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

[ 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 (CNS), including the brain, helps to coordinate this process by communicating with the liver through potassium channels. Control of EGP can be impaired in people with type 2 diabetes, which may contribute to the high levels of glucose seen in these individuals. The purpose of this study is to understand how activating these potassium channels in the control centers of the brain with a medication called diazoxide might inhibit the amount of glucose made by the liver. This is particularly important for people with diabetes who have very high production of glucose, which in turn causes hyperglycemia (high levels of sugar in the blood) that leads to diabetes complications.

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 samples are collected periodically throughout the procedure to measure blood sugar levels and the levels of several hormones that are found in the body and are related to glucose metabolism. Endogenous glucose production (the production of sugar by the liver) will be measured in patients given diazoxide (a medication that activates potassium channels in the brain that may affect glucose production in the liver through brain-liver signaling), compared with when a placebo is given. All experiments will consist of 240 min insulin/somatostatin (250 μg/hr) infusions with replacement of glucoregulatory hormones (glucagon 1 ng/kg·min; growth hormone 3 ng/kg·min). Throughout the study, the plasma glucose concentration will be maintained at basal levels ( \~90 mg/dl). This will be attained by infusion of insulin at adequate rates to maintain normoglycemia without requiring glucose infusion. Primed continuous infusions of High-performance liquid chromatography-purified \[3-3H\]-glucose will be initiated at t=0 (21.6 μCi bolus, then 0.15 μCi/min), to measure glucose fluxes. All infusions will be stopped at t=240 min. From t=0 to t=240 min, blood samples will be obtained for determinations of plasma glucose, insulin, glucagon, C-peptide, cortisol, growth hormone, free fatty acids (FFA), glycerol, and lactate, and for 3-3H-glucose determinations. This registration is exclusive to Aim 1 of the study protocol, which determined the effect of diazoxide on hepatic glucose production in nondiabetic, healthy, young individuals under fixed hormonal conditions. Euglycemic (90 mg/dl x 4 hours) pancreatic clamp studies (n= 10), with either saline or diazoxide infusion.

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 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kyoto | N/A | Japan | 135.75385 | 35.02107 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379 Osaka | N/A | Japan | 135.50107 | 34.69379 Ōita | N/A | Japan | 131.6 | 33.23333 Ōita | N/A | Japan | 131.6 | 33.23333 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895 Tokyo | N/A | Japan | 139.69171 | 35.6895

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). intervention 3: Subjects will be administered orally with 10 mg of anastrozole once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 4: Subjects will be administered orally with 50 mg of clomiphene citrate once daily for 5 days in Cycle 1, 2 and 3 (each cycle = approximately 1 month). intervention 5: Subjects will be administered orally with 100 mg of clomiphene citrate once daily for 5 days in Cycle 2 and 3 (each cycle = approximately 1 month).

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 immunodeficiency virus (HIV)-negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary (lung) TB, will participate in this study. Study volunteers will be given one of the 4 study drugs or a comparison antibiotic, Isoniazid, which has been used around the world as a standard of care treatment for TB. Volunteers will stay in the hospital for 10 days and be given a study antibiotic 7 of those days. Blood and saliva samples will be taken. Six weeks later, volunteers will return for a final health check. All volunteers will receive 6 months of standard tuberculosis treatment.

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 fluoroquinolones and oxazolidinones represent two promising classes of drugs that show activity against Mycobacterium tuberculosis (MTB). This study is a randomized, open label, multiple dose phase I clinical trial to evaluate the early bactericidal activity (EBA) of gatifloxacin, levofloxacin, moxifloxacin, and linezolid compared with an isoniazid (INH) control arm in patients with newly-diagnosed sputum smear-positive pulmonary tuberculosis (TB). Secondary study objectives are to: compare results of sputum MTB messenger ribonucleic acid (mRNA) clearance with results of a standard EBA study \[change in sputum viable counts \[colony forming units (CFU)\]; compare the rate of clearance of sputum cytokine proteins with results of a standard EBA assay CFU; determine the pharmacokinetics (PK) of the study drugs in patients with smear-positive pulmonary TB; and demonstrate that lack of EBA activity is not due to low serum drug concentrations. Seventy human immunodeficiency virus (HIV) negative adults, aged 18-65 years, who have been newly diagnosed with pulmonary TB, will be enrolled and admitted to the Centro de Pesquisa (Clinical Research Ward) at the Hospital Universitario Cassiano Antonio de Moraes of the Universidade Federal do Espírito Santo in Vitória. The subjects will be randomized to receive gatifloxacin, levofloxacin, moxifloxacin, or INH (control), and after these arms are enrolled, they will be randomized to receive either linezolid (600 mg once daily) or linezolid (600 mg twice daily) or INH (control). During the inpatient stay, study drugs will be given for 7 days following a 2-day drug-free period when baseline sputum bacillary counts will be measured. The 7-day duration of the study drug phase will allow measurement of sputum bactericidal activity both during the first 2 days of study drug administration and between days 2 and 7 of study drug administration to gain additional information on the possible sterilizing activity of the drugs. The extended nature of these EBA studies will allow assessment of this possibility in the study drugs that would be missed if a shorter EBA study was performed. Sputum specimens will be collected for 2 days prior to initiation of study drug in order to establish a baseline quantitative culture result and then specimens will be collected daily thereafter. Sputum specimens will be processed to evaluate changes in mycobacterial mRNA/proteins and cytokine proteins. PK studies will be performed after 5 days of study drug administration (Day 5). Safety evaluations including clinical examination, complete blood counts, and serum total bilirubin, aspartate aminotransferase (AST), creatinine, and urinalysis will be followed to monitor for drug toxicity. Drug susceptibility testing will be performed on an initial sputum isolate and will be repeated after completion of 7 days of study drugs, and on isolates from patients with positive sputum cultures at the day 42 study visit to assess for the development of acquired drug resistance. Isolates will be tested against INH, rifampicin, pyrazinamide, ethambutol and the subject's assigned study drug. Patients who are found to be resistant to their assigned study drug at baseline will not be analyzable. After the initial treatment, all subjects will receive 6 months of standard TB treatment outside of the hospital.

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 days. arm 5: 10 subjects to receive linezolid 600 mg orally once daily for 7days. arm 6: 10 subjects to receive moxifloxacin 400 mg orally once daily for 7 days.

[ 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

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 physician that it is in the subject's best interest to stop. intervention 2: intravenous solution; dacarbazine 1000 mg/m2 IV (in the vein), on Day 1 +/- 3 days every 3 weeks; one cycle of dacarbazine is defined as a 3-week period; treatment will continue until progression of the disease, unacceptable toxicity, subject refusal, or opinion of the treating physician that it is in the subject's best interest to stop.

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 remaining on ATV/RTV, whilst continuing their previous NRTI backbone.

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 | 52.37052 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Ulm | N/A | Germany | 9.99155 | 48.39841 Dublin | Dublin | Ireland | -6.24889 | 53.33306 Brescia | N/A | Italy | 10.21472 | 45.53558 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy | 14.5195 | 40.87618 Padua | N/A | Italy | 11.88586 | 45.40797 Riga | N/A | Latvia | 24.10589 | 56.946 Cascais | N/A | Portugal | -9.42147 | 38.69681 Porto | N/A | Portugal | -8.61099 | 41.14961 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Elche | Alicante | Spain | -0.70107 | 38.26218 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Valencia | N/A | Spain | -0.37966 | 39.47391 Bristol | Avon | United Kingdom | -2.59665 | 51.45523 Edinburgh | Central | United Kingdom | -3.19648 | 55.95206 London | Greater London | United Kingdom | -0.12574 | 51.50853

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

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 the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel. Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination. Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging. Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles. Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years. In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans. Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.

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 receive docetaxel/capecitabine induction chemotherapy followed by surgery and doxorubicin/cyclophosphamide adjuvant therapy (TX/AC). We will determine the response rate of TX induction therapy and the toxicities of the sequential combinations (TX/AC). We will also obtain tumor tissue for correlative biological determinations.

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 day 1 intervention 5: 60 mg/m\^2 will be administered as a slow intravenous push on day 1 intervention 6: 20 mg/day orally for five years intervention 7: Dose B - Cohort 2 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15 intervention 8: capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles

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 only abciximab given during coronary intervention.

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 attacks compared to only abciximab given during coronary intervention. This medical research study will also help determine if the combination of abciximab and reduced dose reteplase will decrease the risk of death, and reduce complications of a heart attack at 90 days compared to abciximab alone which is a standard treatment. Patients will receive either abciximab and reteplease or abciximab alone. Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either abciximab and reteplease or abciximab and placebo into a vein in their arm for up to 12 hours.

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 12h arm 3: abciximab placebo; reteplase placebo, abciximab, abciximab placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¼g/kg/min, max 10 ¼g/min infusion x 12h

[ 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 10 ¼g/min infusion x 12h intervention 4: placebo bolus; 1-2 placebo bolus; 0.25 mg/kg bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h intervention 5: 0.25 mg/kg bolus; 1-2 placebo boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h intervention 6: 0.25 mg/kg bolus; 1-2, 5 unit boluses; placebo bolus; 0.125 ¿g/kg/min, max 10 ¿g/min infusion x 12h

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; reteplase placebo; abciximab placebo; abciximab intervention 6: Abciximab; reteplase; abciximab placebo; abciximab

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 Clearwater | Florida | United States | -82.8001 | 27.96585 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Tallahassee | Florida | United States | -84.28073 | 30.43826 Weston | Florida | United States | -80.39977 | 26.10037 Harvey | Illinois | United States | -87.64671 | 41.61003 Rock Island | Illinois | United States | -90.57875 | 41.50948 Lexington | Kentucky | United States | -84.47772 | 37.98869 Louisville | Kentucky | United States | -85.75941 | 38.25424 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Lewiston | Maine | United States | -70.21478 | 44.10035 Worcester | Massachusetts | United States | -71.80229 | 42.26259 Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Pontiac | Michigan | United States | -83.29105 | 42.63892 St Louis | Missouri | United States | -90.19789 | 38.62727 Brooklyn | New York | United States | -73.94958 | 40.6501 Flushing | New York | United States | -73.81736 | 40.76538 Mineola | New York | United States | -73.64068 | 40.74927 New York | New York | United States | -74.00597 | 40.71427 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Akron | Ohio | United States | -81.51901 | 41.08144 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dayton | Ohio | United States | -84.19161 | 39.75895 Westlake | Ohio | United States | -81.91792 | 41.45532 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 Tulsa | Oklahoma | United States | -95.99277 | 36.15398 Hershey | Pennsylvania | United States | -76.65025 | 40.28592 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Sayre | Pennsylvania | United States | -76.5155 | 41.97896 Sellersville | Pennsylvania | United States | -75.3049 | 40.35399 Upland | Pennsylvania | United States | -75.38269 | 39.85261 Wormleysburg | Pennsylvania | United States | -76.91386 | 40.26287 York | Pennsylvania | United States | -76.72774 | 39.9626 Pawtucket | Rhode Island | United States | -71.38256 | 41.87871 Providence | Rhode Island | United States | -71.41283 | 41.82399 Spartanburg | South Carolina | United States | -81.93205 | 34.94957 Bristol | Tennessee | United States | -82.18874 | 36.59511 Kingsport | Tennessee | United States | -82.56182 | 36.54843 Amarillo | Texas | United States | -101.8313 | 35.222 Galveston | Texas | United States | -94.7977 | 29.30135 Houston | Texas | United States | -95.36327 | 29.76328 Lubbock | Texas | United States | -101.85517 | 33.57786 Bremerton | Washington | United States | -122.63264 | 47.56732 Marshfield | Wisconsin | United States | -90.1718 | 44.66885 Waukesha | Wisconsin | United States | -88.23148 | 43.01168 Adrogué | N/A | Argentina | -58.38384 | -34.80041 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Corrientes | N/A | Argentina | -58.8344 | -27.46784 Merlo | N/A | Argentina | -58.72744 | -34.66536 Rosario | N/A | Argentina | -60.63932 | -32.94682 San Martín | N/A | Argentina | -68.47312 | -33.08338 Bruck an der Mur | N/A | Austria | 15.28333 | 47.41667 Deutschlandsberg | N/A | Austria | 15.22222 | 46.81528 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Vienna | N/A | Austria | 16.37208 | 48.20849 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Bonheiden | N/A | Belgium | 4.54714 | 51.02261 Eeklo | N/A | Belgium | 3.55654 | 51.18703 Ghent | N/A | Belgium | 3.71667 | 51.05 Herentals | N/A | Belgium | 4.83248 | 51.17655 Mechelen | N/A | Belgium | 4.47762 | 51.02574 Reet | N/A | Belgium | 4.41264 | 51.10201 Turnhout | N/A | Belgium | 4.94471 | 51.32254 Waregem | N/A | Belgium | 3.42756 | 50.88898 Westmalle | N/A | Belgium | 4.69013 | 51.29767 Dimitrovgrad | N/A | Bulgaria | 25.6 | 42.05 Haskovo | N/A | Bulgaria | 25.55557 | 41.93415 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Montreal | Quebec | Canada | -73.58781 | 45.50884 Repentigny | Quebec | Canada | -73.45008 | 45.74222 Benesov U Prahy | N/A | Czechia | N/A | N/A Bílovec | N/A | Czechia | 18.01581 | 49.75639 Boskovice | N/A | Czechia | 16.65997 | 49.48751 Brno | N/A | Czechia | 16.60796 | 49.19522 Bruntál | N/A | Czechia | 17.4647 | 49.98844 Čáslav | N/A | Czechia | 15.38972 | 49.91099 České Budějovice | N/A | Czechia | 14.47434 | 48.97447 Český Krumlov | N/A | Czechia | 14.31521 | 48.81091 Havíøov 1 | N/A | Czechia | N/A | N/A Hodonín | N/A | Czechia | 17.13244 | 48.84893 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Hranice | N/A | Czechia | 17.73469 | 49.54796 Jeseník | N/A | Czechia | 17.20464 | 50.22937 Jičín | N/A | Czechia | 15.35162 | 50.43723 Jihlava | N/A | Czechia | 15.59124 | 49.3961 Karniva-Ray N/A | N/A | Czechia | N/A | N/A Kyjov | N/A | Czechia | 17.12253 | 49.01018 Most | N/A | Czechia | 13.63617 | 50.50301 Nový Jičín | N/A | Czechia | 18.01028 | 49.59438 Odry | N/A | Czechia | 17.83084 | 49.66255 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Písek | N/A | Czechia | 14.1475 | 49.3088 Poruba | N/A | Czechia | 18.42818 | 49.86247 Prague | N/A | Czechia | 14.42076 | 50.08804 Praha 10 N/A | N/A | Czechia | N/A | N/A Prostějov | N/A | Czechia | 17.11184 | 49.47188 Přerov | N/A | Czechia | 17.4509 | 49.45511 Strakonice | N/A | Czechia | 13.90237 | 49.26141 Svitavy | N/A | Czechia | 16.46829 | 49.75594 Šumperk | N/A | Czechia | 16.97061 | 49.96528 Tábor | N/A | Czechia | 14.6578 | 49.41441 Teplice | N/A | Czechia | 13.82451 | 50.6404 Trutnov | N/A | Czechia | 15.9127 | 50.56101 Tøebíè 1 | N/A | Czechia | N/A | N/A Tøinec 1 | N/A | Czechia | N/A | N/A Ústí nad Labem | N/A | Czechia | 14.03227 | 50.6607 Ústí nad Orlicí | N/A | Czechia | 16.39361 | 49.97387 Valašské Meziříčí | N/A | Czechia | 17.97113 | 49.47181 Vyškov | N/A | Czechia | 16.99897 | 49.27747 Znojmo | N/A | Czechia | 16.0488 | 48.8555 Esbjerg | N/A | Denmark | 8.45187 | 55.47028 Frederikshavn | N/A | Denmark | 10.53661 | 57.44073 Hjÿrring N/A | N/A | Denmark | N/A | N/A Horsens | N/A | Denmark | 9.85034 | 55.86066 Kÿbenhavn Nv N/A | N/A | Denmark | N/A | N/A Kÿbenhavn Sud N/A | N/A | Denmark | N/A | N/A Kÿbenhavn Ÿ | N/A | Denmark | N/A | N/A Odense | N/A | Denmark | 10.38831 | 55.39594 Randers | N/A | Denmark | 10.03639 | 56.4607 Silkeborg | N/A | Denmark | 9.54508 | 56.1697 Viborg | N/A | Denmark | 9.40201 | 56.45319 Ÿlborg | N/A | Denmark | N/A | N/A Ÿrhus N | N/A | Denmark | N/A | N/A Besançon | N/A | France | 6.01815 | 47.24878 Colmar | N/A | France | 7.35584 | 48.08078 Metz | N/A | France | 6.17269 | 49.11911 Nancy | N/A | France | 6.18496 | 48.68439 Nancy Cedex N/A | N/A | France | N/A | N/A Nîmes | N/A | France | 4.35788 | 43.83665 Paris | N/A | France | 2.3488 | 48.85341 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Aachen | N/A | Germany | 6.08342 | 50.77664 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Bad Segeberg | N/A | Germany | 10.30745 | 53.93775 Bremen | N/A | Germany | 8.80717 | 53.07582 Dresden | N/A | Germany | 13.73832 | 51.05089 Eschweiler | N/A | Germany | 6.27184 | 50.81854 Friedberg | N/A | Germany | 10.98461 | 48.35693 Fulda | N/A | Germany | 9.67518 | 50.55162 Hamburg | N/A | Germany | 9.99302 | 53.55073 Kaltenkirchen | N/A | Germany | 9.96042 | 53.83244 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Mannheim | N/A | Germany | 8.46694 | 49.4891 Meißen | N/A | Germany | 8.95489 | 52.26984 München | N/A | Germany | 13.31243 | 51.60698 Münster | N/A | Germany | 7.62571 | 51.96236 Pfaffenhofen | N/A | Germany | 8.97639 | 49.06444 Radebeul | N/A | Germany | 13.66047 | 51.10654 Schönebeck | N/A | Germany | 11.7307 | 52.01682 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Ramat Gan | N/A | Israel | 34.81065 | 32.08227 Leeuwarden | N/A | Netherlands | 5.80859 | 53.20139 Będzin | N/A | Poland | 19.12565 | 50.32607 Bielsko-Biala | N/A | Poland | 19.04686 | 49.82245 Bolesławiec | N/A | Poland | 15.5697 | 51.26418 Brzeg | N/A | Poland | 17.4674 | 50.86079 Częstochowa | N/A | Poland | 19.12409 | 50.79646 Gdansk | N/A | Poland | 18.64912 | 54.35227 Gdynia Poland | N/A | Poland | N/A | N/A Gliwice | N/A | Poland | 18.67658 | 50.29761 Gmina Końskie | N/A | Poland | 20.40607 | 51.19166 Gorlice | N/A | Poland | 21.16035 | 49.65563 Grójec | N/A | Poland | 20.86757 | 51.86252 Jastrzębie Zdrój | N/A | Poland | 18.57479 | 49.95542 Katowice | N/A | Poland | 19.02754 | 50.25841 Konin | N/A | Poland | 18.25121 | 52.22338 Kościerzyna | N/A | Poland | 17.98119 | 54.12226 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Nowy Dwor M | N/A | Poland | N/A | N/A Nysa | N/A | Poland | 17.33437 | 50.47379 Opole | N/A | Poland | 17.92533 | 50.67211 Piotrkow Trybunalski | N/A | Poland | 19.70321 | 51.40547 Poznan | N/A | Poland | 16.92993 | 52.40692 Radomsko | N/A | Poland | 19.44477 | 51.06713 Ruda Śląska | N/A | Poland | 18.85632 | 50.2584 Skierniewice | N/A | Poland | 20.15837 | 51.95485 Swidnica | N/A | Poland | 16.48859 | 50.84378 Tychy | N/A | Poland | 18.96641 | 50.13717 Ustroń | N/A | Poland | 18.80198 | 49.72153 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warszawa Poland | N/A | Poland | N/A | N/A Wroclaw | N/A | Poland | 17.03333 | 51.1 Zabrze | N/A | Poland | 18.78576 | 50.32492 Żyrardów | N/A | Poland | 20.44599 | 52.0488 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Iași | N/A | Romania | 27.6 | 47.16667 Târgu Mureş | N/A | Romania | 24.55747 | 46.54245 Arcadia Pretoria N/A | N/A | South Africa | N/A | N/A Cape Town Western Province | N/A | South Africa | N/A | N/A Roodepoort Central Gauteng | N/A | South Africa | N/A | N/A Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 Santander | N/A | Spain | -3.80444 | 43.46472 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bruderholz | N/A | Switzerland | 7.59902 | 47.5296 Liestal | N/A | Switzerland | 7.73446 | 47.48455 Antrim | N/A | United Kingdom | -6.211 | 54.7175 Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Brighton | N/A | United Kingdom | -0.13947 | 50.82838 Chichester | N/A | United Kingdom | -0.78003 | 50.83673 Durham | N/A | United Kingdom | -1.57566 | 54.77676 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Middlesbrough | N/A | United Kingdom | -1.23483 | 54.57623 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Portadown | N/A | United Kingdom | -6.44434 | 54.42302 Saint Leonards-on-Sea | N/A | United Kingdom | 0.5452 | 50.85565 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Stockton-on-Tees | N/A | United Kingdom | -1.3187 | 54.56848 Worthing | N/A | United Kingdom | -0.37538 | 50.81795

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 colitis. Disease activity will be measured using a standard disease activity index. Calculation of the index requires patients to undergo flexible sigmoidoscopy at the start of the study and at week 12.

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 generally treated with medications against diarrhea and infection, medications which suppress the immune system (the body system that protects a person against foreign substances) or with surgery. It is thought that the chronic inflammation associated with ulcerative colitis may be related to the release of certain chemicals produced by the body. Rosiglitazone has been shown to inhibit the production of some of these chemicals. The active component of rosiglitazone has also been shown to improve colitis in animal models of colitis. The purpose of this study is to evaluate the benefit of the drug for ulcerative colitis by comparing it to placebo. This is a randomized controlled trial of rosiglitazone versus placebo in patients who have failed to respond to 5-ASA therapy. Participants will be randomized to receive either rosiglitazone 4mg bid or placebo bid twice daily for a total of 12 weeks. Disease activity will be measured using the Disease Activity Index (DAI) at visits 3 through 8. Additional outcomes measured will include histological disease activity (visits 3 and 7) and quality of life using the IBDQ (visits 3 through 8). The principle analyses will be an intent-to-treat analysis to examine the efficacy of rosiglitazone at a dose of 4mg twice daily compared to placebo to achieve a partial or complete response. Additionally, the change in NF-κB activation prior to and following therapy with either placebo or rosiglitazone will be examined using immunohistochemistry techniques.

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

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 zidovudine (AZT), (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection. Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPV/r alone.

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 during the early stages of infection because the cells persist for long periods, even with highly active effective antiretroviral therapy, and may later become active. CsA is popularly used as a lifelong immunosuppressant for organ transplant patients. CsA inhibits cellular activation, including CD4 cell activation and proliferation. By reducing CD4 cell activation during acute HIV infection, fewer CD4 cells may be infected and die; more importantly, there may be fewer latent cells with the potential to become active later in the disease. However, CsA has many potential toxic effects, including renal damage, and may affect neurologic, endocrine, and hepatic organ systems. In a previous small study of adults with acute HIV infection, a short 8-week course of CsA was well tolerated, and it is thought that a 4-week course of CsA may result in substantial reduction in both viral load and T cell activation, outweighing any potential toxic effects sustained during the one month treatment. This study will evaluate the safety of and immune response to a 4-week course of CsA with ABC/3TC/AZT and LPV/r compared to ABC/3TC/AZT and LPV/r alone in patients with acute HIV infection. This 48-week study will randomly assign patients to one of two arms. During the first 4 weeks of the study, Arm A will receive one tablet of ABC/3TC/AZT twice daily, 3 capsules or 2 tablets of LPV/r twice daily, and liquid CsA (dose determined by weight) twice daily. At Week 5, Arm A patients will stop CsA but continue both ABC/3TC/AZT and LPV/r. Arm B will receive one tablet of ABC/3TC/AZT twice daily and 3 capsules or 2 tablets of LPV/r twice daily for all 48 weeks. On a case-by-case basis, an investigator may wish to prescribe ABC/3TC rather than ABC/3TC/AZT at initial therapy. Participants with ABC hypersensitivity will be given 3TC/AZT instead of ABC/3TC/AZT. A complete physical exam and medical history assessment will occur at study entry and at Week 48. Study visits will occur every week until Week 4, then every 4 weeks until the end of the study. Blood and urine collection and clinical assessments will occur at each study visit. Additionally, patients in Arm A only will undergo CsA level monitoring at Day 3 and Weeks 1, 2, and 3; CsA dosage may be adjusted as necessary.

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 continue both ABC/3TC/AZT and LPV/r. arm 2: The No Cyclosporin arm (Arm B) will receive one tablet of Abacavir sulfate, Lamivudine, and Zidovudine (ABC/3TC/AZT) twice daily and 3 capsules or 2 tablets of lopinavir/ritonavir (LPV/r) twice daily for all 48 weeks

[ 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

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 | 10.32618 | 44.79935

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 in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

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 and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants. The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization. There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

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

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 blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

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 dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days. intervention 2: 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 placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.

intervention 1: Granulocyte colony-stimulating factor plus plerixafor intervention 2: Granulocyte colony-stimulating factor plus placebo

39

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 intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox. Deferasirox were administered orally once per day for 12 months.

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 data.

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 dispersed.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Deferasirox

3

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 order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.

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. intervention 2: Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.

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 dividing. Suberoylanilide hydroxamic acid may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVES: I. To evaluate the response 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 suberoylanilide hydroxamic acid twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 8 weeks.

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 reduction in alcohol use.

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 shown to reduce drinking and promote abstinence, and reduce drinking in abstinent alcoholics. Levetiracetam is a newer anti-seizure medication, with a structure different than that of other anti-seizure medications, that is safe and generally well tolerated. The Food and Drug Administration (FDA) has approved levetiracetam for use with other anti-seizure medications in the treatment of epilepsy in adults. The metabolism of levetiracetam is less complicated than older anti-seizure medications, which makes it easier to use and better tolerated, and it is not likely to interact with other medicines. Levetiracetam has been shown to prevent anxiety during sedative withdrawal, which is similar to alcohol withdrawal, in a laboratory study using mice. Levetiracetam also had anti-anxiety effects in laboratory study using mice. Given that other anti-seizure medications have been shown to be helpful in treating alcohol dependence, that levetiracetam is not likely to have interactions with other medications, and that in animals levetiracetam appeared to be helpful for treating a condition similar to alcohol dependence and anxiety, we believe it should be studied for the treatment of alcohol dependent patients with anxiety disorders.

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 facets of the immune system. The epithelial linings in the gut and in the respiratory tract are important for the resistance to infections and continuous cell division is required for proper function of these barriers. Zinc is crucial for cellular division and for the maintenance of organs with cells with a rapid turnover, including epithelial cells. Clinical trials in children in developing countries have demonstrated improved growth and reduced prevalence of diarrhea and respiratory tract infections following zinc supplementation. Furthermore, zinc has a well-documented therapeutic effect when given during acute or persistent diarrhea. The effect of zinc may be explained by correction of a deficiency state and/or by a pharmacological, as yet poorly described, action. Due to the promising results from previous studies, WHO are now supporting large clinical trials in Nepal, India and Tanzania to assess whether routine zinc supplementation reduces mortality in early childhood. If the results of these trials show a mortality reduction, routine zinc supplementation or zinc dense foods may be promoted. However, while the first approach is logistically difficult and expensive, the second approach is difficult because zinc dense foods and foods with low phytic acid content are expensive and not readily available. Moreover, both approaches may be perceived to be incompatible with the current breast-feeding recommendations for the youngest children in most developing countries. There is limited information on zinc as adjunct therapy for pneumonia. A recent hospital-based study in young children with severe pneumonia, showed that the zinc group had a faster recovery, resulting in a shortening of stay in hospital of one day. However, this study was small and no community based study has been conducted so far. Whether zinc has an effect during respiratory infections has to be assessed in studies with larger sample sizes in children with less severe disease and should be repeated in children with more severe disease. Short-term zinc administration during infections may become an alternative or an addition to long-term supplementation or promotion of zinc dense foods. Furthermore, therapeutic administration of zinc will not interfere with the current breast-feeding recommendations. Hypothesis: Zinc as adjunct therapy for pneumonia may lead to faster recovery. Furthermore, long-term beneficial effects may include improved immuno-nutritional status measured by thymus size, less morbidity and improved growth. Comparison: Duration of illness, risk of treatment failure, for those with severe pneumonia: length of hospital stay. Number of non-injury clinic visits and hospitalizations during the intervention with Zinc and an in a 6 month period after enrolment. Growth assessed by anthropometry and thymus size assessed by ultrasonography. Explore the efficacy of zinc in etiology-sub groups including those defined by nutritional status, inflammation, fever, gender, breastfeeding status and viral etiology.

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 optimal treatment of PBD. The long range goals of this proposal are threefold: to investigate a range of pharmacotherapeutic agents that are safe and efficacious for PBD, to use fMRI techniques to examine abnormalities in brain function in this disorder, as well as any change in brain function after treatment. In contrast to the adult literature, we are aware of only two prospective studies assessing the efficacy of standard mood stabilizers in a pediatric sample. In one, lithium was found to be moderately effective in PBD with comorbid substance abuse (Geller et al, 1998). In the other, divalproex sodium, lithium and carbamazepine produced a maximum of 50% symptom reduction (Kowatch et al, 2000). Subsequently, Kafantaris et al (2001) observed a potentiation of lithium's antimanic effect when combined with risperidone. Further, a prospective, open trial of olanzapine for PBD reported a 70% symptom reduction (Frazier et al, 2001) with a retention rate of 96% compared to only 7% with classic mood stabilizers (Kowatch et al, 2000). Thus, parallelling adult studies (Sachs et al, 2000), novel antipsychotics are a promising treatment in this population. Further, up to 60% of acute PBD episodes present with psychotic features (Geller et al, in press). Finally, the time to full effect with mood stabilizers is often 4 weeks in children (Kowatch et al, 2000; Geller et al, 1998; Kafantaris et al, 2001), whereas antipsychotics usually have a more rapid response onset (Pavuluri et al, in press). Given the potential efficacy of novel antipsychotics for PBD, the aim is to conduct a randomized trial comparing a novel antipsychotic to a standard mood stabilizer:

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

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 (who failed on two adequate trials of mood stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain activity and/or dysfunction before lamotrigine treatment, and to look for any alteration after lamotrigine treatment. Brain systems associated with attention and emotional processing will targeted.

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 prior to the study drug administration and drug free period post washout required additional time line that is up to 12 weeks over and above the 14 weeks of administering the study drug. Conversely, the range of time is necessary to account for factors such as the child's age, sex, weight, reactions to the medications and side effects. Based on these factors, the time it takes to titrate the medication dose to the optimal amount will vary. Maintaining this flexibility in the protocol is part of good clinical practice where medication is involved. Only children whose medication is not currently improving their symptoms will be recruited. Therefore no children who have been stabilized on a drug will be taken off of it. The initial 2 week screening period includes a diagnostic interview and collection of demographic information. Previous medication will be tapered slowly over 2-12-week period and is based on tolerability and need to keep subjects in drug free state prior to start of study medication. It is an open trial where subjects are aware of the type of medication and the strength (For example, one pill=25 mg strength) of the pill. Research assessment of mood symptoms and side effects will be carried out 5 times over the course of the active trial period. Blood will be collected 3 times: once the subject is washed-out (baseline), once optimal medication dose has been reached, and finally at the end of the 6-week period on full dose. 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. Increasing the medication to final dose will take 8 weeks and the response on full and tolerable dose is further monitored for response over 6 weeks. Therefore, this is a 18-26 week trial (2 to 12 weeks=screening and wash out; 8 weeks=dosing; 6 weeks=acute trial period on full dose). Study 2 involves adolescent subjects (\>10years of age) recruited from the Study 1 sample. This part of the study is a fMRI treatment study to examine how the brain functions before and after receiving lamotrigine medication for bipolar disorder. The goal of study 2 is to understand how and where lamotrigine works in the brain. In order to do this, we will view brain images in a fMRI scanner pre- and post-treatment. This will be done once before subjects begin taking lamotrigine (subjects who require a "wash-out" period, described in study 1, this will occur after the "wash-out.") The second scan will take place after the medication trial (after the 6-week active treatment period). While in the scanner, subjects will complete tasks related to thinking and emotion. Subjects will be shown pictures of faces with varying expressions including happy, neutral and angry and will be asked to identify the emotions of the faces, remember and identify previously seen faces, and determine the age group of various faces (i.e., above or below 30 years). Subjects will also complete tasks that involve processing words that express different emotions (e.g., happy, angry), and respond to different "go" and "no-go" images that flash on a screen. Brain activity will be recorded during these tasks. Each task will take around 5 minutes. Before the actual fMRI scan, subjects practice lying in a simulator, a machine that looks and sounds like a scanner.

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. Increasing the medication to final dose will take 8 weeks and the response on full and tolerable dose is further monitored for response over 6 weeks. Therefore, this is a 18-26 week trial (2 to 12 weeks=screening and wash out; 8 weeks=dosing; 6 weeks=acute trial period on full dose).

[ 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 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.

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 sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.

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 (NCEP ATP III) guidelines for low density lipoprotein (LDL) reduction were achieved between the three groups. Secondary measures examine the safety issues with liver function test (LFT) monitoring and rhabdomyolysis. High-density lipoproteins (HDL) elevations are monitored between the three groups to determine efficacy as a secondary outcome.

: 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 colestipol in addition to current statin therapy. Patients are titrated as tolerated to therapeutic doses of study medications (ezetimibe 10mg/day, niacin 1500mg/day, and colestipol 20gm/day). At baseline, informed consent; a laboratory admission profile (Chem20); weight; height; blood pressure; concomitant medications; cholesterol medication history; and grapefruit juice consumption data are gathered. At weeks 6 and 12, patients have their cholesterol panels and liver function tests assessed. Patients are also interviewed regarding side effects (including rhabdomyolysis), tolerance, changes in concomitant medications, and grapefruit juice consumption, along with weight and blood pressure measurements.

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 propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. Remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. However, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. The combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone. The objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. The results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.

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) arm 2: First patient in this arm will receive a bolus of propofol 2 mg/kg followed by remifentanil 1 mcg/kg. Subsequent patients randomized to this arm will receive propofol 2 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 of remifentanil in subsequent patients will be determined by the Dixon up-and-down method.

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 less adherent.

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 will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

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 in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

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 aripiprazole augmentation. There is no comparator group.

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 at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.

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 analgesic, morphine, post surgery

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 intravenous ibuprofen diluted in 250 milliliters of normal saline 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 1: Normal saline as placebo comparator intervention 2: Intravenous ibuprofen

13

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 objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

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 tablet.

intervention 1: Retigabine intervention 2: Placebo

54

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 received 250 mcg before)

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

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 fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. arm 2: Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy. arm 3: Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.

[ 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. intervention 3: Triamcinolone acetonide administered by intravitreal injection.

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 SRIs is often only partial. About one third of patients do not respond to an SRI. Furthermore, patients may stop taking SRIs because of side effects (e.g., sexual side effects). For these reasons, additional monotherapy and SRI augmentation strategies are greatly needed. Levetiracetam is primarily used as an antiseizure medication and has a wider safety margin than other antiepileptics. Preliminary scientific studies may suggest that it may be helpful for certain psychiatric symptoms and disorders. In the present study we propose to obtain pilot data on 1) levetiracetam monotherapy and 2) levetiracetam augmentation of SRIs in patients with BDD.

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 occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.

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 proportion of pancreas-kidney transplant recipients who experience any GI complaints under MMF-based immunosuppressive treatment.

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 to preserve the masking of the treatment arms. intervention 2: Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 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 to preserve the masking of the treatment arms. intervention 3: Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

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: Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

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 into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.

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

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 metabolic state.The study will also test a lifestyle improvement program to reduce weight.

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 women with PCOS are obese, resulting in a more severe clinical picture. Obesity among adolescents has been increasing in recent years, with overrepresentation of females who show evidence of hyperandrogenism and irregular periods, suggesting an association of obesity and PCOS at an early age. Recent data, however, have drawn attention to the long-term risks of PCOS, including diabetes and cardiovascular disease. Insulin resistance plays a critical role in the pathophysiology of PCOS and is thought to be the metabolic abnormality most closely linked to an increased risk of diabetes and heart disease. Traditional treatments with oral contraceptives are associated with reduction in serum androgens and improvements in menstrual cycles in adolescents with PCOS, however these have not been well-studied in obese adolescents. Oral contraceptives may worsen the dyslipidemia seen in obese women with PCOS and do not address the insulin resistance. Metformin, an insulin sensitizing agent, has been shown to improve metabolic features of PCOS, but combination therapy with oral contraceptives has never been studied in the obese adolescent with PCOS. The major hypothesis of this proposal is that metformin will improve the metabolic profile of obese adolescent girls with PCOS treated with oral contraceptives. Additionally, a secondary hypothesis will be that compliance with a concurrent lifestyle modification program with be associated with the most significant improvements.

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 skills on a regular weekly basis over the 24 week study intervention 4: Quality of Life questionnaire designed for women with Polycystic Ovary Syndrome. Questions concern health and health related issues Performed twice during study, at baseline and conclusion intervention 5: Insulin response to a glucose challenge in an oral glucose tolerance test (OGTT), as measured by area under the curve (AUC). In this study we will administer an OGTT and calculate the AUC as a measure of insulin resistance. Performed twice during study, at baseline and conclusion intervention 6: Initial and conclusion blood draws include; comprehensive metabolic profile, CBC and platelet,hormonal assessment and lipids. intervention 7: transabdominal transducer, which contains integrated software for volume calculation will be used to assess ovarian volume. Performed twice during study, at baseline and conclusion intervention 8: Dual-energy x-ray absorptiometry (DEXA) will be used to assess percent body fat Performed twice during study, at baseline and conclusion intervention 9: placebo capsules, two capsules BID

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 scan) intervention 9: placebo

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: vital signs were recorded; a physical examination, urinalysis, urine drug screen, and urine pregnancy test were performed; a complete blood cell count (CBC) with differential and indices, reticulocyte count, coagulation markers, and blood chemistry assessments were performed and medical and medication history was collected. Eligible subjects were scheduled for a 6-hour pre-dose electrocardiogram (ECG) and vital sign assessment with measurements taken at approx. the same times as Day 1 (dosing day). On Day 0, subjects were admitted to the clinical pharmacology unit to begin the inpatient phase of the study. Subjects had a brief physical examination and all procedures for the inpatient stay were reviewed. On Day 1, pre-dose vital signs and ECG were performed. Subjects then received study drug or placebo by IV bolus infusion. Subjects were closely monitored by evaluating hemodynamic measurements, periodic ECGs, and assessment of spontaneously reported AEs. Blood was drawn for blood count and chemistry analysis 6h and 24h after each dose. PK blood samples were drawn pre-dose and approx. 5min, 20min, 40min, 1h, 2h, 4h, 6h, and 24h after each dose. On Days 2 and 3 subjects received their second and third doses, respectively, of study drug or placebo with the same monitoring and laboratory measurements as for the first dose. Subjects were discharged 24 hours after the 3rd dose of drug or placebo and were followed as outpatients on Days 7, 10, and 15.

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) to atropine treatment with and without a plano lens.

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 improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs. Little is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense. In a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye. The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.

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

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 improvement in vision of the amblyopic eye with each treatment. * To determine whether amblyopia is associated with structural abnormalities of optic nerve fiber layer.

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 years to be the upper age limit for successful treatment. The American Academy of Ophthalmology Preferred Practice Pattern for amblyopia recommends treatment up to age 10 years. The opinion that amblyopia treatment is ineffective in older children may have arisen because the age of 6 to 7 years is thought to be the end of the "critical period" for visual development in humans. This belief, however, was not based on adequate prospectively-collected data. To address this issue of the response of amblyopia to treatment in children 7 years and older, the Pediatric Eye Disease Investigator Group (PEDIG) conducted a randomized trial of 507 patients (aged 7 to \<18 years) with amblyopic eye visual acuity ranging from 20/40 to 20/400. Patients were provided with optimal optical correction and then randomized to a Treatment Group (2 to 6 hours per day of prescribed patching of the sound eye combined with near visual activities for all patients plus atropine one drop per day in the sound eye for 7 to \<13 year olds) or an Optical Correction Group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (2 lines) by 24 weeks were considered responders. In the 7 to \<13 year olds (N=404), 53% of the Treatment Group were responders compared with 25% of the Optical Correction Group (P\<0.001). In the 13 to \<18 year olds (N=103), the responder rates were 25% and 23% respectively overall (adjusted P=0.22), but 47% and 20% respectively among patients not previously treated with patching and/or atropine for amblyopia (adjusted P=0.03). Most patients, including responders, were left with a residual visual acuity deficit. The use of multiple modalities (patching, atropine, near visual activities) in the treatment regimen for the 7 to \<13 year olds in this trial (ATS3) was an effort to maximize the therapeutic response. Patients age 13 years and older were prescribed patching but not atropine because of concern that the continual optical blur from the atropine could have a deleterious effect on their ability to drive and perform other activities. Prescribed patching was 2 to 6 hours a day to limit patch wear to non-school hours and because our prior studies of 3 to \<7 year olds demonstrated that as little as two hours of patching a day (when combined with near visual activities) is as effective as a greater number of hours. Instructing patients to perform at least one hour of near activities while wearing the patch was based on the unproven clinical opinion that near activities can augment the effect of the occlusion therapy. A PEDIG pilot study suggested that near activities are beneficial and this question of benefit of near activities is currently being studied in another randomized clinical trial. Atropine placed in the sound eye once a day and two days a week has been demonstrated in younger children to be beneficial to the acuity of the amblyopic eye, presumably due to its cycloplegic effect of blurring vision in the sound eye especially at near fixation. In a study comparing daily and weekend atropine, daily atropine was not found to be superior. The unanswered question from this completed clinical trial is whether prescribing patching or atropine alone could have produced a response similar to the combination therapy, or whether in this age group, one treatment is better than the other. A poll of PEDIG investigators at an investigator meeting on January 15, 2005 indicated that very few are following the treatment regimen used in the prior study (ATS3); rather, most are prescribing monotherapy-either patching or atropine-as the initial treatment for amblyopia in the 7 to \<13 year age range. Thus, a trial comparing atropine and patching as amblyopia treatments in 7 to \<13 year olds is needed. The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes are: 1) Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day without the aid of reading glasses (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters) and 2) 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 by at least 5 letters). Optional Ancillary Study As part of the optic nerve imaging ancillary study, retinal nerve fiber layer imaging using optical coherence tomography will be performed on some patients. This will be optional for patients at participating sites. The procedure is not part of standard care. The subject's pupils will need to be dilated, if not already dilated as part of the exam. Testing of both eyes can be completed in about 15 minutes.

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 least one hour every day (with increase to daily atropine at 5 weeks if acuity not improved by at least 5 letters)

[ 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

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 ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly.

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 ischemic attacks. However, the consequences of epilepsy in the elderly can be severe leading to impaired cognition, increased falls, and a decreased quality of life. The treatment of epilepsy may be complicated by pharmacokinetic and pharmacodynamic changes occurring in the elderly. Three Veterans Cooperative trials evaluating antiepileptic drug (AED) therapy in the elderly demonstrated that the ability to tolerate the AED is a more determining factor for long term success than the ability to suppress seizure activity. In general, elderly patients appear more intolerable to medications. This may stem from co-morbid conditions, concurrent medications, pharmacokinetic changes, and/or pharmacodynamic changes. Therefore, it is important to study the efficacy and tolerability of AEDs in the elderly. Valproic acid has been available for the treatment of partial and generalized seizures since 1978. Sodium divalproex is metabolized in the gut to valproic acid. Depakote and Depakote-ER (extended release)are among the dosage forms of sodium divalproex. Depakote is an enteric coated tablet that is designed to dissolve in the more alkaline milieu of the small intestine rather than the more acidic milieu of the stomach. This helps the drug to bypass the stomach and reduces gastrointestinal distress. Once the enteric coating dissolves, the sodium divalproex is metabolized to valproic acid and rapidly absorbed. Depakote is administered twice a day. Depakote-ER is a controlled release drug delivery system designed to release drug over a 22 hour period which allows for once a day dosing. The efficacy and tolerability of Depakote-ER has not been described in elderly patients with epilepsy.

Elderly Epilepsy Seizures

Treatment Efficacy pharmacokinetics

null

0

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 daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

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

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, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.

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 for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.

null

Peripheral T-Cell Lymphoma

null

0

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 intervention 2: 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

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-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 cerebrospinal fluid) use in people with chronic pain. Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain. Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain. After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes. Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.

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 cerebrospinal fluid) use in people with chronic pain. intervention 2: Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain. intervention 3: inactive substance intervention 4: inactive substance

intervention 1: clonidine intervention 2: adenosine intervention 3: placebo intervention 4: placebo

2

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 device home-monitored cardiopulmonary evaluations, and rhinitis evaluations and questionnaires. Approximately 30 subjects 18 to 60 years of age with symptomatic PAR (with or without SAR) will be selected and randomized at one study site. The anticipated duration of subject participation in the study is approximately 39 days. Subjects who qualify at the Screening Visit will complete a 10-14 day run-in/screening period. Following the run-in period, subjects who meet the qualifications at the Baseline Visit will be treated with study medication for 4 weeks.

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 substance 30 mg twice a day administered once in the morning and once in the evening.

[ 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 evening. intervention 4: Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin intervention 3: Placebo: tablet of Rivaroxaban intervention 4: Placebo: syringes of Enoxaparin

124

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 taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening. arm 3: The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 2 mg perampanel intervention 2: 4 mg perampanel intervention 3: placebo comparator

114

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 tablets for 12 weeks (after 2 week Up-Titration Period)

[ 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 Administration: Oral use intervention 4: * Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use

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 Montreal | Quebec | Canada | -73.58781 | 45.50884 Québec | Quebec | Canada | -71.21454 | 46.81228 Helsinki | N/A | Finland | 24.93545 | 60.16952 Bron | N/A | France | 4.91303 | 45.73865 Lille | N/A | France | 3.05858 | 50.63297 Paris | N/A | France | 2.3488 | 48.85341 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Belgrade | N/A | Serbia | 20.46513 | 44.80401 Manouba | N/A | Tunisia | 10.09557 | 36.81006

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 study will consist of a screening visit followed by a washout period for all disease modifying antirheumatic drugs (DMARDs) and anti-cytokine therapies except MTX. After the washout period, patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits and a follow-up visit 4 weeks after the last treatment visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

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 anti-cytokine therapies except MTX. The washout period will be 4 weeks for sulfasalazine, hydroxychloroquine, azathioprine, D-penicillamine, etanercept, and anakinra, 8 weeks for gold, infliximab, and adalimumab, and 12 weeks for abatacept. After the washout period, the patients determined to be eligible will be randomized to receive either 25 mg BID or 100 mg BID of oral PG-760564, or placebo for 12 weeks. There will be 6 treatment visits (Weeks 1, 2, 4, 6, 8, and 12) and a follow-up visit 4 weeks after the last treatment visit (Week 16). Patients will not initiate new therapies until after the 4-week follow-up is completed. Liver function tests will be evaluated at every visit. The primary efficacy endpoint will be the proportion of patients meeting the ACR 20 response criteria after 12 weeks of treatment.

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

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, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve health related quality of life (HRQOL). Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump. Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.

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 had a rejection in the last 30 days.

[ 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 is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

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 open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).

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 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 3: Mometasone Furoate 400 mcg 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

[ 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

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 study, month 27.

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 of the additional exclusion criteria were randomized in a 1:1 ratio to either receive an additional 28 days of treatment with tobramycin 300 mg twice a day (56-day group) or to stop study medication (28-day group). All randomized patients had regular study visits until a positive P. aeruginosa sample was obtained. Once P. aeruginosa had recurred, the patient entered a follow-up phase where minimal information was collected for 27 months. During the follow-up phase, patients were treated according to their physicians' discretion. Patients who started treatment with tobramycin but were not randomized (i.e. due to a positive antibody test) and followed up during routine clinic visits. They were allowed to continue their 28-day treatment period and afterwards be treated according to their physicians' discretion.

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 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.

[ 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 the addition of plerixafor to a granulocyte-colony stimulating factor (G-CSF) mobilization regimen on each day prior to apheresis. The purpose of this protocol is to determine the proportion of participants who reach a target number of CD34+ stem cells (≥5\*10\^6 cells/kg) after hematopoietic stem cell mobilization with G-CSF and plerixafor. Safety and PK parameters are also collected.

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 the day prior to apheresis and the collection of blood samples for pharmacokinetic (PK) analysis and pharmacodynamics (PD) analysis by CD34+ fluorescence-activated cell sorting (FACS) analysis. Blood samples for PK and CD34+ FACS analyses will be obtained prior to and after the first dose of plerixafor. Participants will undergo mobilization with G-CSF (10 µg/kg daily) and will receive plerixafor (240 µg/kg) on each day prior to apheresis. Participants will be apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5\*10\^6 cells/kg). After apheresis, all participants will be treated with high dose chemotherapy in preparation for transplantation. Participants will be transplanted with cells obtained from the G-CSF plus plerixafor mobilization regimen. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the investigator's discretion. The primary endpoint is the proportion of HD participants who collect ≥5\*10\^6 CD34+ cells/kg with this mobilization regimen. The secondary endpoints include the safety of this mobilization regimen, the proportion of participants who collect ≥2\*10\^6 CD34+ cells/kg, the change in CD34+ cells circulating in the peripheral blood after a dose of plerixafor, and the number of days of apheresis required to obtain ≥5\*10\^6 CD34+ cells/kg. In addition, success of the transplantation will be evaluated by measuring the time to engraftment of PMNs and PLTs. Participants will be followed for 12 months to assess transplant durability. This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

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 received a morning dose of G-CSF 10 µg/kg and underwent apheresis approximately 10 to 11 hours after the dose of plerixafor (within 60 minutes after administration of G-CSF). Participants continued to receive an evening dose of plerixafor followed the next day by a morning dose of G-CSF and apheresis for up to a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

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 ie RO4607381 (900mg po) or placebo daily, with concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6 months post study NC19453, and the target sample size is approximately 100 individuals.

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

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 surgical replacement of the joint and can be disabling for life. Avascular necrosis is presently not preventable but research has shown that lipid lowering drugs such as lipitor can reduce or prevent avascular necrosis in animals. We therefore hypothesize that lipitor will reduce the incidence of avascular necrosis in lupus patients taking high dose steroids.

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 lipitor but do not contain any medication (called placebo). During the time of the study, you will not know if you are taking lipitor or the placebo. The period of time that you will receive lipitor or placebo is 9 months and you must be willing to return for 5 follow up visits during this time which include blood tests, physical exams and 3 MRI studies of the hips, knees and ankles.

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 delayed MTX clearance. 3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. Secondary Objectives: 1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics. 2. To evaluate the effect of Glucarpidase on the length of hospitalization. 3. To evaluate the effect of Glucarpidase on renal function. 4. To evaluate the effect of Glucarpidase on Quality of Life (QOL). 5. To evaluate the anti-glucarpidase antibody response. 6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.

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 high-dose chemotherapy drug that reduces the supply of an important vitamin (folate) required for the growth of cancer cells. In patients with delayed clearance of MTX from the body, there is a risk of more frequent or severe side effects from the drug. Glucarpidase is a drug that breaks down MTX in the blood, causing the drug to be less toxic and decreasing levels of the drug in the blood. Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Your complete medical history will be recorded. You will have a physical exam, including measurement of your vital signs (temperature, pulse, breathing rate, and blood pressure). You will have blood drawn (about 3 teaspoons) for routine tests. You will also have blood drawn (about 1 teaspoon), right before treatment starts, 28 days after the first dose of study drug in each cycle, and at the end of the study to see if you have any antibodies (proteins in the body that help fight infections and foreign substances in the body) to the study drug. Women who are able to have children must have a negative blood pregnancy test. The blood used for the pregnancy test will come from the sample taken for routine tests. (There is no additional blood draw for the pregnancy test). You may be given either glucarpidase or placebo (a drug that looks like glucarpidase but is not active). Neither you nor the study doctor will know if you have been given glucarpidase or placebo. This is called the blinded phase of this study. Before you can begin on this study, if you are already suffering from side effects (because of difficulty with MTX clearance), such as kidney toxicity, severe mucositis (redness and painful ulcers in the mouth), and/or you have extremely high MTX levels, you will not be randomized and will receive glucarpidase, not placebo. If this is the case, your doctor will know that you have been given glucarpidase. If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 treatment groups, which will be based on the dose of MTX you received. You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive glucarpidase. Participants in the other group will receive placebo. There is a higher chance that you may receive glucarpidase than placebo because for every patient that receives placebo, 2 patients will receive glucarpidase. The glucarpidase or placebo dose that you may receive will be given by vein within 12 hours after you have been found eligible to participate in this study. Glucarpidase or placebo will be given during the first study cycle (after MTX treatment is completed, if after 72 hours your MTX levels are found to be high). You may receive additional doses of glucarpidase (depending upon the level of MTX in your blood) up to a maximum of 2 doses. If this is the case, the second dose will be given at least 24 hours after the first dose you received. Regardless of the treatment group that you are assigned to, you will continue to receive standard treatment (fluids by vein with sodium acetate or sodium bicarbonate and leucovorin) for high MTX levels. In future cycles of MTX, you may receive glucarpidase, if you continue to experience a delay of MTX clearing from your body. The glucarpidase dose may be repeated a maximum of 2 times in a given cycle of chemotherapy. The length of a cycle of chemotherapy will vary, depending on the dose of MTX and the regimen the patient is receiving. One cycle of treatment with glucarpidase is at least 24 hours apart. You will be asked to fill out several questionnaires regarding your quality of life. These questionnaires will ask about your level of pain, fatigue, nausea, sleep disturbances, etc. They will be given during the first study cycle only (before the study drug is given and daily during the first study cycle). They will take about 5 minutes to complete each time. You will also have blood drawn (about 3 teaspoons each), at different times, so that study doctors can monitor your kidney function and liver function, depending on your clinical condition. These blood samples will be drawn at least twice a week while you are on this study. You will again have blood drawn for the presence of antibodies 14 days after treatment with glucarpidase, before every cycle of MTX treatment, and at the end of this study. You will be taken off this study if your disease gets worse, you experience intolerable side effects, or you completed planned therapy (a maximum of 6 cycles of study drug). At the end of this study, your complete medical history will again be recorded. You will have a physical exam, including measurement of your vital signs. You will also have blood drawn (about 1 teaspoon) for routine tests. This is an investigational study. Glucarpidase is not FDA approved or commercially available. The M. D. Anderson Institutional Review Board (IRB) has authorized the use of glucarpidase for research only. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. Glucarpidase and placebo will be provided free of charge during this study. Up to 46 patients will take part in this study. All patients will be enrolled at M. D. Anderson.

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 (FGFR3), which is not normally expressed in plasma cells, is aberrantly expressed in 15 % of multiple myeloma patients. Its expression results from the translocation t4;14.14 Dasatinib weakly inhibits FGFR3.13 Another target for inhibition in multiple myeloma is the epidermal growth factor receptor family, particularly ErbB4. In vitro, ErbB4 was expressed in 4 of 9 myeloma cell lines, and a panErbB inhibitor induces apoptosis in myeloma cell lines.15 Dasatinib has been shown to have moderate affinity for ErbB4.13 Members of the src family of protein-tyrosine kinases are also potential targets for therapy in multiple myeloma. Hematopoietic cell kinase (Hck) is a src family member whose expression is restricted to hematopoietic cells of the myeloid and B-lymphoid lineages. Hck mediates IL-6 induced proliferative signals, which are potent growth and survival factors in multiple myeloma.16 Lyn and Fyn are two additional src family protein-tyrosine kinases that may serve as targets for therapy in myeloma. Lyn is strongly expressed in myeloma cell lines, while Fyn expression is variable. Activation of Lyn and Fyn appears requisite to IL-6-induced proliferation.17 Selective inhibition of Lyn in vitro suppresses IL-6 induced proliferation.18 Dasatinib has high affinity for both Fyn and Lyn, and inhibition may reduce IL-6 induced proliferation.13 The receptor tyrosine kinase c-kit is overexpressed in one-third of cases of multiple myeloma. 19 Inhibition of c-kit with imatinib results in inhibition of proliferation in vitro.20 Unfortunately, in a phase II clinical study of imatinib in relapsed/refractory myeloma, there were no responses.21 However, dasatinib binds c-kit with greater avidity than does imatinib.13 Myeloma cells are heterogeneous in their biological characteristics, such as their proliferative response to IL-6, as well as their immunophenotypes, including CD45 expression. The promiscuous nature of kinase inhibition by dasatinib may tolerate small changes in the kinase and remain able to inhibit mutant kinases. In addition to potential antimyeloma effects of dasatinib, there are potentially additional benefits. Src plays an essential role in osteoclast function and bone resorption.22 As a Src inhibitor, dasatinib inhibits bone resorption in vitro. 11 Src inhibition by dasatinib in patients with multiple myeloma could produce beneficial effects on bone density. We propose a single-arm, phase II, open-label study of dasatinib in patients with relapsed or plateau-phase multiple myeloma.

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 patients with multiple myeloma. Multiple Myeloma is the second most common cancer of the blood. Bortezomib is the first approved cancer treatment in a new class of medicines called proteasome inhibitors. It disrupts the cell cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells. The treatment will be used as second line treatment, which means either the disease has returned after a period of improvement (relapse) or the disease did not respond to the initial treatment (refractory). Patients will receive either bortezomib (PS341), doxorubicin (Adriamycin) and dexamethasone (PAD) or the VAD standard therapy.

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 relapsed multiple myeloma, its efficacy is increased with the addition of dexamethasone and it demonstrates synergy with doxorubicin. The VAD combination has been widely used in multiple myeloma and has demonstrated to be effective in relapsed patients. Based on previous trial results, it is hoped that bortezomib, in replacing vincristine in the VAD standard therapy, can improve the response to treatment of patients with multiple myeloma, with manageable side effects. This is an international, multicentre, randomised, open-label, parallel group study. About 212 patients will take part in the study. Patients will be treated with either bortezomib (PS-341), Adriamycin and Dexamethasone (PAD) or Vincristine, Adriamycin and Dexamethasone (VAD). There will be an initial 14 day screening period to evaluate if the patient is suitable for the study. After screening, eligible patients will be randomised to receive either PAD or VAD. Patients will receive therapy for up to 8 treatment cycles of 28 days each. After the treatment period, there will be a long-term follow-up period with monthly visits until disease progression or relapse. Thereafter follow-up will be continued by at least a phone call every other month. This long-term follow-up period will be performed for all patients until the last patient was treated and followed up for 1 year. Response to treatment will be assessed according to the European group for blood and marrow transplant criteria (EBMT). Disease burden will be monitored by measuring M-protein concentration in serum and in urine every 4 weeks until disease progression or relapse. Thereafter follow-up for survival will be continued every other month by at least a phone call. Safety will be assessed by monitoring of adverse events (AEs), vital signs, physical examination and clinical laboratory tests. Treatment with PAD or VAD will be for up to 8 cycles of 28 days each. Treatment beyond 6 cycles will be discussed on individual basis. Proposed dosages are: bortezomib 1.3 mg/m² intravenous (IV) bolus on Days 1, 4, 8, and 11; vincristine 0.4mg IV push on Days 1 to 4; doxorubicin 9mg/m² IV push on Days 1 to 4; dexamethasone in 1st cycle 40 mg daily on Days 1 to 4, 9 to 12 and 17 to 20, orally (or equivalent parenteral dose) and on subsequent cycles as 40 mg daily on Days 1 to 4 and 17 to 20 only.

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 to 4

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 Bialystok | N/A | Poland | 23.16433 | 53.13333 Gdansk | N/A | Poland | 18.64912 | 54.35227 Poznan | N/A | Poland | 16.92993 | 52.40692 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Samara | N/A | Russia | 50.15 | 53.20007 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Eskişehir | N/A | Turkey (Türkiye) | 30.52056 | 39.77667

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 ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily

[ 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

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 randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

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). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so. arm 2: Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.

[ 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

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 440 pts and dose with either 20, 100, 160 mg BID AGN 203818 or placebo over 12 week treatment duration.

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 supplementation and risk of infection.

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 remains unknown. Furthermore, several retrospective studies have found an association between iron overload and infection. However, the relative risk/benefit profile of enteral iron supplementation with respect to infection has not been studied. The purpose of this study is to evaluate the efficacy of enteral iron supplementation in critically ill patients. The hypothesis is that enteral iron supplementation will result in both an improved hematocrit and a decreased need for blood transfusion, without increasing the risk of infection.

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 breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

null

Pulmonary Disease, Chronic Obstructive Asthma

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: BI 1744CL

42

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 sequential design. The trial will last a total of 17 weeks. There will be a 2 week period to wean off current medication, followed by a 4 week period where the patient will receive placebo (inactive drug) or gradually increasing doses of LCM up to the target dose of 400mg/day. The target dose or placebo will be maintained for 8 weeks followed by a 1 week reduction period then a 2 week safety follow up period. The last subject is expected to be enrolled in December 2007. The study was terminated based on the outcome of the planned first interim analysis, which was performed as defined in the protocol in a subset of patients. It was decided not to continue the trial. No safety concerns were identified.

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 | 51.60698 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Esztegom | N/A | Hungary | N/A | N/A Győr | N/A | Hungary | 17.63512 | 47.68333 Gyula | N/A | Hungary | 21.28333 | 46.65 Verseghy | N/A | Hungary | N/A | N/A Veszprém | N/A | Hungary | 17.91149 | 47.09327 Bialystok | N/A | Poland | 23.16433 | 53.13333 Krakow | N/A | Poland | 19.93658 | 50.06143 Torun | N/A | Poland | 18.59814 | 53.01375 Warsaw | N/A | Poland | 21.01178 | 52.22977 Brăila | N/A | Romania | 27.97429 | 45.27152 Lasi | N/A | Romania | N/A | N/A Târgovişte | N/A | Romania | 25.4567 | 44.92543 Timișoara | N/A | Romania | 21.22571 | 45.75372 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Morriston | N/A | United Kingdom | -3.92941 | 51.66995 Newcastle | N/A | United Kingdom | -5.88979 | 54.21804 Oxford | N/A | United Kingdom | -1.25596 | 51.75222 Stanmore | N/A | United Kingdom | -0.31667 | 51.61667

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 daily (OD) for 7 days

[ 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 Comiso | Ragusa | Italy | 14.60731 | 36.94893 Bari | N/A | Italy | 16.86982 | 41.12066 Benevento | N/A | Italy | 14.77816 | 41.1307 Bergamo | N/A | Italy | 9.66721 | 45.69601 Bologna | N/A | Italy | 11.33875 | 44.49381 Bolzano | N/A | Italy | 11.33982 | 46.49067 Caserta | N/A | Italy | 14.33231 | 41.07262 Catania | N/A | Italy | 15.07041 | 37.49223 Catania | N/A | Italy | 15.07041 | 37.49223 Florence | N/A | Italy | 11.24626 | 43.77925 Foggia | N/A | Italy | 15.55188 | 41.45845 Lecce | N/A | Italy | 18.17244 | 40.35481 Lecco | N/A | Italy | 9.39704 | 45.85589 Matera | N/A | Italy | 16.60463 | 40.66599 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Novara | N/A | Italy | 8.62118 | 45.44694 Pavia | N/A | Italy | 9.15917 | 45.19205 Perugia | N/A | Italy | 12.38878 | 43.1122 Pisa | N/A | Italy | 10.4036 | 43.70853 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Siena | N/A | Italy | 11.33064 | 43.31822 Torino | N/A | Italy | 11.99138 | 44.88856 Torino | N/A | Italy | 11.99138 | 44.88856 Treviso | N/A | Italy | 12.2416 | 45.66673 Udine | N/A | Italy | 13.23715 | 46.0693

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

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 from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day cycles.

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 menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.

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 patients with hypertension and echocardiographic evidence of diastolic dysfunction.

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 approximately 30-32 patients. Study Hypothesis: The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal. Comparison(s): PRIMARY ENDPOINT: Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale). SECONDARY ENDPOINT (S): 1. Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale. 2. Participating doctors assessment of tolerance.

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 study based on the enrollment of 2 subjects in September of 2007. The study is being discontinued for administrative reasons. Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved, but undergoing regulatory review for treatment of skin infections. This is a randomized (patients are assigned to receive the different treatments under study based on chance), double-blind (neither the patient nor the physician knows whether the drug being investigated or the comparator agent is being taken), multicenter study of treatment with ceftobiprole medocaril versus treatment with a comparator in patients 18 years of age or older, who have fever and neutropenia after chemotherapy for cancer that requires intravenous therapy. Patients will be randomly assigned to receive either ceftobiprole medocaril or comparator. In addition, patients in the comparator group who are at risk of serious infections due to gram-positive pathogens (disease-causing bacteria) may also receive an antibiotic with MRSA activity. The study will consist of the following 3 phases: a prerandomization phase (includes screening and baseline assessments); a treatment phase, and a follow-up phase consisting of a primary efficacy visit and a late follow-up visit. The primary endpoint is the clinical cure rate. The total duration of of the study is determined by the time to resolution of fever and neutropenia and the conditions associated with the episode of fever and neutropenia. This is followed by the primary efficacy visit (7 to 10 days after the end of therapy) and the late follow-up visit (28 to 35 days after the end of treatment). Cultures (samples of blood or other suspected sites of infection) will be collected during the study as well as blood samples for hematology and chemistry (safety assessments). All adverse events will also be reported throughout the study and for about 4 to 5 weeks after the last dose of study drug. Patients will be randomized to either ceftobiprole or comparator for approximately 7 to 14 days.

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 are nasal carriers of S. aureus will be enrolled and stratified in a 2:1 ratio so that at least 38 persistent carriers and 19 intermittent carriers complete the study. Each eligible subject will participate in three screening visits, a treatment period, and two follow-up visits. Each subject's participation in the study will be approximately 6 to 10 weeks from screening to the last follow-up visit. Subjects will participate in up to three screening visits to determine S. aureus culture positivity and colonization status.

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

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-relationship program (PRP). Participants will be randomized either to receive BMF or no BMF; both groups will be supported by PRP. The anticipated time on study treatment is 3-12 months.

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 physicians to allow offering the bone marker result in an easy way. Participants will be informed if their results are within or outside of the desired range. In addition, participants will also supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake. arm 2: Postmenopausal women will receive ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants will be supported by PRP, to be carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.

[ 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 Szeged | N/A | Hungary | 20.14824 | 46.253 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Szombathely | N/A | Hungary | 16.62155 | 47.23088 Liepāja | N/A | Latvia | 21.01085 | 56.50474 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Gliwice | N/A | Poland | 18.67658 | 50.29761 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Wroclaw | N/A | Poland | 17.03333 | 51.1 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Constanța | N/A | Romania | 28.63432 | 44.18073 Craiova | N/A | Romania | 23.8 | 44.31667 Timișoara | N/A | Romania | 21.22571 | 45.75372 Irkutsk | N/A | Russia | 104.29585 | 52.29795 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Voronezh | N/A | Russia | 39.1843 | 51.67204 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Yekaterinburg | N/A | Russia | 60.6122 | 56.8519 Banská Bystrica | N/A | Slovakia | 19.15349 | 48.73946 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Ľubochňa | N/A | Slovakia | 19.16891 | 49.12011 Piešťany | N/A | Slovakia | 17.82591 | 48.59479 Prešov | N/A | Slovakia | 21.23393 | 48.99839 Ljubljana | N/A | Slovenia | 14.50513 | 46.05108

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 schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.

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 enhance this process. Also, cardiovascular disease (CVD) occurs more frequently in postmenopausal women than in premenopausal women. This study will determine in postmenopausal women whether estrogen increases the heart's ability to use fats as energy and whether progesterone decreases this effect.

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 these hormones in menopause leads to significant changes in the body. Along with such changes, postmenopausal women are at a higher risk than premenopausal women for certain health problems, such as CVD. Previous studies have revealed that alterations in the breakdown of fatty acids in cardiac muscle play a key role in a variety of cardiac disorders. In studies involving human skeletal muscle, estrogen has been shown to increase the breakdown of fatty acids, while progesterone lessens this effect. This study will determine in postmenopausal women whether estrogen increases the heart's ability to break down fats for energy use and whether progesterone decreases this effect. This study will also analyze ovariectomized mice to determine if the candidate specific estrogen receptor modulators (SERMs) raloxifene and tamoxifen increase the heart's ability to use fats as energy and whether the increase is similar to that seen with estrogen. Study investigators will also create estrogen receptor knock-out mice (mice with estrogen receptors removed) to further explore the roles of estrogen and SERMs in heart metabolism. Participation in this double-blind study will last up to 1 month and will include three study visits. During Visit 1, participants will undergo three standard clinical evaluations. The first evaluation, a medical screening, will include a medical history exam and blood tests to measure estrogen and progesterone levels, liver and kidney function, cholesterol levels, and blood sugar and insulin levels. For the second evaluation, participants will undergo a body composition study to measure total body fat and muscle content using a dual-energy x-ray absorptiometry (DEXA) scan. During the third evaluation, participants will undergo an electrocardiogram (ECG) and an echocardiogram (ECHO), each performed immediately before and after walking on a treadmill. The ECG will measure electrical activity of the heart, and the ECHO will involve imaging the heart with an ultrasound. Visits 2 and 3, occurring 3 days apart, will each include two imaging tests of the heart: a positron-emission tomographic (PET) scan and a resting ECHO. Throughout both tests an ECG and blood pressure cuff will be used to monitor heart rhythm and blood pressure, respectively. During the PET scan, participants will lie flat in an imaging machine for three 45- to 60- minute intervals. Blood will be drawn and radioactive tracers will be injected via intravenous lines placed in the arms. The ECHO test will also be done during the PET scan. Between Visits 2 and 3, participants will be randomly assigned to one of two hormone replacement therapy (HRT) regimens: estrogen plus placebo or estrogen plus progesterone. All participants will wear a patch containing estrogen and take a pill of either placebo or progesterone for the 3 days leading up to Visit 3. All participants will be asked for permission to store a sample of their blood for up to 10 years to be used in future research studies.

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 plus progesterone: estradiol with oral progesterone (Prometrium, 200 mg/day) for 3 days, instead of placebo. Progesterone therapy involves taking a daily oral pill of 200 mg Prometrium for the same 3 days that the estradiol is taken. intervention 3: Placebo progesterone therapy involves taking a daily placebo pill for the same 3 days that the estradiol is taken.

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 still occurs in 10% of such patients. The use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. We observed no thromboembolic episodes when Velcade was added to thalidomide and adriamycin containing chemotherapy. Therefore, we would like to investigate this protective antithrombotic effect of VELCADE in a malignancy associated with a hypercoagulable state in a group of 10 patients with Relapsed/Refractory Multiple Myeloma.

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, and 11 This 21-day period will be considered one treatment cycle; Cycle 2 would commence on Day 22 (Cycle 2, Day 1). Patients may continue to receive treatment every 21 days, provided there is no evidence of disease progression or no unacceptable toxicity for a two cycles.

[ 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 all the procedures necessary to start a study, including an informed consent, before the patient is transferred by helicopter to Iowa City. 2)To test a low risk medication called, Ranitidine, that might lower the chances of developing chemical pneumonitis (irritation of the lungs by stomach contents), a fairly common complication in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 milligrams (mg)) or placebo (normal saline).

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 efficacy of a low risk medication called, Ranitidine, to help lower the chances of developing chemical pneumonitis in patients that have had a stroke. Patients will be randomly assigned to receive a single dose injection of either Ranitidine (50 mg) or placebo (normal saline). Independently of the study injection, the patient will continue to receive the usual standard medical care for their stroke. The patient will be cared for by a team of doctors in the stroke service. Some of these doctors and nurses are investigators for this study and will assess the patient's neurological status to see how much the stroke has affected the patient. They will also determine by the patient's symptoms and the results of a chest x-ray (if that test becomes necessary due to fever) whether the patient has developed chemical pneumonitis They will also administer a questionnaire to the patient or their relative prior to discharge about their thoughts on doing clinical studies while being transported by the helicopter and to collect any thoughts they may have had about improving this process. Completing the questionnaire is voluntary, and the patient is free to skip any question that they would prefer to not answer. Three months after the patient has had the stroke, they or their relative will be contacted by phone to determine the patient's long-term outcome after their stroke. After the follow-up telephone conversation the participation in the study will end.

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 for the treatment of acute pain. The other drugs being tested in this study are pregabalin and naproxen sodium. These drugs are approved for use by the Food and Drug Administration (FDA). This study is designed to test whether these two drugs are effective in treating pain after a bunionectomy.

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. intervention 2: Patients will be randomized just prior to surgery to 1 of 3 study treatments: naproxen sodium (550 mg) treatment will be administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium will be dosed starting 12 hours following T=0 and every 12 hours until 36 hours following T=0. intervention 3: Patients will be randomized just prior to surgery to 1 of 3 study treatments: placebo treatment will be administered approximately 1 hour prior to surgery. Postoperatively, placebo will be dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.

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 symptoms caused by the cancer. Pemetrexed has been approved by the Food and Drug Administration (FDA) to treat Lung Cancer. Oxaliplatin has been approved by the FDA for the treatment of Colon Cancer. The combination of these two drugs has been used to treat patients with Non-Small Cell Lung Cancer in Italy but not yet in the USA Other purposes of this study are: * To better detail the toxic effects of this chemotherapy combination. * To determine whether the level of specific gene and/or gene products (genes are genetic material that allows cells to make proteins such as enzymes) are useful to predict if this chemotherapy combination will work or not.

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 and proteomic) are included in this protocol. Prior to chemotherapy, all patients will undergo a biopsy of the safest and/or most accessible site of tumor in order to obtain tissue for mRNA measurements. Additionally, patients will undergo blood sampling prior to the start of chemotherapy and after 2 and 4 cycles of therapy in order to obtain plasma for the mass spectrometry analysis. Patients, whose second and/or third specimen cannot be collected for any reason, will remain in the trial, and treatment will continue as outlined in the protocol. Expected Number of Patients: The number of patients was calculated according to the procedure described in the Sample Size Calculation section of the protocol. It is estimated that up to 50 patients will be enrolled to obtain the 43 evaluable patients needed to meet the statistical design of the study. Method of Treatment Allocation: A patient number will be assigned sequentially to each patient upon registration. The patient number and the patient initials are to be entered on each page of the Case Report Form. Duration of Study for Each Patient: All patients will be treated with up to 6 cycles of chemotherapy. However, at the discretion of the treating physician and principle investigator, patients may continue chemotherapy, beyond 6 cycles, until disease progression, intolerable toxicity, or the development of any study removal criteria. Patients will undergo an evaluation for extent of disease after every other treatment cycle. Patients will be considered to be on-study for the duration of their treatment and during the 30 days following treatment discontinuation. Treatment discontinuation is defined as the last day of study treatment. All included patients will be followed up until recovery or stabilization of all adverse events or return to baseline condition. Patients who discontinue from the trial prior to experiencing disease progression will be followed monthly until demonstration of progressive disease. Study Centers: The H. Lee Moffitt Cancer Center will conduct this trial through the Moffitt Clinical Research Affiliate Network. Patients will be evaluated and the biopsy will be performed at the H. Lee Moffitt Cancer Center. Since all the chemotherapeutic drugs used in the protocol are FDA approved, and phase I and II safety data regarding this regimen has been published30,31, the chemotherapy may be administered at the patients' primary (referring) oncologists' office. Documentation of the administration of the chemotherapy will be obtained for record keeping purposes.

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 a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

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 rituximab.

[ 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 will be: Gemzar--\>Novantrone--\>Rituxan.

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 may play a role in the symptomatic expression of OCD, and possibly GAD, agents that reduce glutamatergic neurotransmission should provide unique anti-stress and anti-obsessional benefits. Memantine is a specific, uncompetitive antagonist at the NMDA receptor that blocks sustained activation of the NMDA receptor by high concentrations of glutamate under pathological conditions but rapidly leaves the NMDA channel upon transient physiological activation by low concentrations of glutamate.

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 riluzole to be effective for four of six children with treatment-refractory OCD. N-acetylcysteine, an agent that likely attenuates glutamate neurotransmission, was effective as an augmentation in one patient with OCD. Two case reports described memantine treatment of OCD. Poyurovsky et al. reported improvement with memantine augmentation in one patient with treatment resistant OCD, while Pasquini and Biondi noted improvement in one OCD patient with checking compulsions but not in one with contamination obsessions. There have been no controlled or open-label trials of memantine in OCD reported thus far. Few studies have examined the efficacy of anti-glutamatergic agents in GAD. In an open-label trial of riluzole treatment in 18 patients with GAD, twelve patients responded and eight achieved remission. A double-blind, controlled study found that LY354740, a metabotropic glutamate receptor 2/3 (mGlu2/3) agonist, was significantly more effective than placebo for GAD. No studies of memantine in GAD have been reported thus far. We hypothesized that treatment with memantine would result in significant symptom reduction in both OCD and GAD.

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 widely used to evaluate enamel demineralization and remineralization during the caries process. Determination of fluoride uptake in-situ also provides better estimation of true fluoride bioavailability of fluoride dentifrice products. In this study, an in-situ remineralization fluoride uptake model will be used to compare the efficacy of experimental dentifrice with a marketed dentifrice and placebo dentifrice. Participants wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimens were analyzed for SMH recovery and fluoride uptake through microdrill enamel biopsy technique.

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 with a gel to foam dentifrice, containing as active ingredients: 1450 ppm NaF and 5% KNO3 but no isopentane. arm 3: Participants to brush their teeth for one timed minute twice daily with a dentifrice containing 1450 ppm F as NaF. arm 4: Participants to brush their teeth for one timed minute twice daily with a fluoride free dentifrice (0 ppm F).

[ 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