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

[ 3 ]

70

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)

Patients with STEMI who are to undergo primary PCI will be randomized to an intravenous (iv) bolus of placebo vs. PRT060128 prior to angiography.

Myocardial Infarction

STEMI ACS

null

2

arm 1: Placebo for each Dose cohort: 10, 20, 40, and 60 mg arm 2: Experimental drug for each Dose cohort: 10, 20, 40, and 60 mg

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: administration of iv bolus prior to angiography intervention 2: administration of iv bolus prior to angiography

intervention 1: placebo intervention 2: PRT060128 Potassium

31

0

NCT00546260

[ 3 ]

1,334

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study was a dose-ranging efficiacy study in patients with essential hypertension to assess the blood pressure lowering effect, and safety of LCZ696 compared to valsartan and placebo. The study will also evaluate the efficacy and safety of AHU377 as compared to placebo.

null

Hypertension

Hypertension, valsartan, LCZ696

null

8

arm 1: Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 2: Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 3: Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 4: Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 5: Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsatan and AHU377 (5 tablets and 2 capsules) daily. arm 6: Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily. arm 7: Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily. arm 8: Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.

[ 0, 0, 0, 1, 1, 1, 0, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: None intervention 2: None intervention 3: None intervention 4: None

intervention 1: LCZ696 intervention 2: Valsartan intervention 3: AHU377 intervention 4: Placebo

182

0

NCT00549770

[ 4 ]

314

null

PARALLEL

0TREATMENT

null

false

0ALL

null

The primary purpose of this study is to: Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

null

Hypertension

null

0

null

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: telmisartan+amlodipine intervention 2: telmisartan

5

Chofu, Tokyo | N/A | Japan | N/A | N/A Musashino, Tokyo | N/A | Japan | N/A | N/A Nishi-ku, Hiroshima, Hiroshima | N/A | Japan | N/A | N/A Osaka, Osaka | N/A | Japan | N/A | N/A Shinjuku-ku, Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT00550953

[ 3 ]

257

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.

null

Chronic Obstructive Pulmonary Disease (COPD)

COPD Chronic Obstructive Pulmonary Disease Indacaterol QVA149

null

5

arm 1: Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 2: One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 3: One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 4: One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. arm 5: Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study.

[ 0, 0, 0, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 2: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 3: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. intervention 4: Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.

intervention 1: indacaterol/glycopyrrolate intervention 2: indacaterol intervention 3: glycopyrrolate intervention 4: placebo

40

Adelaide | N/A | Australia | 138.59863 | -34.92866 Clayton | N/A | Australia | 145.11667 | -37.91667 Daw Park | N/A | Australia | 138.58407 | -34.98975 Heidelberg | N/A | Australia | 145.06667 | -37.75 Nedlands | N/A | Australia | 115.8073 | -31.98184 Brussels | N/A | Belgium | 4.34878 | 50.85045 Jambes | N/A | Belgium | 4.87166 | 50.45636 Jette | N/A | Belgium | 4.33419 | 50.87309 Liège | N/A | Belgium | 5.56749 | 50.63373 Ostend | N/A | Belgium | 2.927 | 51.21551 Mississauga | N/A | Canada | -79.6583 | 43.5789 Newmarket | N/A | Canada | -79.46631 | 44.05011 Ottawa | N/A | Canada | -75.69812 | 45.41117 Pointe-Claire | N/A | Canada | -73.81669 | 45.44868 Québec | N/A | Canada | -71.21454 | 46.81228 Sainte-Foy | N/A | Canada | -71.29217 | 46.78139 Ambroise | N/A | France | N/A | N/A Lille | N/A | France | 3.05858 | 50.63297 Marseille | N/A | France | 5.38107 | 43.29695 Martigues | N/A | France | 5.05526 | 43.40735 Nantes | N/A | France | -1.55336 | 47.21725 Nice | N/A | France | 7.26608 | 43.70313 Perpignan | N/A | France | 2.89541 | 42.69764 Berlin | N/A | Germany | 13.41053 | 52.52437 Dortmund | N/A | Germany | 7.466 | 51.51494 Erfurt | N/A | Germany | 11.03283 | 50.9787 Hanover | N/A | Germany | 9.73322 | 52.37052 Mainz | N/A | Germany | 8.2791 | 49.98419 Marburg | N/A | Germany | 8.77069 | 50.80904 Florence | N/A | Italy | 11.24626 | 43.77925 Modena | N/A | Italy | 10.92539 | 44.64783 Trieste | N/A | Italy | 13.77678 | 45.64953 Badalona | N/A | Spain | 2.24741 | 41.45004 Barakaldo | N/A | Spain | -2.98813 | 43.29639 Cáceres | N/A | Spain | -6.37224 | 39.47649 Centelles | N/A | Spain | 2.21902 | 41.79746 Mataró | N/A | Spain | 2.4445 | 41.54211 Valencia | N/A | Spain | -0.37966 | 39.47391 Istanbul | N/A | Turkey (Türkiye) | 28.94966 | 41.01384 Izmir | N/A | Turkey (Türkiye) | 27.13838 | 38.41273

0

NCT00558285

[ 5 ]

12

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

null

The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.

See brief summary

Stress Disorders, Post-Traumatic

PTSD Paroxetine Subthreshold

null

2

arm 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. arm 2: None

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration. intervention 2: Placebo: same as paroxetine (active comparator)

intervention 1: Paroxetine intervention 2: Placebo

1

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

0

NCT00560612

[ 4 ]

5

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

A new drug (bortezomib \[VelcadeTM PS-341\]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Multiple Myeloma

null

2

arm 1: VTD = Velcade, Thalidomide, and Dexamethasone arm 2: VMD = velcade, melphalan, and dexamethasone

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles Thalidomide - By Mouth Days 1-28 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles intervention 2: Velcade - Into vein (IV) Days 1, 4, 8, 11 Yr 1: Every 28-35 days-12 cycles Yr 2: Every 8-10 weeks- 6 cycles

intervention 1: Velcade, Thalidomide, and Dexamethasone intervention 2: Velcade, Melphalan, and Dexamethasone

1

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

0

NCT00573391

[ 5 ]

768

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Evaluate the effect of VESIcare® on symptom bother for subjects with OAB

Phase 4, multi-center, randomized, double-blind, placebo-controlled, parallel group study. All subjects that meet the baseline criteria will be randomized in a 1:1 ratio into VESIcare® (solifenacin succinate) or placebo group. The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment. Primary efficacy will be based on OAB-q symptom bother score.

Urinary Bladder, Overactive

Overactive Bladder

null

2

arm 1: Matching placebo tablet taken once daily arm 2: 5mg or 10mg tablet taken once daily

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: Oral Administration intervention 2: Oral Administration

intervention 1: Placebo intervention 2: Solifenacin Succinate

59

0

NCT00573508

[ 3 ]

271

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

null

Ankle Sprain

Ankle, sprain, diclofenac diethylamine

null

3

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

[ 1, 2, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Diclofenac diethylamine 2.32% gel twice daily intervention 2: Vehicle 2 times daily intervention 3: Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

intervention 1: Diclofenac diethylamine 2.32% gel intervention 2: Placebo intervention 3: Diclofenac diethylamine 2.32% gel / Placebo

29

Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Bad Zwischenahn | N/A | Germany | 8.0 | 53.18333 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Dortmund | N/A | Germany | 7.466 | 51.51494 Dresden | N/A | Germany | 13.73832 | 51.05089 Düsseldorf | N/A | Germany | 6.77616 | 51.22172 Eichstätt | N/A | Germany | 11.19675 | 48.88854 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hamburg | N/A | Germany | 9.99302 | 53.55073 Hammelburg | N/A | Germany | 9.89143 | 50.11633 Karlsruhe | N/A | Germany | 8.40444 | 49.00937 Kaufbeuren | N/A | Germany | 10.62192 | 47.88238 Lambrecht/Pfalz | N/A | Germany | N/A | N/A Leipzig | N/A | Germany | 12.37129 | 51.33962 Meersburg | N/A | Germany | 9.27113 | 47.69419 Munich | N/A | Germany | 11.57549 | 48.13743 München | N/A | Germany | 13.31243 | 51.60698 München | N/A | Germany | 13.31243 | 51.60698 München | N/A | Germany | 13.31243 | 51.60698 Neustadt/Aisch | N/A | Germany | N/A | N/A Siegen | N/A | Germany | 8.02431 | 50.87481 Stockach | N/A | Germany | 9.0091 | 47.85105

0

NCT00573768

[ 4 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.

null

Asthma

Pediatric, asthma, albuterol-HFA and Placebo

null

2

arm 1: Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days. HFA-MDI refers to a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. arm 2: A placebo of a metered-dose inhaler (MDI) utilizing a hydrofluoroalkane (HFA) propellant. (Hereafter noted as "Placebo-HFA-MDI.")

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Albuterol HFA MDI 180 mcg four times a day (q.i.d) for a total daily albuterol dose of 720 mcg for 21 days. intervention 2: Placebo HFA MDI four times a day (q.i.d) for 21 days. intervention 3: Proventil® HFA (albuterol sulfate) Inhalation Aerosol (Key Pharmaceuticals) was used as rescue medication in this study. The rescue medication was over-labeled with instructions for emergency use in which subjects were instructed to self-administer up to two puffs every 20 minutes to a maximum of six puffs for any given episode while attempting to seek medical assistance.

intervention 1: Albuterol intervention 2: Placebo intervention 3: Proventil® HFA

13

0

NCT00577655

[ 3 ]

568

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

true

0ALL

false

This is a safety and efficacy study of bromfenac ophthalmic solution

null

Cataract Surgery

null

2

arm 1: None arm 2: None

[ 0, 0 ]

1

[ 0 ]

intervention 1: sterile opthalmic solution

intervention 1: bromfenac ophthalmic solution

1

Irvine | California | United States | -117.82311 | 33.66946

0

NCT00585975

[ 3 ]

95

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (RCC).

null

Carcinoma, Renal Cell

Sorafenib Nexavar Metastatic RCC Renal Cell Carcinoma Unresectable RCC

null

1

arm 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally

[ 0 ]

1

[ 0 ]

intervention 1: Sorafenib 200 mg tablets (400 mg \[2 x 200 mg tablets\] twice daily \[bid\] or 400 mg once daily \[od\] or 400 mg every other day \[qod\]) administered orally

intervention 1: Sorafenib (Nexavar, BAY43-9006)

41

0

NCT00586495

[ 4 ]

38

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We will compare the efficacy estimates in this study with historical smoking abstinence rates with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an open-label, phase II clinical trial.

Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have smoked 10 or more cigarettes per day for at least 6 months; and 3) are motivated to stop smoking. Subjects will be excluded if they have: 1) an unstable medical condition; 2) unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia; 3) personal history of seizures; 4) closed head trauma with any loss of consciousness or amnesia in the last 5 years; 5) ever history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion; 6) a history or psychosis, bipolar disorder, bulimia or anorexia nervosa); 7) have current depression as assessed by Center for Epidemiologic Studies Depression (CES-D); 8) have active substance abuse other than nicotine; 9) have used an investigational drug within the last 30 days; 10) are currently using a behavioral or pharmacologic tobacco treatment and unwilling or unable to discontinue use; 11) use of bupropion or varenicline in the previous 3 months; 12) current (past 14 days) use of antipsychotic or antidepressant; 13) an allergy to bupropion or varenicline; 14) untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100; 15) have another member of their household already participating in this study. The primary aims and hypotheses of this study are: 1. To obtain preliminary evidence of efficacy of 12 weeks of combination therapy with bupropion SR and varenicline for increasing the point prevalence smoking abstinence rates at 12 weeks among cigarette smokers. Hypothesis: The combination of bupropion SR plus varenicline for 12 weeks will increase the point prevalence smoking abstinence rates at 12 weeks among cigarettes smokers. 2. To obtain preliminary evidence of efficacy of combination therapy with bupropion SR and varenicline for decreasing craving and nicotine withdrawal symptoms among cigarette smokers trying to achieve smoking abstinence. Hypothesis: 12 weeks of combination therapy with bupropion SR and varenicline will significantly decrease craving and nicotine withdrawal among cigarette smokers trying to achieve smoking abstinence.

Smoking Tobacco Use Disorder

Smoking Smoking cessation Bupropion Varenicline Tobacco use disorder

null

1

arm 1: All 38 smokers will receive open-label bupropion SR and varenicline. Bupropion SR is an oral medication with recommended dosing of 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline is an oral medication with recommended dosing of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment. Subjects will quit on Day #8 after starting both medications.

