ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01539642
Conditions: Post-Operative Pain
Keywords: In patient, post operative pain Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery
Sponsor: Talphera, Inc
Start date: 2012-02-01; Completion date: 2013-02-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sufentanil NanoTab PCA System/15 mcg intervention 2: Placebo Sufentanil NanoTab PCA System
Intervention descriptions: intervention 1: 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours. intervention 2: Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.

Protocol documents:
Clinical trial NCT01556997
Conditions: Essential Hypertension
Keywords: Hypertension Essential Hypertension
Sponsor: Symplmed Pharmaceuticals LLC
Start date: 2012-02-01; Completion date: 2013-02-01
Enrollment: 837 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.

Detailed description:

Arms: arm 1: fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb) arm 2: None arm 3: None
Interventions: intervention 1: XOMA 985 intervention 2: Amlodipine Besylate intervention 3: Perindopril Erbumine
Intervention descriptions: intervention 1: PERa/AMLb capsule taken once daily by mouth for six weeks intervention 2: AMLb capsule taken once daily by mouth for six weeks intervention 3: PERe capsule taken once daily by mouth for six weeks

Protocol documents:
Clinical trial NCT01562886
Conditions: HIV
Keywords: Rilpivirine CSF pharmacokinetics
Sponsor: Imperial College London
Start date: 2012-03-01; Completion date: 2013-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.

Detailed description:
To investigate the following parameters in HIV-infected patients switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine for 60 days:

* CSF exposure and CSF : plasma ratio of rilpivirine
* Safety and tolerability of switching antiretroviral therapy from TDF/FTC/nevirapine to TDF/FTC/rilpivirine
* Changes in cerebral metabolites measured via 1-H MRS after switching antiretroviral therapy to TDF/FTC/rilpivirine
* Seminal fluid exposure of rilpivirine

Arms: arm 1: TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
Interventions: intervention 1: Rilpivirine
Intervention descriptions: intervention 1: Rilpivirine 26mg

Protocol documents:
Clinical trial NCT01574612
Conditions: Herpes Labialis
Keywords: Xerese acyclovir hydrocortisone cream herpes labialis pediatric
Sponsor: Meda Pharmaceuticals
Start date: 2012-03-01; Completion date: 2013-02-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To test the safety of Xerese (acyclovir and hydrocortisone)Cream 5%/1% for the treatment of recurrent cold sores in children ages 6-11yrs after 5 days of treatment.

Detailed description:

Arms: arm 1: topical cream acyclovir/hydrocortisone used
Interventions: intervention 1: acyclovir/hydrocortisone cream
Intervention descriptions: intervention 1: cream applied topically to lesion five times daily for five days

Protocol documents:
Clinical trial NCT01587651
Conditions: Coronary Artery Disease
Keywords: CAD prasugrel ticagrelor antiplatelet thienopyridine P2Y12 Inhibitors
Sponsor: Daiichi Sankyo
Start date: 2012-03-01; Completion date: 2013-02-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized, 3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have previously received ticagrelor loading does (LD) and maintenance dose (MD)..

Detailed description:

Arms: arm 1: Prasugrel 10 mg QD MD arm 2: Ticagrelor 90 mg twice-daily (BID) MD arm 3: Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)
Interventions: intervention 1: Prasugrel Loading Dose intervention 2: Prasugrel Maintenance Dose intervention 3: Ticagrelor Maintenance Dose
Intervention descriptions: intervention 1: 60mg given as six 10mg film coated tablets intervention 2: 10mg maintenance dose, given as one 10mg film coated tablet intervention 3: one 90mg film coated tablet

Protocol documents:
Clinical trial NCT01622088
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Sponsor: Knopp Biosciences
Start date: 2012-06-01; Completion date: 2013-02-01
Enrollment: 616 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Detailed description:
Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Arms: arm 1: Dexpramipexole open-label
Interventions: intervention 1: Dexpramipexole
Intervention descriptions: intervention 1: Oral tablet 150 mg given twice daily (BID)

Protocol documents:
Clinical trial NCT01641081
Conditions: Asthma
Sponsor: AstraZeneca
Start date: 2012-06-01; Completion date: 2013-02-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this Phase II study is to evaluate efficacy and safety of inhaled formoterol fumarate in the Pressair DPI compared to the Foradil Aerolizer in patients with mild to moderate asthma.

This study will include a screening visit followed by a 4 month treatment period.

Detailed description:

Arms: arm 1: Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose arm 2: Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose arm 3: Foradil Aerolizer, Low Dose arm 4: Foradil Aerolizer, High Dose arm 5: Dose matched placebo
Interventions: intervention 1: Formoterol Fumarate in the Pressair DPI, Low Dose intervention 2: Formoterol Fumarate in the Pressair DPI, High Dose intervention 3: Foradil Aerolizer, Low Dose intervention 4: Foradil Aerolizer, High Dose intervention 5: Placebo
Intervention descriptions: intervention 1: Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days intervention 2: Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days intervention 3: Foradil Aerolizer 12 micrograms, twice a day for 14 days intervention 4: Foradil Aerolizer 24 micrograms, twice per day for 14 days intervention 5: Placebo in the Pressair for 14 days

Protocol documents:
Clinical trial NCT01645709
Conditions: Osteoarthritis of the Knee
Sponsor: Calosyn Pharma, Inc.
Start date: 2012-04-01; Completion date: 2013-02-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of Intra-Articular (IA) verapamil in the treatment of joint pain in patients with knee osteoarthritis (OA). Subjects will discontinue all analgesic medications for the entire duration of the study, except for acetaminophen (taken on an as needed basis at no more than 2 g/day). At visit 2, subjects who meet all entry criteria will be randomized to receive a single injection of IA verapamil or IA placebo at a ratio of 1:1. Treatments will be given with fluoroscopy or ultrasound to confirm needle placement. Subjects will be monitored for blood pressure and heart rate (sitting and standing) for at least 1 hour post-injection. Subjects will be evaluated at weeks 1, 2, 3, 4, 6, 8, and 12 after treatment.

Detailed description:

Arms: arm 1: Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1. arm 2: Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.
Interventions: intervention 1: Verapamil intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01646671
Conditions: Severe Hypertension
Keywords: Hypertension, Severe, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2012-07-01; Completion date: 2013-02-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive Japanese patients

Detailed description:
Summaries for treatment-emergent adverse events, serious adverse events and death were provided by the following actual treatment regimen (actual treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Summaries for others than above were provided by the following treatment regimen (determined by the maximal treatment patients received) in addition to all patients: LCZ696 200mg, 400mg, 400mg+other hypertensive medications.

Arms: arm 1: All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily. arm 2: All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of \< 100 mmHg and mean sitting systolic blood pressure (msSBP) of \< 160 mmHg at week 2 or a msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily. arm 3: All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP \< 90 mmHg and msSBP \< 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
Interventions: intervention 1: LCZ696 intervention 2: LCZ696 intervention 3: LCZ696
Intervention descriptions: intervention 1: LCZ696 200 mg tablet once daily intervention 2: 2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily intervention 3: 2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications

Protocol documents:
Clinical trial NCT01662882
Conditions: Alzheimer's Disease Mild Cognitive Impairment
Sponsor: Avid Radiopharmaceuticals
Start date: 2012-10-01; Completion date: 2013-02-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate florbetapir (18F) positron emission tomography (PET) imaging for distinguishing Japanese healthy control subjects, from Japanese subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Detailed description:

Arms: arm 1: None arm 2: MCI (mild cognitive impairment) arm 3: None
Interventions: intervention 1: florbetapir (18F)
Intervention descriptions: intervention 1: IV injection, 370 MBq(10mCi), single dose

Protocol documents:
Clinical trial NCT01679028
Conditions: Healthy
Keywords: T89 Safety in Healthy Japanese population
Sponsor: Tasly Pharmaceuticals, Inc.
Start date: 2012-08-01; Completion date: 2013-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.

Detailed description:
This is a single centre, double-blind, randomized, placebo controlled, single- and multiple- dose-escalation study.

After informed consent is obtained, subjects were evaluated with a medical history questionnaire, physical examination, blood and urine collections for clinical laboratory safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG. The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally enrolled. For participation in this trial, subjects were instructed to avoid any prescription, over-the-counter (OTC), and alternative / complementary medications or significant changes in diet without advance permission from principal investigator. The subjects were instructed to discontinue alcohol, caffeine and bromine containing beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and Group C.

Arms: arm 1: 150mg Placebo Single dose arm 2: 150mg T89 single dose arm 3: 300mg placebo single dose arm 4: 300mg T89 single dose arm 5: 225mg Placebo bid for 14 days arm 6: 225mg T89 bid for 14 days
Interventions: intervention 1: T89 Group A intervention 2: Placebo Group A intervention 3: Placebo Group B intervention 4: T89 Group B intervention 5: Placebo Group C intervention 6: T89 Group C
Intervention descriptions: intervention 1: 150mg single dose on day 1 intervention 2: 150mg single dose intervention 3: 300mg single dose intervention 4: 300mg single dose intervention 5: 225mg bid intervention 6: 225mg bid

Protocol documents:
Clinical trial NCT01688635
Conditions: Healthy
Keywords: Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-09-01; Completion date: 2013-02-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Detailed description:

Arms: arm 1: Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously, twice during the study arm 2: Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously, twice during the study
Interventions: intervention 1: LY2963016 intervention 2: US Approved Lantus
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents:
Clinical trial NCT01697956
Conditions: Allergic Rhinitis
Keywords: Pediatric Subjects
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2012-10-01; Completion date: 2013-02-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to evaluate the safety and tolerability of BDP nasal aerosol, in subjects 6 to 11 years of age with perennial allergic rhinitis.

Detailed description:

Arms: arm 1: BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period. arm 2: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
Interventions: intervention 1: BDP intervention 2: Placebo
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol. intervention 2: Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.

Protocol documents:
Clinical trial NCT01710345
Conditions: Acute Pain
Sponsor: Talphera, Inc
Start date: 2012-10-01; Completion date: 2013-02-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.

Detailed description:

Arms: arm 1: Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours arm 2: Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours arm 3: Placebo NanoTab as needed every 60 minutes for 12 hours
Interventions: intervention 1: Sufentanil NanoTab 20 mcg intervention 2: Sufentanil NanoTab 30 mcg intervention 3: Placebo NanoTab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01710787
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2012-10-01; Completion date: 2013-02-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of Kovacaine Mist, Tetracaine only, and Placebo for inducing pulpal anesthesia of the maxillary teeth in adults.

Detailed description:
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure.

The intent is to treat 110 subjects, with enrollment balanced evenly between the 2 study sites, 2:2:1 randomization within each study site and an overall goal of 44 subjects treated with Kovacaine Mist, 44 treated with Tetracaine alone, and 22 treated with Placebo. Recruitment will be from diverse dental patient populations.

Arms: arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% arm 2: Tetracaine HCl 3% arm 3: Placebo
Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% intervention 2: Tetracaine HCl 3% intervention 3: Placebo
Intervention descriptions: intervention 1: 3 unilateral intranasal sprays per dose intervention 2: 3 unilateral intranasal sprays per dose intervention 3: 3 unilateral intranasal sprays per dose

Protocol documents:
Clinical trial NCT01713608
Conditions: Malaria
Keywords: malaria dose escalation safety tolerability maximum tolerated dose
Sponsor: Medicines for Malaria Venture
Start date: 2012-11-01; Completion date: 2013-02-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:

* To determine the safety and tolerability of ascending doses of OZ439 OD for three days.
* To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.
* To identify the maximum tolerated dose of OZ439 administered.

Detailed description:
This study will be conducted in a randomised, placebo-controlled dose-escalation design with OZ439 OD administered with full fat milk for three days to healthy male and female subjects between 18 to 55 years of age, using features of an adaptive study design. The study is expected to have three cohorts with a total of 36 healthy male and female subjects. An additional two cohorts may be used if required. The results of this study will inform the maximum tolerated exposure of OZ439 following OD dosing for three days in subjects who are not fasted.

Arms: arm 1: • Cohort 1 (12 subjects: 8 Active \[A\] and 4 on Placebo \[P\]) Active dose will consist of 300mg OZ439 drinking solution administered once daily for 3 days arm 2: • Cohort 2 (12 subjects: 8 A, 4P). Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days arm 3: Cohort 3 (12 subjects: 8 A, 4P). Subjects on active will receive X amount of OZ439 (dose level to be determined based on safety and tolerability of previous dose level) drinking solution once daily for 3 days
Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: OZ439 x mg once daily for 3 days with milk

Protocol documents:
Clinical trial NCT01736254
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-02-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.

Detailed description:

Arms: arm 1: Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1 arm 2: Oral doses of 130 mg evacetrapib once a day (QD) for 10 days (Day 2 through Day 12) arm 3: Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23.
Interventions: intervention 1: Evacetrapib intervention 2: Gemfibrozil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: