ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01129245
Conditions: Ovulation Luteal Development
Keywords: Celebrex prostoglandin inhibitor ovulation emergency contraception
Sponsor: Oregon Health and Science University
Start date: 2009-09-01; Completion date: 2011-09-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.

Detailed description:
A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.

This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.

Arms: arm 1: Control menstrual cycle arm 2: Pre-LH surge dosing of celecoxib arm 3: Post-LH surge dosing of celecoxib
Interventions: intervention 1: Celebrex intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg PO daily intermittently based on hormone and ultrasound findings intervention 2: Placebo identical to celecoxib

Protocol documents:
Clinical trial NCT01140503
Conditions: Dermatomyositis
Sponsor: Stanford University
Start date: 2010-02-01; Completion date: 2011-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is designed to evaluate the safety and efficacy of an oral medicine (called apremilast) for treating skin involvement in patients with the disease dermatomyositis.

Detailed description:

Arms: arm 1: apremilast 20mg bid
Interventions: intervention 1: Apremilast
Intervention descriptions: intervention 1: Apremilast 20mg PO BID

Protocol documents:
Clinical trial NCT01147497
Conditions: Contraception
Keywords: IUD insertion nulliparous women contraception family planning IUD insertion in nulliparous women
Sponsor: Emory University
Start date: 2010-06-01; Completion date: 2011-09-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain.

Detailed description:
There are currently 2 intrauterine devices (IUDs) available in the U.S., the copper T380 (paragard) and levonorgestrel IUD (Mirena). The effectiveness of IUDs is very similar to tubal sterilization\[1\], with an overall unintended pregnancy rate of less than 1% in the first year, and lower failure rates in subsequent years. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers give their patients a dose of this drug prior to insertion. The goal of this study is to evaluate whether misoprostol prior to IUD insertion in nulliparous women eases insertion and decreases pain. The null hypothesis is that misoprostol does not influence difficulty of insertion or patient perception of pain. The primary outcome is the ability to insert the IUD without dilation of the cervix or using ultrasound for guidance.

Arms: arm 1: Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit arm 2: Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
Interventions: intervention 1: Misoprostol intervention 2: Placebo
Intervention descriptions: intervention 1: 400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit intervention 2: Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit

Protocol documents:
Clinical trial NCT01151137
Conditions: Atrial Fibrillation
Sponsor: Sanofi
Start date: 2010-07-01; Completion date: 2011-09-01
Enrollment: 3236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors

Secondary Objective:

* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Detailed description:
The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Arms: arm 1: Dronedarone 400 mg twice a day until the CSED arm 2: Placebo (for Dronedarone) twice a day until the CSED
Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol documents:
Clinical trial NCT01179490
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Sponsor: SymBio Pharmaceuticals
Start date: 2010-09-01; Completion date: 2011-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.

Detailed description:
The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for untreated and maladjustment to hematopoietic stem cell transplantation (HSCT) multiple myeloma to a regimen of bendamustine and prednisolone.

Arms: arm 1: SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
Interventions: intervention 1: SyB L-0501 intervention 2: prednisolone
Intervention descriptions: intervention 1: SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible). intervention 2: Prednisolone will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days.

Protocol documents:
Clinical trial NCT01180400
Conditions: Major Depressive Disorder Depression
Keywords: Major Depressive Disorder MDD Depression Safety add-on therapy
Sponsor: AstraZeneca
Start date: 2010-09-01; Completion date: 2011-09-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

Detailed description:
A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

Arms: arm 1: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID arm 2: Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
Interventions: intervention 1: TC-5214 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Tablet, oral, twice daily for 8 weeks

Protocol documents:
Clinical trial NCT01189760
Conditions: Facial Rhytides Crow's Feet Lines Glabellar Lines
Sponsor: Allergan
Start date: 2010-09-01; Completion date: 2011-09-01
Enrollment: 917 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

Detailed description:

Arms: arm 1: 44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. arm 2: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart. arm 3: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
Interventions: intervention 1: onabotulinumtoxinA 24 U intervention 2: onabotulinumtoxinA 44 U intervention 3: normal saline
Intervention descriptions: intervention 1: 24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart. intervention 2: 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart intervention 3: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.

Protocol documents:
Clinical trial NCT01190475
Conditions: Endometriosis
Keywords: Endometriosis Infertility Pain Vaginal Diseases Uterine Diseases
Sponsor: Mereo BioPharma
Start date: 2010-07-01; Completion date: 2011-09-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Detailed description:

Arms: arm 1: 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. arm 2: 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules arm 3: 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
Interventions: intervention 1: Active treatment with a high dose of BGS649 intervention 2: Active treatment with a low dose of BGS649 intervention 3: Placebo treatment to blind study
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01199133
Conditions: Allergic Rhinitis Due to Dust Mite
Sponsor: Stallergenes Greer
Start date: 2009-10-01; Completion date: 2011-09-01
Enrollment: 471 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Detailed description:
After the screening period, the patients will be administered 300 IR house dust mite allergen based tablets or placebo, once a day, for a period of 36 months with two windows of 8 months and 6 months without treatment. The carry over effect will be evaluated after a treatment free follow up period of 24 months.

An independent Data Monitoring Committee will be constituted to evaluate the efficacy and safety data at the end of Year 1 and Year 3, and the post-treatment long-term efficacy data at the end of year 4.

Arms: arm 1: 300 IR house dust mites allergen extract tablet arm 2: Placebo tablet
Interventions: intervention 1: 300 IR house dust mites allergen extract tablet intervention 2: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily for one year. intervention 2: One sublingual tablet daily for one year.

Protocol documents:
Clinical trial NCT01201772
Conditions: Coronary Artery Disease
Keywords: coronary artery disease percutaneous coronary revascularization prasugrel therapy
Sponsor: University of Florida
Start date: 2010-08-01; Completion date: 2011-09-01
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A higher degree of platelet inhibition remains the goal of peri-interventional and long-term anti-thrombotic therapy in patients with coronary artery disease. In clinical practice, patients undergoing percutaneous coronary intervention with stent implantation who are already on clopidogrel therapy get re-loaded with clopidogrel. This is based on prior observations showing that higher inhibition of platelet aggregation may be achieved by giving a loading dose of clopidogrel in patients with coronary artery disease while on chronic clopidogrel therapy. However, to date it is unknown if greater inhibition of platelet aggregation can be achieved by adding a prasugrel loading dose in patients on chronic prasugrel therapy. Therefore, understanding the pharmacodynamic implications of a prasugrel re-load strategy in patients on already on chronic prasugrel therapy will be useful.

Detailed description:

Arms: arm 1: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel arm 2: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel arm 3: Patients will be randomized to: 10mg, 30mg, or 60mg dose of prasugrel
Interventions: intervention 1: Prasugrel
Intervention descriptions: intervention 1: Prasugrel 10mg, 30mg, or 60mg

Protocol documents:
Clinical trial NCT01207596
Conditions: Neuropathic Pain
Keywords: Pain Neuropathy Neuropathic Pain Hydromorphone
Sponsor: International Clinical Research Institute
Start date: 2010-09-01; Completion date: 2011-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.

Detailed description:
Neuropathic pain state is usually refractory to most analgesic regimens and requires polypharmacy for symptomatic relief. Current treatment options for neuropathic pain include both oral and topical medications. Most commonly prescribed oral treatments include antidepressants (eg, amitriptyline, desipramine, and duloxetine), antiepileptics (eg, gabapentin, pregabalin), and opiates such as tramadol and morphine. Current topical treatments include the lidocaine patch and the capsaicin patch. Many patients have inadequate pain relief in spite of these treatment options.

Currently, there are no treatments available for treatment of neuropathy itself other than treating the underlying cause and addressing the symptomatic relief for pain. Current drug therapies for neuropathic pain provide inadequate pain relief and undesirable side effects including sedation and cognitive dysfunction. It is not uncommon to use a combination of agents for the treatment of neuropathic pain to minimize the side effects. Although treating the mild to moderate pain may be relatively easy, it is very challenging for severe neuropathic pain. Although the use of opiates for neuropathic pain is well accepted, it remains controversial because of the potential for abuse and diversion.

Arms: arm 1: None
Interventions: intervention 1: Hydromorphone
Intervention descriptions: intervention 1: Oral hydromorphone extended release, once daily

Protocol documents:
Clinical trial NCT01213173
Conditions: Angina Pectoris
Keywords: angina pectoris chest pain heart rate
Sponsor: AstraZeneca
Start date: 2010-10-01; Completion date: 2011-09-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Succinate Metoprolol (Betaloc ZOK®) intervention 2: Succinate Metoprolol (Betaloc ZOK®)
Intervention descriptions: intervention 1: treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks intervention 2: Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure\<100mmHg and heart rate \<45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks

Protocol documents:
Clinical trial NCT01229462
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2010-10-01; Completion date: 2011-09-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.

Detailed description:

Arms: arm 1: One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. arm 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
Interventions: intervention 1: brimonidine tartrate/timolol fixed combination ophthalmic solution intervention 2: brimonidine tartrate ophthalmic solution intervention 3: timolol ophthalmic solution intervention 4: fixed combination vehicle
Intervention descriptions: intervention 1: One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 2: One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 3: One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. intervention 4: Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.

Protocol documents:
Clinical trial NCT01235351
Conditions: Myocardial Infarction Percutaneous Coronary Intervention
Keywords: Myocardial infarction Percutaneous coronary intervention Clopidogrel Genetics Platelet Function
Sponsor: The TIMI Study Group
Start date: 2010-10-01; Completion date: 2011-09-01
Enrollment: 335 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

Detailed description:
Clopidogrel blocks the P2Y12 ADP receptor on platelets and has been shown to reduce cardiovascular events in acute coronary syndrome (ACS) patients.However, inter-patient variability in the pharmacodynamic response to clopidogrel is well recognized, and patients with lesser degrees of platelet inhibition in response to clopidogrel have been shown to be at increased risk of cardiovascular events.

One potential source of this variability is the metabolism of clopidogrel, which is a pro-drug requiring biotransformation to become an active antiplatelet compound. Cytochrome P-450 (CYP) enzymes play a role in the metabolism, and carriers of reduced-function genetic variants in CYP2C19 (\~30% of the population) have lower active clopidogrel metabolite levels, diminished platelet inhibition, and higher rates of adverse cardiovascular events as compared with non-carriers in the setting of treatment with standard maintenance doses of clopidogrel.

Aim: To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.

Hypotheses: The primary hypothesis is that subjects who carry a reduced-function CYP2C19 allele will have improvement in platelet inhibition with higher maintenance doses of clopidogrel.The secondary hypothesis is that higher maintenance doses of clopidogrel in carriers of a reduced-function CYP2C19 allele will result in similar platelet inhibition as compared to a standard maintenance dose of clopidogrel in non-carriers.

Arms: arm 1: Clopidogrel for CYP2C19\*2 gene carriers arm 2: Clopidogrel for CYP2C19\*2 gene NON-carriers
Interventions: intervention 1: Clopidogrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype intervention 2: Clopidogrel 75 mg daily, 150 mg daily

Protocol documents: