ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00723203
Conditions: Leukemia
Keywords: Philadelphia chromosome positive adult precursor acute lymphoblastic leukemia recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia
Sponsor: City of Hope Medical Center
Start date: 2008-04-01; Completion date: 2010-09-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying the side effects of panobinostat and to see how well it works in treating patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.

Detailed description:
OBJECTIVES:

Primary

* To determine the antitumor activity of panobinostat, in terms of objective response rate, time to progression, and survival, in patients with relapsed or refractory acute lymphoblastic leukemia or acute myeloid leukemia.
* To assess the toxicity of panobinostat in these patients.

Secondary

* To perform correlative laboratory studies to assess changes in various proteins that may be altered by histone deacetylase inhibition therapy.

OUTLINE: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo peripheral blood and bone marrow sample collection at baseline and on day 28 of course 1 for correlative laboratory studies. Samples are analyzed by RT-PCR for reactivation of FANCG, FOXO3A, GADD45A, GADD45B, GADD45G, H2AX, and TP73.

After completion of study treatment, patients are followed for at least 4 weeks.

PROJECTED ACCRUAL: A total of 74 patients (37 with acute myeloid leukemia and 37 with acute lymphoblastic leukemia) will be accrued for this study.

Arms: arm 1: Patients receive oral panobinostat once on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

panobinostat: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle
Interventions: intervention 1: panobinostat intervention 2: gene expression analysis intervention 3: reverse transcriptase-polymerase chain reaction intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: 40 mg Monday, Wednesday and Friday of every week in a 28 day cycle intervention 2: Day 1 and day 28 samples intervention 3: Day 1 and day 28 samples intervention 4: Day 1 and day 28 samples

Protocol documents:
Clinical trial NCT00737204
Conditions: HIV Infections Fatigue
Keywords: HIV AIDS Armodafinil Depression
Sponsor: New York State Psychiatric Institute
Start date: 2008-06-01; Completion date: 2010-09-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether armodafinil (Nuvigil), an FDA approved medication, is effective in reducing fatigue in adults with HIV/AIDS.

Detailed description:
Fatigue is a common problem for many people with HIV/AIDS, interfering with daily activities and serving as a significant barrier to working among those whose health is otherwise stable or restored by antiretroviral (ARV) medication. Fatigue in HIV is associated with disability and diminished quality of life. It may be caused by ARVs or by the virus itself. A related study tested whether modafinil, of which armodafinil is an r-isomer, could reduce fatigue in HIV/AIDS patients. Armodafinil, believed to have a longer duration and greater effect than modafinil, will be tested on the same criteria.

Participants will be randomly assigned to receive either armodafinil or a placebo daily for 4 weeks. Participants randomized to active medication and who show improvements in symptoms will be offered armodafinil for an additional 12 weeks. For them, the study duration is 16 weeks. Participants who did not receive armodafinil will be offered armodafinil for 16 weeks. For these participants, the study duration is 20 weeks. Participants who did not benefit from armodafinil will receive alternate treatment options. All participants will have weekly study visits for the first 4 weeks of the study and biweekly visits for the remainder of the study. At each visit, participants will complete various tasks to determine cognitive function, and self-report scales will be used to determine symptoms of depression and fatigue. After completion of 16 weeks, participants responding to armodafinil will be transitioned to the publicly available modafinil over the course of 2 weeks.

Arms: arm 1: Participants will take armodafinil for 4 weeks. The dose will be titrated up from 50mg to 250mg per day as clinically indicated, using 50mg tablets. If responsive, participants will be offered 12 additional weeks of armodafinil. arm 2: Participants will receive placebo pills for 4 weeks. Placebo tablets that match the 50mg active medication tablets will given following the same dosing strategy as Arm 1. The dose will be titrated from 1 placebo tablet daily to 5 tablets daily as clinically indicated. Non-responders to placebo will then be offered 16 weeks of active medication.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive 50 mg of armodafinil per day, increasing to 250 mg per day as clinically indicated. intervention 2: Participants will receive placebo pills matched to the active armodafinil and according to the same dosing strategy

Protocol documents:
Clinical trial NCT00739024
Conditions: Migraine Migraine With Aura Migraine Without Aura
Keywords: Migraine Headache
Sponsor: Swedish Medical Center
Start date: 2008-04-01; Completion date: 2010-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if ramelteon will reduce the number of migraine headaches over a 12 week period. The safety and tolerability of ramelteon will also be evaluated. Ramelteon has been approved by the U.S. Food and Drug Administration (FDA) for insomnia (trouble sleeping); however; ramelteon has not been approved for the prevention of migraines.

Detailed description:
Sleep has played an important role in migraine. Younger migraine sufferers usually report relief of migraine after sleep. In older migraine sufferers migraine is sometimes triggered with sleep changes. Occurrence of migraine in the early morning is very common. Therefore in these individuals regulation of sleep may improve the frequency of migraine. Recent PET studies done during migraine demonstrated activation of hypothalamus during migraine. In light of this new data and the known action of ramelteon on the melatonin receptors it may theoretically provide an insight on a possible mechanism of action in migraine.

Arms: arm 1: Ramelteon once daily (double-blind assignment) arm 2: Placebo tablet, once daily (double-blind assignment)
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg tablet, oral, once daily intervention 2: Placebo tablet, oral, once daily

Protocol documents:
Clinical trial NCT00747617
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome androgens ovary LH
Sponsor: University of California, San Diego
Start date: 2007-09-01; Completion date: 2010-09-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.

Detailed description:
Each subject (normal and PCOS women) will be admitted to the UCSD General Clinical Research Center (GCRC) for study on 5 occasions. All subjects will receive an intravenous injection of hCG dose of 1, 10, 25, 100, and 250 micrograms, each of which will be given on one of 5 different days each separated by at least two weeks at 8 AM. Blood samples will be obtained at t -0.5, 0, and 24 hours after injection. All visits to the GCRC will be done as out patients. The total amount of blood withdrawn will be about 35 teaspoons. For normal control subjects this will be over a period of about 4-6 months and for PCOS subjects this will be over a period of about 6-10 weeks.

Arms: arm 1: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions. arm 2: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of recombinant human chorionic gonadotropin administered iv on 5 separate occasions.
Interventions: intervention 1: recombinant human chorionic gonadotropin
Intervention descriptions: intervention 1: Each subject will receive a dose (1, 10, 25, 100, or 250 micrograms) of human chorionic gonadotropin administered intravenously on 5 separate occasions.

Protocol documents:
Clinical trial NCT00749658
Conditions: Nicotine Dependence Nicotine Withdrawal
Keywords: Tobacco Nicotine Smoking Varenicline Bupropion Human laboratory study Stress tolerance Startle response Cognitive assessment Progressive ratio Motivation
Sponsor: University of Minnesota
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-subjects design will be used to assess the additive effects of bupropion and varenicline in 48 treatment seeking smokers \[bupropion SR (300 mg/day)+placebo, varenicline (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)\]. Outcomes include withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of smoking, and smoking topography.

Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.

Detailed description:

Arms: arm 1: Bupropion + Placebo Varenicline \\Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \\Bupropion + Placebo Varenicline arm 2: Bupropion + Varenicline \\Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \\Bupropion + Varenicline
Interventions: intervention 1: Bupropion intervention 2: Varenicline
Intervention descriptions: intervention 1: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. intervention 2: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.

Protocol documents:
Clinical trial NCT00760747
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Children Stimulant Atomoxetine Adolescents
Sponsor: Eli Lilly and Company
Start date: 2008-09-01; Completion date: 2010-09-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.

Detailed description:
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.

Arms: arm 1: Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks arm 2: Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks
Interventions: intervention 1: Atomoxetine
Intervention descriptions: intervention 1: 1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)

Protocol documents:
Clinical trial NCT00763360
Conditions: Cataract
Keywords: Cataract
Sponsor: Alcon Research
Start date: 2008-05-01; Completion date: 2010-09-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

Detailed description:

Arms: arm 1: DisCoVisc® Ophthalmic Viscosurgical Device arm 2: Healon arm 3: Amvisc Plus
Interventions: intervention 1: DisCoVisc® intervention 2: Healon intervention 3: Amvisc Plus
Intervention descriptions: intervention 1: Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure intervention 2: Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure intervention 3: Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Protocol documents:
Clinical trial NCT00763958
Conditions: Opioid Dependence HIV
Keywords: opiates HIV
Sponsor: University of Alabama at Birmingham
Start date: 2008-05-01; Completion date: 2010-09-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.

Detailed description:
This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenorphine medication. After the first 9 participants, women were randomized to either buprenorphine or placebo. Women received the buprenorphine medication for 12 weeks in the community and at the end of the 12 weeks were transitioned either to another buprenorphine provider, methadone provider, or tapered off buprenorphine based on the participant's preferences. One additional follow-up at 3 months after treatment was conducted. The primary outcome was opioid positive urines at all time points.

Arms: arm 1: Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months arm 2: Placebo sublingual medication provided to individuals randomized to control up to 3 months
Interventions: intervention 1: Placebo intervention 2: Buprenorphine
Intervention descriptions: intervention 1: Placebo to match buprenorphine administered for 3 months intervention 2: Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.

Protocol documents:
Clinical trial NCT00781937
Conditions: Metabolism and Nutrition Disorder Obesity
Sponsor: Novo Nordisk A/S
Start date: 2008-10-30; Completion date: 2010-09-01
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amount of lipids in the blood).

Trial has following trial periods: A 12-week run-in period (from week -12 to week 0) followed by a 56-week main trial period (weeks 0-56) and a 12-week follow-up period (weeks 56-68).

Detailed description:

Arms: arm 1: A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period. The starting dose of liraglutide was 0.6 mg, with weekly increments of 0.6 mg every 7 days until the target dose of 3.0 mg was reached arm 2: A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide placebo, once daily, injected subcutaneously for 56 weeks and instructed to follow a standard energy-restricted diet in the 56-week main trial period. Subjects discontinued treatment in the 12-week follow-up period
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily intervention 2: Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily

Protocol documents:
Clinical trial NCT00782184
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.

Detailed description:

Arms: arm 1: Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period arm 2: Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, 40 mg atorvastatin was administered once daily in tablet form during the 6-week double-blind treatment period
Interventions: intervention 1: ezetimibe/simvastatin 10/40 intervention 2: atorvastatin 40 mg intervention 3: atorvastatin 20 mg
Intervention descriptions: intervention 1: ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks. intervention 2: atorvastatin 40 mg tablet once daily for 6 weeks intervention 3: All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization

Protocol documents:
Clinical trial NCT00782210
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-11-01; Completion date: 2010-09-01
Enrollment: 625 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler
Interventions: intervention 1: Olodaterol (BI1744) intervention 2: Olodaterol (BI1744) intervention 3: placebo
Intervention descriptions: intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

Protocol documents:
Clinical trial NCT00787202
Conditions: Ulcerative Colitis
Keywords: treatment of ulcerative colitis; CP 690 550
Sponsor: Pfizer
Start date: 2008-12-01; Completion date: 2010-09-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: CP- 690 550 intervention 2: CP- 690 550 intervention 3: CP- 690 550 intervention 4: CP- 690 550 intervention 5: placebo
Intervention descriptions: intervention 1: Administration via oral route twice daily for the duration of treatment intervention 2: Administration via oral route twice daily for the duration of treatment intervention 3: Administration via oral route twice daily for the duration of treatment intervention 4: Administration via oral route twice daily for the duration of treatment intervention 5: Administration via oral route twice daily for the duration of treatment

Protocol documents:
Clinical trial NCT00789477
Conditions: Diabetic Macular Edema
Sponsor: Regeneron Pharmaceuticals
Start date: 2008-12-01; Completion date: 2010-09-01
Enrollment: 221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Detailed description:
Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up

Arms: arm 1: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks arm 2: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks arm 3: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks arm 4: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria arm 5: Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Interventions: intervention 1: Laser Photocoagulation intervention 2: Intravitreal Aflibercept Injection
Intervention descriptions: intervention 1: laser every 16 weeks as needed intervention 2: None

Protocol documents: