/A | United Kingdom | -4.15262 | 55.93933
Larne | N/A | United Kingdom | -5.81667 | 54.85
Leicester | N/A | United Kingdom | -1.13169 | 52.6386
Limavady | N/A | United Kingdom | -6.95074 | 55.05045
Lockerbie | N/A | United Kingdom | -3.35635 | 55.12302
London | N/A | United Kingdom | -0.12574 | 51.50853
Maidenhead | N/A | United Kingdom | -0.71986 | 51.52279
Manhester | N/A | United Kingdom | N/A | N/A
Motherwell | N/A | United Kingdom | -3.99187 | 55.78924
New Stevenson | N/A | United Kingdom | N/A | N/A
Newcastle | N/A | United Kingdom | -5.88979 | 54.21804
Newtonstewart | N/A | United Kingdom | N/A | N/A
Newtownabbey | N/A | United Kingdom | -5.90858 | 54.65983
Northampton | N/A | United Kingdom | -0.88333 | 52.25
Norwich | N/A | United Kingdom | 1.29834 | 52.62783
Nottingham | N/A | United Kingdom | -1.15047 | 52.9536
Nr Penzance | N/A | United Kingdom | N/A | N/A
Paignton | N/A | United Kingdom | -3.56789 | 50.43565
Paisley | N/A | United Kingdom | -4.43254 | 55.83173
Penzance | N/A | United Kingdom | -5.53715 | 50.11861
Peterborough | N/A | United Kingdom | -0.24777 | 52.57364
Plymouth | N/A | United Kingdom | -4.14305 | 50.37153
Port Glasgow | N/A | United Kingdom | -4.6895 | 55.93464
Praze-on-Beeble | N/A | United Kingdom | N/A | N/A
Reading | N/A | United Kingdom | -0.97113 | 51.45625
Redditch | N/A | United Kingdom | -1.94569 | 52.3065
Renfrew | N/A | United Kingdom | -4.39253 | 55.87197
Saltash | N/A | United Kingdom | -4.22514 | 50.40959
Sandy | N/A | United Kingdom | -0.28925 | 52.12927
Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
Shepshed | N/A | United Kingdom | -1.29021 | 52.7657
Slough | N/A | United Kingdom | -0.59541 | 51.50949
Spalding | N/A | United Kingdom | -0.15141 | 52.78709
Spennymoor | N/A | United Kingdom | -1.60229 | 54.6988
Strathaven | N/A | United Kingdom | -4.0668 | 55.6771
Strathblane | N/A | United Kingdom | -4.30658 | 55.98596
Sunbury-on-Thames | N/A | United Kingdom | -0.41817 | 51.40424
Swindon | N/A | United Kingdom | -1.78116 | 51.55797
Thornhill | N/A | United Kingdom | -3.19283 | 51.54183
Thornton Heath | N/A | United Kingdom | -0.09872 | 51.39884
Tichfield | N/A | United Kingdom | N/A | N/A
Torpoint | N/A | United Kingdom | -4.19566 | 50.37505
Trowbridge | N/A | United Kingdom | -2.20861 | 51.31889
Walsall | N/A | United Kingdom | -1.98396 | 52.58528
Welingborough | N/A | United Kingdom | N/A | N/A
Wells-next-the-Sea | N/A | United Kingdom | 0.8511 | 52.95164
Weston-super-Mare | N/A | United Kingdom | -2.97665 | 51.34603
Whitstable | N/A | United Kingdom | 1.0257 | 51.3607
Wishaw | N/A | United Kingdom | -3.91667 | 55.76667
Yaxley | N/A | United Kingdom | -0.25852 | 52.51768
| 0
|
NCT00463866
|
[
3,
4
] | 253
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
This Phase III clinical trial which incorporates an initial Phase II component will determine the survival of advanced Non-small cell lung cancer patients when treated with MK0683 and paclitaxel plus carboplatin
| null |
Stage IIIB or IV Non-Small Cell Lung Cancer
| null | 2
|
arm 1: vorinostat; IV paclitaxel; IV carboplatin arm 2: Placebo; IV paclitaxel; IV carboplatin
|
[
0,
2
] | 4
|
[
0,
0,
0,
0
] |
intervention 1: vorinostat 400 mg capsules once daily. Up to 6 months of treatment intervention 2: intravenous (IV) paclitaxel 200 mg/m2. Up to 6 months of treatment intervention 3: intravenous (IV) carboplatin AUC 6mg/min/ml. Up to 6 months of treatment. intervention 4: vorinostat 400 mg placebo capsules once daily. Up to 6 months of treatment
|
intervention 1: vorinostat intervention 2: Comparator: paclitaxel intervention 3: Comparator: carboplatin intervention 4: Comparator: placebo
| 0
| null | 1
|
NCT00473889
|
|
[
4
] | 298
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.
| null |
Bipolar Disorder Depression, Bipolar
| null | 2
|
arm 1: Active treatment, double-blind, randomized treatment arm arm 2: Inactive, placebo treatment, double-blind, randomized arm
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day. intervention 2: Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm
|
intervention 1: Ziprasidone intervention 2: Placebo
| 70
|
Chandler | Arizona | United States | -111.84125 | 33.30616
Litchfield Park | Arizona | United States | -112.35794 | 33.49337
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Springdale | Arkansas | United States | -94.12881 | 36.18674
Costa Mesa | California | United States | -117.91867 | 33.64113
Oceanside | California | United States | -117.37948 | 33.19587
San Diego | California | United States | -117.16472 | 32.71571
Torrance | California | United States | -118.34063 | 33.83585
Boca Raton | Florida | United States | -80.0831 | 26.35869
Boca Raton | Florida | United States | -80.0831 | 26.35869
Jacksonville | Florida | United States | -81.65565 | 30.33218
Orlando | Florida | United States | -81.37924 | 28.53834
Sanford | Florida | United States | -81.27312 | 28.80055
St. Petersburg | Florida | United States | -82.67927 | 27.77086
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Chicago | Illinois | United States | -87.65005 | 41.85003
Skokie | Illinois | United States | -87.73339 | 42.03336
Greenwood | Indiana | United States | -86.10665 | 39.61366
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Topeka | Kansas | United States | -95.67804 | 39.04833
Wichita | Kansas | United States | -97.33754 | 37.69224
Lake Charles | Louisiana | United States | -93.2044 | 30.21309
Rockville | Maryland | United States | -77.15276 | 39.084
Boston | Massachusetts | United States | -71.05977 | 42.35843
Watertown | Massachusetts | United States | -71.18283 | 42.37093
Clinton Township | Michigan | United States | -82.91992 | 42.58698
Saint Charles | Missouri | United States | -90.48123 | 38.78394
St Louis | Missouri | United States | -90.19789 | 38.62727
Lincoln | Nebraska | United States | -96.66696 | 40.8
Nashua | New Hampshire | United States | -71.46757 | 42.76537
Cherry Hill | New Jersey | United States | -75.03073 | 39.93484
Clementon | New Jersey | United States | -74.98294 | 39.8115
Brooklyn | New York | United States | -73.94958 | 40.6501
Glen Oaks | New York | United States | -73.71152 | 40.74705
New York | New York | United States | -74.00597 | 40.71427
Olean | New York | United States | -78.42974 | 42.07756
Rochester | New York | United States | -77.61556 | 43.15478
Staten Island | New York | United States | -74.13986 | 40.56233
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Columbus | Ohio | United States | -82.99879 | 39.96118
Dayton | Ohio | United States | -84.19161 | 39.75895
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Memphis | Tennessee | United States | -90.04898 | 35.14953
Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Lake Jackson | Texas | United States | -95.43439 | 29.03386
Charlottesville | Virginia | United States | -78.47668 | 38.02931
Kirkland | Washington | United States | -122.20874 | 47.68149
Richland | Washington | United States | -119.28446 | 46.28569
Seattle | Washington | United States | -122.33207 | 47.60621
Brown Deer | Wisconsin | United States | -87.96453 | 43.16334
Westmead | New South Wales | Australia | 150.98768 | -33.80383
Everton Park | Queensland | Australia | 152.9884 | -27.40732
Spring Hill | Queensland | Australia | 153.02311 | -27.46141
Richmond | Victoria | Australia | 145.00176 | -37.81819
Ellisbridge | Ahmedabad | India | N/A | N/A
Ahmedabad | Gujarat | India | 72.58727 | 23.02579
Aurangabad | Maharashtra | India | 75.34226 | 19.87757
Pune | Maharashtra | India | 73.85535 | 18.51957
Pune | Maharashtra | India | 73.85535 | 18.51957
Delhi | New Delhi | India | 77.23149 | 28.65195
| 1
|
NCT00483548
|
|
[
4
] | 395
|
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 advanced-stage idiopathic Parkinson's disease
|
This is the open-label extension to the randomized, double-blind, placebo-and active controlled SP515 (NCT00244387) trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease that were not well-controlled on levodopa
|
Advanced Stage Parkinson's Disease
|
Rotigotine Neupro®
| null | 1
|
arm 1: Rotigotine
|
[
0
] | 1
|
[
0
] |
intervention 1: Rotigotine trans-dermal patches once daily:
20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)
|
intervention 1: Rotigotine
| 53
|
Bedford Park | N/A | Australia | 138.56815 | -35.02204
Concord | N/A | Australia | 151.10381 | -33.84722
Darlinghurst | N/A | Australia | 151.21925 | -33.87939
East Gosford | N/A | Australia | 151.35338 | -33.43874
Westmead | N/A | Australia | 150.98768 | -33.80383
Innsbruck | N/A | Austria | 11.39454 | 47.26266
Zagreb | N/A | Croatia | 15.97798 | 45.81444
Brno | N/A | Czechia | 16.60796 | 49.19522
Ostrava - Poruba | N/A | Czechia | N/A | N/A
Pardubice | N/A | Czechia | 15.77659 | 50.04075
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Oulu | N/A | Finland | 25.46816 | 65.01236
Pori | N/A | Finland | 21.78333 | 61.48333
Aix-en-Provence | N/A | France | 5.44973 | 43.5283
Lille | N/A | France | 3.05858 | 50.63297
Lyon | N/A | France | 4.84671 | 45.74846
Aachen | N/A | Germany | 6.08342 | 50.77664
Bochum | N/A | Germany | 7.21648 | 51.48165
Budapest | N/A | Hungary | 19.04045 | 47.49835
Miskolc | N/A | Hungary | 20.77806 | 48.10306
Pécs | N/A | Hungary | 18.23083 | 46.0725
Petah Tikva | N/A | Israel | 34.88747 | 32.08707
Tel Aviv | N/A | Israel | 34.78057 | 32.08088
Milan | N/A | Italy | 12.59836 | 42.78235
Napoli | N/A | Italy | 14.5195 | 40.87618
Padua | N/A | Italy | 11.88586 | 45.40797
Pisa | N/A | Italy | 10.4036 | 43.70853
Pozzilli | N/A | Italy | 14.06252 | 41.51142
Roma | N/A | Italy | 11.10642 | 44.99364
Auckland | N/A | New Zealand | 174.76349 | -36.84853
Christchurch | N/A | New Zealand | 172.63333 | -43.53333
Wellington | N/A | New Zealand | 174.77557 | -41.28664
Bergen | N/A | Norway | 5.32415 | 60.39299
Stavanger | N/A | Norway | 5.73332 | 58.97005
Trondheim | N/A | Norway | 10.39506 | 63.43049
Tønsberg | N/A | Norway | 10.40762 | 59.26754
Gdansk | N/A | Poland | 18.64912 | 54.35227
Krakow | N/A | Poland | 19.93658 | 50.06143
Lublin | N/A | Poland | 22.56667 | 51.25
Mosina k/Poznania | N/A | Poland | N/A | N/A
Olsztyn | N/A | Poland | 20.49416 | 53.77995
Warsaw | N/A | Poland | 21.01178 | 52.22977
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Tygerberg | N/A | South Africa | N/A | N/A
Barcelona | N/A | Spain | 2.15899 | 41.38879
Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283
Madrid | N/A | Spain | -3.70256 | 40.4165
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Blackpool | N/A | United Kingdom | -3.05 | 53.81667
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
| 1
|
NCT00501969
|
[
4
] | 712
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| true
|
This trial is conducted in Africa, Asia, Europe, North and South America and Oceania.
The aim of the trial is to evaluate the effect of somatropin (human growth hormone) on survival (primary end-point; "time to death" and health related quality of life in adult patients on chronic haemodialysis.
|
The decision to discontinue the trial is not due to safety concerns. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is expected to have a negative impact on the outcome of the trial.
|
Chronic Kidney Disease End-Stage Renal Disease
| null | 2
|
arm 1: Somatropin once daily from week 0 to end of trial arm 2: Placebo once daily to end of trial
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: 20 mcg/kg/day, injected s.c. (under the skin) intervention 2: Placebo injected s.c (under the skin)
|
intervention 1: somatropin intervention 2: placebo
| 381
|
Alexander City | Alabama | United States | -85.95385 | 32.94401
Birmingham | Alabama | United States | -86.80249 | 33.52066
Madison | Alabama | United States | -86.74833 | 34.69926
Mobile | Alabama | United States | -88.04305 | 30.69436
Mobile | Alabama | United States | -88.04305 | 30.69436
Montgomery | Alabama | United States | -86.29997 | 32.36681
Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tempe | Arizona | United States | -111.90931 | 33.41477
Tucson | Arizona | United States | -110.92648 | 32.22174
Tuscon | Arizona | United States | N/A | N/A
El Dorado | Arkansas | United States | -92.66627 | 33.20763
Fort Smith | Arkansas | United States | -94.39855 | 35.38592
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Little Rock | Arkansas | United States | -92.28959 | 34.74648
McGehee | Arkansas | United States | -91.39956 | 33.629
Paragould | Arkansas | United States | -90.49733 | 36.0584
Pine Bluff | Arkansas | United States | -92.0032 | 34.22843
Beverly Hills | California | United States | -118.40036 | 34.07362
Chula Vista | California | United States | -117.0842 | 32.64005
Covina | California | United States | -117.89034 | 34.09001
Escondido | California | United States | -117.08642 | 33.11921
Glendale | California | United States | -118.25508 | 34.14251
La Mesa | California | United States | -117.02308 | 32.76783
Lakewood | California | United States | -118.13396 | 33.85363
Long Beach | California | United States | -118.18923 | 33.76696
Los Alamitos | California | United States | -118.07256 | 33.80307
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Lynwood | California | United States | -118.21146 | 33.93029
Merced | California | United States | -120.48297 | 37.30216
Mission Hills | California | United States | -120.43683 | 34.68609
Monterey Park | California | United States | -118.12285 | 34.06251
Mountain View | California | United States | -122.08385 | 37.38605
Pasadena | California | United States | -118.14452 | 34.14778
Porterville | California | United States | -119.01677 | 36.06523
Riverside | California | United States | -117.39616 | 33.95335
Sacramento | California | United States | -121.4944 | 38.58157
Torrance | California | United States | -118.34063 | 33.83585
Vacaville | California | United States | -121.98774 | 38.35658
Visalia | California | United States | -119.29206 | 36.33023
Walnut Creek | California | United States | -122.06496 | 37.90631
Whittier | California | United States | -118.03284 | 33.97918
Whittier | California | United States | -118.03284 | 33.97918
Yuba City | California | United States | -121.61691 | 39.14045
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Denver | Colorado | United States | -104.9847 | 39.73915
Lakewood | Colorado | United States | -105.08137 | 39.70471
Middlebury | Connecticut | United States | -73.12761 | 41.52787
Stamford | Connecticut | United States | -73.53873 | 41.05343
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Atlantis | Florida | United States | -80.10088 | 26.5909
Brandon | Florida | United States | -82.28592 | 27.9378
Coral Springs | Florida | United States | -80.2706 | 26.27119
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Naples | Florida | United States | -81.79596 | 26.14234
Orlando | Florida | United States | -81.37924 | 28.53834
Orlando | Florida | United States | -81.37924 | 28.53834
Panama City | Florida | United States | -85.65983 | 30.15946
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Tampa | Florida | United States | -82.45843 | 27.94752
Tampa | Florida | United States | -82.45843 | 27.94752
Weston | Florida | United States | -80.39977 | 26.10037
Zephyrhills | Florida | United States | -82.18119 | 28.23362
Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Augusta | Georgia | United States | -81.97484 | 33.47097
Macon | Georgia | United States | -83.6324 | 32.84069
Marietta | Georgia | United States | -84.54993 | 33.9526
Boise | Idaho | United States | -116.20345 | 43.6135
Meridian | Idaho | United States | -116.39151 | 43.61211
Crestwood | Illinois | United States | -87.74154 | 41.64463
Evergreen Park | Illinois | United States | -87.70172 | 41.72059
Gurnee | Illinois | United States | -87.90202 | 42.3703
Maywood | Illinois | United States | -87.84312 | 41.8792
Evansville | Indiana | United States | -87.55585 | 37.97476
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Michigan City | Indiana | United States | -86.89503 | 41.70754
Des Moines | Iowa | United States | -93.60911 | 41.60054
Kansas City | Kansas | United States | -94.62746 | 39.11417
Topeka | Kansas | United States | -95.67804 | 39.04833
Wichita | Kansas | United States | -97.33754 | 37.69224
Lexington | Kentucky | United States | -84.47772 | 37.98869
Madisonville | Kentucky | United States | -87.49889 | 37.3281
Baton Rouge | Louisiana | United States | -91.18747 | 30.44332
Lafayatte | Louisiana | United States | N/A | N/A
New Iberia | Louisiana | United States | -91.81873 | 30.00354
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Bethesda | Maryland | United States | -77.10026 | 38.98067
Easton | Maryland | United States | -76.07633 | 38.77428
Hagerstown | Maryland | United States | -77.71999 | 39.64176
Rockville | Maryland | United States | -77.15276 | 39.084
Silver Spring | Maryland | United States | -77.02609 | 38.99067
Boston | Massachusetts | United States | -71.05977 | 42.35843
Brockton | Massachusetts | United States | -71.01838 | 42.08343
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Dearborn | Michigan | United States | -83.17631 | 42.32226
Detroit | Michigan | United States | -83.04575 | 42.33143
Detroit | Michigan | United States | -83.04575 | 42.33143
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Lansing | Michigan | United States | -84.55553 | 42.73253
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Columbus | Mississippi | United States | -88.42726 | 33.49567
Gulfport | Mississippi | United States | -89.09282 | 30.36742
Jackson | Mississippi | United States | -90.18481 | 32.29876
City of Saint Peters | Missouri | United States | -90.62651 | 38.80033
Saint Ann | Missouri | United States | -90.38317 | 38.72727
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Billings | Montana | United States | -108.50069 | 45.78329
Kearney | Nebraska | United States | -99.08148 | 40.69946
North Platte | Nebraska | United States | -100.76542 | 41.12389
Eatontown | New Jersey | United States | -74.05097 | 40.29622
Livingston | New Jersey | United States | -74.31487 | 40.79593
Voorhees Township | New Jersey | United States | -74.49062 | 40.4795
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Brooklyn | New York | United States | -73.94958 | 40.6501
Brooklyn | New York | United States | -73.94958 | 40.6501
Buffalo | New York | United States | -78.87837 | 42.88645
Buffalo | New York | United States | -78.87837 | 42.88645
Cooperstown | New York | United States | -74.92426 | 42.70048
Fresh Meadows | New York | United States | -73.79347 | 40.73482
Mineola | New York | United States | -73.64068 | 40.74927
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Port Washington | New York | United States | -73.69819 | 40.82566
Rochester | New York | United States | -77.61556 | 43.15478
Rosedale | New York | United States | -73.73541 | 40.66205
The Bronx | New York | United States | -73.86641 | 40.84985
The Bronx | New York | United States | -73.86641 | 40.84985
Yonkers | New York | United States | -73.89789 | 40.9304
Durham | North Carolina | United States | -78.89862 | 35.99403
Greenville | North Carolina | United States | -77.36635 | 35.61266
Hamlet | North Carolina | United States | -79.69422 | 34.88488
Wilmington | North Carolina | United States | -77.94604 | 34.23556
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cleveland | Ohio | United States | -81.69541 | 41.4995
Columbus | Ohio | United States | -82.99879 | 39.96118
Dayton | Ohio | United States | -84.19161 | 39.75895
Toledo | Ohio | United States | -83.55521 | 41.66394
Xenia | Ohio | United States | -83.92965 | 39.68478
Bend | Oregon | United States | -121.31531 | 44.05817
Medford | Oregon | United States | -122.87559 | 42.32652
Roseburg | Oregon | United States | -123.34174 | 43.2165
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Johnstown | Pennsylvania | United States | -78.92197 | 40.32674
Lewistown | Pennsylvania | United States | -77.57138 | 40.59924
Meadville | Pennsylvania | United States | -80.15145 | 41.64144
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Providence | Rhode Island | United States | -71.41283 | 41.82399
Charleston | South Carolina | United States | -79.93275 | 32.77632
Columbia | South Carolina | United States | -81.03481 | 34.00071
North Charleston | South Carolina | United States | -79.97481 | 32.85462
Orangeburg | South Carolina | United States | -80.85565 | 33.49182
Santee | South Carolina | United States | -80.48648 | 33.47516
Sumter | South Carolina | United States | -80.34147 | 33.92044
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Clarksville | Tennessee | United States | -87.35945 | 36.52977
Dyersburg | Tennessee | United States | -89.38563 | 36.03452
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Nashville | Tennessee | United States | -86.78444 | 36.16589
Nashville | Tennessee | United States | -86.78444 | 36.16589
Nashville | Tennessee | United States | -86.78444 | 36.16589
Arlington | Texas | United States | -97.10807 | 32.73569
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Killeen | Texas | United States | -97.7278 | 31.11712
Lubbock | Texas | United States | -101.85517 | 33.57786
McAllen | Texas | United States | -98.23001 | 26.20341
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Tyler | Texas | United States | -95.30106 | 32.35126
Weslaco | Texas | United States | -97.99084 | 26.15952
Provo | Utah | United States | -111.65853 | 40.23384
Burlington | Vermont | United States | -73.21207 | 44.47588
Alexandria | Virginia | United States | -77.04692 | 38.80484
Charlottesville | Virginia | United States | -78.47668 | 38.02931
Chesapeake | Virginia | United States | -76.27494 | 36.81904
Fairfax | Virginia | United States | -77.30637 | 38.84622
Hampton | Virginia | United States | -76.34522 | 37.02987
Mechanicsville | Virginia | United States | -77.37331 | 37.60876
Norfolk | Virginia | United States | -76.28522 | 36.84681
Portsmouth | Virginia | United States | -76.29827 | 36.83543
Salem | Virginia | United States | -80.05476 | 37.29347
Seattle | Washington | United States | -122.33207 | 47.60621
Bluefield | West Virginia | United States | -81.22232 | 37.26984
Glendale | Wisconsin | United States | -87.93564 | 43.13529
Marshfield | Wisconsin | United States | -90.1718 | 44.66885
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Neenah | Wisconsin | United States | -88.46261 | 44.18582
Oshkosh | Wisconsin | United States | -88.54261 | 44.02471
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Capital Federal | N/A | Argentina | N/A | N/A
Capital Federal | N/A | Argentina | N/A | N/A
Córdoba | N/A | Argentina | -64.18853 | -31.40648
Morón | N/A | Argentina | -58.62205 | -34.65118
Pergamino | N/A | Argentina | -60.57462 | -33.89101
San Miguel de Tucumán | N/A | Argentina | -65.21051 | -26.81601
Sarandí | N/A | Argentina | -58.05953 | -29.74341
Temperley | N/A | Argentina | -58.39347 | -34.77435
Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
Curitiba | N/A | Brazil | -49.27306 | -25.42778
Fortaleza | N/A | Brazil | -38.54306 | -3.71722
Fortaleza | N/A | Brazil | -38.54306 | -3.71722
Jaboatao de Guararapes | N/A | Brazil | N/A | N/A
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
Porto Alegre | N/A | Brazil | -51.23019 | -30.03283
São José Rio Preto | N/A | Brazil | N/A | N/A
São Paulo | N/A | Brazil | -46.63611 | -23.5475
Sorocaba | N/A | Brazil | -47.45806 | -23.50167
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Toronto | Ontario | Canada | -79.39864 | 43.70643
Montreal | Quebec | Canada | -73.58781 | 45.50884
Greenfield Park | N/A | Canada | -73.46223 | 45.48649
London | N/A | Canada | -81.23304 | 42.98339
Peterborough | N/A | Canada | -78.31623 | 44.30012
Regina | N/A | Canada | -104.6178 | 50.45008
Saskatoon | N/A | Canada | -106.66892 | 52.13238
Scarborough | N/A | Canada | -96.0 | 60.0
Thunder Bay | N/A | Canada | -89.25018 | 48.38202
Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Beijing | Beijing Municipality | China | 116.39723 | 39.9075
Nanjing | Jiangsu | China | 118.77778 | 32.06167
Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222
Aalborg | N/A | Denmark | 9.9187 | 57.048
Arhus N | N/A | Denmark | N/A | N/A
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Herlev | N/A | Denmark | 12.43998 | 55.72366
Hilleroed | N/A | Denmark | N/A | N/A
Holbæk | N/A | Denmark | 11.71279 | 55.7175
Odense | N/A | Denmark | 10.38831 | 55.39594
Béziers | N/A | France | 3.21402 | 43.34122
Bordeaux | N/A | France | -0.5805 | 44.84044
Bordeaux | N/A | France | -0.5805 | 44.84044
Cherbourt-Octeville | N/A | France | N/A | N/A
Clermont-Ferrand | N/A | France | 3.08682 | 45.77969
Dunkirk | N/A | France | 2.37681 | 51.0344
Lyon | N/A | France | 4.84671 | 45.74846
Montpellier | N/A | France | 3.87635 | 43.61093
Muret | N/A | France | 1.32541 | 43.45998
Nantes | N/A | France | -1.55336 | 47.21725
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Poissy | N/A | France | 2.04952 | 48.92902
Trappes | N/A | France | 2.01781 | 48.77413
Vichy | N/A | France | 3.42577 | 46.12709
Aschaffenburg | N/A | Germany | 9.15214 | 49.97704
Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925
Bamberg | N/A | Germany | 10.90067 | 49.89873
Berlin | N/A | Germany | 13.41053 | 52.52437
Bernkastel-Kues | N/A | Germany | 7.07664 | 49.91602
Bottrop | N/A | Germany | 6.9285 | 51.52392
Dormagen | N/A | Germany | 6.83167 | 51.09683
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Elsenfeld | N/A | Germany | 9.16355 | 49.84289
Fürstenzell | N/A | Germany | 13.31749 | 48.52163
Gütersloh | N/A | Germany | 8.37853 | 51.90693
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hanover | N/A | Germany | 9.73322 | 52.37052
Heilbronn | N/A | Germany | 9.22054 | 49.13995
Kiel | N/A | Germany | 10.13489 | 54.32133
Krefeld | N/A | Germany | 6.55381 | 51.33645
Limburg an der Lahn | N/A | Germany | 8.0503 | 50.3836
Lüdenscheid | N/A | Germany | 7.6273 | 51.21977
Mettmann | N/A | Germany | 6.97536 | 51.2504
Minden | N/A | Germany | 8.91455 | 52.28953
Nettetal | N/A | Germany | 6.28333 | 51.31667
Passau | N/A | Germany | 13.43122 | 48.5665
Schweinfurt | N/A | Germany | 10.22175 | 50.04937
Straubing | N/A | Germany | 12.57385 | 48.88126
Würzburg | N/A | Germany | 9.95121 | 49.79391
Würzburg | N/A | Germany | 9.95121 | 49.79391
Budapest | N/A | Hungary | 19.04045 | 47.49835
Budapest | N/A | Hungary | 19.04045 | 47.49835
Eger | N/A | Hungary | 20.37329 | 47.90265
Kecskemét | N/A | Hungary | 19.69128 | 46.90618
Sopron | N/A | Hungary | 16.59049 | 47.68501
Hyderabad | Andhra Pradesh | India | N/A | N/A
Hyderabad | N/A | India | 78.45636 | 17.38405
Pune | N/A | India | 73.85535 | 18.51957
Ashkelon | N/A | Israel | 34.57149 | 31.66926
Hadera | N/A | Israel | 34.9039 | 32.44192
Haifa | N/A | Israel | 34.99928 | 32.81303
Jerusalem | N/A | Israel | 35.21633 | 31.76904
Petah Tikva | N/A | Israel | 34.88747 | 32.08707
Rehovot | N/A | Israel | 34.81199 | 31.89421
Tzriffin | N/A | Israel | N/A | N/A
Bologna | N/A | Italy | 11.33875 | 44.49381
Brescia | N/A | Italy | 10.21472 | 45.53558
Genova | N/A | Italy | 11.87211 | 45.21604
Milan | N/A | Italy | 12.59836 | 42.78235
Modena | N/A | Italy | 10.92539 | 44.64783
Pavia | N/A | Italy | 9.15917 | 45.19205
Krakow | N/A | Poland | 19.93658 | 50.06143
Kraśnik | N/A | Poland | 22.22706 | 50.9236
Kwidzyn | N/A | Poland | 18.93114 | 53.72495
Myślenice | N/A | Poland | 19.9383 | 49.83383
Ostrów Mazowiecka | N/A | Poland | 21.89507 | 52.80245
Poznann | N/A | Poland | N/A | N/A
Puławy | N/A | Poland | 21.96939 | 51.41655
Radom | N/A | Poland | 21.14714 | 51.40253
Sieradz | N/A | Poland | 18.73023 | 51.59584
Sochaczew | N/A | Poland | 20.23838 | 52.22944
Słupca | N/A | Poland | 17.87192 | 52.28733
Ul Mlynska 5 | N/A | Poland | N/A | N/A
Wejherowo | N/A | Poland | 18.23559 | 54.60568
Wroclaw | N/A | Poland | 17.03333 | 51.1
Abrantes | N/A | Portugal | -8.2 | 39.46667
Amadora | N/A | Portugal | -9.23083 | 38.75382
Braga | N/A | Portugal | -8.42005 | 41.55032
Corroios | N/A | Portugal | -9.1508 | 38.64004
Entroncamento | N/A | Portugal | -8.46667 | 39.46667
Evora | N/A | Portugal | -7.9 | 38.56667
Setúbal | N/A | Portugal | -8.8882 | 38.5244
Torres Vedras | N/A | Portugal | -9.2586 | 39.09109
Villa Franca de Xira | N/A | Portugal | N/A | N/A
Villa Nova de Gaia | N/A | Portugal | N/A | N/A
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Petrozavodsk | N/A | Russia | 34.34691 | 61.78491
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227
Obervatory | N/A | South Africa | N/A | N/A
Barcelona | N/A | Spain | 2.15899 | 41.38879
Burgos | N/A | Spain | -3.70184 | 42.34106
Córdoba | N/A | Spain | -4.77275 | 37.89155
Granollers | N/A | Spain | 2.28773 | 41.60797
Madrid | N/A | Spain | -3.70256 | 40.4165
Santander | N/A | Spain | -3.80444 | 43.46472
Seville | N/A | Spain | -5.97317 | 37.38283
Valencia | N/A | Spain | -0.37966 | 39.47391
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Uppsala | N/A | Sweden | 17.63889 | 59.85882
Värnamo | N/A | Sweden | 14.04001 | 57.18604
Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987
Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384
Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384
Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384
Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369
Birmingham | N/A | United Kingdom | -1.89983 | 52.48142
Cambridge | N/A | United Kingdom | 0.11667 | 52.2
Coventry | N/A | United Kingdom | -1.51217 | 52.40656
Glasgow | N/A | United Kingdom | -4.25763 | 55.86515
Leicester | N/A | United Kingdom | -1.13169 | 52.6386
Liverpool | N/A | United Kingdom | -2.97794 | 53.41058
London | N/A | United Kingdom | -0.12574 | 51.50853
Londonderry | N/A | United Kingdom | -7.30934 | 54.9981
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
Rhyl | N/A | United Kingdom | -3.49228 | 53.31929
Sheffield | N/A | United Kingdom | -1.4659 | 53.38297
Swansea | N/A | United Kingdom | -3.94323 | 51.62079
Wolverhampton | N/A | United Kingdom | -2.12296 | 52.58547
| 1
|
NCT00503698
|
|
[
4
] | 480
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
| null |
Epilepsy
|
Epilepsy Brivaracetam Partial Onset Seizures
| null | 2
|
arm 1: Matching Placebo tablets administered twice a day arm 2: A flexible dose of Brivaracetam tablets, administered twice a day, starting with a dose of 20 mg/day and could increase to 50 mg/day, 100 mg/day or 150 mg/day
|
[
2,
0
] | 2
|
[
0,
0
] |
intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 16-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, Brivaracetam 20 mg/day or Brivaracetam 50 mg/day or Brivaracetam 100 mg/day or Brivaracetam 150 mg/day, in a double-blinded way for the 16-week Treatment Period
|
intervention 1: Placebo intervention 2: Brivaracetam
| 61
|
Graz | N/A | Austria | 15.45 | 47.06667
Innsbrick | N/A | Austria | N/A | N/A
Linz | N/A | Austria | 14.28611 | 48.30639
Vienna | N/A | Austria | 16.37208 | 48.20849
Bruges | N/A | Belgium | 3.22424 | 51.20892
Godinne | N/A | Belgium | 4.87364 | 50.34809
Leuven | N/A | Belgium | 4.70093 | 50.87959
Montignies-sur-Sambre | N/A | Belgium | 4.49109 | 50.41081
Beroun | N/A | Czechia | 14.072 | 49.96382
Brno | N/A | Czechia | 16.60796 | 49.19522
Ostrava Trebovice | N/A | Czechia | N/A | N/A
Prague | N/A | Czechia | 14.42076 | 50.08804
Zlín | N/A | Czechia | 17.67065 | 49.22645
Berlin | N/A | Germany | 13.41053 | 52.52437
Bernau | N/A | Germany | 8.0383 | 47.80018
Bielefeld | N/A | Germany | 8.53333 | 52.03333
Erlangen | N/A | Germany | 11.00783 | 49.59099
Göttingen | N/A | Germany | 9.93228 | 51.53443
Jena | N/A | Germany | 11.5899 | 50.92878
München | N/A | Germany | 13.31243 | 51.60698
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Bangalore | N/A | India | 77.59369 | 12.97194
Hyderabad | N/A | India | 78.45636 | 17.38405
Mumbai | N/A | India | 72.88261 | 19.07283
New Delhi | N/A | India | 77.2148 | 28.62137
Pune Maharashtra | N/A | India | N/A | N/A
Tirupati | N/A | India | 79.41989 | 13.63551
Bari | N/A | Italy | 16.86982 | 41.12066
Milan | N/A | Italy | 12.59836 | 42.78235
Pavia | N/A | Italy | 9.15917 | 45.19205
Roma | N/A | Italy | 11.10642 | 44.99364
Siena | N/A | Italy | 11.33064 | 43.31822
Bergen | N/A | Norway | 5.32415 | 60.39299
Fredrikstad | N/A | Norway | 10.9298 | 59.2181
Oslo | N/A | Norway | 10.74609 | 59.91273
Sandvika | N/A | Norway | 13.59125 | 64.46377
Trondheim | N/A | Norway | 10.39506 | 63.43049
Kazan' | N/A | Russia | 49.12214 | 55.78874
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Samara | N/A | Russia | 50.15 | 53.20007
Yaroslavi | N/A | Russia | N/A | N/A
Singapore | N/A | Singapore | 103.85007 | 1.28967
Cape Town | N/A | South Africa | 18.42322 | -33.92584
George | N/A | South Africa | 22.46173 | -33.963
Johannesburg | N/A | South Africa | 28.04363 | -26.20227
Tygeberg | N/A | South Africa | N/A | N/A
Gwangju | N/A | South Korea | 126.91556 | 35.15472
Seoul | N/A | South Korea | 126.9784 | 37.566
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Umeå | N/A | Sweden | 20.25972 | 63.82842
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Tainan City | N/A | Taiwan | 120.21333 | 22.99083
Taoyuan Hsien | N/A | Taiwan | N/A | N/A
Donetsk | N/A | Ukraine | 37.80224 | 48.023
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kyiv | N/A | Ukraine | 30.5238 | 50.45466
Lviv | N/A | Ukraine | 24.02324 | 49.83826
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242
| 1
|
NCT00504881
|
[
4
] | 258
|
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 advanced-stage idiopathic Parkinson's Disease.
|
This is the open-label extension to the randomized, double-blind, placebo-controlled SP650 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with advanced-stage idiopathic Parkinson's Disease who are not well-controlled on Levodopa.
|
Parkinson's Disease
|
Rotigotine Neupro
| null | 1
|
arm 1: None
|
[
0
] | 1
|
[
0
] |
intervention 1: Rotigotine transdermal 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
| 41
|
Huntsville | Alabama | United States | -86.58594 | 34.7304
Peoria | Arizona | United States | -112.23738 | 33.5806
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Fountain Valley | California | United States | -117.95367 | 33.70918
Fresno | California | United States | -119.77237 | 36.74773
Irvine | California | United States | -117.82311 | 33.66946
Los Angeles | California | United States | -118.24368 | 34.05223
Danbury | Connecticut | United States | -73.45401 | 41.39482
Fairfield | Connecticut | United States | -73.26373 | 41.14121
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Pompano Beach | Florida | United States | -80.12477 | 26.23786
St. Petersburg | Florida | United States | -82.67927 | 27.77086
Sunrise | Florida | United States | -80.1131 | 26.13397
Atlanta | Georgia | United States | -84.38798 | 33.749
Hoffman Estates | Illinois | United States | -88.0798 | 42.04281
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Kansas City | Kansas | United States | -94.62746 | 39.11417
Lexington | Kentucky | United States | -84.47772 | 37.98869
Boston | Massachusetts | United States | -71.05977 | 42.35843
Southfield | Michigan | United States | -83.22187 | 42.47337
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Henderson | Nevada | United States | -114.98194 | 36.0397
Albany | New York | United States | -73.75623 | 42.65258
Forest Hills | New York | United States | -73.85014 | 40.71621
Louisville | New York | United States | -75.01576 | 44.89755
Asheville | North Carolina | United States | -82.55402 | 35.60095
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Toledo | Ohio | United States | -83.55521 | 41.66394
Upland | Pennsylvania | United States | -75.38269 | 39.85261
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
Richmond | Virginia | United States | -77.46026 | 37.55376
Roanoke | Virginia | United States | -79.94143 | 37.27097
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Montrél | Quebec | Canada | N/A | N/A
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
| 1
|
NCT00594386
|
[
4
] | 611
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| false
|
The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), 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 varying dosages of vortioxetine.
The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):
* Vortioxetine 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 mg
* Placebo (dummy inactive capsule) - 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 up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.
|
Major Depressive Disorder
|
Major Depressive Disorder Depression Drug Therapy Major Depressive Episode
| null | 4
|
arm 1: Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 2: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period. arm 3: Duloxetine 60 mg, capsules, orally, once daily for up to 8 weeks, then duloxetine 30 mg capsules, orally, once daily for 1 week after the treatment period. arm 4: Placebo-matching capsules, orally, once daily for up to 9 weeks.
|
[
0,
0,
1,
2
] | 3
|
[
0,
0,
0
] |
intervention 1: Encapsulated vortioxetine immediate-release tablets intervention 2: Duloxetine capsules intervention 3: Placebo-matching capsules
|
intervention 1: Vortioxetine intervention 2: Duloxetine intervention 3: Placebo
| 38
|
Beverly Hills | California | United States | -118.40036 | 34.07362
Irvine | California | United States | -117.82311 | 33.66946
Santa Ana | California | United States | -117.86783 | 33.74557
Torrance | California | United States | -118.34063 | 33.83585
Upland | California | United States | -117.64839 | 34.09751
Bradenton | Florida | United States | -82.57482 | 27.49893
Coral Springs | Florida | United States | -80.2706 | 26.27119
Fort Walton Beach | Florida | United States | -86.61707 | 30.42059
Gainesville | Florida | United States | -82.32483 | 29.65163
Jacksonville | Florida | United States | -81.65565 | 30.33218
Maitland | Florida | United States | -81.36312 | 28.62778
Orlando | Florida | United States | -81.37924 | 28.53834
South Miami | Florida | United States | -80.29338 | 25.7076
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Atlanta | Georgia | United States | -84.38798 | 33.749
Smyrna | Georgia | United States | -84.51438 | 33.88399
Chicago | Illinois | United States | -87.65005 | 41.85003
Libertyville | Illinois | United States | -87.95313 | 42.28308
Oak Brook | Illinois | United States | -87.92895 | 41.83281
Prairie Village | Kansas | United States | -94.63357 | 38.99167
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Baltimore | Maryland | United States | -76.61219 | 39.29038
Pittsfield | Massachusetts | United States | -73.24538 | 42.45008
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Flowood | Mississippi | United States | -90.13898 | 32.30959
New York | New York | United States | -74.00597 | 40.71427
Olean | New York | United States | -78.42974 | 42.07756
Beachwood | Ohio | United States | -81.50873 | 41.4645
Toledo | Ohio | United States | -83.55521 | 41.66394
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Allenport | Pennsylvania | United States | -77.87 | 40.37369
Lancaster | Pennsylvania | United States | -76.30551 | 40.03788
Memphis | Tennessee | United States | -90.04898 | 35.14953
Austin | Texas | United States | -97.74306 | 30.26715
San Antonio | Texas | United States | -98.49363 | 29.42412
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Seattle | Washington | United States | -122.33207 | 47.60621
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
| 1
|
NCT00672620
|
[
3
] | 39
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| true
|
RATIONALE: Thalidomide may stop the growth of colorectal cancer by stopping blood flow to the tumor. Giving thalidomide after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying surgery and thalidomide to see how well they work compared to surgery alone in treating patients with recurrent or metastatic colorectal cancer.
|
OBJECTIVES:
* Compare the disease-free survival probability in patients with previously resected recurrent or metastatic colorectal carcinoma treated with adjuvant thalidomide vs placebo.
* Compare the time to recurrence in patients treated with these regimens.
* Determine whether serum/plasma levels of vascular endothelial growth factor and basic fibroblast growth factor preresection and postresection correlate with tumor recurrence and determine if these levels, as well as carcinoembryonic antigen (CEA) measurements, aid in predicting time to recurrence in these patients.
* Determine the pharmacokinetics and toxicity of long-term thalidomide therapy in these patients.
* Determine whether patients receiving thalidomide develop measurable antiangiogenic activity.
* Measure the presence of circulating tumor cells preresection and postresection and determine if this type of analysis can be used to predict recurrence in this patient population.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of most recent lesion resection that rendered no evidence of disease (lung vs liver with no more than 3 lesions vs liver with more than 3 lesions vs lung and liver vs all other sites\[including sites that were both resected and ablated\]). Patients without evidence of residual disease are randomized to one of two treatment arms.
* Arm I: Patients receive oral thalidomide once daily.
* Arm II: Patients receive an oral placebo once daily. Treatment continues in both arms for 2 years in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for up to 3 years.
PROJECTED ACCRUAL: A total of 94 patients (47 per treatment arm) will be accrued for this study within 3 years.
|
Colorectal Cancer
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer
| null | 2
|
arm 1: Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). arm 2: Patients receive oral placebo once daily.
|
[
0,
2
] | 3
|
[
0,
3,
10
] |
intervention 1: oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose). intervention 2: Initial dose: 100 mg by mouth (po) every bedtime ( Q hs) for four weeks, then progress to 200 mg po Q hs for four weeks, then progress to maintenance dose: 300 mg po Q hs. intervention 3: oral placebo once daily
|
intervention 1: thalidomide intervention 2: adjuvant therapy intervention 3: Placebo
| 6
|
Goshen | Indiana | United States | -85.83444 | 41.58227
Bethesda | Maryland | United States | -77.10026 | 38.98067
Bethesda | Maryland | United States | -77.10026 | 38.98067
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
| 0
|
NCT00019747
|
[
4
] | 379
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.
|
Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.
|
Bipolar Disorder
|
Mania
| null | 3
|
arm 1: Participants will receive treatment with lithium for 8 to 16 weeks arm 2: Participants will receive treatment with valproate for 8 to 16 weeks arm 3: Participants will receive treatment with risperidone for 8 to 16 weeks
|
[
0,
0,
0
] | 3
|
[
0,
0,
0
] |
intervention 1: Titrated until blood level is 1.1 to 1.3 mEq/L intervention 2: Titrated until blood level is 111 to 125 ug/mL intervention 3: Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
|
intervention 1: Lithium carbonate intervention 2: Valproate intervention 3: Risperidone
| 5
|
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
St Louis | Missouri | United States | -90.19789 | 38.62727
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Galveston | Texas | United States | -94.7977 | 29.30135
| 0
|
NCT00057681
|
[
2,
3
] | 64
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
This study was a Phase I/II trial primarily focused on efficacy of BB-10901 in relapsed small cell lung cancer and other solid tumors.
|
The Phase II efficacy expansion was restricted to SCLC patients with relapsed disease and the MTD was determined by the Phase I portion of the trial (60mg/m2).
|
Small Cell Lung Cancer
| null | 7
|
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: Phase I and Phase II were consecutive and sequential. Different patients received the 60mg/m2 dose in Phase I and in Phase II. arm 6: None arm 7: None
|
[
0,
0,
0,
0,
0,
0,
0
] | 1
|
[
0
] |
intervention 1: I.V. Infusion - See "Arms" for dosage - Once/Week for three weeks - Until Progression of disease.
|
intervention 1: BB-10901
| 11
|
Denver | Colorado | United States | -104.9847 | 39.73915
Ocoee | Florida | United States | -81.54396 | 28.56917
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Albany | New York | United States | -73.75623 | 42.65258
Colombus | Ohio | United States | N/A | N/A
Kettering | Ohio | United States | -84.16883 | 39.6895
Greenville | South Carolina | United States | -82.39401 | 34.85262
Houston | Texas | United States | -95.36327 | 29.76328
Tyler | Texas | United States | -95.30106 | 32.35126
Norfolk | Virginia | United States | -76.28522 | 36.84681
Vancouver | Washington | United States | -122.66149 | 45.63873
| 0
|
NCT00065429
|
|
[
3
] | 39
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| null |
Drugs used in chemotherapy, such as oxaliplatin, irinotecan, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells. This phase II trial is studying how well giving oxaliplatin together with irinotecan and capecitabine works in treating patients with metastatic or inoperable locally advanced gastric cancer or gastroesophageal junction adenocarcinoma (cancer).
|
PRIMARY OBJECTIVES:
I. To assess the total response rate of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.
II. To assess the duration of total responses of the oxaliplatin, irinotecan and capecitabine drug combination in advanced gastric/esophageal junction carcinoma.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Patients are followed annually.
PROJECTED ACCRUAL: A total of 40-80 patients will be accrued for this study within 18 months.
|
Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage IIIA Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer
| null | 1
|
arm 1: Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
|
[
0
] | 3
|
[
0,
0,
0
] |
intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally
|
intervention 1: oxaliplatin intervention 2: irinotecan hydrochloride intervention 3: capecitabine
| 1
|
Cleveland | Ohio | United States | -81.69541 | 41.4995
| 0
|
NCT00084617
|
|
[
3
] | 27
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 1FEMALE
| false
|
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.
|
OBJECTIVES:
* Determine the confirmed complete and partial response rate in women with progressive stage IV adenocarcinoma of the breast treated with imatinib mesylate and capecitabine.
* Determine the 6-month progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Correlate, preliminarily, c-kit and platelet-derived growth factor receptor expression with estrogen and progesterone receptor status, response, survival, and time to disease progression in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate\* once daily on days 1-21 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: \*If the patient tolerates the starting dose of imatinib mesylate in course 1, the dose will be increased in subsequent courses.
Patients are followed every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 25-70 patients (25-45 patients with measurable disease and 25 with non-measurable disease) will be accrued for this study within 2 years.
|
Breast Cancer
|
stage IV breast cancer recurrent breast cancer
| null | 1
|
arm 1: None
|
[
0
] | 2
|
[
0,
0
] |
intervention 1: 1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle intervention 2: 400 mg by mouth daily
|
intervention 1: Capecitabine intervention 2: Imatinib mesylate
| 0
| null | 0
|
NCT00087152
|
[
4
] | 751
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 1FEMALE
| true
|
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.
|
This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assigned), open-label (both the investigator and the participant know the intervention received by the participant), multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant (administration of treatment before surgery) or adjuvant setting (administration of treatment after surgery), and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to docetaxel therapy. Approximately 751 participants will be randomly assigned to either receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is to continue until disease progression or the occurrence of unacceptable treatment related toxicity. Safety evaluations will include assessments of adverse events which will be recorded from the first study related procedure until 30 days after the last dose of medication; clinical laboratory tests and tests for cardiac function (multiple gated acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout the study.
|
Breast Cancer
|
Breast Cancer Advanced breast cancer Breast Tumors Cancer of Breast Human Mammary Carcinoma Mammary Neoplasms, Human DOXIL Docetaxel
| null | 2
|
arm 1: DOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. arm 2: Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle intervention 2: DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
|
intervention 1: Docetaxel intervention 2: DOXIL
| 147
|
Hoover | Alabama | United States | -86.81138 | 33.40539
Fountain Valley | California | United States | -117.95367 | 33.70918
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Palm Springs | California | United States | -116.54529 | 33.8303
Newark | Delaware | United States | -75.74966 | 39.68372
Lakeland | Florida | United States | -81.9498 | 28.03947
Fort Gordon | Georgia | United States | -82.16206 | 33.42097
Centralia | Illinois | United States | -89.1334 | 38.52505
Joliet | Illinois | United States | -88.0834 | 41.52519
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lexington | Kentucky | United States | -84.47772 | 37.98869
Louisville | Kentucky | United States | -85.75941 | 38.25424
Lafayette | Louisiana | United States | -92.01984 | 30.22409
Baltimore | Maryland | United States | -76.61219 | 39.29038
Jackson | Mississippi | United States | -90.18481 | 32.29876
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Newark | New Jersey | United States | -74.17237 | 40.73566
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Cooperstown | New York | United States | -74.92426 | 42.70048
New York | New York | United States | -74.00597 | 40.71427
The Bronx | New York | United States | -73.86641 | 40.84985
Gastonia | North Carolina | United States | -81.1873 | 35.26208
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Upland | Pennsylvania | United States | -75.38269 | 39.85261
Providence | Rhode Island | United States | -71.41283 | 41.82399
Charleston | South Carolina | United States | -79.93275 | 32.77632
North Charleston | South Carolina | United States | -79.97481 | 32.85462
Fort Worth | Texas | United States | -97.32085 | 32.72541
Pasadena | Texas | United States | -95.2091 | 29.69106
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Shumen | N/A | Bulgaria | 26.92286 | 43.27064
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Stara Zagora | N/A | Bulgaria | 25.64194 | 42.43278
Varna | N/A | Bulgaria | 27.91667 | 43.21667
Tartu | N/A | Estonia | 26.72509 | 58.38062
Rabat-les-Trois-Seigneurs | N/A | France | 1.55306 | 42.85589
Tunis | N/A | France | N/A | N/A
Budapest | N/A | Hungary | 19.04045 | 47.49835
Debrecen | N/A | Hungary | 21.62444 | 47.53167
Szeged | N/A | Hungary | 20.14824 | 46.253
Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995
Zalaegerszeg | N/A | Hungary | 16.84389 | 46.84
Ashkelon | N/A | Israel | 34.57149 | 31.66926
Haifa | N/A | Israel | 34.99928 | 32.81303
Jerusalem | N/A | Israel | 35.21633 | 31.76904
Ramat Gan | N/A | Israel | 34.81065 | 32.08227
Tel Aviv | N/A | Israel | 34.78057 | 32.08088
Riga | N/A | Latvia | 24.10589 | 56.946
Kaunas | N/A | Lithuania | 23.90961 | 54.90272
Vilnius | N/A | Lithuania | 25.2798 | 54.68916
Arnhem | N/A | Netherlands | 5.91111 | 51.98
Capelle aan den IJssel | N/A | Netherlands | 4.57778 | 51.92917
Roosendaal | N/A | Netherlands | 4.46528 | 51.53083
The Hague | N/A | Netherlands | 4.29861 | 52.07667
Bialystok | N/A | Poland | 23.16433 | 53.13333
Bydgoszcz | N/A | Poland | 18.00762 | 53.1235
Bytom | N/A | Poland | 18.93282 | 50.34802
Gdansk | N/A | Poland | 18.64912 | 54.35227
Gdynia | N/A | Poland | 18.53188 | 54.51889
Gliwice | N/A | Poland | 18.67658 | 50.29761
Kielce | N/A | Poland | 20.62752 | 50.87033
Koszalin | N/A | Poland | 16.17222 | 54.19438
Krakow | N/A | Poland | 19.93658 | 50.06143
Lodz | N/A | Poland | 19.47395 | 51.77058
Lublin | N/A | Poland | 22.56667 | 51.25
Olsztyn | N/A | Poland | 20.49416 | 53.77995
Poznan | N/A | Poland | 16.92993 | 52.40692
Warsaw | N/A | Poland | 21.01178 | 52.22977
Coimbra | N/A | Portugal | -8.41955 | 40.20564
Matosinhos Municipality | N/A | Portugal | -8.68908 | 41.18207
Bacau | N/A | Romania | 26.91384 | 46.56718
Bucharest | N/A | Romania | 26.10626 | 44.43225
Cluj-Napoca | N/A | Romania | 23.6 | 46.76667
Hunedoara | N/A | Romania | 22.9 | 45.75
Iași | N/A | Romania | 27.6 | 47.16667
Onești | N/A | Romania | 27.12141 | 47.48134
Timișoara | N/A | Romania | 21.22571 | 45.75372
Arkhangelsk | N/A | Russia | 40.55291 | 64.54717
Balashikha | N/A | Russia | 37.94794 | 55.79479
Barnaul | N/A | Russia | 83.7456 | 53.3598
Chelyabinsk | N/A | Russia | 61.42915 | 55.15402
Engels Saratov Region | N/A | Russia | N/A | N/A
Irkutsk | N/A | Russia | 104.29585 | 52.29795
Ivanovo | N/A | Russia | 40.97139 | 56.99719
Izhevsk | N/A | Russia | 53.20448 | 56.84976
Kazan' | N/A | Russia | 49.12214 | 55.78874
Krasnodar | N/A | Russia | 38.97603 | 45.04484
Leningrad Region | N/A | Russia | N/A | N/A
Lipetsk | N/A | Russia | 39.57076 | 52.60311
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow Region | N/A | Russia | N/A | N/A
Murmansk | N/A | Russia | 33.09747 | 68.97398
Nizhny Novgorod | N/A | Russia | 44.00205 | 56.32867
Novosibirsk | N/A | Russia | 82.94339 | 55.03442
Obninsk | N/A | Russia | 36.61238 | 55.10993
Omsk | N/A | Russia | 73.36859 | 54.99244
Oryol | N/A | Russia | 36.07805 | 52.95932
Petrozavodsk | N/A | Russia | 34.34691 | 61.78491
Pyatigorsk | N/A | Russia | 43.05036 | 44.05
Rostov-on-Don | N/A | Russia | 39.72328 | 47.23135
Ryazan | N/A | Russia | 39.6916 | 54.6269
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Samara | N/A | Russia | 50.15 | 53.20007
Smolensk | N/A | Russia | 32.04371 | 54.77944
Stavropol | N/A | Russia | 41.9734 | 45.0428
Tomsk | N/A | Russia | 84.98204 | 56.50032
Tver' | N/A | Russia | 35.90057 | 56.85836
Ulyanovsk | N/A | Russia | 48.38657 | 54.32824
Vladimir | N/A | Russia | 40.39658 | 56.13655
Volgograd | N/A | Russia | 44.50183 | 48.71939
Voronezh | N/A | Russia | 39.1843 | 51.67204
Yaroslavl | N/A | Russia | 39.87368 | 57.62987
Yekaterinburg | N/A | Russia | 60.6122 | 56.8519
Belgrade | N/A | Serbia | 20.46513 | 44.80401
Kamenitz | N/A | Serbia | 19.84263 | 45.22334
Niš | N/A | Serbia | 21.90333 | 43.32472
Cape Town | N/A | South Africa | 18.42322 | -33.92584
Johannesburg | N/A | South Africa | 28.04363 | -26.20227
Kimberley | N/A | South Africa | 24.76232 | -28.73226
Parktown | N/A | South Africa | 28.02671 | -26.18205
Port Elizabeth | N/A | South Africa | 25.61494 | -33.96109
Pretoria | N/A | South Africa | 28.18783 | -25.74486
Pretoria Gauteng | N/A | South Africa | N/A | N/A
Bilbao Vizcaya | N/A | Spain | N/A | N/A
Lleida | N/A | Spain | 0.62218 | 41.61674
Madrid | N/A | Spain | -3.70256 | 40.4165
Santander | N/A | Spain | -3.80444 | 43.46472
Seville | N/A | Spain | -5.97317 | 37.38283
Cherkassy | N/A | Ukraine | 32.05738 | 49.44452
Chernivtsi | N/A | Ukraine | 25.93241 | 48.29045
Dnipro | N/A | Ukraine | 35.04066 | 48.46664
Donetsk | N/A | Ukraine | 37.80224 | 48.023
Kharkiv | N/A | Ukraine | 36.25475 | 49.98177
Kiev | N/A | Ukraine | 30.5238 | 50.45466
Luhansk | N/A | Ukraine | 39.30553 | 48.56814
Lutsk | N/A | Ukraine | 25.35024 | 50.75784
Odesa | N/A | Ukraine | 30.74383 | 46.48572
Poltava | N/A | Ukraine | 34.55367 | 49.58925
Simferopol | N/A | Ukraine | 34.11079 | 44.95719
Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242
Vinnitsa | N/A | Ukraine | 37.71861 | 49.84639
Zhytomyr | N/A | Ukraine | 28.67913 | 50.26235
Huddersfield | N/A | United Kingdom | -1.78416 | 53.64904
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
Nottingham | N/A | United Kingdom | -1.15047 | 52.9536
Sutton | N/A | United Kingdom | -0.2 | 51.35
| 0
|
NCT00091442
|
[
3
] | 150
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 3TRIPLE
| false
| 0ALL
| true
|
This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells.
Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart.
Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease.
For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
|
The object of this study is to determine the safety and efficacy of nitric oxide for inhalation in the treatment of vaso-occlusive pain crisis (VOC) in patients with sickle cell disease. The study population will include patients with sickle cell disease (SS, S-beta-Thalassemia) presenting with vaso-occlusive pain crisis. Patients will be administered either placebo or inhaled nitric oxide to see if the experimental agent, inhaled nitric oxide, can reduce the time it takes for resolution of the vaso-occlusive crisis.
|
Anemia, Sickle Cell
|
Blood Flow Nitric Oxide Pain Crisis Sickle Cell Anemia Vaso-Occlusive Crisis Sickle Cell Disease SCD
| null | 2
|
arm 1: Participants receive Inhaled nitric oxide (INO) arm 2: Participants receive Nitrogen gas
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: Nitric oxide will be delivered for 4 hours at 80 ppm through a face mask. The dose will then be reduced to 40 ppm for 4 hours. After a total of 8 hours of treatment through face mask, the patient will get 6 mL/puls/breath of NO at 800 ppm or 3 m//pulse/breath, depending on patient weight. intervention 2: Nitrogen gas will be delivered in the same manor as the experimental drug.
|
intervention 1: Nitric Oxide intervention 2: Placebo
| 11
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
Oakland | California | United States | -122.2708 | 37.80437
Aurora | Colorado | United States | -104.83192 | 39.72943
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Baltimore | Maryland | United States | -76.61219 | 39.29038
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Cleveland | Ohio | United States | -81.69541 | 41.4995
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
| 0
|
NCT00094887
|
[
3
] | 102
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
|
Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria \[OPDREC\]) that included cutaneous manifestations of disease, lymph node involvement, and circulating malignant T-cells (Sézary cells). Skin involvement was measured using a weighted body surface area skin assessment tool (WBSA/SWAT) or an erythroderma score, depending upon the pt's disease. Disease response was assessed by the Investigators and an Independent Response Review Committee (IRRC) with the IRRC assessment considered supportive of the Investigator's evaluations using the following criteria:
Complete Response (CR):
* Complete resolution of skin patches, skin plaques, and skin tumors, or erythroderma
* No evidence of abnormal lymph nodes
* Absence of circulating Sézary cells.
* No evidence of new tumors (cutaneous or non-cutaneous)
* Findings confirmed by skin biopsy
Clinical complete response (CCR):
\- Same as CR but without skin biopsy
Partial Response (PR):
* ≥50% improvement in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood) with
* At least \>30% improvement in Skin and
* No worsening in Lymph Node or Sézary cells.
* No evidence of new tumors (cutaneous/non-cutaneous)
Stable Disease (SD):
* Not enough improvement or worsening in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood to qualify as PR or PD
* No evidence of new tumors (cutaneous/non-cutaneous)
SD90:
\- SD90 was defined as documented evidence of SD for at least 90 Days Duration
Progressive Disease (PD):
* Evidence of new tumor (cutaneous or non-cutaneous), OR
* \>25% worsening in the summation of (change in Skin + change in Lymph Node + change in Peripheral Blood) with \>15% worsening in change in Skin.
|
Cutaneous T-cell Lymphoma
|
romidepsin
| null | 0
| null | null | 1
|
[
0
] |
intervention 1: Study patients received romidepsin at a dose of 14 mg/m\^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although patients who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.
|
intervention 1: romidepsin (depsipeptide, FK228)
| 11
|
Los Angeles | California | United States | -118.24368 | 34.05223
Stanford | California | United States | -122.16608 | 37.42411
Boston | Massachusetts | United States | -71.05977 | 42.35843
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Nashville | Tennessee | United States | -86.78444 | 36.16589
Houston | Texas | United States | -95.36327 | 29.76328
Multiple Locations | N/A | France | N/A | N/A
Multiple Locations | N/A | Germany | N/A | N/A
Multiple Locations | N/A | Poland | N/A | N/A
Multiple Locations | N/A | Russia | N/A | N/A
Multiple Locations | N/A | United Kingdom | N/A | N/A
| 0
|
NCT00106431
|
[
5
] | 10
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 2DOUBLE
| false
| 0ALL
| true
|
The purpose of this study is to compare ketorolac, a potent, non-steroidal anti-inflammatory drug (NSAID), with ibuprofen, a commonly used NSAID, for the treatment of the painful crisis of sickle cell disease (SCD).
|
BACKGROUND:
SCD is a common disorder among African Americans and other minority groups. It is characterized by chronic anemia and episodic vaso-occlusive crises. The most common of these crises is the painful crisis. Current treatment of the painful crisis includes rest, hydration, and analgesic medication. Morphine is the most commonly prescribed analgesic medication for moderate to severe painful episodes, but there are several side effects associated with its use, including somnolence, respiratory depression, constipation, dysphoria, and pruritus. Other analgesic medications, including NSAIDs, may improve pain control and decrease the need for morphine and other opioid drugs; however, more research is needed to confirm the benefits in individuals with SCD.
DESIGN NARRATIVE:
This study will enroll 120 children who will receive standard opioid and supportive therapy. In addition to this care, participants will be randomly assigned to receive one of the following: 1) intravenous ketorolac and oral placebo; or 2) intravenous placebo and oral ibuprofen. Outcome assessments will include the duration of hospitalization for opioid therapy; the degree of pain intensity and relief determined by validated pain scales; and the utilization of opioid medications during hospitalization. All participants will be monitored for potential adverse effects of the study medications by laboratory measurements and clinical assessments. Additionally, participants will self-report pain levels using the Oucher pain scale. Participants will be monitored for the development of adverse events, including gastrointestinal symptoms and deterioration of kidney function, as determined by daily kidney function tests including BUN, creatinine, and hematuria.
|
Hematologic Diseases Anemia, Sickle Cell
|
Blood Diseases Sickle Cell Anemia
| null | 2
|
arm 1: Intravenous ketorolac and oral placebo arm 2: Intravenous placebo and oral ibuprofen
|
[
1,
1
] | 2
|
[
0,
0
] |
intervention 1: Intravenous ketorolac intervention 2: Ibuprofen, taken orally
|
intervention 1: Intravenous Ketorolac intervention 2: Ibuprofen
| 1
|
Dallas | Texas | United States | -96.80667 | 32.78306
| 0
|
NCT00115336
|
[
3
] | 5
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 1FEMALE
| false
|
RATIONALE: Monoclonal antibodies, such as trastuzumab, 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. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.
|
OBJECTIVES:
Primary
* Determine the antitumor activity of trastuzumab (Herceptin\^®), docetaxel, and carboplatin, as measured by tumor response rate, in women with previously untreated HER2/neu-positive stage IIB, IIIA, IIIB, or IIIC or inflammatory breast cancer.
Secondary
* Determine the pathological complete response in patients treated with this regimen.
* Determine the disease-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine pathologic and molecular markers for predicting efficacy of this regimen in these patients.
OUTLINE: This is a non-randomized, multicenter study.
* Course 1 (days 1-28): Patients receive trastuzumab (Herceptin\^®) IV over 30-90 minutes on days 1, 8, 15, and 22 and docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 8.
* Course 2-6: Patients receive trastuzumab IV over 30 minutes on days 1, 8, and 15 during courses 2-5 and on days 1, 8, 15, and 22 during course 6. Patients also receive docetaxel IV over 1 hour and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 5 additional courses (6 courses total) in the absence of disease progression or unacceptable toxicity.
Three weeks after completion of course 6, patients undergo restaging. Patients with local operable disease undergo modified radical mastectomy or lumpectomy and axillary node dissection followed by radiotherapy. Patients also receive trastuzumab IV once every 3 weeks for up to 52 weeks of total treatment (including the 6 courses of trastuzumab, docetaxel, and carboplatin) in the absence of disease progression or unacceptable toxicity. Patients who do not have local operable disease continue to receive trastuzumab as above.
PROJECTED ACCRUAL: A total of 13-43 patients will be accrued for this study.
|
Breast Cancer
|
inflammatory breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer
| null | 1
|
arm 1: A total of six cycles of TCH \[(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)\] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.
* Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.
* If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.
|
[
0
] | 5
|
[
2,
0,
0,
3,
3
] |
intervention 1: None intervention 2: None intervention 3: None intervention 4: Modified radical mastectomy or lumpectomy and axillary node dissection intervention 5: Whole breast or chest wall irradiation (as determined by radiologist)
|
intervention 1: herceptin intervention 2: carboplatin intervention 3: docetaxel intervention 4: conventional surgery intervention 5: radiation therapy
| 9
|
East Brunswick | New Jersey | United States | -74.41598 | 40.42788
Freehold | New Jersey | United States | -74.27376 | 40.26011
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Montclair | New Jersey | United States | -74.20903 | 40.82593
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Newark | New Jersey | United States | -74.17237 | 40.73566
Summit | New Jersey | United States | -74.36468 | 40.71562
| 0
|
NCT00118053
|
[
5
] | 293
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| null |
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
| null |
Liver Transplantation
| null | 2
|
arm 1: None arm 2: None
|
[
0,
1
] | 4
|
[
0,
0,
0,
0
] |
intervention 1: 1-1.5 g orally or intravenously twice daily intervention 2: As prescribed, for 12 months intervention 3: As prescribed, for 12 months intervention 4: 2-4 mg orally once daily for 9-11 months
|
intervention 1: mycophenolate mofetil [CellCept] intervention 2: Tacrolimus intervention 3: Cyclosporine intervention 4: Sirolimus
| 46
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
La Jolla | California | United States | -117.2742 | 32.84727
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Jacksonville | Florida | United States | -81.65565 | 30.33218
Miami | Florida | United States | -80.19366 | 25.77427
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Burlington | Massachusetts | United States | -71.19561 | 42.50482
Detroit | Michigan | United States | -83.04575 | 42.33143
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Rochester | Minnesota | United States | -92.4699 | 44.02163
St Louis | Missouri | United States | -90.19789 | 38.62727
Newark | New Jersey | United States | -74.17237 | 40.73566
Hawthorne | New York | United States | -73.79597 | 41.10732
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
New York | New York | United States | -74.00597 | 40.71427
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
Cleveland | Ohio | United States | -81.69541 | 41.4995
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
Richmond | Virginia | United States | -77.46026 | 37.55376
Madison | Wisconsin | United States | -89.40123 | 43.07305
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
London | Ontario | Canada | -81.23304 | 42.98339
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
| 0
|
NCT00118742
|
|
[
5
] | 109
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 1FEMALE
| null |
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was \<100 individuals.
| null |
Breast Cancer
| null | 1
|
arm 1: None
|
[
0
] | 2
|
[
0,
0
] |
intervention 1: 1000 mg/m² PO BID on Days 1-15 of each 3-week cycle intervention 2: 15 mg IV on Day 1 of each 3-week cycle
|
intervention 1: Capecitabine intervention 2: Bevacizumab
| 57
|
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Birmingham | Alabama | United States | -86.80249 | 33.52066
Burbank | California | United States | -118.30897 | 34.18084
Glendale | California | United States | -118.25508 | 34.14251
Glendale | California | United States | -118.25508 | 34.14251
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Farmington | Connecticut | United States | -72.83204 | 41.71982
Bonita Springs | Florida | United States | -81.7787 | 26.33981
Boynton Beach | Florida | United States | -80.06643 | 26.52535
Bradenton | Florida | United States | -82.57482 | 27.49893
Cape Coral | Florida | United States | -81.94953 | 26.56285
Fort Myers | Florida | United States | -81.84059 | 26.62168
Fort Myers | Florida | United States | -81.84059 | 26.62168
Naples | Florida | United States | -81.79596 | 26.14234
Naples | Florida | United States | -81.79596 | 26.14234
Port Charlotte | Florida | United States | -82.09064 | 26.97617
Sarasota | Florida | United States | -82.53065 | 27.33643
Sarasota | Florida | United States | -82.53065 | 27.33643
Venice | Florida | United States | -82.45426 | 27.09978
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Tucker | Georgia | United States | -84.21714 | 33.85455
Chicago | Illinois | United States | -87.65005 | 41.85003
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Waterloo | Iowa | United States | -92.34296 | 42.49276
Scarborough | Maine | United States | -70.32172 | 43.57814
Prince Frederick | Maryland | United States | -76.5844 | 38.5404
Lansing | Michigan | United States | -84.55553 | 42.73253
Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973
Kansas City | Missouri | United States | -94.57857 | 39.09973
Lincoln | Nebraska | United States | -96.66696 | 40.8
Omaha | Nebraska | United States | -95.94043 | 41.25626
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Brick | New Jersey | United States | -74.13708 | 40.05928
Neptune City | New Jersey | United States | -74.02792 | 40.20011
Red Bank | New Jersey | United States | -74.06431 | 40.34705
Rochester | New York | United States | -77.61556 | 43.15478
Hickory | North Carolina | United States | -81.3412 | 35.73319
Canton | Ohio | United States | -81.37845 | 40.79895
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Beaufort | South Carolina | United States | -80.66993 | 32.4317
Charleston | South Carolina | United States | -79.93275 | 32.77632
Florence | South Carolina | United States | -79.76256 | 34.19543
Hilton Head Island | South Carolina | United States | -80.73816 | 32.19382
Sumter | South Carolina | United States | -80.34147 | 33.92044
Abingdon | Virginia | United States | -81.97735 | 36.70983
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
| 0
|
NCT00121836
|
|
[
3
] | 10
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.
|
Opiates have a long history of treating mood disorders. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. The clinical use of opiate medications has been limited by their abuse/dependence potential. Studies of opiate receptor subtypes have raised the possibility that medications targeting the kappa/dynorphin system could be used to target mood symptoms with reduced/limited addiction potential. Rodent studies at Mclean indicate that kappa-agonists have pro-depressant effects and kappa-antagonists have anti-depressant effects. In addition, antimanic/antipsychotic medications regulate the activity of dynorphin cells. This study is a pilot open-label investigation using Talwin, a combination of pentazocine and naloxone. Pentazocine is a kappa agonist and mixed mu agonist. Two doses of Talwin will be given to acutely manic inpatients in a cumulative-dosing strategy. Measurements of manic symptoms will be conducted before, during, and after administration. This study will determine whether pentazocine has an immediate or sustained impact on acute mania symptoms.
|
Bipolar Disorder
|
bipolar disorder mania manic state opiate kappa
| null | 1
|
arm 1: Talwin NX
|
[
0
] | 1
|
[
0
] |
intervention 1: Talwin NX 50mg po twice
|
intervention 1: Talwin Nx
| 0
| null | 0
|
NCT00125931
|
[
4
] | 587
|
NA
|
SINGLE_GROUP
| 2DIAGNOSTIC
| 0NONE
| true
| 0ALL
| true
|
The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcomes in subjects with heart failure and in comparison to subjects without cardiovascular disease.
| null |
Heart Failure, Congestive
|
Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG
| null | 1
|
arm 1: Single dose
|
[
0
] | 1
|
[
0
] |
intervention 1: Single dose
|
intervention 1: 123I-mIBG (meta-iodobenzylguanidine)
| 1
|
Princeton | New Jersey | United States | -74.65905 | 40.34872
| 0
|
NCT00126425
|
[
4
] | 145
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
The purpose of this study is to investigate the added benefits of increased high-density lipoprotein (HDL) cholesterol serum levels over and above those achieved by lipid lowering therapy guided by current guidelines, in older individuals with cardiovascular disease.
|
The hypothesis being tested is that the current standard lipid lowering therapy, combined with a 20 percent or greater increase in serum HDL induced by long-acting niacin, reduces plaque size in older individuals with cardiovascular disease. The specific aims of testing this hypothesis are:
1. to determine the effects of statin plus placebo vs. statin plus niacin therapy on plaque size and composition,
2. to determine whether alterations of inflammatory markers of atherosclerosis induced by lipid lowering therapy parallel alterations of plaque architecture and composition in older patients with cardiovascular disease,
3. to determine the effects of these interventions on the incidence of cardiovascular and cerebrovascular events.
The results of the trial will be directly applicable to developing strategies for plaque stabilization in the elderly who suffer the most from the severe complications of advanced cardiovascular atherosclerosis.
A total of 144 participants aged 65 and older with cardiovascular or cerebrovascular disease will be recruited. Participants will be randomized to receive either statin plus niacin or statin plus a placebo for 18 months. Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily. Ten visits are expected, initially every 4 weeks for dose adjustment. Then visits will be every 6 months; MRI, Inflammatory Markers tests, and other lab tests will be done at baseline and the visits at months 6, 12, and 18.
|
Atherosclerosis Cardiovascular Disease
|
atherosclerotic plaque MRI inflammatory markers statins
| null | 2
|
arm 1: any statin plus niacin arm 2: any statin plus placebo
|
[
0,
2
] | 3
|
[
0,
0,
0
] |
intervention 1: Participants will be provided a prescription for fluvastatin 80 mg to be taken on a daily basis, or they may continue their ongoing or any other cholesterol-lowering drugs such as pravastatin 80 mg daily, simvastatin 20 mg daily, atorvastatin up to 20 mg daily or rosuvastatin up to 20 mg daily for 18 months intervention 2: long-acting niacin daily for 18 months intervention 3: matching placebo pill daily for 18 months
|
intervention 1: any statin intervention 2: niacin intervention 3: Placebo
| 1
|
Baltimore | Maryland | United States | -76.61219 | 39.29038
| 0
|
NCT00127218
|
[
4
] | 635
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
This study is being done to find out the good and bad effects of inhaled insulin that is used by oral inhalation, to adult males and females with type 2 diabetes mellitus. The other name for this inhaled insulin is Exubera®.
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
|
Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171029 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
|
Diabetes Mellitus
| null | 2
|
arm 1: Inhalable short-acting insulin arm 2: None
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose intervention 2: Subcutaneous insulin with dose adjusted according to premeal blood glucose
|
intervention 1: Inhaled Insulin intervention 2: Subcutaneous insulin
| 92
|
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | United States | -110.92648 | 32.22174
Fresno | California | United States | -119.77237 | 36.74773
Greenbrae | California | United States | -122.5247 | 37.94854
Los Angeles | California | United States | -118.24368 | 34.05223
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
San Diego | California | United States | -117.16472 | 32.71571
San Luis Obispo | California | United States | -120.65962 | 35.28275
Tustin | California | United States | -117.82617 | 33.74585
Walnut Creek | California | United States | -122.06496 | 37.90631
Denver | Colorado | United States | -104.9847 | 39.73915
Hamden | Connecticut | United States | -72.89677 | 41.39593
Madison | Connecticut | United States | -72.59843 | 41.27954
New Britain | Connecticut | United States | -72.77954 | 41.66121
Waterbury | Connecticut | United States | -73.0515 | 41.55815
Chiefland | Florida | United States | -82.85984 | 29.47496
Clearwater | Florida | United States | -82.8001 | 27.96585
Fort Myers | Florida | United States | -81.84059 | 26.62168
Hollywood | Florida | United States | -80.14949 | 26.0112
Miami | Florida | United States | -80.19366 | 25.77427
Ocala | Florida | United States | -82.14009 | 29.1872
Palm Harbor | Florida | United States | -82.76371 | 28.07807
Tallahassee | Florida | United States | -84.28073 | 30.43826
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Honolulu | Hawaii | United States | -157.85833 | 21.30694
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Springfield | Illinois | United States | -89.64371 | 39.80172
Wilmette | Illinois | United States | -87.72284 | 42.07225
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Bethesda | Maryland | United States | -77.10026 | 38.98067
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Bloomfield Hills | Michigan | United States | -83.24549 | 42.58364
Plymouth | Michigan | United States | -83.47021 | 42.37143
Royal Oak | Michigan | United States | -83.14465 | 42.48948
Southfield | Michigan | United States | -83.22187 | 42.47337
Chesterfield | Missouri | United States | -90.57707 | 38.66311
St Louis | Missouri | United States | -90.19789 | 38.62727
Butte | Montana | United States | -112.53474 | 46.00382
Lincoln | Nebraska | United States | -96.66696 | 40.8
Henderson | Nevada | United States | -114.98194 | 36.0397
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Mineola | New York | United States | -73.64068 | 40.74927
New Hyde Park | New York | United States | -73.68791 | 40.7351
Rochester | New York | United States | -77.61556 | 43.15478
Durham | North Carolina | United States | -78.89862 | 35.99403
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Mansfield | Ohio | United States | -82.51545 | 40.75839
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Warwick | Rhode Island | United States | -71.41617 | 41.7001
Beaumont | Texas | United States | -94.10185 | 30.08605
Beaumont | Texas | United States | -94.10185 | 30.08605
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Corpus Christi | Texas | United States | -97.39638 | 27.80058
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
Irving | Texas | United States | -96.94889 | 32.81402
San Antonio | Texas | United States | -98.49363 | 29.42412
Burlington | Vermont | United States | -73.21207 | 44.47588
Richmond | Virginia | United States | -77.46026 | 37.55376
Renton | Washington | United States | -122.21707 | 47.48288
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Calgary | Alberta | Canada | -114.08529 | 51.05011
Calgary | Alberta | Canada | -114.08529 | 51.05011
Red Deer | Alberta | Canada | -113.802 | 52.26682
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Winnepeg | Manitoba | Canada | N/A | N/A
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
London | Ontario | Canada | -81.23304 | 42.98339
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Toronto | Ontario | Canada | -79.39864 | 43.70643
Toronto | Ontario | Canada | -79.39864 | 43.70643
Laval | Quebec | Canada | -73.692 | 45.56995
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
Aguas Buenas | N/A | Puerto Rico | -66.10294 | 18.2569
Añasco | N/A | Puerto Rico | -67.13962 | 18.28273
Cabo Rojo | N/A | Puerto Rico | -67.14573 | 18.08663
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633
| 0
|
NCT00136916
|
|
[
4
] | 582
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
This study is being done to find out the good and bad effects of a drug that is not approved for sale and the effects if any on measures of pulmonary function in adult males and females with type 1 diabetes mellitus. The drug is called EXUBERA (inhaled insulin).
This study included a 2-year comparative treatment period followed by a 6-month follow-up period during which inhaled insulin-treated subjects were switched back to subcutaneous short-acting insulin. After this follow-up period, all eligible subjects entered a comparative extension period that was to last for 5 years. When the comparative portion of the study was terminated, all subjects were requested to return for a final extension follow-up month 3 visit.
|
Pfizer announced in October 2007 that it would stop marketing Exubera. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, study A2171022 was terminated on June 9, 2008. Neither safety nor efficacy reasons were the cause of the study termination.
|
Diabetes Mellitus, Type 1
| null | 2
|
arm 1: None arm 2: None
|
[
1,
0
] | 2
|
[
0,
0
] |
intervention 1: Subcutaneous insulin with dose adjusted according to premeal blood glucose intervention 2: Inhaled insulin with dose adjusted according to premeal blood glucose
|
intervention 1: Subcutaneous Insulin intervention 2: Inhaled Insulin
| 73
|
Fullerton | California | United States | -117.92534 | 33.87029
Long Beach | California | United States | -118.18923 | 33.76696
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Santa Barbara | California | United States | -119.69819 | 34.42083
Santa Rosa | California | United States | -122.71443 | 38.44047
Tustin | California | United States | -117.82617 | 33.74585
Walnut Creek | California | United States | -122.06496 | 37.90631
Denver | Colorado | United States | -104.9847 | 39.73915
Longmont | Colorado | United States | -105.10193 | 40.16721
Hamden | Connecticut | United States | -72.89677 | 41.39593
Madison | Connecticut | United States | -72.59843 | 41.27954
Newark | Delaware | United States | -75.74966 | 39.68372
Coral Gables | Florida | United States | -80.26838 | 25.72149
Hollywood | Florida | United States | -80.14949 | 26.0112
Miami | Florida | United States | -80.19366 | 25.77427
Tallahassee | Florida | United States | -84.28073 | 30.43826
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Winter Park | Florida | United States | -81.33924 | 28.6
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Wilmette | Illinois | United States | -87.72284 | 42.07225
Bethesda | Maryland | United States | -77.10026 | 38.98067
St Louis | Missouri | United States | -90.19789 | 38.62727
Butte | Montana | United States | -112.53474 | 46.00382
New Hyde Park | New York | United States | -73.68791 | 40.7351
Durham | North Carolina | United States | -78.89862 | 35.99403
Portland | Oregon | United States | -122.67621 | 45.52345
Lansdale | Pennsylvania | United States | -75.28379 | 40.2415
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
San Antonio | Texas | United States | -98.49363 | 29.42412
Burlington | Vermont | United States | -73.21207 | 44.47588
Richmond | Virginia | United States | -77.46026 | 37.55376
Renton | Washington | United States | -122.21707 | 47.48288
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Belo Horizonte | Minas Gerais | Brazil | -43.93778 | -19.92083
Curitiba | Paraná | Brazil | -49.27306 | -25.42778
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
Campinas | São Paulo | Brazil | -47.06083 | -22.90556
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Calgary | Alberta | Canada | -114.08529 | 51.05011
Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Winnepeg | Manitoba | Canada | N/A | N/A
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Kingston | Ontario | Canada | -76.48098 | 44.22976
London | Ontario | Canada | -81.23304 | 42.98339
Mississauga | Ontario | Canada | -79.6583 | 43.5789
Oakville | Ontario | Canada | -79.68292 | 43.45011
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Thornhill | Ontario | Canada | -79.4163 | 43.80011
Toronto | Ontario | Canada | -79.39864 | 43.70643
Laval | Quebec | Canada | -73.692 | 45.56995
Montreal | Quebec | Canada | -73.58781 | 45.50884
Montreal | Quebec | Canada | -73.58781 | 45.50884
Sherbrooke | Quebec | Canada | -71.89908 | 45.40008
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
Mexico City | COL LAS Americas | Mexico | -99.12766 | 19.42847
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
| 0
|
NCT00137046
|
|
[
3
] | 16
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| null |
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
|
PRIMARY OBJECTIVES:
I. To evaluate the response of non-small cell lung cancer to SAHA in the second line setting by applying RECIST criteria.
SECONDARY OBJECTIVES:
I. To estimate the time to progression and overall survival in this patient population.
II. To examine the toxicity profile of SAHA.
TERTIARY OBJECTIVES:
I. To evaluate the molecular activity of SAHA by evaluating its effect on histone acetylation, upregulation of target genes, generation of reactive oxygen species, apoptosis and correlation with P53 status.
II. To explore gene expression profiles that predict response to SAHA.
OUTLINE: This is a multicenter study.
Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then every 3 months for 1 year or until disease progression.
|
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
| null | 1
|
arm 1: Patients receive oral suberoylanilide hydroxamic acid once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
[
0
] | 2
|
[
0,
10
] |
intervention 1: Given PO intervention 2: Correlative studies
|
intervention 1: vorinostat intervention 2: laboratory biomarker analysis
| 5
|
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
La Crosse | Wisconsin | United States | -91.23958 | 43.80136
Madison | Wisconsin | United States | -89.40123 | 43.07305
Madison | Wisconsin | United States | -89.40123 | 43.07305
Manitowoc | Wisconsin | United States | -87.65758 | 44.08861
| 0
|
NCT00138203
|
|
[
4
] | 485
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
| null |
Small Cell Lung Carcinoma
| null | 2
|
arm 1: None arm 2: None
|
[
0,
0
] | 2
|
[
0,
0
] |
intervention 1: etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle intervention 2: irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
|
intervention 1: Etoposide + cisplatin intervention 2: Irinotecan + cisplatin
| 67
|
Wels | N/A | Austria | 14.03333 | 48.16667
Ghent | N/A | Belgium | 3.71667 | 51.05
Leuven | N/A | Belgium | 4.70093 | 50.87959
Liège | N/A | Belgium | 5.56749 | 50.63373
Brno-Bohunice | N/A | Czechia | N/A | N/A
Olomouc | N/A | Czechia | 17.25175 | 49.59552
Ostrava - Poruba | N/A | Czechia | N/A | N/A
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Ústí nad Labem | N/A | Czechia | 14.03227 | 50.6607
Alexandria | N/A | Egypt | 29.91582 | 31.20176
Cairo | N/A | Egypt | 31.24967 | 30.06263
Amiens | N/A | France | 2.3 | 49.9
Bobigny | N/A | France | 2.45012 | 48.90982
Bordeaux | N/A | France | -0.5805 | 44.84044
Brest | N/A | France | -4.48628 | 48.39029
Caen | N/A | France | -0.35912 | 49.18585
Limoges | N/A | France | 1.24759 | 45.83362
Marseille | N/A | France | 5.38107 | 43.29695
Meaux | N/A | France | 2.87885 | 48.96014
Mulhouse | N/A | France | 7.32866 | 47.75205
Pierre-Bénite | N/A | France | 4.82424 | 45.70359
Rennes | N/A | France | -1.67429 | 48.11198
Rouen | N/A | France | 1.09932 | 49.44313
Saint-Brieuc | N/A | France | -2.76838 | 48.51513
Saint-Etienne | N/A | France | 4.39 | 45.43389
Saint-Pierre | N/A | France | 5.40682 | 43.29282
Villefranche-sur-Saône | N/A | France | 4.71961 | 45.98967
Villejuif | N/A | France | 2.35992 | 48.7939
Bad Berka | N/A | Germany | 11.28245 | 50.89982
Berlin | N/A | Germany | 13.41053 | 52.52437
Bovenden-Lenglern | N/A | Germany | N/A | N/A
Ebensfeld | N/A | Germany | 10.95835 | 50.0664
Gauting | N/A | Germany | 11.37703 | 48.06919
Göttingen | N/A | Germany | 9.93228 | 51.53443
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Hamburg | N/A | Germany | 9.99302 | 53.55073
Heidelberg | N/A | Germany | 8.69079 | 49.40768
Hemer | N/A | Germany | 7.77019 | 51.38707
Löwenstein | N/A | Germany | 9.38 | 49.09558
München | N/A | Germany | 13.31243 | 51.60698
Bologna | N/A | Italy | 11.33875 | 44.49381
Perugia | N/A | Italy | 12.38878 | 43.1122
Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
Breda | N/A | Netherlands | 4.77596 | 51.58656
Groningen | N/A | Netherlands | 6.56667 | 53.21917
Maastricht | N/A | Netherlands | 5.68889 | 50.84833
Nieuwegein | N/A | Netherlands | 5.08056 | 52.02917
Lodz | N/A | Poland | 19.47395 | 51.77058
Otwock | N/A | Poland | 21.26129 | 52.10577
Poznan | N/A | Poland | 16.92993 | 52.40692
Warsaw | N/A | Poland | 21.01178 | 52.22977
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow 115 478 | N/A | Russia | N/A | N/A
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Barcelona | BARCELONA | Spain | 2.15899 | 41.38879
Madrid | Madrid | Spain | -3.70256 | 40.4165
Aarau | N/A | Switzerland | 8.04422 | 47.39254
Basel | N/A | Switzerland | 7.57327 | 47.55839
Bellinzona | N/A | Switzerland | 9.01703 | 46.19278
Bern | N/A | Switzerland | 7.44744 | 46.94809
Ch-4101 Bruderholz | N/A | Switzerland | N/A | N/A
Thun | N/A | Switzerland | 7.62166 | 46.75118
Taichung | N/A | Taiwan | 120.6839 | 24.1469
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896
| 0
|
NCT00143455
|
|
[
4
] | 468
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| true
|
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, has shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
| null |
Schizophrenia
| null | 2
|
arm 1: None arm 2: None
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: 5-10 mg sublingually twice daily for up to 26 weeks intervention 2: 5-20 mg by mouth once daily for up to 26 weeks
|
intervention 1: Asenapine intervention 2: Olanzapine
| 0
| null | 0
|
NCT00145496
|
|
[
2,
3
] | 32
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
This study is an open-label study. It has two stages. Stage 1 is a dose escalation phase of the study to determine and evaluate the safety and tolerability of repeated treatments with a genetically engineered herpes simplex virus NV1020 administered locoregionally to the liver.
Stage 2 is to evaluate the dose found in Stage 1 to be "optimally tolerated". Stage 2 is to assess the efficacy of the optimally tolerated dose of NV1020 by itself and in combination with second-line chemotherapy.
Assignment to Stage 1 or Stage 2 of the study is determined by when the patient enters the study.
|
This study is designed to evaluate the effects of repeated treatments with NV1020, prior to second-line chemotherapy, and to determine an appropriate dose level of NV1020 in a multiple dose regimen for later Phase II studies.
Sequential, open-label cohort dose escalation of NV1020 (stage 1) followed by an expansion of one selected dose cohort (stage 2).
Study results will be reviewed periodically by an independent DSMB who will approve each cohort dose escalation.
During the dose escalation stage, 3 cohorts of patients (3 in each) will be treated with 4 fixed doses of NV1020, with the dose level increasing for successive cohorts. A patient will be observed for a minimum of 7 days after the first NV1020 infusion before the next patient in the same cohort is given NV1020. The first patient in the next higher dose cohort will receive NV1020 no earlier than 14 days after the last patient in the prior cohort has finished NV1020 infusions. One additional cohort (half log higher increment) may be approved by the DSMB, if considered necessary to define MTD. Dose-limiting toxicity will be determined using NCI CTC criteria and a suitable dose level for later evaluation will be selected.
In the second stage of the study, the dose cohort considered to show the best therapeutic index will be expanded by the addition of 18 further patients. For all patients in this study, investigational treatment with NV1020 will be followed by a minimum of two cycles of second-line therapy using anti-neoplastic drugs approved by the FDA for colorectal cancer and selected by the investigator.
All patients will be followed up periodically until death. Permission for autopsy will be sought.
|
Colorectal Cancer Liver Neoplasms
|
Colorectal cancer metastases to liver Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Colorectal Neoplasms Rectum Cancer Rectum tumors Rectum carcinoma Colon cancer Colon tumors Colon carcinoma Rectum Neoplasms Colon Neoplasms Liver Neoplasms Hepatic Neoplasms Liver Tumors Liver cancer Hepatic Cancer Hepatic tumors metastatic to the liver
| null | 1
|
arm 1: Stage 1: Four escalating dose cohorts of NV1020 3x10\^6 pfu, 1x10\^7 pfu, 3x10\^7 pfu, and 1x10\^8 pfu administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.
Stage 2: Expansion of one dose cohort from Stage 1 of optimal NV1020 dose administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks followed by 2 cycles of chemotherapy.
|
[
0
] | 1
|
[
0
] |
intervention 1: NV1020 dose levels: 3x10\^6, 1x10\^7, 3x10\^7, and 1x10\^8 plaque forming units, administered via hepatic artery infusion, over 10 minutes and repeated every 1-2 weeks for 4-8 weeks
|
intervention 1: NV1020
| 5
|
San Diego | California | United States | -117.16472 | 32.71571
Boston | Massachusetts | United States | -71.05977 | 42.35843
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Nashville | Tennessee | United States | -86.78444 | 36.16589
Dallas | Texas | United States | -96.80667 | 32.78306
| 0
|
NCT00149396
|
[
3,
4
] | 48
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary
| null |
Aspergillosis
| null | 1
|
arm 1: None
|
[
0
] | 1
|
[
0
] |
intervention 1: Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response.
Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours
|
intervention 1: Voriconazole
| 18
|
Nantes | Cedex | France | -1.55336 | 47.21725
Angers | N/A | France | -0.55202 | 47.47156
Bobigny | N/A | France | 2.45012 | 48.90982
Brest | N/A | France | -4.48628 | 48.39029
Bris Sous Forges | N/A | France | N/A | N/A
Caen | N/A | France | -0.35912 | 49.18585
Dinan | N/A | France | -2.05049 | 48.45553
Grenoble | N/A | France | 5.71479 | 45.17869
Lille | N/A | France | 3.05858 | 50.63297
Lyon | N/A | France | 4.84671 | 45.74846
Montpellier | N/A | France | 3.87635 | 43.61093
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Paris | N/A | France | 2.3488 | 48.85341
Poitiers | N/A | France | 0.34348 | 46.58261
Reims | N/A | France | 4.02853 | 49.26526
Rouen | N/A | France | 1.09932 | 49.44313
Suresnes | N/A | France | 2.22929 | 48.87143
| 0
|
NCT00159822
|
|
[
2,
3
] | 16
|
NON_RANDOMIZED
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
The purpose of this study is to determine whether thymic shielding during total body irradiation can be given and whether it will reduce the risk of infections in Fanconi Anemia patients undergoing alternate donor (not a matched sibling) stem cell transplants.
|
All subjects will be given the same treatment regimen of total body irradiation (TBI), Fludarabine, Cyclophosphamide, and anti-thymocyte globulin (ATG), followed by an alternate donor stem cell transplant. Since this treatment regimen has been given before, without thymic shielding, we will compare the outcomes of these patients with the historical data from subjects who did not receive thymic shielding.
|
Fanconi Anemia
|
Stem Cell Transplant Thymic Shielding Total Body Irradiation Chemotherapy
| null | 1
|
arm 1: Patients who received total body irradiation (450 cGy \[centigray\]) with thymic shielding prior to chemotherapy regimen and Hematopoietic Stem Cell Transplant (HSCT)
|
[
0
] | 4
|
[
3,
3,
3,
0
] |
intervention 1: Bone marrow failure may be treated by giving patients stem cells that come from someone else. This is called a stem-cell transplant. As part of the transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover. intervention 2: protecting the thymus during total body radiation (450 cGy administered) intervention 3: Six days before the stem cells are given (day -6), subjects will receive total body irradiation with thymic shielding. Thymic shielding is done by placing a piece of lead on the chest during the irradiation treatment so that the irradiation beams do not go to the thymus. intervention 4: Day -5 through Day -2, subjects will receive a chemotherapy regimen of Fludarabine, Cyclophosphamide via central line
|
intervention 1: Hematopoietic Stem Cell Transplant intervention 2: Thymic Shielding During Radiation intervention 3: Total Body Irradiation intervention 4: Cyclophosphamide, Fludarabine
| 1
|
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
| 0
|
NCT00167206
|
[
0
] | 164
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 1SINGLE
| false
| 0ALL
| false
|
This study will determine the metabolic processes responsible for high levels of blood glucose, metabolism disorders, and weight gain in people with schizophrenia who have been treated with antipsychotic medications in combination with valproate.
|
This project aims to study the whole-body metabolic processes responsible for hyperglycemia, dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic medications in combination with valproate. The project hypothesizes that combined treatment with valproate and antipsychotic medications will decrease insulin sensitivity at the level of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and lipid metabolism and increased adiposity
Treatment effects of antipsychotic/valproate combination therapy on different components of insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity, are unknown despite the availability of gold-standard methods and the prognostic significance of these issues. Relevant data are needed to target basic research, to identify the potential for acute and long-term complications, and to plan therapeutic interventions. The following specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical antipsychotics who will be randomized to open label treatment with either valproate or no adjuvant. Evaluations are performed at baseline and 3 months of treatment.
|
Schizophrenia
|
Diabetes Metabolic
| null | 2
|
arm 1: 50% of participants will receive placebo arm 2: 50% of participants will receive Depakote ER
|
[
2,
0
] | 2
|
[
0,
0
] |
intervention 1: Depakote ER 500 mg to 3000 mg taken every night intervention 2: Placebo given at same frequency as Valproate
|
intervention 1: Valproate intervention 2: Placebo
| 1
|
St Louis | Missouri | United States | -90.19789 | 38.62727
| 0
|
NCT00167934
|
[
3
] | 23
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 2MALE
| false
|
Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.
| null |
Prostate Cancer
|
prostate cancer
| null | 1
|
arm 1: None
|
[
0
] | 1
|
[
0
] |
intervention 1: application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.
The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.
|
intervention 1: Transdermal Estradiol
| 6
|
Freehold | New Jersey | United States | -74.27376 | 40.26011
Hamilton | New Jersey | United States | -74.08125 | 40.20706
Morristown | New Jersey | United States | -74.48154 | 40.79677
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
New Brunswick | New Jersey | United States | -74.45182 | 40.48622
Summit | New Jersey | United States | -74.36468 | 40.71562
| 0
|
NCT00176644
|
[
3
] | 40
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.
|
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.
|
Cancer
|
gastric stomach esophagus esophageal
| null | 1
|
arm 1: Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.
Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
|
[
0
] | 2
|
[
0,
0
] |
intervention 1: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.
Cycle 2 will begin on day 22. intervention 2: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).
Each cycle will consist of 21 days.
Cycle 2 will begin on day 22.
|
intervention 1: Docetaxel intervention 2: Capecitabine
| 1
|
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
| 0
|
NCT00177255
|
[
3
] | 742
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 1SINGLE
| false
| 1FEMALE
| false
|
The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.
|
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Although the title of the study describes "open", it was in fact single-blinded.
Issues on side effects are addressed in the Adverse Event section.
|
Contraception
| null | 3
|
arm 1: Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro arm 2: Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro arm 3: Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
|
[
0,
0,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years intervention 2: Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years intervention 3: Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
|
intervention 1: Levonorgestrel IUS (BAY86-5028, G04209B) intervention 2: Levonorgestrel IUS (BAY86-5028, G04209C) intervention 3: Levonorgestrel IUS (Mirena, BAY86-5028)
| 35
|
Espoo | N/A | Finland | 24.6522 | 60.2052
Helsinki | N/A | Finland | 24.93545 | 60.16952
Joensuu | N/A | Finland | 29.76316 | 62.60118
Jyväskylä | N/A | Finland | 25.72088 | 62.24147
Kotka | N/A | Finland | 26.94582 | 60.4664
Kuopio | N/A | Finland | 27.67703 | 62.89238
Lahti | N/A | Finland | 25.66151 | 60.98267
Oulu | N/A | Finland | 25.46816 | 65.01236
Oulu | N/A | Finland | 25.46816 | 65.01236
Oulu | N/A | Finland | 25.46816 | 65.01236
Tampere | N/A | Finland | 23.78712 | 61.49911
Turku | N/A | Finland | 22.26869 | 60.45148
Turku | N/A | Finland | 22.26869 | 60.45148
Turku | N/A | Finland | 22.26869 | 60.45148
Békéscsaba | N/A | Hungary | 21.1 | 46.68333
Eger | N/A | Hungary | 20.37329 | 47.90265
Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539
Szeged | N/A | Hungary | 20.14824 | 46.253
Drammen | N/A | Norway | 10.20449 | 59.74389
Elverum | N/A | Norway | 11.56231 | 60.88191
Kolbotn | N/A | Norway | 10.80389 | 59.81056
Larvik | N/A | Norway | 10.03517 | 59.05328
Oslo | N/A | Norway | 10.74609 | 59.91273
Trondheim | N/A | Norway | 10.39506 | 63.43049
Gothenburg | N/A | Sweden | 11.96679 | 57.70716
Huddinge | N/A | Sweden | 17.98192 | 59.23705
Kalmar | N/A | Sweden | 16.36163 | 56.66157
Luleå | N/A | Sweden | 22.15465 | 65.58415
Norrköping | N/A | Sweden | 16.1826 | 58.59419
Örebro | N/A | Sweden | 15.2066 | 59.27412
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Umeå | N/A | Sweden | 20.25972 | 63.82842
Chesterfield | Derbyshire | United Kingdom | -1.41667 | 53.25
Sheffield | South Yorkshire | United Kingdom | -1.4659 | 53.38297
Chesterfield | N/A | United Kingdom | -1.41667 | 53.25
| 0
|
NCT00185380
|
|
[
3
] | 75
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.
|
Upon determination of eligibility, patients will receive:
Pre-operative
* Docetaxel
* Gemcitabine Post-operative
* Docetaxel
* Carboplatin
* Radiation Therapy
Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment
|
Lung Cancer
| null | 1
|
arm 1: Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
|
[
0
] | 4
|
[
0,
0,
0,
4
] |
intervention 1: 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles intervention 2: 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles intervention 3: AUC = 1.5 weekly x 7 intervention 4: To 63 Gy
|
intervention 1: Docetaxel intervention 2: Gemcitabine intervention 3: Carboplatin intervention 4: Radiation
| 1
|
Nashville | Tennessee | United States | -86.78444 | 36.16589
| 0
|
NCT00193427
|
|
[
0
] | 64
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
The purpose of this research was to test whether one treatment was superior over another in the management of type 1.5 diabetes. Specifically we tested recently diagnosed antibody positive type 2 diabetic patients to determine whether treatment with rosiglitazone results in greater preservation of beta cell function compared to treatment with glyburide.
|
Type 1 diabetes and Type 2 diabetes have different underlying pathophysiologic processes. The disease process in classical Type 1 diabetes is an autoimmune destruction of the pancreatic beta cells. In contrast, the disease process in classical Type 2 diabetes is not autoimmune in nature, a decreased sensitivity to insulin action is central to the disease process, and a poorly understood but non-inflammatory beta cell lesion occurs which diminishes insulin secretion. In clinical practice, the diagnosis of Type 1 versus Type 2 diabetes is made phenotypically using variables such as age at onset, apparent abruptness of onset of hyperglycemia, presence of ketosis, degree of obesity (especially central and intra abdominal), prevalence of other autoimmune diseases, and apparent need for insulin replacement. This clinical distinction of Type 1 versus Type 2 diabetes is recognized to be imperfect.
There is also a third group of individuals, who phenotypically are usually like classic Type 2 diabetics but who are positive for one or more of the autoantibodies commonly seen in the Type 1 disease process, namely islet cell antibodies (ICA) and/or insulin autoantibodies (IAA) and/or autoantibodies to glutamic acid decarboxylase (GAD Ab) and/or autoantibodies to the tyrosine phosphatase islet cell autoantibody 512 (IA 2 Ab).
These patients, autoantibody positive \[Ab(+)\] Type 2 or Type 1.5 diabetes, were the focus of our study. Compared to antibody negative Type 2 diabetics, patients with Type 1.5 diabetes have a more rapid decline in beta cell function, fail sulfonylurea therapy and require insulin therapy earlier (4-13).
Hypothesis: Rosiglitazone treatment will ameliorate or slow the underlying disease process in antibody positive Type 2 diabetes.
Patients meeting the inclusion criteria came in for a baseline visit. The nature of the study was explained and informed consent obtained. A fasting blood sample was obtained for autoantibodies, glucose, C peptide of proinsulin molecule (C-peptide), glycosylated hemoglobin (HbA1c), genetic typing, and T lymphocyte (T cell) responses to islet antigens. The beta cell function test was performed. Patients were then randomized to either rosiglitazone or glyburide.
All patients were encouraged to perform self blood glucose monitoring twice per day, before breakfast and before dinner. The treatment goals for all patients was the same: before breakfast and before dinner blood sugar levels between 90-130 milligrams per deciliter (mg/dI) and HbA1c of less then 7% without severe hypoglycemia. Patients unable to reach goal with monotherapy had metformin (initially) or acarbose (secondarily) added, as there is no evidence to suggest that either affect beta-cell function.
The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increased to twice per day if adequate glycemic control was not achieved. For glyburide, therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. The starting dose was raised by 2.5 mg in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control.
If adequate control, HbA1c less than 7%, was not achieved on glyburide or rosiglitazone monotherapy, metformin was added and the dose gradually increased as needed and tolerated to a maximum of 1000 mg twice daily. If necessary, acarbose was also used up to a maximum dose of 100 mg thrice daily as needed and tolerated.
After initiation of the study, patients were seen at 1 month and then every 3 months for up to 3 years. Those patients randomized to rosiglitazone had the liver enzyme alanine transaminase (ALT) monitored every 2 months. In addition, telephone contact was utilized to achieve and maintain glycemic goals. Each participant was followed for up to 3 years. Drs. Chiu and Palmer coordinated the study. If the patient and his/her private physician prefer, the treatment protocol was implemented by the patient's private physician.
|
Type 2 Diabetes Mellitus
|
type 2 diabetes mellitus autoantibodies islet proteins rosiglitazone glyburide c-peptide
| null | 2
|
arm 1: Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. arm 2: Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control.
|
[
1,
1
] | 2
|
[
0,
0
] |
intervention 1: Tablet taken orally at a dosage of 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Study drug was taken up to 3 years. intervention 2: Tablet taken orally, initially 2.5 mg in the morning or dose subject received prior to starting the study. Dosage was increased by 2.5 mg in the evening up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Study drug was taken up to 3 years.
|
intervention 1: rosiglitazone intervention 2: glyburide
| 1
|
Seattle | Washington | United States | -122.33207 | 47.60621
| 0
|
NCT00194896
|
[
4
] | 29
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 4QUADRUPLE
| false
| 0ALL
| false
|
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
|
This study consists of three phases: Screening/Washout Phase, Double-Blind Phase and Taper Phase.
SCREENING/WASHOUT PHASE: Your study doctor or his staff will review with you any medications that you are currently taking and may instruct you, if appropriate, to discontinue taking certain medications. Your study doctor or his staff will explain how long you need to stop taking each drug before you can start the study. Depending on the type of medications you may be taking, the Screening/Washout Visit (Visit 1 of the study) may have to be completed in two visits. The screening/washout phase may take up to 90 days. If you agree to participate, the study doctor or his staff will carry out tests to see if you are eligible for this study. At the Screening/Washout Visit, you will have a medical and psychiatric history review (including medications you have taken for treating Tourette Syndrome) and a physical examination (including sitting blood pressure, pulse, temperature, weight and height). A blood sample will be taken (approximately 2-3 teaspoons) and tested to rule out any abnormalities. You will be asked to give a urine sample that will be tested for drug use and, if you are a female that is capable of having a child, to ensure that you are not pregnant at the time of study entry. The pregnancy test must be negative for you to continue in the study. Additionally, you may not currently be breastfeeding to continue in the study. You will undergo a medical and psychiatric evaluation. You will be asked to answer questions using scales, including one that measures the severity of your symptoms of Tourette Syndrome and one that measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD).
TITRATION/MAINTANENCE PHASE: If you continue to qualify for the study after the Visit 1 tests have been reviewed by the study doctor or his staff and you have completed the washout phase, you will return to your study doctor's office for Visit 2. The length of time between Visit 1 and Visit 2 will depend on the kind of medications you are taking (and may need to stop before entering this study). At Visit 2, you will have your blood pressure, pulse and weight measured. You will be asked to answer questions for the same two scales that you completed at Visit 1. You are asked to return all medication bottles (even if empty, partially used or unused) to each study visit. It is very important for us to be able to check study drug compliance.
You will be asked questions about how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking since your last visit.
If you continue to meet eligibility requirements for the study, you will enter the study. You will be assigned by chance to one of two treatment groups. You may receive either topiramate or placebo (an inactive substance). This makes the assessment of the study drug much fairer. The chances you are receiving the study drug versus placebo are 1 to 1 or equal (50% chance that you will receive topiramate and 50% chance that you will receive placebo).
The study will last approximately 10 weeks. You will begin the study by taking 1 tablet of study medication (topiramate 25 mg or placebo) in the evening. This will be Day 1 of the study. After one week of this phase of the study, your study medication dose will be increased to 2 tablets (topiramate 50 mg or placebo) one tablet in the morning and one in the evening. Your study medication dose may continue to be increased until you have reached the dose level the study doctor determines to be appropriate for you, or, you are taking a maximum dose of 200 mgs per day of study medication (topiramate or placebo). Your study doctor may adjust your study medication dose as necessary. Study medication will be provided in 25 mg tablets of topiramate or placebo. Medication is provided in child-resistant bottles. All bottles should be returned (regardless of whether they are partial, empty or full) at each visit. It is important that you follow your study doctor or his staff's instructions on when and how to take the study medication. You will be expected to visit your study doctor or his staff again on Day 28 (Visit 3), Day 56 (Visit 4) and Day 70 (Visit 5) after beginning treatment. At Visit 5 (Day 70), you will be given instructions about reducing your study medication gradually for the next week.
At each visit, you will have your blood pressure, pulse, temperature and weight measured. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking. At Visits 3 and 5 you will be asked again to answer questions for all of the scales that you completed at Visit 2. At Visits 3, 4 and 5, the study doctor or his staff will complete the scale that assesses the severity of your condition. At Visits 3 and 5, the study doctor or his staff will complete one scale that assesses the severity of your Tourette Syndrome symptoms. At Visits 3, 4 and 5 you will have a urine pregnancy test performed again if you are a female capable of bearing a child. The test must be negative to continue in the study. You will have blood drawn again (approximately one teaspoon) at Visits 3 and 5 to make sure that your liver is functioning properly and that your electrolytes (blood chemistry measurements) are also within normal range. At Visit 5 you will have another physical examination.
You will be called weekly between Visits 2 and 3 (Days 7, 14 and Day 21 of the study) and Visits 3 and 4 (Days 35 and 42 of the study) on the telephone by one of the people working on this study. During these phone calls you will be asked how you are feeling, if you have had any changes in medications you are taking and how you are doing with the study medication.
TAPER PHASE: You will visit the study doctor or his staff again on Day 77 (Visit 6) after you have completely stopped taking the study medication. You must keep all medication packaging and any unused medication, and bring it back to the study doctor or his staff at each visit. At this visit, you will have your blood pressure and pulse taken and your weight measured. You will be asked again to answer questions for the scale that measures the severity of your symptoms of Tourette Syndrome. If you are a female capable of bearing a child, a urine pregnancy test will be performed. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking.
Joseph Jankovic, Joohi Jimenez-Shahed and Lawrence Brown J. Neurol. Neurosurg. Psychiatry published online 1 Sep 2009; doi:10.1136/jnnp.2009.185348
|
Tourette Syndrome
| null | 2
|
arm 1: Placebo or sugar pill arm 2: Topiramate 25 mg to 200 mg
|
[
2,
1
] | 2
|
[
0,
0
] |
intervention 1: Topiramate 25 mg titrated to 200 mg intervention 2: placebo
|
intervention 1: Topiramate (drug) intervention 2: placebo/sugar pill
| 0
| null | 0
|
NCT00206323
|
|
[
4
] | 20
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
Previous studies using topiramate in Tourette subjects have shown that with the use of this medication subjects report that their tics get better. The purpose of this study is to study if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other associated symptoms such as attention or obsessive-compulsive problems.
|
In order to enroll in this study, you must have completed the Double-Blind phase of CAPSS-176 or discontinued the Double-Blind phase of CAPSS-176 after a minimum of 6 weeks because it has been determined that your symptoms of Tourette Syndrome were getting worse. You must also continue to meet the specific inclusion and exclusion criteria outlined in CAPSS-176.
The Titration/Maintenance Period: will last for 10 weeks, as it did during CAPSS-176. During the Titration and Maintenance Periods of the study, you will visit the study center 4 times. Visit 1 (Day 1) will be the same day as your final visit for CAPSS-176. You will have had a physical examination (including sitting blood pressure, pulse and weight), a urine pregnancy test if you are a female that is capable of having a child and been given the scale that measures the severity of your symptoms of Tourette Syndrome as part of the final visit procedures for CAPSS-176. This information will also be included as part of Visit 1.
During this visit, a blood sample will be taken (approximately 3 teaspoons) and tested to rule out any abnormalities and to make sure that your liver is working properly and your electrolytes are normal. You will also be asked to answer questions for the scale that measures your symptoms, if any, of attention deficit hyperactivity disorder (A-D/HD). If you have Bipolar II Disorder, you will be asked to answer questions for one scale that measures your symptoms of mania. If you have obsessive-compulsive disorder (OCD), you will be asked to answer questions for one scale that measures those symptoms. The study doctor or his staff will complete two scales that assess the severity of your condition.
If you continue to be eligible for the study, you will begin the Titration Period of the study by taking 1 tablet of commercial topiramate 25 mg in the evening. This will be Day 1 of the study. After one week of this phase of the study, your topiramate dose will be increased to 2 tablets of topiramate (50 mg total), one tablet in the morning and one in the evening. Your topiramate dose may continue to be increased until you have reached the dose level the study doctor determines to be appropriate for you, or, you are taking a maximum dose of 200 mgs per day of topiramate. Your study doctor may adjust your topiramate dose as necessary.
During the study, you will be expected to visit your study doctor or his staff again on Day 28 (Visit 2), Day 56 (Visit 3) and Day 70 (Visit 4) after beginning treatment. Extra visits may be scheduled at the discretion of your study doctor. At each visit, you will have your blood pressure, pulse and weight measured. You will be asked how you are feeling and if you have started taking any new medications or had changes in other medications you may be taking. All of the scales that were completed at Visit 1, and the scale that was completed at the final visit of CAPSS-176, will be completed again at each visit. You will have a urine pregnancy test performed at each visit if you are a female capable of having a child. The test must be negative to continue in the study. You will have blood drawn again (approximately three teaspoons) at Visits 2 and 4 to make sure that your liver is functioning properly and your electrolytes are normal.
You will be called between Visits 1 and 2 (Day 14 of the study) and Visits 2 and 3 (Day 42 of the study) on the telephone by one of the people working on this study. During these phone calls you will be asked how you are feeling, if you have had any changes in medications you are taking and how you are doing with topiramate.
Commercial topiramate will be provided in 25 mg tablets.Study medication is provided in child resistant bottles.All bottles should be returned(regardless of whether they are partial, empty or full) at each visit. It is important that you follow your study doctor or his staff's instructions on when and how to take the topiramate. At Visit 4 (Day 70), you will be given instructions about reducing your topiramate dose gradually for the next week. You will visit the study doctor or his staff again on Day 77 (Visit 5) after you have completely stopped taking the topiramate.
|
Tourette Syndrome
| null | 1
|
arm 1: Topiramate open label
|
[
0
] | 1
|
[
0
] |
intervention 1: Topiramate 25 mg to 200 mg
|
intervention 1: Topiramate (drug)
| 0
| null | 0
|
NCT00206336
|
|
[
2,
3
] | 36
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.
|
OUTLINE: This is a multi-center study.
Week 1 (day 1):
* Cetuximab 400mg/m2
Week 2 (Cycle 1, Day 1):
* Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.
Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.
Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.
Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity
Performance status: ECOG 0-2
Life expectancy: At least 12 weeks
Hematopoietic:
* ANC \> 1,500/mm3
* Platelets \> 100,000/mm3
Hepatic:
* Bilirubin less than or equal to the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 1.5 X ULN. AST may be \< 5 X ULN for patients with liver metastases
* Alkaline phosphatase \< 5 X ULN
Renal:
* Calculated creatinine clearance \> 45 mL/min (by Cockcroft-Gault)
Cardiovascular:
* No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)
Pulmonary:
* Not specified
|
Non-Small Cell Lung Cancer
|
Non-Small Cell Lung Cancer
| null | 1
|
arm 1: Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
|
[
0
] | 2
|
[
0,
0
] |
intervention 1: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles intervention 2: Cetuximab 400 mg/m2, week 1, day 1
Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle
|
intervention 1: Pemetrexed intervention 2: Cetuximab
| 11
|
Galesburg | Illinois | United States | -90.37124 | 40.94782
Bloomington | Indiana | United States | -86.52639 | 39.16533
Elkhart | Indiana | United States | -85.97667 | 41.68199
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Goshen | Indiana | United States | -85.83444 | 41.58227
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Muncie | Indiana | United States | -85.38636 | 40.19338
South Bend | Indiana | United States | -86.25001 | 41.68338
Baltimore | Maryland | United States | -76.61219 | 39.29038
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Austin | Texas | United States | -97.74306 | 30.26715
| 0
|
NCT00216203
|
[
3
] | 52
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
This study will evaluate the efficacy and safety of chemotherapy given prior to having lung cancer surgically removed. Patients with resectable non-small cell lung cancer will receive gemcitabine and pemetrexed together for 4 times biweekly. Patients will be seen by a medical oncologist prior to each cycle of chemotherapy given. The medical oncologist will review patient's bloodwork and symptoms prior to approving next cycle of chemotherapy. All patients will then be evaluated with scans to determine response to chemotherapy and to determine if patient is a surgical candidate. These patients will then proceed to surgery to have the lung cancer removed. Follow up visits include bloodwork, scans, and a visit with the medical oncologist every three months for two years, then every six months for three years to monitor for disease recurrence.
|
This study will evaluate the efficacy and safety of neoadjuvant chemotherapy with gemcitabine and pemetrexed given together 4-times biweekly in patients with resectable NSCLC. All patients will be seen by members of the Thoracic Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, and they will be discussed in our weekly multidisciplinary thoracic oncology conference. The conference includes pathologists, radiologists, thoracic surgeons, pulmonologists, radiation oncologists, medical oncologists, oncology nurse specialists, case managers, social workers, and clinical trials coordinators. They will have initial tests as outlined in the study timetable. Patients will receive gemcitabine biweekly on days 1, 15, 29, and 43 at a dose of 1,500 mg/m2. They will also receive pemetrexed at a dose of 500 mg/m2 on days 1, 15, 29, and 43. Gemcitabine will be given first over a period of 30 minutes i.v. followed by pemetrexed over 10 minutes i.v. All patients will get a post induction chemotherapy PET scan, CT scan, and PFT's including a DLCO. They will then go on to thoracotomy including bronchoscopy and mediastinal lymph node dissection between days 64 and 77 if the tumor is deemed completely resectable on restaging studies.
The administration of chemotherapy at the earliest time (neoadjuvant or induction chemotherapy) following diagnosis in an effort to reduce the risk of disease recurrence. This approach also allows for investigations of molecular parameters that may affect response to chemotherapy and patients' survival. It is our hypothesis that the expression of genes associated with activation, inactivation, and efficacy of the drugs gemcitabine and pemetrexed will predict response to therapy and prognosis. We further hypothesize that the expression of these genes will be altered during chemotherapy, and that the global assessment of tumor proliferation, apoptosis, and genome damage is associated with response to therapy. We propose a phase II study of neoadjuvant chemotherapy with gemcitabine and pemetrexed in patients with resectable NSCLC, specifically correlating molecular and genetic parameters to the primary clinical study endpoint disease response (radiographic CR+PR) and the secondary endpoints complete pathological response at surgery, disease-free survival, and overall survival.
|
Lung Cancer
|
Non-Small-Cell Lung Cancer resectable NSCLC
| null | 1
|
arm 1: None
|
[
0
] | 3
|
[
0,
0,
3
] |
intervention 1: Gemcitabine (GemzarR) 1500 mg/m2 intervention 2: Pemetrexed (AlimtaR) 500 mg/m2 intervention 3: When the chemotherapy treatment is completed, the patient's tumor response will be evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). If there is no growth or spread of the cancer on any of these tests, patients will then proceed to have surgery by week 10 to remove the cancer.
|
intervention 1: Gemcitabine intervention 2: Pemetrexed intervention 3: Surgery
| 1
|
Tampa | Florida | United States | -82.45843 | 27.94752
| 0
|
NCT00226577
|
[
4
] | 136
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 3TRIPLE
| false
| 0ALL
| null |
The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.
|
A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients
|
Cytomegalovirus Infections
|
Acute rejection Non-CMV infections Resistance
| null | 2
|
arm 1: Valganciclovir 900 mg QD for 9 months post lung transplant. arm 2: placebo for 9 months post lung transplant
|
[
1,
2
] | 2
|
[
0,
10
] |
intervention 1: valgan 900mg QD x 9 months post lung transplant intervention 2: None
|
intervention 1: valganciclovir intervention 2: Placebo
| 1
|
Durham | North Carolina | United States | -78.89862 | 35.99403
| 0
|
NCT00227370
|
[
3
] | 21
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 1SINGLE
| false
| 0ALL
| null |
Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.
|
Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.
Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. Fatigue after TBI is associated with decreased participation in normal activities in the community and has been linked to depression.
Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with TBI.
Current and Future Research Activity: More than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.
|
Fatigue
|
Fatigue TBI brain injury Modafinil traumatic brain injury
| null | 2
|
arm 1: single dose of 200 mg. a day of modafinil for four weeks arm 2: None
|
[
0,
2
] | 2
|
[
0,
0
] |
intervention 1: single dose of 200 mg. a day of modafinil for four weeks intervention 2: daily dose of placebo for four weeks.
|
intervention 1: Modafinil intervention 2: Placebo
| 1
|
New York | New York | United States | -74.00597 | 40.71427
| 0
|
NCT00233090
|
[
5
] | 2,800
|
RANDOMIZED
|
PARALLEL
| 1PREVENTION
| 4QUADRUPLE
| false
| 0ALL
| true
|
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).
| null |
Cerebral Infarction
| null | 2
|
arm 1: cilostazol arm 2: Aspirin
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years intervention 2: oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years
|
intervention 1: Cilostazol intervention 2: Aspirin
| 1
|
Tokyo | N/A | Japan | 139.69171 | 35.6895
| 0
|
NCT00234065
|
|
[
3
] | 45
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.
This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.
|
OUTLINE: This is a multi-center study.
* Cisplatin 70 mg/m2 Day 1
* Gemcitabine 1250 mg/m2 Day 1 and 8
* Bevacizumab 15 mg/kg Day 1
Review toxicity every cycle (every 3 weeks) Review for radiographic response every 2 cycles (every six weeks)
Progressive disease = off protocol therapy
Patients will be treated for up to a maximum of 8 cycles of cisplatin and gemcitabine (24 weeks of therapy). If a patient has not progressed by the end of 24 weeks (completion of cisplatin and gemcitabine), then patient will be treated with bevacizumab at 15 mg/kg every three weeks for a maximum of 12 months of bevacizumab therapy (since study entry).
If at any time patient has undue toxicity or progressive disease, patient will be removed from the study and followed until progression and for survival.
If the patient has Grade 3 or 4 neurotoxicity and/or the creatinine rises above 2.0, then the cisplatin will be discontinued and the patient continued on study and treated with gemcitabine and bevacizumab at the same dose and schedule.
ECOG Performance Status 0 or 1
Hematopoietic:
* White blood cell count \> 3000/mm3
* Absolute neutrophil count (ANC) \> 1500 mm/3
* Platelet count \> 100,000/mm3
* Hemoglobin \> 8 g/dL (may be transfused or receive erythropoietin support to maintain or exceed this level).
* INR \< 1.5
* No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin
Hepatic:
* Total bilirubin of \<1.5 mg/dL
* ALT \<5 times upper limit of normal for subjects with documented liver metastases; \<2.5 times the upper limit of normal for subjects without evidence of liver metastases.
Renal:
* Serum creatinine of \< 1.5 mg/dL.
* Urine protein:creatinine ratio \< 1.0 at screening
Cardiovascular:
* No history of myocardial infarction or stroke within the last 6 months
* No uncontrolled hypertension (blood pressure of \>160 systolic and/or 110 diastolic mmHg on medication)
* No unstable angina, New York Heart Association (NYHA) Grade II or greater congestive heart failure
* No unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), or clinically significant peripheral vascular disease.
Pulmonary:
* Not specified
|
Bladder Cancer
| null | 1
|
arm 1: Cisplatin + Gemcitabine + Bevacizumab
|
[
0
] | 3
|
[
0,
0,
0
] |
intervention 1: Cisplatin 70 mg/m2, day 1 intervention 2: Gemcitabine 1250 mg/m2, day 1 and 8 intervention 3: Bevacizumab 15mg/kg, day 1
|
intervention 1: Cisplatin intervention 2: Gemcitabine intervention 3: Bevacizumab
| 11
|
Chicago | Illinois | United States | -87.65005 | 41.85003
Galesburg | Illinois | United States | -90.37124 | 40.94782
Evansville | Indiana | United States | -87.55585 | 37.97476
Fort Wayne | Indiana | United States | -85.12886 | 41.1306
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Lafayette | Indiana | United States | -86.87529 | 40.4167
South Bend | Indiana | United States | -86.25001 | 41.68338
Terre Haute | Indiana | United States | -87.41391 | 39.4667
St Louis | Missouri | United States | -90.19789 | 38.62727
Cincinnati | Ohio | United States | -84.51439 | 39.12711
| 0
|
NCT00234494
|
|
[
3
] | 21
|
NA
|
SINGLE_GROUP
| 0TREATMENT
| 0NONE
| false
| 0ALL
| null |
The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).
|
To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT).
To assess the time to progression and disease free survival of patients treated with PTK787/ZK 222584.
To assess the safety and tolerability of PTK787/ZK 222584 in multiple myeloma patients following ASCT.
|
Multiple Myeloma
|
Myeloma PTK
| null | 1
|
arm 1: Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
|
[
0
] | 1
|
[
0
] |
intervention 1: None
|
intervention 1: PTK787/ZK 222584
| 1
|
St Louis | Missouri | United States | -90.19789 | 38.62727
| 0
|
NCT00240162
|
[
5
] | 77
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| false
|
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).
|
This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder). Duration of this study will be 24 months. Study assessment visits will be conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12 weeks till Week 88 and at Week 104. All eligible participants will receive either risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or only their current oral medication. Efficacy will be evaluated primarily by Positive and Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational Functioning Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the study mainly by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS).
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorders
|
Schizophrenia Schizoaffective disorder Schizophreniform disorder Risperidone Risperdal Consta
| null | 2
|
arm 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. arm 2: Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants will be switched to another oral therapy as per Investigator's discretion.
|
[
0,
1
] | 2
|
[
0,
0
] |
intervention 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. intervention 2: Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.
|
intervention 1: Risperidone long-acting injection (LAI) intervention 2: Oral Antipsychotic
| 11
|
Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Victoria | British Columbia | Canada | -123.35155 | 48.4359
Dartmouth | Nova Scotia | Canada | -63.57719 | 44.67134
Greater Sudbury | Ontario | Canada | -80.99001 | 46.49
Kingston | Ontario | Canada | -76.48098 | 44.22976
London | Ontario | Canada | -81.23304 | 42.98339
Markham | Ontario | Canada | -79.2663 | 43.86682
Montreal | Quebec | Canada | -73.58781 | 45.50884
Québec | Quebec | Canada | -71.21454 | 46.81228
Verdun | Quebec | Canada | -73.57058 | 45.46005
| 0
|
NCT00246259
|
[
5
] | 60
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 3TRIPLE
| false
| 0ALL
| false
|
This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.
|
Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as poor quality of life and increased risk of suicide. Studies have shown that treating insomnia during a major depressive episode may not only help reduce symptoms of major depression during the day, but also improve an individual's general quality of life. Thus, sleeping pills, also known as hypnotics, are commonly prescribed for people with psychiatric disorders. However, little is known about the safety and efficacy of combining sleeping pills with antidepressant medications. This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.
Participants in this double-blind study will first receive fluoxetine, an antidepressant medication, for 1 week. Participants whose symptoms of insomnia subside after this initial week will continue on fluoxetine for the duration of the study and will not receive sleeping pills. Those who do not experience an improvement in their symptoms of insomnia after 1 week will be randomly assigned to receive either placebo or eszopiclone, which is a sleeping pill, in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend study visits at various points throughout the treatment phase. Follow up visits will occur periodically over the next 4 months. Assessments will include physiological measures during sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of movement during sleep.
|
Sleep Initiation and Maintenance Disorders Depression
|
Depression Hypnotics Sleep Quality of Life Insomnia Suicide
| null | 2
|
arm 1: Participants will receive treatment with eszopiclone and fluoxetine arm 2: Participants will receive treatment with placebo and fluoxetine
|
[
0,
1
] | 3
|
[
0,
0,
0
] |
intervention 1: Eszopiclone 3 mg every night for 8 weeks intervention 2: Fluoxetine 20 mg every morning for 9 weeks intervention 3: Placebo every night for 8 weeks
|
intervention 1: Eszopiclone intervention 2: Fluoxetine intervention 3: Placebo
| 1
|
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
| 0
|
NCT00247624
|
[
5
] | 266
|
RANDOMIZED
|
PARALLEL
| 0TREATMENT
| 0NONE
| false
| 0ALL
| true
|
General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients \>=75 years old with ST-segment elevation or LBBB AMI \<6 hours of evolution without contraindications for TT.
Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients \>=75 years old with AMI.
Participating Centers: 27 Spanish hospitals performing \>50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE).
Procedure: Diagnosis of inclusion/exclusion criteria --\> Centralized randomization --\> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.
|
Hypothesis of the study. In patients of 75 or more years of age with AMI and ST-elevation or LBBB, the treatment strategy based on primary angioplasty is superior to the treatment strategy based on initial fibrinolytic therapy for reducing the incidence of death, re-infarction and disabling CVA at 30 days. This benefit is maintained at 12 months.
Objectives General objective of the study. To compare the efficacy and safety of primary angioplasty and fibrinolytic treatment in \>=75 year-old patients with AMI eligible for fibrinolytic therapy in Spanish medical centers with an active program of primary angioplasty.
Primary end point: Incidence of the combined end point of all-cause death, re-infartion or disabling stroke at 30 days
Secondary end points:
* All-cause death at 30 days
* Incidence of the combined end point of all-cause death, disabling CVA or de novo heart failure at 30 days
* Incidence of recurrent ischemia requiring emergency catheterization in the first 30 days
* Cause of death at 30 days classified in three groups:
1. Shock or heart (pump) failure
2. Mechanical complications (ruptures) or electromechanical dissociation
3. Other causes (including bleeding)
* Incidence of major bleeding during hospital admission
* All-cause mortality at 12 months
* Period of time elapsed until presentation of any of the composite of all-cause death, reinfarction or disabling CVA at 12 months
* Period of time elapsed until the presentation of any composite of all-cause death, reinfarction, disabling CVA or non-elective hospital readmission for cardiac causes (unstable angina, heart failure, non-elective coronary revascularization at 12 months.
TYPE AND DESIGN OF THE CLINICAL TRIAL Clinical trial status Phase IV trial Description of randomization process The treatment strategy will be determined by a centralized randomization process, using a telephone system. Eligible patients will be randomized to one of two (2) treatment arms: fibrinolytic treatment or primary angioplasty.
Control and design This is a randomized multicenter, open blind clinical trial designed to compare the efficacy and safety of primary angioplasty vs. thrombolytic treatment in \>=75 year-old patients with AMI and ST-elevation or de novo LBBB, eligible for thrombolysis, admitted at Spanish medical centers that have an active primary angioplasty program, within the first 6 hours after symptom onset.
Masking techniques Being an open trial there are not masking techniques, nor will there be an emergency opening procedure of emergency codes.
Pre-inclusion / clearance period Not applicable
SUBJECT SELECTION Inclusion / exclusion criteria Subjects must be \>=75 years of age with AMI and ST-elevation or de novo LBBB, eligible for thrombolytic therapy, admitted in any Spanish medical center in which there is an active primary angioplasty program within the first 6 hours after symptom onset.
Each patient must fulfill all inclusion criteria and none of the exclusion criteria.
Inclusion criteria:
1. Subjects of 75 or more years of age
2. Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations:
1. ST-elevation \>=2 mm in 2 or more precordial leads
2. ST-elevation \>=1 mm in 2 or more anterior leads
3. Complete de novo (or probably de novo) left bundle branch block (LBBB)
3. Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable.
Exclusion criteria:
1. Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP \>180 mmHg or diastolic AP \>110 mmHg 1.7. Known thrombocytopenia \< 100.000 platelets/mL 1.8. Prolonged (\>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection
2. Cardiogenic shock
3. Estimated door-to-needle time \>120 minutes
4. Administration of fibrinolysis in the 14 days prior to randomization
5. Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization
6. Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization
7. Actual oral anticoagulant treatment
8. Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents)
9. Dementia or acute confusional state at the time of randomization
10. Subject incapacity or unwillingness to give informed consent -at least, verbally
11. Known renal failure (basal creatinine\> 2,5 mg/dl)
12. Reduced life expectancy (\<12 months) due to advanced or terminal concomitant condition
13. Subject participation in another clinical trial (assessing a drug or a device) in the 30 days prior to randomization
Diagnostic criteria for the pathologies of the study
Patients with a diagnosis of AMI presenting with:
* Chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy and an evolution period of less than 6 hours after symptom onset until randomization process, with, at least, one of the following alterations:
* ST-elevation \>=2 mm in 2 or more precordial leads
* ST-elevation \>=1 mm in 2 or more anterior leads
* Complete de novo (or probably de novo) left bundle branch block (LBBB)
Estimate of sample size For the following conditions: α = 0.05 (2 tailed), power: 80% (β = 0.20) and assuming a composite event incidence rate (death, reinfarction and disabling CVA) based on previous registries (21.7% in the fibrinolysis group and 12.8% in the PA group), a sample size of 282 patients per group is needed to demonstrate that difference (8.9% in absolute terms and 40% in relative terms). Assuming a loss to follow-up rate of 1%, the total number is 570 patients
Estimated loss of patients prior to randomization During a period of 3 months all patients meeting inclusion criteria who, for any reason, are not enrolled in the study will be included in a registry with an abbreviated CRF recording inclusion/exclusion criteria, the reason for non-enrollment and follow-up at 30 days and 12 months.
|
Acute Myocardial Infarction
|
Acute myocardial infarction Elderly Thrombolysis Primary angioplasty Randomized trial Efficacy Safety
| null | 2
|
arm 1: Weight adjusted tenecteplase bolus + Unfrationated heparin arm 2: Primary angioplasty
|
[
1,
1
] | 2
|
[
0,
3
] |
intervention 1: None intervention 2: None
|
intervention 1: Tenecteplase + UFH (+ clopidogrel, since 01/97) intervention 2: Primary angioplasty
| 23
|
Palma de Mallorca | Balearic Islands | Spain | 2.65024 | 39.56939
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
Barcelona | Barcelona | Spain | 2.15899 | 41.38879
L'Hospitalet de Llobregat | Barcelona | Spain | 2.10028 | 41.35967
Santander | Cantabria | Spain | -3.80444 | 43.46472
Granada | Granada | Spain | -3.60667 | 37.18817
Huelva | Huelva | Spain | -6.94004 | 37.26638
A Coruña | La Coruña | Spain | -8.396 | 43.37135
Santiago de Compostela | La Coruña | Spain | -8.54569 | 42.88052
León | León | Spain | -5.57032 | 42.60003
Madrid | Madrid | Spain | -3.70256 | 40.4165
Madrid | Madrid | Spain | -3.70256 | 40.4165
Madrid | Madrid | Spain | -3.70256 | 40.4165
Madrid | Madrid | Spain | -3.70256 | 40.4165
Málaga | Málaga | Spain | -4.42034 | 36.72016
Pamplona | Navarre | Spain | -1.64323 | 42.81687
Oviedo | Principality of Asturias | Spain | -5.84476 | 43.36029
Seville | Sevilla | Spain | -5.97317 | 37.38283
San Cristóbal de La Laguna | Tenerife | Spain | -16.32014 | 28.4853
Toledo | Toledo | Spain | -4.02263 | 39.8581
Valencia | Valencia | Spain | -0.37966 | 39.47391
Valladolid | Valladolid | Spain | -4.72372 | 41.65518
Barakaldo | Vizcaya | Spain | -2.98813 | 43.29639
| 0
|
NCT00257309
|
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