ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00961649
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-Angle Glaucoma Ocular Hypertension Brinzolamide Brimonidine Intraocular Pressure
Sponsor: Alcon Research
Start date: 2009-10-01; Completion date: 2010-02-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:

* its individual components (Brinz and Brim), and
* the concomitant administration of Brinz and Brim (Brinz+Brim).

Detailed description:
This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Arms: arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug. arm 2: Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug. arm 3: Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug. arm 4: Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
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 4: Vehicle
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Inactive ingredients used as placebo

Protocol documents:
Clinical trial NCT00975481
Conditions: Alzheimer's Disease Huntington's Disease
Keywords: oral single-dose 6-way crossover recreational drug users abuse potential pharmacodynamics safety
Sponsor: Pfizer
Start date: 2009-10-01; Completion date: 2010-02-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).

Detailed description:
The main purpose for this study is to determine whether dimebon exhibits abuse potential.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: dimebon intervention 2: dimebon intervention 3: dimebon intervention 4: placebo intervention 5: alprazolam intervention 6: alprazolam
Intervention descriptions: intervention 1: Oral tablet; 20 mg dimebon, single dose intervention 2: Oral tablet; 40 mg dimebon, single dose intervention 3: Oral tablet; 60 mg dimebon, single dose intervention 4: Oral tablet or capsule; placebo, single dose intervention 5: Oral capsule; 1 mg alprazolam, single dose intervention 6: Oral capsule; 3 mg alprazolam, single dose

Protocol documents:
Clinical trial NCT00978029
Conditions: Rhinoconjunctivitis Rhinitis Conjunctivitis Allergy
Keywords: immunotherapy
Sponsor: ALK-Abelló A/S
Start date: 2009-11-01; Completion date: 2010-02-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.

Detailed description:

Arms: arm 1: Matching placebo tablet sublingual, once daily arm 2: 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily arm 3: 12 Amb a 1-U in an AIT, sublingual, once daily
Interventions: intervention 1: Placebo intervention 2: SCH 39641 intervention 3: SCH 39641
Intervention descriptions: intervention 1: Placebo sublingual tablet, once daily intervention 2: Allergy immunotherapy tablet (sublingual) intervention 3: Allergy immunotherapy tablet (sublingual)

Protocol documents:
Clinical trial NCT00983957
Conditions: Chronic Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2009-10-01; Completion date: 2010-02-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BMS-790052 intervention 2: Ortho Tri-Cyclen®
Intervention descriptions: intervention 1: Tablets, Oral, 60 mg, once daily, 10 days intervention 2: Tablets, Oral, once daily, 78 days

Protocol documents:
Clinical trial NCT01010971
Conditions: Seasonal Allergic Rhinitis
Keywords: Mountain Cedar
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-12-01; Completion date: 2010-02-01
Enrollment: 671 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical research study will evaluate the safety and effectiveness of two doses of an investigational medication (ciclesonide nasal aerosol) for the treatment of subjects with of seasonal allergic rhinitis (SAR). The study will consist of a Screening Period to confirm study eligibility, followed by a Single-Blind Placebo Run-in period to acclimate subjects to the proper use of the study medication and to assess the subject's severity of SAR symptoms, followed by a 2-week double-blind treatment period to assess the safety and effectiveness of the study medication when given to eligible subjects.

Detailed description:
This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. This study will consist of a Screening Period, followed by a Single-Blind Placebo Run-in period. The Double-blind Treatment period (14±2 days) will begin at randomization/Day 1 and consist of an interim visit 7±1 days after randomization, and an End of Study (EOS)/Early Termination (ET) visit. All subjects will have either a telephone contact, or in some cases an in-clinic visit, 7±2 days after their last study visit. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: 160 μg once daily arm 2: 80 μg once daily arm 3: Placebo
Interventions: intervention 1: Ciclesonide HFA 160 μg intervention 2: Ciclesonide HFA 80 μg intervention 3: Placebo
Intervention descriptions: intervention 1: Ciclesonide HFA Nasal Aerosol 160 μg once daily intervention 2: Ciclesonide HFA Nasal Aerosol 80 μg once daily intervention 3: Placebo HFA Nasal Aerosol once daily

Protocol documents:
Clinical trial NCT01023724
Conditions: Post Operative Anterior Chamber Inflammation (Flare)
Sponsor: Bucci Laser Vision Institute
Start date: 2009-12-01; Completion date: 2010-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.

Detailed description:

Arms: arm 1: bromfenac 0.09% drops to be given pre operatively for one day BID, and then postoperatively for 14 days. arm 2: Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
Interventions: intervention 1: Ketorolac Tromethamine 0.45% intervention 2: Bromfenac 0.09%
Intervention descriptions: intervention 1: Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days. intervention 2: Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively

Protocol documents:
Clinical trial NCT01030406
Conditions: Opioid Abuse
Keywords: Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence
Sponsor: Acura Pharmaceuticals Inc.
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare the relative abuse potential of two different doses of orally administered Acurox Tablets to orally administered immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.

Detailed description:
In the tretament phase, 5 treatments administered were oxycodone HCl/niacin tablets as follows: (A) 40/0 mg, (B) 80/0 mg, (C) (40/240 mg, (D) 80/480 mg and (E) 0/0 mg. Each treatment was administered as a single dose of 8 tablets once a day at approximately the same time each day. All doses were given with water, and all 8 tablets were to be swallowed in 5 minutes. Doses were separated by 48 (± 1) hours. All subjects received each treatment in a randomized sequence using a Williams design.

Arms: arm 1: 8x oxycodone/niacin 5/0mg tablets arm 2: 8x oxycodone/niacin 10/0mg tablets arm 3: 8x oxycodone/niacin 5/30mg tablets arm 4: 8x oxycodone/niacin 10/60mg tablets arm 5: Placebo
Interventions: intervention 1: 40/0mg taken first intervention 2: 80/0mg taken first intervention 3: 40/240mg taken first intervention 4: 80/480mg taken first intervention 5: 0/0mg taken first
Intervention descriptions: intervention 1: 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses intervention 2: 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses intervention 3: 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses intervention 4: 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses intervention 5: Placebo All arms taken with a 48 hour washout between doses

Protocol documents:
Clinical trial NCT01046396
Conditions: Skin Manifestations
Sponsor: Galderma R&D
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.

Detailed description:

Arms: arm 1: Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks arm 2: Adapalene Lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Interventions: intervention 1: adapalene cream 0.1% and adapalene lotion 0.1% intervention 2: adapalene lotion 0.1%
Intervention descriptions: intervention 1: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks intervention 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Protocol documents:
Clinical trial NCT01046565
Conditions: Skin Manifestations
Sponsor: Galderma R&D
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.

Detailed description:

Arms: arm 1: Adapalene Cream 0.1% - apply once daily on one side of the face for 3 weeks arm 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face
Interventions: intervention 1: adapalene cream 0.1% intervention 2: adapalene lotion 0.1%
Intervention descriptions: intervention 1: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks intervention 2: adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks

Protocol documents:
Clinical trial NCT01055834
Conditions: Insomnia
Keywords: Insomnia primary insomnia insomnia associated with psychiatric or physical disorder(s)
Sponsor: Eisai Co., Ltd.
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eszopiclone 3 mg intervention 2: Eszopiclone 1 mg
Intervention descriptions: intervention 1: Group A Period I, Group B Period II:

Eszopiclone 3 mg tablet taken orally (po) with water as a single administration in the morning after fasting \>=10 hours.

Except for the water taken with the drug, participants were not allowed any food/ drink from 10 hours before until 4 hours after administration of drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of drug.

Group B Period III:

Eszopiclone 3 mg tablet taken po with water as a single administration in the morning 30 minutes after the start of breakfast.

Except for the food/ drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink from 10 hours before until 4 hours after administration of the drug. Except for the food/ drink at breakfast \& the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration. intervention 2: Group A Period II, Group B Period I:

Eszopiclone three 1 mg tablets (total: 3 mg) taken orally with water as a single administration in the morning after fasting 10 or more hours.

Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug.

Protocol documents:
Clinical trial NCT01062256
Conditions: Infection
Keywords: Cough assessment in upper respiratory infection guaifenesin honey
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2010-01-01; Completion date: 2010-02-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.

Detailed description:

Arms: arm 1: Placebo arm 2: Guaifenesin arm 3: Buckwheat Honey
Interventions: intervention 1: Placebo intervention 2: Guaifenesin intervention 3: Buckwheat Honey
Intervention descriptions: intervention 1: One placebo tablet administered orally as a single dose intervention 2: One 400 mg immediate release tablet administered orally as a single dose intervention 3: 10 mL administered orally as a single dose

Protocol documents:
Clinical trial NCT01093469
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis Wake Forest Dermatology Skin Over-the-counter Moisturizer Children
Sponsor: Wake Forest University Health Sciences
Start date: 2009-09-01; Completion date: 2010-02-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and cost effectiveness of Aquaphor Healing Ointment, Atopiclair and EpiCeram as a monotherapy in mild to moderate AD.

The investigators hypothesize that no statistical difference will exist in the efficacy between an over-the-counter moisturizer, Aquaphor Healing Ointment, compared to prescription devices Atopiclair and EpiCeram in treating mild to moderate AD. Therefore, Aquaphor will be most cost-effective than Atopiclair or EpiCeram.

Detailed description:
The primary objective is to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and EpiCeram Skin Barrier Emulsion in children with mild to moderate atopic dermatitis. The secondary objective is to compare the cost-effectiveness of these products. A significant difference exists in the cost of these products; therefore, if our hypothesis is proved correct - that Aquaphor will be just as efficacious as the more expensive counterparts Atopiclair and EpiCeram - this could have a significant impact on the overall cost of treating atopic dermatitis.

This is a single center, investigator blinded, randomized, prospective controlled study of subjects with mild to moderate atopic dermatitis. The study is intended to compare the efficacy of Aquaphor Healing Ointment, Atopiclair Nonsteroidal Cream and the EpiCeram Skin Barrier Emulsion used three times a day in treating mild to moderate atopic dermatitis. All subjects will receive active study medication and will return to study center for efficacy and safety assessments at Days 7 and 21. Approximately 50 subjects will be enrolled in order to obtain 39 completed subjects that will be randomized 1:1:1 (13 to receive Aquaphor, 13 to receive Atopiclair and 13 to receive EpiCeram) according to standard randomization tables. Efficacy will be measured through Investigator's Global Assessment, BSA involvement, Investigator Global Assessment of Improvement, Eczema Area and Severity Index and 100-pt Visual Analog Score for pruritis. Subjects will complete a Subject Global Assessment of Improvement and a drug diary to monitor for compliance. Cost benefit analysis will be calculated as cost in dollars for change in outcome according to EASI, BSA and VAS.

Arms: arm 1: Aquaphor Healing Ointment three times daily to atopic dermatitis arm 2: Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis arm 3: EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
Interventions: intervention 1: Atopiclair Nonsteroidal Cream intervention 2: Aquaphor Healing Ointment intervention 3: EpiCeram
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01126593
Conditions: Rotator Cuff Tear
Sponsor: Orlando Health, Inc.
Start date: 2008-12-01; Completion date: 2010-02-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.

Detailed description:
This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.

Patients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.

Arms: arm 1: The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline. arm 2: The control group patients will receive no continuous infusion catheter. arm 3: Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
Interventions: intervention 1: 0.5% bupivacaine intervention 2: Normal Saline
Intervention descriptions: intervention 1: Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour. intervention 2: The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.

Protocol documents:
Clinical trial NCT01130103
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD anxiety disorders trauma
Sponsor: Research Foundation for Mental Hygiene, Inc.
Start date: 2004-03-01; Completion date: 2010-02-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.

Detailed description:
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.

Arms: arm 1: Paroxetine and Prolonged Exposure Therapy arm 2: Placebo pill plus Prolonged Exposure Therapy
Interventions: intervention 1: Paroxetine intervention 2: Prolonged Exposure Therapy
Intervention descriptions: intervention 1: Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks intervention 2: Weekly for 10 weeks

Protocol documents: