ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01281501
Conditions: Dyspepsia Emergency Pain
Keywords: Dyspepsia Emergency treatment Pantoprazole Antacid Pain measurement
Sponsor: Chulalongkorn University
Start date: 2011-01-01; Completion date: 2011-10-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the immediate synergistic effect on the relief of severe acid-related dyspeptic pain by adding intravenous pantoprazole to the combination of oral antacid and antispasmodic agent (the conventional treatment).

Detailed description:
Acid-related dyspepsia is common among the population. Number of these patients may have so severe symptoms that can lead them to the emergency department. Mixtures of antacid and antispasmodic were widely used over decades to relieve this acute pain with moderate, yet questionable, improvement in pain score. Proton pump inhibitors (PPIs), the novel acid-lowering agents, are undoubtedly effective to reduce acid secretion and control dyspeptic symptoms in short-term and long-term duration. To our knowledge, no previous study was conducted to evaluate the efficacy of such agents on immediate pain relief in patients with severe dyspeptic symptoms in emergency care. Clinically, they are frequently used to treat this circumstance in an unofficial manner since intravenous proton pump inhibitor alone is not yet considered as a well-approved indication to alleviate such condition. Pantoprazole, a proton pump inhibitor, reaches its peak serum concentration within one hour and its acid-lowering effect occurred within first hour following a single intravenous infusion. Thus, it theoretically has rapid onset and prolonged action on acid reduction. Our primary aim of the study is to evaluate the immediate effect of intravenous pantoprazole in addition to the combination of oral antacid and antispasmodic agent (the conventional regimen) on the relief of severe acid-related dyspeptic pain.

Arms: arm 1: Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline arm 2: Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
Interventions: intervention 1: Normal saline intervention 2: Pantoprazole intervention 3: Oral antacid intervention 4: Hyoscine butylbromide
Intervention descriptions: intervention 1: 10 ml of 0.9% sodium chloride solution intervention 2: 80 mg of intravenous pantoprazole intervention 3: 30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide) intervention 4: 20 mg of intravenous hyoscine butylbromide

Protocol documents:
Clinical trial NCT01284296
Conditions: Digital Block
Sponsor: University of California, San Francisco
Start date: 2010-08-01; Completion date: 2011-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will further investigate the Masimo SpHb \[FDA Approved\] continuous non-invasive hemoglobin monitor in spine surgery patients. (See NCT00792597) We will investigate the effect of enhanced circulation to the finger (which will be attached to the sensor) following a local injection (digital block) of lidocaine (an FDA approved local anesthetic), and assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb).

Detailed description:
We have completed a study with 20 patients using the latest version of the SpHb monitor software and finger sensor.

The purpose of this study is to assess the accuracy of the SpHb reading as it relates to a standard laboratory hemoglobin value (tHb) following the digital block.

Arms: arm 1: None
Interventions: intervention 1: Lidocaine digital block intervention 2: Masimo SpHb continuous hemoglobin monitor
Intervention descriptions: intervention 1: One dose of lidocaine 2% injected locally into one finger (2 mls total) intervention 2: Masimo SpHb continuous hemoglobin monitor

Protocol documents:
Clinical trial NCT01291108
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2011-04-01; Completion date: 2011-10-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1. arm 2: AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 3: AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 4: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1. arm 5: bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2. arm 6: bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Interventions: intervention 1: AGN-210669 intervention 2: bimatoprost intervention 3: bimatoprost vehicle
Intervention descriptions: intervention 1: AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2. intervention 2: bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2. intervention 3: bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.

Protocol documents:
Clinical trial NCT01307020
Conditions: Pain
Keywords: Moderate to severe pain Postoperative pain Analgesics Dexketoprofen Tramadol
Sponsor: Menarini Group
Start date: 2011-02-01; Completion date: 2011-10-01
Enrollment: 745 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single component in comparison to placebo on moderate to severe pain following impacted third mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate the pain model.

Detailed description:
The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based on the rationale that more than one drug is necessary in most patients suffering of acute and chronic pain, particularly of moderate to severe intensity.

DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is expect to result in an additive or synergistic analgesia, thus allowing a decrease in the required doses of the individual agents, and consequently a reduced risk of adverse events In this study, patients who present moderate to severe pain after impacted third mandibular molar tooth extraction will be randomised to a total of 10 treatment arms including 4 combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect assessment.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None
Interventions: intervention 1: Dexketoprofen Trometamol intervention 2: Dexketoprofen Trometamol intervention 3: Tramadol Hydrochloride intervention 4: Tramadol Hydrochloride intervention 5: Ibuprofen intervention 6: Placebo intervention 7: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 8: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 9: Dexketoprofen Trometamol + Tramadol Hydrochloride intervention 10: Dexketoprofen Trometamol + Tramadol Hydrochloride
Intervention descriptions: intervention 1: Dexketoprofen Trometamol low dose, oral film-coated table, once intervention 2: Dexketoprofen Trometamol high dose, oral film-coated table, once intervention 3: Tramadol Hydrochloride low dose, oral film-coated table, once intervention 4: Tramadol Hydrochloride high dose, oral film-coated table, once intervention 5: Ibuprofen 400 mg, oral film-coated table, once intervention 6: Placebo, oral film-coated table, once intervention 7: DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once intervention 8: DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once intervention 9: DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once intervention 10: DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once

Protocol documents:
Clinical trial NCT01321723
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis Bone Diseases, Metabolic Bone Diseases Bone Density Conservation Agents
Sponsor: Unigene Laboratories Inc.
Start date: 2011-02-01; Completion date: 2011-10-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to provide information about the bone anabolic properties and absorption profile of Unigene's PTH Analog when administered as oral tablets over a period of 24 weeks to postmenopausal women with osteoporosis.

Detailed description:
The choice of a 24-week treatment period was based on published studies of PTH which demonstrate its potential to produce a statistically significant increase in BMD in patients with postmenopausal osteoporosis within that observation period.

Arms: arm 1: PTH(1-31) 5 mg tablet, once daily arm 2: Placebo matching tablet, once daily arm 3: Forsteo (teriparatide) 20 mcg SC Injection, once daily
Interventions: intervention 1: PTH analog intervention 2: Placebo intervention 3: Forsteo (Teriparatide)
Intervention descriptions: intervention 1: A recombinant 1-31 amino acid fragment of PTH. intervention 2: None intervention 3: A recombinant 1-34 amino acid fragment of PTH.

Protocol documents:
Clinical trial NCT01330459
Conditions: Pain
Keywords: Pain during first trimester surgical abortion
Sponsor: Elizabeth Micks
Start date: 2011-02-01; Completion date: 2011-10-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether preoperatively administered hydrocodone/acetaminophen (HC/APAP) reduces pain during a first trimester surgical abortion.

Detailed description:
The investigators plan to conduct a double-blinded randomized placebo-controlled trial of 120 women undergoing elective first trimester surgical abortion. These women will be premedicated with either two tabs of 5/350 hydrocodone/acetaminophen or 2 tabs of a placebo. All subjects will receive ibuprofen and lorazepam preoperatively and a PCB. This study will examine the incremental benefit of HC/APAP over this standard medication regimen. Randomization will be stratified into two groups. Subjects less than 8 weeks gestation will comprise the early gestational age group. Subjects between 8 weeks 0 days and 10 weeks 6 days will comprise the late gestational age group. The investigators will be assessing patient perception of pain, nausea, satisfaction, and anxiety at multiple points during the clinic visit using 100-mm visual analogue scales (VAS).

Arms: arm 1: Subject will receive hydrocodone/acetaminophen 45-90 minutes prior to abortion procedure.

Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure. arm 2: Subject will receive placebo 45-90 minutes prior to abortion procedure.

Subject will also recieve ibuprofen, lorazepam, and lidocaine 45-90 minutes prior to abortion procedure.
Interventions: intervention 1: Hydrocodone/acetaminophen intervention 2: Placebo intervention 3: Ibuprofen intervention 4: Lorazepam intervention 5: Lidocaine
Intervention descriptions: intervention 1: Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure. intervention 2: Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure. intervention 3: 800 mg oral ibuprofen intervention 4: 2 mg oral lorazepam intervention 5: 20 ml 1% buffered lidocaine, injected

Protocol documents:
Clinical trial NCT01332188
Conditions: Allergic Conjunctivitis
Sponsor: Aciex Therapeutics, Inc.
Start date: 2011-04-01; Completion date: 2011-10-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: AC-170 0.05% intervention 2: AC-170 0.1% intervention 3: AC-170 0.24% intervention 4: AC-170 0%
Intervention descriptions: intervention 1: 1 drop in each eye at 3 separate times during a 21 day period intervention 2: 1 drop in each eye at 3 separate times during a 21 day period intervention 3: 1 drop in each eye at 3 separate times during a 21 day period intervention 4: 1 drop in each eye at 3 separate times during a 21 day period

Protocol documents:
Clinical trial NCT01350128
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2011-05-01; Completion date: 2011-10-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Detailed description:
The primary objective of this study is to demonstrate efficacy relative to placebo of PT001 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of PT001 MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Arms: arm 1: PT001 MDI arm 2: PT001 MDI arm 3: PT001 MDI arm 4: PT001 MDI arm 5: Ipratropium Bromide HFA Inhalation Aerosol arm 6: PT001 Placebo MDI
Interventions: intervention 1: PT001 MDI intervention 2: Ipratropium Bromide HFA Inhalation Aerosol intervention 3: Placebo MDI
Intervention descriptions: intervention 1: PT001 MDI administered as two puffs BID for 7 days intervention 2: Taken as 2 inhalations of the 17 µg per actuation strength MDI QID intervention 3: Matching placebo to PT001 MDI administered as two puffs BID for 7 days

Protocol documents:
Clinical trial NCT01354496
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers Bioavailability
Sponsor: Eli Lilly and Company
Start date: 2011-04-01; Completion date: 2011-10-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.

The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.

There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.

Detailed description:

Arms: arm 1: A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state arm 2: Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal arm 3: Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state arm 4: Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state arm 5: Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state arm 6: Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state
Interventions: intervention 1: LY2409021 Reference Form intervention 2: LY2409021 Test-Med Formulation (medium particle size) intervention 3: LY2409021 Test-High Formulation (high particle size) intervention 4: LY2409021 Test-Low Formulation (low particle size)
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally intervention 4: Administered orally

Protocol documents:
Clinical trial NCT01364922
Conditions: Chronic Low Back Pain
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-06-01; Completion date: 2011-10-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.

Detailed description:
This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.

Arms: arm 1: Hydrocodone/acetaminophen extended release, 2 tablets twice daily arm 2: Hydrocodone/acetaminophen extended release, 1 tablet twice daily arm 3: Placebo, 1 tablet twice daily
Interventions: intervention 1: hydrocodone/acetaminophen extended release intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01370525
Conditions: Heartburn
Keywords: Heartburn
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2011-10-01
Enrollment: 340 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Esomeprazole
Intervention descriptions: intervention 1: Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Protocol documents:
Clinical trial NCT01370538
Conditions: Heartburn
Keywords: Heartburn
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2011-10-01
Enrollment: 341 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Esomeprazole
Intervention descriptions: intervention 1: Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

Protocol documents:
Clinical trial NCT01383200
Conditions: Pain
Keywords: efficacy comfort
Sponsor: University of Miami
Start date: 2011-06-01; Completion date: 2011-10-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. This study will show if one type of anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. In the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your LASIK to get more details about your experience.

\*Of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. This means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine.

when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. This is important to note since the randomization refers to EYE for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).

Detailed description:
Outcome measures involve comparing the right eye and left eye for severity of 12 different symptoms, that are recorded in severity on a 1-5 scale. A score of 1 means no symptoms and 5 means severe. The 12 measurements include sharp pain, dull ache, pain during movement, stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation, pressure sensation, decreased vision, and blurry vision.

Arms: arm 1: Participant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK. arm 2: Participant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK.
Interventions: intervention 1: Tetracaine drop intervention 2: Lidocaine gel
Intervention descriptions: intervention 1: 0.5% Tetracaine Right eye / 2% Lidocaine Left eye intervention 2: 0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Protocol documents:
Clinical trial NCT01386606
Conditions: Secondary Hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2011-06-01; Completion date: 2011-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Detailed description:
Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Arms: arm 1: Androxal 6.25 mg/day arm 2: Androxal 12.5 mg/day arm 3: Androxal 25 mg/day arm 4: AndroGel 5G topical testosterone
Interventions: intervention 1: Androxal (enclomiphene citrate) intervention 2: Testosterone
Intervention descriptions: intervention 1: capsule oral

1X a day 6 weeks intervention 2: topical gel

1X a day 6 weeks

Protocol documents: