phases
list
enrollmentCount
int64
allocation
string
interventionModel
string
primaryPurpose
class label
masking
class label
healthyVolunteers
bool
sex
class label
oversightHasDmc
bool
briefSummary
string
detailedDescription
string
conditions
string
conditionsKeywords
string
protocolPdfText
string
numArms
int64
armDescriptions
string
armGroupTypes
list
numInterventions
int64
interventionTypes
list
interventionDescriptions
string
interventionNames
string
numLocations
int64
locationDetails
string
target
int64
nctid
string
[ 5 ]
10
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
Type 2 diabetes is a chronic condition that affects the ability of the body to regulate glucose (sugar). When glucose levels are low, the liver can make glucose to increase levels in the body. This important process is called endogenous glucose production (EGP). Previous studies suggest that the central nervous system ...
In this study, the investigators will study healthy participants through a procedure called a "pancreatic clamp" study. During the clamp procedure, glucose (a sugar) and insulin (a hormone produced in the pancreas that regulates the amount of glucose in the blood) are infused with an intravenous catheter, and blood sam...
Type 2 Diabetes Glucose Metabolism Disorders Glucose, High Blood
Type 2 Diabetes Diabetes
null
2
arm 1: 4 mg/kg body weight total dosage administered orally during pancreatic clamp study arm 2: Saline administered orally during pancreatic clamp study
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 4 mg/kg body weight total dosage administered orally intervention 2: Oral saline
intervention 1: Diazoxide intervention 2: Placebo
1
The Bronx | New York | United States | -73.86641 | 40.84985
0
NCT01028846
[ 4 ]
378
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.
null
Prostatic Hyperplasia
Benign Prostatic Hyperplasia BPH dutasteride
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: once daily intervention 2: once daily
intervention 1: Dutasteride intervention 2: Placebo
26
Chiba | N/A | Japan | 140.11667 | 35.6 Chiba | N/A | Japan | 140.11667 | 35.6 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kanagawa | N/A | Japan | 139.91667 | ...
0
NCT00368979
[ 3 ]
271
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women with ovulatory dysfunction.
null
Anovulation
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 1, 1, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Subjects will be administered orally with 1 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 2: Subjects will be administered orally with 5 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). inte...
intervention 1: Anastrozole 1 mg intervention 2: Anastrozole 5 mg intervention 3: Anastrozole 10 mg intervention 4: Clomiphene Citrate 50 mg intervention 5: Clomiphene Citrate 100 mg
1
Rockland | Massachusetts | United States | -70.91616 | 42.13066
0
NCT00213148
[ 2, 3 ]
70
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the ability of 4 antibiotics to kill the bacteria that cause tuberculosis (TB). The antibiotics to be studied are linezolid, gatifloxacin, levofloxacin, and moxifloxacin. All are approved by the Brazilian health authorities to treat infections caused by germs other than TB. Seventy human immuno...
Multi-drug resistant tuberculosis now affects all regions of the world and is a significant concern for national tuberculosis (TB) control programs. The development and testing of new drugs and new classes of drugs and immunotherapeutic agents are vital elements in the global response to this challenge. The fluoroquino...
Tuberculosis
Brazil gatifloxacin isoniazid levofloxacin linezolid moxifloxacin tuberculosis
null
6
arm 1: 10 subjects to receive gatifloxacin 400 mg orally once daily for 7 days. arm 2: 20 subjects to receive isoniazid 300 mg orally once daily for 7days. arm 3: 10 subjects to receive levofloxacin 1000 mg orally once daily for 7days. arm 4: 10 subjects to receive linezolid 600 mg orally every 12 hours daily for 7 day...
[ 0, 1, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Gatifloxacin 400 mg/day x 7 days. intervention 2: Isoniazid 300 mg/day x 7 days. intervention 3: Levofloxacin 1000 mg/day x 7 days. intervention 4: Linezolid 600 mg/day x 7 days; Linezolid 600 mg every 12 hours x 7 days. intervention 5: Moxifloxacin 400 mg/day x 7 days.
intervention 1: Gatifloxacin intervention 2: Isoniazid intervention 3: Levofloxacin intervention 4: Linezolid intervention 5: Moxifloxacin
2
San Francisco | California | United States | -122.41942 | 37.77493 Vitória | Espírito Santo | Brazil | -40.33778 | -20.31944
0
NCT00396084
[ 4 ]
859
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which allows increased doses and potential depletion of the enzyme underlaying resistance, is a more effective treatment of metastatic melanoma than single agent dacarbazine.
null
Melanoma
Metastatic Melanoma
null
2
arm 1: temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously) arm 2: dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: oral capsule; 150 mg/m2/day PO (by mouth), on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously); one cycle of temozolomide is defined as a 6-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating ph...
intervention 1: Temozolomide intervention 2: Dacarbazine
0
null
0
NCT00091572
[ 5 ]
252
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the proportion of subjects with HIV-1 RNA viral load \< 50 c/mL through Week 48 of the Maintenance Phase among HIV-infected subjects with an initial undetectable viral load following an Induction Phase with an ATV/RTV containing HAART regimen, when switched to ATV versus remainin...
null
HIV Infections
Treatment Naive HIV-1 infected treatment naive patients
null
3
arm 1: ATV 400 mg + 2 NRTIs (TBD), ATV once daily, NRTIs (TBD) arm 2: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD) arm 3: ATV 300 mg + RTV 100 mg + 2 NRTIs (TBD), ATV and RTV once daily, NRTIs (TBD)
[ 1, 1, 5 ]
2
[ 0, 0 ]
intervention 1: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs) intervention 2: Capsules, tablets, Oral, 48 weeks (after a 26-to-30-week induction phase with ATV 300 mg + RTV 100 mg + 2 NRTIs)
intervention 1: Atazanavir + 2 NRTIs intervention 2: Atazanavir + Ritonavir + 2 NRTIs
27
Tallinn | N/A | Estonia | 24.75353 | 59.43696 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Orléans | N/A | France | 1.90389 | 47.90289 Paris | N/A | France | 2.3488 | 48.85341 Suresnes | N/A | France | 2.22929 | 48.87143 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Hanover | N/A | Germany | 9.73322 | 52.37...
1
NCT00207142
[ 4 ]
169
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)
null
Bipolar Disorder
Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Study medications will include oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 20mg bid to a maximum dose range of 80 mg bid .
intervention 1: Ziprasidone oral capsules
41
Scottsdale | Arizona | United States | -111.89903 | 33.50921 San Diego | California | United States | -117.16472 | 32.71571 Aurora | Colorado | United States | -104.83192 | 39.72943 Altamonte Springs | Florida | United States | -81.36562 | 28.66111 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 North ...
1
NCT00265330
[ 4 ]
890
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
null
Perennial Allergic Rhinitis
rhinitis perennial allergic rhinitis allergic rhinitis
null
2
arm 1: 2 sprays each nostril twice daily arm 2: 2 sprays each nostril twice daily
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 sprays each nostril twice daily intervention 2: 2 sprays each nostril twice daily
intervention 1: Olopatadine 0.6% nasal spray intervention 2: Placebo Nasal Spray
1
Waco | Texas | United States | -97.14667 | 31.54933
1
NCT00578331
[ 3 ]
30
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select...
This phase II trial in patients with stage II and stage III breast cancer will test the feasibility of using cDNA microarray as a measure of a tumor's biological response to chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer before and after primary chemotherapy. Thirty-six patients...
Breast Cancer Breast Neoplasm
cDNA Microarray Stage II and Stage III Breast Cancer Biological Response Molecular Profiling Fine Needle Aspirate Breast Cancer
null
2
arm 1: Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles arm 2: Docetaxel 60 mg/m\^2 intravenous day 1, capecitabine 937.5 mg/m\^2 orally twice daily day 2-15 for 4 cycles
[ 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Dose A-Cohort 1 Docetaxel 75 mg/m\^2 intravenous day 1 intervention 2: 1 mg orally daily for five years intervention 3: 600 mg/m\^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1 intervention 4: Dose B - Cohort 2 Docetaxel 60 mg/m\^2 intravenous...
intervention 1: Docetaxel - Dose A intervention 2: Anastrozole intervention 3: cyclophosphamide intervention 4: Docetaxel - Dose B intervention 5: Doxorubicin hydrochloride intervention 6: Tamoxifen Citrate intervention 7: Capecitabine - Dose B intervention 8: Capecitabine - Dose A
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00005908
[ 4 ]
2,461
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart attacks compared to ...
The purpose of this medical research study is to determine whether abciximab given in combination with reteplase, before patients have a coronary intervention (a standard treatment where a catheter is inserted into the heart artery to get blood flowing past the clot), is safe and effective in the treatment of heart att...
Myocardial Infarction
Myocardial infarction percutaneous coronary intervention abciximab reteplase safety and efficacy
null
3
arm 1: Abciximab; reteplase; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h arm 2: abciximab; reteplase placebo; abciximab placebo; abciximab 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x ...
[ 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h intervention 2: 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h intervention 3: 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¼g/kg/min, max...
intervention 1: abciximab placebo; reteplase placebo, abciximab, abciximab intervention 2: Abciximab; reteplase; abciximab placebo; abciximab intervention 3: abciximab; reteplase placebo; abciximab placebo; abciximab intervention 4: abciximab placebo; reteplase placebo, abciximab, abciximab intervention 5: abciximab; r...
227
Phoenix | Arizona | United States | -112.07404 | 33.44838 Covina | California | United States | -117.89034 | 34.09001 Modesto | California | United States | -120.99688 | 37.6391 Newark | Delaware | United States | -75.74966 | 39.68372 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Clearwa...
0
NCT00046228
[ 3 ]
105
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating rosiglitazone: 4 mg tablets or placebo tablets administered orally twice daily for 12 weeks. The purpose of the study is to evaluate the efficacy and safety of rosiglitazone in the treatment of mild to moderately active ulcerative coli...
Ulcerative colitis is a disease characterized by inflammation (the changes that happen when tissues in the body are injured) of all or a portion of the large intestine. There is presently no medical cure for ulcerative colitis, although surgical removal of the colon would cure the disease. Ulcerative colitis is general...
Ulcerative Colitis Inflammatory Bowel Disease
Rosiglitazone Ulcerative Colitis
null
2
arm 1: 4 mg of rosiglitazone taken twice daily for 12 weeks. arm 2: Identical in appearance to study drug taken twice daily for 12 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 4mg orally twice daily for 12 weeks intervention 2: pill that looks identical to rosiglitazone
intervention 1: Rosiglitazone intervention 2: Placebo
13
Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Chevy Chase | Maryland | United States | -77.07115 | 39.00287 Laurel | Maryland | United States | -76.84831 | 39.09928 Silver Spring | Maryland | United States | -77.02609 | 38.99067 Boston | Massachusetts |...
0
NCT00065065
[ 3 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV. The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate (ABC), lamivudine (3TC), and zi...
During the early stages of HIV infection, HIV replicates unchecked, massive numbers of cluster of differentiation 4 (CD4) T cells are infected and destroyed, and other CD4 cells become infected but enter a latent phase. This latent pool of infected CD4 cells poses a difficult challenge in eliminating HIV infection duri...
HIV Infections
Acute Infection Treatment Naive
null
2
arm 1: Cyclosporin arm (Arm A) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily, 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily, and liquid cyclosporin A (CsA) (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but contin...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: antiretroviral therapy intervention 2: antiretroviral therapy
intervention 1: Abacavir sulfate, Lamivudine, and Zidovudine intervention 2: Lopinavir/Ritonavir
4
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 New York | New York | United States | -74.00597 | 40.71427 New York | New York | United States | -74.00597 | 40.71427 Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00084149
[ 3 ]
54
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to evaluate the anti-cancer activity and safety of BAY43-9006 (Sorafenib) in patients, who suffer from an advanced breast tumour, which has spread to other organs of body despite treatment that the patient has received so far.
null
Breast Neoplasms Breast Cancer
Cancer
null
1
arm 1: Sorafenib 400 mg administered twice daily (b.i.d.)
[ 0 ]
1
[ 0 ]
intervention 1: Sorafenib 400 mg administered twice daily (b.i.d.)
intervention 1: Sorafenib (Nexavar, BAY43-9006)
7
Stuttgart | Baden-Wurttemberg | Germany | 9.17702 | 48.78232 München | Bavaria | Germany | 13.46314 | 48.69668 Frankfurt am Main | Hesse | Germany | 8.68417 | 50.11552 Bologna | N/A | Italy | 11.33875 | 44.49381 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Parma | N/A | Italy | 10...
0
NCT00101400
[ 4 ]
272
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
true
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication ...
The two primary objectives of this study are: * To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). * To evaluate the safety an...
Prostatitis
Prostatitis Non-bacterial Prostatitis Prostatodynia Alfuzosin Alpha-adrenergic blocker
null
2
arm 1: 10 mg of alfuzosin once daily for 12 weeks arm 2: 10 mg of an identical-looking placebo once daily for 12 weeks
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Alfuzosin intervention 2: Placebo
10
Los Angeles | California | United States | -118.24368 | 34.05223 Stanford | California | United States | -122.16608 | 37.42411 Chicago | Illinois | United States | -87.65005 | 41.85003 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massachusetts | United States | -71.05977 | 42.35843 Jackson | Mis...
0
NCT00103402
[ 4 ]
302
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral bl...
Multiple Myeloma
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning do...
intervention 1: Granulocyte colony-stimulating factor plus plerixafor intervention 2: Granulocyte colony-stimulating factor plus placebo
39
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Duarte | California | United States | -117.97729 | 34.13945 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Denver | C...
0
NCT00103662
[ 5 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or inter...
Patients were screened for eligibility to determine if they meet all inclusion/exclusion criteria. The screening period were up to 4 weeks. Patient's baseline LIC will be determined non-invasively by means of MRI R2 analysis. In addition, blood and urine samples will be taken for the determination of baseline safety da...
Myelodysplastic Syndromes Iron Overload
MDS Myelodysplastic Syndrome ICL-670 ICL-670 and Myelodysplastic Syndrome
null
1
arm 1: Participants received deferasirox 20mg/kg/day OD for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely disper...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Deferasirox
3
Stanford | California | United States | -122.16608 | 37.42411 Detroit | Michigan | United States | -83.04575 | 42.33143 Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00117507
[ 3 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
2MALE
false
The purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.
The goal of this study is to determine whether the short-term (4 week), double-blind administration of Merck L-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. This initial, small sample size study (n=9 on L-830982 and n=6 on placebo) is restricted to males in...
Schizophrenia
schizophrenia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy. interve...
intervention 1: Merck L-830982 intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00129441
[ 3 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well suberoylanilide hydroxamic acid works in treating patients with progressive stage IV breast cancer. Drugs used in chemotherapy, such as suberoylanilide hydroxamic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
PRIMARY OBJECTIVES: I. To evaluate the response rate in patients receiving SAHA for stage IV breast cancer. SECONDARY OBJECTIVES: I. Time to progression. II. Overall survival. III. Toxicity profile. IV. Assessment of potential biological correlates. OUTLINE: This is a multicenter study. Patients receive oral suber...
Male Breast Cancer Recurrent Breast Cancer Stage IV Breast Cancer
null
1
arm 1: Patients receive oral suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 10 ]
intervention 1: Given PO intervention 2: Correlative studies
intervention 1: vorinostat intervention 2: laboratory biomarker analysis
1
Duarte | California | United States | -117.97729 | 34.13945
0
NCT00132002
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if levetiracetam is effective in treating alcohol dependence in patients with anxiety symptoms. The researchers hypothesize that individuals are unable to reduce or discontinue alcohol use because of significant anxiety, mood, and sleep disturbance symptoms that accompany reduc...
Alcohol dependence is frequently associated with anxiety disorders. Treatment studies of individuals suffering from both alcohol dependence and anxiety have been limited. Anti-seizure medications have been used for the treatment of alcohol withdrawal for three decades. More recently, anti-seizure medications have been ...
Alcoholism Generalized Anxiety Disorder Panic Disorder Social Phobia Anxiety Disorders
Substance-induced anxiety disorder
null
1
arm 1: Levetiracetam 1500 mg BID
[ 0 ]
1
[ 0 ]
intervention 1: Levetiracetam 1500 mg BID
intervention 1: levetiracetam
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00141115
[ 3 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes
null
Type 2 Diabetes
Mechanism of action insulin sensitivity
null
3
arm 1: colesevelam 3.8g administered daily for 12 weeks arm 2: Colesevelam matching placebo for 12 weeks arm 3: open-label Insulin Glargine for 12 weeks
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Colesevelam 3.8g for 12 weeks intervention 2: Colesevelam matching placebo for 12 weeks intervention 3: Insulin glargine for 12 weeks
intervention 1: Colesevelam intervention 2: Colesevelam matching placebo intervention 3: Insulin glargine (Lantus)
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00147745
[ 3, 4 ]
2,628
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The aim of the study described is to measure the degree with which zinc given as adjunct therapy to standard antibiotic treatment during childhood pneumonia reduces the risk of treatment failure and the duration of the illness.
Hypothesis: Zinc deficiency is a major public health problem in developing counties. Poor zinc status is associated with stunted growth and reduced resistance to infections. Several in vitro experiments and in vivo studies in animals and humans have demonstrated detrimental effects of zinc depletion on almost all facet...
Pneumonia
Child pneumonia Zinc clinical trial Nepal nutrition therapeutic
null
2
arm 1: Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water arm 2: Placebo
[ 0, 2 ]
1
[ 0 ]
intervention 1: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months
intervention 1: Zinc
1
Bhaktapur | N/A | Nepal | 81.82913 | 28.46735
0
NCT00148733
[ 4 ]
65
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The study is to examine the null hypothesis that risperidone and divalproex sodium are equally effective in treating/stabilizing pediatric bipolar disorder.
Pediatric Bipolar Disorder (PBD) severely impairs a child's emotional development, and is associated with alarming rates of suicide, school failure, aggression, risk taking behaviors and substance abuse (Geller et al, 1998; 2001; Carlson et al, 1998). At present, very little is known about the pathophysiology or optima...
Bipolar Disorder
null
2
arm 1: Risperidone is an antimanic medication and is a second generation antipsychotic arm 2: Divalproex sodium is an antiepileptic medication and is a mood stabilizer
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Divalproex sodium is a mood stabilizer intervention 2: Risperidone is a second generation antipsychotic and antimanic drug
intervention 1: Divalproex Sodium intervention 2: risperidone
3
Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00176202
[ 3 ]
48
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be treatment resistant ...
Procedure Study 1 This study is planned to be conducted over 18 months, with an average recruitment of 2 subjects per month. Each subject is involved in the study for 18 to 26 weeks. While the study medication is dosed over 8 weeks and treated with full dose over 6 weeks, withdrawal of medications that are on board pri...
Bipolar Disorder
null
1
arm 1: The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg. Increas...
[ 0 ]
1
[ 0 ]
intervention 1: It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents. The dose of lamotrigine will be 12.5 mg per day beginning the first da...
intervention 1: Lamotrigine
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00176228
[ 4 ]
33
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).
We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy s...
Obsessive-Compulsive Disorder
OCD
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 5 ]
intervention 1: 100mg tablet administered 1 hour prior to each therapy session intervention 2: 10 weekly hour-long behavior therapy sessions
intervention 1: seromycin intervention 2: Behavior Therapy
0
null
0
NCT00182000
[ 5 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To compare LDL reduction compared to baseline in patients using maximum tolerated HMG CoA Reductase inhibitor (statin) therapy with adjunctive therapy with ezetimibe, colestipol, or niacin. The patient's cardiovascular risks are assessed to determine if National Cholesterol Education Program's Adult Treatment Panel III...
: Patients with hyperlipidemia who sign consent and who are currently at maximum tolerated dose of a statin and are not meeting NCEP ATPIII treatment goals for LDL cholesterol are enrolled in 12-week open label, prospective trial. Patients are randomized into one of three groups to receive ezetimibe, niacin, or colesti...
Hyperlipidemia Hypercholesterolemia
ezetimibe niacin colestipol hyperlipidemia adjunct therapy zetia
null
3
arm 1: Niacin dose range of 500-1500mg (average 888mg) arm 2: Colestipol dose range 5-15gm (average 9.5gm) arm 3: Ezitimibe 10mg (average 10mg)
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Niacin intervention 2: Colestipol intervention 3: Ezetimibe
1
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984
0
NCT00203476
[ 2, 3 ]
64
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.
Propofol is the primary medication used by anesthesiologists at HSC to provide sedation for lumbar puncture. Propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of LP needle insertion. To ensure patient immobility, the dose of propofo...
Hematologic Diseases Neoplasms
spinal puncture remifentanil propofol anesthesia dose finding pediatrics
null
2
arm 1: First patient in this arm will receive a bolus of propofol 4 mg/kg followed by remifentanil 0.5 mcg/kg. Subsequent patients randomized to this arm will receive propofol 4 mg/kg but the dose of remifentanil will be determined using the Dixon up-and-down method (i.e. based on the response of the previous patient) ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: The first patient in this group will receive 4 mg/kg propofol and 0.5 ug/kg respectively. The dose of remifentanil in subsequent patients will be determined by the Dixon up-and-down method. intervention 2: The first patient in this group will receive 2 mg/kg propofol and 1.0 ug/kg respectively. The dose...
intervention 1: Remifentanil intervention 2: Remifentanil
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
0
NCT00213239
[ 0 ]
36
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
This study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are le...
An antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.
Allergic Asthma
null
4
arm 1: Placebo comparator arm 2: Salmeterol Diskus 50 mcg twice per day arm 3: placebo diskus, fluticasone MDI 88 mcg twice per day arm 4: Salmeterol diskus 50 mcg BID, fluticasone MDI 88 mcg twice per day
[ 2, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: salmeterol diskus 50 mcg twice per day intervention 2: placebo diskus, fluticasone MDI 88 mcg twice per day intervention 3: placebo diskus
intervention 1: salmeterol intervention 2: Fluticasone intervention 3: Placebo
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
0
NCT00214019
[ 5 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning wil...
This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole...
Depressive Disorder, Major
Major Depression Depression Unipolar Depression Treatment Resistant Depression Adjunctive treatment
null
1
arm 1: Aripiprazole 5 to 30 mg/day
[ 0 ]
1
[ 0 ]
intervention 1: Aripiprazole dose ranging from 5 to 30 mg/day, augmenting antidepressant treatment. Aripiprazole is used as an augmenting medication on an open label basis for patients on antidepressant medication who continue to have depressive symptoms. This is an open label case series in which all subjects receive ...
intervention 1: Aripiprazole
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00220636
[ 3 ]
73
RANDOMIZED
FACTORIAL
0TREATMENT
2DOUBLE
false
0ALL
false
Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients
Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients ...
Indigestion
Epigastric Pain Non-Ulcer Dyspepsia (NUD)
null
2
arm 1: Placebo arm 2: Esomeprazole
[ 2, 1 ]
2
[ 0, 10 ]
intervention 1: Esomeprazole 40 mg QD intervention 2: Placebo
intervention 1: Esomeprazole intervention 2: Placebo
1
Kansas City | Kansas | United States | -94.62746 | 39.11417
0
NCT00222131
[ 4 ]
319
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesi...
null
Pain
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 10, 0 ]
intervention 1: 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5) intervention 2: 800 mg ...
intervention 1: Normal saline as placebo comparator intervention 2: Intravenous ibuprofen
13
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Montgomery | Alabama | Unite...
0
NCT00225732
[ 4 ]
306
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).
This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objectiv...
Seizures
Partial Seizures Anticonvulsant Complex Partial Seizures Potassium Channels Epilepsy
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase intervention 2: Oral tab...
intervention 1: Retigabine intervention 2: Placebo
54
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Northport | Alabama | United States | -87.57723 | 33.22901 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California ...
0
NCT00232596
[ 3 ]
63
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if a higher dose of study drug is more effective in preventing relapses in patients with Multiple Sclerosis.
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Multiple Sclerosis, Relapsing-Remitting
Relapsing multiple sclerosis interferon beta 1b Betaferon Betaseron
null
4
arm 1: Extension Treatment 250 mcg continued arm 2: Extension Treatment 500 mcg reduced to 250 mcg arm 3: Extension Treatment 500 mcg continued arm 4: Extension Treatment 250 mcg increased to 500 mcg
[ 1, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 250 mcg administered s.c.(subcutaneous) every other day intervention 2: 250 mcg administered s.c. every other day (for patients having received 500 mcg before) intervention 3: 500 mcg administered s.c. every other day intervention 4: 500 mcg administered s.c. every other day (for patients having receive...
intervention 1: Interferon beta 1b (Betaseron, BAY86-5046) intervention 2: Interferon beta 1b (Betaseron, BAY86-5046) intervention 3: Interferon beta 1b (Betaseron, BAY86-5046) intervention 4: Interferon beta 1b (Betaseron, BAY86-5046)
17
Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.850...
0
NCT00235989
[ 4 ]
111
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.
null
Macular Degeneration Choroidal Neovascularization
AMD age-related macular degeneration choroidal neovascularization
null
3
arm 1: Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluores...
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion. intervention 2: Pegaptanib sodium 0.3 mg administered by intravitreal injection. in...
intervention 1: Verteporfin photodynamic therapy intervention 2: Pegaptanib intervention 3: Triamcinolone acetonide
1
Austin | Texas | United States | -97.74306 | 30.26715
0
NCT00242580
[ 5 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to assess the usefulness of a medication (Levetiracetam) for people with body dysmorphic disorder.
Body dysmorphic disorder (BDD), a perceived defect in appearance (e.g., a "large" nose or facial "scarring"), is a relatively common disorder that causes marked distress and impairment in functioning. Recent data suggests that adults with BDD may respond to serotonin reuptake inhibitors (SRIs); however, response to SRI...
Body Dysmorphic Disorder
body dysmorphic disorder levetiracetam
null
1
arm 1: Open-label trial; all participants received levetiracetam
[ 5 ]
1
[ 0 ]
intervention 1: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occur...
intervention 1: Levetiracetam
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
0
NCT00265109
[ 4 ]
306
NON_RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.
null
Schizophrenia
null
2
arm 1: asenapine arm 2: olanzapine
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 5-10 mg sublingually twice daily for 26 weeks intervention 2: 5-20 mg by mouth once daily for 26 weeks
intervention 1: asenapine intervention 2: olanzapine
0
null
0
NCT00265343
[ 4 ]
31
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
null
0ALL
null
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes and determine the pr...
null
Pancreas Transplantation Kidney Transplantation
Simultaneous Pancreas-Kidney Transplantation mycophenolate GI problems
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Experimental
intervention 1: Enteric-coated mycophenolate sodium (EC-MPS)
1
Berlin | N/A | Germany | 13.41053 | 52.52437
0
NCT00267150
[ 4 ]
353
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.
null
Age Related Macular Degeneration
Age-related macular degeneration, ranibizumab
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection...
intervention 1: Ranibizumab 0.3 mg - 3 times monthly, then quarterly intervention 2: Ranibizumab 0.5 mg - 3 times monthly, then quarterly intervention 3: Ranibizumab 0.3 mg monthly
1
Basel | N/A | Switzerland | 7.57327 | 47.55839
0
NCT00275821
[ 4 ]
196
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
null
Hypercholesterolemia
null
2
arm 1: Atorvastatin 40mg tablet + Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). arm 2: Atorvastatin 40mg Pbo tablet + Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day).
[ 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks intervention 2: Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks intervention 3: Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks. intervention 4: Atorvas...
intervention 1: Comparator: atorvastatin intervention 2: Comparator: Placebo intervention 3: Comparator: ezetimibe intervention 4: Comparator: Placebo.
0
null
0
NCT00276458
[ 3 ]
108
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
null
This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients in...
null
Prostate Cancer
Prostate cancer metastatic disease
null
1
arm 1: With stratification
[ 1 ]
1
[ 0 ]
intervention 1: Intravenous 1.4 mg/m2 on a 3-week course.
intervention 1: E7389
18
Denver | Colorado | United States | -104.9847 | 39.73915 Melbourne | Florida | United States | -80.60811 | 28.08363 Ocala | Florida | United States | -82.14009 | 29.1872 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Burnsville | Minnesota | United States | -93.27772 | 44.76774 Columbia | Missouri | Unit...
0
NCT00278993
[ 4 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
true
Oral contraceptives are known to improve menstrual cycles and symptoms in PCOS, however may increase cholesterol. Metformin, a drug to improve insulin resistance, may benefit metabolic state. This study is to determine whether metformin added to oral contraceptive therapy in adolescent women with PCOS improves metaboli...
Polycystic Ovary Syndrome (PCOS) is a heterogeneous condition characterized by chronic anovulation and androgen excess that occurs in 4-8% of unselected adult women. Although signs and symptoms of the disorder typically appear at the time of puberty, diagnosis is often delayed until adulthood. At least 50% of adult wom...
Polycystic Ovary Syndrome
Polycystic Ovary Syndrome Overweight Adolescent Girls Irregular Menstrual Cycles
null
2
arm 1: metformin arm 2: placebo
[ 1, 2 ]
9
[ 0, 0, 5, 5, 3, 3, 3, 3, 0 ]
intervention 1: Metformin 500 mg. tabs 2 tabs BID for duration of study intervention 2: Yasmin, drospirenone and ethinyl estradiol 28 tablets 1 tab daily for duration of study intervention 3: Subjects and a parent/guardian will participate in a series of classes for training in diet, exercise \& behavior modification ...
intervention 1: Metformin intervention 2: Oral Contraceptive Pill intervention 3: Lifestyle Management Program intervention 4: Quality of Life Questionnaire intervention 5: Oral Glucose Tolerance Test intervention 6: Blood work intervention 7: Abdominal Ultra Sound intervention 8: Dual-energy x-ray absorptiometry (DEXA...
1
Rochester | New York | United States | -77.61556 | 43.15478
0
NCT00283816
[ 2 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
true
The purpose of this study is to establish the safety, tolerability, and pharmacokinetics of a multiple dose of the antimalarial drug artesunate.
This study was a Phase 1b, randomized, double-blind, placebo-controlled trial using multiple ascending doses of intravenous artensunate (AS) to determine it's safety, tolerability, and PK in healthy subjects. Subjects were screened within 21 days of dosing. At the screening visit, subject underwent baseline assessments...
Malaria Malaria, Cerebral
artesunate artemisinin falciparum
null
4
arm 1: 2 mg/kg of Intravenous artesunate arm 2: 4 mg/kg of Intravenous artesunate arm 3: 8 mg/kg of Intravenous artesunate arm 4: Mannitol (200 mg/vial) diluted in phosphate buffer and delivered in an equivalent volume by subject's weight as artesunate.
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Three doses of Intravenous Artesunate drug at 2, 4, or 8 mg/kg in diluent Phosphate Buffer (0.3 M, pH 8.1) intervention 2: Mannitol (200 mg/vial) diluted in Phosphate Buffer and given IV in equivalent volume by subject's weight.
intervention 1: Intravenous Artesunate intervention 2: Placebo
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
0
NCT00292942
[ 4 ]
240
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is: * To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old. * To provide data on the response of severe amblyopia (20/125 to 20/400...
Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improv...
Amblyopia
Amblyopia Atropine Plano lens
null
2
arm 1: Atropine 1% once each weekend day in the sound eye arm 2: Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye
[ 1, 1 ]
2
[ 0, 1 ]
intervention 1: Atropine 1% once each weekend day intervention 2: Plano lens for the sound eye
intervention 1: Atropine intervention 2: Plano Lens
2
Fullerton | California | United States | -117.92534 | 33.87029 Dallas | Texas | United States | -96.80667 | 32.78306
0
NCT00315302
[ 4 ]
233
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is: * To compare the effectiveness of weekend atropine plus near activities and daily patching plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia (20/125 to 20/400) in improving vision in the amblyopic eye of 7 to \<13 year olds. * To determine the maximum impr...
Although there is consensus that amblyopia can be treated effectively in young children, many eye care practitioners believe that treatment beyond a certain age is ineffective. Some clinicians have believed that a treatment response is unlikely after the age of 6 or 7 years, while others have considered age 9 or 10 yea...
Amblyopia
Amblyopia Atropine Patching
null
2
arm 1: Patching 2 hours per day plus near activities for one hour while patching (with increase to 4 hours per day for moderate amblyopes and \>4 hours per day for severe amblyopes at 5 weeks if acuity not improved at least 5 letters) arm 2: Atropine 1% once each weekend day in the sound eye plus near activities for at...
[ 1, 1 ]
3
[ 0, 1, 3 ]
intervention 1: Atropine 1% each weekend day in the sound eye intervention 2: Patching 2 hours per day intervention 3: near visual activities for at least one hour per day
intervention 1: Atropine intervention 2: Patching intervention 3: Near activities
2
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
0
NCT00315328
[ 4 ]
105
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.
null
Chronic Hepatitis B
treatment naive CHB adefovir monotherapy
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily. intervention 2: Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.
intervention 1: LAM group intervention 2: ADV group
0
null
0
NCT00316719
[ 0 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient isc...
There is a bimodal distribution to the new onset seizures with one peak occurring in the very young and the second peak occurring in persons over age 65 years. The presentation of seizures in the elderly may vary from that of younger patients and the diagnosis may be confused with other conditions such as transient isc...
Elderly Epilepsy Seizures
Treatment Efficacy pharmacokinetics
null
0
null
null
1
[ 0 ]
intervention 1: Once a day dosing
intervention 1: Divalproex Sodium Extended-Release Tablets
1
Richmond | Virginia | United States | -77.46026 | 37.55376
0
NCT00318929
[ 4 ]
677
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once d...
Dementia of the Alzheimer's Type
memantine Alzheimer's disease moderate to severe Alzheimer's disease
null
2
arm 1: Oral administration, once daily. arm 2: 28mg, once daily. Oral administration for 24 weeks.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: 28mg(7mg capsules) once daily and oral administration for 24 weeks. intervention 2: Matching placebo oral administration once daily.
intervention 1: memantine ER intervention 2: Placebo
83
Phoenix | Arizona | United States | -112.07404 | 33.44838 Costa Mesa | California | United States | -117.91867 | 33.64113 Fresno | California | United States | -119.77237 | 36.74773 San Francisco | California | United States | -122.41942 | 37.77493 Santa Ana | California | United States | -117.86783 | 33.74557 Denver |...
0
NCT00322153
[ 4 ]
1,189
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
null
The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.
null
Osteoporosis Osteopenia
Osteoporosis Osteopenia AMG 162 Fracture - hip Postmenopausal
null
2
arm 1: Subjects in this arm will receive active ALN and placebo denosumab arm 2: Subjects in this arm will receive active denosumab and placbo ALN
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: ALN; 70 mg; oral; once weekly intervention 2: 60 mg; SC; every 6 months
intervention 1: Alendronate intervention 2: Denosumab
0
null
0
NCT00330460
[ 3 ]
27
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP,...
Non-Hodgkin's Lymphoma
oxaliplatin ESHAOX refractory relapsed non-hodgkin's lymphoma
null
1
arm 1: relapsed or refractory non-Hodgkin's lymphoma
[ 0 ]
1
[ 0 ]
intervention 1: Oxaliplatin, 130 mg per square meter, on day 1
intervention 1: Oxaliplatin
1
Seoul | N/A | South Korea | 126.9784 | 37.566
0
NCT00336583
[ 3 ]
49
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs...
null
Peripheral T-Cell Lymphoma
null
0
null
null
2
[ 0, 0 ]
intervention 1: ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia i...
intervention 1: Ontak intervention 2: CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
0
NCT00337987
[ 3 ]
24
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications). Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approve...
Pain
pain chronic pain clonidine adenosine complex regional pain syndrome CRPS a2-adrenergic agonists alpha2-adrenergic agonists
null
4
arm 1: clonidine given in first injection adenosine given in second injection arm 2: adenosine given in first injection clonidine given in second injection arm 3: placebo arm 4: placebo
[ 1, 1, 2, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebros...
intervention 1: clonidine intervention 2: adenosine intervention 3: placebo intervention 4: placebo
2
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
0
NCT00349921
[ 5 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated with perennial allergic rhinitis (PAR) using Peak Nasal Inspiratory Flow (PNIF), Embletta devi...
null
Perennial Allergic Rhinitis Obstructive Sleep Apnea Sleep Disorder
Hypopnea Syndrome
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: MFNS, 50 mcg/spray. Each subject to take 200 mcg (4 sprays) once daily in the morning. intervention 2: Placebo nasal spray. Each subject to take 4 sprays once daily in the morning.
intervention 1: Mometasone furoate nasal spray intervention 2: Placebo
0
null
0
NCT00359216
[ 4 ]
3,148
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
null
Venous Thromboembolism
Prevention of venous thromboembolism
null
2
arm 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening. arm 2: Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening. intervention 2: Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening. intervention 3: Placebo tablet of rivaroxaban administered once daily in the eve...
intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Placebo: tablet of Rivaroxaban intervention 4: Placebo: syringes of Enoxaparin
124
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Bakersfield | California | United States | -119.01871 | 35.37329 Encinitas | Cal...
0
NCT00362232
[ 4 ]
752
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study of E2007 in levodopa treated Parkinson's disease patients with motor fluctuations.
null
Parkinson's Disease
null
3
arm 1: The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening. arm 2: The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects t...
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator
intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator
114
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Peoria | Arizona | United States | -112.23738 | 33.5806 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | Un...
0
NCT00368108
[ 4 ]
56
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).
null
Unverricht-Lundborg Disease
Unverricht-Lundborg Disease Baltic Myoclonus Progressive Myoclonic Epilepsies Myoclonus Brivaracetam
null
3
arm 1: Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period) arm 2: Brivaracetam (BRV) 5 mg/day 5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period) arm 3: Brivaracetam (BRV) 150 mg/day 150 mg twice a day (bid) using 25 mg and 50 mg...
[ 2, 0, 0 ]
4
[ 10, 0, 0, 0 ]
intervention 1: * Pharmaceutical Form: Tablet * Concentration: 2.5 mg, 25 mg and 50 mg * Route of Administration: Oral use intervention 2: * Pharmaceutical Form: Tablet * Concentration: 2.5 mg * Route of Administration: Oral use intervention 3: * Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administrat...
intervention 1: Placebo intervention 2: BRV 2.5 mg intervention 3: BRV 25 mg intervention 4: BRV 50 mg
18
San Francisco | California | United States | -122.41942 | 37.77493 Gainesville | Florida | United States | -82.32483 | 29.65163 New York | New York | United States | -74.00597 | 40.71427 Charlottesville | Virginia | United States | -78.47668 | 38.02931 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Montr...
0
NCT00368251
[ 3 ]
254
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This will be a 12-week, double-blind, randomized, placebo-controlled, parallel group, multicenter study to evaluate the safety, efficacy, and PK of oral administration of PG-760564 in adult patients with active RA receiving treatment with MTX. Two oral doses of PG-760564 will be evaluated: 25 mg BID and 100 mg BID. The...
The study will be conducted in North America and Europe at approximately 50 to 60 sites. Approximately 270 patients will be randomized, of which 189 are expected to complete the study. The study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and an...
Rheumatoid Arthritis
null
3
arm 1: Placebo, oral dose, BID arm 2: 25 mg BID, of oral PG-760564 arm 3: 100 mg BID, of oral PG-760564
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 100 mg BID, of oral PG-760564 intervention 2: placebo, BID, oral for 12 weeks intervention 3: 25 mg BID, of oral PG-760564
intervention 1: PG-760564 intervention 2: Placebo dose intervention 3: PG-760564
53
Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Beverly Hills | California | United States | -118.40036 | 34.07362 Mission Viejo | California | United States | -117.672 | 33.60002 Chiefland | Florida | United States | -82.85984 | 29.47496 Dunedin | Florida | United States | -82.77323 | 28.0199 Fort Lauderd...
0
NCT00369928
[ 5 ]
10
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairi...
Pulmonary Hypertension
pulmonary hypertension PAH Remodulin treprostinil Quality of Life Rapid Switch
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump
intervention 1: treprostinil sodium
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
0
NCT00373360
[ 5 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.
Liver Transplantation
Liver Transplant Corticosteroid withdrawal Tacrolimus CellCept MMF Mycophenolate mofetil
null
1
arm 1: All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not ha...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. intervention 2: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. intervention 3: Prednisone ...
intervention 1: tacrolimus intervention 2: mycophenolate mofetil intervention 3: Prednisone
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
0
NCT00374231
[ 4 ]
834
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive ...
null
Asthma
null
3
arm 1: Mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period arm 2: Mometasone Furoate 200 mcg and formoterol 10 mcg fixed d...
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 12 weeks
intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI)
0
null
0
NCT00381485
[ 4 ]
578
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
null
HIV Infections
Miconazole Lauriad Oropharyngeal candidiasis HIV patients Mycology Clinical picture of Oropharyngeal candidiasis Candida culture positive Treatment Experienced
null
2
arm 1: Clotrimazole troches, 10 mg, 5 times per day for 14 days arm 2: Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 50 mg buccal tablet once a day for 14 days intervention 2: 10mg troches administered Five Times a Day for 14 days
intervention 1: miconazole Lauriad intervention 2: Clotrimazole
27
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Palm Springs | California | United States | -116.54529 | 33.8303 Farmington | Connecticut | United States | -72.83204 | 41.71982 Fort L...
0
NCT00390780
[ 4 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety profile of the initial tobramycin treatment was assessed during the first 3 months of the study and patients were followed until the end of the stud...
This was a multi-center, open-label, two-arm, randomized study. All patients diagnosed with CF and who fulfilled the criteria for early infection with P. aeruginosa initially received tobramycin 300 mg twice a day for 28 days. At the end of the 28-day treatment period, patients who met the inclusion criteria and none o...
Cystic Fibrosis
Cystic fibrosis
null
2
arm 1: Patients inhaled tobramycin 300 mg bis in die (bid, twice a day) for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart. arm 2: Patients inhaled tobramycin 300 mg bis in die (bid, twice a day) for 56 da...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Tobramycin solution for inhalation was supplied in 5 mL liquid-filled low-density polyethylene ampoules containing 300 mg tobramycin. Patients used a nebulizer to inhale the contents of the ampoules.
intervention 1: Tobramycin solution for inhalation 300 mg
0
null
0
NCT00391976
[ 3 ]
22
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Participants with Hodgkin's Disease (HD) who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this efficacy, safety and pharmacokinetic (PK) study. The only changes to the standard of care is ...
Participants with HD who have been treated with cyto-reductive chemotherapy, who are to undergo autologous stem cell transplantation, and who meet the inclusion/exclusion criteria are eligible to enter this study. The only changes to the standard of care is the addition of plerixafor to a G-CSF mobilization regimen on ...
Hodgkin's Disease
Hodgkin's Disease Stem cell mobilization apheresis
null
1
arm 1: Participants with Hodgkin's Disease who were eligible for autologous peripheral blood stem cell transplantation.
[ 0 ]
1
[ 0 ]
intervention 1: Randomized participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and receive...
intervention 1: G-CSF Plus Plerixafor
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
NCT00396201
[ 3 ]
77
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed study NC19453. Patients eligible to participate in the extension study will continue on the treatment they were originally assigned to ...
null
Coronary Heart Disease
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 900mg po daily for 24 weeks intervention 2: po daily for 24 weeks
intervention 1: dalcetrapib (RO4607381) intervention 2: placebo
9
Indianapolis | Indiana | United States | -86.15804 | 39.76838 Iowa City | Iowa | United States | -91.53017 | 41.66113 Louisville | Kentucky | United States | -85.75941 | 38.25424 Bethesda | Maryland | United States | -77.10026 | 38.98067 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Statesville | North...
0
NCT00400439
[ 3 ]
43
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
1FEMALE
true
This study uses the cholesterol lowering drug atorvastatin, also known as lipitor, to show reduction of avascular necrosis in steroid treated lupus patients. Avascular necrosis is a disease resulting from the loss of blood supply to the bones which can cause the bone to collapse. The collapse of bone may require a surg...
If you have started on prednisone 30mg or greater and expect to be on it for greater than two weeks you may be a candidate for the study. Also, you would need to be enrolled in the study within three days of starting prednisone. If you are eligible you will receive lipitor 40mg per day or pills which look exactly like ...
Avascular Necrosis
Avascular Necrosis Lipitor SLE
null
2
arm 1: Atorvastatin 40mg arm 2: Tablets identical to atorvastatin 40mg
[ 0, 2 ]
3
[ 0, 3, 0 ]
intervention 1: Atorvastatin 40mg vs placebo 40mg daily intervention 2: MRIs done baseline, four and nine months intervention 3: Tablets identical to atorvastatin 40mg
intervention 1: Atorvastatin intervention 2: MRI, Venipuncture intervention 3: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00412841
[ 2, 3 ]
3
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
true
Primary Objectives: 1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance. 2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a del...
Researchers want to learn how glucarpidase may impact patients' length of stay in the hospital, kidney function, and quality of life. Also, researchers want to learn if glucarpidase may decrease the incidence of neutropenic fever, which may decrease the use of antibiotics by vein to treat this kind of fever. MTX is a ...
Hematologic Malignancy Solid Tumor
Hematologic Malignancy Solid Tumor Glucarpidase Voraxaze Delayed Methotrexate Clearance Placebo
null
2
arm 1: Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy. arm 2: Placebo administered IV following Voraxaze arm.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 50 units/kg IV within 12 hours of study eligibility being confirmed. intervention 2: Administered by IV within 12 hours of study eligibility being confirmed.
intervention 1: Voraxaze (Glucarpidase) intervention 2: Placebo
1
Houston | Texas | United States | -95.36327 | 29.76328
0
NCT00424645
[ 3 ]
21
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
To evaluate the response rate (Complete Response \[CR\] and Partial Response \[PR\]) to dasatinib in patients with relapsed, refractory or plateau phase multiple myeloma whose serum paraprotein levels are \>0.5g/dL or urine paraprotein levels are \>1.0g/24 hours.
Studies have confirmed the ability of dasatinib to inhibit numerous kinases (76 of 148 kinases tested in one series).13 Overexpression or dysregulation of a number of kinases have been implicated in the pathophysiology of MM and could serve as potential targets for inhibition by dasatinib. Fibroblast growth factor 3 (...
Relapsed, Refractory or Plateau Phase Multiple Myeloma
Dasatinib Plateau phase
null
1
arm 1: Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Dasatinib
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
NCT00429949
[ 3 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research study is to test the safety and effectiveness of replacing vincristine with a drug called bortezomib (also known as "Velcade"or PS341) in the standard therapy vincristine, doxorubicin (not limited to, but formerly referred to under the tradename Adriamycin) and dexamethasone (VAD) in patien...
Bortezomib, has been approved for use in patients with multiple myeloma, who have already received at least one prior treatment and whose disease is worsening on their last treatment and who have already undergone or are unsuitable for bone marrow transplantation. Bortezomib has significant activity in patients with re...
Multiple Myeloma
Multiple Myeloma bortezomib Cancer Hematology bone marrow immunoglobulin relapse refractory plasma cell Velcade adriamycin dexamethasone vincristine
null
2
arm 1: vincristine in combination with adriamycin and dexamethasone arm 2: bortezomib in combination with adriamycin and dexamethasone
[ 1, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: adriamycin: 9mg/m² intravenous (IV) push on days 1 to 4 intervention 2: bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11 intervention 3: dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle intervention 4: vincristine: 0.4mg IV push on days 1 ...
intervention 1: adriamycin intervention 2: bortezomib intervention 3: dexamethasone intervention 4: vincristine
16
Zagreb | N/A | Croatia | 15.97798 | 45.81444 Leer | N/A | Germany | 7.461 | 53.23157 Velbert | N/A | Germany | 7.04348 | 51.33537 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Klaipėda | N/A | Lithuania | 21.13912 | 55.7068 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 B...
0
NCT00441168
[ 4 ]
351
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.
null
Asthma
asthma fluticasone propionate children fluticasone propionate/salmeterol
null
2
arm 1: Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily arm 2: Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: fluticasone propionate 100mcg HFA intervention 2: fluticasone propionate/salmeterol 100/50mcg HFA
intervention 1: fluticasone propionate intervention 2: fluticasone propionate/salmeterol
55
Huntington Beach | California | United States | -117.99923 | 33.6603 Long Beach | California | United States | -118.18923 | 33.76696 Long Beach | California | United States | -118.18923 | 33.76696 Riverside | California | United States | -117.39616 | 33.95335 Denver | Colorado | United States | -104.9847 | 39.73915 Lak...
0
NCT00441441
[ 4 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomize...
null
Anemia
null
2
arm 1: Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). T...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: As prescribed, SC intervention 2: 120-360 micrograms SC monthly, starting dose
intervention 1: Epoetin alfa intervention 2: methoxy polyethylene glycol-epoetin beta [Mircera]
29
Birmingham | Alabama | United States | -86.80249 | 33.52066 Bakersfield | California | United States | -119.01871 | 35.37329 Chula Vista | California | United States | -117.0842 | 32.64005 Mountain View | California | United States | -122.08385 | 37.38605 San Leandro | California | United States | -122.15608 | 37.72493...
0
NCT00442416
[ 3 ]
211
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
null
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts. Part A enrolled 211 pts dosed with either 3, 20, 60 mg BID AGN 203818 or placebo over 4 week treatment duration. Part B will enroll 4...
null
Fibromyalgia
null
4
arm 1: Part A: Placebo every 12 hours for 4 weeks arm 2: Part A: 3 mg AGN 203818 every 12 hours for 4 weeks arm 3: Part A: 20 mg AGN 203818 every 12 hours for 4 weeks arm 4: Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Part A: Placebo every 12 hours for 4 weeks intervention 2: Part A: AGN 203818 3 mg every 12 hours for 4 weeks intervention 3: Part A: AGN 203818 20 mg every 12 hours for 4 weeks intervention 4: Part A: AGN 203818 60 mg every 12 hours for 4 weeks
intervention 1: placebo intervention 2: AGN 203818 intervention 3: AGN 203818 intervention 4: AGN 203818
3
Canton | Ohio | United States | -81.37845 | 40.79895 Geneva | N/A | Switzerland | 6.14569 | 46.20222 Stanmore | N/A | United Kingdom | -0.31667 | 51.61667
0
NCT00445705
[ 3 ]
200
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to investigate the efficacy of enteral iron supplementation for improving anemia, decreasing the risk of blood transfusion, and decreasing mortality in patients who are hospitalized in the intensive care unit. This study will also address any relationship between enteral iron supplementatio...
Critical illness is characterized by the anemia of inflammation, which is partially caused by sequestration of iron from bone marrow sites of erythropoiesis into storage within the reticuloendothelial system as ferritin. Also the majority of critically ill patients are hypoferremia, the efficacy of iron supplementation...
Anemic, Critically Ill Patients
iron critical illness anemia infection
null
2
arm 1: Ferrous sulfate 325 mg either by capsule or oral solution three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first. arm 2: Placebo capsule three times a day at 9 am, 1pm and 5 pm until hospital discharge or for 42 days, whichever occurs first.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Iron group intervention 2: Placebo group
intervention 1: Ferrous Sulfate intervention 2: Placebo Oral Tablet
1
New York | New York | United States | -74.00597 | 40.71427
0
NCT00450177
[ 3 ]
409
null
PARALLEL
0TREATMENT
null
false
0ALL
null
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your...
null
Pulmonary Disease, Chronic Obstructive Asthma
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: BI 1744CL
42
Birmingham | Alabama | United States | -86.80249 | 33.52066 Lakewood | California | United States | -118.13396 | 33.85363 Denver | Colorado | United States | -104.9847 | 39.73915 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Stamford | Connec...
0
NCT00452400
[ 3 ]
173
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.
Migraine
Migraine Ketorolac
null
2
arm 1: Intranasal Placebo arm 2: Intranasal ketorolac tromethamine
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride) intervention 2: Intranasal (IN) placebo
intervention 1: Ketorolac tromethamine intervention 2: Placebo
1
Munich | Bavaria | Germany | 11.57549 | 48.13743
0
NCT00483717
[ 3 ]
194
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.
LCM is an investigational drug that is being studied as a treatment in male and female patients who are diagnosed with osteoarthritis of the knee and require therapeutic doses of NSAIDs, COX-2 NSAIDs and/or paracetamol. This trial will be conducted exclusively in Europe. The study has an adaptive 3-stage group sequent...
Osteoarthritis
Osteoarthritis lacosamide VIMPAT
null
2
arm 1: lacosamide (LCM) arm 2: Placebo
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 50 or 100mg tablet, 400mg daily, for 12 weeks intervention 2: 50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide
intervention 1: lacosamide intervention 2: Placebo
26
Kladno | N/A | Czechia | 14.10285 | 50.14734 Prague | N/A | Czechia | 14.42076 | 50.08804 Bad Hersfeld | N/A | Germany | 9.70891 | 50.87197 Berlin | N/A | Germany | 13.41053 | 52.52437 Hamburg | N/A | Germany | 9.99302 | 53.55073 Leipzig | N/A | Germany | 12.37129 | 51.33962 München | N/A | Germany | 13.31243 | 51.6069...
0
NCT00485472
[ 5 ]
293
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
null
Sinusitis Bacterial Infections
Treatment of acute bacterial rhinosinusitis
null
2
arm 1: Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days arm 2: Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once dail...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days intervention 2: Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Amoxicillin/Clavulanate
34
San Benedetto del Tronto | Ascoli Piceno | Italy | 13.87676 | 42.9568 Esine | Brescia | Italy | 10.25102 | 45.92515 Lamezia Terme | Catanzaro | Italy | 16.30938 | 38.96255 Cesena | Forlì | Italy | 12.24315 | 44.1391 Sestri Ponente | Genova | Italy | 8.8485 | 44.42609 Monza | Monza-Brianza | Italy | 9.27246 | 45.58005 C...
0
NCT00493038
[ 3 ]
281
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).
null
Chronic Obstructive Pulmonary Disease (COPD)
COPD glycopyrronium bromide antimuscarinic
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Dry powder inhalation once a day for up to 28 days intervention 2: Placebo to NVA237 dry powder inhalation once a day for up to 28 days intervention 3: Dry powder inhalation once a day for up to 28 days
intervention 1: NVA237 100 µg intervention 2: Placebo intervention 3: NVA237 200 µg
21
Glendale | Arizona | United States | -112.18599 | 33.53865 Phoenix | Arizona | United States | -112.07404 | 33.44838 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Newark | Delaware | United States | -75.74966 | 39.68372 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United Stat...
0
NCT00510510
[ 4 ]
121
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
1FEMALE
false
The primary purpose of this study is to evaluate the effects of the combined oral contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.
null
Contraception
null
2
arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Levonorgestrel and Ethinyl Estradiol Tablets (LNG-EE), 150 mcg LNG and 30 mcg EE
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Nomegestrol Acetate and Estradiol (NOMAC-E2) Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles. intervention 2: Levonorgestrel and Ethinyl Estradiol (LNG-EE) Tablets, 150 mcg LNG and 30 mcg EE taken once daily f...
intervention 1: NOMAC-E2 intervention 2: Levonorgestrel and Ethinyl Estradiol
0
null
0
NCT00511355
[ 4 ]
48
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
true
1FEMALE
false
The primary purpose of this study is to evaluate the effects of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
null
Contraception
null
2
arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles. intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of ...
intervention 1: NOMAC-E2 intervention 2: DRSP-EE
0
null
0
NCT00511433
[ 0 ]
316
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
null
Dry Eye Syndrome
null
2
arm 1: Carboxymethylcellulose and Glycerin based artificial tear arm 2: Carboxymethylcellulose
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 1 to 2 drops into each eye as needed but at least twice daily intervention 2: 1 to 2 drops into each eye as needed but at least twice daily
intervention 1: Carboxymethylcellulose and Glycerin based artificial tear intervention 2: Carboxymethylcellulose
1
San Diego | California | United States | -117.16472 | 32.71571
0
NCT00514852
[ 3, 4 ]
68
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Evaluate the clinical performance of a new IV Dressing in Comparison to a standard IV Dressing
Prospective, controlled, randomized, clinical trial comparing the 3M™ TegadermTM CHG (Chlorhexidine Gluconate) IV Securement Dressing (3M Healthcare, St Paul, MN) to a standard transparent dressing.
Catheterization
null
2
arm 1: Standard of Care Non-Antimicrobial Transparent Adhesive Dressing arm 2: Chlorhexidine gluconate antimicrobial transparent adhesive dressing
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: 2% Chlorhexidine Transparent Dressing applied as needed up to 7 days of wear intervention 2: Standard of Care Non-antimicrobial Transparent Adhesive Dressing applied as needed for up to 7 days of wear
intervention 1: Chlorhexidine gluconate intervention 2: Transparent Adhesive Dressing
0
null
0
NCT00516906
[ 5 ]
229
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the effects of treatment with valsartan + amlodipine to a target systolic blood pressure (SBP)\<130 mmHg compared to the Joint National Commission on the Treatment of Hypertension 7 recommended target SBP of \<140 mmHg on the intrinsic diastolic properties of the myocardium in ...
null
Hypertension Diastolic Dysfunction
Hypertension systolic blood pressure diastolic dysfunction valsartan amlodipine
null
2
arm 1: (Valsartan + Amlodipine to target SBP of \< 140 mmHg) arm 2: (Valsartan + Amlodipine to target SBP \< 130 mm Hg)
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 160 mg or 320 mg tablets once a day intervention 2: 5 mg or 10 mg tablets once a day
intervention 1: valsartan intervention 2: amlodipine
1
USA | New Jersey | United States | N/A | N/A
0
NCT00523549
[ 4 ]
249
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.
Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approxim...
Pharyngitis
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Ambroxol intervention 2: Placebo
4
Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 Wuhan | N/A | China | 114.26667 | 30.58333
0
NCT00525044
[ 4 ]
2
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
This study is being discontinued due to issues regarding the comparator, cefepime. In Nov 2007 FDA issued a MedWatch regarding cefepime and the trial was suspended. As of May 14, 2008 the FDA was still evaluating the data on cefepime and final follow up is pending. There were no safety issues with ceftobiprole in this ...
Fever Neutropenia Gram-positive Bacterial Infections Pseudomonas Infection
Low numbers of neutrophils in the blood increased body temperature cancer chemotherapy ceftobiprole pseudomonas infections
null
2
arm 1: Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion \[250 mL\] arm 2: Cefepime with or without vancomycin 2 g every 8 hrs-30 min infusion vancomycin 1 000mg every 12 hrs-60 min infusion
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 500 mg every 8 hours intervention 2: 120-minute infusion \[250 mL\]
intervention 1: Ceftobiprole Medocaril intervention 2: Cefepime with or without vancomycin
0
null
0
NCT00529282
[ 5 ]
79
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
null
Allergic Conjunctivitis
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Elestat BID for 2 days intervention 2: Pataday QD for 2 days
intervention 1: Elestat intervention 2: Pataday
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00534794
[ 3 ]
57
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
0ALL
false
This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and efficacy of Retapamulin ointment, 1% applied twice daily for 3 or 5 days to the anterior nares of healthy adult subjects who are nasally colonized with S. aureus. Approximately 57 healthy subjects who ...
null
Infections, Bacterial
Altabax SB-275833 retapamulin nasal colonization PK tolerability safety efficacy
null
3
arm 1: 200mg BID retapamulin 5 days arm 2: 200mg BID placebo 5 days arm 3: 200mg BID retapamulin 3 days and placebo BID 2 days for a total of 5 days
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 200mg BID retapamulin 3 days intervention 2: 200mg BID retapamulin 5 days intervention 3: 200mg BID placebo 5 days
intervention 1: retapamulin intervention 2: Retapamulin intervention 3: Placebo
4
San Diego | California | United States | -117.16472 | 32.71571 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Baltimore | Maryland | United States | -76.61219 | 39.29038 Tacoma | Washington | United States | -122.44429 | 47.25288
0
NCT00539994
[ 5 ]
716
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
This 2 arm study will assess the impact of bone marker feedback (BMF), using serum carboxy-terminal collagen crosslinks (CTX) and communication of results at 3 months, on adherence to once monthly ibandronate (150 milligrams \[mg\] per oral \[po\]) in women with post-menopausal osteoporosis supported by patient-relatio...
null
Postmenopausal Osteoporosis
null
2
arm 1: Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, will receive BMF at Month 3. BMF will be given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A "BMF-form" will be provided to the physicia...
[ 0, 1 ]
1
[ 0 ]
intervention 1: Participants will receive ibandronate 150 mg QM orally for 6 months.
intervention 1: Ibandronate
52
Békéscsaba | N/A | Hungary | 21.1 | 46.68333 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Pécs | N/A | Hungary | 18.23083 | 46.0725...
0
NCT00545363
[ 5 ]
313
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
null
Asthma
null
1
arm 1: montelukast sodium
[ 0 ]
1
[ 0 ]
intervention 1: montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
intervention 1: montelukast sodium
0
null
0
NCT00545844
[ 4 ]
1,738
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.
null
Hypertension Metabolic Disorder
null
1
arm 1: Losartan (MK0954) / Losartan + HCTZ (MK0954A)
[ 0 ]
1
[ 0 ]
intervention 1: All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.
intervention 1: losartan potassium (+) hydrochlorothiazide
0
null
0
NCT00546052
[ 4 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.
null
Psychotic Depression
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study. Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizoph...
intervention 1: Aripiprazole
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00556140
[ 0 ]
11
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for the treatment of acne vulgaris.
The purpose of this study is to compare the safety and efficacy of a benzoyl peroxide 2.5% cream formulation plus a moisturizing lotion versus benzoyl peroxide 2.5% cream alone for mild to moderate acne vulgaris.
Acne Vulgaris
Acne
null
2
arm 1: Benzoyl Peroxide (BP) 2.5% arm 2: Benzyol Peroxide 2.5% plus moisturizing lotion
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Benzoyl Peroxide 2.5% intervention 2: None
intervention 1: Benzoyl Peroxide intervention 2: Moisturizing Lotion
1
Chicago | Illinois | United States | -87.65005 | 41.85003
0
NCT00558831
[ 0 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
1FEMALE
false
Estrogen and progesterone are two main female sex hormones. When a woman goes through menopause, the body's production of estrogen and progesterone significantly decreases. Recent studies have shown that the breakdown of fatty acids in cardiac muscle is important in maintaining a healthy heart, and that estrogen may en...
Menopause is a natural event that generally occurs in women between the ages of 45 and 55. During menopause, the body starts producing less estrogen and progesterone until menstruation eventually stops. Estrogen and progesterone are involved in many important functions in a woman's body, and the drastic decline of thes...
Postmenopausal Syndrome
Post-Menopausal PET Estrogen Progesterone Heart Metabolism Cardiovascular Disease
null
2
arm 1: Hormone replacement therapy (HRT): estrogen plus progesterone arm 2: Hormone replacement therapy (HRT): estrogen plus placebo
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Estrogen only plus placebo: estradiol topical patch 0.3 mg placed on the lower abdomen for 3 days plus an oral placebo. Other procedures: heart metabolism tests which includes a positron-emission tomography (PET) scan, an electrocardiogram (ECG), and an echocardiogram (ECHO). intervention 2: Estrogen p...
intervention 1: Estrogen intervention 2: Progesterone intervention 3: Placebo
1
St Louis | Missouri | United States | -90.19789 | 38.62727
0
NCT00565916
[ 4 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat problems with thinking and memory caused by electroconvulsive therapy (ECT).
null
Major Depression Bipolar Depression Schizoaffective Disorder
null
2
arm 1: None arm 2: None
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: The starting dose of study medication is 4 mg twice a day intervention 2: 4 mg, 2 times a day
intervention 1: Razadyne intervention 2: Placebo
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
0
NCT00566735
[ 0 ]
11
NON_RANDOMIZED
SINGLE_GROUP
null
0NONE
true
0ALL
false
To evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing VELCADE treatment for the first time.
Cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. Even with prophylactic anticoagulation, DVT stil...
MULTIPLE MYELOMA
PLASMACYTOMA
null
1
arm 1: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days. After you have gone off study, you will be followed every three months for approximately 2 years. Each cycle will consist of 3 weeks (21 days) according to the schedule below. DRUG ROUTE DOSE DAYS Velcade IV 1.3 mg/m2 1,4,8...
[ 0 ]
1
[ 0 ]
intervention 1: Except for the two PCR-based genotyping assays, which will be conducted only on baseline samples, tests will be assessed at baseline, 1-3 hours after the first dose of Velcade day 1 and on day 11 of the first cycle of Velcade. The platelet Aggregation Test will be done only if Platelet count is 100 000...
intervention 1: Velcade
1
Little Rock | Arkansas | United States | -92.28959 | 34.74648
0
NCT00569868
[ 0 ]
100
RANDOMIZED
FACTORIAL
null
2DOUBLE
false
0ALL
true
We are inviting patients who have been diagnosed with an ischemic or hemorrhagic stroke and are being transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care to participate in this research study to test the following: 1) To test whether it is possible to go through a...
Ischemic or hemorrhagic stroke patients transferred by Air Care helicopters to the University of Iowa Hospitals and Clinics (UIHC) for further care will be invited to participate in a research study testing the following: 1) feasibility of beginning a research study while the patient is in transit to UIHC, and 2)test e...
Stroke
null
4
arm 1: Advanced Notification + Ranitidine arm 2: Advanced Notification + Placebo arm 3: No advanced notification + Ranitidine arm 4: No advanced notification + Placebo
[ 0, 1, 1, 2 ]
4
[ 0, 0, 10, 10 ]
intervention 1: 50 mg single dose injection of Ranitidine intervention 2: 50 mg single dose injection of normal saline (placebo) intervention 3: Advanced notification of study via faxed consent to local Emergency Room (ER) intervention 4: No advanced notification of study via faxed consent to local Emergency Room (ER)
intervention 1: Ranitidine intervention 2: Placebo intervention 3: Advanced notification intervention 4: No advanced notification
1
Iowa City | Iowa | United States | -91.53017 | 41.66113
0
NCT00585351
[ 2 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
We are interested in whether bunionectomy can be used as a model to study the treatment of acute pain. It has been used to study the effect of Non-Steroidal Anti-inflammatory (NSAIDS) medications (such as ibuprofen) and other pain relieving drugs. We are interested to know if this model is useful to study other drugs f...
null
Acute Pain
Primary, unilateral, first metatarsal bunionectomy with osteotomy
null
3
arm 1: None arm 2: None arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Patients will be randomized just prior to surgery to 1 of 3 study treatments: pregabalin (300 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0. int...
intervention 1: pregabalin intervention 2: naproxen sodium intervention 3: Comparator: Placebo
0
null
0
NCT00601458
[ 0 ]
191
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
true
The primary outcomes of this procedure will be: 1. The cleanliness of the prep as measured by the Ottawa Scale (attachment a). Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
null
Bowel Preparation for Colonoscopy
null
2
arm 1: split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment arm 2: split-dose PEG solution without dietary restrictions plus placebo pretreatment
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy intervention 2: placebo gelcap, taken at noon the day prior to the colonoscopy
intervention 1: lubiprostone intervention 2: placebo
1
Fort Sam Houston | Texas | United States | -98.4417 | 29.45303
0
NCT00611442
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is: * To find out if the chemotherapy treatment using Pemetrexed (Alimta) and Oxaliplatin (Eloxatin) given together will kill the cancer cells in the patient's body and shrink the size of their tumor. This may allow patients to live longer or decrease the frequency and/or severity of the symp...
Treatment Plan: This is a non-randomized, two stage design, open-label Phase II trial in newly diagnosed patients with advanced or metastatic NSCLC who have previously received and failed adjuvant platinum-based chemotherapy for early stage, resected NSCLC. Correlative Studies; Molecular correlative studies (genomic ...
Lung Cancer
recurrent non-small cell
null
1
arm 1: Patients will be treated with oxaliplatin 120 mg/m\^2 i.v. over 2 hours and pemetrexed 500 mg/m\^2 i.v. over 10 minutes on Day 1 of a 21day cycle. Cycles of treatment will be repeated every 3 weeks. Folic acid and B12 supplementation is obligatory.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Dose Regimen: 120 mg/m\^2 on Days 1 every 21 days intervention 2: Dose Regimen: 500 mg/m\^2 on Days 1 every 21 days
intervention 1: Oxaliplatin intervention 2: Pemetrexed
1
Tampa | Florida | United States | -82.45843 | 27.94752
0
NCT00612677
[ 5 ]
35
NON_RANDOMIZED
SINGLE_GROUP
null
0NONE
true
0ALL
true
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process...
null
Drug Induced Liver Injury
acetaminophen protein adducts hepatic function drug safety non drinkers
null
1
arm 1: all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
[ 0 ]
1
[ 0 ]
intervention 1: 4 g/day for 10 consecutive days
intervention 1: acetaminophen
1
Denver | Colorado | United States | -104.9847 | 39.73915
0
NCT00616018
[ 3 ]
16
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
null
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
null
1
arm 1: Patients will be treated a maximum of 8 cycles or until the patient has evidence of a response, progressive disease, or until intolerable toxicity develops. Patients with a complete response will receive an additional 2 cycles of treatment (not to exceed 8 cycles). Drug order is gemcitabine, mitoxantrone, and ri...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: 900 mg/m2 on Days 1 and 8 of each 21-day cycle The order of administration will be: Gemzar--\>Novantrone--\>Rituxan. intervention 2: Novantrone 10 mg/m2on Day 1. The order of administration will be: Gemzar--\>Novantrone--\>Rituxan. intervention 3: Rituxan 375 mg/m2 on Day 1. The order of administration...
intervention 1: gemcitabine intervention 2: mitoxantrone intervention 3: rituximab
0
null
0
NCT00656084
[ 4 ]
17
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The objective of this study was to obtain preliminary open-label data on the efficacy and tolerability of memantine, an anti-glutamatergic medication with a unique pharmacodynamic profile, in individuals with OCD and individuals with GAD. Because glutamatergic hyperactivity in frontal and frontal-subcortical circuits m...
Several case reports and an open-label trial have reported efficacy of anti-glutamatergic medications for the treatment of OCD. In an open-label trial of riluzole, a glutamate release inhibitor, seven of 13 adult patients with OCD improved, and five were categorized as treatment responders. Another open trial found ril...
Obsessive-Compulsive Disorder Generalized Anxiety Disorder
Obsessive-compulsive disorder Generalized anxiety disorder Memantine Namenda
null
2
arm 1: OCD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication. arm 2: GAD group - received 12 weeks of open-label memantine 10 mg twice daily, as either mono therapy or augmentation of their existing medication.
[ 1, 1 ]
1
[ 0 ]
intervention 1: Namenda 10mg BID for 12 weeks
intervention 1: Memantine
1
Los Angeles | California | United States | -118.24368 | 34.05223
0
NCT00674219
[ 3 ]
20
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is ...
Dental Erosion
enamel fluoride uptake erosion enamel remineralization
null
4
arm 1: Participants to brush their teeth for one timed minute twice daily with a gel to foam dentifrice containing active ingredients: 1450 ppm F as sodium fluoride (NaF) and 5% potassium nitrate (KNO3) and isopentane as an excipient ingredient. arm 2: Participants to brush their teeth for one timed minute twice daily ...
[ 0, 0, 1, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Experimental toothpaste intervention 2: Experimental toothpaste intervention 3: Active comparator intervention 4: Placebo comparator
intervention 1: NaF/ KNO3/isopentane Dentifrice intervention 2: NaF/KNO3 Dentifrice intervention 3: NaF Dentifrice intervention 4: Placebo Dentifrice
0
null
0
NCT00752089