ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00889200
Conditions: Insomnia
Sponsor: Butler Hospital
Start date: 2007-05-01; Completion date: 2009-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was designed to use a sensitive neuroendocrine probe, the Dexamethasone/Corticotropin-Releasing Hormone (DEX/CRH) test, in a sample of healthy adults with insomnia. The primary aim was to assess cortisol reactivity before and after long-term (6 weeks) administration of eszopiclone. It was hypothesized that treatment with eszopiclone would result in a significant reduction in plasma cortisol response to the DEX/CRH test following treatment of insomnia with standard dose of eszopiclone.

Detailed description:
see above

Arms: arm 1: Standard dosing of drug for 6 weeks for insomnia
Interventions: intervention 1: eszopiclone
Intervention descriptions: intervention 1: 6 weeks standard oral therapy

Protocol documents:
Clinical trial NCT00894322
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta Amylin Lilly
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

Detailed description:

Arms: arm 1: A single 10-mg dose of exenatide once weekly suspension given to healthy participants via 3 subcutaneous (SC) injections at Day 1. arm 2: On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. arm 3: On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, thiazolidinedione (TZD), or a combination of metformin or TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks.
Interventions: intervention 1: exenatide once weekly intervention 2: exenatide once weekly intervention 3: Placebo
Intervention descriptions: intervention 1: subcutaneous injection, 10.0 mg, single injection intervention 2: subcutaneous injection, 2.0 mg, once a week for 12 weeks intervention 3: subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks

Protocol documents:
Clinical trial NCT00894465
Conditions: Vesicoureteral Reflux
Keywords: Midazolam VCUG Anxiety
Sponsor: Washington University School of Medicine
Start date: 2006-08-01; Completion date: 2009-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research is to validate the common administration of oral midazolam to children prior to voiding cystourethrogram (VCUG) to see if this will significantly decrease children's anxiety and make the experience less traumatic.

Detailed description:

Arms: arm 1: Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG. arm 2: Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.
Interventions: intervention 1: midazolam intervention 2: placebo
Intervention descriptions: intervention 1: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG intervention 2: Children are randomized to receive a placebo prior to undergoing VCUG

Protocol documents:
Clinical trial NCT00898222
Conditions: Healthy
Keywords: healthy volunteers aspirin Normal healthy subjects
Sponsor: Brigham and Women's Hospital
Start date: 2009-05-01; Completion date: 2009-08-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hypothesis: Low dose aspirin does not change exhaled inflammatory breath mediators in normal subjects.

Detailed description:
Aim:

1. To study the effect of low dose aspirin on exhaled breath inflammatory mediators
2. To compare the change to that seen in diseased states such as asthma and Lymphangioleiomyomatosis (LAM)

We will interview healthy volunteers to confirm that they do not have any major underlying medical conditions such as heart disease, diabetes, stroke and bleeding disorders. We will collect breath condensate before and after two weeks of low dose over the counter enteric coated aspirin 81 mg/day therapy. Side effects are extremely rare at this dose, but include bleeding, heart burn and allergic reaction.

Arms: arm 1: Low dose daily aspirin in healthy volunteers for two weeks
Interventions: intervention 1: aspirin
Intervention descriptions: intervention 1: 81 mg orally daily for two weeks

Protocol documents:
Clinical trial NCT00899470
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2009-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To demonstrate bioequivalence of a 2.5 mg saxagliptin/500 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 500 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.

Detailed description:

Arms: arm 1: Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M \[fasted\]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M \[fed\]) followed by S/M under fasting conditions (S/M \[fasted\]) followed by S + M under fed conditions (S + M \[fed\]) arm 2: Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed) arm 3: Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted) arm 4: Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
Interventions: intervention 1: Co-administration of Saxagliptin and Metformin IR, Fasted intervention 2: Saxagliptin/Metformin, Fasting intervention 3: Co-administration of Saxagliptin and Metformin IR, Fed intervention 4: Saxagliptin/Metformin, Fed
Intervention descriptions: intervention 1: Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions intervention 2: Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions intervention 3: Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions intervention 4: Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions

Protocol documents:
Clinical trial NCT00904670
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Hyperactivity Attention Deficit Disorder ADHD Pediatric Patients Quillivant methylphenidate
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2009-08-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Quillivant Oral Suspension XR intervention 2: Placebo intervention 3: Placebo
Intervention descriptions: intervention 1: Oral Suspension 25mg/5mL; 20-60 mg/day intervention 2: Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day intervention 3: Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

Protocol documents:
Clinical trial NCT00915538
Conditions: Asthma
Keywords: Asthma Formoterol Long Acting Beta Adrenergic Bronchodilator Symbicort Aerochamber
Sponsor: Western Sky Medical Research
Start date: 2009-07-01; Completion date: 2009-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.

Detailed description:
Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.

Arms: arm 1: The intervention in this group will use inhalation from the pMDI containing budesonide/formoterol pMDI 160/4.5 2 inhalations as approved. (FDA approved product information) without a spacer. The pulmonary function tests (PFTs) will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of budesonide /formoterol; pMDI160/5. arm 2: The intervention in this group will use the pMDI budesonide/formoterol 160/4.5 with a valve holding chamber spacer device, Aerochamber Plus which is the intervention being studied The PFTs will be collected at baseline and for a period of 12 hours post inhalation of 2 inhalation of Symbicort 160/5. This is the intervention to be studied for comparison to the non-spacer inhalations..
Interventions: intervention 1: pMDI budesonide/formotrol 160/4.5 is in group 1 intervention 2: Symbicort 160/4.5 plus Aerochamber Plus included in group 2
Intervention descriptions: intervention 1: The asthmatic subjects will receive budesonide/formoterol pMDI 160/4.5 pMDI 2 inhalations used in conventional fashion, and have pulmonary function measured over 12 hours who are expected to show bronchodilation. intervention 2: Symbicort 160/4.5 2 inhalations will be administered through a valved holding chamber, Aerochamber Plus, Pulmonary functions will be measured over 12 hours in asthmatic subjects who are expected to show bronchodilation.

Protocol documents:
Clinical trial NCT00922441
Conditions: Essential Hypertension
Keywords: Fimasartan Essential Hypertension 24hour ABPM Population PK
Sponsor: Boryung Pharmaceutical Co., Ltd
Start date: 2008-12-01; Completion date: 2009-08-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) during 24 hours by dose in patients with mild to moderate essential hypertension.

Detailed description:
Fimasartan(BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan(BR-A-657-K) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan(BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan(BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A Randomized, Double-blind, Valsartan-referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan(BR-A-657•K) during 24hoursby dose in Patients with Mild to Moderate Essential Hypertension.

Approximately 90 patients will be enrolled over 12 months in 5 centers nationwide.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 3 groups. Subjects will take test/control drug for 8 weeks of treatment period.

If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

Group I : Fimasartan 60mg group. Group II : Fimasartan 120mg group Group III : Valsartan 80mg group

Arms: arm 1: Fimasartan 60 mg group arm 2: Fimasartan 120 mg group arm 3: Reference (Valsartan 80 mg) group
Interventions: intervention 1: Fimasartan 60 mg group intervention 2: Fimasartan 120 mg group intervention 3: Reference (Valsartan 80 mg) group
Intervention descriptions: intervention 1: Fimasartan 60 mg intervention 2: Fimasartan 120 mg intervention 3: Reference (Valsartan 80 mg)

Protocol documents:
Clinical trial NCT00926393
Conditions: Bipolar Depression
Keywords: inpatient bipolar depression quetiapine Seroquel IR Seroquel XR safety tolerability
Sponsor: AstraZeneca
Start date: 2009-06-01; Completion date: 2009-08-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Detailed description:

Arms: arm 1: Quetiapine 25, 100, 200 and 300 mg arm 2: Quetiapine 50, 200, 300
Interventions: intervention 1: Quetiapine Immediate Release intervention 2: Quetiapine Extended Release
Intervention descriptions: intervention 1: Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day intervention 2: Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Protocol documents:
Clinical trial NCT00935311
Conditions: Pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2009-06-01; Completion date: 2009-08-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar extraction.

Detailed description:
Dosing started within 6 hours after completion of third molar extraction. Study drug was given once every 6 hours for 12 hours (for a total of 2 doses). Participants were randomized to receive placebo or active drug (either experimental drug or comparator). The total dose was the same for both groups receiving active drug, but was given as either 1 dose of extended-release tablets (experimental drug), or 2 doses of immediate-release tablets (active comparator).

Arms: arm 1: 1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses). arm 2: 2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses). arm 3: 2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
Interventions: intervention 1: ABT-712 Extended-release intervention 2: Hydrocodone/Acetaminophen Immediate-release intervention 3: Placebo
Intervention descriptions: intervention 1: ABT-712 extended-release tablet intervention 2: Hydrocodone/acetaminophen immediate-release tablet intervention 3: Placebo tablet

Protocol documents:
Clinical trial NCT00939731
Conditions: Healthy
Keywords: bioavailability, capsule, tablet, healthy volunteer
Sponsor: Pfizer
Start date: 2009-07-01; Completion date: 2009-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over, single-dose study employing administration of two PF-02341066 formulations in the fasted state to healthy adult volunteers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-02341066 intervention 2: PF-02341066
Intervention descriptions: intervention 1: A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Powder-in-Capsule and 2 x 100-mg Powder-in-Capsules intervention 2: A 250-mg single dose of PF-02341066 administered as 1 x 50-mg Immediate Release Tablet and 2 x 100-mg Immediate Release Tablets

Protocol documents:
Clinical trial NCT00955825
Conditions: Allergic Rhinitis Due to Grass Pollens
Keywords: allergic rhinoconjunctivitis
Sponsor: Stallergenes Greer
Start date: 2008-10-01; Completion date: 2009-08-01
Enrollment: 473 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and safety of 300 IR sublingual tablet of grass pollen allergen extract compared to placebo in adult patient with allergic rhinoconjunctivitis.

Detailed description:
Allergy is one of the most common chronic disease in the world currently affecting between 10% and 25% of the general population.

Allergies to pollens characteristically result in seasonal rhinitis symptoms and allergic rhinoconjunctivitis is characterized by sneezing, congestion, rhinorrhea, nasal or palatal itching and itchy, watery, red and swollen eyes.

Even if several drugs effectively manage allergic rhinoconjunctivitis symptoms, immunotherapy is considered more appropriate for patients in whom these symptoms are not optimally controlled with relief medications.

In the study, each of the six rhinoconjunctivitis symptoms (sneezing, runny nose, itchy nose, nasal congestion, itchy eyes, watery eyes) will be evaluated daily and relief medication intake (oral antihistamines, eye drop antihistamine, nasal corticosteroid, oral corticosteroid) reported daily during the grass pollen season.

Efficacy and good safety profile of 300IR SLIT tablet administered once per day for approximately six months (starting 4 months before and over the season) will be demonstrated during the grass pollen season compared to placebo.

Arms: arm 1: 300 IR grass pollen allergen extract tablet arm 2: Pacebo tablet
Interventions: intervention 1: 300 IR intervention 2: Placebo
Intervention descriptions: intervention 1: 300 IR grass pollen allergen extract tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season intervention 2: Placebo sublingual tablet taken daily for approximately 6 months starting 4 months before the grass pollen season and over the grass pollen season

Protocol documents:
Clinical trial NCT00957944
Conditions: Healthy Volunteers
Keywords: Rotigotine Neupro®
Sponsor: UCB Pharma
Start date: 2009-07-01; Completion date: 2009-08-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of 2 rotigotine transdermal patches from 2 different manufacturing sites.

Detailed description:

Arms: arm 1: Two single applications of rotigotine patches from two different manufacturing sites in the order A-B separated by a washout phase of at least 5 days arm 2: Two single applications of rotigotine patches from two different manufacturing sites in the order B-A separated by a washout phase of at least 5 days
Interventions: intervention 1: rotigotine transdermal patch (Neupro®)
Intervention descriptions: intervention 1: Rotigotine 4.5 mg/10 cm\^2 patch applied for 24 hours

Protocol documents:
Clinical trial NCT00958893
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Sponsor: Repros Therapeutics Inc.
Start date: 2008-06-01; Completion date: 2009-08-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed description:
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Arms: arm 1: 25 mg Proellex daily
Interventions: intervention 1: 25 mg Proellex
Intervention descriptions: intervention 1: one 25 mg capsules

Protocol documents:
Clinical trial NCT00964366
Conditions: Acne Vulgaris
Sponsor: Stiefel, a GSK Company
Start date: 2009-07-01; Completion date: 2009-08-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, half-face study. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control.

Detailed description:
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide or dapsone gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.

The eligible subjects who qualify will be entered into a 2-week treatment phase. The first of application of the study medication will be supervised at the site, Monday through Friday of each week. Any additional applications should be applied by the subjects at home each evening and the times of application recorded on a diary card. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.

A blinded expert grader will rate comparative product tolerance during the study before study product is applied.

Instrumentation measurements of TEWL will be utilized to evaluate product mildness.

Duplicate sebum samples will be taken from the left and right forehead areas and assessed.

Subject will complete questionnaires and all adverse events will be recorded.

Arms: arm 1: Once-daily applications of clindamycin/BPO gel to the randomized side of the face either left or right. arm 2: Twice-daily applications of dapsone gel to one side of the face.
Interventions: intervention 1: clindamycin and benzoyl peroxide intervention 2: Dapsone gel
Intervention descriptions: intervention 1: Daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide intervention 2: Twice-daily applications of dapsone gel

Protocol documents: