ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01103362
Conditions: Sexual Dysfunctions, Psychological
Sponsor: Sprout Pharmaceuticals, Inc
Start date: 2010-04-01; Completion date: 2011-01-01
Enrollment: 596 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To generate additional long-term safety and efficacy data on flibanserin in premenopausal women and establish long-term safety and tolerability of flibanserin in naturally postmenopausal women with Hypoactive Sexual Desire Disorder who have completed a prior clinical trial of flibanserin (Trial 511.130, 511.147, or 511.156).

Detailed description:

Arms: arm 1: flibanserin 100mg po qd
Interventions: intervention 1: flibanserin
Intervention descriptions: intervention 1: all patients will receive open-label flibanserin 100mg

Protocol documents:
Clinical trial NCT01115673
Conditions: Pain
Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Start date: 2010-06-01; Completion date: 2011-01-01
Enrollment: 540 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

Detailed description:
This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.

Arms: arm 1: 1000 mg Acetaminophen Caplet arm 2: 650 mg Acetaminophen Caplet arm 3: 0 mg Acetaminophen Caplet
Interventions: intervention 1: Acetaminophen intervention 2: Placebo Control
Intervention descriptions: intervention 1: Acetaminophen Caplet - single dose intervention 2: 0 mg Caplet - single dose

Protocol documents:
Clinical trial NCT01126060
Conditions: Thyroid Carcinoma Thyroidectomy
Keywords: Neck dissection
Sponsor: Samsung Medical Center
Start date: 2010-02-01; Completion date: 2011-01-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.

Detailed description:

Arms: arm 1: usage of fibrin sealant after surgery arm 2: No usage of fibrin sealant
Interventions: intervention 1: Usage of Fibrin sealant intervention 2: Thyroidectomy
Intervention descriptions: intervention 1: Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection intervention 2: surgical removal of bilateral thyroid glands

Protocol documents:
Clinical trial NCT01144143
Conditions: Osteoarthritis of the Knee
Keywords: Mild to moderate osteoarthritis of the knee
Sponsor: Herbert Lindsley, MD
Start date: 2007-07-01; Completion date: 2011-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if an anti-inflammatory drug, called infliximab, will reduce inflammation in the synovial lining in patients with an early stage of osteoarthritis of the knee. It will also help determine if the study medication decreases the accumulation of synovial fluid and prevents cartilage breakdown.

Detailed description:
This is an unbalanced randomized, double-blind pilot study of Infliximab (100 mg), placebo (100 mg) and Methylprednisolone acetate (80 mg). A total of 16 subjects will be randomized; 8 subjects will be randomized to receive infliximab, 4 subjects will be randomized to receive placebo and 4 additional subjects will be randomized to receive Methylprednisolone acetate. Subjects will be seen at screening, day 0, day 14, day 28 and day 56. After study drug injection at day 0, patients will return for follow-up visits at approximately 2 weeks, 1 and 2 months in order to obtain clinical endpoint measures for a total of 10 weeks. Outcome measures include blood tests, MRI, ultrasound, synovial lining tissue biopsy questionnaires and adverse events.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Infliximab intervention 2: Placebo intervention 3: Standard of Care: Methylprednisolone acetate
Intervention descriptions: intervention 1: the study drug will be injected into the joint through a needle intervention 2: the placebo will be injected into the joint through a needle intervention 3: Methylprednisolone acetate will be injected into the joint through a needle

Protocol documents:
Clinical trial NCT01153620
Conditions: Wounds
Keywords: Acute traumatic wounds
Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lavasept 0.04% intervention 2: Ringer's Solution
Intervention descriptions: intervention 1: Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.

Dosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress.

Treatment Duration 60 minutes intervention 2: Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.

Dosage Ringers' solution 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes

Protocol documents:
Clinical trial NCT01159665
Conditions: Vitrectomy
Sponsor: ThromboGenics
Start date: 2010-07-01; Completion date: 2011-01-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)

Detailed description:
Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).

Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.

Arms: arm 1: Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection arm 2: Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection arm 3: Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection arm 4: Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection arm 5: Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection arm 6: Control Arm, no ocriplasmin intravitreal injection
Interventions: intervention 1: ocriplasmin intervention 2: ocriplasmin intervention 3: ocriplasmin intervention 4: ocriplasmin intervention 5: ocriplasmin
Intervention descriptions: intervention 1: 125µg ocriplasmin intravitreal injection intervention 2: 125µg ocriplasmin intravitreal injection intervention 3: 125µg ocriplasmin intravitreal injection intervention 4: 125µg ocriplasmin intravitreal injection intervention 5: 125µg ocriplasmin intravitreal injection

Protocol documents:
Clinical trial NCT01163097
Conditions: Oral Mucositis
Sponsor: Swedish Orphan Biovitrum
Start date: 2010-07-01; Completion date: 2011-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of a continuous intravenous infusion of unfractionated heparin on the multiple-dose pharmacodynamics of palifermin in healthy adult subjects.

Detailed description:
The planned study is designed to characterize the impact of heparin on the biologic activity of palifermin and assess the impact of the combination of palifermin and heparin on tolerability. Approximately forty-three (43) eligible healthy adult men and oophorectomized or postmenopausal women between 18-45 years of age will be assigned to one of three treatment groups where treatment group A will receive a daily dose of palifermin 40 µg/kg for three consecutive days as intravenous (IV) bolus injections and continuous heparin IV infusion, treatment B will receive a daily dose of palifermin 40 µg/kg for three consecutive days as IV bolus injections and treatment C will be a control group without any treatment administered. The subjects will be randomized in a 20:15:8 ratio (Treatment A:B:C).

The study consists of a up to 21-days screening period, a 5-days treatment period and a up to 45-days follow-up period.

Arms: arm 1: Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion arm 2: Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections arm 3: Treatment C: control group without any treatment administered.
Interventions: intervention 1: Palifermin intervention 2: Heparin
Intervention descriptions: intervention 1: 40 µg/kg IV bolus injections for three consecutive days intervention 2: Heparin continuous IV infusion

Protocol documents:
Clinical trial NCT01172522
Conditions: Edema
Keywords: Under eye dark circles Under eye puffiness
Sponsor: The Connecticut Sinus Center, PC
Start date: 2010-09-01; Completion date: 2011-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines topical treatment of under eye circles and swelling.

Detailed description:
This study examines topical treatment of under eyes dark circles and under eye swelling.

Arms: arm 1: Topical treatment active versus placebo.

Double blind randomized placebo controlled split face intrasubject comparison. arm 2: Split face double blind
Interventions: intervention 1: Fexofenadine intervention 2: Placebo
Intervention descriptions: intervention 1: Fexofenadine 1% intervention 2: Placebo

Protocol documents:
Clinical trial NCT01174030
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: CD07805/47 Gel intervention 2: Vehicle Gel intervention 3: CD07805/47 Gel intervention 4: CD07805/47 Gel intervention 5: Vehicle Gel
Intervention descriptions: intervention 1: CD07805/47 Gel 0.5% QD intervention 2: Vehicle Gel QD intervention 3: CD07805/47 Gel 0.18% QD intervention 4: CD07805/47 Gel 0.18% BID intervention 5: Vehicle Gel BID

Protocol documents:
Clinical trial NCT01178099
Conditions: Anemia, Sickle Cell
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2011-01-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).

Detailed description:

Arms: arm 1: Participants received a single 10 milligram (mg) dose on Day 1 (single dose \[SD\]), followed by either 5 mg/day (for participants\<60 kilograms \[kg\]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose \[MD\]).
Interventions: intervention 1: Prasugrel
Intervention descriptions: intervention 1: Oral, daily for 12 days

Protocol documents:
Clinical trial NCT01188577
Conditions: Asthma Bronchospasm Wheezing Shortness of Breath
Keywords: asthma bronchospasm wheezing shortness of breath
Sponsor: Amphastar Pharmaceuticals, Inc.
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.

Detailed description:
E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane (HFA-134a) as the propellant.

In order to differentiate the inhaled epinephrine from the fluctuating background of endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine (epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per inhalation).

This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be conducted in \~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3 at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).

Arms: arm 1: Experimental treatment of 10 inhalations of 125 mcg epinephrine base propelled by HFA 134a arm 2: Epinephrine Inhalation Aerosol, CFC propelled, 220 mcg/inhalation , 10 inhalations
Interventions: intervention 1: Epinephrine Inhalation Aerosol, HFA intervention 2: Epinephrine Inhalation Aerosol
Intervention descriptions: intervention 1: 10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation intervention 2: Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations

Protocol documents:
Clinical trial NCT01189812
Conditions: Major Depressive Disorder Dysthymia Depression Not Otherwise Specified Borderline Personality Disorder
Keywords: hopelessness alone sad troubled depression
Sponsor: Columbia Northwest Pharmaceuticals
Start date: 2010-03-01; Completion date: 2011-01-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lithium Carbonate intervention 2: Placebo intervention 3: Citalopram
Intervention descriptions: intervention 1: 300 mg one time per day for 4 weeks intervention 2: Take one time daily for 4 weeks intervention 3: All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)

Protocol documents:
Clinical trial NCT01190878
Conditions: Ocular Inflammation
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: ISV-303 intervention 2: ISV-303 intervention 3: DuraSite Vehicle intervention 4: Xibrom™
Intervention descriptions: intervention 1: 0.075% of bromfenac in DuraSite dosed QD intervention 2: 0.075% of bromfenac in DuraSite dosed BID intervention 3: Vehicle dosed BID intervention 4: 0.09% bromfenac dosed BID

Protocol documents:
Clinical trial NCT01206387
Conditions: Psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
efficacy study in patients with moderate to severe plaque psoriasis.

Detailed description:
A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis

Arms: arm 1: Desoximetasone Spray 0.25% arm 2: vehicle
Interventions: intervention 1: Desoximetasone Spray 0.25% intervention 2: placebo comparator
Intervention descriptions: intervention 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days intervention 2: Placebo administered to affected area twice a day for 28 days

Protocol documents:
Clinical trial NCT01206660
Conditions: Psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2010-08-01; Completion date: 2011-01-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to demonstrate that desoximetasone 0.25% topical spray is effective for the treatment of patients with moderate to severe plaque psoriasis.

Detailed description:

Arms: arm 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days arm 2: Placebo administered to affected area twice a day for 28 days
Interventions: intervention 1: Desoximetasone Spray 0.25% intervention 2: placebo
Intervention descriptions: intervention 1: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days intervention 2: Placebo administered to affected area twice a day for 28 days

Protocol documents:
Clinical trial NCT01209832
Conditions: Advanced Cancer
Keywords: Metastatic Tumors Lymphoma
Sponsor: Eli Lilly and Company
Start date: 2010-09-01; Completion date: 2011-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using midazolam as a sensitive and specific probe substrate of CYP3A.

The study will also assess the safety and tolerability of tasisulam and midazolam given in combination and document any antitumor activity with tasisulam.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tasisulam intervention 2: Midazolam
Intervention descriptions: intervention 1: Patient specific dose, administered intravenously, on Day 1 of a 28-day cycle. Minimum of one (1) 28-day cycle. Patients may continue to receive tasisulam until disease progression or until discontinuation criteria are met. intervention 2: 1.2 milligrams (mg), administered orally once prior to the initiation of tasisulam therapy and once on Day 8 after initiation of tasisulam therapy

Protocol documents:
Clinical trial NCT01209949
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2010-10-01; Completion date: 2011-01-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel
Intervention descriptions: intervention 1: Apply adapalene BPO gel once daily in the evening for 12 weeks

Protocol documents:
Clinical trial NCT01214109
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2010-12-01; Completion date: 2011-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To establish bioequivalence at steady state of:

1)0.375 mg pramipexole extended release tablet q.d. in fasted status versus 0.125 mg pramipexole Immediate release tablet t.i.d. in fasted status 2)1.5 mg pramipexole extended release tablet q.d. in fasted status versus 0.5 mg pramipexole Immediate release tablet t.i.d. in fasted status

To investigate dose proportionality of pharmacokinetics parameters for:

1)pramipexole extended release dosage of 0.375 to 1.5 mg q.d.

Detailed description:

Arms: arm 1: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) arm 2: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
Interventions: intervention 1: pramipexole extended release intervention 2: pramipexole extended release intervention 3: pramipexole immediate release intervention 4: pramipexole immediate release
Intervention descriptions: intervention 1: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) intervention 2: 0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over) intervention 3: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over) intervention 4: 0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)

Protocol documents:
Clinical trial NCT01216163
Conditions: Pain
Keywords: Pain following third molar extraction (wisdom tooth)
Sponsor: Pfizer
Start date: 2010-10-01; Completion date: 2011-01-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Novel Ibuprofen intervention 2: Acetaminophen intervention 3: Placebo
Intervention descriptions: intervention 1: Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) intervention 2: Single-dose of acetaminophen (1000mg) intervention 3: Single-dose of placebo

Protocol documents: