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
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armGroupTypes
list
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nctid
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[ 3 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.
Myocardial Infarction
STEMI ACS
null
2
arm 1: Placebo for each Dose cohort: 10, 20, 40, and 60 mg arm 2: Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: administration of iv bolus prior to angiography intervention 2: administration of iv bolus prior to angiography
intervention 1: placebo intervention 2: PRT060128 Potassium
31
Tallahassee | Florida | United States | -84.28073 | 30.43826 Des Moines | Iowa | United States | -93.60911 | 41.60054 Lexington | Kentucky | United States | -84.47772 | 37.98869 Portland | Maine | United States | -70.2589 | 43.65737 Takoma Park | Maryland | United States | -77.00748 | 38.97789 Detroit | Michigan | Unit...
0
NCT00546260
[ 3 ]
1,334
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.
null
Hypertension
Hypertension, valsartan, LCZ696
null
8
arm 1: Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 2: Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 3: Participants received LCZ696 400 mg (200 mg LCZ696 fo...
[ 0, 0, 0, 1, 1, 1, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: LCZ696 intervention 2: Valsartan intervention 3: AHU377 intervention 4: Placebo
182
Birmingham | Alabama | United States | -86.80249 | 33.52066 Muscle Shoals | Alabama | United States | -87.66753 | 34.74481 Chandler | Arizona | United States | -111.84125 | 33.30616 Buena Park | California | United States | -117.99812 | 33.86751 Fair Oaks | California | United States | -121.27217 | 38.64463 Long Beach ...
0
NCT00549770
[ 4 ]
314
null
PARALLEL
0TREATMENT
null
false
0ALL
null
The primary purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.
null
Hypertension
null
0
null
null
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: telmisartan+amlodipine intervention 2: telmisartan
5
Chofu, Tokyo | N/A | Japan | N/A | N/A Musashino, Tokyo | N/A | Japan | N/A | N/A Nishi-ku, Hiroshima, Hiroshima | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Shinjuku-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT00550953
[ 3 ]
257
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.
null
Chronic Obstructive Pulmonary Disease (COPD)
COPD Chronic Obstructive Pulmonary Disease Indacaterol QVA149
null
5
arm 1: Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 2: One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a s...
[ 0, 0, 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 2: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 3: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for...
intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: glycopyrrolate intervention 4: placebo
40
Adelaide | N/A | Australia | 138.59863 | -34.92866 Clayton | N/A | Australia | 145.11667 | -37.91667 Daw Park | N/A | Australia | 138.58407 | -34.98975 Heidelberg | N/A | Australia | 145.06667 | -37.75 Nedlands | N/A | Australia | 115.8073 | -31.98184 Brussels | N/A | Belgium | 4.34878 | 50.85045 Jambes | N/A | Belgium...
0
NCT00558285
[ 5 ]
12
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
null
The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms...
See brief summary
Stress Disorders, Post-Traumatic
PTSD Paroxetine Subthreshold
null
2
arm 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. intervention 2: Placebo: same as paroxetine (active comparator)
intervention 1: Paroxetine intervention 2: Placebo
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00560612
[ 4 ]
5
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).
A new drug (bortezomib \[VelcadeTM PS-341\]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thali...
Multiple Myeloma
null
2
arm 1: VTD = Velcade, Thalidomide, and Dexamethasone arm 2: VMD = velcade, melphalan, and dexamethasone
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles Thalidomide - By Mouth Days 1-28 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles intervention 2: Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles ...
intervention 1: Velcade, Thalidomide, and Dexamethasone intervention 2: Velcade, Melphalan, and Dexamethasone
1
Little Rock | Arkansas | United States | -92.28959 | 34.74648
0
NCT00573391
[ 5 ]
768
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Evaluate the effect of VESIcare® on symptom bother for subjects with OAB
Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group. The study duration consists of a screening period which includes a minimum of a 14 day treat...
Urinary Bladder, Overactive
Overactive Bladder
null
2
arm 1: Matching placebo tablet taken once daily arm 2: 5mg or 10mg tablet taken once daily
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Oral Administration intervention 2: Oral Administration
intervention 1: Placebo intervention 2: Solifenacin Succinate
59
Montgomery | Alabama | United States | -86.29997 | 32.36681 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Buena Park | California | United States | -117.99812 | 33.86751 Carmichael | California | United States | -121.32828 | 38.61713 Fresno | Californ...
0
NCT00573508
[ 3 ]
271
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.
null
Ankle Sprain
Ankle, sprain, diclofenac diethylamine
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Diclofenac diethylamine 2.32% gel twice daily intervention 2: Vehicle 2 times daily intervention 3: Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
intervention 1: Diclofenac diethylamine 2.32% gel intervention 2: Placebo intervention 3: Diclofenac diethylamine 2.32% gel / Placebo
29
Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Bad Zwischenahn | N/A | Germany | 8.0 | 53.18333 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | ...
0
NCT00573768
[ 4 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
null
Asthma
Pediatric, asthma, albuterol-HFA and Placebo
null
2
arm 1: Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. arm 2: A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Pla...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days. intervention 2: Placebo HFA MDI four times a day (q.i.d) for 21 days. intervention 3: Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in t...
intervention 1: Albuterol intervention 2: Placebo intervention 3: Proventil® HFA
13
Huntington Beach | California | United States | -117.99923 | 33.6603 Palmdale | California | United States | -118.11646 | 34.57943 Paramount | California | United States | -118.15979 | 33.88946 Riverside | California | United States | -117.39616 | 33.95335 Sacramento | California | United States | -121.4944 | 38.58157 ...
0
NCT00577655
[ 3 ]
568
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
false
This is a safety and efficacy study of bromfenac ophthalmic solution
null
Cataract Surgery
null
2
arm 1: None arm 2: None
[ 0, 0 ]
1
[ 0 ]
intervention 1: sterile opthalmic solution
intervention 1: bromfenac ophthalmic solution
1
Irvine | California | United States | -117.82311 | 33.66946
0
NCT00585975
[ 3 ]
95
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).
null
Carcinoma, Renal Cell
Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC
null
1
arm 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
[ 0 ]
1
[ 0 ]
intervention 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally
intervention 1: Sorafenib (Nexavar, BAY43-9006)
41
Akita | Akita | Japan | 140.11667 | 39.71667 Asahi | Chiba | Japan | 140.65 | 35.71667 Chiba | Chiba | Japan | 140.11667 | 35.6 Chiba | Chiba | Japan | 140.11667 | 35.6 Matsuyama | Ehime | Japan | 132.76574 | 33.83916 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Kurume | Fuk...
0
NCT00586495
[ 4 ]
38
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination th...
Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have smoked 10 or more cigarettes per day for at least 6 months; and 3) are motivated to stop smoking. Subjects will be excluded if they have: 1) an unstable medical condition; 2) unstable angina, myocardial infarction, or coronary a...
Smoking Tobacco Use Disorder
Smoking Smoking cessation Bupropion Varenicline Tobacco use disorder
null
1
arm 1: All 38 smokers will receive open-label bupropion SR and varenicline. Bupropion SR is an oral medication with recommended dosing of 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline is an oral medication with recommended dosing of 0.5 mg once daily for 3 days, increasing to 0.5 m...
[ 0 ]
1
[ 0 ]
intervention 1: Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
intervention 1: Bupropion SR & Varenicline
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
0
NCT00587769
[ 2, 3 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.
null
Pain Bladder Cancer Breast Cancer CNS Cancer Colon Cancer Esophageal Cancer Pancreatic Cancer Prostate Cancer Uterine Cancer Head and Neck Cancer Eye Cancer Otorhinolaryngologic Neoplasms
Pain HEENT cancer
null
3
arm 1: This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours. arm 2: patients receiving around the clock opioid therapy-No patients were accrued to this group arm 3: patients not receiving around the clock opioid therapy.No patients were accrued to this...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 8 subjects to receive 40 mg d-Methadone twice a day intervention 2: After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. intervention 3: After randomization, patients will take t...
intervention 1: d-Methadone intervention 2: D-methadone intervention 3: placebo
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00588640
[ 4 ]
490
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The ...
These were a randomized, double-blind, multicenter, placebo-controlled studies that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AK of the face or balding scalp. Subjects were scheduled for a total of 11 visits (1...
Actinic Keratosis
Actinic keratosis Dermatologic disease
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. interventi...
intervention 1: Imiquimod cream intervention 2: Placebo cream intervention 3: Imiquimod cream
26
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Encino | California | United States | -118.50119 | 34.15917 Vista | California | United States | -117.24254 | 33.20004 New Britain | Connecticut | United States | -72.77954 | 41.66121 New Haven | Co...
0
NCT00603798
[ 4 ]
479
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The ...
This was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 pre...
Actinic Keratoses
Actinic keratosis Skin disease
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. int...
intervention 1: imiquimod cream intervention 2: imiquimod cream intervention 3: Placebo
26
Fremont | California | United States | -121.98857 | 37.54827 Los Angeles | California | United States | -118.24368 | 34.05223 Riverside | California | United States | -117.39616 | 33.95335 San Diego | California | United States | -117.16472 | 32.71571 Vallejo | California | United States | -122.25664 | 38.10409 Miami |...
0
NCT00605176
[ 3 ]
178
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.
null
Diabetes Diabetes Mellitus, Type 2
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily intervention 4: Tablets, 1500-2000 mg/day
intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart intervention 3: insulin glargine intervention 4: metformin
28
Alès | N/A | France | 4.08082 | 44.12489 Brest | N/A | France | -4.48628 | 48.39029 La Rochelle | N/A | France | -1.15222 | 46.16308 Le Creusot | N/A | France | 4.41632 | 46.80714 Mont-de-Marsan | N/A | France | -0.49713 | 43.89022 Vénissieux | N/A | France | 4.88593 | 45.69706 Bad Kreuznach | N/A | Germany | 7.86713 |...
0
NCT00614055
[ 5 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.
ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can hel...
Fatigue
Fatigue low energy ALS treatment
null
2
arm 1: Eligible patients will be treated at baseline through Week 4. Those who choose to continue will have additional in-person visits at Weeks 8 and 12 visits (and Week 16 for those starting modafinil at Week 4). arm 2: Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing sch...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks. intervention 2: Placebo capsules are administered on the same schedule as a...
intervention 1: Modafinil intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00614926
[ 3 ]
26
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial cancer.
OBJECTIVES: Primary * To determine the 90-day clinical benefit (defined as the sum of complete responses, partial responses, and stable disease) in patients with recurrent ovarian epithelial cancer treated with single agent fulvestrant. Secondary * To establish the time to termination of treatment (due to all cause...
Ovarian Cancer
recurrent ovarian epithelial cancer
null
1
arm 1: Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
[ 0 ]
1
[ 0 ]
intervention 1: Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.
intervention 1: Fulvestrant
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
0
NCT00617188
[ 2 ]
22
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
0ALL
true
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming. PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteer...
OBJECTIVES: * To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers. * To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period. OUTLINE: Participants are randomized to 1...
Healthy
skin cancer healthy, no evidence of disease
null
2
arm 1: Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo arm 2: Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the r...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks. intervention 2: Participants apply topical placebo to one forearm once daily for 4 weeks.
intervention 1: Topical Myristyl Nicotinate Cream intervention 2: Placebo
1
Tucson | Arizona | United States | -110.92648 | 32.22174
0
NCT00619060
[ 4 ]
173
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.
null
Allergic Rhinitis Chronic Urticaria
Xyzal Levocetirizine Allergy Children Seasonal Allergies
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks intervention 2: Placebo oral drops (5 drops) dosed twice a day for 2 weeks.
intervention 1: Levocetirizine intervention 2: Placebo
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Beverly Hills | California | United States | -118.40036 | 34.07362 Crescent City | California | United States | -124.20175 | 41.75595 Huntington Beach | California | United States | -117.99923 | 33....
0
NCT00619801
[ 4 ]
68
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.
null
Chronic Obstructive Pulmonary Disease
chronic obstructive pulmonary disease COPD indacaterol
null
6
arm 1: In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days vi...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 3: Salmeterol 50 μg was provided in powder filled capsules wi...
intervention 1: Indacaterol 300 μg intervention 2: Placebo to indacaterol intervention 3: Salmeterol 50 μg
14
Normal | Illinois | United States | -88.99063 | 40.5142 Shawnee Mission | Kansas | United States | -94.66583 | 39.02 Lafayette | Louisiana | United States | -92.01984 | 30.22409 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Cincinnati | ...
0
NCT00622635
[ 4 ]
416
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).
null
Chronic Obstructive Pulmonary Disease
chronic obstructive pulmonary disease COPD indacaterol
null
2
arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available fo...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
intervention 1: Indacaterol 150 μg intervention 2: Placebo to indacaterol
120
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Glendale | Arizona | United States | -112.18599 | 33.53865 Phoenix | Arizona | United Stat...
0
NCT00624286
[ 5 ]
18
NON_RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
true
1FEMALE
false
The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, an...
null
Menopause Depression
menopause women major depressive disorder Magnetic Resonance Spectroscopy
null
4
arm 1: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone. arm 2: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. arm 3: Menopausal women between the ages of 40-70 diag...
[ 1, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause. intervention 2:...
intervention 1: MDD diagnosis and Estrogen treatment intervention 2: MDD diagnosis and Fluoxetine treatment intervention 3: MDD diagnosis with both Estrogen and Fluoxetine treatment intervention 4: No depression and estrogen treatment
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00626340
[ 3 ]
150
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.
Bacterial Infection
complicated skin and skin structure infections linezolid ceftaroline clinical response microbiological response Cellulitis Abscess Wound infection Deeper soft tissue Significant surgical intervention Gram-positive bacterial infection Gram-negative bacterial infection bacterial infection cephalosporin broad-spectrum act...
null
2
arm 1: Intramuscular every 12 hours arm 2: Intravenous every 12 hours
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 600 mg injected every 12 hours for at least 5 but not more than 14 days intervention 2: 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days intervention 3: 1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours a...
intervention 1: ceftaroline intervention 2: linezolid intervention 3: Aztreonam
13
Buena Park | California | United States | -117.99812 | 33.86751 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Rolling Hills Estate | California | United States | N/A | N/A San Diego | California | United States | -117.16472 | 32.71571 At...
0
NCT00633152
[ 3 ]
41
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: To determine if CPT-11 given togethe...
OBJECTIVES: * Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck. * Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients. * Determine the palliative effect of irinotecan hydr...
Head and Neck Cancer
recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma...
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Starting dose 30 mg/m2 Dose level -1 20 mg/m2 intervention 2: 50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.
intervention 1: cisplatin intervention 2: irinotecan hydrochloride
8
Macon | Georgia | United States | -83.6324 | 32.84069 Chattanooga | Tennessee | United States | -85.30968 | 35.04563 Jackson | Tennessee | United States | -88.81395 | 35.61452 Johnson City | Tennessee | United States | -82.35347 | 36.31344 Knoxville | Tennessee | United States | -83.92074 | 35.96064 Nashville | Tenness...
0
NCT00639769
[ 5 ]
22
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and co...
The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and co...
Diabetes
diabetes blood pressure oxidative stress
null
2
arm 1: study drug- carvedilol arm 2: study drug metorprolol
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: variable intervention 2: variable
intervention 1: carvedilol intervention 2: metoprolol
1
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
0
NCT00642434
[ 4 ]
832
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
This will be a Phase III, randomized, double-blind, 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 twi...
Seasonal Allergic Rhinitis
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 0, 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: placebo intervention 2: azelastine Hcl 548 mcg intervention 3: azelastine Hcl 548 mcg / fluticasone propionate 200 mcg intervention 4: fluticasone propionate 200 mcg
intervention 1: Placebo intervention 2: azelastine Hcl intervention 3: azelastineHcl / fluticasone propionate intervention 4: fluticasone propionate
43
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Encinitas | California | United States | -117.29198 | 33.03699 Los Angeles | California | United States | -118.24368 | 34.05223 Mission Viejo | California | United States | -117.672 | 33.60002 Rolling Hills Estates | California | United States | -118.35813 | ...
0
NCT00651118
[ 5 ]
580
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life.
null
Seasonal Allergic Rhinitis
levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life
null
2
arm 1: Matched placebo tablets arm 2: 5 mg tablet
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 5 mg daily (oral tablet) for 14 days intervention 2: 0 mg daily (matching oral tablet) for 14 days
intervention 1: levocetirizine dihydrochloride intervention 2: placebo
38
Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 San Francisco | California | United States | -122.41942 | 37.77493 San Jose | California | United States | -121.89496 | 37.33939 Colora...
0
NCT00653224
[ 5 ]
276
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).
null
Gastroesophageal Reflux Disease
GERD Esophageal Reflux Gastro-Esophageal Reflux Regurgitation Gastric
null
2
arm 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate intervention 2: once daily
intervention 1: Esomeprazole intervention 2: Placebo
45
Huntsville | Alabama | United States | -86.58594 | 34.7304 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Anaheim | California | United States | -117.9145 | 33.83529 Burbank | California | United States | -118.30897 | 34.18084 Castro Valley | Calif...
0
NCT00660660
[ 0 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimate...
null
Atelectasis
Atelectasis
null
3
arm 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). arm 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min...
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). intervention 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 m...
intervention 1: Normal saline: intervention 2: Hypertonic Saline intervention 3: Dornase alpha
1
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
0
NCT00671723
[ 3 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma.
This is a multi-center, randomized, single-blind\*, parallel group, placebo-controlled, study with two dosing regimens in subjects diagnosed with moderate to severe asthma using MN-221 or placebo. Subjects will be randomized to receive MN-221 or placebo in a 3:1 ratio, MN-221:placebo. Subjects randomized to receive MN-...
Asthma
asthma randomized placebo controlled dose escalation safety efficacy single blind MN-221
null
2
arm 1: None arm 2: Placebo intravenous infusion with dosing volume equivalent to active treatment.
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg) intervention 2: Subsequent dose: 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg). intervention 3: Placebo intravenous in...
intervention 1: MN-221 intervention 2: MN-221 intervention 3: Placebo
4
Lenexa | Kansas | United States | -94.73357 | 38.95362 North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 Rolla | Missouri | United States | -91.77127 | 37.95143 Greenville | South Carolina | United States | -82.39401 | 34.85262
0
NCT00679263
[ 2 ]
1
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.
This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.
Systemic Lupus Erythematosus Systemic Sclerosis
Autoimmune Disease Reduced Intensity Transplant
null
2
arm 1: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE). arm 2: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).
[ 0, 0 ]
4
[ 3, 0, 0, 0 ]
intervention 1: Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (...
intervention 1: Reduced Intensity Allogeneic Transplant intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Campath
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00684255
[ 3 ]
21
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.
Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the eff...
Hypertension
hypertension controlled hypertension hypertensives
null
6
arm 1: PL3994 Dose A arm 2: PL3994 Dose B arm 3: PL3994 Dose C arm 4: PL3994 Dose D arm 5: PL3994 Dose E arm 6: Placebo
[ 0, 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Study drug intervention 2: Placebo
intervention 1: PL3994 intervention 2: Placebo
0
null
0
NCT00686803
[ 4 ]
57
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium ...
Caries
fluoride in situ remineralization enamel caries
null
5
arm 1: Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. arm 2: Study toothpaste containing 1400 ppm F as NaF arm 3: Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF arm 4: Study toothpaste containing 675 ppm F as NaF arm 5: Fluoride free placebo toothpaste (0 ppm F)
[ 0, 1, 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Fluoride intervention 2: Placebo intervention 3: Fluoride
intervention 1: NaF intervention 2: Placebo intervention 3: NaMFP
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
0
NCT00708097
[ 4 ]
703
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
null
Perennial Allergic Rhinitis
null
2
arm 1: 0.15% azelastine hydrochloride 1644 mcg arm 2: Mometasone furoate 200 mcg
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM intervention 2: 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
intervention 1: 0.15% azelastine hydrochloride intervention 2: Mometasone furoate
59
Oxford | Alabama | United States | -85.83496 | 33.61427 Fountain Valley | California | United States | -117.95367 | 33.70918 Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.052...
0
NCT00720382
[ 5 ]
33
RANDOMIZED
CROSSOVER
9OTHER
2DOUBLE
true
1FEMALE
false
Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.
null
Healthy
Skin health
null
2
arm 1: 3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers arm 2: Purell Surgical Scrub with Moisturizers
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Topical solution, 6 mL, 6 applications/day for 14 days. intervention 2: Topical solution, 4 mL, 6 applications/day for 14 days.
intervention 1: Avagard intervention 2: Purell Surgical Scrub
0
null
0
NCT00731042
[ 3 ]
127
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).
This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also had an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baselin...
Chronic Low Back Pain
Flurbiprofen, low back pain, chronic low back pain
null
4
arm 1: Placebo tape remained on for 12 hours of continuous treatment per day. arm 2: Flurbiprofen tape remained on for 12 hours of continuous treatment per day. arm 3: Placebo tape remained on for 24 hours of continuous treatment per day. arm 4: Flurbiprofen tape remained on for 24 hours of continuous treatment per day...
[ 2, 0, 2, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 2: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose o...
intervention 1: Placebo Tape (Arm 1) intervention 2: Flurbiprofen Tape (Arm 2) intervention 3: Placebo Tape (Arm 3) intervention 4: Flurbiprofen Tape (Arm 4)
10
Phoenix | Arizona | United States | -112.07404 | 33.44838 Walnut Creek | California | United States | -122.06496 | 37.90631 Tampa | Florida | United States | -82.45843 | 27.94752 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Cordova | Tennessee | United States | -89.7762 | 35.15565 Memphis | Tennesse...
0
NCT00759330
[ 4 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.
null
Idiopathic Thrombocytopenic Purpura
null
2
arm 1: Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: rituximab intervention 2: Dexamethasone
22
Bari | N/A | Italy | 16.86982 | 41.12066 Bologna | N/A | Italy | 11.33875 | 44.49381 Brescia | N/A | Italy | 10.21472 | 45.53558 Cagliari | N/A | Italy | 9.11917 | 39.23054 Cuneo | N/A | Italy | 7.54828 | 44.39071 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy ...
0
NCT00770562
[ 0 ]
21
NA
SINGLE_GROUP
0TREATMENT
3TRIPLE
true
0ALL
false
Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel su...
Study completed
Hypertrichosis
Bimatoprost Eyelash lengthening Prostaglandin Analogs Cosmetics
null
1
arm 1: Intervention to be administered: Each subject was given two suspensions, one mixed with Bimatoprost and one mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and l...
[ 1 ]
1
[ 0 ]
intervention 1: see prior
intervention 1: Bimatoprost Suspension
1
Miami | Florida | United States | -80.19366 | 25.77427
0
NCT00773136
[ 3 ]
27
RANDOMIZED
PARALLEL
9OTHER
2DOUBLE
false
0ALL
true
In summary, this pilot study will explore the use of an innovative pharmacologic approach to the treatment of substance dependence through the facilitation of extinction of response to cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this preliminary study, a controlled treatment t...
Cocaine dependence remains a serious problem in the US today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified. Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in relapse. Emerg...
Cocaine Use Disorders
substance related disorders
null
2
arm 1: D-Cycloserine 50 mg is a partial glutamate agonist. Participants received DCS prior to cocaine cue exposure sessions. arm 2: Saline comparator. Participants received placebo prior to cocaine cue exposure sessions.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 50 mg DCS intervention 2: Placebo
intervention 1: D-cycloserine intervention 2: Placebo
1
Charleston | South Carolina | United States | -79.93275 | 32.77632
0
NCT00780442
[ 5 ]
50
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
null
Allergic Conjunctivitis
conjunctivitis
null
4
arm 1: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye arm 2: Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye arm 3: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olo...
[ 0, 0, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: one drop in one eye intervention 2: one drop in one eye intervention 3: one drop in contralateral eye intervention 4: one drop in contralateral eye
intervention 1: Olopatadine 0.1% intervention 2: Tranilast 0.5% intervention 3: Placebo (Olopatadine) intervention 4: Placebo (Tranilast)
0
null
0
NCT00818805
[ 2 ]
12
RANDOMIZED
CROSSOVER
1PREVENTION
3TRIPLE
true
0ALL
false
The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover st...
Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensi...
Dental Caries
Calcium glycerophosphate Fluoride Dentifrice Biofilm Dental caries
null
1
arm 1: 4 types of dentifrices were used in 4 different periods in a crossover study design.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: use of a dentifrice containing CaGP (0.13%) and no fluoride intervention 2: dentifrice without calcium glycerophosphate and no fluoride intervention 3: use of a dentifrice containing fluoride (1500ppm) only intervention 4: calcium glycerophosphate and fluoride dentifrice
intervention 1: calcium glycerophosphate intervention 2: no active ingredient intervention 3: fluoride intervention 4: CAGP + fluoride
1
João Pessoa | Paraíba | Brazil | -34.86306 | -7.115
0
NCT00875212
[ 5 ]
63
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.
One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for re...
Kidney Transplantation
Kidney Transplantation Immunosuppressive Agents
null
3
arm 1: Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL. arm 2: Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL. arm 3: Convert to TAC at target trough levels of 6.0-8.9 ng/mL.
[ 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: Maintain on cyclosporine at target trough level of 50-250 ng/mL. intervention 2: Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).
intervention 1: cyclosporine intervention 2: Prograf (Tacrolimus)
1
Greenville | North Carolina | United States | -77.36635 | 35.61266
0
NCT00905515
[ 5 ]
250
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or dia...
This is a prospective (study following participants forward in time), single-blind (Physician does not know the intervention), randomized (study drug assigned by chance) and comparative multi-center (conducted in more than 1 center) study to assess appropriate administration methods with topiramate preventive therapy i...
Migraine
Migraine Topiramate Propranolol
null
3
arm 1: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. arm 2: Topiramate 25 mg will ...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. intervention 2: Topi...
intervention 1: Topiramate Standard intervention 2: Topiramate Slow intervention 3: Propranolol booster
6
Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Kwangjoo | N/A | South Korea | N/A | N/A Kyunggi-Do | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566 Uijeongbu-si | N/A | South Korea | 127.0474 | 37.7415
0
NCT01060111
[ 2 ]
26
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administer...
null
Healthy
Healthy subjects
null
2
arm 1: OAD: Once A Day arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Dosage form: Extended-release caplets containing 300 mg trazodone HCl Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours. intervention 2: Dosage form: Immediate-release tablets containing...
intervention 1: Trazodone HCl intervention 2: Trazodone HCl
0
null
0
NCT01121900
[ 3 ]
523
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
null
Venous Thromboembolism Deep Vein Thrombosis Total Knee Arthroplasty
prevention venous thromboembolism edoxaban factor Xa
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: DU-176b 5mg tablets oral, once daily for 2 weeks intervention 2: DU-176b 15mg tablets, oral once daily for 2 weeks intervention 3: DU-176b 30 mg tablets, oral, once daily for 2 weeks intervention 4: DU-176b 60 mg tablets, oral, once daily for 2 weeks intervention 5: Matching placebo oral tablets, once d...
intervention 1: DU-176b intervention 2: DU-176b intervention 3: DU-176b intervention 4: DU-176b intervention 5: Placebo
2
Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895
0
NCT01203072
[ 5 ]
395
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for e...
null
Hepatitis C, Chronic
null
4
arm 1: Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W). arm 2: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W. arm 3: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W. ...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 180 mcg sc weekly, 24 weeks intervention 2: 180 mcg sc weekly, 16 weeks intervention 3: 800 mg orally daily intervention 4: 400 mg orally daily
intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: ribavirin intervention 4: ribavirin
18
Gratwein | N/A | Austria | 15.31667 | 47.11667 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Linz | N/A | Austria | 14.28611 | 48.30639 Oberndorf | N/A | Austria | 12.21667 | 47.61667 Ried-innkreis | N/A | Austria | N/A | N/A Salzburg ...
0
NCT01258101
[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical eva...
Onychomycosis
Onychomycosis Fungal Nail
null
1
arm 1: AN2690 Solution, 5.0%
[ 0 ]
1
[ 0 ]
intervention 1: Once daily application for 360 days
intervention 1: AN2690 Solution, 5.0%
2
Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Mexico City | N/A | Mexico | -99.12766 | 19.42847
0
NCT01278394
[ 2 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to compare the pharmaco...
null
Healthy Subjects
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
intervention 1: Ketorolac tromethamine
1
Miami | Florida | United States | -80.19366 | 25.77427
0
NCT01365624
[ 5 ]
20
NON_RANDOMIZED
CROSSOVER
null
0NONE
false
0ALL
null
This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and...
null
Drug Therapy, Combination
null
2
arm 1: Participants will receive warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attend a follow-up visi...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5. intervention 2: Warfarin once daily, at a dose determined through titration by participants' usual hematologist.
intervention 1: Oseltamivir intervention 2: Warfarin
1
Surrey | N/A | United Kingdom | N/A | N/A
0
NCT02780622
[ 5 ]
24
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monothera...
null
Hepatitis B, Chronic
null
2
arm 1: HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. arm 2: HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed...
[ 0, 0 ]
1
[ 0 ]
intervention 1: 180 mcg SC injection QW for 48 weeks.
intervention 1: Peginterferon alfa-2a
6
Auckland | N/A | New Zealand | 174.76349 | -36.84853 Hamilton | N/A | New Zealand | 175.28333 | -37.78333 New Plymouth | N/A | New Zealand | 174.08333 | -39.06667 Riccarton, Christchurch | N/A | New Zealand | N/A | N/A Rotorua | N/A | New Zealand | 176.24516 | -38.13874 Whangarei | N/A | New Zealand | 174.32391 | -35.7...
0
NCT02791269
[ 3 ]
40
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of infectious diarrhoea.
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMXTM technology (CB-01-11) in the treatment of infectious diarrhoea. Primary end points to determine: • The safety and preliminary efficacy ...
Infectious Diarrhoea
Infectious diarrhoea rifamycin SV rifamycin SV MMX MMX
null
3
arm 1: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos. arm 2: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily table...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: 400 mg Rifamycin SV dosage intervention 2: 800 mg Rifamycin SV dosage intervention 3: 1200 mg Rifamycin SV dosage
0
null
0
NCT03447821
[ 3 ]
28
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.
Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, th...
Locally Advanced or Metastatic Pancreatic Cancer
null
1
arm 1: Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable s...
[ 0 ]
1
[ 0 ]
intervention 1: All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.
intervention 1: S-1
0
null
0
NCT00651742
[ 3 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis
null
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic
null
4
arm 1: Twice daily (b.i.d.) arm 2: Twice daily (b.i.d.) arm 3: Twice daily (b.i.d.) arm 4: Twice daily (b.i.d.)
[ 2, 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Capsule intervention 2: Capsule
intervention 1: BIBW 2948 BS intervention 2: Placebo
6
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Francisco | California | United States | -122.41942 | 37.77493 Denver | Colorado | United States | -104.9847 | 39.73915 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Freiburg/Breisgau | N/A | Germany | N/A | N/A Hanover | N/A | Germany...
0
NCT00423137
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a placebo-controlled study evaluating the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).
null
Alzheimer's Disease
rosiglitazone cognition cerebral glucose metabolism positron emission tomography (PET) Alzheimer's Disease
null
2
arm 1: 4 mg once a day for 1 month increasing to 8 mg once a day (Extended Released Tablets) arm 2: Placebo dummy to match
[ 0, 5 ]
2
[ 0, 10 ]
intervention 1: Extended Release Tablets intervention 2: Placebo dummy to match
intervention 1: Rosiglitazone intervention 2: Placebo
15
Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Sun City | Arizona | United States | -112.27182 | 33.59754 Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | Calif...
0
NCT00265148
[ 5 ]
29
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
After 24 weeks of treatment evaluate the efficacy and security.
null
Diabetes Mellitus
null
1
arm 1: sitagliptin
[ 0 ]
1
[ 0 ]
intervention 1: Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets
intervention 1: sitagliptin phosphate
0
null
0
NCT00832390
[ 3 ]
305
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.
null
Arthritis, Rheumatoid
Arthritis Rheumatoid
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 2, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Capsule, once daily (QD) for 12 weeks intervention 2: Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks intervention 3: Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks intervention 4: Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks intervention 5: Capsule, 10 mg of PH-797804, ...
intervention 1: placebo intervention 2: PH-797804 intervention 3: PH-797804 intervention 4: PH-797804 intervention 5: PH-797804
48
Malvern East | Victoria | Australia | 145.04253 | -37.87397 Curitiba | Paraná | Brazil | -49.27306 | -25.42778 Curitiba | Paraná | Brazil | -49.27306 | -25.42778 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 Viña del Mar | Región de Valparaíso | Chile | -71....
0
NCT00383188
[ 3 ]
27
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.
null
Parkinson's Disease
Parkinson's Disease motor complications dyskinesia Motor complications associated with Parkinson's
null
2
arm 1: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days. arm 2: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a pla...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: piclozotan, intravenous (IV) infusion intervention 2: 0.9% sodium chloride (normal saline) intravenous (IV) infusion
intervention 1: piclozotan intervention 2: 0.9% sodium chloride (normal saline)
7
Fountain Valley | California | United States | -117.95367 | 33.70918 Tampa | Florida | United States | -82.45843 | 27.94752 Atlanta | Georgia | United States | -84.38798 | 33.749 New Brunswick | New Jersey | United States | -74.45182 | 40.48622 Brooklyn | New York | United States | -73.94958 | 40.6501 Guatemala City | ...
0
NCT00623363
[ 4 ]
111
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.
Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant Two parallel active arms.
Heart Diseases Heart Transplantation
Antirejection Treatment Outcome Immunosuppression Treatment Effectiveness Anti-rejection therapy
null
4
arm 1: Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 2: Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 3: Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant arm 4: Pediatrics: 6 - 10 mg/ kg/ ...
[ 0, 1, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Oral intervention 2: Oral intervention 3: Intravenous and Oral intervention 4: Intravenous intervention 5: Oral
intervention 1: Tacrolimus intervention 2: Cyclosporine intervention 3: Mycophenolate mofetil intervention 4: Methylprednisolone intervention 5: Prednisone
13
Los Angeles | California | United States | -118.24368 | 34.05223 Calgary | Alberta | Canada | -114.08529 | 51.05011 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Halifax | Nova Scotia | Canada | -63.5...
0
NCT00157014
[ 5 ]
442
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos. This optimization is mainly valuable to a group of infertility patients (9%-24%) who respond poorly to Controlled Ov...
null
Infertility
null
2
arm 1: Use of oral contraceptive pills prior to controlled ovarian stimulation arm 2: No use of oral contraceptive pills prior to controlled ovarian stimulation
[ 1, 4 ]
1
[ 0 ]
intervention 1: oral contraceptive 1 tablet daily for 14 to 21 days
intervention 1: Marvelon
0
null
0
NCT00778999
[ 4 ]
182
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
null
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Chronic Kidney Disease, Stage 5
null
2
arm 1: Fosrenol (Lanthanum carbonate) arm 2: Sevelamer hydrochloride
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets. intervention 2: The starting dose is a total daily dose of 4800mg of sevelamer hydrochlorid...
intervention 1: Fosrenol (Lanthanum Carbonate) intervention 2: Sevelamer hydrochloride
44
Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United States | -110.92648 | 32.22174 Jonesboro | Arkansas | United States |...
0
NCT00441545
[ 4 ]
407
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two...
null
Anemia Kidney Failure
Chronic
null
4
arm 1: Erythropoietin(EPO)-naive BIW arm 2: EPO-naive QW arm 3: EPO QW arm 4: EPO Q2W
[ 1, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: subcutaneous, BIW for 24 weeks intervention 2: subcutaneous, QW for 24 weeks intervention 3: subcutaneous, QW for 24 weeks intervention 4: subcutaneous, Q2W for 24 weeks
intervention 1: Dynepo (Epoetin delta) intervention 2: Dynepo intervention 3: Dynepo intervention 4: Dynepo
53
Graz | Steiemark | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Roeselare | N/A | Belgium | 3.12269 | 50.94653 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne-sur-Mer | N/A | France | 1.61373 | ...
0
NCT00450333
[ 5 ]
152
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
null
Anemia Kidney Failure, Chronic
null
1
arm 1: Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject
[ 0 ]
1
[ 0 ]
intervention 1: Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
intervention 1: Dynepo
1
Lier | N/A | Belgium | 4.57041 | 51.13128
0
NCT00514813
[ 3 ]
148
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place wi...
null
Myelodysplastic Syndromes
MDS CC-5013 Revlimid Celgene
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not exp...
intervention 1: lenalidomide
32
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Rancho Mirage | California | United States | -116.41279 | 33.73974 Stanford | California | United States | -122.16608 | 37.42411 Jacksonville...
1
NCT00065156
[ 4 ]
755
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.
null
Non-Small-Cell Lung Carcinoma
Non-Small Cell Lung Cancer
null
2
arm 1: Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on D...
[ 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: IV, 225 mg/m\^2 intervention 2: IV, 75 mg/m\^2 intervention 3: AUC=6, q 3 weeks (6 cycles maximum) intervention 4: Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2
intervention 1: Paclitaxel (Taxane) intervention 2: Docetaxel (Taxane) intervention 3: Carboplatin intervention 4: Cetuximab
124
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Anchorage | Alaska | United States | -149.90028 | 61.21806 Tucson | Arizona | United States | -110.92648 | 32.22174 Springdale | Arkansas | United States | -94.12881 | 36.18674 Anaheim | California | Unit...
1
NCT00112294
[ 4 ]
789
RANDOMIZED
PARALLEL
null
0NONE
false
0ALL
true
The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.
In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurre...
Bladder Cancer
Bladder Cancer Hexvix Fluorescence Cystoscopy
null
2
arm 1: None arm 2: None
[ 1, 0 ]
2
[ 0, 3 ]
intervention 1: Single Instillation, Transurethral Resection of the Bladder intervention 2: None
intervention 1: Hexvix intervention 2: Standard white light cystoscopy
25
Stanford | California | United States | -122.16608 | 37.42411 Gainesville | Florida | United States | -82.32483 | 29.65163 Miami | Florida | United States | -80.19366 | 25.77427 Pembroke Pines | Florida | United States | -80.22394 | 26.00315 Atlanta | Georgia | United States | -84.38798 | 33.749 Boston | Massachusetts ...
1
NCT00233402
[ 3 ]
144
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laborat...
null
Alzheimer's Disease
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period. intervention 2: MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period
intervention 1: MK0249 intervention 2: Comparator: Placebo (unspecified)
0
null
1
NCT00420420
[ 3, 4 ]
2,059
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol dose...
null
Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive
indacaterol long acting beta-2 agonist
null
7
arm 1: In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued t...
[ 0, 0, 1, 2, 0, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI). intervention 2: Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer. intervention 3: Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDP...
intervention 1: Indacaterol intervention 2: Formoterol (12 µg b.i.d.) intervention 3: Tiotropium (18 µg o.d.) intervention 4: Placebo to Indacaterol intervention 5: Placebo to Formoterol
344
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Homewood | Alabama | United States | -86.80082 | 33.47177 Jasper | Alabama | United States | -87.27751 | 33.83122 Mobile | Alabama | United States | -88.04305 | 30.69436 Glendale | Arizona | United Stat...
0
NCT00463567
[ 3 ]
222
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
2MALE
false
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).
null
Lower Urinary Tract Symptoms Bladder Outlet Obstruction
Lower Urinary Tract Symptoms Bladder Outlet Obstruction Treatment Solifenacin Succinate Tamsulosin hydrochloride
null
3
arm 1: Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. arm 2: Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. arm 3: Participants received once daily, oral doses of 9 mg sol...
[ 2, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Solifenacin succinate tablets intervention 2: Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets intervention 3: None intervention 4: None
intervention 1: solifenacin succinate intervention 2: tamsulosin hydrochloride intervention 3: Placebo to solifenacin intervention 4: Placebo to tamsulosin
33
Homewood | Alabama | United States | -86.80082 | 33.47177 La Mesa | California | United States | -117.02308 | 32.76783 Long Beach | California | United States | -118.18923 | 33.76696 San Bernardino | California | United States | -117.28977 | 34.10834 San Diego | California | United States | -117.16472 | 32.71571 Middle...
1
NCT00507455
[ 3 ]
39
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule ri...
Lymphoma Hodgkin Lymphoma (Category) Nodular Lymphocyte Predominant Hodgkin Lymphoma
null
1
arm 1: 375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks. Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12;...
[ 0 ]
1
[ 0 ]
intervention 1: Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or...
intervention 1: Rituximab
2
Stanford | California | United States | -122.16608 | 37.42411 Stanford | California | United States | -122.16608 | 37.42411
0
NCT00003820
[ 2, 3 ]
85
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem glioma. Imatinib mesylate may interfere with t...
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of imatinib mesylate after completion of radiation in children with newly diagnosed poor prognosis brainstem gliomas. (Phase I, strata I closed to accrual as of 5/28/04.) II. Determine the maximum tolerated dose (MTD) of imatinib mesylate in children wi...
Brain and Central Nervous System Tumors
childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma untreated childhood brain stem glioma recurrent childhood brain stem glioma recurrent childhood cerebral astrocytoma
null
1
arm 1: None
[ 0 ]
2
[ 0, 4 ]
intervention 1: * Phase 1 Stratum I: Starting dose level of 350 mg/m2/day every 28 days X 13 courses (dose escalation) * Phase I Stratum IIA: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation) * Phase I Stratum IIB: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose esc...
intervention 1: imatinib mesylate intervention 2: local irradiation therapy
10
San Francisco | California | United States | -122.41942 | 37.77493 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Chicago | Illinois | United States | -87.65005 | 41.85003 Boston | Massachusetts | United States | -71.05977 | 42.35843 Durham | North Carolina | United States | -78.89862 | 3...
0
NCT00021229
[ 2, 3 ]
38
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purposes of this are: * To determine the highest doses of Taxol and Navelbine that we can safely give to patients; * To determine what kind of side effects are caused by the combination of Taxol, Navelbine and G-CSF; * To determine whether the combination of Taxol, Navelbine and G-CSF is more effective than standa...
Complete response (CR) in advanced breast cancer is an important predictor of improved survival. The largest experience reported with long-term follow-up in this regard is from M.D. Anderson Hospital, with a median survival of 33 months and 5-year survival of 19% among patients who achieved a CR with doxorubicin-based ...
Breast Cancer
null
1
arm 1: Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Paclitaxel weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: ...
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. intervention 2: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol t...
intervention 1: Paclitaxel intervention 2: Vinorelbine intervention 3: Herceptin intervention 4: Filgrastim
1
Seattle | Washington | United States | -122.33207 | 47.60621
0
NCT00041470
[ 3 ]
203
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.
null
Colorectal Cancer Metastases
Colon, Rectal Cancer ABX-EGF, Panitumumab, EGFr Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Vectibix
null
1
arm 1: Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
[ 0 ]
1
[ 0 ]
intervention 1: Administered by intravenous infusion
intervention 1: Panitumumab
0
null
0
NCT00089635
[ 3 ]
50
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine to...
OBJECTIVES: Primary * Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab. Secondary * Determine clinical response in patients treated with this regimen. * Determine toxicity of this regimen in these p...
Pancreatic Cancer
adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer
null
0
null
null
3
[ 2, 0, 0 ]
intervention 1: 30-90 minutes on day 1, every 21 days up to 12 months. intervention 2: twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. intervention 3: IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 ...
intervention 1: bevacizumab intervention 2: capecitabine intervention 3: gemcitabine hydrochloride
2
Buffalo | New York | United States | -78.87837 | 42.88645 Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00100815
[ 3 ]
151
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.
Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules. Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.
Myelodysplastic Syndromes
null
5
arm 1: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle. arm 2: Azacitidine administered subcutaneously at 75mg/m\^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle. arm 3: Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then ...
[ 0, 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Azacitidine is administered subcutaneously Total of 18 cycles on treatment or early discontinuation.
intervention 1: azacitidine
31
Bakersfield | California | United States | -119.01871 | 35.37329 Beverly Hills | California | United States | -118.40036 | 34.07362 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Denver | Colorado | United States | -104.9847 | 39.73915 Washington D.C. | District of Columbia | United States | -77.03...
0
NCT00102687
[ 4 ]
672
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.
null
Atherosclerosis
atheroma IVUS Intravascular ultrasound atherosclerosis
null
2
arm 1: oral anti-diabetic medication arm 2: oral anti-diabetic medication
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: oral anti-diabetic medication intervention 2: oral antidiabetic medication
intervention 1: Glipizide intervention 2: rosiglitazone maleate
156
Birmingham | Alabama | United States | -86.80249 | 33.52066 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Burbank | California | United States | -118.30897 | 34.18084 Huntington Beach | California | United States | -117.99923 | 33.6603 Los Angeles ...
0
NCT00116831
[ 4 ]
375
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may ...
PRIMARY OBJECTIVES: I. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo. II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of ...
Precancerous Condition
null
2
arm 1: Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. arm 2: Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in ...
[ 2, 0 ]
4
[ 10, 0, 0, 10 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Correlative studies
intervention 1: placebo intervention 2: eflornithine intervention 3: sulindac intervention 4: laboratory biomarker analysis
1
Orange | California | United States | -117.85311 | 33.78779
0
NCT00118365
[ 5 ]
500
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.
In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whet...
Pain Depression
Back Pain Knee Pain Hip Pain Stepped Care Antidepressant Relaxation Techniques Exercise
null
3
arm 1: Stepped care group arm 2: Treatment as usual group arm 3: Participants without depression group
[ 0, 1, 4 ]
3
[ 5, 0, 0 ]
intervention 1: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who w...
intervention 1: Stepped Care intervention 2: Antidepressants intervention 3: Usual Care
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
0
NCT00118430
[ 3 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone. This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification...
Opioid Dependence
Heroin Opiates naltrexone memantine
null
3
arm 1: Placebo plus oral naltrexone arm 2: Memantine 30 mg bid plus oral naltrexone arm 3: memantine 15 mg bid plus oral naltrexone
[ 2, 1, 1 ]
2
[ 0, 0 ]
intervention 1: One arm receives 30 mg bid and the other arm receives receives 15mg bid intervention 2: Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
intervention 1: Memantine intervention 2: Naltrexone
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00125515
[ 3 ]
211
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomized (study medication is assigned by chance) to a etravirine (ETR) treatment arm in Phase II TMC125 feeder studies (TMC12...
Human Immunodeficiency Virus Type 1
Human Immunodeficiency Virus Type 1 HIV-1 infection TMC125 Etravirine Enfuvirtide Antiretroviral therapy
null
1
arm 1: None
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available. intervention 2: ...
intervention 1: Etravirine (ETR) intervention 2: Nucleotide reverse transcriptase inhibitors (NRTIs) intervention 3: Protease inhibitors (PIs) intervention 4: Enfuvirtide (ENF)
0
null
0
NCT00128830
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.
null
Glioblastoma Multiforme Astrocytoma
Open label Imatinib mesylate hydroxyurea temozolomide resistant protein tyrosine kinases adenocarcinoma glioblastoma multiforme astrocytoma brain tumor brain cancer
null
2
arm 1: Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based o...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles. intervention 2: None
intervention 1: Imatinib mesylate intervention 2: Hydroxyurea
1
Dülmen | N/A | Germany | 7.28075 | 51.83149
0
NCT00154375
[ 5 ]
18
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate thera...
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience mu...
Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone
Osteogenesis Imperfecta Fractures Pediatric Osteoporosis Juvenile Pagets
null
2
arm 1: 1 mg/kg po qd rounded to nearest 10 or 20 mg dose arm 2: 3 mg/kg IV q4 months
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Alendronate intervention 2: Pamidronate
0
null
0
NCT00159419
[ 0 ]
112
NON_RANDOMIZED
PARALLEL
null
1SINGLE
true
0ALL
false
The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is one of the most important of these metabolic factors. If the production of NO is slowed or stopped the amount of blood to the different...
null
Hypertension Pure Autonomic Failure
Endothelial Nitric Oxide L-NMMA Trimethaphan Autonomic Nervous System Nitric Oxide Inhibition
null
2
arm 1: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in Patients with Autonomic Failure. arm 2: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in normal volunteers...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third. intervention 2: IV infusion for ...
intervention 1: L-NMMA intervention 2: Trimethaphan
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
NCT00178919
[ 4 ]
168
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and ana...
The study focusses on the following primary aims: * To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection). * To compare placebo vers...
Bone Marrow Disease Pain
Pain Management Bone Marrow Aspiration
null
3
arm 1: Fentanyl-1mcg/kg in 3 ml of Normal Saline arm 2: Fentanyl - 0.5 mcg/kg in 3 ml normal saline arm 3: normal saline
[ 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1. Fentanyl - 1 mcg/kg in 3 ml normal saline 2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline intervention 2: All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIV...
intervention 1: Fentanyl intervention 2: EMLA intervention 3: L.M.X4 intervention 4: Propofol
1
Memphis | Tennessee | United States | -90.04898 | 35.14953
0
NCT00187135
[ 3 ]
51
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 h iv infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM) and to obtain the following : * Additional pharmacokinetic information for Aplidin® given as 3-hour IV infusion every 2 w...
Multiple Myeloma
Myeloma Aplidin Plitidepsin PharmaMar
null
0
null
null
1
[ 0 ]
intervention 1: 3-hour infusion every 2 weeks alone or in combination with dexamethasone
intervention 1: Plitidepsin
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00229203
[ 4 ]
518
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen...
This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease...
Non-Small Cell Lung Cancer
Advanced Non-Small Cell Lung Cancer
null
2
arm 1: Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. arm 2: Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Pac...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Administered by intravenous infusion over 1 hour infusion intervention 2: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25). intervention 3: Administered by intravenous infusion ov...
intervention 1: Taxoprexin intervention 2: Carboplatin intervention 3: Paclitaxel
1
Dallas | Texas | United States | -96.80667 | 32.78306
0
NCT00243867
[ 0 ]
43
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.
null
Major Depressive Disorder
Depression Geriatric MRI Sertraline
null
2
arm 1: Healthy Controls undergo MRI and neuropsychological testing arm 2: Depressed subjects receive experimental drug
[ 4, 0 ]
1
[ 0 ]
intervention 1: Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day. Duration of treatment was 12 weeks.
intervention 1: Sertraline
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
0
NCT00245557
[ 5 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the bur...
Alcohol Dependence
Alcohol dependence Acamprosate(drug) Drug Court Probation Parole Criminal justice
null
2
arm 1: Subjects randomized to receive acamprosate arm 2: No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling
[ 0, 4 ]
1
[ 0 ]
intervention 1: Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence
intervention 1: Acamprosate
1
Richmond | Virginia | United States | -77.46026 | 37.55376
0
NCT00249379
[ 5 ]
71
NON_RANDOMIZED
SINGLE_GROUP
1PREVENTION
0NONE
true
1FEMALE
null
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.
Migraine
null
0
null
null
1
[ 0 ]
intervention 1: oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days
intervention 1: eletriptan
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00259649
[ 4 ]
203
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additi...
null
Diabetic Retinopathy
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
intervention 1: Ruboxistaurin
29
Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Huntington Beach | California | United States | -117.99923 | 33.6603 Orange | California | United States | -117.85311 | 33.78779 Sacramento | California | United States | -121.4944 | 38.58157 Hamden | Connec...
0
NCT00266695
[ 5 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, ...
This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg)...
Schizophrenia Schizoaffective Disorder
Schizophrenia Risperidone Risperidal Consta
null
1
arm 1: The RLAI 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.
[ 0 ]
1
[ 0 ]
intervention 1: The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
intervention 1: Risperidone Long-Acting Injectable (RLAI)
1
Seoul | N/A | South Korea | 126.9784 | 37.566
0
NCT00269919
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
Resistant Hypertension
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 2, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: placebo tablet once daily for 12 weeks intervention 2: 10 mg tablets once daily for 10 weeks intervention 3: 50 mg tablet once daily for 10 weeks intervention 4: 100 mg tablet once daily for 10 weeks intervention 5: 200 mg tablet once daily for 10 weeks
intervention 1: Placebo intervention 2: TBC3711 intervention 3: TBC3711 intervention 4: TBC3711 intervention 5: TBC3711
12
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Atlanta | Georgia | United States | -84.38798 | 33.749 Augusta | Georgia | United States | -81.97484 | 33.47097 Shreveport | Louisiana | United States | -93.75018 | 32.52515 Albany | New York | United Sta...
0
NCT00272961
[ 3 ]
231
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration...
This ClinicalTrials.gov record includes the results from two studies (Novartis protocol IDs CSTI571H2201 and CSTI571H2202) which were conducted separately but reported together in a single clinical study report. Both studies were phase II, open-label, multicenter, single-arm studies that evaluated the efficacy of imati...
Recurrent Glioblastoma Multiforme (GBM)
imatinib mesylate hydroxyurea protein tyrosine kinases glioma glioblastoma multiforme recurrent glioblastoma multiforme GBM MacDonald criteria
null
2
arm 1: Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Imatinib was supplied as 100 and 400 mg tablets by Novartis. intervention 2: Hydroxyurea was supplied locally as 500 mg capsules.
intervention 1: Imatinib tablets intervention 2: Hydroxyurea capsules
1
Durham | North Carolina | United States | -78.89862 | 35.99403
0
NCT00290771
[ 3 ]
247
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.
null
Postmenopausal Osteoporosis
Post Menopausal Osteoporosis MicroCT Amgen denosumab Extreme CT XCT Fosamax Alendronate
null
3
arm 1: Placebo for denosumab and placebo for alendronate arm 2: denosumab and placebo for alendronate arm 3: Placebo for denosumab and alendronate
[ 2, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Alendronate 70 mg PO QW intervention 2: denosumab 60 mg SC q 6 mos intervention 3: Placebo for alendronate and placebo for denosumab
intervention 1: Alendronate intervention 2: Denosumab intervention 3: Placebo
0
null
0
NCT00293813
[ 4 ]
1,568
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide f...
null
Chronic Obstructive Pulmonary Disease (COPD)
Roflumilast COPD Chronic obstructive pulmonary disease
null
2
arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily
intervention 1: Roflumilast intervention 2: Placebo
287
Bayou La Batre | Alabama | United States | -88.24852 | 30.40352 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Bullhead City | Arizona | United States | -114.5683 | 35.14778 Phoenix | Ariz...
0
NCT00297115
[ 5 ]
12
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
2MALE
false
To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.
null
Infections, Fungal
Pharmacokinetics Voriconazole Magnetic Resonance Spectroscopy
null
1
arm 1: voriconazole twice daily
[ 0 ]
1
[ 0 ]
intervention 1: Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
intervention 1: voriconazole
1
Belmont | Massachusetts | United States | -71.17867 | 42.39593
0
NCT00300677
[ 4 ]
589
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
null
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes
null
Diabetes, Type I
null
2
arm 1: Technosphere Insulin arm 2: Rapid-acting analogue insulin plus basal insulin glargine
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Inhalation, 15U/30U intervention 2: sc injectable insulin
intervention 1: Technosphere Insulin intervention 2: Active comparator
129
Mobile | Alabama | United States | -88.04305 | 30.69436 Chandler | Arizona | United States | -111.84125 | 33.30616 Chula Vista | California | United States | -117.0842 | 32.64005 Foothill Ranch | California | United States | -117.66088 | 33.68641 Huntington Beach | California | United States | -117.99923 | 33.6603 Ingl...
0
NCT00308308
[ 5 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.
The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primar...
Abdominal Pain Surgical Adhesions
abdominal pain surgical adhesions
null
2
arm 1: Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. arm 2: Patients were randomly assign...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID intervention 2: Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no im...
intervention 1: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks intervention 2: Placebo first followed by open label pregabalin
1
West Bloomfield | Michigan | United States | -83.38356 | 42.56891
0
NCT00310765
[ 5 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life. This pain appears to be primarily musc...
null
Spinal Cord Injury Pain
Botox
null
2
arm 1: Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan. arm 2: Botulism toxi...
[ 2, 1 ]
2
[ 0, 10 ]
intervention 1: Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician pe...
intervention 1: botulinum toxin A intervention 2: placebo
1
Englewood | Colorado | United States | -104.98776 | 39.64777
0
NCT00320281
[ 5 ]
1,771
RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
false
0ALL
true
This study will determine how well four different antiretroviral drug therapies work in patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS) of the South African National Defense Force (SANDF)...
This is a randomized, open label 2x2 factorial study of four regimens of initial therapy. I. AZT + ddl + EFV II. AZT + ddl + r/LPV III. D4T + 3TC + EFV IV. D4T + 3TC + r/LPV Eligible patients will commence their randomly allocated study drugs as soon as possible after randomization. Episodes of treatment limiting ...
HIV
Protease Inhibitors Reverse Transcriptase Inhibitors AIDS Opportunistic Infections Resource-Poor
null
4
arm 1: Zidovudine,Didanosine,Efavirenz ( Zidovudine 600 mg once daily,Didanosine \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily,Efavirenz 600 mg once daily) arm 2: Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily) arm 3: Stavudine,Lamivudine,E...
[ 1, 1, 1, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 600 mg once daily intervention 2: 40 mg once daily intervention 3: \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily intervention 4: 300 mg once daily intervention 5: 600 mg once daily intervention 6: r/LPV 400mg/100mg twice daily
intervention 1: Zidovudine intervention 2: Stavudine intervention 3: Didanosine intervention 4: Lamivudine intervention 5: Efavirenz intervention 6: Lopinavir/Ritonavir
7
Centurion | N/A | South Africa | 28.18577 | -25.85891 Eastaern Cape | N/A | South Africa | N/A | N/A Free State | N/A | South Africa | N/A | N/A Gauteng | N/A | South Africa | N/A | N/A Kwazulu-Natal | N/A | South Africa | N/A | N/A Limpopo | N/A | South Africa | N/A | N/A Western Cape | N/A | South Africa | N/A | N/A
0
NCT00342355