ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00517010
Conditions: Age-related Macular Degeneration
Keywords: Age-related macular degeneration Exudative age-related macular degeneration Wet macular degeneration Intravitreal injection Proton beam irradiation Lucentis Ranibizumab
Sponsor: University of California, Davis
Start date: 2007-05-01; Completion date: 2010-06-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Because a possible synergism of radiation and inhibitors of vascular endothelial growth factor has been shown in cancer patients and patients with wet macular degeneration, this pilot study is being conducted to determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe. Lucentis is an inhibitor of vascular endothelial growth factor which was recently FDA approved for treatment of wet macular degeneration. It appears to be the most effective therapy thus far for wet macular degeneration among all drugs FDA approved for this condition. If no major safety issues are associated with this combination therapy, a larger study will be conducted to determine whether this combination therapy is more effective than Lucentis monotherapy.

Detailed description:
Five subjects diagnosed with wet macular degeneration will be treated with standard of care, i.e. intravitreal Lucentis injection monthly for the first four months and as needed thereafter. Within six weeks of the first Lucentis injection, the eye will also be treated with 24 Gy of proton beam divided into two fractions. Each subject will be followed for 2 yrs with monthly examination.

Arms: arm 1: Intervention is 24Gy proton radiation in 2 fractions given within 6 weeks of first dose of intravitreal ranibizumab (0.5mg) drug combined with four monthly doses of intravitreal lucentis and monthly prn lucentis thereafter.
Interventions: intervention 1: Proton beam irradiation and ranibizumab
Intervention descriptions: intervention 1: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.

Protocol documents:
Clinical trial NCT00518531
Conditions: Osteoporosis
Keywords: osteoporosis low bone mineral density alendronate denosumab adherence preference satisfaction postmenopausal women
Sponsor: Amgen
Start date: 2007-09-01; Completion date: 2010-06-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).

Detailed description:

Arms: arm 1: When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2). arm 2: When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).
Interventions: intervention 1: alendronate intervention 2: denosumab
Intervention descriptions: intervention 1: Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1. intervention 2: Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.

Protocol documents:
Clinical trial NCT00523419
Conditions: Osteosarcoma
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2010-06-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

* To assess how well treatment with pemetrexed works for patients with your type of cancer
* To assess for any side effects that might be associated with pemetrexed.
* To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.

Detailed description:

Arms: arm 1: Participants received pemetrexed 500 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.
Interventions: intervention 1: Pemetrexed
Intervention descriptions: intervention 1: 500 mg/m\^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.

Protocol documents:
Clinical trial NCT00525512
Conditions: Pulmonary Disease, Chronic Obstructive Exercise
Sponsor: Boehringer Ingelheim
Start date: 2007-08-01; Completion date: 2010-06-01
Enrollment: 519 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Detailed description:

Arms: arm 1: Oral inhalation once daily of 18mcg tiotropium via handihaler arm 2: Oral inhalation once daily of placebo matching tiotropium via handihaler
Interventions: intervention 1: tiotropium 18 mcg intervention 2: Placebo
Intervention descriptions: intervention 1: Oral inhalation once daily of 18mcg tiotropium via handihaler intervention 2: Oral inhalation of once-daily placebo matching tiotropium via handihaler

Protocol documents:
Clinical trial NCT00539942
Conditions: Venous Thrombosis
Keywords: Randomized Clinical Trials Randomized Controlled Trial Venous thrombosis Anticoagulant Drugs Doppler Ultrasound Postoperative complications
Sponsor: University of Alabama at Birmingham
Start date: 2007-04-01; Completion date: 2010-06-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized trial to compare intermittent compression devices with or without post-operative Arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. This trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

Detailed description:
To assess the effectiveness of Arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Arms: arm 1: All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial. arm 2: Patients randomized to treatment arm will initiate Arixtra (fondaparinux sodium) treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization time and after hospital discharge).
Interventions: intervention 1: Arixtra (fondaparinux sodium) intervention 2: Intermittent compression devices (ICD)
Intervention descriptions: intervention 1: Treatment will consist of daily injections of pharmacy prepared syringes of Arixtra (fondaparinux sodium) 2.5mg. Treatment will continue for 21 consecutive days to end on post-operative day 22. intervention 2: All patients will receive intermittent compression devices (ICD's) during the patient's entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.

Protocol documents:
Clinical trial NCT00547703
Conditions: Non Ulcer Dyspepsia
Keywords: Nonulcer dyspepsia Functional dyspepsia Antidepressant use in dyspepsia Nortriptyline Tricyclic antidepressants
Sponsor: The Cleveland Clinic
Start date: 2008-02-01; Completion date: 2010-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if use of Nortriptyline will improve symptoms and quality of life in patients who have nonulcer dyspepsia.

Detailed description:
Nonulcer dyspepsia is a common complaint in clinical practice and its management should be based on the best evidence. Many clinical trials of nonulcer dyspepsia suffer from important weaknesses in trial design. This makes it difficult to determine whether truly efficacious therapies exist for this disorder.

Once a diagnosis of nonulcer dyspepsia is confirmed by normal endoscopy, a trial of therapy is commonly prescribed. However, the benefits of all therapies in this condition have been questioned. Small studies have suggested benefit in use of antidepressants such as Nortriptyline and even though the data is insufficient, antidepressants such as Nortriptyline are widely used in clinical practice largely due to lack of proven, reliable therapies for nonulcer dyspepsia.

Our hypothesis is that Nortriptyline will improve symptoms of nonulcer dyspepsia and improve quality of life.

Arms: arm 1: Patients in this group will receive Nortriptyline 25mg at night for 8 weeks. arm 2: Patients in this group will receive an identical placebo capsule at night for 8 weeks.
Interventions: intervention 1: Nortriptyline intervention 2: Placebo
Intervention descriptions: intervention 1: Nortriptyline 25mg capsule, orally administered, every night for 8 weeks intervention 2: An identical placebo capsule containing lactose, administered orally, every night for 8 weeks

Protocol documents:
Clinical trial NCT00550277
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma Refractory LBH589
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Inhibition of histone deacetylase (HDAC) provides a novel approach for cancer treatment. LBH589, an oral HDAC inhibitor, has been well tolerated in phase I trials and has shown activity against several types of cancer. In this nonrandomized phase II trial, we are investigating the activity of LBH589 in the treatment of patients with refractory clear cell renal carcinoma.

Detailed description:
Inhibition of histone deacetylase (HDAC) provides a potential target for cancer treatment. Histones are components of the core proteins of nucleosomes, and acetylation and deacetylation of these proteins play a role in the regulation of gene expression. HDAC activity is known to be increased in many types of malignant cells; HDAC inhibitors have been shown to induce differentiation, cell cycle arrest, and apoptosis in cultured tumor cells. Since this tumor-associated mechanism is common to many types of cancer, HDAC may have a broad role in cancer treatment.

Arms: arm 1: LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: LBHLBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring (Section 3.5.2), all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles.

Protocol documents:
Clinical trial NCT00550394
Conditions: Bipolar Disorder Alcohol Abuse
Keywords: Adolescents
Sponsor: University of Cincinnati
Start date: 2008-04-01; Completion date: 2010-06-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to study the effects (both good and bad) of combining quetiapine and topiramate for treating symptoms of bipolar mania (an illness with periods of elation, excessive excitement, irritability, high energy, racing thoughts, poor sleep, poor judgment, reckless behavior) and to study the effects (both good and bad) of combining quetiapine and topiramate for reducing use of alcohol.

Detailed description:
Specific Aim 1: To collect preliminary data regarding the efficacy and tolerability of topiramate for the treatment of alcohol use disorders (alcohol abuse and dependence) in adolescents with bipolar disorder.

Hypothesis 1: We hypothesize that topiramate in combination with quetiapine will lead to greater reduction in alcohol consumption (number of drinks per day, number of drinks per drinking day, and number of heavy drinking days) and greater abstinence (percentage of days abstinent) compared with quetiapine alone.

Specific Aim 2: To obtain preliminary data regarding the efficacy of topiramate for reducing manic symptoms in adolescents with co-occurring alcohol use and bipolar disorders.

