phases list | enrollmentCount int64 | allocation string | interventionModel string | primaryPurpose class label | masking class label | healthyVolunteers bool | sex class label | oversightHasDmc bool | briefSummary string | detailedDescription string | conditions string | conditionsKeywords string | protocolPdfText string | numArms int64 | armDescriptions string | armGroupTypes list | numInterventions int64 | interventionTypes list | interventionDescriptions string | interventionNames string | numLocations int64 | locationDetails string | target int64 | nctid string |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
[
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.... | 0 | NCT00778921 |
[
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/refr... | 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/... | 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 | 0 | NCT00780143 |
[
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
* ... | 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 a... | 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
... | 0 | NCT00786188 |
[
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 baselin... | 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 | ... | 0 | NCT00793182 |
[
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... | 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-bl... | [
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 | 0 | NCT00793585 |
[
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 co... | 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.... | 0 | NCT00796315 |
[
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.
Stu... | 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 | 0 | NCT00797277 |
[
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 dru... | 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 Da... | [
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 | 0 | NCT00799409 |
[
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 regar... | 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. Ose... | 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 | 0 | NCT00803595 |
[
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 the... | 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... | [
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 | Unit... | 0 | NCT00812955 |
[
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 ... | 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 | 0 | NCT00818337 | |
[
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 wi... | 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 | 0 | NCT00822692 |
[
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 ... | 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... | 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 | 0 | NCT00825994 |
[
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 f... | 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 | 0 | NCT00832572 |
[
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 investi... | 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: Bortezo... | 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... | 0 | NCT00833560 |
[
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 | 0 | NCT00833638 |
[
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 ... | 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
Tag... | 0 | NCT00842361 | |
[
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 i... | intervention 1: MK5757 intervention 2: Comparator: Placebo | 0 | null | 0 | NCT00848484 | |
[
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 | 0 | NCT00852137 |
[
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 | 0 | NCT00855738 |
[
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 mec... | 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-producin... | 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 inv... | [
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 | 0 | NCT00867035 | |
[
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 | 0 | NCT00869167 | |
[
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... | 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 | 0 | NCT00869791 |
[
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 ... | 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 = Placeb... | [
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 | 0 | NCT00874237 |
[
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 add... | 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 | 0 | NCT00887484 |
[
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 | 0 | NCT00903448 |
[
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... | 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. Subje... | 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% ropivicain... | [
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:... | intervention 1: 0.1% Ropivacaine intervention 2: 0.4% Ropivacaine | 1 | San Diego | California | United States | -117.16472 | 32.71571 | 0 | NCT00912873 |
[
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-... | 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... | 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 side... | [
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
Brooksv... | 0 | NCT00916383 |
[
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 ... | 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 | 0 | NCT00932373 |
[
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 i... | intervention 1: carboxymethylcellulose 0.5% +glycerin 0.9% intervention 2: sodium hyaluronate 0.18% | 1 | Ulm | N/A | Germany | 9.99155 | 48.39841 | 0 | NCT00938704 | |
[
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) block... | 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 c... | 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 admin... | intervention 1: paclitaxel intervention 2: CBT-1(Registered Trademark) intervention 3: Tc 99m sestamibi | 1 | Bethesda | Maryland | United States | -77.10026 | 38.98067 | 0 | NCT00972205 |
[
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 duri... | 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 | 0 | NCT01084603 |
[
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 PC... | 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 | 0 | NCT01103440 |
[
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) 22.5m... | 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 | 0 | NCT01136226 |
[
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 explorato... | 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 medic... | 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 | 0 | NCT01202955 |
[
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 ... | [
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 ... | 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 | 0 | NCT01203098 |
[
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, d... | 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 | 0 | NCT01238822 | |
[
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 t... | 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) ... | 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 | 0 | NCT01293084 |
[
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 | 0 | NCT01431508 |
[
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 extracellul... | 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 ... | intervention 1: Exenatide intervention 2: Pioglitazone | 1 | Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT01432405 |
[
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 experim... | [
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% carb... | 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 | 0 | NCT01563172 | |
[
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 pal... | 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 duratio... | 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 | 0 | NCT01577186 |
[
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 d... | 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.... | intervention 1: Miconazole plus Hydrocortisone | 0 | null | 0 | NCT01769339 |
[
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... | 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) p... | 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 | 0 | NCT01774903 |
[
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... | [
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 | 0 | NCT02563834 | |
[
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
Großhans... | 0 | NCT02774278 | |
[
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... | 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% decre... | 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: Particip... | [
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-fluorouraci... | intervention 1: Robatumumab intervention 2: Irinotecan intervention 3: Cetuximab intervention 4: Capecitabine intervention 5: FOLFOX intervention 6: CAPEOX/XELOX intervention 7: FOLFIRI | 0 | null | 0 | NCT00551213 |
[
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 ... | 0 | NCT00411684 | |
[
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 da... | 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 | 0 | NCT00891982 |
[
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 prost... | 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 prosta... | 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... | [
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 | 0 | NCT00060528 |
[
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 anal... | 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 | 0 | NCT00484718 | |
[
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 n... | 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 ... | 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 | 0 | NCT00795769 | |
[
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 | 1 | NCT00423150 | |
[
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 | 0 | NCT03644108 | |
[
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 | 0 | NCT00875017 | |
[
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 f... | 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... | 0 | NCT00612456 |
[
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... | intervention 1: Lanthanum carbonate Granule Formulation intervention 2: Lanthanum carbonate Chewable Tablets (Fosrenol) | 1 | Cypress | California | United States | -118.03729 | 33.81696 | 0 | NCT00880750 |
[
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 ... | 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 Ve... | 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 ... | 0 | NCT00572455 |
[
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 topicall... | [
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 ... | 0 | NCT00778700 | |
[
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... | 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 | 0 | NCT00799487 |
[
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... | [
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 reg... | intervention 1: Balugrastim intervention 2: Pegfilgrastim intervention 3: Chemotherapy Regimen | 0 | null | 0 | NCT00837265 |
[
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.
... | 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 | 1 | NCT00093015 | |
[
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 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 | ... | 1 | NCT00095147 | |
[
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 | 1 | NCT00105157 | |
[
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 ... | 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 | Kent... | 1 | NCT00247416 |
[
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... | 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 ... | 1 | NCT00270634 |
[
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 | Ca... | 1 | NCT00277212 |
[
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 | Bel... | 1 | NCT00289978 |
[
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 c... | 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... | [
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 | 1 | NCT00378599 | |
[
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 | 1 | NCT00467870 |
[
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 t... | 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... | 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. | ... | 1 | NCT01090323 |
[
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.... | 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 combi... | 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 | Uni... | 0 | NCT00003377 |
[
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 laborator... | 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... | 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-... | [
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/... | 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 | 0 | NCT00054665 |
[
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 alo... | 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 i... | 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 1... | [
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... | intervention 1: Scaling and root planing intervention 2: Metronidazole intervention 3: Amoxicillin intervention 4: Doxycycline | 1 | Cambridge | Massachusetts | United States | -71.10561 | 42.3751 | 0 | NCT00066066 | |
[
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 o... | 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. Corr... | 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 | 0 | NCT00074308 | |
[
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 per... | 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 | 32.8... | 0 | NCT00086138 |
[
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 wh... | 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 biomarke... | 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 Sta... | 0 | NCT00088972 |
[
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... | 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 | 0 | NCT00095979 | |
[
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 progres... | 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 tumo... | 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 | 0 | NCT00113360 |
[
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... | 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... | 0 | NCT00127933 | |
[
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 ... | * 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 ... | 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 |... | 0 | NCT00153985 |
[
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 | 0 | NCT00215150 |
[
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 pat... | 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 | 0 | NCT00222105 | |
[
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 atheroscle... | 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 | 0 | NCT00228423 |
[
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 | 0 | NCT00243347 |
[
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 ... | 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 | 0 | NCT00259298 | |
[
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 wh... | 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 pr... | 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 ... | [
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 ... | 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 | 0 | NCT00267046 |
[
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 chemothera... | 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, ... | 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.
P... | [
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 ... | intervention 1: Mitomycin C intervention 2: Cetuximab intervention 3: Irinotecan. | 1 | Ann Arbor | Michigan | United States | -83.74088 | 42.27756 | 0 | NCT00271011 | |
[
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 Y... | 0 | NCT00274651 |
[
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 expressi... | 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 | 0 | NCT00276614 |
[
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 fludarabin... | 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 | 0 | NCT00282282 |
[
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 | 0 | NCT00289653 |
[
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 cance... | 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 p... | 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 | 0 | NCT00290758 | |
[
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 33,51... | [
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 | 0 | NCT00291226 |
[
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. ... | 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 u... | [
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: E... | 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 | 0 | NCT00292162 |
[
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 i... | 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 t... | 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... | [
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... | 0 | NCT00296036 |
[
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 th... | * 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... | 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 receive... | [
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 | 0 | NCT00297882 |
[
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 conduc... | 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 | 0 | NCT00309140 | |
[
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 s... | 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... | intervention 1: Bevacizumab intervention 2: Carboplatin intervention 3: Paclitaxel | 0 | null | 0 | NCT00318136 |
[
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... | 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 rand... | 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 Man... | [
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 Bupropio... | intervention 1: Bupropion SR intervention 2: Contingency Management intervention 3: Placebo | 1 | Charleston | South Carolina | United States | -79.93275 | 32.77632 | 0 | NCT00330187 |
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