ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00929110
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD NVA237 glycopyrronium bromide
Sponsor: Novartis
Start date: 2009-06-01; Completion date: 2011-04-01
Enrollment: 1066 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 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 glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 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 3: Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 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.
Interventions: intervention 1: Glycopyrronium bromide intervention 2: Placebo to glycopyrronium bromide intervention 3: Tiotropium
Intervention descriptions: intervention 1: Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 3: Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.

Protocol documents:
Clinical trial NCT00936065
Conditions: Moderate to Severe Psoriasis
Keywords: Etanercept Acitretin Psoriasis
Sponsor: Pfizer
Start date: 2009-07-01; Completion date: 2011-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Etanercept intervention 2: Etanercept + Acitretin intervention 3: Acitretin
Intervention descriptions: intervention 1: Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks intervention 2: Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks intervention 3: Acitretin at a dose of 10mg BID for 24 weeks

Protocol documents:
Clinical trial NCT00937157
Conditions: Multiple Sclerosis
Keywords: Inflammation Multiple Sclerosis Glatiramer Acetate Gd enhancing lesions 1.5T protocol 3T protocol Magnetization transfer imaging (MTI) Lesion activity analysis Copaxone
Sponsor: University at Buffalo
Start date: 2007-09-01; Completion date: 2011-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will:

* Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.

  * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.
* Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.

This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.

Detailed description:
Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.

Arms: arm 1: Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
Interventions: intervention 1: Copaxone
Intervention descriptions: intervention 1: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.

Protocol documents:
Clinical trial NCT00948753
Conditions: Graft-versus-host Disease Hematopoietic Stem Cell Transplantation
Keywords: Graft-versus-host disease GVHD Maraviroc non-myeloablative allogeneic stem-cell transplantation Hematopoietic stem cell transplantation
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2009-06-01; Completion date: 2011-04-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates the effectiveness and safety of Maraviroc (an oral medication given twice daily given in addition to the standard GVHD prophylaxis) in preventing Graft versus Host Disease (GVHD) in patients undergoing non-myeloablative allogeneic stem-cell transplantation (SCT). Subjects will receive Maraviroc bid (in addition to standard GVHD prophylaxis) beginning after the last dose of the chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Detailed description:

Arms: arm 1: 150mg twice daily arm 2: 300mg twice daily arm 3: 300mg twice daily
Interventions: intervention 1: Maraviroc 150 MG intervention 2: Maraviroc 300 mg intervention 3: Maraviroc 300 mg Phase II
Intervention descriptions: intervention 1: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion. intervention 2: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion. intervention 3: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.

Protocol documents:
Clinical trial NCT00960986
Conditions: Major Depressive Disorder (MDD)
Sponsor: Eli Lilly and Company
Start date: 2009-08-01; Completion date: 2011-04-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess nausea severity in response to four different drug dosing strategies of Duloxetine (30 mg with food, 60 mg with food, 30 mg without food, and 60 mg without food) in Korean patients with major depressive disorder (MDD).

Detailed description:

Arms: arm 1: Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks arm 2: Duloxetine 60 mg capsule po QD without food for 8 weeks arm 3: Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks arm 4: Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
Interventions: intervention 1: Duloxetine hydrochloride
Intervention descriptions: intervention 1: po, QD

Protocol documents:
Clinical trial NCT00970281
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injection of agitation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rapid-Acting Intramuscular Olanzapine intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections intervention 2: Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections

Protocol documents:
Clinical trial NCT00971243
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin resistance
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2009-08-01; Completion date: 2011-04-01
Enrollment: 448 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MP-513 in combination with Metformin in patients with type 2 diabetes for 24 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Metformin with an extension treatment for up to 52 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: MP-513 Lowest Dose and Metformin intervention 2: MP-513 Low Dose and Metformin intervention 3: MP-513 Medium Dose and Metformin intervention 4: MP-513 High Dose and Metformin intervention 5: Placebo and Metformin
Intervention descriptions: intervention 1: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 2: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 3: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 4: MP-513 tablets, once a day and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks. intervention 5: Placebo tablets once a day, and Metformin tablets, for 24 weeks and extension treatment for up to 52 weeks.

Protocol documents:
Clinical trial NCT00971997
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 135 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose is to evaluate the proportion of subjects achieving a Hemoglobin A1c (HbA1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (QD) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (OADs).

Detailed description:
A multicenter, non-randomized, open-label, post-marketing clinical study. The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs. The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks). The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level. During Study Period I, all the subjects will be given a once daily (QD) injection of lispro mix 50/50. During Study Period II, the regimen of lispro mix 50/50 injection will be changed to twice daily (BID) if the HbA1c level at Week 16 is 6.5% or above, and QD injection will be continued if the value is below 6.5%. During Study Period III, if the HbA1c level at Week 32 is 6.5% or above, the subjects on BID treatment during the previous period (Study Period II) will receive three times daily (TID) injections of insulin.

Arms: arm 1: None
Interventions: intervention 1: Lispro Mix 50/50
Intervention descriptions: intervention 1: Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control.

Protocol documents:
Clinical trial NCT00981084
Conditions: Multiple Sclerosis
Sponsor: University of Missouri, Kansas City
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigation will involve a double-blind, placebo controlled, cross-over study examining the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1 standard deviation below the mean on a brief cognitive screen will be given a thorough neuropsychological evaluation at two time points. Half of the patients will be randomized to receive a single oral dose of lactose placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.

Detailed description:

Arms: arm 1: All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design
Interventions: intervention 1: armodafinil
Intervention descriptions: intervention 1: Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.

Protocol documents:
Clinical trial NCT00984620
Conditions: Hepatitis C
Sponsor: Boehringer Ingelheim
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Detailed description:

Arms: arm 1: patients to receive BI201335 with PegIFN/RBV for 12 wks followed by 12 weeks PegIFN/RBV with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV) arm 2: patients to receive BI201335 with PegIFN/RBV for 24 wks with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 NA 3 days after first administration of PegIFN/RBV)
Interventions: intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha (IFN) intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: BI 201335 intervention 2: BI 201335 intervention 3: Pegylated Interferon-alpha intervention 4: Ribavirin (RBV)

Protocol documents:
Clinical trial NCT00988117
Conditions: Parkinsons Disease With Dementia Parkinsons Disease With Mild to Moderate Memory and/or Thinking Problems
Keywords: PDD Parkinson's Disease with Dementia rivastigmine rivastigmine patch open label Parkinson's Disease Parkinsons Disease memory Exelon Exelon Patch
Sponsor: University of California, San Francisco
Start date: 2010-04-01; Completion date: 2011-04-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's Disease who have mild to moderate memory and/or thinking complaints will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in people with Parkinson's disease and memory and/or thinking problems.

Detailed description:
Participation in this study requires four visits: a screening visit to ensure eligibility, an initial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final twelve week follow up visit.

* In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
* At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
* At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
* At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
* Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.

Arms: arm 1: None
Interventions: intervention 1: Rivastigmine Patch 9.5 cm2
Intervention descriptions: intervention 1: Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.

Protocol documents:
Clinical trial NCT00992225
Conditions: Breast Cancer
Keywords: Metastatic
Sponsor: Eli Lilly and Company
Start date: 2009-09-01; Completion date: 2011-04-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636-sodium for metastatic breast cancer.

Detailed description:
Patient will receive a 2-hour intravenous infusion of study drug (LY573636-sodium) once every 28 days. Radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. Patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Arms: arm 1: None
Interventions: intervention 1: LY573636-sodium
Intervention descriptions: intervention 1: Dose is adjusted to target a specific maximum concentration (Cmax) based on patient laboratory parameters, administered intravenously every 28 days until disease progression or other criteria for patient discontinuation are met

Protocol documents:
Clinical trial NCT00999544
Conditions: Narcotic Abuse
Keywords: opioid oxycodone NK1 antagonist aprepitant intranasal abuse
Sponsor: Sharon Walsh
Start date: 2009-10-01; Completion date: 2011-04-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Addressing the issue of opioid dependence and tolerance has public health implications for the treatment of opioid abuse (both heroin as well as pharmaceutical opioids) and for the treatment of pain. Recent preclinical data suggest a role for Substance P (NK-1) receptors in modulating both the acute and chronic response to opioids. The objective of this study is to determine whether pretreatment with aprepitant, a selective neurokinin-1 (NK-1) antagonist can reduce the direct response to an opioid agonist (oxycodone) on measures related to abuse liability and reinforcing effects.

Detailed description:
Healthy adult volunteers with histories of illicit opioid use by the intranasal and oral routes will be admitted to this 6-week inpatient, crossover study. They will participate in 15 experimental test sessions, each lasting approximately 6.5 hours, during which they will receive a range of acute doses of aprepitant, including placebo, followed by challenge with oxycodone or placebo (given intranasally or orally). Multi-dimensional outcomes, including physiological (blood pressure, oxygen saturation, pupil diameter), subjective (questionnaires related to mood, abuse liability) and observer ratings will be collected repeatedly throughout each session. Data will be analyzed using parametric approaches to within-subject designs.

Arms: arm 1: Placebo aprepitant/Placebo oxycodone IN/PO arm 2: Placebo aprepitant/ oxycodone 15 IN 0 PO arm 3: Placebo aprepitant/ oxycodone 30 IN 0 PO arm 4: Placebo aprepitant/ oxycodone 0 IN 20 PO arm 5: Placebo aprepitant/ oxycodone 0 IN 40 PO arm 6: Aprepitant 40 mg/ oxycodone 0 IN 0 PO arm 7: Aprepitant 40 mg/ oxycodone 0 IN 20 PO arm 8: Aprepitant 40 mg/ oxycodone 0 IN 40 PO arm 9: Aprepitant 40 mg/ oxycodone 15 IN 0 PO arm 10: Aprepitant 40 mg/ oxycodone 30 IN 0 PO arm 11: Aprepitant 200 mg/ oxycodone 0 IN 0 PO arm 12: Aprepitant 200 mg/ oxycodone 0 IN 20 PO arm 13: Aprepitant 200 mg/ oxycodone 0 IN 40 PO arm 14: Aprepitant 200 mg/ oxycodone 15 IN 0 PO arm 15: Aprepitant 200 mg/ oxycodone 30 IN 0 PO
Interventions: intervention 1: Aprepitant 0mg intervention 2: Aprepitant 40mg intervention 3: Aprepitant 200mg intervention 4: Oxycodone 0mg, p.o. intervention 5: Oxycodone 20mg, p.o. intervention 6: Oxycodone 40mg, p.o. intervention 7: Oxycodone 0mg, IN intervention 8: Oxycodone 15mg, IN intervention 9: Oxycodone 30mg, IN
Intervention descriptions: intervention 1: Aprepitant 0mg, p.o. pretreatment intervention 2: Aprepitant 40mg, p.o. pretreatment intervention 3: Aprepitant 200mg, p.o. pretreatment intervention 4: Oxycodone 0mg, p.o. intervention 5: Oxycodone 20mg, p.o. intervention 6: Oxycodone 40mg, p.o. intervention 7: Oxycodone 0mg, IN intervention 8: Oxycodone 15mg, IN intervention 9: Oxycodone 30mg, IN

Protocol documents: