ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01337674
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-04-01; Completion date: 2011-11-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the safety and tolerability of MK-4618 when coadministered with antihypertensive agents and will evaluate changes in blood pressure following co-administration of MK-4618 with a beta blocker and a vasodilator. The primary hypothesis of the study is that MK-4618 does not result in a clinically meaningful change in systolic blood pressure relative to placebo when co-administered with a beta-blocker or with amlodipine.

Detailed description:

Arms: arm 1: Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. arm 2: Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1. arm 3: Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1. arm 4: Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
Interventions: intervention 1: MK-4618 intervention 2: Placebo for MK-4618 intervention 3: Metoprolol intervention 4: Amlodipine
Intervention descriptions: intervention 1: Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 intervention 2: Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7 intervention 3: Previously prescribed daily dose of open-label metoprolol for the duration of the study intervention 4: Previously prescribed daily dose of open-label amlodipine for the duration of the study

Protocol documents:
Clinical trial NCT01344759
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea MRI Pediatrics Dexmedetomidine Propofol Anesthesia
Sponsor: Children's Hospital Medical Center, Cincinnati
Start date: 2009-06-01; Completion date: 2011-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.

The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.

Detailed description:
Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dexmedetomidine intervention 2: Propofol
Intervention descriptions: intervention 1: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump. intervention 2: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.

Protocol documents:
Clinical trial NCT01349803
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2011-05-01; Completion date: 2011-11-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Detailed description:

Arms: arm 1: PT005 MDI arm 2: PT001 MDI arm 3: PT003 MDI arm 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Interventions: intervention 1: PT005 MDI intervention 2: PT001 MDI intervention 3: PT003 MDI intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Intervention descriptions: intervention 1: PT005 MDI administered as two puffs BID for 14 days intervention 2: PT001 MDI administered as two puffs BID for 14 days intervention 3: PT003 MDI administered as two puffs BID for 14 days intervention 4: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days

Protocol documents:
Clinical trial NCT01349816
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2011-06-01; Completion date: 2011-11-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT003 MDI Dose 3 arm 4: PT003 MDI Dose 4 arm 5: PT001 MDI arm 6: PT005 MDI
Interventions: intervention 1: PT003 intervention 2: PT001 intervention 3: PT005
Intervention descriptions: intervention 1: PT003 MDI administered as two puffs BID for 7 days intervention 2: PT001 MDI administered as two puffs BID for 7 days intervention 3: PT005 MDI administered as two puffs BID for 7 days

Protocol documents:
Clinical trial NCT01378429
Conditions: Perennial Allergic Rhinitis PAR
Keywords: Perennial Allergic Rhinitis PAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-07-01; Completion date: 2011-11-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, safety study of the effects of ciclesonide nasal aerosol (74 mcg) on the HPA axis when administered once daily to male and premenarchal female subjects 6 to 11 years of age with a diagnosis of PAR.

The study requires that subjects be domiciled during two 24- to 36-hour time periods for sample collection for serum and urinary free cortisol measurements, as well as PK evaluations (single \[predose\] time point during the first domiciled period, and 24-hour sampling during the second domiciled period).

Arms: arm 1: ciclesonide nasal aerosol (74 mcg) arm 2: None
Interventions: intervention 1: ciclesonide nasal aerosol intervention 2: Placebo
Intervention descriptions: intervention 1: ciclesonide nasal aerosol (74 mcg) intervention 2: Placebo

Protocol documents:
Clinical trial NCT01401465
Conditions: Perennial Allergic Rhinitis
Keywords: perennial allergic rhinitis PAR
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-07-01; Completion date: 2011-11-01
Enrollment: 327 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.

Detailed description:
This is a randomized, multicenter, 2-way crossover study in subjects 12 years or older with perennial allergic rhinitis (PAR) to evaluate patient preference, satisfaction and efficacy of ciclesonide nasal aerosol versus mometasone aqueous nasal spray. A novel patient-administered assessment, developed and validated to measure patient satisfaction with and preference of intranasal corticosteroids (INCS) for the treatment of allergic rhinitis (AR), is utilized in this study.

Subjects will be randomized to 1 of 2 treatment sequences:

Sequence 1: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks Sequence 2: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks

Arms: arm 1: 74 mcg ciclesonide nasal aerosol once daily arm 2: 200 mcg mometasone aqueous nasal spray once daily
Interventions: intervention 1: ciclesonide intervention 2: mometasone
Intervention descriptions: intervention 1: 74 mcg ciclesonide nasal aerosol once daily intervention 2: 200 mcg mometasone aqueous nasal spray once daily

Protocol documents:
Clinical trial NCT01405794
Conditions: Healthy
Sponsor: University of Utah
Start date: 2011-07-01; Completion date: 2011-11-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators propose to study oral commercial silver nanoparticle products on human enzyme activity.

Detailed description:

Arms: arm 1: 14 Days Active Silver Solution arm 2: No Silver Nanoparticles
Interventions: intervention 1: 32ppm Silver Particle intervention 2: Placebo
Intervention descriptions: intervention 1: Oral silver dose of 32ppm intervention 2: Sterile Water No Silver

Protocol documents:
Clinical trial NCT01409096
Conditions: Bipolar Disorder Major Depressive Disorder
Sponsor: University of Texas Southwestern Medical Center
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.

Detailed description:
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores.

Secondary

1. Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.
2. Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.

Arms: arm 1: This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks. arm 2: The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
Interventions: intervention 1: Pregnenolone intervention 2: Placebo
Intervention descriptions: intervention 1: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system. intervention 2: Inactive ingredient matching the active medication in appearance.

Protocol documents:
Clinical trial NCT01415583
Conditions: Post-operative Hemorrhage
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2010-07-01; Completion date: 2011-11-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. In order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given during the surgery. Recently, a study showed steroids given at the time of tonsillectomy increase the risk of bleeding significantly over children who did not receive steroids. This finding has raised concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during tonsillectomy in children. The investigators look to explore this question further.

To answer the question of whether perioperative steroid administration significantly affects the rate of post-tonsillectomy bleeding, the investigators propose to test the following hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does not cause an increase in post-operative bleeding rate in tonsillectomy.

Detailed description:
Detailed description is entered above

Arms: arm 1: Placebo is described in chart arm 2: Dexamethasone is described in chart
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: 0.5mg/kg (max dose 20mg)

Protocol documents:
Clinical trial NCT01426867
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension Intraocular Pressure Brinzolamide Brimonidine
Sponsor: Alcon Research
Start date: 2011-09-01; Completion date: 2011-11-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

Detailed description:

Arms: arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days arm 2: Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days arm 3: Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide ophthalmic suspension, 1% intervention 3: Brimonidine tartrate ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01436201
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2011-11-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to study how the body processes digoxin and the effect of dulaglutide on how digoxin is processed by the body. Information about any side effects that may occur will also be collected.

This study is for research purposes only and is not intended to treat any medical condition. This research study requires that a blood sample be obtained and stored for future research involving genetic analysis.

Detailed description:

Arms: arm 1: Digoxin: Two 0.5-milligram (mg) doses, oral, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, oral, once daily on Day 2 to Day 17.

Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15.
Interventions: intervention 1: Digoxin intervention 2: Dulaglutide
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered as subcutaneous injection

Protocol documents:
Clinical trial NCT01451775
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-10-01; Completion date: 2011-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Detailed description:

Arms: arm 1: high dose of empagliflozin after overnight fasting for at least 10 h arm 2: high dose of empagliflozin after a standardised high fat breakfast arm 3: low dose empagliflozin after overnight fasting for at least 10 h
Interventions: intervention 1: Empagliflozin intervention 2: Empagliflozin intervention 3: Empagliflozin
Intervention descriptions: intervention 1: high dose of empagliflozin after overnight fasting for at least 10 h intervention 2: low dose empagliflozin after overnight fasting for at least 10 h intervention 3: high dose of empagliflozin after a standardised high fat breakfast

Protocol documents:
Clinical trial NCT01469234
Conditions: Rhinitis
Sponsor: Bayer
Start date: 2011-10-01; Completion date: 2011-11-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and

Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.

Detailed description:

Arms: arm 1: Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4. arm 2: Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. arm 3: Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
Interventions: intervention 1: loratadine intervention 2: fexofenadine intervention 3: placebo to loratadine intervention 4: placebo to fexofenadine
Intervention descriptions: intervention 1: loratadine, one 10 mg tablet, orally intervention 2: fexofenadine, one 180 mg tablet, orally intervention 3: one tablet, orally intervention 4: one tablet, orally

Protocol documents:
Clinical trial NCT01476267
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Start date: 2011-10-01; Completion date: 2011-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single center, open-label, non-randomized, one-treatment, one-period study will evaluate the metabolic profile and the safety of a single oral radiolabeled dose of dalcetrapib in male healthy volunteers.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: dalcetrapib
Intervention descriptions: intervention 1: Single oral radiolabeled dose

Protocol documents:
Clinical trial NCT01732809
Conditions: Skin Wrinkling
Keywords: wrinkles botulinum toxin abobotulinumtoxinA onabotulinumtoxinA field of anhydrotic effects
Sponsor: Brazilan Center for Studies in Dermatology
Start date: 2011-01-01; Completion date: 2011-11-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activity.

Detailed description:
This is a prospective, single-center, randomized, double-blind study. All participants were recruited from a research center in Porto Alegre, Brazil, and provided written informed consent. The purpose of this study is to assess the fields of anhydrotic effect (FAE) of abobotulinumtoxinA and onabotulinumtoxinA at the same labeled unit dose (1:1 units), comparing both sweat gland and muscle activities. Nineteen patients were enrolled and evaluations were performed at baseline and 28 days after treatment.

Arms: arm 1: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received abobotulinumtoxin A in one of the sides of the forehead. arm 2: Patients were randomized to the side of the forehead (left or right) in which the products were administered. All the patients received onabotulinumtoxin A in one of the sides of the forehead.
Interventions: intervention 1: AbobotulinumtoxinA (ABO) intervention 2: OnabotulinumtoxinA (ONA)
Intervention descriptions: intervention 1: Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead. intervention 2: Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.

Protocol documents:
Clinical trial NCT01821859
Conditions: Ovarian Cancer Peritoneal Cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2010-01-01; Completion date: 2011-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their cancer has become worse or has come back again. Neither one of these study drugs has been approved by the FDA for treatment in these three types of cancer.

Detailed description:

Arms: arm 1: Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.

Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
Interventions: intervention 1: Abraxane intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. intervention 2: Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.

Protocol documents: