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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
4
] | 847 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study will assess the safety and efficacy of combination aliskiren/amlodipine in patients with hypertension not adequately controlled with amlodipine alone. | null | Hypertension | Aliskiren Amlodipine Non-responder to Amlodipine | null | 3 | arm 1: Amlodipine 10 mg arm 2: Aliskiren/Amlodipine 150/10 mg arm 3: Aliskiren/Amlodipine 300/10 mg | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Amlodipine 10 mg intervention 2: Aliskiren/Amlodipine 150/10 mg intervention 3: Aliskiren/Amlodipine 300/10 mg | intervention 1: Amlodipine 10 mg intervention 2: Aliskiren 150 intervention 3: Amlodipine 300 | 7 | Buenos Aires | N/A | Argentina | -58.37723 | -34.61315
Berlin | N/A | Germany | 13.41053 | 52.52437
Oslo | N/A | Norway | 10.74609 | 59.91273
Warsaw | N/A | Poland | 21.01178 | 52.22977
Bratislava | N/A | Slovakia | 17.10674 | 48.14816
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Ankara | N/A | Turkey (Türkiye) | 32.85427 | 39.91987 | 843 | 0 | 0 | 0 | NCT00778921 | 1COMPLETED | 2009-06-01 | 2008-10-01 | Novartis | 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
] | 3 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD. | This is a Phase I/II study to determine:
* the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
* the pharmacokinetic parameters of Plitidepsin in combination with Cytarabine.
* whether Plitidepsin in combination with Cytarabine exerts antiangiogenic effects as measured by reduction in microvessel density and VEGFR-1 expression in bone marrow biopsies of patients with relapsed/refractory leukemia.
* whether measurement of free serum VEGF levels, soluble circulating VEGF Receptor and Peripheral Progenitor Endothelial cells provide an early marker of response to Plitidepsin.
* the effects of Plitidepsin and Cytarabine on cytidine deaminase activity and correlate results with Cytarabine drug resistance.
* changes in leukemic gene expression as a result of Plitidepsin and Cytarabine administration.
* tumor response duration.
* progression free survival and overall survival. | Relapsed/Refractory Leukemia | Tumor Leukemia Plitidepsin Aplidin | null | 1 | arm 1: Plitidepsin in combination with Cytarabine | [
0
] | 1 | [
0
] | intervention 1: Plitidepsin 0.54 mg /m2 (initial dose)daily x 5 one hour infusion every 3 weeks plus Cytarabine 1 g/m2 daily for 5 days. | intervention 1: Plitidepsin plus Cytarabine | 1 | New Brunswick | New Jersey | United States | -74.45182 | 40.48622 | 3 | 0 | 0 | 0 | NCT00780143 | 6TERMINATED | 2009-06-01 | 2007-11-01 | PharmaMar | 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
] | 102 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 1FEMALE | false | This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe postmenopausal vasomotor symptoms (VMS), defined as follows:
* Moderate VMS: Sensation of heat with sweating, able to continue activity
* Severe VMS: Sensation of heat with sweating, causing cessation of activity | Eligible subjects will be entered into a 1-week observation period followed by a 1-week run-in period. Following completion of the run-in period, eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio. Study drug will be administered once daily at bedtime. Symptom assessment questionnaires will be administered at baseline and at Day 28 and Day 57 visits. | Hot Flashes | Menopause Vasomotor Symptoms Hot flash Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP) | null | 2 | arm 1: Eligible subjects will be randomized to receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg. arm 2: Eligible subjects will be randomized to receive a sugar pill. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg. intervention 2: Subjects will receive a sugar pill. | intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Sugar pill | 10 | Lake Worth | Florida | United States | -80.07231 | 26.61708
Naples | Florida | United States | -81.79596 | 26.14234
Greensboro | North Carolina | United States | -79.79198 | 36.07264
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
Richmond | Virginia | United States | -77.46026 | 37.55376
Richmond | Virginia | United States | -77.46026 | 37.55376
Seattle | Washington | United States | -122.33207 | 47.60621
Spokane | Washington | United States | -117.42908 | 47.65966 | 101 | 0 | 0 | 0 | NCT00786188 | 1COMPLETED | 2009-06-01 | 2008-11-01 | 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 |
[
5
] | 6 | RANDOMIZED | PARALLEL | 9OTHER | 3TRIPLE | false | 0ALL | false | The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography. | Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography. | Renal Impairment | Renal Kidney Contrast Induced Nephropathy | null | 2 | arm 1: Ioversol 320 mgI/mL arm 2: Iodixanol 320 mgI/mL | [
1,
1
] | 2 | [
0,
0
] | intervention 1: 125 mL of Ioversol administered in the vein intervention 2: 125 mL of Iodixanol administered in the vein | intervention 1: Ioversol 320 mgI/mL intervention 2: Iodixanol 320 mgI/mL | 13 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Peoria | Illinois | United States | -89.58899 | 40.69365
Auburn | Maine | United States | -70.23117 | 44.09785
Grand Blanc | Michigan | United States | -83.62995 | 42.92753
Rochester | New York | United States | -77.61556 | 43.15478
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Youngstown | Ohio | United States | -80.64952 | 41.09978
Danville | Pennsylvania | United States | -76.61273 | 40.96342
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Tyler | Texas | United States | -95.30106 | 32.35126 | 6 | 0 | 0 | 0 | NCT00793182 | 6TERMINATED | 2009-06-01 | 2009-01-01 | 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 |
[
0
] | 40 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy. | It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be evaluated. | IgA Nephropathy | IgA nephropathy | null | 2 | arm 1: Allopurinol group:allopurinol, 100-300mg/d according to the levels of Scr(serum creatinine) and UA(uric acid), for those Scr \< 1.5mg/dl (133 umol/L) at the baseline, allopurinol was given 100 mg three times daily.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg. arm 2: Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet and continue their usual therapy.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg. | [
0,
5
] | 2 | [
0,
10
] | intervention 1: Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level \< 6mg/dl , the dosage changed to 200mg/d. intervention 2: Patients will receive lifestyle modification and continue their usual therapy. | intervention 1: allopurinol intervention 2: continue their usual therapy | 1 | Guangzhou | Guangdong | China | 113.25 | 23.11667 | 40 | 0 | 0 | 0 | NCT00793585 | 1COMPLETED | 2009-06-01 | 2007-07-01 | Sun Yat-sen 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 |
[
2
] | 41 | NA | SINGLE_GROUP | null | 0NONE | true | 0ALL | false | The primary goal of this study is to characterize the pharmacokinetics of doxylamine succinate in children ages 2 to \< 18 years. Once characterized, these pediatric pharmacokinetic data will be pooled with historical adult PK data from other studies to assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug exposure as that associated with efficacy in adults. | null | Allergic Rhinitis Upper Respiratory Infection | Pharmacokinetic study | null | 1 | arm 1: Doxylamine Succinate United States Pharmacopeia (USP) | [
0
] | 1 | [
0
] | intervention 1: One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL | intervention 1: Doxylamine Succinate USP | 6 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Louisville | Kentucky | United States | -85.75941 | 38.25424
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Kansas City | Missouri | United States | -94.57857 | 39.09973
Durham | North Carolina | United States | -78.89862 | 35.99403
Cleveland | Ohio | United States | -81.69541 | 41.4995 | 41 | 0 | 0 | 0 | NCT00796315 | 1COMPLETED | 2009-06-01 | 2008-12-01 | Procter and Gamble | 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
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The aim of this study was to compare the efficacy and safety of intramuscular 10 mg olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of acute agitated schizophrenic patients of Taiwanese populations. | To date, there have been no published reports of clinical studies of IM olanzapine versus IM haloperidol plus lorazepam in acute schizophrenia patients with moderate to severe degree of agitation. The latter combination of treatment is used quite often as a traditional way to treat agitated schizophrenia patients.
Study Design:
This is a randomized, active-controlled, parallel-group study, consisting of screening and treatment phase. Patients completing the screening phase would be randomized to receive either 10mg olanzapine IM or 5 mg haloperidol plus 2 mg lorazepam IM . The ratio of randomization was 1:1. Treatment assignments are based on a computer-generated randomization code supplied by central unit with block designs. Patients can receive a maximum of 3 injections within the first 24-hour period. Second and third injections are used under the clinical judgment of investigators. The second injection is allowed after 2-hour has elapsed since first injection. The third injection is allowed after 4-hour have passed since the second injection. Prohibited medications include antiarrythmics, antipsychotics, antidepressants, anticonvulsants, antiemetics, and other psychotropic drugs.
Efficacy Assessments:
Patients are assessed by the study investigators at the screening visit and at 15, 30, 60, 120 minutes after first injection. The primary efficacy measure is PANSS-EC, which includes the items tension, uncooperativeness, hostility, poor impulse control, excitement and is derived from the PANSS by its originators using a principal-components factor analysis. Agitation is further assessed by the Agitation-Calmness Evaluation Scale (ACES) (Copyright 1998, Eli Lilly and Company; all rights reserved). Clinical Global Impression-Severity（CGI-S）scale37 is used to assess general psychiatric condition. For each patient, the same rater conducted the assessment throughout the study.
Safety assessments:
During the 24-hour treatment period, safety is assessed by clinical examination and laboratory investigations, recording spontaneously reported adverse events, completing the Simpson-Angus Scale (SAS) and Barnes Akathisia Scales (BAS).
Statistical Procedures:
The efficacy analyses were based on intent to treat (ITT) population defined as consisting of all randomized subjects. The last observation carried forward (LOCF) dataset was used to estimate the missing data. Data were analysed using statistical program R Language version 2.8.0 (http://www.r-project.org/), with significance set at p \< .05. Demographic characteristics and clinical parameters at baseline were compared by treatment group using the t-test for continuous variables and chi-square test for categorical variables. The primary treatment comparison was 2-hour PANSS-EC scores after first injection. Continuous efficacy and safety data were evaluated by multiple linear regression, adjusting for treatment group, center, and treatment-by-center interaction. The treatment-by-center interaction was tested at the 0.10 significant levels and dropped from the model if it was not statistically significant. To compare the number difference in adverse events between two treatment groups, Fisher's exact test was used due to low cell counts. | Schizophrenia Schizoaffective Disorder Agitation | schizophrenia schizoaffective disorder olanzapine haloperidol lorazepam agitation | null | 2 | arm 1: Patients of this arm received 10 mg IM olanzapine after randomization arm 2: Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 10mg olanzapine IM intervention 2: IM 5 mg haloperidol plus IM 2 mg lorazepam | intervention 1: IM olanzapine intervention 2: IM haloperidol plus lorazepam | 1 | Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 67 | 0 | 0 | 0 | NCT00797277 | 1COMPLETED | 2009-06-01 | 2006-07-01 | National Taiwan 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 |
[
5
] | 78 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with attention deficit hyperactivity disorder (ADHD), when compared to placebo. | The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD, when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral, and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD. This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on one of the two laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of methylphenidate HCl. The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks. | Attention Deficit Hyperactivity Disorder | ADHD Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: CONCERTA (methylphenidate HCl) / Placebo Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2 arm 2: Placebo/ CONCERTA (methylphenidate HCl) Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2 | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Placebo once daily on Lab School Day #1 and Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #2 intervention 2: Optimal Subject Dose (18 mg-54 mg) once daily during Lab School Day #1 and Placebo once daily on Lab School Day #2 | intervention 1: Placebo/ CONCERTA (methylphenidate HCl) intervention 2: CONCERTA (methylphenidate HCl) / Placebo | 2 | Irvine | California | United States | -117.82311 | 33.66946
Houston | Texas | United States | -95.36327 | 29.76328 | 220 | 0 | 0 | 0 | NCT00799409 | 1COMPLETED | 2009-06-01 | 2008-12-01 | Ortho-McNeil Janssen Scientific Affairs, 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
] | 1,002 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.
In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose. | null | Influenza, Human | Influenza Neuraminidase inhibitor | null | 3 | arm 1: CS-8958 powder to be inhaled - low-dose arm arm 2: CS-8958 powder to be inhaled - high-dose arm arm 3: oseltamivir phosphate oral capsules | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 2: CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days intervention 3: CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days. | intervention 1: CS-8958 intervention 2: CS-8958 intervention 3: oseltamivir phosphate | 4 | Hong Kong | N/A | China | 114.17469 | 22.27832
Tokyo | N/A | Japan | 139.69171 | 35.6895
Seoul | N/A | South Korea | 126.9784 | 37.566
Taipei | N/A | Taiwan | 121.52639 | 25.05306 | 999 | 0 | 0 | 0 | NCT00803595 | 1COMPLETED | 2009-06-01 | 2008-11-01 | Daiichi Sankyo Co., 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 |
[
4
] | 474 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides. | There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures. | Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia | Dyslipidemia Hypercholesterolemia Hypertriglyceridemia | null | 4 | arm 1: ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 2: ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 3: ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks arm 4: Simvastatin capsules 40 mg daily for 8 weeks | [
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Once daily for 8 weeks intervention 2: Once daily for 8 weeks simvastatin capsules 40 mg | intervention 1: ABT-143 intervention 2: simvastatin | 129 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Columbiana | Alabama | United States | -86.60721 | 33.17817
Huntsville | Alabama | United States | -86.58594 | 34.7304
Ozark | Alabama | United States | -85.64049 | 31.45906
Chandler | Arizona | United States | -111.84125 | 33.30616
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Little Rock | Arkansas | United States | -92.28959 | 34.74648
Anaheim | California | United States | -117.9145 | 33.83529
Carmichael | California | United States | -121.32828 | 38.61713
Chula Vista | California | United States | -117.0842 | 32.64005
Long Beach | California | United States | -118.18923 | 33.76696
Los Angeles | California | United States | -118.24368 | 34.05223
Norwalk | California | United States | -118.08173 | 33.90224
Palm Desert | California | United States | -116.37697 | 33.72255
Roseville | California | United States | -121.28801 | 38.75212
Sacramento | California | United States | -121.4944 | 38.58157
Sacramento | California | United States | -121.4944 | 38.58157
San Diego | California | United States | -117.16472 | 32.71571
Walnut Creek | California | United States | -122.06496 | 37.90631
West Hills | California | United States | -118.64398 | 34.19731
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
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
Coral Gables | Florida | United States | -80.26838 | 25.72149
Daytona Beach | Florida | United States | -81.02283 | 29.21081
Delray Beach | Florida | United States | -80.07282 | 26.46146
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Fort Myers | Florida | United States | -81.84059 | 26.62168
Hollywood | Florida | United States | -80.14949 | 26.0112
Jacksonville | Florida | United States | -81.65565 | 30.33218
Jacksonville | Florida | United States | -81.65565 | 30.33218
Jupiter | Florida | United States | -80.09421 | 26.93422
Longwood | Florida | United States | -81.3384 | 28.70305
Melbourne | Florida | United States | -80.60811 | 28.08363
New Port Richey | Florida | United States | -82.71927 | 28.24418
Ocala | Florida | United States | -82.14009 | 29.1872
Orlando | Florida | United States | -81.37924 | 28.53834
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Sarasota | Florida | United States | -82.53065 | 27.33643
Tampa | Florida | United States | -82.45843 | 27.94752
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Winter Haven | Florida | United States | -81.73286 | 28.02224
Winter Park | Florida | United States | -81.33924 | 28.6
Augusta | Georgia | United States | -81.97484 | 33.47097
Dunwoody | Georgia | United States | -84.33465 | 33.94621
Roswell | Georgia | United States | -84.36159 | 34.02316
Suwanee | Georgia | United States | -84.0713 | 34.05149
Woodstock | Georgia | United States | -84.51938 | 34.10149
Chicago | Illinois | United States | -87.65005 | 41.85003
Peoria | Illinois | United States | -89.58899 | 40.69365
Peoria | Illinois | United States | -89.58899 | 40.69365
Evansville | Indiana | United States | -87.55585 | 37.97476
Indianapolis | Indiana | United States | -86.15804 | 39.76838
South Bend | Indiana | United States | -86.25001 | 41.68338
Arkansas City | Kansas | United States | -97.03837 | 37.06197
Wichita | Kansas | United States | -97.33754 | 37.69224
Louisville | Kentucky | United States | -85.75941 | 38.25424
Mount Sterling | Kentucky | United States | -83.94326 | 38.05647
Baltimore | Maryland | United States | -76.61219 | 39.29038
Bethesda | Maryland | United States | -77.10026 | 38.98067
Oxon Hill | Maryland | United States | -76.9897 | 38.80345
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Kalamazoo | Michigan | United States | -85.58723 | 42.29171
Brooklyn Center | Minnesota | United States | -93.33273 | 45.07608
Edina | Minnesota | United States | -93.34995 | 44.88969
Jackson | Mississippi | United States | -90.18481 | 32.29876
Olive Branch | Mississippi | United States | -89.82953 | 34.96176
City of Saint Peters | Missouri | United States | -90.62651 | 38.80033
St Louis | Missouri | United States | -90.19789 | 38.62727
Billings | Montana | United States | -108.50069 | 45.78329
Omaha | Nebraska | United States | -95.94043 | 41.25626
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Berlin | New Jersey | United States | -74.92905 | 39.79123
Elizabeth | New Jersey | United States | -74.2107 | 40.66399
Hillsborough | New Jersey | United States | -74.62682 | 40.4776
Trenton | New Jersey | United States | -74.74294 | 40.21705
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Johnson City | New York | United States | -75.95881 | 42.11563
Syracuse | New York | United States | -76.14742 | 43.04812
Cary | North Carolina | United States | -78.78112 | 35.79154
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Hickory | North Carolina | United States | -81.3412 | 35.73319
Morehead City | North Carolina | United States | -76.72604 | 34.72294
Salisbury | North Carolina | United States | -80.47423 | 35.67097
Statesville | North Carolina | United States | -80.8873 | 35.78264
Wilmington | North Carolina | United States | -77.94604 | 34.23556
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Akron | Ohio | United States | -81.51901 | 41.08144
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Kettering | Ohio | United States | -84.16883 | 39.6895
Mason | Ohio | United States | -84.30994 | 39.36006
Warren | Ohio | United States | -80.81842 | 41.23756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Medford | Oregon | United States | -122.87559 | 42.32652
Beaver | Pennsylvania | United States | -80.30478 | 40.69534
Duncansville | Pennsylvania | United States | -78.4339 | 40.42341
Harleysville | Pennsylvania | United States | -75.38712 | 40.27955
Jersey Shore | Pennsylvania | United States | -77.26442 | 41.20202
Melrose Park | Pennsylvania | United States | -75.13184 | 40.06178
Perkasie | Pennsylvania | United States | -75.29268 | 40.37205
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Tipton | Pennsylvania | United States | -78.29585 | 40.6359
Warminster | Pennsylvania | United States | -75.09962 | 40.20678
Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407
Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407
Simpsonville | South Carolina | United States | -82.25428 | 34.73706
Summerville | South Carolina | United States | -80.17565 | 33.0185
Germantown | Tennessee | United States | -89.81009 | 35.08676
Jackson | Tennessee | United States | -88.81395 | 35.61452
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Fort Worth | Texas | United States | -97.32085 | 32.72541
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
San Antonio | Texas | United States | -98.49363 | 29.42412
Norfolk | Virginia | United States | -76.28522 | 36.84681
Richmond | Virginia | United States | -77.46026 | 37.55376
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 474 | 0 | 0 | 0 | NCT00812955 | 1COMPLETED | 2009-06-01 | 2008-11-01 | 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 |
[
5
] | 36 | NA | SINGLE_GROUP | 1PREVENTION | 0NONE | true | 1FEMALE | true | The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness. | null | Heart Disease | null | 1 | arm 1: Resistant | [
1
] | 1 | [
0
] | intervention 1: Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily | intervention 1: Aspirin | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 36 | 0 | 0 | 0 | NCT00818337 | 1COMPLETED | 2009-06-01 | 2008-11-01 | Creighton 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
] | 139 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | Patients will be enrolled in a multi-center study (Wilford Hall Medical Center and Brooke Army Medical Center) to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. | All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1) septa double strength two pills orally twice a day x 7 days or 2)placebo. Patients will then return to the emergency room on days 3 and 7 for wound repacking and evaluation. The primary outcome recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics if needed. Data will be analyzed both by initial randomization and intention to treat. | Abscess Methicillin-Resistant Staphylococcus Aureus Infection | Abscess Cellulitis Antibiotics MRSA | null | 2 | arm 1: Trim/sulfa (800/160) two tablets orally (PO) twice a day (BID) x 7 days arm 2: matched placebo 2 pills orally (PO) twice a day (BID) x 7 days | [
1,
2
] | 2 | [
0,
0
] | intervention 1: bactrim DS (800/160) two tablets PO BID x 7 days intervention 2: matched placebo 2 pills PO BID x 7 days | intervention 1: Trim/ Sulfa DS intervention 2: placebo | 1 | Lackland Air Force Base | Texas | United States | -98.61797 | 29.38663 | 139 | 0 | 0 | 0 | NCT00822692 | 1COMPLETED | 2009-06-01 | 2008-07-01 | 59th Medical Wing | 1FED | 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
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to determine if an eight-week intervention with omega-3 fatty acids significantly reduces depressive symptoms in symptomatic peri- and postmenopausal women. We hypothesize that an eight-week trial with omega-3 fatty acids promotes significant improvement in depression symptoms in peri- and postmenopausal women. | The perimenopause is commonly defined as a time of hormonal fluctuation that typically occurs in women 40-55 years of age with changes in menstrual patterns (Soares et al. 2001; Cohen et al. 2003). Women are at a particularly high risk for depressive symptoms during the perimenopause, as demonstrated by epidemiological data that support a higher risk in perimenopause (15-18% prevalence rates) than premenopause (8-12%) (Bromberger et al., 2003). Women may be especially vulnerable to depressive symptoms during perimenopause due to declining levels of estrogen. Estrogen interacts with the neurotransmitter serotonin and its receptor expression, and may have antidepressant effects; estrogen monotherapy may alleviate depressive symptoms and has been associated with improved quality of life (Soares et al. 2001; Cohen et al., 2003). Of great practical clinical importance, hormone replacement therapy has become increasingly controversial in light of the findings of the Women's Health Initiative study (Roussouw et al.,2002). Soares et al. (2003) found that women with perimenopausal and postmenopausal depression responded well with treatment with citalopram alone and in combination with estrogen. Venlafaxine, mirtazapine, escitalopram, and duloxetine appear efficacious in open pilot studies for perimenopausal depression (Ladd et al., 2005, Joffe et al. 2001; Freeman et al., 2006; Joffe et al., 2007). However, antidepressant medications may be associated with significant side effects. Clinicians, researchers, and patients are now seeking alternative treatments for menopausal-related emotional and physical symptoms.
Investigators have demonstrated promising results with omega-3 fatty acids as a treatment intervention for MDD (Major Depressive Disorder). Overall, treatment data in MDD support a role for EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in combination or EPA as the omega-3 fatty acid intervention. The majority of published trials that have utilized EPA and DHA in combination or EPA alone have demonstrated a significant benefit in MDD.
Omega-3 fatty acids (sometimes abbreviated n-3 fatty acids) are nutritional compounds with widely established health benefits. Omega-3 fatty acids are polyunsaturated fatty acids. The American Psychiatric Association's (APA) Committee on Research on Psychiatric Treatments conducted a meta-analysis of placebo-controlled treatment studies of MDD and bipolar depression and found a significant benefit for omega-3 fatty acids (Freeman et al., 2006).
Treatment with estrogen compounds, such as oral contraceptive pills or oral estrogen replacement therapy, has been shown to increase levels of DHA in women, theoretically from the upregulation of DHA synthesis from dietary precursors (Giltay et al., 2004). Increased EPA and DHA in plasma due to hormone replacement therapy have been proposed to account for its antidepressant effects (Sumino et al., 2003). Should decline in endogenous estrogen levels, therefore, lower the amount of omega-3 fatty acids available to the brain, supplementation in the perimenopause may be of particular importance. | Depression | menopause perimenopause postmenopause depression mood sleep hot flashes | null | 1 | arm 1: omega-3 fatty acids, 2grams qd \[every day\] (2 x 1 gram tablets), PO \[by mouth\] | [
0
] | 1 | [
0
] | intervention 1: 2 g omega-3 fatty acids (docosahexaenoic acid \[DHA\] + eicosapentaenoic acid \[EPA\]), PO \[by mouth\], qd \[every day\] | intervention 1: Omega-3 Fatty Acids | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 24 | 0 | 0 | 0 | NCT00825994 | 1COMPLETED | 2009-06-01 | 2008-11-01 | 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 |
[
5
] | 5 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease.
Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks. | null | Coronary Artery Disease Pain Peripheral Nervous System Diseases Polyneuropathy | Coronary Artery Disease Pain Peripheral Neuropathy Polyneuropathy | null | 2 | arm 1: Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12. arm 2: Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12. | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks). intervention 2: Placebo to match ranolazine administered twice a day for 6 weeks | intervention 1: Ranolazine intervention 2: Placebo | 1 | Houma | Louisiana | United States | -90.71953 | 29.59577 | 10 | 0 | 0 | 0 | NCT00832572 | 6TERMINATED | 2009-06-01 | 2009-01-01 | Gilead Sciences | 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
] | 401 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone. | This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome of the study), multi-centre, and non-randomized (participants are assigned to different treatment groups by the investigator) study. The study will be conducted into 2 parts (Part 1 and Part 2). Approximately 400 participants will be enrolled (30 in Part 1 and 370 in Part 2). In Part 1 the optimum dose of cyclophosphamide will be evaluated and in Part 2 the selected dose of cyclophosphamide from Part 1 will be administered. Part 2 will include a screening period of a maximum of 14 days followed by chemotherapy (bortezomib, cyclophosphamide, and dexamethasone) of a maximum of three 21-day cycles. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. | Multiple Myeloma | Multiple Myeloma Untreated multiple myeloma Bortezomib VELCADE Cyclophosphamide Dexamethasone Chemotherapy Remission therapy Induction therapy Stem Cell Transplantation | null | 1 | arm 1: Part 1 will be the dose titration part for cyclophosphamide. Participants will receive cyclophosphamide, bortezomib, and dexamethasone for 3 cycles. In Part 2, participants will receive cyclophosphamide (dose determined in Part 1) with pre-defined dose of bortezomib and dexamethasone for 3 cycles. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: In Part 1, cyclophosphamide with dose ranging from 900 to 1500 mg will be administered intravenously on Day 1 of each 21 day cycle for 3 cycles to determine optimal dose. In Part 2, optimal dose determined in Part 1 will be administered on Day 1 of each 21 day cycle for 3 cycles. intervention 2: Bortezomib 1.3 mg/m2 will be administered intravenously on Days 1,4,8, and 11 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2). intervention 3: Participants will receive dexamethasone 40 mg orally or intravenously on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21 day cycle for 3 cycles in both parts (Part 1 and Part 2). | intervention 1: Cyclophosphamide intervention 2: Bortezomib intervention 3: Dexamethasone | 34 | Berg | N/A | Germany | 12.14161 | 49.81417
Berlin | N/A | Germany | 13.41053 | 52.52437
Bremen | N/A | Germany | 8.80717 | 53.07582
Dresden | N/A | Germany | 13.73832 | 51.05089
Erlangen | N/A | Germany | 11.00783 | 49.59099
Frankfurt am Main | N/A | Germany | 8.68417 | 50.11552
Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959
Göttingen | N/A | Germany | 9.93228 | 51.53443
Greifswald | N/A | Germany | 13.40244 | 54.08905
Halle | N/A | Germany | 11.97947 | 51.48158
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamm | N/A | Germany | 7.82089 | 51.68033
Hanover | N/A | Germany | 9.73322 | 52.37052
Homburg | N/A | Germany | 7.33867 | 49.32637
Jena | N/A | Germany | 11.5899 | 50.92878
Karlsruhe | N/A | Germany | 8.40444 | 49.00937
Kiel | N/A | Germany | 10.13489 | 54.32133
Lübeck | N/A | Germany | 10.68729 | 53.86893
Magdeburg | N/A | Germany | 11.62916 | 52.12773
Mainz | N/A | Germany | 8.2791 | 49.98419
Mutlangen | N/A | Germany | 9.79714 | 48.82588
München | N/A | Germany | 13.31243 | 51.60698
Münster | N/A | Germany | 7.62571 | 51.96236
Nuremberg | N/A | Germany | 11.07752 | 49.45421
Oldenburg | N/A | Germany | 8.21467 | 53.14118
Potsdam | N/A | Germany | 13.06566 | 52.39886
Regensburg | N/A | Germany | 12.10161 | 49.01513
Rehling | N/A | Germany | 10.93333 | 48.48333
Rostock | N/A | Germany | 12.14049 | 54.0887
Stuttgart | N/A | Germany | 9.17702 | 48.78232
Tübingen | N/A | Germany | 9.05222 | 48.52266
Ulm | N/A | Germany | 9.99155 | 48.39841
Villingen-Schwenningen | N/A | Germany | 8.49358 | 48.06226
Würzburg | N/A | Germany | 9.95121 | 49.79391 | 395 | 0 | 0 | 0 | NCT00833560 | 1COMPLETED | 2009-06-01 | 2006-03-01 | Janssen-Cilag G.m.b.H | 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
] | 372 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | true | 2MALE | false | The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day. | null | Erectile Dysfunction | Erectile Dysfunction | null | 3 | arm 1: No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. arm 2: No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. arm 3: No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: One tablet orally daily intervention 2: Orally once daily | intervention 1: Placebo intervention 2: Tadalafil | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 715 | 0 | 0 | 0 | NCT00833638 | 1COMPLETED | 2009-06-01 | 2009-02-01 | 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
] | 66 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Japan. The aim of this clinical trial is to investigate the safety (with emphasis on hypoglycaemia) after switching from long-acting insulin analogue/intermediate-acting insulin or pre-mixed insulin/pre-mixed insulin analogue on a twice daily regimen to NN5401 (SIAC, insulin degludec/insulin aspart) on a twice daily regimen in subjects with type 2 diabetes mellitus. | null | Diabetes Diabetes Mellitus, Type 2 | null | 2 | arm 1: None arm 2: None | [
1,
0
] | 2 | [
0,
0
] | intervention 1: The insulin NN5401 (insulin degludec/insulin aspart) injected subcutaneously immediately before breakfast and dinner. intervention 2: The insulin (biphasic insulin aspart 30) injected subcutaneously immediately before breakfast and dinner. | intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30 | 8 | Chuo-ku, Tokyo | N/A | Japan | N/A | N/A
Miyazaki | N/A | Japan | 131.41667 | 31.91667
Naka-shi, Ibaraki | N/A | Japan | N/A | N/A
Ota-ku, Tokyo | N/A | Japan | N/A | N/A
Oyama-shi, Tochigi | N/A | Japan | 139.73333 | 36.38333
Sendai | N/A | Japan | 140.86667 | 38.26667
Shizuoka | N/A | Japan | 138.38333 | 34.98333
Tagajō-shi | N/A | Japan | 141.0 | 38.3 | 65 | 0 | 0 | 0 | NCT00842361 | 1COMPLETED | 2009-06-01 | 2009-01-01 | 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 | |
[
3
] | 54 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 2MALE | null | This study is to evaluate the safety and efficacy of the study drug compared to placebo in the treatment of cognitive impairment in men with schizophrenia. | null | Schizophrenia | null | 2 | arm 1: MK5757 arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days intervention 2: This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days. | intervention 1: MK5757 intervention 2: Comparator: Placebo | 0 | null | 100 | 0 | 0 | 0 | NCT00848484 | 1COMPLETED | 2009-06-01 | 2008-10-01 | 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 | |
[
3
] | 16 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with actinic keratoses | null | Actinic Keratosis | Peplin PEP005 Actinic Keratosis | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days intervention 2: Vehicle Gel once daily for 2 consecutive days | intervention 1: PEP005 (ingenol mebutate) Gel, 0.05% intervention 2: Vehicle Gel | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 16 | 0 | 0 | 0 | NCT00852137 | 1COMPLETED | 2009-06-01 | 2009-03-01 | Peplin | 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
] | 111 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination therapy (bitherapy) in patients with focal epilepsy. | null | Focal Epilepsy | epilepsy antiepileptic biotherapy | null | 1 | arm 1: None | [
5
] | 1 | [
0
] | intervention 1: * Gabapentin: up to 3.600 mg/d
* Lamotrigine: up to 400 mg/d
* Levetiracetam: up to 3.000 mg/d
* Pregabalin: up to 600 mg/d
* Oxcarbazepine: up to 2.400 mg/d
* Tiagabine: up to 30 mg/d
* Topiramate: up to 400 mg/d
* Zonisamide: up to 500 mg/d | intervention 1: Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide | 0 | null | 151 | 0 | 0 | 0 | NCT00855738 | 1COMPLETED | 2009-06-01 | 2007-05-01 | Pfizer's Upjohn has merged with Mylan to form Viatris 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 |
[
0
] | 22 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | true | Medical center personnel were screened organoleptically for bad breath by 2 investigators using Rosenberg scale 0-5, and measurement of breath sample in portable gas chromatograph. With a threshold score of 2 or more, or 75parts per billion(ppb) hydrogen sulfide(H2S), subjects invited to enter clinical trial of the mechanical effect of daily tongue scraping with the adjunctive use of 0.12% chlorhexidine gluconate mouthwash or 0.1% stabilized chlorine dioxide mouthwash. Subjects randomly assigned in double-blind trial for one week. The null hypothesis is there will be no difference between the two rinses as adjuncts to tongue scraping. | Subjects in trial had oral and periodontal exam and scored the Ramfjord teeth(#3, 9, 12, 19, 25, 28) for Plaque Index(PlI), Gingival Index(GI), probing depth (PD), recession. A tongue coating index is scored and sample of coating on dorsum taken for culture of total viable count and percentage of black sulfide-producing colonies on anaerobe agar with lead acetate added. Subjects given hygiene instruction and instruction on use of scraper, then rinse with 20ml assigned mouthwash 30sec. Breath assessed by organoleptic means and mouth air sample concentration of hydrogen sulfide, methyl mercaptan in portable gas chromatograph at 0, 1, 2, and 4 hours. Subjects use scraper and mouthwash twice daily for one week and return for final exam. | Halitosis | null | 2 | arm 1: The intervention was accomplished by subject after instructions from investigator: twice a day a tongue scraper was used with 4 or more strokes, followed by 20ml of 0.12% chlorhexidine gluconate mouthwash used for 30 sec, for one week. arm 2: The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.1% stabilized chlor8ine dioxide rinse for 30sec, for one week. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: 20ml of mouthwash used for 30sec as adjunct to tongue scraper twice a day intervention 2: The intervention was accomplished by subject after instructions by investigator: twice a day the scraper was used for 4 strokes then 20ml 0.12% chlorhexidine gluconate rinse for 30sec, for one week. | intervention 1: Chlorine dioxide and scraper intervention 2: Chlorhexidine gluconate and scraper | 1 | San Francisco | California | United States | -122.41942 | 37.77493 | 22 | 0 | 0 | 0 | NCT00867035 | 1COMPLETED | 2009-06-01 | 2008-03-01 | University of California, San Francisco | 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
] | 2 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma. | Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks. | Insomnia Asthma | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 1 | [
0
] | intervention 1: melatonin agonist | intervention 1: Ramelteon | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 3 | 0 | 0 | 0 | NCT00869167 | 6TERMINATED | 2009-06-01 | 2008-03-01 | Northwestern 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 | |
[
3
] | 27 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease. | This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms \[ECGs\], clinical laboratory tests, vital signs, adverse events \[AEs\], and concomitant medications) were evaluated over the course of the study. | Parkinson's Disease | Parkinson's | null | 2 | arm 1: Treatment Period 1:
IPX066 - 7 days; Washout Period - 7 days;
Treatment Period 2:
IR CD-LD- 7 days arm 2: Treatment Period 1:
IR CD-LD - 7 days; Washout period - 7 days;
Treatment Period 2:
IPX066- 7 days | [
5,
5
] | 2 | [
0,
0
] | intervention 1: experimental drug product: extended-release carbidopa-levodopa capsules intervention 2: active comparator: immediate-release carbidopa-levodopa capsules | intervention 1: IPX066 intervention 2: IR CD-LD | 1 | Hayward | California | United States | -122.0808 | 37.66882 | 54 | 0 | 0 | 0 | NCT00869791 | 1COMPLETED | 2009-06-01 | 2008-11-01 | Impax Laboratories, 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 |
[
2
] | 48 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | true | 0ALL | false | The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study. | Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. | Thorough QT/QTc Study | Staccato loxapine QT/QTc healthy volunteers Thorough QT/QTc study ADASUVE inhaled loxapine | null | 6 | arm 1: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 2: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 3: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 4: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 5: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg arm 6: Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg | [
5,
5,
5,
5,
5,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: Inhaled Staccato Loxapine 10 mg single dose intervention 2: Inhaled Staccato placebo single dose intervention 3: Oral moxifloxacin 400 mg intervention 4: Oral placebo similar in appearance to moxifloxacin 400 mg | intervention 1: Inhaled loxapine intervention 2: Inhaled placebo intervention 3: Oral moxifloxacin intervention 4: Oral placebo | 1 | Evansville | Indiana | United States | -87.55585 | 37.97476 | 141 | 0 | 0 | 0 | NCT00874237 | 1COMPLETED | 2009-06-01 | 2009-04-01 | Alexza 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 |
[
5
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne. | The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne. | Acne Vulgaris | Acne Acne Vulgaris | null | 2 | arm 1: Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. arm 2: Subject will apply both study products in a split-face fashion. Study products will be applied once-daily in the evening. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. intervention 2: Commencing at baseline, subjects will apply once daily both treatment arm #1 and treatment arm #2 in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. At 2 weeks, subjects will apply benzoyl peroxide/clindamycin gel to the entire face for an additional 6 weeks. | intervention 1: BENZOYL PEROXIDE/ CLINDAMYCIN intervention 2: BENZOYL PEROXIDE/ ADAPALENE | 4 | Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Ciudad Autonoma de Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Ciudad de Buenos Aires | Buenos Aires | Argentina | N/A | N/A | 48 | 0 | 0 | 0 | NCT00887484 | 1COMPLETED | 2009-06-01 | 2009-02-01 | Stiefel, a GSK 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
] | 40 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 3TRIPLE | true | 0ALL | false | The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression. | null | Healthy | Normal Healthy Subject Population | null | 2 | arm 1: Prilosec OTC arm 2: Prevacid | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast intervention 2: Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast | intervention 1: Prilosec OTC (omeprazole-magnesium) intervention 2: Prevacid | 1 | Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 | 80 | 0 | 0 | 0 | NCT00903448 | 1COMPLETED | 2009-06-01 | 2009-04-01 | Procter and Gamble | 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
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a research study to determine if the concentration of local anesthetic through a catheter next to the nerves that go to the hip that is undergoing surgery, affects muscle strength and sense of touch experienced after surgery. This study is looking at the varying concentrations of local anesthetic placed through the catheter. | These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks and help guide future research in this clinically-relevant area.
This investigation will be a randomized, observer-masked, controlled, parallel-arm, human-subjects clinical trial.
Enrollment. Subjects will be patients undergoing hip arthroplasty. Study inclusion will be proposed to eligible patients by the orthopedic surgery or anesthesia services or research coordinator/assistant within four weeks prior to surgery. If a patient desires study participation, written, informed consent will be obtained. Selection for inclusion will not be based on gender, race, or socioeconomic status. The study population of interest includes men and women of all races and socioeconomic status.
Preoperative Management. Prior to surgery but following written, informed consent, subjects will have baseline endpoints measured. Patients will then have a perineural catheter placed on the operative side using standard techniques currently used at UCSD, and previously described. A 15 mL bolus of 2% mepivacaine with epinephrine (5 µg/mL) will be injected through the catheter to demonstrate correct catheter placement and provide intraoperative analgesia. Patients with a misplaced catheter indicated by a lack of sensory changes in the surgical extremity within 15 min will have their catheter replaced or be withdrawn from the study prior to randomization.
The remaining patients will then be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0.1% or 0.4% ("study infusate"). Randomization will be based on computer-generated codes that will be created and maintained by the Investigational Drug Service. Randomization will be in blocks of four, and stratified by hip arthroplasty procedure (either total or resurfacing). A portable electronic infusion pump with study infusate will be attached to the perineural catheter. The basal rate and patient-controlled bolus volume will depend upon the treatment group (note that the basal rate and bolus volume differ for each concentration, but the total dose of local anesthetic is the same for each):
Ropivacaine Concentration 0.1%: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
Ropivacaine Concentration 0.4%: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h)
Intraoperative Management. Patients will receive a standardized general anesthetic with an inhaled anesthetic in N2O and O2. These gasses will be titrated for a Bispectral Index of 40-60 in order to provide adequate anesthesia while minimizing postoperative recovery duration. Esmolol and hydralazine will be used to provide hemodynamic stability, and opioids administered if necessary (fentanyl in 25 µg increments). The ropivacaine infusion provided by the Investigational Drug Service will be initiated using an infusion pump attached to the perineural catheter. Just prior to emergence, IV morphine will be titrated for a respiratory rate of 12-14. Upon emergence, patients will be taken to the recovery room and then to the surgical ward.
Postoperative Pain Management. For the duration of the study, all patients will receive the current usual and customary analgesics for hip arthroplasty patients at Hillcrest and Thornton hospitals. Perineural infusions will be administered per standard UCSD routine: continued administration until recommended discontinuation by the surgical service at which time the catheter is removed by the acute pain service.
Outcome Measurements. We have selected measures that have established reliability and validity. Staff blinded to treatment group assignment will perform all measures and assessments. Preoperative measurements (performed prior to perineural catheter placement the day of surgery): strength of the quadriceps femoris, hip adductors, and hip flexors; and sensory level (measurement descriptions below). Postoperative measurements will be performed the day following surgery as close to 8:00-9:00 and 12:30-13:30 as possible (logistics occasionally preclude therapist evaluation at these exact hours). | Hip Arthroplasty Hip Pain | postoperative pain perineural catheter continuous peripheral nerve block posterior lumbar plexus hip surgery psoas compartment postoperative analgesia | null | 2 | arm 1: Patients will be given 0.1% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures. arm 2: Patients will be given 0.4% ropivicaine provided via infusion pump which will be attached intraoperatively and will remain connected until patient is ready to leave the hospital. In this time a physical therapist will work with the patient to assess outcome measures. | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (12mL/h); Basal Dose (12 mg/h); Bolus Volume (4 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h) intervention 2: Ropivacaine 0.1% will be administered via the perineural catheter as follows: Basal Rate (3 mL/h); Basal Dose (12 mg/h); Bolus Volume (1 mL); Bolus Dose (4 mg); Lockout Duration (30 min); Maximum Dose (20 mg/h) | intervention 1: 0.1% Ropivacaine intervention 2: 0.4% Ropivacaine | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 50 | 0 | 0 | 0 | NCT00912873 | 1COMPLETED | 2009-06-01 | 2008-05-01 | 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 |
[
3
] | 49 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study is designed to assess skin tolerability, skin irritation, and adhesion of the 350 mg Donepezil Transdermal Patch (DTP-system), following 3, 7-day applications to 3 specific areas of the body (upper back, upper middle arm, side of torso) of elderly Alzheimer's patients. The total application time for the DTP-system is 21 days. | This is a randomized, placebo-controlled study designed to evaluate skin irritation, skin tolerability, and adhesion of the 350 mg DTP-system following 3 consecutive 7-day applications to 3 specific areas of the body (upper back, upper arm, side of torso) of elderly Alzheimer's patients. The total exposure time for the DTP-system is 21 days.
All patients receive 1 Donepezil Transdermal Patch (DTP-system) and 1 placebo patch, each applied to opposite sides of the body (e.g., placebo patch to the left side of the upper back, and DTP-system to the right side of the upper back). Patients are randomized to receive the active patch to either the left or the right side of the body according to 1 of 6 treatment sequences listed below. The treatment sequence is repeated for the opposite side of the body for a total of 12 treatment sequences (4 patients in each treatment sequence). The patches are applied to one of 3 body locations for 7 days, for a total exposure period of 21 days, according to one of the following sequences:
1. Upper Back, Upper Arm, Side of Torso (Right)
2. Upper Arm, Side of Torso, Upper Back (Right)
3. Side of Torso, Upper Back, Upper Arm (Right)
4. Upper Back, Side of Torso, Upper Arm (Right)
5. Upper Arm, Upper Back, Side of Torso (Right)
6. Side of Torso, Upper Arm, Upper Back (Right)
7. Upper Back, Upper Arm, Side of Torso (Left)
8. Upper Arm, Side of Torso, Upper Back (Left)
9. Side of Torso, Upper Back, Upper Arm (Left)
10. Upper Back, Side of Torso, Upper Arm (Left)
11. Upper Arm, Upper Back, Side of Torso (Left)
12. Side of Torso, Upper Arm, Upper Back (Left)
Patches are applied on Days 1, 8, and 15 according to the randomization schedule. Oral Aricept is taken daily through Day -1, and is re-started on Day 22 or at the time of early termination if before Day 22. Patients are seen in the clinic at Screening and on Days 1, 8, 15, 22, and at the End of Study Visit; for all other daily visits, the patients may be seen either at the clinic or in their residence, provided the assessments are completed as described in the protocol. Skin irritation is assessed immediately upon patch removal and at 1, 24, and 48 hours after removal. | Irritation/Irritant | Skin Irritation Donepezil Transdermal Patch System Elderly Alzheimer's subjects Skin Irritation in elderly Alzheimer's subjects | null | 3 | arm 1: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of the upper back. arm 2: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite arms. arm 3: 350 mg Donepezil Transdermal Patch (active) and placebo patch, each applied to opposite sides of torso. | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Active and placebo patches will be applied to opposite sides for 7 days. intervention 2: Active and placebo patches will be applied to opposite sides for 7 days. | intervention 1: 350 mg Donepezil Transdermal Patch intervention 2: Placebo Patch | 7 | Phoenix | Arizona | United States | -112.07404 | 33.44838
Fresno | California | United States | -119.77237 | 36.74773
Garden Grove | California | United States | -117.94145 | 33.77391
National City | California | United States | -117.0992 | 32.67811
Santa Ana | California | United States | -117.86783 | 33.74557
Brooksville | Florida | United States | -82.38991 | 28.55554
Miami | Florida | United States | -80.19366 | 25.77427 | 147 | 0 | 0 | 0 | NCT00916383 | 1COMPLETED | 2009-06-01 | 2009-05-01 | Teikoku Pharma USA, 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
] | 54 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II. | null | Metastatic Breast Cancer | HER2-positive breast cancer MBC Trastuzumab emtansine Herceptin T-DM1 | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Intravenous escalating dose | intervention 1: trastuzumab-MCC-DM1 | 0 | null | 52 | 0 | 0 | 0 | NCT00932373 | 1COMPLETED | 2009-06-01 | 2006-04-01 | Genentech, 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
] | 71 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease. | null | Dry Eye Syndromes | null | 2 | arm 1: carboxymethylcellulose 0.5%, glycerin 0.9% arm 2: sodium hyaluronate 0.18% | [
1,
1
] | 2 | [
0,
0
] | intervention 1: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container. intervention 2: To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container. | intervention 1: carboxymethylcellulose 0.5% +glycerin 0.9% intervention 2: sodium hyaluronate 0.18% | 1 | Ulm | N/A | Germany | 9.99155 | 48.39841 | 70 | 0 | 0 | 0 | NCT00938704 | 1COMPLETED | 2009-06-01 | 2009-06-01 | Allergan | 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
] | 12 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Background:
* Some cancer cells have a large amount of a protein called P-glycoprotein, which can pump certain chemotherapy drugs out of their cells. This pump may be part of the reason why it is difficult to shrink some cancers with chemotherapy.
* In laboratory experiments, the drug CBT-1(Registered Trademark) blocked the P-glycoprotein pump, resulting in accumulation of higher amounts of chemotherapy inside the cancer cells, making the chemotherapy more effective.
* Paclitaxel is a cancer drug that has caused tumors to shrink in many types of cancers, including lung, ovarian, breast, renal, cervical and others.
Objectives:
* To determine whether CBT-1(Registered Trademark) can block the P-glycoprotein pump on cancer cells and whether it inhibits the action of the pump found in normal blood cells and liver tissue.
* To evaluate the effectiveness of combination therapy using CBT-1(Registered Trademark) and paclitaxel in treating solid tumors and to determine whether the two drugs together are more effective than paclitaxel alone.
Eligibility:
-Patients over 18 years of age who have a solid tumor that cannot be treated successfully with standard treatments.
Design:
-Patients receive CBT-1(Registered Trademark) and paclitaxel in 21-day cycles. Treatment continues for two cycles after all the cancer is gone, or until it is decided to surgically remove some or all of the remaining cancer, or until the cancer has grown to the point where it defined as progressive disease.
For each cycle, patients take CBT-1(Registered Trademark) by mouth in three divided doses daily for 7 days. On day 6, paclitaxel is given through a vein over 3 hours.
Blood tests are done before starting CBT-1(Registered Trademark) and repeated periodically throughout treatment.
Imaging studies computed tomography or magnetic resonance imaging (CT or MRI) are done every two cycles. In addition, for the first cycle only, patients undergo imaging of tumors and normal tissue with a 99mTc-sestamibi radionuclide scan before and after administration of CBT-1(Registered Trademark). This scan helps show how well the P-glycoprotein pump is being blocked by the treatment. | Background:
This is a pharmacodynamic study aimed at evaluating the efficacy of CBT-1(Registered Trademark) as a modulator of Pgp-mediated drug efflux in patient tumors and normal tissues. The study will build on over a decade of experience with 99mTc-sestamibi imaging and rhodamine accumulation and efflux in normal circulating CD56 plus cells as surrogates for Pgp function. CBA Research, Inc., has carried out Phase I and II testing of CBT-1(Registered Trademark) as a drug resistance reversal agent, but has not yet confirmed that the inhibitor is able to block drug efflux.
Objectives:
Evaluate the impact of CBT-1(Registered Trademark) on the hepatic accumulation and retention of 99mTc-sestamibi in patients with relapsed or refractory solid tumor malignancies.
Evaluate the impact of CBT-1(Registered Trademark) on P-glycoprotein-mediated efflux from CD56 plus peripheral mononuclear cells.
Eligibility:
Patients over 18 years of age who have histologic confirmation of relapsed/refractory cancer, following at least once standard treatment regimen, for whom there is no known standard therapy option capable of extending life expectancy. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, and have hematologic, renal, hepatic, and metabolic parameters suggestive of adequate organ function.
Design:
Patients will be treated according to CBA Research Phase II trial of CBT-1 and Taxol. Patients will begin protocol treatment with orally administered CBT-1(Registered Trademark) in two or three divided doses daily for 7 days. On day 6, 135 mg/m\^2 paclitaxel will be administered by intravenous infusion over 3 hours. Prior to the initiation of CBT-1(Registered Trademark), and on Day 6, patients will undergo blood sampling for the rhodamine assay in CD56 plus circulating mononuclear cells. In addition, patients will undergo imaging of tumors and normal tissue with the 99mTc-sestamibi radionuclide scan. These two assays have shown convincing inhibition of Pgp-mediated drug efflux in past studies with Pgp inhibitors such as tariquidar and valspodar. Twelve patients are planned for enrollment to this study, which is powered to determine a difference between the control scan and the post-treatment scan but not to compare CBT-1(Registered Trademark) with previous inhibitors tested in the intramural program. | Cervical Ovarian Lung Breast Renal | Pgp Solid Tumors Drug Resistance Sestamibi Cancer Solid Tumor | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
4
] | intervention 1: Paclitaxel 135 mg/m\^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days. intervention 2: CBT-1 500 mg/m\^2 oral dose daily for 7 days in divided doses 3 times a day. Cycle days 1-7, repeated every 21 days. no antacids, H2 blocker, or gastric acid inhibiting agents will be administered within 4 hours before or after each daily dose. intervention 3: 20 mCI baseline scan day 0; 20 mCI scan on 6th day of CBT-1 administered. | intervention 1: paclitaxel intervention 2: CBT-1(Registered Trademark) intervention 3: Tc 99m sestamibi | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 12 | 0 | 0 | 0 | NCT00972205 | 1COMPLETED | 2009-06-01 | 2007-12-01 | National Cancer Institute (NCI) | 0NIH | 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
] | 45 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose of nicotine. | This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit. | Tobacco Dependence | Smoking Cessation Nicotine pharmacokinetics | null | 5 | arm 1: One oral administration of 1 mg nicotine arm 2: Two oral administrations of 1 mg nicotine arm 3: Four oral administrations of 1 mg nicotine arm 4: One 4 mg marketed nicotine lozenge arm 5: One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes | [
0,
0,
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: A new l mg oral nicotine product intervention 2: A marketed 4 mg Nicotine lozenge intervention 3: A marketed 4 mg Nicotine Gum | intervention 1: Oral Nicotine intervention 2: NiQuitinTM Nicotine Lozenge intervention 3: Nicorette® Nicotine Gum | 1 | Lund | N/A | Sweden | 13.19321 | 55.70584 | 211 | 0 | 0 | 0 | NCT01084603 | 1COMPLETED | 2009-06-01 | 2009-03-01 | McNeil AB | 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
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (ASA) resistant patients after percutaneous coronary intervention (PCI). | This is the first US based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective PCI through femoral access. The primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the PCI with a secondary outcome of a composite of major adverse cardiac events of death, MI, stent thrombosis and urgent revascularization and bleeding up to 30 days. | Stable Angina | Major Adverse Cardiovascular Event MACE Death MI CK MB greater 3x Normal Urgent Revascularization Stent Thrombosis Bleeding | null | 2 | arm 1: Patient receive 325 mg ASA orally and loading does of 600mg Clopidogrel at time of procedure arm 2: Patient receive 325mg ASA orally and loading does of 600mg Clopidogrel at time of procedure with addition of IV GP IIb/IIIa inhibitor bolus intra procedurally | [
5,
1
] | 2 | [
0,
0
] | intervention 1: IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally intervention 2: Standard antiplatelet PCI treatment | intervention 1: Intravenous Glycoprotein inhibitor + ASA, Clopidogrel intervention 2: Antiplatelet Therapy (ASA, Clopidogrel) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 36 | 0 | 0 | 0 | NCT01103440 | 1COMPLETED | 2009-06-01 | 2007-04-01 | Icahn School of Medicine at Mount Sinai | 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
] | 42 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 2MALE | false | The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard. | This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4). | Prostate Cancer | Prostate Cancer | null | 1 | arm 1: Eligard (TM) administered 22.5mg | [
5
] | 1 | [
0
] | intervention 1: Eligard (TM) 22.5 mg administered at baseline and Month 3 | intervention 1: Eligard (TM) | 0 | null | 29 | 0 | 0 | 0 | NCT01136226 | 1COMPLETED | 2009-06-01 | 2003-10-01 | Chesapeake Urology Research Associates | 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
] | 19 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val. | Despite decades of research to develop pharmacotherapies for nicotine dependence (ND), with current FDA approved medications (bupropion, varenicline and NRTs) the majority (\>60%) of smokers relapse in the first year following treatment (Lerman, Patterson et al. 2005; Tonstad, Tonnesen et al. 2006). Testing novel medications that may reduce abstinence symptoms that prompt smoking relapse is a plausible route to identifying new treatments for nicotine dependence. The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val. Sixteen smokers (8 met/met genotype and 8 val/val genotype) who meet study eligibility criteria will complete two 10-day medication periods: one while taking tolcapone and one while taking placebo (order counterbalanced). The testing session will occur on day 7 of each medication phase and include three computerized tasks. Participants will be asked to refrain from smoking for at least 14 hours (overnight) prior to the testing day in each medication phase. There will be a 3-day medication taper on days 8-10 of each medication period, followed by a washout period of at least 7 days between medication periods. The main outcomes to be evaluated are participant enrollment and retention, side effects, and performance on computerized tasks. Positive results from this pilot study would provide a basis for a larger scale investigation to assess the efficacy of tolcapone as a medication that ameliorates abstinence induced neurocognitive symptoms in smokers. | Nicotine Dependence | Smoking, Abstinence | null | 2 | arm 1: Tolcapone arm 2: Placebo | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day intervention 2: Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day | intervention 1: Tolcapone intervention 2: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 19 | 0 | 0 | 0 | NCT01202955 | 1COMPLETED | 2009-06-01 | 2008-07-01 | 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
] | 264 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty. | null | Venous Thromboembolism Thromboembolism Thrombosis Embolism and Thrombosis Deep Vein Thrombosis Arthroplasty, Replacement, Hip | prevention venous thromboembolism edoxaban anticoagulants | null | 3 | arm 1: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery arm 2: Enoxaparin sodium 20mg (=2000IU) / 0.2mL twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery arm 3: DU-176b 15mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery | [
0,
1,
0
] | 3 | [
0,
0,
0
] | intervention 1: DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 2: DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery. intervention 3: Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery. | intervention 1: DU-176b 15mg intervention 2: DU-176b 30mg intervention 3: Enoxaparin sodium 20 mg (=2000IU) | 3 | Osaka | N/A | Japan | 135.50107 | 34.69379
Tokyo | N/A | Japan | 139.69171 | 35.6895
Kaohsiung City | N/A | Taiwan | 120.31333 | 22.61626 | 261 | 0 | 0 | 0 | NCT01203098 | 1COMPLETED | 2009-06-01 | 2008-07-01 | Daiichi Sankyo Co., 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 |
[
5
] | 96 | RANDOMIZED | CROSSOVER | 6HEALTH_SERVICES_RESEARCH | 4QUADRUPLE | false | 0ALL | false | Children with Attention Deficit Hyperactivity Disorder (ADHD) have numerous areas of neuropsychological dysfunction including response inhibition, working memory, and attention. One neuropsychological outcome measure that consistently reveals between-group differences is response variability. However, until recently, differences in response variability have been reported as an ancillary finding or viewed as a nuisance in the analyses. The specific aims of the present study are to 1) Examine response variability in ADHD patients across neuropsychological tasks to understand the breadth of this specific deficit and to understand the relation between response variability and other neuropsychological outcome measures; 2) Assess whether response variability deficits are specific to either or both of the two most prevalent ADHD subtypes (i.e., Combined Type \[CT\] and Predominantly Inattentive Type \[PIT\]); 3) Determine whether response variability in ADHD patients is affected by either medication or a variety of environmental manipulations (e.g., reward); and 4) Understand the relationship between neuropsychological measures of response variability and naturalistic instances of variable performance. Forty-five children (aged 7-11) with ADHD-CT, 45 children with ADHD-PIT, and 45 normal controls will be recruited to examine response variability across a wide range of neuropsychological tests. Task parameters such as event rate, stimulus saliency, and the presence of operant reward will be modified on each test to determine the conditions under which response variability is manifested in children with ADHD. In addition, all children with ADHD will participate in a placebo-controlled, randomized medication trial with a psychostimulant medication to assess the effects of medication on response variability. Advanced analytic methods utilizing non-Gaussian distributions and fast Fourier Transforms of the reaction time data will be used to conduct detailed analyses of RT patterns across the ADHD and normal control groups. Further, the effects of task parametric manipulations and medication on response variability will be examined. Finally, relations between response variability on neuropsychological tests and response variability in a variety of real-world analog situations will be examined to evaluate the ecological validity of these deficits. | null | Attention Deficit Hyperactivity Disorder | null | 4 | arm 1: None arm 2: Low dose: 18 mg methylphenidate arm 3: Medium Dosage: 36 mg if more than 50 kg and 27 mg if less than 50 kg arm 4: 54 mg if more than 50 kg and 36 mg if less than 50 kg | [
2,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 18 mg methylphenidate intervention 2: Placebo intervention 3: 36 mg methylphenidate intervention 4: 54 mg methylphenidate | intervention 1: Methylphenidate intervention 2: placebo intervention 3: Methylphenidate intervention 4: Methylphenidate | 1 | Cincinnati | Ohio | United States | -84.51439 | 39.12711 | 384 | 0 | 0 | 0 | NCT01238822 | 1COMPLETED | 2009-06-01 | 2006-06-01 | 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 | |
[
3
] | 17 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | Previously, the investigators and others have shown that mucociliary clearance (MCC) is defective in patients with cystic fibrosis (CF) and it is now thought that alterations in airway mucus rheology figure prominently in the impairment. Mucociliary clearance works by trapping toxic particles, bacteria and viruses in the lung mucus and then quickly removing the mucus out of the lungs. Defects in MCC typically lead to the accumulation of mucus in the airways, and this in turn is associated with acute infections, chronic bacterial colonization and chronic inflammation. One treatment strategy that is gaining acceptance as an important therapy for improving MCC in adults with CF is the inhalation of the osmotic stimulus, hypertonic saline (HS). A number of studies have shown that acute inhalation of HS (7% saline) significantly improves MCC in adults with CF and results from a recent study indicate that two weeks of inhaling HS leads to a significant increase in MCC that is sustained for 8 hours post inhalation and is associated with significant improvements in FEV1, FVC and FEF25-75 values. Since MCC in patients with CF appears to be impaired by adulthood, any drug that disrupts or slows the impairment in childhood could prove enormously beneficial in the long-term prognosis of the disease. Nevertheless, no studies have been conducted to determine if HS treatment improves MCC in children with CF. This is most problematic for physicians who care for children with CF who have normal FEV1 and FVC values, since it is unclear if they should treat these children with HS or not. This research study is designed to begin to answer this question. The investigators hypothesize that acute inhalation of hypertonic saline (7%) will improve MCC in CF children with normal pulmonary function. Our hypothesis will be tested in a one-year clinical trial that will be randomized and placebo-controlled. Twelve children with CF who are 7-12 years old and have normal FEV1 and FVC values will participate. Our goal will be to compare MCC in these children on two study visits after acute inhalations of placebo (0.12% saline) or hypertonic saline (HS) (7% saline) aerosol. The investigators predict that MCC values after acute inhalation of 7% HS aerosol will be statistically significantly greater than after placebo inhalation. | Several studies report that mucociliary clearance (MCC) is impaired in adults with CF. Because MCC is an important airway defense mechanism, drugs that slow impairment of MCC in children could prove beneficial in the long-term prognosis of the disease. A few studies have shown that inhalation of hypertonic saline (HS) significantly improves MCC in adults with CF and improvement is associated with increases in pulmonary function and decreases in pulmonary exacerbations. Nevertheless, no studies have examined if HS improves MCC in CF children. This is problematic for physicians who care for CF children with normal pulmonary function, since it is unclear if they should treat with HS or not. This study was designed to begin to answer this question. Twelve children with CF (7-12 yrs; 5 males) and normal pulmonary function (FEV1 and FVC \> 90% of predicted values) participated in a screening visit and two study visits. On the screening visit, children underwent an induced sputum test. On the two study visits, they inhaled 0.12% saline (placebo), or HS, in a double-blind, randomized, cross-over study. Following inhalation of placebo or HS, patients inhaled the radioisotope 99mtechnetium and underwent sequential imaging of their lungs with a gamma camera for 90 min and approximately 24 hrs later. Mucociliary clearance was quantified at 60 min (MCC60), 90 min (MCC90) and 24 hrs (MCC24hrs) after inhalation of the radioisotope. Between the 60 min and 90 min measurements, children coughed 30 times. | Cystic Fibrosis | mucociliary clearance children cystic fibrosis hypertonic saline | null | 2 | arm 1: 5 mL of 7% saline was inhaled once over a 20 minute period. arm 2: 5mL 0.12% saline inhaled once during 20 minutes | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 5mL of 0.12% saline inhaled once over 20 minutes intervention 2: 5mL 7% saline inhaled once over 20 minutes | intervention 1: 0.12% saline intervention 2: 7% saline | 0 | null | 24 | 0 | 0 | 0 | NCT01293084 | 1COMPLETED | 2009-06-01 | 2007-07-01 | Johns Hopkins 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
] | 15 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension. | null | Hypertension | Hypertension | null | 1 | arm 1: Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks. | [
0
] | 1 | [
0
] | intervention 1: Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks | intervention 1: Losartan 50 mg / HCTZ 12.5 mg | 0 | null | 15 | 0 | 0 | 0 | NCT01431508 | 1COMPLETED | 2009-06-01 | 2007-08-01 | Organon and Co | 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
] | 24 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to examine the effect of exenatide, an anti-diabetes medication, on liver fat and blood levels of proteins that influence liver fat. | Obesity is characterized as generalized expansion of all adipose tissue depots, an increase in tissue lipid content, and dyslipidemia, insulin resistance, and type 2 diabetes. The adipocyte functions not only as a storage depot for fat but as an endocrine organ that releases hormones in response to specific extracellular stimuli or changes in metabolic status. These secreted proteins, carry out a variety of diverse functions, and they have been referred to collectively as adipokines. The adipokines have been postulated to play important roles in the pathogenesis of insulin resistance, hypertension, disorders of coagulation, dyslipidemia, and glucose intolerance, abnormalities associated with insulin resistance syndrome.
These observations are of considerable interest because recent studies have provided evidence that increased hepatic fat content is an important determinant of hepatic insulin resistance in type 2 diabetic patients. Fatty liver is common in type 2 diabetic patients. The mechanisms responsible for the increase in hepatic fat content are unclear. It has been suggested that fatty liver results from accelerated fatty acid mobilization from expanded visceral fat stores and their deposition in the liver as well as decreased hepatic fatty acid oxidation. Weight loss in humans with Non Alcoholic Fatty Liver Disease (NAFLD) is associated with a decrease in hepatic fat content. In addition, thiazolidinediones have been shown to reduce hepatic fat content and improve hepatic insulin sensitivity in patients with type 2 diabetes as well as in non-diabetic patients with NAFLD. The thiazolidinediones initiate their action by binding the peroxisome proliferator activator receptors (PPAR) , which primarily are located on adipocytes. Treatment of insulin-resistant mice as well as type 2 diabetic patients with insulin sensitizing PPAR activators, such as thiazolidinediones, and increases plasma adiponectin levels. Indirect evidence suggests that adiponectin might mediate some of the insulin-sensitizing effects of PPAR agonists.
Exenatide, a Glucagon Like Peptide-1 (GLP-1) receptor agonist approved for treatment of type 2 diabetes, elicited dose-dependent reductions in body weight in association with improved glycemic control in type 2 diabetic patients. In animal models of obesity, exenatide reduces hepatic fat. However, the effect of exenatide treatment in combination with a thiazolidinedione on liver fat content and plasma adipocytokines levels in patients with type 2 diabetes remains to be investigated. | Type 2 Diabetes Mellitus | Diabetes | null | 2 | arm 1: Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. arm 2: Pioglitazone 45 mg daily orally for 12 months | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Type 2 diabetic subjects will be randomized to receive exenatide 10 micrograms injected subcutaneously twice daily for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period. intervention 2: Type 2 diabetic subjects will be randomized to receive pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period. | intervention 1: Exenatide intervention 2: Pioglitazone | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 24 | 0 | 0 | 0 | NCT01432405 | 1COMPLETED | 2009-06-01 | 2007-06-01 | Baylor College of Medicine | 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
] | 65 | RANDOMIZED | CROSSOVER | 0TREATMENT | 1SINGLE | true | 0ALL | false | This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU). | null | Dental Caries | null | 5 | arm 1: Participants brush twice a daily for 45 seconds with experimental dentifrice. arm 2: Participants brush twice a daily for 45 seconds with experimental dentifrice. arm 3: Participants brush twice a daily for 2 minutes with experimental dentifrice. arm 4: Participants brush twice a daily for 2 minutes with experimental dentifrice. arm 5: Participants brush twice a daily for 2 minutes with controll dentifrice. | [
0,
0,
0,
0,
1
] | 4 | [
0,
0,
0,
10
] | intervention 1: Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol intervention 2: Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol intervention 3: Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol intervention 4: A non fluoride dentifrice was given to participants of each arm at washout period | intervention 1: Sodium fluoride / silica and carbopol, 0.5g intervention 2: Sodium fluoride / silica and carbopol, 1.5g intervention 3: Sodium fluoride / silica and carbopol, 1.5g intervention 4: Fluoride free dentifrice | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 294 | 0 | 0 | 0 | NCT01563172 | 1COMPLETED | 2009-06-01 | 2009-01-01 | GlaxoSmithKline | 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
] | 480 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER. | This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study. | Schizophrenia | Schizophrenia Paliperidone Extended Release | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion. | intervention 1: Paliperidone ER | 0 | null | 480 | 0 | 0 | 0 | NCT01577186 | 1COMPLETED | 2009-06-01 | 2008-07-01 | Johnson & Johnson Taiwan 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 |
[
5
] | 115 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast infection of the vulva). | This is an open label (all people know the identity of the intervention), single-arm, prospective (study following participants forward in time) study to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in participants with vulvar candidiasis. Participants will be evaluated and assessed on the degree of pruritus (itchiness) and screened for candidiasis on the baseline. Participants will apply the cream once enrolled and will be assessed for 1-hour to get the time to relief. Each participant will apply the study medication topically (applied to skin) to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the vulvar area affected and the treatment should be continued without interruption. Participants will be followed-up after 14 days and will be assessed clinically for signs and symptoms of vulvar candidiasis; if not cured, participants will continue the medication up to Day 28. Primary efficacy endpoint will be the time needed to achieve pruritus relief. Participants' safety will be monitored throughout the study. | Vulva; Candidiasis | Vulvar Candidiasis Miconazole Hydrocortisone Daktacort Feminine Care Cream | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14. | intervention 1: Miconazole plus Hydrocortisone | 0 | null | 115 | 0 | 0 | 0 | NCT01769339 | 1COMPLETED | 2009-06-01 | 2009-01-01 | Janssen Pharmaceutica | 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
] | 45 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to evaluate the efficacy and safety of Transdermal Therapeutic System (TTS)-fentanyl patch (transdermal patch containing a drug that is put on the skin so the drug will enter the body through the skin) in severe (very serious, life threatening) chronic (lasting a long time) low back pain in Thai participants. | This is an open label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time) study conducted to assess the efficacy and safety of TTS-fentanyl in Thai participants with chronic low back pain. All participants start treatment with 12.5 micrograms (µg) per hour patch. The patches will be replaced every 3 days. On Day 3, and every 3 days thereafter, the TTS-fentanyl dose increases will be considered based on rescue medication consumption and pain assessment. No increase in TTS-fentanyl dose will be performed within the 72-hour dosing interval. The duration of the treatment will be 30 days. Primary efficacy assessment will be pain control rated by participants. Assessment time points will be at Day 0 (baseline), on Day 15 and Day 30 (trial end). At the end of study, global preference on efficacy, side effects and overall satisfaction will also be rated by investigator and participants. Participants' safety will be monitored throughout the study. | Low Back Pain | Low Back Pain TTS-fentanyl Durogesic | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days. | intervention 1: TTS-fentanyl | 1 | Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 45 | 0 | 0 | 0 | NCT01774903 | 1COMPLETED | 2009-06-01 | 2008-08-01 | Janssen-Cilag Ltd.,Thailand | 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
] | 18 | NON_RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Studies of myocardial fuel selection using a novel palmitate-based PET probe | A novel Positron Emission Tomography (PET) probe, 16- 18-F-fluoro-4-thiapalmitate, will be used to evaluate myocardial atty acid uptake. Studies will be done in humans with type 2 diabetes mellitus, and in controls. Studies will take place on 2 separate days, under fasting conditions and under insulin clamp conditions. | Type 2 Diabetes Mellitus | null | 2 | arm 1: Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). arm 2: Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate). | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Radiolabeled tracer infusion; occurs in all treatment arms intervention 2: Saline infusion for control intervention 3: Insulin infusion for insulin/glucose clamp procedure | intervention 1: thiapalmitate tracer intervention 2: Saline intervention 3: Insulin | 1 | Indianapolis | Indiana | United States | -86.15804 | 39.76838 | 36 | 0 | 0 | 0 | NCT02563834 | 1COMPLETED | 2009-06-01 | 2007-01-01 | Indiana 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 | |
[
3
] | 264 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death. | null | Non-Squamous Non-Small Cell Lung Cancer | null | 1 | arm 1: Participants will receive erlotinib orally daily until disease progression, unacceptable toxicity or death. | [
0
] | 1 | [
0
] | intervention 1: Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death. | intervention 1: Erlotinib | 29 | Brussels | N/A | Belgium | 4.34878 | 50.85045
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Tallinn | N/A | Estonia | 24.75353 | 59.43696
Tartu | N/A | Estonia | 26.72509 | 58.38062
Montpellier | N/A | France | 3.87635 | 43.61093
Paris | N/A | France | 2.3488 | 48.85341
Cologne | N/A | Germany | 6.95 | 50.93333
Großhansdorf | N/A | Germany | 10.28333 | 53.66667
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
Dublin | N/A | Ireland | -6.24889 | 53.33306
Perugia | N/A | Italy | 12.38878 | 43.1122
Gdansk | N/A | Poland | 18.64912 | 54.35227
Lodz | N/A | Poland | 19.47395 | 51.77058
Lublin | N/A | Poland | 22.56667 | 51.25
Poznan | N/A | Poland | 16.92993 | 52.40692
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Singapore | N/A | Singapore | 103.85007 | 1.28967
Barcelona | N/A | Spain | 2.15899 | 41.38879
Barcelona | N/A | Spain | 2.15899 | 41.38879
Madrid | N/A | Spain | -3.70256 | 40.4165
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Taipei | N/A | Taiwan | 121.52639 | 25.05306
Weston-super-Mare | N/A | United Kingdom | -2.97665 | 51.34603 | 261 | 0 | 0 | 0 | NCT02774278 | 1COMPLETED | 2009-06-01 | 2005-07-01 | 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 | |
[
3
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study was to determine the activity of two doses of robatumumab (SCH 717454, MK-7454) in participants with relapsed or recurrent colorectal cancer.
The primary study hypothesis was that decreases in Positron Emission Tomography (PET)-assessed tumor glucose metabolism (i.e., fluorodeoxyglucose \[FDG\] standardized uptake value \[SUV\]) following administration of 10 mg/kg robatumumab will exceed those following administration of 0.3 mg/kg robatumumab in participants with relapsed or recurrent colorectal cancer who had progressed after first-line chemotherapy.
Investigator choices of standard chemotherapy: irinotecan as a single agent +/- cetuximab OR capecitabine as a single agent, OR FOLFOX (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + oxaliplatin \[OX\]) OR CAPEO(capecitabine \[CAPE\] or Xeloda® \[XEL\] + oxaliplatin \[OX\]) OR FOLFIRI (leucovorin calcium \[folinic acid\]\[FOL\] + fluorouracil \[F\] + irinotecan \[IRI\]) +/- cetuximab OR cetuximab as a single agent. | Standard chemotherapy was used as a positive validation arm. Randomization was performed so that there could be no bias in the selection of participants for enrollment into the fixed-sequence arms. Once three chemotherapy-treated participants demonstrated decreases in FDG-PET SUV in the target lesion (i.e., \>20% decrease in SUVmax in the defined target lesion) in the PET/computed tomography (CT) scan performed following Cycle 1 Period 1 treatment, it was concluded that this positive validation arm had accomplished its purpose, and all subsequent participants enrolled in the study were assigned treatment with robatumumab for Period 1. There was no intention to compare the data in either period across participants who received chemotherapy with those who received robatumumab. | Colorectal Cancer | anti-IGF-1R | null | 2 | arm 1: Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. arm 2: Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles. | [
0,
1
] | 7 | [
2,
0,
2,
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ oxaliplatin (OX) intervention 6: Capecitabine (CAPE) or Xeloda® (XEL) + oxaliplatin (OX) intervention 7: Leucovorin calcium (folinic acid)(FOL) + 5-fluorouracil (F)+ irinotecan (IRI) | intervention 1: Robatumumab intervention 2: Irinotecan intervention 3: Cetuximab intervention 4: Capecitabine intervention 5: FOLFOX intervention 6: CAPEOX/XELOX intervention 7: FOLFIRI | 0 | null | 64 | 0 | 0 | 0 | NCT00551213 | 1COMPLETED | 2009-06-04 | 2007-11-21 | 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 |
[
4
] | 1,623 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse. | null | Emergency Contraception | null | 1 | arm 1: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: CDB-2914 | 17 | San Jose | California | United States | -121.89496 | 37.33939
Denver | Colorado | United States | -104.9847 | 39.73915
Miami | Florida | United States | -80.19366 | 25.77427
Pembroke Pines | Florida | United States | -80.22394 | 26.00315
Bloomington | Indiana | United States | -86.52639 | 39.16533
Ames | Iowa | United States | -93.61994 | 42.03471
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Cleveland | Ohio | United States | -81.69541 | 41.4995
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Seattle | Washington | United States | -122.33207 | 47.60621 | 1,533 | 0 | 0 | 0 | NCT00411684 | 1COMPLETED | 2009-06-05 | 2006-11-01 | HRA Pharma | 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
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash. | null | Acne Vulgaris | Acne Vulgaris | null | 2 | arm 1: Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening arm 2: Soap Free Cleanser in the morning and CTGel in the evening | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days
Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days. intervention 2: Soap Free Cleanser will be used once daily in the morning for 28 days
Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days. | intervention 1: CTGel/ BPO Wash intervention 2: Soap Free Cleanser and CTGel | 5 | Coral Gables | Florida | United States | -80.26838 | 25.72149
Warren | Michigan | United States | -83.01304 | 42.49044
High Point | North Carolina | United States | -80.00532 | 35.95569
Knoxville | Tennessee | United States | -83.92074 | 35.96064
Spokane | Washington | United States | -117.42908 | 47.65966 | 61 | 0 | 0 | 0 | NCT00891982 | 1COMPLETED | 2009-06-05 | 2009-04-01 | Stiefel, a GSK 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,
3
] | 32 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | Background:
" Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.
" Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.
Objectives:
" The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.
" Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis.
" To document any objective anti-tumor responses that may occur.
Eligibility:
" Patients must have androgen insensitive metastatic prostate cancer.
" All patients will have received and progressed on hormonal therapy.
" Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies.
" Must have a life expectancy of more than 6 months and Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
"Patients must be human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+).
" Granulocyte count greater than or equal to 1,500/mm\^3, Platelet greater than or equal to 100,000/mm\^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm\^3 ;Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60
" No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness.
Design:
" Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively.
"This study will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant granulocyte-macrophage colony stimulating factor (GM-CSF), or with either of 2 doses of fowlpox-GM-CSF.
"This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+.
The maximum accrual to the trial should be 62. | Background:
* Adenocarcinoma of the prostate is the most common cancer diagnosis in American males and follows lung cancer as the leading cause of cancer death.
* Vaccine strategies represent a novel therapeutic approach in the treatment for prostate cancer. One potential target for a prostate cancer vaccine is prostatic specific antigen (PSA), due to its restricted expression on prostate cancer and normal prostatic epithelial cells.
Objectives:
* The primary objective is to determine the impact of granulocyte-macrophage colony stimulating factor (GM-CSF) and recombinant fowlpox granulocyte-macrophage colony stimulating factor (rF-GM-CSF) on the immunologic response in patients treated with these vaccines.
* Secondary - to determine the change in prostatic specific antigen (PSA)-specific T cells in patients treated with these vaccines using enzyme linked immunosorbent spot (ELISPOT) assay analysis.
* To document any objective anti-tumor responses that may occur.
Eligibility:
* Patients must have androgen insensitive metastatic prostate cancer.
* All patients will have received and progressed on hormonal therapy.
* Must have objective evidence of metastasis or relapsing local disease. Therefore, must have a rising PSA and at least one of the following: positive bone scan, palpable disease, or positive imaging studies.
* Must have a life expectancy of more than 6 months and the Eastern Cooperative Oncology Group (ECOG) status of 0 to 2.
* Patients must be HLA-A2+.
* Granulocyte count greater than or equal to 1,500/mm\^3, Platelet greater than or equal to 100,000/mm\^3, hemoglobin (Hgb) greater than or equal to 10Gm/dL, Lymphocyte count greater than or equal to 500/mm\^3; Bilirubin less than 1.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5x upper limit of normal (ULN),Creatinine Clearance greater than or equal to 60
* No significant cardiac disease, no significant pulmonary disease, no serious inter-current medical illness.
Design:
* Cohorts three, four and five will provide safety data combining cohort two with rGM-CSF as well as two doses of rFGM-CSF respectively.
* This study will be conducted as a small, randomized pilot study to compare the immunologic effects of the above vaccine strategy alone, with recombinant GM-CSF, or with either of 2 doses of fowlpox-GM-CSF.
* This study will consist of 4 randomized arms of 8 patients each, all of whom are HLA-A2+. | Prostatic Neoplasms | Immunotherapy Cytokines Immune Assays Prostate Cancer | null | 4 | arm 1: No granulocyte macrophage colony stimulating factor (GM-CSF) was given arm 2: Recombinant human GM-CSF (Sargramostim) was administered at 100mcg/day on days 1-4 following each vaccine. Given subcutaneously (s.c.) at site of vaccine. arm 3: recombinant fowlpox GM-CSF was given on day one at 10\^7 in last two arms. Given subcutaneously (s.c.) at site of vaccine. arm 4: recombinant fowlpox GM-CSF was given on day one at 10\^8 in last two arms. Given subcutaneously (s.c.) at site of vaccine. | [
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: Recombinant Fowlpox-GM-CSF intervention 2: Recombinant Fowlpox-PSA (L155)-TRICOM (PROSTVAC-F/TRICOM) intervention 3: Recombinant Vaccinia-PSA (L155)-TRICOM (PROSTVAC-V/TRICOM) intervention 4: Recombinant Human GM-CSF | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 32 | 0 | 0 | 0 | NCT00060528 | 1COMPLETED | 2009-06-08 | 2003-05-22 | National Cancer Institute (NCI) | 0NIH | 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
] | 6 | RANDOMIZED | CROSSOVER | 9OTHER | 2DOUBLE | false | 0ALL | false | The Purpose of this trial is to evaluate the use of a cross-over trial design in an osteoarthritis population. We will determine the inter- and intra-subject variability in osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA endpoints following treatment with 2 different types of analgesics in a crossover study of this design. | Methodology study to evaluate the use of a cross over design and gait analysis. The study was terminated by mutual consent with the study site at a meeting on the 1 April 2009, because of slow recruitment due to a high screen fail rate. The study was not stopped for safety reasons. | Osteoarthritis | null | 3 | arm 1: None arm 2: None arm 3: None | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: oral, 100 mg bid intervention 2: oral, 20 mg bid intervention 3: oral bid | intervention 1: celecoxib intervention 2: Oxycodone intervention 3: placebo | 2 | Palo Alto | California | United States | -122.14302 | 37.44188
Stanford | California | United States | -122.16608 | 37.42411 | 18 | 0 | 0 | 0 | NCT00484718 | 6TERMINATED | 2009-06-10 | 2008-01-17 | 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
] | 49 | NA | SINGLE_GROUP | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | false | RATIONALE: Ondansetron may help lessen or prevent nausea and vomiting in patients undergoing stem cell transplant.
PURPOSE: This phase II trial is studying how well ondansetron works in preventing nausea and vomiting in patients undergoing stem cell transplant. | OBJECTIVES:
I. To determine whether the incidence of nausea and vomiting related to administration of autologous hematopoetic stem cells cryopreserved in DMSO can be reduced by the use of a single dose of intravenous ondansetron prior to the stem cell infusion.
II. To determine the number of patients who experience nausea and vomiting.
OUTLINE: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. | Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Atypical Chronic Myeloid Leukemia, BCR-ABL Negative Blastic Phase Chronic Myelogenous Leukemia Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia de Novo Myelodysplastic Syndromes Disseminated Neuroblastoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Poor Prognosis Metastatic Gestational Trophoblastic Tumor Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Neuroblastoma Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Splenic Marginal Zone Lymphoma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage II Ovarian Epithelial Cancer Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Malignant Testicular Germ Cell Tumor Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Multiple Myeloma Stage III Ovarian Epithelial Cancer Stage III Small Lymphocytic Lymphoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Breast Cancer Stage IV Chronic Lymphocytic Leukemia Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Ovarian Epithelial Cancer Stage IV Small Lymphocytic Lymphoma | null | 1 | arm 1: Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation. | [
0
] | 3 | [
0,
10,
3
] | intervention 1: Given IV intervention 2: Correlative studies intervention 3: Ondansetron IV | intervention 1: ondansetron intervention 2: survey administration intervention 3: management of therapy complications | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 49 | 0 | 0 | 0 | NCT00795769 | 1COMPLETED | 2009-06-10 | 2008-08-08 | Fred Hutchinson 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
] | 86 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included. | null | Colorectal Neoplasm Head and Neck Neoplasm Carcinoma, Non-Small-Cell Lung Esophageal Neoplasm | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Temozolomide capsules 150 mg/m\^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent. | intervention 1: Temozolomide | 0 | null | 86 | 1 | 0.011628 | 1 | NCT00423150 | 6TERMINATED | 2009-06-11 | 2007-01-26 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.002056 | |
[
2
] | 30 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | Evaluate the Pharmacokinetics of Mucinex® 600 mg Extended-Release Bi-Layer Tablet in Normal Healthy Subjects | null | Healthy Subjects | null | 1 | arm 1: Single dose of Mucinex® 600 mg Extended-Release (ER) Bi-Layer tablet taken with 240 mL of water after an overnight fast | [
0
] | 1 | [
0
] | intervention 1: Single dose of Mucinex® 600 mg ER Bi-Layer tablet | intervention 1: Mucinex® ER 600 mg | 0 | null | 30 | 0 | 0 | 0 | NCT03644108 | 1COMPLETED | 2009-06-15 | 2009-06-04 | Reckitt Benckiser 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
] | 31 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The purpose of this study is to compare the absorption of dietary phosphorus following a single dose with lanthanum carbonate (1000mg) and a single dose of sevelamer carbonate (2400mg). | null | Kidney Failure, Chronic | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
1,
4,
4
] | 2 | [
0,
0
] | intervention 1: 1 x 1000mg tablet intervention 2: 3 x 800mg tablets | intervention 1: Lanthanum Carbonate intervention 2: Sevelamer | 1 | Cypress | California | United States | -118.03729 | 33.81696 | 93 | 0 | 0 | 0 | NCT00875017 | 1COMPLETED | 2009-06-16 | 2009-04-20 | Shire | 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
] | 70 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a 28 day study to evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients | Pazopanib has been formulated as an eye drop for the topical treatment of age-related macular degeneration (AMD). Safety, tolerability and pharmacokinetics have been evaluated in a first study conducted in healthy volunteers (MD7108238). In the present study, three dosing regimens of pazopanib eye drops, administered for 28 days, will be evaluated in subjects with occult or minimally classic subtypes of choroidal neovascularization due to AMD. This study is designed to measure pharmacological activity of topically administered pazopanib in target tissues (choroid and retina) of patients with AMD by weekly evaluation of central retinal thickness as measured by optical coherence tomography (OCT). Evaluation of efficacy will be performed on an exploratory basis by weekly measurement of visual acuity. The ocular and systemic safety and systemic pharmacokinetics of pazopanib treatment for 28 days will also be evaluated. | Macular Degeneration | angiogenesis pazopanib, age-related macular degeneration (AMD), vascular endothelial growth factor (VEGF), choroidal neovascularization (CNV), | null | 3 | arm 1: Pazopanib eye drops formulation 5 mg/mL daily for 28 days arm 2: Pazopanib eye drop formulation 5mg/mL TID for 28 days arm 3: Pazopanib eye drop formulation 2mg/mL TID for 28 days | [
0,
0,
0
] | 1 | [
0
] | intervention 1: Pazopanib eye drops formulation | intervention 1: Pazopanib | 27 | Tucson | Arizona | United States | -110.92648 | 32.22174
Beverly Hills | California | United States | -118.40036 | 34.07362
Pasadena | California | United States | -118.14452 | 34.14778
Sacramento | California | United States | -121.4944 | 38.58157
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Winter Haven | Florida | United States | -81.73286 | 28.02224
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Grand Rapids | Michigan | United States | -85.66809 | 42.96336
Toms River | New Jersey | United States | -74.19792 | 39.95373
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Austin | Texas | United States | -97.74306 | 30.26715
Houston | Texas | United States | -95.36327 | 29.76328
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Sydney | New South Wales | Australia | 151.20732 | -33.86785
Melbourne | Victoria | Australia | 144.96332 | -37.814
Perth | Western Australia | Australia | 115.8614 | -31.95224
Leuven | N/A | Belgium | 4.70093 | 50.87959
Trieste | Friuli Venezia Giulia | Italy | 13.77678 | 45.64953
Milan | Lombardy | Italy | 9.18951 | 45.46427
Milan | Lombardy | Italy | 9.18951 | 45.46427
Turin | Piedmont | Italy | 7.68682 | 45.07049
Florence | Tuscany | Italy | 11.24626 | 43.77925
Padua | Veneto | Italy | 11.88586 | 45.40797 | 70 | 0 | 0 | 0 | NCT00612456 | 1COMPLETED | 2009-06-17 | 2008-03-05 | GlaxoSmithKline | 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
] | 72 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations. | null | End Stage Renal Disease | End stage Renal disease | null | 2 | arm 1: Lanthanum carbonate granulated formulation crossover to chewable tablet formulation arm 2: Lanthanum carbonate chewable table formulation crossover to granulated formulation | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.) intervention 2: 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.) | intervention 1: Lanthanum carbonate Granule Formulation intervention 2: Lanthanum carbonate Chewable Tablets (Fosrenol) | 1 | Cypress | California | United States | -118.03729 | 33.81696 | 132 | 0 | 0 | 0 | NCT00880750 | 1COMPLETED | 2009-06-22 | 2009-01-28 | Shire | 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
] | 318 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To evaluate the safety and efficacy of PF-04217329. | null | Primary Open-Angle Glaucoma Ocular Hypertension | Open-Angle Glaucoma Ocular Hypertension | null | 14 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None arm 14: None | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 21 | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study. intervention 2: 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study. intervention 3: 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study. intervention 4: 1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study. intervention 5: 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study. intervention 6: 1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study. intervention 7: 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study. intervention 8: 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study. intervention 9: Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study. intervention 10: 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study. intervention 11: Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study. intervention 12: 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study. intervention 13: Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study. intervention 14: 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study. intervention 15: Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study. intervention 16: 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study. intervention 17: Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study. intervention 18: 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study. intervention 19: Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study. intervention 20: 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study. intervention 21: Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study. | intervention 1: PF-04217329 - Lowest Dose intervention 2: PF-04217329 - Low Dose intervention 3: PF-04217329 - Middle Dose intervention 4: PF-04217329 - High Middle Dose intervention 5: PF-04217329 - High Dose intervention 6: PF-4217329 - Highest Dose intervention 7: PF-04217329 - Vehicle intervention 8: Latanoprost Vehicle intervention 9: PF-04217329 - Low Dose intervention 10: Latanoprost Vehicle intervention 11: PF-04217329 - Middle Dose intervention 12: Latanoprost Vehicle intervention 13: PF-04217329 - High Dose intervention 14: Latanoprost 0.005% intervention 15: PF-04217329 - Low Dose intervention 16: Latanoprost 0.005% intervention 17: PF-04217329 - Middle Dose intervention 18: Latanoprost 0.005% intervention 19: PF-04217329 - High Dose intervention 20: Latanoprost 0.005% intervention 21: PF-04217329 - Vehicle | 23 | Artesia | California | United States | -118.08312 | 33.86585
Newport Beach | California | United States | -117.92895 | 33.61891
Petaluma | California | United States | -122.63665 | 38.23242
Poway | California | United States | -117.03586 | 32.96282
Daytona Beach | Florida | United States | -81.02283 | 29.21081
Daytona Beach | Florida | United States | -81.02283 | 29.21081
Fort Myers | Florida | United States | -81.84059 | 26.62168
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Atlanta | Georgia | United States | -84.38798 | 33.749
Atlanta | Georgia | United States | -84.38798 | 33.749
Morrow | Georgia | United States | -84.33937 | 33.58317
Evansville | Indiana | United States | -87.55585 | 37.97476
Louisville | Kentucky | United States | -85.75941 | 38.25424
Rochester | New York | United States | -77.61556 | 43.15478
Charlotte | North Carolina | United States | -80.84313 | 35.22709
High Point | North Carolina | United States | -80.00532 | 35.95569
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Bristol | Pennsylvania | United States | -74.85183 | 40.10067
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston | South Carolina | United States | -79.93275 | 32.77632
Memphis | Tennessee | United States | -90.04898 | 35.14953
Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715 | 317 | 0 | 0 | 0 | NCT00572455 | 1COMPLETED | 2009-06-26 | 2007-12-11 | 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
] | 199 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each. | null | Psoriasis | null | 4 | arm 1: Vehicle cream, applied topically, once daily from Day 1 to Week 12. arm 2: Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12. arm 3: Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12. arm 4: Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12. | [
2,
0,
0,
0
] | 2 | [
10,
0
] | intervention 1: Cream with no active drug intervention 2: Ruxolitinib phosphate cream | intervention 1: Placebo Cream intervention 2: Ruxolitinib Phosphate | 28 | Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Los Angeles | California | United States | -118.24368 | 34.05223
San Diego | California | United States | -117.16472 | 32.71571
Santa Monica | California | United States | -118.49138 | 34.01949
Vallejo | California | United States | -122.25664 | 38.10409
New Haven | Connecticut | United States | -72.92816 | 41.30815
Miami | Florida | United States | -80.19366 | 25.77427
Ormond Beach | Florida | United States | -81.05589 | 29.28581
Naperville | Illinois | United States | -88.14729 | 41.78586
Wheaton | Illinois | United States | -88.10701 | 41.86614
Evansville | Indiana | United States | -87.55585 | 37.97476
South Bend | Indiana | United States | -86.25001 | 41.68338
Boston | Massachusetts | United States | -71.05977 | 42.35843
Clinton Township | Michigan | United States | -82.91992 | 42.58698
Fridley | Minnesota | United States | -93.26328 | 45.08608
St Louis | Missouri | United States | -90.19789 | 38.62727
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Rochester | New York | United States | -77.61556 | 43.15478
Norman | Oklahoma | United States | -97.43948 | 35.22257
Simpsonville | South Carolina | United States | -82.25428 | 34.73706
Austin | Texas | United States | -97.74306 | 30.26715
College Station | Texas | United States | -96.33441 | 30.62798
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
Salt Lake City | Utah | United States | -111.89105 | 40.76078
Norfolk | Virginia | United States | -76.28522 | 36.84681
Walla Walla | Washington | United States | -118.34302 | 46.06458
Madison | Wisconsin | United States | -89.40123 | 43.07305 | 398 | 0 | 0 | 0 | NCT00778700 | 1COMPLETED | 2009-06-26 | 2008-10-28 | Incyte Corporation | 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
] | 89 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate HCl), is safe and effective in improving academic performance and behavior in children with Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo. | The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving academic performance and behavior in children with ADHD when compared to placebo as demonstrated using specified study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled, crossover study evaluating the academic, behavioral and cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD This means that all eligible children will receive treatment with methylphenidate HCl throughout the study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2 laboratory classroom days. On the other laboratory classroom day they will receive their regular dose of CONCERTA (methylphenidate HCl). The primary efficacy variable in this study is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and comprehension, and memory. Assessments will be completed during each of the laboratory assessment days (12.5 hours). Participants will be assessed for adverse events throughout the study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a maximum of 8 weeks. | Attention Deficit Hyperactivity Disorder | ADHD Attention Deficit Hyperactivity Disorder | null | 2 | arm 1: CONCERTA (methylphenidate HCl) or placebo Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2 arm 2: CONCERTA (methylphenidate HCl) or placebo Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1 | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2 intervention 2: Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1 | intervention 1: CONCERTA (methylphenidate HCl) or placebo intervention 2: CONCERTA (methylphenidate HCl) or placebo | 3 | Little Rock | Arkansas | United States | -92.28959 | 34.74648
Las Vegas | Nevada | United States | -115.13722 | 36.17497
Durham | North Carolina | United States | -78.89862 | 35.99403 | 223 | 0 | 0 | 0 | NCT00799487 | 1COMPLETED | 2009-06-26 | 2009-01-02 | Ortho-McNeil Janssen Scientific Affairs, 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 |
[
3,
4
] | 334 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | Determination of the effect of balugrastim on the duration and severity of severe neutropenia. | null | Chemotherapy-induced Neutropenia | Breast Cancer Supportive Care Neutropenia | null | 7 | arm 1: Participants will receive balugrastim low dose administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 2: Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 3: Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 4: Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 5: Participants will receive balugrastim medium dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 6: Participants will receive balugrastim high dose administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). arm 7: Participants will receive pegfilgrastim 6 mg administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). | [
0,
0,
0,
1,
0,
0,
1
] | 3 | [
2,
0,
0
] | intervention 1: Balugrastim (Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor) will be administered per dose and schedule specified in the arm description. intervention 2: Pegfilgrastim will be administered per dose and schedule specified in the arm description. intervention 3: The chemotherapy regimen consisting of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 will be administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles. | intervention 1: Balugrastim intervention 2: Pegfilgrastim intervention 3: Chemotherapy Regimen | 0 | null | 331 | 0 | 0 | 0 | NCT00837265 | 1COMPLETED | 2009-06-26 | 2008-08-21 | Teva Branded Pharmaceutical Products R&D, 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
] | 4,038 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.
Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD | null | Kidney Disease Diabetes Mellitus Anemia | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Volume and dose frequency changes resembling dosing in the active treatment group intervention 2: Starting dose : 0.75 mcg/kg subcutaneous (SC) every two weeks (Q2W); subsequent doses titrated to achieve hemoglobin (Hb) target of 13.0 g/dL | intervention 1: Placebo intervention 2: darbepoetin alfa | 0 | null | 4,023 | 5 | 0.001243 | 1 | NCT00093015 | 1COMPLETED | 2009-07-01 | 2004-08-01 | Amgen | 4INDUSTRY | false | false | false | null | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000531 | |
[
4
] | 431 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this clinical research study is to learn if Abatacept or Infliximab in combination with Methotrexate demonstrate a greater reduction in disease activity over placebo. | null | Rheumatoid Arthritis | null | 5 | arm 1: Days 1-365 arm 2: Days 1-365 arm 3: Days 1-197 arm 4: Participants received placebo plus methotrexate for days 1-197, and abatacept plus methotrexate for days 198-365 arm 5: Days 365 to 729 All participants receive Active Drug | [
1,
1,
2,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Abatacept, intravenous (IV) Solution, Infusion, Depends on participant weight, Monthly, 12 months. intervention 2: Infliximab, IV Solution, Infusion, Depends on participant weight, Every 2 Months, 12 months. intervention 3: Placebo, IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. intervention 4: Placebo=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months. Abatacept=IV Solution, Infusion, Depends on participant weight, Monthly, 6 months intervention 5: Abatacept, IV solution, Infusion. Depends on participant weight, Monthly, 12+ months | intervention 1: Abatacept (ABA) + Methotrexate (MTX), double-blind (DB) intervention 2: Infliximab (INF) + MTX, DB intervention 3: Placebo (PLA) + MTX, DB intervention 4: PLA + MTX switched to ABA+ MTX, DB intervention 5: ABA, open-label (OL) | 76 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Denver | Colorado | United States | -104.9847 | 39.73915
Boca Raton | Florida | United States | -80.0831 | 26.35869
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
Largo | Florida | United States | -82.78842 | 27.90979
Indianapolis | Indiana | United States | -86.15804 | 39.76838
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Springfield | Massachusetts | United States | -72.58981 | 42.10148
Worcester | Massachusetts | United States | -71.80229 | 42.26259
Flowood | Mississippi | United States | -90.13898 | 32.30959
Syracuse | New York | United States | -76.14742 | 43.04812
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Bethlehem | Pennsylvania | United States | -75.37046 | 40.62593
Willow Grove | Pennsylvania | United States | -75.11573 | 40.144
Austin | Texas | United States | -97.74306 | 30.26715
Dallas | Texas | United States | -96.80667 | 32.78306
Buenos Aires | Buenos Aires | Argentina | N/A | N/A
Capital Federal | Buenos Aires | Argentina | N/A | N/A
Quilmes | Buenos Aires | Argentina | -58.25454 | -34.72065
Córdoba | Córdoba Province | Argentina | -64.18853 | -31.40648
San Miguel de Tucumán | Tucumán Province | Argentina | -65.21051 | -26.81601
Cairns | Queensland | Australia | 145.76613 | -16.92366
Cotton Tree | Queensland | Australia | 153.10116 | -26.65355
Clayton | Victoria | Australia | 145.11667 | -37.91667
Heidelberg | Victoria | Australia | 145.06667 | -37.75
Malvern | Victoria | Australia | 145.02811 | -37.86259
Parkville | Victoria | Australia | 144.95 | -37.78333
Perth | Western Australia | Australia | 115.8614 | -31.95224
Curitiba | Paraná | Brazil | -49.27306 | -25.42778
Recife | Pernambuco | Brazil | -34.88111 | -8.05389
Rio de Janeiro | Rio de Janeiro | Brazil | -43.18223 | -22.90642
Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283
São Paulo | São Paulo | Brazil | -46.63611 | -23.5475
Calgary | Alberta | Canada | -114.08529 | 51.05011
Edmonton | Alberta | Canada | -113.46871 | 53.55014
Winnipeg | Manitoba | Canada | -97.14704 | 49.8844
St. John's | Newfoundland and Labrador | Canada | -52.70931 | 47.56494
Hamilton | Ontario | Canada | -79.84963 | 43.25011
Kitchener | Ontario | Canada | -80.5112 | 43.42537
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Montreal | Quebec | Canada | -73.58781 | 45.50884
Ste-Foy | Quebec | Canada | N/A | N/A
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
Kitchener | N/A | Canada | -80.5112 | 43.42537
Prague | N/A | Czechia | 14.42076 | 50.08804
Copenhagen | N/A | Denmark | 12.56553 | 55.67594
Tijuana | Estado de Baja California | Mexico | -117.00371 | 32.5027
León | Guanajuato | Mexico | -101.67374 | 21.12908
Guadalajara | Jalisco | Mexico | -103.34749 | 20.67738
Mexico City | Mexico City | Mexico | -99.12766 | 19.42847
Monterrey | Nuevo León | Mexico | -100.31721 | 25.68435
San Luis Potosí City | San Luis Potosí | Mexico | -100.97135 | 22.15234
Lima | N/A | Peru | -77.02824 | -12.04318
Poznan | N/A | Poland | 16.92993 | 52.40692
Sopot | N/A | Poland | 18.56003 | 54.4418
Warsaw | N/A | Poland | 21.01178 | 52.22977
Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745
Moscow | N/A | Russia | 37.61556 | 55.75222
Muckleneuk | Gauteng | South Africa | N/A | N/A
Berea | KwaZulu-Natal | South Africa | 30.99337 | -29.85185
Panorama | Western Cape | South Africa | N/A | N/A
Seoul | N/A | South Korea | 126.9784 | 37.566
A Coruña | N/A | Spain | -8.396 | 43.37135
Barcelona | N/A | Spain | 2.15899 | 41.38879
Córdoba | N/A | Spain | -4.77275 | 37.89155
Madrid | N/A | Spain | -3.70256 | 40.4165
Falun | N/A | Sweden | 15.62597 | 60.60357
Linköping | N/A | Sweden | 15.62157 | 58.41086
Lund | N/A | Sweden | 13.19321 | 55.70584
Stockholm | N/A | Sweden | 18.06871 | 59.32938
Uppsala | N/A | Sweden | 17.63889 | 59.85882
Bern | N/A | Switzerland | 7.44744 | 46.94809
Sankt Gallen | N/A | Switzerland | 9.37477 | 47.42391 | 803 | 1 | 0.001245 | 1 | NCT00095147 | 1COMPLETED | 2009-07-01 | 2005-02-01 | Bristol-Myers Squibb | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.00022 | |
[
3
] | 179 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies. | null | HIV Infections Acquired Immunodeficiency Syndrome | null | 4 | arm 1: MK0518 200 mg arm 2: MK0518 400 mg arm 3: MK0518 600 mg arm 4: Placebo | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: MK0518 oral tablets 200 mg b.i.d, for 24 weeks intervention 2: MK0518 oral tablets 400 mg b.i.d, for 24 weeks intervention 3: MK0518 oral tablets 600 mg b.i.d, for 24 weeks intervention 4: Placebo to MK0518, oral tablet b.i.d, for 24 weeks | intervention 1: Comparator: MK0518 intervention 2: MK0518 intervention 3: MK0518 intervention 4: Placebo | 0 | null | 178 | 1 | 0.005618 | 1 | NCT00105157 | 1COMPLETED | 2009-07-01 | 2005-03-01 | Merck Sharp & Dohme LLC | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000992 | |
[
3
] | 60 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to find better treatment for lung cancer and to find out what effects the combined treatment of carboplatin and gemcitabine when given with or without dexamethasone have on cancer.
This study will determine if dexamethasone, when given before standard chemotherapy will increase the cancer fighting effects and reduce the side effects of chemotherapy. | Subjects enrolled in the study will be placed in one of two treatment arms. All subjects have a 50-50 chance of being placed into either treatment arm. Treatment Arm 1 will receive chemotherapy alone, Treatment Arm 2 will receive chemotherapy with dexamethasone given pre-treatment. | Stage IV Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer | Untreated Lung Cancer non-small cell gemcitabine gemzar carboplatin dexamethasone | null | 2 | arm 1: No Dexamethasone arm 2: Dexamethasone | [
5,
0
] | 3 | [
0,
0,
0
] | intervention 1: Gemcitabine 1000 mg/m\^2 intravenously over 30 minutes on days 5 and 12. intervention 2: 16 mg bid for 4 days prior to each chemotherapy start. intervention 3: AUC 6.0 intravenously over 30 minutes on day 5. | intervention 1: Gemcitabine intervention 2: Dexamethasone intervention 3: Carboplatin | 7 | Danville | Kentucky | United States | -84.77217 | 37.64563
Lexington | Kentucky | United States | -84.47772 | 37.98869
Louisville | Kentucky | United States | -85.75941 | 38.25424
Morehead | Kentucky | United States | -87.17638 | 37.27115
Mount Sterling | Kentucky | United States | -83.94326 | 38.05647
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Paducah | Kentucky | United States | -88.60005 | 37.08339 | 59 | 1 | 0.016949 | 1 | NCT00247416 | 1COMPLETED | 2009-07-01 | 2005-08-01 | Susanne Arnold | 7OTHER | false | false | false | null | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.002998 |
[
3
] | 334 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | This study will see if voclosporin is safe and effective in preventing kidney transplant rejection. | Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity, nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the prevention of organ graft rejection.
Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to tacrolimus | Kidney Diseases | Randomized Controlled Trials Immunosuppression Adult Kidney Transplantation Treatment Outcome | null | 4 | arm 1: Low dose voclosporin arm 2: Mid Dose Voclosporin arm 3: High Dose Voclosporin arm 4: Standard Dose Tacrolimus | [
1,
1,
1,
1
] | 2 | [
0,
0
] | intervention 1: voclosporin 0.4, 0.6, 0.8 mg/kg po BID intervention 2: tacrolimus 0.05 mg/kg po BID | intervention 1: Voclosporin intervention 2: tacrolimus | 45 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Los Angeles | California | United States | -118.24368 | 34.05223
Orange | California | United States | -117.85311 | 33.78779
Palo Alto | California | United States | -122.14302 | 37.44188
San Diego | California | United States | -117.16472 | 32.71571
San Francisco | California | United States | -122.41942 | 37.77493
Denver | Colorado | United States | -104.9847 | 39.73915
Gainesville | Florida | United States | -82.32483 | 29.65163
Tampa | Florida | United States | -82.45843 | 27.94752
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
Lexington | Kentucky | United States | -84.47772 | 37.98869
New Orleans | Louisiana | United States | -90.07507 | 29.95465
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts | United States | -71.05977 | 42.35843
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Detroit | Michigan | United States | -83.04575 | 42.33143
Rochester | Minnesota | United States | -92.4699 | 44.02163
Livingston | New Jersey | United States | -74.31487 | 40.79593
Buffalo | New York | United States | -78.87837 | 42.88645
Hawthorne | New York | United States | -73.79597 | 41.10732
New York | New York | United States | -74.00597 | 40.71427
Rochester | New York | United States | -77.61556 | 43.15478
Durham | North Carolina | United States | -78.89862 | 35.99403
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Portland | Oregon | United States | -122.67621 | 45.52345
Portland | Oregon | United States | -122.67621 | 45.52345
Portland | Oregon | United States | -122.67621 | 45.52345
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Charleston | South Carolina | United States | -79.93275 | 32.77632
Memphis | Tennessee | United States | -90.04898 | 35.14953
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328
Richmond | Virginia | United States | -77.46026 | 37.55376
Edmonton | Alberta | Canada | -113.46871 | 53.55014
London | Ontario | Canada | -81.23304 | 42.98339
Toronto | Ontario | Canada | -79.39864 | 43.70643
Montreal | Quebec | Canada | -73.58781 | 45.50884
Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238 | 334 | 1 | 0.002994 | 1 | NCT00270634 | 1COMPLETED | 2009-07-01 | 2006-01-01 | Aurinia Pharmaceuticals Inc. | 4INDUSTRY | false | false | false | null | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000529 |
[
5
] | 1,169 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode | null | Bipolar Disorder | Bipolar I Disorder with a recent manic or mixed episode | null | 2 | arm 1: Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole arm 2: Phase 2 Double-Blind Treatment: Lamotrigine + Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
Aripiprazole 10-30 mg/day intervention 2: Tablets, Oral, once daily, Phase 2 - up to 52 weeks
Lamotrigine 100-200 mg/day
placebo 0 mg/day | intervention 1: Lamotrigine + Aripiprazole intervention 2: Lamotrigine + Placebo | 66 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Tucson | Arizona | United States | -110.92648 | 32.22174
Anaheim | California | United States | -117.9145 | 33.83529
Costa Mesa | California | United States | -117.91867 | 33.64113
Los Angeles | California | United States | -118.24368 | 34.05223
Oceanside | California | United States | -117.37948 | 33.19587
Pasadena | California | United States | -118.14452 | 34.14778
Stanford | California | United States | -122.16608 | 37.42411
Torrance | California | United States | -118.34063 | 33.83585
Upland | California | United States | -117.64839 | 34.09751
Boca Raton | Florida | United States | -80.0831 | 26.35869
Coral Springs | Florida | United States | -80.2706 | 26.27119
Daytona Beach | Florida | United States | -81.02283 | 29.21081
Fort Myers | Florida | United States | -81.84059 | 26.62168
Miami | Florida | United States | -80.19366 | 25.77427
Port Charlotte | Florida | United States | -82.09064 | 26.97617
West Palm Beach | Florida | United States | -80.05337 | 26.71534
Atlanta | Georgia | United States | -84.38798 | 33.749
Greenwood | Indiana | United States | -86.10665 | 39.61366
Terre Haute | Indiana | United States | -87.41391 | 39.4667
Prairie Village | Kansas | United States | -94.63357 | 38.99167
Wichita | Kansas | United States | -97.33754 | 37.69224
Lexington | Kentucky | United States | -84.47772 | 37.98869
Owensboro | Kentucky | United States | -87.11333 | 37.77422
Baltimore | Maryland | United States | -76.61219 | 39.29038
Glen Burnie | Maryland | United States | -76.62469 | 39.16261
Rockville | Maryland | United States | -77.15276 | 39.084
Farmington Hills | Michigan | United States | -83.37716 | 42.48531
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
Flowood | Mississippi | United States | -90.13898 | 32.30959
Cherry Hill | New Jersey | United States | -75.03073 | 39.93484
Buffalo | New York | United States | -78.87837 | 42.88645
Rochester | New York | United States | -77.61556 | 43.15478
Staten Island | New York | United States | -74.13986 | 40.56233
Durham | North Carolina | United States | -78.89862 | 35.99403
Raleigh | North Carolina | United States | -78.63861 | 35.7721
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Canton | Ohio | United States | -81.37845 | 40.79895
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cleveland | Ohio | United States | -81.69541 | 41.4995
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Portland | Oregon | United States | -122.67621 | 45.52345
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
DuBois | Pennsylvania | United States | -78.76003 | 41.11923
East Stroudsburg | Pennsylvania | United States | -75.18129 | 40.99954
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Memphis | Tennessee | United States | -90.04898 | 35.14953
Nashville | Tennessee | United States | -86.78444 | 36.16589
Piney Flats | Tennessee | United States | -82.30403 | 36.41955
Houston | Texas | United States | -95.36327 | 29.76328
San Antonio | Texas | United States | -98.49363 | 29.42412
Charlottesville | Virginia | United States | -78.47668 | 38.02931
Virginia Beach | Virginia | United States | -75.97799 | 36.85293
Bothell | Washington | United States | -122.2054 | 47.76232
Seattle | Washington | United States | -122.33207 | 47.60621
Morgantown | West Virginia | United States | -79.9559 | 39.62953
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
Cabo Rojo | N/A | Puerto Rico | -67.14573 | 18.08663
Ponce | N/A | Puerto Rico | -66.62398 | 18.01031
Rio Piedras | N/A | Puerto Rico | -66.04989 | 18.39745
San Juan | N/A | Puerto Rico | -66.10572 | 18.46633 | 1,128 | 1 | 0.000887 | 1 | NCT00277212 | 1COMPLETED | 2009-07-01 | 2005-12-01 | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000157 |
[
4
] | 1,272 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS) | null | Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis FTY720 Fingolimod | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: Patients self-administered fingolimod 1.25 mg capsules orally once daily. intervention 2: Patients self-administered fingolimod 0.5 mg capsules orally once daily. intervention 3: Patients self-administered a fingolimod placebo capsule orally once daily. | intervention 1: Fingolimod 1.25 mg intervention 2: Fingolimod 0.5 mg intervention 3: Placebo | 115 | Woodville South | South Australia | Australia | 138.53477 | -34.88186
Burrabil Avenue, Suite 17, Gosford | N/A | Australia | 151.34399 | -33.4244
Chatswood | N/A | Australia | 151.18333 | -33.8
Fitzroy | N/A | Australia | 144.97833 | -37.79839
Heidelberg | N/A | Australia | 145.06667 | -37.75
Ruddershove | Brugge | Belgium | 3.7606 | 50.88235
Route de Lennik 808 | Brussels Capital | Belgium | N/A | N/A
Boulevard Paul Janson 92 | Charleroi | Belgium | N/A | N/A
Department Neurology, Herestraat 49 | Leuven | Belgium | N/A | N/A
Department of Neurology & Rehab-Umit, Gentsesteenweg 132 | Sijsele | Belgium | N/A | N/A
St.Trudo, Diestersteenweg 100, | St.Truiden | Belgium | N/A | N/A
Boemerangstraat 2, Overpelt | N/A | Belgium | 5.41557 | 51.21038
Vanheylenstraat 16, Melsbroek | N/A | Belgium | 4.47985 | 50.91559
Me498 2211 Wesbrook Mall, Vancouver | British Columbia | Canada | -123.11934 | 49.24966
Halifax | Nova Scotia | Canada | -63.57688 | 44.64269
Connell 7, 76 Stuart Street, Kingston | Ontario | Canada | -76.48098 | 44.22976
Ottawa | Ontario | Canada | -75.69812 | 45.41117
Toronto | Ontario | Canada | -79.39864 | 43.70643
Trillium Health Center, 00 Queesway West, Mississauga | Ontario | Canada | -79.6583 | 43.5789
Montreal | Quebec | Canada | -73.58781 | 45.50884
Regina | Saskatchewan | Canada | -104.6178 | 50.45008
Department of Neurology, Zabrdovicka 3 | Brno | Czechia | N/A | N/A
First Department of Neurology, Pekarska 53 | Brno | Czechia | N/A | N/A
Department of Neurology, I.P. Paulova 6 | Olomouc | Czechia | N/A | N/A
Department of Neurology, Kyjevska 44 | Pardubice | Czechia | N/A | N/A
Department of Neurology, Alej Svobody 80 | Plzeň | Czechia | N/A | N/A
Kralovske Vinohrady, Srobarova 50 | Prague | Czechia | 14.44367 | 50.07438
Department of Neurology, V Uvalu 84 | Prague 5 | Czechia | N/A | N/A
MS Centrum, Neurologicka Klinika, Karlovo Namesti 32 | Praha 2 | Czechia | N/A | N/A
Neurology Department of Hospital Teplice, Duchcovska 53 | Teplice | Czechia | N/A | N/A
Jiraskova 1389, Rychnov Nad Kneznou | N/A | Czechia | 16.27488 | 50.16284
Ostrava | N/A | Czechia | 18.28204 | 49.83465
Mannnerheiminaukio 1 B 2 Floor | Helsinki | Finland | N/A | N/A
Brahenkatu 11 D, | Turku | Finland | N/A | N/A
Hämeenkatu 18, 6th Fl., Tampere | N/A | Finland | 23.78712 | 61.49911
Kiinanmyllynkatu 11- 14, Turku | N/A | Finland | 22.26869 | 60.45148
Neurologian Poliklinikka, Sairaalankatu 1, Hyvinkää | N/A | Finland | 24.86667 | 60.63333
Service Neurologie, Boulevard Jean Moulin, Marsielle Cedex 5 | N/A | France | N/A | N/A
Berlin | N/A | Germany | 13.41053 | 52.52437
Berlin | N/A | Germany | 13.41053 | 52.52437
Düsseldorf | N/A | Germany | 6.77616 | 51.22172
Giessen | N/A | Germany | 8.67554 | 50.58727
Hamburg | N/A | Germany | 9.99302 | 53.55073
Hamburg | N/A | Germany | 9.99302 | 53.55073
Leipzig | N/A | Germany | 12.37129 | 51.33962
Magdeburg | N/A | Germany | 11.62916 | 52.12773
München | N/A | Germany | 13.31243 | 51.60698
München | N/A | Germany | 13.31243 | 51.60698
Münster | N/A | Germany | 7.62571 | 51.96236
Regensburg | N/A | Germany | 12.10161 | 49.01513
Seesen/Harz | N/A | Germany | N/A | N/A
Stuttgart | N/A | Germany | 9.17702 | 48.78232
Tübingen | N/A | Germany | 9.05222 | 48.52266
Würzburg | N/A | Germany | 9.95121 | 49.79391
Athens | N/A | Greece | 23.72784 | 37.98376
Mesogeion 154 Ave., Athens | N/A | Greece | 23.72784 | 37.98376
Terma Zaimi, Melissia-Athens | N/A | Greece | N/A | N/A
Thessaloniki | N/A | Greece | 22.93086 | 40.64361
Ashkelon | N/A | Israel | 34.57149 | 31.66926
Haifa | N/A | Israel | 34.99928 | 32.81303
Safed | N/A | Israel | 35.496 | 32.96465
Tel Hashomer, Ramat-Gan, | N/A | Israel | N/A | N/A
Eiveniu 2, Kaunas | N/A | Lithuania | 23.90961 | 54.90272
De Boelelaan 1118 | Amsterdam | Netherlands | N/A | N/A
Postbus 2500 | Nieuwegein | Netherlands | N/A | N/A
Heiweg 97 | Nyimegen | Netherlands | N/A | N/A
Dr. Molewaterplein 40 | Rotterdam | Netherlands | N/A | N/A
Hilvarenbeekse Weg 60 | Tilburg | Netherlands | N/A | N/A
Walramstraat 23, BK Sittard | N/A | Netherlands | N/A | N/A
Klinika Neurologii, Ul. Marii Skłodowskiej-Curie 24 A | Bialystok | Poland | N/A | N/A
Ul. Swietego Mikolaja 1/8 | Bialystok | Poland | N/A | N/A
Mozgu, Nowe Ogrody 1/6 | Gdańsk | Poland | N/A | N/A
Ul. Medykow 14 | Katowice | Poland | N/A | N/A
Department of Neurology, Ul. Przybyszewskiego 49 | Poznan | Poland | N/A | N/A
Department of Neurology, Wołoska 137 | Warsaw | Poland | N/A | N/A
II Klinika Neurologii, Ul. Sobieskiego 1/9 | Warsaw | Poland | N/A | N/A
MSWiAw Warszawie, Woloska 137 | Warszawa | Poland | N/A | N/A
Ul. Banacha 1A | Warszawa | Poland | N/A | N/A
Lodz | N/A | Poland | 19.47395 | 51.77058
Kazan' | N/A | Russia | 49.12214 | 55.78874
Moscow | N/A | Russia | 37.61556 | 55.75222
Moscow | N/A | Russia | 37.61556 | 55.75222
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
Limbová 5 | Bratislava Region | Slovakia | N/A | N/A
Kollárova 2, Martin | N/A | Slovakia | 18.92399 | 49.06651
Mickiewiczova 13, Bratislava | N/A | Slovakia | 17.10674 | 48.14816
ul.V. Spanyola 43, Žilina | N/A | Slovakia | 18.73941 | 49.22315
Umhlanga | KZN | South Africa | 31.08583 | -29.72528
E 8-74, Groote Schuur Hospital, Observatory Cape Town | N/A | South Africa | N/A | N/A
Sandton | N/A | South Africa | 28.054 | -26.104
Forskningsenhet, SU/Östra CKÖ Plan 0 | Gothenburg | Sweden | N/A | N/A
Department of Neurology R54, Stockholm | N/A | Sweden | 18.06871 | 59.32938
Neuroimmunology Unit, CMM L8:04, Stockholm | N/A | Sweden | 18.06871 | 59.32938
Neurology-Neurosurgical, Petersgraben 4 | Basel | Switzerland | N/A | N/A
Rue Du Bugnon | Lausanne | Switzerland | N/A | N/A
Frauenklinikstr. 26, Zurich | N/A | Switzerland | 8.55 | 47.36667
Department of Neurology | Ankara | Turkey (Türkiye) | N/A | N/A
Medical Faculty Neurology Department | Besevler Ankara | Turkey (Türkiye) | N/A | N/A
Medical Faculty Hospital Neurolgy Department | Bornova Izmir | Turkey (Türkiye) | N/A | N/A
Departement of Neurology | Capa Istanbul | Turkey (Türkiye) | N/A | N/A
Department of Neurology | Cerrahpasa Istanbul | Turkey (Türkiye) | N/A | N/A
Neurology Department | Gaziantep | Turkey (Türkiye) | N/A | N/A
Tip Fakultesi, Noroloji ABD | Görükle / Bursa | Turkey (Türkiye) | N/A | N/A
Hospital Neurology Service, 35120 Gaziler Cad. Izmir | N/A | Turkey (Türkiye) | N/A | N/A
Inciralti, Izmir | N/A | Turkey (Türkiye) | N/A | N/A
Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384
Noroloji ABD, Mersin | N/A | Turkey (Türkiye) | 34.63886 | 36.81196
Noroloji Klinigi, Göztepe Istanbul | N/A | Turkey (Türkiye) | N/A | N/A
P041 Institute of Psychiatry, Denmark Hill | London | United Kingdom | N/A | N/A
Division of Clinical Neurology Medical School | Nottingham | United Kingdom | N/A | N/A
Glossop Road | Sheffield | United Kingdom | N/A | N/A
Backshaw Road, London | N/A | United Kingdom | -0.12574 | 51.50853
Beckspool Road, Bristol | N/A | United Kingdom | -2.59665 | 51.45523
Queen Victoria Road, Newcastle-upon-Tyne | N/A | United Kingdom | -1.61396 | 54.97328 | 1,272 | 1 | 0.000786 | 1 | NCT00289978 | 1COMPLETED | 2009-07-01 | 2006-01-01 | Novartis | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000139 |
[
4
] | 125 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at 24-week follow-up to 48 week in subjects after orthotopic liver transplantation (OLT) with chronic hepatitis C (HCV) recurrence. | null | Liver Transplantation Hepatitis C, Chronic Liver Cirrhosis | null | 1 | arm 1: PEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was \>10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing \<65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing \>85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM). | [
0
] | 1 | [
0
] | intervention 1: 1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks
2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks | intervention 1: Combination of (a) pegylated interferon alfa-2b and (b) rebetol | 0 | null | 125 | 1 | 0.008 | 1 | NCT00378599 | 1COMPLETED | 2009-07-01 | 2006-05-01 | 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 | 1 | 0 | 0 | 0 | 0.001414 | |
[
4
] | 531 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | To evaluate the pharmacokinetics of TU 750 mg and TU 1000 mg via multiple measurements of serum total testosterone. | null | Hypogonadism Primary Hypogonadism Secondary Hypogonadism | investigational testosterone testosterone undecanoate TU Hypogonadism primary hypogonadism secondary hypogonadism | null | 2 | arm 1: 750 mg dose of testosterone undecanoate arm 2: 1000 mg dose testosterone undecanoate | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Testosterone Undecanoate 750 mg intervention 2: Testosterone Undecanoate 1000 mg | 1 | Lexington | Massachusetts | United States | -71.2245 | 42.44732 | 524 | 1 | 0.001908 | 1 | NCT00467870 | 1COMPLETED | 2009-07-01 | 2006-03-01 | Endo 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000337 |
[
3
] | 185 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis. | The treatment period started once the patient completed the core study and signed informed consent. It is continued for up to 4 years. Safety parameters were assessed every 4 weeks. Eye and Ear examinations were performed on a yearly basis. To further investigate the extent of iron overload, serum ferritin, iron, and transferrin were monitored every four weeks. The Program Safety Board monitored the safety of ICL670 during the study to evaluate and categorize any serious case reported in association with ICL670. | Sickle Cell Disease | Deferasirox ICL670A Iron chelators Sickle Cell Disease Transfusional Hemosiderosis | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years. | intervention 1: ICL670 | 39 | Mobile | Alabama | United States | -88.04305 | 30.69436
Loma Linda | California | United States | -117.26115 | 34.04835
Los Angeles | California | United States | -118.24368 | 34.05223
Oakland | California | United States | -122.2708 | 37.80437
Denver | Colorado | United States | -104.9847 | 39.73915
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
Tampa | Florida | United States | -82.45843 | 27.94752
Atlanta | Georgia | United States | -84.38798 | 33.749
Augusta | Georgia | United States | -81.97484 | 33.47097
Chicago | Illinois | United States | -87.65005 | 41.85003
Chicago | Illinois | United States | -87.65005 | 41.85003
New Orleans | Louisiana | United States | -90.07507 | 29.95465
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Boston | Massachusetts | United States | -71.05977 | 42.35843
Detroit | Michigan | United States | -83.04575 | 42.33143
Brooklyn | New York | United States | -73.94958 | 40.6501
New York | New York | United States | -74.00597 | 40.71427
The Bronx | New York | United States | -73.86641 | 40.84985
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Cincinnati | Ohio | United States | -84.51439 | 39.12711
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Columbia | South Carolina | United States | -81.03481 | 34.00071
Sumter | South Carolina | United States | -80.34147 | 33.92044
Memphis | Tennessee | United States | -90.04898 | 35.14953
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Temple | Texas | United States | -97.34278 | 31.09823
Norfolk | Virginia | United States | -76.28522 | 36.84681
Toronto | N/A | Canada | -79.39864 | 43.70643
Créteil | N/A | France | 2.46569 | 48.79266
Paris | N/A | France | 2.3488 | 48.85341
Catania | N/A | Italy | 15.07041 | 37.49223
Genova | N/A | Italy | 11.87211 | 45.21604
Milan | N/A | Italy | 12.59836 | 42.78235
Roma | N/A | Italy | 11.10642 | 44.99364
London | N/A | United Kingdom | -0.12574 | 51.50853 | 185 | 1 | 0.005405 | 1 | NCT01090323 | 1COMPLETED | 2009-07-01 | 2004-07-01 | 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 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.000955 |
[
2
] | 29 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | true | RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen. | OBJECTIVES:
* Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy (as radiation sensitization) in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes.
* Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population.
* Determine the effect of this treatment regimen on progression-free survival, overall survival, and site of recurrence (local vs distant) in these patients.
OUTLINE: This is a multicenter, dose-escalation study of paclitaxel.
Patients receive external beam radiotherapy (RT) to the para-aortic nodes and the pelvis daily for 5 weeks; RT must be completed within 8 weeks of its initiation. During or after external beam RT, intracavitary radiation is administered 1-5 times. Concurrently with external beam RT, patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1, 8, 15, 22, 29, and 36.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until the time of recurrence or death.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 4 years. | Cervical Cancer | stage III cervical cancer stage IVA cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma cervical adenosquamous cell carcinoma | null | 1 | arm 1: None | [
5
] | 4 | [
0,
0,
4,
4
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: cisplatin intervention 2: paclitaxel intervention 3: brachytherapy intervention 4: radiation therapy | 13 | Miami | Florida | United States | -80.19366 | 25.77427
Chicago | Illinois | United States | -87.65005 | 41.85003
Iowa City | Iowa | United States | -91.53017 | 41.66113
Camden | New Jersey | United States | -75.11962 | 39.92595
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Cleveland | Ohio | United States | -81.69541 | 41.4995
Columbus | Ohio | United States | -82.99879 | 39.96118
Columbus | Ohio | United States | -82.99879 | 39.96118
Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 29 | 0 | 0 | 0 | NCT00003377 | 1COMPLETED | 2009-07-01 | 1999-11-01 | Gynecologic Oncology Group | 5NETWORK | 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
] | 50 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will examine the safety and effectiveness of an experimental drug called Bortezomib (PS-341), given alone and in combination with a chemotherapy regimen called Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin and Filgrastim (EPOCH), in treating non-Hodgkin's B-cell lymphoma. In the laboratory, PS-341 kills lymphoma cells and makes them more sensitive to chemotherapy. The EPOCH treatment regimen includes the drugs doxorubicin, etoposide, vincristine, cyclophosphamide, prednisone, and filgrastim.
Patients 18 years of age and older with an aggressive non-Hodgkin's lymphoma that has relapsed after treatment or is not responding to chemotherapy may be eligible for this study. Candidates will be screened with a medical history and physical examination. Other tests that may be required include blood and urine tests; lung function studies; imaging tests such as magnetic resonance imaging, computed tomography and x-rays; and biopsy (surgical removal of a small tissue sample) of tumor, bone marrow, or other tissue.
Upon entering the study, all participants will receive PS-341. The drug is given as a 3- to 5-second intravenous (through a vein) injection twice a week for 2 weeks. This is followed by a 1-week rest. Each 3-week period comprises one treatment cycle. The number of cycles a patient receives depends on how well he or she responds to the drug. Patients who do not have a complete remission or whose tumor grows on this therapy will be offered PS-341 in combination with up to six cycles of EPOCH chemotherapy. The treatment for patients taking PS-341 plus EPOCH is as follows:
* PS-341, given by 3- to 5-second intravenous (IV) injection on days 1 and 4 of each cycle.
* Doxorubicin, etoposide, and vincristine, given by continuous IV infusion over 4 days, beginning on day 1 and ending on day 5 of each cycle. The drugs are delivered through a lightweight portable infusion pump to an indwelling IV catheter (plastic tube) in a vein.
* Cyclophosphamide, given by IV infusion over 15 minutes on day 5 of each cycle.
* Prednisone, given by mouth (pills) twice a day on days 1 through 5 of each cycle.
* Filgrastim, given by injection under the skin starting on day 6 of each cycle and continuing until the white blood cell count increases or until day 19 of the cycle.
Patients also take a combination of antibiotics 3 days a week during EPOCH to prevent infection while resistance is lowered because of the chemotherapy. Etoposide, doxorubicin, and cyclophosphamide doses are adjusted as needed, based on white blood cell counts of the previous cycle. The first patients in the study will receive a low dose of PS-341. The dose will be increased in subsequent small groups of patients as long as the preceding dose is well tolerated.
Drug therapy for patients who are candidates for bone marrow transplant will be tailored to permit transplantation. Patients who are not eligible for or who choose not to have a bone marrow transplant will be followed at the National Institutes of Health (NIH) every 3 months the first year, every 4 months the second year, every 6 months the third year, and then once a year until their disease progresses or the study ends. Patients may have tumor and bone marrow biopsies, blood draws, and computed tomography (CT) scans periodically to evaluate disease status and drug side effects. | Diffuse large B-cell lymphomas (DLBCL) have been molecularly sub-classified into germinal center like B-cell (GCB) and activated B-cell like (ABC) DLBCL. Clinically, the ABC subtype has a significantly higher rate of drug resistance and lower survival. The ABC subtype has overexpression of nuclear factor-kappa B (NF-kB) with transcriptional activation of B cell lymphoma 2 (bcl-2), which may account for the drug resistance. The ability of NF-kB to inhibit responses to cancer therapeutic agents may also contribute to the refractory clinical behavior of ABC subtype, and inhibition of NF-kB can synergize with the chemotherapy to kill tumor cells. This protocol aims to study the affect of NF-kB inhibition, through proteasome inhibition by PS-341, on response to PS-341 and PS-341 with EPOCH chemotherapy in DLBCL. It will also assess the affect of PS-341 on NF-kB and BCL-2 tumor expression by microarray, and provide information on the specificity of PS-341. | B-Cell Lymphoma | BCL-2 NFK-B Drug Resistance Translational Lymphoma Large B-Cell Lymphoma | null | 2 | arm 1: 1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks arm 2: PS-341: level 1: 0.5 mg/m\^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m\^2 IV days 1, 4; level 3: 1.5 mg/m\^2 IV days 1, 4; level 4: 1.7 mg/m\^2 IV days 1, 4.
EPOCH: Etoposide: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m\^2 day IV day 5 bolus; Prednisone: 60 mg/m\^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycles every 21 days. | [
0,
0
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: 1.3 mg/m\^2 intravenous injection days 1, 4, 8, 11 every 3 weeks intervention 2: 50 mg/m\^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion. Repeat cycle every 21 days. intervention 3: 10 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days. intervention 4: 0.4 mg/m\^2 day CIV days 1-4, 96 hour infusion. Repeat cycle every 21 days. intervention 5: 750 mg/m\^2 day IV day 5 bolus. Repeat cycle every 21 days. intervention 6: 60 mg/m\^2 by mouth twice a day days 1-5. Repeat cycle every 21 days. intervention 7: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm\^3. Repeat cycle every 21 days. | intervention 1: PS-341 intervention 2: Etoposide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Cyclophosphamide intervention 6: Prednisone intervention 7: Filgrastim | 2 | Bethesda | Maryland | United States | -77.10026 | 38.98067
Buffalo | New York | United States | -78.87837 | 42.88645 | 68 | 0 | 0 | 0 | NCT00054665 | 1COMPLETED | 2009-07-01 | 2003-02-01 | National Cancer Institute (NCI) | 0NIH | 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
] | 146 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine in current and non-smokers the clinical and microbiological effects of 3 therapies: scaling and root planing (SRP) alone; SRP in combination with the orally administered antibiotic metronidazole; and SRP with the orally administered antibiotics metronidazole and amoxicillin along with the locally delivered antibiotic doxycycline at periodontal pockets \>= 4 mm. | Cigarette smokers have more severe periodontal disease and more widespread colonization by periodontal pathogens than non smokers. In addition, smokers respond less well to periodontal therapies, particularly mechanical therapies such as scaling and root planing (SRP) and surgery. Recent data from our laboratory have indicated that treatment that included antibiotics produced a better clinical effect in smokers than mechanical therapy alone. Thus, the purpose of the present investigation is to compare the immediate and long-term effects of 3 periodontal therapies on clinical, microbiological and host parameters in current and non smokers. In this double blind, placebo-controlled, randomized study, 108 current smokers and 108 non smokers will be randomly assigned to 1 of 3 treatment groups: SRP alone; SRP + systemically administered metronidazole; SRP + systemically administered amoxicillin and metronidazole and local delivery of doxycycline at pockets \> 4 mm. Plaque Index, Gingival Index, % of sites with bleeding on probing, suppuration, pocket depth and attachment level will be measured at 6 sites per tooth at all teeth excluding 3rd molars at baseline, 3, 6, 12, 18 and 24 months. Subgingival plaque samples taken from the mesial aspect of each tooth at the same time points will be analyzed individually for their content of 40 subgingival species using checkerboard DNA-DNA hybridization. Antibody levels to 20 subgingival species will be measured in serum samples taken at baseline, 6 and 24 months. Levels of IL-1b, IL-10 and IFNg will be measured in GCF samples taken from the 4 deepest pockets at baseline, 3, 6 and 24 months. The major hypothesis to be tested is whether smokers respond better to periodontal therapies that include 1 or more antibiotics. Other hypotheses will test whether host and microbiological parameters differ between smokers and non smokers and if such parameters are comparably altered after therapy in both groups. The results will be of immediate clinical benefit to the large segment of periodontal patients who smoke cigarettes. Smokers make up 26 - 30% of the adult population and form a disproportionately high segment of the population requiring periodontal treatment. They may have special needs in terms of periodontal therapy which should be clarified by the proposed investigation. In addition, the cigarette smoker is an example of a periodontal patient who is "compromised" in terms of his/her ability to cope with infectious diseases. The proposed investigation should provide a model to examine methods that could be useful in treating compromised patients whether compromised by harmful habits such as smoking, systemic disease or genetic background. | Periodontitis Periodontal Diseases | null | 3 | arm 1: Full mouth scaling and root planing (SRP) alone plus a placebo pill taken twice daily for 2 weeks. arm 2: Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 days arm 3: Full mouth Scaling and Root Planing plus Metronidazole (MET) 250 mg tid x 14 d and Amoxicillin (AMOX) 500 mg tid for 14 days and local drug delivery of Doxycycline (TET LDD) in pockets \>4mm | [
2,
1,
1
] | 4 | [
3,
0,
0,
0
] | intervention 1: Scaling and root planning (SRP) is the mechanical debridement of the tooth and root surfaces and is standard of care in periodontal therapy. intervention 2: Metronidazole (MET) is an antibiotic that is particularly effective against Gram negative bacterial species. The dose for this study is: 250 mg tid x 14d. intervention 3: Amoxicillin (AMOX) is a broad spectrum antibiotic and was prescribed at 500 mg tid for 14d. intervention 4: The ATRIDOX (doxycycline hyclate) ® product is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DLlactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days. Doxycycline is a broad-spectrum antibiotic synthetically derived from oxytetracycline. | intervention 1: Scaling and root planing intervention 2: Metronidazole intervention 3: Amoxicillin intervention 4: Doxycycline | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 146 | 0 | 0 | 0 | NCT00066066 | 1COMPLETED | 2009-07-01 | 2003-07-01 | The Forsyth 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 | |
[
2,
3
] | 40 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | Phase II trial to study the effectiveness of combining imatinib mesylate with bevacizumab in treating patients who have advanced melanoma or other metastatic or unresectable cancer. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining imatinib mesylate with bevacizumab may kill more tumor cells | OBJECTIVES:
I. Determine the tolerability, maximum tolerated dose, and lowest biologically active dose of imatinib mesylate and bevacizumab in patients with advanced melanoma or other advanced cancers.
II. Determine the response rate, time to progression, and survival of patients treated with this regimen.
III. Correlate clinical activity with inhibition of platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor, flt-1, and markers of angiogenesis in patients treated with this regimen.
IV. Correlate clinical activity with alterations in tumor perfusion as assessed by dynamic contrast-enhanced MRI and Doppler ultrasound in patients treated with this regimen.
V. Correlate toxicity, clinical activity, and correlative endpoints with the steady-stage plasma concentration of imatinib mesylate in patients treated with this regimen.
OUTLINE: This is a dose-escalation, open-label study.
PHASE I (closed to accrual as of 8/23/04): Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PHASE II: Patients receive imatinib mesylate and bevacizumab as in phase I at the MTD. | Recurrent Melanoma Stage III Melanoma Stage IV Melanoma Unspecified Adult Solid Tumor, Protocol Specific | null | 1 | arm 1: Patients receive oral imatinib mesylate once or twice daily on days 1-28 and bevacizumab IV over 30-90 minutes on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 4 | [
0,
2,
10,
10
] | intervention 1: Given orally intervention 2: Given IV intervention 3: Correlative studies intervention 4: Correlative studies | intervention 1: imatinib mesylate intervention 2: bevacizumab intervention 3: pharmacological study intervention 4: laboratory biomarker analysis | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 40 | 0 | 0 | 0 | NCT00074308 | 1COMPLETED | 2009-07-01 | 2003-10-01 | National Cancer Institute (NCI) | 0NIH | 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
] | 131 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of this study is to learn whether treating individuals with Alzheimer's disease and depression with the anti-depressant medication sertraline (Zoloft) is helpful to people with Alzheimer's disease and to their families and caregivers. | Participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. There are 8 scheduled in-person visits in the 24 weeks. Visits include neuropsychological testing. Caregivers are asked to are the patient on a Daily Affect Diary for 6 weeks during the study period. Telephone followup is done at weeks 36 and 48. Both groups receive caregiver support/education. | Alzheimer's Disease Depression | Alzheimer's disease Depression | null | 2 | arm 1: Participants will receive sertraline at a target dose of 100mg daily. arm 2: Participants will receive placebo matched to sertraline | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Sertraline: range of 25 to 125 mg per day for 24 weeks intervention 2: Placebo designed to mimic sertraline taken daily for 24 weeks | intervention 1: Sertraline (Zoloft) intervention 2: Placebo | 5 | Los Angeles | California | United States | -118.24368 | 34.05223
Baltimore | Maryland | United States | -76.61219 | 39.29038
Rochester | New York | United States | -77.61556 | 43.15478
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
North Charleston | South Carolina | United States | -79.97481 | 32.85462 | 131 | 0 | 0 | 0 | NCT00086138 | 1COMPLETED | 2009-07-01 | 2004-07-01 | Johns Hopkins 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 |
[
3
] | 8 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 1FEMALE | true | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing breast cancer.
PURPOSE: This randomized phase II trial is studying how well celecoxib works in preventing breast cancer in premenopausal women who are at risk for developing the disease. | OBJECTIVES:
* Compare 1-year mammographic density in premenopausal women at high risk for developing breast cancer treated with celecoxib vs placebo.
* Compare 1-year proliferation of breast epithelial cells, as measured by Ki67 staining, in patients treated with these drugs.
* Compare the expression of other biomarkers, including cyclo-oxygenase-2 (COX-2) enzyme and a marker of apoptosis, in breast tissue of patients treated with these drugs.
* Compare 1-year plasma levels of insulin-like growth factor (IGF)-1, IGF binding protein-3, and prostaglandin E\_2 in patients treated with these drugs.
* Compare the toxicity of these drugs in these patients.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to risk category (lobular carcinoma in situ or ductal carcinoma in situ vs BRCA1/2 mutation AND any Gail risk vs Gail risk ≥1.7% but \< 5% vs Gail risk ≥ 5%) and prior tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
* Celocoxib: Patients receive oral celecoxib twice daily.
* Placebo: Patients receive oral placebo twice daily. In both arms, treatment continues for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study. | Breast Cancer | breast cancer breast cancer in situ lobular breast carcinoma in situ ductal breast carcinoma | null | 2 | arm 1: Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. arm 2: Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer. | [
0,
2
] | 2 | [
0,
10
] | intervention 1: Given orally intervention 2: Given orally | intervention 1: celecoxib intervention 2: placebo | 9 | Glendale | California | United States | -118.25508 | 34.14251
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Houston | Texas | United States | -95.36327 | 29.76328
Seattle | Washington | United States | -122.33207 | 47.60621
Seattle | Washington | United States | -122.33207 | 47.60621 | 8 | 0 | 0 | 0 | NCT00088972 | 6TERMINATED | 2009-07-01 | 2004-11-01 | SWOG Cancer Research Network | 5NETWORK | 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
] | 52 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in treating patients with recurrent or persistent endometrial cancer. | PRIMARY OBJECTIVES:
I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.
II. Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 2.5 years. | Endometrial Adenocarcinoma Recurrent Endometrial Carcinoma Stage IV Endometrial Carcinoma | null | 1 | arm 1: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. | [
0
] | 1 | [
0
] | intervention 1: Given IV | intervention 1: ixabepilone | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 50 | 0 | 0 | 0 | NCT00095979 | 1COMPLETED | 2009-07-01 | 2005-05-01 | National Cancer Institute (NCI) | 0NIH | 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
] | 67 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Objectives:
Primary endpoint:
-Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma.
Secondary endpoints:
* Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide.
* Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma.
* To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide.
* To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination.
* To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers. | RAD001 is a new drug that is designed to block a protein that is important in the growth of cancer cells. Octreotide Depot is FDA approved for the treatment of carcinoid syndrome and hormonal symptoms from certain islet cell carcinomas. Octreotide Depot may also help to block certain proteins that are important in tumor growth.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your heart rate, temperature, breathing rate, blood pressure, height, and weight will be measured. You will be asked about your ability to perform every day activities. Blood (about 2 teaspoons) will be collected for routine tests. You will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart) and scans (either Computed Tomography/CT or Magnetic Resonance Imaging/MRI) to evaluate the cancer. Women who are able to have children must have a negative blood pregnancy test.
If the screening evaluations show you are eligible to take part in the study, you may begin treatment. You will take RAD001 by mouth once a day, every day while on study. You should take it in a fasting state or after no more than a light, fat-free meal. You should take RAD001 about the same time each day. Octreotide Depot will be given as an injection into the muscle of either buttock once every 4 weeks while on study. This will be done at M. D. Anderson. Four weeks (28 days) is called one course of treatment.
Clinic visits will occur every 2 weeks during the first 4 weeks and every 4 weeks from then on. At each clinic visit, you will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your heart rate, temperature, breathing rate, blood pressure, height, and weight will be measured. You will be asked about your ability to perform every day activities. Blood samples (about 1 teaspoons) for routine tests will be collected every 2 weeks for the first 8 weeks. After that, blood samples (about 2 teaspoons) will be collected every 4 weeks. CT or MRI scan(s) will be performed every 12 weeks.
If a sample of your tumor tissue that was removed previously is available, it will be analyzed for expression of proteins that may effect tumor growth. However, if a sample is not available, you will not be asked to undergo a biopsy to collect this tissue. This sample may analyzed at any time during the study.
If you experience severe side effects, treatment may be delayed, stopped, or you may receive smaller doses of RAD001 and/or Octreotide Depot. You may continue to receive up to at least 12 courses of study treatment unless the disease gets worse, you decide not to take part any longer, or your doctor decides it is in your best interest to stop treatment. It may be possible to continue treatment beyond 12 courses if you are benefitting from this treatment.
When you stop study treatment, you will be asked to have some tests and evaluations done. About 4 teaspoons of blood will be taken for routine lab tests, You will also have a physical exam and CT scan or MRI scan will be done to check the size and location of your disease.
This is an investigational study. RAD001 is investigational and is not commercially available. The drug combination in this study is also investigational. RAD001 is manufactured by Novartis Pharmaceuticals Corporation. About 60 patients will take part in this study. All will be enrolled at M. D. Anderson. | Neuroendocrine Carcinoma Islet Cell Carcinoma | Neuroendocrine Carcinoma Low Grade Neuroendocrine Carcinoma Neuroendocrine Carcinoid Islet Cell Carcinoma RAD001 Everolimus Octreotide Depot Sandostatin LAR Octreotide long-acting release (LAR) Octreotide LAR | null | 1 | arm 1: RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days. | [
0
] | 2 | [
0,
0
] | intervention 1: Starting dose of 5 or 10 mg by mouth daily. intervention 2: 30 mg injection into the muscle of either buttock once every 28 (±7) days. | intervention 1: RAD001 intervention 2: Octreotide Depot | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 64 | 0 | 0 | 0 | NCT00113360 | 1COMPLETED | 2009-07-01 | 2005-01-01 | 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 |
[
5
] | 157 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | null | This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. | null | Breast Cancer | null | 2 | arm 1: None arm 2: None | [
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 2: 75mg/m2 iv on day 1 of each 3 week cycle intervention 3: 4mg/kg iv (loading dose) followed by 2mg/kg iv weekly intervention 4: 825mg/m2 po bid on days 1-14 of each 3 week cycle intervention 5: 75mg/m2 iv on day 1 of each 3 week cycle | intervention 1: capecitabine [Xeloda] intervention 2: Taxotere intervention 3: Herceptin (HER2-neu positive patients only) intervention 4: capecitabine [Xeloda] intervention 5: Taxotere | 38 | Los Angeles | California | United States | -118.24368 | 34.05223
Montebello | California | United States | -118.10535 | 34.00946
Palm Springs | California | United States | -116.54529 | 33.8303
San Diego | California | United States | -117.16472 | 32.71571
Farmington | Connecticut | United States | -72.83204 | 41.71982
Melbourne | Florida | United States | -80.60811 | 28.08363
Miami | Florida | United States | -80.19366 | 25.77427
Tamarac | Florida | United States | -80.24977 | 26.21286
Savannah | Georgia | United States | -81.09983 | 32.08354
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Indianapolis | Indiana | United States | -86.15804 | 39.76838
Iowa City | Iowa | United States | -91.53017 | 41.66113
Alexandria | Louisiana | United States | -92.44514 | 31.31129
Scarborough | Maine | United States | -70.32172 | 43.57814
Baltimore | Maryland | United States | -76.61219 | 39.29038
Edina | Minnesota | United States | -93.34995 | 44.88969
Jefferson City | Missouri | United States | -92.17352 | 38.5767
Rolla | Missouri | United States | -91.77127 | 37.95143
St Louis | Missouri | United States | -90.19789 | 38.62727
Neptune City | New Jersey | United States | -74.02792 | 40.20011
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
Santa Fe | New Mexico | United States | -105.9378 | 35.68698
New York | New York | United States | -74.00597 | 40.71427
Charlotte | North Carolina | United States | -80.84313 | 35.22709
Canton | Ohio | United States | -81.37845 | 40.79895
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
Pottsville | Pennsylvania | United States | -76.1955 | 40.68565
Charleston | South Carolina | United States | -79.93275 | 32.77632
Georgetown | South Carolina | United States | -79.2945 | 33.37683
Sumter | South Carolina | United States | -80.34147 | 33.92044
Memphis | Tennessee | United States | -90.04898 | 35.14953
Memphis | Tennessee | United States | -90.04898 | 35.14953
Dallas | Texas | United States | -96.80667 | 32.78306
Dallas | Texas | United States | -96.80667 | 32.78306
Burlington | Vermont | United States | -73.21207 | 44.47588
Abingdon | Virginia | United States | -81.97735 | 36.70983 | 156 | 0 | 0 | 0 | NCT00127933 | 1COMPLETED | 2009-07-01 | 2005-08-01 | 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 | |
[
3
] | 2 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to determine if treatment with reduced-dose busulfex, fludarabine and alemtuzumab (CAMPATH) followed by sten cell infusion will allow for donor stem cells to grow in patients with hemoglobinopathies bone marrow and restore circulating blood counts. In addition the incidence and severity of side effects and of graft vs. host disease (GVHD) will be monitored. | * In order to undergo transplant procedure, patients will be admitted to the hospital for approximately 10-14 days.
* To prepare patient's bone marrow to accept donor stem cells, they will receive fludarabine and busulfex. Fludarabine will be given intravenously once daily for 4 days. Busulfex will be given once daily for the same 4 days.
* One day before patients receive busulfex and fludarabine, they will also be given alemtuzumab intravenously once daily for 5 days.
* Three days after the end of chemotherapy, patients will receive the infusion of donor stem cells.
* If patients have thalassemia, they will receive subcutaneous injections of filgrastim starting on day one after the donor stem cell transfusion and will continue receiving filgrastim every day until it appears that the donor stem cells have been accepted. If the patient has sickle cell disease, filgrastim will not be given,
* Additional drugs will be given to help prevent infection (i.e. antibiotics).
* After stem cell infusion patients will be examined and have blood tests weekly for 1 month. Bone marrow biopsies, and blood work will also be performed 1 month, 3 months, 6 months and 1 year after stem cell infusion.
* Patients will be on the study for about 12 months. After study is completed progress will be monitored on an annual basis. | Hemoglobinopathies Sickle Cell Disease Thalassemia | Hemoglobinopathies Sickle cell anemia sickle cell-hemoglobin C disease sickle cell-B-thalassemia transfusion-dependant thalassemia allogeneic transplant nonmyeloablative transplant Stem cell transfusion graft vs. host disease | null | 0 | null | null | 4 | [
0,
0,
0,
3
] | intervention 1: Given once daily for 4 days intervention 2: Given intravenously once daily for 4 days intervention 3: One day before fludarabine and busulfex are started, alemtuzumab will be given once daily for 5 days. intervention 4: Performed three days after the end of chemotherapy | intervention 1: Busulfex intervention 2: Fludarabine intervention 3: Alemtuzumab intervention 4: Stem Cell Transfusion | 6 | Atlanta | Georgia | United States | -84.38798 | 33.749
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Columbus | Ohio | United States | -82.99879 | 39.96118 | 2 | 0 | 0 | 0 | NCT00153985 | 1COMPLETED | 2009-07-01 | 2004-03-01 | Dana-Farber 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
] | 51 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone | This is a two-phase study consisting of 8 weeks of open label treatment with sertraline (50-200 mg/day) in patients with SAD and in those who fail to demonstrate symptom remission on sertraline alone, 8 weeks of randomized, double-blind, placebo-controlled augmentation with ziprasidone. | Social Anxiety Disorder | anxiety disorder SAD ziprasidone sertraline antidepressant antipsychotic | null | 3 | arm 1: 8 weeks of open label treatment with sertraline arm 2: 8 weeks of treatment with sertraline augmented with ziprasidone arm 3: 8 weeks of treatment with sertraline augmented by placebo | [
5,
5,
5
] | 2 | [
0,
0
] | intervention 1: Sertraline augmentation with ziprasidone intervention 2: Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase | intervention 1: Ziprasidone intervention 2: Sertraline | 2 | Durham | North Carolina | United States | -78.89862 | 35.99403
Durham | North Carolina | United States | -78.89862 | 35.99403 | 59 | 0 | 0 | 0 | NCT00215150 | 1COMPLETED | 2009-07-01 | 2004-11-01 | Duke 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 |
[
3
] | 25 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Four monthly treatments with pegylated liposomal doxorubicin, thalidomide and dexamethasone for newly diagnosed myeloma patients as induction therapy prior to high dose chemotherapy and autologous stem cell transplant. | Multiple myeloma (MM) is an incurable hematological malignancy of plasma cell origin. Plasma cell clonality and dysfunctional immunoglobulin production characterize the disease. The consequences of abnormal plasma cell growth are manifested by a myriad of symptoms and signs that often have significant impact on the patient's quality of life. These include pancytopenia secondary to predominant distribution of tumor cells within the bone marrow along with many other effects.
This study is focused on the efficacy of Doxil® (pegylated liposomal doxorubicin) with low dose Dexamethasone and Thalidomide (Ddt) in previously untreated patients with multiple myeloma. | Multiple Myeloma | null | 1 | arm 1: Doxil, Thalidomide, Dexamethasone | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Doxil 40 mg/m2 IV day 1 intervention 2: 50-100 mg day 1-28 intervention 3: Dexamethasone 40 mg day 1-4 and 15-18 | intervention 1: Doxil intervention 2: Thalidomide intervention 3: Dexamethasone | 0 | null | 25 | 0 | 0 | 0 | NCT00222105 | 1COMPLETED | 2009-07-01 | 2002-11-01 | University of Kansas 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
] | 113 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to determine whether the combination of clopidogrel with aspirin prevents the development of blockages (atherosclerosis) in vein grafts one year after coronary artery bypass surgery (CABG) compared to aspirin alone. | Saphenous vein graft disease remains a major limitation of coronary artery bypass graft surgery (CABG). The process of saphenous vein intimal hyperplasia is mediated by platelet aggregation and begins just days after surgical revascularization. Subsequently, areas of intimal hyperplasia in turn develop graft atherosclerotic disease and its sequelae. Clopidogrel improves outcomes in patients with atherosclerotic disease, and is effective at reducing intimal hyperplasia in animal models of thrombosis. Therefore, the goal of this study will be to evaluate the efficacy of clopidogrel and aspirin therapy versus aspirin alone in the prevention of saphenous vein graft intimal hyperplasia following one year after CABG.
Patients undergoing multi-vessel CABG and in whom at least two saphenous vein grafts will be used are eligible for the study. Patients will be randomized to receive daily clopidogrel 75 mg or placebo, in addition to daily aspirin 162 mg, for the duration of one year starting as soon as postoperative bleeding has been ruled out on the day of surgery. At the end of one year, all patients will undergo coronary angiography and intravascular ultrasound assessment of one saphenous vein graft as selected by randomization. The study will be powered to test the hypothesis that clopidogrel and aspirin will reduce vein graft intimal hyperplasia by 20% compared to aspirin alone at one year following bypass surgery. | Atherosclerosis | Saphenous vein Intimal hyperplasia Coronary artery bypass graft surgery Antiplatelet therapy Clopidogrel Saphenous vein graft disease | null | 2 | arm 1: 75mg clopidogrel. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. arm 2: Water pill. 162mg ASA is also given, but is a standard-of-care post operative to cardiac surgery. | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Daily dose of 75 mg Clopidogrel intervention 2: Daily dose of water pill (placebo) | intervention 1: Clopidogrel 75 mg daily intervention 2: water pill daily | 1 | Ottawa | Ontario | Canada | -75.69812 | 45.41117 | 113 | 0 | 0 | 0 | NCT00228423 | 1COMPLETED | 2009-07-01 | 2006-05-01 | Ottawa Heart Institute Research Corporation | 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
] | 19 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied. | null | Carcinoma Non-Small-Cell Lung Carcinoma Head and Neck Neoplasms | RECENTIN | null | 0 | null | null | 1 | [
0
] | intervention 1: oral tablet | intervention 1: AZD2171 | 2 | Houston | Texas | United States | -95.36327 | 29.76328
Barcelona | N/A | Spain | 2.15899 | 41.38879 | 19 | 0 | 0 | 0 | NCT00243347 | 1COMPLETED | 2009-07-01 | 2005-12-01 | 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 |
[
5
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 1FEMALE | false | The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped. | null | Osteoporosis | null | 1 | arm 1: Participants receive teriparatide 20 microgram once daily by subcutaneous injection for 18 months followed by 6 months off therapy | [
0
] | 1 | [
0
] | intervention 1: Subcutaneous, 20 microgram (mcg)/day, 18 months | intervention 1: teriparatide | 1 | London | N/A | United Kingdom | -0.12574 | 51.50853 | 12 | 0 | 0 | 0 | NCT00259298 | 1COMPLETED | 2009-07-01 | 2005-11-01 | 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 | |
[
3
] | 49 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 0ALL | true | Primary:
1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle chemotherapy.
2. To evaluate the pharmacokinetics (PK) of palifermin when given pre chemotherapy.
3. To evaluate the safety profile of palifermin when combined with multicycle chemotherapy.
Exploratory:
1. To evaluate the biologic effect of palifermin on oral mucosa.
2. To investigate potential biomarker development by biochemical analysis in blood cells, serum, and plasma.
3. To investigate the effects of genetic variation in mucositis genes, drug metabolism genes, and drug target genes on patient response to the treatment regimen. | Palifermin is similar to a protein keratinocyte growth factor (KGF) that is naturally made in your body in small amounts. The function of palifermin is to stimulate the growth of specific cells that form the tissue lining of your mouth and digestive tract. Damage to these cells results in the breakdown of the normal protective barrier that these cells usually provide, potentially resulting in infection.
If you are eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to receive either palifermin or placebo by vein 3 days before each cycle of chemotherapy. This will be done for 18 weeks (a total of 12 injections). A placebo is a substance that looks like the study drug, but which has no active ingredients. The infusion time will last 15-30 seconds. At the beginning of the study, for every 3 patients who are enrolled on this study, 2 of the 3 will receive palifermin. Neither you nor the study doctor will know which study drug you are assigned to receive.
Within 1 or 2 days before you receive your first dose of palifermin and between 48 to 72 hours after you receive your first dose of palifermin, additional non-invasive optical imaging procedures may be performed. The purpose of these imaging procedures is to evaluate the effects of palifermin on mucosa (mucosal thickness). The types of optical imaging that may be done include optical coherence tomography (OCT), fluorescence and reflectance spectroscopy, or confocal microscopy. The oral cavity will be inspected and photographed. A probe about the size of a pen will be placed on one or two sites of oral buccal mucosa. A beam of light will then be directed to the oral tissue and optical signals will be collected from each site. This will take about 1 minute for each site. Before using the probe for each new participant, it will be disinfected per standard practice.
You will receive adriamycin with ifosfamide or cisplatin chemotherapy. Adriamycin will be given as a continuous infusion through your central venous catheter (CVC) for 3 days. Ifosfamide will be given intravenously (intravenously (IV)--through a needle in your vein) through your CVC over 3 hours, every day for 4 days. Mesna will be given as a 24-hour IV infusion through your CVC every day for 4 days through the same catheter. Mesna is used to protect against bladder-related side effects. For patients with certain types of sarcoma, vincristine will be given through the catheter by rapid infusion on Day 1 only. In patients with bone sarcoma, cisplatin will be given on the first day as IV or intra-arterial infusion over around 4 hours instead of ifosfamide.
You will need to come in to M. D. Anderson every 3 weeks for about 4 to 5 months during the treatment period, unless your doctor decides you need to come in more frequently. At these visits, you will have your vital signs measured and routine blood tests (about 3 teaspoons each) will be performed. In addition, you may have your oral cavity examined and photographed before and after receiving the study drug. Every effort will be made to take photographs in which you cannot be identified.
Additional blood samples (about 3 teaspoons) will be taken before each cycle and as frequently as needed to measure your blood count and other tests to monitor the drug side effects and treatment effects. By the end of the study, you will have given about 10 tablespoons of blood. This amount includes the optional blood draws should you choose to allow it to be drawn.
You will be responsible for notifying study staff (at your doctors visits or over the phone with the study staff) of any side effects you experience or medications (over the counter or prescription) that you take during the treatment period. You will also be required to notify any other doctors (separate from the study doctors) you see that you are participating in this research study.
If your anemia becomes severe while you are on study, then a transfusion may be recommended. If mucositis develops, the prohibited medicines can be allowed for treatment of the condition. If you experience an intolerable side effect while on study, you may be taken off study. If you leave the study early for any reason, your doctor will continue to follow your progress for 4 weeks and will access your medical records for a minimum of 1 year after the last dose of study drug (either palifermin or placebo) was given.
At your end of study visit, you will be evaluated for your disease status with imaging studies \[computed tomography (CT) scans or magnetic resonance images (MRI)\] and your weight and vitals signs will be measured. You will report any medications you have taken since your last visit and any side effects or blood transfusion that you have had. You will also have a final blood draw (about 3 teaspoons) for routine tests.
The total length of your involvement in this study is expected to be about 18 weeks (4 to 5 months). | Sarcoma Oral Mucositis | Sarcoma Soft Tissue Sarcoma Oral Mucositis Doxorubicin Adriamycin Ifosfamide Palifermin Vincristine Cisplatin Placebo | null | 2 | arm 1: Palifermin + Chemotherapy (Adriamycin (Doxorubicin)+ Ifosfamide (AI) or Adriamycin (Doxorubicin) + Cisplatin (AP) Regimen); Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m\^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m\^2. Ifosfamide 2.5 g/m\^2 IV bolus Days 0-3 (total 10 g/m\^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m\^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m\^2); Cisplatin 120 mg/m\^2 on day 0. arm 2: Placebo + Chemotherapy (AI or AP Regimen);
AI = Doxorubicin (Adriamycin) + Ifosfamide:
A single dose placebo prior to chemotherapy; Adriamycin 30 mg/m\^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m\^2. Ifosfamide 2.5 g/m\^2 IV bolus Days 0-3 (total 10 g/m\^2); Vincristine 2 mg IV Day 0.
AP=Doxorubicin (Adriamycin) + Cisplatin:
A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m\^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m\^2); Cisplatin 120 mg/m\^2 on day 0. | [
0,
2
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: 180 mcg/kg 3 days prior to chemotherapy intervention 2: Single dose 3 days prior to chemotherapy intervention 3: 30 mg/m\^2 IV continuous infusion for 72 hours; days 0, 1, 2 (infusion completing on day 3) (total dose = 90 mg/m\^2). intervention 4: 2.5 g/m\^2 IV bolus over 3 hours, days 0,1, 2, 3 (total dose = 10 g/m\^2); for patients receiving the AI Regimen. intervention 5: 2 mg IV on day 0, for patients with small cell histology receiving the AI Regimen. intervention 6: 120 mg/m\^2 on day 0, for patients receiving the AP Regimen. | intervention 1: Palifermin intervention 2: Placebo intervention 3: Adriamycin (Doxorubicin) intervention 4: Ifosfamide intervention 5: Vincristine intervention 6: Cisplatin | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 48 | 0 | 0 | 0 | NCT00267046 | 1COMPLETED | 2009-07-01 | 2005-12-01 | 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 |
[
3
] | 13 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Colorectal cancer (CRC) is one of the more common cancers in the United States with over 145,000 new cases expected in 2005. Surgery is the main treatment for CRC. However for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced CRC. Some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. This study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their CRC and it has returned. This study will also evaluate any rash that is associated with the drug Cetuximab. The three therapy drugs are Mitomycin C, Irinotecan, and Cetuximab. | We propose a phase II trial which combines mitomycin C, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated K-Ras. The goals of this investigation are to develop an effective systemic therapy for previously treated patients with CRC with wild type K-Ras, to further explore the relationship of mitomycin C induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash. | Colorectal Cancer | null | 1 | arm 1: Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.
Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.
Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2. | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle. intervention 2: Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle. intervention 3: Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1\*28 allele will receive irinotecan 110 mg/m2. | intervention 1: Mitomycin C intervention 2: Cetuximab intervention 3: Irinotecan. | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 13 | 0 | 0 | 0 | NCT00271011 | 6TERMINATED | 2009-07-01 | 2005-12-01 | University of Michigan Rogel 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
] | 53 | NON_RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle. | null | Cutaneous T-Cell Lymphoma Peripheral T-Cell Lymphoma Non-Hodgkin's Lymphoma | CTCL PTCL lymphoma Non-Hodgkin's Lymphoma Cutaneous T-Cell Lymphomas (CTCL) Peripheral T-Cell Lymphomas (PTCL) Other Types of Non-Hodgkin's Lymphoma belinostat | null | 2 | arm 1: PXD101 1000 mg/m2 once daily for 5 days every 21 days arm 2: PXD101 1000 mg/m2 once daily for 5 days every 21 days | [
0,
0
] | 1 | [
0
] | intervention 1: None | intervention 1: belinostat | 15 | Stanford | California | United States | -122.16608 | 37.42411
New Haven | Connecticut | United States | -72.92816 | 41.30815
Lenexa | Kansas | United States | -94.73357 | 38.95362
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
New York | New York | United States | -74.00597 | 40.71427
Cleveland | Ohio | United States | -81.69541 | 41.4995
Houston | Texas | United States | -95.36327 | 29.76328
Pessac | N/A | France | -0.6324 | 44.80565
Toulouse | N/A | France | 1.44367 | 43.60426
Essen | N/A | Germany | 7.01228 | 51.45657
Jerusalem | N/A | Israel | 35.21633 | 31.76904
Petah Tikva | N/A | Israel | 34.88747 | 32.08707
Hat Yai | N/A | Thailand | 100.47668 | 7.00836
Patumwan | N/A | Thailand | N/A | N/A | 53 | 0 | 0 | 0 | NCT00274651 | 6TERMINATED | 2009-07-01 | 2006-01-01 | Valerio 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
] | 4 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with metastatic kidney cancer. | OBJECTIVES:
Primary
* Determine, preliminarily, the efficacy of bortezomib in patients with metastatic non-clear cell renal cell carcinoma in terms of objective response rate after a minimum of 2 courses of treatment.
Secondary
* Correlate clinical response in these patients with baseline von Hippel-Lindau expression and nuclear factor-KB activity.
OUTLINE: This is an open-label study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month and then periodically for 2 years.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study. | Kidney Cancer | stage IV renal cell cancer recurrent renal cell cancer papillary renal cell carcinoma | null | 1 | arm 1: Velcade IV twice a week for two weeks on Days 1, 4, 8 and 11 of each cycle. A 10 day-rest period (Days 12-21) with no Velcade will follow the 2 weeks of treatment in each cycle. one cycle = 21 days | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: bortezomib | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 4 | 0 | 0 | 0 | NCT00276614 | 1COMPLETED | 2009-07-01 | 2006-04-01 | 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
] | 31 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to extend the use of Tacrolimus and Sirolimus to determine how effective it is in preventing graft versus host disease (GVHD)in patients that have received non-myeloablative peripheral blood stem cell transplantation. | * After the screening procedures confirm that the patient is eligible to participate in the research study, they will be admitted to the hospital to receive chemotherapy and stem cell transplantation (SCT). The duration of the hospitalization for the procedure is approximately 8 days.
* Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days and busulfex once daily over 3 hours intravenously each day for the same 4 days.
* Just prior to the transplant and following the transplant the patient will receive sirolimus and tacrolimus to help prevent Graft versus Host Disease (GvHD). Both medications are taken orally.
* Patients will also take medications to help prevent possible infections (e.g. acyclovir). Filgrastim, a white blood cell growth factor, will be given daily in an injection under the skin, starting the day after the stem cell transplant and until the patients blood counts have recovered.
* After the stem cell infusion, the patient will be examined and have blood tests weekly for 1 month. At about the 1-month visit, a bone marrow biopsy and/or blood tests will be performed to determine the percentage of donor's cells in the blood or bone marrow. These tests will be repeated at 3-4 months after transplant.
* At 3-4 months after the transplant, patients will also have tests to reassess the response of your disease to transplant. This may involve a bone marrow biopsy, blood tests, and/or radiology studies depending upon the type of cancer.
* Follow-up will continue for the remainder of the patients life. | Graft Versus Host Disease GVHD | non-myeloablative peripheral blood stem cell PBSCT tacrolimus sirolimus | null | 0 | null | null | 4 | [
0,
0,
0,
0
] | intervention 1: Given orally just prior to and following stem cell transplant intervention 2: Given orally just prior to and following stem cell transplant intervention 3: Given once daily over 30 minutes for 4 days intervention 4: Given intravenously over 3 hours for 4 days | intervention 1: tacrolimus intervention 2: sirolimus intervention 3: fludarabine intervention 4: busulfex | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 29 | 0 | 0 | 0 | NCT00282282 | 1COMPLETED | 2009-07-01 | 2006-01-01 | Dana-Farber 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
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes. | Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes. | Nicotine Dependence | nicotine dependence, transdermal nicotine patch, smoking while receiving nicotine replacement, comorbidities | null | 1 | arm 1: Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: Nicoderm | 1 | Toronto | Ontario | Canada | -79.39864 | 43.70643 | 23 | 0 | 0 | 0 | NCT00289653 | 1COMPLETED | 2009-07-01 | 2005-09-01 | Centre for Addiction and Mental Health | 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
] | 126 | RANDOMIZED | PARALLEL | 1PREVENTION | 2DOUBLE | false | 1FEMALE | true | This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of genistein may prevent breast cancer in women at high risk for breast cancer. | PRIMARY OBJECTIVE:
I. Determine the effect of genistein on the proliferation of breast epithelial cells obtained by fine needle aspiration (FNA), as measured by Ki-67 labeling index, in women who are at high risk for breast cancer.
SECONDARY OBJECTIVE:
I. Determine the effect of this drug on cellular and molecular parameters using epithelial cells obtained by FNA, nipple aspirate fluid, and blood from these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to menopausal status (premenopausal vs postmenopausal) and history of breast cancer (no history of breast cancer vs history of estrogen receptor \[ER\] positive breast cancer vs history of ER negative breast cancer). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily.
ARM II: Patients receive oral placebo once daily.
In both arms, treatment continues for up to 6 months in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed at 30-37 days. | Breast Cancer | null | 2 | arm 1: Patients receive oral genistein once daily for up to 6 months. arm 2: Patients receive oral placebo once daily for up to 6 months. | [
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies | intervention 1: placebo intervention 2: genistein intervention 3: laboratory biomarker analysis | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 126 | 0 | 0 | 0 | NCT00290758 | 1COMPLETED | 2009-07-01 | 2006-01-01 | National Cancer Institute (NCI) | 0NIH | 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
] | 8 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | Glycine is a natural amino acid neurotransmitter that acts as a co-agonist at NMDA receptors in brain. We hypothesize that symptoms of the schizophrenia prodrome will improve with glycine to a greater degree than with placebo. | A pilot clinical trial comparing glycine to placebo in patients with the schizophrenia prodrome. | Schizophrenia Prodrome | schizophrenia prodrome | null | 2 | arm 1: Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing \> 100 kg were limited to a total daily dose of 80 g daily. Glycine was dispensed under IND 33,515 (DCJ). arm 2: Placebo was dispensed as a proprietary formulations developed by Glytech, Inc, consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech placebo formulation, consisting of proprietary pre-flavored sugar powders to be dissolved in 8 ounces of water. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Glycine 0.4 g/kg bid intervention 2: Placebo | intervention 1: Glycine intervention 2: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 8 | 0 | 0 | 0 | NCT00291226 | 1COMPLETED | 2009-07-01 | 2006-03-01 | 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
] | 41 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart. | null | Chronic Heart Failure Atrial Fibrillation | Chronic Heart Failure Atrial Fibrillation Radiofrequency Ablation | null | 2 | arm 1: Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin arm 2: Isolation of the pulmonary veins using radiofrequency ablation | [
1,
1
] | 4 | [
3,
0,
0,
0
] | intervention 1: isolation of the pulmonary veins with radiofrequency ablation (RFA) intervention 2: Evidence based treatment for heart failure. Dose and type will depend on patient tolerability. intervention 3: Evidence based treatment for heart failure. Dose and type will depend on patient tolerance. intervention 4: Evidence based treatment for heart failure. Dose and type will depend on patient to treatment. | intervention 1: radiofrequency ablation intervention 2: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril intervention 3: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol intervention 4: Aldosterone Antagonists - spironolactone | 1 | Glasgow | Scotland | United Kingdom | -4.25763 | 55.86515 | 41 | 0 | 0 | 0 | NCT00292162 | 1COMPLETED | 2009-07-01 | 2007-01-01 | NHS Greater Glasgow and Clyde | 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
] | 137 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 2DOUBLE | false | 0ALL | true | RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome.
PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer. | OBJECTIVES:
* Determine whether the prophylactic use of a topical urea/lactic acid cream can decrease the incidence/severity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast and/or other cancer.
* Evaluate the potential toxicity of this cream.
* Determine whether the prophylactic use of vitamin B6 can decrease the incidence and/or severity of capecitabine-caused palmar-plantar erythrodysesthesia.
* Evaluate the potential toxicity of vitamin B6.
* Determine whether the prophylactic use of a topical urea/lactic acid cream in combination with vitamin B6 can decrease the incidence and/or severity of capecitabine caused palmar-plantar erythrodysesthesia.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (\< 50 years old vs 50-60 years old vs \> 60 years old), sex, capecitabine dose level (2000 mg/day vs 2500 mg/day), cancer type (breast vs other), and mode of therapy (adjuvant \[including neo-adjuvant\] therapy vs metastatic disease). Patients are randomized to 1 of 6 treatment arms (treatment arms I-IV closed to accrual as of 10/24/007).
* Arm I (closed to accrual as of 10/24/2007): Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.
* Arm II (closed to accrual as of 10/24/2007): Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
* Arm III (closed to accrual as of 10/24/2007): Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).
* Arm IV (closed to accrual as of 10/24/2007):Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).
* Arm V: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.
* Arm VI: Patients receive placebo cream applied to palms and soles twice daily on days 1-21.
In all arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. | Breast Cancer Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific | drug/agent toxicity by tissue/organ stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer unspecified adult solid tumor, protocol specific | null | 6 | arm 1: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21. arm 2: Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21. arm 3: Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007). arm 4: Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007). arm 5: Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. arm 6: Patients receive placebo cream applied to palms and soles twice daily on days 1-21. | [
0,
0,
0,
2,
0,
2
] | 3 | [
7,
0,
10
] | intervention 1: Given orally intervention 2: Applied topically intervention 3: Given orally or applied topically | intervention 1: pyridoxine hydrochloride intervention 2: urea/lactic acid-based topical cream intervention 3: placebo | 231 | Scottsdale | Arizona | United States | -111.89903 | 33.50921
Aurora | Colorado | United States | -104.83192 | 39.72943
Boulder | Colorado | United States | -105.27055 | 40.01499
Colorado Springs | Colorado | United States | -104.82136 | 38.83388
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Colorado | United States | -104.9847 | 39.73915
Denver | Colorado | United States | -104.9847 | 39.73915
Englewood | Colorado | United States | -104.98776 | 39.64777
Grand Junction | Colorado | United States | -108.55065 | 39.06387
Greeley | Colorado | United States | -104.70913 | 40.42331
Lone Tree | Colorado | United States | -104.8863 | 39.55171
Longmont | Colorado | United States | -105.10193 | 40.16721
Loveland | Colorado | United States | -105.07498 | 40.39776
Pueblo | Colorado | United States | -104.60914 | 38.25445
Thornton | Colorado | United States | -104.97192 | 39.86804
Wheat Ridge | Colorado | United States | -105.07721 | 39.7661
Hollywood | Florida | United States | -80.14949 | 26.0112
Jacksonville | Florida | United States | -81.65565 | 30.33218
Aurora | Illinois | United States | -88.32007 | 41.76058
Bloomington | Illinois | United States | -88.99369 | 40.4842
Canton | Illinois | United States | -90.03512 | 40.55809
Carthage | Illinois | United States | -91.13625 | 40.41643
Eureka | Illinois | United States | -89.27286 | 40.72143
Galesburg | Illinois | United States | -90.37124 | 40.94782
Galesburg | Illinois | United States | -90.37124 | 40.94782
Havana | Illinois | United States | -90.06095 | 40.30004
Hopedale | Illinois | United States | -89.41454 | 40.42087
Joliet | Illinois | United States | -88.0834 | 41.52519
Macomb | Illinois | United States | -90.6718 | 40.45921
Moline | Illinois | United States | -90.51513 | 41.5067
Moline | Illinois | United States | -90.51513 | 41.5067
Normal | Illinois | United States | -88.99063 | 40.5142
Normal | Illinois | United States | -88.99063 | 40.5142
Ottawa | Illinois | United States | -88.84258 | 41.34559
Ottawa | Illinois | United States | -88.84258 | 41.34559
Pekin | Illinois | United States | -89.64066 | 40.56754
Peoria | Illinois | United States | -89.58899 | 40.69365
Peoria | Illinois | United States | -89.58899 | 40.69365
Peoria | Illinois | United States | -89.58899 | 40.69365
Peoria | Illinois | United States | -89.58899 | 40.69365
Peoria | Illinois | United States | -89.58899 | 40.69365
Peru | Illinois | United States | -89.12897 | 41.32753
Princeton | Illinois | United States | -89.46481 | 41.36809
Spring Valley | Illinois | United States | -89.19981 | 41.32754
Urbana | Illinois | United States | -88.20727 | 40.11059
Urbana | Illinois | United States | -88.20727 | 40.11059
Beech Grove | Indiana | United States | -86.08998 | 39.72199
Elkhart | Indiana | United States | -85.97667 | 41.68199
Kokomo | Indiana | United States | -86.1336 | 40.48643
Michigan City | Indiana | United States | -86.89503 | 41.70754
Richmond | Indiana | United States | -84.89024 | 39.82894
South Bend | Indiana | United States | -86.25001 | 41.68338
South Bend | Indiana | United States | -86.25001 | 41.68338
South Bend | Indiana | United States | -86.25001 | 41.68338
South Bend | Indiana | United States | -86.25001 | 41.68338
Ames | Iowa | United States | -93.61994 | 42.03471
Bettendorf | Iowa | United States | -90.51569 | 41.52448
Cedar Rapids | Iowa | United States | -91.64407 | 42.00833
Cedar Rapids | Iowa | United States | -91.64407 | 42.00833
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Des Moines | Iowa | United States | -93.60911 | 41.60054
Ottumwa | Iowa | United States | -92.4113 | 41.02001
Sioux City | Iowa | United States | -96.40031 | 42.49999
Sioux City | Iowa | United States | -96.40031 | 42.49999
Sioux City | Iowa | United States | -96.40031 | 42.49999
Chanute | Kansas | United States | -95.4572 | 37.67921
Dodge City | Kansas | United States | -100.01708 | 37.7528
El Dorado | Kansas | United States | -96.86225 | 37.81724
Independence | Kansas | United States | -95.70831 | 37.22424
Kingman | Kansas | United States | -98.11367 | 37.64585
Liberal | Kansas | United States | -100.921 | 37.04308
Newton | Kansas | United States | -97.34504 | 38.04668
Parsons | Kansas | United States | -95.26108 | 37.34034
Pratt | Kansas | United States | -98.73759 | 37.64391
Salina | Kansas | United States | -97.61142 | 38.84028
Wellington | Kansas | United States | -97.37171 | 37.2653
Wichita | Kansas | United States | -97.33754 | 37.69224
Wichita | Kansas | United States | -97.33754 | 37.69224
Wichita | Kansas | United States | -97.33754 | 37.69224
Wichita | Kansas | United States | -97.33754 | 37.69224
Wichita | Kansas | United States | -97.33754 | 37.69224
Winfield | Kansas | United States | -96.99559 | 37.23975
Adrian | Michigan | United States | -84.03717 | 41.89755
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
Dearborn | Michigan | United States | -83.17631 | 42.32226
Escanaba | Michigan | United States | -87.06458 | 45.74525
Flint | Michigan | United States | -83.68746 | 43.01253
Flint | Michigan | United States | -83.68746 | 43.01253
Grosse Pointe Woods | Michigan | United States | -82.90686 | 42.44365
Iron Mountain | Michigan | United States | -88.06596 | 45.82023
Jackson | Michigan | United States | -84.40135 | 42.24587
Lambertville | Michigan | United States | -83.62799 | 41.76588
Lansing | Michigan | United States | -84.55553 | 42.73253
Livonia | Michigan | United States | -83.35271 | 42.36837
Monroe | Michigan | United States | -83.39771 | 41.91643
Monroe | Michigan | United States | -83.39771 | 41.91643
Pontiac | Michigan | United States | -83.29105 | 42.63892
Port Huron | Michigan | United States | -82.42491 | 42.97086
Saginaw | Michigan | United States | -83.95081 | 43.41947
Saint Joseph | Michigan | United States | -86.48002 | 42.10976
Warren | Michigan | United States | -83.01304 | 42.49044
Albert Lea | Minnesota | United States | -93.36827 | 43.64801
Alexandria | Minnesota | United States | -95.37754 | 45.88524
Bemidji | Minnesota | United States | -94.88028 | 47.47356
Burnsville | Minnesota | United States | -93.27772 | 44.76774
Coon Rapids | Minnesota | United States | -93.28773 | 45.11997
Duluth | Minnesota | United States | -92.10658 | 46.78327
Duluth | Minnesota | United States | -92.10658 | 46.78327
Duluth | Minnesota | United States | -92.10658 | 46.78327
Edina | Minnesota | United States | -93.34995 | 44.88969
Fergus Falls | Minnesota | United States | -96.07756 | 46.28302
Fridley | Minnesota | United States | -93.26328 | 45.08608
Hutchinson | Minnesota | United States | -94.36971 | 44.88774
Lichfield | Minnesota | United States | N/A | N/A
Mankato | Minnesota | United States | -94.00915 | 44.15906
Maplewood | Minnesota | United States | -92.99522 | 44.95302
Maplewood | Minnesota | United States | -92.99522 | 44.95302
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
Robbinsdale | Minnesota | United States | -93.33856 | 45.03219
Rochester | Minnesota | United States | -92.4699 | 44.02163
Saint Cloud | Minnesota | United States | -94.16249 | 45.5608
Saint Cloud | Minnesota | United States | -94.16249 | 45.5608
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483
Saint Louis Park | Minnesota | United States | -93.34801 | 44.9483
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
Shakopee | Minnesota | United States | -93.5269 | 44.79802
Waconia | Minnesota | United States | -93.78691 | 44.8508
Woodbury | Minnesota | United States | -92.95938 | 44.92386
Woodbury | Minnesota | United States | -92.95938 | 44.92386
St Louis | Missouri | United States | -90.19789 | 38.62727
St Louis | Missouri | United States | -90.19789 | 38.62727
Billings | Montana | United States | -108.50069 | 45.78329
Billings | Montana | United States | -108.50069 | 45.78329
Billings | Montana | United States | -108.50069 | 45.78329
Billings | Montana | United States | -108.50069 | 45.78329
Bozeman | Montana | United States | -111.03856 | 45.67965
Butte | Montana | United States | -112.53474 | 46.00382
Great Falls | Montana | United States | -111.30081 | 47.50024
Great Falls | Montana | United States | -111.30081 | 47.50024
Great Falls | Montana | United States | -111.30081 | 47.50024
Great Falls | Montana | United States | -111.30081 | 47.50024
Havre | Montana | United States | -109.68409 | 48.55
Kalispell | Montana | United States | -114.31291 | 48.19579
Kalispell | Montana | United States | -114.31291 | 48.19579
Kalispell | Montana | United States | -114.31291 | 48.19579
Missoula | Montana | United States | -113.994 | 46.87215
Missoula | Montana | United States | -113.994 | 46.87215
Missoula | Montana | United States | -113.994 | 46.87215
Lincoln | Nebraska | United States | -96.66696 | 40.8
Omaha | Nebraska | United States | -95.94043 | 41.25626
Omaha | Nebraska | United States | -95.94043 | 41.25626
Rutherfordton | North Carolina | United States | -81.95677 | 35.36929
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Bismarck | North Dakota | United States | -100.78374 | 46.80833
Fargo | North Dakota | United States | -96.7898 | 46.87719
Fargo | North Dakota | United States | -96.7898 | 46.87719
Grand Forks | North Dakota | United States | -97.03285 | 47.92526
Bellefontaine | Ohio | United States | -83.75966 | 40.36116
Bowling Green | Ohio | United States | -83.65132 | 41.37477
Chillicothe | Ohio | United States | -82.9824 | 39.33312
Columbus | Ohio | United States | -82.99879 | 39.96118
Columbus | Ohio | United States | -82.99879 | 39.96118
Columbus | Ohio | United States | -82.99879 | 39.96118
Columbus | Ohio | United States | -82.99879 | 39.96118
Columbus | Ohio | United States | -82.99879 | 39.96118
Dayton | Ohio | United States | -84.19161 | 39.75895
Dayton | Ohio | United States | -84.19161 | 39.75895
Dayton | Ohio | United States | -84.19161 | 39.75895
Dayton | Ohio | United States | -84.19161 | 39.75895
Dayton | Ohio | United States | -84.19161 | 39.75895
Delaware | Ohio | United States | -83.06797 | 40.29867
Elyria | Ohio | United States | -82.10765 | 41.36838
Findlay | Ohio | United States | -83.64993 | 41.04422
Franklin | Ohio | United States | -84.30411 | 39.55895
Kettering | Ohio | United States | -84.16883 | 39.6895
Lancaster | Ohio | United States | -82.59933 | 39.71368
Lima | Ohio | United States | -84.10523 | 40.74255
Marietta | Ohio | United States | -81.45484 | 39.41535
Maumee | Ohio | United States | -83.65382 | 41.56283
Maumee | Ohio | United States | -83.65382 | 41.56283
Newark | Ohio | United States | -82.40126 | 40.05812
Oregon | Ohio | United States | -83.48688 | 41.64366
Oregon | Ohio | United States | -83.48688 | 41.64366
Sandusky | Ohio | United States | -82.70796 | 41.44894
Springfield | Ohio | United States | -83.80882 | 39.92423
Springfield | Ohio | United States | -83.80882 | 39.92423
Sylvania | Ohio | United States | -83.71299 | 41.71894
Tiffin | Ohio | United States | -83.17797 | 41.1145
Toledo | Ohio | United States | -83.55521 | 41.66394
Toledo | Ohio | United States | -83.55521 | 41.66394
Toledo | Ohio | United States | -83.55521 | 41.66394
Toledo | Ohio | United States | -83.55521 | 41.66394
Toledo | Ohio | United States | -83.55521 | 41.66394
Toledo | Ohio | United States | -83.55521 | 41.66394
Troy | Ohio | United States | -84.20328 | 40.0395
Wauseon | Ohio | United States | -84.14161 | 41.54922
Westerville | Ohio | United States | -82.92907 | 40.12617
Wilmington | Ohio | United States | -83.82854 | 39.44534
Xenia | Ohio | United States | -83.92965 | 39.68478
Zanesville | Ohio | United States | -82.01319 | 39.94035
Tulsa | Oklahoma | United States | -95.99277 | 36.15398
Allentown | Pennsylvania | United States | -75.49018 | 40.60843
Anderson | South Carolina | United States | -82.65013 | 34.50344
Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Spartanburg | South Carolina | United States | -81.93205 | 34.94957
Rapid City | South Dakota | United States | -103.23101 | 44.08054
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Sioux Falls | South Dakota | United States | -96.70033 | 43.54997
Fredericksburg | Virginia | United States | -77.46054 | 38.30318
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
Green Bay | Wisconsin | United States | -88.01983 | 44.51916
Marinette | Wisconsin | United States | -87.63066 | 45.09998
Oconto Falls | Wisconsin | United States | -88.14288 | 44.87388
Sturgeon Bay | Wisconsin | United States | -87.37704 | 44.83416 | 130 | 0 | 0 | 0 | NCT00296036 | 1COMPLETED | 2009-07-01 | 2006-06-01 | Alliance for Clinical Trials in Oncology | 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
] | 816 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | true | This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs, and on putative marker mutations of the development of resistance to ACT. The study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be determined using a WHO standardized 28-day protocol. Safety will be monitored through clinical examination and biochemical and hematological indices. Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy. | * Outpatients will be screened for malaria by blood film examination
* Malaria-positive children will be examined by the physician for inclusion or exclusion(see below)
* Informed consent will be sought from the guardians of potential patients
* Patients or guardians will be interviewed and a case record form completed
* Patients will be randomized into one of the two arms in the ratio 4:1 AQ/Art: CoArtem and issued a study card
* Filter paper and 5ml venous blood samples will be collected
* Patients will be hospitalised for three days to allow completion of therapy under observation
* The patient will be asked to return on days 7, 14 and 28 for assessment of clearance or recrudescence of parasites
* Patient will be examined for parasites and evaluated for early treatment failure (ETF), late treatment failure (LTF), late parasitological failure (LPF) or adequate clinical and parasitological response.(ACPR).
* If a patient does not appear for follow up, a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature ≥ 37.5°C
* Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
* Filter paper samples will be air dried and stored with dessicant until required.
* Whole blood samples collected into citrate as anticoagulant will be processed for plasma, aliquoted into 300µl lots and stored at -70°C.
* Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week, along with the hard copies of the case report forms.
* Analysis will be performed on the samples within three months of collection for molecular markers of resistance, genetic structure of parasites and for blood drug levels of medications used in the trial | Malaria | Efficacy Safety Children Cameroon | null | 2 | arm 1: Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days. arm 2: Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart). intervention 2: Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg | intervention 1: 1. Artemether-Lumefantrine (AL) intervention 2: 2. Amodiaquine-Artesunate (AQ-AS) | 0 | null | 816 | 0 | 0 | 0 | NCT00297882 | 1COMPLETED | 2009-07-01 | 2006-07-01 | London School of Hygiene and Tropical Medicine | 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
] | 23 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.
The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy. | null | Neoplasms Cancer | null | 1 | arm 1: None | [
0
] | 1 | [
0
] | intervention 1: 500 milligrams (mg), oral, daily, six 42-day cycle and subsequent cycles or until participants met study discontinuation criteria of progressive disease or unacceptable toxicity | intervention 1: enzastaurin | 1 | Sun City | Arizona | United States | -112.27182 | 33.59754 | 23 | 0 | 0 | 0 | NCT00309140 | 1COMPLETED | 2009-07-01 | 2006-03-01 | 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
] | 47 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | This is an open-label, single-arm, multicenter pilot study to evaluate the safety and efficacy of carboplatin/paclitaxel+bevacizumab in subjects with locally advanced (Stage IIIb with pleural effusion/pericardial effusion), Stage IV, or recurrent squamous Non-Small Cell Lung Cancer (NSCLC) who have not received prior systemic therapy for metastatic disease. | null | Non-small Cell Lung Cancer | BRIDGE NSCLC Lung Cancer Avastin | null | 1 | arm 1: None | [
0
] | 3 | [
0,
0,
0
] | intervention 1: 15 mg/kg administered intravenously on Day 1 of each 21- to 28-day cycle, beginning on Cycle 3 intervention 2: Dose based on Calvert formula, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles intervention 3: Dose based on patient's body surface area, on Day 1 of each 21- to 28-day cycle for a total of 6 cycles | intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel | 0 | null | 31 | 0 | 0 | 0 | NCT00318136 | 1COMPLETED | 2009-07-01 | 2005-09-01 | Genentech, 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
] | 134 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | null | In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation outcomes AND retention of adolescent smokers in the study.
Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.
Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency management (CM) treatment will have increased retention and increased abstinence rates when compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased drop-out of participants, urine cotinine and continuous abstinence).
Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only. | To test the hypotheses, 216 adolescent smokers will be recruited. Fifty-four adolescent smokers will be recruited in each of the four groups: bupropion SR only, bupropion SR + CM, CM + placebo, and placebo only. The cells will be balanced for gender and attention deficit hyperactivity disorder using permuted block randomization. A counseling intervention was added for all groups because it was reasoned that it would be unethical not to provide an active treatment to cigarette smoking adolescents. The counseling intervention will consist of two quit smoking brochures that provide information on tips to help quit smoking.
The study will consist of a one-week lead in period followed by a six-week treatment trial. For the medication groups, medications will be titrated during the one-week lead-in period. The primary outcome measure is urine cotinine and self-report of cigarette use collected using the Time-Line Follow-Back at the end of six weeks. | Nicotine Dependence Nicotine Use Disorder | nicotine dependence bupropion SR smoking cessation adolescents contingency management | null | 4 | arm 1: Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits. arm 2: Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management, with escalating rewards for abstinence (and re-sets for non-abstinence) at twice-weekly visits. arm 3: Bupropion SR capsules, with goal dose of 300 mg/day, for 6 weeks of treatment. Contingency Management is not provided in this arm. arm 4: Placebo capsules, matched in appearance to Bupropion SR capsules, for 6 weeks of treatment. Contingency Management is not provided in this arm. | [
0,
1,
1,
2
] | 3 | [
0,
5,
10
] | intervention 1: Bupropion SR, with goal dose 300 mg/day, for 6 weeks of active treatment intervention 2: Contingency Management provided at twice-weekly visits during the 6-week active treatment. Escalating schedule, with resets, reinforcing smoking abstinence. intervention 3: Placebo, matched in appearance to Bupropion SR, for 6 weeks of treatment | intervention 1: Bupropion SR intervention 2: Contingency Management intervention 3: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 134 | 0 | 0 | 0 | NCT00330187 | 1COMPLETED | 2009-07-01 | 2004-03-01 | Medical University of South Carolina | 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 |
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