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

[ 5 ]

128

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

true

0ALL

false

This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.

Skin Irritation

Cetaphil Daily Facial Moisturizer with SPF 50+ Hypoallergenicity Skin Irritation

null

1

arm 1: All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+

[ 0 ]

1

[ 0 ]

intervention 1: All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+

intervention 1: Facial Moisturizer with SPF 50+

1

Colorado Springs | Colorado | United States | -104.82136 | 38.83388

0

NCT01892657

[ 3 ]

11

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the safety and side effects of two experimental vaccines in patients with kidney cancer and determine whether the vaccines "turn on" an immune response to the cancer. Each vaccine contains one of two peptides (pieces of proteins) from the fibroblast growth factor 5 (FGF-5) antigen, a protein produced by some cancer cells, and an oil-based liquid called Incomplete Freud's Adjuvant (Montanide ISA-51) that enhances the immune response to the vaccine. Patients 16 years of age and older who have kidney cancer that has spread beyond the kidney or whose primary kidney tumor has been removed within 6 months before entering the study and are at high risk for disease recurrence may be eligible for this study. Patients must have tissue type human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2) or human leukocyte antigen serotype within HLA-A A serotype group (HLA-A3) (determined by a blood test for human leukocyte antigen (HLA) typing) and their tumors must produce the FGF-5 peptide. Candidates are screened with a physical examination, blood and urine tests, electrocardiogram (EKG), tumor biopsy (removal of a small sample of tumor for examination) in patients whose tumor is easily accessible, and scans (computed tomography (CT), bone scans) and x-rays if current scans are not available. Participants are divided into two groups according to their HLA type (HLA-A2 or HLA-A3) to receive the vaccine appropriate for their HLA type. They are then further divided into three groups: 1) Group 1 includes patients who do not need or are ineligible for treatment with interleukin-2 (IL-2), a protein made by certain infection-fighting white cells that helps fight tumors) and patients who have previously had IL-2 therapy; 2) Group 2 includes patients who require immediate treatment with IL-2; and 3) Group 3 includes patients whose cancer has been surgically removed but who are at risk for recurrence. Patients in Groups 1 and 3 receive two peptide injections four times a week every 3 weeks for up to a year, or until their tumor grows (or returns in patients in Group 3) or the side effects are too severe to continue. Tumors are evaluated with a physical examination and scans or x-rays every 12 weeks and blood tests are done every 3 weeks. Patients in Group 2 receive two peptide injections every day for 4 days, along with doses of IL-2 starting the day after the first peptide injection. The vaccines are given as injections under the skin of the thigh. IL-2 is infused through a vein over 15 minutes every 8 hours for up to 12 doses, depending on tolerance. The vaccine and IL-2 are repeated every 10 to 14 days, with tumor evaluations every 2 months. Patients stay in the hospital about 1 week during each treatment cycle to receive the IL-2. All patients undergo leukapheresis, a procedure for collecting large numbers of white blood cells. Blood is collected through a needle in an arm vein and flows through a cell separator machine, where the white cells are extracted. The rest of the blood is returned to the patient through the same needle or a needle in the other arm. The white cells are examined to evaluate how the vaccines change the action of immune cells. Some patients may undergo an additional biopsy of normal skin and tumor or lymph node to look at the effects of the vaccine on the immune cells in the tumor. Patients in Group 1 whose cancer grows and patients in Group C whose cancer returns may be offered IL-2 treatments as given to Group 2 patients, along with the peptide vaccine. If the disease responds to IL-2, the treatment may be repeated after 2 months.

Background: Several preliminary clinical results in the treatment of cancer lend credence to the hypothesis that augmented T-cell responses will improve IL-2 therapy. A peptide vaccine derived from the melanoma/melanosomal antigen, GP100, when given with high-dose IL-2 resulted in a response rate over 30% in a small Phase II study. These results have led to efforts to identify similar T-cells and tumor-associated antigens for IL-2 responsive tumors such as renal cell cancer. Work in our laboratory generated a renal cancer-reactive T-cell clone, raised from tumor-infiltrating lymphocytes (TIL) within a renal cell cancer (RCC) metastasis undergoing spontaneous regression. This clone was HLA-A3 restricted and recognized autologous tumor as well as a number of allogeneic RCC lines also expressing HLA-A3. Expression cloning of the antigen recognized by this clone demonstrated that the RCC-associated antigen being recognized was unmutated fibroblast growth factor 5 (FGF-5). We concluded from numerous studies that FGF-5 was a tumor associated antigen over-expressed by a majority of RCC and that it had several favorable characteristics as a target for immunotherapy. At this point, having demonstrated in the laboratory that tumor-reactive T-cells generated from patients with renal cancer can recognize naturally presented FGF-5 in either the context of HLA-A2 or HLA-A3 via the minimal determinants 117-126:FGF-5 (MLSVLEIFAV) or FGF-5:172-176/217-220 (NTYASPRFK), respectively. With this study we plan to determine if vaccination with these peptides can enhance the number of FGF-5-reactive cytotoxic T lymphocytes (CTL) precursors in patients with renal cancer or affect the anticipated response rate from high-dose IL-2. Objectives: The primary objective for patients with renal cell carcinoma will be to determine overall response rates and toxicity of peptide vaccination with HLA-A2 and HLA-A3- binding peptides from FGF-5 in HLA-appropriate patients, and to explore the effect of such vaccination on the response rate to high-dose IL-2. The primary objective for patients who are receiving vaccination in the adjuvant setting will be to evaluate the immunologic responses and toxicity of FGF-5 peptide vaccination who are likely to receive repeat vaccination prior to requiring IL-2. The secondary objective is to evaluate the immunologic responses to FGF-5 peptide vaccination. Eligibility: Patients who are HLA-A2+ or HLA-A3+, must be age greater than or equal to 16, and have an expected survival greater than three months. For cohort A and B, patients must have measurable metastatic renal cancer and FGF-5 tumor expression. For cohort C, patients are required to have had a Stage III primary tumor (i.e. T3/T4 or N1/N2) excised within the last 6 months.) Patients in cohorts A and B must have tumor sites safely accessible for biopsy or indications for resection of a site of tumor (e.g. an indicated nephrectomy or symptomatic metastasis) and be willing to undergo biopsy, and have FGF-5 expression determined by reverse transcription polymerase chain reaction (RT-PCR) and will only be eligible if it is detectable. Patients must meet specific safety laboratory criteria. May not have undergone other systemic therapies for their cancer in the past 3 weeks (6 weeks for nitrosureas), not have any major medical illnesses, or require systemic steroid therapy. Design: Patients will first be divided into cohorts with measurable metastatic disease (Cohorts A and B) or high-risk loco-regional disease (Cohort C). Patients with measurable metastatic disease will then be separated into those who require immediate IL-2 therapy (Cohort B) or those who do not (cohort A). Cohort A will begin receiving vaccination with HLA-appropriate peptide emulsified in Montanide ISA-51 or Montanide® (Registered Trademark) ISA 51 VG daily for four days every 3 weeks and will continue this for up to a year, or until tumor progression is documented. At that point, those ineligible for high-dose IL-2 or who have had previous IL-2 as an inpatient (considered high dose at doses greater than or equal to 600,000 IU/kg) will be taken off of study, and those still eligible for IL-2 who have not yet received it, will have high-dose intravenous bolus IL-2 (720,000 IU/kg/dose every 8 hours up to 12 doses) added to their peptide vaccination regimen. Two cycles, separated by 10-14 days, will be given during every two-month period (constitutes a course.). Patients in Cohort A crossing over to vaccination plus IL-2 therapy, will receive peptide in MONTANIDE ISA-51 or Montanide® (Registered Trademark) ISA 51 VG vaccination the day prior to starting an IL-2 cycle (instead of every 3 weeks, to accommodate the IL-2 regimen) and repeated daily for three additional days (for a total of four days) during IL-2 administration. Patients in Cohort B will begin with high-dose bolus IL-2 therapy in two cycles within every two month period, with each cycle preceded by a peptide in MONTANIDE ISA-51 or Montanide® (Registered Trademark) ISA 51 VG vaccine the day prior to starting each IL-2 cycle with peptide in MONTANIDE ISA-51 or Montanide® (Registered Trademark) ISA 51 VG repeated daily for three additional days (for a total of four days) during IL-2 administration. Patients in Cohort C will undergo the same HLA-appropriate vaccination with peptide and MONTANIDE ISA-51 or Montanide® (Registered Trademark) ISA 51 VG daily for four days every 3 weeks and continue for up to 6 months or until disease relapse is documented. At the time of relapse, eligible patients in Cohort C will receive treatment with high-dose bolus IL-2 and continuing peptide vaccination using the same schedule as specified for the Cohort A crossover arm above. For patients in cohort A on peptide vaccine alone, evaluation will be performed every 3 months during the first 6 months of therapy and if stable, every 3-6 months thereafter. For cohorts A and B during peptide vaccine plus high-dose IL-2 therapy, evaluation will be performed every 2 months while on IL-2, and every 3-6 months for stable patients off therapy. For cohort C, evaluations will be performed every 3 months for the first year and every 6-12 months thereafter. The maximal accrual possible would be 210 patients (Cohort A with 80 patients, Cohort B with 66 patients and Cohort C with 64 patients), and maximal enrollment could take up to 5 years.

Kidney Cancer

Clinical Response Toxicity Immunologic Response Adjuvant IL-2 Renal Cancer

null

3

arm 1: Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy. A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other. arm 2: Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1)- two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other. 720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses). arm 3: Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy. A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)

[ 0, 0, 0 ]

3

[ 0, 0, 10 ]

intervention 1: Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other. intervention 2: Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other. intervention 3: 720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).

intervention 1: 117-126:Fibroblast growth factor 5 (FGF-5) intervention 2: Fibroblast growth factor 5 (FGF-5):172-176/217-220 intervention 3: IL-2

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00089778

[ 2 ]

83

RANDOMIZED

CROSSOVER

7BASIC_SCIENCE

4QUADRUPLE

true

0ALL

null

To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females

null

Healthy Volunteers

QT/QTc

null

3

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

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6. intervention 2: Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6. intervention 3: Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

intervention 1: immediate release guanfacine hydrochloride intervention 2: moxifloxacin intervention 3: Placebo

1

Tacoma | Washington | United States | -122.44429 | 47.25288

0

NCT00672984

[ 4 ]

526

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

null

Insomnia

null

4

arm 1: Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 2: Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 3: Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 4: Placebo to esmirtazapine

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime. intervention 2: Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

intervention 1: Esmirtazapine intervention 2: Placebo

0

null

0

NCT00482612

[ 4 ]

299

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).

null

Hepatic Encephalopathy

null

2

arm 1: Participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation. arm 2: Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Oral intervention 2: Oral

intervention 1: Rifaximin intervention 2: Placebo

0

null

0

NCT00298038

[ 5 ]

14

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in the early stage of Alzheimer's Disease (AD).

null

Alzheimer's Disease

Functional magnetic resonance imaging examination Alzheimer's Disease Donepezil hydrochloride Aricept

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks

intervention 1: Donepezil hydrochloride

1

Milwaukee | Wisconsin | United States | -87.90647 | 43.0389

0

NCT00477659

[ 4 ]

126

NON_RANDOMIZED

null

0TREATMENT

0NONE

false

0ALL

false

To evaluate the safety of the long-term use of pregabalin.

null

Neuralgia, Postherpetic

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

intervention 1: pregabalin

33

0

NCT00424372

[ 4 ]

629

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Clostridium Infections Diarrhea

CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea

null

2

arm 1: Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin arm 2: Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 200 mg oral capsules two times daily (q12h regimen) intervention 2: 125 mg capsules q6hr (4 times a day) intervention 3: Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

intervention 1: Fidaxomicin intervention 2: Vancomycin intervention 3: Matching Placebo to Fidaxomicin

0

null

1

NCT00314951

[ 3, 4 ]

262

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

null

Lupus Erythematosus, Systemic

Rituxan SLE Lupus

null

2

arm 1: Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. arm 2: Participants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.

[ 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Rituximab will be supplied as a sterile liquid for IV administration. intervention 2: Placebo will be supplied as a sterile liquid for IV administration. intervention 3: None intervention 4: None intervention 5: None

intervention 1: Rituximab intervention 2: Placebo intervention 3: Prednisone intervention 4: Acetaminophen intervention 5: Diphenhydramine

65

0

NCT00137969

[ 2 ]

14

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).

null

Peripheral Vascular Diseases

null

2

arm 1: Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks arm 2: Participants will be orally administered placebo once daily for 12 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks. intervention 2: Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

intervention 1: MK-0736 intervention 2: Comparator: placebo (unspecified)

0

null

1

NCT00679055

[ 3 ]

27

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 weeks, and all criteria listed below for each type of response were to be concomitantly met to result into a response.

Leukemia, Myeloid, Chronic

Refractory Chronic Myeloid Leukemia accelerated phase blast phase (blast crisis) adults oral LBH589

null

1

arm 1: Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: LBH589

26

0

NCT00449761

[ 5 ]

339

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.

null

Depressive Disorder, Major

null

2

arm 1: Duloxetine 60 mg arm 2: Duloxetine 120 mg

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Capsule intervention 2: Capsule

intervention 1: Duloxetine intervention 2: Placebo

0

null

0

NCT02229825

[ 3 ]

72

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.

null

Esophageal Cancer Gastric Cancer

Esophagus Gastric Adenocarcinoma EGFR matuzumab EMD 72000 randomized Epirubicin cisplatin capecitabine Metastatic Esophago-Gastric cancer

null

2

arm 1: None arm 2: None

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn. intervention 2: Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles. intervention 3: Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles. intervention 4: Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.

intervention 1: Matuzumab intervention 2: Epirubicin intervention 3: Cisplatin intervention 4: Capecitabine

22

Essen | N/A | Germany | 7.01228 | 51.45657 Hamburg | N/A | Germany | 9.99302 | 53.55073 Oldenburg | N/A | Germany | 8.21467 | 53.14118 Recklinghausen | N/A | Germany | 7.19738 | 51.61379 A Coruña | N/A | Spain | -8.396 | 43.37135 Barcelona | N/A | Spain | 2.15899 | 41.38879 Cadiz | N/A | Spain | -6.2891 | 36.52672 Valencia | N/A | Spain | -0.37966 | 39.47391 Bern | N/A | Switzerland | 7.44744 | 46.94809 Geneva | N/A | Switzerland | 6.14569 | 46.20222 Lausanne | N/A | Switzerland | 6.63282 | 46.516 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Northwood | Middlesex | United Kingdom | -0.42454 | 51.61162 Bournemouth | N/A | United Kingdom | -1.8795 | 50.72048 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 Chelmsford | N/A | United Kingdom | 0.46958 | 51.73575 Guildford | N/A | United Kingdom | -0.57427 | 51.23536 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 London | N/A | United Kingdom | -0.12574 | 51.50853 Newcastle | N/A | United Kingdom | -5.88979 | 54.21804 Northwood | N/A | United Kingdom | -0.42454 | 51.61162 Portsmouth | N/A | United Kingdom | -1.09125 | 50.79899

0

NCT00215644

[ 4 ]

17,802

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Elevated High-sensitivity C-Reactive Protein (hsCRP)

Primary prevention Cardiovascular disease Statin therapy C-reactive protein

null

2

arm 1: Rosuvastatin 20 mg once daily arm 2: Placebo once daily

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Oral intervention 2: Oral

intervention 1: Rosuvastatin intervention 2: Placebo

856

0

NCT00239681

[ 4 ]

1,083

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

1FEMALE

false

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

null

Endometrial Hyperplasia Osteoporosis

Endometrium Uterus Menopause

null

4

arm 1: BZA 20mg/CE 0.625 arm 2: BZA 20mg/CE 0.45 arm 3: CE 0.45mg/MPA1.5mg arm 4: Placebo

[ 0, 0, 1, 2 ]

4

[ 0, 0, 0, 10 ]

intervention 1: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 2: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 3: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 4: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

intervention 1: Bazedoxifene/Conjugated Estrogen intervention 2: Bazedoxifene/Conjugated Estrogen intervention 3: CE 0.45 mg/MPA 1.5mg intervention 4: Placebo

9

1

NCT00242710

[ 5 ]

550

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).

null

Skin Diseases, Bacterial

skin infection antibiotics

null

2

arm 1: Arm 1: Tigecycline arm 2: Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs. A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.

intervention 1: Tigecycline intervention 2: ampicillin-sulbactam

57

1

NCT00368537

[ 0 ]

853

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This was an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported here) enrolled patients with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort enrolled patients with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). The results of the second cohort are reported separately (NCT01442064). The first cohort of this study enrolled two subsets of patients: ranibizumab experienced and ranibizumab-naive. Patients were enrolled within 14 days of completion of the 24 month treatment phase of the previous study.

null

Choroidal Neovascularization, Age-related Macular Degeneration

CNV Lucentis AMD Age-related macular degeneration RVO

null

1

arm 1: Ranibizumab 0.5 mg intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment.

[ 0 ]

1

[ 0 ]

intervention 1: Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year)

intervention 1: Ranibizumab 0.5 mg

0

null

1

NCT00379795

[ 4 ]

116

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.

The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21. The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.

Immune Thrombocytopenic Purpura

null

1

arm 1: Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

[ 0 ]

1

[ 0 ]

intervention 1: Octagam 10% was supplied as a ready-to-use solution in glass bottles.

intervention 1: Octagam 10%

1

Vienna | N/A | Austria | 16.37208 | 48.20849

1

NCT00426270

[ 4 ]

348

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe. The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

null

Diabetes Diabetes Mellitus, Type 1

null

2

arm 1: insulin detemir + insulin aspart arm 2: NPH insulin + insulin aspart

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: s.c. injection, once or twice daily. intervention 2: s.c. injection, once or twice daily. intervention 3: s.c. injection, at main meals.

intervention 1: insulin detemir intervention 2: insulin NPH intervention 3: insulin aspart

43

Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Varna | N/A | Bulgaria | 27.91667 | 43.21667 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Glostrup Municipality | N/A | Denmark | 12.40377 | 55.6666 Kolding | N/A | Denmark | 9.47216 | 55.4904 Odense | N/A | Denmark | 10.38831 | 55.39594 Viborg | N/A | Denmark | 9.40201 | 56.45319 Espoo | N/A | Finland | 24.6522 | 60.2052 Helsinki | N/A | Finland | 24.93545 | 60.16952 Oulu | N/A | Finland | 25.46816 | 65.01236 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Angers | N/A | France | -0.55202 | 47.47156 Montpellier | N/A | France | 3.87635 | 43.61093 Paris | N/A | France | 2.3488 | 48.85341 Toulouse | N/A | France | 1.44367 | 43.60426 Budapest | N/A | Hungary | 19.04045 | 47.49835 Miskolc | N/A | Hungary | 20.77806 | 48.10306 Skopje | N/A | North Macedonia | 21.43141 | 41.99646 Gdansk | N/A | Poland | 18.64912 | 54.35227 Kielce | N/A | Poland | 20.62752 | 50.87033 Siedlce | N/A | Poland | 22.29006 | 52.16772 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Warsaw | N/A | Poland | 21.01178 | 52.22977 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Altunizade-Istanbul | N/A | Turkey (Türkiye) | N/A | N/A Antalya | N/A | Turkey (Türkiye) | 30.69556 | 36.90812 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Kayseri | N/A | Turkey (Türkiye) | 35.48528 | 38.73222 Aberdeen | N/A | United Kingdom | -2.09814 | 57.14369 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 Dundee | N/A | United Kingdom | -2.97489 | 56.46913 Norfolk | N/A | United Kingdom | N/A | N/A

1

NCT00435019

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to understand the safety and tolerability of INCB018424 in patients with rheumatoid arthritis

null

Rheumatoid Arthritis

Rheumatoid arthritis

null

5

arm 1: INCB018424 15 mg twice daily (BID) or matching placebo arm 2: INCB018424 5 mg BID or matching placebo arm 3: INCB018424 25 mg BID or matching placebo arm 4: INCB018424 50 mg once daily (QD) or matching placebo arm 5: Matching placebo, oral

[ 0, 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: INCB018424 intervention 2: Placebo

15

1

NCT00550043

[ 2 ]

104

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.

null

Neuralgia, Postherpetic Diabetic Neuropathy Painful Small-Fiber Neuropathy Idiopathic Distal Sensory Polyneuropathy

null

2

arm 1: Patients in Group A will remain on pregabalin (up to 600 mg/day po) treatment for the entire double-blind period. arm 2: Patients in Group B will be treated with placebo.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks intervention 2: pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks

intervention 1: Comparator: pregabalin intervention 2: Comparator: Placebo (unspecified)

0

null

1

NCT00570310

[ 4 ]

649

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in participants with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is greater than (\>)500 individuals.

null

Renal Cell Cancer

null

2

arm 1: Bevacizumab infusions will be administered every 2 weeks at a dose of 10 milligram per kilogram (mg/kg) for 52 weeks or until disease progression or unacceptable toxicity. Interferon alfa-2a (IFN-Alfa-2A) will be administered 3 times per week as a subcutaneous injection at a dose of 9 million international units (MIU) for 52 weeks or until disease progression or major toxicity. arm 2: Placebo matched with Bevacizumab infusions will be administered every 2 weeks for 52 weeks or until disease progression or unacceptable toxicity. IFN-Alfa-2A will be administered 3 times per week as a subcutaneous injection at a dose of 9 MIU for 52 weeks or until disease progression or major toxicity.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 10 mg/kg IV every 2 weeks intervention 2: 9 MIU SC 3 times/week intervention 3: IV every 2 weeks

intervention 1: Bevacizumab [Avastin] intervention 2: Interferon alfa 2a [Roferon] intervention 3: Placebo

104

Adelaide | N/A | Australia | 138.59863 | -34.92866 Adelaide | N/A | Australia | 138.59863 | -34.92866 Brisbane | N/A | Australia | 153.02809 | -27.46794 Canberra | N/A | Australia | 149.12807 | -35.28346 Frankston | N/A | Australia | 145.12291 | -38.14458 Kurralta Park | N/A | Australia | 138.56702 | -34.95142 Melbourne | N/A | Australia | 144.96332 | -37.814 Perth | N/A | Australia | 115.8614 | -31.95224 Sydney | N/A | Australia | 151.20732 | -33.86785 Sydney | N/A | Australia | 151.20732 | -33.86785 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Chomutov | N/A | Czechia | 13.41779 | 50.46048 České Budějovice | N/A | Czechia | 14.47434 | 48.97447 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Pilsen | N/A | Czechia | 13.37759 | 49.74747 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Angers | N/A | France | -0.55202 | 47.47156 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Clermont-Ferrand | N/A | France | 3.08682 | 45.77969 Grenoble | N/A | France | 5.71479 | 45.17869 Lille | N/A | France | 3.05858 | 50.63297 Limoges | N/A | France | 1.24759 | 45.83362 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Nice | N/A | France | 7.26608 | 43.70313 Poitiers | N/A | France | 0.34348 | 46.58261 Saint-Herblain | N/A | France | -1.651 | 47.21154 Strasbourg | N/A | France | 7.74553 | 48.58392 Suresnes | N/A | France | 2.22929 | 48.87143 Toulouse | N/A | France | 1.44367 | 43.60426 Villejuif | N/A | France | 2.35992 | 48.7939 Berlin | N/A | Germany | 13.41053 | 52.52437 Darmstadt | N/A | Germany | 8.65027 | 49.87167 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Mannheim | N/A | Germany | 8.46694 | 49.4891 Marburg | N/A | Germany | 8.77069 | 50.80904 München | N/A | Germany | 13.31243 | 51.60698 Planegg | N/A | Germany | 11.42483 | 48.10672 Budapest | N/A | Hungary | 19.04045 | 47.49835 Szombathely | N/A | Hungary | 16.62155 | 47.23088 Holon | N/A | Israel | 34.77918 | 32.01034 Ramat Gan | N/A | Israel | 34.81065 | 32.08227 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Ẕerifin | N/A | Israel | 34.84852 | 31.95731 Livorno | N/A | Italy | 10.32615 | 43.54427 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Perugia | N/A | Italy | 12.38878 | 43.1122 Roma | N/A | Italy | 11.10642 | 44.99364 Rozzano | N/A | Italy | 9.1559 | 45.38193 Torino | N/A | Italy | 11.99138 | 44.88856 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Ålesund | N/A | Norway | 6.15492 | 62.47225 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Trondheim | N/A | Norway | 10.39506 | 63.43049 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Krakow | N/A | Poland | 19.93658 | 50.06143 Lodz | N/A | Poland | 19.47395 | 51.77058 Olsztyn | N/A | Poland | 20.49416 | 53.77995 Tarnów | N/A | Poland | 20.98698 | 50.01381 Warsaw | N/A | Poland | 21.01178 | 52.22977 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Obninsk | N/A | Russia | 36.61238 | 55.10993 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Granada | N/A | Spain | -3.60667 | 37.18817 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Pontevedra | N/A | Spain | -8.64435 | 42.431 Santander | N/A | Spain | -3.80444 | 43.46472 Valencia | N/A | Spain | -0.37966 | 39.47391 Zaragoza | N/A | Spain | -0.87734 | 41.65606 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bern | N/A | Switzerland | 7.44744 | 46.94809 Geneva | N/A | Switzerland | 6.14569 | 46.20222 Chang Gung | N/A | Taiwan | N/A | N/A Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taipei | N/A | Taiwan | 121.52639 | 25.05306 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

1

NCT00738530

[ 3 ]

42

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a single arm study. The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides. Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell (APC) vaccine is performed. Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and maximum is 100,000,000/kg. Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This therapy usually consists of multiagent chemotherapy in the context of a separate protocol. Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines. Interleukin -2 (IL-2) is administered as a continuous intravenous (IV) infusion for 4 days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed infusions.

Eradication of low tumor burdens can occur in vivo when T-cell mediated responses are generated against specific tumor antigens. The Ewing's sarcoma family of tumors (ESFT) and alveolar rhabdomyosarcoma (AR) display several features which make them candidate diseases for trials of such immunotherapy. First, intensive cytotoxic chemotherapy is generally able to eradicate bulk disease in patients with metastatic disease, but tumor relapse eventually occurs in nearly all patients. Second, tumor-specific chromosomal translocations resulting in the production of novel fusion proteins have been identified in the great majority of these tumors. Peptides derived from these fusion proteins have been shown to function as tumor antigens for cytolytic T cells in animal studies. Third, studies of immune reconstitution after intensive cytotoxic therapy have provided evidence that antigen-specific T cells can be generated in vivo when the adoptive transfer of peripheral T cells and antigen are provided during the period of T cell regeneration. This process can be augmented in murine models by the use of human immunodeficiency virus (HIV) active protease inhibitor, indinavir, potentially through inhibition of programmed cell death in expanding T cells. Merging these concepts, this protocol will attempt to eradicate minimal residual disease in pediatric patients with metastatic ESFT and AR via vaccination with tumor-specific peptides undertaken concomitant with autologous T cell transplantation and indinavir.

Ewing's Sarcoma Rhabdomyosarcoma

Rhabdomyosarcoma Ewing's Sarcoma Immunotherapy Tumor Vaccine Interleukin-2

null

1

arm 1: Patients receive oral indinavir sulfate 350 mg/m\^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10\^6 injection; harvested autologous T cells (minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.

[ 0 ]

3

[ 2, 0, 3 ]

intervention 1: 3 syringes containing 1 x 10\^6peptide pulsed dendritic cells intervention 2: Oral dose, 350 mg/m\^2 administered every 8 hours. Maximum dose is 800 mg every 8 hours. intervention 3: Harvested autologous T cells, minimum dose 1 x 10\^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.

intervention 1: therapeutic autologous dendritic cells intervention 2: indinavir sulfate intervention 3: peripheral blood stem cell transplantation

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00001566

[ 3 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).

null

Non-Hodgkin's Lymphoma

null

1

arm 1: 500 milligrams (mg), oral, daily (QD), up to six (6) 28-day cycles

[ 0 ]

1

[ 0 ]

intervention 1: 500 mg, oral, QD, up to six 28 day cycles

intervention 1: LY317615

3

0

NCT00042666

[ 4 ]

630

null

PARALLEL

0TREATMENT

null

false

0ALL

null

Demonstrate the safety and efficacy of Tipranavir/Ritonavir versus an active treatment regimen in highly treatment experienced Human Immunodeficiency virus 1(HIV-1) infected patients.

null

HIV Infections

null

2

arm 1: None arm 2: None

[ 5, 5 ]

3

[ 0, 0, 0 ]

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

intervention 1: Tipranavir intervention 2: Ritonavir(r) intervention 3: Comparator Protease Inhibitor (CPI)

117

0

NCT00054717

[ 3 ]

106

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

null

Carcinoma, Renal Cell

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity

intervention 1: SU011248

15

0

NCT00077974

[ 3, 4 ]

469

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.

Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed. Participants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion.

Heart Failure, Congestive Chronic Heart Failure Depression

Antidepressive Agents

null

2

arm 1: Participants will take sertraline for 12 weeks arm 2: Participants will take placebo for 12 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dosage ranging from 50 mg to 200 mg once a day intervention 2: Dosage ranging from 50 mg to 200 mg once a day

intervention 1: Sertraline intervention 2: Placebo

1

Durham | North Carolina | United States | -78.89862 | 35.99403

0

NCT00078286

[ 3 ]

170

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.

Approximately one-third of the world's population is infected with Mycoplasma tuberculosis; 7 to 8 million new cases of active TB occur each year. TB is the second most common infectious cause of death worldwide. Appropriate treatment of persons with active TB is very important in limiting the transmission of M. tuberculosis and preventing TB-related mortality. Current therapy requires 6 months of a four-drug regimen of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and EMB. The development of alternative regimens is a priority, and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease. This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection. Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks. Participants will have study visits weekly during these 8 weeks. After 8 weeks, participants will discontinue MOX, EMB, and PZA and will continue taking INH and RFP for 4 months. Participants will have study visits at Months 4, 6, 12, and 18. Study visits will include a medical interview, physical exam, blood and urine tests, and sputum tests for TB.

Tuberculosis

null

2

arm 1: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks arm 2: INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks

[ 0, 2 ]

1

[ 0 ]

intervention 1: 400mg daily for 8 weeks

intervention 1: Moxifloxacin

1

Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642

0

NCT00082173

[ 3 ]

33

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line therapy.

PRIMARY OBJECTIVES: I. To determine the efficacy of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant based on clinical benefit rate (CBR, a combination of complete response rate, partial response rate, and stable disease for more than 24 weeks) in postmenopausal women with hormone receptor-positive metastatic breast cancer who have progressive disease after first-line endocrine therapy. SECONDARY OBJECTIVES: I. To determine the median time to progression (TTP) and duration of response of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant in postmenopausal women with hormone receptor-positive metastatic breast cancer. II. To determine the median overall survival of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant in postmenopausal women with hormone receptor- positive metastatic breast cancer who have progressive disease after first-line endocrine therapy. III. To determine the toxicity profile of tipifarnib (R115777, Zarnestra™) in combination with fulvestrant versus fulvestrant alone (from historical control) in postmenopausal women with hormone receptor positive metastatic breast cancer who have progressive disease after first-line endocrine therapy. OUTLINE: Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\*. NOTE: \*Fulvestrant continues even if tipifarnib is held for toxicity. Patients are followed every 3 months.

Estrogen Receptor-positive Breast Cancer Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer

null

1

arm 1: Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity\*.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Given intramuscularly intervention 2: Given IV

intervention 1: fulvestrant intervention 2: tipifarnib

1

The Bronx | New York | United States | -73.86641 | 40.84985

0

NCT00082810

[ 4 ]

750

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

null

Carcinoma, Renal Cell

null

2

arm 1: None arm 2: None

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: 3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity intervention 2: 50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity

intervention 1: Interferon-alfa intervention 2: SU011248

123

0

NCT00083889

[ 0 ]

341

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period. Methods: During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

Hypotension, Orthostatic

Aging Blood pressure Hypotension Orthostatic Rehabilitation

null

1

arm 1: Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)

[ 5 ]

3

[ 10, 0, 10 ]

intervention 1: * Patient Education * Physical Therapy Exercises * Increased Salt Intake * Elevation of head of bed with 2-4 inch wedge * Medication Review by MD, Pharma intervention 2: Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. * Fludrocortisone * Salt tablet intervention 3: Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.

intervention 1: Treatment Phase 1 intervention 2: Treatment Phase 2 intervention 3: Treatment Phase 3

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00117585

[ 4 ]

515

NA

SINGLE_GROUP

2DIAGNOSTIC

0NONE

true

0ALL

true

The study is designed to study the utility of 123I-mIBG as a diagnostic imaging agent to predict cardiac outcome in subjects with heart failure and in comparison to subjects without cardiovascular disease.

null

Heart Failure, Congestive

Heart Failure nuclear cardiology sympathetic innervation 123I-mIBG

null

1

arm 1: Single dose

[ 0 ]

1

[ 0 ]

intervention 1: Single Dose

intervention 1: 123I-mIBG (meta-iodobenzylguanidine)

1

Princeton | New Jersey | United States | -74.65905 | 40.34872

0

NCT00126438

[ 4 ]

208

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

true

Primary end points * incidence of depression defined as a Montgomery Asberg Depression Scale Score (MADRS) of 13 or higher during antiviral therapy (up to 48 weeks, depending on genotype) * effect of an antidepressive pre-treatment over two weeks and a continuously concomitant treatment with Escitalopram (S-citalopram) on frequency and severity of depression in patients with chronic hepatitis C (HCV) treated with Peg-interferon alfa-2a (PEGASYS) and ribavirin, measured by the Montgomery Asberg Depression Scale Secondary end points * time to depression defined as a MADRS score of 13 or higher * incidence of major depression defined by Diagnostic and Statistical Manual IV (DSM-IV) criteria * severe depression according to MADRS scale (score 25 or higher) * Health related quality of life (HRQOL) measured by the Short Form 36 (SF-36) * sustained virologic response * tolerability * safety * changes/group differences in other psychiatric depression scales (Hamilton Depression Rating Scale, Beck Depression Inventory) Other investigations: * cognitive function, anxiety (word fluency test, trail making test part A and B, othe scales) * Predictive parameters for patients especially gaining from an antidepressive therapy (e.g. age, gender, weight, height, alanine aminotransferase (ALAT) quotient defined as median ALAT values before treatment divided by the upper standard value, HCV-RNA serum concentration level of fibrosis in liver histology, baseline values of the different psychometric scales) * alanine aminotransferase (ALAT), aspartate transaminase (ASAT), thyrotrophin (TSH) * biomarkers (genetic parameters, cytokines,...)

null

Depression

Pegasys-Induced depression

null

2

arm 1: After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram. arm 2: After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.

[ 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: Patients with HCV genotype 1 or 4 received treatment for 48 weeks with PEGinterferon-alfa2a, 180 mcg weekly. Patients with genotype 2 or 3 received PEGinterferon-alfa2a, 180 mcg weekly. intervention 4: Patients with HCV genotype 1 or 4 received treatment for 48 weeks with ribavirin, 1000 mg per day (body weight 75 kg) or 1200 mg per day (body weight, 75 kg). Patients with HCV genotype 2 or 3 received ribavirin, 800 mg per day for 24 weeks.

intervention 1: Escitalopram intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin

1

Leipzig | N/A | Germany | 12.37129 | 51.33962

0

NCT00136318

[ 3 ]

66

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Bortezomib (Velcade) has just recently been approved by the FDA for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. This study will determine if Velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. We will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of Velcade and after treatment with Velcade.

Primary Objective • To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma. Secondary Objectives * To evaluate the tolerability and toxicity. * To evaluate time to progression. * To assess the frequency and severity of peripheral neuropathy. * To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy. Exploratory Objectives • To perform pharmacogenomic analysis of molecular markers associated with response or non-response. Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is \>0.95 with a true ORR of 55% and \<0.07 with a true ORR of 35%.

Multiple Myeloma

multiple myeloma Velcade bortezomib

null

1

arm 1: Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: bortezomib

6

0

NCT00153920

[ 5 ]

300

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.

null

Renal Transplantation

Renal transplantation, everolimus, immunosuppressants, CNI-free

null

2

arm 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant. arm 2: Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL. intervention 2: Tablets orally twice a day to maintain protocol specific target blood levels intervention 3: Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. intervention 4: Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

intervention 1: Everolimus intervention 2: Cyclosporine intervention 3: Enteric-coated mycophenolate sodium intervention 4: Corticosteroids

3

Nuremberg | N/A | Germany | 11.07752 | 49.45421 Basel | N/A | Switzerland | 7.57327 | 47.55839 Bern | N/A | Switzerland | 7.44744 | 46.94809

0

NCT00154310

[ 2, 3 ]

89

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The study objective is to evaluate the maximum tolerated dose, safety and efficacy of patupilone in patients with NSCLC who have progressed after prior chemotherapy.

null

Carcinoma, Non-Small-Cell Lung

EPO EPO906 Brain metastasis Lung cancer Lung metastasis NSCLC

null

0

null

1

[ 0 ]

intervention 1: Patupilone (2.5 mg/mL) was supplied as a clear, colorless concentrate for solution for infusion in glass vials containing 5 mg/2 mL in Phase I and 10 mg/4 mL in Phase II part of the study. Patupilone was administered as a single intravenous (i.v.) infusion over 5 to 10 minutes (Amendment 1) till Amendment 2 and over 10 to 20 minutes (Amendment 2) till the completion of Phase I part of the study. Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks in Phase II part of the study.

intervention 1: Patupilone

4

0

NCT00171834

[ 3 ]

60

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Outline of Therapy: Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years. Therapy will be divided into five phases: Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow). Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse. Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times. Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks. Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis. Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.

Acute Lymphocytic Leukemia

Acute Lymphocytic Leukemia Leukemia

null

2

arm 1: 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin arm 2: 6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C

[ 0, 0 ]

12

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

intervention 1: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 2: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 3: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 4: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 5: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 6: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 7: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 8: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 9: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 10: Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation intervention 11: None intervention 12: None

intervention 1: aminopterin intervention 2: L-asparaginase intervention 3: cyclophosphamide intervention 4: cytarabine intervention 5: daunomycin intervention 6: dexamethasone intervention 7: 6-mercaptopurine intervention 8: methotrexate intervention 9: 6-thioguanine intervention 10: vincristine intervention 11: Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone) intervention 12: Leucovorin

2

0

NCT00176462

[ 4 ]

554

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This trial is conducted globally. The purpose of the trial is to evaluate that activated recombinant human factor VII (eptacog alfa (activated)) is safe and effective in severely injured trauma patients by assessing mortality and morbidity. Please note that this trial and trial F7TRAUMA-1648 (NCT00323570) have been merged.

The decision to discontinue the F7TRAUMA-1711 trial is not due to any safety concerns. The result of the pre-planned futility analysis performed in June 2008 predicted a very low likelihood of reaching a successful outcome on the primary efficacy endpoint at the end of the trial and as a consequence, the company has decided to close the trial as this juncture.

Acquired Bleeding Disorder Trauma

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 2, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Sterile, freeze-dried powder in single-use vials to be reconstituted with sterile water for injection. Three doses of 200, 100 and 100 mcg/kg to be administered bolus i.v. (intravenous) over approx. three hours. intervention 2: placebo

intervention 1: eptacog alfa (activated) intervention 2: placebo

14

Princeton | New Jersey | United States | -74.65905 | 40.34872 Säo Paulo | N/A | Brazil | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Paris La Défense Cedex | N/A | France | N/A | N/A Mainz | N/A | Germany | 8.2791 | 49.98419 Vouliagment | N/A | Greece | N/A | N/A Kowloon | N/A | Hong Kong | 114.18333 | 22.31667 Budapest | N/A | Hungary | 19.04045 | 47.49835 Rome | N/A | Italy | 12.51133 | 41.89193 Alphen aan den Rijn | N/A | Netherlands | 4.65546 | 52.12917 Sandton | N/A | South Africa | 28.054 | -26.104 Madrid | N/A | Spain | -3.70256 | 40.4165 Zurich | N/A | Switzerland | 8.55 | 47.36667 Crawley | N/A | United Kingdom | -0.18312 | 51.11303

0

NCT00184548

[ 0 ]

47

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.

It has been estimated that approximately ¼ of the US population has the Insulin Resistant Syndrome (IRS). The notion that insulin resistance and compensatory hyperinsulinemia lead to a cluster of abnormalities that increase CVD risk was first introduced in 1988, and central to the changes identified was a dyslipidemia characterized by a high plasma triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentration. The atherogenic lipoprotein pattern associated with the IRS has grown to include enhanced postprandial lipemia and smaller and denser low-density lipoprotein (LDL) particles. In addition to being associated with insulin resistance and compensatory hyperinsulinemia, these changes in lipoprotein metabolism have been identified as increasing CVD risk. The power of the dyslipidemia associated with the IRS is reinforced by reports that the plasma TG/HDL-C concentration ratio is as powerful a predictor of CVD, if not more so, than the more conventional total plasma cholesterol/LDL-C concentration ratio, and evidence from the Copenhagen Male Study of the interaction between the plasma TG and HDL-C concentrations, "conventional" CVD risk factors, and CVD events. Specifically, these latter investigators were able to show in a prospective study (11) that CVD events were substantially attenuated in: 1) smokers; 2) patients with high blood pressure; 3) individuals with a high LDL-C concentration; and 4) subjects who were sedentary; as long as they were in the lowest 1/3rd of the population with the lowest TG/HDL-C concentration ratio and presumably insulin sensitive. Conversely, if they were in the tertile with the highest plasma TG/HDL-C concentration ratio, and presumably insulin resistant, they had a significant increase in CVD events in the absence of the four conventional CVD risk factors evaluated. An obvious alternative therapeutic approach to decreasing CVD risk in patients with the IRS would be to administer a thiazolidinedione (TZD) compound in an effort to directly treat the basic defect of the syndrome. However, based upon our own results with rosiglitazone (ROSI) in several different patient populations, improvements in insulin sensitivity were not associated with a significant improvement in dyslipidemia. For example, in a recent study (unpublished) of ROSI-treated patients with type 2 diabetes, neither plasma TG (358 to 347 mg/dL) nor HDL-C (40 to 42 mg/dL) concentrations improved, and both total (215 to 239 mg/dL and LDL-C (118-142mg/dL) concentrations actually increased. Since the patients in this study became more insulin sensitive with treatment, and had lower daylong plasma glucose, insulin, and free fatty acid concentrations, the reason for the lack of a beneficial effect of ROSI on lipoprotein metabolism is not clear. On the other hand, given evidence of the importance of dyslipidemia in increasing CVD risk in insulin resistant individuals, it seems reasonable to question the notion that TZD compounds provide the most beneficial approach to decreasing CVD risk in the dyslipidemic patient with the IRS. With this background in mind, we propose to initiate a study in which insulin resistant individuals with the dyslipidemia characteristic of the IRS will be randomized to treatment with fenofibrate,ROSI, or weight loss and the effect of these three treatments on CVD risk factors compared. It is postulated that although insulin resistance will improve to a greater degree with ROSI treatment, the atherogenic lipoprotein profile known to link IRS and CVD will only significantly improve following treatment with fenofibrate and effects of weight loss can effect both of these.

Insulin Resistance Hypertriglyceridemia

Insulin resistance Insulin resistance syndrome dyslipidemia atherogenic dyslipidemia triglyceride/HDL-C ratio

null

3

arm 1: 160 mg daily for 12 weeks arm 2: 4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks arm 3: calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks

[ 1, 1, 1 ]

3

[ 0, 0, 5 ]

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

intervention 1: Rosiglitazone intervention 2: Fenofibrate intervention 3: Weight Loss

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00186537

[ 4 ]

107

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Type 1 Diabetes

Diabetes Implantable Insulin Pump Intraperitoneal Insulin Delivery

null

2

arm 1: The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin. arm 2: The control group will remain on their current pre-study subcutaneous insulin therapy of either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used, or be required to change or modify their current diabetes therapy for the purpose of the study.

[ 0, 4 ]

3

[ 0, 1, 0 ]

intervention 1: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. intervention 2: The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. intervention 3: 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

intervention 1: Medtronic MiniMed Implantable Pump Human Recombinant Insulin intervention 2: Medtronic MiniMed Implantable Pump System intervention 3: Aventis HOE21PH U400

5

0

NCT00211536

[ 0 ]

20

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

true

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy. Eligible patients found to have nasal polyps will be offered the chance to participate in this study. They will undergo non-invasive pH probe monitoring for 24 hours. If extraesophageal (laryngopharyngeal) reflux is discovered, they will be provided (at no cost) proton pump inhibitor medication (PPI), prescribed in accordance with published standards in the otolaryngology literature. Their polyposis will be treated as any other patient presenting with polyposis; participation in the study will not affect the course of polyp treatment. The incidence of recurrence will be monitored and recorded over the first year after treatment. Included: Subjects will be adults with nasal polyposis, recruited from the PI's private practice, will not be currently taking a PP!, will be able and willing to undergo a noninvasive 24 hour pH probe study, and willing to take a PPI. Excluded: patients who are pregnant, have a history of surgical treatment for reflux disease, history of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period, and those not meeting inclusion criteria. In addition to routine office otolaryngology examination, subjects will undergo noninvasive 24 hour esophageal pH probe monitoring. The probe is swallowed and placed in the same manner as a feeding tube. The procedure is done in the office. No sedation is required, but the mucosa may be sprayed with topical 4% lidocaine for comfort. This procedure is the standard for diagnosis of extraesophageal (laryngopharyngeal) reflux, and will be performed in accordance with manufacturer guidelines Risks include temporary dysphagia while the probe is in place, and nasal irritation. Mild, self-limited epistaxis has been rarely reported The procedure will be done within manufcturer guidelines under direct vision. Topical Afrin may be used to control any mild epistaxis. Topical 4% lidocaine will be applied to minimize dysphagia. These steps have proven very affective in minimizing these risks. If the study hypothesis is correct, the patient may have an diminished risk of recurrence of their nasal polyposis. If the patient is found to have previously undiagnosed reflux disease, this will allow it to be treated appropriately. Undiagnosed/untreated reflux has been associated with multiple medical problems including laryngeal and esophageal cancer. The patient will be given their PPI medication free of charge for the duration of the study. The noninvasive pH probe study will be done free of charge. No direct monetary payment will be given to participants.

Nasal Polyps Gastroesophageal Reflux

Nasal polyps Gastroesophageal Reflux

null

0

null

1

[ 0 ]

intervention 1: Lansoprazole 30 mg BID for 1 year

intervention 1: lansoprazole

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00215787

[ 5 ]

57

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.

This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.

Detrusor Hyperreflexia

null

2

arm 1: Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day arm 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 1.3, 2.6, 3.9 mg/day transdermal intervention 2: 5 to 15 mg/day immediate release or extended release tablets, or syrup

intervention 1: Oxybutynin intervention 2: Oxybutynin

23

0

NCT00224016

[ 5 ]

473

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

null

Appendicitis Cholecystitis Diverticulitis Intra-Abdominal Abscess Intra-Abdominal Infection Peritonitis

Intra-Abdominal Infections Abscess

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours) intervention 2: Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

intervention 1: tigecycline intervention 2: ceftriaxone plus metronidazole

68

Nambour | Queensland | Australia | 152.95941 | -26.62613 Cairns | N/A | Australia | 145.76613 | -16.92366 Parkville | N/A | Australia | 144.95 | -37.78333 Shanghai | N/A | China | 121.45806 | 31.22222 Odense | N/A | Denmark | 10.38831 | 55.39594 Lahti | N/A | Finland | 25.66151 | 60.98267 Seinäjoki | N/A | Finland | 22.82822 | 62.79446 Tampere | N/A | Finland | 23.78712 | 61.49911 Marseille | N/A | France | 5.38107 | 43.29695 Nîmes | N/A | France | 4.35788 | 43.83665 Pierre-Bénite | N/A | France | 4.82424 | 45.70359 Saint-Denis | N/A | France | 2.35387 | 48.93564 Bochum | N/A | Germany | 7.21648 | 51.48165 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lübeck | N/A | Germany | 10.68729 | 53.86893 Münster | N/A | Germany | 7.62571 | 51.96236 Tübingen | N/A | Germany | 9.05222 | 48.52266 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 New Territories | N/A | Hong Kong | 114.11095 | 22.42441 Pokfulam | N/A | Hong Kong | N/A | N/A Hyderabad | Telangana | India | 78.45636 | 17.38405 Bhopal | N/A | India | 77.40289 | 23.25469 Lucknow | N/A | India | 80.92313 | 26.83928 Mumbai | N/A | India | 72.88261 | 19.07283 New Delhi | N/A | India | 77.2148 | 28.62137 Brescia | N/A | Italy | 10.21472 | 45.53558 Genova | N/A | Italy | 11.87211 | 45.21604 Pavia | N/A | Italy | 9.15917 | 45.19205 Rome | N/A | Italy | 12.51133 | 41.89193 Udine | N/A | Italy | 13.23715 | 46.0693 Vicenza | N/A | Italy | 11.5475 | 45.54672 Manila | N/A | Philippines | 120.9822 | 14.6042 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Almada | N/A | Portugal | -9.1569 | 38.67902 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Porto | N/A | Portugal | -8.61099 | 41.14961 Porto | N/A | Portugal | -8.61099 | 41.14961 Riyadh | N/A | Saudi Arabia | 46.72185 | 24.68773 Bellville | N/A | South Africa | 18.62847 | -33.90022 Kuilsriver | N/A | South Africa | N/A | N/A Parow | N/A | South Africa | 18.59992 | -33.89723 Pietermaritzburg | N/A | South Africa | 30.39278 | -29.61679 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bilbao | N/A | Spain | -2.92528 | 43.26271 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Murcia | N/A | Spain | -1.13004 | 37.98704 Bern | N/A | Switzerland | 7.44744 | 46.94809 Geneva | N/A | Switzerland | 6.14569 | 46.20222 Lugano | N/A | Switzerland | 8.96004 | 46.01008 Zurich | N/A | Switzerland | 8.55 | 47.36667 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Taichung | N/A | Taiwan | 120.6839 | 24.1469 Tainan City | N/A | Taiwan | 120.21333 | 22.99083 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Stockport | Cheshire | United Kingdom | -2.15761 | 53.40979 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Wigan | N/A | United Kingdom | -2.63706 | 53.54296

0

NCT00230971

[ 3 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

Randomized clinical trial of sertraline vs. placebo for post-TBI depression

Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression. Background: Major depression is experienced by many more people after TBI than prior to injury and more often than in people without a brain injury. Many studies have also shown that this higher than 'normal' incidence looms for many years post TBI. Major depression is associated with a variety of negative outcomes, including poorer functioning in basic activities, reduced employment, elevated divorce rate, reduced social and recreational activity and increased sexual dysfunction. Need for Research: Of the current drug treatments for major depression, sertraline and similar drugs (known as selective serotonin reuptake inhibitors, or selective serotonin reuptake inhibitor (SSRIs)) have few side effects in people who have experienced a brain injury and have been shown to be effective in people with no known brain injury. However, information on the impact of SSRIs on post-TBI depression, based on randomized, double-blind studies, is unavailable. Current Research Activity: Approximately 50 men and women volunteers who are post TBI and currently diagnosed with major depressive disorder are being randomly assigned to a 12-week period of taking Zoloft or a placebo. Over the period of study, participants will have the severity of their depressive symptoms assessed (as well as their symptoms of anxiety); a simple measure of the volunteer's perceived quality of life will be implemented prior to the study and at its termination. It is hypothesized that sertraline will reduce the symptoms of depression and anxiety and will increase the person's perceived quality of life to a significantly greater extent than will the placebo.

Depression

Sertraline TBI depression SSRI brain injury

null

2

arm 1: Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg). arm 2: Placebo for 10 weeks.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Sertraline arm intervention 2: Placebo

intervention 1: Sertraline intervention 2: Placebo

1

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

0

NCT00233103

[ 4 ]

52

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in oxygenation allows there to be decreased time on FiO2\>0.60, evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not. Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first 4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for the next 4 hours).. Blood gases were monitored once an hour during study participation (total of 8 hours). Final PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.

Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome ARDS Nitric Oxide

null

2

arm 1: Subjects will be randomized to receive Nitric Oxide (NO) immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide (NO) will be turned off and subjects will receive no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects will receive standard clinical are. Blood gases will be monitored once an hour for 4 hours. arm 2: Subjects will be randomized to receive no intervention (no nitric oxide) for he first 4 hours of study participation. During this time, all subjects will receive standard clinical care. Blood gases will be monitored once an hour for 4 hours. After the first 4 hours of study participation, the nitric oxide will be turned on and subjects will receive 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases will be monitored once an hour for 4 hours.

[ 1, 1 ]

2

[ 0, 10 ]

intervention 1: Subjects will receive inhaled Nitric Oxide at a dose of 10 parts per million (ppm) for a 4 hour study period. Blood gases will be collected once an hour. intervention 2: Subjects will receive no intervention (i.e., no nitric oxide treatment) for a 4 hour study period. Blood gases will be collected once an hour. During this time, all subjects will receive standard clinical care.

intervention 1: Nitric Oxide intervention 2: No Intervention

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00240487

[ 5 ]

39

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

true

2MALE

true

This study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are being treated with testosterone suppression therapy. Hypothesis: Treating men who have prostate CA with daily Revival will result in at least a 50% reduction in hot flashes compared to placebo.

This research study will look at the effects of a soy supplement called Revival on memory, quality of life, and hot flashes in men with prostate cancer who are undergoing (ADT) androgen deprivation therapy. Participants will be given either placebo or Revival. Participants will be asked to take their supplement once/day for 14 weeks.Blood will be drawn to check on liver, kidney, thyroid, cholesterol,and prostate health. Urine will be collected to check on bone markers. Patients will be asked to complete questionnaires to test memory, attention span, and vocabulary.Possible benefits may include increase in memory, decrease in hot flashes, and a general increase in quality of life.

Hot Flashes

prostate cancer soy androgen deprivation quality of life isoflavones

null

2

arm 1: Isoflavone arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Isoflavone intervention 2: Placebos

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00245518

[ 5 ]

93

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of attention deficit hyperactivity disorder (ADHD) in young children.

Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders in children. Children with ADHD often have impaired functioning in home and school and usually experience difficulty relating to peers. If left untreated, the disorder can have long-term adverse effects into adolescence and adulthood. Atomoxetine is a selective noradrenergic reuptake inhibitor that is FDA-approved for the treatment of ADHD in children, adolescents, and adults. Unlike most other medications for ADHD, atomoxetine is not a stimulant. Studies have shown that atomoxetine is effective in treating ADHD, but more information is needed on its effectiveness in young children. This study will evaluate the effectiveness of atomoxetine in reducing the symptoms of ADHD in young children. Participants in this double-blind study will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. In addition, all children will receive parent training for the duration of the study. For the first 5 weeks, participants will report to the study site weekly for assessments of ADHD symptoms. Study visits will occur every other week for the remainder of the study.

Attention Deficit Disorder With Hyperactivity

ADHD Atomoxetine

null

2

arm 1: atomoxetine capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks arm 2: matching placebo capsules, dose 0.5mg/kg/day to 1.8mg/kg/day administered once daily for 8 weeks

[ 0, 2 ]

3

[ 0, 0, 5 ]

intervention 1: Participants will receive atomoxetine for 8 weeks up to a maximum of 1.8 mg/kg/day. Dosed once daily in capsule formulation. intervention 2: Participants will receive placebo for 8 weeks. Dosed once daily, capsule formulation. intervention 3: All children will receive parent training for the duration of the study.

intervention 1: Atomoxetine intervention 2: Placebo intervention 3: Parent Training

3

0

NCT00254462

[ 0 ]

7

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

0NONE

false

0ALL

true

RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia caused by cancer and chemotherapy. It may also help relieve fatigue in patients with anemia. PURPOSE: This randomized clinical trial is studying how well epoetin alfa works in treating patients with anemia who are undergoing chemotherapy for cancer.

OBJECTIVES: Primary * Determine the efficacy, in terms of maintenance of target hemoglobin and hematocrit levels, of interval dosing with epoetin alfa in treating patients with anemia undergoing chemotherapy for nonhematologic cancer. Secondary * Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. * Correlate hemoglobin and hematocrit response with patient age (\> 65 years vs \< 65 years) in patients treated with this drug. * Determine quality of life of patients treated with this drug. * Determine the adverse effects of this drug in these patients. * Determine the change over time of symptom and quality of life variables (e.g., fatigue) in patients treated with this drug. OUTLINE: This is a partially randomized, pilot study. Patients are stratified according to age (\< 65 years vs ≥ 65 years). Patients are assigned to 1 of 2 treatment groups based on participation in the pharmacokinetic (PK) portion of the study. * Group 1 (PK study, initial therapy): Patients are randomized to 1 of 2 treatment arms. * Arm I: Five patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. * Arm II: Five patients receive epoetin alfa SC once weekly until hematocrit is \> 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients in both arms also undergo PK sampling periodically during study treatment. * Group 2 (non-PK study, initial therapy): Fifteen patients receive epoetin alfa SC once weekly until hematocrit is \> 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. * Maintenance therapy: Patients receive epoetin alfa SC once every other week for up to 24 weeks of total treatment (including both initial therapy and maintenance therapy). Patients whose blood counts fall below the critical levels are placed on a weekly dosing schedule. Patients whose blood counts rise too high discontinue study drug until blood counts are reduced. Quality of life (including fatigue) is assessed at baseline and then every 4 weeks for 28 weeks. After completion of study therapy, patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Anemia Fatigue Unspecified Adult Solid Tumor, Protocol Specific

fatigue anemia unspecified adult solid tumor, protocol specific

null

3

arm 1: Weekly dosing schedule subjects will get the study drug once every week until the end of the study. arm 2: Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who consented to pharmacokinetic testing arm 3: Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. Subjects who did not consent to pharmacokinetic testing.

[ 1, 0, 0 ]

2

[ 0, 0 ]

intervention 1: The dose is standard of care, the investigational piece is the dosing schedule itself. Either weekly or Interval-dosing schedule subjects will get the study drug once every week until hematocrit is greater than 36% or Hemoglobin reaches a value of 12 g/dl, then they will get study drug once every other week. intervention 2: The dosing of Procrit is standard of care, it is the schedule that is the investigational piece.

intervention 1: Weekly procrit dosing intervention 2: Interval Dosing

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00258440

[ 5 ]

406

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control. Response to omalizumab over time will be assessed by physicians and patients evaluating the overall improvement in control of their asthma. THIS STUDY IS NOT ENROLLING PATIENTS IN THE US.

null

Asthma

Asthma omalizumab Severe persistent allergic asthma

null

2

arm 1: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level. arm 2: During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for 32 weeks.

[ 0, 1 ]

2

[ 0, 10 ]

intervention 1: Omalizumab administered by subcutaneous injection. The dosage received was individualized based on body weight and serum IgE level. intervention 2: Optimized asthma therapy (OAT) according to Global Initiative for Asthma (GINA) 2004 guidelines during the first 4 weeks of the run-in period of the study.

intervention 1: Omalizumab intervention 2: Optimized asthma therapy

17

Brussels | N/A | Belgium | 4.34878 | 50.85045 Montreal | N/A | Canada | -73.58781 | 45.50884 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Berlin | N/A | Germany | 13.41053 | 52.52437 Athens | N/A | Greece | 23.72784 | 37.98376 Budapest | N/A | Hungary | 19.04045 | 47.49835 Dublin | N/A | Ireland | -6.24889 | 53.33306 Haifa | N/A | Israel | 34.99928 | 32.81303 Roma | N/A | Italy | 11.10642 | 44.99364 Oslo | N/A | Norway | 10.74609 | 59.91273 Lodz | N/A | Poland | 19.47395 | 51.77058 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Madrid | N/A | Spain | -3.70256 | 40.4165 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Bern | N/A | Switzerland | 7.44744 | 46.94809 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536

0

NCT00264849

[ 4 ]

1,565

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

true

1FEMALE

true

This is a multicenter, randomized, double-masked, controlled, phase III study of repeated use of C31G vaginal gel compared to Conceptrol® Vaginal Gel as the primary method of contraception over six months (183 days) and at least six cycles of use. In addition, there is an opportunity for subjects to continue with study treatment for up to twelve months (365 days) and twelve cycles of treatment upon completion of the first six months of treatment.

Approximately 85% of American women (52 million) between the ages of 15 and 44 are sexually active . Approximately two-thirds or 38 million women use some form of birth control and/or STD prevention. With growing awareness of the risk of STDs, increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function. Currently there is no single, reasonably effective method to achieve both ends. Condoms, both male and female, present problems of acceptability for the partners of many at-risk women and, thus, cannot be considered an effective contraceptive and STD preventive for many people. A spermicide that also has the ability to prevent transmission of STDs would be a major advance, and of tremendous value to women worldwide. C31G is an effective spermicide with in vitro activity equal to that of N-9 . C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals, active against both gram-positive and gram-negative organisms, including chlamydia, and a range of antibiotic resistant strains. It is also active against enveloped viruses including HIV and HSV. Thus, the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol® Vaginal Gel. The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months. Additional evaluations include the incidence of urinary tract infections (UTI), bacterial vaginosis (BV) and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol® Vaginal Gel.

Pregnancy

contraception

null

2

arm 1: C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel arm 2: Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The subject will insert one applicator of C31G prior to each episode of vaginal intercourse during her participation in the study. intervention 2: The subject will insert one applicator of Conceptrol® vaginal gel (nonoxynol-9) prior to each episode of vaginal intercourse during her participation in the study.

intervention 1: C31G intervention 2: nonoxynol-9 (N-9)

15

0

NCT00274261

[ 5 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

The purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach. The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and is already marketed for treating GERD. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very small, unnoticeable amounts of rising stomach acid may cause patients to cough. Because there may be a link between chronic cough and GERD, study doctors are interested in learning if giving high-dose Nexium (40 milligrams, twice daily) will help in treating chronic cough.

This study will be a randomized, double-blind, placebo controlled, comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the Otolaryngology/ Head and Neck Surgery, Pulmonary Medicine, and Gastroenterology outpatient clinics at the University of North Carolina Hospital system. Potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics. Those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough. Potential subjects will be consented for the study prior to leaving the enrolling clinic. A total of 40 subjects will be recruited into our study.

Cough GERD

null

2

arm 1: 40mg Esomeprazole BID arm 2: placebo capsules

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 40mg capsule BID for 12 weeks intervention 2: placebo capsule BID for 12 weeks

intervention 1: Esomeprazole intervention 2: Placebo

1

Chapel Hill | North Carolina | United States | -79.05584 | 35.9132

0

NCT00287339

[ 4 ]

1,523

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

null

Chronic Obstructive Pulmonary Disease (COPD)

Roflumilast COPD Chronic obstructive pulmonary disease

null

2

arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily

intervention 1: Roflumilast intervention 2: Placebo

179

Fullerton | California | United States | -117.92534 | 33.87029 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Palmdale | California | United States | -118.11646 | 34.57943 Rancho Mirage | California | United States | -116.41279 | 33.73974 San Diego | California | United States | -117.16472 | 32.71571 Bay Pines | Florida | United States | -82.77816 | 27.81419 Miami | Florida | United States | -80.19366 | 25.77427 Panama City | Florida | United States | -85.65983 | 30.15946 Atlanta | Georgia | United States | -84.38798 | 33.749 Marietta | Georgia | United States | -84.54993 | 33.9526 Hines | Illinois | United States | -87.8395 | 41.85364 South Bend | Indiana | United States | -86.25001 | 41.68338 Lebanon | Kentucky | United States | -85.25274 | 37.56979 Metairie | Louisiana | United States | -90.15285 | 29.98409 New Orleans | Louisiana | United States | -90.07507 | 29.95465 Slidell | Louisiana | United States | -89.78117 | 30.27519 Sunset | Louisiana | United States | -92.06845 | 30.41131 Bangor | Maine | United States | -68.77265 | 44.79884 Baltimore | Maryland | United States | -76.61219 | 39.29038 North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 Edina | Minnesota | United States | -93.34995 | 44.88969 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Chesterfield | Missouri | United States | -90.57707 | 38.66311 St Louis | Missouri | United States | -90.19789 | 38.62727 Billings | Montana | United States | -108.50069 | 45.78329 Missoula | Montana | United States | -113.994 | 46.87215 Lincoln | Nebraska | United States | -96.66696 | 40.8 Omaha | Nebraska | United States | -95.94043 | 41.25626 Reno | Nevada | United States | -119.8138 | 39.52963 Cherry Hill | New Jersey | United States | -75.03073 | 39.93484 Springfield | New Jersey | United States | -74.31723 | 40.70491 New York | New York | United States | -74.00597 | 40.71427 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Columbus | Ohio | United States | -82.99879 | 39.96118 Toledo | Ohio | United States | -83.55521 | 41.66394 Youngstown | Ohio | United States | -80.64952 | 41.09978 Lake Oswego | Oregon | United States | -122.67065 | 45.42067 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Cranston | Rhode Island | United States | -71.43728 | 41.77982 East Providence | Rhode Island | United States | -71.37005 | 41.81371 Austin | Texas | United States | -97.74306 | 30.26715 Dallas | Texas | United States | -96.80667 | 32.78306 Charlottesville, VA | Virginia | United States | -78.47668 | 38.02931 Bellingham | Washington | United States | -122.48822 | 48.75955 Marietta | Wisconsin | United States | N/A | N/A Adelaide South Australia | N/A | Australia | N/A | N/A Box Hill | N/A | Australia | 145.12545 | -37.81887 Camperdown | N/A | Australia | 151.17642 | -33.88965 Clayton | N/A | Australia | 145.11667 | -37.91667 Concord | N/A | Australia | 151.10381 | -33.84722 Geelong | N/A | Australia | 144.36069 | -38.14711 Kippa-Ring | N/A | Australia | 153.0835 | -27.22586 Nedlands | N/A | Australia | 115.8073 | -31.98184 South Brisbane | N/A | Australia | 153.02049 | -27.48034 Toorak Gardens | N/A | Australia | 138.63639 | -34.93478 Wayville | N/A | Australia | 138.59132 | -34.94468 Feldbach | N/A | Austria | 15.88833 | 46.95306 Gänserndorf | N/A | Austria | 16.72016 | 48.33925 Hallein | N/A | Austria | 13.1 | 47.68333 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Natters | N/A | Austria | 11.37342 | 47.23414 Spittal an der Drau | N/A | Austria | 13.5 | 46.8 Belo Horizonte - MG CEP | N/A | Brazil | N/A | N/A Botucatu - SP CEP | N/A | Brazil | N/A | N/A Curitiba-PR | N/A | Brazil | N/A | N/A Florianópolis-SC | N/A | Brazil | N/A | N/A Juiz de Fora-MG | N/A | Brazil | N/A | N/A Porto Alegre | N/A | Brazil | -51.23019 | -30.03283 Porto Alegre-RS | N/A | Brazil | N/A | N/A Porto Alegre-RS | N/A | Brazil | N/A | N/A Quadra 605 Brasilia - DF | N/A | Brazil | N/A | N/A Recife - PE | N/A | Brazil | N/A | N/A Rio de Janeiro-RJ | N/A | Brazil | N/A | N/A Santo André-SP | N/A | Brazil | N/A | N/A São Paulo-SP | N/A | Brazil | N/A | N/A São Paulo-SP | N/A | Brazil | N/A | N/A São Paulo-SP | N/A | Brazil | N/A | N/A Beuvry | N/A | France | 2.68541 | 50.51674 Chauny | N/A | France | 3.21857 | 49.61514 Clermont-Ferrand Cedex1 | N/A | France | N/A | N/A Ferolles-Attily | N/A | France | N/A | N/A Grasse | N/A | France | 6.92537 | 43.65783 La Teste-de-Buch | N/A | France | -1.14513 | 44.63278 Lens | N/A | France | 2.82791 | 50.43302 Libourne | N/A | France | -0.24186 | 44.91449 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Marcq-en-Barœul | N/A | France | 3.08333 | 50.66667 Martigues | N/A | France | 5.05526 | 43.40735 Metz | N/A | France | 6.17269 | 49.11911 Montigny-lès-Metz | N/A | France | 6.15271 | 49.0956 Montpellier | N/A | France | 3.87635 | 43.61093 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Nîmes | N/A | France | 4.35788 | 43.83665 Ollioules | N/A | France | 5.84766 | 43.1399 Paris | N/A | France | 2.3488 | 48.85341 Perpignan | N/A | France | 2.89541 | 42.69764 Saint-Etienne | N/A | France | 4.39 | 45.43389 Saint-Laurent-du-Var | N/A | France | 7.19 | 43.67323 Saint-Quentin | N/A | France | 3.28757 | 49.84889 Toulon | N/A | France | 5.92836 | 43.12442 Vieux-Condé | N/A | France | 3.56738 | 50.45944 Deggendorf | N/A | Germany | 12.96068 | 48.84085 Fulda | N/A | Germany | 9.67518 | 50.55162 Kassel | N/A | Germany | 9.5 | 51.31667 Lübeck | N/A | Germany | 10.68729 | 53.86893 Marburg | N/A | Germany | 8.77069 | 50.80904 Schwetzingen | N/A | Germany | 8.5823 | 49.38217 Balassagyarmat | N/A | Hungary | 19.29614 | 48.07296 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 Gyula | N/A | Hungary | 21.28333 | 46.65 Komárom | N/A | Hungary | 18.11913 | 47.74318 Mosdós | N/A | Hungary | 17.98853 | 46.35379 Mosonmagyaróvár | N/A | Hungary | 17.26994 | 47.86789 Nyiregyháza | N/A | Hungary | N/A | N/A Pécs | N/A | Hungary | 18.23083 | 46.0725 Szeged | N/A | Hungary | 20.14824 | 46.253 Tapolca | N/A | Hungary | 17.44117 | 46.88152 Tauranga | N/A | New Zealand | 176.16667 | -37.68611 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 Bucharest | N/A | Romania | 26.10626 | 44.43225 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Baillieston, Glasgow | N/A | United Kingdom | N/A | N/A Bangor, Northern Ireland | N/A | United Kingdom | -5.66802 | 54.66079 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Bath, Avon | N/A | United Kingdom | N/A | N/A Belfast | N/A | United Kingdom | -5.92541 | 54.59682 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Chesterfield | N/A | United Kingdom | -1.41667 | 53.25 Co. Antrim | N/A | United Kingdom | N/A | N/A Cottingham, E York | N/A | United Kingdom | -0.7554 | 52.50243 County Antrim | N/A | United Kingdom | N/A | N/A Downpatrick, Northern Ireland | N/A | United Kingdom | -5.71529 | 54.32814 East Sussex | N/A | United Kingdom | N/A | N/A East Sussex | N/A | United Kingdom | N/A | N/A Fife | N/A | United Kingdom | N/A | N/A Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Glengormley Newtownabbey | N/A | United Kingdom | N/A | N/A Harrow | N/A | United Kingdom | -0.33208 | 51.57835 Kent | N/A | United Kingdom | 0.52021 | 51.27893 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536 Randalstown | N/A | United Kingdom | -6.3 | 54.75 Royal Leamington Spa | N/A | United Kingdom | -1.52 | 52.2852 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297 Solihull | N/A | United Kingdom | -1.78094 | 52.41426 Southampton | N/A | United Kingdom | -1.40428 | 50.90395 Southdown, Bath | N/A | United Kingdom | N/A | N/A Sunbury on Thames, Middlesex | N/A | United Kingdom | N/A | N/A Vale of Glamorgan | N/A | United Kingdom | N/A | N/A

0

NCT00297102

[ 4 ]

37

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

null

Asthma

Asthma AMP Ciclesonide Fluticasone propionate

null

2

arm 1: Ciclesonide 160 µg arm 2: Fluticasone 100 µg

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: inhaled Ciclesonide 160 µg, once daily in the morning intervention 2: inhaled Fluticasone 100 µg, twice daily

intervention 1: Ciclesonide intervention 2: Fluticasone

1

RB Groningen | N/A | Netherlands | N/A | N/A

0

NCT00306163

[ 3 ]

60

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine whether food has any effect on a single dose of Cediranib (AZD2171, Recentin™)followed by an assessment of the safety and tolerability of fixed daily dosing in comparison to varying dose levels on a patient-by-patient basis.

null

Cancer

Advanced solid tumours Advanced cancer tumor tumour RECENTIN

null

4

arm 1: Part A: Cediranib 45 mg Fed State arm 2: Part A: Cediranib 45 mg Fasted State arm 3: Part B: Cediranib 45 mg Fixed Dose arm 4: Part B: Cediranib 30 - 90 mg Dose Escalation

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 45 mg oral dose intervention 2: oral tablet dose escalation

intervention 1: Cediranib intervention 2: Cediranib 30 - 90 mg

4

Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Headington | N/A | United Kingdom | -1.21974 | 51.75737 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT00306891

[ 4 ]

677

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

null

The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

null

Diabetes Type 2

null

2

arm 1: Technosphere® Insulin Inhalation Powder + insulin glargine arm 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Inhalation, 15U/30U intervention 2: BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

151

0

NCT00309244

[ 3 ]

11

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults. There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system \[immune system\]) which have been used in a small number of patients are not well known and can cause long term problems. The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.

This study consists of 11 visits (including screening). Screening Procedures: A chest radiograph (PA and lateral) must be obtained within 3 months prior to the first study injection. It must indicate that subject is free of tuberculosis (TB). The chest radiograph will also be used to confirm the stage of the disease. Histologically proven sarcoidosis will be confirmed. Demographic data, a complete medical history (including signs and symptoms of sarcoidosis), a physical examination (including vital signs, weight and height). The medical history will include questions about history of recent TB and history of close contact with persons who might have TB. Concomitant medications, including the use of oral corticosteroids and immunosuppressants, will be reviewed and recorded. In addition the inclusion and exclusion criteria will be reviewed. A tuberculin skin test will be performed. A serum pregnancy test will be performed for all women within the 4-week period prior to the Baseline (Week 0) Visit. All women must test negative for pregnancy at screening. ATS dyspnea score will be assessed. The 6-minute walk test will be performed with Borg's CR10 dyspnea score obtained before and after. Pulmonary function tests \[PFTs\] (spirometry) will be performed. Blood samples for routine laboratory analyses will be obtained. AE monitoring will also be performed. Subjects who qualify for the study should be assigned to receive treatment within 14 days of the screening visit except if additional time is required for repeat TB skin testing. Patients should still meet all of the inclusion criteria and none of the exclusion criteria at the time of the baseline visit before starting the injections. Subjects must agree to use appropriate contraception. The procedures involved at all study visits are described below. * Informed Consent: (Screening Visit): Subjects will be asked to review this consent form and discuss with the study doctor or study staff any questions they may have * Health and Medication Questions: (Screen, Weeks 0, 2, 6, 12, 24, 30, 36, 45, 52): Subjects will be asked to answer questions about their health, their medical history, and the medications they take. * Physical Exam: (Screen, Weeks 6, 24, 52): Do a physical exam. * Vital Signs: (Screen, Weeks 0, 6, 12, 24, 52): Blood Pressure, Pulse, Temperature * Height and Weight: (Screen, Week 52) * Blood Tests: (Screen, Weeks 12, 24, 45, 52): Approximately 3 teaspoons of blood will be drawn from a vein in subject's hand or arm for these tests. * Lung Function Test: (Screen, Weeks 24, 52): Subject will be given a mouthpiece and asked to take deep breaths into a machine connected to a computer according to the cues of a staff member. The machine will measure the capacity of subject's lungs. * Chest X-ray: (Screen, Weeks 12, 24, 52): * Tuberculosis Test: (Screen only): Subject will be asked specific questions regarding their history of tuberculosis (also called TB: a type of bacterial lung infection) or personal contact with people with active tuberculosis. Subjects with active tuberculosis cannot be in the study. Subjects will be given a skin test for tuberculosis. For all subjects in this trial, a TB skin test with negative results must be obtained. * 6 Minute Walk Test: (Screen, Weeks 0, 12, 24, 52): Subject will be asked to complete a test where they will walk for 6 minutes. Subject will be asked specific questions regarding any shortness of breath they have. * Pregnancy Test: (Screen only): A pregnancy blood test will be performed on all women of childbearing potential at the screening visit. The results of the test must be negative in order for subject to participate in the study. * ECG: (Week 0 only) * Study Drug Administration: (Weeks 0, 2, 6, 12, 18, 24, 30, 36, 45): Subject will receive study drug at the Week 0 Visit and be taught how to give themselves injections. Subject will be given a supply of study drug and clinical supplies that will last until the next study visit. Subject will be required to return all unused study drug as well as the packaging for the used study drug at each visit. * Questionnaires: (Weeks 0, 2, 12, 18, 24, 30, 36, 45): Prior to receiving any study drug, subject will be asked questions about their symptoms and quality of life, including their ability to care for themselves and carry out normal everyday activities (respiratory and health surveys) and health questionnaires. All subjects will return for efficacy and safety evaluations at each time point including week 52, whether or not they complete the entire treatment schedule and whether or not they are (still) responding to treatment. We will watch carefully for signs and symptoms of CHF and active TB at follow-up evaluations for all patients. The study agent will be stopped in subjects who are found to have NYHA Class III or IV CHF, severe right-sided heart failure, cor pulmonale, and/or active TB after enrollment in the study but they must return for further follow-up evaluations.

Sarcoidosis

Sarcoidosis Humira Adalimumab Tumor Necrosis Factor Inhibitors

null

1

arm 1: Patients received adalimumab 40 mg weekly for 45 weeks, with a final follow-up at Week 52

[ 0 ]

1

[ 0 ]

intervention 1: Subjects will give themselves a dose of Adalimumab at 40 mg/every week by subcutaneous injection for a total of 45 weeks.

intervention 1: Adalimumab

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00311246

[ 4 ]

768

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Diabetes

null

3

arm 1: Metformin 500-2500 mg (as needed) arm 2: Metformin 500-2500 mg (as needed) arm 3: Metformin 500-2500 mg (as needed)

[ 0, 0, 2 ]

6

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

intervention 1: Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term \[ST\], 12 months long-term \[LT\]) intervention 2: Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT). intervention 3: Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT) intervention 4: Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT) intervention 5: Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT) intervention 6: Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Glyburide intervention 4: Placebo intervention 5: Glyburide intervention 6: Metformin

115

0

NCT00313313

[ 5 ]

220

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)

null

Central Neuropathic Pain

Post-stroke pain, pregabalin

null

2

arm 1: The change from in pain scores from baseline to endpoint among stroke subjects receiving pregabalin will be compared to change in pain scores from baseline to endpoint among stroke subjects receiving matched placebo. arm 2: The change in pain scores from baseline to endpoint will be compared among the two treatment groups- ie subjects receiving 12 weeks of pregabalin treatment vs subjects receiving 12 weeks of placebo treatment.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13. intervention 2: Eligible subjects with post-stroke central pain will be randomized to receive double blinded treatment using pregabalin or matched placebo. The effects of pregabalin as compared to placebo on pain pain symptoms will be compared over the 13 week clinical trial. At baseline following pain ratings and clinical measures, subjects randomized to pregabalin receive instructions to take 75mg twice a day for 7days. The dosing of pregabalin or matching placebo will be titrated over the first 4 weeks (based on tolerability and pain scores). (Range 150-600mg) After the 4th week, the dose of medication will be maintained until week 12 (when tapering of medication begins) Ratings of Pain severity, review of pain/sleep diaries as well as medication tolerance occur bi-weekly throughout the study. Tapering off med occurs from week 12-13.

intervention 1: Pregabalin intervention 2: Placebo

33

Darlinghurst | New South Wales | Australia | 151.21925 | -33.87939 East Gosford | New South Wales | Australia | 151.35338 | -33.43874 St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Warrawong | New South Wales | Australia | 150.88833 | -34.485 Herston | Queensland | Australia | 153.01852 | -27.44453 Footscray | Victoria | Australia | 144.9 | -37.8 Perth | Western Australia | Australia | 115.8614 | -31.95224 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Guangzhou | N/A | China | 113.25 | 23.11667 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 121.45806 | 31.22222 New Territories | N/A | Hong Kong | 114.11095 | 22.42441 Bangalore | N/A | India | 77.59369 | 12.97194 Bangalore | N/A | India | 77.59369 | 12.97194 Chennai | N/A | India | 80.27847 | 13.08784 Lucknow | N/A | India | 80.92313 | 26.83928 New Delhi | N/A | India | 77.2148 | 28.62137 Jakarta | N/A | Indonesia | 106.84513 | -6.21462 Surabaya | N/A | Indonesia | 112.75083 | -7.24917 George Town | N/A | Malaysia | 100.33543 | 5.41123 Kuala Lumpur | N/A | Malaysia | 101.68653 | 3.1412 Kuala Selangor | N/A | Malaysia | 101.25 | 3.35 Karachi | Sindh | Pakistan | 67.0104 | 24.8608 Karachi | N/A | Pakistan | 67.0104 | 24.8608 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Seoul | N/A | South Korea | 126.9784 | 37.566 Gueishan Shiang | Taoyuan Hsien | Taiwan | N/A | N/A Taichung | N/A | Taiwan | 120.6839 | 24.1469 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Ratchatewee | Bangkok | Thailand | N/A | N/A Bangkok | N/A | Thailand | 100.50144 | 13.75398

0

NCT00313820

[ 3 ]

225

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

true

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of budesonide may keep lung cancer from forming in patients with lung nodules. PURPOSE: This randomized phase II trial is studying how well inhalation budesonide works in treating patients with lung nodules who are at high risk of lung cancer.

OBJECTIVES: Primary * Evaluate the effect, in terms of size and number reduction of computed tomography (CT) scan-detected undetermined lung nodules, in asymptomatic subjects with lung nodules at high-risk for developing lung cancer treated with inhaled budesonide vs placebo. Secondary * Compare average modification of nodule size and nodule number due to inhaled budesonide versus placebo. * Correlate the modulation of biological markers of lung cancer in serum and sputum after treatment with the modification of lung nodules sizes. * Determine treatment toxicity, side effects, and safety of inhaled budesonide. * Evaluate the role of CT scans in estimating the grade of respiratory impairment and emphysema. * Determine the effect of inhaled budesonide on respiratory function before and after treatment. OUTLINE: This is a randomized, double-blind, placebo controlled study. Participants are stratified according to gender, smoking habit (current vs former smoker), and nodule characteristics (solid vs semisolid or non-solid). Participants are randomized into 1 of 2 treatment arms. * Arm I: Subjects receive inhaled budesonide twice daily for 1 year in the absence of unacceptable toxicity. * Arm II: Subjects receive inhaled placebo twice daily for 1 year in the absence of unacceptable toxicity. Participants undergo blood and sputum collection periodically during study for biomarker and correlative studies. After completion of study therapy, subjects are followed at 1 month and continue CT scan screening. PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Lung Cancer

Small cell lung cancer Non-small cell lung cancer Budesonide Entocort EC Pulmicort Respules Rhinocort aqua Aerosol budesonide treatment Smoking

null

2

arm 1: Inhaled Budesonide 800 ug twice daily for 1 year arm 2: Inhaled placebo twice daily for 1 year

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Inhaled Budesonide 800 micrograms (ug) twice daily for one year. intervention 2: Inhaled placebo twice daily for one year.

intervention 1: Budesonide intervention 2: Placebo

1

Milan | N/A | Italy | 9.18951 | 45.46427

0

NCT00321893

[ 4 ]

92

NON_RANDOMIZED

SINGLE_GROUP

2DIAGNOSTIC

0NONE

false

0ALL

false

The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.

null

Central Nervous System Diseases

disease of the central nervous system (brain or spine)

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: A dose of 0.10 mmol/kg (i.e., 0.2 mL/kg) of 0.5 molar MultiHance was injected intravenously at a rate of 2 mL/sec as a single dose.

intervention 1: gadobenate dimeglumine

1

Princeton | New Jersey | United States | -74.65905 | 40.34872

0

NCT00323310

[ 5 ]

404

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is an initial placebo-controlled study followed by open treatment evaluating the effectiveness and tolerability of ropinirole long-term in patients with moderate to severe Restless Legs Syndrome.

A randomised, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of ropinirole for 26 weeks and to further evaluate the incidence of augmentation and rebound for a further 40 weeks open-label extension treatment period in subjects suffering from moderate to severe Restless Legs Syndrome.

Restless Legs Syndrome

Moderate Restless Legs Syndrome Severe ropinirole

null

2

arm 1: Double-blind (Ropinirole:Placebo) for 12 to 26 weeks arm 2: Open label ropinirole for 40 weeks

[ 2, 5 ]

2

[ 0, 0 ]

intervention 1: Matching Placebo intervention 2: Ropinirole IR 0.25mg/day to 4mg/day for RLS

intervention 1: Placebo intervention 2: Ropinirole

39

Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Kippa-Ring | Queensland | Australia | 153.0835 | -27.22586 Woodville | South Australia | Australia | 138.54291 | -34.877 Clayton | Victoria | Australia | 145.11667 | -37.91667 East Melbourne | Victoria | Australia | 144.9879 | -37.81667 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava | N/A | Czechia | 18.28204 | 49.83465 Pardubice | N/A | Czechia | 15.77659 | 50.04075 Prague | N/A | Czechia | 14.42076 | 50.08804 Aalborg | N/A | Denmark | 9.9187 | 57.048 Odense C | N/A | Denmark | 10.39538 | 55.40841 Vejle | N/A | Denmark | 9.5357 | 55.70927 Bamberg | Bavaria | Germany | 10.90067 | 49.89873 Munich | Bavaria | Germany | 11.57549 | 48.13743 Regensburg | Bavaria | Germany | 12.10161 | 49.01513 Marburg | Hesse | Germany | 8.77069 | 50.80904 Westerstede | Lower Saxony | Germany | 7.92737 | 53.25682 Schwerin | Mecklenburg-Vorpommern | Germany | 11.41316 | 53.62937 Berlin | State of Berlin | Germany | 13.41053 | 52.52437 Berlin | State of Berlin | Germany | 13.41053 | 52.52437 Bologna | Emilia-Romagna | Italy | 11.33875 | 44.49381 Rome | Lazio | Italy | 12.51133 | 41.89193 Pavia | Lombardy | Italy | 9.15917 | 45.19205 Hamar | N/A | Norway | 11.06798 | 60.7945 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Dubnica nad Váhom | N/A | Slovakia | 18.16634 | 48.95981 Levoča | N/A | Slovakia | 20.59212 | 49.02173 Žilina | N/A | Slovakia | 18.73941 | 49.22315 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165 San Sebastián | N/A | Spain | -5.9 | 43.56667 Avesta | N/A | Sweden | 16.16295 | 60.14274 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Örebro | N/A | Sweden | 15.2066 | 59.27412 Bern | N/A | Switzerland | 7.44744 | 46.94809 Zurich | N/A | Switzerland | 8.55 | 47.36667

0

NCT00329602

[ 4 ]

206

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

null

Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis free radical scavenger

null

2

arm 1: MCI-186 arm 2: Placebo of MCI-186

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2: Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

intervention 1: MCI-186 intervention 2: Placebo of MCI-186

0

null

0

NCT00330681

[ 3 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.

null

Metastatic Colorectal Cancer Skin Rash Skin Toxicities Colon Cancer Colorectal Cancer

STEPP STEP STEEP mCRC Skin Toxicities Skin Rash Metastatic Colorectal Cancer Anti-EGFr Skin Rash colon cancer colorectal cancer rectal cancer

null

2

arm 1: Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy. arm 2: Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.

[ 0, 0 ]

5

[ 2, 0, 0, 0, 0 ]

intervention 1: Administered by intravenous infusion intervention 2: Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines. intervention 3: Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines. intervention 4: Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily). intervention 5: Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine)

intervention 1: Panitumumab intervention 2: Irinotecan intervention 3: FOLFIRI intervention 4: Pre-emptive Skin Treatment intervention 5: Reactive Skin Treatment

0

null

0

NCT00332163

[ 3 ]

25

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.

The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in 20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Kleptomania

Compulsive Shoplifting Kleptomania Compulsive Stealing

null

2

arm 1: Naltrexone arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: daily intervention 2: daily

intervention 1: Naltrexone intervention 2: Placebo

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00332579

[ 3 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis

null

Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis

bowel obstruction, peritoneal carcinomatosis Octreotide inoperable

null

2

arm 1: Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. arm 2: Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

[ 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Octreotide long-acting release (LAR) 30 mg intramuscular injection. intervention 2: Immediate-release Octreotide supplied in 100 µg/mL ampules. intervention 3: methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). intervention 4: Physiologic saline solution

intervention 1: Octreotide LAR intervention 2: Octreotide (Immediate release) intervention 3: methylprednisolone intervention 4: Placebo

1

Créteil | N/A | France | 2.46569 | 48.79266

0

NCT00332696

[ 2 ]

16

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.

null

Tumors

Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists

null

3

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

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: tablets, Oral, 100 mg, once daily for 4 weeks intervention 2: tablets, Oral, 150 mg, once daily, 4 weeks intervention 3: tablets, Oral, 200 mg, once daily for 4 weeks

intervention 1: Dasatinib intervention 2: Dasatinib intervention 3: Dasatinib

2

0

NCT00339144

[ 3 ]

388

null

PARALLEL

0TREATMENT

null

false

0ALL

null

This is a 16 week multicentre, multinational, randomised, double-blind, double-dummy, placebo-controlled, parallel group study to evaluate the long-term efficacy and safety of tiotropium compared to salmeterol in moderate persistent asthmatic (GINA step 3) patients homozygous for arginine at the 16th amino acid position of the beta-adrenergic receptor (ADRB2). Following an initial 4-week run-in period on salmeterol MDI patients will be randomised into the 16 week double-blind treatment period in which they receive either tiotropium once daily administered from the Respimat inhaler or salmeterol twice daily administered from the hydrofluoro-alkane Metered Dose Inhaler (MDI), or placebo twice daily. After the 16 week treatment period all patients will receive salmeterol MDI twice daily for four weeks. The patients perform daily morning and evening peak flow (PEF) and Forced Expiratory Volume in the First Second (FEV1) measurements with an electronic peak flow meter throughout the study. Daily data on asthma control and use of rescue medication are recorded using an electronic diary included in the electronic peak flow meter. On study visits the Mini-Asthma Quality of Life Questionnaire (Elizabeth Juniper) is administered, pulse and blood pressure and pre-dose pulmonary function testing (FEV1 and Forced Vital Capacity) are performed.

null

Asthma

null

0

null

3

[ 0, 0, 0 ]

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

intervention 1: Tiotropium bromide intervention 2: Placebo intervention 3: Salmeterol xinafoate

109

Graz | N/A | Austria | 15.45 | 47.06667 Trofaiach | N/A | Austria | 15.00681 | 47.42524 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Wels | N/A | Austria | 14.03333 | 48.16667 Anderlecht | N/A | Belgium | 4.31454 | 50.83619 Angleur | N/A | Belgium | 5.59942 | 50.6113 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 Herentals | N/A | Belgium | 4.83248 | 51.17655 Malmedy | N/A | Belgium | 6.02794 | 50.42686 Menen | N/A | Belgium | 3.12245 | 50.79722 Montigny-le-Tilleul | N/A | Belgium | 4.37582 | 50.38056 Namur | N/A | Belgium | 4.86746 | 50.4669 Turnhout | N/A | Belgium | 4.94471 | 51.32254 Yvoir | N/A | Belgium | 4.88059 | 50.3279 Aalborg | N/A | Denmark | 9.9187 | 57.048 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 København NV | N/A | Denmark | 12.52343 | 55.71258 Odense C | N/A | Denmark | 10.39538 | 55.40841 Helsinki | N/A | Finland | 24.93545 | 60.16952 Jyväskylä | N/A | Finland | 25.72088 | 62.24147 Lahti | N/A | Finland | 25.66151 | 60.98267 Tampere | N/A | Finland | 23.78712 | 61.49911 Brest | N/A | France | -4.48628 | 48.39029 Chamalières | N/A | France | 3.06703 | 45.77364 Chauny | N/A | France | 3.21857 | 49.61514 Grenoble | N/A | France | 5.71479 | 45.17869 Montpellier | N/A | France | 3.87635 | 43.61093 Poitiers | N/A | France | 0.34348 | 46.58261 Saint Pierre La Réunion | N/A | France | N/A | N/A Saint Pierre La Réunion | N/A | France | N/A | N/A Beelitz-Heilstätten | N/A | Germany | 12.92662 | 52.25965 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bruchsal | N/A | Germany | 8.59804 | 49.12426 Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Kassel | N/A | Germany | 9.5 | 51.31667 Mainz | N/A | Germany | 8.2791 | 49.98419 Minden | N/A | Germany | 8.91455 | 52.28953 Neuruppin | N/A | Germany | 12.80311 | 52.92815 Rathenow | N/A | Germany | 12.33696 | 52.60659 Rüdersdorf | N/A | Germany | 13.78631 | 52.46927 Weinheim | N/A | Germany | 8.66697 | 49.54887 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Heraklion | N/A | Greece | 25.14341 | 35.32787 Kavala | N/A | Greece | 24.40687 | 40.93959 Larissa | N/A | Greece | 22.41761 | 39.63689 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Ferrara | N/A | Italy | 11.62057 | 44.83804 Florence | N/A | Italy | 11.24626 | 43.77925 Genova | N/A | Italy | 11.87211 | 45.21604 Modena | N/A | Italy | 10.92539 | 44.64783 Orbassano (to) | N/A | Italy | 7.53813 | 45.00547 Pavia | N/A | Italy | 9.15917 | 45.19205 Pisa | N/A | Italy | 10.4036 | 43.70853 Sesto San Giovanni (mi) | N/A | Italy | 9.22585 | 45.53329 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 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Banská Bystrica | N/A | Slovakia | 19.15349 | 48.73946 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Trenčín | N/A | Slovakia | 18.04436 | 48.89452 Žilina | N/A | Slovakia | 18.73941 | 49.22315 Bellville | N/A | South Africa | 18.62847 | -33.90022 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Centurion | N/A | South Africa | 28.18577 | -25.85891 Durban | N/A | South Africa | 31.0292 | -29.8579 George | N/A | South Africa | 22.46173 | -33.963 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Barcelona | N/A | Spain | 2.15899 | 41.38879 Centelles | N/A | Spain | 2.21902 | 41.79746 Guadalajara | N/A | Spain | -3.16185 | 40.62862 Las Palmas de Gran Canaria | N/A | Spain | -15.41343 | 28.09973 Lleida | N/A | Spain | 0.62218 | 41.61674 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Santander | N/A | Spain | -3.80444 | 43.46472 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 İzmit | N/A | Turkey (Türkiye) | 29.92928 | 40.76499 Manisa | N/A | Turkey (Türkiye) | 27.42647 | 38.61202 Aylesbury | N/A | United Kingdom | -0.81458 | 51.81665 Chertsey | N/A | United Kingdom | -0.50782 | 51.38812 Greenisland | N/A | United Kingdom | -5.87479 | 54.70081 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 Nottingham | N/A | United Kingdom | -1.15047 | 52.9536

0

NCT00350207

[ 2, 3 ]

8

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a Phase I/II trial of elderly patients (\> 70 years of age). Patients in this age group with previously un-treated Advanced Stage Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Therapy consists of three drugs (Premetrexed\[Alimta™\], Bevacizumab and Erlotinib\[Tarceva™\]) which are given every 28 days.

This is a Phase I/II trial of elderly patients (\> 70 years of age) with previously un-treated Advanced Stage Non-Squamous NSCLC with Stage IIIB (with malignant pleural effusion) and stage IV disease will be enrolled. Treatment Regimen: Premetrexed (Alimta™) 500 milligrams(mg)/Meter squared(m20 Intravenous(I.V.) Day 1 and Day 15; Bevacizumab 10mg/Kilogram(Kg) I. V. Day 1 and Day 15; Erlotinib (Tarceva™) 150mg Per Orally(PO) Once Daily(QD) for 7 days starting day 2 and day 15; Repeat cycles every 28 days. All three drugs will be continued for two cycles after maximal response. After which patient will be maintained only on the Bevacizumab and Erlotinib until progression. If patient has stable disease after the first two cycles then patient will be given another two cycles with all three drugs before maintenance treatment with Bevacizumab and Erlotinib is initiated.

Non-Small Cell Lung Cancer

null

1

arm 1: Single Arm Phase II trial in elderly patients with advanced stage Non-Squamous Non-Small Cell Lung Cancer

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Treatment Regimen Item 1: Bevacizumab 10 mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. intervention 2: Treatment Regimen Item 2: Erlotinib 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. intervention 3: Treatment Regimen Item 3: Premetrexed 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days.

intervention 1: Bevacizumab intervention 2: Erlotinib intervention 3: Pemetrexed

1

Tampa | Florida | United States | -82.45843 | 27.94752

0

NCT00351039

[ 4 ]

42

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a reaction to an infection elsewhere in the body. It is characterized by inflammation of the joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet are common. This study will determine the effectiveness of antibiotic therapy in treating people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.

The initial infection that causes reactive arthritis is caused by one of two bacteria: Chlamydia trachomatis, which is usually acquired through sexual contact, or Chlamydia pneumoniae, which can cause respiratory infections. Most people recover fully from the initial flare of arthritis symptoms. However, about 20% of people with reactive arthritis experience long-lasting symptoms. In these individuals, the Chlamydia bacteria exist in a persistent metabolically active state within the joint tissue, even years after the initial exposure. The bacteria produce heat shock proteins (HSPs), which are thought to play a key role in the chronic persistent state of Chlamydia and which may stimulate the immune inflammatory response seen in reactive arthritis. This indicates the need for antimicrobial therapy that can reduce Chlamydia's HSP production and block its metabolism. The purpose of this study is to determine the effectiveness of long-term combination antibiotic therapy in treating people with chronic reactive arthritis. The study will use two different combinations of common antibiotics: doxycycline paired with rifampin and azithromycin paired with rifampin. This study will entail 6 months of treatment followed by 3 months of follow-up. After screening, eligible participants will be randomly assigned to one of three treatment groups: rifampin once a day plus doxycycline twice a day; rifampin once a day plus azithromycin once a day for 5 days, then twice weekly; or placebo. Study visits will occur at baseline and Months 1, 3, 6, and 9. At all visits, participants will undergo an interview, a physical examination, and blood collection. They will also complete a questionnaire related to their symptoms and functional status. At screening and Month 6, a synovial biopsy may be performed. This will involve taking a sample of the tissue that lines the joints.

Arthritis, Reactive Reiter Disease

Chlamydia

null

3

arm 1: Participants received Azithromycin and Rifampin arm 2: Participants received Doxycycline and Rifampin arm 3: Participants received placebo

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: doxycycline 100mg daily; rifampin 300mg daily (both for 6 months) intervention 2: Azithromycin 500mg daily for 5 days and then twice weekly; Rifampin 300mg daily (both for 6 months) intervention 3: Methylcellulose

intervention 1: Doxycycline and Rifampin intervention 2: Azithromycin and Rifampin intervention 3: Placebo

3

0

NCT00351273

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Trichotillomania

Trichotillomania Hair-pulling

null

2

arm 1: N-Acetyl Cysteine arm 2: Placebo

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: daily intervention 2: 600mg capsules in varying doses for 12 weeks.

intervention 1: Placebo intervention 2: N-Acetyl Cysteine

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00354770

[ 3 ]

10

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

We are doing this research study to evaluate the effectiveness and safety of fluphenazine decanoate when injected with a needle into psoriasis lesions in adults. Fluphenazine decanoate is FDA (U.S. Food and Drug Administration) approved for use in people who have schizophrenia and psychotic symptoms. Fluphenazine decanoate is not approved by the FDA for use in psoriasis. Fluphenazine decanoate slows T cell growth in cells in laboratory test tubes. Its usefulness and safety in people with psoriasis will be investigated in this study.

Psoriasis is a hyperproliferative, inflammatory, immune-mediated skin disease that affects approximately 2% of the United States and European populations (Tutrone 2001, Kipnis 2005). This disease manifests as red, scaly plaques that are itchy and/or painful. Patients with psoriasis may be socially stigmatized because of their appearance. Currently, there is no cure for this condition. Often, repeated medical treatments are necessary and can become expensive. Treatment with topical corticosteroids is the mainstay therapy for mild to moderate psoriasis. In more severe cases, systemic therapies (e.g., cyclosporine) and phototherapy (e.g., ultraviolet B (UVB) irradiation) are used. These treatments, however, are associated with toxicities or inconvenience. There is anecdotal evidence to suggest that antipsychotic drugs have a beneficial effect on psoriasis (Gupta 2001, 2003). Fluphenazine is a phenothiazine antipsychotic drug. In vitro, fluphenazine kills activated human T cells under conditions that do not affect resting T cells (Immune Control Inc. data not shown). To determine the size of a therapeutic window for human peripheral blood mononuclear cells (PBMC)s, Immune Control Inc. performed the following experiments. First, phytohemagglutinin- (PHA)-activated cells were exposed to 2, 10, or 20 µM fluphenazine for 0, 18, 24, 36, 48, or 72 hours. Second, resting cells were exposed to identical fluphenazine concentrations for identical time periods, after which the drug was washed out of the cells, and the cells activated with PHA. In all cases, deoxyribonucleic acid (DNA) synthesis was measured by exposing the cells to tritiated thymidine, and measuring the incorporated nucleotide by scintillation counting. The data show that exposure of activated cells to 10 µM fluphenazine for 72 hours, or 20 µM fluphenazine for 36 hours, caused the death of virtually all of the activated cells. The ability of the resting cells to initiate DNA synthesis after activation, by contrast, was largely unaffected by these fluphenazine exposures. Although we cannot precisely control intralesional fluphenazine concentrations, we expect that injections of up to 1 mg fluphenazine decanoate will yield local concentrations that exceed 10 µM without significant systemic fluphenazine concentrations. We propose that fluphenazine will suppress proliferating T-lymphocytes in psoriatic plaques in vivo and thus result in healing of plaques. The objective of this study is to assess the safety and biologic activity of intralesional injection of fluphenazine decanoate in adult subjects with psoriasis.

Psoriasis

null

2

arm 1: Treated with fluphenazine arm 2: Treated with Placebo

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Fluphenazine decanoate marketed by APP Pharmaceuticals (25 mg/mL, 5 mL vial) was used in this study. This was an ascending dose study with the first cohort of 5 subjects dosed at 10 µg/mL, followed by 5 subject dosed in the second cohort at 100 µg/mL. Note: "APP Pharmaceuticals" is the name of the pharmaceutical company; APP is not an acronym. intervention 2: The sterile placebo (sesame oil with 1.2% (w/v) benzyl alcohol) was prepared at the University of Iowa, Division of Pharmaceutical Services, a FDA registered pharmaceutical manufacturing facility.

intervention 1: Fluphenazine Decanoate intervention 2: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00356200

[ 2 ]

12

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma.

Phase I trial, dose escalating, prospective, open-label, non-randomized, multicenter study. The purpose is to determine the safety, tolerability, dose limiting toxicity (DLT) and recommended dose (RD) of PM00104, administered intravenously over 1 hour daily for 5 days every 3 weeks (this is considered as 1 cycle) to subjects with advanced malignant solid tumors or lymphoma. Secondary objectives are to determine the preliminary pharmacokinetics of PM00104, to evaluate the relationship between pharmacokinetics/pharmacodynamics and to evaluate the preliminary antitumor activity of PM00104. Dose-escalation guidelines will follow an accelerated phase I design for conventional cytotoxic agents in order to minimize the number of subjects treated at the subtoxic dose levels. The trial will be conducted in compliance with the protocol, Good clinical practice (GCP) and applicable regulatory requirements.

Solid Tumors Lymphoma

Tumor Lymphoma Zalypsis PharmaMar PM00104

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Intravenously over 1 hour daily for 5 days, every 3 weeks.

intervention 1: PM00104

2

0

NCT00359294

[ 3 ]

171

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.

null

Alzheimer's Disease

Alzheimer Dementia

null

3

arm 1: AC-3933, 5mg twice daily arm 2: AC-3933, 20 mg twice daily arm 3: Sugar Pill twice daily

[ 0, 0, 2 ]

3

[ 0, 0, 10 ]

intervention 1: 5mg twice daily intervention 2: AC-3933, 20 mg twice daily intervention 3: Sugar Pill twice daily

intervention 1: AC-3933 intervention 2: AC-3933 intervention 3: Sugar Pill

34

0

NCT00359944

[ 5 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

People with allergies frequently complain of a loss or reduction in the sense of smell. In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.

null

Seasonal Allergic Rhinitis

null

2

arm 1: Mometasone intranasal steroid therapy daily for 2 weeks arm 2: 2 puffs of placebo spray in each nostril once daily

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 2 puffs in each nostril once daily of nasal spray intervention 2: 2 puffs in each nostril once daily of nasal spray

intervention 1: Mometasone intervention 2: Placebo

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00361439

[ 4 ]

39

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine if the study drug is effective and safe in the treatment of Multiple Sclerosis (MS) in patients of Chinese origin.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Multiple Sclerosis

MS

null

1

arm 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

[ 0 ]

1

[ 0 ]

intervention 1: Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)

intervention 1: Interferon beta-1b (Betaseron, BAY86-5046)

3

Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222

0

NCT00370071

[ 3 ]

19

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to monitor the blood values of these biomolecules at different time intervals, to optimize the synergism between pemetrexed and gemcitabine.

null

Non Small Cell Lung Cancer

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue intervention 2: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.

intervention 1: Pemetrexed - Before Protocol Amendment intervention 2: Pemetrexed - After Protocol Amendment

1

Milan | N/A | Italy | 12.59836 | 42.78235

0

NCT00370292

[ 3 ]

55

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

null

Breast Cancer Metastasis

Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer

null

2

arm 1: None arm 2: None

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months) intervention 2: Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg \<6 months)

intervention 1: Dasatinib intervention 2: Dasatinib

10

0

NCT00371254

[ 3 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

null

The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.

Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine self-administration to assess the potential efficacy of the novel antipsychotic, aripiprazole. Aripiprazole is a partial agonist at both the dopamine D2 receptor and at the serotonin 5HT1a receptor, while antagonizing the 5HT2a receptor. By functioning as a partial D2 agonist, aripiprazole is hypothesized to function as a D2 antagonist during hypodopaminergic states, such as during cocaine use, while functioning as a D2 agonist during hypodopaminergic states, such as during cocaine withdrawal. This 42-day, outpatient/inpatient/outpatient/inpatient protocol will evaluate the effects of aripiprazole maintenance (0, 15 mg/day) on cocaine craving, subjective effects, and self-administration using a within-subjects design. Non-treatment seeking cocaine abusers will be maintained outpatient for 16 days of dose maintenance prior to inpatient cocaine self-administration sessions. During the inpatient phases, volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to choose between repeated doses of smoked cocaine and $5. In addition to measuring their cocaine self-administration, we will measure the cardiovascular and subjective effects of cocaine under each aripiprazole maintenance condition.

Cocaine Abuse

Aripiprazole Cocaine abuse

null

2

arm 1: Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg). arm 2: Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg). intervention 2: Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

intervention 1: Aripiprazole + Cocaine intervention 2: Placebo + Cocaine

1

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

0

NCT00373880

[ 3 ]

99

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.

Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression. The thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts. This study will last 24 weeks. Participants will be randomly assigned to one of four arms: * Arm A participants will receive placebo * Arm B participants will receive palifermin 20 mcg/kg * Arm C participants will receive palifermin 40 mcg/kg * Arm D participants will receive palifermin 60 mcg/kg Participants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.

HIV Infections

Treatment Experienced

null

4

arm 1: Participants will receive palifermin placebo injection on Days 1, 2, and 3 arm 2: Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3 arm 3: Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3 arm 4: Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3

[ 2, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Keratinocyte growth factor administered via injection intervention 2: Keratinocyte growth factor placebo administered via injection

intervention 1: Palifermin intervention 2: Palifermin placebo

22

0

NCT00376935

[ 3 ]

27

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

The intent of this protocol is to screen a new agent for activity in patients with advanced or recurrent endometrial carcinoma. This phase II trial is studying how well pemetrexed disodium works in treating patients with advanced or recurrent endometrial carcinoma.

null

Neoplasms Neoplasms by Site Urogenital Neoplasms Genital Neoplasms, Female Uterine Neoplasms Endometrial Neoplasms Cancer of Endometrium Endometrial Cancer Cancer of the Endometrium Endometrium Cancer Neoplasms, Endometrial

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 900 mg/m2, intravenous (IV), every 21 days, until disease progression

intervention 1: pemetrexed

1

Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238

0

NCT00377520

[ 5 ]

484

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

null

Diabetes Mellitus, Type 2

diabetes type 2

null

2

arm 1: Insulin lispro mid mixture (MM) up to three times a day (TID) arm 2: Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks intervention 2: Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

intervention 1: Insulin lispro mid mixture (MM) intervention 2: Insulin glargine

25

Keswick | South Australia | Australia | 138.57459 | -34.94178 Fitzroy | Victoria | Australia | 144.97833 | -37.79839 Fremantle | Western Australia | Australia | 115.74557 | -32.05632 London | Ontario | Canada | -81.23304 | 42.98339 Granby | Quebec | Canada | -72.73243 | 45.40008 Sherbrooke | Quebec | Canada | -71.89908 | 45.40008 Regina | Saskatchewan | Canada | -104.6178 | 50.45008 Mantes-la-Jolie | N/A | France | 1.7167 | 48.99048 Menton | N/A | France | 7.50435 | 43.77649 Pau | N/A | France | -0.35583 | 43.31117 Poitiers | N/A | France | 0.34348 | 46.58261 Toulouse | N/A | France | 1.44367 | 43.60426 Chihuahua City | N/A | Mexico | -106.08889 | 28.63528 Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Arkhangelsk | N/A | Russia | 40.55291 | 64.54717 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Goyang-Si/Kyunggi-Do | N/A | South Korea | N/A | N/A Kwangju | N/A | South Korea | 127.1279 | 36.9122 Seoul | N/A | South Korea | 126.9784 | 37.566 Alicante | N/A | Spain | -0.48149 | 38.34517 Almería | N/A | Spain | -2.45974 | 36.83814 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bilbao | N/A | Spain | -2.92528 | 43.26271 Málaga | N/A | Spain | -4.42034 | 36.72016

0

NCT00377858

[ 3 ]

17

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurs first.

null

Non-small Cell Lung Cancer

null

1

arm 1: Single arm treatment with docetaxel, gemcitabine and bevacizumab

[ 0 ]

3

[ 0, 0, 0 ]

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

intervention 1: docetaxel intervention 2: gemcitabine intervention 3: bevacizumab

1

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

0

NCT00378573

[ 4 ]

781

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (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 hours) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) \[Time Frame: Baseline to Week 12\] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

null

Asthma

null

4

arm 1: None arm 2: None arm 3: None arm 4: None

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 200 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks

intervention 1: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID intervention 2: Mometasone furoate MDI (MF MDI) 200 mcg intervention 3: formoterol fumarate 10 mcg intervention 4: Placebo

0

null

0

NCT00383240

[ 4 ]

339

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.

GW has shown in phase II and III studies that Sativex has analgesic properties that are effective in relieving neuropathic pain. These studies suggested that Sativex is well tolerated and may also improve sleep and quality of life. GW is conducting this study to further demonstrate these effects.

Multiple Sclerosis

Central Neuropathic Pain

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg. intervention 2: Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.

intervention 1: Sativex intervention 2: Placebo

6

0

NCT00391079

[ 4 ]

1,683

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

true

1FEMALE

false

This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

null

Contraception

null

1

arm 1: Norethindrone/Ethinyl Estradiol

[ 0 ]

1

[ 0 ]

intervention 1: one tablet per day

intervention 1: Norethindrone acetate/ethinyl estradiol

66

0

NCT00391807

[ 3 ]

53

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Lymphoblastic Leukemia, Acute

Ph+ Acute Lymphoblastic Leukaemia Dasatinib targeted therapy Patients with Ph positive and or BCR ABL positive ALL

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Dasatinib

36

0

NCT00391989

[ 3 ]

44

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in advanced gastric cancer, which is the investigators study rationale.

There is presently no chemotherapy regimen considered to be the global standard of care for patients with AGC, and there is still a need for new agents and/or regimens to improve the efficacy and safety of chemotherapy in advanced stomach cancers. The combination of 5-fluorouracil plus cisplatin (FP) has been widely used for the first-line treatment of advanced gastric cancer in many countries. Randomized phase III trial investigating capecitabine plus cisplatin(XP) versus FP showed XP is at least as good as FP with improved patients' preference. A Phase II study of capecitabine plus oxaliplatin (XELOX) was conducted in our study group.

Gastric Cancer

gastric cancer chemotherapy cetuximab capecitabine oxaliplatin

null

1

arm 1: Capecitbine, oxaliplatin and cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.

[ 0 ]

1

[ 0 ]

intervention 1: Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.

intervention 1: Capecitabine, Oxaliplatin, Cetuximab

3

Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00398398

[ 5 ]

312

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo. Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

null

Parkinson Disease

null

4

arm 1: None arm 2: Pramipexole 0.5 mg tid (three times a day) arm 3: Pramipexole 0.5 mg bid (bis in die (two times a day)) arm 4: Pramipexole 0.75 mg bid (bis in die (two times a day))

[ 5, 5, 5, 5 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Pramipexole intervention 2: Placebo

39

0

NCT00402233

[ 4 ]

34

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

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 in liver transplant recipients

null

Liver Transplantation

Liver transplantation, mycophenolate, GI problems, Quality of Life

null

1

arm 1: Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.

[ 0 ]

1

[ 0 ]

intervention 1: experimental

intervention 1: Enteric-coated Mycophenolate sodium (EC-MPS)

1

Nuremberg | N/A | Germany | 11.07752 | 49.45421

0

NCT00405652

[ 5 ]

26

RANDOMIZED

FACTORIAL

0TREATMENT

3TRIPLE

false

0ALL

false

This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.

This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, continuation-phase study.

Major Depression

null

2

arm 1: Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. 300 mg of lamotrigine 2 hrs prior to ketamine infusion. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions. arm 2: 2 hours prior to ketamine infusion each patient received three capsules of placebo identical in size, weight, appearance, and taste to the lamotrigine tablets. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: anticonvulsant medication intervention 2: subanesthetic dose of NMDAR antagonist intervention 3: glutamate release inhibitor

intervention 1: Lamotrigine intervention 2: Ketamine intervention 3: Riluzole

1

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

0

NCT00419003

[ 5 ]

24

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

null

Spondylarthropathies, Enthesitis

Refractory Heel Enthesitis in Spondylarthropathy Spondylarthropathy Refractory Heel Enthesitis

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: 50 mg injection once weekly intervention 2: placebo

intervention 1: Etanercept intervention 2: Placebo

15

Arles | N/A | France | 4.63031 | 43.67681 Avignon | N/A | France | 4.80892 | 43.94834 Bordeaux | N/A | France | -0.5805 | 44.84044 Grenoble | N/A | France | 5.71479 | 45.17869 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Orléans | N/A | France | 1.90389 | 47.90289 Paris (Bichat) | N/A | France | 2.3488 | 48.85341 Paris (cochin) | N/A | France | 2.3488 | 48.85341 Paris (Pitie Salpetriere) | N/A | France | 2.3488 | 48.85341 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Herne | N/A | Germany | 7.22572 | 51.5388 Maastricht | N/A | Netherlands | 5.68889 | 50.84833

0

NCT00420303

[ 3 ]

92

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

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.

Postmenopause Hypertension Pre-Hypertension

Pre-Hypertension in Postmenopausal Women

null

3

arm 1: 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 2: 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 3: 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: SH K 00641 A -Active study medication encapsulated tablet intervention 2: SH K 00641 B - Active study medication encapsulated tablet intervention 3: Active control encapsulated tablet

intervention 1: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 2: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 3: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)

9

0

NCT00420342

[ 5 ]

121

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

null

Hyponatremia Euvolemia Hypervolemia

Hyponatremia Euvolemia Hypervolemia Conivaptan Vaprisol® YM087

null

4

arm 1: Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule arm 2: Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule arm 3: Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag arm 4: Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag

[ 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: ampoule or premix bag intervention 2: ampoule or premix bag

intervention 1: Conivaptan intervention 2: placebo

18

Charleston | South Carolina | United States | -79.93275 | 32.77632 Bangalore | N/A | India | 77.59369 | 12.97194 Bangalore | N/A | India | 77.59369 | 12.97194 Bhopal | N/A | India | 77.40289 | 23.25469 Hyderabaad | N/A | India | N/A | N/A Karnāl | N/A | India | 76.98448 | 29.69197 Afula | N/A | Israel | 35.2892 | 32.60907 Ashkelon | N/A | Israel | 34.57149 | 31.66926 Haifa | N/A | Israel | 34.99928 | 32.81303 Haifa | N/A | Israel | 34.99928 | 32.81303 Holon | N/A | Israel | 34.77918 | 32.01034 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Jerusalem | N/A | Israel | 35.21633 | 31.76904 Rehovot | N/A | Israel | 34.81199 | 31.89421 Safed | N/A | Israel | 35.496 | 32.96465 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Ẕerifin | N/A | Israel | 34.84852 | 31.95731

0

NCT00435591

[ 3 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources. The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia). More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing. Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom \[UK\] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis). The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.

Different application times of the study treatment were being investigated.

Photoaged Skin

PDT Photoaging Galderma

null

3

arm 1: Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\^2. The total study duration was 20 weeks. arm 2: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks. arm 3: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks.

[ 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants were treated with topical administration of Metvix cream. intervention 2: Participants were treated with topical administration of Metvix Vehicle cream.

intervention 1: Metvix Cream 160 mg/g intervention 2: Metvix Vehicle Group

3

Madrid | N/A | Spain | -3.70256 | 40.4165 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095

0

NCT00437320

[ 4 ]

456

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.

This is a multi-centre, randomised, double-blind, double-dummy, parallel-group, non-inferiority study comparing the efficacy and safety of the fixed combination of pyronaridine/artesunate (ie, PP/AS \[PA\]) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute uncomplicated P. vivax malaria. The study population will include 456 patients, comprising male and female children (≥20 kg body weight) and adults recruited from study sites in South East Asia and India. Patients will be randomised in a 1:1 ratio to receive either oral PA (180:60 mg tablets) plus chloroquine-placebo or oral chloroquine (155 mg tablets).plus PA-placebo, once a day for 3 consecutive days (Days 0, 1, and 2). For PA, posology was based on body weight ranges with subjects receiving 1 to 4 tablets depending on their body weight. The dose range covered by this regimen is 7.2:2.4 mg/kg to 13.8:4.6 mg/kg, which has been shown to be effective and safe in Phase I and II studies. The chloroquine daily dose is 10 mg/kg on Days 0 and 1 and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1 and 310 mg on Day 2 for adults. Patients will be confined to the study facility for ≥4 days (Days 0,1,2 \& 3) and ideally remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later. The primary efficacy end point for the study is the crude cure rate on Day 14, which is defined as the absence of P. vivax parasitaemia on Day 14. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event. For patients who complete the study up to Day 28 and who have normal glucose-6-phosphate dehydrogenase (G-6-PD) activity, a 14-day course of primaquine (15 mg/day for adults and 0.3 mg/kg/day for children) will be administered starting on Day 28 to complete their radical cure. Subjects who are deficient in G-6-PD and who completed the study up to Day 28 will be treated per country policy.

Malaria

P vivax malaria artemisinin based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)

null

2

arm 1: The tablet strength is 180:60 mg oral PA plus chloroquine-placebo. Depending on their body weight, patients receive 1 to 4 tablets once a day, for 3 days. The actual dose-level range covered by this regimen is 7.2: 2.4 mg/kg to 13.8:4.6 mg/kg pyronaridine artesunate. arm 2: The tablet strength is 155 mg oral chloroquine plus PA-placebo. Patients receive: For adults: 620 mg (i.e. 4 tablets) on Days 0 and 1 and 310 mg (i.e. 2 tablets) on Day 2. For children: 10 mg/kg on Days 0 and 1 and 5 mg/kg on Day 2.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Pyronaridine artesunate intervention 2: Chloroquine

5

0

NCT00440999

[ 5 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial obstruction attending emergency services

null

Acute Bronchial Obstruction, Asthma

Asthma, Formoterol, Bronchial Obstruction, Children

null

2

arm 1: Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. arm 2: Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 12 micrograms stat (twice if necessary). Inhaled via aerolizer intervention 2: 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

intervention 1: Formoterol fumerate intervention 2: fenoterol/ipratropium bromide

2

Caracas | N/A | Venezuela | -66.87919 | 10.48801 Maracaibo | N/A | Venezuela | -71.61089 | 10.64232

0

NCT00460577

[ 5 ]

171

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

null

Bacterial Conjunctivitis

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Day 1-6 = 1 drop of study medication three times a day intervention 2: Day 1-6 = 1 drop of study medication three times a day

intervention 1: gatifloxacin intervention 2: moxifloxacin 0.5% eye drops

2

0

NCT00464438

[ 3 ]

34

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IV melanoma.

OBJECTIVES: Primary * Determine the overall response rate, response duration, and frequency of progression-free survival at 6 months in patients with stage IV melanoma treated with erlotinib hydrochloride and bevacizumab. * Determine objective responses in patients treated with this regimen. Secondary * Determine the overall safety and tolerability of this regimen in these patients. * Evaluate tissue blocks for EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization(FISH)7p12-specific probe-overexpression or amplification in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral erlotinib hydrochloride once daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tissue collection to analyze EGFR by monoclonal antibody H11 (DAKO) or fluorescence in situ hybridization (FISH) 7p12-specific probe-overexpression or amplification. Biological markers AKT, MAPK, p27, p21, CD13, CD34, and factor VIII are also measured. After completion of study treatment, patients are followed periodically.

Melanoma

stage IV melanoma recurrent melanoma

null

1

arm 1: Tarceva and Avastin: * Tarceva: 150mg PO, days 1-28 * Avastin: 10mg/kg, IV infusion, days 1,15 Regimen will be repeated every 28 days = 1 course

[ 0 ]

7

[ 2, 0, 6, 6, 10, 10, 3 ]

intervention 1: 10mg/kg, slow IV infusion, Days 1 and 14 intervention 2: 150mg PO qd intervention 3: Targeting multiple genetic aberrations in isolated tumor cells. intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy

intervention 1: bevacizumab intervention 2: erlotinib hydrochloride intervention 3: fluorescence in situ hybridization intervention 4: gene expression analysis intervention 5: immunologic technique intervention 6: laboratory biomarker analysis intervention 7: biopsy

4

0

NCT00466687

[ 3 ]

12

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to determine the safety of intravenous cocaine in subjects receiving oral donepezil.

This is a randomized, double-blind, double-dummy, placebo controlled, inpatient, single-center, parallel group evaluation of the potential for oral donepezil to attenuate cocaine-induced craving. Non-treatment-seeking cocaine-experienced volunteers will receive baseline treatment with intravenous cocaine (30Mg). Forty-two subjects that tolerate baseline cocaine infusions will then receive two subsequent intravenous doses of cocaine during double-blind treatment with oral placebo or 5 mg daily of donepezil. Each dose of cocaine will be preceded or followed by administration of intravenous placebo (saline) in a random order.

Cocaine Abuse and Dependence

Acetylcholine Acetylcholinesterase Butyrylcholinesterase Cholinesterase Inhibitor

null

2

arm 1: Three days of daily treatment with oral placebo, followed by three days of daily treatment with 5 mg of donepezil arm 2: Three days of daily treatment with 5 mg of donepezil, followed by three days of daily treatment with oral placebo.

[ 0, 0 ]

2

[ 0, 10 ]

intervention 1: This is a commercially available cholinesterase inhibitor that is approved for use in Alzheimer's disease. intervention 2: Inactive Comparator with Similar Appearance to Active Medication

intervention 1: Donepezil, 5 mg daily intervention 2: Oral Placebo

1

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

0

NCT00467389

[ 4 ]

385

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

true

1FEMALE

false

The purpose of this study is to determine whether the study drug is safe and effective

Acronym is used in result section: suspected/diagnosed (susp/diag)

Neural Tube Defects Contraception Oral Contraceptives (OC)

Healthy women requesting contraception Folic Acid

null

2

arm 1: 1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks arm 2: 1 tablet 0.020 mg EE/3.0 mg DRSP \[YAZ\] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 0.020 mg ethinylestradiol with 3.0 mg drospirenone and 0.451 mg L-5-methyltetrahydrofolate (L-5-MTHF) intervention 2: 0.020 mg ethinylestradiol with 3.0 mg drospirenone

intervention 1: Drospirenone/Ethinylestradiol/Methyltetrahydrofolate intervention 2: Drospirenone/Ethinylestradiol (Yaz)

9

0

NCT00468481