ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01069523
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Disorder with Hyperactivity Guanfacine Event Related Potentials
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2010-03-01; Completion date: 2011-08-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.

Detailed description:
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and frontal-central P300, and such changes will correlate with clinical response.

Arms: arm 1: Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets). arm 2: Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
Interventions: intervention 1: Guanfacine Extended Release intervention 2: Placebo
Intervention descriptions: intervention 1: Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet. intervention 2: Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.

Protocol documents:
Clinical trial NCT01088984
Conditions: Leukemia
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-08-01; Completion date: 2011-08-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of phase 1 of this study is to establish the recommended phase II dose (RP2D). The primary objective of phase 2 of this study is to evaluate the safety and efficacy of bendamustine at the recommended pediatric dose for the treatment of pediatric patients with relapsed or refractory acute leukemia.

Detailed description:

Arms: arm 1: Bendamustine 90 or 120 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
Interventions: intervention 1: Bendamustine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01089543
Conditions: Functional Dyspepsia
Keywords: dyspepsia rabeprazole Japan
Sponsor: Eisai Co., Ltd.
Start date: 2010-04-01; Completion date: 2011-08-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of rabeprazole compared to placebo in Japanese subjects with Functional Dyspepsia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Rabeprazole intervention 2: Rabeprazole intervention 3: Rabeprazole intervention 4: Placebo
Intervention descriptions: intervention 1: Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 2: Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 3: Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks. intervention 4: Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.

Protocol documents:
Clinical trial NCT01103960
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.

Detailed description:

Arms: arm 1: combination therapy arm 2: Monotherapy
Interventions: intervention 1: Telmisartan80mg+Amlodipine5mg intervention 2: amlodipine 5mg intervention 3: Telmisartan80mg+Amlodipine 5mg
Intervention descriptions: intervention 1: combination therapy intervention 2: monotherapy intervention 3: combination therapy

Protocol documents:
Clinical trial NCT01105936
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis pain paracetamol Blood-Oxygen-Level-Dependent functional magnetic resonance imaging
Sponsor: GlaxoSmithKline
Start date: 2010-09-01; Completion date: 2011-08-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Blood-Oxygen-Level-Dependent (BOLD) responses to painful mechanical stimulation of the OA knee following treatment with four consecutive doses (at 8 hour intervals) on giving sustained released paracetamol treatment or placebo will be compared. The fMRI and pain assessments will occur approximately 2-5 hours after taking the final dose.

Detailed description:
The objective of this study is to investigate if functional magnetic response imaging (fMRI) can detect the effects of a known pain medicine at over-the-counter doses in people with osteoarthritis (OA) of the knee. The fMRI is a harmless and painless technique that is used in the current study to collect images of brain activity to see if is changed when feeling pain. In this study, BOLD response to mechanical stimulation via pressure stimuli applied to the tibio-femoral joint and patello-femoral in participants with knee OA following four treatment doses of any of three treatment will be compared.

Arms: arm 1: Two 665 mg sustained release paracetamol caplets administered orally with water. arm 2: Two placebo caplets administered orally with water.
Interventions: intervention 1: Paracetamol intervention 2: Placebo
Intervention descriptions: intervention 1: 665 mg sustained release paracetamol caplets intervention 2: Placebo caplets

Protocol documents:
Clinical trial NCT01107925
Conditions: Coronary Artery Disease
Keywords: Platelet function
Sponsor: Eli Lilly and Company
Start date: 2010-03-01; Completion date: 2011-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The 5-milligram (mg) dose of prasugrel in low body weight (LBW) patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg dose in higher body weight (HBW) patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: prasugrel intervention 2: clopidogrel
Intervention descriptions: intervention 1: Administered orally, daily for 12 days intervention 2: Administered orally, daily for 12 days

Protocol documents:
Clinical trial NCT01118949
Conditions: Epilepsy
Keywords: Primary Generalized Tonic-Clonic (PGTC) Seizures Absence Seizures Myoclonic Seizures Idiopathic Generalized Epilepsy (IGE)
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2010-05-01; Completion date: 2011-08-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.

Protocol documents:
Clinical trial NCT01125514
Conditions: Heart Failure
Keywords: Heart failure, aliskiren, furosemide, diuretic efficacy, interaction
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-01; Completion date: 2011-08-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.

Detailed description:

Arms: arm 1: Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily. arm 2: Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily. arm 3: Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.
Interventions: intervention 1: Aliskiren 150 mg intervention 2: Furosemide 60 mg intervention 3: Placebo for Aliskiren intervention 4: Aliskiren 300 mg
Intervention descriptions: intervention 1: Aliskiren 150 mg tablet intervention 2: Furosemide 60 mg commercially-available tablets intervention 3: Matching placebo for aliskiren 150 mg and 300 mg intervention 4: Aliskiren 300 mg tablet

Protocol documents:
Clinical trial NCT01128738
Conditions: Hyperhidrosis
Keywords: Neuromuscular Agents Botulinum Toxin Type A Sweating Sweat Gland Disease Axillary Hyperhidrosis Skin Disease
Sponsor: GlaxoSmithKline
Start date: 2010-04-01; Completion date: 2011-08-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate superiority of single treatment of GSK1358820 (hereinafter, referred to as BOTOX®) over placebo in terms of the efficacy of treatment with BOTOX® 50 U in each axilla (100 U in total for each patient) as intradermal injections based on gravimetric assessment (measurement of spontaneous axillary sweat production) for axillary hyperhidrosis.

Detailed description:

Arms: arm 1: Onabotulinum toxin type A arm 2: Placebo
Interventions: intervention 1: GSK1358820 intervention 2: Placebo
Intervention descriptions: intervention 1: Onabotulinum toxin type A intervention 2: Placebo

Protocol documents:
Clinical trial NCT01138735
Conditions: Acne
Sponsor: Galderma R&D
Start date: 2010-06-01; Completion date: 2011-08-01
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Detailed description:

Arms: arm 1: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks arm 2: Topical Gel Vehicle applied topically once daily for 12 weeks
Interventions: intervention 1: adapalene/benzoyl peroxide intervention 2: Topical Gel Vehicle
Intervention descriptions: intervention 1: daily topical application for 12 weeks intervention 2: daily topical application for 12 weeks

Protocol documents:
Clinical trial NCT01142661
Conditions: Breast Cancer
Keywords: Advanced breast cancer refractory to all commercially available therapies
Sponsor: Eisai Inc.
Start date: 2010-08-01; Completion date: 2011-08-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide eribulin to patients with advanced breast cancer who have no other treatment options and therapy is requested by an Investigator.

Detailed description:
This compassionate use program will consist of a Pretreatment Phase and a Treatment Phase. Patients with locally advanced or metastatic breast cancer who fulfill the eligibility criteria may be treated. Safety data will be collected, but a minimal amount of other data will also be collected.

Arms: arm 1: None
Interventions: intervention 1: Eribulin Mesylate
Intervention descriptions: intervention 1: Eribulin Mesylate: A dose of 1.4 mg/m\^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.

Protocol documents:
Clinical trial NCT01144624
Conditions: Severe Sepsis Septic Shock
Keywords: TNF neutralisation
Sponsor: AstraZeneca
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773.

The secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic shock.

Detailed description:

Arms: arm 1: AZD9773 250 units/kg (1 infusion) + 50 units/kg (9 infusions) (Dose Cohort 1):

AZD9773 500 units/kg (1 infusion) + 100 units/kg (9 infusions) (Dose Cohort 2) arm 2: None
Interventions: intervention 1: AZD9773 intervention 2: Placebo
Intervention descriptions: intervention 1: A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days intervention 2: Intravenous infusion of a saline solution

Protocol documents:
Clinical trial NCT01146951
Conditions: Lennox-Gastaut Syndrome
Keywords: Epilepsy Seizures
Sponsor: Eisai Limited
Start date: 2010-06-01; Completion date: 2011-08-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rufinamide (E2080) intervention 2: Placebo
Intervention descriptions: intervention 1: Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.

Target maintenance dose:

15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) \>= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening) intervention 2: Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.

Protocol documents:
Clinical trial NCT01152450
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.

Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.

Detailed description:

Arms: arm 1: two actuations delivered via Respimat® inhaler arm 2: two actuations delivered via Respimat® inhaler arm 3: N/A (two actuations of placebo) delivered via Respimat® inhaler
Interventions: intervention 1: Tiotropium 2.5 µg b.i.d intervention 2: Placebo intervention 3: Tiotropium 5 µg q.d.
Intervention descriptions: intervention 1: 2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler intervention 2: N/A (two actuations of placebo) delivered via Respimat® inhaler intervention 3: 5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler

Protocol documents:
Clinical trial NCT01159262
Conditions: Sedation
Keywords: Initially intubated and mechanically ventilated neonates
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).

Detailed description:

Arms: arm 1: Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr. arm 2: Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr. arm 3: Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.
Interventions: intervention 1: Midazolam intervention 2: Fentanyl/Morphine intervention 3: Dexmedetomidine
Intervention descriptions: intervention 1: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion intervention 2: Per package insert, N-PASS scores and investigator discretion. intervention 3: None

Protocol documents:
Clinical trial NCT01160614
Conditions: Opioid Analgesia
Keywords: Pediatric Post-operative Nonsurgical patients Opioid
Sponsor: Purdue Pharma LP
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.

Detailed description:

Arms: arm 1: ORF Tablets
Interventions: intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets
Intervention descriptions: intervention 1: Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours

Protocol documents:
Clinical trial NCT01175135
Conditions: Schizophrenia
Keywords: schizophrenia acute exacerbation inpatient
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2011-08-01
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change in symptoms for PF-02545920 compared to risperidone and placebo treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PF-02545920 intervention 2: PF-02545920 intervention 3: Placebo intervention 4: Risperidone
Intervention descriptions: intervention 1: 5 mg tablet every 12 hours for 28 days intervention 2: 15 mg tablet every 12 hours for 28 days intervention 3: One tablet/capsule every 12 hours for 28 days intervention 4: 3 mg capsule every 12 hours for 28 days

Protocol documents:
Clinical trial NCT01177410
Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: IBS Diarrhea IBS-D Irritable Bowel Syndrome Abdominal pain Bloating
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Mesalamine Granules 750 mg intervention 3: Mesalamine Granules 1500 mg
Intervention descriptions: intervention 1: placebo capsules once daily for 12 weeks intervention 2: 750 mg mesalamine granules once daily for 12 weeks intervention 3: 1500 mg mesalamine granules once daily for 12 weeks

Protocol documents: