FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
38
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will evaluate whether AG-013736 when combined with cisplatin and gemcitabine shows activity and is safe in patients with squamous type of non-small cell lung cancer
null
Carcinoma, Non-Small-Cell Lung (NSCLC)
AG-013736 axitinib cisplatin gemcitabine NSCLC squamous cell lung cancer
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: AG-013736 5 mg tablets orally, twice daily, until disease progression intervention 2: 200-mg or 1 g lyophilized powder, to be administered as 1250 mg/m\^2 IV infusion on Day 1 and Day 8 of 21-day cycle. For a maximum of 6 cycles intervention 3: 1mg/ml solution or as lyophilized powder, to be administere...
intervention 1: AG-013736 intervention 2: gemcitabine intervention 3: cisplatin
10
Torun | N/A | Poland | 18.59814 | 53.01375 Wodzislaw Sl. | N/A | Poland | N/A | N/A Cluj-Napoca | Cluj | Romania | 23.6 | 46.76667 Bucharest | N/A | Romania | 26.10626 | 44.43225 Oradea | N/A | Romania | 21.91833 | 47.0458 Parktown | N/A | South Africa | 28.02671 | -26.18205 Dnipropetrovsk | N/A | Ukraine | 35.04066 | ...
38
0
0
0
NCT00735904
1COMPLETED
2011-11-01
2008-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don...
null
Neovascular Age Related Macular Degeneration
ARMD AMD exudative AMD
null
2
arm 1: Ranibizumab injections every month for 12 months. arm 2: Ranibizumab injections monthly for 4 months then as needed thereafter.
[ 1, 1 ]
2
[ 1, 0 ]
intervention 1: OCT performed monthly. Fluorescein Angiography performed at baseline, month 3, month 5, month 8 and month 12. Microperimetry performed at baseline, month 3, month 5, month 8, and month 12 for monthly ranibizumab and at baseline, month 3, month 5 through month 12 for as needed ranibizumab. Multifocal E...
intervention 1: OCT, Multifocal ERG, Microperimetry intervention 2: Ranibizumab Ophthalmic
1
Torrance | California | United States | -118.34063 | 33.83585
77
0
0
0
NCT00764738
1COMPLETED
2011-11-01
2008-10-01
Retina Macula Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
719
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), wit...
null
Hepatitis C, Chronic
null
7
arm 1: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients arm 2: 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 we...
[ 0, 0, 2, 0, 0, 0, 0 ]
14
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: 240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks intervention 2: PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks intervention 3: 120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks intervention 4: PegIFN (180 µg/wk) and RBV (1000/1200mg/d),4...
intervention 1: BI 201335 NA 240 mg QD / LI intervention 2: PegIFN/RBV intervention 3: BI 201335 NA 120mg QD / LI intervention 4: PegIFN/RBV intervention 5: BI 201335 NA 240 mg QD intervention 6: PegIFN/RBV intervention 7: BI 201335 NA 240 mg QD intervention 8: PegIFN/RBV intervention 9: BI 201335 NA 240 mg BID interve...
100
San Francisco | California | United States | -122.41942 | 37.77493 San Francisco | California | United States | -122.41942 | 37.77493 Chicago | Illinois | United States | -87.65005 | 41.85003 Lutherville | Maryland | United States | -76.62608 | 39.42122 New York | New York | United States | -74.00597 | 40.71427 New Yor...
712
0
0
0
NCT00774397
1COMPLETED
2011-11-01
2008-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
15
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
true
0ALL
false
To determine whether the combination of ezetimibe and simvastatin improves biomarkers of atherothrombosis compared to simvastatin alone in patients with the metabolic syndrome.
1. To assess the ex vivo effects of ezetimibe/simvastatin (E/S) (Vytorin 10/40mg) and simvastatin (S) (Zocor 40mg) on platelet and inflammation biomarkers in patients with documented metabolic syndrome. 2. To compare platelet-related effects including PAR-1 receptor inhibition of E/S with those of the established anti-...
Metabolic Syndrome
triglycerides hypertension low hdl obesity
null
2
arm 1: Simvastatin 40 mg daily arm 2: Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. intervention 2: Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.
intervention 1: simvastatin intervention 2: ezetimibe/simvastatin
3
Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038
30
0
0
0
NCT00819403
1COMPLETED
2011-11-01
2009-01-01
University of Maryland, Baltimore
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
15
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to evaluate the Patent Ductus Arteriosus (PDA) closure rate of early vs. late use of Ibuprofen (Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate than later use of Ibu. Early use is defined as medication given before the infant reaches 96 hrs old. Late us...
Infants with birth weight at \<1200gm and/or \<28 weeks gestation who have been diagnosed with a Patent Ductus Arteriosus (PDA) qualify for the study if there are no contraindications to treatment. Infants are randomized into treatment arms of \<96 hrs old and \>96 hrs old. Ibuprofen is given in the dosage of 10 mg/kg ...
Patent Ductus Arteriosus Prematurity
premature infants PDA ibuprofen
null
2
arm 1: Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old arm 2: Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose intervention 2: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
intervention 1: Ibuprofen intervention 2: Ibuprofen
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
15
0
0
0
NCT00833365
6TERMINATED
2011-11-01
2009-01-01
University of Utah
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
295
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.
null
Epilepsy
Epilepsy Monotherapy
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respect...
intervention 1: Zonisamide intervention 2: Carbamazepine
133
Camperdown | New South Wales | Australia | 151.17642 | -33.88965 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Clayton | Victoria | Australia | 145.11667 | -37.91667 Fitzroy | Victoria | Australia | 144.97833 | -37.79839 Heidelberg West | Victoria | Australia | 145.04034 | -37.73922 Parkville | Vic...
876
0
0
0
NCT00848549
1COMPLETED
2011-11-01
2008-10-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
13
NON_RANDOMIZED
SEQUENTIAL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep the cancer cell from...
OUTLINE: This is a multicenter study. * Induction therapy: Patients receive zidovudine IV twice daily on days 1-14, and recombinant interferon alfa-2b IV twice daily on days 3-14. Patients achieving clinical complete response (CR) proceed to part 1 maintenance therapy; patients achieving partial response (PR) receive ...
Lymphoma Precancerous/Nonmalignant Condition
recurrent adult T-cell leukemia/lymphoma stage I adult T-cell leukemia/lymphoma stage II adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma HTLV-1 infection
null
4
arm 1: For one cycle, up to Day 21. All participants are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR). Participants who achieve a clinical CR at Day 14 response assessment will go on to Part 1 maintenance therapy. Patient...
[ 0, 0, 0, 0 ]
4
[ 2, 2, 0, 0 ]
intervention 1: Administered subcutaneously. intervention 2: Administered intravenously. intervention 3: Administered orally. intervention 4: Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B).
intervention 1: PEG-interferon alfa-2b intervention 2: Interferon alfa-2b intervention 3: Valproic Acid intervention 4: Zidovudine
1
Miami | Florida | United States | -80.19366 | 25.77427
25
0
0
0
NCT00854581
6TERMINATED
2011-11-01
2007-11-01
University of Miami
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
1SINGLE
false
0ALL
false
The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.
null
Parkinson's Disease
amyloid burden Parkinson's disease florbetapir PET amyloid PET imaging
null
3
arm 1: Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores of ≥9, indicating normal cognitive performance. arm 2: Subjects with age-and education-adjusted standardized Mattis Dementia Rating Scale scores between 6 and 8, inclusive, indicating mild cognitive deficits. arm 3: Subject...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: 10 millicurie (mCi) (370 MBq) florbetapir F 18 Injection
intervention 1: florbetapir F 18
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
31
0
0
0
NCT00857532
1COMPLETED
2011-11-01
2009-01-01
Avid Radiopharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
26
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Everolimus is an oral mTOR inhibitor with demonstrated preliminary efficacy and safety in diffuse large B-cell lymphoma (DLBCL) in both preclinical and clinical studies. The purpose of this research study is to determine whether Everolimus plus rituximab is safe and effective in participants with relapsed or refractory...
Participants will receive oral Everolimus and intravenous rituximab for DLBCL that has relapsed or been refractory to prior therapy. * Each treatment cycle lasts 28 days (4 weeks). Everolimus will be taken orally, once daily in the morning. * Rituximab will be administered by an intravenous (IV) infusion on Days 1, 8,...
Diffuse Large B-cell Lymphoma
rituximab everolimus DLBCL mTOR
null
0
null
null
2
[ 0, 0 ]
intervention 1: Taken orally once daily in the morning intervention 2: Given intravenously on Days 1, 8, 15, and 22 of Cycle 1 then on Day 1 of cycles 2-6
intervention 1: Everolimus intervention 2: rituximab
2
Boston | Massachusetts | United States | -71.05977 | 42.35843 Boston | Massachusetts | United States | -71.05977 | 42.35843
24
0
0
0
NCT00869999
1COMPLETED
2011-11-01
2009-05-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blo...
PRIMARY OBJECTIVES: I. To evaluate the response by prostate specific antigen (PSA) of docetaxel/prednisone plus sunitinib (sunitinib malate) in chemotherapy-naive, hormone refractory prostate cancer subjects with biochemical relapse. SECONDARY OBJECTIVES: I. To determine the objective response rate (ORR) and duratio...
Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer
null
1
arm 1: Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat ...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Given PO intervention 2: Given IV intervention 3: Given PO
intervention 1: sunitinib malate intervention 2: docetaxel intervention 3: prednisone
1
Orange | California | United States | -117.85311 | 33.78779
4
0
0
0
NCT00879619
6TERMINATED
2011-11-01
2009-07-01
John P. Fruehauf
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
214
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Oxcarbazepine Extended-Release (OXC XR)
NAP
Partial Epilepsy
null
1
arm 1: Open Label Study
[ 5 ]
1
[ 0 ]
intervention 1: Open Label Study
intervention 1: Oxcarbazepine XR
58
Huntsville | Alabama | United States | -86.58594 | 34.7304 Northport | Alabama | United States | -87.57723 | 33.22901 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Riverside | California | ...
214
0
0
0
NCT00908349
1COMPLETED
2011-11-01
2009-06-01
Supernus Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
2
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine if administration of pasireotide LAR for one year to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
Gonadotroph adenomas are the most common pituitary macroadenomas. Currently no medical treatment as been found that decreases the size of these adenomas, so surgery is the only treatment. The reason to think that pasireotide might affect gonadotroph adenomas is that pasireotide binds avidly to somatostatin subtype 5 re...
Gonadotroph Adenomas
pituitary tumor endocrine
null
1
arm 1: 80 mg IM once monthly
[ 0 ]
1
[ 0 ]
intervention 1: pasireotide LAR 80 mg IM once a month
intervention 1: pasireotide LAR
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
2
0
0
0
NCT00929669
6TERMINATED
2011-11-01
2009-06-01
University of Pennsylvania
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
12
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
true
0ALL
false
DESCRIPTION: (Verbatim from the Applicant's Abstract) Abnormalities of eye movement control and spatial cognition are well-established deficits in schizophrenia. However, the regional disturbances in brain function causing these deficits are not yet known. This application proposes a series of integrated behavioral stu...
We will be assessing clinical symptoms and cognition before and after treatment.
Schizophrenia
schizophrenia antipsychotic risperidone
null
1
arm 1: Antipsychotic
[ 0 ]
1
[ 0 ]
intervention 1: Risperidone is the first line antipsychotic followed by others per clinician choice. Flexible dosing QD x 4-6 weeks.
intervention 1: Antipsychotic
1
Chicago | Illinois | United States | -87.65005 | 41.85003
12
0
0
0
NCT00931996
6TERMINATED
2011-11-01
2009-06-01
University of Illinois at Chicago
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
60
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.
This was a one year long-term safety study of HPN-100 in UCD subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication. Forty subjects wi...
Urea Cycle Disorders
Urea Cycle Disorder UCD hyperammonemia Buphenyl Sodium Phenylbutyrate
null
1
arm 1: Patients who were treated with HPN-100
[ 0 ]
1
[ 0 ]
intervention 1: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do.
intervention 1: HPN-100
22
Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Stanford | California | United States | -122.16608 | 37.42411 Aurora | Colorado | United States | -104.83192 | 39.72943 New Haven | Connecticut | United States | -72.92816 | 41.30815 Washingt...
60
0
0
0
NCT00947297
1COMPLETED
2011-11-01
2009-11-01
Amgen
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
9
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
0NONE
false
0ALL
true
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss...
OBJECTIVES: Primary * To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss. Secondary * To c...
Leukemia Lymphoma Malnutrition Myelodysplastic Syndromes Unspecified Childhood Solid Tumor, Protocol Specific Weight Changes
malnutrition weight changes childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia untreated childhood acute myeloid leukemia other myel...
null
2
arm 1: Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity. arm 2: Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\> 10 years of age) twice daily for up to 24 weeks i...
[ 0, 0 ]
3
[ 7, 7, 0 ]
intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally
intervention 1: Ensure intervention 2: PediaSure intervention 3: cyproheptadine hydrochloride
0
null
9
0
0
0
NCT00949117
6TERMINATED
2011-11-01
2009-09-01
University of South Florida
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the us...
null
Nerve Block
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % intervention 2: 20mL de ropivacaïne 0,5 %
intervention 1: levobupivacaïne 0,5 % intervention 2: ropivacaïne 0,5 %
1
Nantes | N/A | France | -1.55336 | 47.21725
35
0
0
0
NCT00956709
6TERMINATED
2011-11-01
2008-12-01
Nantes University Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
67
NA
SINGLE_GROUP
null
0NONE
false
0ALL
null
RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking. PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.
OBJECTIVES: Primary * To assess the impact of factual information (a fact sheet) about the relative harms of smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about relative harmfulness. * To assess the impact of trying samples of NR and/or SL products on intentions to use such products as al...
Bladder Cancer Cervical Cancer Esophageal Cancer Gastric Cancer Head and Neck Cancer Kidney Cancer Leukemia Liver Cancer Lung Cancer Pancreatic Cancer Tobacco Use Disorder
tobacco use disorder bladder cancer cervical cancer esophageal cancer gastric cancer renal cell carcinoma adult primary liver cancer non-small cell lung cancer small cell lung cancer pancreatic cancer hypopharyngeal cancer laryngeal cancer lip and oral cavity cancer nasopharyngeal cancer oropharyngeal cancer paranasal ...
null
1
arm 1: Single-armed study
[ 5 ]
5
[ 5, 0, 10, 10, 10 ]
intervention 1: 10-15 minute web-based survey on a computer intervention 2: One week supply intervention 3: None intervention 4: None intervention 5: Given out week 2, 3 and 4.
intervention 1: telephone-based intervention intervention 2: nicotine replacement therapy intervention 3: informational intervention intervention 4: internet-based intervention intervention 5: questionnaire administration
1
Buffalo | New York | United States | -78.87837 | 42.88645
59
0
0
0
NCT00957424
1COMPLETED
2011-11-01
2009-06-01
Roswell Park Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
25
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to conduct a clinical trial of two formulations of budesonide (nebulized/swallowed versus viscous/swallowed) in patients with EoE to determine if medication contact time and distribution in the esophagus relates to treatment response. The investigators will also determine if there is system...
null
Eosinophilic Esophagitis
eosinophilic esophagitis
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: medication will be nebulized and then swallowed intervention 2: viscous suspension of budesonide will be swallowed
intervention 1: inhaled/swallowed budesonide intervention 2: viscous/swallowed budesonide
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
22
0
0
0
NCT00961233
1COMPLETED
2011-11-01
2009-10-01
University of North Carolina, Chapel Hill
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
169
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The purpose of this study is to assess the safety and effectiveness of S-equol in menopausal patients with hot flushes and night sweats.
The study is a randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of 3 doses of S-equol to placebo in menopausal patients with vasomotor symptoms. The study objective is an evaluation of the dose response of 3 dose levels o...
Menopause
null
4
arm 1: Placebo arm 2: S-equol 20 mg total daily dose arm 3: S-equol 100 mg total daily dose arm 4: S-equol 300 mg total daily dose
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: Eligible patients meeting all study entry criteria were randomly assigned to receive one of the following active treatments for 4 weeks: * S-equol 10 mg BID (20 mg total daily dose) * S-equol 50 mg BID (100 mg total daily dose) * S-equol 150 mg BID (300 mg total daily dose)
intervention 1: Placebo intervention 2: S-equol
9
Louisville | Kentucky | United States | -85.75941 | 38.25424 Cincinnati | Ohio | United States | -84.51439 | 39.12711 Cleveland | Ohio | United States | -81.69541 | 41.4995 Greenville | South Carolina | United States | -82.39401 | 34.85262 West Jordon | Utah | United States | N/A | N/A Ashfield | New South Wales | Aust...
169
0
0
0
NCT00962585
1COMPLETED
2011-11-01
2010-06-01
Ausio Pharmaceuticals, LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
344
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to 11 months of age.
Rabeprazole sodium belongs to the class of drugs known as proton pump inhibitors, which suppress gastric acid secretion. The drug is approved in the United States for the treatment of adults with GERD and other acid-related gastrointestinal disorders, and has been studied in adolescents (older than 12 years of age) wit...
Gastroesophageal Reflux
Gastroesophageal Reflux Gastroesophageal Reflux Disease GERD Proton Pump Inhibitor PPI Regurgitation Infants AcipHex, PARIET ALFENCE
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Rabeprazole Sodium 5 mg capsules once daily in the morning. intervention 2: Rabeprazole Sodium 10 mg capsules once daily in the morning. intervention 3: Matching placebo capsules once daily in the morning.
intervention 1: Rabeprazole sodium 5 mg intervention 2: Rabeprazole sodium 10 mg intervention 3: Placebo
81
Birmingham | Alabama | United States | -86.80249 | 33.52066 Columbiana | Alabama | United States | -86.60721 | 33.17817 Dothan | Alabama | United States | -85.39049 | 31.22323 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United St...
611
0
0
0
NCT00992589
1COMPLETED
2011-11-01
2009-11-01
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 day...
null
Postoperative Pain
Post operative pain Local anaesthesia Postoperative pain after arthroscopic shoulder surgery
null
6
arm 1: double-blind arm 2: double-blind arm 3: double-blind arm 4: double-blind arm 5: double-blind arm 6: double-blind
[ 0, 2, 1, 0, 2, 1 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: 5.0 ml intervention 2: 5.0 ml intervention 3: 20.0 ml intervention 4: 7.5 ml intervention 5: 7.5 ml intervention 6: 20.0 ml
intervention 1: SABER-Bupivacaine Treatment 1a intervention 2: Placebo SABER-Bupivacaine Treatment 1b intervention 3: Bupivacaine HCl Treatment 1c intervention 4: SABER-Bupivacaine Treatment 2a intervention 5: Placebo SABER-Bupivacaine Treatment 2b intervention 6: Bupivacaine HCl Treatment 2c
10
Graz | N/A | Austria | 15.45 | 47.06667 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Berlin | N/A | Germany | 13.41053 | 52.52437 Dresden | N/A | Germany | 13.73832 | 51.05089 Marburg | N/A | Germany | 8.77069 | 50.80904 Riga | N/A | Latvia | 24.10589 | 56.946 Valmiera | N/A...
107
0
0
0
NCT00993798
1COMPLETED
2011-11-01
2009-04-01
Durect
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
837
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the safety and tolerability of azilsartan medoxomil plus chlorthalidone, once daily (QD), versus olmesartan medoxomil-hydrochlorothiazide in adults with essential hypertension.
High Blood Pressure (Hypertension) is the most common cause of preventable death in developed nations. Uncontrolled hypertension greatly increases the risk of heart disease, brain disease, and kidney failure. As the population ages, the incidence of hypertension will continue to increase if effective preventive measure...
Essential Hypertension
Hypertensive Blood Pressure, High Cardiovascular disease Vascular Disease Drug Therapy
null
2
arm 1: Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. arm 2: Participants in the United States: Ol...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Combination tablet. intervention 2: Combination tablet.
intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Olmesartan medoxomil and hydrochlorothiazide
26
Graz | Styria | Austria | 15.45 | 47.06667 Karlsruhe | Baden-Wurttemberg | Germany | 8.40444 | 49.00937 Hanover | Lower Saxony | Germany | 9.73322 | 52.37052 Kiel-Kronshagen | Schleswig-Holstein | Germany | N/A | N/A Breda | North Brabant | Netherlands | 4.77596 | 51.58656 Eindhoven | North Brabant | Netherlands | 5.47...
837
0
0
0
NCT00996281
1COMPLETED
2011-11-01
2009-10-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
22
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if treatment with paricalcitol, an active form of vitamin D, has beneficial effects on metabolic abnormalities in people with stage 3-4 Chronic Kidney Disease (CKD).
Persons with chronic kidney disease (CKD) are at markedly increased risk of death, particularly from cardiovascular disease (CVD). A number of metabolic abnormalities may contribute to adverse health outcomes in CKD, including glucose intolerance, altered immune cell function, and oxidative stress. Each of these metabo...
Chronic Kidney Disease
Chronic kidney disease Vitamin D Paricalcitol Placebo Kidney Renal Oxidative Stress Immune cell function Glucose Glucose tolerance
null
2
arm 1: Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. arm 2: Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Two 1 mcg soft gels by mouth daily for 8 weeks intervention 2: Two soft gels by mouth daily for 8 weeks
intervention 1: Paricalcitol intervention 2: Placebo
1
Seattle | Washington | United States | -122.33207 | 47.60621
43
0
0
0
NCT01003275
1COMPLETED
2011-11-01
2009-10-01
University of Washington
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
43
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.
null
Carcinoma, Non-Small-Cell Lung
null
1
arm 1: patient to receive afatinib(BIBW 2992) po QD in an open-label manner
[ 0 ]
1
[ 0 ]
intervention 1: afatinib (BIBW 2992) po QD
intervention 1: afatinib (BIBW 2992)
3
Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566
42
0
0
0
NCT01003899
1COMPLETED
2011-11-01
2009-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
If subjects are listed for kidney transplant and are considered sensitized, this means they have a high amount of antibodies in their blood that could react to a kidney transplant offered for them. Antibodies are protein substances made by the body that fight anything that the body considers as a threat to it, such as ...
Approximately one third of patients awaiting kidney transplant at our transplant center have significant levels of antibodies in their blood leading to a longer wait time for a kidney transplant and death. Antibodies in the blood may be due to prior transplants, pregnancy, or blood transfusions. These antibodies sensit...
Desensitization
belimumab Benlysta LymphoStat B BLyS specific inhibitors
null
1
arm 1: Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have f...
[ 0 ]
1
[ 0 ]
intervention 1: Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time ...
intervention 1: Belimumab
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
8
0
0
0
NCT01025193
6TERMINATED
2011-11-01
2010-02-01
University of Pennsylvania
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the response rate by RECIST criteria of oral dichloroacetate in patients with recurrent and/or metastatic and pretreated breast and non-small cell lung cancer.
In the United States, approximately 180,000 new cases of breast cancer occur annually, and there are more than 40,000 deaths. More than 150,000 cases develop each year in Canada and the European community together, resulting in over 60,000 deaths from breast cancer. The vast majority of patients who die from breast can...
Metastatic Breast Cancer Lung Cancer
metastatic breast cancer lung cancer Previously treated metastatic breast cancer stage IIIb lung cancer stage IV lung cancer
null
1
arm 1: Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
[ 0 ]
1
[ 0 ]
intervention 1: Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart
intervention 1: Dichloroacetate (DCA)
1
Los Angeles | California | United States | -118.24368 | 34.05223
7
0
0
0
NCT01029925
6TERMINATED
2011-11-01
2009-12-01
Jonsson Comprehensive Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
773
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of...
null
Major Depressive Disorder
OPC-34712 Major Depressive Disorder Adjunctive Treatment
null
2
arm 1: OPC-34712 Tablets, Oral, 1 - 3 mg OPC-34712 + ADT arm 2: Placebo + ADT
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets, Oral, 1 - 3 mg OPC-34712 intervention 2: Placebo intervention 3: None
intervention 1: OPC-34712 intervention 2: Placebo intervention 3: ADT
43
Birmingham | Alabama | United States | -86.80249 | 33.52066 Arcadia | California | United States | -118.03534 | 34.13973 Beverly Hills | California | United States | -118.40036 | 34.07362 Oceanside | California | United States | -117.37948 | 33.19587 San Diego | California | United States | -117.16472 | 32.71571 Santa ...
372
0
0
0
NCT01052077
1COMPLETED
2011-11-01
2010-03-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
null
Diabetic Foot Ulcers Foot Wounds
Diabetic Foot Ulcers Diabetic Foot Wounds
null
2
arm 1: 2 mm Santyl applied once daily arm 2: Daily gauze and optional sharp debridement
[ 1, 3 ]
2
[ 0, 3 ]
intervention 1: 2 mm Santyl applied once daily. intervention 2: Daily gauze and optional sharp debridement
intervention 1: Santyl intervention 2: Control
9
Phoenix | Arizona | United States | -112.07404 | 33.44838 Lincoln | Nebraska | United States | -96.66696 | 40.8 Altoona | Pennsylvania | United States | -78.39474 | 40.51868 Langhorne | Pennsylvania | United States | -74.92267 | 40.17455 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Arlington | Tex...
48
0
0
0
NCT01056198
1COMPLETED
2011-11-01
2010-02-01
Healthpoint
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
427
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.
null
Prevention
Gastric ulcer Duodenal ulcer Low-dose aspirin
null
2
arm 1: Esomeprazole 20mg once daily oral arm 2: Placebo once daily oral
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 20mg, capsule, 72 weeks intervention 2: Placebo, capsule, 72 weeks
intervention 1: Esomeprazole intervention 2: Placebo
46
Yotsukaidou | Chiba | Japan | N/A | N/A Fukui-shi | Fukui | Japan | 136.22257 | 36.06443 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Kitakyushu-Shi | Fukuoka | Japan | N/A | N/A Onga-Gun | Fukuoka | Japan | N/A | N/A Yukuhashi | Fukuoka | Japan | 130.983 | 33.72873 Fukushima | Fukushima | Japan | 140.46667 | 37.75 Kōr...
427
0
0
0
NCT01069939
1COMPLETED
2011-11-01
2010-02-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
157
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
null
Prostate Cancer
null
1
arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day inte...
[ 0 ]
1
[ 0 ]
intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injection...
intervention 1: Degarelix 240/80 mg
11
Daegu | Daegu | South Korea | 128.59111 | 35.87028 Pyungchon | Gyunggi-do | South Korea | N/A | N/A Mulgeum-eup | Gyungnam | South Korea | N/A | N/A Seongnam | N/A | South Korea | 127.39683 | 35.54127 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea |...
156
0
0
0
NCT01071915
1COMPLETED
2011-11-01
2010-03-01
Ferring Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
126
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
null
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of p...
null
Pulmonary Disease, Chronic Obstructive
null
3
arm 1: Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler arm 2: Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler arm 3: Age and gender matched control subj...
[ 1, 2, 4 ]
2
[ 0, 0 ]
intervention 1: double blind randomized crossover intervention 2: inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
intervention 1: Tiotropium intervention 2: Placebo
15
Birmingham | Alabama | United States | -86.80249 | 33.52066 Jasper | Alabama | United States | -87.27751 | 33.83122 Torrance | California | United States | -118.34063 | 33.83585 Hartford | Connecticut | United States | -72.68509 | 41.76371 Springfield | Illinois | United States | -89.64371 | 39.80172 Muncie | Indiana |...
244
0
0
0
NCT01072396
1COMPLETED
2011-11-01
2010-02-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
99
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.
Nephrolithiasis, also called kidney stone disease, occurs in patients with genetic susceptibility and who may have a broad spectrum of metabolic disorders and other comorbid conditions (for example obesity or diabetes). These renal stones develop as a result of supersaturation. Calcium oxalate (CaOx) is the most common...
Hyperuricosuria Kidney Stones
Kidney Calculi Kidney Stones Nephrolithiasis Drug Therapy Uric Acid
null
3
arm 1: Febuxostat 80 mg, capsules, orally, once daily for up to 6 months. arm 2: Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months. arm 3: Placebo-matching capsules, orally, once daily for up to 6 months.
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Febuxostat capsules intervention 2: Allopurinol capsules intervention 3: Placebo-matching capsules
intervention 1: Febuxostat intervention 2: Allopurinol intervention 3: Placebo
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Anchorage | Alaska | United States | -149.90028 | 61.21806 Tucson | Arizona | United States | -110.92648 | 32.22174 Costa Mesa | California | United States | -117.91867 | 33.64113 Orange | California | United States | -117.85311 | 33.78779 Palmdale | Californi...
99
0
0
0
NCT01077284
1COMPLETED
2011-11-01
2010-02-01
Takeda
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis
Peri-implantitis
null
2
arm 1: PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm arm 2: Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Chlorhexidine 2.5 mg intervention 2: Placebo chip
2
Haifa | N/A | Israel | 34.99928 | 32.81303 Tel Aviv | N/A | Israel | 34.78057 | 32.08088
60
0
0
0
NCT01079663
1COMPLETED
2011-11-01
2010-03-01
Dexcel Pharma Technologies Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
35
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.
In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomyc...
Primary Sclerosing Cholangitis
null
4
arm 1: The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Comparison of different doses of drug intervention 2: Comparison of different doses of drug intervention 3: Comparison of different doses of drug intervention 4: Comparison of different doses of drug intervention 5: Comparison of different drug doses
intervention 1: Vancomycin intervention 2: Vancomycin intervention 3: Metronidazole intervention 4: Metronidazole intervention 5: Vancomycin
1
Rochester | Minnesota | United States | -92.4699 | 44.02163
35
0
0
0
NCT01085760
1COMPLETED
2011-11-01
2010-02-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
987
RANDOMIZED
FACTORIAL
0TREATMENT
1SINGLE
false
0ALL
false
Research shows that smoking cessation is the most significant preventable health behavior change that a person can make to lower cancer risk. In addition, telephone quitlines are an effective, science-based smoking cessation treatment that is universally accessible to smokers in the U.S. However, little research has ex...
The study design is a fully crossed 2x2x2 factorial design that tested the effect of two versus six weeks of nicotine replacement therapy (NRT), the effect of NRT monotherapy (nicotine patch alone) versus NRT combination therapy (nicotine patch + oral NRT), and the effect of cognitive medication adherence counseling (C...
Smoking Smoking Cessation
Smoking Smoking cessation Medication adherence
null
8
arm 1: Participants in this randomization arm received 2 weeks of nicotine patch and standard cessation counseling (but no Cognitive Medication Adherence Counseling) 2 Weeks of Nicotine patch dosed as follows: If \> 10 cigs/day: one 21 mg nicotine patch per day for 2 weeks If \< or = 10 cigs/day: one 14 mg nicotine ...
[ 1, 1, 1, 1, 1, 1, 1, 1 ]
3
[ 0, 0, 5 ]
intervention 1: If \> 10 cigs/day: one 21 mg nicotine patch per day If \< or = 10 cigs/day: one 14 mg nicotine patch per day intervention 2: If \< 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects. I...
intervention 1: Nicotine patch intervention 2: Nicotine gum intervention 3: CMAC
2
Seattle | Washington | United States | -122.33207 | 47.60621 Madison | Wisconsin | United States | -89.40123 | 43.07305
987
0
0
0
NCT01087905
1COMPLETED
2011-11-01
2010-04-01
University of Wisconsin, Madison
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
811
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a c...
null
Diabetic Neuropathy, Painful
null
4
arm 1: Initial Treatment: Duloxetine 30 milligram (mg) daily for 1 week Duloxetine 60 mg daily for 7 weeks Intensive Treatment: Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks arm 2: Initial Treatment: Pregabalin 150 mg daily f...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks
intervention 1: Duloxetine intervention 2: Pregabalin intervention 3: Placebo
54
Newcastle | New South Wales | Australia | 151.7801 | -32.92953 Warrawong | New South Wales | Australia | 150.88833 | -34.485 Elizabeth Vale | South Australia | Australia | 138.66819 | -34.74857 Kelowna | British Columbia | Canada | -119.48568 | 49.88307 Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Winn...
1,143
0
0
0
NCT01089556
1COMPLETED
2011-11-01
2010-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Ritonavir and lopinavir may stop the growth of gliomas by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well giving ritonavir together with lopinavir works in treating patients with progressive or recurrent high-grade...
PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free survival in patients with recurrent or progressive high grade gliomas treated with ritonavir and lopinavir. SECONDARY OBJECTIVES: I. To evaluate the toxicity of ritonavir and lopinavir in this patient population. OUTLINE: Patients receive oral ritonavir an...
Brain Tumor Anaplastic Astrocytoma Anaplastic Ependymoma Anaplastic Oligodendroglioma Brain Stem Glioma Giant Cell Glioblastoma Glioblastoma Gliosarcoma Mixed Glioma
adult brain tumor adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult brain stem glioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult mixed glioma recurrent adult brain tumor
null
1
arm 1: Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Given orally intervention 2: Given orally
intervention 1: ritonavir intervention 2: lopinavir
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
19
0
0
0
NCT01095094
6TERMINATED
2011-11-01
2009-01-01
Case Comprehensive Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Effectiveness of Floseal for the treatment of posterior epistaxis.
Floseal, a hemostatic agent, is an effective treatment for anterior epistaxis as well as numerous other acute bleeding conditions throughout the body. The investigators hypothesize that Floseal is an effective treatment for posterior epistaxis. If so, then this will also lead to significant cost savings in comparison t...
Epistaxis
Posterior Epistaxis
null
1
arm 1: Received 1 syringe of Floseal for treatment of posterior epistaxis.
[ 0 ]
1
[ 0 ]
intervention 1: Received 1 syringe of Floseal as treatment for posterior epistaxis.
intervention 1: Floseal
0
null
20
0
0
0
NCT01098578
1COMPLETED
2011-11-01
2010-04-01
Ottawa Hospital Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
570
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
1FEMALE
false
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows: 1. Moderate VMS: Sensation of heat with sweating, able to continue activity 2. Severe VMS: Sensation of ...
Hot Flashes
Vasomotor Symptoms Menopause Hot Flashes Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
null
2
arm 1: Brisdelle (paroxetine mesylate) arm 2: Sugar pill
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio. intervention 2: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Placebo capsules
32
Montgomery | Alabama | United States | -86.29997 | 32.36681 Chandler | Arizona | United States | -111.84125 | 33.30616 San Diego | California | United States | -117.16472 | 32.71571 Santa Ana | California | United States | -117.86783 | 33.74557 Denver | Colorado | United States | -104.9847 | 39.73915 Waterbury | Connec...
570
0
0
0
NCT01101841
1COMPLETED
2011-11-01
2010-03-01
Noven Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
4
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.
The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The existing clinical approaches has contributed ...
Chronic Obstructive Pulmonary Disease Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease Emphysema Cell therapy Bone marrow mononuclear cells stem cells
null
2
arm 1: emphysema patients evaluated prior to the stem cells infusion arm 2: emphysema patients evaluated 30 days after the stem cells infusion
[ 1, 0 ]
3
[ 0, 3, 6 ]
intervention 1: Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure. intervention 2: pullout of 200ml of bone marrow through the puncture of the iliac crest intervention 3: slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
intervention 1: Stem cells stimulation intervention 2: stem cells collection intervention 3: stem cells infusion
1
Assis | São Paulo | Brazil | -50.41222 | -22.66167
4
0
0
0
NCT01110252
1COMPLETED
2011-11-01
2009-05-01
UPECLIN HC FM Botucatu Unesp
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
282
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pr...
null
Acute Coronary Syndrome
Plavix, Effient
null
3
arm 1: Placebo loading dose administered once orally before percutaneous coronary intervention (PCI) and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. arm 2: 600-mg clopido...
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. intervention 2: Loading dose administered once orally. intervention 3: Loading dose administered once orally
intervention 1: Prasugrel intervention 2: Clopidogrel intervention 3: Placebo
3
Bangalore | N/A | India | 77.59369 | 12.97194 Hyderabaad | N/A | India | N/A | N/A New Delhi | N/A | India | 77.2148 | 28.62137
276
0
0
0
NCT01115738
1COMPLETED
2011-11-01
2010-05-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
6
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
true
The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that has spread to the bones by using new imaging techniques. In particular, this study will use fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI scans to look for changes in bone metastas...
null
Prostate Cancer
Metastatic castrate-resistant prostate cancer bone metastasis
null
1
arm 1: ZD4054 + multimodal PET/MRI imaging
[ 0 ]
1
[ 0 ]
intervention 1: All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 wee...
intervention 1: ZD4054
1
Madison | Wisconsin | United States | -89.40123 | 43.07305
6
0
0
0
NCT01119118
6TERMINATED
2011-11-01
2010-04-01
University of Wisconsin, Madison
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
211
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .
null
Chronic Obstructive Pulmonary Disease
COPD NVA237
null
2
arm 1: 50µg once daily arm 2: 18µg once daily
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®) intervention 2: 18µg capsules for inhalation, delivered via HandiHaler®
intervention 1: NVA237 intervention 2: Tiotropium
40
Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Iizuka | Fukuoka | Japan | 130.68678 | 33.63654 Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Kurume | Fukuoka | Japan | 130.51667 | 33.31667 Ōnojō | Fukuoka | Japan | 130.47861 | 33.53567 Yanagawa | Fukuoka | Japan |...
163
0
0
0
NCT01119937
1COMPLETED
2011-11-01
2010-05-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to compare the use of insulin glargine plus insulin lispro to human regular insulin for treatment of hyperglycemia in the hospital setting in patients without known prior history of diabetes.
This study involves a comparison of 2 methods for administering subcutaneous insulin therapy to non-critically ill adult patients with hyperglycemia and without known history of diabetes who are admitted to non-intensive care unit (ICU) general medical hospital services. Basal-bolus therapy, considered the gold standar...
Hyperglycemia
Hyperglycemia Diabetes Hospital Diabetic
null
2
arm 1: None arm 2: None
[ 1, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization) intervention 2: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 day...
intervention 1: Human regular insulin intervention 2: Insulin lispro intervention 3: Insulin glargine
12
Birmingham | Alabama | United States | -86.80249 | 33.52066 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 Weston | Florida | United States | -80.39977 | 26.10037 Atlanta | Georgia | United States | -84.38798 | 33.749 Topeka | Kansas | United States ...
16
0
0
0
NCT01136746
6TERMINATED
2011-11-01
2011-03-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
65
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
null
Congenital Bleeding Disorder Haemophilia A
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen. intervention 2: Subjects will undergo half-life evaluation of their current factor VIII product...
intervention 1: turoctocog alfa intervention 2: turoctocog alfa
38
Phoenix | Arizona | United States | -112.07404 | 33.44838 Orange | California | United States | -117.85311 | 33.78779 Torrance | California | United States | -118.34063 | 33.83585 Tampa | Florida | United States | -82.45843 | 27.94752 Augusta | Georgia | United States | -81.97484 | 33.47097 Iowa City | Iowa | United St...
63
0
0
0
NCT01138501
1COMPLETED
2011-11-01
2010-06-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
17
RANDOMIZED
FACTORIAL
9OTHER
0NONE
true
0ALL
true
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
This is an open-labeled, single-center Phase IV clinical trial. The study will consist of patients with moderate hypovolemia/dehydration requiring parenteral rehydration. It is expected that this study will describe the onset or change in cardiac output using Hylenex augmented subcutaneous rehydration from ages 2 month...
Dehydration Cardiac Output Pediatrics
cardiac output dehydration pediatrics
null
2
arm 1: control arm of the study arm 2: 1ml subcutaneous with initiation of intravenous fluids then every 24 hours with a maximum dose of 3 injections in 72 hours
[ 4, 0 ]
1
[ 0 ]
intervention 1: 1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours
intervention 1: Hylenex
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
0
0
0
0
NCT01139294
1COMPLETED
2011-11-01
2010-02-01
Vanderbilt University Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
149
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The purpose of this study is to characterize the long-term safety and tol...
null
Schizophrenia Schizoaffective Disorder
Schizophrenia Lurasidone Latuda
null
1
arm 1: Subjects will continue on treatment with the same dose of lurasidone flexible dosing - 40 mg to 12 mg once daily taken orallay at endpoint of the D1050289 ( NCT01143077) core study.
[ 0 ]
1
[ 0 ]
intervention 1: 40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
intervention 1: Lurasidone HCl
27
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Escondido | California | United States | -117.08642 | 33.11921 Garden Grove | California | United States | -117.94145 | 33.77391 Oakland | California | United States | -122.2708 | 37.80437 Paramount | California | United States | -118.15979 | 33.88946 Pasade...
148
0
0
0
NCT01143090
1COMPLETED
2011-11-01
2010-08-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
19
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
true
Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults. The management of MS-patients requires treatment with disease-modifying agents, monoclonal antibodies such as natalizumab or immunosuppressants. Natalizumab showed good efficacy and is approved for treatment of relapsin...
At present, there is no cure for multiple sclerosis and the management of MS-patients requires treatment with disease-modifying agents such as interferon-beta or glatiramer acetate, monoclonal antibodies such as natalizumab or immunsuppressants such as mitoxantrone, azathioprine or methotrexate. Acute relapses are usua...
Relapsing-remitting Multiple Sclerosis
Natalizumab Interferon-beta 1b De-escalation Ticino
null
2
arm 1: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions. arm 2: 250 mcg (8 MIU) ...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwis...
intervention 1: interferon beta-1b intervention 2: Natalizumab
1
Lugano | Canton Ticino | Switzerland | 8.96004 | 46.01008
19
0
0
0
NCT01144052
1COMPLETED
2011-11-01
2010-06-01
Claudio Gobbi
2OTHER_GOV
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Exenatide has been shown to result in better glycemic control in type II diabetes patients. Obesity and diabetes are states of increased inflammation; exenatide is expected to lead to decreased inflammation by virtue of better glycemic control and weight loss. The purpose of this study is to determine if the addition ...
null
Type 2 Diabetes
type 2 diabetes obesity
null
3
arm 1: exenatide 5 mcg arm 2: exenatide 10 mcg arm 3: placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: exenatide 5 mcg intervention 2: exenatide 10 mcg intervention 3: saline sq
intervention 1: exenatide 5 mcg intervention 2: exenatide 10 mcg intervention 3: placebo
1
Buffalo | New York | United States | -78.87837 | 42.88645
24
0
0
0
NCT01154933
1COMPLETED
2011-11-01
2008-04-01
University at Buffalo
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
319
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.
A multicenter, randomized, double-blind, parallel group, placebo-controlled, phase III efficacy and safety study of TC-5214 (S-mecamylamine) in flexible doses as an adjunct to an antidepressant in patients with major depressive disorder with an inadequate response to antidepressant therapy.
Major Depressive Disorder Depression
Major Depressive Disorder MDD Depression Safety add-on therapy
null
2
arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks
intervention 1: TC-5214 intervention 2: Placebo
51
Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Chino | California | United States | -117.68894 | 34.01223 Costa Mesa | California | United States | -117.91867 | 33.64113 Encino | Californi...
316
0
0
0
NCT01157078
1COMPLETED
2011-11-01
2010-06-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
410
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
false
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.
null
Erectile Dysfunction
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Administered orally, once daily for 12 weeks intervention 2: Administered orally, once daily for 12 weeks intervention 3: Administered orally, once daily for 12 weeks intervention 4: Administered orally, once daily for 12 weeks
intervention 1: LY2452473 intervention 2: tadalafil intervention 3: placebo (tadalafil) intervention 4: placebo (LY2452473)
36
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Glendora | California | United States | -117.86534 | 34.13612 Irvine | California | United States | -117.82311 | 33.66946 Long Beach | California | United States | -118.18923 | 33.76696 Newport Beach | ...
941
0
0
0
NCT01160289
1COMPLETED
2011-11-01
2010-10-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
203
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.
null
Brain Fibrillarab Levels
Amyloid PET-Positron Emission Tomography SUVR-Standard uptake value ratios
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
intervention 1: [18F] Flutemetamol
1
Princeton | New Jersey | United States | -74.65905 | 40.34872
180
0
0
0
NCT01165554
1COMPLETED
2011-11-01
2010-05-01
GE Healthcare
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
17
RANDOMIZED
PARALLEL
null
0NONE
false
0ALL
false
In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.
To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any...
Candidemia
Phase 3b Efficacy and Safety evaluation of Anidulafungin ICC
null
1
arm 1: None
[ 1 ]
1
[ 0 ]
intervention 1: Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days
intervention 1: Anidulafungin/Fluconazole
7
Guangzhou | Guangdong | China | 113.25 | 23.11667 Nanjing | Jiangsu | China | 118.77778 | 32.06167 Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222 Hangzhou | Zhejiang | China | 120.16142 | 30.29365 Hangzhou | Zhejiang | China | 120.16142 | 30.29365 Beijing | N/A | China | 116.39723 | 39.9075 Shanghai | ...
17
0
0
0
NCT01176058
6TERMINATED
2011-11-01
2010-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
2
NA
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
1FEMALE
false
This research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2 ...
Key eligibility criteria include: * Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment * No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the st...
Stage I Breast Cancer Stage II Breast Cancer Stage III Breast Cancer Invasive Breast Cancer
Preoperative Neoadjuvant
null
1
arm 1: Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
[ 0 ]
1
[ 0 ]
intervention 1: vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
intervention 1: Vorinostat and Tamoxifen
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
2
0
0
0
NCT01194427
6TERMINATED
2011-11-01
2011-03-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
21
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers. Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cre...
Actinic Keratosis
Imiquimod Photodynamic therapy Actinic keratoses Sequential therapy Therapeutic uses
null
2
arm 1: Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light arm 2: Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-w...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Administered 4 weeks after completion of imiquimod therapy intervention 2: Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation
intervention 1: Photodynamic therapy intervention 2: Imiquimod
3
Englewood | Colorado | United States | -104.98776 | 39.64777 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Nashville | Tennessee | United States | -86.78444 | 36.16589
21
0
0
0
NCT01203878
6TERMINATED
2011-11-01
2010-09-01
Tennessee Clinical Research Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
416
RANDOMIZED
PARALLEL
2DIAGNOSTIC
4QUADRUPLE
false
0ALL
false
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compar...
Diagnostic Self Evaluation Central Nervous System Diseases
CNS Contrast Agent MRI Dotarem Magnevist
null
3
arm 1: Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. arm 2: Dotarem and Magnevist were randomised as 2:1 ratio arm 3: Pediatric patients were assigned to Dotarem group only.
[ 0, 1, 0 ]
2
[ 0, 0 ]
intervention 1: 0.1 mmol/kg by body weight, single IV injection intervention 2: 0.1 mmol/kg by body weight, single IV injection
intervention 1: Dotarem (gadoterate meglumine) intervention 2: Magnevist (gadopentetate dimeglumine)
52
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Indian Wells | California | United States | -116.34311 | 33.71791 Hollywood | Florida | United States | -80.14949 | 26.0112 Chicago | Illinois | U...
395
0
0
0
NCT01211873
1COMPLETED
2011-11-01
2010-09-01
Guerbet
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of the study was to evaluate the proportion of subjects with a bowel movement (BM) without straining or without hard and/or lumpy stool within the first 24 h of treatment for subjects taking 1 of 3 single doses of Polyethylene Glycol (PEG) plus Electrolytes (PEG+E) (13.125 g, 26.25 g, 39.375 g). T...
null
Constipation
null
3
arm 1: Single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time arm 2: Two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time arm 3: Three sachets of PEG+E (39.375 g) dissol...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: 13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
intervention 1: PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)
1
Cork | N/A | Ireland | -8.47061 | 51.89797
154
0
0
0
NCT01212445
1COMPLETED
2011-11-01
2010-10-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3, 4 ]
78
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
null
Chronic Kidney Disease Secondary Hyperparathyroidism Vitamin D Insufficiency
Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Hyperparathyroidism, Secondary Vitamin D Hyperparathyroidism Kidney Diseases Kidney Failure Renal Insufficiency, Chronic
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 2, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 60µg of CTAP101 capsules given once daily for 42 days. intervention 2: 90µg of CTAP101 capsules given once daily for 42 days. intervention 3: Placebo capsules given once daily for 42 days. intervention 4: 30µg of CTAP101 capsules given once daily for 42 days. intervention 5: Placebo capsules given once ...
intervention 1: Cohort 1 CTAP101 Capsules- 60µg intervention 2: Cohort 1 CTAP101 Capsules - 90µg intervention 3: Cohort 1 Matching Sugar Capsule intervention 4: Cohort 2 CTAP101 Capsules - 30µg intervention 5: Cohort 2 Matching Sugar Capsule
1
Bannockburn | Illinois | United States | -87.86646 | 42.19336
77
0
0
0
NCT01219855
1COMPLETED
2011-11-01
2010-10-01
OPKO Health, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
154
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in t...
null
Pulmonary Disease, Chronic Obstructive
null
5
arm 1: Tiotropium inhalation solution low dose arm 2: Tiotropium inhalation solution medium dose arm 3: Tiotropium inhalation solution high dose arm 4: Tiotropium inhalation powder 18mcg arm 5: Placebo inhalation solution
[ 0, 0, 0, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Tiotropium inhalation solution medium dose intervention 2: Tiotropium inhalation solution low dose intervention 3: Tiotropium inhalation solution high dose intervention 4: Tiotropium inhalation powder 18mcg intervention 5: Placebo inhalation solution
intervention 1: Tiotropium medium intervention 2: Tiotropium low intervention 3: Tiotropium high intervention 4: Tiotropium 18mcg intervention 5: Tiotropium placebo
11
Genk | N/A | Belgium | 5.50082 | 50.965 Ghent | N/A | Belgium | 3.71667 | 51.05 Hasselt | N/A | Belgium | 5.33781 | 50.93106 Copenhagen K | N/A | Denmark | N/A | N/A København NV | N/A | Denmark | 12.52343 | 55.71258 Odense C | N/A | Denmark | 10.39538 | 55.40841 Helsinki | N/A | Finland | 24.93545 | 60.16952 Tampere |...
735
0
0
0
NCT01222533
1COMPLETED
2011-11-01
2010-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Yearly in the United States over 500,000 newborns are delivered prematurely. This population is at high risk of catastrophic bowel disease known as necrotizing enterocolitis. Infants with necrotizing enterocolitis are at high risk of death, and survivors are at increased risk of mental retardation. Metronidazole is an ...
null
Serious Systemic Infections Necrotizing Enterocolitis
Metronidazole Neonate Premature Sepsis Necrotizing enterocolitis
null
1
arm 1: Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
[ 0 ]
1
[ 0 ]
intervention 1: Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with \>=14 postnatal days and every 24 hours for infants \<14 postnatal days.
intervention 1: Metronidazole
3
Orange | California | United States | -117.85311 | 33.78779 Wichita | Kansas | United States | -97.33754 | 37.69224 Durham | North Carolina | United States | -78.89862 | 35.99403
24
0
0
0
NCT01222585
1COMPLETED
2011-11-01
2011-01-01
Michael Cohen-Wolkowiez
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
268
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.
null
Nocturia
null
2
arm 1: Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period. arm 2: Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duratio...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Desmopressin intervention 2: Placebo
45
Huntsville | Alabama | United States | -86.58594 | 34.7304 Scottsdale | Arkansas | United States | N/A | N/A Foothill Ranch | California | United States | -117.66088 | 33.68641 Los Angeles | California | United States | -118.24368 | 34.05223 Santa Rosa | California | United States | -122.71443 | 38.44047 Denver | Color...
261
0
0
0
NCT01223937
1COMPLETED
2011-11-01
2010-11-01
Ferring Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
28
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the effects of the amino acid supplement N-Acetylcysteine versus placebo on working memory and other cognitive functions in persons with a diagnosis of schizophrenia.
Working memory impairment in Schizophrenia is produced by deficiencies of feedback inhibition of glutamate release, due to low cysteine-glutamate antiporter activity. Because of this mechanism, we are interested in whether acute administration of N-Acetylcysteine will improve performance of patients with schizophrenia ...
Schizophrenia
Schizophrenia working memory N-Acetylcysteine
null
2
arm 1: Group A first receives the commercially available sustained release form of N-acetylcysteine, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days). arm 2:...
[ 0, 2 ]
2
[ 7, 0 ]
intervention 1: N-acetylcysteine 1200mg bid for 3 days intervention 2: Placebo
intervention 1: N-Acetylcysteine intervention 2: Placebo
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
45
0
0
0
NCT01232790
1COMPLETED
2011-11-01
2010-02-01
Yale University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
42
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
true
1FEMALE
false
This pilot study is being performed to investigate the influence that starting contraception with an IUD has on the local immune cell populations and features, with a particular focus on the cells and cell-surface features that are important in HIV transmission (CD4 cells and CCR5 cell receptors). Based on results fro...
null
Genital Tract Mucosal Immunity Genital Tract Microflora
intrauterine device IUD levonorgestrel copper CD4 CCR5 microflora
null
3
arm 1: Healthy volunteers not at risk of pregnancy and not using any hormonal contraception. arm 2: Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS. arm 3: Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
[ 4, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD ...
intervention 1: IUD placement intervention 2: Levonorgestrel IUD intervention 3: Copper T380A IUD
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
42
0
0
0
NCT01240811
1COMPLETED
2011-11-01
2010-11-01
Sharon Achilles
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the safety and tolerability of LY2584702 in Japanese patients with advanced and/or metastatic solid tumors for which no proven effective therapy exists.
null
Cancer
Advanced Cancer Metastatic Cancer p70s6 inhibitor
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle. Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met.
intervention 1: LY2584702
1
Chiba | N/A | Japan | 140.11667 | 35.6
9
0
0
0
NCT01241461
1COMPLETED
2011-11-01
2010-11-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
248
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
The routine administration of 75 mg of intravenous aminophylline following regadenoson (Lexiscan®), a commonly used medication for nuclear stress testing of the heart, can reduce the gastrointestinal (diarrhea and stomach upset) and other side effects related to regadenoson.
Approximately 250 patients who are referred for a nuclear stress testing of the heart with regadenoson (Lexiscan®) will be recruited to participate in the study. Following regadenoson (administered as part of a stress routine test protocol) participants will receive either aminophylline (75 mg - intravenously) or a mat...
Patients Being Assessed With Nuclear Stress Testing of the Heart Using the Stress Agent Regadenoson, Lexiscan
regadenoson lexiscan aminophylline SPECT Myocardial Perfusion Imaging pharmacologic stress test
null
2
arm 1: 75 mg of intravenous aminophylline. arm 2: Matching normal saline placebo (sterile salt water).
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 75 mg of intravenous aminophylline intervention 2: Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
intervention 1: Aminophylline intervention 2: Placebo
1
Chicago | Illinois | United States | -87.65005 | 41.85003
248
0
0
0
NCT01250496
6TERMINATED
2011-11-01
2010-11-01
Rush University Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
26
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The primary purpose of this study is to help answer the following research questions, and not to provide treatment for any condition: * To evaluate how much of the study drug (LY2189265) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function. * To assess t...
null
Diabetes Mellitus, Type 2
null
4
arm 1: LY2189265: A single, subcutaneous (SC) 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function arm 2: LY2189265: A single, SC 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A) arm 3: LY2189265: A single, SC 1.5-mg injection on Day 1 in participants w...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: Subcutaneous (SC) injection
intervention 1: LY2189265
2
Munich | N/A | Germany | 11.57549 | 48.13743 Budapest | N/A | Hungary | 19.04045 | 47.49835
26
0
0
0
NCT01253304
1COMPLETED
2011-11-01
2010-11-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
The purpose of this Phase III trial is to confirm the efficacy of intravaginal dehydroepiandrosterone (DHEA) in postmenopausal women with vaginal atrophy.
null
Vaginal Atrophy
Vulvar/vaginal atrophy Atrophic Vaginitis Dehydroepiandrosterone DHEA Prasterone Vaginorm Menopause Intrarosa
null
3
arm 1: None arm 2: None arm 3: None
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo vaginal suppository intervention 2: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks. intervention 3: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
intervention 1: Placebo intervention 2: DHEA intervention 3: DHEA
33
Montgomery | Alabama | United States | -86.29997 | 32.36681 Tucson | Arizona | United States | -110.92648 | 32.22174 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32.71571 Denver | Color...
253
0
0
0
NCT01256684
1COMPLETED
2011-11-01
2010-12-01
EndoCeutics Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
21
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.
Currently, limited objective measures are available to quantify lung function in CF patients with mild lung disease. Lung clearance index (LCI) derived from inert gas multiple-breath washout (MBW) testing hold considerable promise to evaluate early lung disease as studies have detected abnormalities in a high percentag...
Cystic Fibrosis
null
2
arm 1: Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2. arm 2: Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Sequence 2.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 150 mg tablet, oral use, twice daily every 12 hours (q12h) intervention 2: Tablet, oral use, twice daily every 12 hours (q12h)
intervention 1: Ivacaftor intervention 2: Placebo
8
Stanford | California | United States | -122.16608 | 37.42411 Iowa City | Iowa | United States | -91.53017 | 41.66113 Durham | North Carolina | United States | -78.89862 | 35.99403 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Toronto | Ontario | Canada | -79.39864 | 43.70643 Belfast | N/A | United K...
37
0
0
0
NCT01262352
1COMPLETED
2011-11-01
2011-01-01
Vertex Pharmaceuticals Incorporated
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
113
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.
null
Heart Failure
null
2
arm 1: Investigational drug: 15 g CLP per day given as capsules arm 2: Placebo, capsules
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Oral administration intervention 2: Oral administration
intervention 1: CLP intervention 2: Placebo
3
Yerevan | N/A | Armenia | 44.5126 | 40.17765 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Chisinau | N/A | Moldova | 28.85938 | 47.00902
111
0
0
0
NCT01265524
1COMPLETED
2011-11-01
2011-04-01
Sorbent Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
77
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)
null
Hypercholesterolemia
null
5
arm 1: Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 2: Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. arm 3: Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or...
[ 2, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Alirocumab two SC injections in the abdomen only. intervention 2: Placebo two SC injections in the abdomen only.
intervention 1: Alirocumab intervention 2: Placebo
22
Huntsville | Alabama | United States | -86.58594 | 34.7304 Mission Viejo | California | United States | -117.672 | 33.60002 Newport Beach | California | United States | -117.92895 | 33.61891 Bridgeport | Connecticut | United States | -73.18945 | 41.17923 Jacksonville | Florida | United States | -81.65565 | 30.33218 Mia...
77
0
0
0
NCT01266876
1COMPLETED
2011-11-01
2011-01-01
Regeneron Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
256
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
null
Skin and Subcutaneous Tissue Bacterial Infections
null
3
arm 1: 300 mg IV (intravenous) every 12 hours for 5-14 days arm 2: 15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas arm 3: 600 mg IV every 12 hours for 5-14 days
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 300mg IV every 12 hours for 5-14 days intervention 2: 600mg IV every 12 hours for 5-14 days intervention 3: 15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
intervention 1: Delafloxacin intervention 2: Linezolid intervention 3: Vancomycin
31
Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | United States | -86.29997 | 32.36681 Buena Park | California | United States | -117.99812 | 33.86751 Chula Vista | California | United States | -117.0842 | 32.64005 La Mesa | California | United States | -117.02308 | 32.76783 Los Angeles | C...
249
0
0
0
NCT01283581
1COMPLETED
2011-11-01
2011-01-01
Melinta Therapeutics, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
243
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to test the feasibility of sending pre-cessation nicotine patches and to examine the effects associated with the pre-cessation treatment phase. Specifically, this study aims to: 1. See if subjects will use pre-cessation nicotine patches. 2. See if subjects in the pre-cessation nico...
Quitlines have become central to state tobacco control efforts in the U.S. In addition to offering telephone counseling, many quitlines have begun providing quitting aids (e.g., nicotine patch) to eligible smokers. The nicotine patch has been shown repeatedly to double the rate of quitting success compared to a placebo...
Smoking Cessation
tobacco cessation smoking cessation nicotine counseling telephone self-help smoking abstinence tobacco use disorder nicotine replacement therapy
null
3
arm 1: Nicotine patches (2 weeks' worth) are mailed directly to the subject. Clients will be encouraged to start using these patches PRIOR to their quit date. Counseling includes a comprehensive pre-quit session (to include motivation, planning, discussion of nicotine patch use, and setting of a quit date) and up to 4...
[ 0, 1, 1 ]
2
[ 5, 0 ]
intervention 1: Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, ano...
intervention 1: Telephone Counseling intervention 2: Nicotine Patches
1
San Diego | California | United States | -117.16472 | 32.71571
243
0
0
0
NCT01287377
1COMPLETED
2011-11-01
2010-11-01
University of California, San Diego
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
85
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
null
This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
null
COPD
COPD QVA149 tiotropium exercise exercise tolerance combination bronchodilator moderate to severe COPD
null
3
arm 1: QVA149 delivered once daily via single-dose dry powder inhaler. arm 2: Placebo, delivered once daily via single-dose dry powder inhaler. arm 3: Tiotropium delivered once daily via HandiHaler® device.
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: indacaterol and glycopyrronium bromide (QVA149) intervention 2: placebo intervention 3: tiotropium
13
Frankfurt | N/A | Germany | 10.53333 | 49.68333 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Hamburg | N/A | Germany | 9.99302 | 53.55073 Lübeck | N/A | Germany | 10.68729 | 53.86893 Mainz | N/A | Germany | 8.2791 | 49.98419 Rudersdorf | N/A | Germany | 11.45 | 51.1 Wiesbaden | N/A | Germany | 8.24932 | 50.08258 ...
237
0
0
0
NCT01294787
1COMPLETED
2011-11-01
2011-02-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
439
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
null
Opioid-induced Bowel Dysfunction
null
2
arm 1: 24 mcg capsules twice daily (BID) arm 2: 0 mcg capsules twice daily (BID)
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 24 mcg administered orally twice daily (BID) intervention 2: Matching placebo, 0 mcg administered orally twice daily (BID)
intervention 1: Lubiprostone intervention 2: Placebo
142
Athens | Alabama | United States | -86.97219 | 34.80243 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Foley | Alabama | United States | -87.6836 | 30.40659 Montgomery | Alabama | United ...
439
0
0
0
NCT01298219
1COMPLETED
2011-11-01
2010-12-01
Sucampo Pharma Americas, LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
177
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
null
Inflammation Pain Cataract
null
2
arm 1: Mapracorat ophthalmic suspension arm 2: Vehicle of mapracorat ophthalmic suspension
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks. intervention 2: Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
intervention 1: Mapracorat intervention 2: Vehicle
1
Rochester | New York | United States | -77.61556 | 43.15478
177
0
0
0
NCT01298752
6TERMINATED
2011-11-01
2011-02-01
Bausch & Lomb Incorporated
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
66
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this study is to compare the mean serum sodium after 48 hours of therapy with either 0.45% NaCl/dextrose 5% or 0.9% NaCl/dextrose 5%, in critically ill children requiring IV maintenance fluid administration.
In patients without possibilities of oral intake, maintenance fluids provide electrolytes and water. Since the original descriptions by Holliday and Segar, the recommended standard maintenance solutions are based on "physiological needs", containing 30-50 mEq/L of sodium. However hyponatremia has become increasingly r...
Hyponatremia
hyponatremia maintenance solutions pediatrics
null
2
arm 1: Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids. arm 2: Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 0.45% NaCl/5% dextrose IV maintenance fluids intervention 2: 0.9% NaCl/5% dextrose IV maintenance fluids
intervention 1: hypotonic intervention 2: isotonic
1
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
66
0
0
0
NCT01301274
1COMPLETED
2011-11-01
2011-02-01
Hospital General de Niños Pedro de Elizalde
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
36
RANDOMIZED
CROSSOVER
null
3TRIPLE
false
0ALL
false
This is an intra-subject crossover comparative safety study to evaluate the effect of intravenous (IV) bolus injection of SonoVue on pulmonary hemodynamics.
Subjects will be divided into two groups based on their baseline mean pulmonary arterial pressure. Each subject will receive two injections in randomized order during right heart catheterization: one administration of SonoVue and one administration of placebo, either SonoVue followed by Placebo or Placebo followed by S...
Pulmonary Hypertension
Pulmonary hypertension Right heart Catheterization
null
2
arm 1: Ultrasound contrast agent under development arm 2: normal saline 0.9% for injection used as the comparator
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: dose of 4.8 mL administered intravenously one time intervention 2: Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)
intervention 1: SonoVue intervention 2: Placebo
1
Teaneck | New Jersey | United States | -74.01597 | 40.8976
36
0
0
0
NCT01306292
1COMPLETED
2011-11-01
2011-04-01
Bracco Diagnostics, Inc
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
12
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
true
Sports-related concussions are a serious problem in football, boxing, and other full contact sports. After experiencing consecutive concussions, there is an increase in neurological deficits that can lead to long-term cognitive problems (Dementia pugilistica). To combat this increase in brain damage, novel strategies n...
Each year, approximately 3 million sports-related concussions occur in athletes. Only about 5% of these concussions are treated in the hospital setting. To date, there are no effective interventions used at decreasing the levels of oxidant injury and inflammation within these athletes. The standard form of care in thes...
Sports Concussion
Mild Brain Injury Concussions Resveratrol Boxers ImPACT MRI
null
2
arm 1: Placebo control arm 2: Intervention
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury. intervention 2: The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
intervention 1: Resveratrol intervention 2: Placebo
1
Dallas | Texas | United States | -96.80667 | 32.78306
12
0
0
0
NCT01321151
1COMPLETED
2011-11-01
2011-03-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
29
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal function.
Renal function was assessed during screening with the estimated glomerular filtration rate (eGFR), which was calculated with the 4-variable modification of diet in renal disease (MDRD) equation using a minimum of 2 creatinine measurements. The eGFR values were used to categorize participants into 1 of 3 mutually exclus...
Autosomal Dominant Polycystic Kidney Disease
null
3
arm 1: Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM \[8 hours later\]) to the maximally tolerated dose. arm 2: Participants received tolvaptan for the first 3 weeks of...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tolvaptan was supplied as 15 and 30 mg tablets.
intervention 1: Tolvaptan
1
Groningen | N/A | Netherlands | 6.56667 | 53.21917
29
0
0
0
NCT01336972
1COMPLETED
2011-11-01
2010-10-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
26
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of the study is that MK-4618 does not result in a clinically m...
null
Hypertension
null
4
arm 1: Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows P...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 intervention 2: Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 intervention 3: Previously prescribed daily dose of open-label metoprolol for the duration of the study intervention 4...
intervention 1: MK-4618 intervention 2: Placebo for MK-4618 intervention 3: Metoprolol intervention 4: Amlodipine
0
null
50
0
0
0
NCT01337674
1COMPLETED
2011-11-01
2011-04-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan. The results of this stud...
Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI sc...
Sleep Apnea, Obstructive
Obstructive Sleep Apnea MRI Pediatrics Dexmedetomidine Propofol Anesthesia
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump. intervention 2: Once an IV is in place, atropine 10 mcg/kg will be give...
intervention 1: Dexmedetomidine intervention 2: Propofol
1
Cincinnati | Ohio | United States | -84.51439 | 39.12711
60
0
0
0
NCT01344759
1COMPLETED
2011-11-01
2009-06-01
Children's Hospital Medical Center, Cincinnati
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
4
RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
false
0ALL
false
This pilot study will evaluate the implementation of a stepped care intervention that combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications, and information technology innovations at a level 1 trauma center to community linkage components to reduce the symptoms of posttraumatic stre...
The investigators plan to implement a pilot linkage program in which trauma center based care facilitators will use a population-based recruitment strategy to facilitate outpatient follow-up for acutely injured trauma center inpatients and emergency department patients. All patients recruited into the trial will be low...
Posttraumatic Stress Disorder
PTSD
null
2
arm 1: Combination of behavioral therapy and drug therapy arm 2: None
[ 0, 1 ]
4
[ 5, 5, 0, 5 ]
intervention 1: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months. intervention 2: Motivational interviewing is designed to address alcohol and dr...
intervention 1: Cognitive Behavioral Therapy intervention 2: Motivational Interviewing intervention 3: FDA-Approved Anti-Anxiety Medications intervention 4: Standard Care Control
1
Seattle | Washington | United States | -122.33207 | 47.60621
4
0
0
0
NCT01347541
6TERMINATED
2011-11-01
2011-01-01
University of Washington
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
237
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
null
Chronic Obstructive Pulmonary Disease
COPD
null
4
arm 1: PT005 MDI arm 2: PT001 MDI arm 3: PT003 MDI arm 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
[ 0, 0, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: PT005 MDI administered as two puffs BID for 14 days intervention 2: PT001 MDI administered as two puffs BID for 14 days intervention 3: PT003 MDI administered as two puffs BID for 14 days intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
intervention 1: PT005 MDI intervention 2: PT001 MDI intervention 3: PT003 MDI intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
20
Glendale | Arizona | United States | -112.18599 | 33.53865 Fullerton | California | United States | -117.92534 | 33.87029 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Pensacola | Florida | United States | -87.21691 | 30.42131 Lafayette |...
237
0
0
0
NCT01349803
1COMPLETED
2011-11-01
2011-05-01
Pearl Therapeutics, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
185
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
null
Chronic Obstructive Pulmonary Disease
COPD
null
6
arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT003 MDI Dose 3 arm 4: PT003 MDI Dose 4 arm 5: PT001 MDI arm 6: PT005 MDI
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: PT003 MDI administered as two puffs BID for 7 days intervention 2: PT001 MDI administered as two puffs BID for 7 days intervention 3: PT005 MDI administered as two puffs BID for 7 days
intervention 1: PT003 intervention 2: PT001 intervention 3: PT005
13
Rancho Mirage | California | United States | -116.41279 | 33.73974 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Waterbury | Connecticut | United States | -73.0515 | 41.55815 Clearwater | Florida | United States | -82.8001 | 27.96585 Pensacola | Florida | United States | -87.21691 | 30.42131 Stock...
350
0
0
0
NCT01349816
1COMPLETED
2011-11-01
2011-06-01
Pearl Therapeutics, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR. The study requires that subjects be ...
Perennial Allergic Rhinitis PAR
Perennial Allergic Rhinitis PAR
null
2
arm 1: ciclesonide nasal aerosol (74 mcg) arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: ciclesonide nasal aerosol (74 mcg) intervention 2: Placebo
intervention 1: ciclesonide nasal aerosol intervention 2: Placebo
7
Costa Mesa | California | United States | -117.91867 | 33.64113 Stockbridge | Georgia | United States | -84.23381 | 33.54428 Normal | Illinois | United States | -88.99063 | 40.5142 Plymouth | Minnesota | United States | -93.45551 | 45.01052 El Paso | Texas | United States | -106.48693 | 31.75872 New Braunfels | Texas |...
89
0
0
0
NCT01378429
1COMPLETED
2011-11-01
2011-07-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
327
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
false
0ALL
false
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to ...
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to ...
Perennial Allergic Rhinitis
perennial allergic rhinitis PAR
null
2
arm 1: 74 mcg ciclesonide nasal aerosol once daily arm 2: 200 mcg mometasone aqueous nasal spray once daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 74 mcg ciclesonide nasal aerosol once daily intervention 2: 200 mcg mometasone aqueous nasal spray once daily
intervention 1: ciclesonide intervention 2: mometasone
15
Huntington Beach | California | United States | -117.99923 | 33.6603 Mission Veijo | California | United States | N/A | N/A San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32.71571 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 No...
623
0
0
0
NCT01401465
1COMPLETED
2011-11-01
2011-07-01
Sumitomo Pharma America, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
12
NON_RANDOMIZED
CROSSOVER
null
2DOUBLE
true
0ALL
true
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.
null
Healthy
null
2
arm 1: 14 Days Active Silver Solution arm 2: No Silver Nanoparticles
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral silver dose of 32ppm intervention 2: Sterile Water No Silver
intervention 1: 32ppm Silver Particle intervention 2: Placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
24
0
0
0
NCT01405794
1COMPLETED
2011-11-01
2011-07-01
University of Utah
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores. Secondary 1. Determine if pregnenolone supplementation is associ...
Bipolar Disorder Major Depressive Disorder
null
2
arm 1: This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. arm 2: The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. intervention 2: Inactive ingredient matching the active medication in appearance.
intervention 1: Pregnenolone intervention 2: Placebo
1
Dallas | Texas | United States | -96.80667 | 32.78306
73
0
0
0
NCT01409096
1COMPLETED
2011-11-01
2010-03-01
University of Texas Southwestern Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
10
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to extend findings from the creatine dose-finding study (CREST-UP1) in Huntington's disease to evaluate the long-term safety, tolerability, and clinical impact of high dose creatine.
PRÉCIS Protocol Title Creatine Safety \& Tolerability in Huntington's Disease (CREST-X): A Single-Center, Open-Label, Long-Term Safety \& Tolerability Extension Study of Creatine in Subjects with HD Study Phase Phase II Clinical Trial Funding Departmental Funds Drug Supply Provided By The Avicena Group, Inc (Palo Al...
Huntington's Disease (HD)
Symptomatic Huntington's Disease HD
null
1
arm 1: single arm long-term open label follow-up
[ 5 ]
1
[ 0 ]
intervention 1: Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
intervention 1: Creatine monohydrate
1
Charlestown | Massachusetts | United States | -71.062 | 42.37787
10
0
0
0
NCT01412151
1COMPLETED
2011-11-01
2005-04-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
314
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-...
Detailed description is entered above
Post-operative Hemorrhage
null
2
arm 1: Placebo is described in chart arm 2: Dexamethasone is described in chart
[ 2, 0 ]
1
[ 0 ]
intervention 1: 0.5mg/kg (max dose 20mg)
intervention 1: Dexamethasone
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
314
0
0
0
NCT01415583
1COMPLETED
2011-11-01
2010-07-01
Massachusetts Eye and Ear Infirmary
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
103
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.
null
Open-Angle Glaucoma Ocular Hypertension
Open-Angle Glaucoma Ocular Hypertension Intraocular Pressure Brinzolamide Brimonidine
null
3
arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days arm 2: Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days arm 3: Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in ...
[ 0, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide ophthalmic suspension, 1% intervention 3: Brimonidine tartrate ophthalmic solution, 0.2%
0
null
101
0
0
0
NCT01426867
1COMPLETED
2011-11-01
2011-09-01
Alcon Research
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected. This study is for research purposes only and is not intended to treat any medical condition. This researc...
null
Diabetes Mellitus, Type 2
null
1
arm 1: Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17. Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
[ 0 ]
2
[ 0, 2 ]
intervention 1: Administered orally intervention 2: Administered as subcutaneous injection
intervention 1: Digoxin intervention 2: Dulaglutide
1
Daytona Beach | Florida | United States | -81.02283 | 29.21081
45
0
0
0
NCT01436201
1COMPLETED
2011-11-01
2011-09-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
18
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
null
Healthy
null
3
arm 1: high dose of empagliflozin after overnight fasting for at least 10 h arm 2: high dose of empagliflozin after a standardised high fat breakfast arm 3: low dose empagliflozin after overnight fasting for at least 10 h
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: high dose of empagliflozin after overnight fasting for at least 10 h intervention 2: low dose empagliflozin after overnight fasting for at least 10 h intervention 3: high dose of empagliflozin after a standardised high fat breakfast
intervention 1: Empagliflozin intervention 2: Empagliflozin intervention 3: Empagliflozin
1
Biberach | N/A | Germany | 8.03333 | 48.33333
54
0
0
0
NCT01451775
1COMPLETED
2011-11-01
2011-10-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
255
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamb...
null
Rhinitis
null
3
arm 1: Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4. arm 2: Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. arm 3: Participants will receive one dose of placebo following randomiza...
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: loratadine, one 10 mg tablet, orally intervention 2: fexofenadine, one 180 mg tablet, orally intervention 3: one tablet, orally intervention 4: one tablet, orally
intervention 1: loratadine intervention 2: fexofenadine intervention 3: placebo to loratadine intervention 4: placebo to fexofenadine
0
null
255
0
0
0
NCT01469234
1COMPLETED
2011-11-01
2011-10-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
6
NA
SINGLE_GROUP
9OTHER
0NONE
true
2MALE
null
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.
null
Healthy Volunteer
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Single oral radiolabeled dose
intervention 1: dalcetrapib
1
Zuidlaren | N/A | Netherlands | 6.68194 | 53.09417
6
0
0
0
NCT01476267
1COMPLETED
2011-11-01
2011-10-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The goal of this clinical research study is to see if high-dose chemotherapy (BEAM) and rituximab, given together with the new drug 90Y Zevalin, followed by a transplant of blood or marrow stem cells is safe. Another goal is to learn if this treatment can help decrease the chances of the cancer coming back.
BEAM chemotherapy is the standard treatment for lymphoma. BEAM is a combination of chemotherapy drugs (carmustine, cytarabine, etoposide, and melphalan). Rituximab is an antibody made from human and mouse proteins. It reacts with a certain molecule on the surface of lymphoma cells and helps the body's immune system des...
Lymphoma
Lymphoma Relapse B-cell CD20+ non-Hodgkin's lymphoma High-dose BEAM chemotherapy Y Zevalin In Zevalin Rituxan Rituximab BCNU 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea Carmustine BiCNU VP-16 Ara-C Cytarabine Cytosar DepoCyt Cytosine Arabinosine Hydrochloride Melphalan Alkeran G-CSF Filgrastim Neupogen S...
null
1
arm 1: Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (20...
[ 0 ]
9
[ 0, 0, 0, 0, 0, 0, 0, 3, 0 ]
intervention 1: Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14. intervention 2: Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21. intervention 3: 250 mg/m2 by vein on Day -21 and on Day -14. 1000 mg/m2 by vein on Days +1 and +8. intervention 4: 300 mg/m2 by vein on Day -6. interve...
intervention 1: Y Zevalin intervention 2: In Zevalin intervention 3: Rituxan intervention 4: BCNU intervention 5: VP -16 intervention 6: Ara-C intervention 7: Melphalan intervention 8: Stem Cell Infusion intervention 9: G-CSF
1
Houston | Texas | United States | -95.36327 | 29.76328
40
0
0
0
NCT01538472
1COMPLETED
2011-11-01
2003-09-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
The purpose of this study is to develop new treatment options for osteoporosis in men. The Investigators will study two medications and three treatment regimens. First, risedronate (FDA approved) will be studied as monotherapy. Second, the investigators will study injectable parathyroid hormone (PTH 134, teriparatide; ...
Study Design: This study involves a 24month commitment, constituting 12 visits as outlined below. The study coordinator will contact patients remotely by phone or email at the Month 9 visit, the Month 15, and the Month 21 visit so these do not require travel to Columbia University Medical Center. This randomized, dou...
Osteoporosis
osteoporosis male
null
3
arm 1: Active Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months arm 2: Active Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months arm 3: Placebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months
[ 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: weekly risedronate intervention 2: daily teriparatide intervention 3: daily placebo of teriparatide intervention 4: weekly placebo of Risedronic Acid
intervention 1: Risedronate intervention 2: Teriparatide intervention 3: Placebo Teriparatide intervention 4: placebo Risedronate
1
New York | New York | United States | -74.00597 | 40.71427
29
0
0
0
NCT01611571
1COMPLETED
2011-11-01
2003-12-01
Columbia University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
19
RANDOMIZED
PARALLEL
9OTHER
2DOUBLE
true
1FEMALE
false
The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.
This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the sa...
Skin Wrinkling
wrinkles botulinum toxin abobotulinumtoxinA onabotulinumtoxinA field of anhydrotic effects
null
2
arm 1: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead. arm 2: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead. intervention 2: Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
intervention 1: AbobotulinumtoxinA (ABO) intervention 2: OnabotulinumtoxinA (ONA)
1
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
38
0
0
0
NCT01732809
1COMPLETED
2011-11-01
2011-01-01
Brazilan Center for Studies in Dermatology
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their canc...
null
Ovarian Cancer Peritoneal Cancer
null
1
arm 1: Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion. Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. intervention 2: Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abrax...
intervention 1: Abraxane intervention 2: Bevacizumab
1
Portland | Oregon | United States | -122.67621 | 45.52345
5
0
0
0
NCT01821859
6TERMINATED
2011-11-01
2010-01-01
OHSU Knight Cancer Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based ch...
null
Non-Small Cell Lung Cancer
null
2
arm 1: None arm 2: None
[ 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily intervention 2: orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application intervention 3: 1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles intervention 4: ...
intervention 1: erlotinib [Tarceva] intervention 2: placebo intervention 3: gemcitabine intervention 4: cisplatin intervention 5: carboplatin
19
Campbelltown | N/A | Australia | 150.81667 | -34.06667 Camperdown | N/A | Australia | 151.17642 | -33.88965 Liverpool | N/A | Australia | 150.92588 | -33.91938 Guangzhou | N/A | China | 113.25 | 23.11667 Guangzhou | N/A | China | 113.25 | 23.11667 Shanghai | N/A | China | 121.45806 | 31.22222 Shanghai | N/A | China | 1...
153
0
0
0
NCT01998919
1COMPLETED
2011-11-01
2006-08-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0