Hypothesis 2: We hypothesize that the topiramate in combination with quetiapine will produce greater reduction in Young Mania Rating Scale (YMRS) scores than quetiapine alone.

Arms: arm 1: Quetiapine and Placebo arm 2: Quetiapine and Topiramate
Interventions: intervention 1: quetiapine and placebo intervention 2: Quetiapine and Topiramate
Intervention descriptions: intervention 1: Dosing Schedule and Titration of Quetiapine: open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4. intervention 2: Dosing Schedule and Titration of Quetiapine:

open-label quetiapine beginning day 1 at 100 mg/day titrated to 400 mg/day by the end of week 1

Dosing Schedule and Titration of Topiramate:

All subjects will be randomized to topiramate or matching placebo which will be administered in a double-blind manner.

Topiramate/Placebo titrated from 25 mg twice daily to 150 mg bid by week 4.

Protocol documents:
Clinical trial NCT00559637
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 184 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.

Protocol documents:
Clinical trial NCT00563316
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal cancer chemotherapy cancer metastatic irinotecan EGFr epidermal growth factor
Sponsor: Amgen
Start date: 2008-03-01; Completion date: 2010-06-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.

Detailed description:

Arms: arm 1: Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
Interventions: intervention 1: Panitumumab intervention 2: Irinotecan
Intervention descriptions: intervention 1: The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter. intervention 2: The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.

Protocol documents:
Clinical trial NCT00573859
Conditions: ADHD
Keywords: Smoking ADHD Stimulant medication
Sponsor: University of California, Irvine
Start date: 2006-09-01; Completion date: 2010-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
Whereas the smoking prevalence rates in the general population are declining, rates among people diagnosed with attention-deficit hyperactivity disorder (ADHD) continue to be elevated. Smoking may be a form of self-medication in people with ADHD, which has specific reinforcing mechanisms such as improvement of ADHD core symptoms, enhancement of moods and arousal, or a combination of both. In addition, the reinforcing effects of smoking may be potentiated by stimulant medication.

The study examined the reinforcing effects of ad libitum smoking with and without ADHD medication in adult smokers with clinically diagnosed ADHD. Participants were adults with ADHD. The effects of two day of ADHD medication compared to two days on placebo for were studied on nicotine intake (i.e., cotinine levels). In addition, task performance on the Continuous Performance Task and nicotine withdrawal symptoms were examined in response to ADHD medication + smoking a cigarette versus ADHD medication + abstinence versus placebo medication + smoking versus placebo medication + abstinence.

The study identified the reinforcing mechanisms of smoking in interaction with ADHD medication. The findings will contribute to a better understanding of nicotine addiction and facilitate the development of targeted smoking cessation and prevention programs for individuals with ADHD and other people with deficiencies in impulse control and excessive risk taking.

Detailed description:

Arms: arm 1: For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication (e.g., Dextroamphetamine; Amphetamine mixed salts; Atomoxetine; O-Methylphenidate; Lisdexamfetamine). For the placebo condition, a placebo pill was administered.
Interventions: intervention 1: ADHD medication intervention 2: Placebo
Intervention descriptions: intervention 1: For the ADHD medication condition, participants received their usual dosage of their usual ADHD medication for two consecutive days. intervention 2: For the placebo condition, participants received placebo pills for two consecutive days.

Protocol documents:
Clinical trial NCT00576303
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-04-01; Completion date: 2010-06-01
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: 120, 200 or 360 micrograms iv monthly (starting dose)

Protocol documents:
Clinical trial NCT00577460
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2007-12-01; Completion date: 2010-06-01
Enrollment: 391 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole extended release (ER), in daily doses from 0.375mg to 4.5mg once daily (qd), in patients who have previously completed a pramipexole double-blind study in advanced Parkinson's disease (PD) (248.525 trial).

Detailed description:

Arms: arm 1: Patients to receive Pramipexole ER 0.375 - 4.5 mg in tablet form daily arm 2: Patients to receive placebo tablets identical to Pramipexole ER tablets only during transfer phase
Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: Pramipexole ER 0.375 -4.5 mg intervention 2: Placebo tablets identical to Pramipexole ER tablets

Protocol documents: