ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01267201
Conditions: Biological Availability
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)
Sponsor: Pfizer
Start date: 2010-11-01; Completion date: 2010-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: methylprednisolone intervention 2: methylprednisolone intervention 3: methylprednisolone
Intervention descriptions: intervention 1: powder for oral suspension 4 mg/mL single dose (8 mL) intervention 2: powder for oral suspension 4 mg/mL singe dose (8 ml) intervention 3: tablet 32 mg single dose

Protocol documents:
Clinical trial NCT01277081
Conditions: Common Cold
Keywords: Paracetamol Common cold
Sponsor: GlaxoSmithKline
Start date: 2010-10-01; Completion date: 2010-12-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet

Detailed description:

Arms: arm 1: Hot drink containing paracetamol arm 2: Paracetamol tablets
Interventions: intervention 1: Paracetamol hot drink intervention 2: Paracetamol tablets
Intervention descriptions: intervention 1: Hot drink containing paracetamol intervention 2: Paracetamol tablets

Protocol documents:
Clinical trial NCT01286324
Conditions: Primary Insomnia Chronic Insomnia
Keywords: Matricaria Chamomile Herb Insomnia
Sponsor: University of Michigan
Start date: 2008-07-01; Completion date: 2010-12-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigue and functioning.

Detailed description:
Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with decreased quality of life, work limitations and increased healthcare utilization. Currently there is no treatment for chronic insomnia that is readily available, affordable, without significant side-effects and demonstrated to be safe for long term use. Consequently, treatments that would fill this gap are needed.

Chamomile (Matricaria recutita) has been used as a gentle sleep agent by herbalists for several hundred years. It has been studied in animals for its sedative potential and shows promise for treating insomnia. Currently, chamomile's sedative mechanisms of action are unknown, but are thought to be through the major inhibitory neurotransmitter in the central nervous system, γ - aminobutyric acid (GABA). However, no study has examined chamomile's efficacy and safety for treating insomnia.

The investigators propose a double-blind, placebo-controlled, randomized trial of chamomile in primary care patients with chronic insomnia. Thirty-four patients will be randomized to either Chamomile High Grade Extract, three 5 mg tablets standardized to 0.4% (-)-α-bisabolol twice daily or placebo and will be followed for 28 days for changes in a sleep diary (sleep efficiency, total sleep time, sleep-onset latency and sleep quality), insomnia severity and sleep disturbances. Secondary endpoints include assessing changes in day time functioning (measures of global quality of life, depression and anxiety) and monitoring for any signs of toxicity. The investigators will also determine the feasibility of conducting a larger trial with this agent.

Arms: arm 1: Each capsule contains 90 mg dry extract of chamomile flowering tops \[6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops\] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet arm 2: Contained lactose
Interventions: intervention 1: Chamomile High Grade Extract intervention 2: Placebo Tablet
Intervention descriptions: intervention 1: three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days intervention 2: None

Protocol documents:
Clinical trial NCT01342445
Conditions: Attention-deficit/Hyperactivity Disorder
Sponsor: University of Rhode Island
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).

Detailed description:
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, \& 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).

Arms: arm 1: All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design
Interventions: intervention 1: lisdexamfetamine dimesylate intervention 2: Placebo
Intervention descriptions: intervention 1: 30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design intervention 2: None

Protocol documents:
Clinical trial NCT01350973
Conditions: Hypertriglyceridemia
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2009-11-01; Completion date: 2010-12-01
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

Detailed description:
TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Arms: arm 1: TAK-085 2 g, orally, once daily for up to 12 weeks. arm 2: TAK-085 2 g, orally, twice daily for up to 12 weeks. arm 3: Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
Interventions: intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) intervention 2: Eicosapentaenoic acid-ethyl (EPA-E)
Intervention descriptions: intervention 1: Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters. intervention 2: EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.

Protocol documents:
Clinical trial NCT01466361
Conditions: Smoking Smoking Cessation
Keywords: Nicotine Nicotine craving
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2010-12-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

Detailed description:

Arms: arm 1: lower dose nicotine lozenge arm 2: higher dose Nicotine lozenge arm 3: Placebo
Interventions: intervention 1: Nicotine lower dose intervention 2: Nicotine higher dose intervention 3: Placebo
Intervention descriptions: intervention 1: lower dose nicotine lozenge intervention 2: higher dose nicotine lozenge intervention 3: placebo

Protocol documents:
Clinical trial NCT01796548
Conditions: Detrusor Function, Overactive
Keywords: Detrusor function, overactive Urinary incontinence Oxybutynin Lyrinel
Sponsor: Janssen-Cilag Ltd.,Thailand
Start date: 2008-12-01; Completion date: 2010-12-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrinel) including safety and quality of life assessment in participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor muscle do not work properly leading to frequent feeling of need to urinate during the day, night, or both).

Detailed description:
This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), multi-center study of participants with NDO. The initial dose of Oxybutynin ER will be 10 milligram (mg) and will be titrated to a maximum of 30 mg. Dosage will be adjusted in 5-mg increments at approximately 14-day intervals until continence is achieved or the participant cannot tolerate side effects. The duration of participation in the study will be 12 weeks. The study will consist of 6 visits: baseline, Weeks 2, 4, 6, 8 and 12. Week 4 and Week 8 will be telephone visits. Overall safety and efficacy of Oxybutinin ER will be assessed as well as safety and efficacy during the titration and maintenance phases. The efficacy of treatment will be assessed using urodynamic parameters (the force and flow of urine) and clinical parameters (voiding diary and catheterization \[use or insertion of a tubular device to drain the bladder\] schedules). The quality of life will also be monitored in the study.

Arms: arm 1: Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Interventions: intervention 1: Oxybutinin Extended-Release
Intervention descriptions: intervention 1: Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally

Protocol documents:
Clinical trial NCT02126306
Conditions: Compliance Behavior
Sponsor: Hadassah Medical Organization
Start date: 2006-01-01; Completion date: 2010-12-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.

Detailed description:
Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.

Arms: arm 1: Normal saline administered orally daily as a placebo arm 2: Beta glucosylceramide administered orally daily
Interventions: intervention 1: Beta Glucosylceramide intervention 2: Placebo
Intervention descriptions: intervention 1: Beta Glucosylceramide intervention 2: normal saline

Protocol documents:
Clinical trial NCT02127372
Conditions: Non-small Cell Lung Cancer
Keywords: non-small cell lung cancer
Sponsor: Duke University
Start date: 2004-11-01; Completion date: 2010-12-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1/Phase 2 study of STI571 combined with docetaxel and cisplatin for treatment of patients with recurrent and metastatic Non-Small Cell Lung Cancer (NSCLC).

This research study has 2 parts to it. The first part (Phase 1) is called a dose-escalation. Not all subjects enrolled into this phase of the study will receive the same dose. The purpose of the dose-escalation is to determine the highest safe dose of STI571 that can be used in combination with docetaxel and cisplatin. That dose will be used in Phase 2.

Detailed description:

Interventions: intervention 1: Docetaxel, Cisplatin and STI571 intervention 2: Docetaxel intervention 3: Cisplatin
Intervention descriptions: intervention 1: Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.

Phase 1 dose levels are:

* Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg
* Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg
* Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg
* Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg
* Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg
* Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg

Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II. intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02171247
Conditions: Coronary Computed Tomographic Angiography
Keywords: coronary computed tomographic angiography contrast
Sponsor: Duke University
Start date: 2008-04-01; Completion date: 2010-12-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.

Detailed description:

Arms: arm 1: Isovue 370 is a contrast agent with increased iodine concentration. arm 2: Standard protocol is Visipaque 320.
Interventions: intervention 1: Isovue 370 intervention 2: Visipaque 320
Intervention descriptions: intervention 1: Isovue 370 is a contrast agent with increased iodine concentration. intervention 2: Visipaque 320 is standard protocol.

Protocol documents:
Clinical trial NCT00963937
Conditions: Migraine Disorders
Keywords: adolescent sumatriptan children migraine
Sponsor: GlaxoSmithKline
Start date: 2009-09-28; Completion date: 2010-12-03
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of a range of doses of oral sumatriptan for the acute treatment of migraine in children ages 10 to 17.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sumatriptan 25 mg intervention 2: Sumatriptan 50 mg intervention 3: Placebo
Intervention descriptions: intervention 1: One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. intervention 2: Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. intervention 3: Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale.

Protocol documents:
Clinical trial NCT00854100
Conditions: Major Depressive Disorder
Keywords: Adjunctive Depression Major Depressive Disorder (MDD)
Sponsor: Forest Laboratories
Start date: 2009-06-30; Completion date: 2010-12-06
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.

Detailed description:

Arms: arm 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo arm 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR)+ cariprazine low dose arm 3: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine high dose
Interventions: intervention 1: Antidepressant + placebo intervention 2: Antidepressant + cariprazine (0.1-0.3 mg/day) intervention 3: Antidepressant + cariprazine (1-2 mg/d)
Intervention descriptions: intervention 1: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + Placebo Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. intervention 2: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (0.1-0.3 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period. intervention 3: Drug: Antidepressant (citalopram, duloxetine, escitalopram, sertraline, or venlafaxine XR) + cariprazine (1-2 mg/d) Oral, once daily for 8 weeks following an 8 week Prospective Treatment (Baseline) Period.

Protocol documents:
Clinical trial NCT00925015
Conditions: Colorectal Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-06-17; Completion date: 2010-12-06
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purposes of this study were to assess the safety, tolerability, pharmacokinetic interactions, and the Human Anti-Human Antibody of dalotuzumab in combination with cetuximab and irinotecan in participants with advanced or metastatic colorectal cancer in Japan.

Detailed description:

Arms: arm 1: After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long. arm 2: After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long. arm 3: Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For Drug-Drug Interaction (DDI). Each cycle was 6 weeks long.
Interventions: intervention 1: Dalotuzumab 10 mg/kg intervention 2: Cetuximab intervention 3: Irinotecan intervention 4: Dalotuzumab 15/7.5 mg/kg
Intervention descriptions: intervention 1: Dalotuzumab at 10 mg/kg was intravenously administered once weekly intervention 2: Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2 intervention 3: Irinotecan was administered with an intravenous infusion of 150 mg/m\^2, once every other week for 42 days intervention 4: Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg

Protocol documents:
Clinical trial NCT01054456
Conditions: Patients With Confirmed Malignant Disease to Receive Low Emetogenic Chemotherapy (LEC) or Who Experienced at Least Nausea and Vomiting During Last Cycle of LEC
Keywords: LEC Low Emetogenic Chemotherapy Nausea and Vomiting Nausea Vomiting Anti- emetic
Sponsor: Eisai Inc.
Start date: 2009-10-27; Completion date: 2010-12-08
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Detailed description:
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.

Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.

Arms: arm 1: Participants will receive palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
Interventions: intervention 1: palonesetron
Intervention descriptions: intervention 1: One dose administered intravenously 30 minutes pre-chemotherapy

Protocol documents:
Clinical trial NCT04704713
Conditions: Polymorphic Light Eruption
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2010-05-05; Completion date: 2010-12-09
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).

Detailed description:

Arms: arm 1: Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. arm 2: Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Interventions: intervention 1: Afamelanotide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: