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

[ 4 ]

185

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.

null

Pain

null

2

arm 1: 250 milliliters normal saline as a placebo comparator was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period. arm 2: 800 mg of intravenous ibuprofen diluted in 250 milliliters normal saline was administered every 6 hours for a total of five doses over the first 24 hours. Those patients who received the initial five doses could continue to receive additional doses as needed every 6 hours through the 120-hour treatment period.

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: 800 milligrams intravenous intervention 2: Placebo comparator

intervention 1: Caldolor intervention 2: Normal Saline

9

0

NCT00470600

[ 3 ]

1

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine what dose of bortezomib in combination with tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective in treating relapsed and refractory NHL. Administer of the agents together may sensitize the cells to the radiation from Tositumomab I-131.

null

Follicular Lymphoma

Non-Hodgkin's Lymphoma Follicular Non-Hodgkin's Lymphoma Lymphoma

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: Bortezomib and Tositumomab I-131

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00479167

[ 0 ]

136

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

1FEMALE

false

Epidural chloroprocaine is often used in obstetrical anesthesia because of its fast onset and short duration. These properties make it an ideal drug to use for epidural anesthesia in patients undergoing postpartum tubal ligation. When epidural morphine is given after chloroprocaine, there is a decreased efficacy of analgesia as compared to lidocaine (1). Several studies have hypothesized a specific opioid receptor mediated antagonism of chloroprocaine (2,3). Karambelkar raised the question whether this decreased efficacy is due to a disparity between the time the chloroprocaine anesthesia resolves and the onset of epidural morphine analgesia, resulting in a time window of pain (2). The duration of action of epidural 2-CP anesthesia is 30-45 minutes and the onset of epidural morphine analgesia is 60-70 minutes, therefore the regression of sensory blockade before the onset of the morphine analgesia could result in a window of pain (2). Hess and colleagues studied epidural morphine analgesia and women who had a Cesarean delivery under spinal bupivacaine anesthesia (3). Subjects were randomized to receive epidural 2-CP and morphine or epidural saline and morphine. There was no difference in postoperative analgesia between the two groups (3 and personal communication, Dr. Philip Hess). A literature search cross referencing epidural chloroprocaine, using Pub Med, did not produce any articles comparing epidural morphine given before the procedure (in an attempt to time the onset of analgesia with the resolution of chloroprocaine anesthesia) to the standard administration time after the procedure.

Women undergoing post partum tubal ligation with an epidural in-situ will be randomly double blindedly selected into one of three groups for pain control. The groups are epidural 1) epidural morphine-chloroprocaine 2) epidural chloroprocaine-morphine 3) epidural morphine-lidocaine. Groups 1 and 3 will receive morphine 30 minutes prior to local anesthetic dosing followed by saline placebo after local dosing. Group 2 will receive placebo 30 minutes prior to local anesthetic dosing followed by epidural morphine. Pain scores and supplemental analgesic requirements will be evaluated 30 minutes, 1hr, 2hr, 4hr and every 4 hrs for the first 24hrs.

Labor Analgesia, Epidural

analgesia tubal ligation chloroprocaine

null

3

arm 1: morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision arm 2: saline will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level;morphine will be administered at skin incision arm 3: Saline will be administered 30 min prior to epidural anesthesia; lidocaine will be used to achieve a T4 level; morphine will be administered at skin incision

[ 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision intervention 2: 6ml of saline will be administered epidurally 30 min prior to epidural anesthesia. Epidural 3% 2CP will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 3mg of preservative free morphine will be administered at skin incision intervention 3: 3mg of preservative free morphine will be administered epidurally 30 min prior to epidural anesthesia. Epidural 2% lidocaine with epinephrine 1:200,000 will be used to achieve a T4 dermatomal level for surgical anesthesia for PPTL. 6ml of epidural saline will be administered at skin incision

intervention 1: Morphine-CP-saline (MCS) intervention 2: saline-2CP-morphine (SCM) intervention 3: saline-lidocaine-morphine (SLM)

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00487084

[ 4 ]

442

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 detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

null

Diabetes Mellitus Type 2

diabetes type 2

null

2

arm 1: Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. arm 2: Detemir: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks. intervention 2: Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

intervention 1: Insulin Lispro Protamine Suspension intervention 2: Detemir

56

0

NCT00494013

[ 3 ]

43

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral doses of PF 00232798 in HIV-positive patient volunteers.

null

HIV

Treatment Experienced Treatment Naive

null

6

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

[ 1, 1, 1, 1, 1, 1 ]

6

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

intervention 1: Solution, 20 mg. once daily, 10 days intervention 2: Solution, 150 mg. once daily, 10 days intervention 3: Solution, 5 mg. once daily, 10 days intervention 4: Solution, 40 mg. once daily, 10 days intervention 5: Solution, 300 mg. once daily, 10 days intervention 6: Solution, 400 mg. once daily, 10 days

intervention 1: PF-00232798 intervention 2: PF-00232798 intervention 3: PF-00232798 intervention 4: PF-00232798 intervention 5: PF-00232798 intervention 6: PF-00232798

2

Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552

0

NCT00495677

[ 3 ]

86

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.

null

Prostate Cancer Metastatic Hormone Refractory

prostate cancer zactima vandetanib metastatic

null

0

null

3

[ 0, 0, 0 ]

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

intervention 1: Zactima (vandetanib) intervention 2: Docetaxel intervention 3: Prednisolone

11

Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Tübingen | N/A | Germany | 9.05222 | 48.52266 Budapest | N/A | Hungary | 19.04045 | 47.49835 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Umeå | N/A | Sweden | 20.25972 | 63.82842 Uppsala | N/A | Sweden | 17.63889 | 59.85882

0

NCT00498797

[ 4 ]

155

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The primary objective of this study is to assess the immunogenic potential of the liquid formulation of omalizumab administered over a period of 6 months in moderate to severe persistent allergic asthma patients 12 years of age or older, with no previous exposure to the drug (omalizumab naïve patients). The secondary objective of this study is to assess the safety of the liquid formulation of omalizumab in the same patients.

null

Asthma

Asthma omalizumab safety allergic asthma adolescents

null

0

null

1

[ 0 ]

intervention 1: The liquid formulation of omalizumab was packaged in a pre-filled safety syringe containing either 75 mg (0.5ml) or 150 mg (1.0 ml) of drug. The syringes were clearly marked so that the health care provider could differentiate between the 75 mg or 150 mg syringe.

intervention 1: omalizumab

31

0

NCT00500539

[ 0 ]

2

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Primary Objective: 1\. To determine whether rhG-CSF treatment will increase the frequency of donor-derived cells contributing to repair of damaged epithelial/endothelial or solid organ-specific tissue caused by graft-versus-host disease (GVHD) in patients who underwent sex-mismatched stem cell transplantation. Secondary Objective: 1\. To determine whether rhG-CSF treatment can alleviate GVHD-induced damage to epithelial/endothelial or solid organ-specific tissue.

It has been found that cells circulating in the blood are capable of forming cells lining the oral cavity, skin cells, and/or cells of various organs. RhG-CSF is used to support cell recovery after stem cell transplantation and is commercially available. Before treatment starts, participants will have at least one (and up to three) biopsy(ies) of damaged tissue performed to find out about the severity of tissue damage. A biopsy is taken with a large needle. Women able to have children must have a negative blood pregnancy test. Participants in this study will receive rhG-CSF as an injection under the skin once a day over one week. This will be repeated every other week for a total of 4 weeks. Blood tests (about 2 teaspoons each) will be performed 3 times while at M. D. Anderson or once a week while outpatient to make sure that the white blood count stays in a safe range. Participants will have at least one (and up to three) biopsy(ies) again performed about 8 weeks after the start of rhG-CSF treatment. An additional biopsy at 3 months after the start rhG-CSF treatment will only be performed in case your regular treatment follow up requires it, and not for research purposes only. Participants will be taken off study if severe side effects occur. The study will end after the last biopsy or biopsies are taken, about 3 months after the start of rhG-CSF treatment. This is an investigational study. RhG-CSF is FDA approved and commercially available, though its use in this study is investigational. A maximum of 5 patients will be treated on this protocol. All will be enrolled at M. D. Anderson.

Graft-Versus-Host Disease

Graft-Versus-Host Disease Stem Cell Transplantation Tissue Repair Organ-Specific Tissue Damage Filgrastim RhG-CSF

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 5 mg/kg ID Once Daily x 1 Week

intervention 1: Filgrastim

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00501228

[ 3 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

This study was intended to assess the safety, efficacy, and response to treatment using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) and to investigate a potential biomarker profile in adult patients with established rheumatoid arthritis

null

Rheumatoid Arthritis

null

2

arm 1: Healthy Volunteers: Single administration of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1. Rheumatoid Arthritis (RA) Patients: Dose of 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43. arm 2: Healthy Volunteers: Single administration of 600 mg of Placebo Intravenous (IV) on Day 1. Rheumatoid Arthritis (RA) Patients: Dose of 600 mg of Placebo Intravenous (IV) on Day 1, Day 15, and Day 43.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: The ACZ885 was supplied in 6 mL colorless glass vials each containing nominally 150 mg ACZ885 (with 20% overfill). The vials were kept at 2-8°C. At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered. intervention 2: Matching placebo of ACZ885 was supplied in the form of a lyophilized cake (Powder for Solution for Infusion). At the investigator's site, solutions for infusion were prepared depending on the volume and dose administered.

intervention 1: ACZ885 (investigational) intervention 2: Placebo

4

Moscow | N/A | Russia | 37.61556 | 55.75222 Barcelona | N/A | Spain | 2.15899 | 41.38879 Bern | N/A | Switzerland | 7.44744 | 46.94809 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384

0

NCT00504595

[ 3 ]

520

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

1FEMALE

null

This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection \[IVF/ICSI\]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female \[RFF\] Pen) in regards to the number of fertilized oocytes.

Infertile women who are candidates for ART will be prospectively screened for enrollment at 24 clinical trial sites in the United States and Argentina. Enrolled subjects will start treatment using oral contraceptives (OCP) and will then receive a Gonadotropin releasing hormone (GnRH)-agonist (leuprolide acetate) for pituitary desensitization. Once down-regulation is achieved, the subjects will be randomized in a 1:1:1:1 ratio to begin ovarian stimulation with one of 3 doses of AS900672-Enriched or with follitropin alfa (Gonal-f®) daily injections. Subjects will be recruited to the four study arms in parallel. Beginning on S1, the subjects will receive either a single injection of AS900672-Enriched or start daily injections of follitropin alfa. The subjects' response to treatment will be monitored by ovarian ultrasound and E2 levels. On S6, subjects randomized to AS900672-Enriched may begin receiving supplemental follitropin alfa 150 IU, according to the each subject's ovarian response, and subjects randomized to follitropin alfa 150 IU daily injections will continue treatment at the same dose. Recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) will be administered to subjects meeting response criteria and who are not at risk for ovarian hyperstimulation syndrome (OHSS). Oocyte retrieval will occur within 34-38 hours after r-hCG administration and subjects will begin luteal phase support using vaginal progesterone (Crinone® 8 percent or Prochieve® 8 percent) the following day. Fertilization will be done by conventional IVF or ICSI. Embryo transfer will occur in accordance with the specific requirements of each subject and the clinical trial site's standard practice, with the exception that a maximum of two embryos at the cleavage or blastocyst stage may be transferred. Subjects who undergo embryo transfer will be assessed for pregnancy and a follow-up visit will be performed 15-20 days post r-hCG administration. Subjects with a positive pregnancy test will undergo a confirmatory ultrasound evaluation at Day 35 - 42 post r-hCG. Additionally, all subjects recruited at certain trial centers will participate in a pharmacokinetic (PK) sub-study.

Infertility

Assisted reproductive technology, follicle stimulating hormone

null

4

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

[ 0, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone \[r-hFSH\]), 50 mcg will be administered subcutaneously on Stimulation Day 1 (S1). Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. intervention 2: Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. intervention 3: Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg will be administered subcutaneously on S1. Duration of treatment cycle will up to adequate follicular response or maximum of 21 days. intervention 4: Follitropin alfa (Gonal-f®) 150 IU will be administered subcutaneously once daily from S1 up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. Subjects who will be receiving AS900672-Enriched 50, 100 and 150 mcg will also receive daily dose of follitropin alfa 150 IU subcutaneously from Stimulation Day 6 (S6) up to S21. Duration of treatment cycle will be up to adequate follicular response or maximum of 21 days. intervention 5: Recombinant human chorionic gonadotropin (r-hCG) will be administered as a single dose of 250 mcg subcutaneously, when follicular response is adequate (that is, at least 1 follicle with a diameter of greater than or equal to \[\>=\] 18 millimeter \[mm\], two or more additional follicles with a diameter of \>= 16 mm, and Estradiol \[E2\] levels will approximately 150 picogram per milliliter \[pg/mL\] per mature follicle).

intervention 1: AS900672-Enriched 50 microgram (mcg) intervention 2: AS900672-Enriched 100 mcg intervention 3: AS900672-Enriched 150 mcg intervention 4: Follitropin alfa 150 international unit (IU) intervention 5: Recombinant human chorionic gonadotropin (r-hCG)

1

Rockland | Massachusetts | United States | -70.91616 | 42.13066

0

NCT00505752

[ 2 ]

4

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Primary Objective: To evaluate the impact of postoperative exogenous nocturnal melatonin supplementation on the early regulation of the sleep-wake cycle and its clinical impact (subjective improvement of the quality of sleep and reduction of cardiopulmonary events) during the first postoperative week following anesthesia and surgery in older breast cancer patients receiving a unilateral segmental mastectomy with or without intraoperative lymph node mapping, sentinel node biopsy and axillary node dissection. Secondary Objective: To collect data and validate the Postoperative Srejic Sleep SAT Survey Questionnaire (SAT implies relative subjective satisfaction of the patient's sleep in a scaled score out of 100 with 100 being the highest degree of satisfaction).

Melatonin is produced by a small gland in the brain called the pineal gland. During times of stress, use of certain medications, and increasing age, melatonin production may be disrupted or weakened. This may cause sleep disturbance. Many of the drugs used for pain, anesthesia, or cancer treatment may affect the body's natural secretion of melatonin. Participants in this study will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive melatonin. Participants in the other group will receive a placebo. A placebo is a substance that looks like the study drug, but which has no active ingredients. There is an equal chance of being in either group. Neither you nor the study doctor will know to which group you are assigned. You will take either two, three, or four capsules 30 minutes before you go to bed. You will go to bed at about the same time each day (around 10:00PM). The number of capsules will be prescribed according to your body weight. Researchers will attach two monitors to you while you are sleeping to test for changes during sleep. An actigraph wrist monitor will be worn on the non-dominant wrist (to measure sleep movement and patterns). A pulse oximeter will be worn on the opposite hand/finger (to measure the amount of oxygen in the blood). You may use these devices as an inpatient or outpatient at home. Each day of the study (for one week after the operation and anesthesia) you will fill out 1-2 questionnaires depending on the day. The researchers will ask questions about your last night's sleep and how you are feeling. The questionnaires will be filled out each evening. This will take less than 10 minutes. If on Day 4 you require any additional sleep medicine or have been experiencing any unpleasant side effects of melatonin, you may remove yourself from the study. The entire length of this study is made up of the one week after your surgery. Should you take any other sleep aids during the time of the study, please tell the research staff as your questionnaire data cannot then be used for this study. You will visit your cancer doctor and the study doctor at least one time after your surgery. This follow-up visit will be coordinated with your surgical postoperative visit. Researchers may go over some parts of the questionnaires and retrieve the actigraph and pulse oximeter from you. This is an investigational study. Melatonin has not gone through the FDA approval process. However, melatonin supplements are commercially available in over-the-counter form. Forty patients will take part in this study. All will be enrolled at UTMDACC.

Breast Cancer

Breast Cancer Sleep Melatonin Placebo Survey Postoperative Srejic Sleep SAT Survey

null

2

arm 1: 0.15 mg/kg capsules by mouth daily arm 2: Starch capsules by mouth daily

[ 0, 2 ]

3

[ 0, 0, 5 ]

intervention 1: 0.15 mg/kg by mouth (PO) Daily intervention 2: Two, three, or four starch tablet or capsules before bed intervention 3: Sleep study surveys, two per day completed each evening, lasting 10 minutes

intervention 1: Melatonin intervention 2: Placebo intervention 3: Questionnaire

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00506064

[ 4 ]

40

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The objective of this study is to compare the efficacy and safety of Tipranavir/ritonavir (TPV/r, 500mg/200mg twice daily) to the safety and efficacy of Darunavir/ritonavir (DRV/r 600 mg /100 mg twice daily) in combination with investigator selected optimised background regimens in patients who are three-class (Nucleoside reverse transcriptase inhibitors (NRTI), Nonnucleoside reverse transcriptase inhibitors (NNRTI), and Protease inhibitor (PI)) treatment-experienced (a minimum of 3-months duration for each class) with resistance to more than one PI on the screening virtual phenotype resistance testing.

null

HIV Infections

null

0

null

3

[ 0, 0, 0 ]

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

intervention 1: Tipranavir intervention 2: Darunavir intervention 3: Ritonavir

54

Beverly Hills | California | United States | -118.40036 | 34.07362 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Miami | Florida | United States | -80.19366 | 25.77427 Miami | Florida | United States | -80.19366 | 25.77427 Tampa | Florida | United States | -82.45843 | 27.94752 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Portland | Oregon | United States | -122.67621 | 45.52345 Houston | Texas | United States | -95.36327 | 29.76328 Longview | Texas | United States | -94.74049 | 32.5007 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brussels | N/A | Belgium | 4.34878 | 50.85045 Charleroi | N/A | Belgium | 4.44448 | 50.41136 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Montreal | Quebec | Canada | -73.58781 | 45.50884 Bondy | N/A | France | 2.48931 | 48.9018 Garches | N/A | France | 2.18232 | 48.84226 Lyon | N/A | France | 4.84671 | 45.74846 Lyon | N/A | France | 4.84671 | 45.74846 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Tourcoing | N/A | France | 3.16117 | 50.72391 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Mainz | N/A | Germany | 8.2791 | 49.98419 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Piraeus | N/A | Greece | 23.64619 | 37.94203 Antella (fi) | N/A | Italy | 11.32233 | 43.72774 Brescia | N/A | Italy | 10.21472 | 45.53558 Florence | N/A | Italy | 11.24626 | 43.77925 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Pescara | N/A | Italy | 14.20283 | 42.4584 Amadora | N/A | Portugal | -9.23083 | 38.75382 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Ponce | N/A | Puerto Rico | -66.62398 | 18.01031 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 L'Hospitalet de Llobregat | N/A | Spain | 2.10028 | 41.35967 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Santiago de Compostela | N/A | Spain | -8.54569 | 42.88052 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Bangkok Noi | N/A | Thailand | 100.47798 | 13.76266 Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Khon Kaen | N/A | Thailand | 102.833 | 16.44671 Nonthaburi | N/A | Thailand | 100.51477 | 13.86075 Phathumwan | N/A | Thailand | N/A | N/A Nassau | N/A | The Bahamas | -77.34306 | 25.05823

0

NCT00517192

[ 2 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to investigate the effectiveness, safety, and tolerability of MK7009 in patients infected with Hepatitis C

null

Hepatitis C

null

8

arm 1: 25 mg b.i.d. MK7009 arm 2: 75 mg b.i.d. MK7009 arm 3: 250 mg b.i.d. MK7009 arm 4: 500 mg b.i.d. MK7009 arm 5: 700 mg b.i.d. MK7009 arm 6: 125 mg q.d. MK7009 arm 7: 600 mg q.d. MK7009 arm 8: Placebo

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

2

[ 0, 0 ]

intervention 1: Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8. intervention 2: MK7009 Placebo

intervention 1: Comparator: MK7009 intervention 2: Comparator: Placebo

0

null

0

NCT00518622

[ 3 ]

37

RANDOMIZED

FACTORIAL

4SUPPORTIVE_CARE

0NONE

false

0ALL

true

Cachexia is a presentation of a chronic manifestation of acute metabolic stress, a hypercatabolic nutritional state in which the normal fat and protein sparing mechanisms are not functioning and increased nutrition is not utilized. To switch the nutritional system from a hypercatabolic to a normal nutritional state, therapy must block multi-factorial stress signaling a threshold of activation. Consistent with the synergistic hypothesis, propranolol and etodolac have been evaluated in subjects with advanced cancer demonstrating cachexia. This trial will evaluate the safety and efficacy of VT-122 in subjects with NSCLC who have hypercatabolic cachexia.

The objective of this trial is to evaluate the safety and dose tolerability of VT-122 regimen and to evaluate the efficacy of VT-122 regimen This trial is to be conducted on patients who have a diagnosis of Stage IV NSCLC, are not on chemotherapy, have lost 5% of their body weight in the previous 2 months and are deemed to be hypercatabolic.

Cachexia

NSCLC anorexia cachexia grip strength lean body mass

null

3

arm 1: Supportive care only arm 2: VT-122 (dose of etodolac: 400 mg/day) + supportive care arm 3: VT-122 (dose of etodolac: 800 mg/day) + supportive care

[ 4, 1, 1 ]

2

[ 0, 0 ]

intervention 1: VT-122 low dose, dose escalated intervention 2: VT-122 high dose, dose escalated

intervention 1: VT-122 low dose intervention 2: VT-122 high dose

8

Waco | Texas | United States | -97.14667 | 31.54933 Bangalore | N/A | India | 77.59369 | 12.97194 Hyderabaad | N/A | India | N/A | N/A Kolkata | N/A | India | 88.36304 | 22.56263 Nashik | N/A | India | 73.79096 | 19.99727 New Delhi | N/A | India | 77.2148 | 28.62137 New Delhi | N/A | India | 77.2148 | 28.62137 Pune | N/A | India | 73.85535 | 18.51957

0

NCT00527319

[ 3 ]

1

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Primary Objectives: 1. To examine the effect of celecoxib treatment on histological response, markers of proliferation (Ki-67), and apoptosis. Secondary endpoints include time to second primary or recurrence and survival. 2. To examine the toxicity associated with celecoxib administration in patients with previously treated Head and Neck Head and neck squamous cell carcinomas (HNSCC)or Non-small-cell lung carcinoma (NSCLC).

In order to enroll in this trial, you must also be enrolled in Protocol 2003-0424. The study procedures and tests that are part of this study are the same procedures and tests that are part of Protocol 2003-0424. Even though a procedure or test is described in both this consent and the consent for Protocol 2003-0424, you will only have the described procedure or test done once. For example, both this study and Protocol 2003-0424 require a complete physical exam before beginning treatment. In this case, you will only have one physical exam that will count for both studies. Celecoxib is a drug that slows the production of chemicals in the body that cause inflammation. Celecoxib works by interfering with the action of the chemical cyclooxygenase, a chemical that is involved in inflammation. It is believed that the product of chemicals that cause inflammation may be involved in cancer development. Before treatment starts, you will have a complete physical exam, including measurement of height, weight, blood pressure, and vital signs. You will have blood samples drawn for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons) . Women who are able to have children must have a negative pregnancy test (blood or urine). You will also have a chest x-ray and a CT scan of your chest. You will also have a bronchoscopy (tissue sample from the lung) at the beginning of this study for lab analysis. For this procedure, you will be given drugs to relax. Then, a local anesthetic will be sprayed in your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your lungs. Tweezers will be fed through the tube to collect lung tissue (biopsy) samples from 6 different places in your lungs. During the bronchoscopy procedure, a complete inspection of the airways will be performed. Any suspicious areas that are seen under the white-light and autofluorescence bronchoscopy will be identified and more biopsies and brushings will be performed to evaluate whether any pre-cancerous tissue is present. You will also have a bronchial brushing next to each biopsy site. In a bronchial brushing, a small brush is fed through the tube into your lungs and a sample of lung tissue is gently scraped off. When the biopsies and brushings are done, you will have a bronchial lavage (bronchial washing). In the bronchial lavage, a small amount of water (about 4 tablespoons) is sprayed into your lungs and then suctioned out through the tube. This fluid is used to collect additional tissue and mucous samples. In addition, a sputum (saliva) sample will be taken and the inside of your cheek will be scraped (buccal sample). If you have had HNSCC, you will also have a laryngoscopy. In a laryngoscopy, a lighted tube is placed down your throat and the larynx is checked. The back of your throat will be sprayed with an anesthetic before this procedure to make the procedure more comfortable. In this study you will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in one group will receive celecoxib. Participants in the other group will receive no treatment. Current standard practice for individuals who have had therapy for early stage NSCLC or HNSCC is follow-up (no treatment). You have a 2 to 1 chance of being assigned to the treatment group. That means that 2 out of every 3 participants in this study will be assigned to the treatment group. If you are assigned to the treatment group you will take celecoxib by mouth in two divided doses at least 8 hours apart every day. Your study doctor will tell you exactly how many pills you should take each day. You will take celecoxib for up to 12 months. You will be taken off study if intolerable side effects occur or if the disease comes back. If you are assigned to the treatment (celecoxib) group, you will have a physical exam by a physician or nurse at months 3, 6, and 12 for the first year of treatment. If you are assigned to the "no treatment" group, the nurse will contact you by phone every 3 months for the first year on this study to see how you are doing and you will have a physical exam by either a physician or a nurse every 6 months. During the first year, all participants will have blood samples taken at each clinic visit for routine blood tests (about 3 teaspoons) and for research purposes (about 4 teaspoons). In addition, all participants will have a chest x-ray and chest CT at months 6 and 12. All participants will also have a bronchoscopy and provide sputum, saliva, and buccal smear samples at 12 months. If you have been treated for HNSCC, you will have a laryngoscopy at 12 months. After the first year, you will be followed for a minimum of 2 more years and a maximum of 6 years. You will have physical exams at 24 and 36 months. You will have blood draws (about 3 teaspoons for routine tests and 4 teaspoons for research purposes), a chest x-ray and a chest CT at 18, 24, 30 and 36 months. After 36 months, you will have a physical exam by a physician or nurse every 6 months for up to 6 years. Every 12 months the physical exam will be done by a physician. The other physical exams will be done by a nurse. You will have blood drawn for routine tests (about 3 teaspoons) and research purposes (about 4 teaspoons) every 12 months. This research study includes two bronchoscopies done one year apart. These bronchoscopies are being done primarily for research purposes and are unlikely to provide information useful in your individual treatment. These bronchoscopies do have risks associated with them. These risks are described in section 4 of this informed consent document. Recent research on early stage NSCLC indicates that adjuvant chemotherapy after surgery increases the length of time a person may survive and the length of time before cancer recurs. However, this adjuvant chemotherapy also has side effects that can be severe and in rare cases fatal. If you have had surgery for NSCLC and wish to receive adjuvant chemotherapy, you may only enroll in this study and Protocol 2003-0424 after you have completed the adjuvant chemotherapy. As part of this study you will provide samples of your lung tissue, saliva, blood, and scrapings from the inside of your cheek. Fluid and mucous collected during the bronchoscopies will also collected. These samples will be studied by scientists to learn about genes and proteins in people who have been treated for early NSCLC or HNSCC. The samples will also be used to grow cells and cultures that will be used to test chemotherapy drugs. These cells and cultures will also be used to learn about genes and proteins. This is an investigational study. Celecoxib is a commonly used drug that is approved by the FDA for treatment of arthritis, colon polyps, and pain. The use of celecoxib to help prevent cancer is approved by the FDA for research only. A total of up to 70 individuals will take part in this multicenter study. Up to 50 will be enrolled at UT MD Anderson Cancer Center.

Head and Neck Cancer Lung Cancer

Head and Neck Cancer Lung Cancer Non-Small Cell Lung Cancer Celecoxib Celebrex

null

2

arm 1: 600 mg orally (PO) daily arm 2: None

[ 0, 4 ]

1

[ 0 ]

intervention 1: 600 mg by mouth daily for a total of 12 months.

intervention 1: Celecoxib

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT00527982

[ 3 ]

72

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

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 orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.

null

Major Depressive Disorder

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is \>40 kg, initial dose is 30 mg, then titrated up.

intervention 1: duloxetine

22

0

NCT00529789

[ 3 ]

66

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine whether PF-03654746 is effective in the treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD). This will be a randomized, double-blind, crossover study in which adults with ADHD will receive 3 weeks of treatment with PF-03654746, either a low dose (1 mg), or flexible dose (0.50 mg titrated up to 2 mg), and 3 weeks of placebo. A washout period will separate the 2 treatment periods. Participants will be required to washout of prior ADHD medication before entering the study. Participants will be required to come to the site for 10 visits over approximately a 10-week period.

null

Attention Deficit Hyperactivity Disorder

null

3

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

[ 0, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 0.5 mg QD for Days 1-7, then 1.0 mg QD Days 8-14, then 2.0 mg QD Days 15-21 intervention 2: Dosage Form: matching placebo capsules Dosage: Subjects will take two placebo capsules each morning throughout the 3 week double-blind treatment placebo treatment period. intervention 3: Dosage Form: 0.5 mg capsules of PF-03654746 Dosage: 1 mg (2 x 0.5 mg capsules) of PF-03654746 given daily for three weeks

intervention 1: PF-03654746 intervention 2: Placebo capsules intervention 3: PF-03654746

7

0

NCT00531752

[ 4 ]

409

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

null

Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States

Generalized anxiety disorders anxiety adjunct treatment in anxiety anxiety disorder partial or non-responder in anxiety

null

2

arm 1: Adjunctive Placebo Seroquel XR to anxiety treatment arm 2: Adjunctive Seroquel XR to anxiety treatment

[ 5, 0 ]

2

[ 0, 0 ]

intervention 1: oral intervention 2: oral

intervention 1: Placebo intervention 2: quetiapine fumarate XR

53

0

NCT00534599

[ 5 ]

106

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study will evaluate hyperemia and ocular surface tolerability in patients on prostaglandin analogues

null

Open Angle Glaucoma Ocular Hypertension

null

3

arm 1: bimatoprost 0.03% arm 2: travoprost 0.004% arm 3: latanoprost 0.005%

[ 0, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: bimatoprost 0.03%, 1 drop nightly for 3 months intervention 2: travoprost 0.004% eye drops, 1 drop nightly for 3 months intervention 3: latanoprost 0.005%, 1 drop nightly for 3 months

intervention 1: Bimatoprost 0.03% intervention 2: travoprost 0.004% intervention 3: latanoprost 0.005% eye drops

1

San Diego | California | United States | -117.16472 | 32.71571

0

NCT00539526

[ 4 ]

531

null

PARALLEL

0TREATMENT

null

false

0ALL

null

To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.

null

Hypertension

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: telmisartan+amlodipine intervention 2: amlodipine

41

Azumino, Nagano | N/A | Japan | N/A | N/A Higashiosaka, Osaka | N/A | Japan | N/A | N/A Itabashi-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Kashihara, Osaka | N/A | Japan | N/A | N/A Kitaazumi-gun, Nagano | N/A | Japan | 138.18333 | 36.65 Kiyose, Tokyo | N/A | Japan | N/A | N/A Kobe, Hyogo | N/A | Japan | N/A | N/A Komoro, Nagano | N/A | Japan | N/A | N/A Koriyama, Fukushima | N/A | Japan | N/A | N/A Koriyama, Fukushima | N/A | Japan | N/A | N/A Koriyama, Fukushima | N/A | Japan | N/A | N/A Koshigaya, Saitama, | N/A | Japan | N/A | N/A Koto-ku, Tokyo | N/A | Japan | N/A | N/A Matsudo, Chiba | N/A | Japan | N/A | N/A Mito, Ibaraki | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Japan | N/A | N/A Okayama, Okayama, | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Saitama, Saitama | N/A | Japan | N/A | N/A Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sapporo, Hokkaido | N/A | Japan | 141.35 | 43.06667 Sendai, Miyagi | N/A | Japan | N/A | N/A Sendai, Miyagi | N/A | Japan | N/A | N/A Sendai, Miyagi | N/A | Japan | N/A | N/A Shimoina-gun, Nagano | N/A | Japan | 138.18333 | 36.65 Shinjuku-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Shinjyuku-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895 Shinjyuku-ku,Tokyo | N/A | Japan | 139.69171 | 35.6895 Shizuoka, Shizuoka | N/A | Japan | N/A | N/A Suita, Osaka, | N/A | Japan | N/A | N/A Takamatsu, Kagawa | N/A | Japan | N/A | N/A Takamatsu, Kagawa | N/A | Japan | N/A | N/A Takamatsu, Kagawa | N/A | Japan | N/A | N/A Takaoka, Toyama | N/A | Japan | N/A | N/A Takaoka,Toyama | N/A | Japan | N/A | N/A Tsuchiura, Ibaraki | N/A | Japan | N/A | N/A

0

NCT00558064

[ 4 ]

1,098

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The primary objectives of this trial are (a) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is superior in reducing blood pressure at eight weeks compared with A5 (b) to demonstrate that the fixed-dose combination T40/A5 or the fixed-dose combination T80/A5 is not inferior in reducing blood pressure at eight weeks compared with A10 and (c) to demonstrate that the incidence of oedema on the fixed-dose combination T40/A5 pooled with the fixed-dose combination T80/A5 is superior (less oedema) to A10 in patients who fail to respond adequately to six weeks treatment with A5.

null

Hypertension

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: fixed dose combination of telmisartan+amlodipine intervention 2: amlodipine

129

Aywaille | N/A | Belgium | 5.67684 | 50.47411 Brussels | N/A | Belgium | 4.34878 | 50.85045 Gozée | N/A | Belgium | 4.35273 | 50.33461 Linkebeek | N/A | Belgium | 4.33688 | 50.76781 Mol | N/A | Belgium | 5.11662 | 51.19188 Natoye | N/A | Belgium | 5.058 | 50.34294 Tavier | N/A | Belgium | 5.47063 | 50.49634 Tienen-Kumtich | N/A | Belgium | N/A | N/A Turnhout | N/A | Belgium | 4.94471 | 51.32254 Coquitlam | British Columbia | Canada | -122.78217 | 49.2846 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Bay Roberts | Newfoundland and Labrador | Canada | -53.26478 | 47.59989 Mount Pearl | Newfoundland and Labrador | Canada | -52.78135 | 47.51659 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Corunna | Ontario | Canada | -82.43313 | 42.88338 Etobicoke | Ontario | Canada | -79.56985 | 43.64415 Hamilton | Ontario | Canada | -79.84963 | 43.25011 London | Ontario | Canada | -81.23304 | 42.98339 Ottawa | Ontario | Canada | -75.69812 | 45.41117 Sarnia | Ontario | Canada | -82.40407 | 42.97866 Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 Birkerød | N/A | Denmark | 12.42791 | 55.84759 Haderslev | N/A | Denmark | 9.48771 | 55.24943 Herning | N/A | Denmark | 8.97662 | 56.13615 Hinnerup | N/A | Denmark | 9.05874 | 56.7347 Rødovre Municipality | N/A | Denmark | 12.45373 | 55.68062 Rødovre Municipality | N/A | Denmark | 12.45373 | 55.68062 Vaerløse | N/A | Denmark | N/A | N/A Vildbjerg | N/A | Denmark | 8.76667 | 56.2 Joensuu | N/A | Finland | 29.76316 | 62.60118 Joensuu | N/A | Finland | 29.76316 | 62.60118 Turku | N/A | Finland | 22.26869 | 60.45148 Turku | N/A | Finland | 22.26869 | 60.45148 Aigrefeuille S/Maine | N/A | France | N/A | N/A Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Angers | N/A | France | -0.55202 | 47.47156 Avrillé | N/A | France | -0.58955 | 47.50663 Beaucouzé | N/A | France | -0.63219 | 47.47514 Bono | N/A | France | -2.94986 | 47.6404 Bourg Des Cptes | N/A | France | N/A | N/A Briollay | N/A | France | -0.50805 | 47.56446 Cholet | N/A | France | -0.87974 | 47.05893 Cholet | N/A | France | -0.87974 | 47.05893 Cholet | N/A | France | -0.87974 | 47.05893 Cholet | N/A | France | -0.87974 | 47.05893 Garchizy | N/A | France | 3.09625 | 47.04786 Grandchamps | N/A | France | N/A | N/A Guérigny | N/A | France | 3.20182 | 47.08703 Jarny | N/A | France | 5.8764 | 49.15873 La Chapelle /s Erdre | N/A | France | N/A | N/A La Chapelle-sur-Erdre | N/A | France | -1.55239 | 47.29964 La Fresnais | N/A | France | -1.84333 | 48.59555 La Jubaudière | N/A | France | -0.89215 | 47.17202 La Montagne | N/A | France | -1.68395 | 47.18987 Le Mesnil-en-Vallée | N/A | France | -0.93485 | 47.36551 Le Temple-de-Bretagne | N/A | France | -1.79143 | 47.32868 Les Ponts-de-Cé | N/A | France | -0.52477 | 47.42315 Loudun | N/A | France | 0.08296 | 47.00788 Louvigné Le Bais | N/A | France | N/A | N/A Mouliherne | N/A | France | 0.01586 | 47.46657 Mûrs-Erigné | N/A | France | -0.55293 | 47.39592 Mûrs-Erigné | N/A | France | -0.55293 | 47.39592 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nantes | N/A | France | -1.55336 | 47.21725 Nevers | N/A | France | 3.159 | 46.98956 Nevers | N/A | France | 3.159 | 46.98956 Nort-sur-Erdre | N/A | France | -1.49909 | 47.4399 Orvault | N/A | France | -1.62361 | 47.27117 Parçay-les-Pins | N/A | France | 0.16312 | 47.43668 Saint Aubin Les Châteaux | N/A | France | N/A | N/A Saint-Georges-de-Montaigu | N/A | France | -1.29262 | 46.94655 Saint-Ouen-la-Rouërie | N/A | France | -1.44093 | 48.46234 Saint-Pierre-Montlimart | N/A | France | -1.02738 | 47.26976 Sautron | N/A | France | -1.67222 | 47.26345 Segré | N/A | France | -0.87268 | 47.68672 Thouars | N/A | France | -0.21175 | 46.9815 Tinténiac | N/A | France | -1.83545 | 48.32908 Vannes | N/A | France | -2.76205 | 47.65688 Vihiers | N/A | France | -0.5346 | 47.1458 Beerzerveld | N/A | Netherlands | 6.57361 | 52.49333 Bennebroek | N/A | Netherlands | 4.59861 | 52.32083 Hoogwoud | N/A | Netherlands | 4.93889 | 52.71583 Musselkanaal | N/A | Netherlands | 7.01528 | 52.9325 Nijverdal | N/A | Netherlands | 6.46806 | 52.36 Oude Pekela | N/A | Netherlands | 7.00972 | 53.10417 Roelofarendsveen | N/A | Netherlands | 4.63333 | 52.20333 Voerendaal | N/A | Netherlands | 5.92978 | 50.88327 Ålesund | N/A | Norway | 6.15492 | 62.47225 Bergen | N/A | Norway | 5.32415 | 60.39299 Hamar | N/A | Norway | 11.06798 | 60.7945 Oslo | N/A | Norway | 10.74609 | 59.91273 Makati City | N/A | Philippines | 121.03269 | 14.55027 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Manila | N/A | Philippines | 120.9822 | 14.6042 Pasay | N/A | Philippines | 121.00144 | 14.53748 Pasig | N/A | Philippines | 121.0614 | 14.58691 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Quezon City | N/A | Philippines | 121.0509 | 14.6488 Boksburg | N/A | South Africa | 28.25958 | -26.21197 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Cape Town | N/A | South Africa | 18.42322 | -33.92584 Durban | N/A | South Africa | 31.0292 | -29.8579 Johannesburg | N/A | South Africa | 28.04363 | -26.20227 Krugersdorp | N/A | South Africa | 27.77515 | -26.08577 Lenasia | N/A | South Africa | 27.83564 | -26.32052 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejeon | N/A | South Korea | 127.38493 | 36.34913 Gangwon-Do | N/A | South Korea | N/A | N/A Gwangju | N/A | South Korea | 126.91556 | 35.15472 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Luleå | N/A | Sweden | 22.15465 | 65.58415 Rättvik | N/A | Sweden | 15.11787 | 60.88632 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Changhua | N/A | Taiwan | 120.5512 | 24.0692 Hualien City | N/A | Taiwan | 121.60444 | 23.97694 Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 Taichung | N/A | Taiwan | 120.6839 | 24.1469

0

NCT00558428

[ 4 ]

756

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

null

Obesity

null

7

arm 1: VI-0521; high dose phentermine/topiramate arm 2: VI-0521; mid dose phentermine/topiramate arm 3: mid dose topiramate arm 4: high dose topiramate arm 5: mid dose phentermine arm 6: high dose phentermine arm 7: None

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

7

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

intervention 1: phentermine 15 mg and topiramate 92 mg, po once daily intervention 2: phentermine 7.5 mg and topiramate 46 mg, po once daily intervention 3: topiramate 46 mg, po once daily intervention 4: topiramate 92 mg, po once daily intervention 5: phentermine 7.5 mg, po once daily intervention 6: phentermine 15 mg, po once daily intervention 7: placebo, po once daily

intervention 1: VI-0521 intervention 2: VI-0521 intervention 3: topiramate intervention 4: topiramate intervention 5: phentermine intervention 6: phentermine intervention 7: VI-0521

2

0

NCT00563368

[ 4 ]

244

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

This research study will look at the pain relieving ability and safety of using repeated doses of intravenous (into the vein \[IV\]) acetaminophen in the treatment of moderate postoperative pain after planned or elective abdominal laparoscopic surgery, such as a laparoscopic abdominal hysterectomy or laparoscopic cholecystectomy (removal of the gall bladder).

To assess the analgesic efficacy of repeated doses of intravenous acetaminophen (IV APAP) versus Placebo in the treatment of moderate postoperative pain after abdominal laparoscopic surgery.

Pain

Abdominal Laparoscopic Surgery

null

4

arm 1: IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total). arm 2: IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total). arm 3: IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total). arm 4: IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).

[ 2, 2, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: IV, every 6 hours for 24 hours (4 doses total) intervention 2: IV, every 4 hours for 24 hours (6 doses total) intervention 3: IV, every 6 hours for 24 hours (4 doses total) intervention 4: IV, every 4 hours for 24 hours (6 doses total)

intervention 1: IV Placebo intervention 2: IV Placebo intervention 3: IV Acetaminophen intervention 4: IV Acetaminophen

17

0

NCT00564486

[ 3 ]

8

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

null

Methamphetamine Dependence

null

0

null

1

[ 0 ]

intervention 1: subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7

intervention 1: Modafinil

1

Little Rock | Arkansas | United States | -92.28959 | 34.74648

0

NCT00569374

[ 3 ]

154

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

null

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

null

Chronic Obstructive Pulmonary Disease (COPD)

QVA, Indacaterol, Glycopyrrolate, Concept1, COPD, cross over study, safety and efficacy, trough FEV1

null

4

arm 1: One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 2: Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. arm 3: One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days. arm 4: Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

[ 0, 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 2: Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days. intervention 3: Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: placebo

22

St Louis | Missouri | United States | -90.19789 | 38.62727 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Raleigh | North Carolina | United States | -78.63861 | 35.7721 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ghent | N/A | Belgium | 3.71667 | 51.05 Jambes | N/A | Belgium | 4.87166 | 50.45636 Sankt Vith | N/A | Belgium | 6.12724 | 50.28146 Moncton | N/A | Canada | -64.7965 | 46.09454 Montreal | N/A | Canada | -73.58781 | 45.50884 Toronto | N/A | Canada | -79.39864 | 43.70643 Bad Wörishofen | N/A | Germany | 10.59666 | 48.00674 Berlin | N/A | Germany | 13.41053 | 52.52437 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Mainz | N/A | Germany | 8.2791 | 49.98419 Rudersdorf | N/A | Germany | 11.45 | 51.1 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 Almelo | N/A | Netherlands | 6.6625 | 52.35667 Breda | N/A | Netherlands | 4.77596 | 51.58656 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Heerlen | N/A | Netherlands | 5.98154 | 50.88365 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Veldhoven | N/A | Netherlands | 5.40278 | 51.41833

0

NCT00570778

[ 5 ]

11

NA

SINGLE_GROUP

null

0NONE

false

0ALL

false

The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.

null

Antimicrobial Prophylaxis

MRSA Increased risk for infection

null

1

arm 1: Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV

[ 0 ]

1

[ 0 ]

intervention 1: daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)

intervention 1: daptomycin 6 mg/kg IV

1

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

0

NCT00572260

[ 3 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

true

The purpose of this study is to find out what effects, good and bad, the combination of docetaxel with CG1940/CG8711 (immunotherapy drugs) have on destroying prostate cancer before removal the prostate (prostatectomy).

null

Prostate Cancer

null

0

null

2

[ 0, 2 ]

intervention 1: Docetaxel 75mg/m2 will be given intravenously every 3 weeks for four cycles. intervention 2: Immunotherapy allogeneic GM-CSF secreting cellular vaccine

intervention 1: Docetaxel intervention 2: CG1940/CG8711

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00577356

[ 3 ]

12

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

This study is being done to see if we can improve the response of Interleukin-2 by adding Zoledronic acid. The effectiveness of the combination of drugs in kidney cancer is unknown and will be investigated in this study. In particular, this study will evaluate the effect of this combination on kidney cancer and will also examine the safety and side effects of IL-2 with Zoledronic acid.

The purpose of this research is to evaluate the antitumor response of low-dose Interleukin-2 in combination with Zoledronic acid on subjects with previously untreated, unresectable metastatic renal cell carcinoma. Also, the study will assess the tolerability, safety, pharmacodynamic effects, and immunologic effects of low-dose Interleukin-2 in combination with Zoledronic acid on angiogenesis inhibition and anti-metastatic potential by measuring serum/plasma angiogenic/metastatic factor levels and by quantitating changes in cytokine expression, antigen-specific T-cell immune responses, and peripheral gd T-cell frequency and function.

Kidney Cancer

Renal Cell Cancer Metastatic

null

1

arm 1: Interleukin-2 subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles in combination with Zoledronic acid IV on day 1 of every 4 week (28 days) cycle.

[ 0 ]

2

[ 0, 0 ]

intervention 1: Interleukin-2 will be given at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles. intervention 2: Zoledronic acid will be given on day 1 intravenously over 15 or 30 minutes starting at 400mcg. If no significant increase in gamma delta-T cell augmentation is seen, the dose of zoledronic acid will be increased in the subsequent cycle up to a maximum dose of 3mg.

intervention 1: IL2 intervention 2: Zoledronic acid

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00582790

[ 3 ]

64

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

false

This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date. Inclusion Criteria: Patients presenting to the ED with at least one of the following * nausea * vomiting documented in the ED

Nausea and Vomiting

null

2

arm 1: Patients receiving Prochlorperazine 10mg IV arm 2: Patient receiving Ondansetron 4mg IV

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Patients receiving Prochlorperazine intervention 2: Patients receiving Ondansetron

intervention 1: Prochlorperazine intervention 2: Ondansetron

2

0

NCT00590317

[ 3 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

This multicenter study will be divided into 2 phases. The first phase will be an open label, dose-escalation phase, while the second will be a blinded, randomized, vehicle-controlled, parallel-group, dose-response phase. The second phase will only start if the first phase succeeds in establishing well tolerated dose(s). Patients with moderate to severe acne vulgaris in the face will be included.The results from part 2 has been presented in the result section.

For the second part: All patients will receive 4 PDT sessions 2 weeks apart using a light dose of 37 J/cm2. One treatment group will receive vehicle cream, while the other 2 groups will receive MAL cream with a concentration of 40 mg/g and 80 mg/g, respectively. The MAL and vehicle cream will be applied in a thin layer on clean skin and left for 1.5 hours under occlusion before illumination.

Acne Vulgaris

null

3

arm 1: PDT using MAL concentration A arm 2: PDT using MAL concentration B arm 3: PDT using Placebo cream

[ 0, 0, 2 ]

1

[ 0 ]

intervention 1: Cream application followed by illumination with red light

intervention 1: Methyl aminolevulinate (MAL) PDT

14

0

NCT00594425

[ 4 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This randomized, double-blind, parallel-group, controlled, multi-center clinical trial of 6 months duration is designed to assess the efficacy, tolerability and safety of PN400 versus diclofenac/misoprostol in subjects at high risk for developing NSAID-associated gastric ulcers. Approximately 100 sites will participate to enroll a total of 200 subjects (100 per arm). At least 20% of the subjects enrolled will be age 65 years and older.

To determine the incidence of gastric ulcers following administration of PN 400 in a high risk population over six months. Diclofenac/misoprostol will be used as a positive control. Secondary: * To determine the incidence of duodenal ulcers during treatment with PN 400 and diclofenac/misoprostol in a high risk population * To evaluate the degree of upper gastrointestinal injury as measured by Lanza scores (1991) during treatment with PN400 and diclofenac/misoprostol in a high risk population * To compare gastrointestinal symptoms in subjects treated with PN 400 versus diclofenac/misoprostol as measured by scores on the Gastrointestinal Symptoms Rating Scale (GSRS) instrument * To evaluate the safety and tolerability of PN400 and diclofenac/misoprostol in a high risk population

Gastric Ulcer

NSAID Gastric Ulcer High risk Arthrotec Vimovo

null

2

arm 1: PN 400 (esomeprazole/naproxen) dosed twice daily arm 2: diclofenac 75mg/misoprostol 200 mcg dosed twice daily

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: PN400 tablet (500 mg delayed-release naproxen/20 mg immediate-release esomeprazole) given by mouth twice daily (bid). intervention 2: Over-encapsulated ARTHROTEC® 75 (75 mg diclofenac sodium/200 mcg misoprostol) capsules given by mouth bid.

intervention 1: PN400 (VIMOVO) intervention 2: Diclofenac/Misoprostol

1

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

0

NCT00594854

[ 3 ]

1

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).

Hepatic encephalopathy (HE) is a reversible neuropsychiatric syndrome seen in patients with liver disease. The pathogenesis of HE is incompletely understood, but several pieces of evidence identify ammonia as a key factor in the development of HE. The liver normally detoxifies ammonia produced in the gastrointestinal tract. However, in patients with cirrhosis, portosystemic shunting allows ammonia to bypass the liver and reach the systemic circulation and the brain. The accumulation of ammonia in the brain, through mechanisms not yet fully defined, lead to changes of consciousness, intellectual function, and behavior. Ammonul is currently approved as adjuvant therapy for the management of hyperammonemia and associated encephalopathy in patients with deficiencies in the enzymes of the urea cycle. Ammonul removes nitrogenous ammonia in these patients through pathways alternative to the urea cycle. It is anticipated that in patients with HE, Ammonul may lead to the scavenging of ammonia through these alternative biochemical pathways taking place in tissues other than the liver. This study is designed to test the efficacy and safety of IV Ammonul® as a treatment for acute episodes of elevated ammonia in patients with Grade 3 or 4 HE. Study was terminated due to lack of enrollment and business decisions. Study with completed results acquired from Horizon in 2024

Hepatic Encephalopathy

Ammonul® sodium phenylacetate and sodium benzoate hepatic encephalopathy Grade 3 or 4 Hepatic Encephalopathy

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours) intervention 2: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours) intervention 3: Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)

intervention 1: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 2: sodium phenylacetate and sodium benzoate injection 10% / 10% intervention 3: placebo solution (10% dextrose)

3

0

NCT00597909

[ 3 ]

614

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma

null

Asthma

dose ranging placebo asthma safety efficacy pharmacokinetics

null

2

arm 1: Placebo Multi dose dry powder inhlaer arm 2: GW642444M

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: GW642444M intervention 2: Placebo mulit-dose dry powder inhaler

intervention 1: GW642444M intervention 2: Placebo

89

0

NCT00600171

[ 3 ]

140

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

null

Arthritis, Rheumatoid

Phase II MTX add-on study in Japan

null

5

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

[ 2, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 0 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 2: 10 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 3: 1 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 4: 3 mg BID, 3 blinded tablets administered BID for 12 weeks intervention 5: 5 mg BID, 3 blinded tablets administered BID for 12 weeks

intervention 1: Placebo intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550

18

0

NCT00603512

[ 5 ]

83

RANDOMIZED

PARALLEL

6HEALTH_SERVICES_RESEARCH

2DOUBLE

true

1FEMALE

false

This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.

Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects. Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months. Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.

Healthy

Gonadal Steroid Hormones Healthy Volunteers Antidepressant Side Effects Fluoxetine Bupropion Prolactin Testosterone Estradiol Progesterone Sexual Function Serotonin Reuptake Inhibitors 17-OH Pregnenolone

null

2

arm 1: Participants will receive treatment with fluoxetine for 2 months arm 2: Participants will receive treatment with bupropion for 2 months

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants will begin taking 10 mg of fluoxetine, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 20 mg of fluoxetine once a day after 7 days, to be maintained until the luteal phase (start of ovulation) of menstrual cycle 3. If side effects are intolerable, the dose will be lowered to 10 mg of fluoxetine per day. Participants will undergo a total of 2 months of treatment with fluoxetine. intervention 2: Participants will begin taking 150 mg of bupropion, once a day by mouth, on the first day of their second menstrual cycle during the study. Dosage will be increased to 300 mg of bupropion once a day after 7 days, to be maintained until the luteal phase of menstrual cycle 3. If side effects are intolerable, the dose will be decreased to 150 mg of bupropion per day. Participants will undergo a total of 2 months of treatment with bupropion.

intervention 1: Fluoxetine intervention 2: Bupropion

0

null

0

NCT00611975

[ 3 ]

6

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments. We will see if adding Raltegravir (MK-0518) and Valproic acid (VPA) to current ART can decrease the amount of latent HIV.

The purpose of this research study is to see if HIV that persists despite current antiviral therapy can be targeted by new treatments. Eradicating this hidden, persistent virus (which we will call "latent HIV") may some day allow HIV to be eliminated from an infected person. Recently it has been discovered that a class of medicines, called histone deacetylase (HDAC) inhibitors, may cause the HIV that hides within some of the cells of your body to be expressed ("unmasked"). The HDAC inhibitor we will use in this study to unmask or flush out the latent HIV within your cells is called valproic acid (VPA) and is commonly used to treat seizures and depression under the brand name Depakote. VPA has been safely given to people with HIV for the treatment of seizures or depression. In our first study, we recruited 4 volunteers with HIV-1 infection taking antiviral therapy in whom there were \<50 copies/ml (undetectable) of HIV virus RNA in their blood for over 6 months. In addition to continuing their anti-HIV medications, we started them on Fuzeon, a new injected anti-HIV medication, for one month. We then added VPA to the anti-HIV medications and Fuzeon for 3 months. At the end of the study, we found that latent HIV was significantly decreased. No safety problems with VPA and antiviral medicines were noted. However, having initiated Fuzeon and VPA simultaneously we could not determine with confidence that our findings were due to the effect of VPA alone. In the next study we added VPA to the therapy of patients taking standard antiretroviral therapy (ART). Eight patients have been studied so far, but only three have yet had a significant decrease in latent HIV. It may be that VPA does not work in everyone, or that stronger HIV therapy is needed in some people to drain latent HIV. And in a different study, no decrease at all was found in the number of infected cells in people taking ART who were prescribed valproate for other reasons. In this study, we wish to add a different new anti-HIV medicine, which is a pill, Raltegravir (MK-0518). Raltegravir blocks the virus from permanently entering the DNA of your T cells, and so is called an integrase inhibitor. Raltegravir is investigational. This means the U.S. Food and Drug Administration (FDA) have not yet approved it for sale. We will see if adding Raltegravir and VPA to your current ART can decrease the amount of latent HIV. If adding Raltegravir and VPA to your ART has no effect, you will have reached the end of the study. If adding Raltegravir and VPA decreases latent infection, we will stop VPA but continue Raltegravir to see if this new integrase inhibitor decreases latent infection. This study does not expect to cure your HIV, but only to take the first step towards that far-away goal. You are asked to join this study because you are infected with the HIV-1 virus; you are 18 years of age; you are able and willing to sign an informed consent.; you are able to have laboratory tests within the study specific criteria; and you have adequate vein access for leukopheresis.

HIV Infections

latent HIV resting CD4+ T cell valproic acid (VPA) Raltegravir (MK-0518) intensification HIV replication treatment experienced

null

1

arm 1: raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily

[ 0 ]

1

[ 0 ]

intervention 1: raltegravir 400mg po BID; valproic acid 1000mg - 2000mg daily

intervention 1: Raltegravir; valproic acid

1

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

0

NCT00614458

[ 0 ]

115

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

0ALL

true

Chronic abdominal pain (CAP) is an extremely pervasive childhood condition and, like IBS in adults, it is one of the functional bowel disorders without a clear framework of understanding or an effective treatment. However, new research suggests that small intestinal bacterial overgrowth (SIBO) may be the unifying pathophysiology that explains the variety of symptoms experienced by patients with IBS. As CAP in children is believed to be a precursor to IBS in adults, we hypothesize that children with this disorder have a significantly greater prevalence of small intestinal bacterial overgrowth (SIBO) than normal, healthy children, and that eradication of bacterial overgrowth with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To prove this, we will first aim to determine the prevalence of SIBO in both healthy children and those with CAP. We will do this by performing a lactulose breath hydrogen test, the gold standard for the noninvasive measurement of SIBO, on 40 healthy controls and 80 subjects with CAP. We will then assess whether eradication of SIBO with antibiotics will reduce symptoms of chronic abdominal pain in children with this condition. To do this we will randomize, in a double-blinded fashion, the 80 CAP patients to receive a 10-day course of either the antibiotic Rifaximin or a placebo. After completion of the treatment we will evaluate all these patients for eradication of bacterial overgrowth by repeating a lactulose breath hydrogen test. We will also assess for symptom improvement by re-administering questionnaires.

null

Chronic Abdominal Pain Small Intestinal Bacterial Overgrowth

null

3

arm 1: Healthy controls arm 2: 2/3 Patients with CAP arm 3: 1/3 patients with CAP

[ 1, 1, 2 ]

4

[ 3, 0, 0, 3 ]

intervention 1: Healthy controls will receive one lactulose breath test to assess for SIBO intervention 2: xifaxan 550mg TID x10days intervention 3: placebo TID x 10days intervention 4: Children with CAP will receive one lactulose breath test to assess for SIBO and one after receiving either Rifaximin or Placebo

intervention 1: Lactulose Breath Test intervention 2: xifaxan intervention 3: placebo intervention 4: Lactulose Breath Test

1

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

0

NCT00619970

[ 3 ]

17

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Patients with chronic kidney disease (CKD) and albuminuria are at increased risk of developing cardiovascular disease (CVD) which is often associated with hypertension, left ventricular hypertrophy, endothelial dysfunction and increased generation of reactive oxygen species (ROS). These patients also manifest a decrease in nitric oxide (NO) availability which is thought to play an important role in their progressive vascular disease. Tetrahydrobiopterin (BH4), an essential cofactor for endothelial nitric oxide synthase(eNOS), an important regulator of NO and that is a key mediator of endothelial dysfunction. Changes in NO availability are believed to contribute to endothelial dysfunction seen in CKD and common CVD states. 6R-tetrahydrobiopterin (6R-BH4 or sapropterin dihydrochloride) is an investigational oral drug that is being evaluated to determine whether it will restore NO availability, leading to beneficial effects on vascular function and ultimately positive clinical outcomes in patients with CKD. The primary endpoint in this study is the level of albuminuria, an easily measured marker that has served as a predictor of kidney disease progression. If 6R-BH4 reduces albuminuria in patients with kidney disease, it may have implications to slow the disease progression as well as decreased risk of CVD.

ABSTRACT Background: Chronic kidney disease (CKD) is characterized by a high propensity to cardiovascular disease (CVD); therefore treatments that impact both CKD and CVD are needed. CKD is accompanied by endothelial dysfunction and nitric oxide (NO) deficiency. Tetrahydrobiopterin (BH4), an important co-factor for endothelial NO synthase (eNOS) increases the availability of NO. Administration of BH4 has the potential to improve endothelial function and thereby reduce albuminuria in CKD. Patients and Methods: This Phase 2 open-label study is designed to assess the efficacy and safety of twice daily oral dosing of 6R-BH4 in 30 subjects with CKD (estimated glomerular filtration rate (eGFR) ≥40ml/min/1.73m2). Trial Design: Subjects will receive 6R-BH4 400mg bid for 6 weeks, sequentially followed by 6R-BH4 plus Vitamin C 500mg bid for another 6 weeks. Patients will have scheduled visits at Weeks 0,3,6,9 and 12, with an exit-visit at week 16. Albuminuria will be assessed in 24-hour urine collections as well as early morning spot urine samples for albumin:creatinine ratio. Blood and urine will be tested for routine clinical laboratory tests, blood NO, and also archived for later assays for special biomarkers. The primary outcome will be level of albuminuria as measured in a 24-hour urine collection at 6 and 12 weeks of therapy. Secondary outcomes will include urine albumin/creatinine ratio, eGFR, and blood pressure. Adverse events will be monitored closely. Data analysis: For all patients combined and for each of the above outcomes, we will sequentially compare each time point to the baseline level using paired t-tests. For the comparison of 6R-BH4 versus 6R-BH4+vitamin C, we will compare albuminuria at 6 and 12-weeks, adjusted for baseline values, using regression analysis. We will also use regression to test for an interaction between baseline value and treatment group. Anticipated results: We postulate that 6R-BH4 alone or in conjunction with high dose vitamin C will reduce albuminuria in patients with CKD by improvement in endothelial function that is integral to glomerular filtration. Future Implications: Reduction in albuminuria if demonstrable, will have implications for simultaneous renal and cardiovascular protection. This will need to be confirmed in a larger randomized controlled clinical trial in subjects with CKD.

Kidney Disease Albuminuria

Kidney Disease Albuminuria Glomerular filtration rate

null

1

arm 1: Subjects will receive 6R-BH4 400mg bid for 6 weeks, sequentially followed by 6R-BH4 plus Vitamin C 500mg bid for another 6 weeks. Patients will have scheduled visits at Weeks 0,3,6,9 and 12, with an exit-visit at week 16. Albuminuria will be assessed in 24-hour urine collections as well as early morning spot urine samples for albumin:creatinine ratio. Blood and urine will be tested for routine clinical laboratory tests, blood nitric oxide (NO), and also archived for later assays for special biomarkers. The primary outcome will be level of albuminuria as measured in a 24-hour urine collection at 6 and 12 weeks of therapy. Secondary outcomes will include urine albumin/creatinine ratio, estimated glomerular filtration rate (eGFR), and blood pressure .

[ 0 ]

2

[ 0, 7 ]

intervention 1: 400 mg 6R BH4 oral BID for 6 weeks then 400 mg of 6R BH4 for another 6 weeks in all arms intervention 2: 500 mg Vitamin C oral BID for another 6 weeks

intervention 1: 6R BH4 intervention 2: Vitamin C

1

Ann Arbor | Michigan | United States | -83.74088 | 42.27756

0

NCT00625820

[ 3 ]

46

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses.

This Phase 2a study was conducted in 2 parts. Part A was a randomized, single-dose, double-blind, placebo- and active-controlled, 3-way crossover phase during which participants were administered study medication in the clinical facility. Part B was a 14-day, randomized, double-blind, placebo-controlled, parallel-group, multiple-dose phase in which participants self-administered study medication at home.

Rheumatoid Arthritis

Rheumatoid arthritis arthritis

null

5

arm 1: ADL5859: 200 milligrams (mg), capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 2: Naproxen: 500 mg, capsules, administered orally as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 3: Matching placebo, capsules, administered orally, as a single dose during 1 of 3 Treatment Periods in Part A of the study arm 4: ADL5859: 100 mg, capsules, administered orally, twice daily (BID) for 2 weeks during Part B of the study arm 5: Matching placebo, capsules, administered orally, BID for 2 weeks during Part B of the study

[ 0, 1, 2, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

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

intervention 1: ADL5859 intervention 2: Naproxen intervention 3: Placebo intervention 4: ADL5859 intervention 5: Placebo

8

0

NCT00626275

[ 4 ]

69

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

To determine the safety of levocetirizine in children ages 6-11 months with symptoms of allergic rhinitis or chronic idiopathic urticaria.

null

Allergic Rhinitis Chronic Urticaria

Xyzal Levocetirizine Allergy Children Seasonal Allergies

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 10 ]

intervention 1: Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed once a day for 2 weeks intervention 2: Placebo oral liquid once a day for two weeks

intervention 1: Levocetirizine 1.25 mg intervention 2: Placebo

26

0

NCT00628108

[ 4 ]

430

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Asthma

Symbicort Turbuhaler Persistent Asthma

null

2

arm 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) arm 2: Conventional Best Practice for Treatment of Asthma

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed) intervention 2: Salbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage

intervention 1: Symbicort TBH - Turbuhaler intervention 2: beta-II-agonist, inhale steroid

15

Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 Antalya | N/A | Turkey (Türkiye) | 30.69556 | 36.90812 Bursa | N/A | Turkey (Türkiye) | 29.06013 | 40.19559 Denizli | N/A | Turkey (Türkiye) | 29.0875 | 37.77417 Diyarbakır | N/A | Turkey (Türkiye) | 40.21721 | 37.91363 Edirne | N/A | Turkey (Türkiye) | 26.55597 | 41.67719 Eski?ehir | N/A | Turkey (Türkiye) | N/A | N/A Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273 Kocaeli | N/A | Turkey (Türkiye) | 27.51145 | 39.62497 Malatya | N/A | Turkey (Türkiye) | 38.31667 | 38.35018 Manisa | N/A | Turkey (Türkiye) | 27.42647 | 38.61202 Mersin | N/A | Turkey (Türkiye) | 34.63886 | 36.81196 Samsun | N/A | Turkey (Türkiye) | 36.3361 | 41.27976 Zonguldak | N/A | Turkey (Türkiye) | 31.79305 | 41.45139

0

NCT00628758

[ 0 ]

1

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

3TRIPLE

false

2MALE

null

RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma. PURPOSE: This randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.

OBJECTIVES: Primary * To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagnosed high-grade glioma. Secondary * To compare the difference in percent change from baseline timed functional tests (TFT) between patients who are treated with testosterone gel and those who are not. * To compare the difference in percent change from baseline activities of daily living as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) between patients who are treated with testosterone gel and those who are not. * To compare the difference in percent change from baseline leg muscle mass as assessed by CT scan imaging between patients who are treated with testosterone gel and those who are not. * To estimate the side effects of testosterone gel in these patients. OUTLINE: Patients are stratified according to daily glucocorticoid dose (\< 16 mg/day vs ≥ 16 mg/day), Karnofsky performance status (≤ 80% vs \> 80%), and age (≤ 50 years of age vs \> 50 years of age). Patients are randomized to 1 of 2 treatment arms. * Arm I (control): Patients receive oral whey protein powder once daily for 7 months. * Arm II (treatment): Patients apply topical testosterone gel to the shoulder, upper chest, or forearm once daily for 7 months. Patients undergo strength testing and functional testing (TFT) and complete an activities of daily living questionnaire at baseline and at 1, 3, 5, and 7 months. Patients also undergo CT scan of the leg and laboratory testing at baseline and at 3 and 7 months. Testosterone levels are obtained at baseline and at 1, 3, and 7 months. Patients complete a daily log of their glucocorticoid dose and to affirm compliance with therapy. Major clinical events related to underlying tumor (i.e., surgery, radiotherapy, initiating chemotherapy, concurrent antiepileptic therapy, deep vein thrombosis, pulmonary embolism, transfusions, seizures, pneumonia, and other forms of infection) are also recorded.

Brain and Central Nervous System Tumors Musculoskeletal Complications

musculoskeletal complications adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma

null

2

arm 1: whey protein powder arm 2: Testosterone Gel (10g pouch/day) applied to skin

[ 2, 1 ]

2

[ 0, 7 ]

intervention 1: Application of testosterone gel intervention 2: None

intervention 1: testosterone gel applied to skin intervention 2: whey powder protein

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00631137

[ 5 ]

93

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

Randomized, multi-center, open label, active-comparator study to compare the efficacy and tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with moderate to severe acne vulgaris.

Efficacy of Doryx Delayed Release Tablets to doxycycline hyclate will be assessed using an Investigator's Global Assessment (IGA) score and the absolute change from baseline to 12 weeks in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline to 12 weeks in non-inflammatory lesions count of Doryx Delayed Release Tablets compared to doxycycline hyclate will be evaluated.

Acne Vulgaris

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 150mg/day, oral, delayed release tablets intervention 2: 100 mg/day, oral, tablets, immediate release

intervention 1: Doxycycline hyclate (Doryx) intervention 2: Doxycycline hyclate

4

0

NCT00635609

[ 3 ]

38

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.

Buprenorphine sublingual and buccal soluble films are being developed to be used for the same indication and over the same buprenorphine dose range as Subutex and Suboxone sublingual tablets in the treatment of opioid dependence. However, only films administered by the sublingual route were evaluated in this study. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Subutex and Suboxone product: * Mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * Improvement in subject convenience and compliance by ensuring rapid disintegration. * Protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * Provision of a unit dose product format for hospital and institutional use. * Decreased product damage during shipping as compared to Subutex and Suboxone tablets.

Opioid-related Disorders

Opioid dependence Opioid withdrawal symptoms

null

2

arm 1: Day 1: Buprenorphine soluble film administered at a dose of 4 mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2-5: Buprenorphine soluble film administered at a dose of 16 mg to 24 mg once per day, plus placebo. Dosing occurred at 0900 hours. arm 2: Day 1: Buprenorphine/naloxone soluble film administered at a dose of 4mg/1mg 3 times per day, plus placebo. Dosing occurred at 0900, 1100, and 2000 hours. Days 2 to 5: Buprenorphine/naloxone soluble film administered at a dose of 16mg/4 mg to 24 mg/6 mg once per day, plus placebo. Dosing occurred at 0900 hours.

[ 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment. intervention 2: Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment. intervention 3: Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.

intervention 1: Buprenorphine soluble film intervention 2: Buprenorphine/naloxone film strip intervention 3: Placebo

1

Baltimore | Maryland | United States | -76.61219 | 39.29038

0

NCT00637000

[ 4 ]

322

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

true

0ALL

true

To evaluate the safety and tolerability of raxibacumab in healthy subjects.

null

Healthy

healthy volunteers

null

4

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

[ 0, 0, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 40 mg/kg intravenously, double dose (day 0 and 14), Group 3 intervention 2: 40 mg/kg intravenously, double dose (day 0 and 14), Group 1 intervention 3: 40 mg/kg placebo, single dose (day 0), Group 4 intervention 4: 40 mg/kg intravenously, single dose, day 0, Group 2

intervention 1: placebo intervention 2: raxibacumab intervention 3: placebo intervention 4: raxibacumab

0

null

0

NCT00639678

[ 0 ]

27

NA

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

false

0ALL

false

This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.

Coronary Artery Disease Chest Pain

Platelets, platelet aggregation inhibitors

null

0

null

1

[ 0 ]

intervention 1: All subjects will receive a 300 mg loading dose

intervention 1: Clopidogrel

1

Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756

0

NCT00644657

[ 3 ]

376

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in promoting weight loss in patients who are overweight or obese and who do not have diabetes.

The prevalence of obesity is increasing worldwide. Obesity and being overweight are major risk factors for chronic cardiovascular disease, type 2 diabetes mellitus, hypertension and stroke, and certain types of cancers. JNJ-28431754 is being investigated in this study for its possible effectiveness in promoting weight loss when taken over a 12-week period. The study consists of 3 phases: a pretreatment phase that includes a 7-day screening period and a 4-week run-in period, a 12-week double-blind treatment phase (neither the patient nor the investigator will know which treatment the patient is receiving) with an end-of-treatment visit, and a posttreatment phase. In the pretreatment phase, after giving written informed consent, patients will undergo screening evaluations. Patients who successfully complete the screening period will enter the 4-week run-in period and be given dietary and exercise counseling as standardized non-drug therapy for weight loss. During the 12 weeks of treatment, all patients will continue on the study diet and exercise non-drug therapy and will visit the study site about every 3 weeks to have their weight and the results of other safety and effectiveness tests recorded, and to have blood samples collected to measure the concentration of JNJ-28431754 in their blood. In the posttreatment phase, patients will return to the study site for a follow-up visit 14 days after receiving their last dose of study drug. Patient safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); pregnancy tests; physical examinations; electrocardiograms; vital signs measurements; overnight urine collection to measure albumin excretion; assessment of calcium and phosphate homeostasis (balance), bone formation and reabsorption markers, and hormones regulating calcium and phosphorus homeostasis; and self administered vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis and urinary tract infection. Patients will complete 2 questionnaires to record their reactions to taking the study drug and the effect of body weight on their daily lives. About 100 patients of the approximately 400 who qualify for the study, and who consent to this, will take part in 2 oral glucose tolerance tests (OGTTs). During the OGTTs they will drink a glucose solution and have a series of blood samples collected to measure glucose concentration, collect their urine over a 2 hour period, and (at the second OGTT only) have blood samples collected to measure JNJ 28431754 blood concentrations. The primary clinical theory for this study is that at well-tolerated doses, JNJ-28431754 is superior to placebo as measured by the percent change in body weight from baseline (Day 1 of the double-blind treatment period) through Week 12.

Obesity

Obesity Overweight Weight loss Anti-Obesity Agents Human

null

4

arm 1: Each patient will receive 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 2: Each patient will receive 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 3: Each patient will receive 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks. arm 4: Each patient will receive matching placebo once daily for 12 weeks.

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks. intervention 2: One matching placebo capsule orally once daily for 12 weeks.

intervention 1: Canagliflozin (JNJ-28431754) intervention 2: Placebo

36

0

NCT00650806

[ 4 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with that of 50 µg/kg neostigmine. Residual neuromuscular blockade is defined as the fourth twitch to first twitch (T4/T1) ratio of \< 0.90.

Undetected residual neuromuscular blockade is common in the post-anesthesia care unit (PACU). In fact, 16%-42% of patients receiving intermediate-acting muscle relaxants in the operating room have T4/T1 ratios \<0.7-0.8 in the PACU. Respiratory and pharyngeal muscle function can be adversely affected during minimal neuromuscular blockade. Studies in awake volunteers and surgical patients have demonstrated that T4/T1 ratios of 0.7 - 0.9 are associated with impaired airway protective reflexes, upper airway obstruction, a decreased hypoxic ventilatory response, and post-operative hypoxemia. The incidence and severity of residual neuromuscular blockade at the time of tracheal extubation will be evaluated to determine how these influence the length of stay in the operating room and PACU.

Anesthesia

null

2

arm 1: 4 mg/kg sugammadex arm 2: 50 µg/kg neostigmine

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Participants received 4 mg/kg sugammadex at 1-2 Post Tetanic Counts (PTCs) or better after the last dose of rocuronium bromide. intervention 2: Participants received 50 µg/kg neostigmine combined with 10 µg/kg glycopyrrolate after the last dose of rocuronium bromide as per standard of care. intervention 3: Participants received a single intubation bolus dose of 0.6 mg/kg rocuronium bromide, followed if necessary to maintain neuromuscular blockade by one or more single bolus dose(s) of 0.15 mg/kg rocuronium bromide.

intervention 1: Sugammadex intervention 2: Neostigmine intervention 3: Rocuronium

0

null

0

NCT00675792

[ 2 ]

42

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

true

The primary objective of this study is to determine the bioequivalence of the combination of pyronaridine and artesunate (180:60mg) to-be-marketed tablet to the clinical trial reference tablet administered as a single total dose of 720:240 mg in healthy adults. The secondary objective is to assess the safety of the two formulations.

This is a phase I, randomized, single dose, two-way cross-over study of two tablet formulations of the combination of pyronaridine and artesunate (180:60 mg). The study will include 42 healthy participants, comprising male and female adults. Participants will be randomized to receive either reference tablet formulation or to-be-marketed formulation first and then will be crossed over to receive the opposite Intervention. The study will consist of two single dose treatments of 720:240 mg tablets, separated by a washout period of 43 days. Participants will go to the clinic the evening before dosing (dosing days were Day 0 for period 1 and Day 43 for period 2) under fasting condition and remain in the hospital for 24 hours after receiving dosing. Participants will stay in the hospital for 24 hours after their arrival at the clinic. They will return to the clinic at Day 2, 3, 5, 7, 14, 21, 28, 35 and 42 on an ambulatory basis. At Day 43, the dosing for the second sequence will start and a similar schedule of visits will be followed. Each participant will be followed-up for an additional 42 days after the start of the second study period, until the final visit (Day 85). The total duration of participation is 85 days plus a maximum of 2 weeks screening period.

Malaria

Malaria anti-malarial pyronaridine pyronaridine artesunate (Pyramax) artemisinin based combination therapy (ACT)

null

2

arm 1: Participants first received clinical trial reference 720:240 mg tablets on Day 0. After a washout period of 43 days, they then received to-be-marketed 720:240 mg tablets on Day 43, with a follow-up period of 42 days. arm 2: Participants first received to-be-marketed 720:240 mg tablets on Day 0. After a washout period of 43 days, they then received clinical trial reference 720:240 mg tablets on Day 43, with a follow-up period of 42 days.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg) intervention 2: Single total oral dose of 720:240 mg (4 tablets of 180:60 mg)

intervention 1: pyronaridine artesunate clinical trial reference tablets intervention 2: pyronaridine artesunate to-be-marketed tablets

1

Arzo | N/A | Switzerland | 8.94103 | 45.87606

0

NCT00682630

[ 5 ]

11

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

null

Hepatitis C, Chronic Hepacivirus HIV Infections

HIV

null

1

arm 1: PEG-IFN + RBV therapy in previously untreated chronic HCV subjects coinfected with HIV

[ 0 ]

2

[ 2, 0 ]

intervention 1: Subjects will be given peginterferon alfa-2b (PEG-IFN) subcutaneously, at a dose of 1.5 ug/kg weekly. Treatment duration will be 48 weeks for subjects with Hepatitis C Virus (HCV) genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline Hepatitis C Virus-ribonucleic acid (HCV-RNA) below 800,000 IU/mL. intervention 2: Subjects will be given ribavirin 800 mg/day orally(PO) when body weight is \<65 kg, 1000 mg/day when body weight is between 65 kg and 85 kg, and 1200 mg/day when body weight is \>85 kg. Treatment duration will be 48 weeks for subjects with HCV genotype 1 and 24 weeks for subjects with HCV genotype 2 or 3 and baseline HCV-RNA below 800,000 IU/mL.

intervention 1: Peginterferon alfa-2b (SCH 054031) intervention 2: Ribavirin (SCH 018908)

0

null

0

NCT00687544

[ 3 ]

44

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

Evaluate the efficacy of combination therapy AEGR-733 plus atorvastatin 20 mg versus monotherapy on serum lipoproteins over 4 and 8 weeks of therapy. The primary efficacy parameter is percent change in LDL-C after 8 weeks of therapy.

Following a 35-day washout of current lipid-lowering medication (if any) and adherence to a low-fat diet, subjects will receive either atorvastatin 20 mg for 8 weeks, OR AEGR-733 2.5 mg + atorvastatin 20 mg for 4 weeks followed by AEGR-733 5 mg + atorvastatin 20 mg for 4 additional weeks. During the entire study, subjects will be instructed to follow a low-fat/low cholesterol diet and limit alcohol consumption to -/\< 1 drink per day.

Hypercholesterolemia

Hyperlipidemia

null

2

arm 1: 2.5 mg AEGR 733 plus atorvastatin 20 mg weeks 1-4 followed by 5 mg AEGR 733 plus atorvastatin 20 mg weeks 5-8 arm 2: Following 35-day washout + diet run-in, subjects receive atorvastatin 20 mg for 8 wks.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: atorvastatin 20 mg tablets, daily dosing, for 8 weeks. intervention 2: 2.5 mg AEGR-733 capsules, daily dosing, 4 weeks followed by 5 mg AEGR-733 capsules, daily dosing, 4 weeks

intervention 1: Atorvastatin intervention 2: AEGR-733

5

0

NCT00690443

[ 4 ]

100

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

false

The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia. Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.

Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.

Anesthesia

Anesthesia Induction Pain

null

2

arm 1: Modified propofol (Propofol 0.5%) arm 2: Propofol 1%

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Propofol (drug), intravenous, induction of anesthesia intervention 2: Propofol (drug), intravenous, induction of anesthesia

intervention 1: Propofol intervention 2: Propofol 1%

1

Leverkusen | North Rhine-Westphalia | Germany | 6.98432 | 51.0303

0

NCT00690495

[ 5 ]

26

RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this research study is to better understand adherence to Locoid when people use it to treat atopic dermatitis.

An investigator-blinded prospective study of subjects with mild to moderate atopic dermatitis (\>5% Body Surface area and 2 or 3 on the Investigator Global Assessment (IGA) scale). The drug will be used within FDA-approved labeling. Subjects will be randomized to each of the following topical hydrocortisone 17-butyrate 0.1% preparations- ointment, cream or lipocream- in the manufacturer's original tube fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened and this data can be downloaded and tabulated with the associated software. The study will consist of a 2-week Treatment Phase (visits at Baseline and Week 2). Subjects will be instructed to apply the medication twice daily (morning and evening) for 2 weeks to all of their AD lesions. Adherence will be measured by MEMs cap.

Atopic Dermatitis

null

3

arm 1: topical hydrocortisone 17-butyrate 0.1% Cream preparation applied twice daily to all lesions of atopic dermatitis arm 2: topical hydrocortisone 17-butyrate 0.1% Ointment preparation applied twice daily to all lesions of atopic dermatitis arm 3: topical hydrocortisone 17-butyrate 0.1% Lipocream preparation applied twice daily to all lesions of atopic dermatitis

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Apply medication twice a day to affected areas of atopic dermatitis intervention 2: Apply medication twice a day to affected areas of atopic dermatitis intervention 3: Apply medication twice a day to affected areas of atopic dermatitis

intervention 1: hydrocortisone 17-butyrate 0.1% Cream preparation intervention 2: hydrocortisone 17-butyrate 0.1% Ointment preparation intervention 3: hydrocortisone 17-butyrate 0.1% Lipocream preparation

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00693693

[ 3 ]

25

RANDOMIZED

SINGLE_GROUP

0TREATMENT

1SINGLE

true

0ALL

false

The objective of the study is to compare the healing of wounds induced by cryo-injury when treated with white petrolatum versus an ointment vehicle.

null

Wounds

White Petrolatum Xenaderm Vehicle Partial thickness wounds Healing Cryo-surgery

null

2

arm 1: Xenaderm Vehicle arm 2: Placebo Comparator

[ 5, 2 ]

2

[ 0, 10 ]

intervention 1: Ointment to be applied three times a day on cryo-surgery wound for 21 days. intervention 2: Ointment to be applied three times a day on cryo-surgery wound for 21 days.

intervention 1: Xenaderm Vehicle intervention 2: Placebo comparator

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00713349

[ 5 ]

51

RANDOMIZED

SINGLE_GROUP

0TREATMENT

1SINGLE

false

0ALL

false

Pliaglis® Cream versus compounded topical anesthetic for pain management during Restylane® injections for the correction of nasolabial folds.

Open-label, randomized study designed to assess the effectiveness of a topical anesthetic (Pliaglis® Cream) versus a compounded topical anesthetic at needle stick, immediately after, one and three hours after Restylane® injections in the nasolabial folds.

Nasolabial Folds

Nasolabial folds wrinkles topical anesthetic

null

2

arm 1: tetracaine 4% / lidocaine 7% cream; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face. arm 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections; this was a randomized, split face study where Pliaglis® Cream was used on one side of the face and a compounded topical anesthetic ointment was used on the other side of the face. Restylane® was injected into both sides of the face.

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Apply tetracaine/lidocaine cream once on one side of the face prior to Restylane® injections intervention 2: apply benzocaine / lidocaine / tetracaine ointment once on the other side of the face prior to Restylane® injections

intervention 1: tetracaine 7% / lidocaine 7% cream (Pliaglis® Cream) intervention 2: benzocaine 20% / lidocaine 6% / tetracaine 4% ointment

4

0

NCT00716443

[ 4 ]

328

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of JNS013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.

This is a multi-center (conducted in more than one center), double-blind (neither Physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm \[no pain\] to 100 mm \[worst possible pain\]), following extraction of an impacted mandibular wisdom tooth. The study consists of 3 parts: Pre-observation (7 days before study commences on Day 1); Treatment (Day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and Follow-up (Day 2 and 8). All the eligible participants will be randomly assigned to 1 of the 3 study treatments. Efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. Participants' safety will be monitored throughout the study.

Pain Postoperative Pain

Pain Tooth extraction Oral surgery Postoperative pain JNS013 Tramadol hydrochloride Acetaminophen

null

3

arm 1: Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively, along with two oral capsules of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed greater than or equal to (\>=) 50.0 millimeter (mm) on the Visual Analog Scale (VAS), score ranging from 0 mm (no pain) to 100 mm (worst possible pain). arm 2: Tramadol hydrochloride will be administered as single oral dosing of two capsules once at a dose of 75 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain). arm 3: Acetaminophen will be administered as single oral dosing of two capsules once at a dose of 650 milligram, along with two oral tablets of matching placebo, within 30 minutes after the intensity of pain associated with tooth extraction showed \>= 50.0 mm on the VAS, score ranging from 0 mm (no pain) to 100 mm (worst possible pain).

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Tramadol hydrochloride two oral capsules will be administered once as 75 milligram (mg). intervention 2: Acetaminophen two oral capsules will be administered once as 650 mg. intervention 3: Two oral tablets or capsules of matching Placebo will be administered once along with Tramadol Hydrochloride and/or acetaminophen. intervention 4: Tramadol hydrochloride and acetaminophen combination tablet will be administered as single oral dosing of two tablets at a dose of 75 and 650 milligram respectively.

intervention 1: Tramadol Hydrochloride intervention 2: Acetaminophen intervention 3: Placebo intervention 4: Tramadol plus Acetaminophen

11

Isehara | N/A | Japan | 139.31019 | 35.39932 Kitakyushu | N/A | Japan | 130.85034 | 33.85181 Kumamoto | N/A | Japan | 130.69181 | 32.80589 Ohta-Ku | N/A | Japan | N/A | N/A Osaka | N/A | Japan | 135.50107 | 34.69379 Sapporo | N/A | Japan | 141.35 | 43.06667 Shimotsuga | N/A | Japan | N/A | N/A Shimotsuke | N/A | Japan | 139.86622 | 36.41323 Tokyo | N/A | Japan | 139.69171 | 35.6895 Yokohama | N/A | Japan | 139.65 | 35.43333 Yokosuka | N/A | Japan | 139.66722 | 35.28361

0

NCT00737048

[ 5 ]

45

RANDOMIZED

PARALLEL

2DIAGNOSTIC

2DOUBLE

true

0ALL

false

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special application for evaluation of inflammation bowel disease and other small bowel conditions. Several adjuncts are used to enhance the examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod, simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents have been tried and some show improved visualization or increased propulsion where more capsules reach to colonic cecum while still recording within the limits of its 8 hour battery. Recently, our group had an observational report of our experience showing that either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation. This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose was chosen because other medications used in similar single dose in our pilot studies appear effective.

Inflammatory Bowel Disease

capsule endoscopy prokinetic lubiprostone Normal volunteers

null

2

arm 1: lubiprostone 24mcg single dose po prior to capsule endoscopy arm 2: Placebo (sugar pill) - matched single dose po prior to capsule endoscopy

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 24 mcg oral administration intervention 2: Oral administration

intervention 1: Lubiprostone intervention 2: Placebo

1

Mobile | Alabama | United States | -88.04305 | 30.69436

0

NCT00746395

[ 0 ]

79

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.

null

Osteoarthritis

osteoarthritis knee corticosteroids ultrasound

null

2

arm 1: 40 mg of intraarticular triamcinolone acetonide arm 2: Intraarticular injection of 0.9% saline

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: single intraarticular injection of 40 mg of triamcinolone acetonide intervention 2: Single intraarticular injection of 1 ml of 0.9% saline

intervention 1: triamcinolone acetonide intervention 2: saline

2

0

NCT00746889

[ 0 ]

76

RANDOMIZED

CROSSOVER

4SUPPORTIVE_CARE

2DOUBLE

true

0ALL

false

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Ametropia

comfort wetability protein deposit lipid deposit

null

4

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

[ 1, 1, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover intervention 2: Marketed Multipurpose Disinfecting Care System intervention 3: Marketed Multipurpose Disinfecting Care Systems

intervention 1: Alcon Opti-Free® RepleniSH® with Supraclens® intervention 2: Alcon Opti-Free® RepleniSH® intervention 3: B&L ReNu MultiPlus™

1

Waterloo | Ontario | Canada | -80.51639 | 43.4668

0

NCT00754338

[ 4 ]

24

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

true

0ALL

false

To compare the antimicrobial efficacy of three dentifrices on oral bacteria

null

Oral Bacteria

null

3

arm 1: fluoride toothpaste arm 2: Stannous fluoride toothpaste arm 3: fluoride/triclosan/copolymer toothpaste

[ 2, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Brush twice a day for 14 days intervention 2: Brush twice daily for 14 days intervention 3: Brush twice daily for 14 days

intervention 1: Fluoride intervention 2: Fluoride, Triclosan intervention 3: Stannous Fluoride

1

Newark | New York | United States | -77.09525 | 43.04673

0

NCT00762177

[ 0 ]

39

RANDOMIZED

PARALLEL

6HEALTH_SERVICES_RESEARCH

0NONE

false

0ALL

true

The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.

null

Hypercholesterolemia

Cholesterol Ezetimibe

null

2

arm 1: A whole ezetimibe 10 mg tablet arm 2: Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Ezetimibe 10 mg daily for 4 weeks intervention 2: Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

intervention 1: Ezetimibe 10 mg intervention 2: Ezetimibe 5 mg

1

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

0

NCT00762229

[ 5 ]

13

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective spine or orthopedic (related to bones) surgery.

This is an open-label (participants and physicians are told which treatment the participants are receiving), multi-center (when more than one hospital or medical school team work on a medical research study), single-arm study of fentanyl ITS. The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. All eligible participants (who require pain treatment with strong opioids \[morphine like medications\] for at least 48 hours after an elective spine or elective orthopedic surgery) will be treated with fentanyl ITS, delivering 40 microgram (mcg) fentanyl per on-demand dose, each deliver over 10 minutes for a maximum of 6 doses per hour (240 mcg per hour) for 24 hours or a maximum of 80 doses (3.2 milligram). Participants will be analyzed for the use of intravenous (giving a medicine directly into a vein) access during postoperative pain treatment with fentanyl ITS. Participant's safety will be monitored.

Pain, Postoperative

IONSYS Fentanyl Iontophoretic Transdermal System Postoperative pain

null

1

arm 1: 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an Iontophoretic Transdermal System (ITS). Total duration of treatment will be 72 hours.

[ 0 ]

1

[ 0 ]

intervention 1: 40 mcg per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period from an ITS. Total duration of treatment will be 72 hours.

intervention 1: Fentanyl ITS

3

Aalst | N/A | Belgium | 4.0355 | 50.93604 Brussels | N/A | Belgium | 4.34878 | 50.85045 Edegem | N/A | Belgium | 4.44504 | 51.15662

0

NCT00779038

[ 3 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

1FEMALE

false

The purpose of this study is to determine the effectiveness of paracervical block for pain relief in office hysteroscopy - particularly with the placement of the Essure device. Subjects will be randomized to receive either paracervical block or saline, and will have pain assessments performed throughout the procedure. Subjects and physicians will be blinded to group assignments.

null

Paracervical Block

Hysteroscopy Pain medication Lidocaine Office Procedures

null

2

arm 1: 5cc 1% lidocaine injection in each paracervical region arm 2: 5cc Normal Saline injection in each paracervical region

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 5cc 1% lidocaine injection in each paracervical region intervention 2: 5cc Normal Saline injection in each paracervical region

intervention 1: Lidocaine paracervical block intervention 2: Normal Saline

1

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

0

NCT00811187

[ 5 ]

113

RANDOMIZED

PARALLEL

9OTHER

2DOUBLE

false

0ALL

false

It is hypothesized that treating insomnia in migraineurs, many of whom also have tension headaches, prolongs total sleep time to the extent that it decreases overall headache frequency. Chronic headache sufferers also feel more tired during the day, undoubtedly affecting daytime functioning, which is hypothesized to improve as well with prolonged total sleep time.

The objective of the study is to determine the effect of prolonging total sleep time in migraineurs with insomnia on overall headache frequency, daytime alertness, fatigue, and functioning. The prolongation of total sleep time is accomplished by bedtime administration of 3 mg eszopiclone (Lunesta™), compared with placebo through a parallel-group design.

Insomnia Migraine

insomnia migraine eszopiclone insomnia in migraineurs

null

2

arm 1: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with 3mg eszopiclone, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit. arm 2: Participants with IHS-II migraine with and/or without aura and with DSM-IV primary insomnia. They were treated for 6 weeks with placebo, followed by a 2-week runout period. Participants came in for five visits: a screening visit, a randomization visit, a compliance visit, an end-treatment visit, and an exit/early termination visit.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 3 mg tablet every night at bedtime intervention 2: 1 tablet every night at bedtime

intervention 1: eszopiclone intervention 2: placebo

0

null

0

NCT00812214

[ 0 ]

55

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Both Ping On Ointment and Vaseline are considered intervention.

Aims: To compare the effectiveness of using topical cream of Ping On Ointment and using Vaseline cream in the treatment of temporomandibular joint (TMJ) and masticatory muscle pain, in order to establish the true efficacy of Ping On Ointment. Methods: In this randomized, double-blinded, placebo-controlled trial, 55 subjects with TMJ and/or masticatory pain (Group 1 patients according to the Research Diagnostic Criteria for Temporomandibular Disorder (RDC/TMD) received Ping On Ointment for 4 weeks; or placebo for 4 weeks. Subjects were evaluated with standard measures of efficacy: pain intensity measured by visual analogue scale and maximal comfortable mandibular opening, at baseline and again after 4 weeks of treatment.

Temporomandibular Disorders

null

2

arm 1: Ping On Ointment arm 2: Vaseline with minor trace of Ping On ointment to give medicinal smell

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Ping On Ointment intervention 2: Placebo

intervention 1: Ping On Ointment intervention 2: Vaseline

1

Hong Kong | Hong Kong | China | 114.17469 | 22.27832

0

NCT00812604

[ 4 ]

580

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment of patients with Alzheimer's disease.

This is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient know the name of the study medication), placebo-controlled, parallel-group study to evaluate the efficacy and safety of two fixed doses of galantamine (16 and 24 milligrams per day \[mg/day\]) in patients with Alzheimer's disease. The study consists of a 4-week screening period during which all patients will receive placebo, and a 24-week double-blind treatment period during which patients will receive placebo, galantamine 16 mg/day, or galantamine 24 mg/day. For patients receiving galantamine treatment, the starting dose is 8 mg/day and increases at 4-week intervals in increments of 8 mg/day. The primary measures of effectiveness are the change from baseline to the end of the study (week 24) in the Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog) and the Clinician's Interview-Based Impression of Change plus - Japan (CIBIC plus-J). Safety assessments include the incidence of adverse events, clinical laboratory tests, vital signs, electrocardiograms (ECGs), and physical examination findings. The study hypothesis is that galantamine will be effective in the treatment of Alzheimer's disease. Study drug taken orally twice a day.

Alzheimer's Disease

Alzheimer's Disease Cognitive dysfunction Dementia Galantamine R113675

null

3

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

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks. intervention 2: Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks. intervention 3: Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.

intervention 1: Placebo intervention 2: Galantamine 16 mg/day intervention 3: Galantamine 24 mg/day

1

Fukuoka | N/A | Japan | 130.41667 | 33.6

0

NCT00814801

[ 4 ]

12

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

This study will help determine if behavior modification performed in conjunction with oral Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. This study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral Vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral Vesicare anticholinergic therapy alone.

Overactive Bladder

urinary incontinence overactive bladder urinary frequency

null

2

arm 1: Vesicare alone arm 2: Vesicare plus behavioral modification

[ 1, 1 ]

2

[ 0, 5 ]

intervention 1: 5mg po qd intervention 2: 5 mg dose po once daily plus behavioral modification

intervention 1: Vesicare (solifenacin) intervention 2: Vesicare (solifenacin) plus behavioral modification

1

Burlington | Massachusetts | United States | -71.19561 | 42.50482

0

NCT00821184

[ 3 ]

536

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The primary objective of this study is to compare the incidence of hemorrhagic events in patients treated for non-valvular atrial fibrillation with DU-176b at each dose level versus warfarin potassium (warfarin). The secondary objective includes between-group comparisons with regard to incidence of thromboembolic events, pharmacodynamic parameters, and biomarkers for the efficacy evaluation, as well as incidence of adverse events and adverse reaction for the safety evaluation.

null

Atrial Fibrillation

Atrial fibrillation Factor Xa inhibition

null

4

arm 1: DU-176b low dose arm 2: DU-176b intermediate dose arm 3: DU-176b high dose arm 4: Warfarin

[ 0, 0, 0, 1 ]

2

[ 0, 0 ]

intervention 1: DU-176b tablets taken once daily for up to 12 weeks intervention 2: Warfarin potassium tablets taken once daily for up to 12 weeks

intervention 1: DU-176b tablets intervention 2: Warfarin potassium tablets

1

Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00829933

[ 5 ]

23

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

The main purpose of this study is to determine whether treatment with acarbose attenuates post-prandial glycemic excursions in non-diabetic/pre-diabetic obese children as determined by continuous glucose monitoring systems (CGMS). To this effect the current pilot study involves a 6 week intervention with acarbose given to all subjects with either impaired glucose tolerance or an area under the curve of \>130 mg/dl during the screening oral glucose tolerance test. Three consecutive days of CGMS are then compared to before and during the intervention. The secondary objective addressed in this protocol is the collection of baseline measures of endothelial function in obese and lean children. Even though the duration of acarbose treatment may be too short to demonstrate a vascular effect, the pre and post intervention data would serve as preliminary data for anticipated future studies that assess the vascular effect of reduced post-prandial blood glucose levels.

We are particularly interested in examining whether acarbose lowered the percentage of glucose excursions ≥ 140 mg/dl in a real-life, home environment. At baseline, subjects underwent an oral glucose tolerance test (OGTT) and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.

Pediatric Obesity Insulin Resistance Impaired Glucose Tolerance Cardiovascular Disease

Pediatric Obesity Insulin Resistance Glucose Tolerance Adolescents Acarbose Continuous Glucose Monitoring (CGMS) Endothelial Dysfunction

null

1

arm 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.

[ 0 ]

1

[ 0 ]

intervention 1: At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.

intervention 1: Acarbose

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00846521

[ 5 ]

137

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

1FEMALE

true

The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.

This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will be then randomized either to 2% Lidocaine Hydrochloride jelly (Akorn, Buffalo Grove, IL) or Surgilube (Fougera, Melville, NY) using computer generated blocks of 10. The latter is a commonly used, commercially available aqueous lubricant gel. Both the urogynecologist who perform the examinations and the patient will be blinded to the randomization. The appearances of the study gels are indistinguishable. Based on our power analysis targeting a power of 0.80, an α value of 0.05, and 20% difference in pain perception between the groups, we are aiming to recruit a sample of minimum132 subjects. First, demographic information including the age, parity, previous vaginal births, body mass index (BMI), race, diabetes, vaginal atrophy, neurological impairment, current estrogen use, indication for visit and exam anxiety will be collected as a part of patient history. Immediately after voiding, each patient will be placed in a lithotomy position. An independent nurse who is not involved in patient's care will prepare the study gels according to the randomization. After cleansing external urethral meatus with povidone iodine solution, a lubricated a sterile 14-French polyvinyl chloride Mentor Self-Cath catheter (Coloplast, Minneapolis, MN) will be placed transurethrally into the bladder to measure the postvoid residual volume. Following removal of the catheter, a cotton swab, lubricated with the same allocated gel, will be advanced to the urethrovesical junction until resistance was felt. The angle of the Q-tip with the horizontal plane will be measured at rest and with Valsalva maneuver. All the examinations will be performed by the same urogynecologist in the same order. Immediately following the Q-tip test, patient's perception of pain level will be measured using a validated pain scoring system, the Wong-Baker FACES visual scale where 0 represented no pain and 5 represented worst imaginable pain. The rest of the physical examination will be completed after this pain assessment. We will evaluate patient characteristics and pain score variables by exposure to either Lidocaine or Surgilube using SPSS Version 11.01 software (Chicago, Illinois). For continuous variables, we will calculate the mean and standard deviation and then evaluate significant differences using the Mann Whitney U test. For categorical variables, we will calculate the number and percent and then evaluate significant differences using Pearson's chi-square test. Significance for all results was set at an alpha of \<0.05.

Pain

female urethral catheterization Lidocaine lubricant Q-tip test Q tip test K-Y jelly pain perception straight catheterization

null

2

arm 1: 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. arm 2: Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test. intervention 2: Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.

intervention 1: 2% Lidocaine jelly intervention 2: Plain aqueous gel

1

Springfield | Massachusetts | United States | -72.58981 | 42.10148

0

NCT00883103

[ 5 ]

76

RANDOMIZED

CROSSOVER

9OTHER

0NONE

true

0ALL

false

To determine whether new 80 mg atorvastatin tablets are bioequivalent to 80 mg commercial atorvastatin tablets (Lipitor®).

null

Hypercholesterolemia

Bioqeuivalence, Pharmacokinetics, Atorvastatin

null

2

arm 1: 80 mg atorvastatin tablets arm 2: New 80 mg atorvastatin tablets

[ 5, 0 ]

2

[ 0, 6 ]

intervention 1: A single 80 mg dose of marketed 80 mg atorvastatin tablets intervention 2: A single dose of new formulation of 80 mg atorvastatin tablets

intervention 1: Atorvastatin intervention 2: Atorvastatin

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00917644

[ 2 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

The primary objective was to investigate whether multiple-dose administration of eslicarbazepine acetate affects the pharmacokinetics of metformin.

null

Neuropathic Pain

eslicarbazepine acetate zebinix metformin

null

2

arm 1: Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period arm 2: Metformin period followed by washout period followed by Eslicarbazepine acetate + Metformin period

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days intervention 2: None

intervention 1: Metformin intervention 2: Eslicarbazepine acetate

1

Mamede Do Coronado | N/A | Portugal | N/A | N/A

0

NCT00971295

[ 2 ]

46

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To determine the long term safety and tolerability of dasatinib exposure in subjects previously treated in CA180-002.

null

Leukemia

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Tablets, Oral, The dosing ranges from 50mg to a total of 240mg daily with the following 3 schedules: * 5 days on, 2 days off * 6 days on, 1 day off * Continuous daily dosing Once Daily (QD) or Twice Daily (BID) dosing, Subjects will be treated until progression of disease despite escalation/reductions of dose to the level deemed safe by available data, until intolerable/unacceptable toxicity or until subject withdrawal from the study or discontinuation of the study

intervention 1: Dasatinib

0

null

0

NCT00978731

[ 0 ]

39

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

false

The objective of this study was to prove the bioequivalence of Imipramine Pamoate 75 mg Capsules under fasting conditions

null

Depression

null

2

arm 1: First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period) arm 2: First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)

[ 1, 1 ]

1

[ 0 ]

intervention 1: 75 mg capsule

intervention 1: Imipramine Pamoate

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT01107353

[ 5 ]

506

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to measure the safety, efficacy and quality of life of lansoprazole in patients with reflux disease over a five year period.

Lansoprazole is currently approved in Germany for the treatment of erosive reflux esophagitis and active duodenal and gastric ulcer disease, and for long-term treatment including maintenance of healed reflux esophagitis and duodenal ulcer disease and treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome. This study was conducted to evaluate the safety, efficacy and quality of life of patients receiving up to five years of treatment with lansoprazole.

Gastroesophageal Reflux

GERD Gastroesophageal Reflux Disease Drug Therapy

null

1

arm 1: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.

[ 0 ]

1

[ 0 ]

intervention 1: Lansoprazole capsules

intervention 1: Lansoprazole

0

null

0

NCT01135368

[ 3 ]

47

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

At the end of the study, eligible participants could enroll and receive treatment and follow-up in Study C13004 (NCT00619489). Participants who did not proceed into Study C13004 were followed by telephone contact at 6-month intervals for 2 years after the last administration of study treatment to collect reports of adverse events, including colectomy, severe infections \[including progressive multifocal leukoencephalopathy (PML)\], and dysplasia/cancer.

Ulcerative Colitis

null

4

arm 1: Vedolizumab-matching placebo, intravenous (IV), infusion on Days 1, 15, 29 and 85. arm 2: Vedolizumab, 2 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 3: Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85. arm 4: Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.

[ 2, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion

intervention 1: Vedolizumab intervention 2: Placebo

0

null

0

NCT01177228

[ 3 ]

438

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study was to evaluate the long-term safety and efficacy of SYR-322, once daily (QD), to an α-glucosidase inhibitor, three times daily (TID), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. To evaluate the long-term safety and efficacy of alogliptin, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study SYR-322/CCT-001 (NCT01263470).

Type 2 Diabetes Mellitus

Diabetes Mellitus - Type 2 Diabetes Mellitus Drug Therapy

null

5

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

[ 0, 0, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks. intervention 2: Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks. intervention 3: Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks. intervention 4: Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks. intervention 5: Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

intervention 1: Alogliptin intervention 2: Alogliptin intervention 3: Alogliptin intervention 4: Alogliptin intervention 5: Voglibose

0

null

0

NCT01263496

[ 3 ]

45

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.

null

Kidney Transplantation

null

1

arm 1: Participants received an initial dose of mycophenolate mofetil (MMF), 1 gram (g), orally (PO), twice per day (BID), within 5 days of transplant for 24 weeks. Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1 g PO BID for 24 weeks intervention 2: According to manufacturer recommendation intervention 3: According to manufacturer recommendation intervention 4: According to manufacturer recommendation

intervention 1: mycophenolate mofetil intervention 2: antibody induction intervention 3: Cyclosporine intervention 4: corticosteroid

7

Bari | N/A | Italy | 16.86982 | 41.12066 Brescia | N/A | Italy | 10.21472 | 45.53558 Coppito | N/A | Italy | 13.34358 | 42.3673 Napoli | N/A | Italy | 14.5195 | 40.87618 Roma | N/A | Italy | 11.10642 | 44.99364 Torino | N/A | Italy | 11.99138 | 44.88856 Verona | N/A | Italy | 10.9938 | 45.43854

0

NCT01292226

[ 2 ]

36

RANDOMIZED

CROSSOVER

null

0NONE

true

1FEMALE

false

The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed product, FEMCON® Fe (norethindrone/ethinyl estradiol and ferrous fumarate) 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott) under fed conditions in healthy, non-tobacco using, adult female subjects.

null

Healthy

Healthy Subjects Bioequivalence

null

2

arm 1: Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva) arm 2: FEMCON® Fe 0.4 mg/0.035 mg Chewable tablets (Warner Chilcott)

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 0.4 mg/0.035 mg Chewable Tablets intervention 2: 0.4 mg/0.035 mg Chewable Tablets

intervention 1: Norethindrone/Ethinyl Estradiol intervention 2: FEMCON® Fe

1

Houston | Texas | United States | -95.36327 | 29.76328

0

NCT01344369

[ 5 ]

174

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the safety and tolerability of the fentanyl iontophoretic transdermal (through the skin) system (fentanyl-ITS) in daily clinical practice for management of acute (a quick and severe form of illness in its early stage) moderate to severe post-operative pain (pain after surgery) including the comprehensibility and usefulness of the accompanying information material.

This is an open label (all people know the identity of the intervention), single arm, and multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate safety and efficacy of the fentanyl-ITS for management of acute moderate to severe pain in post-operative participants' who have undergone elective surgery (surgery which could be postponed or not done at all without danger to the participant). The study will consists of 2 phases: screening phase (which comprises of pre-operative and post-operative stages) and an open label treatment phase. The participants will be treated with 40 microgram (mcg) of fentanyl transdermally per on-demand dose; each delivered over 10 minutes for a maximum of 6 doses (240 mcg) per hour for 24 hours and a maximum of 80 doses (3.2 milligram \[mg\]). Each system will inactivate at 80 doses or 24 hour, whichever occurs first. A new system will be applied every 24 hours unless the participant has used 80 doses in less than 24 hours. Maximum treatment duration of 72 hours is allowed. Participants will be expected to require parenteral (administration by injection) opioids (morphine like medications) for at least 24 hours post-operatively. This study will evaluate participant's, nurse's and physician's assessment of fentanyl-ITS under routine conditions. Participants' safety will be monitored throughout the study.

Postoperative Pain

Postoperative Pain Fentanyl Hydrochloride IONSYS

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.

intervention 1: Fentanyl-ITS

22

Augsburg | N/A | Germany | 10.89851 | 48.37154 Berlin | N/A | Germany | 13.41053 | 52.52437 Bremen | N/A | Germany | 8.80717 | 53.07582 Cologne | N/A | Germany | 6.95 | 50.93333 Detmold | N/A | Germany | 8.87318 | 51.93855 Dresden | N/A | Germany | 13.73832 | 51.05089 Erfurt | N/A | Germany | 11.03283 | 50.9787 Erlangen | N/A | Germany | 11.00783 | 49.59099 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Halle | N/A | Germany | 11.97947 | 51.48158 Jena | N/A | Germany | 11.5899 | 50.92878 Kiel | N/A | Germany | 10.13489 | 54.32133 Leipzig | N/A | Germany | 12.37129 | 51.33962 Lünen | N/A | Germany | 7.52872 | 51.61634 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 Marburg | N/A | Germany | 8.77069 | 50.80904 Münster | N/A | Germany | 7.62571 | 51.96236 Ravensburg | N/A | Germany | 9.61062 | 47.78198 Regensburg | N/A | Germany | 12.10161 | 49.01513 Schwerin | N/A | Germany | 11.41316 | 53.62937 Solingen | N/A | Germany | 7.0845 | 51.17343

0

NCT01804673

[ 3 ]

149

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

null

This study will evaluate the efficacy and safety of pertuzumab in combination with carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian cancer. The anticipated time on study treatment is 3-12 months.

null

Ovarian Cancer

null

2

arm 1: None arm 2: None

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks intervention 2: 175 mg/m2 IV every 3 weeks for 6 cycles intervention 3: 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles intervention 4: Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles

intervention 1: pertuzumab intervention 2: paclitaxel intervention 3: gemcitabine intervention 4: carboplatin

34

Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Wilrijk | N/A | Belgium | 4.39513 | 51.16734 Calgary | Alberta | Canada | -114.08529 | 51.05011 Kelowna | British Columbia | Canada | -119.48568 | 49.88307 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Győr | N/A | Hungary | 17.63512 | 47.68333 Parma | Emilia-Romagna | Italy | 10.32618 | 44.79935 Milan | Lombardy | Italy | 9.18951 | 45.46427 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Kazan' | N/A | Russia | 49.12214 | 55.78874 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Tomsk | N/A | Russia | 84.98204 | 56.50032 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Madrid | Madrid | Spain | -3.70256 | 40.4165 Valencia | Valencia | Spain | -0.37966 | 39.47391 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095 Plymouth | N/A | United Kingdom | -4.14305 | 50.37153 Sutton | N/A | United Kingdom | -0.2 | 51.35 Yeovil | N/A | United Kingdom | -2.63211 | 50.94159

0

NCT02004093

[ 2 ]

34

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

2MALE

false

The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.

Single centre, double-blind, randomised, placebo-controlled study of four dosage regimens of BIA 9-1067 in four groups of healthy male volunteers. In each group, the study will consist of an once-daily (o.d.) 8-day multiple-dose period. Progression to the next dose level will only occur if the previous dose level was considered to be safe and well tolerated. An appropriate interval (will separate the investigation of doses to permit a timely review and evaluation of safety data prior to proceeding to a higher dose level.

Parkinson's Disease (PD)

Parkinson's disease (PD) Opicapone Bial BIA 9-1067

null

5

arm 1: BIA 9-1067 (OPC, Opicapone) 5 mg arm 2: BIA 9-1067 (OPC, Opicapone) 10 mg arm 3: BIA 9-1067 (OPC, Opicapone) 20 mg arm 4: BIA 9-1067 (OPC, Opicapone) 30 mg arm 5: Placebo, PLC

[ 0, 0, 0, 0, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: BIA 9-1067 intervention 2: Placebo

1

Rueil | Malmaison | France | 1.87938 | 49.047

0

NCT02071810

[ 3 ]

220

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.

null

Low Back Pain

null

3

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

[ 1, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Oral naproxen 500 mg twice daily for Weeks 1-12. intervention 2: Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12. intervention 3: Single IV infusion of 200 micrograms/kg RN624 on Day 1

intervention 1: Naproxen intervention 2: Placebo intervention 3: PF-04383119 (RN624)

38

0

NCT00584870

[ 2, 3 ]

117

NON_RANDOMIZED

SEQUENTIAL

0TREATMENT

0NONE

false

0ALL

false

This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2-part design.

The first part, Phase I, was designed to assess whether there is a pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well as to collect safety data when these two drugs are co-administered. The second part, (Phase II), was designed to assess the potential efficacy of the combination in imatinib-resistant GIST patients in two strata of patients: * Patients resistant to imatinib as first-line drug therapy and in whom the maximum tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory) * Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2, post second-line therapy). It was decided to discontinue the study and close to further enrollment based on alternative treatment options that became available. Phase 1 and Phase 2 Stratum 1 were ended early on 02-Nov-2006. Investigators were allowed to complete the enrollment in the Phase 2 Stratum 2.

Gastrointestinal Stromal Tumors

RAD001 everolimusGIST everolimus mTOR Imatinib resistant Imatinib-refractory/resistant gastrointestinal stromal tumors Gastrointestinal Stromal Tumors(GIST) soft tissue sarcoma stomach tumor tumor of interstitial cells of Cajal (ICC) digestive system cancer

null

6

arm 1: RAD001 20 mg was given once a week. arm 2: RAD001 2.5 mg was given in combination with Glivec/Gleevec 600mg/day. arm 3: RAD001 5 mg was given in combination with Glivec/Gleevec 600mg/day. arm 4: RAD001 2.5 mg was given in combination with Glivec/Gleevec 800mg/day. arm 5: All first-line resistant/refractory patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day. arm 6: All post-second-line patients received RAD001 2.5mg/day in combination with Glivec/Gleevec at a dose of 600mg/day

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

3

[ 0, 0, 0 ]

intervention 1: RAD001 was in tablets of 0.5 mg, 1.0 mg, 2.5 mg and 5.0 mg strength and was taken by mouth, once a week or once a day depending upon the treatment group the patient was enrolled into. intervention 2: Glivec/Gleevec was supplied as commercialized 100 mg and 400 mg tablets. Gleevec/Glivec was provided as capsules of 100 mg strength in bottles containing 60 capsules each. The use of this supply was study center specific. Glivec/Gleevec was taken, by mouth, at a dose of 300 mg twice a day. The Glivec/Gleevec regimen was changed from 600 mg once a day to 300 mg BID, by an amendment since taking too many tablets at once was difficult for patients with gastro-intestinal disease. In the phase II part of the study all patients received Glivec 600 mg/day. intervention 3: Glivec/Gleevec was supplied as commercialized 100 mg and 400 mg tablets. Gleevec/Glivec was provided as capsules of 100 mg strength in bottles containing 60 capsules each. The use of this supply was study center specific. Glivec/Gleevec was taken, by mouth. In the phase II part of the study all patients received Glivec 600 mg/day, except for 2 patients who received Glivec at a dose of 800 mg/day. This dose was permitted in Phase II as it was found to be safe in Phase I.

intervention 1: RAD001 intervention 2: Imatinib 600mg/day (Glevec is the brand name for imatinib) intervention 3: Imatinib 800mg/day (Glevec is the brand name for imatinib)

16

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 Edegem | Antwerpen | Belgium | 4.44504 | 51.15662 Leuven | N/A | Belgium | 4.70093 | 50.87959 Bordeaux | N/A | France | -0.5805 | 44.84044 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Villejuif | N/A | France | 2.35992 | 48.7939 Berlin | N/A | Germany | 13.41053 | 52.52437 Cologne | N/A | Germany | 6.95 | 50.93333 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Hamburg | N/A | Germany | 9.99302 | 53.55073 München | N/A | Germany | 13.31243 | 51.60698 Tübingen | N/A | Germany | 9.05222 | 48.52266

0

NCT01275222

[ 4 ]

862

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the investigational drug, is an extended-release form of RSG. This study tests whether RSG XR safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a new approach to AD therapy and this study tests whether one's genes alter the effectiveness of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be lower in the brains of AD patients, and their brain cells may also use glucose less well than in unaffected people. The proper function of brain cells may be critical to memory and thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells properly use glucose may help a person maintain normal memory and thinking. Data suggesting that RSG may help AD patients was first seen in a small study at the Univ. of Washington and then from a larger international GSK study. In the first study, those receiving RSG once daily for 6 months scored better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month treatment. This study will directly test the effect of RSG XR on people who either have or lack the APOE e4 gene.

A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease. (REFLECT-1)

Alzheimer's Disease

apolipoprotein E monotherapy cognition mild rosiglitazone Alzheimer's disease moderate

null

2

arm 1: XR (extended release) oral tablets arm 2: Placebo (Double-Dummy to Match)

[ 0, 5 ]

1

[ 0 ]

intervention 1: XR (extended release) oral tablets

intervention 1: Rosiglitazone

138

1

NCT00428090

[ 4 ]

668

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

Houston | Texas | United States | -95.36327 | 29.76328 São Paulo | N/A | Brazil | -46.63611 | -23.5475 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Bogotá | N/A | Colombia | -74.08175 | 4.60971 Kowloon | N/A | Hong Kong | 114.18333 | 22.31667 Tamil Nadu | N/A | India | N/A | N/A Udine | N/A | Italy | 13.23715 | 46.0693 Auckland | N/A | New Zealand | 174.76349 | -36.84853 Poznan | N/A | Poland | 16.92993 | 52.40692 Singapore | N/A | Singapore | 103.85007 | 1.28967 Seoul | N/A | South Korea | 126.9784 | 37.566 Alicante | N/A | Spain | -0.48149 | 38.34517 London | N/A | United Kingdom | -0.12574 | 51.50853

0

NCT00168298

[ 3 ]

129

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome (DS). Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.

null

Down Syndrome

Down Syndrome trisomy 21

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Blinded donepezil 2.5 milligram per day (mg/day) (2.5 milliliter per day \[mL/day\]) orally for participants with body weight (BW) 20 and less than (\<) 25 kilogram (kg), 5 mg/day (5 mL/day) orally for participants with BW 25 to \<50 kg, and 10 mg/day (10 mL/day) orally for participants with BW greater than or equal to (\>=) 50 kg liquid formulation (1 milligram per 1 milliliter \[1 mg/1 mL\]) (titrated to 0.1 to 0.2 milligram per kilogram per day \[mg/kg/day\] based on BW). intervention 2: Liquid formulation matched to active treatment for oral administration.

intervention 1: Donepezil HCl intervention 2: Placebo

31

0

NCT00570128

[ 3 ]

54

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

1FEMALE

false

The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after abdominal hysterectomy surgery.

Hysterectomy is the second most common surgery among women in the United States (US). According to the National Center for Health Statistics, there were 617,000 hysterectomies performed in the US in 2004. Effective postoperative pain management after hysterectomy is important in ensuring that surgical subjects have a smooth and successful recovery after their operation. Morphine and other narcotic pain medications are often used to help control pain after hysterectomy, but the large quantities required can lead to fatigue, nausea and vomiting, as well as the inability to walk around much because of drowsiness. Reducing narcotic pain medication use can reduce these negative side effects. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery. This study will compare the amount of narcotic pain medication required after surgery in patients who receive the CollaRx Bupivacaine implant, a plain collagen implant or no implant at all.

Postoperative Pain

Post Operative Pain Hysterectomy

null

3

arm 1: A total of three 5 × 5-cm bupivacaine sponges implanted at specified layers in the wound prior to wound closure arm 2: A total of three 5 × 5-cm collagen sponges implanted at specified layers in the wound prior to wound closure arm 3: The patient will recieve the standard of care, but no implant during surgery

[ 0, 2, 4 ]

2

[ 0, 0 ]

intervention 1: The bupivacaine sponge contains 70 mg Type I collagen and 50 mg bupivacaine hydrochloride. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision. intervention 2: The placebo sponge contains 70 mg Type I collagen. A total of 3 sponges will be implanted during surgery; one sponge divided between areas in the vault, one sponge divided and placed across the incision in the peritoneum and the final sponge divided and placed between the sheath and skin around the incision.

intervention 1: Bupivacaine Collagen Sponge (CollaRx®) intervention 2: placebo

1

Winston-Salem | North Carolina | United States | -80.24422 | 36.09986

0

NCT00624910

[ 3 ]

183

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Efficacy study of ecabet ophthalmic solution in dry eye disease

null

Dry Eye Disease

null

2

arm 1: ecabet ophthalmic solution arm 2: Placebo comparator

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

intervention 1: ecabet ophthalmic solution intervention 2: placebo

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00667004

[ 3 ]

5

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving busulfan together with cyclophosphamide and antithymocyte globulin followed by donor stem cell transplant works in treating patients with hematologic cancer.

OBJECTIVES: Primary * To determine the incidence of grade II-IV acute graft-versus-host disease in patients with hematologic cancer or other diseases treated with a myeloablative conditioning regimen comprising targeted (steady-state concentration of 800-1,000 ng/mL) busulfan, cyclophosphamide, and anti-thymocyte globulin followed by matched unrelated donor allogeneic hematopoietic stem cell transplantation. * To determine the day +100 transplantation-related mortality in these patients. Secondary * To determine the effect of cyclophosphamide pharmacokinetic parameters on day +100 transplantation-related mortality in these patients. * To determine the ability of low-dose anti-thymocyte globulin administered on day +5 to induce activation-induced cell death of activated donor lymphocytes. * To determine the incidence of chronic graft-versus-host disease in patients treated with this regimen. * To determine event-free and overall survival of patients treated with this regimen. * To evaluate pharmacogenomic associations between genetic polymorphisms in drug disposition enzymes with the pharmacokinetics of busulfan and cyclophosphamide. OUTLINE: * Myeloablative conditioning regimen: Patients receive busulfan IV over 2 hours on days -8 to -5; cyclophosphamide IV over 4 hours on days -3 to -2; and anti-thymocyte globulin IV over 6 hours on day -3 and then over 4 hours on days -2, -1, and 5. * Allogeneic hematopoietic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell infusion on day 0. * Graft-versus-host-disease prophylaxis: Patients receive tacrolimus IV continuously or orally on days 6 to150, followed by an even taper to day 180 in the absence of graft-versus-host-disease. Patients also receive mycophenolate mofetil IV or orally beginning on day 6 and continuing to day 28. Patients undergo blood collection periodically during study for pharmacokinetic, pharmacogenomic, and other translational studies. Genomic DNA extracted from blood samples is analyzed by polymerase chain reaction for genetic polymorphisms in cyclophosphamide/busulfan disposition enzymes. Activated donor lymphocytes are assessed using flow cytometry to measure activation-induced cell death, as reflected by apoptosis in activated T cells. Chimerism on or around day 100 is also assessed using fluorescence in situ hybridization analysis and DNA fingerprinting. After completion of study treatment, patients are followed periodically.

Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Secondary Myelofibrosis

graft versus host disease adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia untreated adult acute myeloid leukemia untreated adult acute lymphoblastic leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia stage III multiple myeloma refractory multiple myeloma de novo myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable previously treated myelodysplastic syndromes secondary myelodysplastic syndromes secondary myelofibrosis secondary acute myeloid leukemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult T-cell leukemia/lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma recurrent adult acute lymphoblastic leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma adult nasal type extranodal NK/T-cell lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma stage III small lymphocytic lymphoma stage IV small lymphocytic lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma refractory hairy cell leukemia stage I multiple myeloma stage II multiple myeloma

null

1

arm 1: Matched unrelated donor allogeneic stem cell transplantation with a conditioning regimen of targeted busulfan, cyclophosphamide and thymoglobulin.

[ 0 ]

14

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

intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None intervention 11: None intervention 12: None intervention 13: None intervention 14: None

intervention 1: anti-thymocyte globulin intervention 2: busulfan intervention 3: cyclophosphamide intervention 4: mycophenolate mofetil intervention 5: tacrolimus intervention 6: polymerase chain reaction intervention 7: polymorphism analysis intervention 8: flow cytometry intervention 9: laboratory biomarker analysis intervention 10: pharmacogenomic studies intervention 11: pharmacological study intervention 12: allogeneic bone marrow transplantation intervention 13: allogeneic hematopoietic stem cell transplantation intervention 14: peripheral blood stem cell transplantation

1

Omaha | Nebraska | United States | -95.94043 | 41.25626

0

NCT00611351

[ 4 ]

180

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

null

The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.

null

Atrophy Vaginal Diseases

Menopausal symptoms Urogenital atrophy Vulvar and vaginal atrophy in menopausal women Vaginal atrophy

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

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

intervention 1: Ospemifene (Dose 1) intervention 2: Ospemifene (Dose 2) intervention 3: Placebo

0

null

0

NCT01585558

[ 3 ]

627

RANDOMIZED

PARALLEL

0TREATMENT

null

false

0ALL

false

This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.

A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder Twice Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma Symptomatic on Moderate-Dose ICS Therapy

Asthma

Adolescents Adults Asthma Pharmacokinetics Pharmacogenetics GW685698X

null

1

arm 1: GW685698X

[ 0 ]

1

[ 0 ]

intervention 1: GW685698X

154

1

NCT00603746

[ 3 ]

29

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic phase chronic myeloid leukemia with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

null

Chronic Myeloid Leukemia in Chronic Phase

Refractory Chronic Myeloid Leukemia in Chronic Phase adults oral LBH589

null

1

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

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: LBH589

10

Brussels | N/A | Belgium | 4.34878 | 50.85045 Godinne | N/A | Belgium | 4.87364 | 50.34809 Leuven | N/A | Belgium | 4.70093 | 50.87959 Cologne | N/A | Germany | 6.95 | 50.93333 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Hamburg | N/A | Germany | 9.99302 | 53.55073 Leipzig | N/A | Germany | 12.37129 | 51.33962 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 Munich | N/A | Germany | 11.57549 | 48.13743

0

NCT00451035

[ 4 ]

882

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The objective of this study is to demonstrate the safety and efficacy of tipranavir/ritonavir versus an active control arm in highly treatment experienced Human immunodeficiency virus-1 infected patients. Patients must have a viral load \> =1000 cells/mL, and genotype indicating at least one resistance conferring protease inhibitor-mutation as determined from a predefined panel of mutations. Any CD4+ count is acceptable.

null

HIV Infections

null

2

arm 1: None arm 2: None

[ 5, 5 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Tipranavir (with low dose ritonavir) intervention 2: Comparator protease inhibitor(CPI)/low dose ritonavir(r)

174

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 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 Charleroi | N/A | Belgium | 4.44448 | 50.41136 Ghent | N/A | Belgium | 3.71667 | 51.05 Luxembourg | N/A | Belgium | N/A | N/A Campinas - SP | N/A | Brazil | N/A | N/A Curitiba - PR | N/A | Brazil | N/A | N/A Nova Iguaçu - RJ | N/A | Brazil | N/A | N/A Rio de Janeiro - RJ | N/A | Brazil | N/A | N/A Rio de Janeiro - RJ | N/A | Brazil | N/A | N/A Salvador - BA | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A São Paulo - SP | N/A | Brazil | N/A | N/A Aarhus N | N/A | Denmark | 10.17317 | 56.20367 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 København Ø | N/A | Denmark | 12.56862 | 55.70968 Odense C | N/A | Denmark | 10.39538 | 55.40841 Besançon | N/A | France | 6.01815 | 47.24878 Bordeaux | N/A | France | -0.5805 | 44.84044 Bordeaux | N/A | France | -0.5805 | 44.84044 Caen | N/A | France | -0.35912 | 49.18585 Clamart | N/A | France | 2.26692 | 48.80299 Le Kremlin-Bicêtre | N/A | France | 2.36073 | 48.81471 Lyon | N/A | France | 4.84671 | 45.74846 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Marseille | N/A | France | 5.38107 | 43.29695 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Paris | N/A | France | 2.3488 | 48.85341 Rennes | N/A | France | -1.67429 | 48.11198 Strasbourg | N/A | France | 7.74553 | 48.58392 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Villejuif | N/A | France | 2.35992 | 48.7939 Aachen | N/A | Germany | 6.08342 | 50.77664 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Bonn | N/A | Germany | 7.09549 | 50.73438 Cologne | N/A | Germany | 6.95 | 50.93333 Cologne | N/A | Germany | 6.95 | 50.93333 Dortmund | N/A | Germany | 7.466 | 51.51494 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Erlangen | N/A | Germany | 11.00783 | 49.59099 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/Breisgau | N/A | Germany | N/A | N/A Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hanover | N/A | Germany | 9.73322 | 52.37052 Hanover | N/A | Germany | 9.73322 | 52.37052 Heidelberg | N/A | Germany | 8.69079 | 49.40768 Mannheim | N/A | Germany | 8.46694 | 49.4891 München | N/A | Germany | 13.31243 | 51.60698 München | N/A | Germany | 13.31243 | 51.60698 Osnabrück | N/A | Germany | 8.0498 | 52.27264 Regensburg | N/A | Germany | 12.10161 | 49.01513 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Stuttgart | N/A | Germany | 9.17702 | 48.78232 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Goudi, Athens | N/A | Greece | N/A | N/A Pátrai | N/A | Greece | 21.73444 | 38.24444 Peraeus | N/A | Greece | N/A | N/A Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Dublin | N/A | Ireland | -6.24889 | 53.33306 Ancona | N/A | Italy | 13.5103 | 43.60717 Antella (fi) | N/A | Italy | 11.32233 | 43.72774 Bari | N/A | Italy | 16.86982 | 41.12066 Bergamo | N/A | Italy | 9.66721 | 45.69601 Brescia | N/A | Italy | 10.21472 | 45.53558 Busto Arsizio (va) | N/A | Italy | 8.84914 | 45.61128 Ferrara | N/A | Italy | 11.62057 | 44.83804 Florence | N/A | Italy | 11.24626 | 43.77925 Genova | N/A | Italy | 11.87211 | 45.21604 Genova | N/A | Italy | 11.87211 | 45.21604 Lecco | N/A | Italy | 9.39704 | 45.85589 Macerata | N/A | Italy | 13.45293 | 43.29789 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Milan | N/A | Italy | 12.59836 | 42.78235 Modena | N/A | Italy | 10.92539 | 44.64783 Napoli | N/A | Italy | 14.5195 | 40.87618 Padua | N/A | Italy | 11.88586 | 45.40797 Pavia | N/A | Italy | 9.15917 | 45.19205 Pavia | N/A | Italy | 9.15917 | 45.19205 Rimini | N/A | Italy | 12.56528 | 44.05755 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Torino | N/A | Italy | 11.99138 | 44.88856 Torino | N/A | Italy | 11.99138 | 44.88856 Torino | N/A | Italy | 11.99138 | 44.88856 Treviso | N/A | Italy | 12.2416 | 45.66673 Mexico | N/A | Mexico | -98.43784 | 18.88011 Mexico | N/A | Mexico | -98.43784 | 18.88011 Mexico City | N/A | Mexico | -99.12766 | 19.42847 Monterrey, N.l. | N/A | Mexico | -100.31721 | 25.68435 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Groningen | N/A | Netherlands | 6.56667 | 53.21917 Nijmegen | N/A | Netherlands | 5.85278 | 51.8425 Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 The Hague | N/A | Netherlands | 4.29861 | 52.07667 Cascais | N/A | Portugal | -9.42147 | 38.69681 Coimbra | N/A | Portugal | -8.41955 | 40.20564 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Lisbon | N/A | Portugal | -9.1498 | 38.72509 Porto | N/A | Portugal | -8.61099 | 41.14961 Alicante | N/A | Spain | -0.48149 | 38.34517 Badalona | N/A | Spain | 2.24741 | 41.45004 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 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 L'Hospitalet de Llobregat | N/A | Spain | 2.10028 | 41.35967 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Madrid | N/A | Spain | -3.70256 | 40.4165 Málaga | N/A | Spain | -4.42034 | 36.72016 Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Valencia | N/A | Spain | -0.37966 | 39.47391 Vigo | N/A | Spain | -8.72264 | 42.23282 Gothenburg | N/A | Sweden | 11.96679 | 57.70716 Malmo | N/A | Sweden | 13.00073 | 55.60587 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Basel | N/A | Switzerland | 7.57327 | 47.55839 Geneva | N/A | Switzerland | 6.14569 | 46.20222 Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 Zurich | N/A | Switzerland | 8.55 | 47.36667 Brighton | N/A | United Kingdom | -0.13947 | 50.82838 Edinburgh | N/A | United Kingdom | -3.19648 | 55.95206 Liverpool | N/A | United Kingdom | -2.97794 | 53.41058 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 London | N/A | United Kingdom | -0.12574 | 51.50853 London | N/A | United Kingdom | -0.12574 | 51.50853 Newcastle upon Tyne | N/A | United Kingdom | -1.61396 | 54.97328 Portsmouth | N/A | United Kingdom | -1.09125 | 50.79899

1

NCT00144170

[ 4 ]

504

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Parkinson's Disease

Parkinson's Disease levodopa end of dose wearing off OFF time

null

1

arm 1: Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.

[ 0 ]

1

[ 0 ]

intervention 1: Oral istradefylline (KW-6002) 20 or 40 mg once daily.

intervention 1: Istradefylline

1

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

1

NCT00199381

[ 3 ]

70

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

false

0ALL

false

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

This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Kidney Transplantation

Pharmacokinetics Therapy Immunosuppression Drugs, Investigational Adult

null

1

arm 1: Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 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

9

1

NCT00282568

[ 4 ]

565

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this clinical research study is to learn whether Saxagliptin added to thiazolidinedione (TZD) therapy is more effective than TZD alone as a treatment for Type 2 diabetic subjects who are not sufficiently controlled with TZD alone

All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive metformin (defined as rescue medication) added onto their blinded study medication

Diabetes Mellitus, Type 2

null

3

arm 1: Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) arm 2: Saxagliptin PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication) arm 3: Placebo PLUS pioglitazone OR rosiglitazone PLUS open-label metformin (as needed as rescue medication)

[ 0, 0, 2 ]

6

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

intervention 1: Tablets, Oral, 2.5 mg, Once daily (6 months ST, 12 months LT) intervention 2: Tablets, Oral, 5 mg, once daily (6 months ST, 12 months LT) intervention 3: Tablets, Oral, 0 mg, Once daily (6 months ST, 12 months LT) intervention 4: Tablets, Oral, 30 mg or 45 mg, once daily (6 months ST, 12 months LT) intervention 5: Tablets, Oral, 4 mg, once daily or 8 mg, either as once or twice daily (6 months ST, 12 months LT) intervention 6: Tablets, Oral, 500-2500 mg, as needed (12 months LT)

intervention 1: Saxagliptin intervention 2: Saxagliptin intervention 3: Placebo intervention 4: pioglitazone intervention 5: rosiglitazone intervention 6: metformin

133

1

NCT00295633

[ 4 ]

2,053

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

null

Pulmonary Safety in Diabetics with T/I

null

Diabetes, Type 1 Diabetes, Type 2

null

3

arm 1: Technosphere® Insulin Inhalation Powder arm 2: Usual care arm 3: Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)

[ 0, 5, 4 ]

2

[ 0, 0 ]

intervention 1: Inhalation, 15U/30U intervention 2: Subjects will receive antidiabetes treatment at the discretion of their physicians

intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Usual Care

176

1

NCT00308737

[ 4 ]

504

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

null

Atrial Fibrillation

Atrial Fibrillation sinus rhythm amiodarone

null

2

arm 1: dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg arm 2: over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: oral administration intervention 2: oral administration

intervention 1: dronedarone (SR33589) intervention 2: amiodarone

23

Bridgewater | New Jersey | United States | -74.64815 | 40.60079 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Cove | N/A | Australia | N/A | N/A Vienna | N/A | Austria | 16.37208 | 48.20849 Diegem | N/A | Belgium | 4.43354 | 50.89727 Laval | N/A | Canada | -73.692 | 45.56995 Santiago | N/A | Chile | -70.64827 | -33.45694 Shangaï | N/A | China | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Helsinki | N/A | Finland | 24.93545 | 60.16952 Paris | N/A | France | 2.3488 | 48.85341 Berlin | N/A | Germany | 13.41053 | 52.52437 Milan | N/A | Italy | 9.18951 | 45.46427 Mexico | N/A | Mexico | -98.43784 | 18.88011 Casablanca | N/A | Morocco | -7.61138 | 33.58831 Gouda | N/A | Netherlands | 4.70833 | 52.01667 Warsaw | N/A | Poland | 21.01178 | 52.22977 Moscow | N/A | Russia | 37.61556 | 55.75222 Seoul | N/A | South Korea | 126.9784 | 37.566 Bromma | N/A | Sweden | 17.94 | 59.34 Mégrine | N/A | Tunisia | 10.23639 | 36.76917 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384

1

NCT00489736

[ 2 ]

16

NA

SINGLE_GROUP

5SCREENING

0NONE

false

0ALL

false

The purpose of this pilot study is to determine whether there is a correlation between viral load reduction (at Day 4, 7 or 14) following a short course (14 days) of Maraviroc added to a failing regimen, and the R5 result of the TrofileTM assay at screening.

The study A4001060 has been discontinued on April 22, 2008. A review of the poor rate of enrollment has projected difficulties in completing the study in a timely manner, despite the best efforts by the sponsor and the sites. Given the difficulties encountered in this pilot study and the need to conduct an even larger confirmatory study, the decision to discontinue the study has therefore been made. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

HIV Infections

Treatment Experienced

null

1

arm 1: None

[ 5 ]

2

[ 0, 3 ]

intervention 1: Treatment-experienced subjects on failed therapy, with HIV RNA ≥ 1000 copies/mL, are eligible who will receive a tropism assay at screening (Day -14 to 0). Subjects who are eligible will receive maraviroc added to a failing regimen from Day 1 to 14. On day 15, subjects will discontinue the current treatment regimen and begin a new OBT. Subjects with only R5 HIV will continue receiving maraviroc plus OBT. Subjects with non-R5 virus will discontinue receiving maraviroc but continue to receive the new OBT. Investigator selects OBT based on results of phenotype/genotype testing at baseline. The nominal dose for maraviroc is 300 mg BID. The maraviroc dose should be adjusted based on OBT patient is taking. If OBT includes CYP3A4 inhibitor (with or without inducers) maraviroc dose should be 150 mg BID and if OBT includes CYP3A4 inducer (without inhibitors) maraviroc dose should be 600mg BID. If OBT does not include any CYP3A4 inducers or inhibitors maraviroc dose should be 300 mg BID. intervention 2: Trofile Assay and HIV RNA quantification assay

intervention 1: maraviroc intervention 2: Trofile Assay and HIV RNA quantification assay

10

1

NCT00496782