ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01361620
Conditions: Platelet Dysfunction Due to Aspirin
Keywords: genomic markers aspirin resistance
Sponsor: George Washington University
Start date: 2007-12-01; Completion date: 2011-04-01
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study seeks to identify genomic markers associated with aspirin resistance.

Detailed description:
Not desired

Arms: arm 1: All subjects took 7-10 days of 81 mg aspirin
Interventions: intervention 1: aspirin
Intervention descriptions: intervention 1: aspirin 81mg, 7-10 days

Protocol documents:
Clinical trial NCT01364558
Conditions: Epilepsy
Sponsor: University of Minnesota
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration

Detailed description:
Diazepam is a medication that is used for the treatment of seizures. It was approved by the Food and Drug Administration (FDA) for use in the United States and is currently sold as Valium® tablets, Diazepam Injection and Diastat® rectal gel.

This study will evaluate two intranasal (nasal spray) formulations of diazepam which will be supplied by Neurelis, Inc. The purpose of this clinical research study is to assess the bioavailability and pharmacokinetics of two formulations of diazepam after intranasal (nasal spray) and injectable diazepam after intravenous (I.V.) administration. "Bioavailability" is a measure of how much drug is absorbed and present in the blood. "Pharmacokinetics" means to study the way a drug enters and leaves the blood and tissues over time

Arms: arm 1: Diazepam Nasal Suspension - 10 mg arm 2: Diazepam Nasal Spray Solution - 10 mg arm 3: Diazepam injection IV - 5 mg
Interventions: intervention 1: Diazepam intervention 2: Diazepam
Intervention descriptions: intervention 1: Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose. intervention 2: IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.

Protocol documents:
Clinical trial NCT01391013
Conditions: Human Immunodeficiency Virus 1
Keywords: Human immunodeficiency virus 1 Acquired immunodeficiency syndrome Immunologic deficiency syndrome Darunavir/ritonavir Darunavir Ritonavir Nucleoside reverse transcriptase inhibitors (NRTIs) Prezista
Sponsor: Janssen-Cilag S.p.A.
Start date: 2009-06-01; Completion date: 2011-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare change of brachial artery flow mediated vasodilatation using Darunavir/Ritonavir (DRV/r) 800/100 mg once daily as a monotherapy (use of a single medication) versus a triple combination therapy containing 2 nucleoside reverse transcriptase inhibitors (NRTIs) and DRV/r in Human immunodeficiency virus-1 (HIV-1) infected participants.

Detailed description:
This is a Phase II, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), controlled, single centre study. The study consists of 3 phases including, the screening phase (4 weeks before administration of study medication), treatment phase (48 weeks), and the follow-up phase (4 weeks). In the treatment phase, HIV-infected participants who have not changed their first-line treatment of highly active antiretroviral therapy (HAART) for at least 8 weeks and have documented evidence of their HIV- ribonucleic acid (RNA) measurements being virologically suppressed (HIV-RNA less than 50 copies/mL) for at least 24 weeks prior to the screening, will be randomly assigned equally in two treatment arms: triple combination therapy arm (DRV/r 800/100 mg once daily plus 2 NRTIs) or monotherapy arm (DRV/r 800/100 mg once daily). Participants in the triple combination arm who are already on 2 NRTIs prior to randomization may remain on these or switch them at baseline, where the participants on the monotherapy arm will discontinue HAART at baseline and will start DRV/r 800/100 mg once daily. Safety evaluations will include assessment of adverse events, significant vital signs, and significant laboratory tests. The total duration of the study will be 56 weeks.

Arms: arm 1: Monotherapy: darunavir/ritonavir (DRV/r) will be administered for 48 weeks. arm 2: DRV/r along with 2 nucleoside reverse transcriptase inhibitors (NRTIs) will be administered for 48 weeks and whenever possible, participants should take these medications at the same time. Switch of NRTIs will be allowed in the event of suspected toxicity/intolerance, providing this change can be linked to a documented adverse event (AE)/serious AE.
Interventions: intervention 1: Darunavir(DRV) intervention 2: Ritonavir intervention 3: 2 nucleoside reverse transcriptase inhibitors (NRTIs)
Intervention descriptions: intervention 1: Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks intervention 2: Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks intervention 3: 2 NRTIs will be administered as per the package inserts.

Protocol documents:
Clinical trial NCT01422135
Conditions: Healthy
Keywords: PK and safety Pharmacokinetic profile (PK) and safety
Sponsor: Agile Therapeutics
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a pharmacokinetics and safety study over 3 weekly applications.

Detailed description:
Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15 following application at three different anatomical sites (abdomen, buttock and upper torso).

Arms: arm 1: Patch was placed on abdomen, buttock then the upper torso excluding breast.

Intervention: AG200-15 patch arm 2: Patch was placed on abdomen, upper torso excluding breast then the buttock.

Intervention: AG200-15 patch arm 3: Patch was placed on the buttock, abdomen, then the upper torso excluding breast.

Intervention: AG200-15 patch arm 4: Patch was placed on the buttock, upper torso excluding breast then the abdomen

Intervention: AG200-15 patch arm 5: Patch was placed on the upper torso excluding breast, abdomen then buttock.

Intervention: AG200-15 patch arm 6: Patch was place on the upper torso excluding breast, buttock, then abdomen.

Intervention: AG200-15 patch
Interventions: intervention 1: AG200-15
Intervention descriptions: intervention 1: A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.

Protocol documents:
Clinical trial NCT01450683
Conditions: Prostate Cancer Prostatic Neoplasms Castrate-resistant Prostate Cancer (CRPC) Androgen-insensitive Prostate Cancer Hormone-refractory Prostate Cancer Metastatic Disease
Sponsor: Stanford University
Start date: 2010-09-01; Completion date: 2011-04-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates if itraconazole causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).

Detailed description:
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need, largely expressed as the lack of durable response. New therapies that extend survival of patients beyond that provided by chemotherapy are needed.

It is hypothesized that the triazole antifungal drug itraconazole, through its activity as a potent inhibitor of the Hedgehog (Hh) signaling pathway via the Smoothened (Smo) pathway, may provide clinical benefit in the treatment of prostate cancer. The Hh signaling pathway is a critical embryonic developmental pathway whose aberrant activity has been implicated in the growth and metastases of a variety of tumor types including prostate cancer. Itraconazole is structurally related to ketoconazole, demonstrated to reduce serum PSA by more than 50% in about 20 to 25% of treated prostate cancer subjects.

This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer.

Arms: arm 1: 600 mg/day oral (PO)
Interventions: intervention 1: Itraconazole
Intervention descriptions: intervention 1: 600 mg/day oral (PO)

IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-\[4-(4-{\[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl\]methoxy}phenyl)piperazin-1-yl\]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Protocol documents:
Clinical trial NCT01453296
Conditions: Asthma
Keywords: Asthma Tolerability Safety Pharmacokinetics GW642444
Sponsor: GlaxoSmithKline
Start date: 2010-08-01; Completion date: 2011-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will investigate the effect of dosing paedeatric asthmatic subjects with GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor.

Detailed description:
This study will investigate the effect of dosing with 25 μg GW642444, an orally inhaled long-acting agonist of the β2-adrenoceptor, in asthmatic subjects aged 5 to 11. GW642444 is currently under development as the long-acting beta-agonist component of a combination product containing an inhaled corticosteroid and a longacting beta-agonist.

Subjects will receive a single dose via a novel dry powder inhaler, then 7 days once-daily repeat dosing following a washout period. The study will be a randomized two-way crossover, with a placebo control. Approximately 26 subjects will be recruited to this study, with the aim that 20 will complete the study. Safety, tolerability, pharmacokinetics and glucose and potassium levels will be investigated.

Arms: arm 1: 8-11 years old; Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence.

Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home).

Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods. arm 2: 5-7 years old. Subjects will be assigned to receive GW642444 25μg or matching placebo (in a 1:1 ratio) in an AB or BA (A= GW64244, B= Placebo) sequence.

Following randomisation (AB or BA) subjects will receive a single dose treatment, followed by 7 day washout period. This will then be followed by a repeat dose session of the same treatment (Day 8 and Day 14 in house, Days 9-13 at home).

Each subject will then complete the same sequence for the alternative treatment in the second session. There will be a washout period of at least 7 days between the treatment periods.
Interventions: intervention 1: GW642444 intervention 2: Placebo
Intervention descriptions: intervention 1: GW642444 25 μg; Novel dry powder inhaler intervention 2: Matching placebo; Novel dry powder inhaler

Protocol documents:
Clinical trial NCT01466348
Conditions: Common Cold
Keywords: Paracetomol Caffeine Common cold
Sponsor: GlaxoSmithKline
Start date: 2011-02-01; Completion date: 2011-04-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A reduction in alertness and lower levels of performance are commonly associated with the common cold. Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds. This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Detailed description:

Arms: arm 1: Paracetamol and caffeine arm 2: Paracetamol
Interventions: intervention 1: Paracetamol and Caffeine intervention 2: Paracetamol
Intervention descriptions: intervention 1: Paracetamol 1000 mg and caffeine 130 mg intervention 2: Paracetamol 1000 mg

Protocol documents:
Clinical trial NCT02135900
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Heliox Obstructive Sleep Apnea
Sponsor: Northwell Health
Start date: 2009-12-01; Completion date: 2011-04-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goals of the project is to evaluate the effects of Heliox therapy on obstructive sleep apnea syndrome (OSAS).

Detailed description:
Obstructive sleep apnea syndrome (OSAS) is a common condition affecting up to 2-4 % of the general population. The pathophysiologic consequences of OSA include: excessive daytime sleepiness leading to increased car and work related accidents; and increased incidence of hypertension (HTN), stroke and possibly coronary artery events. In addition, patients with severe and untreated obstructive sleep apnea (OSA) have increased mortality compared to patients with treated severe OSA.The main stay of treatment of OSAS is the application of continuous positive airway pressure (CPAP) during sleep. The main problem with CPAP therapy is compliance. Heliox, a mixture of oxygen and helium has been used for many years in the treatment of upper airway obstruction. In this study, the investigators will evaluate the effectiveness of Heliox in the treatment of OSAS. Adult subjects with the diagnosis of obstructive sleep apnea syndrome who are referred for repeat sleep study for CPAP titration will be evaluated.

Arms: arm 1: Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.
Interventions: intervention 1: Heliox
Intervention descriptions: intervention 1: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.

Protocol documents:
Clinical trial NCT01134562
Conditions: Hyperparathyroidism, Secondary
Keywords: Clinical Trial, Phase 1 Renal Dialysis Secondary Hyperparathyroidism Parathyroid hormone
Sponsor: KAI Pharmaceuticals
Start date: 2010-09-07; Completion date: 2011-04-02
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to characterize the safety and tolerability of single rising doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.

Detailed description:

Arms: arm 1: Participants received a single dose of placebo intravenous (IV) injection after hemodialysis. arm 2: Participants received a single dose of etelcalcetide by intravenous (IV) injection after hemodialysis.
Interventions: intervention 1: Placebo intervention 2: Etelcalcetide
Intervention descriptions: intervention 1: Single IV injection. intervention 2: Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.

Protocol documents:
Clinical trial NCT01059448
Conditions: Rheumatoid Arthritis
Keywords: Amgen RA AMG 827 20090061
Sponsor: Amgen
Start date: 2010-06-03; Completion date: 2011-04-05
Enrollment: 211 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989). All subjects in this study will receive a 210mg injection of AMG827 for treatment for their Rheumatoid Arthritis for up to 5 years.

Detailed description:

Arms: arm 1: Participants who were administered matching placebo in parent study 20090061 and were administered 210 mg subcutaneous (SC) AMG 827 at Day 1, Week 1, Week 2, and every other week thereafter (Q2WK). Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. arm 2: Participants who were administered 70 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2 and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. arm 3: Participants who were administered 140 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate. arm 4: Participants who were administered 210 mg AMG 827 in parent study 20090061 and were administered 210 mg SC AMG 827 at Day 1, Week 1, Week 2, and Q2WK thereafter. Participants also continued to receive weekly intramuscular, oral or SC doses of methotrexate and folic acid or folate.
Interventions: intervention 1: AMG 827
Intervention descriptions: intervention 1: AMG 827 210 mg

Protocol documents:
Clinical trial NCT00115076
Conditions: Psoriasis
Keywords: skin psoriasis
Sponsor: Rockefeller University
Start date: 2003-08-04; Completion date: 2011-04-06
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Efalizumab, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris.

Detailed description:
The eligible patient will receive the drug Efalizumab, weekly for 12 weeks, by injection. The patient will be seen weekly for 12 weeks and every other week for the 12 weeks of follow up. At those visits, the patient can expect that a physical and skin exam will be done. At specific weeks, blood work will be drawn, clinical photography taken and a skin biopsy done. Two types of skin biopsies will be done after local anesthesia has been administered. One is a punch biopsy where a small piece of skin will be taken, the approximate size of a pencil eraser. The second type of skin biopsy is shave biopsy, where a postage sized piece of skin will be taken.

Arms: arm 1: moderate to severe plaque psoriasis
Interventions: intervention 1: Efalizumab
Intervention descriptions: intervention 1: 24 weekly doses of 1.0 mg/kg Efalizumab. Study drug will be administered by SC injection

Protocol documents:
Clinical trial NCT00151281
Conditions: Non-Hodgkin's Lymphoma
Keywords: relapsed mantle cell lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2004-11-01; Completion date: 2011-04-07
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

Evaluate the clinical activity of the RT-PEPC combination regimen (rituximab, thalidomide, and prednisone, etoposide, procarbazine, cyclophosphamide) in patients with relapsed mantle cell lymphoma. Specifically, response rate (RR) and time to disease progression (TTP) will be assessed.

Secondary Objectives:

1. Assess the toxicity profiles of RT-PEPC treatment in patients with relapsed mantle cell lymphoma.
2. Prospectively characterize the angiogenic profile of patients with mantle cell lymphoma during treatment with RT-PEPC. The dynamics of the angiogenic profile will be correlated with clinical response to RT-PEPC therapy.
3. Assess the quality of life of patients receiving RT-PEPC treatment

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PEPC intervention 2: Thalidomide intervention 3: Rituximab
Intervention descriptions: intervention 1: Induction phase (month 1-3)

• PEPC daily (prednisone 20 mg/day, cyclophosphamide 50 mg/day, etoposide 50 mg/day, and procarbazine 50 mg/day) until expected drop in neutrophil count (ANC \< 3000), unless due to disease. After ANC returns to above 2,000/ul, PEPC resumes at alternate day or fractionated weekly basis.

Maintenance phase (month 4-12) • PEPC QOD or fractionated weekly basis.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• PEPC QOD or fractionated weekly basis intervention 2: Induction phase (month 1-3)

• Daily thalidomide at 50 mg/day for the first 8 weeks, then dose escalated as tolerated to a maximum of 100 mg/day.

Maintenance phase (month 4-12) • Daily low dose thalidomide (50-100 mg/d)

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Daily low dose thalidomide (50-100mg/d) intervention 3: Induction phase (month 1-3)

• Rituximab weekly x 4 (375 mg/m2/week) starting at week 1.

Maintenance phase (month 4-12) • Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months.

Post-Month 12 Maintenance phase (post-month 12 until disease progression)

• Rituximab (375 mg/m2/week) weekly x 4 administered every 4 months

Protocol documents:
Clinical trial NCT00658619
Conditions: Macular Degeneration
Sponsor: Allergan
Start date: 2008-05-01; Completion date: 2011-04-08
Enrollment: 119 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Detailed description:

Arms: arm 1: Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 2: Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 3: Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 4: Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6. arm 5: Stage 2: sham in both eyes on Day 1 and Month 6.
Interventions: intervention 1: 400 µg Brimonidine Tartrate Implant intervention 2: 200 µg Brimonidine Tartrate Implant intervention 3: Sham (no implant)
Intervention descriptions: intervention 1: 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. intervention 2: 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. intervention 3: Sham in one or both eyes on Day 1 and Month 6.

Protocol documents: