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

[ 3 ]

151

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This study evaluated the safety and efficacy of ranibizumab on retinal edema and visual acuity in patients with diabetic macular edema with center involvement.

null

Diabetic Macular Edema

DME Diabetic macular edema ranibizumab Diabetic macular edema with center involvement

null

3

arm 1: Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. arm 2: Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections. arm 3: Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.

[ 0, 0, 3 ]

3

[ 0, 0, 0 ]

intervention 1: 6 mg/ml ranibizumab solution for intravitreal injection intervention 2: 10 mg/ml ranibizumab solution for intravitreal injection intervention 3: Non-treatment control for sham intravitreal injection.

intervention 1: Ranibizumab 0.3 mg intervention 2: Ranibizumab 0.5 mg intervention 3: Sham injection

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00284050

[ 4 ]

94

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

null

Kidney Diseases

Dose optimization immune suppressive regimen enteric-coated mycophenolate sodium EC-MPS renal transplantation kidney transplant maintenance patients Renal transplantation in maintenance

null

2

arm 1: Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day. arm 2: Patients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.

[ 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: At a dose of at least 5 mg/day.

intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Tacrolimus intervention 3: Corticosteroids

1

Basel | N/A | Switzerland | 7.57327 | 47.55839

0

NCT00284934

[ 3 ]

147

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

1FEMALE

false

A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.

This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing.

Cervical Intraepithelial Neoplasia Uterine Cervical Dysplasia

Cervical Intraepithelial Neoplasia (CIN) High-grade Cervical Intraepithelial Neoplasia High-grade Squamous Intraepithelial Lesions (HSIL) Human Papilloma Virus (HPV) High-Grade Cervical Intraepithelial Lesions (CIN 2/3)

null

2

arm 1: Placebo administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles. arm 2: 0.25% A007 administered topically to the cervix via intravaginal applicator for 5 consecutive days of a 28-day cycle for 2 cycles.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 5 days of 28 day cycle for 2 cycles intervention 2: 5 days of 28 day cycle

intervention 1: placebo intervention 2: A007

29

0

NCT00285207

[ 4 ]

244

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the safety of BEMA fentanyl at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption. BioDelivery Sciences International, Inc. (BDSI) has developed BEMA (BioErodible MucoAdhesive) fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small disc that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the disc readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the disc are water soluble, so the entire dosage form dissolves within 30 minutes of application.

null

Pain Cancer

Breakthrough Pain in Cancer Patients

null

1

arm 1: BEMA Fentanyl

[ 0 ]

1

[ 0 ]

intervention 1: buccal soluble film; 200, 400, 600, 800, 1200 mcg fentanyl; up to 4 times daily

intervention 1: BEMA Fentanyl

1

Austin | Texas | United States | -97.74306 | 30.26715

0

NCT00293020

[ 3 ]

67

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Osteoarthritis of both the knee and hip joints are common conditions; knee osteoarthritis affects 6% of adults over 30 years of age and osteoarthritis of the hip affects between 3% and 6% of the Caucasian population. Both forms of osteoarthritis are associated with disability. Conventional treatment (analgesics and the use non-steroidal anti-inflammatory, NSAIDS) is prophylactic, aimed at decreasing pain and improving function. However long term use of NSAIDS is associated with a high incidence of adverse events (gastrointestinal tract symptoms). A safer alternative treatment would therefore be beneficial. Both anecdotal evidence and recent studies have implicated the potential of the herbal remedy Devil's Claw (Harpagophytum procumbens) for the treatment of painful, chronic arthritic type conditions (Ernst and Chrubasik, 2000). Devil's Claw is an extract obtained from the root of the Harpagophytum procumbens plant, a member of the sesame family found in the Kalahari region in South Africa. It has been shown that this herbal remedy has anti-inflammatory and analgesic effects (Baghdikian et al, 1997). Currently Devil's Claw is marketed for use as a supportive treatment of degenerative arthrosis, is not a Medicines Control Agency licensed product and is freely available to the general public in health food stores and pharmacies. The objectives of this study are to assess the efficacy, optimum dosage and safety of the herbal remedy Devil's Claw (Harpagophytum) in the treatment of osteoarthritis of the knee and/or hip. The primary objective of this study is to investigate the following three principal questions: 1. To compare the efficacy of Devil's Claw with placebo in the treatment of osteoarthritis of the knee and/or hip 2. To determine the optimum dose of Devil's Claw and 3. To evaluate the safety and tolerability of three doses of Devil's Claw in the treatment of osteoarthritis of the knee/hip and to compare them to placebo There are also a number of secondary research objectives that will also be addressed (see later). These objectives are based on the following hypotheses : Hypotheses * Devil's Claw has anti-inflammatory properties (as assessed by the reduction in pain, stiffness and disability aspects on the WOMAC) in chronic osteoarthritis of the knee and/or hip after 16 weeks of treatment, as compared to placebo. * A dose response effect exists in the treatment of osteoarthritis of the knee/hip by Devil's Claw.

STUDY DESIGN: Randomized, placebo-controlled, dose-ranging two-centre study PREPARATIONS FOR INVESTIGATION: Devil's Claw (Allya®)/placebo as tablets STATISTICAL METHODS: Analysis on an intention to treat basis. The following tests will be performed and all statistical significance will be set at p \< 0.05: Primary efficacy analysis: The primary outcome will be the reduction in WOMAC total score from baseline to week 16. The week 16 means for the four treatment groups will be compared using an analysis of covariance taking account of baseline assessments and any demographic differences, age, gender, etc, which are found to be significant. Multiple comparison tests will be used to examine specific differences of initially specified interest, such as the two highest doses of Devil's Claw versus placebo. Secondary Efficacy Analysis: Similar analyses of covariance will be used to examine treatment group differences at week 16 compared with baseline for WOMAC subscales (pain, stiffness and physical function), and Quality of Life assessments (SF-36). Changes in the subject's well-being and overall global assessment will be compared using appropriate non-parametric tests, e.g. Mann-Whitney test or MacNemar's test. Changes in attitudes and health beliefs to CAM will be assessed using Chi-Squared tests. Safety Evaluation: Group differences between adverse event reporting will be assessed by descriptive methods. NUMBER OF PATIENTS: 264 (50 patients in each group, with an expected total of 64 drop-outs) NUMBER OF SITES: 2 TIME SCHEDULE: Study Start: April 2004 Study End: March 2007 Observation period/patient: 20 weeks

Osteoarthritis, Knee Osteoarthritis, Hip

double blind randomised controlled trial phase II Devil's Claw osteoarthritis of the knee osteoarthritis of the hip

null

4

arm 1: Sub clinical dose if the 3 doses employed arm 2: Active dose arm 3: Active dose arm 4: Comparator for all active intervention arms

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dose ranging study so will elucidate dose Frequency is four times daily intervention 2: Placebo has same dosing freq as for active intervention and for same time period

intervention 1: Devil Claw intervention 2: Placebo

1

Southampton | Hants | United Kingdom | -1.40428 | 50.90395

0

NCT00295490

[ 3 ]

55

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to evaluate the objective tumor response rate to SNS-595 in patients with small cell lung cancer (SCLC).

Other objectives of this study are to assess the safety, survival rate, best response, time to disease progression, duration of tumor response, and to explore several potential biomarkers to see how these levels change after administration of SNS-595.

Carcinoma, Small Cell Small Cell Lung Cancer

Lung Squamous Cell Small Cell Carcinoma Cancer Small Cell Lung Cancer

null

1

arm 1: SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.

[ 0 ]

1

[ 0 ]

intervention 1: None

intervention 1: SNS-595

17

0

NCT00298896

[ 3 ]

36

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

false

* There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new cancer treatments. * SU011248 is an exciting, new, experimental drug that inhibits a number of proteins, or more specifically receptor tyrosine kinases, in tumor cells. These proteins are active in cellular pathways that are important for development and growth of a variety of different cancers. The targets of SU011248 include the receptors for vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and others. By blocking the VEGF and PDGF pathways, SU011248 can induce death of the blood vessels that nourish the cancer cells and death of the cancer cells themselves. * SU011248 has demonstrated significant anti-tumor activity in renal cell carcinoma, gastrointestinal stromal tumors, and other cancers. Its effect against prostate cancer has not been studied to date. * This study is directed at two populations of men with advanced prostate cancer: 1. Men with advanced prostate cancer who have a rising PSA despite hormone therapy, but have not yet received any chemotherapy. 2. Men with metastatic prostate cancer who have received prior chemotherapy (with a docetaxel-based regimen) and have increasing disease following chemotherapy. * Men in this study will receive SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The goals of the study are: 1. to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and 2. to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future.

Background: There are nearly 30,000 deaths per year in the United States from prostate cancer, making this a large and important target patient population for new therapeutics. The mainstay of therapy for advanced prostate cancer is androgen deprivation therapy (ADT). Although ADT is effective in the large majority of men with advanced prostate cancer, the favorable response to ADT is only transient. In hormone-refractory, metastatic prostate cancer the only effective systemic treatment is cytotoxic chemotherapy. The median duration of response to standard, taxane-based chemotherapy is approximately six months, and median survival in contemporary studies is only 16-18 months. Thus, there is an urgent need for new therapeutic agents to treat advanced prostate cancer. SU011248 is an orally administered inhibitor of the vascular endothelial growth factor (VEGF) receptors, platelet-derived growth factor (PDGF) receptor, FLT-3 and c-KIT. SU011248 has demonstrated significant clinical activity in other malignancies, but its activity in prostate cancer has not been studied to date. Clinical trials have demonstrated that SU011248 is generally well tolerated, with mild fatigue and diarrhea the most common adverse effects. Preclinical studies have demonstrated that levels of VEGF and PDGF are elevated in prostate cancer and may correlate with worse outcome. The inhibition of several pathways implicated in prostate cancer progression by SU011248 suggests that it might have significant anti-tumor activity in men with AIPC. Many of the new, targeted agents are efficacious in only a subset of patients with a particular malignancy, and these subsets may be definable on the basis of specific tumor mutations or patterns of gene expression. Identification of reliable predictive methods is crucial in moving forward with targeted therapies, and we believe that exploratory clinical trials such as this one should incorporate assays designed to address this issue. Objective/Hypothesis: The objective of this proposal is to determine whether SU011248 is an effective treatment in two cohorts of men with advanced prostate cancer: men with androgen-independent prostate cancer (AIPC) who have not been treated with chemotherapy (Group A), and men with taxane-refractory, metastatic disease (Group B). We hypothesize that specific serum biomarkers and tumor mutations may predict response and may allow optimal subject selection in the future. Specific Aims: (1) To evaluate the efficacy and safety of SU011248 in men with chemo-naïve AIPC, (2) to evaluate the efficacy and safety of SU011248 in men with metastatic, taxane-resistant AIPC, (3) to measure serum biomarkers in men with AIPC prior to and following treatment with SU011248 and correlate these markers with clinical response, and (4) to mutational analysis from tumor specimens of men with metastatic prostate cancer treated with SU011248 and correlate with clinical response. Study Design: We will conduct a phase II clinical trial in two groups of subjects: men with AIPC who have not yet developed overt metastases (Group A), and men with taxane-refractory, metastatic disease (Group B). Men in both groups will receive single-agent SU011248 on a six-week repeating schedule, with four weeks of daily treatment followed by a two-week rest. The primary endpoint will be PSA response rate. Secondary endpoints will include time to disease progression, objective response rate, and safety parameters. Eligibility for this study will require signed informed consent, adenocarcinoma of the prostate, documented PSA progression despite ADT, reasonable functional status, resolution of toxic effects from prior treatments, and acceptable bone marrow, hepatic, renal and cardiac function. A Simon's two-stage design will be employed to allow early termination for lack of efficacy. Ultimately, 30 patients will be enrolled in each group, for a total of 60 patients. A defined program of history and physical examinations, radiographic studies, and laboratory tests including PSA will be carried out to determine the efficacy and safety of SU011248 in this patient population. All subjects will have blood and urine collected for research purposes, and men in Group B will have tumor biopsy prior to enrollment. Translational studies aimed at identifying specific biomarkers in the blood will include analysis of serum cytokine levels including VEGF and others, circulating endothelial cells and endothelial precursors, white blood cell differential, and bone turnover markers. Tumor samples will be analyzed for the presence of predictive tumor mutations. Relevance: Our ultimate goals are to determine whether SU011248 is an important therapeutic agent in men with advanced prostate cancer, and to identify predictive markers of anti-cancer activity within individual subjects that would allow selective treatment of appropriate subjects in the future. The data obtained should also contribute to our general understanding of serum biomarkers and genetic changes in advanced prostate cancer. Positive results of our trial would lead to expanded, multi-center trials of SU011248 in men with advanced prostate cancer.

Prostate Cancer

Sutent Sunitinib Bone Metastatic Hormone-refractory Biomarkers

null

1

arm 1: Sunitinib

[ 0 ]

1

[ 0 ]

intervention 1: Sunitinib 50 mg daily, 4/2 schedule

intervention 1: Sunitinib

3

0

NCT00299741

[ 4 ]

1,025

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

null

Fibromyalgia

null

2

arm 1: Placebo, oral administration, twice daily for 12 weeks arm 2: Milnacipran 100mg/day (50mg BID \[twice a day\])

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Placebo, oral administration, twice daily for 12 weeks intervention 2: Milnacipran 100mg per day (50mg BID \[twice a day\])

intervention 1: Placebo intervention 2: Milnacipran 100mg

24

0

NCT00314249

[ 5 ]

10

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

null

This investigation will assess the effectiveness of topiramate in reducing ethanol consumption by alcohol dependent subjects. It also will seek to establish whether topiramate can be safely used in this population including whether it might be subject to abuse by alcohol dependent individuals. A secondary goal of this study is to assess the effects of topiramate on verbal fluency during treatment for alcohol dependence.

Alcoholism is a disorder that produces extensive morbidity and mortality. Substantial progress has been made in the development of medications that can help to promote abstinence in alcohol dependent individuals. However, investigations of the most promising drugs, particularly naltrexone and acamprosate, suggest that these agents have at best moderate efficacy and there is a great need for additional medications for the treatment of alcoholism. The results of a recent study suggest that the administration of the anticonvulsant agent ,topiramate helps alcoholic individuals to maintain abstinence (Johnson et al., 2003). The objectives of this study is to determine whether topiramate will reduce the consumption of alcohol in subjects dependent on this substance, as has been previously reported.Other study objectives are to assess the abuse liability properties of topiramate in alcohol dependent subjects and to examine the effects of chronic topiramate administration on cognitive functioning. This will be a thirteen week long open label clinical trial of the effects of topiramate administration on ethanol consumption by alcohol dependent subjects. Subjects will be asked to provide informed consent and then will be screened on the same day to determine if they meet study eligibility criteria. Subjects will be asked to return to provide two urines over the following week. Baseline measures of mood, craving, withdrawal, cognitive functioning and physical health will be obtained. In the afternoon they will receive their first dose of medication. Their responses to this medication challenge will be assessed over a 3-hour period. During the drug treatment phase subjects will be asked to come to the clinic weekly for assessment and manual guided therapy during weeks 1-4 and biweekly during weeks 6-8. On day 85 subjects will be seen at the clinic for a termination visit.

Alcoholism

Alcoholism Heavy Drinking Alcohol Dependence

null

1

arm 1: In this open label non-placebo controlled trial all subjects received topiramate, the active medication. Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM

[ 1 ]

1

[ 0 ]

intervention 1: Medication Dosing Schedule: Days 1-3 50 mg q PM Days 4-7 50 mg BID Days 8-11 50 mg q AM \& 100 mg q PM Days 12-15 100mg BID Days 16-19 100 mg q AM \& 150 mg q PM Days 20-23 150 mg BID Days 24-27 150 mg qAM \& 200 mg q PM Days 28-70 200 mg BID Days 71-77 150 mg BID Days 78-84 100mg BID Days 85-87 50 mg BID Days 88-91 50 mg qPM

intervention 1: Topiramate (Topamax)

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00329407

[ 4 ]

218

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).

null

Behavioral Symptoms Autistic Disorder

Serious behavioral problems in children and adolescents with AD

null

4

arm 1: 5 mg arm 2: 10 mg arm 3: 15 mg arm 4: None

[ 0, 0, 0, 2 ]

2

[ 0, 0 ]

intervention 1: Tablets, Oral, once daily, 8 weeks intervention 2: Tablets, Oral, once daily, 8 weeks

intervention 1: Aripiprazole intervention 2: Placebo

31

0

NCT00337571

[ 3 ]

15

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

The purpose of this research study is to learn if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer. Platinum containing drugs such as carboplatin are the standard treatment for ovarian cancer, and are effective for many women. However, in many women the cancer eventually stops responding to the chemotherapy (becomes resistant). The active part of NOV-002 is a substance made by the body that is involved in many chemical reactions in cells. NOV-002 does not directly kill cancer cells, but previous research has shown that it may make cancer cells more likely to be killed by chemotherapy drugs. Specifically, it may help platinum chemotherapy kill cancer that has become resistant to platinum chemotherapy. Previous trials have also shown that patients receiving NOV-002 in addition to carboplatin may have tolerated chemotherapy better than those who received chemotherapy alone. NOV-002 has been used in other research studies on various types of cancer. It is approved for use in Russia. It is not approved by the US Food and Drug Administration (FDA) for use outside of research studies. In this research study, the investigators are looking to see if adding NOV-002 to the chemotherapy drug carboplatin works in treating ovarian cancer in women whose cancer has stopped responding to carboplatin chemotherapy alone.

Ovarian Cancer

Platinum Resistant Tumors of Ovarian Origin

null

1

arm 1: NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.

[ 0 ]

2

[ 0, 0 ]

intervention 1: 60 mg / mL / day / 20-23 Days intervention 2: AUC 5 following IV bolus administration of NOV-002

intervention 1: NOV-002 intervention 2: Carboplatin

2

0

NCT00345540

[ 2, 3 ]

6

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickle cell disease.

Increasing evidence suggests that pulmonary hypertension, defined by an elevated tricuspid regurgitant jet velocity (TRJV) on echocardiogram, is a major cause of morbidity and mortality in adults with sickle cell disease (SCD). However, both the prevalence and optimal treatment of pulmonary hypertension in children and young adults with SCD are unknown. We hypothesize that short term therapy with hydroxyurea will decrease TRJV in children and young adults with pulmonary hypertension found on screening. Patients eligible for treatment will have had evidence of pulmonary hypertension on at least 2 screening echocardiograms. Baseline laboratory tests will be obtained and other causes of secondary pulmonary hypertension will be excluded prior to initiation of treatment. Patients will be treated with hydroxyurea according to a standard dose escalation schedule for a total of 12 months. A clinic visit will be required every 2 months and standard screening for toxicity will be performed monthly. There will be an interim analysis of the primary outcome at 6 months following therapy.

Sickle Cell Disease Pulmonary Hypertension

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.

intervention 1: Hydroxyurea

1

Chicago | Illinois | United States | -87.65005 | 41.85003

0

NCT00350844

[ 3 ]

10

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.

null

Carcinoma, Non-Small-Cell Lung

null

2

arm 1: Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. arm 2: Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles. Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles. Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions. Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

[ 5, 0 ]

3

[ 0, 0, 4 ]

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

intervention 1: Paclitaxel poliglumex intervention 2: Carboplatin intervention 3: External beam radiation therapy

8

0

NCT00352690

[ 3 ]

38

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The aim of the study is to determine if atomoxetine treatment combined with motivational enhancement therapy is effective in reducing marijuana use in adult individuals with attention-deficit hyperactivity disorder and marijuana dependence.

The purpose of this study is to determine whether the medication atomoxetine, or Strattera, plus 3 sessions of counseling can help people to reduce the symptoms of ADHD and to help cut back on their marijuana use. Participation in the study is approximately 12 weeks of medication treatment and doctor's visits once a week. The first 2 visits consist of evaluations to determine if you qualify to participate. These visits are approximately 2-3 hours long and will include questions about your past and present substance use, psychiatric history, a routine physical exam, bloodwork, and paper and pencil questionnaires about your marijuana use. Once you are enrolled in the study, visits are typically 30 minutes long, once a week. The one-on-one counseling sessions regarding marijuana use are 1 hour long and you will have 3 sessions throughout the study. If you qualify for this study, you will receive either atomoxetine, or a placebo (sugar pill). Study participants will have a 50% chance of receiving atomoxetine. Atomoxetine is a non-stimulant, commonly used to treat ADHD.

Marijuana Abuse Attention Deficit Disorder With Hyperactivity

null

2

arm 1: Atomoxetine plus Motivational Enhancement Therapy arm 2: Placebo plus Motivational Enhancement Therapy

[ 0, 2 ]

3

[ 0, 3, 0 ]

intervention 1: 25 to 100 mg daily intervention 2: Three sessions intervention 3: 25 to 100 mg daily

intervention 1: Atomoxetine intervention 2: Motivational enhancement therapy intervention 3: Placebo

1

Charleston | South Carolina | United States | -79.93275 | 32.77632

0

NCT00360269

[ 4 ]

165

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

1FEMALE

false

The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Acronyms in the Adverse Event Section: * IUCD Intrauterine Contraceptive Device * MedDRA Medical Dictionary for Regulatory Activities This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Menorrhagia

Idiopathic Menorrhagia

null

2

arm 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. arm 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. intervention 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

intervention 1: Levonorgestrel IUS (Mirena, BAY86-5028) intervention 2: Medroxyprogesterone acetate

54

0

NCT00360490

[ 4 ]

3

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.

null

Leukemia

Leukemia (chronic myeloid leukemia - chronic phase)

null

2

arm 1: 50-180 mg once daily (QD) arm 2: 200-800 mg QD

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Tablets, Oral, Once daily, 5-7 years intervention 2: Tablets, Oral, Once daily, 5-7 years

intervention 1: Dasatinib intervention 2: Imatinib

45

0

NCT00362466

[ 3 ]

334

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

null

Chronic Hepatitis C

null

4

arm 1: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. arm 2: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. arm 3: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. arm 4: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.

[ 2, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: tablet intervention 2: Solution for injection intervention 3: tablet intervention 4: tablet

intervention 1: Ribavirin intervention 2: Pegylated Interferon Alfa 2a intervention 3: Placebo intervention 4: Telaprevir

4

Call For Information | N/A | Austria | N/A | N/A Call For Information | N/A | France | N/A | N/A Call For Information | N/A | Germany | N/A | N/A Call For Information | N/A | United Kingdom | N/A | N/A

0

NCT00372385

[ 3 ]

21

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to determine whether intravenous N-acetylcysteine (also known as Acetadote), an antioxidant medication that has been used for years to treat Tylenol overdose, helps prevent heart dysfunction in the early postoperative period following congenital heart surgery. Children undergoing major heart surgery, such as the arterial switch operation, routinely develop temporary heart dysfunction in the first 12-24 hours after surgery. This heart dysfunction may be severe and contributes to an increased risk for death or prolonged hospitalization. Current standard treatments include intravenous medications such as dopamine, epinephrine, and vasopressin that support your child's blood pressure and heart function. Unfortunately, high doses of these medications have the potential to cause severe side effects including loss of fingers and toes, liver and kidney dysfunction, and heart rhythm abnormalities. Our goal is to find a way to reduce heart dysfunction after major heart surgery in order to promote a smoother postoperative period, and reduce the risks associated with heart operations in children.

This is a randomized, placebo-controlled, blinded study of intravenous N-acetylcysteine (NAC) for the prevention of postoperative myocardial dysfunction and apoptosis in infants undergoing arterial switch for D-transposition of the great arteries. Subjects will be age 0-3 months, and no distinctions will be made based on gender or race. Infants operated before 36 weeks post-conceptional age or with birth weight less than 1.8 kilograms will be excluded. Informed consent will be obtained from the patient's parent by one of the investigators in the hospital before the infants undergo surgery. Subjects will be randomized based on a block randomization scheme to receive placebo or NAC infusion, starting with a loading dose 1 hour prior to surgery. If there is any concern by the ICU physician that the patient is developing toxicity to the medicine, the study drug will be discontinued and the patient removed from the study. Patients will have a thermodilution catheter placed during surgery for postoperative direct measurement of cardiac output. Endomyocardial biopsy will be performed by the surgeon pre- and post-bypass for measurement of markers of apoptosis. Postoperatively, patients will continue to receive an infusion of IV NAC for 24 hours. Blood draws will be through existing arterial and central venous catheters. Serum labs collected will include serial lactate values (already collected routinely), liver and renal function tests, CK-MB and troponin-I levels as a marker of myocardial injury, and S100b level as a marker of brain injury. Total additional blood removed for research purposes will be less than 15 mL. Cardiac output will be measured serially by thermodilution. Serial transthoracic echocardiography will be used to determine left ventricular function. Inotropic score, duration of mechanical ventilation, length of ICU stay, and length of hospitalization will be recorded.

Transposition of Great Vessels Congenital Heart Disease

N-acetylcysteine Myocardial dysfunction Transposition of the Great Arteries

null

2

arm 1: These patients receive a placebo infusion of D5W prior to and after surgery arm 2: These patients receive a loading dose of N-Acetylcysteine 100 mg/kg in D5W IV 1 hour prior to surgery. They receive a maintenance infusion of N-Acetylcysteine 10 mg/kg/hr in D5W IV for 24 hours after surgery.

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Loading dose: Subjects randomized to IV NAC will receive a total loading dose of 100 mg/kg of 10% (100 mg/mL) solution. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the loading dose will be 1 mL/kg, anticipated to be 2.5-5 mL in our patient population. The loading dose will be administered over 1 hr beginning 1 hr prior to the patient's OR time. Subjects in the placebo group will receive 1 mL/kg of D5W over 1 hr. Maintenance infusion: Subjects randomized to IV NAC will receive an infusion of 10 mg/kg/hr of 10% (100 mg/mL) solution for 24 hrs, starting in the OR after weaning from CPB. Acetadote is supplied as a 20% solution (200 mg/mL) and will be diluted 1:1 with an equal volume of D5W. The volume of the maintenance infusion will be 0.1 mL/kg/hr, anticipated to be 0.25-0.5 mL/hr in our patient population. Subjects in the placebo group will receive 0.1 mL/kg/hr of D5W for 24 hrs. intervention 2: D5W bolus prior to surgery and D5W infusion after surgery in an equal volume to the drug arm.

intervention 1: N-acetylcysteine intervention 2: Placebo

1

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

0

NCT00374088

[ 4 ]

127

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.

null

Nasal Polyps

null

8

arm 1: Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None

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

2

[ 0, 0 ]

intervention 1: 100 mcg nasal spray intervention 2: One spray of placebo nasal spray in each nostril once daily for 4 months.

intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo nasal spray

0

null

0

NCT00378378

[ 5 ]

95

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa

null

Parkinson's Disease

Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets. intervention 2: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

intervention 1: Levodopa/carbidopa/entacapone intervention 2: Levodopa/carbidopa

26

A Coruña | N/A | Spain | -8.396 | 43.37135 Alcalá de Henares, Madrid | N/A | Spain | N/A | N/A Alcorcón (Madrid | N/A | Spain | N/A | N/A Alicante | N/A | Spain | -0.48149 | 38.34517 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Barcelona | N/A | Spain | 2.15899 | 41.38879 Burgos | N/A | Spain | -3.70184 | 42.34106 Donostia / San Sebastian | N/A | Spain | -1.97499 | 43.31283 Granada | N/A | Spain | -3.60667 | 37.18817 L'Hospitalet de Llobregat , Barcelona | N/A | Spain | N/A | N/A 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 Pamplona | N/A | Spain | -1.64323 | 42.81687 Sant Cugat Del Valles, Barcelona | N/A | Spain | N/A | N/A Seville | N/A | Spain | -5.97317 | 37.38283 Terrassa, Barcelona | N/A | Spain | N/A | N/A Valencia | N/A | Spain | -0.37966 | 39.47391 Valencia | N/A | Spain | -0.37966 | 39.47391 Valencia | N/A | Spain | -0.37966 | 39.47391

0

NCT00391898

[ 5 ]

258

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.

null

Metabolic Syndrome X

rosuvastatin lipoprotein metabolic syndrome

null

2

arm 1: None arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: 10mg intervention 2: 10mg

intervention 1: Rosuvastatin intervention 2: Atorvastatin

3

Pusan | N/A | South Korea | 128.3681 | 36.3809 Seoul | N/A | South Korea | 126.9784 | 37.566 Suwon | N/A | South Korea | 127.00889 | 37.29111

0

NCT00395486

[ 4 ]

100

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

null

Dysfunctional Central Venous Access Catheters

TNKase CVA CVAD Central venous access catheter CVA catheter

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg). intervention 2: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

intervention 1: placebo intervention 2: tenecteplase

0

null

0

NCT00395876

[ 4 ]

251

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.

null

Dysfunctional Central Venous Access Catheters

TNKase CVA CVAD Central venous access catheter

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

intervention 1: tenecteplase

0

null

0

NCT00396318

[ 5 ]

400

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

null

Renal Transplantation

RenalTransplantation KidneyTransplantation MPA EC-MPS

null

2

arm 1: Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. arm 2: Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Enteric-coated mycophenolate sodium supplied as 180 mg tablets. intervention 2: Mycophenolate mofetil supplied as 250 mg capsules. intervention 3: Placebo to mycophenolate sodium matching tablets. intervention 4: Placebo to mycophenolate mofetil matching capsules.

intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Mycophenolate mofetil intervention 3: Placebo to mycophenolate sodium intervention 4: Placebo to mycophenolate mofetil

53

0

NCT00400400

[ 3 ]

28

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

2MALE

null

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

OBJECTIVES: * Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy. * Determine the safety and feasibility of GM-CSF and thalidomide. OUTLINE: This is an open-label study. Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity. Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9. PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Prostate Cancer

stage III prostate cancer stage II prostate cancer adenocarcinoma of the prostate stage I prostate cancer stage IV prostate cancer

null

1

arm 1: taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.

[ 0 ]

4

[ 2, 0, 3, 3 ]

intervention 1: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day intervention 2: doses up to 400 mg/day intervention 3: SOC care surgery intervention 4: post radical prostatectomy

intervention 1: sargramostim intervention 2: thalidomide intervention 3: conventional surgery intervention 4: neoadjuvant therapy

1

Cleveland | Ohio | United States | -81.69541 | 41.4995

0

NCT00400517

[ 4 ]

813

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

null

Abscess Wound Infection Diabetic Foot Ulcer

null

2

arm 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. arm 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. intervention 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.

intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid

123

Graz | Styria | Austria | 15.45 | 47.06667 Graz | N/A | Austria | 15.45 | 47.06667 Vienna | N/A | Austria | 16.37208 | 48.20849 Bornem | N/A | Belgium | 4.24364 | 51.09716 Bruxelles - Brussel | N/A | Belgium | N/A | N/A Bruxelles - Brussel | N/A | Belgium | N/A | N/A Edegem | N/A | Belgium | 4.44504 | 51.15662 Dobrich | N/A | Bulgaria | 27.83333 | 43.56667 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Annecy | N/A | France | 6.12565 | 45.90878 Avignon | N/A | France | 4.80892 | 43.94834 Boulogne-sur-Mer | N/A | France | 1.61373 | 50.72485 Denain | N/A | France | 3.3943 | 50.3293 Grenoble | N/A | France | 5.71479 | 45.17869 Le Grau-du-Roi | N/A | France | 4.13559 | 43.53881 Nevers | N/A | France | 3.159 | 46.98956 Quimper | N/A | France | -4.09795 | 47.99597 Tourcoing | N/A | France | 3.16117 | 50.72391 Mannheim | Baden-Wurttemberg | Germany | 8.46694 | 49.4891 München | Bavaria | Germany | 13.46314 | 48.69668 Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073 Darmstadt | Hesse | Germany | 8.65027 | 49.87167 Wiesbaden | Hesse | Germany | 8.24932 | 50.08258 Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 Bochum | North Rhine-Westphalia | Germany | 7.21648 | 51.48165 Münster | North Rhine-Westphalia | Germany | 7.62571 | 51.96236 Mainz | Rhineland-Palatinate | Germany | 8.2791 | 49.98419 Magdeburg | Saxony-Anhalt | Germany | 11.62916 | 52.12773 Lübeck | Schleswig-Holstein | Germany | 10.68729 | 53.86893 Athens | Attica | Greece | 23.72784 | 37.98376 Athens | Attica | Greece | 23.72784 | 37.98376 Athens | Greece | Greece | 23.72784 | 37.98376 Athens | N/A | Greece | 23.72784 | 37.98376 Rio Patras | N/A | Greece | N/A | N/A Thessaloniki | N/A | Greece | 22.93086 | 40.64361 Budapest | N/A | Hungary | 19.04045 | 47.49835 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Győr | N/A | Hungary | 17.63512 | 47.68333 Kaposvár | N/A | Hungary | 17.8 | 46.36667 Székesfehérvár | N/A | Hungary | 18.41034 | 47.18995 Veszprém | N/A | Hungary | 17.91149 | 47.09327 Wilton | Cork | Ireland | N/A | N/A Dublin | Dublin | Ireland | -6.24889 | 53.33306 Galway | Galway | Ireland | -9.05095 | 53.27245 Dublin | N/A | Ireland | -6.24889 | 53.33306 Dublin | N/A | Ireland | -6.24889 | 53.33306 Sligo | N/A | Ireland | -8.46943 | 54.26969 Haifa | N/A | Israel | 34.99928 | 32.81303 Tel Litwinsky | N/A | Israel | 34.84588 | 32.05096 Chieti | N/A | Italy | 14.16494 | 42.34827 Milan | N/A | Italy | 12.59836 | 42.78235 Pavia | N/A | Italy | 9.15917 | 45.19205 Roma | N/A | Italy | 11.10642 | 44.99364 Siena | N/A | Italy | 11.33064 | 43.31822 Daugavpils | N/A | Latvia | 26.53333 | 55.88333 Liepāja | N/A | Latvia | 21.01085 | 56.50474 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Riga | N/A | Latvia | 24.10589 | 56.946 Valmiera | N/A | Latvia | 25.42751 | 57.54108 Kaunas | N/A | Lithuania | 23.90961 | 54.90272 Šiauliai | N/A | Lithuania | 23.31667 | 55.93333 Ukmerge | N/A | Lithuania | 24.75 | 55.25 Vilnius | N/A | Lithuania | 25.2798 | 54.68916 Alkmaar | N/A | Netherlands | 4.74861 | 52.63167 Eindhoven | N/A | Netherlands | 5.47778 | 51.44083 Krakow | N/A | Poland | 19.93658 | 50.06143 Lublin | N/A | Poland | 22.56667 | 51.25 Lublin | N/A | Poland | 22.56667 | 51.25 Lublin | N/A | Poland | 22.56667 | 51.25 Poznan | N/A | Poland | 16.92993 | 52.40692 Puławy | N/A | Poland | 21.96939 | 51.41655 Warsaw | N/A | Poland | 21.01178 | 52.22977 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Iași | N/A | Romania | 27.6 | 47.16667 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Yaroslavl | N/A | Russia | 39.87368 | 57.62987 Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Pretoria | Gauteng | South Africa | 28.18783 | -25.74486 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Cape Town | Western Cape | South Africa | 18.42322 | -33.92584 Worcester | Western Cape | South Africa | 19.44852 | -33.64651 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Barcelona | Barcelona | Spain | 2.15899 | 41.38879 Terrassa (Barcelona) | Catalonia | Spain | 2.01667 | 41.56667 Madrid | Madrid | Spain | -3.70256 | 40.4165 Madrid | Madrid | Spain | -3.70256 | 40.4165 Madrid | Madrid | Spain | -3.70256 | 40.4165 Oviedo | Principality of Asturias | Spain | -5.84476 | 43.36029 Salamanca | Salamanca | Spain | -5.66388 | 40.96882 Ivano-Frankivsk | N/A | Ukraine | 24.71248 | 48.92312 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Lviv | N/A | Ukraine | 24.02324 | 49.83826 Odesa | N/A | Ukraine | 30.74383 | 46.48572 Uzhhorod | N/A | Ukraine | 22.2947 | 48.6242 London | Greater london | United Kingdom | -0.12574 | 51.50853 Winchester | Hampshire | United Kingdom | -1.3187 | 51.06513 Inverness | Highland | United Kingdom | -4.22398 | 57.47908 Edinburgh | Lothian | United Kingdom | -3.19648 | 55.95206 Manchester | Manchester | United Kingdom | -2.23743 | 53.48095 Glasgow | Stratchclyde | United Kingdom | -4.25763 | 55.86515 Newcastle upon Tyne | Tyne and Wear | United Kingdom | -1.61396 | 54.97328 Leeds | West Yorkshire | United Kingdom | -1.54785 | 53.79648 York | York | United Kingdom | -1.08271 | 53.95763

0

NCT00402727

[ 0 ]

110

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to examine the overall effectiveness of anti-arrhythmic medicines (to control heart rhythm) prescribed after an ablation procedure for atrial fibrillation.

Atrial fibrillation (AF) is the most common heart rhythm disorder in the US and it is associated with shortness of breath, palpitations, stroke occurrence and increased mortality. Traditional treatment for AF includes anticoagulation, drugs that slow the heart rate and antiarrhythmic agents. More recently, catheter based treatments to address atrial fibrillation have been developed, which involves using radiofrequency energy to isolate the arrhythmogenic foci localized in the pulmonary veins. During the first weeks following pulmonary vein isolation (PVI), it is not unusual for patients to experience early recurrences of atrial fibrillation or atrial tachycardia due to irritability from the ablation. While these arrhythmias tend to resolve over time, it is nevertheless standard practice to prescribe antiarrhythmic drugs for the first 2-3 months after the intervention to prevent these early recurrences. However, the efficacy of this practice has never been formally evaluated. In addition, we have identified a small group of patients whose atrial tachycardias have terminated after cessation of antiarrhythmic therapy, suggesting that proarrhythmia from these agents may promote reentrant tachycardias in some patients. We therefore designed a study protocol that will evaluate the usefulness of short term antiarrhythmic drug therapy in order to prevent atrial fibrillation and atrial tachycardia episodes during the first 6 weeks following PVI. The target population of the study includes all patients with paroxysmal atrial fibrillation referred for PVI. After the ablation procedure, patients will be randomized to receive or not receive antiarrhythmic drugs for a period of 6 weeks. Arrhythmia occurrence during this period will be monitored via twice daily transtelephonic monitoring. Clinical visits including a physical exam and 12 lead ECG recording will be scheduled at 6 weeks. The primary endpoint of the study will be a composite endpoint including 1) atrial arrhythmias persisting \> 24 hours or requiring initiation of antiarrhythmic therapy 2) need for cardioversion/hospital admission 3) need for repeat ablation or 4) adverse outcome/intolerance of antiarrhythmic agent requiring drug cessation or change during the 6 week follow up period.

Atrial Fibrillation

Atrial fibrillation Atrial arrhythmia

null

2

arm 1: Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below. arm 2: Subjects do not receive membrane-active anti-arrhythmic medications after ablation.

[ 5, 5 ]

2

[ 0, 1 ]

intervention 1: Above drugs prescribed per established guidelines for treatment of AF intervention 2: A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

intervention 1: propafenone; flecainide; sotalol; dofetilide intervention 2: Radiofrequency catheter ablation

2

0

NCT00408200

[ 5 ]

58

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current literature.

null

Stroke

Cerebral Infarction acute ischemic stroke Brain ischemia

null

1

arm 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

[ 0 ]

1

[ 0 ]

intervention 1: 0.6 mg/kg of Alteplase is intravenously administered

intervention 1: Alteplase

1

Hokkaido | N/A | Japan | N/A | N/A

0

NCT00412867

[ 4 ]

558

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

null

Asthma

Moderate asthma Severe asthma

null

2

arm 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily arm 2: budesonide HFA pMDI 160 μg x 2 actuations twice daily

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily intervention 2: Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Budesonide HFA pMDI

39

0

NCT00419757

[ 4 ]

29

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to develop and implement an evidence based protocol for the secondary prevention of osteoporotic fractures and falls, and to determine how compliance with this intervention improves muscle strength and functional status following a fracture.

Following a fracture, few persons are screened or treated for osteoporosis (Feldstein et al). It is not surprising, then, that the risk of future osteoporotic fractures remains high. Although little data exists on the secondary prevention of osteoporosis, calcium, vitamin D, and bisphosphonates have all been shown to be effective in the primary prevention of osteoporotic fractures, and they are likely beneficial in reducing secondary fractures as well. Targeting falls prevention is another approach that is likely effective in reducing the risk of fracture. In the U.S., acute rehabilitation (rehab) settings offer a unique environment to initiate osteoporotic therapy. Therefore, this study will develop and implement evidence based interventions for the secondary prevention of osteoporotic fractures in the acute rehab setting with the following objectives: Specific Aim I: Assess overall compliance with pharmacological and non-pharmacological interventions initiated in an acute rehab setting following a fragility fracture. Hypothesis: Non-compliant participants are less likely to show improvement in functional status, muscle strength, or vitamin D levels following the intervention. Specific Aim II: Describe the incidence of fragility fractures and falls in participants at 6-months and one-year following the osteoporotic intervention introduced during acute rehab. Hypothesis: Similar to community based studies, a number of participants will go on to experience repeat falls and resulting fractures within one-year of follow-up. Compliant participants are less likely to experience falls and fractures. Specific Aim III: Confirm the high prevalence of vitamin D deficiency in a rehab setting. Describe the relationship between changes in vitamin D levels in participants between baseline and 6-month follow-up and changes in functional outcomes. Hypothesis: There will be a direct association between a change in vitamin D levels and a change in functional status. Consecutive individuals admitted with the primary or secondary diagnosis of fracture in the rehabilitation unit of Hebrew Rehabilitation Center will be offered enrollment. All participants enrolled will receive the same intervention: calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention interventions. Specific interventions for preventing falls include optimization of visual acuity, a review of medications associated with falls, personalized exercises to improve strength and balance, and a home hazards safety evaluation when indicated. All participants will have their functional status, muscle strength, and vitamin D level measured at baseline during their rehab stay. At the six-month follow-up, a home visit will be performed for all participants to again assess functional status, muscle strength, vitamin D level, satisfaction with the intervention, and reasons for non-compliance. A history of interim falls and fractures will be collected by telephone interviews, during home nursing visits, and during the exit 6-month visit.

Osteoporosis

disease/disorder proneness/risk osteoporotic fractures accidental falls aging

null

1

arm 1: calcium, vitamin D, a weekly oral bisphosphonate, and falls prevention measures. No comparator group. All participants received the same intervention

[ 5 ]

3

[ 0, 0, 5 ]

intervention 1: alendronate 70mg /cholecalciferol 2800IU orally once weekly intervention 2: calcium carbonate 500mg /cholecalciferol 200IU orally twice daily intervention 3: personalized exercises, home safety evaluation, referral to an eye doctor if needed, review of medications

intervention 1: alendronate with cholecalciferol intervention 2: calcium carbonate with cholecalciferol intervention 3: Falls prevention measures

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00421343

[ 4 ]

237

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography \[CT\] imaging of the sinuses).

null

Sinusitis

null

2

arm 1: Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. arm 2: Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days intervention 2: Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days

intervention 1: MFNS and antibiotic intervention 2: Matching Placebo nasal spray plus antibiotic

0

null

0

NCT00423176

[ 5 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

1FEMALE

false

The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.

Pelvic Pain

chronic pain pelvic pain nicotine patch

null

3

arm 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. arm 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. arm 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. intervention 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. intervention 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

intervention 1: Placebo intervention 2: Nicotine (5 mg) intervention 3: Nicotine (10 mg)

1

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

0

NCT00440505

[ 4 ]

117

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.

null

Hepatitis C, Chronic

null

1

arm 1: PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks

[ 0 ]

2

[ 2, 0 ]

intervention 1: Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks

intervention 1: PegIntron (peginterferon alfa-2b) intervention 2: Rebetol (ribavirin)

0

null

0

NCT00441584

[ 2 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin combination in patients with squamous cell carcinoma of head and neck (SCCHN).

Open-label, non-randomized and dose escalation study in which groups of 3-6 patients with squamous cell carcinoma of the head and neck will receive sequentially increased dosages of azacitidine SC injection in combination with a fixed dose of cisplatin IV injection until dose-limiting toxicity is demonstrated in 2 of the 6 patients.

Squamous Cell Carcinoma

Head and Neck Cancer

null

1

arm 1: Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Patients will receive Azacitidine and cisplatin.

[ 0 ]

2

[ 0, 0 ]

intervention 1: SC azacitidine intervention 2: cisplatin 75 mg/m\^2 day 8 every 28 days

intervention 1: Azacitidine intervention 2: Cisplatin

1

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

0

NCT00443261

[ 4 ]

134

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

NCT00415623 (protocol A0531085)

Hypertension

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

intervention 1: Amlodipine

9

0

NCT00443456

[ 4 ]

526

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

null

Onychomycosis

Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses

null

4

arm 1: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks arm 2: Vehicle (placebo) for 48 weeks arm 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks arm 4: Vehicle (placebo) for 24 weeks

[ 0, 2, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks intervention 2: Vehicle (placebo) once daily for 48 weeks intervention 3: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks intervention 4: Vehicle (placebo) once daily for 24 weeks

intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo

23

0

NCT00443820

[ 4 ]

518

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.

null

Onychomycosis

Toenail fungus Onychomycosis Nail fungus Toenail fungal infection Tinea unguium Dermatophytes Foot dermatoses

null

4

arm 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks arm 2: vehicle (placebo) applied once daily for 48 weeks arm 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks arm 4: vehicle (placebo) applied once daily for 24 weeks

[ 0, 2, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks intervention 2: vehicle (placebo) applied once daily for 48 weeks intervention 3: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks intervention 4: vehicle (placebo) applied once daily for 24 weeks

intervention 1: terbinafine intervention 2: Placebo intervention 3: terbinafine intervention 4: Placebo

22

0

NCT00443898

[ 2 ]

32

RANDOMIZED

SINGLE_GROUP

0TREATMENT

2DOUBLE

false

0ALL

false

Assess the safety, tolerability and pharmacokinetics of multiple oral doses of PF-00868554 in HCV positive patient volunteers

null

Hepatitis C

null

5

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

[ 0, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: 300 mg BID intervention 2: 450 mg BID intervention 3: 100 mg BID intervention 4: 300 mg TID intervention 5: Placebo

intervention 1: PF-00868554 intervention 2: PF-00868554 intervention 3: PF-00868554 intervention 4: PF-00868554 intervention 5: Placebo

4

Brussels | N/A | Belgium | 4.34878 | 50.85045 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Dundee | N/A | United Kingdom | -2.97489 | 56.46913

0

NCT00445315

[ 4 ]

96

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

This is a randomized placebo-controlled trial. The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Hereditary Angioedema (HAE)

null

2

arm 1: DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections. arm 2: Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections. intervention 2: given as three 1mL subcutaneous injections.

intervention 1: ecallantide intervention 2: Phosphate Buffer Saline (PBS), pH 7.0

45

0

NCT00457015

[ 3 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

The greenlight laser has an absorption maximum which is exactly the same as for hemoglobin. In the presence of hemoglobin, its application causes vaporization of the tissue and this effect depends on the concentration of hemoglobin in the respective tissue. Therefore, increase of blood-flow in the tissue (here: prostate gland) should exert better efficacy of the laser application and consequently shortening of the required duration of laser application.

null

Prostatic Hypertrophy, Benign

null

2

arm 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. arm 2: One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced. intervention 2: One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before Greenlight(TM) laser ablation of prostate commenced.

intervention 1: Vardenafil (Levitra, BAY38-9456) intervention 2: Placebo

1

Heidelberg | Baden-Wurttemberg | Germany | 8.69079 | 49.40768

0

NCT00461123

[ 2, 3 ]

20

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.

Milk Hypersensitivity

Food Allergy Oral Immunotherapy Immunoglobulin E

null

2

arm 1: Pre-measured doses of dry, nonfat powered milk prepared by the clinical research-registered dieticians arm 2: None

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Milk powder given orally in escalating doses to a goal of 500 mg for approximately 23 weeks intervention 2: None

intervention 1: cow's milk powder intervention 2: Placebo

2

0

NCT00465569

[ 4 ]

98

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind treatment withdrawal phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.

null

Gastroesophageal Reflux Disease (GERD)

pediatrics neonates

null

3

arm 1: This is an open label, run-in phase. All patients received Esomeprazole. arm 2: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo. arm 3: This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 2: Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg) intervention 3: Double Blind Placebo

intervention 1: Open Label Run In Esomeprazole intervention 2: Double Blind Esomeprazole intervention 3: Double Blind Placebo

25

0

NCT00468559

[ 3 ]

308

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

false

The purpose of this study is to evaluate the dose-response of OPC-12759 suspension in dry eye patients

null

Dry Eye Syndromes

Dry Eye Syndromes OPC-12759

null

3

arm 1: 0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 2: 1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks. arm 3: 2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.

[ 2, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: comparison of different dosages of drug intervention 2: comparison of different dosages of drug intervention 3: comparison of different dosages of drug

intervention 1: placebo intervention 2: 1% OPC-12759 ophthalmic suspension intervention 3: 2% OPC-12759 ophthalmic suspension

6

Chubu Region | N/A | Japan | N/A | N/A Kansai Region | N/A | Japan | N/A | N/A Kanto Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A

0

NCT00475319

[ 3 ]

360

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.

Post Herpetic Neuralgia PHN Neuropathy Nerve Pain

Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Topical

null

3

arm 1: Np-1 cream and placebo gabapentin arm 2: gabapentin caps and placebo cream arm 3: placebo cream and capsules

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks intervention 2: 1800mg/day capsules for 4 weeks intervention 3: placebo cream and caps

intervention 1: EpiCept-NP-1 Cream intervention 2: Gabapentin Capsules intervention 3: placebo

1

New Delhi | N/A | India | 77.2148 | 28.62137

0

NCT00475904

[ 5 ]

52

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site. The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

Dehydration

dehydration fluid therapy pediatrics emergency medicine hyaluronoglucosaminidase hyaluronidase hypodermoclysis clysis subcutaneous hydration subcutaneous rehydration hyaluronan rHuPH20

null

1

arm 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

[ 0 ]

1

[ 0 ]

intervention 1: Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

intervention 1: hyaluronidase (human recombinant)/rehydration fluid

0

null

0

NCT00477152

[ 4 ]

137

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is an open-label clinical research study of an oral glycopyrrolate liquid for the treatment of chronic moderate to severe drooling in patients with cerebral palsy or other neurological conditions. Patients participating in the study will receive oral glycopyrrolate liquid (1 mg/5 ml) three times a day (TID) for study duration of 24 weeks. After a washout, screening, and 2-day baseline period, patients will be enrolled in a 4-week dose titration period. Glycopyrrolate liquid doses will be titrated using dose levels in the Dose Titration Schedule. Titration will begin at 0.02 mg/kg per dose TID and sequentially increased in 0.02 mg/kg per dose increments TID every 5-7 days during the first four weeks until optimal individualized response is obtained for each patient or a maximum dose of 0.1 mg/kg TID is reached, not exceeding 3 mg TID or Dose-level 5 in the Dose Titration Schedule, whichever is lesser. Optimal dose for each patient is the dose at which he/she is receiving the maximum benefit from the study drug (greatest improvement in drooling) while experiencing minimum side effects. All patients will receive close attention by study staff throughout the study.

null

Cerebral Palsy Neurological Conditions Mental Retardation Sialorrhea

Mental Retardation Neurological Impairment Cerebral Palsy Drooling Neurological Conditions

null

1

arm 1: Arm receiving study drug

[ 5 ]

1

[ 0 ]

intervention 1: Study medication is administered three times a day at 7-8 AM, 1-2 PM, and 7-8 PM by the parent/caregiver

intervention 1: Oral Glycopyrrolate Liquid

7

0

NCT00491894

[ 5 ]

660

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

null

Chronic Obstructive Pulmonary Disease, COPD

null

2

arm 1: Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily arm 2: Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Symbicort (budesonide/formoterol turbuhaler 320/9ug) intervention 2: Spiriva (tiotropium bromide 18ug)

93

Concord | New South Wales | Australia | 151.10381 | -33.84722 Sydney | New South Wales | Australia | 151.20732 | -33.86785 Auchenflower | Queensland | Australia | 152.99213 | -27.47443 Carina Heights | Queensland | Australia | 153.09126 | -27.50721 North Mackay | Queensland | Australia | 149.17941 | -21.12009 Adelaide | South Australia | Australia | 138.59863 | -34.92866 Daw Park | South Australia | Australia | 138.58407 | -34.98975 Clayton | Victoria | Australia | 145.11667 | -37.91667 Malvern | Victoria | Australia | 145.02811 | -37.86259 Nedlands | Western Australia | Australia | 115.8073 | -31.98184 Calgary | Alberta | Canada | -114.08529 | 51.05011 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Winnipeg | Manitoba | Canada | -97.14704 | 49.8844 St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494 Halifax | Nova Scotia | Canada | -63.57688 | 44.64269 Mississauga | Ontario | Canada | -79.6583 | 43.5789 Toronto | Ontario | Canada | -79.39864 | 43.70643 La Malbaie | Quebec | Canada | -70.15268 | 47.654 Trois-rivires | Quebec | Canada | N/A | N/A Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 Québec | N/A | Canada | -71.21454 | 46.81228 Chamalières | N/A | France | 3.06703 | 45.77364 Creil | N/A | France | 2.48477 | 49.25672 Férolles-Attilly | N/A | France | 2.63088 | 48.73184 Grasse | N/A | France | 6.92537 | 43.65783 Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Metz | N/A | France | 6.17269 | 49.11911 Montpellier | N/A | France | 3.87635 | 43.61093 Perpignan | N/A | France | 2.89541 | 42.69764 Poitiers | N/A | France | 0.34348 | 46.58261 Saint-Laurent-du-Var | N/A | France | 7.19 | 43.67323 Sélestat | N/A | France | 7.4489 | 48.26195 Strasbourg | N/A | France | 7.74553 | 48.58392 Toulouse | N/A | France | 1.44367 | 43.60426 Berlin | N/A | Germany | 13.41053 | 52.52437 Gelsenkirchen | N/A | Germany | 7.09654 | 51.50508 Hagen | N/A | Germany | 7.47168 | 51.36081 Hanover | N/A | Germany | 9.73322 | 52.37052 Kassel | N/A | Germany | 9.5 | 51.31667 Koblenz | N/A | Germany | 7.57883 | 50.35357 Leipzig | N/A | Germany | 12.37129 | 51.33962 Marburg | N/A | Germany | 8.77069 | 50.80904 Potsdam | N/A | Germany | 13.06566 | 52.39886 Aszód | N/A | Hungary | 19.4785 | 47.65174 Baja | N/A | Hungary | 18.95307 | 46.18299 Balassagyarmat | N/A | Hungary | 19.29614 | 48.07296 Budapest | N/A | Hungary | 19.04045 | 47.49835 Cegléd | N/A | Hungary | 19.79952 | 47.17266 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Füzesabony | N/A | Hungary | 20.41667 | 47.75 Jászberény | N/A | Hungary | 19.91667 | 47.5 Komló | N/A | Hungary | 18.26494 | 46.19278 Nyíregyháza | N/A | Hungary | 21.71671 | 47.95539 Törökbálint | N/A | Hungary | 18.91356 | 47.42931 Vásárosnamény | N/A | Hungary | 22.31325 | 48.12542 Bydgoszcz | N/A | Poland | 18.00762 | 53.1235 Chrzanów | N/A | Poland | 19.40203 | 50.13546 Iława | N/A | Poland | 19.56849 | 53.59601 Krakow | N/A | Poland | 19.93658 | 50.06143 Piekary Śląskie | N/A | Poland | 18.92653 | 50.38017 Tarnów | N/A | Poland | 20.98698 | 50.01381 Turek | N/A | Poland | 18.50055 | 52.01548 Zawadzkie | N/A | Poland | 18.48467 | 50.60503 Łomża | N/A | Poland | 22.05935 | 53.17806 Košice | N/A | Slovakia | 21.25808 | 48.71395 Liptovský Hrádok | N/A | Slovakia | 19.72335 | 49.03962 Lučenec | N/A | Slovakia | 19.66708 | 48.33249 Nové Mesto nad Váhom | N/A | Slovakia | 17.8309 | 48.75763 Nové Zámky | N/A | Slovakia | 18.16195 | 47.98544 Piešťany | N/A | Slovakia | 17.82591 | 48.59479 Poprad | N/A | Slovakia | 20.29798 | 49.06144 Považská Bystrica | N/A | Slovakia | 18.42169 | 49.12153 Prešov | N/A | Slovakia | 21.23393 | 48.99839 Prievidza | N/A | Slovakia | 18.6275 | 48.77446 Revúca | N/A | Slovakia | 20.11734 | 48.68346 Trnava | N/A | Slovakia | 17.58723 | 48.37741 Žilina | N/A | Slovakia | 18.73941 | 49.22315 Barcelona | Catalonia | Spain | 2.15899 | 41.38879 Reus (tarragona) | Catalonia | Spain | 1.10687 | 41.15612 Pontevedra | Galicia | Spain | -8.64435 | 42.431 Madrid | Madrid | Spain | -3.70256 | 40.4165 Requena (valencia) | Valencia | Spain | -1.10044 | 39.48834 Valencia | Valencia | Spain | -0.37966 | 39.47391 Åtvidaberg | N/A | Sweden | 15.9977 | 58.20152 Höllviken | N/A | Sweden | 12.9558 | 55.40982 Limhamn | N/A | Sweden | 12.95 | 55.58333 Lund | N/A | Sweden | 13.19321 | 55.70584 Malmo | N/A | Sweden | 13.00073 | 55.60587 Motala | N/A | Sweden | 15.03649 | 58.53706 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Uppsala | N/A | Sweden | 17.63889 | 59.85882 Lindesberg | Örebro County | Sweden | 15.2304 | 59.59202

0

NCT00496470

[ 4 ]

5

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine whether the use of botulinum toxin A injected into the lateral thigh muscle improves knee function and reduces knee pain secondary to patellofemoral syndrome. The study hypothesis is that botulinum toxin + specific exercises will be superior to specific exercises alone in improving knee function and reducing knee pain in individuals with patellofemoral syndrome.

Patellofemoral pain syndrome is a leading cause of knee pain in persons under 45 and is particularly common in women. The prevailing theory for the etiology of patellofemoral pain is an imbalance in force or timing of the pull of the knee extensor muscles on the patella resulting in improper tracking of the patella in the femoral grove. Specifically, the vastus medialis is thought to be ineffective in overcoming the lateral pull of the vastus lateralis. When exercises designed to focus on improving strength and timing of activation of the vastus medialis fail, surgical release of part of the attachment of the vastus lateralis to the patella is considered. Botulinum toxin temporarily blocks acetylcholine release from motor neurons and is used clinically to produce muscle relaxation. Subjects with patellofemoral syndrome will be recruited into the study. Half of the subjects will be given a placebo injection while the other half will be given an injection of Botox (Botulinum Toxin A, Allergen) into the vastus lateralis muscle. Group assignment will be randomized and a double blind protocol used. Prior to injection, the subject will record their level of knee pain, fill out several knee function questionnaires, and have the strength and endurance of their knee extensor muscles tested. All subjects will be given an exercise program designed to target strengthening of the medial thigh muscles as well as stretching of lateral structures. At 4, 6 and 12 weeks knee pain and knee function will again be assessed.

Patellofemoral Pain Syndrome

Botulinum toxin type A Patellofemoral pain syndrome Knee Injuries Exercise Therapy

null

2

arm 1: Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program arm 2: Placebo injection + exercise

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Injection of 100 units Botox (Botulinum toxin type A) into the Vastus Lateralis of the study leg + 12 weeks of exercise for patellofemoral pain intervention 2: Injection of 2 cc placebo containing 0.1cc sodium bicarbonate 8.4% (1meq/cc), 0.9cc normal saline and 1 cc of lidocaine into the vastus lateralis of the study leg followed by 12 weeks of exercise for patellofemoral pain syndrome

intervention 1: Botulinum toxin A + exercise intervention 2: Placebo

1

Richmond | Virginia | United States | -77.46026 | 37.55376

0

NCT00496964

[ 4 ]

578

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

null

Bacterial Conjunctivitis

null

2

arm 1: Gatifloxacin 0.5% Eye Drops arm 2: Placebo Eye Drops

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily intervention 2: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

intervention 1: Gatifloxacin 0.5% eye drops intervention 2: placebo eye drops

1

Gretna | Louisiana | United States | -90.05396 | 29.91465

0

NCT00509873

[ 3 ]

230

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Pediculus Humanus Capitis Head Lice

Head Lice Lice Infestation Pediculosis Pediculosis Capitis

null

4

arm 1: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 2: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 3: Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair. arm 4: None

[ 1, 1, 1, 2 ]

2

[ 0, 0 ]

intervention 1: Vehicle Only intervention 2: BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.

intervention 1: Placebo intervention 2: BGC20-0582

1

Florida City | Florida | United States | -80.47922 | 25.44789

0

NCT00528021

[ 3 ]

27

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

false

This study investigated the effect of exercise and high-dose salbutamol on the maximum heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving therapeutic doses of indacaterol, salmeterol and placebo.

null

Chronic Obstructive Pulmonary Disease

COPD cycle ergometry exercise testing spirometry cardiovascular salbutamol indacaterol chronic obstructive pulmonary disease

null

6

arm 1: Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. arm 2: Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. arm 3: Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. arm 4: Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI. Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. arm 5: Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. arm 6: Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.

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

3

[ 0, 0, 0 ]

intervention 1: Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am). intervention 2: Single dose indacaterol matching placebo via Concept 1 device intervention 3: Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.

intervention 1: Indacaterol intervention 2: Placebo intervention 3: Salmeterol

1

Antwerp | N/A | Belgium | 4.40026 | 51.22047

0

NCT00531050

[ 3, 4 ]

105

NON_RANDOMIZED

PARALLEL

1PREVENTION

0NONE

false

0ALL

false

Trauma patients are at high risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE). The incidence of DVT varies greatly from 5-63% among studies depending on patient's individual risk factors, modality of prophylaxis, and methods of detection. The incidence of PE may be as low (0.3-4.3%) but carries a mortality of 20-50% which makes prevention of DVT of the utmost importance. The current standard of care for DVT prophylaxis in the trauma patient with high risk of DVT is enoxaparin, a low molecular weight heparin, administered twice a day as long as anticoagulation in not contraindicated. Many studies have demonstrated its efficacy when compared to mechanical compression and to unfractionated heparin, however one of the most robust of these studies still reported an DVT incidence of 35% in patients treated with enoxaparin. Another drug, fondaparinux, is a selective factor Xa inhibitor that could offer added benefits over enoxaparin such as once daily dosing and a drastically reduced risk of heparin induced thrombocytopenia (HIT). Fondaparinux has been already be widely used in post-operative hip surgery and major knee surgery patients with good results. It has also been shown to be effective in DVT prophylaxis in patients who have had major abdominal surgery and also in acute medical patients. Fondaparinux has yet to be used in trauma patients. Trauma patients are a diverse and distinct population given the acuity of their injuries and their increased risk of bleeding who at this time still do not have a perfect method for DVT prophylaxis. We hypothesize that fondaparinux will be effective in decreasing the risk of DVT when used in the trauma patient population. This is a non randomized prospective cohort study designed to test the efficacy of fondaparinux in the prophylaxis of DVT and PE in trauma patients.

Patients with trauma admitted to San Francisco General Hospital and qualify for the study will be assigned to +fondaparinux and no fondaparinux arms based on guidelines that were developed for and are considered the standard of care for the use of low molecular weight heparin in the same group of patients for the same indication. These guidelines will separate patients at risk for DVT into those that are high risk and very high risk. The primary efficacy outcome measures will be DVT and PE. Presence of DVT will be assessed with serial color flow duplex ultrasound during the patients in hospital stay at weekly intervals up to 3 weeks and when the patient has symptoms of DVT. PE will be diagnosed according to clinical suspicion by the patients treating physicians and subsequent imaging by CT. We plan on enrolling approximately 100 patients in the +fondaparinux and 100 patients in the no fondaparinux arm. We will compare both the incidence of DVT and PE in these groups and to the incidences in the literature and historical controls. A second aim of the study is to evaluate the adverse outcomes such as increased bleeding in patients who receive fondaparinux. A third and final aim of the study is to describe the effect of fondaparinux on antifactor Xa levels in trauma patients.

Venous Thromboembolism

deep vein thrombosis venous thromboembolism pulmonary embolism

null

4

arm 1: Patients at high risk for venous thromboembolism (criteria: age\>=40, pelvic fracture, lower extremity fracture, shock on presentation, spinal cord injury, head injury with Abbreviated Injury Scale (AIS) \>=3). These patients will receive fondaparinux 2.5mg via subcutaneous administration (SubQ) daily. arm 2: Patients at high risk for venous thromboembolism (criteria: age\>=40, pelvic fracture, lower extremity fracture, shock on presentation, spinal cord injury, head injury with AIS \>=3) who also have a contraindication to anticoagulant(enoxaparin)administration such as renal failure with creatine clearance \<30 mL/min, head injury with head AIS \>=3), uncontrolled hemorrhage, uncorrected coagulopathy, persistent thrombocytopenia. These patients will receive mechanical compression. arm 3: Patients at very high risk for venous thromboembolism (criteria: major operative procedure, venous injury, ventilator days \>3, 2 or more high risk factors). These patients will receive fondaparinux 2.5mg SubQ daily and mechanical compression. arm 4: Patients at very high risk for venous thromboembolism (criteria: major operative procedure, venous injury, ventilator days \>3, 2 or more high risk factors) who also have a contraindication to anticoagulant(enoxaparin)administration such as renal failure creatine clearance \<30 mL/min, head injury with head AIS \>=3), uncontrolled hemorrhage, uncorrected coagulopathy, persistent thrombocytopenia. These patients will receive mechanical compression and possibly temporary inferior vena cava (IVC) filter(as determined by the patient's care givers).

[ 0, 1, 0, 1 ]

2

[ 0, 1 ]

intervention 1: fondaparinux 2.5mg SubQ daily for DVT prophylaxis to be started by treating physicians once deemed safe and to be discontinued once patient in discharged from the hospital or at discretion of treating physicians. intervention 2: Sequential compression devices at all times during the patient's hospital admission will be used in patients who have a contraindication to pharmacologic DVT prophylaxis. This is already the current standard of care.

intervention 1: fondaparinux sodium intervention 2: sequential compression devices

1

San Francisco | California | United States | -122.41942 | 37.77493

0

NCT00531843

[ 3 ]

9

RANDOMIZED

CROSSOVER

0TREATMENT

3TRIPLE

false

0ALL

false

This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia

null

Neuralgia

null

2

arm 1: AGN201781 50 mg capsules three-time daily for 2 weeks arm 2: placebo 50 mg capsules three-times daily for 2 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: AGN201781 50 mg capsules three-times daily for 2 weeks intervention 2: placebo 50 mg capsules three-times daily for 2 weeks

intervention 1: AGN201781 intervention 2: placebo

2

St Leonards | New South Wales | Australia | 151.19836 | -33.82344 Kiel | N/A | Germany | 10.13489 | 54.32133

0

NCT00533351

[ 0 ]

228

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

null

Dry Eye Syndrome

null

2

arm 1: Carboxymethylcellulose and Glycerin based artificial tear arm 2: Carboxymethylcellulose based artificial tear

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake intervention 2: As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake

intervention 1: Carboxymethylcellulose and Glycerin based artificial tear intervention 2: Carboxymethylcellulose

1

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

0

NCT00544713

[ 3 ]

199

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

2MALE

true

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

null

Schizophrenia

null

3

arm 1: None arm 2: 4mg/day arm 3: matching placebo

[ 0, 1, 2 ]

3

[ 0, 0, 10 ]

intervention 1: This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study intervention 2: None intervention 3: None

intervention 1: vabicaserin intervention 2: risperidone intervention 3: placebo

33

0

NCT00563706

[ 3 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI). The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

Acute Myocardial Infarction ST Elevation MI STEMI

INOT44 NOMI

null

2

arm 1: Inhaled Nitric oxide administered at 80 parts per million (ppm) arm 2: Inhaled nitrogen gas (Placebo) administered at 80 ppm

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Nitric oxide for inhalation intervention 2: Nitrogen gas (placebo) for inhalation

intervention 1: Nitric Oxide intervention 2: Placebo

14

0

NCT00568061

[ 5 ]

116

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

0NONE

true

0ALL

false

The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

null

Bacterial Infections Eye Infections Cataract Extraction

null

2

arm 1: One drop two times a day for two days and once a day for the next five days arm 2: One drop three times a day for seven days

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: One drop two times a day for two days and once a day for the next five days. intervention 2: One drop three times a day for seven days

intervention 1: AzaSite Eye Drops intervention 2: Vigamox Eye Drops

13

0

NCT00575380

[ 0 ]

75

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2 hours. This study had two parts. In the first part, eligible patients were randomized to either receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with neither the patient nor the study team knowing which patient received the study drug. In the second part, patients who were not eligible to participate in the randomized study or who refused to participate in the randomized study were enrolled in a prospective arm where they knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the patient's weight, and patients were given additional doses of midazolam syrup as necessary to control their anxiety. The primary hypothesis of this study was that a single dose of oral midazolam syrup to patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis of this study was that patients given oral midazolam would have the rate of adverse events that was not worse than 25% higher than in the placebo group.

The main objective of this study was to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for efficacy in producing safe anxiolysis of short duration. A parallel prospective arm of the study involved administration of midazolam in an unblinded fashion. Based on available studies of orally administered midazolam, the expectation was that the only observed adverse events will be minor and the major adverse event rate for midazolam would be similar to placebo. Data was collected on vital signs, anxiety, adverse events, and overall satisfaction with the anxiolytic agent.

Basal Cell Carcinoma Squamous Cell Carcinoma Skin Cancer Anxiety

mohs micrographic surgery skin cancer anxiety basal cell carcinoma squamous cell carcinoma midazolam versed

null

3

arm 1: Single-dose midazolam arm 2: None arm 3: None

[ 1, 2, 0 ]

4

[ 0, 10, 0, 0 ]

intervention 1: Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup. intervention 2: The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam. intervention 3: Lidocaine 1% with 1:100,000 epinephrine intervention 4: Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (\>45 to 77 kg, 10 mg; \>77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.

intervention 1: Randomized Midazolam intervention 2: Placebo intervention 3: Local Anesthesia intervention 4: Prospective Midazolam

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00578214

[ 3 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to assess how effective celecoxib is in limiting production of a hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression of an existing cancer. To answer this question, some subjects are given the new investigational drug, and other subjects a placebo. A placebo is a capsule that contains inactive ingredients. Only by comparing the response of two subject groups, one receiving placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or not celecoxib actually works. The outcome we are assessing is the hormone activity before and after celecoxib is given.

We propose to test the hypothesis that celecoxib, a specific inhibitor of cyclooxygenase -2 (COX-2), will effectively inhibit the enzymatic activity in all tissues sampled after oral administration of celecoxib for 7 days preoperatively. One hundred twenty patients (120) undergoing standard surgical resection for the treatment of primary colorectal adenomas or carcinomas would be randomized to celecoxib or placebo given for 7 days prior to operation. Peripheral blood will be drawn prior to drug or placebo administration, and then morning of operation. At the time of definitive resection of the specimen, normal intestinal mucosa and primary tumor would be harvested and immediately snap frozen at -80 degrees. Levels of COX-2 activity (prostaglandin production) as well as expression of COX-2 and other markers (matrix metalloproteinases(MMPs), tissue inhibitors of MMPs (TIMPs), cell adhesion and cell cycle control molecules will be evaluated in normal mucosa and primary tumor compared between celecoxib and placebo treated patients.

Colorectal Adenoma Colorectal Carcinoma

null

2

arm 1: 400 mg Celecoxib the study drug will be given for 7 days before surgery arm 2: Placebo in a one to one randomization prior to surgery

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 400 mg twice a day for 7 days prior to surgery intervention 2: one tablet of placebo will be given for 7 days prior to surgery

intervention 1: Celecoxib intervention 2: Placebo

1

Birmingham | Alabama | United States | -86.80249 | 33.52066

0

NCT00582660

[ 2, 3 ]

18

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

To evaluate and compare the effects on safety measures and clinical chemistry after BLI800 in two groups of patients and one group of healthy controls. The patient groups will be those with mild or moderate hepatic impairment or moderate renal disease.

null

Colonoscopy Bowel Preparation

null

3

arm 1: Patients with moderate renal impairment arm 2: Healthy volunteers arm 3: Patients with mild/moderate hepatic impairment.

[ 0, 1, 0 ]

1

[ 0 ]

intervention 1: BLI-800 oral solution (two doses)

intervention 1: BLI-800

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00583713

[ 0 ]

1

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

The study is designed to define the underlying vascular abnormalities present in patients with diastolic heart failure and test the effect of a therapy aimed at vascular abnormalities. This study is designed to investigate the effects of therapy with atorvastatin in subjects with diastolic heart failure to improve abnormalities of vascular and myocardial structure and function, with particular emphasis on arterial stiffness and endothelial dysfunction.

Forty subjects will be given either drug (atorvastatin 40 mg) or placebo in a randomized fashion once daily for six months. Using echocardiography, tonometry, and flow mediated dilation of conduit arteries and arterioles, baseline cardiovascular anatomy and physiology will be defined. Subjects that enroll in the study will be required to come in for 5 study visits. The initial visit is a screening visit; subject consent is obtained and an echocardiogram is performed as well as blood tests. At the randomization visit (4-14 days following screening), the subject will be provided with drug or placebo in a blinded fashion.Also at this visit, subjects will be asked to do a 6 minute walk, QOL questionnaire, and vascular function testing. There will be follow-up study visits at 1 and 3 months following randomization. At each follow-up visit a medical history, pill count and brief physical examination will be performed, a repeat QOL questionnaire administered, and blood tests to assess safety of the statin therapy. At 6 months, the final study visit will occur. At this visit a full history and detailed physical examination will be performed. Repeat echocardiogram, 6 minute walk test, QOL questionnaire, and vascular function examinations will be performed.

Diastolic Heart Failure

Heart Failure, Congestive

null

2

arm 1: Heart failure patients assigned to atorvastatin arm 2: None

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Atorvastatin - 40 mg orally daily for 6 months intervention 2: placebo

intervention 1: Atorvastatin intervention 2: placebo

1

Madison | Wisconsin | United States | -89.40123 | 43.07305

0

NCT00585611

[ 4 ]

130

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

Efficacy and safety study of bepotastine besilate ophthalmic solution in allergic conjunctivitis

null

Allergic Conjunctivitis

null

3

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

[ 0, 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution

intervention 1: Bepreve (bepotastine besilate ophthalmic solution) 1.5% intervention 2: placebo comparator intervention 3: Bepotastine Besilate Ophthalmic Solution 1.0%

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00586664

[ 2 ]

7

RANDOMIZED

null

0TREATMENT

1SINGLE

true

0ALL

false

A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The study involves each subject taking a 2- week supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving vigilance.

Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus patients by assessing pre-attentional and attentional processes (e.g., the amplitude of auditory evoked responses and simple reaction time).

Tinnitus

P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time

null

2

arm 1: None arm 2: None

[ 1, 2 ]

2

[ 0, 10 ]

intervention 1: 200 mg/day, morning dose intervention 2: Sugar pill once per day in the morning.

intervention 1: Modafinil intervention 2: Placebo

1

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

0

NCT00591019

[ 3 ]

51

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by mouth, it can be given daily over a long period of time. We think that temozolomidemay work best if it is given every day for 6 weeks at a time. Temozolomide given by this extended schedule is experimental, although we have found that it is safe and can shrink melanoma in some patients. One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it can be given daily over a long period of time rather than off and on like DTIC. We think that TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule is experimental although we have found that TMZ given in this way is safe and can shrink melanoma in some patients. When extended dosing TMZ was given with either thalidomide or long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in melanoma by themselves. In this study, we will treat patients with TMZ alone using this extended dosing schedule to see how many patients experience tumor shrinkage. We also want to learn more about which tumors are more likely to shrink from TMZ treatment. We will test samples of your tumor for whether or not a gene called MGMT has been turned on,

null

Melanoma

Memorial Sloan-Kettering Cancer Center patients with measurable, unresectable stage III or IV melanoma

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: One group treatment study

intervention 1: Temozolomide (TMZ)

1

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

0

NCT00591370

[ 3 ]

70

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back. The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.

null

Breast Cancer

breast cancer adenocarcinoma of the breast cardiac safety Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center

null

1

arm 1: single arm study

[ 0 ]

1

[ 0 ]

intervention 1: AC \[Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)\] Followed By Paclitaxel (P)

intervention 1: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)

1

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

0

NCT00591851

[ 3 ]

117

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

null

Primary Open Angle Glaucoma Ocular Hypertension

null

4

arm 1: A single drop of each, once daily in study eye for 28 days arm 2: A single drop of each, once daily in study eye for 28 days arm 3: A single drop of each, once daily in study eye for 28 days arm 4: A single drop of each, once daily in study eye for 28 days

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207. intervention 4: None

intervention 1: PF-03187207 intervention 2: Latanoprost 0.005% intervention 3: PF-03187207 Vehicle intervention 4: Latanoprost Vehicle

13

0

NCT00595101

[ 0 ]

1

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.

null

Uveal Melanoma

Melanoma Eye Avastin

null

1

arm 1: AVASTIN

[ 0 ]

1

[ 0 ]

intervention 1: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.

intervention 1: AVASTIN

1

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

0

NCT00596362

[ 0 ]

54

NON_RANDOMIZED

PARALLEL

7BASIC_SCIENCE

0NONE

true

0ALL

false

The purpose of this study is to determine, with Positron Emission Tomography (PET), the role of nitric oxide in the age-associated effect on fatty acid and glucose delivery on myocardial substrate metabolism.

Aging is associated with an increased incidence and severity of various cardiovascular disorders. Previously, our laboratory has demonstrated an age-related shift in the substrates used by the heart for metabolism from primarily fatty acids to primarily glucose. Furthermore, other institutions have demonstrated that a similar shift can be induced, in animal models, with specific nitric oxide synthase inhibitors, such as L-NAME (N-Nitro-L-Arginine Methyl Ester). Our hypothesis is that a reduction in nitric oxide (NO) synthesis is responsible for the age-related shift in heart function. Accordingly, we aim to demonstrate, in young patients, an acute, transient shift in substrate use from fatty acids to glucose with L-NMMA (citrate) in association with depressed heart function. Also, we aim to demonstrate in the elderly an acute, transient shift in substrate use from glucose to fatty acids with L-arginine, in association with improved cardiac function. These results will demonstrate a portion of the mechanism for the age-related shift in substrate utilization. Each participant will undergo a screening visit which will include a Glucose Tolerance Test, an echocardiogram in conjunction with a treadmill stress test to exclude cardiac disease, and baseline blood work. Then each patient will have 3 PET study days, each lasting about 5-6 hours. During this time, the patient will have two IVs (one in each arm). They will have 4 injections of different radioactive isotopes (015 Water, C11 Acetate, C11 Glucose, and C11 Palmitate). After each injection, about 8-10 blood samples will be drawn over the course of about ½ to 1 hour of time. In between each injection, there will be about an hour break for the patient to rest and move around. During one of the breaks, the patient will have another echocardiogram. On the day 2 and 3 PET, the patient will have a 30-60 minute infusion of L-NAME. Then the PET study will commence. After the study is over the participant will have a 10-minute infusion of L-arginine to reverse the effects of L-NAME.

Cardiovascular Diseases

PET Heart metabolism Nitric oxide Myocardial remodeling

null

5

arm 1: 20 individuals age 18-35 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME. arm 2: 25 individuals age 18-35 will be getting an infusion of phenylephrine (primarily an alpha agonist) during 3 separate PET study days arm 3: 20 individuals age 18-35 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days arm 4: 20 individuals age 60-75 will be getting an infusion of L-arginine 125 mcg/kg/min for 120 to 140 minutes during 3 separate PET study days arm 5: 20 individuals age 60-75 will be getting an infusion of L-NAME (a nitric oxide inhibitor) during 3 separate PET study days, then a 10-minute infusion of L-arginine to reverse effects of L-NAME

[ 1, 1, 1, 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: nitric oxide synthase inhibitor 4mg/kg infusion over 30-60 minutes prior to PET imaging intervention 2: aids in nitric oxide production intervention 3: alpha agonist; 10 μg/kg/min infusion during PET study

intervention 1: L-NAME intervention 2: L-Arginine intervention 3: Phenylephrine

1

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

0

NCT00603720

[ 3 ]

59

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

A three sequence, open-label, multi-center, prospective, study in stable liver transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules. Stable liver transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 14 days with one fixed dose change allowed at Day 15. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.

Liver Failure

Tacrolimus Pharmacokinetics Liver Transplantation

null

1

arm 1: Prograf was administrated BID, doses per product labeling, with an interval of 12±1 hours between the morning and evening doses. Patients continued on the same dose from Day 0 through Day 7. On Day 8, all patients were converted to LCP Tacro QD for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro was administered orally once daily in the morning, with an interval of 24 ± 1 h between doses. Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL. LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.

[ 0 ]

2

[ 0, 0 ]

intervention 1: In the morning of Day 8 (after completing one week treatment with Prograf), all patients will be converted to LCP Tacro QD with a conversion ratio of 0.66-0.8. LCP-Tacro will be administered for 14 Days with one fixed dose change allowed at Day 15. LCP-Tacro will be administered orally once daily in the morning, with an interval of 24 ± 1 h between doses. Trough levels were to be maintained within predefined therapeutic ranges of 5 to 15 ng/mL. intervention 2: Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day 0 through Day 7 to maintain target trough levels of 5-12 ng/mL.

intervention 1: LCP Tacro intervention 2: Prograf

1

Cincinnati | Ohio | United States | -84.51439 | 39.12711

0

NCT00608244

[ 5 ]

315

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to compare the effects (effectiveness and safety) of an intranasal corticosteroid (fluticasone furoate nasal spray \[FFNS\]), with a placebo nasal spray for the treatment of perennial (year-round) allergic rhinitis.

null

Rhinitis, Allergic, Perennial

Perennial allergic rhinitis; fluticasone furoate nasal spray

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo

37

0

NCT00609674

[ 3 ]

178

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.

null

Diabetes Diabetes Mellitus, Type 1

null

3

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

[ 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily intervention 4: Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin glargine intervention 4: insulin aspart

33

Walnut Creek | California | United States | -122.06496 | 37.90631 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Idaho Falls | Idaho | United States | -112.03414 | 43.46658 Des Moines | Iowa | United States | -93.60911 | 41.60054 Hyattsville | Maryland | United States | -76.94553 | 38.95594 Chattanooga | Tennessee | United States | -85.30968 | 35.04563 Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Renton | Washington | United States | -122.21707 | 47.48288 Wollongong | New South Wales | Australia | 150.89345 | -34.424 Keswick | South Australia | Australia | 138.57459 | -34.94178 East Ringwood | Victoria | Australia | N/A | N/A Geelong | N/A | Australia | 144.36069 | -38.14711 Miranda | N/A | Australia | 151.10005 | -34.03857 Aschaffenburg | N/A | Germany | 9.15214 | 49.97704 Bad Kreuznach | N/A | Germany | 7.86713 | 49.8414 Dresden | N/A | Germany | 13.73832 | 51.05089 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hohenmölsen | N/A | Germany | 12.1 | 51.15769 Neuwied | N/A | Germany | 7.47057 | 50.4336 Saint Ingbert | N/A | Germany | N/A | N/A Bergen | N/A | Norway | 5.32415 | 60.39299 Bergen | N/A | Norway | 5.32415 | 60.39299 Elverum | N/A | Norway | 11.56231 | 60.88191 Kristiansand | N/A | Norway | 7.9956 | 58.14671 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Alingsås | N/A | Sweden | 12.53345 | 57.93033 Karlstad | N/A | Sweden | 13.50357 | 59.3793 Lund | N/A | Sweden | 13.19321 | 55.70584 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Umeå | N/A | Sweden | 20.25972 | 63.82842

0

NCT00612040

[ 5 ]

345

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.

This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in participants with overactive bladder. The total study duration will be 12 weeks and will include following visits: Screening (Week -2), Baseline, Week 2, 4, 6 and 12. Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day. Efficacy will primarily be evaluated by assessment of goal achievement (percentage of participants who show a score 4 or 5 in the Likert scale for treatment goal) at Week 12. Participants' safety will also be monitored at each visit.

Urinary Bladder, Overactive

Overactive bladder Oxybutynin chloride OROS

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day.

intervention 1: Oxybutynin chloride OROS

0

null

0

NCT00613327

[ 5 ]

58

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

true

1FEMALE

false

The purpose of this study is to assess the level of pain women experience with an Essure procedure and the effect that lidocaine might have on that pain. We will also assess the absorption of lidocaine in the uterus by measuring lidocaine levels in the blood.

We intend to conduct a randomized, blinded, and placebo- controlled clinical trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette to determine if intrauterine lidocaine infusion will decrease the amount of pain subjects experience during and after Essure transcervical tubal sterilization. We plan to enroll women who have selected Essure as their method of tubal sterilization who will be randomized to one of two groups on the days of their procedures. Subjects in Group 1, the treatment group, will receive a standard paracervical block with lidocaine intrauterine infusion and subjects in Group 2, the control group, will receive a standard paracervical block with saline intrauterine infusion. The subjects will be asked to rate their pain on a 100 mm Visual Analog Scale (VAS) at five points during the procedure and once thirty minutes following the procedure. Subjects will also be asked to rate their overall satisfaction with their care prior to leaving the recovery room.

Pain

Essure sterilization pain management intrauterine lidocaine infusion

null

2

arm 1: Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization arm 2: Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 5 ml intrauterine infusion of 4% lidocaine using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes intervention 2: 5 ml intrauterine infusion of sterile saline using a sterile 3 mm Novak curette will be infused slowly over 4 1/2 minutes

intervention 1: Lidocaine intervention 2: Sterile Saline

2

0

NCT00613834

[ 3 ]

83

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

null

Papulopustular Rosacea

rosacea papulopustular azelaic acid foam

null

2

arm 1: Participants received azelaic acid foam, 15% topically twice daily for 12 weeks arm 2: Participants received vehicle foam topically twice daily for 12 weeks

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 15% foam to be applied topically twice daily intervention 2: Active-ingredient-free vehicle to be applied topically twice daily

intervention 1: Azelaic acid intervention 2: Vehicle foam

7

0

NCT00617903

[ 5 ]

67

RANDOMIZED

PARALLEL

4SUPPORTIVE_CARE

4QUADRUPLE

true

0ALL

false

The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.

Research Summary Purpose of Study This prospective, randomized, blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty (TKA) with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 0.5% in conjunction with a continuous femoral nerve catheter. We believe the results of this study will show an improvement in pain control and physical therapy outcomes compared to traditional methods of analgesia in post-op total knee arthroplasty. To the best of our knowledge, there are no studies in the literature using this combination of femoral nerve analgesia and posterior capsular injection. Certainly regional anesthesia methods such as femoral nerve blocks used alone or in conjunction with sciatic nerve blocks have improved patient pain outcome measures in total knee arthroplasty. Several studies have shown a beneficial effect of intra-articular analgesia after capsular closure. We believe our study design will combine the beneficial effects of the aforementioned methods, and ultimately improve patient pain, therapy effort, and safety through less narcotic use. Our goal is to share these results in a peer-reviewed journal, and at national orthopaedic or anesthesia meetings. The data collected will ideally improve care and safety in the post-operative total knee arthroplasty patient. Background and Significance Post-operative pain control in total knee arthroplasty is an area of great study in the orthopaedic surgery and anesthesia literature. The use of spinal/epidural alone or in combination with regional anesthesia is well studied in the recent literature. These techniques have significantly improved patient pain management, physical/occupational therapy outcomes, and shortened time to discharge. Additionally, intra-articular injection of local anesthetic after capsular closure has been studied recently. Several studies have demonstrated a beneficial effect of intra-articular local anesthetic on pain outcome measures (6, 8, 9, 10, 15). Although other studies have reported more equivocal results. The impact of capsular analgesia has on post-operative pain is intriguing. Decreased afferent pain perception by the capsular nerves from local anesthetic may improve outcomes, especially in sensory distributions where regional anesthesia is inadequate or not performed. Much study has centered on regional anesthesia, specifically the use of single shot or continuous femoral nerve blockade (4, 5, 11, 14, 16). Such studies have demonstrated a statistically significant decrease in total narcotic use, sedation scores, and visual analog pain scores. Femoral nerve blockade is now an accepted method of post-op pain control in the total knee arthroplasty patient. Further investigation has centered on the addition of sciatic nerve blockade to femoral nerve block (1-3, 7, 12, 13). Several studies demonstrate a further improvement in pain outcomes compared to isolated femoral nerve anesthesia. Sciatic nerve blocks can slow physical therapy efforts secondary to a dense motor blockade. Equivocal results have been reported in other studies due to this motor block, however, the sensory component appears to provide improved pain outcome measures. Femoral nerve blockade is a well-accepted modality for analgesia in total knee arthroplasty. However, femoral nerve block alone does not provide adequate anesthesia to the posterior aspect of the knee. We believe that intra-operative injection of ropivicaine 0.5% into the posterior capsule will provide analgesia analogous to the sensory component of a sciatic nerve block, while eliminating the limiting effects of the motor blockade. The combination of femoral nerve block and intra-operative posterior capsular injection will ideally yield improved pain management and physical therapy efforts above a baseline femoral nerve block. Design and procedures This is a prospective double-blinded, randomized trial consisting of two study groups: posterior capsular saline injection (control), and the experimental posterior capsular ropivicaine 0.5% injection group. All patients will receive spinal anesthesia and a continuous femoral nerve block. Each group will include 45 patients (n = 90 patients). All patients will have an elective primary total knee arthroplasty performed. No revision or bilateral cases will be included. Exclusion criteria will include patients with a known allergy to ropivicaine or fentanyl, a known history of narcotic abuse or chronic pain, a known diagnosis of peripheral neuropathy or complex regional pain syndrome, or a significant impediment to physical therapy participation. Following the informed consent process, patients will receive a continuous femoral nerve block via catheter placed by experienced regional anesthesiologists at our institution. Each patient will also receive spinal anesthesia for intra-operative pain control. A standard midline skin incision with medial para-patellar arthrotomy will be performed followed by implantation of either a Next Gen (Zimmer/Warsaw, IN), or Natural Knee II (Zimmer, Warsaw, IN), or Posterior Femoral Component (PFC) Sigma (DePuy, Warsaw, IN) system. Prior to surgery, patients will be randomized to the saline or ropivicaine groups. Both groups will receive their respective injection prior to implantation of the components. The posterior capsule of the knee will be divided in to four quadrants, each receiving a saline or ropivicaine injection per randomization. Safety measures will include standard pre-injection aspiration to check for vascular blush and intra-operative Doppler ultrasound to identify vascular structures in the posterior knee. Additionally, the anesthesiologist will not be blinded, as he/she will be responsible for assuring the appropriate medication is used, and will be closely monitoring for cardiac arrhythmias in the unlikely event that an intravascular injection occurs. Post-operatively, a standard bulky dressing will be applied. All patients will be weight bearing as tolerated post-operative day 1. A fentanyl PCA will be initiated in the PACU, and will be continued until post-operative day 2. Dosing will be calculated based on lean body mass. Continuous femoral nerve blockade will continue until post-operative day 2 as well. Outcomes will include total PCA narcotic use, visual analog pain scale with a diagram to localize pain, and Ramsey sedation scores. This data will be collected at the following intervals: in the PACU, 4, 8, 12, and 24 hours post-operatively. We will also measure post-operative day 1 knee range of motion, total ambulation distance, and time to straight leg raise. A standard, Institutional Review Board (IRB) approved, data collection sheet will be utilized. We hypothesize that total post-operative narcotic use, visual analog pain scores, and Ramsey sedation scores will be significantly lower in the study group (posterior capsular ropivicaine 0.5% injection). Additionally, we anticipate the knee range of motion, total ambulation distance, and time to straight leg raise to be significantly improved as well.

Osteoarthritis

null

2

arm 1: Subjects receive intra-op saline injection per protocol arm 2: Subjects receive intra-op Ropivicaine 0.5% injection per protocol

[ 2, 0 ]

2

[ 10, 0 ]

intervention 1: 20 cc of sterile, injectable saline intervention 2: Ropivicaine

intervention 1: Placebo saline injection intervention 2: Ropivicaine 0.5%

1

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

0

NCT00620828

[ 5 ]

596

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The study objective is to investigate the efficacy of levocetirizine in reducing symptoms associated with seasonal allergic rhinitis and in improving rhinitis-related Quality of Life

null

Seasonal Allergic Rhinitis

levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life

null

2

arm 1: Matched placebo tablets once daily arm 2: 5 mg levocetirizine dihydrochloride tablet

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: 5mg daily (oral tablet) for 14 days intervention 2: 0mg (matching oral tablet)for 14 days

intervention 1: levocetirizine dihydrochloride intervention 2: placebo

26

0

NCT00621959

[ 4 ]

66

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants switched from morphine preparations, oral oxycodone preparations, fentanyl citrate injection or fentanyl patch for cancer pain.

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 3 periods: Pre-treatment observation period (4-7 days), Treatment period (10 days) and Follow-up period (2 days). Treatment will be initiated at 12.5 microgram per hour (mcg/hr) and the initial dose of fentanyl will be determined based on the daily dose of the opioid analgesic taken by the participant before entering the study and will be maintained for 2 days to ensure safety of participants. Dose escalation or reduction will be as per the Investigator's discretion from Day 3 to Day 7 and thereafter dose will be again maintained from Day 7 to Day 9, ranging from 12.5 mcg/hr-100 mcg/hr and the maximum application dose will be 300 mcg/hr. The patch will be applied on areas including the chest, abdomen, upper arm or thigh and will be replaced daily for 10 days (a total of 9 applications; including the day of final patch removal). Efficacy will primarily be evaluated by visual analog scale (VAS) score. Participants' safety will be monitored throughout the study.

Pain Cancer

Pain Cancer Fentanyl JNS020QD

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Fentanyl 1-day application transdermal patch releasing the drug at the rate of 12.5 microgram per hour (mcg/hr) to 100 mcg/hr applied once daily, and maintained for 2 days. Dose escalation or reduction is as per Investigator's discretion (maximum applied dose is 300 mcg/hr) up to Day 7 and then dose is fixed for next 3 days that is Day 10 (end of treatment period).

intervention 1: Fentanyl

1

Kitakyushu | N/A | Japan | 130.85034 | 33.85181

0

NCT00641667

[ 3 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.

Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each. Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study Day 1. Each subject is their own intra-subject control with the alternative study drug (fomepizole or placebo) administered on the next day (Study Day 2). Four subjects in each cohort will receive study drug (fomepizole or placebo) administered 30 minutes prior to ethanol, 4 with study drug (fomepizole or placebo) administered 30 minutes after ethanol. The study will assess safety and tolerability of fomepizole and the PK/PD of 4-MP, ethanol and acetaldehyde in the subject population. Study with completed results acquired from Horizon in 2024.

Aldehyde Dehydrogenase-2 (ALDH2) Deficiency

acetaldehyde ethanol ALDH2

null

4

arm 1: Participants receive alternating study treatment (oral fomepizole 1.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. arm 2: Participants receive alternating study treatment (oral fomepizole 3.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol or 30 minutes after ethanol. arm 3: Participants receive alternating study treatment (oral fomepizole 5.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol. arm 4: Participants receive alternating study treatment (oral fomepizole 7.0 mg/kg or placebo) on 2 sequential days (Study Day 1 and Study Day 2), administered 30 minutes prior to ethanol.

[ 0, 0, 0, 0 ]

3

[ 0, 0, 10 ]

intervention 1: None intervention 2: None intervention 3: oral dose of ethanol (0.5 g/kg)

intervention 1: Antizol intervention 2: Placebo intervention 3: Ethanol

1

Honolulu | Hawaii | United States | -157.85833 | 21.30694

0

NCT00661141

[ 3 ]

63

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Because of its success in advanced NSCLC both as a single agent and in combination with other chemotherapeutics, it is reasonable to investigate the efficacy and toxicity of docetaxel as a multimodality regimen in this patient population. Docetaxel at a dose of 20 mg/m2 appears to be a well-tolerated "weekly" dose when combined with either cisplatin 25 mg/m2 20-22 or carboplatin area under the curve (AUC) 2 23-25 concomitant with radiation therapy. PURPOSE: To explore the potential benefits of the radiosensitizing effects of weekly docetaxel/carboplatin/radio therapy concurrent therapy followed full dose systemic docetaxel/carboplatin consolidation therapy on overall response rate, survival, progression-free survival, safety and toxicity in patients with locally advanced NSCLC.

OBJECTIVES: Primary * To determine the overall survival (0S) for advanced NSCLC patients receiving concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation therapy followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin. Secondary * To determine the overall response rate in patients treated with this regimen. * To determine the time to disease progression in patients treated with this regimen. * To assess the safety and tolerability of this regimen in these patients. OUTLINE: * This is a Phase II, open label, multi-center study to determine the overall survival rate for patients treated with concurrent chemoradiotherapy with weekly docetaxel, carboplatin and radiation followed by two cycles of consolidation chemotherapy with docetaxel and carboplatin. Eligible patients will receive concurrent therapy with docetaxel (20 mg/m2) administered weekly for seven weeks as a 30-minute intra-venous (IV) infusion followed by carboplatin (AUC 2) administered weekly for seven weeks as a 30-minute IV infusion. Concurrent radiation therapy will be administered at a dose of 1.8 Gy daily 5 days/week for 25 fractions followed by a dose of 2.0 Gy daily, 5 days/week for 9 fractions (total of 34 fractions). There will be a three-week rest period following the end of the concurrent chemotherapy after which the consolidation phase will begin. During this phase of the study, patients will be treated with docetaxel (75 mg/m2) administered as a 1-hour IV infusion followed by carboplatin (AUC 6) administered as a 30-minute IV infusion. Patient will be treated every three weeks for a total of two cycles.

Lung Cancer

stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer

null

1

arm 1: None

[ 0 ]

3

[ 0, 0, 4 ]

intervention 1: Carboplatin will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Carboplatin will be given once every three weeks as a 30-minute intravenous infusion immediately following the infusion of docetaxel. Patients will receive two cycles of consolidation treatment. intervention 2: Docetaxel will be given weekly for seven weeks beginning on Day 1 of the study as a 30-minute intravenous infusion during concurrent therapy. Docetaxel will be given once every three weeks administered as a one-hour IV infusion. Patients will receive two cycles of consolidation treatment (1 cycle = 3 weeks). intervention 3: Radiotherapy will be administered daily X 5 day/week for 34 days beginning on Day 1 of the study. Radiotherapy will follow immediately after the infusions of docetaxel and carboplatin.

intervention 1: Carboplatin intervention 2: Docetaxel intervention 3: radiation therapy

15

0

NCT00664105

[ 3 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

null

The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.

null

Pain

Analgesic effect

null

3

arm 1: None arm 2: None arm 3: Placebo matching AZD1386

[ 0, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 95mg, oral solution, single dose intervention 2: 500mg, capsule, single dose intervention 3: AZD1386 Placebo oral solution

intervention 1: AZD1386 intervention 2: Naproxen intervention 3: Placebo

1

Salt Lake City | Utah | United States | -111.89105 | 40.76078

0

NCT00672646

[ 4 ]

60

RANDOMIZED

CROSSOVER

null

0NONE

true

0ALL

false

Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.

Enrolled participants were divided into 2 groups, with 30 participants in each group. Group 1: This group was randomized into a 2-way crossover design with an added third period. These participants received single administrations (day 1 dosing only) of Zegerid Powder for Oral Suspension, and Prilosec OTC (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a minimum of a 2-week washout period between treatment legs. Following completion of the 2-way crossover study, and a subsequent washout period (minimum of 2 weeks), all participants then received a single administration of sodium bicarbonate (at same dose as contained in Zegerid Powder for Oral Suspension) in Period 3. This group underwent a 24-hour intragastric pH study on each of the 3 dosing occasions. Group 2: This group was randomized into a 2-way crossover design in which they received 7 days administration of Zegerid Powder for Oral Suspension and Prilosec OTC tablets, respectively. As with the prior group, there was a minimum of a 2-week washout period between treatment legs. Participants assigned to this treatment group also underwent 24-hour intragastric pH recordings on the days on which they received their 1st and last (7th) dose of the two treatment drugs. In addition to the above detailed procedures, all participants (both groups) underwent a 24-hour baseline intragastric pH study prior to starting their randomized treatments. This study design enabled all 60 participants to be evaluated for effects of the first dose of Prilosec OTC and Zegerid Powder for Oral Suspension on change in intragastric pH during the subsequent 24-hour period following the first dose.

Gastric Acid Human Experimentation

null

3

arm 1: Omeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension arm 2: Omeprazole magnesium 20 mg over-the-counter (OTC) Tablet arm 3: Sodium Bicarbonate 1680 mg Oral Suspension

[ 0, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Omeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days. intervention 2: Omeprazole 20 mg tablet. Single dose per day for either 1 or 7 days. intervention 3: Sodium bicarbonate. Single dose.

intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium intervention 3: sodium bicarbonate

0

null

0

NCT00674115

[ 3 ]

1,084

RANDOMIZED

PARALLEL

1PREVENTION

3TRIPLE

false

0ALL

true

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

null

Nonvalvular Atrial Fibrillation

Anticoagulant Treatment Risk Factors For Stroke

null

5

arm 1: AZD0837 450 mg arm 2: AZD0837 200 mg arm 3: AZD0837 300 mg arm 4: AZD0837 150 mg arm 5: Vitamin-K antagonist at INR 2-3

[ 0, 0, 0, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: ER tablet, PO, once daily for a period of 3-9 months. intervention 2: Tablet, PO for a period of 3-9 months. intervention 3: ER tablet, PO, twice daily for a period of 3-9 months

intervention 1: AZD0837 intervention 2: Vitamin-K antagonist at INR 2-3 intervention 3: AZD0837

0

null

0

NCT00684307

[ 5 ]

36

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To evaluate the efficacy of prednisolone acetate 1% ophthalmic suspension as compared to prednisolone acetate 0.12% ophthalmic suspension, loteprednol etabonate 0.2% ophthalmic suspension, and placebo (Tears Naturale® II) in the prevention of the signs and symptoms of allergic conjunctivitis. Comparisons will be made following 1 week of twice daily (BID) dosing and 1 week of four times daily (QID) dosing.

Structure: Prospective, single center, randomized, double-masked, parallel treatment comparison study. Subjects will be randomized to one of the following treatment arms to be dosed bilaterally twice daily (BID) for the first dosing period and four times daily (QID) for the second dosing period: 1. Prednisolone Acetate 1% ophthalmic suspension 2. Prednisolone Acetate 0.12% ophthalmic suspension 3. Loteprednol Etabonate 0.2% ophthalmic suspension 4. Tears Naturale® II Duration: Approximately four (4) weeks Controls: Artificial Tears (Tears Naturale® II)

Allergic Conjunctivitis

Allergic conjunctivitis

null

4

arm 1: Prednisolone acetate 1.0% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 2: Prednisolone acetate 0.12% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 3: Loteprednol Etabonate 0.2% in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. arm 4: Tears Naturale (Artificial Tears) in each eye BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

[ 1, 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 2: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 3: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days. intervention 4: One drop in both eyes (OU) BID starting at Visit 2 (Day 0) for 6 days. Then in each eye QID starting the day after Visit 5 (Day 21) for 6 days.

intervention 1: Prednisolone Acetate 1% intervention 2: Prednisolone Acetate 0.12% intervention 3: Loteprednol Etabonate 0.2% intervention 4: Placebo

1

Andover | Massachusetts | United States | -71.137 | 42.65843

0

NCT00689078

[ 2 ]

21

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

true

0ALL

false

To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.

null

Dry Eye

normal volunteers anti-infective tobramycin

null

3

arm 1: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension arm 2: TOBREX® Ophthalmic Solution arm 3: TOBRADEX® Ophthalmic Suspension

[ 0, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline intervention 3: TOBREX Ophthalmic Solution 1 drop each eye at baseline

intervention 1: TOBRADEX Ophthalmic Suspension intervention 2: Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension intervention 3: TOBREX Ophthalmic Solution

1

Fort Worth | Texas | United States | -97.32085 | 32.72541

0

NCT00695435

[ 3 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

Phase II systemic bioavailability crossover study to measure the exposure of Col-118 topical 0.18 % Facial Gel and Brimonidine Ophthalmic Solution 0.2%

A double-blind, randomized, 2-way crossover, safety, pharmacokinetic/-dynamic (PK/PD) study of 0.18% COL-118 facial gel and 0.2% brimonidine ophthalmic solution administered in male and female patients with moderate to severe erythematous rosacea. Twenty male and female subjects with moderate to severe erythematous rosacea will be randomized into 2 groups of 10 subjects. Each group will be randomized to receive 2 treatments (Treatments A and B, in Sequence 1: A/B or Sequence 2: B/A), as follows: Treatment A: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours; Treatment B: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically. There will be at least a 1-day washout between dose administrations (Period 1 and Period 2). Blood samples for PK analysis of brimonidine levels will be collected at the following time points during Period 1 and Period 2: 0 Hour (prior to dose) and at 1, 2, 3, 4 (prior to 2nd dose), 5, 6, 7, and 8 hours post-dose.

Erythematous Rosacea

erythematous rosacea facial gel brimonidine ophthalmic solution

null

2

arm 1: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after four hours arm 2: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically

[ 0, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours intervention 2: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically. intervention 3: One 1-g application of 0.18% COL-118 facial gel (1.8 mg brimonidine) administered topically plus one drop of Advanced Eye Relief™ in each eye, once in the morning. 1 g of 0.18% COL-118 facial gel is reapplied once after 4 hours intervention 4: One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically

intervention 1: 0.18% COL-118 facial gel (1.8 mg brimonidine) intervention 2: 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) intervention 3: Advanced Eye Relief intervention 4: COL-118 facial gel vehicle

1

Broomall | Pennsylvania | United States | -75.35658 | 39.9815

0

NCT00697541

[ 0 ]

99

NON_RANDOMIZED

PARALLEL

9OTHER

0NONE

true

0ALL

false

This study will examine activation of a brain circuit that regulates emotion in depressed patients before and after treatment to see which areas of the brain are involved in chronic depression.

Major depressive disorder can be a recurrent problem for many people, interfering with their ability to function normally in day-to-day life. Although research shows that activation in certain brain areas corresponds to certain emotional functions, it is not well known which specific changes in brain functioning are related to or caused by depression. A proposed theory holds that depression is related to abnormal regulation of emotions and thoughts. This study will focus particularly on a brain circuit involved in emotional regulation, which includes the amygdala, the affective division of the anterior cingulate (ACad), and dorsolateral prefrontal cortex (DLPFC). The amygdala detects critical emotional information, especially threats; the ACad judges relevance of motivational cues, detects conflict, and regulates emotional responses; and the DLPFC has a critical role in supporting a wide range of cognitive control functions. This study will compare brain scans from people with and without depression to attempt to clarify which changes in brain functioning are related to depression. Participation in this study will last 8 weeks. All participants will undergo initial screening in a telephone interview, then a diagnostic interview and brief physical examination. After passing through screening, participants will schedule a functional magnetic resonance imaging (fMRI) scan. The fMRI scan, lasting approximately 2 hours, will take pictures of both brain structure and brain functioning during different tasks. Also at this visit but outside the fMRI scanner, participants will be asked to complete an additional 2 hours of tasks on a computer. Depressed participants will then be given Lexapro, an approved drug for the treatment of depression. Participants taking Lexapro will go to scheduled doctor's visits after 2, 4, and 6 weeks of treatment to assess health, effectiveness of the drug, and side effects. On the eighth week, all participants will again undergo fMRI scanning and computer testing. At both the initial and follow-up fMRI study visits, images of brain function and anatomy will be recorded, heart rate will be monitored, and anxiety and arousal will be measured in the computer tests.

Depression

Emotional Circuitry fMRI

null

2

arm 1: The depressed participants in this arm will be given Lexapro. arm 2: The nondepressed participants in this arm will not be given any intervention for depression.

[ 0, 4 ]

1

[ 0 ]

intervention 1: 10 mg by mouth once per day for first 2 weeks, with psychiatric re-evaluation every 2 weeks to determine if any change in dosage is required, with a maximum of 20 mg per day

intervention 1: Lexapro

0

null

0

NCT00749125

[ 5 ]

296

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate whether familial relationships and psychological status of participants or caregivers as well as Attention Deficit Hyperactivity Disorder (ADHD) symptoms of participants can be improved by switching from Immediate-release Methylphenidate (IR-MPH) to Osmotic Release Oral Delivery System Methylphenidate (OROS-MPH).

This is a prospective (study following participants forward in time), single-arm, open-label (all people know the identity of the intervention), 8-week, multi-centric (conducted in more than 1 center) study. OROS-MPH will be administered orally for 2 months at doses of 18, 36, or 54 milligram (mg) to replace IR-MPH. Clinicians will adjust the dose of each participant according to participant's clinical responses and/or side effects. During the study period, participants will be assessed on Week 2, 4, and 8. Efficacy will be evaluated primarily based on change from baseline in Chinese version of the 26-item Swanson, Nolan and Pelham-Fourth Edition (SNAP-IV) rating scale assessed by parents and Chinese Health Questionnaire (CHQ). Safety will be monitored throughout the study.

Attention Deficit Disorder With Hyperactivity

Attention Deficit Disorder With Hyperactivity Methylphenidate Concerta

null

1

arm 1: Participants willl receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

[ 0 ]

1

[ 0 ]

intervention 1: Participants will receive Osmotic Release Oral Delivery System (OROS) methylphenidate (MPH) 18 milligram (mg), 36 mg or 54 mg once daily for 8 weeks. Dose will be adjusted for each participant based on clinical responses and/or side effects.

intervention 1: OROS Methylphenidate

0

null

0

NCT00758160

[ 5 ]

50

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

null

Dry Eye Syndromes

null

2

arm 1: Optive Eyedrops arm 2: Hylocomod Eyedrops

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: Eyedrops as required, but at least 3 times per day intervention 2: Eyedrops as required, but at least 3 times per day

intervention 1: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® intervention 2: Sodium hyaluronate

1

London | London | United Kingdom | -0.12574 | 51.50853

0

NCT00761202

[ 4 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

true

0ALL

false

Evaluate clinical efficacy of a prototype toothpaste on control of dental plaque gingival inflammation

null

Gingival Diseases

null

3

arm 1: commercially available Fluoride toothpaste arm 2: fluoride/triclosan/copolymer toothpaste arm 3: fluoride/herbal toothpaste

[ 2, 1, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Brush twice daily intervention 2: Brush twice daily intervention 3: Brush twice daily

intervention 1: Fluoride intervention 2: Triclosan and fluoride intervention 3: Herbal Ingredient and fluoride

1

Rochester | New York | United States | -77.61556 | 43.15478

0

NCT00761930

[ 4 ]

20

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

true

0ALL

false

The objective is to develop a method to determine active ingredient uptake in oral care products.

null

Dental Plaque

null

2

arm 1: fluoride toothpaste from Thailand arm 2: fluoride/triclosan/copolymer toothpaste

[ 2, 1 ]

2

[ 0, 0 ]

intervention 1: Brush half mouth once with assigned study treatment intervention 2: Brush half mouth once with assigned study treatment

intervention 1: Fluoride intervention 2: Fluoride and triclosan

1

Bangkok | Bangkok 10110 | Thailand | 100.50144 | 13.75398

0

NCT00762853

[ 0 ]

24

RANDOMIZED

CROSSOVER

2DIAGNOSTIC

2DOUBLE

false

0ALL

false

Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.

null

Allergic Rhinitis Allergic Conjunctivitis

allergy skin testing eye drops antihistamines

null

2

arm 1: participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days arm 2: participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day intervention 2: placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day

intervention 1: olopatadine intervention 2: placebo

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00775658

[ 4 ]

780

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.

The study will be carried out among children aged ≥ 8 to \< 14 years (boys) and ≥ 8 to \< 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.

Malaria Intermittent Preventive Treatment

Malaria Intermittent preventive treatment Efficacy Safety Tolerability Schoolchildren Uganda

null

4

arm 1: Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets arm 2: Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet) arm 3: Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya) arm 4: sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets

[ 1, 1, 2, 1 ]

4

[ 0, 0, 0, 10 ]

intervention 1: 25 mg/kg po once on day 0 intervention 2: Amodiaquine: 10 mg/kg po daily for 3 days (on days 0, 1, 2) SP: 25 mg/kg po once on day 0 intervention 3: 2.1/17.1 mg/kg daily for three days (on days 0, 1, 2) intervention 4: dosed as for amodiaquine (10mg/kg po daily on days 1, 2)

intervention 1: sulfadoxine-pyrimethamine intervention 2: amodiaquine + sulfadoxine-pyrimethamine intervention 3: dihydroartemisinin-piperaquine intervention 4: Placebo

0

null

0

NCT00852371

[ 4 ]

253

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

This was a phase III, 2-part multicenter study. Part I was an 26-week parallel-group, randomized, placebo-controlled design consisting of an 8 week baseline period, a 2 week double-blinded titration period, 12 week maintenance period, and a 4 week tapering-off period. After completing the baseline period, patients were randomized in a 1:1:1 ratio to 1 of the 2 ESL daily dose levels (1200 or 800 mg) or placebo. Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day. Patients who completed Part II could participate in a study extension and continue treatment with ESL until marketing authorization is obtained or clinical development is discontinued, with visits scheduled at the discretion of the investigator but at least every 6 months. Results from Part I \& II were presented in two separate reports.

Partial Epilepsy

epilepsy

null

4

arm 1: ESL 800mg daily arm 2: ESL 1200mg daily arm 3: placebo arm 4: All patients were treated with only ESL during Part II.

[ 0, 0, 2, 0 ]

3

[ 0, 0, 0 ]

intervention 1: oral tablet, 800 mg or 1200 mg once daily intervention 2: once daily placebo comparator intervention 3: Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

intervention 1: eslicarbazepine acetate intervention 2: placebo (Part I) intervention 3: ESL - Open-label Extension (Part II)

1

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

0

NCT00957372

[ 5 ]

42

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.

Introduction: Many complications in liver resection surgery, such as post-operative hepatic insufficiency, sepsis, and multi-organ liver failure, have been attributed to ischemia-reperfusion injury and the release of pro-inflammatory agents. Previous studies had shown that ketamine inhibited the synthesis of interleukin 6 (IL-6) in some cardiac surgeries, and that IL-6 levels had a direct correlation with mortality in critically ill patients. Goal: The purpose of our study was to determine the effect of ketamine on IL-6 levels in patients undergoing liver resections with temporary porto-arterial occlusion (Pringle maneuver). Material and Methods: Our prospective, controlled, randomized, and blinded study was approved by the Research Ethics Committee of the Hospital Italiano of Buenos Aires (CEPI). All procedures were carried out according to the Declaration of Helsinski. All patients voluntarily consented to the study and signed the appropriate informed consent approved by the CEPI. Inclusion criteria were age of 21 years or older and planned liver resection with Pringle maneuver lasting 30-60 minutes. Those with chronic illness requiring corticosteroids, cirrhosis, hemodynamic instability prior to the surgery, diabetes, sepsis, surgical interventions or chemotherapy treatments within the past 30 days, pregnancy, illnesses that could potentially affect the hepatic circulation, arterial or ocular hypertension (contraindications for the use of ketamine), ketamine allergy, preoperative portal embolization / radiofrequency ablation, or requiring emergency surgeries were not considered. From March 2002 to June 2008, 44 consecutive patients agreed to participate and were enrolled in the study. Those who did not require the Pringle maneuver during the resection, who did not undergo the planned procedure, or whose hematocrit was less than 20% for over 30 minutes were excluded. Patients were assigned to one of two groups according to a computer generated randomization. The study group received ketamine 0.25 mg/kg, while the control group was administered an identical volume of saline. Syringes containing 10 ml of either ketamine or saline were delivered by the hospital pharmacy personnel to the corresponding anesthesiologist, who was blinded to their contents. In order to calculate the correct dose that was administered immediately after induction of anesthesia, the ketamine and placebo concentration was established at 10 mg/ml. Both anesthesia and surgical teams were the same in all cases. Members of both teams, as well as all personnel involved with blood collection remained blinded at all times. All patients were transported to the operating room with an intravenous line in place and premedicated with midazolam 0.04 mg/Kg. Once in the operating room, they received intravenous antibiotics, non-invasive cardiac monitoring, blood pressure monitoring, and pulse oxymetry. Remifentanil 0.25 micrograms/kg/min was administered prior to induction with sodium thiopental 2-2.5 mg/Kg. Vecuronium 0.1 mg/Kg was used for muscle relaxation. After waiting approximately 3 minutes, patients were intubated endotracheally and a nasogastric tube was placed. Remifentanil 0.5 micrograms/kg/min, ibuprofen 10 mg/Kg, and morphine 0.15 mg/kg were administered during the case. Anesthesia was maintained with Sevorane in the setting of an FiO2 of 0.70. Mechanical ventilation was adjusted to allow an EtCO2 of 25-30 mmHg and a plateau pressure \< 30 cmH2O. An arterial line was placed after induction of anesthesia to serve for invasive monitoring as well as for blood sampling. A central line was placed in the right internal jugular vein to monitor intra-operative central venous pressure (CVP). All patients received body warmers and warmed fluids. We aimed for a CVP \< 5 cm H2O at the time of resection to diminish bleeding. Intravenous fursemide at doses of 10-20 mg as well as fluid restriction were employed when necessary in order to reach the desired value. Potassium levels were kept at or above 3.5 mmol/lt. Phenylephrine was used when necessary to maintain a median arterial pressure of at least 70 mmHg. Patients who underwent extensive resections were admitted to the Intensive Care Unit (ICU) and maintained on mechanical ventilation for 6-8 hours prior to extubation. In all other cases patients were extubated at the end of the procedure, observed in the post anesthesia care unit (PACU) for at least 8 hours, and subsequently transferred to the floor if hemodynamically stable. Pain management in patients extubated intraoperatively was with synthetic opioids (dextropropoxifen 1 mg/kg and dipyrone 2.5 mg. In cases of persistent pain (4 or more in a visual scale of 10), analgesia was supplemented with 2 mg of morphine every 20 minutes until relief of symptoms, somnolence, or a respiratory rate of 8 or less per minute was observed. Blood samples for IL-6 levels were obtained prior to surgery upon placement of the first intravenous line, and at 4, 12, 24, 72 and 120 hours after the Pringle maneuver, on the postoperative period. In all cases peripheral venous blood was sampled at a site where no contamination with any of the infused fluids could occur. Immediately after obtaining the sample, the blood was centrifuged, the plasma isolated, and frozen to -70 degrees centigrade. In all cases, two plasma tubes of each sample were individually labeled and stored. IL 6 was quantified by means of the IL 6 EASIA (BIOSOURCE, Europe Belgium) based on oligoclonal antibodies coupled with monoclonal antibodies to various IL 6 epitopes. This method showed sensitivity for both low and standard IL 6 ranges. The results expressed in our manuscript represent the mean of both samples obtained for each time point of the study. Statistical analysis Based on previous studies that reported a \> 100 picograms/mL difference among both groups with a SD \< 50 picograms/mL, we based our calculations on a predicted difference among both groups of 50 picograms/mL with a SD of 50 picograms/mL (17). Based on the fact that since sixteen patients in each group would allow rejection of the null hypothesis with an 80% confidence in the setting of a difference \>50 picograms/mL among both groups, a total of 36 patients were randomized. P\<0.05 was considered significant.

Hepatectomy

hepatectomy IL 6 organ failure ketamine Pringle

null

2

arm 1: Ketamine: 0.25 mg/kg, intravenously, one dose. arm 2: Placebo: saline solution

[ 0, 2 ]

2

[ 0, 10 ]

intervention 1: Ketamine: 0.25 mg/kg, intravenously, one dose. intervention 2: saline solution

intervention 1: Ketamine intervention 2: Placebo

1

Buenos Aires | N/A | Argentina | -58.37723 | -34.61315

0

NCT00978757

[ 3 ]

124

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

true

To compare intraocular pressure lowering effectiveness of a new fixed combination drug.

This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.

Primary Open Angle Glaucoma Ocular Hypertension

Open-angle glaucoma Ocular hypertension POAG Treatment

null

2

arm 1: IOP Dorzolamide-Timolol-Brimonidine group arm 2: IOP dorzolamide-timolol group

[ 1, 1 ]

1

[ 0 ]

intervention 1: Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will received 1 drop twice a day of either formulations.

intervention 1: dorzolamide-timolol-brimonidine

1

Montemorelos | Nuevo León | Mexico | -99.82865 | 25.18909

0

NCT01062971

[ 4 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

2MALE

false

Context: The treatment of alcoholism is a challenge for psychiatrists and patients. Some studies have shown that alcohol alters the environment of the membranes, mainly by modifying their permeability through the lipid fraction. These lipids are known as essential fatty acids (EFA) because they are obtained only through the diet, as the human body is unable to synthesize them. Linolenic acid (LA), or omega 6, and alpha-linolenic acid (ALA), or omega 3, are polyunsaturated fatty acids (PUFAs). Finally, ethanol changes the absorption and metabolism of PUFAs, and it's supplementation may be helpful for alcohol dependence recovery. Objective: to assess the effectiveness of PUFAs supplementation in the treatment of alcohol dependent patients.

null

Alcohol Dependence

PUFAs Alcoholism Treatment Effectiveness

null

4

arm 1: Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA; arm 2: Naltrexone chlorhydrate 50 mg arm 3: Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone; Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil. arm 4: Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA; Naltrexone chlorhydrate 50 mg

[ 0, 1, 2, 5 ]

4

[ 0, 0, 0, 0 ]

intervention 1: A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil. intervention 2: Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone. intervention 3: A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil). intervention 4: A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.

intervention 1: Naltrexone intervention 2: PUFAs intervention 3: Placebo intervention 4: Naltrexone + Placebo

1

São Paulo | São Paulo | Brazil | -46.63611 | -23.5475

0

NCT01211769

[ 2 ]

24

NON_RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

false

This was an open label, three way study in participants with symptomatic allergic rhinitis. The following 3 treatments were administered to each subject during dosing periods 1, 2 and 3, respectively: * Treatment A: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1. * Treatment B: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2. * Treatment C: Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3. Subjects remained resident in the Clinical Unit from Day 1 until the morning of Day 2 in each period and there was a washout period of 2 to 7 days between periods. A post study medical was performed within 7 days of Period 3. The objectives of this study were: * To assess the pharmacokinetics (PK) of intranasal ketorolac in participants with symptomatic allergic rhinitis. * To assess the effects of a single dose of intranasal oxymetazoline hydrochloride on the pharmacokinetics and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis. * To assess the effects of chronic administration of fluticasone propionate on the bioavailability and tolerability of intranasal ketorolac in participants with symptomatic allergic rhinitis.

null

Allergic Rhinitis

null

3

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

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1 intervention 2: Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2 intervention 3: Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3

intervention 1: Ketorolac Tromethamine intervention 2: Oxymetazoline Hydrochloride intervention 3: Fluticasone Propionate

1

Adelaide | N/A | Australia | 138.59863 | -34.92866

0

NCT01365650

[ 5 ]

31

NON_RANDOMIZED

PARALLEL

9OTHER

0NONE

true

0ALL

true

This study evaluated the blood levels of atazanavir according to a genetic makeup for CYP3A5 (cytochrome P450 3A5, an enzyme that metabolizes atazanavir). The hypothesis was that people with a slow-metabolizing genotype would have higher blood levels of atazanavir compared to people with the normal metabolizing genotype.

null

HIV

Pharmacokinetics Clinical Pharmacology Pharmacogenomics HIV

null

2

arm 1: A pre-screening genetic test determines CYP3A5 expressor status arm 2: A pre-screening genetic test determines CYP3A5 non-expressor status

[ 1, 1 ]

1

[ 0 ]

intervention 1: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days

intervention 1: Atazanavir

1

Aurora | Colorado | United States | -104.83192 | 39.72943

0

NCT01388543

[ 0 ]

197

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

true

1FEMALE

false

Objectives To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions: 1. To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills. 2. To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills. 3. To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills. Hypothesis Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.

null

Breast Feeding Contraception

Breastfeeding rates Contraceptive continuation Birth control pills Lactation

null

2

arm 1: Study Arm A is one of two interventions (Combined estrogen-progestin pill) arm 2: Study Arm B is one of two interventions (Progestin-only pill)

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo intervention 2: .35 mg norethindrone once a day orally

intervention 1: Combined estrogen-progestin pill intervention 2: Progestin-only pill

0

null

0

NCT01465022

[ 5 ]

150

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

null

Hepatitis B, Chronic

null

2

arm 1: Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up. arm 2: Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.

[ 0, 0 ]

1

[ 0 ]

intervention 1: Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

intervention 1: peginterferon alfa-2a [Pegasys]

7

Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 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 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT01519921