ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01225068
Conditions: Low Back Pain
Sponsor: Northwestern University
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

Detailed description:
This exploratory study aims to evaluate Milnacipran in individuals with chronic neuropathic low back pain. A sample of 40 individuals with chronic low back pain will be enrolled in a double-blind, randomized, parallel group study comparing twice daily administration of milnacipran with placebo (total 100 mg bid-or equivalent placebo dosing). The study will last 6 weeks with subjects being evaluated at the start of the study, at the end of a one-week drug-free period, and at 1, 2 and 6 weeks of treatment. Additionally, subjects will evaluated after treatment has ended. Both standard endpoint outcome measures as well as validated daily self-report measures of pain and activity/disability will be utilized.

Arms: arm 1: milnacipran 50 mg bid; can be increased to 100 mg bid arm 2: Placebo
Interventions: intervention 1: Milnacipran intervention 2: Placebo
Intervention descriptions: intervention 1: Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6. intervention 2: 2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.

Protocol documents:
Clinical trial NCT01236534
Conditions: Multiple Sclerosis Constipation
Keywords: Multiple Sclerosis Constipation Multiple Sclerosis Associated Constipation
Sponsor: University of Rochester
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.

Detailed description:
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the bowel. In people with MS, the covering around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with MS may experiences constipation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 24 mcg twice daily for 21 days. intervention 2: matching placebo twice daily for 21 days.

Protocol documents:
Clinical trial NCT01239511
Conditions: Chronic Stable Angina
Sponsor: Sinphar Pharmaceutical Co., Ltd
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.

Detailed description:
The objective of this study is to evaluate the dose-response of three different dose levels of STA-2 (900 mg daily, 1800 mg daily and 2700 mg daily for 42 days) versus placebo in patients with chronic stable angina.

Treatment Group A:

150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)

Treatment Group B:

300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)

Treatment Group C:

450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)

Placebo Group:

Placebo capsule, 2 capsules t.i.d., after meal

Arms: arm 1: placebo capsule 2# t.i.d./day arm 2: 150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day) arm 3: 300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day) arm 4: 450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
Interventions: intervention 1: green tea polyphenols (STA-2)
Intervention descriptions: intervention 1: 2 capsules t.i.d., after meal

Protocol documents:
Clinical trial NCT01242527
Conditions: Severe Hypertriglyceridemia
Keywords: dyslipidemia hyperlipidemia omega-3 carboxylic acid
Sponsor: AstraZeneca
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the efficacy of Epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: placebo intervention 2: omefas intervention 3: omefas intervention 4: omefas
Intervention descriptions: intervention 1: 4 capsules (1g) daily for 12 weeks intervention 2: 2 capsules (1g) + 2 placebo daily for 12 weeks intervention 3: 3 capsules (1g) + 1 placebo daily for 12 weeks intervention 4: 4 capsules (1g)daily for 12 weeks

Protocol documents:
Clinical trial NCT01249833
Conditions: Influenza
Keywords: Influenza Cognition Attention Simple Reaction Time Alertness Calmness Contentment Mood
Sponsor: Trial Management Group Inc.
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has been designed to determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention / working memory / processing speed / mood as compared to subjects receiving standard of care alone. The cognitive tests employed are objective measures developed and administered online by HeadMinder Inc.

Detailed description:
Primary Objective:

To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in attention as compared to subjects receiving standard of care alone.

Secondary Objectives:

To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in working memory and processing speed as compared to subjects receiving standard of care alone.

Supportive Objectives:

1. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated alertness as compared to subjects receiving standard of care alone.
2. To determine if subjects treated with oseltamivir in addition to standard of care treatment for influenza demonstrate a greater improvement in self-rated calmness and contentment as compared to subjects receiving standard of care alone.
3. To determine if there is a correlation between the rate of improvement in symptom scores and the rate of change in attention and working memory.

Arms: arm 1: Added to standard of care for influenza arm 2: Standard of care for influenza
Interventions: intervention 1: Oseltamivir
Intervention descriptions: intervention 1: Oseltamivir 75mg BID for 5 days

Protocol documents:
Clinical trial NCT01255787
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder Depression Melancholia Drug Therapy
Sponsor: Takeda
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.

Detailed description:
The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying doses of vortioxetine.

The study enrolled 600 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 5 mg
* Vortioxetine 10 mg
* Vortioxetine 20 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in 14 countries in Europe and Asia. The overall time to participate in this study was up to 13 weeks. Participants made weekly visits to the clinic during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to the end of the 8-week treatment period. Participants who completed the 8-week treatment period entered a 2-week discontinuation period to assess potential discontinuation symptoms 1 and 2 weeks after the end of the 8-week treatment period. A safety follow-up contact (visit or phone call) was made 4 weeks after completion of the 8-week double-blind treatment period (2 weeks after the end of the 2-week discontinuation period).

Arms: arm 1: Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks. arm 2: Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. arm 3: Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks. arm 4: Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Vortioxetine tablets intervention 2: Vortioxetine placebo-matching tablets

Protocol documents:
Clinical trial NCT01256411
Conditions: Essential Hypertension
Keywords: hypertension blood pressure LCZ696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (ARNi)
Sponsor: Novartis Pharmaceuticals
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 341 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the long-term safety, tolerability and efficacy of LCZ696.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LCZ696 intervention 2: Amlodipine intervention 3: Hydrochlorothiazide (HCTZ)
Intervention descriptions: intervention 1: Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control. intervention 2: Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control. intervention 3: Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.

Protocol documents:
Clinical trial NCT01260454
Conditions: Pulmonary Hypertension Pulmonary Arterial Hypertension
Keywords: Qutenza Capsaicin Remodulin Treprostinil
Sponsor: University of Rochester
Start date: 2010-11-01; Completion date: 2012-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site.

Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site.

In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.

Detailed description:

Arms: arm 1: All participants actively treated with Qutenza
Interventions: intervention 1: Qutenza (8% capsaicin)
Intervention descriptions: intervention 1: We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.

Protocol documents:
Clinical trial NCT01276353
Conditions: Alzheimer's Type Dementia
Keywords: Alzheimer Disease Dementia Delirium Amnestic Cognitive Disorders Donepezil Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Mental Disorders Cholinesterase Inhibitors Enzy
Sponsor: Eisai Inc.
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: E2020 intervention 2: E2020
Intervention descriptions: intervention 1: Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation intervention 2: 10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.

Protocol documents:
Clinical trial NCT01302691
Conditions: Hypertension
Keywords: Essential hypertension Uncontrolled hypertension Antihypertensive agents Blood pressure
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-01-01; Completion date: 2012-04-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to evaluate the efficacy, safety, and tolerability of losartan potassium 50 mg (L50) + hydrochlorothiazide 12.5 mg (H12.5) + amlodipine besylate 5 mg (A5) (MK-0954E). The primary hypothesis is that L50/H12.5/A5 is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to L50+A5 in Japanese participants with essential hypertension who are not adequately controlled following an 8-week treatment with filter period study drug (L50+A5).

Detailed description:

Arms: arm 1: Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks. arm 2: Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
Interventions: intervention 1: losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E) intervention 2: Losartan potassium intervention 3: Amlodipine besylate intervention 4: Placebo to MK-0954E intervention 5: Placebo to losartan potassium intervention 6: Placebo to amlodipine besylate
Intervention descriptions: intervention 1: One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks. intervention 2: One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks. intervention 3: One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks. intervention 4: One tablet, containing placebo, orally, once daily, for 8 weeks. intervention 5: One tablet, containing placebo, orally, once daily, for 8 weeks. intervention 6: One capsule, containing placebo, orally, once daily, for 8 weeks.

Protocol documents:
Clinical trial NCT01303744
Conditions: Alzheimer's Disease
Sponsor: CERESPIR
Start date: 2011-03-01; Completion date: 2012-04-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.

Detailed description:

Arms: arm 1: oral tablet, multidose arm 2: oral tablet, multidose arm 3: oral tablet, multidose arm 4: placebo, oral tablet, multidose
Interventions: intervention 1: CHF 5074 1x intervention 2: CHF 5074 2x intervention 3: CHF 5074 3x intervention 4: Placebo
Intervention descriptions: intervention 1: oral tablet, 1x, once a day in the morning for 12 weeks intervention 2: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks intervention 3: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks intervention 4: oral tablet, once a day in the morning for 12 weeks

Protocol documents:
Clinical trial NCT01316380
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-03-01; Completion date: 2012-04-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent asthma. Efficacy and safety will be assessed by measuring the effects on lung functions, effects on lung exacerbations, effects on asthma control and numbers of adverse events.

Detailed description:

Arms: arm 1: once daily delivered via Respimat inhaler arm 2: once daily delivered via Respimat inhaler arm 3: once daily delivered via Respimat inhaler
Interventions: intervention 1: placebo intervention 2: tiotropium 2.5 mcg intervention 3: tiotropium 5 mcg
Intervention descriptions: intervention 1: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler intervention 2: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler intervention 3: To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler

Protocol documents:
Clinical trial NCT01322360
Conditions: Pain
Sponsor: Roxane Laboratories
Start date: 2011-04-01; Completion date: 2012-04-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration.

To determine multiple-dose pharmacokinetics (PK) of morphine sulfate in pediatric subjects.

To compare plasma concentration of morphine sulfate in each age group of pediatric subjects with adult plasma morphine sulfate concentrations.

Detailed description:

Arms: arm 1: oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines
Interventions: intervention 1: Morphine Sulfate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01323192
Conditions: Attention-Deficit Hyperactivity Disorder
Keywords: Concerta Adults Attention-Deficit/Hyperactivity Disorder ADHD Methylphenidate hydrochloride
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2011-03-01; Completion date: 2012-04-01
Enrollment: 284 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to placebo.

Detailed description:
This is a randomized (the study drug is assigned by chance), double-blind (DB, neither physician nor patient knows the name of the assigned drug), multicenter, placebo-controlled, parallel group (each group of patients will be treated at the same time), dose-titration study. This study consists of a screening period, a DB phase (titration period and efficacy assessment period), and post-study phase. The study includes a 1 to 2-week screening period for wash-out of prohibited drugs, and screening for eligibility. Eligible patients will be randomly assigned to receive JNS001 or placebo in a ratio of 1:1. The study also includes a 4-week titration period. Patients will be titrated from a starting dose of 18 mg/day or matching placebo for 7 days (+/- 2 days), and continue with a weekly (+/- 2 days) increment of 18 mg until an individualized dose is achieved. Once an individualized dose is achieved, patients will remain on that dose for the rest of the titration period as far as tolerable. Doses can be tapered down only once during the titration period in the study, and their dose cannot be up-titrated again for the rest of the period. The 4-week titration period will be followed by the 4-week efficacy assessment period. The post-study phase for collection of additional safety data will be scheduled for 1 week after a patient's final study treatment. The study drug will be administered with water once daily in the morning at doses of 18 mg, 36 mg, 54 mg, 72 mg per day or the matching placebo. The study treatment period is 8 weeks (titration period of 4 weeks and efficacy assessment period of 4 weeks).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: JNS001 intervention 2: Placebo
Intervention descriptions: intervention 1: Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks. intervention 2: Participants will receive matching placebo orally once daily for 8 weeks.

Protocol documents:
Clinical trial NCT01337596
Conditions: Migraines
Keywords: pain neuropathic pain headaches
Sponsor: Eli Lilly and Company
Start date: 2011-04-01; Completion date: 2012-04-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of LY2951742 given as single or multiple subcutaneous injection in healthy male subjects

Detailed description:

Arms: arm 1: Administered single subcutaneous injection arm 2: Administered single subcutaneous injection arm 3: Administered single subcutaneous injection arm 4: Administered single subcutaneous injection arm 5: Administered single subcutaneous injection arm 6: Administered single subcutaneous injection arm 7: Administered single subcutaneous injection arm 8: Administered subcutaneously every 2 weeks for 6 weeks (4 doses) arm 9: Administered subcutaneously every 2 weeks for 6 weeks (4 doses)
Interventions: intervention 1: LY2951742 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents: