ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01682538
Conditions: Healthy Volunteers
Keywords: Orfadin Nitisinone Bioequivalence Bioavailability
Sponsor: Swedish Orphan Biovitrum
Start date: 2012-08-01; Completion date: 2012-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

Detailed description:
This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as hard gelatin capsules (fasting only). There will be a 2-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Arms: arm 1: Orfadin capsules, single dose, 30 mg arm 2: Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL) arm 3: Orfadin suspension 4mg/mL, single dose 30 mg (7,5 mL)
Interventions: intervention 1: Nitisinone, capsule intervention 2: Nitisinone, suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01700140
Conditions: Radiotherapy-induced Nausea and Vomiting (RINV)
Sponsor: SymBio Pharmaceuticals
Start date: 2011-05-01; Completion date: 2012-10-01
Enrollment: 189 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

Detailed description:
Exploratory study of dose response of SyB D-0701 to preventing effects for nausea and emesis associated with radiotherapy (fractionated/localized irradiation)

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: SyB D-0701 intervention 2: Placebo
Intervention descriptions: intervention 1: Study drug patches \[Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch\] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation. intervention 2: Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.

Protocol documents:
Clinical trial NCT01701505
Conditions: Anesthesia
Keywords: operative dental procedure
Sponsor: St. Renatus, LLC
Start date: 2012-10-01; Completion date: 2012-10-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

Detailed description:
This is a single-center, open-label, randomized, parallel-groups, dose-ranging study to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

The study will employ an open-label design to determine the lowest effective doses (LEDs), and assess the safety and efficacy of Kovacaine Mist administered intranasally for inducing pulpal anesthesia of maxillary primary teeth numbers A to J and maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure, and will be carried out in healthy children of either sex between the ages of 3 and 17 years, inclusive.

Arms: arm 1: 400uL of Kovacaine Mist, as 2 sprays of 200uL. arm 2: 200uL of Kovacaine Mist, as 2 sprays of 100uL. arm 3: 120uL of Kovacaine Mist, as 2 sprays of 60uL.
Interventions: intervention 1: 400uL of Kovacaine Mist intervention 2: 200uL of Kovacaine Mist intervention 3: 120uL of Kovacaine Mist
Intervention descriptions: intervention 1: 2 unilateral intranasal sprays of 200uL each. intervention 2: 2 unilateral intranasal sprays of 100uL each. intervention 3: 2 unilateral intranasal sprays of 60uL each.

Protocol documents:
Clinical trial NCT01768013
Conditions: Psoriasis Vulgaris
Sponsor: LEO Pharma
Start date: 2012-07-01; Completion date: 2012-10-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The pharmacokinetics of LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate) in Japanese subjects with extensive psoriasis vulgaris.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LEO 90105
Intervention descriptions: intervention 1: Once daily for four weeks

Protocol documents:
Clinical trial NCT01919606
Conditions: Postoperative Pain
Keywords: hysterectomy analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-08-01; Completion date: 2012-10-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the optimal of two different volumes of EXPAREL 266 mg when administered via infiltration into the transversus abdominis plane (TAP) for prolonged postoperative analgesia in subjects undergoing open total abdominal hysterectomy.

Detailed description:
This is a prospective, open-label, non-randomized study with two treatment groups differing only in the volume of EXPAREL infiltrated into the TAP. All subjects will undergo an open total abdominal hysterectomy. The dose of EXPAREL for the TAPs will be the same for all 20 subjects, 133 mg on the right side of the abdomen and 133 mg on the left side of the abdomen.

Arms: arm 1: EXPAREL 266 mg diluted with saline to a volume of 40 mL arm 2: EXPAREL 266 mg diluted with saline to a volume of 60 mL
Interventions: intervention 1: EXPAREL
Intervention descriptions: intervention 1: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.

Protocol documents:
Clinical trial NCT01963091
Conditions: Cocaine Dependence
Sponsor: Medical University of South Carolina
Start date: 2011-07-01; Completion date: 2012-10-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Stress is associated with drug craving and relapse in substance-dependent individuals. Hormones released from the brain may mediate the behavioral response to stress. For example, several studies have indicated that oxytocin reduces stress in laboratory stress paradigms. Specifically, it appears that oxytocin promotes trust, social interaction, and calmness; yet, little is known about the potential affects of oxytocin in cocaine-dependent individuals. Given these properties of oxytocin, it may have a therapeutic role in ameliorating the negative affect commonly observed prior to relapse in cocaine-dependent individuals, as well as the anxiety associated with withdrawal. This pilot protocol will provide important preliminary data on the effect of oxytocin on stress in cocaine-dependent individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: oxytocin intervention 2: saline
Intervention descriptions: intervention 1: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary. intervention 2: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.

Protocol documents:
Clinical trial NCT01999114
Conditions: ECG Effects
Keywords: Healthy subjects Opioid Transdermal ECG
Sponsor: Purdue Pharma LP
Start date: 2012-03-01; Completion date: 2012-10-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ECG effects of 10, 40, and 80 mcg/hr buprenorphine delivered by BTDS alone, or by BTDS dosed with naltrexone, relative to placebo in healthy male and female subjects.

Detailed description:

Arms: arm 1: Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr arm 2: Buprenorphine transdermal patches 10, 40 (2 x 20), and 80 (4 x 20) mcg/hr and naltrexone 50 mg tablets arm 3: Naltrexone 50 mg tablets arm 4: Matching placebo for transdermal patches and/or naltrexone tablets and/or moxifloxacin tablets arm 5: Moxifloxacin 400-mg tablets
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Naltrexone tablet intervention 3: Placebos (for TDS and for naltrexone and for moxifloxacin) intervention 4: Moxifloxacin tablet
Intervention descriptions: intervention 1: Buprenorphine patch applied transdermally intervention 2: Naltrexone tablet; 1 tablet taken orally every 12 hours intervention 3: Matching placebos intervention 4: Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17

Protocol documents:
Clinical trial NCT02014272
Conditions: Healthy Volunteers
Keywords: Bioequivalence RIN 150 Healthy volunteers
Sponsor: Pfizer
Start date: 2012-09-01; Completion date: 2012-10-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.

Detailed description:

Arms: arm 1: RIN 150 contains 150 rifampicin and 75 mg isoniazid arm 2: Individual references of rifampicin and isoniazid
Interventions: intervention 1: RIN 150 intervention 2: reference drugs
Intervention descriptions: intervention 1: Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid. intervention 2: Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.

Protocol documents:
Clinical trial NCT02084797
Conditions: Electrolyte Imbalance Hyponatremia Hypernatremia
Keywords: arginine vasopressin sweat sodium V2 antagonist running
Sponsor: Oakland University
Start date: 2011-06-01; Completion date: 2012-10-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This primary aim of this study was to critically assess whether or not sweat water content and sodium concentration were acutely regulated by dynamic changes in antidiuretic hormone (arginine vasopressin or AVP) acting on the Vasopressin 2 receptor (V2R) during exercise. Secondary aims were to evaluate running performance and core temperature to further characterize the role of AVP in the coordinated balance of fluid and temperature homeostasis during exercise. The primary hypothesis was that activation of the V2R in sweat glands would result in water reabsorption and fluid conservation during endurance exercise.

Detailed description:
Ten healthy habitual runners (\> 50km running per week) between 18-60 years of age participated in this double blind randomized control trial. Each subject presented to the exercise lab on four separate occasions. Trial 1 was a familiarization trial to determine each subject's maximal aerobic capacity and peak treadmill running speak (VO2 Peak test). Trials 2, 3 and 4 utilized the same exact protocol, differing only in pharmacological intervention. In a randomized, double-blind order (both participant and investigator blinded to the intervention), either a placebo pill, the V2 receptor antagonist tolvaptan (Samsca™, 30mg tablet), or the V2 receptor agonist desmopressin (DDAVP™, 0.2mg tablet) was ingested along with the CorTemp™ Core Temperature Sensor two hours before commencement of the Exercise Trial with 240mL of bottled water. The exercise protocol consisted of 60 minutes of treadmill running at 60% of peak speed (steady-state) followed by a performance test (the VO2 Peak test). Blood, saliva and urine, were collected before the exercise trial (baseline) and again after both the steady-state run and performance runs. Sweat was obtained from sweat patches after both the steady-state and performance runs. Core temperature, fluid intake, performance time, body weight, thirst and sodium palatability ratings were also assessed. Free access to water was allowed during the trial and all urine produced during the trial was measured and collected. The main outcome measure was sweat sodium concentration.

Arms: arm 1: All study participants received all interventions. V2R Antagonist: 30mg Tolvaptan tablet ingested 2 hours before exercise. V2R agonist: 0.2mg DDAVP tablet ingested 2 hours before exercise Placebo
Interventions: intervention 1: V2R (Vasopressin 2 receptor)
Intervention descriptions: intervention 1: All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state).

Protocol documents:
Clinical trial NCT02144259
Conditions: Weight
Sponsor: University of Pennsylvania
Start date: 2011-04-01; Completion date: 2012-10-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective mixed methods study to assess weight changes in women randomized to receive Implanon ® or Depo Provera® (DMPA) immediately postpartum compared to women who choose non-hormonal contraception or no contraception immediately postpartum. After enrollment, subjects return for a visit at 3, 6 and 12 months postpartum to be asked a series of questions, take a pregnancy test, and be weighed. Total length of participation for each subject is 1 year or until pregnancy.

Detailed description:

Arms: arm 1: Subjects randomized to receive DepoProvera(DMPA) immediately post-partum. arm 2: Subjects randomized to receive Implanon immediately post-partum. arm 3: Subjects selecting their own method of contraception or no contraception.
Interventions: intervention 1: DMPA immediately postpartum intervention 2: Implanon immediately postpartum
Intervention descriptions: intervention 1: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate. intervention 2: Implanon ® is a subdermal implant that contains 68mg of etonogestrel.

Protocol documents:
Clinical trial NCT03887442
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer Cetuximab Erbitux Paclitaxel Extreme Metastatic Recurrent
Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Start date: 2011-02-16; Completion date: 2012-10-02
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) after progression to first line EXTREME-type treatment in patients undergoing maintenance treatment with cetuximab.

Detailed description:

Arms: arm 1: Paclitaxel 80 mg/m2 may be infused, intravenously, every week. arm 2: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
Interventions: intervention 1: Paclitaxel intervention 2: Cetuximab + Paclitaxel
Intervention descriptions: intervention 1: Paclitaxel 80 mg/m2 may be infused, intravenously, every week. intervention 2: Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.

Protocol documents:
Clinical trial NCT01513291
Conditions: Migraine Headache
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-02-06; Completion date: 2012-10-03
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of MK-6096 versus placebo for preventing migraines in participants with episodic migraine. After a 28-day Screening period during which baseline number of monthly migraine days was assessed, participants were randomized to receive MK-6096 or placebo for a 12-week Treatment Period. Participants who completed all 12 weeks of the Treatment Period received drug or placebo for an additional 2 weeks in the Run-out Period. Treatment assignment in the Run-out Period was determined at the initial randomization. In the Run-out Period, participants who received placebo in the Treatment Period continued to receive placebo and participants who received MK-6096 in the Treatment Period 2 received either MK-6096 or placebo in a 1:1 ratio. The hypothesis tested in the study is that MK-6096 10 mg is superior to placebo in reducing migraine frequency as measured by the mean change from baseline in monthly migraine days averaged over the 12- week treatment period.

Detailed description:

Arms: arm 1: Participants were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period were randomized 1:1 to receive double-blind MK-6096 or placebo once daily in the 2-week Run-out Period. arm 2: Participants were randomized to receive double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period. Those who completed the Treatment Period continued to receive double-blind placebo once daily in the 2-week Run-out Period.
Interventions: intervention 1: MK-6096 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily intervention 2: Placebo, 2 tablets, orally, once daily

Protocol documents:
Clinical trial NCT01392573
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-11-28; Completion date: 2012-10-04
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) and insulin degludec (IDeg) in subjects with type 2 diabetes. Subjects continue their pre-trial treatment with metformin throughout the entire trial.

Detailed description:

Arms: arm 1: IDegLira was injected subcutaneously once daily for 26 weeks. arm 2: IDeg was injected subcutaneously once daily for 26 weeks.
Interventions: intervention 1: insulin degludec/liraglutide intervention 2: insulin degludec
Intervention descriptions: intervention 1: IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily. intervention 2: IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.

Protocol documents:
Clinical trial NCT01577537
Conditions: Bacterial Vaginosis
Keywords: SPL7013 VivaGel bacterial vaginosis BV
Sponsor: Starpharma Pty Ltd
Start date: 2012-04-17; Completion date: 2012-10-05
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).

After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 1% SPL7013 Gel intervention 2: Placebo
Intervention descriptions: intervention 1: Vaginal gel, daily for 7 days intervention 2: Vaginal gel, daily for 7 days

Protocol documents:
Clinical trial NCT01196871
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Pharmacokinetics
Sponsor: Amicus Therapeutics
Start date: 2011-02-02; Completion date: 2012-10-09
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.

Detailed description:
This open-label study was conducted in 2 stages (Stage 1, Stage 2). Stage 1 included migalastat 150 mg; Stage 2 included migalastat 450 mg. Each dose of migalastat was selected to evaluate interaction with each of 3 doses of recombinant agalsidase: 0.5 mg/kilogram (kg) agalsidase beta; 1.0 mg/kg agalsidase beta; 0.2 mg/kg agalsidase alfa.

Migalastat was administered orally. Agalsidase alfa was administered as a 40-minute intravenous (IV) infusion and agalsidase beta was administered as a 2-hour (hr) IV infusion.

Stage 1 consisted of 3 treatment periods with 14 days intervening between each period.

Period 1, Day 1: agalsidase was administered alone.

Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.

Period 3, Day 7: migalastat was administered alone.

Stage 2 consisted of two 14-day treatment periods in which the plasma exposure of migalastat was characterized when migalastat was administered with agalsidase solely to confirm the attainment of adequate migalastat plasma concentrations.

Period 1, Day 1: agalsidase was administered as an IV infusion using a calibrated infusion pump.

Period 2, Day 1: migalastat was administered, followed 2 hrs later by agalsidase.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Migalastat HCl intervention 2: Agalsidase Beta intervention 3: Agalsidase Alfa
Intervention descriptions: intervention 1: Oral capsules, single dose intervention 2: IV infusion, single dose intervention 3: IV infusion, single dose

Protocol documents: