ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01241786
Conditions: Chronic Lymphocytic Leukemia(CLL) Small Lymphocytic Lymphoma
Keywords: chronic lymphocytic leukemia (CLL) Small Lymphocytic Lymphoma
Sponsor: Hackensack Meridian Health
Start date: 2010-07-01; Completion date: 2011-08-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the response to the combination of Revlimid (Lenalidomide)+ Vidaza (Azacitidine) in patients with relapsed/refractory CLL and SLL

Hypothesis- lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

Detailed description:
Treatment response of lenalidomide's activity in combination with azacitidine may further enhance its activity and the durability of treatment response.

Arms: arm 1: response to combination of azacitidine + lenalidomide A Phase II, Single Arm Study Examining the Combination of Revlimid (Lenalidomide) and Vidaza (Azacitidine) (RA-CLL) for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
Interventions: intervention 1: Revlimid intervention 2: Azacitidine
Intervention descriptions: intervention 1: Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and \< 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21). intervention 2: Azacitidine 75 mg/m2 IV or SC D 1-5

Protocol documents:
Clinical trial NCT01266824
Conditions: Pain Retinopathy of Prematurity
Keywords: Pain Retinopathy of Prematurity Neonates
Sponsor: Children's Hospital of Philadelphia
Start date: 2010-12-01; Completion date: 2011-08-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, we will be evaluating whether premedication with an anesthetic eye drops leads to a decreased sensation of pain when given dilating eye drops prior to eye examinations to evaluate for retinopathy of prematurity in neonatal intensive care unit (NICU) infants.

Detailed description:
A. Randomization of subjects: Infants will be randomized to receive Proparacaine versus no intervention based on computerized randomization performed by our statistician. Due to the lack of a placebo group, practitioners present at the time of examination will not able to be blinded to group assignment. Each infant will only be enrolled for one examination.

B. Monitor setup/application: The Central Nervous System (CNS) Neonatal Neurological Monitor (Moberg Research) will be used to videotape each patient encounter and record vital sign information during the study period. The CNS monitor will record physiologic variables indirectly via cables attached to the bedside monitor. Before scheduled eye drop administration takes place, the appropriate connections between the bedside monitor and CNS monitor will be made in order to continuously record heart rate, respiratory rate, pulse oximetry, and blood pressure. A video camera attached to the CNS monitor will also be positioned to capture the subjects' facial activity and gross body movements. The monitor will be set up with enough time prior to eye drop administration such that baseline data can be collected before any intervention is performed. In addition, a video recording of the method of eyedrop administration will be assessed. The monitor will remain in place up to 5 minutes after completion of eye drop administration.

C. Eye drop administration: The CNS Monitor will be in place at least 3 minutes prior to administration of any eye drops to record baseline data on the infant. One drop of Proparacaine anesthetic ophthalmic solution will be applied to each eye of infants randomized to receive Proparacaine prior to the mydriatic eye drops. At least 30 seconds and no longer than 5 minutes after administration of Proparacaine, the mydriatic eye drops will be given as per routine standard practice for ophthalmologic examinations in the NICU.

Arms: arm 1: Infants in this group will receive 1 drop of Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops arm 2: Infants in this arm will not receive Proparacaine Hydrochloride Ophthalmic Solution (anesthetic eye drop) prior to mydriatic eye drops.
Interventions: intervention 1: Proparacaine Hydrochloride Ophthalmic Solution
Intervention descriptions: intervention 1: 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops

Protocol documents:
Clinical trial NCT01272934
Conditions: Acute Ankle Sprain
Keywords: Ankle Sprain, soft tissue injury
Sponsor: Novartis
Start date: 2011-01-01; Completion date: 2011-08-01
Enrollment: 205 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Detailed description:

Arms: arm 1: None arm 2: Diclofenac sodium topical gel 1%
Interventions: intervention 1: Diclofenac Sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Topical gel 1%-4 times daily intervention 2: Topical gel-4 times daily

Protocol documents:
Clinical trial NCT01288781
Conditions: High Altitude Headache
Keywords: High Altitude Headache; intra-cranial pressure; hypoxia
Sponsor: Bangor University
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether increased pressure in the head is elevated in people who suffer from High Altitude Headache. We hypothesise that head pressure will be elevated in people with High Altitude Headache.

Detailed description:
High Altitude Headache is the primary symptom of Acute Mountain Sickness. However, at present the reason why some individuals suffer from High Altitude Headache and others do not remains unknown. It is widely believed that elevated pressure within the brain leads to stretching of pain sensitive fibres and thus headache. However, evidence of raised intracranial pressure during High Altitude Headache is currently unavailable. Therefore, this study aims to examine a proxy measure of intracranial pressure (Optic Nerve Sheath Diameter) in persons visiting High Altitude, half of whom have been given the drug acetazolamide that is known to reduce headache symptoms.

Arms: arm 1: Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m). arm 2: Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
Interventions: intervention 1: Acetazolamide intervention 2: Lactose monohydrate
Intervention descriptions: intervention 1: During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two. intervention 2: During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.

Protocol documents:
Clinical trial NCT01300260
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-02-01; Completion date: 2011-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake.

Detailed description:

Arms: arm 1: LY2189265 (Dulaglutide) then Placebo: A single 1.5 milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 in Period 1, followed by a single SC injection of Placebo on Day 1 in Period 2.

On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \[g/kg\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hour glucose \>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \[mL/h\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.

There was a washout period of at least 28 days between Periods 1 and 2. arm 2: Placebo then LY2189265 (Dulaglutide): A single subcutaneous injection of Placebo on Day 1 in Period 1, followed by a single 1.5 milligrams (mg) subcutaneous injection of LY2189265 on Day 1 in Period 2.

On Day 3 of each period, participants underwent a 6-hour insulin infusion, followed by an intravenous (IV) dextrose bolus (0.3 gram/kilogram \[g/kg\] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus of 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter \[mmol/L\] or 15 g of 50% dextrose for participants with 3-hour glucose \>10 mmol/L), followed by a 20% dextrose at the set infusion rate of 600 milliliter/hour \[mL/h\] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.

There was a washout period of at least 28 days between Periods 1 and 2.
Interventions: intervention 1: LY2189265 intervention 2: Placebo intervention 3: Insulin intervention 4: Glucose intervention 5: Glucagon
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously intervention 3: Administered intravenously intervention 4: Administered intravenously intervention 5: Administered intravenously

Protocol documents:
Clinical trial NCT01300650
Conditions: Heart Failure
Keywords: Heart failure Inflammation Interleukin-1 Cardiopulmonary exercise
Sponsor: Virginia Commonwealth University
Start date: 2011-02-01; Completion date: 2011-08-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-randomized, pilot-study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with heart failure. Subjects will undergo cardiopulmonary exercise testing at baseline and after 2-weeks treatment with anakinra (recombinant human Interleukin-1 receptor antagonist).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Anakinra
Intervention descriptions: intervention 1: Anakinra 100 mg subcutaneous injection daily

Protocol documents:
Clinical trial NCT01307319
Conditions: Seasonal Allergic Rhinitis SAR
Keywords: Allergies Hayfever
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-03-01; Completion date: 2011-08-01
Enrollment: 715 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of an investigational nasal aerosol at two doses compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis in children (6-11 years of age).

Detailed description:

Arms: arm 1: Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 2: Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days. arm 3: Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
Interventions: intervention 1: BDP HFA intervention 2: Placebo nasal aerosol
Intervention descriptions: intervention 1: BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm. intervention 2: Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.

Protocol documents:
Clinical trial NCT01324388
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2011-08-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is twofold:

1. To evaluate the effect of LY2189265 on how the body absorbs a blood pressure lowering drug (lisinopril) in participants with high blood pressure who are currently taking lisinopril.
2. To evaluate the effect of LY2189265 on heart rate and blood pressure in healthy volunteers when taken with a Beta-blocker drug (metoprolol).

In Part 1, participants will receive four weekly injections of LY2189265 with continued use of normal lisinopril therapy.

Part 2 is a cross-over study design. Participants will receive a single injection of LY2189265 in one period, and seven daily doses of metoprolol and a single injection of LY2189265 in another period.

Detailed description:

Arms: arm 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.

Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study. arm 2: Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.

Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study. arm 3: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.

Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.

There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study). arm 4: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.

Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.

There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study).
Interventions: intervention 1: LY2189265 intervention 2: Metoprolol intervention 3: Lisinopril intervention 4: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered subcutaneously

Protocol documents:
Clinical trial NCT01339897
Conditions: Healthy
Keywords: N6022, GSNORi
Sponsor: Nivalis Therapeutics, Inc.
Start date: 2011-04-01; Completion date: 2011-08-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and metabolism of N6022 in humans.

Detailed description:
This is a double-blind, randomized, placebo-controlled, multiple ascending dose study, in at least three ascending cohorts. Twenty-four subjects will be enrolled initially in the first three cohorts, with up to 40 subjects to be enrolled overall if additional cohorts are required to reach the maximum tolerated dose (MTD). The cohorts will be enrolled in two groups of 4 each with approximately 7 days between groups to conduct safety monitoring committee review for approval to proceed to the second group in the cohort. Eight subjects will be enrolled per cohort, randomized 3:1 to N6022: placebo. Each subject will undergo screening (Day -28 to Day -2) and, if eligible, they will be instructed to begin a low-nitrate diet on Day -4. Subjects will return to the clinical site on Day -1, and eligibility will be reconfirmed. Eligible subjects will receive a dose of investigational medicinal product (\[IMP\], N6022 or placebo) by intravenous (IV) infusion on study Days 1 through 7 and will be followed for safety, PK, and PD until discharge on the morning of Day 8. Subjects will return to the clinic for a follow-up visit on Day 15 (± 1 day) and will be contacted via telephone on Day 28 (± 1 day) for the end-of-study safety follow-up visit. Participation of an individual subject may last approximately 56 days from the time of screening until the end-of-study follow-up visit.

A Safety Monitoring Committee (SMC) will review the safety data in each cohort after the Day 15 Follow-up visit, before proceeding to the next ascending dose cohort, modifying the dose, repeating a dose, or stopping the study according to the stopping rules outlined in the protocol.

Arms: arm 1: Injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days. arm 2: Injectable formulation normal saline arm 3: Injectable formulation, given at doses of 10 mg given QD each day over 7 days. arm 4: Injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 days.
Interventions: intervention 1: 5 mg/N6022 intervention 2: Placebo intervention 3: 10mg/N6022 intervention 4: 20mg/N6022
Intervention descriptions: intervention 1: Intravenous formulation, given at doses of 5 mg once each day over 7 days. intervention 2: Same administration procedures as active intervention 3: Intravenous formulation given at doses of 10 mg once each day over 7 days. intervention 4: Intravenous formulation given at doses of 20 mg once each day over 7 days.

Protocol documents:
Clinical trial NCT01371786
Conditions: Allergic Rhinitis (AR)
Keywords: Ciclesonide Allergic Rhinitis
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2011-06-01; Completion date: 2011-08-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.

Detailed description:
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10 14 patients with symptomatic allergic rhinitis, aged 18 65 years. In order to ensure that patients will be symptomatic at the time of dosing, participants will be asked to withhold their usual treatments for perennial or seasonal allergic rhinitis, beginning at the Screening Visit until after Study Visit 3.

Each patient will be randomly assigned to one of two treatment sequences. The two treatments in this study are a single dose (one 37 mcg actuation per nostril) of radiolabeled solution of ciclesonide nasal aerosol 74 µg (Regimen A) and a single dose (two 50 mcg actuations per nostril) of a radiolabeled suspension of mometasone aqueous nasal spray 200 µg (Regimen B).

Arms: arm 1: A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle arm 2: A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
Interventions: intervention 1: ciclesonide nasal aerosol intervention 2: mometasone Aqueous (AQ) nasal spray
Intervention descriptions: intervention 1: A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister intervention 2: A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle

Protocol documents:
Clinical trial NCT01378988
Conditions: Sedation Pain
Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Start date: 2011-06-01; Completion date: 2011-08-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through \<24 months, administered as an intravenous loading dose followed by continuous infusion for a minimum of 6 hours and up to 24 hours in an intensive care setting.

Detailed description:
Phase II, randomized, open-label, single-center, study evaluating the pharmacokinetics and pharmacodynamics of dexmedetomidine in pediatric subjects across two dose levels (Dose Level 1 consists of a 0.7 mcg/kg loading dose immediately followed by a 0.5 mcg/kg/hr maintenance infusion; Dose Level 2 consists of a 1.0 mcg/kg loading dose immediately followed by a 0.75 mcg/kg/hr maintenance infusion). The study population will consist of intubated and mechanically ventilated pediatric subjects who require sedation in an intensive care setting for a minimum of 6 hours but not to exceed 24 hours. Subjects eligible for enrollment are 12 months to \<24 months of age.

Arms: arm 1: Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion arm 2: Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: For sedation according to protocol

Protocol documents:
Clinical trial NCT01383486
Conditions: Pain
Keywords: Self Selection Tria
Sponsor: Bayer
Start date: 2011-07-01; Completion date: 2011-08-01
Enrollment: 253 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Detailed description:

Arms: arm 1: Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
Interventions: intervention 1: Naproxen sodium ER (BAYH6689) intervention 2: Advil
Intervention descriptions: intervention 1: Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain intervention 2: Commercially available Advil; oral caplet upon incidence of pain

Protocol documents: