ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01260142
Conditions: Anesthesia
Sponsor: Eisai Inc.
Start date: 2010-11-01; Completion date: 2011-03-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Fospropofol disodium, propofol intervention 2: Fospropofol disodium, propofol intervention 3: Fospropofol disodium, propofol
Intervention descriptions: intervention 1: Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus. intervention 2: Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus. intervention 3: Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.

Protocol documents:
Clinical trial NCT01263093
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2011-03-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure how much of the study drugs (clopidogrel and LY2216684) reach the blood stream and how long it takes the body to dispose of them and to determine how clopidogrel and LY2216684 might affect each other in the body. Information about any side effects that may occur will also be collected.

Detailed description:
Clopidogrel is rapidly converted to R-130964 by the enzyme cytochrome P450 2C19 (CYP2C19). Enrollment in the study was limited to participants with specific genotypes of the CYP2C19 gene, including the \*1/\*1 genotype (CYP2C19 extensive metabolizers) and the \*1/\*17 or \*17/\*17 genotypes (CYP2C19 ultra-rapid metabolizers). All primary and secondary objectives were limited to participants with the CYP2C19\*1/\*1 genotype.

Arms: arm 1: Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1).

Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).

There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2. arm 2: Period 1: an 18-milligram (mg) dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2).

Period 2: a single 300-mg dose of clopidogrel administered orally on Day 1 (Treatment 1).

There was a washout period of at least 14 days between the last dose of study drug in Period 1 and the first dose in Period 2.
Interventions: intervention 1: Clopidogrel intervention 2: LY2216684
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01263314
Conditions: Hypertension
Keywords: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-11-01; Completion date: 2011-03-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled study. The hypothesis for this study is that single oral doses of MK-8266 selected for this study are sufficiently safe and well tolerated by elderly male and elderly female participants with hypertension to permit continued clinical investigation.

Detailed description:
Two panels, each consisting of eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8 elderly females with mild to moderate hypertension in Panel B) will be randomized to receive either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of MK-8266 or matching placebo in three treatment periods (Periods 1 through 3). In both Panel A and Panel B, doses will escalate in a rising, fixed sequence. In Period 1 (0.3 mg), Period 2 (0.6 mg), and Period 3 (0.7 mg and then 0.3 mg 10 hours later) once daily doses of MK-8266 or matching placebo will be administered.

All participants will receive at least 2 doses of MK-8266. Participants completing placebo treatment in Period 1 will flow to the MK-8266 arm in the next period, with 2 participants from the MK-8266 arm receiving placebo in the next period.

Blood samples will be obtained pre-dose and at selected time points up to 48 hours post-dose for determination of MK-8266 plasma concentrations.

Arms: arm 1: MK-8266 single dose 0.3 mg arm 2: MK-8266 single dose 0.6 mg arm 3: MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours arm 4: Placebo to MK-8266 single dose arm 5: MK-8266 single dose 0.3 mg arm 6: MK-8266 single dose 0.6 mg arm 7: MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours arm 8: Placebo to MK-8266 single dose
Interventions: intervention 1: MK-8266 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsules, 0.1 mg potency intervention 2: Oral placebo capsules to match MK-8266 capsules

Protocol documents:
Clinical trial NCT01282138
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Sponsor: Alcon Research
Start date: 2010-12-01; Completion date: 2011-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Detailed description:
Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Arms: arm 1: One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. arm 2: One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Interventions: intervention 1: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) intervention 2: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Intervention descriptions: intervention 1: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test. intervention 2: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.

Protocol documents:
Clinical trial NCT01286454
Conditions: Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
Keywords: BIOAVAILABILITY FOOD EFFECT
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.

Detailed description:
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.

Arms: arm 1: 4 mg fesoterodine IR beads in capsule under fasting condition arm 2: 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition arm 3: 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. arm 4: 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. arm 5: 4 mg fesoterodine ER tablets under fasting condition. arm 6: 4 mg fesoterodine TBD % coated ER beads in capsule under fed condition.
Interventions: intervention 1: fesoterodine intervention 2: fesoterodine intervention 3: fesoterodine intervention 4: fesoterodine intervention 5: fesoterodine intervention 6: fesoterodine
Intervention descriptions: intervention 1: single dose of beads in capsule intervention 2: single dose of beads in capsule intervention 3: single dose of beads in capsule intervention 4: single dose of beads in capsule intervention 5: single dose of tablet intervention 6: single dose of beads in capsule

Protocol documents:
Clinical trial NCT01293396
Conditions: Type 2 Diabetes
Keywords: insulin aspart 30 insulin aspart 70 insulin aspart postprandial glucose and lipid metabolism consecutive mixed meals
Sponsor: Medical University of Graz
Start date: 2010-06-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of the study is to investigate meal-related treatment with either premixed Insulin Aspart 30, Aspart 70 and Aspart with regard to postprandial glucose, triglyceride and free fatty acids excursions after a standard breakfast and lunch.

Detailed description:
Whereas the effects of each of the established types of insulin (remixed Insulin Aspart 30, Aspart 70 and Aspart) have been shown before, their specific glucose and lipid lowering capacities have so far not been investigated in a simulated physiological situation.

Arms: arm 1: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch arm 2: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch arm 3: 35% of their usual total daily insulin dose before the standardized breakfast and 25% prior to lunch
Interventions: intervention 1: Insulin Aspart intervention 2: Insulin Aspart 30 intervention 3: Insulin Aspart 70
Intervention descriptions: intervention 1: Patients received insulin aspart before breakfast and before lunch. intervention 2: Patients received biphasic insulin aspart 30 before breakfast and before lunch. intervention 3: Patients received biphasic insulin aspart 70 before breakfast and before lunch.

Protocol documents:
Clinical trial NCT01299285
Conditions: Healthy Volunteers
Keywords: Absorption Distribution Metabolism Excretion Mass balance Metabolic profile Radiolabeled study 14C
Sponsor: Eli Lilly and Company
Start date: 2011-02-01; Completion date: 2011-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single dose study of radiolabeled \[14C\]-LY3009104 in healthy male volunteers to study the absorption, distribution, metabolism, and elimination of LY3009104. This study requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
Interventions: intervention 1: LY3009104
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01523808
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer asparaginase
Sponsor: ERYtech Pharma
Start date: 2009-11-01; Completion date: 2011-03-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines. Interestingly, these studies suggest an additional effect of L-asparaginase associated to gemcitabine.GRASPA is a suspension of red blood cells encapsulating L-asparaginase. The aim of this phase I clinical trial is to evaluate the Maximum Tolerated Dose (MTD) of GRASPA on locally advanced or metastatic pancreatic tumors, after therapy failure of first or second line chemotherapy using gemcitabine.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: GRASPA
Intervention descriptions: intervention 1: Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose

Protocol documents:
Clinical trial NCT01570309
Conditions: Vitamin D Deficiency Coronary Artery Disease Endothelial Dysfunction Inflammation
Keywords: vitamin D, vitamin D deficiency coronary artery disease ergocalciferol endothelial function adhesion molecules inflammation IL-12 interferon-gamma CXCL-10 reactive hyperemia peripheral arterial tonometry endothelial dysfunction cytokines chemokines
Sponsor: Seth I. Sokol, M.D.
Start date: 2008-08-01; Completion date: 2011-03-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.

The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.

Detailed description:
100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.

Arms: arm 1: 50,000 units of ergocalciferol once a week for 12 weeks arm 2: None
Interventions: intervention 1: Ergocalciferol intervention 2: Sugar pill
Intervention descriptions: intervention 1: Oral capsule, 50,000 units, once a week, 12 weeks intervention 2: Oral capsule, once a week, 12 weeks

Protocol documents:
Clinical trial NCT01833741
Conditions: Glaucoma, Primary Open Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2009-12-01; Completion date: 2011-03-01
Enrollment: 1137 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.

Detailed description:

Arms: arm 1: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
Interventions: intervention 1: Bimatoprost 0.01%
Intervention descriptions: intervention 1: Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.

Protocol documents:
Clinical trial NCT02406586
Conditions: Hypertension Diabetes
Sponsor: Emory University
Start date: 2009-07-01; Completion date: 2011-03-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if salsalate, an Nuclear factor-kappaB (NF-κB) mediated inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and oxidative stress, and autonomic dysfunction in obese normotensive subjects.

Detailed description:
During postprandial lipemia, dietary triglycerides transported by intestinal chylomicrons are hydrolyzed by lipoprotein lipase lining the vascular bed, with subsequent release of FFA for transport across the endothelium. Whether the intermittent flux of FFA has the same impact as the i.v. lipid infusion will be examined. Decreased endothelial function has been reported after a single or long-term dietary high fat load in normal subjects; however, others have found no effects on brachial artery vasoreactivity. Our preliminary studies indicate that high oral fat loads (60 g) resulted in higher FFA levels and BP changes, and reduced FMD compared to low fat load (25 g).

Arms: arm 1: Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject has no side effects, the dose will be increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point. arm 2: Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject has no side effects, the dose will be increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point. arm 3: Obese, normotensive, healthy subjects will receive an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose will be increased to two placebo tablets twice daily for the remaining four weeks. The subjects will then receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
Interventions: intervention 1: Salsalate intervention 2: Carvedilol intervention 3: Placebo intervention 4: Intralipid 20%
Intervention descriptions: intervention 1: Salsalate 750 mg intervention 2: Carvedilol 3.125 mg intervention 3: One tablet intervention 4: 24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)

Protocol documents:
Clinical trial NCT00954993
Conditions: Chronic Hepatitis C Infection
Keywords: Hepatitis C Virus (HCV) Vaniprevir MK-7009
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-01-13; Completion date: 2011-03-04
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the hepatic (liver) and plasma pharmacokinetics of Vaniprevir (MK-7009) by evaluation of ribonucleic acid (RNA) of the hepatitis C virus (HCV) in genotype 1, HCV-infected participants.

Detailed description:

Arms: arm 1: For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken twice daily by each participant on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
Interventions: intervention 1: Vaniprevir
Intervention descriptions: intervention 1: Period 1: Vaniprevir 600 mg twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg on Day 4. Period 2: Vaniprevir 300 mg twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg on Day 4. There was at least a 30-day (up to approximately 140-day) washout interval between periods 1 and 2.

Protocol documents:
Clinical trial NCT04943159
Conditions: Acne Vulgaris
Sponsor: Clinuvel Pharmaceuticals Limited
Start date: 2010-08-24; Completion date: 2011-03-08
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Afamelanotide
Intervention descriptions: intervention 1: Group A is administered afamelanotide implant on Days 0, 21 and 42; Group B is administered afamelanotide implant on Days 0 and 28.

Protocol documents:
Clinical trial NCT00667953
Conditions: Melanoma Advanced Melanoma
Keywords: Temzolomide Gleevec Melanoma Advanced melanoma Phase II
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2003-01-01; Completion date: 2011-03-09
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study has been designed to evaluate the side effects of Gleevec when given in combination with Temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.

Detailed description:

Arms: arm 1: Temozolomide plus imatinib
Interventions: intervention 1: Gleevec intervention 2: Temodar
Intervention descriptions: intervention 1: Gleevec (600 mg) daily. intervention 2: Temzolomide (1000 mg/m2) over 5 days on a 28 day cycle.

Protocol documents:
Clinical trial NCT00509236
Conditions: Diabetes Mellitus, Type 2 End-Stage Kidney Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-10-19; Completion date: 2011-03-14
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in participants with type-2 diabetes mellitus (T2DM) and end-stage renal disease on dialysis who do not have adequate glycemic control.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sitagliptin intervention 2: Glipizide
Intervention descriptions: intervention 1: 25 mg (one 25-mg tablet) once daily intervention 2: 2.5 mg (1/2 of a 5-mg tablet) once daily, up to 10 mg twice daily (four 5-mg tablets), for a maximum of 20 mg

Protocol documents: