ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02114177
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C Virus Infection Simeprevir Sofosbuvir HCV Cirrhosis
Sponsor: Janssen Infectious Diseases BVBA
Start date: 2014-04-01; Completion date: 2015-04-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

Detailed description:
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), multicenter study. The study will consist of a screening phase up to 6 weeks, open-label treatment phase of 8 weeks or 12 weeks, and post-treatment follow up phase up to 24 weeks after end of treatment. Approximately 300 participants will be randomly allocated in a 1:1 ratio to receive 150 mg simeprevir in combination with 400 mg sofosbuvir once daily either for 12 weeks (Arm 1) or 8 weeks (Arm 2). Safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum study duration for each participant will be approximately 42 weeks.

Arms: arm 1: 150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks. arm 2: 150 participants will receive 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks.
Interventions: intervention 1: Simeprevir intervention 2: Simeprevir intervention 3: Sofosbuvir intervention 4: Sofosbuvir
Intervention descriptions: intervention 1: 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1. intervention 2: 150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2 intervention 3: 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1. intervention 4: 150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.

Protocol documents:
Clinical trial NCT02117050
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Rebif ® Tecfidera ™ treatment change
Sponsor: EMD Serono
Start date: 2014-06-01; Completion date: 2015-04-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase IV, prospective, open-label, multi-center trial to assess the treatment satisfaction in patients with relapsing forms of Multiple Sclerosis (MS) who are currently being treated with, but are considering discontinuing treatment with Tecfidera™.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Rebif®
Intervention descriptions: intervention 1: Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.

Protocol documents:
Clinical trial NCT02118766
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Sponsor: Pfizer
Start date: 2014-03-01; Completion date: 2015-04-01
Enrollment: 763 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.

Detailed description:

Arms: arm 1: AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days arm 2: Matching vehicle control, applied twice daily for up to 28 days
Interventions: intervention 1: AN2728 Topical Ointment, 2% intervention 2: Matching vehicle control
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02118792
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Sponsor: Pfizer
Start date: 2014-03-01; Completion date: 2015-04-01
Enrollment: 764 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.

Detailed description:

Arms: arm 1: AN2728 Topical Ointment, 2%, applied twice daily for up to 28 days arm 2: Matching vehicle control, applied twice daily for up to 28 days
Interventions: intervention 1: AN2728 Topical Ointment, 2% intervention 2: Matching vehicle control
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02121522
Conditions: Wet Macular Degeneration
Sponsor: Boehringer Ingelheim
Start date: 2014-06-01; Completion date: 2015-04-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.

Detailed description:

Arms: arm 1: twice daily
Interventions: intervention 1: BI 144807
Intervention descriptions: intervention 1: twice daily

Protocol documents:
Clinical trial NCT02139540
Conditions: Depression Major Depressive Disorder
Keywords: Treatment
Sponsor: Washington University School of Medicine
Start date: 2012-11-01; Completion date: 2015-04-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Major depressive disorder (MDD) is a global medical problem with significant shortcomings in current therapy. Chief among these is the delay between initiation of pharmacologic therapy and clinical improvement in symptoms. Recently ketamine, an NDMA-receptor antagonist has been shown to rapidly and effectively reverse the symptoms of MDD. Nitrous oxide, another NMDA-receptor antagonist, may produce the same effect with a cleaner side-effect profile and perhaps without the need for intravenous access and anesthesia personnel. Therefore, we propose conducting a pilot randomized placebo controlled double-blind crossover study in which patients will receive up to 50% nitrous oxide in oxygen or up to 50% oxygen in air for a period of one hour in addition to standard medical therapy. Depression severity will be assessed by a blinded observer pre-treatment, 30 minutes and 2 hours post treatment using the Hamilton depression rating scale.

Detailed description:
We will study 20 patients with non-treatment resistant major depression and 20 patients with treatment-resistant major depression, defined as failure of at least 2 antidepressants in the current depressive episode and 3 lifetime medication failures.

Arms: arm 1: First session: Nitrous oxide Second session: placebo arm 2: First session: Placebo Second session: Nitrous Oxide
Interventions: intervention 1: Nitrous Oxide intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or "placebo" (50% nitrogen \[inert\]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart. intervention 2: 50% nitrogen \[inert\]/50% oxygen - otherwise completely identical administration and setup

Protocol documents:
Clinical trial NCT02146248
Conditions: Tubal Patency
Keywords: hysterosalpingography, DMPA, combined oral contraceptive, tubal patency
Sponsor: Jeffrey Jensen
Start date: 2014-05-01; Completion date: 2015-04-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators' research group is working to develop a highly effective, low cost non-surgical method of permanent contraception for women. To support this goal, we need to know more about the normal fallopian tube (tube that passes the egg from the ovary into the womb). The purpose of this study is to learn about how menstrual cycles and hormonal contraceptives affect tubal patency. Normally there is an opening between the tube and uterus to permit the flow of fluid and cells. If this opening is blocked, this can result in infertility. Tubal patency is when a woman's fallopian tubes are not blocked. Tubal patency is determined by an x-ray test called a hystero-(uterus)salpingo-(fallopian tube)graphy (HSG). HSG is a standard radiological imaging study that is used to determine if the fallopian tubes are open and free of disease. It is commonly done in women with an infertility diagnosis. The investigators usually do this test in the first 10 days of the menstrual cycle. Sometimes the tubes will appear to be blocked on the HSG when they are actually open. The timing of the HSG study during the menstrual cycle, or the use of hormonal contraception may make a difference in whether the tubes appear blocked on the HSG when they are actually patent.

The results of the HSG test provide a good model for how our nonsurgical permanent contraception method might work. The investigators think that if the tubes are not patent, that our treatment will not work as well. Therefore, in this study we want to learn if menstrual cycle timing or current hormonal contraception use will affect the patency of the tubes as assessed by the HSG. The investigators want to examine the same women to see if tubal patency is changes during the menstrual cycle and during the use of a birth control pill and the birth control shot.

Detailed description:

Arms: arm 1: Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).

2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.
Interventions: intervention 1: combined oral contraceptive intervention 2: DepoProvera
Intervention descriptions: intervention 1: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption intervention 2: injectable hormonal contraceptive

Protocol documents:
Clinical trial NCT02168361
Conditions: Chronic Hepatitis C
Keywords: cirrhosis
Sponsor: Center For Hepatitis C, Atlanta, GA
Start date: 2013-12-01; Completion date: 2015-04-01
Enrollment: 93 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.

Detailed description:
Patients can be treatment naive or prior null response to Peg/RBV, and must be genotype subtype 1a.

Must have Child's Class A cirrhosis/compensated and no history of decompensation

Arms: arm 1: Pegylated Interferon Alfa-2b (1.5 ugm/kg/week subcutaneously) plus ribavirin (1000-1200 mg daily orally) plus sofosbuvir (400 mg daily) for 12 weeks arm 2: (SIM-SOF) which is Simeprevir + Sofosbuvir for 12 weeks
Interventions: intervention 1: Pegylated Interferon alfa-2b intervention 2: Simeprevir intervention 3: Ribavirin intervention 4: Sofosbuvir
Intervention descriptions: intervention 1: 1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total intervention 2: 150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks intervention 3: 1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir intervention 4: 12 weeks of combination sofosbuvir and simeprevir

Protocol documents:
Clinical trial NCT02201342
Conditions: Single Ventricle Heart Disease After Fontan Surgery
Keywords: Fontan Pharmacokinetics Pharmacodynamics Exercise capacity Maximal Oxygen Consumption Vascular function EndoPAT Myocardial performance
Sponsor: Mezzion Pharma Co. Ltd
Start date: 2014-07-01; Completion date: 2015-04-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.