[ 0 ]

1

[ 0 ]

intervention 1: Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.

intervention 1: Bupropion SR & Varenicline

1

Rochester | Minnesota | United States | -92.4699 | 44.02163

0

NCT00587769

[ 2, 3 ]

10

RANDOMIZED

CROSSOVER

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.

null

Pain Bladder Cancer Breast Cancer CNS Cancer Colon Cancer Esophageal Cancer Pancreatic Cancer Prostate Cancer Uterine Cancer Head and Neck Cancer Eye Cancer Otorhinolaryngologic Neoplasms

Pain HEENT cancer

null

3

arm 1: This is an open label dose-ranging trial. The first cohort of 8 patients will receive 40mg of d-methadone every 12 hours. arm 2: patients receiving around the clock opioid therapy-No patients were accrued to this group arm 3: patients not receiving around the clock opioid therapy.No patients were accrued to this group

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: 8 subjects to receive 40 mg d-Methadone twice a day intervention 2: After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24. intervention 3: After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.

intervention 1: d-Methadone intervention 2: D-methadone intervention 3: placebo

1

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

0

NCT00588640

[ 4 ]

490

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of AKs.

These were a randomized, double-blind, multicenter, placebo-controlled studies that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AK of the face or balding scalp. Subjects were scheduled for a total of 11 visits (1 prestudy screening visit and 10 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator. The duration of each subject's study participation was approximately 21 weeks, including a 4-week maximum screening period and a 17-week study period. At the End of Study (EOS) visit, eligible subjects may have been invited to participate in a separate study evaluating AK recurrence.

Actinic Keratosis

Actinic keratosis Dermatologic disease

null

3

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

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. intervention 2: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment. intervention 3: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.

intervention 1: Imiquimod cream intervention 2: Placebo cream intervention 3: Imiquimod cream

26

0

NCT00603798

[ 4 ]

479

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has been shown to be safe and effective for the treatment of AKs.

This was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable AKs of the face or balding scalp. Subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits). Subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. The creams were applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. The investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). Subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. Study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Ears were excluded from both assessment and treatment. Rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (LSRs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator. The duration of each subject's study participation was approximately 18 weeks, including a 4-week maximum screening period and a 14-week study period.

Actinic Keratoses

Actinic keratosis Skin disease

null

3

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

[ 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. intervention 2: cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. intervention 3: cream, 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.

intervention 1: imiquimod cream intervention 2: imiquimod cream intervention 3: Placebo

26

0

NCT00605176

[ 3 ]

178

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) 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

3

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

[ 1, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily intervention 2: Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily intervention 3: Treat-to-target dose titration scheme, injection s.c., once daily intervention 4: Tablets, 1500-2000 mg/day

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

28

Alès | N/A | France | 4.08082 | 44.12489 Brest | N/A | France | -4.48628 | 48.39029 La Rochelle | N/A | France | -1.15222 | 46.16308 Le Creusot | N/A | France | 4.41632 | 46.80714 Mont-de-Marsan | N/A | France | -0.49713 | 43.89022 Vénissieux | N/A | France | 4.88593 | 45.69706 Bad Kreuznach | N/A | Germany | 7.86713 | 49.8414 Bad Mergentheim | N/A | Germany | 9.77361 | 49.4925 Dormagen | N/A | Germany | 6.83167 | 51.09683 Hohenmölsen | N/A | Germany | 12.1 | 51.15769 Neuss | N/A | Germany | 6.68504 | 51.19807 Neuwied | N/A | Germany | 7.47057 | 50.4336 Elverum | N/A | Norway | 11.56231 | 60.88191 Hamar | N/A | Norway | 11.06798 | 60.7945 Kongsvinger | N/A | Norway | 11.99772 | 60.19049 Oslo | N/A | Norway | 10.74609 | 59.91273 Stavanger | N/A | Norway | 5.73332 | 58.97005 Tromsø | N/A | Norway | 18.95508 | 69.6489 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Bucharest | N/A | Romania | 26.10626 | 44.43225 Almería | N/A | Spain | -2.45974 | 36.83814 Partida de Bacarot | N/A | Spain | N/A | N/A Seville | N/A | Spain | -5.97317 | 37.38283 Valencia | N/A | Spain | -0.37966 | 39.47391 Valladolid | N/A | Spain | -4.72372 | 41.65518

0

NCT00614055

[ 5 ]

32

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

The purpose of this pilot study is to evaluate whether modafinil is helpful in alleviating fatigue, low energy, drowsiness and difficulty concentrating among patients with amyotrophic lateral sclerosis (ALS), and to evaluate incidence and frequency of adverse events, if any.

ALS is an untreatable, progressive, fatal neurodegenerative disease whose etiology is unknown and whose course is relatively rapid (median survival 3 years after diagnosis). Palliative care, including symptom management, can contribute greatly to improved quality of life. In this context, alleviation of fatigue can help maintain function, extend the duration of time when employment is feasible for those still working, and can enable patients to more fully participate in and enjoy social and recreational activities. Given the prevalence of fatigue in this population, identification of effective treatment is a meaningful goal.

Fatigue

Fatigue low energy ALS treatment

null

2

arm 1: Eligible patients will be treated at baseline through Week 4. Those who choose to continue will have additional in-person visits at Weeks 8 and 12 visits (and Week 16 for those starting modafinil at Week 4). arm 2: Sugar pill equivalent to the active comparator. Dosing schedule will be the same as the dosing schedule for Modafinil.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks. intervention 2: Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.

intervention 1: Modafinil intervention 2: Placebo

1

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

0

NCT00614926

[ 3 ]

26

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

1FEMALE

true

RATIONALE: Estrogen can cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial cancer.

OBJECTIVES: Primary * To determine the 90-day clinical benefit (defined as the sum of complete responses, partial responses, and stable disease) in patients with recurrent ovarian epithelial cancer treated with single agent fulvestrant. Secondary * To establish the time to termination of treatment (due to all causes including progression and intolerance) for patients treated with this drug. * To describe the toxicities observed in patients treated with this drug. * To evaluate the quality of life of patients treated with this drug. * To determine the effect that prolonged estrogen receptor antagonism has on markers of bone mineral turnover. OUTLINE: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 of all subsequent courses. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients in continued response at the end of 1 year may continue treatment at the discretion of the treating physician. Urinary N-telopeptide and serum skeletal-specific alkaline phosphatase are assessed at baseline and at 1, 3, and 6 months during study to determine the influence of estrogen blockade on bone mineral turnover. Quality of life is assessed at baseline and every 3 months during treatment, and at the end of treatment using The Functional Assessment of Cancer Therapy - Ovarian (FACT-O) cancer questionnaire. After completion of study treatment, patients are followed at approximately 30 days.

Ovarian Cancer

recurrent ovarian epithelial cancer

null

1

arm 1: Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.

[ 0 ]

1

[ 0 ]

intervention 1: Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.

intervention 1: Fulvestrant

1

Minneapolis | Minnesota | United States | -93.26384 | 44.97997

0

NCT00617188

[ 2 ]

22

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

true

0ALL

true

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of topical myristyl nicotinate cream may stop skin cancer from forming. PURPOSE: This randomized phase I trial is studying the side effects and best way to give topical myristyl nicotinate cream on the skin of healthy volunteers.

OBJECTIVES: * To determine if topical myristyl nicotinate (MN) is a safe, tolerable treatment in healthy volunteers. * To determine if topically administered MN cream is associated with any significant local or systemic toxicity in normal human subjects in a one-month period. OUTLINE: Participants are randomized to 1 of 2 treatment arms and serve as their own controls. * Arm I: Participants apply topical myristyl nicotinate to one forearm and topical placebo to the other forearm once daily for 4 weeks. * Arm II: Participants receive treatment as in arm I but on opposite forearms. All participants undergo blood collection for chemistry analysis (SMA-20 and CBC) at baseline and at 2 and 4 weeks.

Healthy

skin cancer healthy, no evidence of disease

null

2

arm 1: Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left) Topical Myristyl Nicotinate Cream and Placebo arm 2: Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Participants apply topical myristyl nicotinate to one forearm once daily for 4 weeks. intervention 2: Participants apply topical placebo to one forearm once daily for 4 weeks.

intervention 1: Topical Myristyl Nicotinate Cream intervention 2: Placebo

1

Tucson | Arizona | United States | -110.92648 | 32.22174

0

NCT00619060

[ 4 ]

173

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

null

The purpose of this study is to determine the safety of the oral formulation of levocetirizine in children ages 1 to less than 6 years old who suffer from allergic rhinitis or chronic urticaria of unknown origin.

null

Allergic Rhinitis Chronic Urticaria

Xyzal Levocetirizine Allergy Children Seasonal Allergies

null

2

arm 1: None arm 2: None

[ 2, 0 ]

2

[ 0, 0 ]

intervention 1: Levocetirizine dihydrochloride 1.25 mg oral drops formulation (5 drops containing 5mg/mL) dosed twice a day for 2 weeks intervention 2: Placebo oral drops (5 drops) dosed twice a day for 2 weeks.

intervention 1: Levocetirizine intervention 2: Placebo

28

0

NCT00619801

[ 4 ]

68

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

null

This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.

null

Chronic Obstructive Pulmonary Disease

chronic obstructive pulmonary disease COPD indacaterol

null

6

arm 1: In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 4: In treatment period 1, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received indacaterol 300 μg once daily for 14 days via SDDPI; and in treatment period 3, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI). There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 5: In treatment period 1, patients received indacaterol 300 μg once daily for 14 days via single-dose dry-powder inhaler (SDDPI); in treatment period 2, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); and in treatment period 3, patients received placebo to indacaterol once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 6: In treatment period 1, patients received salmeterol 50 μg twice daily for 14 days via multi-dose dry-powder inhaler (MDDPI); in treatment period 2, patients received placebo to indacaterol once daily for 14 days via single-dose dry-powder inhaler (SDDPI); and in treatment period 3, patients received indacaterol 300 μg once daily for 14 days via SDDPI. There was a washout period of 14 days between each treatment period. Indacaterol and placebo to indacaterol were administered double-blind; salmeterol was administered open-label. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

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

3

[ 0, 0, 0 ]

intervention 1: Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 3: Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).

intervention 1: Indacaterol 300 μg intervention 2: Placebo to indacaterol intervention 3: Salmeterol 50 μg

14

0

NCT00622635

[ 4 ]

416

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).

null

Chronic Obstructive Pulmonary Disease

chronic obstructive pulmonary disease COPD indacaterol

null

2

arm 1: Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

intervention 1: Indacaterol 150 μg intervention 2: Placebo to indacaterol

120

0

NCT00624286

[ 5 ]

18

NON_RANDOMIZED

FACTORIAL

0TREATMENT

0NONE

true

1FEMALE

false

The purpose this study is to measure cortical gama-aminobutyric acid levels (GABA) levels in menopausal women with major depressive disorder and healthy subjects using nuclear magnetic resonance spectroscopy (MRS). Measurements will be compared in 1) menopausal healthy subjects before and after estrogen replacement, and after fourteen days of medroxyprogesterone administration; and 2) in depressed menopausal subjects before and after treatment of their depression with antidepressant alone, estrogen alone or antidepressant plus estrogen. Cortical GABA levels will be correlated with plasma GABA and neurosteroid levels. Neurosteroids to be measured include progesterone, allopregnanolone, pregnenolone, and pregnenolone sulfate.

null

Menopause Depression

menopause women major depressive disorder Magnetic Resonance Spectroscopy

null

4

arm 1: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen alone. arm 2: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. arm 3: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined. arm 4: Non-depressed menopausal women between the ages of 40-70 receiving treatment with estrogen alone.

[ 1, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Treatment for major depressive disorder occurring in the context of the menopause while participating in brain imaging sessions pre and post treatment. Women receiving treatment for depression will be compared to normal controls receiving estrogen only for physical symptoms of menopause. intervention 2: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with fluoxetine alone. intervention 3: Menopausal women between the ages of 40-70 diagnosed with Major Depressive Disorder receiving treatment with estrogen and fluoxetine combined. intervention 4: Control participants with no MDD diagnosis received estrogen only for the treatment of physical symptoms of menopause.

intervention 1: MDD diagnosis and Estrogen treatment intervention 2: MDD diagnosis and Fluoxetine treatment intervention 3: MDD diagnosis with both Estrogen and Fluoxetine treatment intervention 4: No depression and estrogen treatment

1

New Haven | Connecticut | United States | -72.92816 | 41.30815

0

NCT00626340

[ 3 ]

150

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. The primary focus is bacterial infection.

Bacterial Infection

complicated skin and skin structure infections linezolid ceftaroline clinical response microbiological response Cellulitis Abscess Wound infection Deeper soft tissue Significant surgical intervention Gram-positive bacterial infection Gram-negative bacterial infection bacterial infection cephalosporin broad-spectrum activity

null

2

arm 1: Intramuscular every 12 hours arm 2: Intravenous every 12 hours

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: 600 mg injected every 12 hours for at least 5 but not more than 14 days intervention 2: 600 mg parenteral infused over 60 minutes for a minimum of 5 days and a maximum of 14 days intervention 3: 1000 mg infused over 60 minutes every 24 hours may be started with linezolid or added later (up to 72 hours after the first dose of linezolid) for subjects with a gram-negative infection indicated.

intervention 1: ceftaroline intervention 2: linezolid intervention 3: Aztreonam

13

0

NCT00633152

[ 3 ]

41

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as irinotecan and cisplatin, 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) may kill more tumor cells. PURPOSE: To determine if CPT-11 given together with cisplatin is effective in treating recurrent or metastatic head and neck cancer.

OBJECTIVES: * Evaluate the efficacy of irinotecan hydrochloride and cisplatin in patients with local-regionally recurrent or metastatic squamous cell carcinoma of the head and neck. * Evaluate the toxicity of irinotecan hydrochloride and cisplatin in these patients. * Determine the palliative effect of irinotecan hydrochloride and cisplatin on head and neck cancer symptoms using the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey. OUTLINE: Patients receive irinotecan hydrochloride IV over 60 minutes and cisplatin IV on days 1, 8, 22, and 29. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients complete the Vanderbilt Cancer Center (VICC) Head and Neck Cancer Symptom Survey at baseline, before each course, at the completion of study therapy, and then at each follow-up visit. After completion of study therapy, patients are followed every 6 weeks for 1 year and then every 3 months thereafter.

Head and Neck Cancer

recurrent squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the larynx recurrent verrucous carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma recurrent metastatic squamous neck cancer with occult primary untreated metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer

null

1

arm 1: None

[ 0 ]

2

[ 0, 0 ]

intervention 1: Starting dose 30 mg/m2 Dose level -1 20 mg/m2 intervention 2: 50 mg/m2 IV over 60 minutes, plus Cisplatin 30mig/m2 IV, repeated weekly for two weeks. followed by a one-week rest. This 3-week schedule given two times to equal one 6-week cycle. Maximum of 6 cycles.

intervention 1: cisplatin intervention 2: irinotecan hydrochloride

8

0

NCT00639769

[ 5 ]

22

RANDOMIZED

PARALLEL

2DIAGNOSTIC

3TRIPLE

false

0ALL

true

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation. Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler

The purpose of this study is to determine if there are differences, (benefits) between carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes. Specifically we will be looking at differences in blood pressure and blood sugar control, endothelial function, inflammation, oxidative stress and coagulation. Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done, Inflammatory and oxidative stress markers will be measured. Endothelial function will be measured using brachial artery ultrasound and laser skin Doppler. Baseline visit will be done when subjects are off all antihypertension medications except ACEI/ARB. Following the baseline study subjects will be randomized to study drug. The dose will be titrated until goal blood pressure is reached. Add on medication will be used if needed. Subjects will then undergo a second study. The third study will take place after 5 months on treatment. Stud drug will then be stoppped and subjects will be restudied 2 weeks later

Diabetes

diabetes blood pressure oxidative stress

null

2

arm 1: study drug- carvedilol arm 2: study drug metorprolol

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: variable intervention 2: variable

intervention 1: carvedilol intervention 2: metoprolol

1

Albuquerque | New Mexico | United States | -106.65114 | 35.08449

0

NCT00642434

[ 4 ]

832

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray. Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.

Seasonal Allergic Rhinitis

null

4

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

[ 1, 0, 2, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: placebo intervention 2: azelastine Hcl 548 mcg intervention 3: azelastine Hcl 548 mcg / fluticasone propionate 200 mcg intervention 4: fluticasone propionate 200 mcg

intervention 1: Placebo intervention 2: azelastine Hcl intervention 3: azelastineHcl / fluticasone propionate intervention 4: fluticasone propionate

43

0

NCT00651118

[ 5 ]

580

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

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

null

Seasonal Allergic Rhinitis

levocetirizine Xyzal Seasonal Allergic Rhinitis total symptom score quality of life

null

2

arm 1: Matched placebo tablets arm 2: 5 mg tablet

[ 2, 0 ]

2

[ 0, 0 ]

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

intervention 1: levocetirizine dihydrochloride intervention 2: placebo

38

0

NCT00653224

[ 5 ]

276

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

null

Gastroesophageal Reflux Disease

GERD Esophageal Reflux Gastro-Esophageal Reflux Regurgitation Gastric

null

2

arm 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate intervention 2: once daily

intervention 1: Esomeprazole intervention 2: Placebo

45

0

NCT00660660

[ 0 ]

33

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

Despite the lack of trials proving the efficacy of DNase in non cystic fibrosis patients, it is currently heavily used in this population. In fact, per evidence of barcode scanning via Meditech computer system at OU Medical Center 93% of the DNase prescribed in 2005 was for non Cystic fibrosis patients with an estimated yearly cost of $341,968.15.In vitro studies showed that the effect of Dnase was minimal on sputum viscosity when compared to Hypertonic saline . Furthermore recent studies on hypertonic saline in cystic fibrosis patients showed that it is an inexpensive and safe therapy when preceded by a bronchodilator in patients with cystic fibrosis. We hereby propose a prospective randomized trial to compare the efficacy of hypertonic saline, DNase, vs. normal saline in the treatment of atelectasis in non cystic fibrosis, mechanically ventilated patient.

null

Atelectasis

null

3

arm 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). arm 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). arm 3: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

[ 2, 1, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Nebulized isotonic saline solution (4 ml of 0.9 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). intervention 2: Nebulized hypertonic saline solution (4 ml of 7 % NaCl) twice daily, for a fixed period of 15 min, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl). intervention 3: 2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted in 3 ml of 0.9 % NaCl).

intervention 1: Normal saline: intervention 2: Hypertonic Saline intervention 3: Dornase alpha

1

Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756

0

NCT00671723

[ 3 ]

17

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of this study is to evaluate the safety and tolerability of MN-221 at two different dosing rates administered through a continuous infusion in subjects diagnosed with moderate to severe asthma.

This is a multi-center, randomized, single-blind\*, parallel group, placebo-controlled, study with two dosing regimens in subjects diagnosed with moderate to severe asthma using MN-221 or placebo. Subjects will be randomized to receive MN-221 or placebo in a 3:1 ratio, MN-221:placebo. Subjects randomized to receive MN-221 will be dosed with active study drug at both dosing visits, and subjects randomized to the placebo arm will receive placebo at both dosing visits. Approximately 25 subjects diagnosed with moderate to severe asthma who have not received inhaled corticosteroid therapy within one month of Screen Visit 1 will be enrolled and will participate throughout the study. Initial dose: * 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg MN-221 or Placebo) Subsequent dose: * 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg MN-221 or Placebo) There will be approximately a two to four week period between each dose regimen, during which time a safety review will be performed before proceeding to the next dose level. Subjects will be screened for eligibility and continued eligibility will be determined for each subject prior to administering each dose. After the initiation of the intravenous infusion of MN-221 or placebo, serial spirometry will be measured for approximately 24 hours. For each dose evaluation period, subjects will be domiciled in the clinical research unit (CRU) for 2 nights, beginning on Day -1, one day before dosing. Determination of continued study eligibility will be made on Day -1 for each dose level. Day 1 will include study drug infusion and approximately a 24-hour observation period into Day 2 to allow safety monitoring, serial spirometry, and serum PK measurements. Subjects will be discharged from the CRU on Day 2. They will return to the CRU approximately 2-4 weeks later to participate in the subsequent dose group. \*This is a "modified" single-blind study in which the subject and Investigator are both blinded regarding the treatment arm.

Asthma

asthma randomized placebo controlled dose escalation safety efficacy single blind MN-221

null

2

arm 1: None arm 2: Placebo intravenous infusion with dosing volume equivalent to active treatment.

[ 0, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg) intervention 2: Subsequent dose: 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg). intervention 3: Placebo intravenous infusion with dosing volume equivalent to active treatment.

intervention 1: MN-221 intervention 2: MN-221 intervention 3: Placebo

4

0

NCT00679263

[ 2 ]

1

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to determine if a reduced intensity (RI) (non-myeloablative) chemoimmunotherapy followed by Allogeneic Stem Cell Transplantation AlloSCT (matched family donors and matched unrelated cord blood donors) will be well tolerated.

This is to test whether a reduced intensity will result in a high degree of mixed or complete donor chimerism and stabilization of autoimmune disease in a select group of patients with medically refractory SLE or SSc.

Systemic Lupus Erythematosus Systemic Sclerosis

Autoimmune Disease Reduced Intensity Transplant

null

2

arm 1: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with medically refractory Systemic Lupus Erythematosus (SLE). arm 2: RI regimen of fludarabine/busulfan and Alemtuzumab (FBA) followed by AlloSCT in selected patients with Systemic Sclerosis (SSc).

[ 0, 0 ]

4

[ 3, 0, 0, 0 ]

intervention 1: Eeduced intensity allogeneic stem cell transplantation with a fludarabine/busulfan/alemtuzumab conditioning regimen is anticipated to result in mixed and/or complete donor chimerism and potentially alter the natural history and outcome of patients with medically refractory Systemic Lupus Erythematosus (SLE) or Systemic Sclerosis (SSc). intervention 2: Fludarabine 30 mg/m2 Day -7, -6, -5, -4, -3, -2 intervention 3: Busulfan 3.2 mg/kg Days \_8, -7, -6, -5 intervention 4: Campath: 2 mg/m2 Day -5; 6 mg/m2 Day -4, -3; 20 mg/m2 Day -2

intervention 1: Reduced Intensity Allogeneic Transplant intervention 2: Fludarabine intervention 3: Busulfan intervention 4: Campath

1

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

0

NCT00684255

[ 3 ]

21

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this evaluation is the effect PL3994 has on blood pressure.

Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Hypertension

hypertension controlled hypertension hypertensives

null

6

arm 1: PL3994 Dose A arm 2: PL3994 Dose B arm 3: PL3994 Dose C arm 4: PL3994 Dose D arm 5: PL3994 Dose E arm 6: Placebo

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

2

[ 0, 0 ]

intervention 1: Study drug intervention 2: Placebo

intervention 1: PL3994 intervention 2: Placebo

0

null

0

NCT00686803

[ 4 ]

57

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

true

0ALL

false

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model

In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).

Caries

fluoride in situ remineralization enamel caries

null

5

arm 1: Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. arm 2: Study toothpaste containing 1400 ppm F as NaF arm 3: Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF arm 4: Study toothpaste containing 675 ppm F as NaF arm 5: Fluoride free placebo toothpaste (0 ppm F)

[ 0, 1, 1, 1, 2 ]

3

[ 0, 0, 0 ]

intervention 1: Fluoride intervention 2: Placebo intervention 3: Fluoride

intervention 1: NaF intervention 2: Placebo intervention 3: NaMFP

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00708097

[ 4 ]

703

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

null

Perennial Allergic Rhinitis

null

2

arm 1: 0.15% azelastine hydrochloride 1644 mcg arm 2: Mometasone furoate 200 mcg

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM intervention 2: 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

intervention 1: 0.15% azelastine hydrochloride intervention 2: Mometasone furoate

59

0

NCT00720382

[ 5 ]

33

RANDOMIZED

CROSSOVER

9OTHER

2DOUBLE

true

1FEMALE

false

Evaluate the effect of two hand antiseptic products on hand skin conditions of healthy volunteers.

null

Healthy

Skin health

null

2

arm 1: 3M Avagard Surgical and healthcare Personnel Hand Antiseptic with Moisturizers arm 2: Purell Surgical Scrub with Moisturizers

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Topical solution, 6 mL, 6 applications/day for 14 days. intervention 2: Topical solution, 4 mL, 6 applications/day for 14 days.

intervention 1: Avagard intervention 2: Purell Surgical Scrub

0

null

0

NCT00731042

[ 3 ]

127

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

false

The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).

This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also had an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase. The study began with a 14-day washout period of previously used pain medications. At the end of the 14-day baseline phase, patients were randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours, Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12 hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase, patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24 hours of continuous treatment, depending on the treatment to which they were randomized. Patients were provided with rescue medication. After 7 days of tape treatment, patients returned to the clinic for a study exit visit.

Chronic Low Back Pain

Flurbiprofen, low back pain, chronic low back pain

null

4

arm 1: Placebo tape remained on for 12 hours of continuous treatment per day. arm 2: Flurbiprofen tape remained on for 12 hours of continuous treatment per day. arm 3: Placebo tape remained on for 24 hours of continuous treatment per day. arm 4: Flurbiprofen tape remained on for 24 hours of continuous treatment per day.

[ 2, 0, 2, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 2: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg. intervention 3: Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. intervention 4: Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

intervention 1: Placebo Tape (Arm 1) intervention 2: Flurbiprofen Tape (Arm 2) intervention 3: Placebo Tape (Arm 3) intervention 4: Flurbiprofen Tape (Arm 4)

10

0

NCT00759330

[ 4 ]

103

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

null

Idiopathic Thrombocytopenic Purpura

null

2

arm 1: Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. arm 2: Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (\<) 20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: rituximab intervention 2: Dexamethasone

22

Bari | N/A | Italy | 16.86982 | 41.12066 Bologna | N/A | Italy | 11.33875 | 44.49381 Brescia | N/A | Italy | 10.21472 | 45.53558 Cagliari | N/A | Italy | 9.11917 | 39.23054 Cuneo | N/A | Italy | 7.54828 | 44.39071 Genova | N/A | Italy | 11.87211 | 45.21604 Milan | N/A | Italy | 12.59836 | 42.78235 Napoli | N/A | Italy | 14.5195 | 40.87618 Padua | N/A | Italy | 11.88586 | 45.40797 Palermo | N/A | Italy | 13.3636 | 38.1166 Pavia | N/A | Italy | 9.15917 | 45.19205 Pesaro | N/A | Italy | 12.9164 | 43.90921 Pescara | N/A | Italy | 14.20283 | 42.4584 Ravenna | N/A | Italy | 12.20121 | 44.41344 Reggio Emilia | N/A | Italy | 10.63125 | 44.69825 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Roma | N/A | Italy | 11.10642 | 44.99364 Siena | N/A | Italy | 11.33064 | 43.31822 Taranto | N/A | Italy | 17.24707 | 40.46438 Udine | N/A | Italy | 13.23715 | 46.0693 Verona | N/A | Italy | 10.9938 | 45.43854

0

NCT00770562

[ 0 ]

21

NA

SINGLE_GROUP

0TREATMENT

3TRIPLE

true

0ALL

false

Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.

Study completed

Hypertrichosis

Bimatoprost Eyelash lengthening Prostaglandin Analogs Cosmetics

null

1

arm 1: Intervention to be administered: Each subject was given two suspensions, one mixed with Bimatoprost and one mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The intervention was the one eye with the Bimatoprost.

[ 1 ]

1

[ 0 ]

intervention 1: see prior

intervention 1: Bimatoprost Suspension

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT00773136

[ 3 ]

27

RANDOMIZED

PARALLEL

9OTHER

2DOUBLE

false

0ALL

true

In summary, this pilot study will explore the use of an innovative pharmacologic approach to the treatment of substance dependence through the facilitation of extinction of response to cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this preliminary study, a controlled treatment trial will be planned. This novel approach could have implications for the treatment of multiple substance use disorders including methamphetamine, marijuana and opiate dependence.

Cocaine dependence remains a serious problem in the US today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified. Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in relapse. Emerging data supports the role of glutamate in extinction of associative learning in animal models of rear-conditioning and clinical studies of exposure treatment for anxiety disorders. A recent study demonstrated DCS acceleration of cocaine-induced conditioned place preference in rats. Exploration of DCS in facilitating extinction of response to drug-related cues in humans is needed. The proposed study will extend these innovative and promising findings from the basic science arena and anxiety disorders field in a proof of concept investigation of DCS facilitation of extinction of response to cocaine-related cues in a human laboratory paradigm.

Cocaine Use Disorders

substance related disorders

null

2

arm 1: D-Cycloserine 50 mg is a partial glutamate agonist. Participants received DCS prior to cocaine cue exposure sessions. arm 2: Saline comparator. Participants received placebo prior to cocaine cue exposure sessions.

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: 50 mg DCS intervention 2: Placebo

intervention 1: D-cycloserine intervention 2: Placebo

1

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

0

NCT00780442

[ 5 ]

50

RANDOMIZED

CROSSOVER

0TREATMENT

1SINGLE

true

0ALL

false

To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.

null

Allergic Conjunctivitis

conjunctivitis

null

4

arm 1: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye arm 2: Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye arm 3: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye arm 4: Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye

[ 0, 0, 2, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: one drop in one eye intervention 2: one drop in one eye intervention 3: one drop in contralateral eye intervention 4: one drop in contralateral eye

intervention 1: Olopatadine 0.1% intervention 2: Tranilast 0.5% intervention 3: Placebo (Olopatadine) intervention 4: Placebo (Tranilast)

0

null

0

NCT00818805

[ 2 ]

12

RANDOMIZED

CROSSOVER

1PREVENTION

3TRIPLE

true

0ALL

false

The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.

Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.

Dental Caries

Calcium glycerophosphate Fluoride Dentifrice Biofilm Dental caries

null

1

arm 1: 4 types of dentifrices were used in 4 different periods in a crossover study design.

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: use of a dentifrice containing CaGP (0.13%) and no fluoride intervention 2: dentifrice without calcium glycerophosphate and no fluoride intervention 3: use of a dentifrice containing fluoride (1500ppm) only intervention 4: calcium glycerophosphate and fluoride dentifrice

intervention 1: calcium glycerophosphate intervention 2: no active ingredient intervention 3: fluoride intervention 4: CAGP + fluoride

1

João Pessoa | Paraíba | Brazil | -34.86306 | -7.115

0

NCT00875212

[ 5 ]

63

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.

One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al concluded that cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe acute rejection and better lipid profiles than cyclosporine-treated patients. Cardiovascular disease is the primary cause of premature death in renal and other transplant recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk factors such as hypertension, hyperlipidemia, obesity and diabetes. This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Kidney Transplantation

Kidney Transplantation Immunosuppressive Agents

null

3

arm 1: Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL. arm 2: Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL. arm 3: Convert to TAC at target trough levels of 6.0-8.9 ng/mL.

[ 1, 1, 1 ]

2

[ 0, 0 ]

intervention 1: Maintain on cyclosporine at target trough level of 50-250 ng/mL. intervention 2: Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).

intervention 1: cyclosporine intervention 2: Prograf (Tacrolimus)

1

Greenville | North Carolina | United States | -77.36635 | 35.61266

0

NCT00905515

[ 5 ]

250

RANDOMIZED

PARALLEL

0TREATMENT

1SINGLE

false

0ALL

false

The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea) by comparing standard titration (slow increase in drug dosage, guided by patient's responses) therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol in participants with migraine with or without aura (having to do with the ear) for more than or equal to 2 attacks per month.

This is a prospective (study following participants forward in time), single-blind (Physician does not know the intervention), randomized (study drug assigned by chance) and comparative multi-center (conducted in more than 1 center) study to assess appropriate administration methods with topiramate preventive therapy in participants with migraine. The study consists of 3 periods: Screening period (4 weeks), Treatment period consisting of 2 titration periods (3 weeks each) and Maintenance period (4 weeks). During Screening period, after the diagnosis of participants' headache, symptoms and severity of migraine will be investigated through a headache diary and participants will be selected for treatment period. In the treatment period, the selected participants will be randomly assigned to either of the 3 topiramate therapy: 'topiramate standard group', 'topiramate slow group', and 'topiramate slow plus propranolol (booster) group'. In the 'topiramate standard group' - participants will receive an initial dose of topiramate 25 milligram (mg) once daily and the dose of topiramate will be increased by 25 mg per day at an interval of 1-week up to the target dose of 50 mg to 100 mg up to Week 6; and a maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow group' - participants will start with an initial dose of 25 mg once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. In 'topiramate slow plus propranolol (booster) group' - participants will follow the same dosage regimen as in the 'topiramate slow group' along with concurrent administration of booster dose of propranolol 80 mg once daily (40 mg each time in the morning and in the evening) for 6 weeks. The participants will primarily be evaluated for reduction in migraine frequency between Week 7 and 10 using a headache diary questionnaire maintained by them. Participants' quality of life will be assessed using Migraine Disability Assessment (MIDAS) score and intensity of pain in migraine will be assessed using Visual Analogue Scale (VAS). Participants' safety will be monitored throughout the study.

Migraine

Migraine Topiramate Propranolol

null

3

arm 1: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. arm 2: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. arm 3: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.

[ 0, 0, 0 ]

3

[ 0, 0, 0 ]

intervention 1: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. intervention 2: Topiramate 25 mg will be administered once daily and the dose will be increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg will be administered twice daily up to Week 10 as per Physician's discretion. intervention 3: Propranolol 80 mg will be administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.

intervention 1: Topiramate Standard intervention 2: Topiramate Slow intervention 3: Propranolol booster

6

Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Kwangjoo | N/A | South Korea | N/A | N/A Kyunggi-Do | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566 Uijeongbu-si | N/A | South Korea | 127.0474 | 37.7415

0

NCT01060111

[ 2 ]

26

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

true

0ALL

null

The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.

null

Healthy

Healthy subjects

null

2

arm 1: OAD: Once A Day arm 2: None

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Dosage form: Extended-release caplets containing 300 mg trazodone HCl Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours. intervention 2: Dosage form: Immediate-release tablets containing 100 mg trazodone HCl Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.

intervention 1: Trazodone HCl intervention 2: Trazodone HCl

0

null

0

NCT01121900

[ 3 ]

523

RANDOMIZED

PARALLEL

1PREVENTION

4QUADRUPLE

false

0ALL

true

The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

null

Venous Thromboembolism Deep Vein Thrombosis Total Knee Arthroplasty

prevention venous thromboembolism edoxaban factor Xa

null

5

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

[ 0, 0, 0, 0, 2 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: DU-176b 5mg tablets oral, once daily for 2 weeks intervention 2: DU-176b 15mg tablets, oral once daily for 2 weeks intervention 3: DU-176b 30 mg tablets, oral, once daily for 2 weeks intervention 4: DU-176b 60 mg tablets, oral, once daily for 2 weeks intervention 5: Matching placebo oral tablets, once daily for 2 weeks

intervention 1: DU-176b intervention 2: DU-176b intervention 3: DU-176b intervention 4: DU-176b intervention 5: Placebo

2

Osaka | N/A | Japan | 135.50107 | 34.69379 Tokyo | N/A | Japan | 139.69171 | 35.6895

0

NCT01203072

[ 5 ]

395

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

null

Hepatitis C, Chronic

null

4

arm 1: Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W). arm 2: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W. arm 3: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W. arm 4: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.

[ 0, 0, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 180 mcg sc weekly, 24 weeks intervention 2: 180 mcg sc weekly, 16 weeks intervention 3: 800 mg orally daily intervention 4: 400 mg orally daily

intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: ribavirin intervention 4: ribavirin

18

Gratwein | N/A | Austria | 15.31667 | 47.11667 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Linz | N/A | Austria | 14.28611 | 48.30639 Linz | N/A | Austria | 14.28611 | 48.30639 Oberndorf | N/A | Austria | 12.21667 | 47.61667 Ried-innkreis | N/A | Austria | N/A | N/A Salzburg | N/A | Austria | 13.04399 | 47.79941 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Villach | N/A | Austria | 13.85583 | 46.61028 Wels | N/A | Austria | 14.03333 | 48.16667 Wiener Neustadt | N/A | Austria | 16.23196 | 47.80485

0

NCT01258101

[ 3 ]

29

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit. This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.

Onychomycosis

Onychomycosis Fungal Nail

null

1

arm 1: AN2690 Solution, 5.0%

[ 0 ]

1

[ 0 ]

intervention 1: Once daily application for 360 days

intervention 1: AN2690 Solution, 5.0%

2

Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Mexico City | N/A | Mexico | -99.12766 | 19.42847

0

NCT01278394

[ 2 ]

30

NA

SINGLE_GROUP

0TREATMENT

0NONE

true

0ALL

false

This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose. The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.

null

Healthy Subjects

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

intervention 1: Ketorolac tromethamine

1

Miami | Florida | United States | -80.19366 | 25.77427

0

NCT01365624

[ 5 ]

20

NON_RANDOMIZED

CROSSOVER

null

0NONE

false

0ALL

null

This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a washout period of at least 4 days. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

null

Drug Therapy, Combination

null

2

arm 1: Participants will receive warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study. arm 2: Participants will receive oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive warfarin (on Days 1-5) in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5. intervention 2: Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

intervention 1: Oseltamivir intervention 2: Warfarin

1

Surrey | N/A | United Kingdom | N/A | N/A

0

NCT02780622

[ 5 ]

24

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

null

Hepatitis B, Chronic

null

2

arm 1: HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. arm 2: HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.

[ 0, 0 ]

1

[ 0 ]

intervention 1: 180 mcg SC injection QW for 48 weeks.

intervention 1: Peginterferon alfa-2a

6

Auckland | N/A | New Zealand | 174.76349 | -36.84853 Hamilton | N/A | New Zealand | 175.28333 | -37.78333 New Plymouth | N/A | New Zealand | 174.08333 | -39.06667 Riccarton, Christchurch | N/A | New Zealand | N/A | N/A Rotorua | N/A | New Zealand | 176.24516 | -38.13874 Whangarei | N/A | New Zealand | 174.32391 | -35.73167

0

NCT02791269

[ 3 ]

40

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of infectious diarrhoea.

To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMXTM technology (CB-01-11) in the treatment of infectious diarrhoea. Primary end points to determine: • The safety and preliminary efficacy data of the three doses of the new rifamycin SV formulation tested based upon the time elapsed from the ingestion of the 1st dose of study medication to the passage of the last unformed stool (TLUS), in compliance with the relevant guidelines Secondary end-points to determine: * The number of patients showing improvement in diarrhoea during a 24-h interval, i.e. \>50 % reduction of bowel movements. * The number of unformed stools passed per 24-h interval, after dosing. * The number of patients who are declared to be "well". Wellness is defined as the patient having 48 hours with no unformed stools, a maximum of two soft stools and no clinical symptoms of infectious diarrhoea. * The number of treatment failures. A treatment failure is defined as clinical deterioration or worsening of symptoms or illness continuing after 120 h following the first dose. * The number and percentage of patients recovered from diarrhoea. Patients were considered to have recovered if fewer than three unformed stools were passed in the previous 24 hours and no symptom of enteric infection were present.

