ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00866294
Conditions: Depressive Disorder
Keywords: Immediate-release formulation of paroxetine (paroxetine IR) HAM-D (17 items) Controlled-release formulation of paroxetine (paroxetine CR)
Sponsor: GlaxoSmithKline
Start date: 2009-04-01; Completion date: 2010-02-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety based on adverse events, laboratory data and vital signs, and to describe the efficacy and safety of immediate release (IR) formulation of paroxetine.

Detailed description:

Arms: arm 1: controlled-release (CR) of paroxetine 12.5 to 50mg/day arm 2: Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm arm 3: matched placebo to both paroxetine CR and paroxetine IR
Interventions: intervention 1: paroxetine IR 10mg tablet intervention 2: paroxetine IR 20mg tablet intervention 3: matched placebo to paroxetine IR 10mg or 20mg intervention 4: Paroxetine CR 12.5mg tablet intervention 5: Paroxetine CR 25mg tablet intervention 6: matched placebo to paroxetine CR 12.5mg or 25mg
Intervention descriptions: intervention 1: 1 or 2 tablets once a day intervention 2: 1 tablet once a day intervention 3: 1 or 2 tablets once a day intervention 4: 1 or 2 tablets once a day intervention 5: 1 or 2 tablets once a day intervention 6: 1 or 2 tablets once a day

Protocol documents:
Clinical trial NCT00871572
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: LY2409021 intervention 2: Placebo
Intervention descriptions: intervention 1: 4 capsules by mouth taken once daily for 12 weeks intervention 2: 4 capsules by mouth once daily for 12 weeks

Protocol documents:
Clinical trial NCT00877383
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: chronic obstructive pulmonary disease COPD indacaterol tiotropium bronchodilation
Sponsor: Novartis Pharmaceuticals
Start date: 2009-04-01; Completion date: 2010-02-01
Enrollment: 1142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). 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: Indacaterol 150 μg intervention 2: Tiotropium 18 μg intervention 3: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device. intervention 2: Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®). intervention 3: Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Protocol documents:
Clinical trial NCT00878228
Conditions: Nausea and Vomiting, Postoperative
Sponsor: Hospital for Special Surgery, New York
Start date: 2009-04-01; Completion date: 2010-02-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a randomized placebo controlled trial to determine whether repeated postoperative prophylactic ondansetron ("Zofran") administration will prevent postoperative and/or postdischarge nausea and vomiting in patients undergoing ambulatory hip arthroscopy. Ondansetron will be administered in the intra- and post-operative period. These individuals will be followed on postoperative days 1, 2, and 3. It is hypothesized that the incidence of postdischarge nausea and vomiting (PDNV) will be significantly decreased by postoperative prophylactic administration of multiple doses of ondansetron (Zofran).

Detailed description:

Arms: arm 1: The study group will receive intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days). arm 2: The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
Interventions: intervention 1: Ondansetron intervention 2: Placebo
Intervention descriptions: intervention 1: The study group will receive 4 mg of IV ondansetron perioperatively and also postoperative oral ondansetron tablets (8 mg each day for two days). The tablets will be concealed in generic capsules prepared by the pharmacy at the Hospital for Special Surgery to make the ondansetron tablets indistinguishable from the placebos. intervention 2: The control group will receive IV ondansetron intraoperatively and then oral placebo tablets (for 2 days). These placebo tablets will contain lactose and be indistinguishable from the study medication.

Protocol documents:
Clinical trial NCT00883051
Conditions: Migraine Disorders
Keywords: COL-144 acute treatment migraine
Sponsor: Eli Lilly and Company
Start date: 2009-07-01; Completion date: 2010-02-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.

Detailed description:
Migraine is a common chronic neurological disorder characterized by recurrent disabling episodes of moderate to severe headache accompanied by nausea, vomiting, photophobia, and phonophobia. Acute pharmacologic therapy for migraine aims to terminate the attack or reduce its severity. Analgesics are commonly used or, if these are ineffective, triptans. Since triptans are contraindicated in patients with coronary artery disease, uncontrolled hypertension, and cerebrovascular disease alternative medications are required for patients where simple analgesics do not work. COL-144 has no vasoconstrictor activity at clinically relevant concentrations and might meet this need. COL-144 was effective when given intravenously in a placebo-controlled dose-ranging study. This study investigates which dose of oral COL-144 is effective in the in acute treatment of migraine headache.

Arms: arm 1: 50 mg lasmiditan administered orally (PO) arm 2: 100 mg lasmiditan administered orally (PO) arm 3: 200 mg lasmiditan administered orally (PO) arm 4: 400 mg lasmiditan administered orally (PO) arm 5: Placebo administered orally (PO)
Interventions: intervention 1: Lasmiditan intervention 2: Placebo
Intervention descriptions: intervention 1: Oral application of one dose of either 50 mg lasmiditan,100 mg lasmiditan, 200 mg lasmiditan, 400 mg lasmiditan or placebo as the first treatment for a new migraine attack providing that any aura symptoms have resolved and the headache is either moderate or severe and has been so for less than 4 hours. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00885378
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-05-01; Completion date: 2010-02-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Saxagliptin plus metformin IR intervention 2: Placebo plus metformin IR
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, Twice daily, 12 weeks intervention 2: Tablets, Oral, Placebo, Twice daily, 12 weeks

Protocol documents:
Clinical trial NCT00894647
Conditions: Actinic Keratosis
Keywords: actinic keratosis skin disease
Sponsor: Graceway Pharmaceuticals, LLC
Start date: 2009-05-01; Completion date: 2010-02-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).

Detailed description:
In this multicenter, randomized, double-blind, placebo-controlled study, the efficacy and safety of imiquimod 3.75% cream following cryosurgery to treat clinically typical visible or palpable AK lesions on the face was compared with that of placebo cream. Based on a 1:1 randomization, approximately 120 subjects applied imiquimod 3.75% cream daily (up to 500 mg cream daily \[18.75 mg imiquimod\]) and approximately 120 subjects applied placebo cream daily during two 2-week periods (Cycle 1 and Cycle 2) separated by 2 weeks of no treatment. Subjects visited the clinic 9 times-1 screening/cryosurgery visit (additional visits might be needed during the screening period to assess healing from the cryosurgery), 4 treatment visits(treatment initiation at Weeks 0 and 4 and treatment follow-up at the end of Weeks 2 and 6), and 4 posttreatment visits (4, 8, 14, and 20 weeks after the last administration of study treatment at the end of Week 6). The total study duration for a subject, including a 2-week screening period, was up to 28 weeks.

Prior to cryosurgery, subjects had to have ≥10 clinically typical visible or palpable AK lesions in an area that exceeded 25 cm\^2 on the face to be eligible for participation in the study. At screening, a minimum of 5 visible lesions were not treated with cryosurgery, and 5 to 14 visible lesions were treated with cryosurgery. Subjects had to have at least 5 AK lesions after the skin healed sufficiently from the cryosurgery to be eligible for randomization to either imiquimod 3.75% or placebo cream. Subjects applied up to 2 packets of study cream (500 mg total) as a thin layer to the entire face, avoiding the periocular areas, lips, and nares; ears were excluded from both assessment and treatment. Study cream was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. Rest periods from daily treatment could be approved by the investigator as needed, with treatment resumption at the investigator's discretion.

Arms: arm 1: placebo cream in 250mg/packet, up to 2 packets applied daily arm 2: Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
Interventions: intervention 1: imiquimod cream intervention 2: placebo cream
Intervention descriptions: intervention 1: Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period intervention 2: cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period

Protocol documents:
Clinical trial NCT00900159
Conditions: Shift-Work Sleep Disorder
Keywords: Shift-work SWSD eszopiclone MWT shiftworkers
Sponsor: Brigham and Women's Hospital
Start date: 2009-05-01; Completion date: 2010-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

Detailed description:
The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.

Arms: arm 1: Treatment with eszopiclone arm 2: Treatment with matching placebo
Interventions: intervention 1: eszopiclone intervention 2: matching placebo
Intervention descriptions: intervention 1: 3mg eszopiclone prior to daytime sleep for 3 days (at home) and 1 day (in lab) intervention 2: matching placebo prior to daytime sleep for 3 days (at home) and 1 day (in lab)

Protocol documents:
Clinical trial NCT00925353
Conditions: Adverse Effects
Keywords: lidocaine pre-medication mammography pain safety
Sponsor: Mountain States Tumor and Medical Research Institute
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening mammography does not result in adverse effects, electrocardiogram (EKG) changes, or systemically toxic plasma concentration of lidocaine or its principal metabolite, monoethylglycinexylidide (MEGX).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 4% lidocaine gel
Intervention descriptions: intervention 1: 1 ounce 4% lidocaine gel on skin of breasts and chest wall for 1 hour under occlusion, then removed with warm water

Protocol documents:
Clinical trial NCT00937040
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Osmotic Release Oral System (OROS®) Extended Release Methylphenidate HCl CONCERTA® (OROS MPH)
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Start date: 2009-07-01; Completion date: 2010-02-01
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.

Detailed description:
The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult patient in the study with ADHD. The primary efficacy variable in this study is the change from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or matching placebo at baseline and continue morning dosing with increases every week until an optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo. Eligible patients will remain in the study for a maximum of 6 weeks.

Arms: arm 1: OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks arm 2: Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
Interventions: intervention 1: OROS MPH intervention 2: Placebo intervention 3: OROS MPH Tablets intervention 4: Placebo Tablets
Intervention descriptions: intervention 1: Optimal Patient Dose (18 mg-72 mg) once daily for 6 weeks intervention 2: Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily for 6 weeks intervention 3: Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks intervention 4: Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks

Protocol documents:
Clinical trial NCT00955266
Conditions: Diastolic Dysfunction
Keywords: Separation Cardiopulmonary bypass Calcium chloride
Sponsor: Brigham and Women's Hospital
Start date: 2009-07-01; Completion date: 2010-02-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Successful heart surgery requires the resumption of a strong beating heart prior to separation from the heart and lung machine. There are different ways to do this. At this hospital, the surgical team usually gives calcium to people when they come off of the heart and lung machine because some doctors believe that calcium can "jump start" the heart. Not every hospital does this.

Some people think that calcium may have a side effect of making the heart more stiff. Stiff hearts do not beat as well or receive as much blood to tissues as non-stiff hearts. If calcium makes the heart stiff, then doctors may have to use other medicines to support the heart in the operating room and the intensive care unit. This may ultimately lead to poorer outcomes including a longer stay in the intensive care unit and in the hospital.

This study is being performed to find out if calcium has the side effect of making the heart more stiff. This study compares calcium to placebo. The placebo looks exactly like the calcium, but it contains no calcium. During this study patients may receive placebo instead of calcium. Neither the doctor nor the study team will know which drug the subject will receive.

Detailed description:

Arms: arm 1: Calcium chloride, 10mg/kg arm 2: Normal saline
Interventions: intervention 1: Calcium Chloride intervention 2: Placebo
Intervention descriptions: intervention 1: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes intervention 2: Normal saline, 50cc delivered over 5 minutes

Protocol documents:
Clinical trial NCT00959842
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia Omega-3 Fatty Acids Lipoprotein Statin Lovaza
Sponsor: Sanford Research
Start date: 2009-09-01; Completion date: 2010-02-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Detailed description:
This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Arms: arm 1: Lovaza was given as the only agent; there was no comparator agent or arm
Interventions: intervention 1: Lovaza
Intervention descriptions: intervention 1: 1 gram gel capsule 4 capsules per day for 8 weeks

Protocol documents: