ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02121301
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye Dry Eye Syndrome SkQ1 Keratoconjunctivitis Dry Eye Disease
Sponsor: Mitotech, SA
Start date: 2014-04-01; Completion date: 2014-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

Detailed description:
Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).

The following primary endpoints were tested:

* Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline;
* Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.

Arms: arm 1: Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days arm 2: Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days arm 3: Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
Interventions: intervention 1: Low Dose 0.155µg/mL SkQ1 ophthalmic solution intervention 2: High Dose 1.55µg/mL SkQ1 ophthalmic solution intervention 3: Placebo (Vehicle) opthalmic solution
Intervention descriptions: intervention 1: eyedrops intervention 2: eyedrops intervention 3: eyedrops

Protocol documents:
Clinical trial NCT02139826
Conditions: Healthy Participants
Sponsor: Ixchelsis Limited
Start date: 2014-05-01; Completion date: 2014-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the absorption and blood levels of IX-01 when given as a capsule compared to liquid form, and how food affects the absorption in healthy men.

Detailed description:

Arms: arm 1: Singe oral dose of 800 milligrams of IX-01 as a capsule, while fasting, in 1 of 3 treatment periods arm 2: Single oral dose of 800 milligrams IX-01 as an aqueous dispersion, while fasting in 1 of 3 treatment periods arm 3: Single oral dose of 800 milligrams IX-01 as a capsule, after food, in 1 of 3 treatment periods
Interventions: intervention 1: IX-01
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02168478
Conditions: Allergy
Keywords: Neo-Synalar Patch Test Sodium lauryl sulfate Saline Presensitization
Sponsor: Noah Rosenberg, MD
Start date: 2014-06-01; Completion date: 2014-06-01
Enrollment: 206 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline).

The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.

Detailed description:
Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale).

The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.

Arms: arm 1: All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.

Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.
Interventions: intervention 1: Neo-Synalar Cream intervention 2: Sodium Lauryl Sulfate Aqueous Solution (0.40%) intervention 3: Saline
Intervention descriptions: intervention 1: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours. intervention 2: Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours. intervention 3: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Protocol documents:
Clinical trial NCT02180100
Conditions: Vulvovaginal Candidiasis
Sponsor: Peking University Shenzhen Hospital
Start date: 2013-08-01; Completion date: 2014-06-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.

Detailed description:
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.

Arms: arm 1: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days arm 2: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Interventions: intervention 1: Terconazole Vaginal Suppository intervention 2: Fluconazole
Intervention descriptions: intervention 1: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days intervention 2: orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.

Protocol documents:
Clinical trial NCT02181387
Conditions: Pain
Keywords: labor pain acetaminophen
Sponsor: Wake Forest University Health Sciences
Start date: 2013-09-05; Completion date: 2014-06-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.

Detailed description:
Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups

Arms: arm 1: 1000 mg every 6 hours during labor up to maximum 3 doses arm 2: placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses
Interventions: intervention 1: Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: administered every 6 hours by mouth up to 4 doses intervention 2: None

Protocol documents:
Clinical trial NCT02189941
Conditions: Healthy
Keywords: Deferiprone Deferiprone sustained-release tablets Pharmacokinetics
Sponsor: ApoPharma
Start date: 2014-05-01; Completion date: 2014-06-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to evaluate the pharmacokinetic and safety profile of the sustained-release formulation of deferiprone under both fasting and fed conditions, and evaluate the relative bioavailability of this sustained-release formulation when compared to immediate-release formulation of deferiprone under fasting conditions.

Detailed description:
This was an open-label, single-dose, randomized, three-way crossover study under fed and fasting conditions designed to determine the pharmacokinetics, safety, and tolerability of deferiprone sustained-release tablets in healthy volunteers. Subjects were randomized to receive the following 3 treatments in different orders, with a washout period of 7 days between treatments:

* 2000 mg of deferiprone sustained-release tablets under fed conditions
* 2000 mg of deferiprone sustained-release tablets under fasted conditions
* 2000 mg of Ferriprox immediate-release tablets under fasted conditions

In each period, blood samples for pharmacokinetics (PK) assessment were collected prior to dosing and at specified time points up to 24 hours post-dose. Safety assessments were conducted throughout the study.

Arms: arm 1: A single 1000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast. arm 2: A single 1000 mg dose of deferiprone sustained-release under fasting conditions. arm 3: A single 1000 mg dose of Deferiprone immediate-release under fasting conditions.
Interventions: intervention 1: Deferiprone sustained-release intervention 2: Deferiprone immediate-release
Intervention descriptions: intervention 1: Deferiprone sustained-release tablets intervention 2: Deferiprone immediate-release tablets

Protocol documents:
Clinical trial NCT02209454
Conditions: Acute Pain
Keywords: Dexketoprofen Bioavailability Comparative Pharmacokinetic
Sponsor: Menarini Group
Start date: 2014-04-01; Completion date: 2014-06-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation). In addition, this study intends to evaluate the safety and tolerability of Test and Reference formulations.

Detailed description:
The study was conducted in 1 site and included 26 successfully screened and randomized healthy subjects(12 female and 14 male).

The study consisted of:

* Screening Visit (performed within 3 weeks prior to 1st PK study session), for the evaluation of study eligibility.
* Two pharmacokinetic (PK) study sessions, separated by a minimum of a 7 day washout period, including the administration of one out of 2 study treatments at each study session (namely 25mg DKP.TRIS given as Enantyum® oral solution or Keral® tablet) according to the sequence as per randomisation list, and blood sampling for PK assessment on plasma at pre-defined time up to 24 hours post-dose.
* End of Study Visit (7-10 days after last treatment administration).

Arms: arm 1: 25mg DKP.TRIS oral solution arm 2: 25mg DKP.TRIS tablet
Interventions: intervention 1: Enantyum® oral solution intervention 2: Keral® tablet
Intervention descriptions: intervention 1: One dose of 25 mg DKP oral solution intervention 2: One dose of 25 mg DKP tablet

Protocol documents:
Clinical trial NCT02249767
Conditions: Acne
Sponsor: Spear Pharmaceuticals
Start date: 2013-11-01; Completion date: 2014-06-01
Enrollment: 574 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a double-blind, randomized, three-treatment, parallel study. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.

Detailed description:
This was a double-blind, randomized, three-treatment, parallel study conducted at three locations with a single investigator. Normal, healthy male and female children and adults (i.e., ages 12 to 40 years) with at least Grade 2 (i.e., mild severity) acne vulgaris were treated on the full face once daily for 84 days with the Tretinoin Gel 0.05%, Brand (tretinoin) Gel 0.05%, or Gel Vehicle. Acne lesions were graded by a single blinded observer at screening and at Weeks 0 (i.e., baseline), 2, 4, 8, and 12 at each location.

The assigned study treatment was self-applied topically once daily for 84 consecutive days. Scheduled study visits included:

* Visit 1 (Baseline Visit, Day 0)
* Visit 2 (First Interim Visit, Day 14)
* Visit 3 (Second Interim Visit, Day 28)
* Visit 4 (Third Interim Visit, Day 56)
* Visit 5 (Forth Interim Visit, Day 84)

A window of ± 4 days was considered acceptable for each scheduled visit following the Baseline Visit. Subjects were admitted into the study if they had a clinical diagnosis of acne vulgaris and if they met the inclusion/exclusion criteria. During the study visits, the following procedures were performed:

* Counts of inflammatory, non-inflammatory, and nodulocystic lesions
* The Investigator's Global Assessment (IGA)
* Assessment of application site reactions Safety was assessed by the monitoring of AEs and documenting signs and/or symptoms of application site reactions.

Arms: arm 1: Treatment of acne once daily over 12 weeks arm 2: Treatment of Acne once daily over 12 weeks arm 3: Treatment of acne once daily over 12 weeks
Interventions: intervention 1: Tretinoin
Intervention descriptions: intervention 1: Treatment of acne once daily in evening

Protocol documents:
Clinical trial NCT02276274
Conditions: Clinical Pharmacology
Sponsor: Takeda
Start date: 2014-06-01; Completion date: 2014-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, open-label, crossover study to determine the effect of food when a combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after breakfast in Japanese healthy adult male subjects.

Detailed description:
The primary objective of this clinical trial is to determine the effect of food on the pharmacokinetics of single oral dose administration of SYR-322-MET tablets in Japanese healthy adult male subjects

Arms: arm 1: Oral administration arm 2: Oral administration
Interventions: intervention 1: SYR-322-MET
Intervention descriptions: intervention 1: Oral administration of SYR-322-MET

Protocol documents:
Clinical trial NCT02305277
Conditions: Parkinson
Sponsor: Bial - Portela C S.A.
Start date: 2014-03-01; Completion date: 2014-06-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.

Detailed description:

Arms: arm 1: volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 2: volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 3: volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation

CM - clinical micronized TBM - to-be-marketed arm 4: volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed arm 5: volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed arm 6: volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation

CM - clinical micronized TBM - to-be-marketed
Interventions: intervention 1: BIA 9-1067 (clinical micronized, CM) intervention 2: BIA 9-1067 (to-be-marketed, TBM)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02308748
Conditions: Drug-induced QT Prolongation Pharmacokinetics Pharmacodynamics
Sponsor: Food and Drug Administration (FDA)
Start date: 2014-05-01; Completion date: 2014-06-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this research study is to test the hypothesis that late sodium current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).

Detailed description:
This is a randomized, double-blind, 5-period crossover study in healthy male and female subjects, 18 to 35 years of age, to compare the electrophysiological response of hERG potassium channel blocking drugs with and without the addition of late sodium or calcium channel blocking drugs. The 5 treatment periods are 1) dofetilide alone, 2) mexiletine with and without dofetilide, 3) lidocaine with and without dofetilide, 4) moxifloxacin with and without diltiazem and 5) placebo. During each treatment period, 12 blood samples for pharmacokinetic measurements are obtained with matched 12-lead ECG recordings.

Arms: arm 1: Dofetilide alone arm arm 2: Dofetilide combined with mexiletine arm 3: Dofetilide combined with lidocaine arm 4: Moxifloxacin with and without diltiazem. arm 5: Placebo (#2 gelcap and intravenous saline)
Interventions: intervention 1: Dofetilide intervention 2: Mexiletine intervention 3: Lidocaine intervention 4: Moxifloxacin intervention 5: Diltiazem intervention 6: Placebo
Intervention descriptions: intervention 1: * 8 am: Placebo
* 12 pm (noon): 250 µg
* 5:30 pm: 250 µg intervention 2: * 8 am: weight x 4 mg/kg
* 12 pm (noon): Same as at 8 am
* 5:30 pm: Same as at 8 am intervention 3: * 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes
* 2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes
* 7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes intervention 4: * 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)
* 2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)
* 7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes) intervention 5: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes intervention 6: Placebo (#2 Gelcap or IV saline)

Protocol documents:
Clinical trial NCT02512783
Conditions: Pain
Keywords: Propofol Lidocaine Intravenous propofol
Sponsor: Children's Hospitals and Clinics of Minnesota
Start date: 2013-05-01; Completion date: 2014-06-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

Detailed description:
Propofol is a short-acting, intravenously administered anesthetic. It has become a popular choice for procedural sedation in both children and adults. Despite its many advantages, Propofol is associated with a burning sensation during injection. Propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. Lidocaine is often used in an attempt to reduce Propofol injection pain, but neither its delivery mode nor concentration has been standardized.

The purpose of this study is to determine the efficacy of premedication with 1% Lidocaine in decreasing the burning sensation caused by intravenous Propofol.

This is a double blind, randomized, controlled study. The sedationist performing the sedation procedure will inject the appropriate amount of either a 1% Lidocaine solution or a placebo before the administration of Propofol. A research staff will observe the patient simultaneously with the induction of Propofol to determine the patient's pain level, as measured by the FLACC scale.

Arms: arm 1: Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. arm 2: Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.
Interventions: intervention 1: Lidocaine intervention 2: Normal Saline intervention 3: Propofol
Intervention descriptions: intervention 1: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation intervention 2: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation intervention 3: Intravenous administration of propofol according to standard care to sedate patient.

Protocol documents:
Clinical trial NCT00299494
Conditions: B-Cell Lymphoma
Keywords: Lymphoma NHL
Sponsor: Pfizer
Start date: 2006-05-04; Completion date: 2014-06-02
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of the study is to determine the tolerability, the initial safety profile and maximum tolerated dose, and to obtain preliminary information on the antitumor activity of inotuzumab ozogamicin \[CMC-544\] in combination with rituximab in subjects with follicular, diffuse large B-Cell, or mantle cell NHL.

Detailed description:

Arms: arm 1: Follicular arm 2: Diffuse Large B-cell Lymphoma arm 3: Refractory Aggressive NHL
Interventions: intervention 1: inotuzumab ozogamicin intervention 2: inotuzumab ozogamicin intervention 3: inotuzumab ozogamicin intervention 4: Rituximab
Intervention descriptions: intervention 1: IV, 1.8 mg/m2, q4w intervention 2: IV, 1.8 mg/m2, q4w intervention 3: IV, 1.8 mg/m2, q4w intervention 4: rituximab 375 mg/m\^2 via IV infusion on Day 1

Protocol documents:
Clinical trial NCT00949702
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2009-09-30; Completion date: 2014-06-03
Enrollment: 132 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label single arm study will assess the efficacy, safety and tolerability of Vemurafenib in previously treated patients with metastatic melanoma. Patients will receive oral Vemurafenib \[RG7204; PLEXXIKON: PLX4032\] at a dose of 960 mg b.i.d. continuously until disease progression or withdrawal from study and will be assessed at regular intervals for tumour response and tolerability. Target sample size is \<100 patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: vemurafenib
Intervention descriptions: intervention 1: 960 mg b.i.d. continuous oral dosing

Protocol documents: