ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01507233
Conditions: Bowel Obstruction
Keywords: open colectomy colectomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-05-01; Completion date: 2012-07-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome extended-release injectable suspension), compared with postsurgical administration of standardized intravenous (IV) morphine sulfate, for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Arms: arm 1: morphine sulfate (or Sponsor-approved equivalent) arm 2: EXPAREL (bupivacaine liposome injectable suspension)
Interventions: intervention 1: IV morphine sulfate intervention 2: EXPAREL (bupivacaine liposome injectable suspension)
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 hour. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.

All patients will be offered rescue analgesia, as needed.

Protocol documents:
Clinical trial NCT01521117
Conditions: Parkinson's Disease
Keywords: donepezil parkinson's disease balance cholinesterase inhibitor
Sponsor: Oregon Health and Science University
Start date: 2011-12-01; Completion date: 2012-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and muscle rigidity. Current medications for the treatment of PD do not improve gait and balance difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The investigators study will look at what aspects of gait and balance are improved by the study drug. The study drug is not approved to treat PD in the United States or other countries because we do not know enough about it.

Detailed description:
Parkinson's disease (PD) is a common neuro-degenerative disease affecting about 2% of the adult population in the United States over the age of 65. Some of the most disabling symptoms of Parkinson's disease are balance and gait dysfunction, leading to falls. These symptoms do not respond to current dopamine directed therapies. Evidence from both pathologic studies and advanced imaging has demonstrated that a cholinergic deficiency in the thalamus and basal ganglia is found in individuals with PD who fall compared to non-fallers. The central acting acetylcholine esterase inhibitor, donepezil, has been demonstrated to decrease falls in individuals with PD. The mechanism by which falls decreased is unknown. Our open label pilot data indicates that donepezil can improve quantitative measures of balance in individuals with PD. Suggesting that improvements in balance in the mechanism by which donepezil reduces falls. Our goal is to determine whether donepezil will:

* Improve quantitative measures of balance in subjects with Parkinson's disease compared to placebo.
* Improve quantitative measures of gait in subjects with Parkinson's disease compared to placebo.
* Improve cognitive measures in non-demented subjects with Parkinson's disease.

Arms: arm 1: Donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. After a washout period of 4 weeks, placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6. arm 2: Placebo 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.

After a washout period of 4 weeks, donepezil 5 mg a day for weeks 1 - 3, if tolerated increased to 10 mg a day for weeks 4 - 6.
Interventions: intervention 1: Donepezil intervention 2: Placebo
Intervention descriptions: intervention 1: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days. intervention 2: Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.

Protocol documents:
Clinical trial NCT01528592
Conditions: Parkinson's Disease
Sponsor: Northwestern University
Start date: 2011-06-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Based on studies showing better responsiveness of motor versus cognitive symptoms to Parkinson's Disease medication, also known as dopaminergic treatments, the investigators hypothesize that comparison of resting state networks in the on versus off medication state in Parkinson's Disease patients will show greater effects on brain networks associated with motor control.

Detailed description:
Subject participation includes two 25-30 minute MRI scans. The subject will arrive in the "off" state (PD medications withheld for approximately 12 hours prior to the scan). Following the initial scan, the subject will receive 125% of his or her usual daily morning dose of PD medications which is calculated as levodopa dose equivalents (LDE) and is given as carbidopa-levodopa. The subject will then wait for an hour allowing for the medication to begin working. During this time the subject will complete cognitive assessments, questionnaires regarding the history and current state of PD, and motor assessments. The subject will then undergo a second MRI scan of approximately 25-30 minutes. The subject after completing the second MRI scan is free to leave. The entire study is approximately 2 and 1/2 hours long.

Arms: arm 1: Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
Interventions: intervention 1: Carbidopa-Levodopa
Intervention descriptions: intervention 1: Equivalent amount of carbidopa-levodopa will be provide to you

Protocol documents:
Clinical trial NCT01528787
Conditions: Ocular Hypertension Open Angle Glaucoma
Keywords: Intraocular pressure visual field Ocular hypertension or open angle glaucoma
Sponsor: Aerie Pharmaceuticals
Start date: 2012-03-01; Completion date: 2012-07-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.

Detailed description:

Arms: arm 1: 1 drop to study eye once daily arm 2: 1 drop to study eye once daily arm 3: 1 drop to study eye once daily arm 4: 1 drop to study eye once daily
Interventions: intervention 1: AR-13324 Ophthalmic Solution 0.01% intervention 2: AR-13324 Ophthalmic Solution 0.02% intervention 3: AR-13324 Ophthalmic Solution 0.04% intervention 4: AR-13324 Ophthalmic Solution Vehicle
Intervention descriptions: intervention 1: Administered to study eye, once daily (QD) in the morning (AM) for 7 days intervention 2: Administered to study eye, QD AM for 7 days intervention 3: Administered to study eye, QD AM for 7 days intervention 4: Administered to study eye, QD AM for 7 days

Protocol documents:
Clinical trial NCT01532518
Conditions: Colic
Keywords: Feeding intolerance Infant tachykinin antagonist Infant colic Nepadutant
Sponsor: Menarini Group
Start date: 2011-08-01; Completion date: 2012-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.

Detailed description:
Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory.

Nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit.

This phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days.

The experimental clinical phase encompasses the following periods:

* Screening period (no study medication), lasting approximately 7 days prior to randomization
* Treatment period, lasting fourteen days (7 days fore each dose)with once daily administration
* A safety follow-up visit, approximately four weeks after start of treatment.

Arms: arm 1: Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days arm 2: Nepadutant medium dose (0.5mg/kg) for 7 days followed by Nepadutant high dose (1mg/kg) for additional 7 days arm 3: Nepadutant low dose (0.1mg/kg) for 7 days followed by Nepadutant medium dose (0.5mg/kg) for additional 7 days
Interventions: intervention 1: Nepadutant
Intervention descriptions: intervention 1: Nepadutant oral solution

Protocol documents:
Clinical trial NCT01534273
Conditions: Healthy Volunteers
Keywords: Mild Cognitive Impairment
Sponsor: Eli Lilly and Company
Start date: 2012-02-01; Completion date: 2012-07-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this phase I study in healthy participants will be to evaluate the safety and tolerability of LY2886721 single and multiple doses, to evaluate how the body handles the drug, and to evaluate the drug's effect on the body.

Detailed description:

Arms: arm 1: Single oral dose and/or once daily (QD) oral dosing for 14 consecutive days arm 2: QD oral dosing for 14 consecutive days arm 3: Single oral dose or single oral dose followed by QD oral dosing for 14 consecutive days arm 4: Single oral dose
Interventions: intervention 1: LY2886721 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered orally.

Protocol documents:
Clinical trial NCT01537081
Conditions: Acute Upper Respiratory Tract Infection
Sponsor: Reckitt Benckiser LLC
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 2810 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.

Detailed description:

Arms: arm 1: The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600 mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet. arm 2: The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days. arm 3: Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
Interventions: intervention 1: Mucinex intervention 2: Immediate-release Guaifenesin intervention 3: Placebo
Intervention descriptions: intervention 1: Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water. intervention 2: Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water. intervention 3: Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water

Protocol documents:
Clinical trial NCT01543685
Conditions: Other Acute Postoperative Pain
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2012-02-01; Completion date: 2012-07-01
Enrollment: 462 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Indomethacin intervention 2: Indomethacin intervention 3: Indomethacin intervention 4: Celecoxib intervention 5: Placebo
Intervention descriptions: intervention 1: 40 mg TID capsules intervention 2: 40 mg BID capsules intervention 3: 20 mg TID capsules intervention 4: 200 mg capsules intervention 5: Capsules

Protocol documents:
Clinical trial NCT01556594
Conditions: Hypoglycemia
Keywords: Hypoglycemia Diabetes mellitus
Sponsor: Eli Lilly and Company
Start date: 2012-03-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.

The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.

Detailed description:
In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.

Arms: arm 1: Nasal glucagon (NG) administered as single dose of 1 milligram (mg). arm 2: NG administered as single dose of 2 mg. arm 3: Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection. arm 4: NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).
Interventions: intervention 1: Nasal Glucagon 1 mg intervention 2: Nasal Glucagon 2 mg intervention 3: SC Glucagon intervention 4: Nasal Glucagon 3 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01582477
Conditions: Postsurgical Pain Analgesia Prostatectomy
Keywords: TAP, robot-assisted prostatectomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-03-01; Completion date: 2012-07-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.

Detailed description:
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.

Arms: arm 1: 20 mL (266 mg) undiluted EXPAREL with 133 mg infiltrated on each the right and left side of the abdomen. arm 2: 20 mL (266 mg) EXPAREL diluted with an equal volume of preservative-free 0.9% normal saline to a total of 40 mL and infiltrated equally to the right and left side of the abdomen.
Interventions: intervention 1: EXPAREL 20 mL intervention 2: EXPAREL 40 mL
Intervention descriptions: intervention 1: EXPAREL 266 mg (undiluted) intervention 2: EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.

Protocol documents:
Clinical trial NCT01600950
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2012-05-01; Completion date: 2012-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Detailed description:

Arms: arm 1: A single 0.3 units per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously followed by a minimum washout period of 7 days. arm 2: A single 0.3 U/kg dose of Lantus will be administered subcutaneously followed by a minimum washout period of 7 days.
Interventions: intervention 1: LY2963016 intervention 2: Lantus
Intervention descriptions: intervention 1: Single 0.3 U/kg dose administered subcutaneously intervention 2: Single 0.3 U/kg dose administered subcutaneously

Protocol documents:
Clinical trial NCT01637142
Conditions: Healthy Participants
Sponsor: Denovo Biopharma LLC
Start date: 2012-07-01; Completion date: 2012-07-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the extent and rate of absorption of LY2140023 in healthy participants. The study has two periods. In Treatment Period 1, participants will receive a single oral dose of 80 milligrams (mg) LY2140023 followed by a 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) \[14C\]-LY2140023. In Treatment Period 2, participants will receive an oral dose of 80 mg LY2140023 followed by a 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi \[14C\]-LY404039. There will be at least a 3-day washout between doses.

Detailed description:

Arms: arm 1: Treatment Period 1: On Day 1, a single oral dose of 80 milligrams (mg) LY2140023 (parent compound) followed by a single 2-hour intravenous (IV) infusion of approximately 100 micrograms (µg) LY2140023 containing approximately 100 nanocuries (nCi) \[14C\]-LY2140023. arm 2: Treatment Period 2: On Day 1, a single oral dose of 80 mg LY2140023 (parent compound) followed by a single 2-hour IV infusion of approximately 100 µg LY404039 containing approximately 100 nCi \[14C\]-LY404039 (active metabolite).
Interventions: intervention 1: LY2140023 intervention 2: 14C-LY2140023 intervention 3: 14C-LY404039
Intervention descriptions: intervention 1: Administered orally. intervention 2: Administered IV. intervention 3: Administered IV.

Protocol documents:
Clinical trial NCT01639729
Conditions: Pharmacokinetics
Keywords: pharmacokinetics area under curve time to maximum concentration
Sponsor: Talphera, Inc
Start date: 2012-07-01; Completion date: 2012-07-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.

Detailed description:

Arms: arm 1: 15 mcg: Sufentanil IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral arm 2: 15 mcg: IV, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral,Sufentanil NanoTab Buccal arm 3: 15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Oral arm 4: 15 mcg: Sufentanil IV, Sufentanil NanoTab Buccal, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual arm 5: 15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Sublingual, Sufentanil NanoTab Buccal arm 6: 15 mcg: Sufentanil IV, Sufentanil NanoTab Oral, Sufentanil NanoTab Buccal, Sufentanil NanoTab Sublingual
Interventions: intervention 1: Treatment A: Sufentanil IV intervention 2: Treatment B: Sufentanil NanoTab Sublingual intervention 3: Treatment C: Sufentanil NanoTab Buccal intervention 4: Treatment D: Sufentanil NanoTab Oral
Intervention descriptions: intervention 1: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) intervention 2: Single Sufentanil NanoTab 15 mcg given sublingually (SL) intervention 3: Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) intervention 4: Single Sufentanil NanoTab 15 mcg swallowed (PO)

Protocol documents: