ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01878656
Conditions: Emergence Agitation
Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Start date: 2013-04-01; Completion date: 2014-02-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Emergence agitation is a major concern in patients undergoing orthognathic surgery. The patients may experience the sense of suffocation during emergence due to nasotracheal intubation and orofacial edema. Postoperative pain is also associated with emergence agitation. Although there is a lot of studies about emergence agitation in children, there is a few in adults, furthermore, no data about comparison of emergence agitation between sevoflurane and desflurane anesthesia in adults. Therefore, the investigators would like to compare the incidence and severity of emergence agitation between sevoflurane and desflurane anesthesia in adults after orthognathic surgery.

Detailed description:

Arms: arm 1: administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia arm 2: administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia
Interventions: intervention 1: Sevoflurane intervention 2: Desflurane
Intervention descriptions: intervention 1: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued. intervention 2: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.

Protocol documents:
Clinical trial NCT01887353
Conditions: Atrial Fibrillation Heart Failure
Keywords: atrial fibrillation heart failure ranolazine cardioversion persistent AF paroxysmal AF
Sponsor: Intermountain Health Care, Inc.
Start date: 2013-06-01; Completion date: 2014-02-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will take ranolazine 1000 mg tablets twice daily intervention 2: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Protocol documents:
Clinical trial NCT01902134
Conditions: Acute Pain
Keywords: Moderate to severe acute pain Postoperative pain Hip arthroplasty Analgesics Dexketoprofen Tramadol
Sponsor: Menarini Group
Start date: 2013-04-01; Completion date: 2014-02-01
Enrollment: 641 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (DKP) and tramadol hydrochloride (TRAM) in comparison to the single agents (and placebo for the single dose phase only) Approximately 600 male and female patients presenting moderate to severe pain after an elective primary hip arthroplasty are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

Detailed description:
In this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). Namely:

* DKP/TRAM followed by DKP/TRAM;
* DKP followed by DKP;
* TRAM followed by TRAM;
* placebo followed by DKP;
* placebo followed by TRAM;
* placebo followed by DKP/TRAM;

The analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: DKP/TRAM, DEXKETOPROFEN, TRAMADOL, and Placebo.

The analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: DKP/TRAM, DEXKETOPROFEN, and TRAMADOL.

Arms: arm 1: Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses arm 2: Dexketoprofen-single dose followed by Dexketoprofen-multiple doses arm 3: Tramadol-single dose followed by Tramadol-multiple doses arm 4: Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses arm 5: Placebo single dose followed by Dexketoprofen-multiple doses arm 6: Placebo single dose followed by Tramadol-multiple doses
Interventions: intervention 1: Placebo intervention 2: Tramadol-single dose intervention 3: Dexketoprofen-single dose intervention 4: Dexketoprofen/Tramadol-single dose intervention 5: Tramadol-multiple doses intervention 6: Dexketoprofen-multiple doses intervention 7: Dexketoprofen/Tramadol-multiple doses
Intervention descriptions: intervention 1: Placebo single oral dose (first 8 hours) intervention 2: Tramadol single oral dose (first 8 hours) intervention 3: Dexketoprofen single oral dose (first 8 hours) intervention 4: Dexketoprofen/Tramadol oral single dose (first 8 hours) intervention 5: Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses) intervention 6: Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses) intervention 7: Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)

Protocol documents:
Clinical trial NCT01910389
Conditions: Heart Failure Pulmonary Hypertension
Keywords: Heart failure Pulmonary hypertension tadalafil Phosphodiesterase Type 5 Inhibition
Sponsor: Carelon Research
Start date: 2013-11-01; Completion date: 2014-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multi-center, prospective, randomized, double blind, placebo-controlled clinical trial. Subjects in the study will be adults with New York Heart Association (NYHA) Class II-IV heart failure (HF) due to left ventricular systolic dysfunction (LVSD), left ventricular ejection fraction (LVEF) \<0.40, and secondary pulmonary hypertension (PH). The purpose of the study is to evaluate the safety, effectiveness, and effects of tadalafil compared to placebo on the subjects' functional capacity / quality of life.

Detailed description:

Arms: arm 1: Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial. arm 2: Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
Interventions: intervention 1: Tadalafil intervention 2: Placebo for tadalafil
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01915823
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2013-07-01; Completion date: 2014-02-01
Enrollment: 348 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Dymista nasal spray is better and safer than placebo in treating children ages 4 to \<12 years old who have seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray

Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily arm 2: Dose: vehicle only Regimen: 1 spray per nostril twice daily
Interventions: intervention 1: azelastine hydrochloride and fluticasone propionate intervention 2: Dymista vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01917318
Conditions: Post Traumatic Stress Disorder
Keywords: Post traumatic stress disorder Treatment of post traumatic stress disorder Symptoms of arousal in post traumatic stress disorder Iloperidone in post traumatic stress disorder
Sponsor: University of Colorado, Denver
Start date: 2013-07-01; Completion date: 2014-02-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.

Detailed description:
During Period A, subjects will receive 8 weeks of iloperidone or placebo (2 weeks titration period followed by 6 weeks on stable dose). Then they will be reassessed for response during Period A; study drug will be discontinued and washed out over the following 2 weeks. They will then begin Period B on the alternate blinded treatment with similar titration and assessment, initially weekly and then every other week for a total of another 8 weeks. The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.

Arms: arm 1: During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo. arm 2: During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.
Interventions: intervention 1: Iloperidone intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.

During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period) intervention 2: During 8 weeks subjects will receive oral placebo

Protocol documents:
Clinical trial NCT01919190
Conditions: Pain
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2013-08-01; Completion date: 2014-02-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures.

Detailed description:
The purpose of this prospective, blinded assessor, randomized trial is to assess opioid use and patient-reported outcomes of EXPAREL as a foundation in postsurgical pain therapy in Transversus Abdominis Plane (TAP) infiltration in lower abdominal surgical procedures; primary endpoint signal seen during pre-specified interim analysis.

Arms: arm 1: EXPAREL (266mg/20 ml) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP arm 2: The placebo control will be established using a grade-2 sham, no infiltration will occur
Interventions: intervention 1: EXPAREL intervention 2: Placebo
Intervention descriptions: intervention 1: TAP with EXPAREL intervention 2: Placebo

Protocol documents:
Clinical trial NCT01936649
Conditions: Heart Failure (HF) Ventricular Dysfunction, Left
Keywords: Nuclear imaging Radiopharmaceutical Iobenguane I-123 reproducibility Quantitative measurements myocardial uptake SPECT imaging planar imaging AdreView™
Sponsor: GE Healthcare
Start date: 2013-08-01; Completion date: 2014-02-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study was to assess the reproducibility of quantitative measurements of myocardial uptake of Iobenguane I 123 on planar and single photon emission computed tomography (SPECT) imaging following intravenous (i.v.) administration of AdreView. Efficacy was assessed based upon the absolute differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days apart.

Detailed description:

Arms: arm 1: Two administrations of single intravenous (i.v) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
Interventions: intervention 1: AdreView (Iobenguane I 123 Injection)
Intervention descriptions: intervention 1: AdreView 10 mCi as a single i.v administration

Protocol documents:
Clinical trial NCT01957202
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: levocabastine fixed dose combination, Rhinitis, Allergic, Perennial and Seasonal, Allergic Rhinitis, fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2013-10-01; Completion date: 2014-02-01
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study duration for each individual participating in the study will be a maximum of up to 20 weeks (including the screening and follow-up). This will be a three period study and subjects will be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days between two treatment periods. The rational for this study is to demonstrate proof of concept with the FDC of FF and levocabastine compared with each of the components administered alone.

Detailed description:

Arms: arm 1: Each Subject will be assigned to a sequence of three treatments (e.g ABC, BCD, ACD): A=Two, 50 microliter (mcqL) sprays per nostril of FF, total dose 100 microgram (mcg); B=Two, 50 mcqL sprays per nostril of levocabastine, total dose 200 mcg; C=Two, 50 mcql sprays per nostril of FF/levocabastine FDC, total daily dose 100 mcg FF and 200 mcg levocabastine; D=Two, 50 mcql sprays per nostril of placebo. There will be a wash out period of 14-28 days between two treatment periods
Interventions: intervention 1: FF/levocabastine intervention 2: FF intervention 3: levocabastine intervention 4: Placebo
Intervention descriptions: intervention 1: FF/levocabastine (25mcg/50 mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. intervention 2: FF (25mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. intervention 3: levocabastine (50mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered. intervention 4: Placebo will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.

Protocol documents:
Clinical trial NCT01972152
Conditions: Hypoglycemia
Keywords: Hypoglycemia Glucagon
Sponsor: Xeris Pharmaceuticals
Start date: 2013-10-01; Completion date: 2014-02-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.

Detailed description:
Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1 mg

Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon Injection) 1 mg

Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg \[test\] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection \[rDNA origin\]) 1 mg (reference)

Arms: arm 1: G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection arm 2: G-Pen(TM) (glucagon injection), single 0.5 mg SC injection arm 3: Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection
Interventions: intervention 1: G-Pen(TM) 1 mg intervention 2: Lilly Glucagon(TM) 1 mg intervention 3: G-Pen(TM) 0.5 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01981863
Conditions: Pathologic Fibrinolysis
Keywords: cardiac surgery cardiopulmonary bypass fibrinolysis thromboelastography D-Dimers antifibrinolytic agents
Sponsor: Stanford University
Start date: 2013-07-01; Completion date: 2014-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is common practice to use antifibrinolytic agents before and during cardiopulmonary bypass. They are not without side effects. The investigators want to show that there is no proof of fibrinolysis in standard sternotomy cardiac surgery patients before cardiopulmonary bypass, and that antifibrinolytic agents should only be started on cardiopulmonary bypass.

Detailed description:
Double-blind, placebo controlled, prospective study in two groups of 20 patients. Control group (A) receives standard Epsilonaminocaproic acid treatment before cardiopulmonary bypass (10 gr loading dose, and 1 gr/hr infusion), and second group (B) receives placebo. Before start of Epsilonaminocaproic acid/placebo, D-Dimers and Thromboelastography are measured, repeated just before full heparinization. After heparinization group A receives placebo, and group B Epsilonaminocaproic acid.

Arms: arm 1: One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo arm 2: Placebo: same IV volume as experimental arm
Interventions: intervention 1: Epsilonaminocaproic acid intervention 2: Placebo
Intervention descriptions: intervention 1: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo. intervention 2: Placebo administered in same volume as in experimental arm.

Protocol documents:
Clinical trial NCT01996644
Conditions: Anorexia and Bulimia Nervosa
Keywords: Anorexia, Bulimia, Anxiety, Exposure
Sponsor: Washington University School of Medicine
Start date: 2013-02-01; Completion date: 2014-02-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

Detailed description:
This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Arms: arm 1: 250 mg DCS (setraline) versus placebo plus exposure arm 2: Placebo group plus exposure
Interventions: intervention 1: Placebo vs Setraline intervention 2: Setraline
Intervention descriptions: intervention 1: Placebo intervention 2: 250mg DCS

Protocol documents:
Clinical trial NCT02028767
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2014-01-01; Completion date: 2014-02-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed dose combination tablets compared to tablets administered together in healthy male and female volunteers under fed conditions.

Detailed description:

Arms: arm 1: 12.5 mg Empagliflozin / 500mg metformin fixed dose combination arm 2: Empagliflozin and Metformin tablets
Interventions: intervention 1: Empagliflozin 2.5 mg intervention 2: Empagliflozin 10 mg intervention 3: Metformin 500 mg intervention 4: Empagliflozin/Metformin FDC
Intervention descriptions: intervention 1: Empagliflozin 2.5 mg tablet intervention 2: Empagliflozin 10 mg tablet intervention 3: Metformin 500 mg tablet intervention 4: 12.5 mg Empagliflozin / 500 mg Metformin

Protocol documents:
Clinical trial NCT02083107
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage Intrapartum blood loss Misoprostol
Sponsor: Ain Shams University
Start date: 2013-02-01; Completion date: 2014-02-01
Enrollment: 636 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the work is to evaluate \& compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.

Detailed description:

Arms: arm 1: will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". arm 2: will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". arm 3: will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".
Interventions: intervention 1: Misoprostol intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of different routes of administration of 400 micro gram misoprostol intervention 2: None

Protocol documents:
Clinical trial NCT02096458
Conditions: Gastroesophageal Reflux Disease Erosive Esophagitis Heartburn
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2014-02-01; Completion date: 2014-02-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to measure the in-vivo disintegration time of a single dexlansoprazole delayed-release orally disintegrating (OD) tablet.

Detailed description:
The drug being tested in this study is called dexlansoprazole. An orally disintegrating (OD) form of dexlansoprazole is being tested to look at the average time that it takes for one tablet to disintegrate in the mouth of healthy volunteers. At the point at which the panelist would normally swallow the granules, they will record the time and expectorate the disintegrated tablet mass and not actually swallow the tablet or granules.

The study will enroll approximately 8 healthy volunteers. All participants will take one dexlansoprazole 30 mg OD tablet on up to three separate study days. No more than 60 mg of dexlansoprazole will be tested in any one day.

This single-centre trial will be conducted in the United States. The overall time to participate in this study is approximately 2 weeks. Participants will make up to 4 visits to the clinic, and will be contacted by telephone approximately 1 week after last dose of study drug for a follow-up assessment.

Arms: arm 1: Dexlansoprazole 30 mg delayed-release orally disintegrating tablets at Assessment 1 Day 1, Assessment 2 Day 1, and Assessment 3 Day 1.
Interventions: intervention 1: Dexlansoprazole
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release orally disintegrating tablets

Protocol documents: