ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00614406
Conditions: Ovulation (Follicular Rupture Yes/no) Menstrual Cycles (Total Length, Bleeding Days) Gonadotropin and Ovarian Hormone Levels (FSH, LH, E2, P)
Keywords: Celebrex prostaglandin inhibitor ovulation menstrual cycles
Sponsor: Oregon Health and Science University
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to test the hypothesis that the use of a prostaglandin inhibitor will result in premature luteolysis (ovulation failure) in women.

Detailed description:
Currently available methods of emergency contraception (EC) only work during a very narrow time period prior to the hormonal trigger for ovulation or the release of an egg. Women having unprotected sex outside this window receive no benefits from this emergency therapy. Prostaglandins are critical before, during, and after ovulation, thus their inhibition may cause an EC effect that works over a longer time period. We wanted to determine if celecoxib might work as an EC with a wider window of action.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Celebrex intervention 2: Placebo
Intervention descriptions: intervention 1: One 400mg tablet daily. intervention 2: One tablet daily.

Protocol documents:
Clinical trial NCT00629239
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD tolerability inhalation
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2008-08-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Detailed description:

Arms: arm 1: AZD4818 arm 2: Placebo
Interventions: intervention 1: AZD4818 intervention 2: Placebo
Intervention descriptions: intervention 1: Dry Powder, inhalation, b.i.d., 4 weeks intervention 2: None

Protocol documents:
Clinical trial NCT00634972
Conditions: Retinopathy of Prematurity Retinal Detachment Blindness
Keywords: Retinopathy of Prematurity Premature Infants ACULAR Refresh Tears
Sponsor: University of South Alabama
Start date: 2005-11-01; Completion date: 2008-08-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear).

The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.

Detailed description:
Each year ROP affects an estimated 14,000-16,000 premature, low birth weight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires surgical treatment. Despite those treatment, about 400-600 infants with severe ROP still become legally blind each year.

ACULAR® (Ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (NSAIDs) available for toipcal ocular use. ACULAR acts as prostaglandin inhibitor and as such decrease prostaglandin E2 production. An increase in prostaglandin production has been associated with various inflammatory eye disease.For instance ACULAR has been shown to be effective in preventing the post cataract surgery inflammation that result in macular edema in adults. Activation of the prostaglandin cascade has been demonstrated in animal models of ROP. A previous non randomized study using ACULAR for ROP prevention has shown a possible beneficial effect and no observed adverse effect. To clearly demonstrated and confirm this finding a randomized study is thus necessary before one can advocate its use for prevention of ROP.The medication is FDA approved in pediatrics for allergic conjunctivitis and post surgical ocular inflammation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ACULAR intervention 2: REFRESH TEARS intervention 3: placebo
Intervention descriptions: intervention 1: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 2: infants enrolled in the study will receive 1 drop of the ROP Study drug in each eye 3 times a day (every 8 hours. intervention 3: None

Protocol documents:
Clinical trial NCT00636961
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, Indacaterol Maleate, Exercise testing
Sponsor: Novartis
Start date: 2008-02-01; Completion date: 2008-08-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluated the effect of QAB149 on dynamic and static hyperinflation, breathlessness, and health status in COPD patients

Detailed description:

Arms: arm 1: In period I, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study. arm 2: In period I, matching placebo was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. In period II, indacaterol 300μg was taken by inhalation once daily via the Concept 1 inhaler device for 2 weeks. For each treatment period and for each patient, the doses were to be administered between 7am and 12am. A period of at least 4 days but no more than 21 days separated each treatment period. Rescue medication (short-acting beta-agonist (SABA)) was prescribed by the investigator for the duration of the study.
Interventions: intervention 1: Indacaterol 300μg intervention 2: Placebo
Intervention descriptions: intervention 1: 300μg indacaterol maleate inhalation powder in hard gelatin capsules administered via Concept1 inhalation device intervention 2: Matching placebo devices and hard gelatin capsules

Protocol documents:
Clinical trial NCT00646776
Conditions: Antivirals/HIV
Sponsor: Bristol-Myers Squibb
Start date: 2008-04-01; Completion date: 2008-08-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the exposure of rifabutin (RIB) when administered with atazanavir and ritonavir (ATV/RTV)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rifabutin intervention 2: Rifabutin + Atazanavir + Ritonavir
Intervention descriptions: intervention 1: Capsule, Oral, 150 mg, once daily, 11 Days intervention 2: Capsules, Oral, 18 Days

Rifabutin (150 mg, 2x/wk)

Atazanavir (300 mg, once daily)

Ritonavir (100 mg, once daily)

Protocol documents:
Clinical trial NCT00650858
Conditions: Intraventricular Hemorrhage
Keywords: Intraventricular hemorrhage (IVH) rt-PA
Sponsor: Johns Hopkins University
Start date: 2004-02-01; Completion date: 2008-08-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.

Detailed description:
The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.

Arms: arm 1: In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. arm 2: In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage. arm 3: In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage.
Interventions: intervention 1: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)
Intervention descriptions: intervention 1: 0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.

Protocol documents:
Clinical trial NCT00651313
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea Periods Menstrual Primary dysmenorrhea in women with recurrent dysmenorrhea
Sponsor: Juniper Pharmaceuticals, Inc.
Start date: 2007-08-01; Completion date: 2008-08-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel).

Detailed description:
The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea.

The secondary objectives of this study are the following:

* to assess the safety of 10% (150 mg) lidocaine gel compared with placebo
* to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel.

Arms: arm 1: Lidocaine 10% (150mg) vaginal gel arm 2: Placebo vaginal gel
Interventions: intervention 1: Lidocaine intervention 2: Placebo
Intervention descriptions: intervention 1: Lidocaine vaginal gel 10% (150mg) administered once daily for 4 days intervention 2: Placebo vaginal gel administered once daily for 4 days

Protocol documents:
Clinical trial NCT00656474
Conditions: Wounds
Keywords: burn wounds wound healing
Sponsor: TR Therapeutics
Start date: 2008-03-01; Completion date: 2008-08-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study is intended to evaluate safety and efficacy parameters in patients treated with GLYC-101 gel or placebo after laser ablation.

Detailed description:
The proposed pilot-study will document feasibility, safety and efficacy of topically applied Glucoprime gel (GLYC-101 gel 1.0 %) in promoting wound healing in healthy volunteer subjects undergoing retro-auricular Carbon Dioxide Laser Skin Resurfacing (CO2 LSR). The study will observe the effects of the topical agent over the course of 1 month following the treatment. as a preparation for study GLYC-101-1b (Double-blind, randomized, placebo-controlled Phase 2 Pilot Study to investigate the safety and efficacy of 1.0 % topically applied GLYC 101 compared to placebo, in patients undergoing Carbon Dioxide Laser Skin Resurfacing).

Arms: arm 1: GLYC-101 Active Retro-auricular Site (1 per participant) arm 2: Placebo Retro-auricular Site (1 per participant)

This arm undergoes laser ablation with subsequent Placebo gel administration
Interventions: intervention 1: Placebo gel intervention 2: GLYC-101 gel (1.0 %)
Intervention descriptions: intervention 1: Administration of Placebo gel on Day 1, 3 and 5 post ablation. intervention 2: Administration on Day 1, 3 and 5 post laser ablation.

Protocol documents:
Clinical trial NCT00671749
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2007-12-01; Completion date: 2008-08-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Detailed description:
Same as above.

Arms: arm 1: adapalene gel, 0.3%

Other Names:

Differin® Gel, 0.3% Applied once daily at bedtime

clindamycin/benzoyl peroxide gel

Other Names:

Duac® Gel Applied once daily in the morning
Interventions: intervention 1: adapalene gel, 0.3% intervention 2: clindamycin/benzoyl peroxide gel
Intervention descriptions: intervention 1: Applied once daily at bedtime intervention 2: Applied once daily in the morning

Protocol documents:
Clinical trial NCT00681265
Conditions: Keratoconjunctivitis Sicca
Keywords: ocular lubricants
Sponsor: Calm Water Therapeutics LLC
Start date: 2008-06-01; Completion date: 2008-08-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Detailed description:
Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Arms: arm 1: One eye will randomly receive a single instillation of one drop of a new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient. arm 2: The other eye will receive a single instillation of one drop of an artificial tear with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent.
Interventions: intervention 1: glycerin intervention 2: polyethylene glycol 400/propylene glycol
Intervention descriptions: intervention 1: Eye drop with active agent glycerin 1%, new topical ophthalmic formulation with polylysine-graft-polyethylene glycol as an excipient, single instillation. intervention 2: Eye drop with the active agents polyethylene glycol 400 0.4% /propylene glycol 0.3%, topical ophthalmic formulation, single instillation

Protocol documents:
Clinical trial NCT00696761
Conditions: BPH
Keywords: LUTS BPH bladder outlet obstruction bladder contractility
Sponsor: Asan Medical Center
Start date: 2006-05-01; Completion date: 2008-08-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.

It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.

Detailed description:
1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Arms: arm 1: Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 2: BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month. arm 3: BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 4: BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.
Interventions: intervention 1: Alfuzosin intervention 2: Alfuzosin intervention 3: Alfuzosin intervention 4: Alfuzosin
Intervention descriptions: intervention 1: 10mg, once daily, 12months intervention 2: 10mg, once daily, 12months intervention 3: 10mg, once daily, 12months intervention 4: 10mg, once daily, 12months

Protocol documents:
Clinical trial NCT00699010
Conditions: Opioid Abuse
Keywords: Abuse Liability Abuse Prevention Abuse Resistance Abuse Deterrence
Sponsor: Acura Pharmaceuticals Inc.
Start date: 2008-03-01; Completion date: 2008-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of Acurox (oxycodone HCl 40 mg plus niacin 240 mg) versus oxycodone HCL 40 mg alone in subjects with a history of opioid abuse.

Detailed description:
In the Treatment Phase, subjects randomly received oxycodone HCl 40 mg administered in combination with niacin 240 mg and oxycodone HCl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. The purpose of the Treatment Phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of Acurox® Tablets 5/30 mg versus oxycodone HCl 40 mg alone (8 tablets per dose).

All 30 subjects received a single dose of each study treatment. Subjects were fasted prior to dosing on all dose days.

Arms: arm 1: oxycodone HCl/Niacin 5/30mg tablets; 8 tablets per dose arm 2: oxycodone HCl 5mg tablets; 8 tablets per dose
Interventions: intervention 1: Acurox 5/30mg taken first intervention 2: Oxycodone 5mg taken first
Intervention descriptions: intervention 1: followed by oxycodone 5mg with 48 hour washout intervention 2: followed by Acurox 5/30mg with 48 hour washout

Protocol documents:
Clinical trial NCT00699803
Conditions: Cataract
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-05-01; Completion date: 2008-08-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study of T-PRED(TM) compared to Pred Forte(R)

Detailed description:

Arms: arm 1: Tobramycin prednisolone acetate combination arm 2: Prednisolone acetate
Interventions: intervention 1: T-PRED intervention 2: Pred Forte
Intervention descriptions: intervention 1: T-PRED sterile ophthalmic solution intervention 2: Pred Forte sterile ophthalmic solution

Protocol documents:
Clinical trial NCT00700271
Conditions: Hypertension
Keywords: Hypertension ambulatory blood pressure monitoring
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2008-08-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a multicenter, randomized, PROBE-type (prospective, randomized, open label, blinded end-point) study of 12 weeks duration comprising four visits, carried out in patients with essential arterial hypertension not controlled on four weeks treatment with amlodipine 5 mg alone.

Detailed description:

Arms: arm 1: After randomization, participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the morning between 6-10 am. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study. arm 2: After randomization participants received a single daily oral dose of 5 mg amlodipine and 160 mg valsartan free combination therapy, taken in the evening between 6-10 pm. At week 4, uncontrolled patients (msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg or msSBP \>= 130 mmHg and/or msDBP \>= 80 mmHg in the case of diabetes or renal insufficiency measured by using conventional methods) received amlodipine/valsartan 10/160 mg for 4 additional weeks. Patients who were controlled at Week 4 (msSBP \< 140 mmHg and msDBP \< 90 mmHg or msSBP \< 130 mmHg and msDBP \< 80 mmHg in the case of diabetes or renal insufficiency) continued their amlodipine/valsartan 5/160 mg treatment for the remaining 4 weeks of the study.
Interventions: intervention 1: Amlodipine intervention 2: Valsartan
Intervention descriptions: intervention 1: 5 mg or 10 mg tablets. intervention 2: 160 mg capsules.

Protocol documents: