ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00676364
Conditions: Pain Anxiety
Keywords: pediatric patients pain anxiety topical anesthetic randomized control trial
Sponsor: Jenny Boucher, PharmD
Start date: 2003-03-01; Completion date: 2008-02-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.

Detailed description:
Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to the EMLA, making it a more desirable medication when urgent labs are required. This medication is being evaluated to assess the anxiety and pain associated with venipuncture in 15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or outpatient in the local Emergency Department, compared to standard care (no prior treatment).

Arms: arm 1: This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick. arm 2: This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.
Interventions: intervention 1: 4% lidocaine topical anesthetic cream intervention 2: Placebo cream
Intervention descriptions: intervention 1: A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture intervention 2: A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

Protocol documents:
Clinical trial NCT00695578
Conditions: Actinic Keratosis
Sponsor: Wake Forest University
Start date: 2006-10-01; Completion date: 2008-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.

Detailed description:
Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.

Arms: arm 1: Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit. arm 2: Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.
Interventions: intervention 1: Biafine intervention 2: Polysporin
Intervention descriptions: intervention 1: Apply to wounds 3 times daily for 4 weeks: ingredients: purified water, liquid paraffin, glycol monostearate, stearic acid, propylene glycol, paraffin wax, squalene, avocado oil, trolamine sodium alginate, cetyl palmitate, methylparaben, sorbic acid, propyl paraben and fragrance. intervention 2: over the counter Polysporin ointment 3 times daily for 4 weeks to wounds

Protocol documents:
Clinical trial NCT00705536
Conditions: Diabetes Mellitus
Keywords: rHuPH20 Hyaluronidase Insulin
Sponsor: Halozyme Therapeutics
Start date: 2007-12-01; Completion date: 2008-02-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of Humalog (insulin lispro) or Humulin-R (recombinant human insulin) when administered as a single subcutaneous (SC) injection of 20 units (U) with or without coadministration of recombinant human hyaluronidase PH20 (rHuPH20).

The study hypothesizes that the time required to reach maximum insulin concentration (tmax) when insulin is administered with rHuPH20 will be comparable or shorter than the time required without rHuPH20.

Detailed description:

Arms: arm 1: Humalog first, then Humalog + recombinant human hyaluronidase PH20 (rHuPH20)

A single subcutaneous (SC) injection of 20 units (U) Humalog on Day 1 of the study, followed by a single SC injection of 20 U Humalog + 300 U rHuPH20 after a washout period of at least 6 days arm 2: Humalog + recombinant human hyaluronidase PH20 (rHuPH20) first, then Humalog

A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20 on Day 1 of the study, followed by a single SC injection of 20 U Humalog after a washout period of at least 6 days arm 3: Humulin-R (recombinant human insulin) first, then Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20)

A single subcutaneous (SC) injection of 20 units (U) Humulin-R on Day 1 of the study, followed by a single SC injection of 20 U Humulin-R + 240 U rHuPH20 after a washout period of at least 6 days arm 4: Humulin-R (recombinant human insulin) + recombinant human hyaluronidase PH20 (rHuPH20) first, then Humulin-R

A single subcutaneous (SC) injection of 20 units (U) Humulin-R + 240 U rHuPH20 on Day 1 of the study, followed by a single SC injection of 20 U Humulin-R after a washout period of at least 6 days
Interventions: intervention 1: Humalog intervention 2: Humulin-R intervention 3: Recombinant human hyaluronidase PH20 (rHuPH20)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00714714
Conditions: Acne Vulgaris
Keywords: acne irritation objective sensory methods
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-01-01; Completion date: 2008-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.

Detailed description:
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products on their faces, each on half face. The side of face receiving each product is randomly assigned. One group will use tretinoin facial gel on the left side and adapalene facial gel on the right side of the face daily for two consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for two consecutive weeks after washing with the same study-supplied facial wash.

Subjects will return to the study center every weekday morning for evaluation and for the morning application of both study products. Study personnel will monitor application on the weekdays. There will be a daily clinical evaluation of skin irritation by a blinded dermatologist and by subjects. At baseline and at the end of each week subjects will be photographed and have chromometer readings.

Arms: arm 1: Adapalene facial gel and tretinoin facial gel applied daily for two weeks on opposite sides of the face (in a split-face model)
Interventions: intervention 1: Adapalene Gel intervention 2: Tretinoin Gel
Intervention descriptions: intervention 1: adapalene gel 0.3% topically applied daily in a split-face model for two weeks intervention 2: Tretinoin 0.1% topically applied daily in a split face model for two weeks

Protocol documents:
Clinical trial NCT00739050
Conditions: Systemic Lupus Erythematosus
Sponsor: Organon and Co
Start date: 2007-09-19; Completion date: 2008-02-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.

Detailed description:

Arms: arm 1: Arm 1: Drug arm 2: Arm 2: Placebo
Interventions: intervention 1: simvastatin intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: simvastatin 20mg daily at nights for 12 weeks. Tablets intervention 2: placebo daily at nights for 12 weeks. Tablets

Protocol documents:
Clinical trial NCT00743444
Conditions: Reflux Episodes
Keywords: GERD transient lower esophageal sphincter relaxations (TLESRs) reflux
Sponsor: AstraZeneca
Start date: 2007-02-01; Completion date: 2008-02-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.

Detailed description:

Arms: arm 1: AZD3355 arm 2: None
Interventions: intervention 1: AZD3355 intervention 2: Placebo
Intervention descriptions: intervention 1: 65 mg capsules, oral, 3 single doses intervention 2: capsules, oral, 3 single doses

Protocol documents:
Clinical trial NCT00760084
Conditions: Acute Myelogenous Leukemia Myelodysplastic Syndrome
Keywords: Acute Myelogenous Leukemia Myelodysplastic Syndrome Dacogen Decitabine
Sponsor: Eisai Inc.
Start date: 2005-07-01; Completion date: 2008-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.

Detailed description:
The objectives of this trial are:

* To generate additional information about the overall safety profile,
* To generate safety information of hepatically or renally impaired patients, as appropriate, and
* To generate safety information when patients are also taking concomitant medications and/or therapies without trial restrictions when decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with MDS or AML (≥ 30% blasts).

The purpose of this open-label, expanded-access trial is to provide decitabine to patients with AML or MDS who have completed participation per protocol in the DACO-018 study and for whom continuation of treatment with decitabine is indicated, per the opinion of the investigator. In order to continue treatment with decitabine, at a minimum, there must be no disease progression while the patient was participating in the DACO-018 trial and during the period after the patient discontinued from the DACO-018 study and before entering this trial. Patients must enroll in this trial within 8 weeks of discontinuing from the DACO-018 study and not have received any other chemotherapy for their disease during this interim period.

Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.

Arms: arm 1: Decitabine will be administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks.
Interventions: intervention 1: Decitabine
Intervention descriptions: intervention 1: Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).

Protocol documents:
Clinical trial NCT00816751
Conditions: Abortion, Induced Pain
Keywords: Local anesthesia Paracervical Intracervical Abortion Pain Local anesthesia for elective first trimester abortion
Sponsor: University of California, San Diego
Start date: 2007-12-01; Completion date: 2008-02-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Paracervical block intervention 2: Intracervical intervention 3: Buffered Lidocaine, vasopressin, sodium bicarbonate
Intervention descriptions: intervention 1: The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub. intervention 2: The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub. intervention 3: The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.

Protocol documents:
Clinical trial NCT00828542
Conditions: Breastfeeding Contraception
Keywords: Adverse Effects Etonogestrel Postpartum period Contraception Hemostasis Metabolism
Sponsor: University of Sao Paulo
Start date: 2007-07-01; Completion date: 2008-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study to assess the safety of the etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate puerperium of healthy women.

Detailed description:
Many contraceptive methods are currently available. However, about 50% of all pregnancies in the world are not planned, most of them occurring in developing countries. Long-lasting reversible contraceptives such as the etonogestrel implant represent an option for the reduction of unwanted pregnancies, especially among patients at risk for a short intergestational period. In addition to preventing an undesired pregnancy, these methods have an impact on the reduction of the maternal-fetal morbidity-mortality known to be associated with these short intervals, also minimizing the malnutrition and the cycle of poverty caused by multiparity.

On the basis of inclusion and exclusion criteria, we will selected 40 puerperae aged 18 to 35 years at the Low Risk Prenatal Care Program of the University Hospital of Ribeirão Preto, University of São Paulo (HC-FMRP). The subjects will be randomized to two types of treatment (etonogestrel-releasing implant to be inserted 24 to 48 hours after delivery or 150 mg medroxyprogesterone administered every three months starting 6 weeks after delivery). Blood samples (40 mL) will be collected in a single procedure from these patients and stored for later determination of multiple hemostatic and metabolic variables at 24-48 hours and at 6 and 12 weeks after delivery. Data on maternal and neonatal clinical parameter will be also collected.

Arms: arm 1: Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is compounded by 68mg of etonogestrel, 3years of duration. arm 2: At the 6th week postpartum, this group received intramuscular 150 mg of depot medroxyprogesterone acetate (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil).
Interventions: intervention 1: etonogestrel implant intervention 2: depot medroxyprogesterone acetate
Intervention descriptions: intervention 1: Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum) intervention 2: 150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery

Protocol documents:
Clinical trial NCT00912990
Conditions: Intubation,Endotracheal
Keywords: Pediatric
Sponsor: Rady Children's Hospital, San Diego
Start date: 2007-01-01; Completion date: 2008-02-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators' primary specific aims are to demonstrate that:

1. Pediatric patients with normal airways, undergoing elective surgical procedures, can be successfully intubated when deeply sedated, without the use of muscle relaxants using the Shikani Optical Stylet.
2. Shikani intubation of pediatric patients is equally effective in children that are deeply sedated or paralyzed as evidenced by a non-significant difference in:

   * Time to intubation (defined as no more than a 30 second time difference between the two groups);
   * Incidence of adverse events.

Detailed description:

Arms: arm 1: Normal saline volume calculated to be equal to the volume of cisatracurium 0.2mg/kg arm 2: Subjects in this arm will be given Cisatracurium 0.2mg/kg IV dose one time prior to intubation.
Interventions: intervention 1: Cisatracurium intervention 2: Normal saline
Intervention descriptions: intervention 1: One intravenous dose: 0.2mg/kg/dose intervention 2: One Intravenous dose

Protocol documents:
Clinical trial NCT00961259
Conditions: Healthy
Keywords: healthy pharmacokinetics therapeutic equivalency fenofibric acid
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2008-02-01; Completion date: 2008-02-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Safety and tolerability of these regimens will also be evaluated.

Detailed description:
This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of three fenofibric acid dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of the first day of each dosing period, after an overnight fast of at least 10 hours, subjects will receive single doses of fenofibric acid (1 x 35 mg tablet), fenofibric acid (3 x 35 mg tablets - 105 mg total dose), or fenofibric acid (1 x 105 mg tablet). Fasting will continue for 4 hours after dose administration. Blood samples will be drawn from all participants prior to dosing and for 72 hours post-dose, at times sufficient to adequately define fenofibric acid pharmacokinetics. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours after each dose to coincide with peak plasma concentrations. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.

Arms: arm 1: 1 x 35 mg tablet administered after an overnight fast of at least 10 hours arm 2: 3 x 35 mg tablets administered after an overnight fast of at least 10 hours arm 3: 1 x 105 mg tablet administered after an overnight fast of at least 10 hours
Interventions: intervention 1: Fenofibric Acid 35 mg Tablet intervention 2: Fenofibric Acid 35 mg Tablet intervention 3: Fenofibric Acid 105 mg Tablet
Intervention descriptions: intervention 1: 1 x 35 mg tablet administered after an overnight fast of at least 10 hours intervention 2: 3 x 35 mg tablets administered after an overnight fast of at least 10 hours intervention 3: 105 mg tablet administered after an overnight fast of at least 10 hours

Protocol documents:
Clinical trial NCT00988364
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome LDL subfraction L5 The reduction of LDL in patients with Metabolic Syndrome The prevalence of L5 in patients with Metabolic Syndrome The reduction of L5 in patients with Metabolic Syndrome
Sponsor: Baylor College of Medicine
Start date: 2007-03-01; Completion date: 2008-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* To identify the common factor for L5 prevalence in patients with Metabolic Syndrome.
* To determine whether Ezetimibe, Simvastatin, and Vytorin can correct the L5- promoting factor and reduce L5 in Metabolic Syndrome patients.

Detailed description:
Epidemiological evidence indicates that metabolic syndrome (MS) is a strong predisposing condition for atherosclerosis. Elevation of plasma low-density lipoprotein (LDL) cholesterol(LDL-C) concentration is the most important risk factor for atherosclerosis; however, LDL-C elevation is not a criterion for metabolic syndrome, raising the question of LDL's role in the syndrome's association with atherosclerosis. L5, a highly electronegative and mildly oxidized LDL subfraction that we recently isolated from hypercholesterolemic human plasma, may provide a key to answering this question. In cultured vascular endothelial cells (EC), L5 inhibits proliferation and induces apoptosis and monocyte-EC adhesion. In our preliminary studies, L5 could also be detected in patients with MS without elevated LDL-C. Because other LDL subfractions were harmless to EC, the presence of MS-L5 prompted us to hypothesize that the atherogenic role of LDL is not solely determined by plasma LDL-C concentration, but more importantly, by its composition. The proposed study is designed to test this hypothesis. The first question we will address is what lipid factor determines the prevalence of L5 in MS.

Subsequently, we will examine whether treatment with selected medicines can effectively reduce L5 in MS patients by correcting the factor favorable for L5 formation.

We are in the process of identifying the active components of L5 to fully characterize the atherogenic role of L5 in MS,. In the current proposal, we focus our interest on the efficacy of Ezetimibe, Simvastatin, and Vytorin in reducing L5 from the plasma of MS patients.

Arms: arm 1: Randomly chosen participants will receive ezetimibe 10mg daily for 3 months. arm 2: Randomly chosen participants will receive Simvastatin 20mg daily for 3 months. arm 3: Randomly chosen participants will receive Vytorin 20/10mg daily for 3 months. arm 4: Randomly chosen participants will receive Placebo tab 1 daily for 3 months.
Interventions: intervention 1: Simvastatin intervention 2: Vytorin intervention 3: Placebo intervention 4: Ezetimibe
Intervention descriptions: intervention 1: Simvastatin 20mg daily for 3 months. intervention 2: Vytorin 20/10mg daily for 3 months. intervention 3: Placebo one tablet daily times 3 months. intervention 4: Ezetimibe 10mg daily for 3 months.

Protocol documents: