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
] | 191 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The current trial will examine the efficacy and safety of Exubera administered as a mealtime insulin compared to lispro, when added to an existing regimen of basal insulin glargine + or = Oral Agents (OAs). Dose titrations will be provided which should allow a large proportion of subjects to reach target glycosylated h... | null | Diabetes Mellitus | type two diabetes, insulin, HbA1c | null | 2 | arm 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. arm 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insu... | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents. intervention 2: Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, i... | intervention 1: Insulin Lispro intervention 2: Exubera | 63 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mobile | Alabama | United States | -88.04305 | 30.69436
Phoenix | Arizona | United States | -112.07404 | 33.44838
Malvern | Arkansas | United States | -92.81295 | 34.36231
Foot Hill Ranch | California | United States | N/A | N/A
Fresno | California | United St... | 0 | NCT00348374 |
[
5
] | 106 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs. | null | Diabetes Mellitus, Type 2 | null | 2 | arm 1: Bolus arm arm 2: Control arm | [
5,
5
] | 4 | [
0,
0,
0,
0
] | intervention 1: One daily injection at bedtime intervention 2: At same dosage as during the run-in period intervention 3: One bolus given before the main meal intervention 4: At same dosage as during the run-in period | intervention 1: Insulin Glargine intervention 2: Glimepiride intervention 3: Insulin Glulisine intervention 4: Metformin | 3 | Bridgewater | New Jersey | United States | -74.64815 | 40.60079
Moscow | N/A | Russia | 37.61556 | 55.75222
Guildford | N/A | United Kingdom | -0.57427 | 51.23536 | 0 | NCT00360698 | |
[
4
] | 108 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as... | null | Generalized Anxiety Disorder | null | 2 | arm 1: Pregabalin treatment for GAD during 6 week taper/discontinuation from alprazolam treatment; followed by 6 weeks pregabalin treatment 'alprazolam free'. arm 2: Placebo treatment of GAD during 6 week taper/discontinuation of alprazolam treatment followed by 6 weeks continuation of placebo treatment 'alprazolam fre... | [
1,
2
] | 2 | [
0,
0
] | intervention 1: GAD subjects on stable dose of alprazolam will be randomized to double-blind pregabalin at starting dose of 75mg twice daily. Weekly assessments of tolerability, need for rescue medication, anxiety/withdrawal symptoms will guide flexible dose titration of pregabalin at dose range between 75 and 300mg tw... | intervention 1: Pregabalin intervention 2: Placebo | 21 | San Pedro | Provincia de San José | Costa Rica | -84.05074 | 9.92829
Pilsen | N/A | Czechia | 13.37759 | 49.74747
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Prague | N/A | Czechia | 14.42076 | 50.08804
Praha-Bubenec | N/A | Czechia | N/A | N/A
Paris | Cedex 12 | France | 2... | 0 | NCT00368745 | |
[
3
] | 35 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | null | The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects. | There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and... | Marijuana Dependence | Marijuana Comparison between joints and blunts Pharmacokinetic effects | null | 2 | arm 1: marijuana blunt (0%, 1.8%, or 3.6% THC) arm 2: marijuana cigarette (0%, 1.8%, or 3.6% THC) | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg). intervention 2: Marijuana cigarettes were provided by the National Institute on Drug Abuse. | intervention 1: Marijuana blunt intervention 2: marijuana cigarette | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00374127 |
[
4
] | 43 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | null | This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration \[FDA\] for the treatment of hepatitis B virus \[HBV\]) versus adefovir dipivoxil used alon... | null | Hepatitis B | lamivudine resistance Hepatitis B virus | null | 2 | arm 1: Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks. arm 2: Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 600mg/day oral tablet for 96 weeks intervention 2: 10 mg of adefovir by mouth once daily | intervention 1: telbivudine intervention 2: adefovir dipivoxil | 6 | San Diego | California | United States | -117.16472 | 32.71571
San Mateo | California | United States | -122.32553 | 37.56299
Pok Fu Lam | N/A | Hong Kong | 114.12924 | 22.26861
Seoul | N/A | South Korea | 126.9784 | 37.566
Kaohsuing | N/A | Taiwan | N/A | N/A
Bangkok | N/A | Thailand | 100.50144 | 13.75398 | 0 | NCT00376259 |
[
5
] | 356 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 1FEMALE | null | This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive... | null | Post Menopausal Osteoporosis | null | 2 | arm 1: None arm 2: None | [
0,
1
] | 2 | [
0,
0
] | intervention 1: 35mg po weekly for 12 weeks intervention 2: 150mg po monthly for 3 months | intervention 1: Risedronate intervention 2: ibandronate [Bonviva/Boniva] | 48 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Mesa | Arizona | United States | -111.82264 | 33.42227
Scottsdale | Arizona | United States | -111.89903 | 33.50921
Jonesboro | Arkansas | United States | -90.70428 | 35.8423
Anaheim | California | United States | -117.9145 | 33.83529
San Diego | California | ... | 0 | NCT00377234 | |
[
4
] | 746 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (... | null | Asthma | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 100 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks | intervention 1: Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID intervention 2: Mometasone Furoate MDI (MF MDI) intervention 3: Formoterol Fumarate 10 mcg intervention 4: Placebo | 0 | null | 0 | NCT00383552 | |
[
4
] | 1,080 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonid... | The drug being tested is called ciclesonide. This study looked at the safety and efficacy of inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.
Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the patient and study doctor during the study:• Ciclesonid... | Asthma | Asthma Ciclesonide children | null | 4 | arm 1: Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. ... | [
1,
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: inhaled Ciclesonide intervention 2: Ciclesonide placebo-matching inhaler intervention 3: Salbutamol inhalation powder | intervention 1: Ciclesonide intervention 2: Placebo intervention 3: Salbutamol | 122 | Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Plovdiv | N/A | Bulgaria | 24.75 | 42.15
Rousse | N/A | Bulgaria | 25.9534 | 43.84872
Sofia | N/A | Bulgaria | 23.32415 | 42.69751
Vama | N/A | Bulgaria | N/A | N/A
Dresden | N/A | Germany | 13.73832 | 51.05089
Freising | N/A | Germany | 11.74876 | 48.40351
Fulda | N/A | Germany... | 0 | NCT00384189 |
[
5
] | 261 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus. | null | Diabetes Mellitus, Type 2 | type 2 diabetes, insulin, glycemic control | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents. intervention 2: Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents. | intervention 1: Insulin Glargine (Lantus®) intervention 2: Inhaled Human Insulin (Exubera®) | 62 | Bornem | N/A | Belgium | 4.24364 | 51.09716
Brussels | N/A | Belgium | 4.34878 | 50.85045
Genk | N/A | Belgium | 5.50082 | 50.965
Liège | N/A | Belgium | 5.56749 | 50.63373
Kuopio | N/A | Finland | 27.67703 | 62.89238
Lahti | N/A | Finland | 25.66151 | 60.98267
Oulu | N/A | Finland | 25.46816 | 65.01236
Besançon | N/A ... | 0 | NCT00391027 |
[
4
] | 128 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | Efficacy/ safety for the combination of anti-IgE (Omalizumab) and specific immunotherapy (Depigoid) in patients with not adequately controlled seasonal allergic asthma and comorbid seasonal allergic rhinoconjunctivitis. | This was an open-label extension period of the previously randomized, multicenter, double-blind, placebo-controlled, parallel-group trial to demonstrate the benefit of pre- and co-seasonal combination therapy with anti-IgE (omalizumab) and specific immunotherapy (Depigoid) in patients with seasonal allergic asthma and ... | Allergic Asthma | null | 2 | arm 1: Xolair® (Omalizumab, double-blind core study period only), Depigoid® (grass/rye pollen 50/50) arm 2: Depigoid® (grass/rye pollen 50/50) + Placebo | [
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL) intervention 2: anti-IgE (Omalizumab) given during the 2006 core study intervention 3: Placebo given during the 2006 core study | intervention 1: Depigoid intervention 2: Omalizumab intervention 3: Placebo | 1 | Nuremberg | N/A | Germany | 11.07752 | 49.45421 | 0 | NCT00396409 | |
[
3
] | 200 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 2MALE | false | This study examined the safety, tolerability, and efficacy of mirabegron (YM178) compared to placebo. | null | Lower Urinary Tract Symptoms Bladder Outlet Obstruction | Beta-3 Receptor Agonist YM178 Men Lower Urinary Tract Symptoms Bladder Outlet Obstruction | null | 3 | arm 1: Participants received matching mirabegron placebo tablets orally once daily for 12 weeks. arm 2: Participants received 50 mg mirabegron tablets orally once daily for 12 weeks. arm 3: Participants received 100 mg mirabegron tablets orally once daily for 12 weeks. | [
2,
0,
0
] | 2 | [
0,
0
] | intervention 1: oral intervention 2: oral | intervention 1: Mirabegron intervention 2: Placebo | 27 | Tuscon | Arizona | United States | N/A | N/A
Atherton | California | United States | -122.19774 | 37.46133
Culver City | California | United States | -118.39647 | 34.02112
Fresno | California | United States | -119.77237 | 36.74773
San Diego | California | United States | -117.16472 | 32.71571
Torrance | California | U... | 0 | NCT00410514 |
[
4
] | 2,281 | RANDOMIZED | PARALLEL | 1PREVENTION | 0NONE | true | 1FEMALE | false | The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years. | null | Contraception | null | 2 | arm 1: Nomegestrol Acetate (NOMAC) and Estradiol (E2), 2.5 mg NOMAC and 1.5 mg E2 monophasic combined oral contraceptive arm 2: Drospirenone (DRSP) and Ethinyl Estradiol (EE), 3 mg DRSP and 30 mcg EE monophasic combined oral contraceptive | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28 for 13 consecutive 28-day menstrual cycles (1 year). intervention 2: Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from ... | intervention 1: NOMAC-E2 intervention 2: DRSP-EE | 0 | null | 0 | NCT00413062 | |
[
3
] | 509 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis. | null | Arthritis, Rheumatoid | DMARD therapy | null | 7 | arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: Dummy tablets | [
0,
0,
0,
0,
0,
0,
2
] | 7 | [
0,
0,
0,
0,
0,
0,
10
] | intervention 1: 4 blinded tablets administered BID intervention 2: 4 blinded tablets administered BID intervention 3: 4 blinded tablets administered BID intervention 4: 4 blinded tablets administered BID intervention 5: 4 blinded tablets administered BID intervention 6: Oral tablets intervention 7: Placebo | intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: CP-690,550 intervention 5: CP-690,550 intervention 6: CP-690,550 intervention 7: placebo | 82 | Gilbert | Arizona | United States | -111.78903 | 33.35283
Hot Springs | Arkansas | United States | -93.05518 | 34.5037
Upland | California | United States | -117.64839 | 34.09751
Denver | Colorado | United States | -104.9847 | 39.73915
Newark | Delaware | United States | -75.74966 | 39.68372
DeBary | Florida | United S... | 0 | NCT00413660 |
[
0
] | 130 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | true | The purpose of this study is to investigate the efficacy of Flavangenol® (Toyo Shinyaku, Japan), a pine bark extract, in lowering blood pressure and improving glycemic control and plasma lipoprotein profile. | Cardiovascular disease is the number one cause of death in the Unites States. Our study tests the efficacy of pine bark extract in improving a number of cardiovascular disease risk factors. We are conducting a randomized, placebo-controlled, double-blind, parallel trial that will investigate the efficacy and safety of ... | Hypertension | null | 2 | arm 1: Placebo delivered as four tablets matching the active product once daily orally. arm 2: Flavangenol 200 mg Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day. | [
2,
1
] | 1 | [
0
] | intervention 1: Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.
Dosage delivered as four tablets, each containing 50 mg Flavangenol, all 4 tablets taken once per day orally for 12 weeks. | intervention 1: Pine Bark Extract (Flavangenol®) | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00425945 | |
[
0
] | 4 | RANDOMIZED | CROSSOVER | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to determine:
1. whether there is a difference between insulin aspart and insulin lispro in continuous insulin pump therapy
2. whether duration of the insulin infusion set placement effect blood sugar control if the infusion set is in place for longer then 72-96 hours | Insulin instability in pump infusion systems can result in unexplained hyperglycemia in patients on continuous subcutaneous insulin infusion (CSII) therapy. We have noted that some pump patients develop glycemic instability with use of insulin lispro, and that this resolves with change to insulin aspart. Several patien... | Type 1 Diabetes Mellitus | type 1 diabetes, insulin pump therapy, glycemic stability | null | 2 | arm 1: Insulin aspart will be used for diabetes management, and will be delivered continuously, subcutaneously using a pump for a four week period. Insulin aspart doses will be adjusted by the principal investigator as needed to maintain glycemic control. Insulin dose adjustments will vary from patient to patient based... | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Subjects will be randomly assigned to insulin aspart versus insulin lispro via random number generation. Half of the patients will begin with insulin aspart, and then will be crossed over to insulin lispro. The insulin sequence will be reversed for the other half of the patients. intervention 2: Subject... | intervention 1: Insulin Aspart versus Insulin Lispro intervention 2: Insulin Lispro versus Insulin Aspart | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00428207 |
[
0
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The primary objective of this pilot study is to determine whether neoadjuvant capecitabine/oxaliplatin/cetuximab and external beam radiation therapy followed by surgical resection \[and then followed by post operative adjuvant capecitabine, oxaliplatin and cetuximab\] is feasible and tolerable. | It is clear that new approaches are needed to improve the therapeutic ratio in esophageal cancer. This study proposes to evaluate the novel combination of preoperative capecitabine, oxaliplatin, and cetuximab concurrently with radiation therapy. This will be followed by esophagectomy 6-9 weeks after the completion of c... | Esophageal Adenocarcinoma | Esophageal Esophagus | null | 1 | arm 1: Patients enrolled on the trial will receive neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This will be followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab | [
0
] | 3 | [
0,
0,
0
] | intervention 1: Given 650 mg/m\^2 BID on days of ration therapy, 825 mg/m\^2 day 1-14, day 15-20 off x 4 intervention 2: Oxaliplatin 30 mg/m\^2, 130mg/m2 IV Q 21 days x 4 intervention 3: Initial Cetuximab 400 mg/m\^2 IV starting no earlier than 8 weeks and no later than 10 weeks after surgical resection | intervention 1: Capecitabine intervention 2: Oxaliplatin intervention 3: Cetuximab | 1 | Aurora | Colorado | United States | -104.83192 | 39.72943 | 0 | NCT00430027 |
[
2,
3
] | 9 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The purpose of this study is to identify the maximum tolerated dosage of sodium phenylbutyrate in children with spinal muscular atrophy types II or III; and to determine if the drug has an effect on SMN mRNA and protein levels. | Spinal muscular atrophy (SMA) is a genetic, neuromuscular disorder caused by progressive degeneration of motor neurons in the spinal cord, which results from the loss of survival motor neuron (SMN) protein. The disorder is characterized by weakness and wasting of the voluntary muscles and is a leading cause of heredita... | Spinal Muscular Atrophy Type II Spinal Muscular Atrophy Type III | spinal muscular atrophy type II/III SMA type II/III spinal muscular atrophy SMA sodium phenylbutyrate motor neuron disease neuromuscular survival motor neuron SMN dose escalation | null | 1 | arm 1: Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The dosage of the next cohort was determined by the Modified Continual Re-assessment Method (MCRM) calculation and approval of the Stud... | [
0
] | 1 | [
0
] | intervention 1: 500 mg/kg/day, depending upon tolerability subsequent dosages may increase to 675, 900, or 1200 mg/kg/day to identify maximum tolerated dose (MTD) and then an additional 6 participants will enroll at the MTD | intervention 1: sodium phenylbutyrate | 5 | Stanford | California | United States | -122.16608 | 37.42411
St Louis | Missouri | United States | -90.19789 | 38.62727
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Dallas | Texas | United States | -96.80667 | 32.78306 | 0 | NCT00439569 |
[
2
] | 25 | NON_RANDOMIZED | SEQUENTIAL | 0TREATMENT | 0NONE | false | 0ALL | true | Phase I study of lapatinib and gemcitabine for patients with metastatic pancreaticobiliary cancer. | To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer. | Metastatic Pancreatic Cancer | Pancreatic Cancer | null | 4 | arm 1: Gemcitabine 1000mg/m2 with lapatinib 1000mg/d weekly x 3 weeks arm 2: Gemcitabine 1000mg/m2 with lapatinib 1500mg/d weekly X 3 weeks arm 3: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days 1 and 14 of a 28-day cycle with lapatinib 1000 mg/d arm 4: gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2 on days ... | [
0,
0,
0,
0
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: 1000mg/m2 30 minutes intervention 2: 1000mg/d intervention 3: 1500mg/d intervention 4: 1000mg/m2 100minutes intervention 5: 100mg/m2 | intervention 1: Gemcitabine 1000mg/m2 30 minutes intervention 2: Lapatinib 1000mg/d intervention 3: Lapatinib 1500mg/d intervention 4: Gemcitabine 1000mg/m2 100minutes intervention 5: Oxaliplatin 100mg/m2 | 1 | Providence | Rhode Island | United States | -71.41283 | 41.82399 | 0 | NCT00447122 |
[
3
] | 75 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | false | 0ALL | true | The primary objective of this study was to assess the efficacy and safety of 2 dose levels of ecallantide versus placebo in reducing blood loss following cardiopulmonary bypass (CPB), as measured by chest tube drainage during the first 12 hours postoperatively or until the chest tube was removed, whichever came first, ... | This was a Phase 2, randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy and safety of 2 dose levels of ecallantide compared to placebo in reducing chest tube drainage in participants requiring CPB for primary CABG, single valve repair, or single valve replacement. Participan... | Blood Loss, Surgical | null | 3 | arm 1: Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end... | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Ecallantide intervention 2: Placebo | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Phoenix | Arizona | United States | -112.07404 | 33.44838
Aurora | Colorado | United States | -104.83192 | 39.72943
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachusetts | United States | -71.05977 | 42.35843
Boston | Massachuset... | 0 | NCT00448864 | |
[
5
] | 31 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study will evaluate whether conversion from cyclosporine, a calcineurin inhibitor (CI) to sirolimus (SRL) results in improved long-term renal function without a negative impact on safety or immunosuppressive efficacy, and to further examine the potential of SRL to reduce the severity and/or progression of chronic ... | This open-label, randomized, parallel-group, comparative, outpatient study will be conducted in multiple centers in Taiwan.
The study will randomize approximately 120 patients. 80 patients will be randomized to the SRL therapy group (conversion from CI- to SRL-based immunosuppression: group A) and 40 patients to the C... | Kidney Transplantation | null | 2 | arm 1: Sirolimus therapy arm 2: Calcineurin Inhibitor therapy (either cyclosporine or tacrolimus) | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Corticosteroids will be administered according to local practice, within a daily maintenance dosage range of 2.5 to15 mg for prednisone or prednisolone (2 to 12 mg/day for methylprednisolone) or the alternate day equivalent. intervention 2: The maintenance dose of:
1. MMF will not exceed 1500 mg/day or... | intervention 1: Sirolimus+MMF or MPS or AZA+Steroid intervention 2: Calcineurin Inhibitors (either cyclosporine or tacrolimus)+MMF or MPS or AZA+Steroid | 1 | Select Cities | N/A | Taiwan | N/A | N/A | 0 | NCT00452361 | |
[
4
] | 395 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with moderate to severe pain from diabetic peripheral neuropathy. | The primary objective of this randomized-withdrawal (randomized means study medication assigned to patients by chance and withdrawal means to stop using), multicenter, double-blind (neither patient nor investigator knows the study medication), placebo-controlled, Phase 3 study is to determine the effectiveness and safe... | Diabetic Neuropathy | Diabetic neuropathy Painful Diabetic Polyneuropathy Polyneuropathy Peripheral neuropathy | null | 2 | arm 1: placebo matching placebo twice daily for 12 weeks arm 2: CG5503 100, 150, 200, 250mg twice daily given for up to 15 weeks | [
2,
0
] | 2 | [
0,
0
] | intervention 1: 100, 150, 200, 250 mg twice daily given for up to 15 weeks intervention 2: matching placebo twice daily for 12 weeks | intervention 1: CG5503 intervention 2: placebo | 0 | null | 0 | NCT00455520 |
[
2,
3
] | 36 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.
Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at th... | null | Gastrointestinal Stromal Tumors | Evaluate of RTD for Japanese GIST patients | null | 1 | arm 1: 25 , 50 or 75 mg/day of SU011248 | [
0
] | 1 | [
0
] | intervention 1: SU011248 | intervention 1: Sunitinib malate (SU011248) | 4 | Kashiwa | Chiba | Japan | 139.97732 | 35.86224
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Suita | Osaka | Japan | 135.51567 | 34.76143
Chuo-ku | Tokyo | Japan | N/A | N/A | 0 | NCT00457743 |
[
3
] | 39 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | true | The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G5... | This was a double-blind, placebo-controlled, cross-over, multiple dose study of up to 28 days of dosing, in subjects with cystic fibrosis (CF) who have a G551D-CTFR gene mutation. Enrollment of 39 subjects occurred at 15 centers in the US, Canada, and Germany.
The study was conducted in 2 parts:
* Part 1 consisted of... | Cystic Fibrosis | G551D mutation Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes | null | 4 | arm 1: Subjects in Part 1 who first received 25 mg or 75 mg of ivacaftor every 12 hours (q12h) for 14 days, then crossed over to receive the alternate dose for another 14 days. arm 2: Subjects in Part 1 who first received 75 mg or 150 mg of ivacaftor q12h for 14 days then crossed over to receive the alternate dose for ... | [
0,
0,
0,
2
] | 4 | [
0,
0,
0,
0
] | intervention 1: 25 mg or 75 mg q12h for a total of 28 days (Part 1) intervention 2: 75 mg or 150 mg q12h for a total of 28 days (Part 1) intervention 3: 150 mg or 250 mg of ivacaftor q12h for 28 days (Part 2) intervention 4: Given q12h for 28 days each in Part 1 and Part 2 of the study | intervention 1: Ivacaftor 25 mg/75 mg intervention 2: Ivacaftor 75 mg/150 mg intervention 3: Ivacaftor 150 mg or 250 mg intervention 4: Placebo | 15 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Palo Alto | California | United States | -122.14302 | 37.44188
Aurora | Colorado | United States | -104.83192 | 39.72943
Iowa City | Iowa | United States | -91.53017 | 41.66113
Baltimore | Maryland | United States | -76.61219 | 39.29038
Boston | Massachusetts ... | 0 | NCT00457821 |
[
5
] | 20 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | true | The purpose of the study is to compare the glycemic control between insulins aspart and lispro 48 to 100 hours after pump infusion line change in subjects with type 1 using diabetes using an insulin pump. | Continuous subcutaneous insulin infusion (Insulin pump therapy) is a well established tool for the management of type 1 diabetes. In clinical trials, insulin pump therapy has been shown to have increased efficacy over multiple daily injections. However, the overall glycemic control in patients using insulin pumps has b... | Type 1 Diabetes Mellitus | Type 1 diabetes mellitus Glycemic control Continuous subcutaneous insulin infusion Continuous glucose monitoring system | null | 2 | arm 1: Either insulin Aspart or insulin Lispro were randomized to be insulin 1. arm 2: Between insulin Aspart and insulin Lispro, the one that was not used as insulin 1 was then used as the second insulin for the second arm of the study. | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Either one of these insulins were given to the patient as the second insulin (depending on which was given as the first one, the other insulin was insulin 2). Patients used this insulin in the same dose as they did prior to entering the study. intervention 2: Patients were given either insulin Aspart or... | intervention 1: Insulin Aspart intervention 2: Insulin Lispro | 1 | New Orleans | Louisiana | United States | -90.07507 | 29.95465 | 0 | NCT00461331 |
[
3
] | 8 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | null | RATIONALE: Sunitinib 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 sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma. | OBJECTIVES:
Primary
* Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma.
Secondary
* Determine overall and progression-free survival.
OUTLINE: Patients receive oral sunitinib mala... | Kidney Cancer Melanoma (Skin) Metastatic Cancer | stage IV melanoma tumors metastatic to brain stage IV renal cell cancer recurrent melanoma recurrent renal cell cancer | null | 1 | arm 1: Patients will be treated with 50 mg daily for four out of every six weeks. | [
0
] | 1 | [
0
] | intervention 1: None | intervention 1: sunitinib malate | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00462982 |
[
3
] | 124 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to examine the safety and efficacy of rebamipide by once daily intracolonial administration at 0 (placebo), 60, 150, or 300 mg for 6 weeks in patients with active ulcerative colitis, who are being treated with oral aminosalicylic acid (ASA). | null | Colitis, Ulcerative | Rebamipide Enema Ulcerative Colitis | null | 4 | arm 1: 0mg rebamipide arm 2: 60mg rebamipide arm 3: 150mg rebamipide arm 4: 300mg rebamipide | [
2,
0,
0,
0
] | 1 | [
0
] | intervention 1: 0, 60, 150, 300mg of rebamipide per day for 6 weeks into colon | intervention 1: rebamipide | 5 | Chubu Region | N/A | Japan | N/A | N/A
Chugoku Region | N/A | Japan | N/A | N/A
Hokkaido Region | N/A | Japan | N/A | N/A
Kinki Region | N/A | Japan | N/A | N/A
Kyushu Region | N/A | Japan | N/A | N/A | 0 | NCT00463151 |
[
3
] | 133 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | true | The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of ... | An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy. | Prostate Cancer | Prostate Cancer | null | 2 | arm 1: Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. arm 2: Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injecti... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, \& 10 months. intervention 2: Experimental
Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by... | intervention 1: Degarelix intervention 2: Degarelix | 29 | Homewood | Alabama | United States | -86.80082 | 33.47177
Laguna Woods | California | United States | -117.72533 | 33.6103
Aventura | Florida | United States | -80.13921 | 25.95648
Ocala | Florida | United States | -82.14009 | 29.1872
Shreveport | Louisiana | United States | -93.75018 | 32.52515
Carmel | New York | Uni... | 0 | NCT00468286 |
[
5
] | 46 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension | null | Open-angle Glaucoma Ocular Hypertension | null | 2 | arm 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) arm 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:... | [
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) intervention 2: treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) ... | intervention 1: Travatan intervention 2: Cosopt intervention 3: Placebo (Timolol Vehicle) | 1 | Coimbra | N/A | Portugal | -8.41955 | 40.20564 | 0 | NCT00471068 | |
[
4
] | 50 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia | null | Hyponatremia | hyponatremia hypervolemic euvolemic edematous conivaptan | null | 3 | arm 1: 20 mg conivaptan once a day arm 2: 20 mg conivaptan two times a day arm 3: None | [
0,
0,
2
] | 2 | [
0,
0
] | intervention 1: premix bag intervention 2: premix bag | intervention 1: Conivaptan intervention 2: Placebo | 26 | Huntsville | Alabama | United States | -86.58594 | 34.7304
Tucson | Arizona | United States | -110.92648 | 32.22174
Los Angeles | California | United States | -118.24368 | 34.05223
Denver | Colorado | United States | -104.9847 | 39.73915
Jacksonville | Florida | United States | -81.65565 | 30.33218
Port Charlotte | Flo... | 0 | NCT00478192 |
[
5
] | 22 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 4QUADRUPLE | true | 0ALL | false | The goal of the study is to assess the role of cholinesterase inhibitors in affecting the driving ability of cognitively intact seniors using driving simulators. We hypothesize that the use of a cholinesterase inhibitor for two weeks will be associated with improvement in safe driving behavior on a simulated driving ta... | Alzheimer's disease (AD) is the most common cause of dementia, and while it is known that AD poses substantial risks of motor vehicle collisions, many people in the earliest stages of AD continue to drive. Memory problems themselves are poor predictors of who is actually unsafe on the road, and various medications that... | Mental Health Geriatrics | Donepezil Driving Cholinesterase Inhibitors Geriatric Psychiatry Psychopharmacology Aricept | null | 2 | arm 1: donepezil, capsule, 5mg daily once daily for 14 days arm 2: placebo (cornstarch), capsule, once daily for 14 days | [
0,
2
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: donepezil intervention 2: Placebo (cornstarch) | 2 | Thunder Bay | Ontario | Canada | -89.25018 | 48.38202
Toronto | Ontario | Canada | -79.39864 | 43.70643 | 0 | NCT00482001 |
[
3
] | 98 | RANDOMIZED | PARALLEL | 9OTHER | 3TRIPLE | false | 2MALE | false | The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl. | Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital st... | Postoperative Pain | hernia unilateral postoperative analgesia | null | 4 | arm 1: Bupivacaine HCl given during hernia repair arm 2: SKY0402 low dose given during hernia repair arm 3: SKY0402 middle dose given during hernia repair arm 4: SKY0402 high dose given during hernia repair | [
1,
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: Bupivacaine HCl given during hernia repair intervention 2: SKY0402 given during hernia repair | intervention 1: Bupivacaine HCl intervention 2: SKY0402 | 7 | Arcadia | California | United States | -118.03534 | 34.13973
Laguna Hills | California | United States | -117.71283 | 33.61252
Pasadena | California | United States | -118.14452 | 34.14778
New York | New York | United States | -74.00597 | 40.71427
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
Houst... | 0 | NCT00485433 |
[
4
] | 796 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients. | null | Diabetes Mellitus Type 2 | null | 2 | arm 1: Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. arm 2: Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study. | [
5,
1
] | 2 | [
0,
0
] | intervention 1: One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. intervention 2: ER niacin/laropiprant Placebo | intervention 1: ER niacin/laropiprant intervention 2: Comparator : placebo (unspecified) | 0 | null | 0 | NCT00485758 | |
[
5
] | 137 | RANDOMIZED | CROSSOVER | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease. | null | Chronic Obstructive Pulmonary Disease | COPD | null | 3 | arm 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily arm 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler... | [
0,
0,
2
] | 3 | [
0,
0,
10
] | intervention 1: Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms intervention 2: Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily intervention 3: Placebo, 1 inhalation twice daily | intervention 1: budesonide/formoterol Turbuhaler 320/9µg intervention 2: formoterol Turbuhaler 9µg intervention 3: Placebo | 9 | Berlin | N/A | Germany | 13.41053 | 52.52437
Erfurt | N/A | Germany | 11.03283 | 50.9787
Fulda | N/A | Germany | 9.67518 | 50.55162
Fürth | N/A | Germany | 10.98856 | 49.47593
Geesthacht | N/A | Germany | 10.3779 | 53.43575
Grobhansdorf | N/A | Germany | N/A | N/A
Leipzig | N/A | Germany | 12.37129 | 51.33962
Neuruppin... | 0 | NCT00489853 |
[
3
] | 165 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 1FEMALE | false | A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis | null | Osteoporosis | null | 5 | arm 1: Macroflux® placebo patch arm 2: Macroflux® 20 mcg patch arm 3: Macroflux® 30 mcg patch arm 4: Macroflux® 40 mcg patch arm 5: FORTEO® 20 mcg injection | [
2,
0,
0,
0,
1
] | 2 | [
0,
0
] | intervention 1: Macroflux® patch applied to the abdomen for 30 minutes daily intervention 2: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh | intervention 1: teriparatide intervention 2: teriparatide | 0 | null | 0 | NCT00489918 | |
[
4
] | 182 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | true | The purpose of this study is to determine if the consumption of a yogurt drink containing a high dose of probiotics decreases absences, due to illnesses, in daycare centers for children between the ages of 1 and 3. | It is reported that more than half of all young children attend daycare centers in the United States. Absences due to illnesses are costly both on an individual and societal level; these absences are generally due to diarrhea or upper respiratory infections.
In the U.S., children under five years of age experience 20-... | Healthy | probiotic health bifidobacterium lactis BB-12 | null | 2 | arm 1: Subjects were provided 4 fluid ounces (112 grams) administered orally per day of placebo drink. arm 2: Subjects were provided 4 fluid ounces (112 grams) administered orally per day of active drink. | [
2,
0
] | 2 | [
0,
0
] | intervention 1: The active drink is currently available commercially on campus at The Berkey Creamery at Penn State in State College, Pennsylvania. The active drink combined a commercial blend (YFL-702, Chr.) of the following active cultures, Streptococcus thermophilus and Lactobacillus delbrueckii subsp. bulgaricus. T... | intervention 1: Bifidobacterium lactis (BB-12) intervention 2: Placebo | 1 | Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 | 0 | NCT00492583 |
[
5
] | 15 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 1SINGLE | true | 0ALL | false | RATIONALE: Garlic supplements may alter the pharmacokinetics of oxycodone, thereby affecting its effectiveness as an opioid analgesic for the relief of moderate or severe pain.
PURPOSE: This randomized phase 4 trial is studying how garlic supplements may change the pharmacokinetics of oxycodone and its analgesic and s... | OBJECTIVES:
* To determine whether CYP3A (Cytochrome P450 3A) and/or P-glycoprotein mediated interactions exist between garlic supplements and oxycodone (a commonly used oral opioid analgesic) in healthy volunteers.
OUTLINE:
This is a single-blind, randomized, crossover study. Participants are randomized to 1 of 2 a... | Healthy, No Evidence of Disease | Healthy, No Evidence of Disease | null | 2 | arm 1: Two 30-day treatment periods separated by a washout of at least 4 weeks. In Period 1, participants receive oral garlic powder tablet twice daily on days 1-30, oral oxycodone on day 28, and a combination of oral midazolam and digoxin on day 29. In Period 2, participants receive oral placebo twice daily on days 1-... | [
5,
5
] | 2 | [
7,
0
] | intervention 1: Each Garlicin tablet has a claimed allicin content of 3,200 microgram per tablet intervention 2: Single administration of three 5-mg oxycodone tablets or a 15-mg dose | intervention 1: garlic powder tablets intervention 2: oxycodone | 1 | Seattle | Washington | United States | -122.33207 | 47.60621 | 0 | NCT00499460 |
[
3
] | 41 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 0NONE | false | 0ALL | true | RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Amifostine may decrease the side effects caused by chemotherapy and radiation therapy. It is not y... | OBJECTIVES:
Primary
* To compare the incidence and severity of acute and chronic swallowing dysfunction in stage III or IV head and neck cancer patients receiving concurrent chemoradiation with or without amifostine
Secondary
* To assess the relative incidence and severity of acute and chronic xerostomia in stage I... | Dysphagia Head and Neck Cancer Mucositis Xerostomia | xerostomia mucositis dysphagia radiation toxicity chemotherapeutic agent toxicity stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage III verrucous carcinoma of... | null | 4 | arm 1: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. arm 2: Patients undergo SNT and low weight resistance training (LWRT). arm 3: Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMR... | [
1,
1,
0,
0
] | 3 | [
5,
0,
3
] | intervention 1: Patients undergo low weight resistance training. intervention 2: Given subcutaneously intervention 3: Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction. | intervention 1: exercise intervention intervention 2: amifostine trihydrate intervention 3: therapeutic dietary intervention | 1 | Nashville | Tennessee | United States | -86.78444 | 36.16589 | 0 | NCT00503776 |
[
4
] | 165 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 1SINGLE | false | 0ALL | false | This study is conducted to compare the contrast effect and safety of SH L562BB with ProHance, which has already been approved as a pharmaceutical product of similar indication. | null | Brain Metastases | MRI Brain Metastasis Gadolinium Imaging Diagnostic Agent | null | 3 | arm 1: Participants received first injection (intravenous \[i.v.\]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw arm 2: Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injectio... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Gadobutrol enhanced MRI (first injection of gadobutrol 0.1 mmol/kg bw, corresponding to a dose of 0.1 mmol/kg bw) intervention 2: Gadobutrol enhanced MRI (second injection of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw) intervention 3: ProHance enhanced MRI (two injections... | intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 3: ProHance | 20 | Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147
Matsuyama | Ehime | Japan | 132.76574 | 33.83916
Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
Kobe | Hyōgo | Japan | 135.183 | 34.6913
Sagamihara | Kanagawa | Japan | 139.24167 | 35.56707
Yokohama | Kanagawa | Japan ... | 0 | NCT00522951 |
[
3
] | 6 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | null | false | 1FEMALE | true | RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells.
PUR... | OBJECTIVES:
Primary
* To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.
Secondary
* To assess the overall clinical local regional response in patients treated wit... | Breast Cancer | stage IIIA breast cancer stage IIIB breast cancer | null | 0 | null | null | 4 | [
0,
0,
3,
3
] | intervention 1: None intervention 2: None intervention 3: None intervention 4: None | intervention 1: docetaxel intervention 2: pegylated liposomal doxorubicin hydrochloride intervention 3: conventional surgery intervention 4: neoadjuvant therapy | 1 | Buffalo | New York | United States | -78.87837 | 42.88645 | 0 | NCT00524459 |
[
4
] | 234 | NON_RANDOMIZED | SINGLE_GROUP | 2DIAGNOSTIC | 0NONE | false | 0ALL | true | Participants who had been diagnosed or suspected by doctors to have focal liver lesions that need further evaluation in order to make an accurate diagnosis. Participants would need to have an enhanced magnetic resonance imaging (MRI) scan so that doctors could have further information about the number and characteristi... | Adult Chinese patients with known focal or suspected liver lesions, referred for magnetic resonance imaging (MRI) for further diagnostic work-up, who have undergone or are scheduled to undergo a defined SOR procedure, within one month before or after the study MRI.
The data for the Secondary Outcome Measure "Lesion si... | Known or Suspected Focal Liver Lesions | Primovist Chinese patients Liver MRI | null | 1 | arm 1: Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient | [
0
] | 1 | [
0
] | intervention 1: Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient | intervention 1: Gadoxetic Acid Disodium (Primovist, BAY86-4873) | 6 | Nanjing | Jiangsu | China | 118.77778 | 32.06167
Suzhou | Jiangsu | China | 120.59538 | 31.30408
Xi'an | Shaanxi | China | 108.92861 | 34.25833
Beijing | N/A | China | 116.39723 | 39.9075
Shanghai | N/A | China | 121.45806 | 31.22222
Shanghai | N/A | China | 121.45806 | 31.22222 | 0 | NCT00526188 |
[
5
] | 54 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | false | 0ALL | false | The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension. | null | Open-Angle Glaucoma Ocular Hypertension | Comfort | null | 2 | arm 1: Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. arm 2: Latanoprost assigned to one eye, with travoprost... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost. | intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®) | 0 | null | 0 | NCT00527592 |
[
4
] | 805 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | null | This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma. | null | Asthma | asthma QAB149 indacaterol | null | 3 | arm 1: Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 07:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the even... | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Indacaterol was supplied as powder filled capsules together with a single dose dry powder inhaler (SDDPI). intervention 2: Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device. intervention 3: Placebo to indacaterol was supplied as p... | intervention 1: Indacaterol 300 μg intervention 2: Salmeterol 50 μg intervention 3: Placebo to indacaterol intervention 4: Placebo to salmeterol | 126 | Glendale | Arizona | United States | -112.18599 | 33.53865
Phoenix | Arizona | United States | -112.07404 | 33.44838
Encinitas | California | United States | -117.29198 | 33.03699
Huntington Beach | California | United States | -117.99923 | 33.6603
Long Beach | California | United States | -118.18923 | 33.76696
Long Be... | 0 | NCT00529529 |
[
5
] | 586 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | null | The study will compare the safety and efficacy of Bimatoprost and Latanoprost in patients with glaucoma or ocular hypertension | null | Ocular Hypertension Glaucoma | null | 2 | arm 1: bimatoprost 0.03% eye drops arm 2: latanoprost 0.005% eye drops | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized treatment of bimatoprost 0.03% 1 drop every evening for 12 weeks intervention 2: Open-labeled latanoprost 0.005% 1 drop into each eye every evening for 6 weeks followed by a masked randomized t... | intervention 1: bimatoprost 0.03% eye drops intervention 2: latanoprost 0.005% eye drops | 1 | Newport Beach | California | United States | -117.92895 | 33.61891 | 0 | NCT00541242 | |
[
5
] | 442 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD Symbicort Seretide | null | 2 | arm 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg arm 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | [
0,
0
] | 2 | [
0,
0
] | intervention 1: None intervention 2: None | intervention 1: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg intervention 2: Seretide Diskus (salmeterol/fluticasone) 50/500 μg | 59 | Monte Grande | Buenos Aires | Argentina | -58.46592 | -34.8194
Quilmes | Buenos Aires | Argentina | -58.25454 | -34.72065
San Miguel de Tucumán | Tucumán Province | Argentina | -65.21051 | -26.81601
Ciudad Autonoma de Bs. As. | N/A | Argentina | N/A | N/A
Ciudad de Buenos Aires | N/A | Argentina | N/A | N/A
Concord | N... | 0 | NCT00542880 |
[
0
] | 20 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to test the effects of sleep and eszopiclone, a drug that helps people sleep, on how the body processes glucose (sugar). Eszopiclone is approved by the U.S. Food and Drug Administration (FDA) for sale for the treatment of insomnia. It is marketed in the United States as LUNESTA.
Main Hypot... | Insomnia is the most common sleep disorder, affecting nearly one-third of all adults in any given year, and chronically affecting 10-15% of the adult population. Reduced sleep time, independent of insomnia, has been associated with a variety of deleterious long term effects, including an increased risk of incident myoc... | Primary Insomnia | sleep metabolism insulin glucose actigraphy diary volumetry GABA | null | 2 | arm 1: active medication (eszopiclone 3mg tablet) by mouth nightly 30 min before bed arm 2: identical placebo tablet by mouth nightly 30 min before bed | [
0,
2
] | 2 | [
0,
0
] | intervention 1: 3mg tablet, by mouth nightly 30 min before bed, for two months intervention 2: inactive placebo tablet, by mouth nightly 30 minutes before bed, for two months | intervention 1: eszopiclone intervention 2: placebo | 1 | Boston | Massachusetts | United States | -71.05977 | 42.35843 | 0 | NCT00555750 |
[
2,
3
] | 120 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data. | Fungal ulcers tend to have very poor outcomes with the most common treatments, amphotericin B and natamycin. There has been only a single randomized trial of anti-fungal therapy for fungal ulcers and no new medications have been approved by the FDA since the 1960s. There are studies that indicate that the newer triazol... | Fungal Keratitis | Keratitis Eye Infection, Fungal Fungal Eye Infection Ocular Infection, Fungal Fungal Keratitis Mycotic Infections, Ocular Voriconazole Natamycin | null | 4 | arm 1: Topical voriconazole with corneal de-epithelialization arm 2: Topical voriconazole without corneal de-epithelialization arm 3: Topical natamycin with corneal de-epithelialization arm 4: Topical natamycin without corneal de-epithelialization | [
1,
1,
1,
1
] | 3 | [
0,
0,
3
] | intervention 1: One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake intervention 2: Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution.
One drop of medication should be given ... | intervention 1: Natamycin 5% intervention 2: Voriconazole intervention 3: Corneal de-epithelialization | 2 | Madurai | Tamil Nadu | India | 78.11953 | 9.919
Pondicherry | Tamil Nadu | India | N/A | N/A | 0 | NCT00557362 |
[
3
] | 21 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | An H3 receptor antagonist should reduce the congestion associated with allergic rhinitis. A nasal allergen challenge will be given to patients to induce rhinitis symptoms and acoustic rhinometry will be used to measure the congestion. | null | Allergic Rhinitis | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
2,
1,
1,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: A single oral dose of Placebo is dosed during the study in order to ascertain the effect of placebo on measures and in order to maintain the blind of the other drugs. intervention 2: A single oral dose of Allegra is dosed to subjects in combination with PF-03654746. intervention 3: A single oral dose of... | intervention 1: Placebo intervention 2: Allegra intervention 3: Allegra-D intervention 4: PF-03654746 | 1 | Omaha | Nebraska | United States | -95.94043 | 41.25626 | 0 | NCT00562120 | |
[
0
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients. | null | Bipolar Depression | Keppra Levetiracetam Anticonvulsant Depression Bipolar Disorder Affective Disorders Mood Disorders Double Blind Acute Antidepressant Effects | null | 2 | arm 1: None arm 2: None | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Flexible dose up to 2500mg per day, for 6 weeks. intervention 2: Flexible dose up to 2500mg per day, for 6 weeks. | intervention 1: Levetiracetam intervention 2: Placebo | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00566150 |
[
2
] | 153 | RANDOMIZED | PARALLEL | 4SUPPORTIVE_CARE | 1SINGLE | true | 0ALL | false | Pharmacokinetics, Bioavailability, Safety and Immunogenicity of Single Doses of Belatacept Administered Subcutaneously to Healthy Subjects | null | Transplantation | null | 8 | arm 1: Belatacept 50 mg subcutaneous (SC) injection arm 2: Belatacept 100 mg SC injection arm 3: Belatacept 125 mg SC injection arm 4: 2 SC injections of 75 mg Belatacept arm 5: 2 SC injections of 100 mg Belatacept arm 6: 2 SC injections of 125 mg Belatacept arm 7: 125 mg Belatacept intravenous (IV) injection arm 8: SC... | [
1,
1,
1,
1,
1,
1,
1,
2
] | 2 | [
0,
0
] | intervention 1: single dose, 116 days intervention 2: Subcutaneous injection of placebo solution (product ID: 224818-N000- 029) | intervention 1: belatacept intervention 2: Placebo | 1 | Austin | Texas | United States | -97.74306 | 30.26715 | 0 | NCT00569803 | |
[
0
] | 12 | NA | SINGLE_GROUP | 7BASIC_SCIENCE | 0NONE | true | 0ALL | false | The main purpose of this protocol is to study the effect of an HIV medication, Kaletra (lopinavir/ritonavir), on buprenorphine in non-HIV infected people who have been receiving the same dose of buprenorphine for at least 3 weeks.
Study Hypothesis:
Kaletra (lopinavir/ritonavir) will increase buprenorphine plasma leve... | Buprenorphine (BUP) is a partial opiate agonist dosed sublingually for both supervised opiate withdrawal and maintenance for opiate dependence. Until recently, methadone has been the mainstay of pharmacological treatment for opiate-dependent persons with HIV infection. In October, 2002, buprenorphine (BUP) was approved... | HIV Infections | HIV Pharmacokinetics Buprenorphine Kaletra HIV Seronegativity | null | 1 | arm 1: HIV negative subjects currently enrolled in a long-term buprenorphine maintenance therapy program for at least 3 months who have been on stable dose of buprenorphine for at least 3 weeks will be admitted to the General Clinical Research Center (GCRC) for pharmacokinetic (PK) blood draws at intervals over a 24-ho... | [
0
] | 3 | [
0,
0,
10
] | intervention 1: 4 tablets, once a day (800 mg/dose) on Days 2 through 14 of this study intervention 2: Buprenorphine will be obtained through prescription at the subject's drug treatment program. intervention 3: Physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG), clinical laboratory evaluat... | intervention 1: Kaletra (lopinavir/ritonavir) intervention 2: buprenorphine intervention 3: Clinical evaluations/Blood draws | 1 | New Haven | Connecticut | United States | -72.92816 | 41.30815 | 0 | NCT00571961 |
[
5
] | 36 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study is being done to examine the influence of Tiotropium (good or bad) on heart function at rest and during exercise in patients with moderate to severe chronic obstructive pulmonary disease (COPD). | Patients who develop chronic obstructive pulmonary disease (COPD) have a loss of elastic recoil of the lungs, have remodeling in the airways and pulmonary vasculature, develop inhomogeneities in ventilation (VA) and perfusion (Qc) and gradually lose their reserves for producing expiratory flow, particularly over the mi... | Chronic Obstructive Pulmonary Disease COPD | COPD Tiotropium Spiriva | null | 3 | arm 1: Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder. arm 2: Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard act... | [
0,
2,
4
] | 2 | [
0,
0
] | intervention 1: Participants received once daily Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device. intervention 2: Participants randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose, using the HandiHaler ... | intervention 1: Tiotropium intervention 2: Placebo | 1 | Rochester | Minnesota | United States | -92.4699 | 44.02163 | 0 | NCT00578968 |
[
0
] | 12 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to see if changing from one pain medication like morphine or oxycodone to another pain medication, oxymorphone (OPANA®), will be helpful to patients. This study will examine if the switching from one pain medication to another can be done over a 24 hour period. Oxymorphone, the drug being s... | null | Pain | Sciatica Diabetic Neuropathies Complex Regional Pain Syndromes Low Back Pain Neck Pain Headache Back Pain Arthritis Brachial Plexus Injury (stinger/burner) Chronic Pain Contractures Diabetes Fibromyalgia Foot Pain Fracture Hip Herpes Zoster (shingles) Migraine Neuropathic Pain Osteoarthritis Osteoporosis Rheumatoid Art... | null | 1 | arm 1: participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed | [
0
] | 1 | [
0
] | intervention 1: IV PO | intervention 1: Oxymorphone | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00580294 |
[
0
] | 13 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | true | The study is a prospective open label study to examine the effects of oral and intravenous fat load on blood pressure, endothelial function, sympathetic activity, and oxidative stress in obese healthy subjects. Subjects will receive either 8-hour of intravenous or oral fat loads in either low or high doses or normal sa... | Insulin resistance has been implicated as the central mechanism in the development of several cardiovascular risk factors including hypertension, diabetes, lipid disorders, and coagulation disorders. Recent evidence suggests that increased levels of a circulation fat (free fatty acids or FFAs) are a leading candidate c... | Endothelial Dysfunction Hypertension | hypertension metabolic syndrome vascular reactivity Elevated blood pressure lipid toxicity | null | 5 | arm 1: Intralipid 20% IV infusion at 20cc/hour arm 2: Intralipid 20% IV infusion at 40cc/hour arm 3: Normal Saline continuous IV infusion at 40cc/hour for 8 hours arm 4: 32-gram oral fat load once arm 5: 64-gram oral fat load once | [
1,
1,
2,
1,
1
] | 5 | [
0,
0,
0,
7,
7
] | intervention 1: In this arm subjects received Intralipid 20% Intravenous IV continuous infusion at 20cc/hour for 8 hours. The 20% intralipid solution is a long-chain triglyceride emulsion composed of 50% polyunsaturated fatty acids, 26% monounsaturated fatty acids, and 19% saturated fatty acids. During the intralipid i... | intervention 1: Intralipid 20% @ 20cc/hour intervention 2: Intralipid 20%@ 40cc/hour intervention 3: Normal Saline intervention 4: 32-gram oral fat load intervention 5: 64-gram oral fat load | 1 | Atlanta | Georgia | United States | -84.38798 | 33.749 | 0 | NCT00589888 |
[
5
] | 74 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | true | The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA). | Diabetic ketoacidosis (DKA) is the most serious emergency in patients with diabetes. With an estimated 100,000 admissions per year in the United States, DKA is also the leading cause of death in children with type 1 diabetes, and accounts for a significant proportion of admissions in adult patients with type 1 and type... | Diabetic Ketoacidosis | Diabetic ketoacidosis insulin therapy DKA | null | 2 | arm 1: Daily insulin glargine + glulisine before meals arm 2: Split-mixed NPH + Regular insulin twice daily | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Daily insulin glargine + glulisine before meals intervention 2: Split-mixed NPH + Regular insulin twice daily | intervention 1: insulin glargine+ glulisine intervention 2: NPH + Regular insulin | 2 | Atlanta | Georgia | United States | -84.38798 | 33.749
Minneapolis | Minnesota | United States | -93.26384 | 44.97997 | 0 | NCT00590044 |
[
0
] | 38 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 0ALL | true | This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication. | Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final... | Nicotine Dependence | Varenicline, Imaging, fMRI | null | 2 | arm 1: None arm 2: None | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily intervention 2: Participants will take placebo pills for 13 days using the same regimen as the varenicline study period. | intervention 1: Varenicline intervention 2: Placebo | 1 | Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 | 0 | NCT00602927 |
[
3
] | 245 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes. | null | Diabetes Diabetes Mellitus, Type 2 | null | 4 | arm 1: None arm 2: None arm 3: None arm 4: None | [
0,
0,
0,
1
] | 5 | [
0,
0,
0,
0,
0
] | intervention 1: Treat-to-target dose titration scheme, s.c. injection. intervention 2: Formulation D: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 3: Formulation E: Treat-to-target dose titration scheme, s.c. injection, once daily intervention 4: Formulation D: Treat-to-target dose tit... | intervention 1: insulin glargine intervention 2: insulin degludec intervention 3: insulin degludec intervention 4: insulin degludec intervention 5: metformin | 29 | Inglewood | California | United States | -118.35313 | 33.96168
Los Angeles | California | United States | -118.24368 | 34.05223
Redlands | California | United States | -117.18254 | 34.05557
Spring Valley | California | United States | -116.99892 | 32.74477
Jacksonville | Florida | United States | -81.65565 | 30.33218
I... | 0 | NCT00611884 | |
[
3
] | 30 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is:
1. To assess and characterize the PK and PD of PRO 140 administered IV
2. To assess the antiviral activity of PRO 140
3. To assess the safety and tolerability of PRO 140 | null | HIV Infections | HIV treatment naïve | null | 3 | arm 1: 10 mg/kg PRO 140, one IV dose (N=10) arm 2: 5 mg/kg PRO 140, one IV dose (N=10) arm 3: Placebo, one IV dose (N=10) | [
0,
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: 10 mg/kg PRO 140, one IV dose (N=10) intervention 2: 5 mg/kg PRO 140, one IV dose (N=10) intervention 3: PBO, one IV dose (N=10) | intervention 1: PRO 140 intervention 2: PRO 140 intervention 3: Placebo | 1 | Tarrytown | New York | United States | -73.85875 | 41.07621 | 0 | NCT00613379 |
[
3
] | 182 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination \[SIAC\], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes. | null | Diabetes Diabetes Mellitus, Type 2 | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 2: Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 3: Treat-to-target dose titration scheme, injection s.c., twice daily intervention 4: Tablets, 1500-2000 mg/dai... | intervention 1: insulin degludec/insulin aspart intervention 2: insulin degludec/insulin aspart intervention 3: biphasic insulin aspart intervention 4: metformin | 31 | Helsinki | N/A | Finland | 24.93545 | 60.16952
Kuopio | N/A | Finland | 27.67703 | 62.89238
Lahti | N/A | Finland | 25.66151 | 60.98267
Pori | N/A | Finland | 21.78333 | 61.48333
Bar-le-Duc | N/A | France | 5.16108 | 48.77275
Grenoble | N/A | France | 5.71479 | 45.17869
Hayange | N/A | France | 6.06278 | 49.32881
La Ro... | 0 | NCT00613951 | |
[
0
] | 11 | RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 2DOUBLE | true | 1FEMALE | false | The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women. | Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and a... | Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P) | Celebrex prostaglandin inhibitor ovulation menstrual cycles | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 2 | [
0,
0
] | intervention 1: One 400mg tablet daily. intervention 2: One tablet daily. | intervention 1: Celebrex intervention 2: Placebo | 1 | Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00614406 |
[
4
] | 96 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | false | 0ALL | false | This study was conducted to provide detailed information on the efficacy of indacaterol (in terms of the spirometry assessment forced expiratory volume in 1 second \[FEV1\]) over the full 24-h time period | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD, bronchodilator, long acting beta agonist, LABA | null | 12 | arm 1: In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In perio... | [
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: 300 µg dosed in the morning/evening via single dose dry powder inhaler (SDDPI) intervention 2: 50 µg twice daily delivered via dry powder inhaler (DPI) intervention 3: Placebo matching indacaterol was delivered via SDDPI. intervention 4: Placebo matching salmeterol was delivered via DPI | intervention 1: Indacaterol intervention 2: Salmeterol intervention 3: Placebo to Indacaterol intervention 4: Placebo to Salmeterol | 7 | Beuvry | N/A | France | 2.68541 | 50.51674
Nantes | N/A | France | -1.55336 | 47.21725
Berlin | N/A | Germany | 13.41053 | 52.52437
Hamburg | N/A | Germany | 9.99302 | 53.55073
Leipzig | N/A | Germany | 12.37129 | 51.33962
Mainz | N/A | Germany | 8.2791 | 49.98419
Barcelona | N/A | Spain | 2.15899 | 41.38879 | 0 | NCT00615030 |
[
3
] | 65 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo. | null | Chronic Obstructive Pulmonary Disease (COPD) | COPD tolerability inhalation | null | 2 | arm 1: AZD4818 arm 2: Placebo | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Dry Powder, inhalation, b.i.d., 4 weeks intervention 2: None | intervention 1: AZD4818 intervention 2: Placebo | 12 | Hvidovre | N/A | Denmark | 12.47708 | 55.64297
København NV | N/A | Denmark | 12.52343 | 55.71258
Odense C | N/A | Denmark | 10.39538 | 55.40841
Helsinki | N/A | Finland | 24.93545 | 60.16952
Preitilä | N/A | Finland | 22.73781 | 60.46203
Tampere | N/A | Finland | 23.78712 | 61.49911
Breda | N/A | Netherlands | 4.77596... | 0 | NCT00629239 |
[
5
] | 83 | RANDOMIZED | PARALLEL | 1PREVENTION | 3TRIPLE | true | 0ALL | false | The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear).
The hypothesis would be that ACULAR treatment wi... | Each year ROP affects an estimated 14,000-16,000 premature, low birth weight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires surgical treatment. Despite those treatment, abou... | Retinopathy of Prematurity Retinal Detachment Blindness | Retinopathy of Prematurity Premature Infants ACULAR Refresh Tears | null | 2 | arm 1: None arm 2: None | [
0,
2
] | 3 | [
0,
0,
0
] | intervention 1: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 2: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 3: None | intervention 1: ACULAR intervention 2: REFRESH TEARS intervention 3: placebo | 1 | Mobile | Alabama | United States | -88.04305 | 30.69436 | 0 | NCT00634972 |
[
3
] | 27 | RANDOMIZED | CROSSOVER | 4SUPPORTIVE_CARE | 4QUADRUPLE | false | 0ALL | false | This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients | null | Chronic Obstructive Pulmonary Disease | COPD, Indacaterol Maleate, Exercise testing | null | 2 | arm 1: In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device intervention 2: Matching placebo devices and hard gelatin capsules | intervention 1: Indacaterol 300μg intervention 2: Placebo | 3 | Berlin | N/A | Germany | 13.41053 | 52.52437
Mönchengladbach | N/A | Germany | 6.44172 | 51.18539
Wiesbaden | N/A | Germany | 8.24932 | 50.08258 | 0 | NCT00636961 |
[
5
] | 67 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 1FEMALE | true | After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which ... | This study would include a total of 60 patients randomized into 2 equal groups. Patients will be interviewed in the holding area and informed signed consent will be obtained. Patients will be induced with general anesthesia in keeping with standard practice. At the end of surgical procedure, before the patient is extub... | Postoperative Pain | null | 2 | arm 1: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day arm 2: Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site | [
1,
0
] | 2 | [
0,
0
] | intervention 1: Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day intervention 2: Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine | intervention 1: Ketorolac intervention 2: Ketorolac and Ropivacaine | 1 | Brooklyn | New York | United States | -73.94958 | 40.6501 | 0 | NCT00638508 | |
[
5
] | 48 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for... | This is an open label, multicenter, 6 week study of the conversion from oral selegiline to orally disintegrating selegiline in PD patients with or without motor fluctuations, and currently taking levodopa. The study consists of the substitution of the oral selegiline with 1.25 mg of orally disintegrating selegiline for... | Parkinson's Disease | Parkinson's disease selegiline to Zelapar switch orally disintegrating formulation | null | 1 | arm 1: Open label switch from current oral selegiline dose to orally disintegrating selegiline (Zelapar) titrated to a dose of 2.5 mg QD. | [
0
] | 1 | [
0
] | intervention 1: Switch from oral selegiline to Zelapar 1.25 mg QD titrated to 2.5 mg QD | intervention 1: Zelapar | 5 | La Jolla | California | United States | -117.2742 | 32.84727
Sunnyvale | California | United States | -122.03635 | 37.36883
Boca Raton | Florida | United States | -80.0831 | 26.35869
Dallas | Texas | United States | -96.80667 | 32.78306
Houston | Texas | United States | -95.36327 | 29.76328 | 0 | NCT00640159 |
[
2
] | 85 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | true | 0ALL | false | The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV) | null | Antivirals/HIV | null | 2 | arm 1: None arm 2: None | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Capsule, Oral, 150 mg, once daily, 11 Days intervention 2: Capsules, Oral, 18 Days
Rifabutin (150 mg, 2x/wk)
Atazanavir (300 mg, once daily)
Ritonavir (100 mg, once daily) | intervention 1: Rifabutin intervention 2: Rifabutin + Atazanavir + Ritonavir | 1 | Hamilton | New Jersey | United States | -74.08125 | 40.20706 | 0 | NCT00646776 | |
[
3
] | 52 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | true | The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system. | The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were... | Intraventricular Hemorrhage | Intraventricular hemorrhage (IVH) rt-PA | null | 3 | arm 1: In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. arm 2: In stage 1 of the protoc... | [
1,
1,
0
] | 1 | [
0
] | intervention 1: 0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage. | intervention 1: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo) | 25 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Los Angeles | California | United States | -118.24368 | 34.05223
Palo Alto | California | United States | -122.14302 | 37.44188
Hartford | Connecticut | United States | -72.68509 | 41.76371
Maywood | Illinois | United States | -87.84312 | 41.8792
Wichita | Kan... | 0 | NCT00650858 |
[
3
] | 81 | RANDOMIZED | CROSSOVER | 1PREVENTION | 4QUADRUPLE | true | 1FEMALE | false | The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel). | The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.
The secondary objectives of this study are the following:
* to assess the safety of 10% (150 mg) lidocain... | Dysmenorrhea | Dysmenorrhea Periods Menstrual Primary dysmenorrhea in women with recurrent dysmenorrhea | null | 2 | arm 1: Lidocaine 10% (150mg) vaginal gel arm 2: Placebo vaginal gel | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days intervention 2: Placebo vaginal gel administered once daily for 4 days | intervention 1: Lidocaine intervention 2: Placebo | 4 | Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
Memphis | Tennessee | United States | -90.04898 | 35.14953
Austin | Texas | United States | -97.74306 | 30.26715
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00651313 |
[
2,
3
] | 12 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | true | 0ALL | null | Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation. | The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent ov... | Wounds | burn wounds wound healing | null | 2 | arm 1: GLYC-101 Active Retro-auricular Site (1 per participant) arm 2: Placebo Retro-auricular Site (1 per participant)
This arm undergoes laser ablation with subsequent Placebo gel administration | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Administration of Placebo gel on Day 1, 3 and 5 post ablation. intervention 2: Administration on Day 1, 3 and 5 post laser ablation. | intervention 1: Placebo gel intervention 2: GLYC-101 gel (1.0 %) | 1 | Beverly Hills | California | United States | -118.40036 | 34.07362 | 0 | NCT00656474 |
[
0
] | 10 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | true | 2MALE | false | Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. We are interested in knowing if a medication named Ondansetron can help ease or prevent symptoms a... | We hope to learn if Palonosetron and/or combination with hydroxyzine can be used to prevent or attenuate the signs and symptoms of opioid withdrawal. If we find that it can help prevent these symptoms, it may become a new treatment that can aid patients suffering from these symptoms. | Substance-Related Disorders | Palonosetron Hydroxyzine Acute opioid withdrawal | null | 6 | arm 1: At T = 0 (minutes), healthy (non-opioid dependent, non-substance abuser) male volunteers (N=10) were pre-treated with either placebo (0.9% normal saline), palonosetron IV (0.75mg), or palonosetron IV (0.75mg) and hydroxyzine per os (PO) (100mg) in a crossover study design. This was followed at T = 30 by intraven... | [
0,
0,
0,
0,
0,
0
] | 3 | [
0,
0,
10
] | intervention 1: Over 3 study visits, patients will receive one of the following treatment regimens:
* Placebo saline IV and sugar pill
* 0.75 mg Palonosetron IV and sugar pill
* 0.75 mg Palonosetron IV and 100 mg hydroxyzine PO intervention 2: Over 3 study visits, patients will receive one of the following treatment r... | intervention 1: Palonosetron intervention 2: Hydroxyzine intervention 3: Placebo | 1 | Stanford | California | United States | -122.16608 | 37.42411 | 0 | NCT00661674 |
[
4
] | 89 | RANDOMIZED | CROSSOVER | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study will evaluate the onset of action of indacaterol (150 and 300 µg) as compared to placebo, salbutamol 200 µg and salmeterol/fluticasone 50/500 µg | null | Chronic Obstructive Pulmonary Disease | chronic obstructive pulmonary disease COPD indacaterol adults | null | 5 | arm 1: Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, pa... | [
0,
0,
0,
0,
0
] | 6 | [
0,
0,
0,
0,
0,
0
] | intervention 1: Indacaterol 150 and 300 μg, delivered via single-dose dry-powder inhaler (SDDPI) intervention 2: Salmeterol/fluticasone 50/500 μg fixed-dose combination delivered via manufacturer's proprietary Multi-Dose Dry-Powder Inhaler (MDDPI). intervention 3: Salbutamol 200 μg delivered via manufacturer's propriet... | intervention 1: Indacaterol intervention 2: Salmeterol/fluticasone (50/500 μg) intervention 3: Salbutamol (200 µg) intervention 4: Placebo to Indacaterol intervention 5: Placebo to Salmeterol/fluticasone intervention 6: Placebo to salbutamol | 17 | Tamarac | Florida | United States | -80.24977 | 26.21286
Lafayette | Louisiana | United States | -92.01984 | 30.22409
Saint Charles | Missouri | United States | -90.48123 | 38.78394
Shelby | North Carolina | United States | -81.53565 | 35.29235
Beaver | Pennsylvania | United States | -80.30478 | 40.69534
Antwerp | N/A ... | 0 | NCT00669617 |
[
5
] | 100 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris. | Same as above. | Acne Vulgaris | null | 1 | arm 1: adapalene gel, 0.3%
Other Names:
Differin® Gel, 0.3% Applied once daily at bedtime
clindamycin/benzoyl peroxide gel
Other Names:
Duac® Gel Applied once daily in the morning | [
0
] | 2 | [
0,
0
] | intervention 1: Applied once daily at bedtime intervention 2: Applied once daily in the morning | intervention 1: adapalene gel, 0.3% intervention 2: clindamycin/benzoyl peroxide gel | 4 | Sacramento | California | United States | -121.4944 | 38.58157
Louisville | Kentucky | United States | -85.75941 | 38.25424
Warren | Ohio | United States | -80.81842 | 41.23756
Portland | Oregon | United States | -122.67621 | 45.52345 | 0 | NCT00671749 | |
[
0
] | 16 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | true | 0ALL | false | This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye. | Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with prop... | Keratoconjunctivitis Sicca | ocular lubricants | null | 2 | arm 1: One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. arm 2: The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol... | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation. intervention 2: Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillat... | intervention 1: glycerin intervention 2: polyethylene glycol 400/propylene glycol | 1 | Rochester | New York | United States | -77.61556 | 43.15478 | 0 | NCT00681265 |
[
5
] | 232 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 2MALE | false | Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.
It is not well known if a stratification based on the grade of BOO and bladder contractility has any ... | 1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 mo... | BPH | LUTS BPH bladder outlet obstruction bladder contractility | null | 4 | arm 1: Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 2: BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month. arm 3: BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 4: BOOI\<2... | [
1,
1,
1,
1
] | 4 | [
0,
0,
0,
0
] | intervention 1: 10mg, once daily, 12months intervention 2: 10mg, once daily, 12months intervention 3: 10mg, once daily, 12months intervention 4: 10mg, once daily, 12months | intervention 1: Alfuzosin intervention 2: Alfuzosin intervention 3: Alfuzosin intervention 4: Alfuzosin | 0 | null | 0 | NCT00696761 |
[
3
] | 30 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse. | In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to rec... | Opioid Abuse | Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence | null | 2 | arm 1: oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose arm 2: oxycodone HCl 5mg tablets; 8 tablets per dose | [
1,
1
] | 2 | [
0,
0
] | intervention 1: followed by oxycodone 5mg with 48 hour washout intervention 2: followed by Acurox 5/30mg with 48 hour washout | intervention 1: Acurox 5/30mg taken first intervention 2: Oxycodone 5mg taken first | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00699010 |
[
5
] | 8 | RANDOMIZED | PARALLEL | 1PREVENTION | 4QUADRUPLE | true | 0ALL | false | The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week period. Participants will be evaluated with regard to BMI, percent body fat, insulin activity, and hunger. | The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to i... | Obesity Diabetes Mellitus, Type 2 | null | 2 | arm 1: nutrition education plus active supplement arm 2: nutrition education plus inactive supplement | [
1,
2
] | 2 | [
0,
0
] | intervention 1: After all baseline measures have been completed, participants will be randomly assigned to either the nutrition education + supplement group, or the nutrition education + placebo group. The length of the intervention is twelve weeks. Nutrition classes will take place once a week for 1 1/2 hours. Subject... | intervention 1: nutrition education plus active supplement intervention 2: nutrition education plus inactive supplement | 1 | Los Angeles | California | United States | -118.24368 | 34.05223 | 0 | NCT00699413 | |
[
3
] | 64 | RANDOMIZED | PARALLEL | 7BASIC_SCIENCE | 4QUADRUPLE | false | 0ALL | false | Study of T-PRED(TM) compared to Pred Forte(R) | null | Cataract | null | 2 | arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate | [
1,
1
] | 2 | [
0,
0
] | intervention 1: T-PRED sterile ophthalmic solution intervention 2: Pred Forte sterile ophthalmic solution | intervention 1: T-PRED intervention 2: Pred Forte | 1 | Irvine | California | United States | -117.82311 | 33.66946 | 0 | NCT00699803 | |
[
5
] | 478 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone. | null | Hypertension | Hypertension ambulatory blood pressure monitoring | null | 2 | arm 1: After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of d... | [
0,
0
] | 2 | [
0,
0
] | intervention 1: 5 mg or 10 mg tablets. intervention 2: 160 mg capsules. | intervention 1: Amlodipine intervention 2: Valsartan | 2 | Paris | N/A | France | 2.3488 | 48.85341
Tunisia | N/A | Tunisia | N/A | N/A | 0 | NCT00700271 |
[
5
] | 16 | RANDOMIZED | CROSSOVER | 2DIAGNOSTIC | 1SINGLE | true | 0ALL | false | The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. | Increased amygdala and insula activity have been implicated in neurobiological models of anxiety. Using fMRI, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. This study aims to replicate those results but by using a differ... | Anxiety Disorders | functional magnetic resonance imaging fMRI alprazolam anxiety disorders | null | 3 | arm 1: 0.25 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan.
One-time, single dose.
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. arm 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
One-time, s... | [
1,
1,
2
] | 3 | [
0,
0,
0
] | intervention 1: 0.25 mg alprazolam PO (liquid) to be administered 1 hour prior to fMRI scan
Note that subjects receive all 3 treatments in randomized order (cross-over study), approximately 7-10 days apart. intervention 2: 1 mg alprazolam PO (liquid) will be administered 1 hour prior to fMRI scan
Note that subjects r... | intervention 1: 0.25 mg alprazolam intervention 2: 1.0 mg alprazolam intervention 3: placebo | 1 | La Jolla | California | United States | -117.2742 | 32.84727 | 0 | NCT00703885 |
[
3
] | 35 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | false | 0ALL | null | GSK1349572 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase IIa, multicenter, randomized, parallel, double-blind, dose ranging, placebo-controlled 'proof of concept' study is to be conducted to compare antiviral effect, safety, tolerability, and pharmacokinetics of GSK1349... | null | Infection, Human Immunodeficiency Virus | dose-ranging study phase IIa integrase inhibitor HIV-1 infection | null | 3 | arm 1: GSK1349572 2 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 2: GSK1349572 10 mg or placebo every 24 hours for 10 days. Screening visit up to 30 days prior to first dose and follow-up for 11 days after last dose. arm 3: GS... | [
0,
0,
0
] | 2 | [
0,
0
] | intervention 1: GSK1349572 is an experimental drug being developed for the treatment of HIV. It is in the class of integrase inhibitors. intervention 2: Placebo is a tablet with no drug in it. | intervention 1: GSK1349572 intervention 2: Placebo | 18 | Bakersfield | California | United States | -119.01871 | 35.37329
Long Beach | California | United States | -118.18923 | 33.76696
Newport Beach | California | United States | -117.92895 | 33.61891
Northridge | California | United States | -118.53675 | 34.22834
San Francisco | California | United States | -122.41942 | 37... | 0 | NCT00708110 |
[
4
] | 19 | RANDOMIZED | CROSSOVER | 7BASIC_SCIENCE | 2DOUBLE | true | 0ALL | false | The study is designed to compare the abuse liabilities of intravenous buprenorphine and buprenorphine/naloxone in individuals who are physically dependent on sublingual buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower than that of buprenorphine alone. | Drug dependence is a major international public health problem of which opioid dependence, notably involving heroin, is a major component. Opioid dependence affects an estimated 13 million injection drug users (IDUs) worldwide. The high health service costs for the treatment of diseases related to non-medical drug use ... | Opioid-related Disorders | null | 7 | arm 1: Heroin 25 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 2: Naloxone (NAL) .4 mg. Administered intravenously, while participants were under 2, 8 and 24 sublingual (SL) Bup maintenance conditions. arm 3: Combined dosing groups of (4 mg and... | [
1,
1,
0,
0,
0,
0,
2
] | 7 | [
0,
0,
0,
0,
0,
0,
0
] | intervention 1: Heroin (25 mg) intervention 2: .4 mg intervention 3: 4 and 8 mg intervention 4: 8mg and 16 mg intervention 5: Buprenorphine/Naloxone 4/1 mg, 8/2 mg intervention 6: Buprenorphine/Naloxone 8/2 mg, 16/4 mg intervention 7: Placebo control administration | intervention 1: Heroin intervention 2: Naloxone intervention 3: Low Bup Dose intervention 4: High Bup Dose intervention 5: Low Bup/Nal Dose intervention 6: High Bup/Nal Dose intervention 7: Placebo (PCB) | 1 | New York | New York | United States | -74.00597 | 40.71427 | 0 | NCT00710385 | |
[
4
] | 312 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain. | null | Toothache | Dental Pain Analgesia | null | 2 | arm 1: single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. arm 2: Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery. | [
0,
2
] | 2 | [
0,
0
] | intervention 1: Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery intervention 2: Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery | intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Placebo | 3 | Austin | Texas | United States | -97.74306 | 30.26715
Austin | Texas | United States | -97.74306 | 30.26715
Salt Lake City | Utah | United States | -111.89105 | 40.76078 | 0 | NCT00720057 |
[
4
] | 600 | RANDOMIZED | PARALLEL | 0TREATMENT | 4QUADRUPLE | false | 0ALL | false | The purpose of this study is to determine the efficacy of pioglitazone, twice daily (BID), combined with metformin versus pioglitazone taken alone and metformin taken alone in treating Type 2 Diabetes Mellitus. | Pioglitazone hydrochloride (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones, which act by reducing insulin resistance. Insulin resistance is a key feature of dysmetabolic syndrome and has been suggested to be the common pathophysiologic basis of both atherosclerosis and type 2 dia... | Diabetes Mellitus | Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus, Lipoatrophic Dyslipidemia Drug Therapy | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
1,
1
] | 3 | [
0,
0,
0
] | intervention 1: Pioglitazone 15 mg /metformin 850 mg combination, tablets, orally, twice daily for up to 24 weeks. intervention 2: Pioglitazone 15 mg, tablets, orally, twice daily for up to 24 weeks. intervention 3: Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks. | intervention 1: Pioglitazone and metformin intervention 2: Pioglitazone intervention 3: Metformin | 77 | Birmingham | Alabama | United States | -86.80249 | 33.52066
Haleyville | Alabama | United States | -87.62141 | 34.22649
Montgomery | Alabama | United States | -86.29997 | 32.36681
Pell City | Alabama | United States | -86.28609 | 33.58621
Phoenix | Arizona | United States | -112.07404 | 33.44838
Tucson | Arizona | Unit... | 0 | NCT00727857 |
[
0
] | 20 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 0NONE | true | 1FEMALE | true | The purpose of this study is to determine if a reduction in the enzyme 1-hydroxylase, which activates Vitamin D, is the cause of overactivity of the parathyroid glands (called secondary hyperparathyroidism - normal blood calcium and elevated parathyroid hormone) in a selected group of young patients with normal kidney ... | Vitamin D, an essential nutrient, is produced by the skin after sunlight shines on it. Vitamin D must then be activated by both the liver and the kidneys to perform its function of maintaining strong bones and helping to prevent heart disease, infection, diabetes and cancer. Reduced kidney activation of Vitamin D occur... | Secondary Hyperparathyroidism | hyperparathyroidism parathyroid vitamin D vitamin D deficiency | null | 2 | arm 1: control subject arm 2: Patient with secondary hyperparathyroidism | [
1,
0
] | 1 | [
0
] | intervention 1: Teriparatide will be given by continuous intravenous infusion at a rate of 12 pmol/kg/hr for 8 hours to both "patients" and "controls" | intervention 1: Teriparatide | 1 | Baltimore | Maryland | United States | -76.61219 | 39.29038 | 0 | NCT00754442 |
[
5
] | 14 | NON_RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | The primary objective of this study is to evaluate quality of life changes in Puerto Rican subjects with Rheumatoid Arthritis treated with Humira (adalimumab) as their first Anti-TNF Monoclonal Antibody. | null | Rheumatoid Arthritis | null | 1 | arm 1: All subjects will receive Adalimumab | [
0
] | 1 | [
0
] | intervention 1: 40 mg eow | intervention 1: Humira (adalimumab) | 10 | Aguada | N/A | Puerto Rico | -67.18824 | 18.37939
Bayamón | N/A | Puerto Rico | -66.15572 | 18.39856
Caguas | N/A | Puerto Rico | -66.0485 | 18.23412
Caguas | N/A | Puerto Rico | -66.0485 | 18.23412
Humacao | N/A | Puerto Rico | -65.82738 | 18.14968
Manatí | N/A | Puerto Rico | -66.49212 | 18.42745
Rio Piedras | N/A | ... | 0 | NCT00761514 | |
[
3,
4
] | 216 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia. | The study evaluates the efficacy and safety of the use of desflurane (BLM-240) (with and without nitrous oxide) in maintenance of general anesthesia in adult patients undergoing surgical procedures typically performed under general anesthesia in Japan (thoracic, abdominal, joints, back, and neck), where analgesics and ... | Anesthesia | anesthesia desflurane | null | 3 | arm 1: None arm 2: None arm 3: None | [
0,
0,
1
] | 3 | [
0,
0,
0
] | intervention 1: volatile liquid for inhalation intervention 2: volatile liquid for inhalation with gas for inhalation intervention 3: volatile liquid for inhalation and gas for inhalation | intervention 1: desflurane intervention 2: desflurane/nitrous oxide intervention 3: sevoflurane/nitrous oxide | 15 | Kagoshima | N/A | Japan | 130.55 | 31.56667
Kyoto | N/A | Japan | 135.75385 | 35.02107
Nagoya | N/A | Japan | 136.90641 | 35.18147
Okayama | N/A | Japan | 133.93333 | 34.65
Osaka | N/A | Japan | 135.50107 | 34.69379
Sapporo | N/A | Japan | 141.35 | 43.06667
Shizuoka | N/A | Japan | 138.38333 | 34.98333
Tokyo | N/A | Ja... | 0 | NCT00762372 |
[
4
] | 6 | RANDOMIZED | CROSSOVER | 0TREATMENT | 2DOUBLE | true | 0ALL | false | To determine the effect of an amino acid on bacterial glycolytic acid formation in human interdental plaque. | null | Dental Plaque | null | 3 | arm 1: fluoride/triclosan/copolymer toothpaste arm 2: fluoride only toothpaste arm 3: fluoride/triclosan/amino acid toothpaste | [
1,
2,
0
] | 3 | [
0,
0,
0
] | intervention 1: Rinse 3 times daily with assigned toothpaste slurry intervention 2: Rinse 3 times daily with assigned toothpaste slurry intervention 3: Rinse 3 times daily with assigned toothpaste slurry | intervention 1: Triclosan, Fluoride intervention 2: fluoride intervention 3: Fluoride, triclosan, amino acid | 1 | Zurich | N/A | Switzerland | 8.55 | 47.36667 | 0 | NCT00762450 | |
[
4
] | 44 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The objective is to compare two commerical oral products for the treatment of gingivitis. | null | Dental Plaque | null | 2 | arm 1: commercially available Fluoride only toothpaste arm 2: Commercially available triclosan/copolymer/fluoride toothpaste | [
2,
1
] | 3 | [
0,
0,
0
] | intervention 1: Brush teeth two times daily for 6 weeks intervention 2: Brush two times daily for 6 weeks intervention 3: Brush two times daily for 6 weeks | intervention 1: Fluoride intervention 2: Triclosan intervention 3: Fluoride | 1 | Louisville | Kentucky | United States | -85.75941 | 38.25424 | 0 | NCT00762515 | |
[
4
] | 105 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | true | 0ALL | false | The efficacy of two dentifrices in controlling gingivitis and plaque in adults with implants | null | Gingival Diseases | null | 2 | arm 1: fluoride toothpaste (Ultrabrite) arm 2: fluoride/triclosan/copolymer toothpaste | [
2,
1
] | 2 | [
0,
0
] | intervention 1: Brush twice daily intervention 2: Brush twice daily | intervention 1: Fluoride intervention 2: Triclosan, fluoride | 2 | Buffalo | New York | United States | -78.87837 | 42.88645
Jerusalem | N/A | Israel | 35.21633 | 31.76904 | 0 | NCT00762619 | |
[
4
] | 60 | RANDOMIZED | CROSSOVER | null | 0NONE | true | 0ALL | false | Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. | Enrolled participants were divided into 2 groups, with 30 participants in each group.
Group 1: This group was randomized into a single-dose, 2-way crossover design. These participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and Prilosec OTC Tablets (both at a 20 mg omeprazole dose)... | Gastric Acid Human Experimentation | null | 2 | arm 1: Omeprazole 20 mg /sodium bicarbonate 1100 mg over-the-counter (OTC) Capsule arm 2: Omeprazole magnesium 20 mg OTC tablet | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days. intervention 2: Single dose of omeprazole magnesium per day for either 1 or 7 days. | intervention 1: Omeprazole/sodium bicarbonate intervention 2: omeprazole magnesium (20 mg equivalent) | 0 | null | 0 | NCT00765206 | |
[
0
] | 223 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | true | To compare flavocoxid with naproxen for patients with moderate to severe osteoarthritis of the knee. | Efficacy of flavocoxid 500 mg compared with naproxen 500 mg in subjects with moderate-severe osteoarthritis of the knee. | Osteoarthritis of Knee | null | 2 | arm 1: flavonoid mixture arm 2: nonsteroidal anti-inflammatory drug | [
0,
1
] | 2 | [
7,
0
] | intervention 1: medical food intervention 2: antiinflammatory drug | intervention 1: flavocoxid intervention 2: Naproxen | 0 | null | 0 | NCT00790985 | |
[
5
] | 169 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene... | Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial.
Acne vulgaris is the most common dermatol... | Acne Vulgaris | Differin quality of life Acne Duac Acne Vulgaris | null | 2 | arm 1: Duac Gel arm 2: Differin gel | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Duac® Gel will be applied to the face once daily at night, for 12 weeks. intervention 2: Differin Gel will be applied to the face once daily at night, for 12 weeks. | intervention 1: Duac Gel intervention 2: Differin gel | 8 | A Coruña | N/A | Spain | -8.396 | 43.37135
Badalona | N/A | Spain | 2.24741 | 41.45004
Barcelona | N/A | Spain | 2.15899 | 41.38879
Madrid | N/A | Spain | -3.70256 | 40.4165
Madrid | N/A | Spain | -3.70256 | 40.4165
Málaga | N/A | Spain | -4.42034 | 36.72016
Pamplona | N/A | Spain | -1.64323 | 42.81687
Salamanca | N/A ... | 0 | NCT00807014 |
[
0
] | 10 | NA | SINGLE_GROUP | 0TREATMENT | 0NONE | false | 0ALL | false | This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required. | null | Schizophrenia | null | 1 | arm 1: Allopurinal 300mg once daily by mouth for four weeks | [
0
] | 1 | [
0
] | intervention 1: 300mg once daily by mouth for four weeks | intervention 1: Allopurinal | 0 | null | 0 | NCT00823199 | |
[
5
] | 33 | RANDOMIZED | PARALLEL | 0TREATMENT | 1SINGLE | false | 0ALL | false | To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline in the treatment of moderate acne | To compare the efficacy and safety of Benzoyl peroxide used in combination with clindamycin vs. Benzoyl peroxide used in combination with clindamycin and doxycycline once daily in the treatment of moderate acne | Acne | Acne | null | 2 | arm 1: Benzoyl peroxide (BPO) wash with clindamycin foam arm 2: Benzoyl peroxide (BPO) wash with clindamycin foam and doxycycline capsules | [
1,
1
] | 2 | [
0,
0
] | intervention 1: Benzoyl peroxide wash - Clindamycin foam intervention 2: Benzoyl peroxide wash - Clindamycin foam - Doxycycline capsules | intervention 1: Benzoyl peroxide with clindamycin intervention 2: Benzoyl peroxide with clindamycin and doxycycline | 2 | Fremont | California | United States | -121.98857 | 37.54827
Las Vegas | Nevada | United States | -115.13722 | 36.17497 | 0 | NCT00837213 |
[
0
] | 10 | RANDOMIZED | SINGLE_GROUP | 0TREATMENT | 2DOUBLE | true | 0ALL | true | This study is a split face, paired-comparison, pilot study of at least 10 subjects to complete. Participants in this study will be patients seen at Children's Memorial Hospital, who are clinically diagnosed with mild to moderate acne vulgaris. Participants will be recruited from one of the clinics, as well as from prev... | Acne vulgaris is a follicular disorder occurring in pilosebaceous units in the skin of the face, neck, and upper trunk. These sebaceous follicles have follicular channels and adjacent multiacinar sebaceous glands. In the lubrication process of normal skin, sebum travels through the follicular canal to the skin surface,... | Acne Vulgaris | Acne | null | 1 | arm 1: None | [
0
] | 2 | [
0,
0
] | intervention 1: Formulation A will be applied to the randomly-assigned single (left or right) side of the face twice daily. intervention 2: Formulation B will be applied to the randomly-assigned single (left or right) side of the face twice daily. | intervention 1: Formulation A intervention 2: Formulation B | 1 | Chicago | Illinois | United States | -87.65005 | 41.85003 | 0 | NCT00848744 |
[
5
] | 49 | RANDOMIZED | PARALLEL | 0TREATMENT | 2DOUBLE | true | 0ALL | false | The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice | null | Gingivitis | null | 2 | arm 1: Triclosan/Copolymer/fluoride toothpaste arm 2: sodium monofluorophosphate toothpaste | [
1,
2
] | 2 | [
0,
0
] | intervention 1: Twice daily usage intervention 2: Twice daily usage | intervention 1: Triclosan/Copolymer/fluoride toothpaste intervention 2: sodium monofluorophosphate toothpaste | 1 | Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 | 0 | NCT00941668 | |
[
5
] | 217 | RANDOMIZED | PARALLEL | 0TREATMENT | 0NONE | false | 0ALL | false | The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the protective lining on the inner wall of the lower ... | This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), randomized (study drug assigned by chance) study in participants with reflux esophagitis. The study will include 4 visits: Visit 1 (Screeni... | Reflux Esophagitis | Reflux esophagitis Rabeprazole Lansoprazole | null | 2 | arm 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. arm 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days. | [
0,
1
] | 2 | [
0,
0
] | intervention 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. intervention 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days. | intervention 1: Rabeprazole intervention 2: Lansoprazole | 0 | null | 0 | NCT01008696 |
[
2
] | 18 | RANDOMIZED | CROSSOVER | 9OTHER | 0NONE | true | 0ALL | false | This study conducted in healthy male and female adult participants compared the bioavailability and relative safety and tolerance of a single dose of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered under fasting conditions with and without water with that of a single dose of Zofran Orally Dissolving Ta... | This was an open-label, single oral dose,randomized sequence, three-way crossover study to compare the bioavailability, safety and tolerability of ondansetron 8 mg Orally Dissolving Filmstrip (ODFS) administered without (Test Treatment A) and with water (Test Treatment B) with that of Zofran Orally Dissolving Tablets (... | Healthy Participants | bioavailability | null | 3 | arm 1: Six subjects received a single dose of each of the 3 study treatments in the following order: Test Treatment A (Ondansetron 8 mg ODFS without water), Test Treatment B (Ondansetron 8 mg ODFS with water), Test Treatment C (Zofran ODT® containing ondansetron 8 mg without water). Each dose was administered following... | [
0,
0,
0
] | 3 | [
0,
0,
0
] | intervention 1: Single dose of Ondansetron 8 mg (ODFS) administered without water intervention 2: Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water intervention 3: Single dose of Zofran ODT (containing ondansetron 8 mg) administered without w... | intervention 1: Ondansetron 8 mg ODFS without water intervention 2: Ondansetron 8 mg ODFS with water intervention 3: Zofran ODT (ondansetron 8 mg) without water | 0 | null | 0 | NCT01220167 |
[
2
] | 21 | RANDOMIZED | PARALLEL | 0TREATMENT | 3TRIPLE | false | 0ALL | false | This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication. | Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing pha... | Schizophrenia Schizoaffective Disorder Central Nervous System Diseases | Schizophrenia Schizoaffective CNS | null | 3 | arm 1: Matching placebo was administered as one capsule per day for 21 days. arm 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. arm 3: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. | [
2,
0,
0
] | 4 | [
0,
0,
0,
0
] | intervention 1: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. intervention 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. intervention 3: Matching placebo was administered as one capsule per day for 21 days. intervention 4: Concomitant therapy with antipsychotic medicatio... | intervention 1: EVP-6124 (0.3 mg/day) intervention 2: EVP-6124 (1.0 mg/day) intervention 3: Placebo intervention 4: Antipsychotic therapy | 1 | Wichita | Kansas | United States | -97.33754 | 37.69224 | 0 | NCT01556763 |
[
2
] | 20 | NON_RANDOMIZED | PARALLEL | 2DIAGNOSTIC | 1SINGLE | true | 0ALL | false | This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner. | null | Alzheimer Disease | Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging | null | 4 | arm 1: Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel arm 2: Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 arm 3: Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 arm 4: Healthy controls who received 370MBq (10 mCi) of florbetapir F 18. | [
0,
0,
0,
0
] | 1 | [
0
] | intervention 1: single dose IV injection | intervention 1: florbetapir F 18 | 3 | West Palm Beach | Florida | United States | -80.05337 | 26.71534
North East | Maryland | United States | -75.94133 | 39.60011
Clementon | New Jersey | United States | -74.98294 | 39.8115 | 0 | NCT01565330 |
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