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

[ 4 ]

607

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

null

Pancreatic Cancer

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Intervenous repeating dose

intervention 1: bevacizumab [Avastin]

101

Adelaide | N/A | Australia | 138.59863 | -34.92866 Camperdown | N/A | Australia | 151.17642 | -33.88965 Footscray | N/A | Australia | 144.9 | -37.8 Heidelberg | N/A | Australia | 145.06667 | -37.75 Kurralta Park | N/A | Australia | 138.56702 | -34.95142 Melbourne | N/A | Australia | 144.96332 | -37.814 Melbourne | N/A | Australia | 144.96332 | -37.814 St Leonards | N/A | Australia | 151.19836 | -33.82344 Sydney | N/A | Australia | 151.20732 | -33.86785 Sydney | N/A | Australia | 151.20732 | -33.86785 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Salzburg | N/A | Austria | 13.04399 | 47.79941 Vienna | N/A | Austria | 16.37208 | 48.20849 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Edmonton | Alberta | Canada | -113.46871 | 53.55014 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Toronto | Ontario | Canada | -79.39864 | 43.70643 Montreal | Quebec | Canada | -73.58781 | 45.50884 Québec | Quebec | Canada | -71.21454 | 46.81228 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | N/A | China | 121.45806 | 31.22222 Brno | N/A | Czechia | 16.60796 | 49.19522 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Helsinki | N/A | Finland | 24.93545 | 60.16952 Besançon | N/A | France | 6.01815 | 47.24878 Bordeaux | N/A | France | -0.5805 | 44.84044 Boulogne-Billancourt | N/A | France | 2.24128 | 48.83545 Clichy | N/A | France | 2.30952 | 48.90018 Limoges | N/A | France | 1.24759 | 45.83362 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Rouen | N/A | France | 1.09932 | 49.44313 Saint-Herblain | N/A | France | -1.651 | 47.21154 Strasbourg | N/A | France | 7.74553 | 48.58392 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Halle | N/A | Germany | 11.97947 | 51.48158 Hamburg | N/A | Germany | 9.99302 | 53.55073 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Leipzig | N/A | Germany | 12.37129 | 51.33962 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Mainz | N/A | Germany | 8.2791 | 49.98419 Mönchengladbach | N/A | Germany | 6.44172 | 51.18539 München | N/A | Germany | 13.31243 | 51.60698 Trier | N/A | Germany | 6.63935 | 49.75565 Kfar Saba | N/A | Israel | 34.90694 | 32.175 Petah Tikva | N/A | Israel | 34.88747 | 32.08707 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tel Aviv | N/A | Israel | 34.78057 | 32.08088 Bergamo | N/A | Italy | 9.66721 | 45.69601 Bologna | N/A | Italy | 11.33875 | 44.49381 Brescia | N/A | Italy | 10.21472 | 45.53558 Chieti | N/A | Italy | 14.16494 | 42.34827 Genova | N/A | Italy | 11.87211 | 45.21604 Napoli | N/A | Italy | 14.5195 | 40.87618 Orbassano | N/A | Italy | 7.53813 | 45.00547 Parma | N/A | Italy | 10.32618 | 44.79935 San Giovanni Rotondo | N/A | Italy | 15.7277 | 41.70643 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Christchurch | N/A | New Zealand | 172.63333 | -43.53333 Lima | N/A | Peru | -77.02824 | -12.04318 Lima | N/A | Peru | -77.02824 | -12.04318 Gliwice | N/A | Poland | 18.67658 | 50.29761 Lublin | N/A | Poland | 22.56667 | 51.25 Szczecin | N/A | Poland | 14.55302 | 53.42894 Wroclaw | N/A | Poland | 17.03333 | 51.1 Singapore | N/A | Singapore | 103.85007 | 1.28967 Singapore | N/A | Singapore | 103.85007 | 1.28967 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Córdoba | N/A | Spain | -4.77275 | 37.89155 Elche | N/A | Spain | -0.70107 | 38.26218 Madrid | N/A | Spain | -3.70256 | 40.4165 Santander | N/A | Spain | -3.80444 | 43.46472 Valencia | N/A | Spain | -0.37966 | 39.47391 Valencia | N/A | Spain | -0.37966 | 39.47391 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Kueishan | N/A | Taiwan | N/A | N/A Taipei | N/A | Taiwan | 121.52639 | 25.05306 Glasgow | N/A | United Kingdom | -4.25763 | 55.86515 Leicester | N/A | United Kingdom | -1.13169 | 52.6386 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Northwood | N/A | United Kingdom | -0.42454 | 51.61162 Sutton | N/A | United Kingdom | -0.2 | 51.35 Truro | N/A | United Kingdom | -5.05436 | 50.26526

1

NCT01214720

[ 4 ]

228

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients with schizophrenia over a long term period.

This is a 48-week, multicenter, open-label (all people know the identity of the intervention), non-controlled, arbitrary-dose study. The patients included in this study are those who participated in the preceding double-blind (neither physician nor patient knows the treatment that the patient receives) comparative trial (study JNS007ER-JPN-S31) of JNS007ER and completed the study, or those who remained in the study up to the evaluation at 2 weeks and discontinued the study after that for insufficient treatment efficacy. The study will assess the safety of JNS007ER in the clinical recommended dose range in a long term treatment. The dosage will be started at 6 mg/day, and it can be increased or decreased 3 mg at a time depending on the patient's symptom within the range of 3 mg/day to 12 mg/day. For dose adjustments, the investigator will evaluate the psychiatric symptoms before defining the dose change. Detailed Description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures.

Schizophrenia

Schizophrenia JNS007ER Paliperidone extended-release

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks.

intervention 1: Paliperidone extended-release (JNS007ER)

0

null

1

NCT01561898

[ 3 ]

21

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study will examine the effectiveness of the drug pirfenidone in treating focal segmental glomerulosclerosis (FSGS). Patients with this disease have kidney fibrosis (scarring) and proteinuria (excessive excretion of protein in the urine). About half of patients with FSGS eventually require kidney dialysis or transplant. Steroids, which are currently used to treat the disease, are effective in only a minority of patients. Other drugs, such as cyclosporin and cyclophosphamide, improve proteinuria in a very small percentage of patients and have serious side effects. Patients with FSGS who wish to participate in this study will undergo pre-study evaluation with blood and urine tests. Patients must be on a stable dose of an ACE inhibitor (a drug that lowers blood pressure and reduces proteinuria) for at list 6 months before starting pirfenidone therapy. (Patients who are not already taking an ACE inhibitor will be started on the drug; those who cannot tolerate ACE inhibitors will be given a different drug.) Patients with elevated cholesterol will take a cholesterol-lowering drug. A diet containing approximately 1 gram of protein per kilogram of body weight per day will be recommended. Patients will take pirfenidone by mouth 3 times a day for 12 months. Blood and urine will be tested once a month, either at NIH or by the patient's local kidney specialist. They will collect two 24-hour urine samples at the beginning of the treatment period, at 2-month intervals throughout the study, and at a 6-month follow-up. Patients will also be asked to give three to five tubes of blood and urine samples for analysis during the study. In animal studies, pirfenidone improved kidney function and proteinuria and reduced kidney scarring in rats with a disease similar to FSGS. In human studies, pirfenidone improved breathing and survival in patients with lung fibrosis.

The objective of this pilot phase II trial is to evaluate the ability of pirfenidone, a novel anti-fibrotic agent, to reduce the proteinuria and slow the rate of progression of renal insufficiency in patients with focal segmental glomerulosclerosis (FSGS). We will enroll 25 patients with renal biopsy proven FSGS and evidence of impaired renal function (glomerular filtration rate, GFR, of 10-80 ml/min; after 1/02 must have GFR greater than 25 ml/min) as assessed by the 4 variable Modification of Diet in Renal Disease equation. As standard of care therapy, all patients will also receive angiotensin converting enzyme inhibitor (ACEI) therapy, and will receive an HMG Co-A reductase inhibitor drug if hypercholesterolemic. Preliminary evaluation will assure that the patients meet the study requirements, and an evaluation period will be used to ensure that patients are on maximal conservative therapy prior to the baseline period. Patients will receive treatment with pirfenidone daily, with dose adjusted for body weight and level of kidney function. The primary end point will be the decrease glomerular filtration as a marker of glomerular injury; reduction in proteinuria will be a secondary end-point. If the pilot study suggests this drug delays progression of renal insufficiency or reduces proteinuria in patients with FSGS, we will proceed with a large scale randomized, placebo-controlled study.

Fibrosis Focal Glomerulosclerosis Kidney Failure Nephrotic Syndrome Proteinuria

Fibrosis Nephrotic Syndrome Proteinuria Renal Failure TGF-Beta Focal Segmental Glomerulosclerosis FSGS

null

0

null

1

[ 0 ]

intervention 1: During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.

intervention 1: Pirfenidone

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00001959

[ 3 ]

19

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Current therapies for adults with anaplastic astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with anaplastic astrocytoma. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with anaplastic astrocytoma.

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in adults with anaplastic astrocytoma as measured by an objective response to therapy (complete response, partial response) or stable disease. * To determine the safety and tolerance of Antineoplaston therapy in adults with anaplastic astrocytoma. OVERVIEW: This is a single arm, open-label study in which adults with anaplastic astrocytoma receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment. To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Adult Brain Tumor

adult anaplastic astrocytoma

null

1

arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

[ 0 ]

1

[ 0 ]

intervention 1: Adults with an anaplastic astrocytoma will receive Antineoplaston therapy (Atengenal + Astugenal).

intervention 1: Antineoplaston therapy (Atengenal + Astugenal)

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00003537

[ 2, 3 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The goal of this clinical research study is to find the highest safe dose of the new drug ZARNESTRA (R115777) and temozolomide that can be given to patients with brain tumors (glioblastoma multiforme, GBM). The second goal is to learn if these drugs given in combination can shrink or slow the growth of brain tumors. The safety of this treatment will also be studied.

Temozolomide works by killing cancer cells. R115777 is a new drug that may slow down the growth of cancer cells. Used in combination, the two drugs may control the growth of brain tumors. Before treatment starts, patients will have a complete exam, including measurement of height and weight. Blood tests (less than 2 tablespoons of blood) will be performed. A MRI scan will be done. Women who are able have children must have a negative blood pregnancy test. Temozolomide and R115777 will both be taken by mouth. Participants in this study will take temozolomide once a day for 7 days every other week (Days 1-7 and 15-21). This will be repeated every 28 days (1 course). Patients must not eat for 1 hour before and after taking the drug; drinking water is allowed. All treatment may be given on an outpatient basis. During the alternate weeks (Days 8-14 and 22-28), participants will take R115777 tablets by mouth in the morning and evening with food. At the beginning of the study, groups of 3 participants each will take increasing doses of both R115777 and temozolomide until the highest safe dose of each drug, when given in combination, is found. Participants entering the study after the highest safe dose is found will receive that dosage. If tumors do not grow and serious side effects do not occur, participants may keep on taking temozolomide and R115777 for up to 2 year. If your physician thinks it is advisable, treatment may continue with R115777 alone after that time. In this case, routine blood tests for counts, liver and kidney function (less than 2 tablespoons) will be repeated every 4 weeks and MRI scans, physical, and neurological exams will be done every 8 weeks. Participants may not receive any other treatment for cancer (including surgery) while taking part in this study. Participants will come to the clinic to have a complete physical and neurological exam and blood tests (less than 2 tablespoons of blood) before each course. Blood tests will be repeated once a week for the first 2 courses of treatment and then on Days 14 and 28 of each later course. A MRI scan will be done before the odd-numbered (3, 5, 7, etc.) courses of treatment or at any time clinically indicated. At the end of the study, participants will have another complete physical exam. Blood tests (less than 2 tablespoons of blood) will be performed. A MRI scan will be done. This is an investigational study. Temozolomide is approved by the FDA for the treatment of some brain tumors and is commercially available. R115777 is approved for research use only in the treatment of brain tumors. The use of these two drugs together is experimental.

Glioblastoma Multiforme

Brain Neoplasms CNS Diseases Glioblastoma Multiforme Temozolomide Temodar R115777 Zarnestra

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: Starting Dose Level: 100 mg/m\^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period. intervention 2: Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 weeks.

intervention 1: Temozolomide intervention 2: R115777

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00050986

[ 4 ]

353

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Multiple Myeloma

Multiple Myeloma Refractory and Relapsed Revlimid CC5013

null

2

arm 1: CC-5013 (lenalidomide) plus oral high-dose dexamethasone arm 2: Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle. intervention 2: Subjects in the CC-5013/Dex and Placebo/Dex treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

intervention 1: CC-5013 intervention 2: Dexamethasone

49

0

NCT00056160

[ 3 ]

90

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).

IED is a condition characterized by a failure to resist aggressive impulses. IED is a behavioral defined condition for which effective treatments have not been identified. Research suggests that serotonin (5-HT), a chemical that helps regulate mood and emotions, may play a role in the response to pharmacological IED treatments. This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex. In addition, this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems. Participants in this study will be randomly assigned to receive either fluoxetine, divalproex, or placebo for 12 weeks. Scale ratings will be used to assess the aggression levels of participants. Biologic evaluations of the 5-HT system will be conducted throughout the study.

Intermittent Explosive Disorder

null

3

arm 1: Participants will to receive treatment with fluoxetine for 12 weeks arm 2: Participants will to receive treatment with divalproex for 12 weeks arm 3: Participants will to receive treatment with placebo for 12 weeks

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Fluoxetine capsules by mouth, up to 60 mg daily intervention 2: Divalproex ER capsules by mouth, up to 3000 mg daily intervention 3: Placebo capsules by mouth, up to 8 capsules daily

intervention 1: Fluoxetine intervention 2: Divalproex intervention 3: Placebo

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00078754

[ 5 ]

115

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of clinical recurrence of hepatitis C infection. The anticipated time on study treatment was 3-12 months, and the target sample size was 100-500 individuals.

null

Hepatitis C, Chronic

null

2

arm 1: None arm 2: None

[ 0, 4 ]

2

[ 0, 0 ]

intervention 1: 135 micrograms subcutaneously (SC) weekly for 4 weeks followed by 180 micrograms SC weekly for 44 weeks intervention 2: 400 mg orally (PO) daily escalating to 1200 mg PO daily, for 48 weeks

intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: Copegus

28

0

NCT00087633

[ 3 ]

32

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

null

Breast Cancer

Advanced Breast Cancer

null

1

arm 1: Participants received albumin-bound paclitaxel, 100 mg/m\^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.

[ 0 ]

3

[ 0, 0, 0 ]

intervention 1: Administered by intravenous infusion. intervention 2: Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity. intervention 3: Administered by IV infusion

intervention 1: Albumin-bound paclitaxel intervention 2: Carboplatin intervention 3: Herceptin®

14

0

NCT00093145

[ 4 ]

547

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.

null

Colorectal Neoplasms

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 0, 0, 0, 0, 5 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID \[two times a day\] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment). intervention 2: Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing. I m m e d i a t e l y f o l l o w e d b y : 5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID \[two times a day\] oral Every 2 weeks intervention 3: Day 1 Bevacizumab 7.5mg/kg IV \*over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID \[two times a day\] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID \[two times a day\] continues daily without interruption Every 3 weeks intervention 4: Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID \[two times a day\](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment). intervention 5: Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID \[two times a day\] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).

intervention 1: Modified Bolus 5-FU/LV with Irinotecan intervention 2: FOLFIRI + bevacizumab intervention 3: miFL + bevacizumab intervention 4: Infusional 5-FU/LV with Irinotecan intervention 5: Oral Capecitabine with Irinotecan

175

0

NCT00101686

[ 3 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer). Secondary Objective(s) To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer). To assess the pharmacokinetics (PK) of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen, and the PK of irinotecan (IR) and its active metabolite SN-38 when IR is given in combination with ABX-EGF, leucovorin (LV), and 5-fluorouracil (5-FU) in subjects with metastatic colorectal cancer)

Colorectal Cancer

Immunex Panitumumab ABX-EGF Abgenix

null

2

arm 1: Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen) arm 2: Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)

[ 0, 0 ]

4

[ 0, 2, 0, 0 ]

intervention 1: Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate. intervention 2: Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles. intervention 3: Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate. intervention 4: Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.

intervention 1: Irinotecan intervention 2: Panitumumab intervention 3: 5-Fluorouracil intervention 4: Leucovorin

0

null

0

NCT00111761

[ 2, 3 ]

42

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

null

Carcinoma, Renal Cell

null

1

arm 1: Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib

[ 0 ]

1

[ 0 ]

intervention 1: Until disease progression or unacceptable toxicity.

intervention 1: Gefitinib + Sunitinib

3

0

NCT00113529

[ 2, 3 ]

32

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy

PRIMARY OBJECTIVES: I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept. II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease. III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response. OUTLINE: Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes

null

1

arm 1: Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 2 ]

intervention 1: Given SC or IV intervention 2: Given SC

intervention 1: azacitidine intervention 2: etanercept

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00118287

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

HIV lipoatrophy is a condition marked by fat loss; it occurs in many patients taking antiretroviral (ARV) therapy that includes nucleoside reverse transcriptase inhibitors (NRTIs). Lipoatrophy may be related to mitochondrial toxicity, a condition that can damage the heart, nerves, muscles, kidneys, and liver, and can affect the body's ability to produce energy. NucleomaxX is a food supplement consisting of a sugar cane extract high in nucleosides, which are building blocks that may counteract the negative effects of NRTIs. Tenofovir disoproxil fumarate (TDF) is an NRTI that may cause less lipoatrophy than other drugs in its class, such as zidovudine (ZDV) or stavudine (d4T). The purpose of this study is to determine whether nucleoside supplementation with NucleomaxX and substitution of TDF for ZDV or d4T in an ARV regimen can reverse fat loss caused by mitochondrial toxicity in HIV infected adults. Study hypotheses: 1) The substitution of TDF for d4T or ZDV in patients with HIV lipoatrophy will result in an increase in mitochondrial DNA content in fat, skeletal muscle, and peripheral blood mononuclear cells (PBMCs), which in turn will lead to an improvement in mitochondrial function as assessed by electron transport chain (ETC) and oxidative phosphorylation pathway (OXPHOS) activity. The latter should lead to a decrease in fat apoptosis and in mitochondrial and lipid oxidative damage biomarkers. 2) Supplementation with uridine (via NucleomaxX) will increase mtDNA content in adipose tissue and increase body fat content.

NRTIs are an important part of many ARV regimens used to treat HIV infected patients; however, the relationship between NRTI-induced mitochondrial dysfunction and lipoatrophy is still unclear and requires additional research. Additionally, the relationship between the gain in dual-energy x-ray absorptiometry (DEXA)-measured limb fat and mitochondrial DNA (mtDNA) content, mitochondrial function, fat apoptosis, and oxidative damage will also be examined in this study. Patients will participate in this study for 48 weeks. Participants will be randomly assigned to one of two groups. Group 1 patients will receive NucleomaxX every other day. Group 2 patients will substitute TDF for ZDV or d4T every day in their current stable NRTI-containing ARV regimen. NucleomaxX will be provided to Group 1 patients, but TDF or any other ARV will not be provided by this study. There will be 10 study visits, which will occur at study entry and Weeks 2, 4, 8, 12, 18, 24, 30, 36, and 48. Blood collection will occur at all visits. Additionally, urine collection, DEXA scans, and fat biopsies will be done at study entry and Weeks 24 and 48.

HIV Infections Lipodystrophy Metabolic Diseases Nutrition Disorders

lipoatrophy mitochondria HIV treatment experienced

null

2

arm 1: NucleomaxX 36 grams TID every other day arm 2: Switch of AZT or d4T to Tenofovir Disoproxil Fumarate

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: NucleomaxX 36 grams TID every other day intervention 2: Switch of thymidine nucleoside reverse transcriptase inhibitors to Tenofovir Disoproxil Fumarate

intervention 1: NucleomaxX intervention 2: Tenofovir Disoproxil Fumarate

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00119379

[ 4 ]

187

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies.

Paroxysmal Hemoglobinuria, Nocturnal

transfusion dependent paroxysmal nocturnal hemoglobinuria hemolytic

null

1

arm 1: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: eculizumab

40

0

NCT00122317

[ 4 ]

288

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

null

Asthma Diabetes Mellitus

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine. intervention 2: Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

intervention 1: Inhaled Insulin intervention 2: Subcutaneous Insulin

102

0

NCT00139659

[ 0 ]

6

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.

Adult patients with Dexa scan (bone scan) z-scores \< -1.0 (meaning low bone density) in at least one site will be selected for randomization. All patients who qualify for randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase (BSAP) and n-terminal telopeptides of collagen (NTX) levels. Recent bloodwork obtained as part of their ongoing long-term Pediatric Oncology and/or Endocrine clinic follow-up evaluation will be reviewed to exclude any baseline correctable confounding causes of osteopenia (low bone density). All women of childbearing potential will have a pregnancy test. For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1(Insulin like growth factor) monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.

Osteopenia

osteopenia growth hormone deficiency pediatric malignancy

null

2

arm 1: No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months. arm 2: Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months

[ 1, 0 ]

3

[ 0, 7, 7 ]

intervention 1: Bisphosphonate therapy given to patients with growth hormone deficiency intervention 2: Vitamin D given to patients with growth hormone deficiency intervention 3: calcium supplement given to patients with growth hormone deficiency

intervention 1: bisphosphonate therapy (risedronate) intervention 2: Vitamin D supplement intervention 3: Calcium

1

Syracuse | New York | United States | -76.14742 | 43.04812

0

NCT00145704

[ 5 ]

23

NON_RANDOMIZED

SINGLE_GROUP

9OTHER

0NONE

false

0ALL

true

The purpose of this study is to examine the efficacy of quetiapine (Seroquel) in reducing substance use in persons diagnosed with schizophrenia. The primary hypothesis is that quetiapine treatment will be associated with a decrease in substance use.

Comorbid alcohol/substance use disorder (SUD) in schizophrenia is a major concern, both in view of the high frequency of SUD among patients with schizophrenia and the difficulty in managing such patients. Though antipsychotic medications are effective in reducing symptoms and impairment in persons with schizophrenia, the typical antipsychotic agents are of limited value in controlling alcohol/substance use in these patients. Extrapyramidal, dysphoric side effects of conventional neuroleptics may actually promote the use of substances in an attempt to counteract these effects. Novel antipsychotics have radically altered treatment expectations and outcomes for patients with severe forms of schizophrenia. With the greater availability of novel agents in clinical practice, it has been noted that these benefits have also extended to specific subgroups of patients including patients with comorbid SUD. Several retrospective studies have demonstrated a decrease in comorbid substance use in patients with schizophrenia treated with clozapine. There is little data available, however, on the efficacy of quetiapine in patients with schizophrenia and comorbid SUD. Its receptor profile, including a weak Dopamine2 (D2) receptor blocking ability and substantial effects at noradrenergic receptors, makes it a logical antipsychotic to use in the comorbid population. The study is an open-label investigation of the efficacy of quetiapine in a group of 30 patients with schizophrenia and comorbid substance use disorder. Patients diagnosed with schizophrenia or schizoaffective disorder and a comorbid substance use disorder are switched to quetiapine for 12 weeks. We hypothesize that quetiapine treatment will be associated with a decrease in substance use. Moreover, we further hypothesize that measures of symptoms, cognition and quality of life will also improve over baseline assessments in patients treated with quetiapine. Data suggesting a beneficial effect of quetiapine will have to be confirmed in a prospective double-blind study. This pilot investigation will provide preliminary data and effect sizes that will be used in the design of this subsequent investigation.

Schizophrenia Schizoaffective Disorder Psychotic Disorder Substance Abuse Alcohol Abuse

Quetiapine Seroquel Schizophrenia Dual Diagnosis Substance Abuse Alcohol Abuse

null

1

arm 1: After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.

[ 0 ]

1

[ 0 ]

intervention 1: After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.

intervention 1: Quetiapine

4

0

NCT00156715

[ 4 ]

599

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

null

Macular Edema Retinal Vein Occlusion

null

3

arm 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. arm 2: 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. arm 3: Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.

[ 0, 0, 3 ]

3

[ 0, 0, 10 ]

intervention 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. intervention 2: 350 µg Dexamethasone intravitreal implant administered on Day 0. intervention 3: Sham injection on Day 0.

intervention 1: 700 µg Dexamethasone intervention 2: 350 µg Dexamethasone intervention 3: Sham Injection

13

Los Angeles | California | United States | -118.24368 | 34.05223 Sydney | N/A | Australia | 151.20732 | -33.86785 Graz | N/A | Austria | 15.45 | 47.06667 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Brno | N/A | Czechia | 16.60796 | 49.19522 Créteil | N/A | France | 2.46569 | 48.79266 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Rehovot | N/A | Israel | 34.81199 | 31.89421 Tabacalera | N/A | Mexico | -99.15532 | 19.43635 Makati | N/A | Philippines | 121.1226 | 16.412 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Arcadia | N/A | South Africa | 27.90482 | -33.00877 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626

0

NCT00168324

[ 4 ]

43

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

null

Schizophrenia

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

intervention 1: Ziprasidone

14

Avignon | N/A | France | 4.80892 | 43.94834 DOLE Saint YLIE | N/A | France | N/A | N/A Liévin | N/A | France | 2.78068 | 50.4198 Lyon | N/A | France | 4.84671 | 45.74846 Montfavet | N/A | France | 4.87342 | 43.93335 Orvault | N/A | France | -1.62361 | 47.27117 Rennes | N/A | France | -1.67429 | 48.11198 Saint-Égrève | N/A | France | 5.68154 | 45.23313 Saint-Rémy | N/A | France | 4.83928 | 46.76334 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulon | N/A | France | 5.92836 | 43.12442 Toulouse | N/A | France | 1.44367 | 43.60426 Toulouse | N/A | France | 1.44367 | 43.60426 Versailles | N/A | France | 2.13424 | 48.80359

0

NCT00174447

[ 3 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate cancer progression, when fewer tumor cells are present, will have greater anti-tumor activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and anti-tumor activity.

null

Prostate Cancer

prostate cancer recurrent prostate cancer stage IV prostate cancer

null

1

arm 1: Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy. Total duration of therapy is 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Therapy will continue in this alternating manner for 24 weeks. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.

[ 0 ]

2

[ 0, 0 ]

intervention 1: 50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide. intervention 2: 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated

intervention 1: Etoposide intervention 2: Cyclophosphamide

7

0

NCT00176605

[ 3 ]

89

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES: I. To evaluate the efficacy of BAY 43-0006 in previously-treated, platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer (E-SCLC) in terms of response rate (confirmed and unconfirmed, complete and partial). SECONDARY OBJECTIVES: I. To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population. II. To assess overall survival in this group of patients treated with BAY 43-9006. III. To collect specimens via the Lung Cancer Specimen Repository Protocol (S9925) in order to perform exploratory analyses of the relationship between selected markers and patient outcomes. OUTLINE: This is a multicenter study. Patients are stratified according to platinum sensitivity status (platinum sensitive vs platinum refractory). Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 2 years from study entry.

Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer

null

1

arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

[ 0 ]

1

[ 0 ]

intervention 1: Given orally

intervention 1: sorafenib tosylate

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00182689

[ 3 ]

226

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

null

Non-small Cell Lung Cancer

null

2

arm 1: Pemetrexed 500 mg/m2 arm 2: Pemetrexed 1000 mg/m2

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 500 mg/m2, intravenous (IV), every 21 days, one year from registration date intervention 2: 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date

intervention 1: Pemetrexed 500 mg/m2 intervention 2: Pemetrexed 1000 mg/m2

16

Chiba | N/A | Japan | 140.11667 | 35.6 Ehime | N/A | Japan | N/A | N/A Fukuoka | N/A | Japan | 130.41667 | 33.6 Gifu | N/A | Japan | 136.76039 | 35.42291 Gunma | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Miyagi | N/A | Japan | 128.18236 | 26.62566 Niigata | N/A | Japan | 139.04125 | 37.92259 Okayama | N/A | Japan | 133.93333 | 34.65 Osaka | N/A | Japan | 135.50107 | 34.69379 Saitama | N/A | Japan | 139.65657 | 35.90807 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00191191

[ 3 ]

150

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

null

Breast Cancer

null

3

arm 1: Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. arm 2: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). arm 3: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) intervention 2: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). intervention 3: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).

intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Herceptin

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00191451

[ 3 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

null

Dysmenorrhea

cyclic pelvic pain dysmenorrhea oral contraceptives

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 1 tablet daily by mouth intervention 2: 1 tablet daily by mouth

intervention 1: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets intervention 2: Placebo tablet

13

0

NCT00196313

[ 5 ]

176

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.

A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.

Asthma

salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control

null

2

arm 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg arm 2: fluticasone propionate 2 x 100 mcg

[ 1, 5 ]

2

[ 0, 0 ]

intervention 1: comparator intervention 2: comparator

intervention 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg intervention 2: fluticasone propionate 2 x 100 mcg

18

Almere Stad | N/A | Netherlands | 5.21413 | 52.37025 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Arnhem | N/A | Netherlands | 5.91111 | 51.98 Breda | N/A | Netherlands | 4.77596 | 51.58656 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Enschede | N/A | Netherlands | 6.89583 | 52.21833 Gouda | N/A | Netherlands | 4.70833 | 52.01667 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Helmond | N/A | Netherlands | 5.66111 | 51.48167 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Leeuwarden | N/A | Netherlands | 5.80859 | 53.20139 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Sittard | N/A | Netherlands | 5.86944 | 50.99833 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Utrecht | N/A | Netherlands | 5.12222 | 52.09083 Veldhoven | N/A | Netherlands | 5.40278 | 51.41833 Zwolle | N/A | Netherlands | 6.09444 | 52.5125

0

NCT00197106

[ 0 ]

35

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This new drug may have an added benefit of being able to help with some of the difficulties in problem solving and memory that many patients with schizophrenia experience. The present study wants to look at ziprasidone and two other drugs frequently used to treat the symptoms of schizophrenia (risperidone and olanzapine) to see if problem solving and memory get better with ziprasidone treatment. Moreover, we will look at symptoms and how they change with treatment.

Typical neuroleptics (i.e., haloperidol, chlorpromazine) are effective at ameliorating the positive psychotic symptoms of schizophrenia but are less efficacious in the treatment of negative symptoms, and there is limited evidence to support their ability to attenuate the cognitive dysfunction observed in schizophrenia (Meltzer et al. 1999). The primary mechanism through which typical neuroleptics achieve their effect is through dopamine (DA) blockade, but recent data suggest that DA blockade may be associated with diminished cognitive improvement despite effective clinical treatment. For example, in a recent molecular genetics study we have shown that subjects with greater DA availability display better cognitive performance on a task of executive functioning (Malhotra et al. in press). Thus, DA blockade may interfere with potential cognitive improvements associated with antipsychotic drug treatment. Atypical antipsychotics have a higher 5-hydroxytryptamine-2 (5-HT2) to D2 receptor binding ratio than typical agents, and therefore may be more effective in the treatment of cognitive impairments.Unfortunately, there is limited data on the cognitive properties of the new atypical agent, ziprasidone. In addition to having a high 5-HT2 to D2 receptor binding ratio, like the other atypicals, ziprasidone also has weak anticholinergic effects and minimal activity at muscarinic (M1), histaminergic (H1) and alpha1-adrenergic receptors (Casey, 2001) which may also beneficially influence cognitive performance (Byerly et al., 2001). Therefore, ziprasidone may have a unique ability to improve the cognitive performance of patients with schizophrenia. Evidence from neuropsychology (Gold, Carpenter, Randolph, Goldberg, \& Weinberger, 1997), brain imaging (Buchsbaum et al., 1992) and electrophysiology (Shelley et al., 1996) all converge to implicate impaired working memory (WM) function in schizophrenia. As such, the neural substrates that subsume WM, the temporal course of information flow through this system, and importantly whether ziprasidone intervention can aid in normalization of function, are critical issues in schizophrenia research. In the present study, we propose to integrate: 1. A novel cognitive electrophysiological assessment specifically designed to detect subtle differences in the stages of information processing where WM deficits become manifest. 2. A state of the art computerized neuropsychological battery that assesses WM and other cognitive domains. 3. Positron emission tomography (PET) of dopamine D2 receptor occupancy. These methods will provide a means to specifically characterize the effects of ziprasidone on cognitive performance and dopamine blockade in patients with schizophrenia. The primary hypotheses to be tested are 1) that ziprasidone treatment will be associated with improvements in WM and, 2) WM performance will be associated with D2 occupancy in ziprasidone treated patients. Data will be collected in the context of an open label, randomized clinical trial comparing the efficacy of ziprasidone to the atypical agents, olanzapine and risperidone. This trial will compare the effects of ziprasidone with risperidone or olanzapine on positive and negative psychotic symptoms, mood, and side effects, as well as provide the first comprehensive data on the effects of these drugs on information processing, working memory and dopamine D2 receptor occupancy. These pilot data will allow us to test the hypotheses that 1) ziprasidone will be associated with improvements in information processing and working memory. 2) ziprasidone will be associated with improvements in psychotic symptoms and mood. 3) ziprasidone associated improvements in cognition and behavioral symptoms will be at least as significant as those associated with treatment with olanzapine or risperidone. Finally, we will examine the relative D2 occupancies of these drugs using PET Subjects will be randomized to drug treatment with ziprasidone, olanzapine or risperidone, such that 30 subjects will receive ziprasidone, and 30 will receive either risperidone or olanzapine. Patients who enter the study on risperidone or with a history of risperidone treatment within the past 6 months will be randomized to either ziprasidone or olanzapine. Patients entering on olanzapine or with a history of olanzapine treatment within the past 6 months will be randomized to either ziprasidone or risperidone. Patients on other medications, with no history of olanzapine, risperidone or ziprasidone treatment, will be will be randomized to any of the three drugs. Patients treated with ziprasidone, at any time in the past, will be excluded. The final groups will consist of 30 subjects receiving ziprasidone, and 30 subjects receiving risperidone or olanzapine depending on their treatment history. Target dose for ziprasidone will be 160 mg/d with this dosage achieved within two weeks of initiation of drug treatment. Target dose for olanzapine will be 20 mg/d with this dosage achieved within two weeks of initiation of drug treatment. Target dose for risperidone will be 4 mg/d with this dosage achieved within two weeks of initiation of drug treatment. Dosage will be fixed at the target dose for the remainder of the trial. Patients who cannot tolerate the target dose will continue in the study, if feasible, and maintained at a lower dose. Extra-pyramidal side effects, if any, will be treated with benztropine as needed. Concomitant medications will not be permitted. Patients will be re-assessed every month following the initiation of treatment for the 3 months following baseline. Subjects will be re-assessed with the information processing assessment, neurocognitive battery , behavioral and side effect ratings, and information about drug dosage and compliance with treatment at each visit. Moreover, subjects will be asked to participate in a PET study of dopamine D2 occupancy at the third month visit . Trained raters blind to patient's drug condition will conduct behavioral and side effect ratings. The cognitive electrophysiological assessment will employ a parametrically designed A-X Continuous Performance Test (AX-CPT) task with increasing levels of difficulty proven to elicit traditional behavioral measures of WM function such as reaction time (RT) and accuracy (Bates et al, 2000). This paradigm provides a means to evaluate the efficacy of ziprasidone treatment in remitting cognitive dysfunction in patients with schizophrenia. However, accuracy and RT only index the final motor response and do not capture information about antecedent stages of information processing. Visual evoked response potentials (ERP's) will be collected while subjects perform the AX-CPT tasks allowing for assessment of early sensory registration of stimuli (N1), and the time course of subsequent cognitive analysis (P3) (Bates et al, 2000). This methodology will facilitate assessment of the stage of information processing where schizophrenia deficits in WM become manifest. Topographical analysis will assess whether schizophrenia patients display amplitude attenuation over scalp sites correlating to prefrontal cortex while performing the WM tasks, and if functioning improves over the course of ziprasidone intervention. Visual ERP's will be employed for the following reasons. Auditory P3 attenuation has proven not to change with administration of typical neuroleptics in longitudinal designs (Pfefferbaum et al., 1989). Visual P3, however, may provide a more sensitive measure for detecting changes in illness severity as it is though to be related more to clinical state (Duncan, 1988). The proposed study could possibly reveal improved functioning that has gone undetected in studies employing auditory ERPs. The proposed study would be the first to assess the longitudinal effects of ziprasidone treatment on WM functioning using parametrically altered WM tasks while concurrently obtaining visual ERP's. The neurocognitive battery will employ tasks of WM, executive functioning, memory, motor function and verbal fluency. This paradigm provides a means to evaluate the effects of ziprasidone treatment in improving cognitive function across multiple domains in patients with schizophrenia. PET imaging with \[carbon-11 (11C)\]-raclopride provides an in vivo measure of dopamine D2 receptor occupancy during ziprasidone treatment and will be used to assess the relationship between ziprasidone's D2 occupancy and measures of WM and cognition. It is hypothesized that moderate D2 occupancy is associated with clinical improvement and the degree of occupancy will be correlated with WM performance. The \[11C\]-raclopride studies will be performed in a subset of 30 patients after twelve weeks of ziprazidone treatment. As \[11C\]-raclopride studies of the D2 receptor have consistently shown comparable levels of binding in controls and untreated patients with schizophrenia (e.g. Farde et al.1990), the treated patients can be compared to the untreated controls. We are using this approach because it may not be feasible to scan the patients in the unmedicated state. It is extremely difficult to justify a two to four week drug free period that would be needed to assess baseline D2 receptor availability. The PET studies will be performed at the PET Center at the North Shore University Hospital. On the day of the PET scan an intravenous line will be placed in an antecubital vein for radiotracer administration, and to draw a plasma drug level at the time of scanning. The subject will be positioned in the General Electric (GE) Advance scanner. A fifteen-minute transmission scan will be obtained. Then, 15 millicuries (mCi) of \[11C\]-raclopride will be injected. Scanning will begin immediately after radiotracer injection and will last for 60 minutes. Radiotracer: \[11C\]-raclopride is a relatively selective radiotracer for the dopamine (D2/D3) receptor and is a commonly used radiotracer in normal controls and psychiatric patients (e.g. Smith et al., 1995, Volkow et al., 1994, Farde et al., 1990). An magnetic resonance (MR) scan will be performed to rule out structural brain pathology, for image registration with the PET scan and correction for the effects of cerebral atrophy. The MR scans will be performed with a GE Signa 1.5 Tesla scanner.

Schizophrenia

null

2

arm 1: ziprasidone arm 2: risperidone or olanzapine

[ 0, 1 ]

1

[ 0 ]

intervention 1: ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day

intervention 1: ziprasidone vs risperidone or olanzapine

1

Glen Oaks | New York | United States | -73.71152 | 40.74705

0

NCT00225498

[ 4 ]

1,683

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

null

Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis

Deferasirox Congenital Anemias Anemias Red Blood Cell Disorders Chronic Iron Overload Transfusional Iron Overload Iron Chelators Oral Iron Chelators Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis ICL670A

null

1

arm 1: Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Starting dose was determined by the frequency of blood transfusions and recommended initial daily dose of deferasirox is 20 mg/kg body weight for patients receiving blood transfusion, 10 mg/kg for patients receiving less frequent transfusion/exchange transfusion and 30 mg/kg for patients receiving more frequent blood transfusions.

[ 0 ]

1

[ 0 ]

intervention 1: 125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.

intervention 1: Deferasirox

141

Little Rock | Arkansas | United States | -92.28959 | 34.74648 Berkeley | California | United States | -122.27275 | 37.87159 Orange | California | United States | -117.85311 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Stanford | California | United States | -122.16608 | 37.42411 Wilmington | Delaware | United States | -75.54659 | 39.74595 Melbourne | Florida | United States | -80.60811 | 28.08363 Pensacola | Florida | United States | -87.21691 | 30.42131 Tampa | Florida | United States | -82.45843 | 27.94752 Tampa | Florida | United States | -82.45843 | 27.94752 Savannah | Georgia | United States | -81.09983 | 32.08354 Baton Rouge | Louisiana | United States | -91.18747 | 30.44332 Kalamazoo | Michigan | United States | -85.58723 | 42.29171 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Jackson | Mississippi | United States | -90.18481 | 32.29876 Kansas City | Missouri | United States | -94.57857 | 39.09973 New Brunswick | New Jersey | United States | -74.45182 | 40.48622 New Hyde Park | New York | United States | -73.68791 | 40.7351 Columbus | Ohio | United States | -82.99879 | 39.96118 Dayton | Ohio | United States | -84.19161 | 39.75895 Portland | Oregon | United States | -122.67621 | 45.52345 Hershey | Pennsylvania | United States | -76.65025 | 40.28592 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Houston | Texas | United States | -95.36327 | 29.76328 Norfolk | Virginia | United States | -76.28522 | 36.84681 Richmond | Virginia | United States | -77.46026 | 37.55376 Seattle | Washington | United States | -122.33207 | 47.60621 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Charleroi | N/A | Belgium | 4.44448 | 50.41136 Liège | N/A | Belgium | 5.56749 | 50.63373 Montegnée | N/A | Belgium | 5.51411 | 50.64576 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Edmonton | N/A | Canada | -113.46871 | 53.55014 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Montreal | N/A | Canada | -73.58781 | 45.50884 Québec | N/A | Canada | -71.21454 | 46.81228 Toronto | N/A | Canada | -79.39864 | 43.70643 Toronto | N/A | Canada | -79.39864 | 43.70643 Vancouver | N/A | Canada | -123.11934 | 49.24966 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Göttingen | N/A | Germany | 9.93228 | 51.53443 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Ulm | N/A | Germany | 9.99155 | 48.39841 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Corfu | N/A | Greece | 19.92016 | 39.62441 Corinth | N/A | Greece | 22.9513 | 37.94007 Heraklion | N/A | Greece | 25.14341 | 35.32787 Ioannina | N/A | Greece | 20.85189 | 39.66486 Kalamata | N/A | Greece | 22.11265 | 37.03913 Karditsa | N/A | Greece | 21.92191 | 39.36485 Karditsa | N/A | Greece | 21.92191 | 39.36485 Larissa | N/A | Greece | 22.41761 | 39.63689 Mytilene | N/A | Greece | 26.55529 | 39.10772 Nikaia | N/A | Greece | 23.65 | 37.96667 Pátrai | N/A | Greece | 21.73444 | 38.24444 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Volos | N/A | Greece | 22.94769 | 39.36923 Xánthi | N/A | Greece | 24.888 | 41.13488 Augusta | N/A | Italy | 15.22121 | 37.24065 Bari | N/A | Italy | 16.86982 | 41.12066 Brindisi | N/A | Italy | 17.93607 | 40.63215 Cagliari | N/A | Italy | 9.11917 | 39.23054 Carbonara di Bari | N/A | Italy | 16.86667 | 41.06667 Catania | N/A | Italy | 15.07041 | 37.49223 Catania | N/A | Italy | 15.07041 | 37.49223 Catania | N/A | Italy | 15.07041 | 37.49223 Catanzaro | N/A | Italy | 16.60086 | 38.88247 Cosenza | N/A | Italy | 16.25307 | 39.2989 Empoli | N/A | Italy | 10.94758 | 43.71795 Ferrara | N/A | Italy | 11.62057 | 44.83804 Florence | N/A | Italy | 11.24626 | 43.77925 Genova | N/A | Italy | 11.87211 | 45.21604 Itala | N/A | Italy | 15.43706 | 38.05144 Matera | N/A | Italy | 16.60463 | 40.66599 Messina | N/A | Italy | 15.55256 | 38.19394 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Palermo | N/A | Italy | 13.3636 | 38.1166 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Pesaro | N/A | Italy | 12.9164 | 43.90921 Pisa | N/A | Italy | 10.4036 | 43.70853 Ragusa | N/A | Italy | 14.72443 | 36.92574 Reggio Calabria | N/A | Italy | 15.66129 | 38.11047 Roma | N/A | Italy | 11.10642 | 44.99364 San Gavino Monreale- CA | N/A | Italy | N/A | N/A Sassari | N/A | Italy | 8.55552 | 40.72586 Sciacca | N/A | Italy | 13.08399 | 37.50693 Talassemie | N/A | Italy | N/A | N/A Taranto | N/A | Italy | 17.24707 | 40.46438 Torino | N/A | Italy | 11.99138 | 44.88856 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Almería | N/A | Spain | -2.45974 | 36.83814 Badajoz | N/A | Spain | -6.97061 | 38.87789 Barakaldo | N/A | Spain | -2.98813 | 43.29639 Cadiz | N/A | Spain | -6.2891 | 36.52672 Canara | N/A | Spain | -1.7688 | 38.14046 Madrid | N/A | Spain | -3.70256 | 40.4165 Manresa | N/A | Spain | 1.82399 | 41.72815 Santander | N/A | Spain | -3.80444 | 43.46472 Toledo | N/A | Spain | -4.02263 | 39.8581 Valencia | N/A | Spain | -0.37966 | 39.47391 Vigo | N/A | Spain | -8.72264 | 42.23282 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taipei | N/A | Taiwan | 121.52639 | 25.05306 Taoyuan District | N/A | Taiwan | 121.3187 | 24.9896 Tau-Yuan County | N/A | Taiwan | N/A | N/A Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Khon Kaen | N/A | Thailand | 102.833 | 16.44671 Adana | N/A | Turkey (Türkiye) | 35.32531 | 36.98615 Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Antalya | N/A | Turkey (Türkiye) | 30.69556 | 36.90812 Gaziantep | N/A | Turkey (Türkiye) | 37.3825 | 37.05944 Isparta | N/A | Turkey (Türkiye) | 30.55222 | 37.76444 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 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 Tooting | N/A | United Kingdom | -0.16394 | 51.42524

0

NCT00235391

[ 3 ]

120

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

null

To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.

null

Breast Cancer

null

3

arm 1: Anastrozole Monotherapy arm 2: Fulvestrant Monotherapy arm 3: Anastrozole + Fulvestrant

[ 1, 0, 0 ]

2

[ 0, 0 ]

intervention 1: 500 mg intramuscular injection intervention 2: oral tablet

intervention 1: Fulvestrant intervention 2: Anastrazole

1

Nottingham | N/A | United Kingdom | -1.15047 | 52.9536

0

NCT00259090

[ 4 ]

303

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.

Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.

ADHD Substance Abuse

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use. intervention 2: Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.

intervention 1: Methylphenidate (OROS-MPH) intervention 2: Methylphenidate (OROS-MPH) - Placebo

12

0

NCT00264797

[ 4 ]

1,166

RANDOMIZED

PARALLEL

1PREVENTION

0NONE

true

1FEMALE

false

The purpose of the study is to determine safety and efficacy of long-cycle regimens of an oral contraceptive.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG (BSP AG), Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial. The previously posted secondary Outcome Measure "Parameters of safety and tolerability" has been removed from result posting as it is covered by the Adverse Event section.

Contraception

null

3

arm 1: 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. arm 2: 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. arm 3: 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment. intervention 2: 3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected. intervention 3: 13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.

intervention 1: Flexible (extended) treatment of EE20/DRSP (YAZ, BAY86-5300) intervention 2: Fixed extended treatment of EE20/DRSP (YAZ, BAY86-5300) intervention 3: Standard 24+4 treatment of EE20/DRSP (YAZ, BAY86-5300)

35

0

NCT00266032

[ 4 ]

1,057

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

null

HIV Infections

HIV Treatment Naive

null

2

arm 1: Participants were administered an oral dose of ATV 300 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of ATV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks. arm 2: Participants were administered an oral dose of LPV 400 mg and RTV 100 mg once daily along with food on a background of fixed dose combination TDF 300 mg plus FTC 200 mg (TDF/FTC) once daily. Doses of LPV and RTV were taken 24 hours apart at the same time as the background TDF/FTC, up to 96 Weeks.

[ 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 300mg Oral capsules for 96 weeks intervention 2: 100mg Oral Capsules for 96 weeks intervention 3: One tablet with 300 mg - 200 mg once a day for 96 weeks. intervention 4: 400 mg (3 133mg capsules) BID for 96 weeks

intervention 1: ATV intervention 2: RTV intervention 3: Tenofovi-Emtricitabine (TDF/FTC) tablet intervention 4: LPV

79

0

NCT00272779

[ 2, 3 ]

9

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine the effects of nesiritide on urine output and hemodynamics following cardiopulmonary bypass in infants. Safety and pharmacokinetic data will also be obtained.

Nesiritide, a recombinant human B-type natriuretic peptide, has vasodilatory, lusitropic and diuretic properties in healthy humans, and improves hemodynamics and symptoms in adults with decompensated congestive heart failure. Several retrospective case series suggest that nesiritide has beneficial effects on hemodynamics and urine output in adults and children following cardiac surgery. The purpose of this prospective, randomized, double-blind, crossover study is to evaluate the effects of a continuous infusion of nesiritide on postoperative hemodynamics and urine output in infants with congenital heart disease who undergo cardiac surgery requiring cardiopulmonary bypass (CPB). Patients less than 1 year of age following cardiac surgery will be eligible for the study if they have received two conventional diuretics (furosemide and chlorothiazide) for at least 12 hours, yet are not effectively achieving a negative fluid balance, thus prohibiting sternal closure or tracheal extubation. Patients will be randomized to receive either a 10-hour infusion of nesiritide, a two hour washout period, followed by a 10-hour infusion of placebo, or this study drug sequence in reverse order. During the 24-hour study period, serial cardiac output measurements and BNP levels will be obtained, vital signs and intracardiac filling pressures will be recorded, and urine output will be measured.

Heart Defects, Congenital Cardiopulmonary Bypass

Nesiritide Natriuretic Peptide, Brain Heart Defects, Congenital Cardiopulmonary Bypass Diuretics

null

2

arm 1: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours. arm 2: In this crossover pilot study, patients are randomly assigned to receive either nesiritide or placebo infusion for 10 hours, followed by a two hour washout period, and then the other study drug for 10 hours.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: nesiritide 0.015 mcg/kg/hour x 10 hours intervention 2: 0.9% sodium chloride infusion

intervention 1: nesiritide intervention 2: Placebo

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00281671

[ 3 ]

70

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Liver Transplantation

Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult

null

1

arm 1: After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study. Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Oral intervention 2: Oral

intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus

10

0

NCT00282243

[ 3 ]

19

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Liver Transplantation

Child Pharmacokinetics Immunosuppression Drugs Hepatic transplant Liver Transplantation

null

1

arm 1: Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Oral intervention 2: Oral

intervention 1: tacrolimus modified release (MR) intervention 2: tacrolimus

5

0

NCT00282256

[ 3 ]

42

NA

SINGLE_GROUP

1PREVENTION

0NONE

false

1FEMALE

false

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Breast Cancer

breast atypia open label pilot study letrozole fine needle aspiration high risk for breast cancer breast epithelial hyperplasia Ki-67 hormones plus chemoprevention chemoprevention

null

1

arm 1: Oral Letrozole 2.5 mg daily for six months

[ 0 ]

1

[ 0 ]

intervention 1: Letrozole 2.5 mg daily

intervention 1: letrozole

1

Kansas City | Kansas | United States | -94.62746 | 39.11417

0

NCT00291135

[ 3 ]

184

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

A 1-year randomized Phase II core trial was conducted to investigate the efficacy of deferasirox in regularly transfused patients with β-thalassemia and other rare chronic anemia 2 years of age and older. Patients who successfully completed the main trial may continue in the extension trial to receive chelation therapy with deferasirox for up to 3 years. Extension was prolonged to 4 years. The objective of this study is to assess the long-term safety and efficacy of deferasirox in these patient groups.

null

Anemia Hemosiderosis

β-thalassemia rare chronic anemia iron overload deferasirox chronic anemias transfusional hemosiderosis

null

1

arm 1: Deferasirox daily oral dose between 5-40 mg/kg/day

[ 0 ]

1

[ 0 ]

intervention 1: Deferasirox available as 125 mg, 250 mg or 500 mg tablets

intervention 1: Deferasirox

28

Oakland | California | United States | -122.2708 | 37.80437 Stanford | California | United States | -122.16608 | 37.42411 Boston | Massachusetts | United States | -71.05977 | 42.35843 New York | New York | United States | -74.00597 | 40.71427 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Bruges | N/A | Belgium | 3.22424 | 51.20892 Brussels | N/A | Belgium | 4.34878 | 50.85045 Ghent | N/A | Belgium | 3.71667 | 51.05 La Louvière | N/A | Belgium | 4.18785 | 50.48657 Leuven | N/A | Belgium | 4.70093 | 50.87959 Montreal | N/A | Canada | -73.58781 | 45.50884 Toronto | N/A | Canada | -79.39864 | 43.70643 Créteil | N/A | France | 2.46569 | 48.79266 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Lille | N/A | France | 3.05858 | 50.63297 Troyes | N/A | France | 4.08524 | 48.30073 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Hanover | N/A | Germany | 9.73322 | 52.37052 Ulm | N/A | Germany | 9.99155 | 48.39841 Bologna | N/A | Italy | 11.33875 | 44.49381 Brindisi | N/A | Italy | 17.93607 | 40.63215 Cagliari | N/A | Italy | 9.11917 | 39.23054 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 9.18951 | 45.46427 Pavia | N/A | Italy | 9.15917 | 45.19205 Rome | N/A | Italy | 12.51133 | 41.89193 Torino | N/A | Italy | 11.99138 | 44.88856 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00303329

[ 4 ]

11

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

3TRIPLE

false

0ALL

true

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine. PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.

OBJECTIVES: * Determine the efficacy of celecoxib in reducing the incidence and severity of hand/foot syndrome caused by capecitabine in patients with metastatic breast cancer or colorectal cancer. OUTLINE: This is a placebo-controlled, randomized, double-blind, multicenter study. Patients are stratified according to metastatic disease (breast vs colorectal), ECOG performance status (0 or 1 vs 2), prior chemotherapy (yes vs no). Patients receive 1 of 2 treatment regimens. * Regimen A (concurrent radiotherapy): Patients undergo radiotherapy 5 days a week for 5-6 weeks and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine as in regimen B. * Regimen B (no radiotherapy): Patients receive oral capecitabine once daily on days 1-14. Courses repeat every 21 days. Patients are also randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral celecoxib twice daily on days 1-21. * Arm II: Patients receive oral placebo twice daily on days 1-21. In both arms, treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study.

Breast Cancer Colorectal Cancer Pain

Hand-Foot Syndrome cancer-related problem/condition drug/agent toxicity by tissue/organ pain palmar-plantar erythrodysesthesia stage IV breast cancer male breast cancer recurrent breast cancer stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer Celecoxib Celebrex Capecitabine Xeloda

null

2

arm 1: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day). arm 2: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m\^2 orally twice/day)

[ 0, 2 ]

4

[ 0, 0, 3, 0 ]

intervention 1: Initial dose of 750-1500 mg/m\^2 orally twice a day for each 21 day cycle. intervention 2: 200 mg given orally twice a day for each 21 day cycle. intervention 3: Some patients may undergo radiation therapy 5 days a week for 5-6 weeks, and receive oral capecitabine twice daily 5 days a week. Following completion of radiotherapy, patients may continue oral capecitabine once daily on days 1-14. intervention 4: Oral placebo twice daily on days 1-21

intervention 1: Capecitabine intervention 2: Celecoxib intervention 3: Radiation Therapy intervention 4: Placebo

14

0

NCT00305643

[ 4 ]

269

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

null

Attention Deficit Disorder With Hyperactivity

null

3

arm 1: Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks arm 2: Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks arm 3: Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

[ 0, 0, 0 ]

1

[ 0 ]

intervention 1: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

intervention 1: atomoxetine

20

Acireale | N/A | Italy | 15.16577 | 37.60886 Avellino | N/A | Italy | 14.79103 | 40.91494 Bosisio Parini | N/A | Italy | 9.29 | 45.80075 Brescia | N/A | Italy | 10.21472 | 45.53558 Catania | N/A | Italy | 15.07041 | 37.49223 Coppito | N/A | Italy | 13.34358 | 42.3673 Cremona | N/A | Italy | 10.02129 | 45.13325 Milan | N/A | Italy | 12.59836 | 42.78235 Ostuni | N/A | Italy | 17.57675 | 40.72913 Palermo | N/A | Italy | 13.3636 | 38.1166 Perugia | N/A | Italy | 12.38878 | 43.1122 Rho | N/A | Italy | 9.0402 | 45.53245 Rome | N/A | Italy | 12.51133 | 41.89193 Sassari | N/A | Italy | 8.55552 | 40.72586 Savigliano | N/A | Italy | 7.65677 | 44.64808 Siena | N/A | Italy | 11.33064 | 43.31822 Trieste | N/A | Italy | 13.77678 | 45.64953 Troina | N/A | Italy | 14.59605 | 37.78437 Udine | N/A | Italy | 13.23715 | 46.0693 Viterbo | N/A | Italy | 12.1056 | 42.41937

0

NCT00320528

[ 3 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works in treating patients with recurrent or metastatic non-small cell lung cancer.

OBJECTIVES: Primary * Evaluate the response rate in patients with recurrent or metastatic non-small cell lung cancer treated with gemcitabine hydrochloride and imatinib mesylate. Secondary * Assess time to progression in patients treated with this regimen. * Assess overall survival and 1-year survival of patients treated with this regimen. * Assess the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, nonrandomized, uncontrolled, open-label study. Patients receive gemcitabine hydrochloride IV on days 3 and 10 and oral imatinib mesylate once daily on days 1-5 and 8-12. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Lung Cancer

recurrent non-small cell lung cancer stage IV non-small cell lung cancer

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days. intervention 2: 400 mg/day orally, given Days 1-5 and 8-12 every 21 days

intervention 1: gemcitabine hydrochloride intervention 2: imatinib mesylate

3

0

NCT00323362

[ 3, 4 ]

120

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

A blood clot in the veins, also known as deep venous thrombosis (DVT), is one of the most common complications after surgery. This may result in death if a clot breaks off and travel to the lungs; this is referred to as pulmonary embolism (PE). After heart surgery the incidence of DVT ranges from 20-48% and following lung surgery the incidence is 19-26%. In order to decrease the likelihood of this complication, patients receive by injection a blood thinning medicine. Heparin is the usual medicine used for this purpose following heart and lung surgery. Recently there have been reports that other medicines may be more effective than heparin for this purpose. Also there have been reports that some patients develop antibodies to heparin. When this occurs, this may prevent the heparin from being effective and may even promote the formation of blood clots. Antibodies to heparin may be present more often following heart and lung surgery than other types of surgery. There is a new medicine called desirudin (Iprivask), which may be used instead of heparin to prevent blood clots following heart and lung surgery. Desirudin is currently approved by the FDA to prevent blood clots following hip surgery. The purpose of this study is to compare desirudin with heparin for the prevention of vein clots after heart and lung surgery.

null

Deep Venous Thrombosis

Deep venous thrombosis DVT Heparin induced thrombocytopenia HIT Direct thrombin inhibitor

null

2

arm 1: Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100). arm 2: Both groups of patients will receive study drug three times a day (TID) for DVT prophylaxis. The current TID schedule is 0900, 1300, and 2100. Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points.

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Patients who are randomized to the desirudin (study) group will receive 15 mg of subcutaneous desirudin twice a day (at 0900 and 2100). These patients will also receive an injection of normal saline placebo at 1300 so that patients in both groups will receive three injections at the same time points. intervention 2: The patients who are randomized to the Heparin (standard of care) group will receive subcutaneous injections of heparin three times a day (0900, 1300 and 2100).

intervention 1: Desirudin (Iprivask™) intervention 2: Heparin

1

St Louis | Missouri | United States | -90.19789 | 38.62727

0

NCT00329433

[ 3 ]

54

NA

SINGLE_GROUP

4SUPPORTIVE_CARE

0NONE

false

0ALL

true

RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer. PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.

OBJECTIVES: Primary * Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever. Secondary * Assess the percentage of bacterial cures in patients with documented gram-positive bacterial infections. * Assess time to afebrile state. * Assess the pharmacokinetic data of daptomycin in neutropenic patients. * Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear. * Assess the tolerability of daptomycin in neutropenic patients. * Assess and document adverse events and toxicity due to daptomycin. OUTLINE: This is an open-label, pilot study. Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the patient is still febrile at 72 hours, daptomycin is administered. Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not neutropenic (absolute neutrophil count \[ANC\] \> 500/mm³), and have no signs of infection after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic (ANC \< 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count (ANC) \> 500/mm³ for 2 consecutive days. Patients who are febrile with or without continued neutropenia (ANC \< 500/mm³) after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Fever Sweating Hot Flashes Infection Neutropenia Unspecified Adult Solid Tumor, Protocol Specific

neutropenia infection unspecified adult solid tumor, protocol specific fever, sweats, and hot flashes

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.

intervention 1: Daptomycin

1

Portland | Oregon | United States | -122.67621 | 45.52345

0

NCT00335478

[ 4 ]

1,155

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA), a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug that has anti inflammatory and neuroprotective properties. The study treatment duration is 12 months.

null

Relapsing Remitting Multiple Sclerosis

null

2

arm 1: None arm 2: None

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months intervention 2: Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months

intervention 1: Glatiramer Acetate (GA) 40 mg intervention 2: glatiramer acetate 20 mg

0

null

0

NCT00337779

[ 3 ]

20

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

Pancreatic Cancer

Stereotactic Body Radiotherapy (SBRT) pancreas cancer locally advanced local control Gemcitabine

null

1

arm 1: Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.

[ 0 ]

4

[ 4, 0, 10, 4 ]

intervention 1: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator intervention 2: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes intervention 3: Patients will undergo this imaging procedure prior to treatment for planning purposes. intervention 4: Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

intervention 1: Stereotactic Body Radiotherapy intervention 2: Gemcitabine intervention 3: 4D pancreatic protocol CT scan intervention 4: FDG PET scan

1

Stanford | California | United States | -122.16608 | 37.42411

0

NCT00350142

[ 3 ]

135

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

null

Coronary Heart Disease

null

2

arm 1: Dalcetrapib 900mg po daily for 24 weeks arm 2: Placebo po daily for 24 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: po daily for 24 weeks intervention 2: 900mg po daily for 24 weeks

intervention 1: Placebo intervention 2: dalcetrapib

17

0

NCT00353522

[ 2 ]

16

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL)

Adult T-Cell Leukemia ATL Adult Peripheral T-Cell Lymphoma PTCL

null

1

arm 1: KW-0761

[ 0 ]

1

[ 0 ]

intervention 1: IV administration at 4 escalating dose levels.

intervention 1: KW-0761

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00355472

[ 4 ]

1,381

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans. The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component. Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities). Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200 mg of itraconazole (Sporanox®, Janssen Pharmaceutical Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Onychomycosis

Nail fungus Onychomycosis Itraconazole Toenail

null

3

arm 1: Itraconazole 200 mg tablets arm 2: Two Itraconazole 100 mg capsules were taken daily. arm 3: The itraconazole 200-mg tablets and placebo tablets exactly matched one another and were white to slightly grey in color, were oblong and biconvex in shape, and were melt-extrusion, film-coated.

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Subjects took two 100mg capsules once per day after a full meal. The dose dose was taken the day before the Week 12 visit. intervention 2: Subjects took one 200mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit. intervention 3: Placebo tablets are the same as the Itraconazole tablets but without the active drug included. Subjects took one tablet once per day after a full meal. The last tablet was taken the day before the Week 12 visit.

intervention 1: Itraconazole 100mg capsules intervention 2: Itraconazole 200mg tablets intervention 3: Placebo tablets

68

0

NCT00356915

[ 3 ]

13

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

null

Breast Cancer

Breast neoplasms breast cancer early breast cancer oncology cancer breast cancer micrometastasis fulvestrant

null

2

arm 1: Anastrozole monotherapy arm 2: Anastrozole + Fulvestrant

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: intramuscular injection intervention 2: 1 mg oral tablet

intervention 1: Fulvestrant intervention 2: Anastrozole

25

Feldkirch | N/A | Austria | 9.6 | 47.23306 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Klagenfurt | N/A | Austria | 14.30528 | 46.62472 Leoben | N/A | Austria | 15.09144 | 47.3765 Linz | N/A | Austria | 14.28611 | 48.30639 Salzburg | N/A | Austria | 13.04399 | 47.79941 Sankt Veit im Pongau | N/A | Austria | 13.15 | 47.33333 Vienna | N/A | Austria | 16.37208 | 48.20849 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485 Bayreuth | N/A | Germany | 11.57893 | 49.94782 Essen | N/A | Germany | 7.01228 | 51.45657 Hamburg-Eppendorf | N/A | Germany | N/A | N/A Heidelberg | N/A | Germany | 8.69079 | 49.40768 Munich | N/A | Germany | 11.57549 | 48.13743 Rostock | N/A | Germany | 12.14049 | 54.0887 Tübingen | N/A | Germany | 9.05222 | 48.52266 Drammen | N/A | Norway | 10.20449 | 59.74389 Fredrikstad | N/A | Norway | 10.9298 | 59.2181 Kristiansand | N/A | Norway | 7.9956 | 58.14671 Oslo | N/A | Norway | 10.74609 | 59.91273 Porsgrunn | N/A | Norway | 9.6561 | 59.14054 Stavanger | N/A | Norway | 5.73332 | 58.97005 Trondheim | N/A | Norway | 10.39506 | 63.43049 Tønsberg | N/A | Norway | 10.40762 | 59.26754

0

NCT00357110

[ 3 ]

52

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.

null

Non-Small-Cell Lung Cancer

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.

intervention 1: LY573636-sodium

7

Gauting | N/A | Germany | 11.37703 | 48.06919 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Hamburg | N/A | Germany | 9.99302 | 53.55073 Löwenstein | N/A | Germany | 9.38 | 49.09558 Mannheim | N/A | Germany | 8.46694 | 49.4891 Orbassano | N/A | Italy | 7.53813 | 45.00547 San Sisto | N/A | Italy | 11.80346 | 45.0476

0

NCT00363766

[ 5 ]

84

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.

null

Type 2 Diabetes Mellitus

Beta cell function Type 2 diabetes Combination treatment

null

0

null

3

[ 0, 0, 0 ]

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

intervention 1: rosiglitazone-metformin intervention 2: Metformin intervention 3: metformin+ gliclazide

0

null

0

NCT00367055

[ 4 ]

840

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The study involves the enrollment of patients over 18 years of age with diabetic macular edema(DME). Patients with one study eye will be randomly assigned (stratified by visual acuity and prior laser) with equal probability to one of the three treatment groups: 1. Laser photocoagulation 2. 1mg intravitreal triamcinolone acetonide injection 3. 4mg intravitreal triamcinolone acetonide injection For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by visual acuity and prior laser) will be randomly assigned with equal probabilities to one of the three treatment groups listed above. The left eye will be assigned to the alternative treatment (laser or triamcinolone). If the left eye is assigned to triamcinolone, then the dose (1mg or 4 mg) will be randomly assigned to the left eye with equal probability (stratified by visual acuity and prior laser). The study drug, triamcinolone acetonide, has been manufactured as a sterile intravitreal injectable by Allergan. Study eyes assigned to an intravitreal triamcinolone injection will receive a dose of either 1mg or 4mg. There is no indication of which treatment regimen will be better. Patients enrolled into the study will be followed for three years and will have study visits every 4 months after receiving their assigned study treatment. In addition, standard of care post-treatment visits will be performed at 4 weeks after each intravitreal injection.

Diabetic retinopathy is a major cause of visual impairment in the United States. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision. Data from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR) estimate that after 15 years of known diabetes, the prevalence of diabetic macular edema is approximately 20% in patients with type 1 diabetes mellitus (DM), 25% in patients with type 2 DM who are taking insulin, and 14% in patients with type 2 DM who do not take insulin. In a review of three early studies concerning the natural history of diabetic macular edema, Ferris and Patz found that 53% of 135 eyes with diabetic macular edema, presumably all involving the center of the macula, lost two or more lines of visual acuity over a two year period. In the Early Treatment Diabetic Retinopathy Study (ETDRS), 33% of 221 untreated eyes available for follow-up at the 3-year visit, all with edema involving the center of the macula at baseline, had experienced a 15 or more letter decrease in visual acuity score (equivalent to a doubling of the visual angle, e.g., 20/25 to 20/50, and termed "moderate visual acuity loss"). In the ETDRS, focal/grid photocoagulation of eyes with clinically significant macular edema (CSME) reduced the risk of moderate visual loss by approximately 50% (from 24% to 12%, three years after initiation of treatment). Therefore, 12% of treated eyes developed moderate visual loss in spite of treatment. Furthermore, approximately 40% of treated eyes that had retinal thickening involving the center of the macula at baseline still had thickening involving the center at 12 months, as did 25% of treated eyes at 36 months. Although several treatment modalities are currently under investigation, the only demonstrated means to reduce the risk of vision loss from diabetic macular edema are laser photocoagulation, as demonstrated by the ETDRS, and intensive glycemic control, as demonstrated by the Diabetes Control and Complications Trial (DCCT) and the United Kingdom Prospective Diabetes Study (UKPDS). In the DCCT, intensive glucose control reduced the risk of onset of diabetic macular edema by 23% compared with conventional treatment. Long-term follow-up of patients in the DCCT show a sustained effect of intensive glucose control, with a 58% risk reduction in the development of diabetic macular edema for the DCCT patients followed in the Epidemiology of Diabetes Interventions and Complications Study. The frequency of an unsatisfactory outcome following laser photocoagulation in some eyes with diabetic macular edema has prompted interest in other treatment modalities. One such treatment is pars plana vitrectomy. These studies suggest that vitreomacular traction, or the vitreous itself, may play a role in increased retinal vascular permeability. Removal of the vitreous or relief of mechanical traction with vitrectomy and membrane stripping may be followed by substantial resolution of macular edema and corresponding improvement in visual acuity. However, this treatment may be applicable only to a specific subset of eyes with diabetic macular edema. It also requires a complex surgical intervention with its inherent risks, recovery time, and expense. Other treatment modalities such as pharmacologic therapy with oral protein kinase C inhibitors and antibodies targeted at vascular endothelial growth factor (VEGF) are under investigation. The use of intravitreal corticosteroids is another treatment modality that has generated recent interest. The optimal dose of corticosteroid to maximize efficacy with minimum side effects is not known. A 4mg dose of Kenalog is principally being used in clinical practice. However, this dose has been used based on feasibility rather than scientific principles. There is also experience using Kenalog doses of 1mg and 2mg. These doses anecdotally have been reported to reduce the macular edema. There is a rationale for using a dose lower than 4mg. Glucocorticoids bind to glucocorticoid receptors in the cell cytoplasm, and the steroid-receptor complex moves to the nucleus where it regulates gene expression. The steroid-receptor binding occurs with high affinity (low dissociation constant (Kd) which is on the order of 5 to 9 nanomolar). Complete saturation of all the receptors occurs about 20-fold higher levels, i.e., about 100-200 nanomolar. A 4mg dose of triamcinolone yields a final concentration of 7.5 millimolar, or nearly 10,000-fold more than the saturation dose. Thus, the effect of a 1mg dose may be equivalent to that of a 4mg dose, because compared to the 10,000-fold saturation, a 4-fold difference in dose is inconsequential. It is also possible that higher doses of corticosteroid could be less effective than lower doses due to down-regulation of the receptor. The steroid implant studies provide additional justification for evaluating a lower dose, a 0.5mg device which delivers only 0.5 micrograms per day has been observed to have a rapid effect in reducing macular edema. There has been limited experience using doses greater than 4mg. Jonas' case series reported results using a 25mg dose. However, others have not been able to replicate this dose using the preparation procedure described by Jonas. In the trial, 4mg and 1mg doses will be evaluated. The former will be used because it is the dose that is currently most commonly used in clinical practice and the latter because there is reasonable evidence for efficacy and the potential for lower risk. Although there is good reason to believe that a 1mg dose will reduce the macular edema, it is possible that the retreatment rate will be higher with this dose compared with 4mg since the latter will remain active in the eye for a longer duration than the former. Insufficient data are available to warrant evaluating a dose higher than 4mg at this time.

Diabetic Macular Edema

diabetic macular edema intravitreal triamcinolone laser photocoagulation DME

null

3

arm 1: Standard of care group: conventional treatment consisting of focal/grid photocoagulation. arm 2: Intravitreal injection of 1mg of triamcinolone acetonide arm 3: Intravitreal injection of 4mg of triamcinolone acetonide

[ 1, 0, 0 ]

3

[ 3, 0, 0 ]

intervention 1: Standard of care group: conventional treatment consisting of focal/grid photocoagulation. intervention 2: Intravitreal injection of 1mg of triamcinolone acetonide at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment. intervention 3: 4mg intravitreal triamcinolone acetonide injection at baseline. At each 4-month interval visit, the investigator will assess whether persistent or recurrent DME is present that warrants retreatment with the randomization assigned treatment. Retreatment, when indicated, will be performed within four weeks after the follow-up visit. Retreatment should not be performed sooner than 3.5 months from the time of the last treatment.

intervention 1: Standard of Care Group intervention 2: 1mg triamcinolone acetonide intervention 3: 4mg triamcinolone acetonide

84

0

NCT00367133

[ 5 ]

30

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Studies in humans and animals support that stress and/or elevations in corticosteroids lead to changes in hippocampal structure and functioning. This is important as patients with major depression frequently have elevated cortisol, and millions of patients receive prescription corticosteroids (e.g. prednisone). Both depression and corticosteroid therapy are associated with memory impairment and hippocampal atrophy. Our research uses corticosteroid-treated patients to explore interventions that might protect the brain from the effects of stress or corticosteroids. We propose to give 30 corticosteroid-treated asthma patients acetaminophen or placebo. Between group differences in mood, memory and other neurocognitive measures will serve as outcome measures.

SCIENTIFIC PROPOSAL Aims Primary 1. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in declarative memory than those receiving placebo. 2. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller increases in manic/hypomanic symptoms than those receiving placebo. Secondary 1. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller declines in cognitive domains other than declarative memory such as working memory and executive functioning than those receiving placebo. 2. Determine if patients receiving prescription corticosteroid therapy who are given acetaminophen have smaller increases in depressive symptoms than those receiving placebo. Background/Significance Impact of stress or corticosteroids on the hippocampus: Studies in animals suggest that stress-induced elevations in endogenous corticosteroids or the administration of exogenous corticosteroids are associated with cognitive deficits and changes in hippocampal structure which can (after extended exposure) include irreversible neuronal loss (Brown et al. 1999, 2004a; McEwen 1997, 2000). These findings have important implications as common psychiatric illnesses including major depressive and bipolar disorders are frequently associated with acute or chronic elevations in cortisol (Brown et al. 1999). In addition, each year approximately 10 million Americans are given prescription corticosteroids, such as prednisone or dexamethasone, for illnesses such as asthma, allergies, arthritis, and dermatological conditions (Brown et al. 1999). The hippocampus is important as it mediates important cognitive processes and provides negative feedback to the hypothalamic-pituitary-adrenal (HPA) axis (Jacobson \& Sapolsky 1991). Thus, hippocampal impairment could result in both memory loss and potentially even greater cortisol levels due to loss of normal negative feedback. This concept of hippocampal dysfunction leading to greater elevation in cortisol levels and additional hippocampal dysfunction has been termed the "glucocorticoid cascade hypothesis" (Sapolsky et al. 1986). Several lines of evidence suggest that stress and corticosteroids may impair human hippocampal structure and functioning. Starkman et al. (1992) examined hippocampal volumes using Magnetic Resonance Imaging (MRI) in 12 patients with cortisol elevations of 1-4 years duration secondary to Cushing's disease. In three patients, hippocampal volumes fell outside the 95% confidence interval reported in the literature. Atrophy correlated with mean cortisol levels. Our group recently reported poorer performance on a declarative memory task (a measure of hippocampal functioning), smaller hippocampal volume and lower levels of N-acetyl aspartate, a putative marker of neuronal viability, in a group of 17 asthma and arthritis patients receiving long-term prednisone therapy than in a control group of similar age, education level and medical history not receiving prednisone (Brown et al 2004b). Studies in humans also suggest smaller hippocampal volumes by Magnetic Resonance Imaging (MRI) in people with chronic or recurrent major depressive or bipolar disorders (Sheline et al. 1996; Bremner et al. 2000). Although none of these studies documented elevated cortisol levels at the time of the neuroimaging, mood disorders can be associated with an elevation in cortisol. Therefore, one explanation for these findings is hippocampal atrophy due to an excess of cortisol at some point in the illness. Corticosteroids are associated with deficits in cognitive functioning, which may occur very rapidly after exposure and long before any changes in hippocampal structure could be detected with available imaging techniques. Thus, cognitive instruments may be a sensitive measure of early changes in the hippocampus due to corticosteroids. Declarative memory, assessed with instruments such as word lists or paragraph recall, appears to be particularly sensitive to hippocampal functioning (Squire 1992). Memory deficits have been reported in patients receiving short (days) (Naber et al. 1996, Bender et al. 1988, Newcomer et al. 1994, 1999) or long term (weeks, months or years) (Brown et al. 2004b, Keenan et al. 1996) exposures to exogenous corticosteroids. Mood symptom with prescription corticosteroids In addition to cognitive effects, corticosteroids are also associated with changes in mood. Brief courses of prescription corticosteroids are associated primarily with manic or hypomanic symptoms (Brown et al. 2002; Naber et al. 1996) although clinically significant depressive symptoms are reported in some patients (Naber et al. 1996). Longer-term exposure to lower dosages of prednisone may be associated more strongly with depressive symptoms (Brown et al. 2004b; Keenan et al. 1996). We found lifetime prednisone-induced mood disorders in 60% of patients receiving chronic prednisone therapy (Bolanos et al. 2004). Interventions to prevent or reverse hippocampal changes secondary to stress or corticosteroids In animal models, pharmacological interventions focusing on agents that directly reduce corticosteroid levels or reduce corticosteroid-induced elevations in serotonin or glutamate have been explored. A novel antidepressant not currently available in the U.S. for use in humans, tianeptine, appears to prevent and reverse morphological changes in the rat hippocampus during a stress paradigm (Conrad et al. 1996; Watanabe et al. 1992; Magarinos et al. 1999). An additional agent, which appears to prevent stress-induced hippocampal damage in rats, is the glutamate-release inhibitor phenytoin (Watanabe et al. 1992; Magarinos et al. 1999). If an excess of corticosteroids is associated with memory impairment and eventual hippocampal volume loss, interventions that may prevent or reverse these changes are of great importance. Memory deficits secondary to brief (days to weeks) exposure to corticosteroids are clearly reversible with medication discontinuation. Even hippocampal changes with longer term corticosteroid exposure may be reversible. Starkman et al (1999) reported significant increases in hippocampal volumes, measured on MRI, and improvement in declarative memory in 22 patients with Cushing's disease approximately 3-18 months (mean 12 months) following successful treatment and normalization of cortisol levels. We reported on the use of lamotrigine, a glutamate release inhibitor, for 12 weeks in a group of 10 patients receiving long-term prednisone therapy (Brown et al 2003). We found statistically significant improvement in declarative memory, suggestive of a neuroprotective effect on the hippocampus, following lamotrigine therapy. We recently completed a randomized, double-blind, placebo-controlled trial of phenytoin in patients receiving prednisone therapy (Brown et al 2005). Phenytoin was associated with a significantly smaller increase in hypomanic symptom severity than placebo during the prednisone exposure. However, it appears that phenytoin, not unexpectedly, may have also been associated with some negative effects on cognition. Thus, a medication with few cognitive effects may be a better choice for use in our model system. Interventions to prevent or reverse the mood effects of prescription corticosteroids Only two controlled clinical trials have been conducted in patients with psychiatric symptoms secondary to corticosteroids. Falk et al. (1979) reported that lithium pretreatment might attenuate corticosteroid-induced mood symptoms. While 14% of patients receiving corticotropin therapy suffered from mood symptoms, none of the patients receiving corticotropin following lithium pretreatment had a mood disturbance. As discussed above, we gave a group of adult asthma patients either phenytoin or placebo at the same time they began a course of oral prednisone therapy. The group receiving phenytoin has a significantly smaller increase in manic symptom severity than the group receiving placebo (Brown et al. 2005, see also preliminary studies section). Case reports and small open-label studies suggest that lithium and other mood stabilizers including lamotrigine, carbamazepine, gabapentin, valproic acid, traditional neuroleptics (Ahmad and Rasul, 1999) and the newer atypical agents (Brown et al. 2004c) may effectively treat or prevent corticosteroid-induced mood symptoms after their development (Brown, 2003, Brown et al. 2003). Our group has developed a research program using humans who receive prescription corticosteroids as anti-inflammatory and immunosuppressant therapy to explore the effects of the stress hormones on the hippocampus. Our current focus is on interventions that may prevent or reverse the effects of stress or corticosteroids on the hippocampus. Acetaminophen as a neuroprotective agent Data suggest that acetaminophen is widely distributed in the central nervous system (Caurad et al. 2001a) and may have neuroprotective properties. Pertinent to the proposed study acetaminophen protects dopaminergic neurons against glutamate excitotoxicity in vitro (Casper et al. 2000) and protects hippocampal neurons from oxidative stress (Bisaglia et al 2002). Acetaminophen also reduces staphylococcal enterotoxin-induced increases in glutamate release in the rabbit brain (Huang et al 2004). Acetaminophen also alters monoamines in the rat brain (Courad et al. 2001b), and synaptic plasticity in the hippocampus through presynaptic serotonin receptors (Chen and Bazan, 2003). No reports were found on the effect of acetaminophen on mood or memory. Summary A reliable early effect (beginning 1-2 days into therapy) of corticosteroids on the human hippocampus is a decline in performance on declarative memory tasks (e.g. word lists). Preclinical data suggest that acetaminophen may have neuroprotective properties. We propose to give patients scheduled to receive prescription corticosteroids either acetaminophen or placebo along with the corticosteroids. Our aim is to determine if the acetaminophen attenuates the decline in declarative memory, and development of hypomanic symptomatology (e.g. insomnia, irritability, agitation) better than placebo. If this pilot study shows promising results we would anticipate conducting a larger, more definitive study, with funding from National Institutes of Health (NIH).

Asthma Rheumatic Disease

Acetaminophen corticosteroids prednisone

null

2

arm 1: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days. arm 2: Participants will be given an identical appearing placebo (two 500 mg tablets) four times daily for 7 days.

[ 0, 2 ]

1

[ 0 ]

intervention 1: Acetaminophen: Participants will be given acetaminophen (two 500 mg tablets) four times daily for 7 days, not exceeding 4,000 mg/day. Placebo: Participants will be given placebo(two 500 mg tablets) four times daily for 7 days

intervention 1: Drug: Acetaminophen, Drug: Placebo

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00377364

[ 3 ]

84

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

null

Biliary Tract Cancer

null

2

arm 1: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. arm 2: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1000 milligrams per square meter (mg/m2), intravenous (IV) intervention 2: 25 milligrams per square meter (mg/m2), intravenous (IV)

intervention 1: gemcitabine intervention 2: cisplatin

7

Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Fukuoka | N/A | Japan | 130.41667 | 33.6 Hokkaido | N/A | Japan | N/A | N/A Kanagawa | N/A | Japan | 139.91667 | 37.58333 Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00380588

[ 5 ]

97

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).

null

Autistic Disorder Attention Deficit Disorder With Hyperactivity

null

2

arm 1: atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks arm 2: placebo every day (QD), by mouth (PO) for 8 weeks Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Atomoxetine intervention 2: Placebo

8

Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Oosterhout | N/A | Netherlands | 4.85972 | 51.645 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Utrecht | N/A | Netherlands | 5.12222 | 52.09083

0

NCT00380692

[ 4 ]

125

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

null

Acromegaly

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks. intervention 2: Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

intervention 1: lanreotide (Autogel formulation) intervention 2: Pegvisomant

24

Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Prague | N/A | Czechia | 14.42076 | 50.08804 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Créteil | N/A | France | 2.46569 | 48.79266 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 München | N/A | Germany | 13.31243 | 51.60698 Piraeus | N/A | Greece | 23.64619 | 37.94203 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy | 14.5195 | 40.87618 Torino | N/A | Italy | 11.99138 | 44.88856 Leiden | N/A | Netherlands | 4.49306 | 52.15833 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Alicante | N/A | Spain | -0.48149 | 38.34517 Madrid | N/A | Spain | -3.70256 | 40.4165 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Sheffield | N/A | United Kingdom | -1.4659 | 53.38297

0

NCT00383708

[ 4 ]

654

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

null

Asthma, Bronchial

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Symbicort (budesonide/formoterol) Turbuhaler intervention 2: Conventional treatment

52

A Coruña | N/A | Spain | -8.396 | 43.37135 Alagón | N/A | Spain | -1.11906 | 41.76964 Alicante | N/A | Spain | -0.48149 | 38.34517 Almoradí | N/A | Spain | -0.79197 | 38.10879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Burgos | N/A | Spain | -3.70184 | 42.34106 Cadiz | N/A | Spain | -6.2891 | 36.52672 Caravaca | N/A | Spain | -1.86343 | 38.10558 Cartagena | N/A | Spain | -0.98397 | 37.60197 Coslada | N/A | Spain | -3.56129 | 40.42378 Córdoba | N/A | Spain | -4.77275 | 37.89155 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 Dos Hermanas | N/A | Spain | -5.92088 | 37.28287 Elche | N/A | Spain | -0.70107 | 38.26218 Fuencarral | N/A | Spain | -3.68333 | 40.5 Fuenlabrada | N/A | Spain | -3.79415 | 40.28419 Galdakao | N/A | Spain | -2.8429 | 43.23073 Gallur | N/A | Spain | -1.31577 | 41.8683 Gandia | N/A | Spain | -0.18333 | 38.96667 Getafe | N/A | Spain | -3.73295 | 40.30571 Gijón | N/A | Spain | -5.66152 | 43.53573 Granada | N/A | Spain | -3.60667 | 37.18817 Huelva | N/A | Spain | -6.94004 | 37.26638 Huesca | N/A | Spain | -0.4087 | 42.13615 Idiazabal | N/A | Spain | -2.23356 | 43.01189 Jaén | N/A | Spain | -3.79028 | 37.76922 Lugo | N/A | Spain | -7.55602 | 43.00992 Madrid | N/A | Spain | -3.70256 | 40.4165 Mataró | N/A | Spain | 2.4445 | 41.54211 Málaga | N/A | Spain | -4.42034 | 36.72016 Oviedo | N/A | Spain | -5.84476 | 43.36029 Pamplona | N/A | Spain | -1.64323 | 42.81687 Pinto | N/A | Spain | -3.69999 | 40.24147 Pozuelo de Alarcón | N/A | Spain | -3.81338 | 40.43293 Sagunto | N/A | Spain | -0.26667 | 39.68333 Salamanca | N/A | Spain | -3.67975 | 40.42972 San Juan | N/A | Spain | -1.16667 | 39.53333 Santander | N/A | Spain | -3.80444 | 43.46472 Santiago | N/A | Spain | -4.13866 | 37.9358 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Seville | N/A | Spain | -5.97317 | 37.38283 Terrassa | N/A | Spain | 2.01667 | 41.56667 Valdemoro | N/A | Spain | -3.67887 | 40.19081 Valencia | N/A | Spain | -0.37966 | 39.47391 Valladolid | N/A | Spain | -4.72372 | 41.65518 Vigo | N/A | Spain | -8.72264 | 42.23282 Viladecans | N/A | Spain | 2.01427 | 41.31405 Vilanova | N/A | Spain | -7.01667 | 42.81667 Villabona | N/A | Spain | -2.05304 | 43.1854 Villanueva de la Cañada | N/A | Spain | -4.00428 | 40.44689 Vitoria-Gasteiz | N/A | Spain | -2.67268 | 42.84998 Zaragoza | N/A | Spain | -0.87734 | 41.65606

0

NCT00385593

[ 4 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity. Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion. A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14. * Drug: Infliximab Control (double-blinded) * Drug: Infliximab Increased Dose (double-blinded) * Drug: Infliximab Increased Frequency (open-label)

null

Rheumatoid Arthritis

null

3

arm 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks arm 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks arm 3: Continuation of infliximab 3 mg/kg every 8 weeks

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks intervention 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks intervention 3: Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks

intervention 1: Infliximab Increased Frequency intervention 2: Infliximab Increased Dose intervention 3: Infliximab Control

0

null

0

NCT00394589

[ 4 ]

223

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

The study consisted of four visits that corresponded to consecutive HD sessions for each patient, as well as one follow-up visit. Patients could receive up to three treatments with open-label tenecteplase during the study: one or two treatments during an initial treatment course, and eligible patients whose catheter became dysfunctional again within 21 days of the first visit received an additional treatment as part of a retreatment (RT) course. At Visit 1, patients eligible at the beginning of HD had 2 mL (2 mg) of tenecteplase instilled into each of the two lumens of the HD catheter. After a dwell time of 1 hour, study drug was withdrawn and all subjects underwent HD. The duration of the HD session was not fixed by the study protocol, but rather by the site's HD practice, physician orders, and individual patient response during the session. Patients who did not experience treatment success at the end of Visit 1 had 2 mL (2 mg) of tenecteplase instilled into each lumen of their catheter as part of the initial treatment course. The treatment was left to dwell for an extended time, until the second HD session at Visit 2 (up to 72 hours later). Patients who received extended-dwell tenecteplase had the treatment withdrawn from their catheter at the beginning of Visit 2. Patients underwent HD as prescribed or to the extent possible. Patients who had treatment success at Visit 1 or Visit 2 and had a recurrence of catheter dysfunction within 21 days of Visit 1 and met the re-treatment eligibility criteria had 2 mL (2 mg) of tenecteplase instilled into each lumen, followed by a 1-hour dwell time at re-treatment Visit 1.

Dysfunctional Hemodialysis Catheters

HD TNKase Hemodialysis Catheter clearance

null

1

arm 1: At each treatment, subjects had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Subjects could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all subjects at Visit 1. At the end of hemodialysis at Visit 1, eligible subjects had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).

[ 0 ]

1

[ 0 ]

intervention 1: 2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter.

intervention 1: Tenecteplase

0

null

0

NCT00396253

[ 4 ]

135

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

null

Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.

null

Male Osteoporosis

male osteoporosis osteoporosis bisphonates bone

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Ibandronate orally (tablet) at a dose of 150 mg once per month intervention 2: Placebo orally (tablet) at a dose of 150 mg once per month

intervention 1: Ibandronate intervention 2: placebo

41

0

NCT00397839

[ 5 ]

6

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious. Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes: 1. Safety. 1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured. 2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria. 2. Efficacy. 1. Clinical efficacy. * Time to clearance of bacteremia * Cure at 6 weeks following completion of antibiotic therapy * Mortality at 6 weeks following completion of antibiotic therapy 2. Microbiologic efficacy. * Peak and trough serum bactericidal titers * The minimum bactericidal concentration of Enterococci to daptomycin We expect to enroll 40 patients over 2 years.

null

Endocarditis, Bacterial

Enterococcus Daptomycin Endocarditis

null

2

arm 1: Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving arm 2: Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician

[ 0, 4 ]

1

[ 0 ]

intervention 1: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis

intervention 1: Daptomycin

1

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

0

NCT00401960

[ 3 ]

3,490

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.

This is a randomized (patients will be assigned to study treatment by chance), double-blind (neither the patient nor the study doctor will know the identity of the assigned study treatment) study to evaluate the safety and efficacy of rivaroxaban (study drug) compared to placebo (a tablet identical in appearance to study drug but contains no active drug) in patients with acute coronary syndrome (ACS \[a condition where blood flow in a blood vessel in the heart is restricted because of a blood clot\]). Rivaroxaban is a drug that acts as a blood thinner and is being tested to see if it will be safe and effective in patients diagnosed ACS. The goal of this study is to identify the dose and dosing schedule (once-a-day or twice-a-day dosing) of rivaroxaban that will be safe and effective in preventing adverse cardiovascular outcomes such as death, myocardial infarctions (MI) including repeat myocardial infarction (reMI), stroke, or ischemia (inadequate blood supply to a local area) requiring revascularization (ie, the re-establishment of blood supply to a part or an organ) in patients with ACS who are receiving antiplatelet therapy (ie, aspirin alone or aspirin plus an approved thienopyridine, a type of drug such as clopidogrel that acts to inhibit the formation of blood clots). Approximately 3500 patients are planned to participate in the study for approximately 7 months. At study entry, all patients who are currently receiving treatment for ACS with antiplatelet therapy will be permitted to continue this therapy during the study. Patients will be enrolled and randomized to receive placebo, rivaroxaban administered as a once-daily dose, or rivaroxaban administered as a twice-daily dose at each dose level of rivaroxaban tested. Patients randomized at each dose level will continue to receive the same treatment for 6 months. Near the end of enrollment at the first dose level, available safety and efficacy data from patients will be assessed by an Operations Committee before enrolling and randomizing additional patients to the next higher dose level of rivaroxaban. Increasing dose levels of rivaroxaban are planned; however, progression to each higher dose level will be at the discretion of the Operations Committee. Patient safety will be monitored by evaluating adverse events reported, results from clinical laboratory tests, findings from electrocardiograms (ECGs) and vital signs measurements, findings from physical examinations, and the number of patients with protocol-defined major or minor bleeding, or bleeding requiring medical attention. All patients will take study drug or placebo tablets orally (by mouth) twice daily for 6 months starting at an initial total daily dose of 5 mg. Both once- and twice-daily dosing regimens will be tested at each rivaroxaban dose level planned.

Acute Coronary Syndrome

Acute Coronary Syndrome (ACS) Myocardial Ischemia Rivaroxaban (BAY59-7939) Anti-platelet agents Aspirin Thienopyridine Clopidogrel

null

3

arm 1: Rivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. arm 2: Rivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. arm 3: Placebo 1 placebo tablet twice daily for 6 months.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level. intervention 2: 1 placebo tablet twice daily for 6 months. intervention 3: 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.

intervention 1: Rivaroxaban/Placebo intervention 2: Placebo intervention 3: Rivaroxaban

0

null

0

NCT00402597

[ 5 ]

84

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.

null

Ankylosing Spondylitis

null

1

arm 1: Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: Etanercept 50 mg SC injection once weekly

intervention 1: Enbrel (etanercept)

16

Fredriksberg | N/A | Denmark | N/A | N/A Odense | N/A | Denmark | 10.38831 | 55.39594 Svendborg | N/A | Denmark | 10.60677 | 55.05982 Vejle | N/A | Denmark | 9.5357 | 55.70927 Helsinki | N/A | Finland | 24.93545 | 60.16952 Hyvinkää | N/A | Finland | 24.8606 | 60.63195 Kuopio | N/A | Finland | 27.67703 | 62.89238 Tampere | N/A | Finland | 23.78712 | 61.49911 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Basingstoke | N/A | United Kingdom | -1.08708 | 51.26249 Bath | N/A | United Kingdom | -2.36172 | 51.3751 Cambridge | N/A | United Kingdom | 0.11667 | 52.2 Cannock | N/A | United Kingdom | -2.03085 | 52.69045 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 Metropolitan Borough of Wirral | N/A | United Kingdom | -3.10501 | 53.37616 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328

0

NCT00410046

[ 3 ]

125

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

null

Vitrectomy

null

4

arm 1: 25µg of ocriplasmin intravitreal injection arm 2: 75µg of ocriplasmin intravitreal injection arm 3: 125µg of ocriplasmin intravitreal injection arm 4: Intravitreal injection of placebo

[ 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin. intervention 2: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin. intervention 3: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin. intervention 4: Intravitreal injection of placebo

intervention 1: Ocriplasmin 25µg intervention 2: Ocriplasmin 75µg intervention 3: Ocriplasmin 125µg intervention 4: Placebo

20

0

NCT00412958

[ 4 ]

233

RANDOMIZED

PARALLEL

2DIAGNOSTIC

0NONE

false

0ALL

null

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. The hypothesis is to test whether the 1-year recurrence rate is different with Hexvix assisted TURB compared to standard white light TURB.

The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer. Patients will be followed 4, 8 and 12 months after the initial TURB. This follow-up regimen is according to standard clinical practice in Denmark. Recurrence of non-invasive bladder cancer is frequent, and this study is designed to investigate whether Hexvix assisted TURB can reduce the early recurrence compared to standard TURB

Bladder Cancer

Recurrence of bladder cancer Fluorescence cystoscopy

null

2

arm 1: None arm 2: Standard White light cystoscopy

[ 1, 5 ]

2

[ 0, 10 ]

intervention 1: Single installation, TURB intervention 2: None

intervention 1: Hexvix intervention 2: Standard white light cystoscopy

2

Frederiksberg | N/A | Denmark | 12.53463 | 55.67938 Odense | N/A | Denmark | 10.38831 | 55.39594

0

NCT00412971

[ 4 ]

424

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

null

Anemia

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]

105

Aachen | N/A | Germany | 6.08342 | 50.77664 Aachen | N/A | Germany | 6.08342 | 50.77664 Alzey | N/A | Germany | 8.11513 | 49.74657 Ansbach | N/A | Germany | 10.5931 | 49.30481 Augsburg | N/A | Germany | 10.89851 | 48.37154 Bad König | N/A | Germany | 9.0075 | 49.7432 Bad Nenndorf | N/A | Germany | 9.37904 | 52.33703 Bad Oeynhausen | N/A | Germany | 8.80365 | 52.20699 Bad Orb | N/A | Germany | 9.34782 | 50.22788 Bayreuth | N/A | Germany | 11.57893 | 49.94782 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bottrop | N/A | Germany | 6.9285 | 51.52392 Bovenden | N/A | Germany | 9.9222 | 51.58836 Braunschweig | N/A | Germany | 10.52673 | 52.26594 Bremen | N/A | Germany | 8.80717 | 53.07582 Coesfeld | N/A | Germany | 7.16809 | 51.94349 Cologne | N/A | Germany | 6.95 | 50.93333 Darmstadt | N/A | Germany | 8.65027 | 49.87167 Darmstadt | N/A | Germany | 8.65027 | 49.87167 Daun | N/A | Germany | 6.82942 | 50.19716 Demmin | N/A | Germany | 13.03142 | 53.90762 Dessau | N/A | Germany | 12.24555 | 51.83864 Dortmund | N/A | Germany | 7.466 | 51.51494 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Erfurt | N/A | Germany | 11.03283 | 50.9787 Essen | N/A | Germany | 7.01228 | 51.45657 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Freudenstadt | N/A | Germany | 8.41371 | 48.46695 Fulda | N/A | Germany | 9.67518 | 50.55162 Fürstenzell | N/A | Germany | 13.31749 | 48.52163 Fürth | N/A | Germany | 10.98856 | 49.47593 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Gerolstein | N/A | Germany | 6.65984 | 50.22224 Giessen | N/A | Germany | 8.67554 | 50.58727 Göttingen | N/A | Germany | 9.93228 | 51.53443 Greifswald | N/A | Germany | 13.40244 | 54.08905 Gütersloh | N/A | Germany | 8.37853 | 51.90693 Halle | N/A | Germany | 11.97947 | 51.48158 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hannoversch Münden | N/A | Germany | 9.65046 | 51.41505 Harsewinkel | N/A | Germany | 8.22766 | 51.96224 Heide | N/A | Germany | 9.09742 | 54.19562 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Heilbronn | N/A | Germany | 9.22054 | 49.13995 Hildesheim | N/A | Germany | 9.95112 | 52.15077 Homburg | N/A | Germany | 7.33867 | 49.32637 Homburg/saar | N/A | Germany | N/A | N/A Idar-Oberstein | N/A | Germany | 7.30776 | 49.71443 Jena | N/A | Germany | 11.5899 | 50.92878 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Kiel | N/A | Germany | 10.13489 | 54.32133 Krefeld | N/A | Germany | 6.55381 | 51.33645 Lauterbach | N/A | Germany | 9.39777 | 50.63558 Leipzig | N/A | Germany | 12.37129 | 51.33962 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lennestadt | N/A | Germany | 8.06707 | 51.11721 Ludwigsburg | N/A | Germany | 9.19161 | 48.89731 Ludwigshafen | N/A | Germany | 9.06138 | 47.81663 Lüdenscheid | N/A | Germany | 7.6273 | 51.21977 Marburg | N/A | Germany | 8.77069 | 50.80904 Marl | N/A | Germany | 7.09038 | 51.65671 Meiningen | N/A | Germany | 10.41521 | 50.56787 Memmingen | N/A | Germany | 10.18527 | 47.98372 Minden | N/A | Germany | 8.91455 | 52.28953 Mönchengladbach | N/A | Germany | 6.44172 | 51.18539 München | N/A | Germany | 13.31243 | 51.60698 Neuruppin | N/A | Germany | 12.80311 | 52.92815 Oberschleißheim | N/A | Germany | 11.56667 | 48.25 Offenbach | N/A | Germany | 8.76647 | 50.10061 Offenburg | N/A | Germany | 7.94495 | 48.47377 Potsdam | N/A | Germany | 13.06566 | 52.39886 Recklinghausen | N/A | Germany | 7.19738 | 51.61379 Regensburg | N/A | Germany | 12.10161 | 49.01513 Reutlingen | N/A | Germany | 9.20427 | 48.49144 Ribnitz-Damgarten | N/A | Germany | 12.45666 | 54.2422 Rostock | N/A | Germany | 12.14049 | 54.0887 Rostock | N/A | Germany | 12.14049 | 54.0887 Saarbrücken | N/A | Germany | 7.00982 | 49.23262 Schloss Holte-stutenbrock | N/A | Germany | N/A | N/A Schwerin | N/A | Germany | 11.41316 | 53.62937 Schwerin | N/A | Germany | 11.41316 | 53.62937 Schwetzingen | N/A | Germany | 8.5823 | 49.38217 Stralsund | N/A | Germany | 13.0818 | 54.30911 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Trier | N/A | Germany | 6.63935 | 49.75565 Waiblingen | N/A | Germany | 9.31641 | 48.83241 Weinheim | N/A | Germany | 8.66697 | 49.54887 Weinheim | N/A | Germany | 8.66697 | 49.54887 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Wiesloch | N/A | Germany | 8.69846 | 49.29504 Wuppertal | N/A | Germany | 7.14816 | 51.25627 Wuppertal | N/A | Germany | 7.14816 | 51.25627 Würzburg | N/A | Germany | 9.95121 | 49.79391

0

NCT00413894

[ 4 ]

236

RANDOMIZED

SINGLE_GROUP

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily can help patients with Chronic Low Back Pain. Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.

null

Back Pain Without Radiation

null

2

arm 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase arm 2: every day (QD), by mouth (PO), 13 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase intervention 2: every day (QD), by mouth (PO), 13 weeks

intervention 1: Duloxetine intervention 2: Placebo

17

Curitiba | N/A | Brazil | -49.27306 | -25.42778 São Paulo | N/A | Brazil | -46.63611 | -23.5475 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Amiens | N/A | France | 2.3 | 49.9 Marseille | N/A | France | 5.38107 | 43.29695 Paris | N/A | France | 2.3488 | 48.85341 Saint-Affrique | N/A | France | 2.88915 | 43.95575 Saint-Etienne | N/A | France | 4.39 | 45.43389 Ellwangen | N/A | Germany | 10.13173 | 48.96164 Gräfelfing | N/A | Germany | 11.42939 | 48.11878 Hamburg | N/A | Germany | 9.99302 | 53.55073 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Monterrey | N/A | Mexico | -100.31721 | 25.68435 San Pedro Garza García | N/A | Mexico | -100.40651 | 25.6604 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225

0

NCT00424593

[ 3, 4 ]

42

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This study will evaluate the effect of Octreotide LAR® on the liver volumes of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. A total of 42 patients will be recruited -14 who will receive placebo and 28 the study drug. Preliminary evidence indicates that this drug is safe and non-toxic in other disease states. Treatment with this drug holds promise not only for individuals with liver involvement, but also for many more patients with polycystic kidney disease.

The primary aim of this study is to compare the effect of Octreotide LAR® Depot on the liver volume of patients with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation compared with placebo. The secondary aims of the study are: (1)Assess the effect of Octreotide LAR® Depot on the total kidney volume and iothalamate clearance in patients with polycystic kidney disease associated with severe polycystic liver disease who are not candidates or decline surgical treatments such as liver cyst fenestration, liver resection or liver transplantation. (2)Evaluate quality of life changes associated with the administration of Octreotide LAR® Depot in these patients. (3)Assess toxicity of Octreotide LAR® Depot in patients with polycystic liver disease (PLD). Note: Subjects who completed this 1 year randomized trial were offered enrollment into an open-label (all subjects received Octreotide) extension trial for an additional two years of treatment.

Polycystic Kidney, Autosomal Dominant Polycystic Liver Disease Hepatomegaly Liver Diseases Kidney, Polycystic Abdominal Pain

null

2

arm 1: Participants received Octreotide LAR® Depot injections (up to 40 mg) intramuscularly every 28 days (+/- 5 days) for one year arm 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Participants received Octreotide LAR® Depot injections (up to 40 mg)intramuscularly every 28 days (+/- 5 days) for one year intervention 2: Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year

intervention 1: Octreotide intervention 2: Placebo

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00426153

[ 3 ]

128

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate whether maraviroc, an investigational drug given with methotrexate (MTX) is safe and effective in the treatment of rheumatoid arthritis in adult patients.

Following a planned interim analysis in the POC component on 21 August 2008 by the internal DMC (Data Monitoring Committee) of study A4001056, the trial was discontinued due to lack of efficacy. All participating investigators/country offices and monitors were notified on 22 August 2008 to cease patient enrollment. The DMC indicated that maraviroc was well tolerated in the Rheumatoid Arthritis patients and there were no safety concerns in the study. The termination date of this trial was 07 October 2008 when the last patient last visit occurred.

Arthritis, Rheumatoid

null

2

arm 1: None arm 2: This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks. intervention 2: Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.

intervention 1: Maraviroc intervention 2: Maraviroc Placebo

44

0

NCT00427934

[ 4 ]

33

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary purpose of this study is to: 1. Demonstrate the safety and efficacy of tipranavir/ritonavir (TPV/r) among a racially diverse HIV+ population (males and females) who are three-class (nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), and protease inhibitor (PI)) experienced with documented resistance to more than one PI. 2. Determine pharmacokinetic data in this racially and gender diverse population. 3. Determine the potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

null

HIV Infections

null

2

arm 1: Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted. arm 2: Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.

[ 5, 5 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: Patients received between two and four active anti-retroviral medications based on resistance testing results, as background treatment, and remained on these for the duration of the trial.

intervention 1: tipranavir intervention 2: ritonavir intervention 3: Optimized Background Regimen (OBR)

30

0

NCT00440271

[ 3 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study will determine whether pioglitazone (Actos, a drug approved to treat diabetes, can benefit HIV-infected people with fatty liver. Fatty changes of the liver (also known as steatosis) have been linked to diabetes and long-term liver damage in some patients. Pioglitazone has been shown to improve fatty liver in people without HIV; this study will see if it is beneficial for people with HIV as well. HIV-infected patients 18 years of age and older with increased fat in the liver may be eligible for this study. Screening includes a CT scan and liver biopsy (withdrawal of a small sample of liver tissue through a needle). Participants are randomly assigned to take either 45 mg of pioglitazone or placebo (sugar pill) by mouth once a day for 48 weeks. At the end of 48 weeks, all participants stop taking their medication and are followed for an additional 48 weeks to see what, if any benefits, of pioglitazone persist after treatment is stopped. In addition to taking the study medication, participants undergo the following procedures: * Visits to the NIH Clinical Center over a period of approximately 2 years at day 0 and weeks 2, 8, 16, 24, 32, 40, 48, 52, 72, and 96. Most visits take about 1 hour and include blood drawing for various laboratory tests. * Insulin clamp test at day 0 and weeks 24 and 48 to see how the body processes glucose. This test takes 4 to 6 hours and may include an overnight stay at the Clinical Center. A catheter (plastic tube) is placed in a vein in the arm to infuse insulin and another is placed in a vein on the back of the hand to draw blood samples. Blood sugar is checked frequently and glucose is given to keep blood sugar at normal values. * Nutrition evaluations at day 0 and weeks 24 and 48. Subjects write down all the food they eat and drink for 4 days before the visit. They meet with a nutritionist to review the food record and to complete simple measurements of body fat and shape. * CT scan of liver and abdomen at weeks 24, 48, 72 and 96. * Liver biopsy at week 48.

While the introduction of antiretroviral therapy for HIV/AIDS has transformed HIV disease into a chronic infection for many, the use of antiretroviral therapy is also often associated with metabolic abnormalities including insulin resistance, central fat accumulation and peripheral fat atrophy. Fatty infiltration of the liver or hepatic steatosis may be an important consequence of these metabolic derangements or may represent a direct toxicity associated with HIV infection and/or antiretroviral medications. Preliminary data suggests that hepatic steatosis may be very common and perhaps present in up to 50 percent of HIV-infected patients receiving antiretroviral therapy. Hepatic steatosis represents one step in the potential progression towards hepatocellular injury, non-alcoholic steatohepatitis (NASH), and, in a small percentage of patients, subsequent fibrosis and cirrhosis. In addition, hepatic fat content is closely associated with impaired insulin resistance and type 2 diabetes, conditions increasingly recognized among HIV-infected patients. In the setting of type 2 diabetes mellitus and NASH, thiazolidinediones such as pioglitazone, have been shown to reduce hepatic steatosis, lower transaminase levels and improve insulin sensitivity. In order to determine the potential benefits of pioglitazone therapy in the setting of HIV infection and hepatic steatosis, we will conduct a 96-week, double-blind, randomized placebo controlled trial of pioglitazone (45 mg/day) in 50 HIV-infected men and women, with 48 weeks of active treatment and 48 weeks of observational follow-up after study treatment ends. We anticipate needing to screen 100 subjects to identify a sufficient number of eligible participants to enroll in the study. The primary outcome variable of interest in this trial will be the change in hepatic fat score, liver-to-spleen ratio, which is calculated from CT scan of the abdomen. Important secondary outcomes will be histologic improvement on liver biopsy performed at baseline and 48 weeks, as well as improvements in transaminase levels and insulin sensitivity measured by hyperinsulinemic euglycemic clamp. All participants will be followed for 48 weeks after discontinuing study treatment to evaluate the short-term natural history of steatosis in those who received placebo and to assess the durability of any potential benefits of pioglitazone upon withdrawal. In this way, important information about the efficacy of pioglitazone to treat hepatic steatosis and improve the metabolic profile in HIV-infected patients will be obtained, as well as preliminary data on whether benefits of pioglitazone are sustained after treatment is discontinued.

HIV Infections Hepatic Steatosis Insulin Resistance

Pioglitazone Hepatic Steatosis Liver Toxicity Liver Biopsy HIV Treatment Experienced Treatment Naive

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: Pioglitazone

1

Bethesda | Maryland | United States | -77.10026 | 38.98067

0

NCT00441272

[ 3 ]

22

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

Primary Objective: 1\. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by objective response rate Secondary Objectives: 1. To evaluate the efficacy of glufosfamide in subjects with advanced soft tissue sarcoma as measured by duration of response, progression-free survival and overall survival 2. To evaluate the safety of glufosfamide in subjects with advanced soft tissue sarcoma Exploratory Objectives: 1. To evaluate the biological effect of glufosfamide on the metabolic profile in subjects with advanced soft tissue sarcomas, as determined by FDG-PET 2. To correlate efficacy endpoints with expression of tumor-associated glucose transporter proteins

null

Soft Tissue Sarcoma

null

1

arm 1: Glufosfamide

[ 0 ]

1

[ 0 ]

intervention 1: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.

intervention 1: Glufosfamide

7

0

NCT00441467

[ 3 ]

99

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This is a two-part study conducted at multiple centers, of navarixin (SCH 527123, MK-7123) in participants with moderate to severe chronic obstructive pulmonary disease (COPD). Part 1 of the study is a double-blind, placebo-controlled, randomized, rising-dose study consisting of four treatment groups enrolled in three cohorts. The duration of treatment, for each cohort, will be a 2-week run-in period, followed by a 12-week double-blind treatment period. Treatment initiation for each cohort was staggered by 4 weeks to allow for safety assessment prior to use of higher doses of navarixin. Part 2 of the study will be a double-blind, placebo-controlled, randomized, parallel group study consisting of four treatment groups enrolled as one cohort. The duration of treatment will consist of a 2-week run-in period, followed by a 12-week double-blind treatment period.

null

Chronic Obstructive Pulmonary Disease

null

10

arm 1: Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks arm 2: Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 3: Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 4: Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 5: Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 6: Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks arm 7: Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks arm 8: Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks arm 9: Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks arm 10: Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks

[ 0, 2, 0, 2, 0, 2, 0, 0, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Navarixin 1 mg capsules intervention 2: Navarixin 10 mg capsules intervention 3: Placebo to navarixin capsules intervention 4: Salbutamol/albuterol - 2 puffs of salbutamol/albuterol approximately every 4 hours as needed for dyspnea relief

intervention 1: Navarixin 1 mg intervention 2: Navarixin 10 mg intervention 3: Placebo to match navarixin intervention 4: Rescue medication

0

null

0

NCT00441701

[ 2, 3 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Dose Finding and Efficacy Evaluation of DOXIL (Doxorubicin HCL Liposome Injection) in Combination with Abraxane (Abraxane) in Patients with Metastatic Breast Cancer (MBC) \[Phase I and II\]

Phase I Objectives * To determine the Maximum Tolerated Dose (MTD) of the combination of (DOXIL) and Abraxane in patients with Metastatic Breast Cancer (MBC). * Determine the dose-limiting toxicity (DLT) of DOXIL and Abraxane. Phase II Objectives Primary Objective * To determine the response rate of DOXIL and Abraxane in patients with MBC. Secondary Objectives * To determine the time to disease progression in patients with MBC receiving DOXIL and Abraxane. * To assess the tolerability of this regimen in women with MBC and assess toxicity profile

Metastatic Breast Cancer

breast cancer advanced breast cancer

null

1

arm 1: Limited dose-escalation study of Abraxane and fixed dose of DOXIL in order to identify correct dose and side effect profile of the combination.

[ 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: DOXIL intervention 2: Abraxane

1

Morgantown | West Virginia | United States | -79.9559 | 39.62953

0

NCT00442260

[ 5 ]

229

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines

null

Hypercholesterolemia

Hypercholesterolaemia

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: simvastatin (+) ezetimibe 10/20mg, tablet, once daily, 12wks(sub group:24wks) intervention 2: atorvastatin 10mg, tablet, once daily, 12wks(sub group:24wks)

intervention 1: simvastatin (+) ezetimibe intervention 2: Comparator: atorvastatin

0

null

0

NCT00442897

[ 5 ]

3,029

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.

null

GERD

Gastroesophageal Reflux Disease Acid Reflux

null

5

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

[ 0, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed intervention 2: This randomized study was conducted on parallel groups and included two phases: * One initial phase during when the patients received once daily, either esomeprazole 20 mg or esomeprazole 40 mg, depending on the investigator's decision * One maintenance treatment phase, patients were randomized to one of the following three groups, either esomeprazole 20 mg once daily, or esomeprazole 20 mg on demand or antacid treatment as needed

intervention 1: esomeprazole (Nexium®) intervention 2: Xolaam®

1

Rouen | N/A | France | 1.09932 | 49.44313

0

NCT00444275

[ 4 ]

11

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The main purposes of this study are: demonstrate the safety and efficacy of TPV/r among HCV or hepatitis B virus (HBV) co-infected HIV+population, three-class (NRTI, NNRTI, and PI) experienced, with documented resistance to more than one PI. Determine pharmacokinetic data in this co-infected population and potential utility of using therapeutic drug monitoring (TDM) in improving efficacy outcomes.

null

HIV Infections

treatment experienced

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: tipranavir intervention 2: ritonavir

30

Beverly Hills | California | United States | -118.40036 | 34.07362 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Providence | Rhode Island | United States | -71.41283 | 41.82399 Austin | Texas | United States | -97.74306 | 30.26715 Houston | Texas | United States | -95.36327 | 29.76328 Capital Federal | N/A | Argentina | N/A | N/A Sacomã - São Paulo | N/A | Brazil | N/A | N/A Santo André | N/A | Brazil | -46.53833 | -23.66389 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Vila Mariana - Sao Paulo | N/A | Brazil | N/A | N/A Garches | N/A | France | 2.18232 | 48.84226 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Perpignan | N/A | France | 2.89541 | 42.69764 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Ancona | N/A | Italy | 13.5103 | 43.60717 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Pavia | N/A | Italy | 9.15917 | 45.19205 Barcelona | N/A | Spain | 2.15899 | 41.38879 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00447902

[ 5 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).

null

Overactive Bladder

OAB symptoms of urgency, frequency, and urge incontinence

null

1

arm 1: None

[ 0 ]

2

[ 1, 0 ]

intervention 1: The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). intervention 2: None

intervention 1: Urgent PC Neuromodulation System intervention 2: Tolterodine

1

Minnetonka | Minnesota | United States | -93.50329 | 44.9133

0

NCT00448175

[ 4 ]

906

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen. Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion. Study with completed results acquired from Horizon in 2024.

Ulcer

ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain

null

2

arm 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg arm 2: Ibuprofen 800mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg administered orally 3 times daily for 24 weeks

intervention 1: Ibuprofen/famotidine intervention 2: Ibuprofen

0

null

0

NCT00450216

[ 4 ]

627

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen. Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion. Study with completed results acquired from Horizon in 2024

Peptic Ulcer

ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain

null

2

arm 1: HZT-501: Ibuprofen 800mg/Famotidine 26.6mg arm 2: Ibuprofen 800mg

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks intervention 2: Ibuprofen 800mg orally 3 times daily for 24 weeks

intervention 1: HZT-501 intervention 2: Ibuprofen

0

null

0

NCT00450658

[ 5 ]

127

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

null

Constipation

null

3

arm 1: Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight arm 2: Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight arm 3: Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 12 mcg capsule once daily (QD) intervention 2: 12 mcg capsule twice daily (BID) intervention 3: 24 mcg capsule twice daily (BID)

intervention 1: Lubiprostone intervention 2: Lubiprostone intervention 3: Lubiprostone

19

0

NCT00452335

[ 5 ]

87

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

null

Diabetes Diabetes Mellitus, Type 2

null

1

arm 1: None

[ 1 ]

1

[ 0 ]

intervention 1: Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).

intervention 1: insulin detemir

1

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

0

NCT00455858

[ 3 ]

2

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vandetanib together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving vandetanib together with carboplatin and paclitaxel works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

OBJECTIVES: Primary * Determine the feasibility of neoadjuvant vandetanib in combination with carboplatin and paclitaxel in patients with resectable stage IB, II, or IIIA non-small cell lung cancer. Secondary * Assess the 30-day postoperative mortality rate in these patients. * Assess the toxicity of this regimen in these patients. * Determine the percentage of patients who complete all planned courses of therapy. * Assess the clinical response rate in patients treated with this regimen. * Assess the pathologic complete response rate in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral vandetanib once daily on days 1-21. Patients also receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses. Patients undergo surgery at least 3 weeks after the last course of chemotherapy. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Lung Cancer

stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer

null

1

arm 1: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle. Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.

[ 0 ]

4

[ 0, 0, 0, 3 ]

intervention 1: Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 intervention 2: Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. intervention 3: Zactima- 100 mg orally daily, starting on day 1 of cycle 1. intervention 4: Neoadjuvant surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.

intervention 1: carboplatin intervention 2: paclitaxel intervention 3: Zactima intervention 4: neoadjuvant therapy

1

Detroit | Michigan | United States | -83.04575 | 42.33143

0

NCT00459121

[ 3 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Non Small Cell Lung Cancer

null

1

arm 1: None

[ 0 ]

3

[ 2, 0, 4 ]

intervention 1: 8 mg/kg intervention 2: Combination of cisplatin and docetaxel administered as two cycles given every three weeks intervention 3: 64 Gy in 32 fractions over 6.5 weeks

intervention 1: Zalutumumab intervention 2: Induction chemotherapy intervention 3: Radiotherapy

8

Towson | Maryland | United States | -76.60191 | 39.4015 Portland | Oregon | United States | -122.67621 | 45.52345 Ghent | N/A | Belgium | 3.71667 | 51.05 Liège | N/A | Belgium | 5.56749 | 50.63373 Liège | N/A | Belgium | 5.56749 | 50.63373 Reims | Cedex | France | 4.02853 | 49.26526 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Sutton, Surrey | N/A | United Kingdom | -0.2 | 51.35

0

NCT00460551

[ 4 ]

10

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.

This is a multi-center, open-label (doctors and patients know which drug is being given), Phase IIIb clinical trial to evaluate the effectiveness, safety and tolerability of the combination of PREZISTA (darunavir)/ritonavir and TMC125 when substituted for enfuvirtide, current protease inhibitor(s) and Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) in antiretroviral resistant patients with viral suppression but who are intolerant of enfuvirtide. This study will be conducted in the U.S. at up to 5 sites where 40 patients will receive PREZISTA (darunavir) /ritonavir twice daily (600/100mg) and TMC125 (200 mg) twice daily over a 48-week treatment period. The study will consist of a total of 11 patient visits. At the screening visit (Week -1 to -6) blood will be collected from patients to determine eligibility. Once all data are available to determine the eligibility of the patient, the baseline visit will be scheduled and trial treatment initiated at this visit. The Baseline Visit (Day 1) will be followed by a 48-week treatment period. The patient will be evaluated at Weeks 2, 4, 8, 12, 16, 24, 36, and 48. Patients will be asked to return for a 2-week follow up visit at Week 50. Treatment will include PREZISTA (darunavir) /ritonavir and TMC125 plus continued nucleosides. The patient must continue all existing nucleosides in their background regimen for the duration of the study. During the treatment period, the patient will be seen at regular visits during which the investigator will assess the patient's medical condition, any Adverse Events and study drug compliance. Laboratory evaluations for efficacy and safety will be done at regular visits. Study patients will receive oral (by mouth) PREZISTA (darunavir) 600 mg and 100 mg of ritonavir twice a day in combination with TMC125 200mg orally twice a day for 48 weeks.

HIV

HIV AIDS Immunodeficiency Virus, Human PREZISTA darunavir TMC114 TMC125 Protease Inhibitor Non-Nucleoside Reverse Transcriptase Inhibitor enfuvirtide Treatment Experienced

null

1

arm 1: TMC125, Darunavir; RitonavirTMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

[ 0 ]

1

[ 0 ]

intervention 1: TMC125-200mg two times a day for 48 weeks; Darunavir -200mg two times a day for 48 weeks; Ritonavir-100mg two times a day for 48 weeks;

intervention 1: TMC125, Darunavir; Ritonavir

1

Los Angeles | California | United States | -118.24368 | 34.05223

0

NCT00460746

[ 4 ]

110

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To evaluate the efficacy and safety of 7-day repeated oral administration of OPC-41061 15 mg or placebo in congestive heart failure (CHF) patients with extracellular volume expansion despite the use of a conventional diuretic.

null

Edema, Cardiac

Cardiac edema OPC-41061 Vasopressin antagonist

null

2

arm 1: 0mg arm 2: 15mg OPC-41061

[ 2, 0 ]

1

[ 0 ]

intervention 1: 0, 15mg of OPC-41061 per day for 7days p.o. administration

intervention 1: OPC-41061(Tolvaptan)

8

Chubu Region | N/A | Japan | N/A | N/A Chugoku Region | N/A | Japan | N/A | N/A Hokkaido Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A

0

NCT00462670

[ 4 ]

35

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study is designed to provide efficacy and safety data for ACZ885 (a fully human anti-interleukin-1beta (anti-IL-1beta) monoclonal antibody) administered as an injection subcutaneously (s.c.) in patients with Muckle-Wells Syndrome. Part I is an 8-week open-label, active treatment period to identify ACZ885 responders. Part II is a double-blind, placebo-controlled period to assess primarily the efficacy of ACZ885 compared to placebo. Part III is an open-label, active treatment period where patients will receive ACZ885 every 8 weeks after withdrawal or completion of Part II.

null

Muckle Wells Syndrome

Muckle-Wells Syndrome children systemic autoinflammatory disease CIAS-1 gene NALP-3 ACZ885 human monoclonal anti-human interleukin-1beta (IL-1beta) antibody autosomal dominant familial autoinflammatory syndrome

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: ACZ885 intervention 2: Placebo

12

San Francisco | California | United States | -122.41942 | 37.77493 Chicago | Illinois | United States | -87.65005 | 41.85003 Madison | Wisconsin | United States | -89.40123 | 43.07305 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Lille | N/A | France | 3.05858 | 50.63297 Montpellier | N/A | France | 3.87635 | 43.61093 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Tübingen | N/A | Germany | 9.05222 | 48.52266 New Delhi | N/A | India | 77.2148 | 28.62137 Barcelona | N/A | Spain | 2.15899 | 41.38879 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00465985

[ 3 ]

296

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with asthma. The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

null

Asthma

null

0

null

1

[ 0 ]

intervention 1: None

intervention 1: BI 1744 CL

37

0

NCT00467740

[ 5 ]

46

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

Double blind, crossover randomized, multicentric study to compare efficacy and tolerability of concomitant administration of travoprost and brinzolamide versus timolol-dorzolamide fixed combination in patients with glaucoma or ocular hypertension

null

Glaucoma Ocular Hypertension

null

2

arm 1: 3 period, 2 treatment cross-over model: Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks) arm 2: 3 period, 2 treatment cross-over model: Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Group A = concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) intervention 2: group B = fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).

intervention 1: travoprost 0.004% and brinzolamide 1% intervention 2: fixed combination of timolol 0.5% and dorzolamide 2% plus travoprost vehicle

1

Catania | N/A | Italy | 15.07041 | 37.49223

0

NCT00471380

[ 3 ]

157

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to test the effectiveness of the study drug, AEGR-733 alone and in combination with the medication, atorvastatin (Lipitor), on cholesterol in volunteers with moderately high cholesterol.

Recent studies suggest more intensive cholesterol lowering treatment for people at very high risk of a heart attack, specifically for patients who have heart disease plus major risk factors. Available medications used alone at even the highest approved doses are not expected to reach these new target recommendations for cholesterol in a large number of subjects. Thus, the development of new medications that can provide additional cholesterol lowering may be beneficial. This study tests the effectiveness of different doses of the study drug, AEGR-733 alone and in combination with the approved cholesterol lowering drug, atorvastatin (Lipitor), on cholesterol. Volunteers will be randomized to one of 6 different study treatments and will take the assigned medication (3 capsules daily) for 8 weeks.

Hypercholesterolemia

cholesterol

null

6

arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

[ 2, 1, 0, 0, 0, 0 ]

6

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

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

intervention 1: Atorvastatin 20 mg intervention 2: AEGR-733 5 mg intervention 3: AEGR-733 10 mg intervention 4: Placebo intervention 5: AEGR-733 5 mg + atorvastatin 20 mg intervention 6: AEGR-733 10 mg + atorvastatin 20 mg

17

0

NCT00474240

[ 0 ]

188

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

Pain control after cesarean delivery is associated with improved breastfeeding and infant rooming-in times. In addition, inadequate analgesia leads to elevated plasma catecholamine concentrations, which negatively affect every organ system. There is growing evidence that ketamine, N-methyl-D-aspartate receptor antagonist, is efficacious when used as an adjuvant in postoperative pain control. A 2006 Cochrane Collaboration systemic review and meta-analysis concluded, "Ketamine in subanesthetic doses….is effective in reducing morphine requirements in the first 24 hours after surgery." Ketamine's prolonged analgesic effect, despite its short half-life and its use in low doses, is theorized to be due to blockade of spinal cord central sensitization. Central sensitization is a phenomenon whereby repeated painful stimulus leads to more severe pain perception over time despite no change in the intensity of the painful stimulus.Ketamine may also prevent the development of acute opioid tolerance. Ketamine's analgesic effects have also demonstrated in the obstetric population. Post-cesarean delivery morphine requirements in women who received ketamine as part of a general anesthesia technique were decreased. Similary, low-dose ketamine in conjunction with bupivacaine-only spinal anesthesia reduced postoperative analgesic requirements compared to bupivacaine-only spinal anesthesia and bupivacaine-fentanyl spinal anesthesia. In the United States, healthy women scheduled for elective cesarean delivery commonly receive spinal anesthesia with bupivacaine-fentanyl-morphine. To our knowledge, IV ketamine has not been studied as an adjuvant to this regimen in the analgesic management in post-cesarean delivery patients. Multimodal therapy for postoperative pain control is widely practiced due to the advantage it provides in blocking multiple pain pathways while minimizing side effects of each individual pain medication. We hypothesize that low dose intravenous ketamine will improve multi-modal post-cesarean analgesia compared to placebo. The purpose of this study is to evaluate this hypothesis and study the possible side effects of this regimen in combination with bupivacaine-fentanyl-morphine spinal anesthesia.

Eligible women for elective cesarean section admitted to the Labor and Delivery Unit of Prentice Women's Hospital will be approached for study participation immediately after the routine preanesthetic evaluation. This occurs shortly after admission to the Labor and Delivery Unit. Women who agree to participate will give written, informed consent at this time. Subjects will be prepared preoperatively in the usual fashion with intravenous (IV) access, aspiration prophylaxis and intraoperative monitoring. Preincision antibiotics will be given and uterotonic medications will be used as per usual practice after delivery. The anesthesiologist will perform a spinal anesthetic per routine with the subject in the sitting position using sterile technique at the L3-4 interspace (± one vertebral interspace). The spinal anesthetic will consist of 12 mg of hyperbaric bupivacaine + 15 μg fentanyl + 150 μg of morphine. The subject will be placed supine with left lateral tilt to alleviate aortocaval compression. Cesarean section will commence after adequate anesthesia is assured to a T4 sensory level to pinprick. Vasopressors and IV fluids will be administered at the anesthesiologist's discretion per usual practice. At the time of delivery, subjects will be randomized to one of two groups using a computer generated random number table. Randomization will be blocked based on whether the cesarean procedure is a primary or a repeat procedure. Randomization assignments will be kept in sequentially numbered opaque envelopes. The envelope will be opened by a research nurse who will prepare a 20 mL syringe labeled "study drug". The syringe will be given to the anesthesiologist blinded to the treatment group who will subsequently administer the study drug. Subjects randomized to the treatment group will receive ketamine 10 mg (ketamine 10 mg/mL) diluted to 20 mL with 0.9% preservative free saline. Subjects randomized to the placebo group will receive 20 mL preservative free saline. The study drug will be administered into the intravenous line via an infusion pump over 10 minutes. Five minutes after placebo or drug administration, the anesthesiologist will ask the subject if she has nausea, vomiting and pruritus. Nausea and pruritus will be graded as none, mild, moderate or severe; and vomiting as present or absent. Any spontaneous complaints of psychedelic effects will be noted at this time. Sedation will be assessed via the Richmond agitation-sedation scale (RASS \[see Appendix 1\]). Upon completion of the cesarean section, the subject will be transported to the post anesthesia recovery unit. Patients will receive ketorolac 30 mg every 6 hours time 4 doses beginning shortly after admission to the PACU. At 1 h, 4 h, 8 h, 12 h and at 24 h after administration of the study drug, the subject's pain will be assessed using the numeric rating scale for pain NRS 0-10 (see Appendix 2). Patients may request rescue analgesia if they are experiencing discomfort. The time of first rescue analgesia request will be noted, and the NRS will be determined at the time of request for rescue analgesia. Rescue medication will consist of hydrocodone 10 mg plus acetaminophen 325 mg per os. An additional dose of hydrocodone 10 mg plus acetaminophen 325 mg will be provided after 1 hour if the pain is not relieved to the subject's satisfaction. These are routine oral analgesic medications for postoperative cesarean delivery analgesia. Standard orders will be written for monitoring sedation and respiratory rate, and treatment of side effects (nausea, vomiting, pruritus and respiratory depression). The total amount of rescue medication will be determined for each subject after 24, 48 and 72 hours. The presence of nausea, vomiting, and pruritus will be assessed at the same time intervals as the NRS for pain: 1 h, 4 h, 8 h, 12 h and 24 h after IV infusion of ketamine or placebo. The subjective psychedelic effects of ketamine and morphine will be assessed using a set of true/false questions from the LSD and morphine short form of the Addiction Research Center Inventory, ARCI (Appendix 3). These questions will be administered verbally by the anesthesiologist or researcher blinded to the treatment group upon admission to the PACU and at 4 h. The following data will be collected in addition to the primary and secondary outcome data: maternal age, height, weight, prepregnancy weight, gestational age and IV fluids administered during cesarean section. In addition, all intraoperative and postoperative medications will be recorded, including those administered for the treatment of side effects listed above. Protocol specific analgesia assessment ends 24 hours after administration of the study drug. At 72 hours the subject will be asked about her satisfaction with postoperative analgesia (100 mm scale, 0 mm = not satisfied at all, 100 mm = very satisfied). One telephone follow-up evaluation 2 weeks after delivery will again, assess for satisfaction with analgesia and average pain (NRS) since the procedure.

Ketamine Adverse Reaction Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Complication of Labor and/or Delivery

Ketamine Spinal Anesthesia C-section

null

2

arm 1: Subjects receive IV ketamine 10 mg 5 minutes after infant delivery. arm 2: Subjects receive IV Saline 20 mL 5 minutes after infant delivery

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ketamine 10 mg diluted to 20 mL delivered over 10 minutes via an infusion pump set at 2ml/minute intervention 2: Saline 20 mL IV infusion delivered over 10 minutes via an infusion pump set at 2ml/minute

intervention 1: Ketamine intervention 2: Placebo

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00486902

[ 5 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were terminated from the study. The anticipated time on study treatment was 3-9 months, and the target sample size was 210 individuals.

null

HIV Infections

Treatment Experienced

null

2

arm 1: Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® \[raltegravir\] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs). arm 2: In the randomized comparator Phase II of the trial- (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL from Phase I were randomized to 1 of 2 treatment arms of (Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs or (Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs.

[ 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 90 mg SC twice daily intervention 2: As prescribed intervention 3: As prescribed intervention 4: 180 mg SC once daily

intervention 1: enfuvirtide [Fuzeon] intervention 2: Optimized background ARV intervention 3: Integrase inhibitor intervention 4: enfuvirtide [Fuzeon]

43

0

NCT00488059

[ 4 ]

539

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Low Back Pain

Chronic pain opioid transdermal Moderate to severe chronic low back pain

null

2

arm 1: Buprenorphine transdermal system 10 or 20 mcg/h applied for 7-day wear arm 2: Placebo transdermal system to match BTDS patches, applied for 7 days

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Buprenorphine transdermal system 10 or 20 mcg/h worn for 7 days intervention 2: transdermal system (placebo) worn for 7 days

intervention 1: Buprenorphine transdermal system intervention 2: Placebo

86

0

NCT00490919

[ 3 ]

4

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Two 21-day cycles of pemetrexed (500 milligrams per square meter \[mg/m2\] intravenous \[IV\] infusion) and carboplatin (target area under the curve \[AUC\] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray \[Gy\] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Small Cell Lung Cancer

null

1

arm 1: None

[ 0 ]

3

[ 0, 0, 3 ]

intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles intervention 2: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles intervention 3: 2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)

intervention 1: pemetrexed intervention 2: carboplatin intervention 3: radiotherapy

12

Orbassano | N/A | Italy | 7.53813 | 45.00547 Parma | N/A | Italy | 10.32618 | 44.79935 San Sisto | N/A | Italy | 11.80346 | 45.0476 Terni | N/A | Italy | 12.64329 | 42.56335 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Madrid | N/A | Spain | -3.70256 | 40.4165 Palma de Mallorca | N/A | Spain | 2.65024 | 39.56939 Valencia | N/A | Spain | -0.37966 | 39.47391 Southampton | Hants | United Kingdom | -1.40428 | 50.90395 Guildford | Surrey | United Kingdom | -0.57427 | 51.23536 Wolverhampton | West Midlands | United Kingdom | -2.12296 | 52.58547

0

NCT00494026

[ 3 ]

2

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.

Eligible pediatric patients with acute flares of ileocecal Crohn's disease will be randomized to receive either PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, or an identical-appearing placebo preparation. Patients will be required to maintain a daily diary and to return at 2 weeks for blood and stool tests. At the four week mark, patients will return for clinical evaluation, global assessment of disease activity and change in disease activity, as well as additional laboratory tests.

Crohn's Disease

Crohn's Crohn's Disease Acute Flare Mild to Moderate Crohn's Disease Children Pediatrics Ileo-cecal Pediatric Crohn's Disease New Onset Crohn's Disease Recently diagnosed Crohn's Disease

null

2

arm 1: 4-Aminosalicylic acid extended release granules (as volume equivalent of active product), 50 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 50 mg/kg orally two times daily for 2 weeks arm 2: Placebo granules identical in appearance to the active arm (as volume equivalent of active product), 0 mg/kg orally three times daily for two weeks followed by (as volume equivalent) 0 mg/kg orally two times daily for 2 weeks

[ 0, 2 ]

1

[ 0 ]

intervention 1: Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm

intervention 1: 4-Aminosalicylic acid extended release granules

5

0

NCT00495521

[ 3 ]

84

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

Primary Objectives: 1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups. 2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups. Secondary Objectives: 1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging. 2. To determine the incidence of disease progression/relapse at 12 months in the two groups.

Granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage-colony stimulating factor (GM-CSF) are synthetic (man-made) versions of substances naturally produced in your body. These substances, called colony stimulating factors, help the bone marrow to make new white blood cells. When certain cancer medicines fight your cancer cells, they also affect those white blood cells that fight infection. To help decrease the risk of infections when these cancer medicines are used, colony stimulating factors may be given. Colony stimulating factors are also used to help the bone marrow recover after bone marrow transplantation and stem cell transplantation. They are also used to increase the stem cell count in the blood so that adequate number of stem cells can be collected for purposes of transplantation. Before the study begins, you will have a complete physical exam and have blood (around 1-2 tablespoons) and urine collected for routine tests. You will have x-rays and CT scans to check on the status of the disease. A sample of bone marrow will be collected for tests. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. Your heart and lung function will be evaluated. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and either a echocardiogram or a multigated acquisition scan (MUGA) (these are tests that measure heart functions). You will also have lung function tests. Women who are able to have children must have a negative blood or urine pregnancy test. You will have a plastic tube (central venous catheter - CVL) inserted under your collarbone. The CVL will be left in place for the duration of the treatment. The catheter will be used to deliver most of the drugs and for the collection and transfusion of the stem cells. When possible, all drugs that need to be given by vein will be given using the catheter. All treatment will be given at M. D. Anderson. First, you will be given chemotherapy to increase the number of stem cells in your blood stream. This chemotherapy will include the drugs ifosfamide, etoposide, and rituximab. You will receive a higher dose of rituximab than is standard of care. The drug ifosfamide will be started on Day 2 and will be given as a continuous injection into a vein over 72 hours. The drug etoposide will also be started on Day 2 and will be given by vein over 2 hours every 12 hours. Rituximab will be given by vein over 4-6 hours on Days 1 and 8. To help decrease the risk of developing side effects caused by the chemotherapy, you will be given fluids by vein and a drug called mesna. Mesna will be given by vein over 24 hours after treatment with ifosfamide is finished. You will have to stay in the hospital for 4-6 days for this part of the treatment. You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive G-CSF and GM-CSF. Participants in the other group will receive G-CSF alone. After completion of chemotherapy, you will get GM-CSF and G-CSF or just G-CSF injections (given under the skin) twice a day. These drugs are given to help increase the number of white blood cells and will continue to be given until an adequate number of stem cells have been collected. During this time, you will have blood collected for tests (around 1 tablespoon) at least 3 times a week. If your doctor feels it is necessary, you may have blood collected more often. Blood stem cells will be collected when your blood counts have returned to normal (about 10-16 days after the chemotherapy). The process of stem cell collection takes about 4 hours. It may take 1-6 sessions to collect the number of stem cells needed for the transplant. The process of stem cell collection is called apheresis. A machine is attached to the catheter under the collar bone and blood is withdrawn. The blood then flows through the machine, which removes stem cells from the blood. The blood is then returned back to you through the catheter. The stem cells are then frozen and stored. These stem cells will be given back to you after the next phase of treatment to help your blood counts recover after high dose chemotherapy. After enough stem cells have been collected, you will be admitted to the hospital for high dose chemotherapy. You will have check-up visits at various times over the next year as part of your standard evaluation after transplantation to check on the status of the disease. This is an investigational study. All of the drugs used in this study are FDA approved and are commercially available. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

Lymphoma

Non-Hodgkin's Lymphoma Lymphoma Etoposide G-CSF GM-CSF Isophosphamide Rituximab Ifosfamide Sargramostim Leukine Filgrastim Neupogen Apheresis Stem Cell Collection

null

2

arm 1: Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF) arm 2: Growth Factor = granulocyte-colony stimulating factor (G-CSF)

[ 0, 0 ]

6

[ 0, 0, 0, 0, 0, 3 ]

intervention 1: 150 mg/m\^2 given intravenously over 2 hours every 12 hours x 6 doses. intervention 2: Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis. intervention 3: 250 mcg/m\^2 injection given every evening till the completion of apheresis. intervention 4: 10 g/m\^2 given intravenously continuous infusion over 72 hours. intervention 5: Days +1 (375 mg/m\^2) and +8 (1000 mg/m\^2) given intravenously. intervention 6: Peripheral blood stem cell collection.

intervention 1: Etoposide intervention 2: G-CSF intervention 3: GM-CSF intervention 4: Isophosphamide intervention 5: Rituximab intervention 6: Apheresis

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00499343

[ 4 ]

241

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.

null

Asthma

Asthma Bronchial

null

2

arm 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily arm 2: Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily intervention 2: According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

intervention 1: Budesonide intervention 2: Conventional Asthma Therapy

1

Takizawa | Iwate | Japan | 141.13466 | 39.8028

0

NCT00509028

[ 4 ]

471

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin glargine as basal insulin therapy in adults with type 2 diabetes.

null

Diabetes Mellitus, Type 2

diabetes type 2

null

2

arm 1: Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks arm 2: Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks intervention 2: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks

intervention 1: Insulin Lispro Protamine Suspension intervention 2: Insulin Glargine

17

0

NCT00510952

[ 3 ]

28

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

null

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

PRIMARY OBJECTIVES: I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC). II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530. III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population. OUTLINE: This is a multicenter study. Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.

Hormone-resistant Prostate Cancer Recurrent Prostate Cancer

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1

arm 1: Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

[ 0 ]

2

[ 0, 10 ]

intervention 1: Given orally intervention 2: Correlative studies

intervention 1: saracatinib intervention 2: laboratory biomarker analysis

1

Duarte | California | United States | -117.97729 | 34.13945

0

NCT00513071

[ 4 ]

6

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Myelogenous Leukemia

leukemia bone marrow leukemia symptoms cml complete blood count lymphocyte blood cancer leukocytes chronic leukemia bone marrow biopsy leukemia research leukemia cells bone marrow disease chronic myeloid leukemia blood cancer symptoms white blood cell diseases chronic myelogenous leukemia leukemia treatment leukemia facts leucemia facts about leukemia myelogenous leukemia newly diagnosed CML suboptimal response Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

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2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days. intervention 2: Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.

intervention 1: Imatinib intervention 2: Nilotinib (AMN107)

80

0

NCT00519090

[ 5 ]

18

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

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Common Variable Immunodeficiency Agammaglobulinemia

Previously Untreated Patient (PUP) Primary Immunodeficiency (PID) CVID XLA Subcutaneous immunoglobulin (SCIG) IgG trough level Quality of life Common variable immunodeficiency (CVID) X-linked agammaglobulinemia (XLA)

null

1

arm 1: Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

[ 0 ]

1

[ 0 ]

intervention 1: Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

intervention 1: Vivaglobin

6

Edmonton | Alberta | Canada | -113.46871 | 53.55014 Montreal | Quebec | Canada | -73.58781 | 45.50884 Leipzig | N/A | Germany | 12.37129 | 51.33962 Brescia | N/A | Italy | 10.21472 | 45.53558 Roma | N/A | Italy | 11.10642 | 44.99364 Madrid | N/A | Spain | -3.70256 | 40.4165

0

NCT00520494