Infectious Diarrhoea

Infectious diarrhoea rifamycin SV rifamycin SV MMX MMX

null

3

arm 1: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Four of the six daily tablet taken in this group were placebos. arm 2: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. Two of the six daily tablet taken in this group were placebos. arm 3: Two enteric coated, modified release tablets, each containing 200 mg Rifamycin SV, taken three times daily. None of the six daily tablet taken in this group were placebos.

[ 1, 1, 1 ]

3

[ 0, 0, 0 ]

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

intervention 1: 400 mg Rifamycin SV dosage intervention 2: 800 mg Rifamycin SV dosage intervention 3: 1200 mg Rifamycin SV dosage

0

null

0

NCT03447821

[ 3 ]

28

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.

Locally advanced or metastatic pancreatic cancer is relatively unresponsive to chemotherapy. This is true for the nucleoside analogue gemcitabine, with a response rate of approximately 10%, as well as for 5-fluorouracil (5-FU). Even when gemcitabine is combined with other chemotherapeutic drugs or biological agents, the overall tumor response rate remains basically unchanged. S-1 is a new generation oral fluoropyrimidine that combines Tegafur (5-fluoro-1-(tetrahydro-2-furanyl)-2,4(1H,3H)-pyrimidinedione \[FT\]), an oral prodrug of 5-FU, with two modulators, Gimeracil (5-chloro-2,4-dihydroxypyridine \[CDHP\]), which inhibits 5-FU degradation by dihydropyrimidine dehydrogenase (DPD) inhibition, and Oteracil potassium (Oxo), which inhibits 5-FU phosphorylation in the digestive tract. This combination of 3 compounds is designed to achieve enhanced antitumor activity while decreasing gastrointestinal toxicity.

Locally Advanced or Metastatic Pancreatic Cancer

null

1

arm 1: Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.

[ 0 ]

1

[ 0 ]

intervention 1: All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.

intervention 1: S-1

0

null

0

NCT00651742

[ 3 ]

48

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

null

Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic

null

4

arm 1: Twice daily (b.i.d.) arm 2: Twice daily (b.i.d.) arm 3: Twice daily (b.i.d.) arm 4: Twice daily (b.i.d.)

[ 2, 2, 0, 0 ]

2

[ 0, 0 ]

intervention 1: Capsule intervention 2: Capsule

intervention 1: BIBW 2948 BS intervention 2: Placebo

6

0

NCT00423137

[ 3 ]

80

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

This is a placebo-controlled study evaluating the effects of rosiglitazone on functional brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).

null

Alzheimer's Disease

rosiglitazone cognition cerebral glucose metabolism positron emission tomography (PET) Alzheimer's Disease

null

2

arm 1: 4 mg once a day for 1 month increasing to 8 mg once a day (Extended Released Tablets) arm 2: Placebo dummy to match

[ 0, 5 ]

2

[ 0, 10 ]

intervention 1: Extended Release Tablets intervention 2: Placebo dummy to match

intervention 1: Rosiglitazone intervention 2: Placebo

15

0

NCT00265148

[ 5 ]

29

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

After 24 weeks of treatment evaluate the efficacy and security.

null

Diabetes Mellitus

null

1

arm 1: sitagliptin

[ 0 ]

1

[ 0 ]

intervention 1: Patients will receive sitagliptin with metformin for 24 weeks, given as oral tablets

intervention 1: sitagliptin phosphate

0

null

0

NCT00832390

[ 3 ]

305

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.

null

Arthritis, Rheumatoid

Arthritis Rheumatoid

null

5

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

[ 2, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Capsule, once daily (QD) for 12 weeks intervention 2: Capsule, 0.5 mg of PH-797804, once daily (QD) for 12 weeks intervention 3: Capsule, 3 mg of PH-797804, once daily (QD) for 12 weeks intervention 4: Capsule, 6 mg of PH-797804, once daily (QD) for 12 weeks intervention 5: Capsule, 10 mg of PH-797804, once daily (QD) for 12 weeks

intervention 1: placebo intervention 2: PH-797804 intervention 3: PH-797804 intervention 4: PH-797804 intervention 5: PH-797804

48

Malvern East | Victoria | Australia | 145.04253 | -37.87397 Curitiba | Paraná | Brazil | -49.27306 | -25.42778 Curitiba | Paraná | Brazil | -49.27306 | -25.42778 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 Viña del Mar | Región de Valparaíso | Chile | -71.55183 | -33.02457 Rancagua | Región del Libertador General Bernardo O’Higgins | Chile | -70.74053 | -34.1691 Santiago | RM | Chile | -70.64827 | -33.45694 Santiago | RM | Chile | -70.64827 | -33.45694 Santiago | RM | Chile | -70.64827 | -33.45694 Brno | N/A | Czechia | 16.60796 | 49.19522 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava - Trebovice | N/A | Czechia | N/A | N/A Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.08804 Zlín | N/A | Czechia | 17.67065 | 49.22645 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Tallinn | N/A | Estonia | 24.75353 | 59.43696 Hyderabad | Andhra Pradesh | India | N/A | N/A Hyderabad | Andhra Pradesh | India | N/A | N/A Bangalore | Karnataka | India | 77.59369 | 12.97194 Mumbai | Maharashtra | India | 72.88261 | 19.07283 Ludhiana | Punjab | India | 75.85379 | 30.91204 Coimbatore | Tamil Nadu | India | 76.96612 | 11.00555 Lima | N/A | Peru | -77.02824 | -12.04318 Lima | N/A | Peru | -77.02824 | -12.04318 Lima | N/A | Peru | -77.02824 | -12.04318 Bialystok | N/A | Poland | 23.16433 | 53.13333 Bialystok | N/A | Poland | 23.16433 | 53.13333 Poznan | N/A | Poland | 16.92993 | 52.40692 Warsaw | N/A | Poland | 21.01178 | 52.22977 Moscow | N/A | Russia | 37.61556 | 55.75222 Moscow | N/A | Russia | 37.61556 | 55.75222 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863 Smolensk | N/A | Russia | 32.04371 | 54.77944 Johannesburg | Gauteng | South Africa | 28.04363 | -26.20227 Parktown | Johannesburg | South Africa | 28.02671 | -26.18205 Bloemfontein | N/A | South Africa | 26.214 | -29.12107 Durban | N/A | South Africa | 31.0292 | -29.8579 Kempton Park | N/A | South Africa | 28.2377 | -26.10859 Pretoria | N/A | South Africa | 28.18783 | -25.74486 Anyang | N/A | South Korea | 127.1464 | 36.9577 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126.9784 | 37.566 Barakaldo | Vizcaya | Spain | -2.98813 | 43.29639 Seville | N/A | Spain | -5.97317 | 37.38283

0

NCT00383188

[ 3 ]

27

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to obtain preliminary information on the effect of piclozotan on motor complications associated with Parkinson's Disease.

null

Parkinson's Disease

Parkinson's Disease motor complications dyskinesia Motor complications associated with Parkinson's

null

2

arm 1: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of piclozotan administered at a plasma level of 30 ng/mL over 2 inpatient days. arm 2: Participants will be randomized to receive two 12-hour intravenous (IV) infusions of 0.9 % sodium chloride (normal saline) administered at a plasma level of 30 ng/mL over 2 inpatient days.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: piclozotan, intravenous (IV) infusion intervention 2: 0.9% sodium chloride (normal saline) intravenous (IV) infusion

intervention 1: piclozotan intervention 2: 0.9% sodium chloride (normal saline)

7

0

NCT00623363

[ 4 ]

111

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Subcellular markers will be assessed in relationship to cellular acute rejection in de novo cardiac transplant recipients receiving either tacrolimus or cyclosporine as their primary immunosuppressant Two parallel active arms.

Heart Diseases Heart Transplantation

Antirejection Treatment Outcome Immunosuppression Treatment Effectiveness Anti-rejection therapy

null

4

arm 1: Adults: 0.05 - 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 2: Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant arm 3: Pediatrics: 0.05 - 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant arm 4: Pediatrics: 6 - 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant

[ 0, 1, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: Oral intervention 2: Oral intervention 3: Intravenous and Oral intervention 4: Intravenous intervention 5: Oral

intervention 1: Tacrolimus intervention 2: Cyclosporine intervention 3: Mycophenolate mofetil intervention 4: Methylprednisolone intervention 5: Prednisone

13

0

NCT00157014

[ 5 ]

442

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

1FEMALE

false

The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos. This optimization is mainly valuable to a group of infertility patients (9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for an additional 2.6% of the infertility patients who manifest a high response to gonadotropin and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive research was carried out and led to the introduction of GnRH antagonist, as an alternative to Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH antagonist regimen is safe, well tolerated and results in a good clinical outcome. This protocol is now frequently applied in the US and Europe. Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful in determining individualized clinical management strategies for low and high responders and thus avoiding cancellation. Such prediction when based on reliable scientific evidence is valuable in consulting patients about their chances of success. A large number of studies have been performed, which used certain clinical, ultrasonographic and hormonal markers (called predictive factors), to try to optimize a COS protocol for patients who were down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models have also been used to adjust the starting dose of FSH to prevent a too low or too high ovarian response. To date, however, none have been performed for women undergoing ovarian stimulation with a GnRH antagonist protocol. The primary objective of this randomized, open-label, multicenter clinical trial was to identify one or more factors capable of predicting ovarian response in women treated with a daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH antagonist for assisted reproduction, the trial evaluated also whether intervention with oral contraceptives affects the accuracy of predictive models for ovarian response.

null

Infertility

null

2

arm 1: Use of oral contraceptive pills prior to controlled ovarian stimulation arm 2: No use of oral contraceptive pills prior to controlled ovarian stimulation

[ 1, 4 ]

1

[ 0 ]

intervention 1: oral contraceptive 1 tablet daily for 14 to 21 days

intervention 1: Marvelon

0

null

0

NCT00778999

[ 4 ]

182

RANDOMIZED

CROSSOVER

0TREATMENT

0NONE

false

0ALL

null

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Chronic Kidney Disease, Stage 5

null

2

arm 1: Fosrenol (Lanthanum carbonate) arm 2: Sevelamer hydrochloride

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets. intervention 2: The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.

intervention 1: Fosrenol (Lanthanum Carbonate) intervention 2: Sevelamer hydrochloride

44

0

NCT00441545

[ 4 ]

407

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

null

Anemia Kidney Failure

Chronic

null

4

arm 1: Erythropoietin(EPO)-naive BIW arm 2: EPO-naive QW arm 3: EPO QW arm 4: EPO Q2W

[ 1, 1, 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: subcutaneous, BIW for 24 weeks intervention 2: subcutaneous, QW for 24 weeks intervention 3: subcutaneous, QW for 24 weeks intervention 4: subcutaneous, Q2W for 24 weeks

intervention 1: Dynepo (Epoetin delta) intervention 2: Dynepo intervention 3: Dynepo intervention 4: Dynepo

53

0

NCT00450333

[ 5 ]

152

NA

SINGLE_GROUP

9OTHER

0NONE

false

0ALL

false

To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

null

Anemia Kidney Failure, Chronic

null

1

arm 1: Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject

[ 0 ]

1

[ 0 ]

intervention 1: Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject

intervention 1: Dynepo

1

Lier | N/A | Belgium | 4.57041 | 51.13128

0

NCT00514813

[ 3 ]

148

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

null

Myelodysplastic Syndromes

MDS CC-5013 Revlimid Celgene

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen.

intervention 1: lenalidomide

32

1

NCT00065156

[ 4 ]

755

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

null

Non-Small-Cell Lung Carcinoma

Non-Small Cell Lung Cancer

null

2

arm 1: Cetuximab was administered at an initial dose (Week 1) of 400 mg/m\^2 intravenous (IV) infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m\^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks. arm 2: A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m\^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m\^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

[ 1, 1 ]

4

[ 0, 0, 0, 0 ]

intervention 1: IV, 225 mg/m\^2 intervention 2: IV, 75 mg/m\^2 intervention 3: AUC=6, q 3 weeks (6 cycles maximum) intervention 4: Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2

intervention 1: Paclitaxel (Taxane) intervention 2: Docetaxel (Taxane) intervention 3: Carboplatin intervention 4: Cetuximab

124

1

NCT00112294

[ 4 ]

789

RANDOMIZED

PARALLEL

null

0NONE

false

0ALL

true

The purpose of this study is to document the additional detection of papillary bladder cancer and the reduced early recurrence due to the improved detection and resection of these tumors after Hexvix cystoscopy compared to standard cystoscopy in patients with papillary bladder cancer.

In superficial bladder cancer macroscopic tumors including non-invasive papillary tumors (Ta) in the bladder are relatively easy to visualize by cystoscopic examination under white light. However, dysplasia, carcinoma in situ (CIS) or small exophytic tumors are easily overlooked. These lesions are predictive of recurrence and progression of disease, and the identification of these lesions is a crucial factor for the prognosis of the patient. The present situation with 50-75% recurrence rate show the inadequacy of white light cystoscopy for detection and resection of the lesions. A better detection of papillary bladder cancer and early detection of CIS lesions will provide the patient with a more complete TURB, a more optimal pharmacological treatment when needed, may reduce the need for follow up cystoscopies and hopefully result in a better prognosis for the patient. The aim of the present study is to compare Hexvix cystoscopy with white light cystoscopy in the detection of histology confirmed papillary bladder cancer in patients with papillary bladder cancer and to compare early recurrence rate after Hexvix and white light transurethral resection (TURB) with white light TURB in patients with superficial bladder cancer.

Bladder Cancer

Bladder Cancer Hexvix Fluorescence Cystoscopy

null

2

arm 1: None arm 2: None

[ 1, 0 ]

2

[ 0, 3 ]

intervention 1: Single Instillation, Transurethral Resection of the Bladder intervention 2: None

intervention 1: Hexvix intervention 2: Standard white light cystoscopy

25

1

NCT00233402

[ 3 ]

144

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The purpose of this study is to test the efficacy and safety of an investigational medication for improving symptoms of Alzheimer's Disease. Subjects will receive either active medication or placebo for 28 days. Tests of memory, concentration will be included. Safety will be monitored using routine clinical and laboratory tests.

null

Alzheimer's Disease

null

2

arm 1: None arm 2: None

[ 0, 2 ]

2

[ 0, 0 ]

intervention 1: MK0249 two (2) 2.5 mg capsules quaque die (qd) for 28 day treatment period. intervention 2: MK0249 two (2) 2.5 mg Pbo capsules qd for a 28 day treatment period

intervention 1: MK0249 intervention 2: Comparator: Placebo (unspecified)

0

null

1

NCT00420420

[ 3, 4 ]

2,059

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

null

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

null

Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive

indacaterol long acting beta-2 agonist

null

7

arm 1: In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 2: In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 3: Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 4: In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 5: In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 6: In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study. arm 7: In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2. Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.

[ 0, 0, 1, 2, 0, 0, 1 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI). intervention 2: Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer. intervention 3: Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI. intervention 4: In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI). intervention 5: In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

intervention 1: Indacaterol intervention 2: Formoterol (12 µg b.i.d.) intervention 3: Tiotropium (18 µg o.d.) intervention 4: Placebo to Indacaterol intervention 5: Placebo to Formoterol

344

0

NCT00463567

[ 3 ]

222

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

2MALE

false

A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

null

Lower Urinary Tract Symptoms Bladder Outlet Obstruction

Lower Urinary Tract Symptoms Bladder Outlet Obstruction Treatment Solifenacin Succinate Tamsulosin hydrochloride

null

3

arm 1: Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. arm 2: Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. arm 3: Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

[ 2, 0, 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Solifenacin succinate tablets intervention 2: Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets intervention 3: None intervention 4: None

intervention 1: solifenacin succinate intervention 2: tamsulosin hydrochloride intervention 3: Placebo to solifenacin intervention 4: Placebo to tamsulosin

33

1

NCT00507455

[ 3 ]

39

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months. This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Lymphoma Hodgkin Lymphoma (Category) Nodular Lymphocyte Predominant Hodgkin Lymphoma

null

1

arm 1: 375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks. Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months).

[ 0 ]

1

[ 0 ]

intervention 1: Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.

intervention 1: Rituximab

2

0

NCT00003820

[ 2, 3 ]

85

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

Phase I/II trial to estimate the maximum tolerated dose of imatinib mesylate in newly diagnosed brain stem gliomas and recurrent high grade gliomas and to assess the effectiveness of imatinib mesylate in treating young patients who have newly diagnosed intrinsic brain stem glioma. Imatinib mesylate may interfere with the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining imatinib mesylate with radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of imatinib mesylate after completion of radiation in children with newly diagnosed poor prognosis brainstem gliomas. (Phase I, strata I closed to accrual as of 5/28/04.) II. Determine the maximum tolerated dose (MTD) of imatinib mesylate in children with recurrent high-grade intracranial glioma stratified according to the use of enzyme-inducing anticonvulsant drugs (EIACDs). (Phase I, strata IIA and IIB closed to accrual as of 8/15/03 and 8/15/04, respectively) III. Determine the safety and efficacy of this drug in patients with newly diagnosed diffuse intrinsic brainstem gliomas. (Phase II) SECONDARY OBJECTIVES: I. Explore neuroimaging and biological correlatives of therapeutic activity of this regimen in these patients. (Phase I, all strata closed to accrual as of 8/15/04) II. Determine the pharmacokinetics of these regimens in these patients overall and by enzyme-inducing anticonvulsant drugs (EIACDs) (Phase I, all strata closed to accrual as of 8/15/04.) III. Estimate the progression-free survival (PFS) and overall survival (OS) of newly diagnosed diffuse intrinsic brainstem gliomas treated with this drug. (Phase I and II) OUTLINE: This is a phase I dose-escalation, multicenter study followed by a phase II. Patients are stratified according to tumor type (newly diagnosed intrinsic brainstem glioma vs recurrent/refractory intracranial high-grade glioma). Patients in stratum II (phase I only) are further stratified according to concurrent use of enzyme-inducing anticonvulsant drugs (EIACDs) (yes vs no). Patients are assigned to one of three strata in the phase I study. * Phase I * Stratum I (newly diagnosed brainstem glioma): Patients undergo radiotherapy once daily five days a week for 6 weeks. Beginning 1-3 weeks after completion of radiotherapy, patients without evidence of intratumoral bleed receive oral imatinib mesylate twice daily. Imatinib mesylate treatment repeats every 4 weeks for up to 13 courses in the absence of disease progression or unacceptable toxicity. (Closed to accrual as of 5/28/04.) * Stratum II A (recurrent or refractory high-grade intracranial gliomas/no concurrent EIACDs): Patients receive imatinib mesylate as in stratum I. (Closed to accrual as of 8/15/03.) * Stratum II B (recurrent or refractory high-grade intracranial gliomas and concurrent EIACDs): Patients receive imatinib mesylate as in stratum I. (Closed to accrual as of 8/15/04.) Cohorts of 2-3 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is estimated that 20% of patients will experience dose-limiting toxicity. MTDs are independently estimated in each strata. For stratum I, newly diagnosed brain stem gliomas, the dose level which at least 5 of 6 patients experience no dose-limiting toxicity will be the dose used in the efficacy and safety phase (phase II). * Phase II: (Open to accrual as of 5/28/04.) * Stratum I only: Patients undergo radiotherapy as in phase I. Patients receive imatinib mesylate at the MTD established in phase I. Patients enrolled in the phase I portion and not treated at the MTD are to be followed for the shortest of 1) three months after the last protocol based treatment or 2) the date other therapy is initiated. Stratum I patients treated at the MTD in the phase I portion and all patients in the phase II portion of the study are to be followed until death or withdrawal from the study PROJECTED ACCRUAL: Approximately 140 patients will be accrued for this study within 2 years.

Brain and Central Nervous System Tumors

childhood central nervous system germ cell tumor childhood high-grade cerebral astrocytoma untreated childhood brain stem glioma recurrent childhood brain stem glioma recurrent childhood cerebral astrocytoma

null

1

arm 1: None

[ 0 ]

2

[ 0, 4 ]

intervention 1: * Phase 1 Stratum I: Starting dose level of 350 mg/m2/day every 28 days X 13 courses (dose escalation) * Phase I Stratum IIA: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation) * Phase I Stratum IIB: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation) * Phase II: Phase I Stratum I determined dose (Maximum tolerated dose) every 28 days X 13 courses. intervention 2: * Phase I Stratum I: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib. * Phase II: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib.

intervention 1: imatinib mesylate intervention 2: local irradiation therapy

10

0

NCT00021229

[ 2, 3 ]

38

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purposes of this are: * To determine the highest doses of Taxol and Navelbine that we can safely give to patients; * To determine what kind of side effects are caused by the combination of Taxol, Navelbine and G-CSF; * To determine whether the combination of Taxol, Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life;

Complete response (CR) in advanced breast cancer is an important predictor of improved survival. The largest experience reported with long-term follow-up in this regard is from M.D. Anderson Hospital, with a median survival of 33 months and 5-year survival of 19% among patients who achieved a CR with doxorubicin-based chemotherapy.19 We believe that our institutional experience to date indicates that CR rates in excess of 20% can be achieved in second-line chemotherapy from the combination of vinorelbine and a taxane, provided that G-CSF is given. For the reasons outlined, we believe that dose density is likely to be important for both classes of agents, but dose intensity may be most important for vinorelbine. Both paclitaxel and docetaxel can be given on a weekly schedule with some success, but it appears that myelosuppression is a more frequent dose-limiting toxicity on this schedule for docetaxel. For the current trial, we therefore propose to study weekly paclitaxel in combination with dose-intensive vinorelbine, utilizing continuous G-CSF support as in our prior studies. We believe that starting doses of 60 mg/m2 for paclitaxel and 20 mg/m2 for vinorelbine will be well tolerated, but our experience to date, treating 3 patients off study at these doses without G-CSF support, indicates that some will require G-CSF even at this dose level: we observed grade 4 neutropenia in 2 of the 3. Our intention in this trial is to determine the optimal dose of these two agents when continuous growth factor support is provided. We will be starting at a ratio of 0.8 for vinorelbine and 0.75 for paclitaxel (assuming 80 mg/m2/week as a "full" dose for the later agent). It is now widely appreciated that patients with metastatic breast cancer whose tumors over express HER-2-neu demonstrate benefit from the addition of trastuzumab (Herceptin) to a chemotherapy program with paclitaxel as a single agent.20 Such patients will be allowed to receive trastuzumab in the standard dose and schedule (4 mg/kg loading dose, then 2 mg/kg/week) given IV, in addition to paclitaxel and vinorelbine. Since trastuzumab does not produce myelosuppression or neuropathy (the anticipated dose-limiting toxicities for vinorelbine and paclitaxel, respectively), and neither of these agents combined separately with trastuzumab produces unusual or severe new side effects, this should not affect the dose escalation scheme for the chemotherapeutic agents.

Breast Cancer

null

1

arm 1: Weekly paclitaxel (50 mg/m2 IV) and weekly vinorelbine (20 mg/m2 IV) with daily G-CSF support and Herceptin for patients with HER-2/neu positive disease. Paclitaxel weekly. Dose levels: 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2 Vinorelbine (Navelbine) administered one hour after paclitaxel, weekly. Dose levels: 20 mg/m2, 22.5 mg/m2, 25 mg/m2, 27.5 mg/m2 Patients who are HER-2+ and IV infusion. Herceptin 4 mg/kg IV given only on day 1 of the first cycle. Herceptin 2 mg/kg IV, maintenance dose will be given every week starting with week 2. G-CSF (filgrastim, Neupogen) 5 mg/kg/day s.c., administered daily

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 50 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. intervention 2: 20 mg/m2 IV weekly. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. intervention 3: 4 mg/kg IV loading dose day 1 of first week followed by 2 mg/kg IV maintenance dose on each subsequent week. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment. intervention 4: 5 mcg/kg daily including the day of IV chemotherapy. Treatment continues until disease progression, excessive toxicity or other reason to remove the patient from protocol treatment.

intervention 1: Paclitaxel intervention 2: Vinorelbine intervention 3: Herceptin intervention 4: Filgrastim

1

Seattle | Washington | United States | -122.33207 | 47.60621

0

NCT00041470

[ 3 ]

203

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

null

The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and oxaliplatin chemotherapy.

null

Colorectal Cancer Metastases

Colon, Rectal Cancer ABX-EGF, Panitumumab, EGFr Immunex, Abgenix, Amgen Metastatic Colorectal Cancer Vectibix

null

1

arm 1: Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.

[ 0 ]

1

[ 0 ]

intervention 1: Administered by intravenous infusion

intervention 1: Panitumumab

0

null

0

NCT00089635

[ 3 ]

50

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

true

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.

OBJECTIVES: Primary * Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab. Secondary * Determine clinical response in patients treated with this regimen. * Determine toxicity of this regimen in these patients. * Determine quality of life of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline then weekly for 3 weeks. Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5 months.

Pancreatic Cancer

adenocarcinoma of the pancreas recurrent pancreatic cancer stage IV pancreatic cancer

null

0

null

3

[ 2, 0, 0 ]

intervention 1: 30-90 minutes on day 1, every 21 days up to 12 months. intervention 2: twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity. intervention 3: IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

intervention 1: bevacizumab intervention 2: capecitabine intervention 3: gemcitabine hydrochloride

2

0

NCT00100815

[ 3 ]

151

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to determine if azacitidine, combined with Best Supportive Care (BSC), is effective in treating myelodysplastic syndromes (MDS) when given according to a different doses and dosing schedules.

Comparison/Control Interventions: The comparison is azacitidine at different doses and schedules. Duration of Intervention: Treatment lasted for a maximum of 18 cycles, which is up to 24 months.

Myelodysplastic Syndromes

null

5

arm 1: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days on a 28 day cycle. arm 2: Azacitidine administered subcutaneously at 75mg/m\^2 for 5days with 2 days off, then for an additional 2 days, on a 28 day cycle. arm 3: Azacitidine administered subcutaneously at 50mg/m\^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle. arm 4: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 4 weeks. arm 5: Azacitidine administered subcutaneously at 75mg/m\^2 for 5 days every 6 weeks.

[ 0, 0, 0, 0, 0 ]

1

[ 0 ]

intervention 1: Azacitidine is administered subcutaneously Total of 18 cycles on treatment or early discontinuation.

intervention 1: azacitidine

31

0

NCT00102687

[ 4 ]

672

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

null

Atherosclerosis

atheroma IVUS Intravascular ultrasound atherosclerosis

null

2

arm 1: oral anti-diabetic medication arm 2: oral anti-diabetic medication

[ 1, 0 ]

2

[ 0, 0 ]

intervention 1: oral anti-diabetic medication intervention 2: oral antidiabetic medication

intervention 1: Glipizide intervention 2: rosiglitazone maleate

156

0

NCT00116831

[ 4 ]

375

RANDOMIZED

PARALLEL

1PREVENTION

2DOUBLE

false

0ALL

null

This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer

PRIMARY OBJECTIVES: I. Compare the rate of new adenomatous polyp formation in patients with a history of adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo. II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content in the flat mucosa with the rate of new adenoma formation in these patients. III. Compare the rate of side effects in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no). Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral double placebo once daily. Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

Precancerous Condition

null

2

arm 1: Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy. arm 2: Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.

[ 2, 0 ]

4

[ 10, 0, 0, 10 ]

intervention 1: Given orally intervention 2: Given orally intervention 3: Given orally intervention 4: Correlative studies

intervention 1: placebo intervention 2: eflornithine intervention 3: sulindac intervention 4: laboratory biomarker analysis

1

Orange | California | United States | -117.85311 | 33.78779

0

NCT00118365

[ 5 ]

500

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

true

This study will evaluate the effectiveness of a stepped care approach in treating depression and reducing pain.

In the United States, pain accounts for nearly 20% of all primary health care visits. In the majority of cases, the pain is musculoskeletal and primarily affects the lower back, hips, and knees. Studies have shown that at least one-third of patients with pain also suffer from depression. It has not been determined whether treatments for depression are effective in patients with comorbid pain and depression. The "Stepped Care for Affective Disorders and Musculoskeletal Pain" (SCAMP) study will determine the most effective treatment for patients with pain and depression. This study will last 12 months and will comprise depressed and nondepressed participants. Nondepressed participants will receive no treatment. Depressed patients will be randomly assigned to receive standard of care or stepped care for 12 weeks. Standard of care may include cognitive therapy, antidepressant treatment, or other treatments. The stepped care group will receive 12 weeks of antidepressant treatment. Participants who respond to antidepressant treatment will continue their treatment for the duration of the study. Participants who do not respond to the treatment after 12 weeks will receive 6 weekly pain self-management sessions. During these sessions, an educator will teach participants how to manage their pain through exercise and relaxation techniques. Self-report scales and questionnaires will be used to assess participants' pain, depressive symptoms, health care usage and costs, and quality of life. Depressed participants will undergo assessments at study start and at Months 1, 3, 6, and 12. Nondepressed participants will undergo assessments at study start and at Months 3 and 12. Study hypotheses: 1) Stepped care is more effective than usual care in improving depression and pain. 2) Stepped care is more effective than usual care in improving health-related quality of life, negative pain beliefs and behaviors, reduced opiate use, and health care costs. 3) Patients with musculoskeletal pain who are not depressed at baseline will have an incidence of depression less than 20% over 12 months of follow-up, characteristics that can be identified as risk factors for incident depression, baseline characteristics distinguishing them from depressed patients, and better pain and health status outcomes, compared to depressed patients.

Pain Depression

Back Pain Knee Pain Hip Pain Stepped Care Antidepressant Relaxation Techniques Exercise

null

3

arm 1: Stepped care group arm 2: Treatment as usual group arm 3: Participants without depression group

[ 0, 1, 4 ]

3

[ 5, 0, 0 ]

intervention 1: Stepped care will consist of 12 weeks of antidepressant therapy, followed by a pain self-management program (PSMP) in those who fail to achieve both a good pain and global clinical response to antidepressant therapy. Treatment will be delivered by a nurse depression-pain clinical specialist (DPCS) who will be trained in providing both components of the stepped care treatment. The DPCS will meet weekly to review cases with a physician-investigator who will also be available to discuss any management issues that arise between the weekly case meetings. All participants will have six clinical contacts with the DPCS during the acute treatment phase and two clinical contacts during the continuation phase to assess medication adherence, adverse effects, and depression response. intervention 2: Participants will be assigned to one of the following antidepressant regimens: venlafaxine (37.5 mg, increased to 75, 150, 225 mg); duloxetine (60 mg, increased to 120 mg); fluoxetine (20 mg, increased to 30 to 40 mg); sertraline (50 mg, increased to 100 to 150 mg); citalopram (20 mg, increased to 30 to 40 mg); paroxetine (20 mg, increased to 30 to 40 mg); or nortriptyline (25 mg, increased to 50 to 75 mg). intervention 3: This group will receive care as usual from their providers and completes the same outcome assessments as the stepped care group.

intervention 1: Stepped Care intervention 2: Antidepressants intervention 3: Usual Care

1

Indianapolis | Indiana | United States | -86.15804 | 39.76838

0

NCT00118430

[ 3 ]

81

RANDOMIZED

PARALLEL

0TREATMENT

3TRIPLE

false

0ALL

true

The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.

The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone. This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.

Opioid Dependence

Heroin Opiates naltrexone memantine

null

3

arm 1: Placebo plus oral naltrexone arm 2: Memantine 30 mg bid plus oral naltrexone arm 3: memantine 15 mg bid plus oral naltrexone

[ 2, 1, 1 ]

2

[ 0, 0 ]

intervention 1: One arm receives 30 mg bid and the other arm receives receives 15mg bid intervention 2: Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.

intervention 1: Memantine intervention 2: Naltrexone

1

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

0

NCT00125515

[ 3 ]

211

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.

This is a Phase II, open-label (all people know the identity of the intervention), roll-over study (participants may go ahead and participate in another clinical study). Participants who were randomized (study medication is assigned by chance) to a etravirine (ETR) treatment arm in Phase II TMC125 feeder studies (TMC125-C203, TMC125-C209, TMC125-C223 and TMC125-C211), were treated for at least 48 weeks with etravirine, and who will derive continued benefit from etravirine therapy, as judged by the investigator, will be enrolled in this study. The final visit of the sponsor-selected Phase II ETR study will be the first (baseline) visit of this study. Approximately 300 participants will be enrolled in this study who will receive 800 mg twice daily of etravirine (formulation TF035) until the formulation 200 mg twice daily (formulation F060) is available. Once this formulation becomes available all the participants will be switched to receive F060 which will be given in combination with an investigator-selected, optimized underlying therapy (nucleotide reverse transcriptase \[NRTIs\] and/or allowed protease inhibitors and/or enfuvirtide). Participants will continue to receive ETR until they are no longer benefitted or this medication becomes commercially available. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.

Human Immunodeficiency Virus Type 1

Human Immunodeficiency Virus Type 1 HIV-1 infection TMC125 Etravirine Enfuvirtide Antiretroviral therapy

null

1

arm 1: None

[ 0 ]

4

[ 0, 0, 0, 0 ]

intervention 1: Participants will receive 800 mg of ETR (2 x 4 tablets of formulation TF035) twice daily and after the formulation switch they will receive 200 mg of ETR (2 x 2 tablets of formulation F060) twice daily until the participants benefitted from etravirine or it became comercially available. intervention 2: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). intervention 3: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF). intervention 4: Participants will receive 2 additonal approved antiretrovirals (ARVs) along with ETR. ARVs may be NRTIs and/or allowed protease inhibitors (PIs) and/or enfuvirtide (ENF).

intervention 1: Etravirine (ETR) intervention 2: Nucleotide reverse transcriptase inhibitors (NRTIs) intervention 3: Protease inhibitors (PIs) intervention 4: Enfuvirtide (ENF)

0

null

0

NCT00128830

[ 4 ]

240

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

null

This is a Phase III study comparing Imatinib mesylate and hydroxyurea combination therapy with hydroxyurea monotherapy in patients with temozolomide resistant progressive glioblastoma.

null

Glioblastoma Multiforme Astrocytoma

Open label Imatinib mesylate hydroxyurea temozolomide resistant protein tyrosine kinases adenocarcinoma glioblastoma multiforme astrocytoma brain tumor brain cancer

null

2

arm 1: Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening. arm 2: 1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles. intervention 2: None

intervention 1: Imatinib mesylate intervention 2: Hydroxyurea

1

Dülmen | N/A | Germany | 7.28075 | 51.83149

0

NCT00154375

[ 5 ]

18

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

true

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). In its most severe form, the disorder is lethal in infancy. We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI. Additionally, we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.

Osteogenesis Imperfecta Osteoporosis Paget Disease of Bone

Osteogenesis Imperfecta Fractures Pediatric Osteoporosis Juvenile Pagets

null

2

arm 1: 1 mg/kg po qd rounded to nearest 10 or 20 mg dose arm 2: 3 mg/kg IV q4 months

[ 1, 1 ]

2

[ 0, 0 ]

intervention 1: None intervention 2: None

intervention 1: Alendronate intervention 2: Pamidronate

0

null

0

NCT00159419

[ 0 ]

112

NON_RANDOMIZED

PARALLEL

null

1SINGLE

true

0ALL

false

The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is one of the most important of these metabolic factors. If the production of NO is slowed or stopped the amount of blood to the different parts of the body is decreased. There is increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO function is reduced in patients with risk factors for atherosclerosis (hardening of the arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes mellitus, and is also impaired in smokers. This NO "deficiency" is believed to contribute to the greater cardiovascular risk that marks these patient populations. This study is designed to examine if endothelial nitric oxide is an important control mechanism of blood pressure under normal conditions, and if impairment of nitric oxide contributes to hypertension.

null

Hypertension Pure Autonomic Failure

Endothelial Nitric Oxide L-NMMA Trimethaphan Autonomic Nervous System Nitric Oxide Inhibition

null

2

arm 1: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in Patients with Autonomic Failure. arm 2: To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system in normal volunteers and hypertensive subjects.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third. intervention 2: IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.

intervention 1: L-NMMA intervention 2: Trimethaphan

1

Nashville | Tennessee | United States | -86.78444 | 36.16589

0

NCT00178919

[ 4 ]

168

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control. Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.

The study focusses on the following primary aims: * To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection). * To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The first BMT/LPIT for which patients receive any fentanyl will be used in this comparison. The study focusses on the following secondary aims: * To determine which dose regimen ensures best conditions to perform bone marrow aspiration (lack of motion) and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration. * To evaluate the safety and complications for each dose regimen.

Bone Marrow Disease Pain

Pain Management Bone Marrow Aspiration

null

3

arm 1: Fentanyl-1mcg/kg in 3 ml of Normal Saline arm 2: Fentanyl - 0.5 mcg/kg in 3 ml normal saline arm 3: normal saline

[ 1, 1, 2 ]

4

[ 0, 0, 0, 0 ]

intervention 1: 1. Fentanyl - 1 mcg/kg in 3 ml normal saline 2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline intervention 2: All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours. intervention 3: All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes. intervention 4: Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.

intervention 1: Fentanyl intervention 2: EMLA intervention 3: L.M.X4 intervention 4: Propofol

1

Memphis | Tennessee | United States | -90.04898 | 35.14953

0

NCT00187135

[ 3 ]

51

NON_RANDOMIZED

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).

This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 h iv infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM) and to obtain the following : * Additional pharmacokinetic information for Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM. * To obtain additional genomic and pharmacodynamics information on MM and Aplidin. * To assess the safety and tolerability of Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM alone or in combination with dexamethasone given orally as a 20 mg daily for 4 days * To determine the response rate in the second cohort of patients following treatment with Aplidin®, given as a 3 hour infusion every 2 weeks, plus dexamethasone given orally as a 20 mg daily for 4 days, starting the same day of Aplidin® administration, as a second treatment stage in patients with suboptimal response to Aplidin® as single agent (progressive disease after three cycles or stable disease after four cycles).

Multiple Myeloma

Myeloma Aplidin Plitidepsin PharmaMar

null

0

null

1

[ 0 ]

intervention 1: 3-hour infusion every 2 weeks alone or in combination with dexamethasone

intervention 1: Plitidepsin

1

Boston | Massachusetts | United States | -71.05977 | 42.35843

0

NCT00229203

[ 4 ]

518

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.

Non-Small Cell Lung Cancer

Advanced Non-Small Cell Lung Cancer

null

2

arm 1: Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. arm 2: Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.

[ 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Administered by intravenous infusion over 1 hour infusion intervention 2: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25). intervention 3: Administered by intravenous infusion over 3 hour infusion

intervention 1: Taxoprexin intervention 2: Carboplatin intervention 3: Paclitaxel

1

Dallas | Texas | United States | -96.80667 | 32.78306

0

NCT00243867

[ 0 ]

43

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

false

The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.

null

Major Depressive Disorder

Depression Geriatric MRI Sertraline

null

2

arm 1: Healthy Controls undergo MRI and neuropsychological testing arm 2: Depressed subjects receive experimental drug

[ 4, 0 ]

1

[ 0 ]

intervention 1: Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day. Duration of treatment was 12 weeks.

intervention 1: Sertraline

1

Belmont | Massachusetts | United States | -71.17867 | 42.39593

0

NCT00245557

[ 5 ]

26

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole. Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Alcohol Dependence

Alcohol dependence Acamprosate(drug) Drug Court Probation Parole Criminal justice

null

2

arm 1: Subjects randomized to receive acamprosate arm 2: No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling

[ 0, 4 ]

1

[ 0 ]

intervention 1: Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence

intervention 1: Acamprosate

1

Richmond | Virginia | United States | -77.46026 | 37.55376

0

NCT00249379

[ 5 ]

71

NON_RANDOMIZED

SINGLE_GROUP

1PREVENTION

0NONE

true

1FEMALE

null

Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Migraine

null

0

null

1

[ 0 ]

intervention 1: oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days

intervention 1: eletriptan

1

Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062

0

NCT00259649

[ 4 ]

203

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.

null

Diabetic Retinopathy

null

1

arm 1: None

[ 0 ]

1

[ 0 ]

intervention 1: 32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.

intervention 1: Ruboxistaurin

29

0

NCT00266695

[ 5 ]

40

NA

SINGLE_GROUP

0TREATMENT

0NONE

false

0ALL

false

The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.

Schizophrenia Schizoaffective Disorder

Schizophrenia Risperidone Risperidal Consta

null

1

arm 1: The RLAI 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.

[ 0 ]

1

[ 0 ]

intervention 1: The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.

intervention 1: Risperidone Long-Acting Injectable (RLAI)

1

Seoul | N/A | South Korea | 126.9784 | 37.566

0

NCT00269919

[ 3 ]

60

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

false

The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.

Resistant Hypertension

null

5

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

[ 2, 0, 0, 0, 0 ]

5

[ 0, 0, 0, 0, 0 ]

intervention 1: placebo tablet once daily for 12 weeks intervention 2: 10 mg tablets once daily for 10 weeks intervention 3: 50 mg tablet once daily for 10 weeks intervention 4: 100 mg tablet once daily for 10 weeks intervention 5: 200 mg tablet once daily for 10 weeks

intervention 1: Placebo intervention 2: TBC3711 intervention 3: TBC3711 intervention 4: TBC3711 intervention 5: TBC3711

12

0

NCT00272961

[ 3 ]

231

NON_RANDOMIZED

PARALLEL

0TREATMENT

0NONE

false

0ALL

false

This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the survival rate at 12 and 24 months.

This ClinicalTrials.gov record includes the results from two studies (Novartis protocol IDs CSTI571H2201 and CSTI571H2202) which were conducted separately but reported together in a single clinical study report. Both studies were phase II, open-label, multicenter, single-arm studies that evaluated the efficacy of imatinib mesylate plus hydroxyurea in subjects with progressive glioblastoma multiforme. The studies were identical in design with two exceptions: Patients in study CSTI571H2201 received a dose of imatinib 600 mg once daily and were not allowed concomitant use of enzyme-inducing anticonvulsant drugs (EIACDs); patients in study CSTI571H2202 received a dose of imatinib 500 mg twice daily and were allowed concomitant use of EIACDs.

Recurrent Glioblastoma Multiforme (GBM)

imatinib mesylate hydroxyurea protein tyrosine kinases glioma glioblastoma multiforme recurrent glioblastoma multiforme GBM MacDonald criteria

null

2

arm 1: Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs. arm 2: Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.

[ 0, 0 ]

2

[ 0, 0 ]

intervention 1: Imatinib was supplied as 100 and 400 mg tablets by Novartis. intervention 2: Hydroxyurea was supplied locally as 500 mg capsules.

intervention 1: Imatinib tablets intervention 2: Hydroxyurea capsules

1

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

0

NCT00290771

[ 3 ]

247

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

1FEMALE

null

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

null

Postmenopausal Osteoporosis

Post Menopausal Osteoporosis MicroCT Amgen denosumab Extreme CT XCT Fosamax Alendronate

null

3

arm 1: Placebo for denosumab and placebo for alendronate arm 2: denosumab and placebo for alendronate arm 3: Placebo for denosumab and alendronate

[ 2, 0, 1 ]

3

[ 0, 0, 0 ]

intervention 1: Alendronate 70 mg PO QW intervention 2: denosumab 60 mg SC q 6 mos intervention 3: Placebo for alendronate and placebo for denosumab

intervention 1: Alendronate intervention 2: Denosumab intervention 3: Placebo

0

null

0

NCT00293813

[ 4 ]

1,568

RANDOMIZED

PARALLEL

0TREATMENT

2DOUBLE

false

0ALL

null

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

null

Chronic Obstructive Pulmonary Disease (COPD)

Roflumilast COPD Chronic obstructive pulmonary disease

null

2

arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily

intervention 1: Roflumilast intervention 2: Placebo

287

0

NCT00297115

[ 5 ]

12

NON_RANDOMIZED

SINGLE_GROUP

7BASIC_SCIENCE

0NONE

true

2MALE

false

To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

null

Infections, Fungal

Pharmacokinetics Voriconazole Magnetic Resonance Spectroscopy

null

1

arm 1: voriconazole twice daily

[ 0 ]

1

[ 0 ]

intervention 1: Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily

intervention 1: voriconazole

1

Belmont | Massachusetts | United States | -71.17867 | 42.39593

0

NCT00300677

[ 4 ]

589

RANDOMIZED

PARALLEL

0TREATMENT

0NONE

true

0ALL

null

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

null

Diabetes, Type I

null

2

arm 1: Technosphere Insulin arm 2: Rapid-acting analogue insulin plus basal insulin glargine

[ 0, 1 ]

2

[ 0, 0 ]

intervention 1: Inhalation, 15U/30U intervention 2: sc injectable insulin

intervention 1: Technosphere Insulin intervention 2: Active comparator

129

0

NCT00308308

[ 5 ]

18

RANDOMIZED

CROSSOVER

0TREATMENT

4QUADRUPLE

false

0ALL

false

The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Abdominal Pain Surgical Adhesions

abdominal pain surgical adhesions

null

2

arm 1: Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. arm 2: Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.

[ 1, 2 ]

2

[ 0, 0 ]

intervention 1: First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID intervention 2: Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.

intervention 1: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks intervention 2: Placebo first followed by open label pregabalin

1

West Bloomfield | Michigan | United States | -83.38356 | 42.56891

0

NCT00310765

[ 5 ]

19

RANDOMIZED

PARALLEL

0TREATMENT

4QUADRUPLE

false

0ALL

true

As clinicians, it is often a struggle to find effective pain control for a certain subgroup of patients with tetraplegia. These patients often have severe upper back, neck, and shoulder pain, limiting rehabilitation productivity and potential, and always limiting quality of life. This pain appears to be primarily musculoskeletal. Muscles in the upper back and neck become shortened, rock hard, and extremely tender with even the slightest touch or stretch. Refractory to multiple classes of medications, modalities, and other treatments, patients truly suffer-not only from pain, but from fatigue, sedation, expense, and loss of useful rehabilitation time due to attempted remedies. Unfortunately, this subgroup of patients is not small and the problem is significant, as anyone who specializes in the treatment of spinal cord injury patients will recognize. In search for another form of treatment, botulinum toxin A (BTXA) may be promising for pain control in that group of patients with tetraplegia whose pain has proven to be refractory to treatment. It did not take long searching the literature to find compelling evidence that BTXA may have another mechanism of action for direct pain control, apart from its well known mechanism for spasticity control. Clinically, it is increasingly being recommended and used for this purpose. In fact, one of the specific indications now recognized by most for BTXA treatment is for myogenic pain due to short, tight, strained muscles-just as we see with our population. Yet, it's application has not been studied in people with tetraplegia. Thus, the genesis of the project and the hope to help our patients evolved. Study hypotheses: * In addition to traditional treatments used for pain control, injection of BTXA into cervical and upper back muscles will effectively reduce cervical/shoulder pain severity reported by individuals with cervical spinal cord injuries, regardless of the etiology of pain. * Pain reduction secondary to the use of BTXA will be associated with a decrease in total analgesic medication use among SCI patients during acute inpatient rehabilitation. * BTXA to treat cervical/shoulder pain will increase active participation in the rehabilitation program for individuals with tetraplegia during inpatient rehabilitation.

null

Spinal Cord Injury Pain

Botox

null

2

arm 1: Normal saline injections were used for placebo injections. Injections were based on treatment plan determined in clinical setting by study PI and physical therapist. 25 cc syringe was used and amount of saline injected was unit based on muscles to be injected according to the treatment plan. arm 2: Botulism toxin A dosage was based on plan developed in clinical setting with study PI and physical therapist. Drug was dosed in 25 cc syringe,diluted with normal saline and injections occured based on treatment plan.

[ 2, 1 ]

2

[ 0, 10 ]

intervention 1: Injection of BTXA into cervical and upper back muscles based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit.Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded. intervention 2: Injection of normal saline into cervical and upper back muscles was also based on treatment plan prescribed for each participant individually based on muscle soreness and tightness. Injections occured on one single clinic visit. Both the saline and BTXA were dosed in 25 cc syringes and looked the same for the physician performing the injections to ensure both participant and study physician remained blinded.

intervention 1: botulinum toxin A intervention 2: placebo

1

Englewood | Colorado | United States | -104.98776 | 39.64777

0

NCT00320281

[ 5 ]

1,771

RANDOMIZED

FACTORIAL

0TREATMENT

0NONE

false

0ALL

true

This study will determine how well four different antiretroviral drug therapies work in patients with advanced HIV disease. The trial is part of the South Africa-U.S. Project Phidisa Programme - a collaboration between the South African Military Health Service (SAMHS) of the South African National Defense Force (SANDF), the U.S. Department of Defense, and the U.S. National Institutes of Health - to help prevent HIV transmission among South African military and civilian employees and their families. Members of the SANDF with HIV infection may be eligible for this study. HIV-infected family members who are 14 years of age and older may also participate. All participants must have a CD4 count of less than 200 or an AIDS-defining illness. Participants are randomly assigned to one of the following four antiretroviral drug regimens, which require taking 5 pills or more every day: * AZT (zidovudine) + ddl (didanosine) + EFV (efavirenz) * AZT (zidovudine) + ddl (didanosine) + r/LPV (lopinavir/ritonavir) * D4T (stavudine) + 3TC (lamivudine) + EFV (efavirenz) * D4T (stavudine) + 3TC (lamivudine) + r/LPV (lopinavir/ritonavir) Patients are followed for up to 6 years. Clinic visits are scheduled once a month for the first 3 months and then once every 3 months for the next five years. Patients undergo a medical history, physical examination, and blood tests at each visit, and complete questionnaires of behavior, quality of life, and force readiness every year.

This is a randomized, open label 2x2 factorial study of four regimens of initial therapy. I. AZT + ddl + EFV II. AZT + ddl + r/LPV III. D4T + 3TC + EFV IV. D4T + 3TC + r/LPV Eligible patients will commence their randomly allocated study drugs as soon as possible after randomization. Episodes of treatment limiting toxicity will be managed in keeping with protocol specified guidelines. Patients who experience treatment failures (as specified in the protocol) will be managed by changing their regimen to that corresponding to one of the other treatment groups.

HIV

Protease Inhibitors Reverse Transcriptase Inhibitors AIDS Opportunistic Infections Resource-Poor

null

4

arm 1: Zidovudine,Didanosine,Efavirenz ( Zidovudine 600 mg once daily,Didanosine \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily,Efavirenz 600 mg once daily) arm 2: Zidovudine,Didanosine,Lopinavir/Ritonavir(AZT 600 mg once daily,DDI 100 mg twice daily,r/LPV 400mg/100mg twice daily) arm 3: Stavudine,Lamivudine,Efavirenz(d4T 40 mg twice daily,3TC 300 mg once daily,EFV 600 mg once daily) arm 4: Stavudine,Lamivudine,Lopinavir/Ritonavir(d4T 40m mg twice daily,3TC 300 mg once daily,r/LPV 400mg/100mg twice daily)

[ 1, 1, 1, 1 ]

6

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

intervention 1: 600 mg once daily intervention 2: 40 mg once daily intervention 3: \<60 kg/125 mg twice daily or \>60kg/200 mg twice daily intervention 4: 300 mg once daily intervention 5: 600 mg once daily intervention 6: r/LPV 400mg/100mg twice daily

intervention 1: Zidovudine intervention 2: Stavudine intervention 3: Didanosine intervention 4: Lamivudine intervention 5: Efavirenz intervention 6: Lopinavir/Ritonavir

7

Centurion | N/A | South Africa | 28.18577 | -25.85891 Eastaern Cape | N/A | South Africa | N/A | N/A Free State | N/A | South Africa | N/A | N/A Gauteng | N/A | South Africa | N/A | N/A Kwazulu-Natal | N/A | South Africa | N/A | N/A Limpopo | N/A | South Africa | N/A | N/A Western Cape | N/A | South Africa | N/A | N/A

0

NCT00342355