Detailed description:
A dose escalation trial to determine the pharmacokinetics, safety and tolerance of udenafil in male and female adolescent subjects with single ventricle physiology that that have undergone the Fontan surgical procedure. Pharmacodynamic data will also be collected to evaluate the effect of udenafil on acute exercise performance, peripheral vascular function and indices of myocardial performance. Five udenafil cohorts will be evaluated in additional to one drug free cohort

Arms: arm 1: Udenafil 37.5 mg tablet once daily for 5 days arm 2: Udenafil 37.5 mg tablet twice daily for 5 days arm 3: Udenafil 87.5 mg tablet once daily for 5 days arm 4: Udenafil 87.5 mg tablet twice daily for 5 days arm 5: Udenafil 125 mg tablet once daily for 5 days arm 6: Cohort undergoing exercise test only
Interventions: intervention 1: Udenafil
Intervention descriptions: intervention 1: Drug

Protocol documents:
Clinical trial NCT02209181
Conditions: Pain
Keywords: dental pain post-surgical dental pain
Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Start date: 2014-08-01; Completion date: 2015-04-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

Detailed description:
This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232, administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. Subjects will stay at the research center for \~24 hours after administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. They will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: JNJ-10450232 / Not yet marketed intervention 2: JNJ-10450232 / Not yet marketed intervention 3: JNJ-10450232 / Not yet marketed intervention 4: acetaminophen / Tylenol
Intervention descriptions: intervention 1: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. intervention 2: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. intervention 3: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level. intervention 4: Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

Protocol documents:
Clinical trial NCT02213250
Conditions: Hemophilia B
Sponsor: Pfizer
Start date: 2015-03-01; Completion date: 2015-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: BENEFIX
Intervention descriptions: intervention 1: Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.

Protocol documents:
Clinical trial NCT02218424
Conditions: Pain
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Start date: 2014-10-01; Completion date: 2015-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a double-blind randomized controlled trial using intravenous magnesium versus placebo to determine if systemic magnesium can decrease postoperative pain in pediatric patients undergoing tonsillectomy.

Participants will be in one of two arms. Those in Arm 1 will receive magnesium (30 mg/kg bolus followed by a 10mg/kg/hr infusion) while those in Arm 2 will receive an equal volume of normal saline bolus followed by infusion (placebo).

The primary objective is to determine if systemic magnesium will decrease postoperative pain in patients undergoing tonsillectomy. The secondary objectives will determine if systemic magnesium administration is associated with a decrease in opioid-related side effects, decrease the incidence of emergence delirium, and improve postoperative functional recovery.

The study hypothesis is that the use of intravenous magnesium will decrease postoperative pain, decrease opioid-related side effects, decrease the incidence of emergence delirium, and improve functional recovery in patients undergoing tonsillectomy.

Detailed description:

Arms: arm 1: Intravenous magnesium. After IV placed intraoperatively, a bolus dose of magnesium 30 mg/kg is given over 15 minutes, followed by a continuous infusion of magnesium at 10 mg/kg/hr until the completion of the procedure. arm 2: Intravenous normal saline will be given as placebo. An equal amount of volume normal saline will be given intravenously as the control group.
Interventions: intervention 1: Magnesium intervention 2: Normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02220712
Conditions: Schizophrenia
Keywords: Aripiprazole Deltoid
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-07-01; Completion date: 2015-04-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-14597 IMD
Intervention descriptions: intervention 1: Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Protocol documents:
Clinical trial NCT02226653
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2014-09-01; Completion date: 2015-04-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.

Detailed description:

Arms: arm 1: Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods arm 2: Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT02227693
Conditions: Thrombocytopenia Associated With Chronic Liver Disease
Keywords: Thrombocytopenia Chronic Liver Disease
Sponsor: Eisai Co., Ltd.
Start date: 2014-07-01; Completion date: 2015-04-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver disease. This study will assess the effect of avatrombopag on platelet counts in Japanese subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count measured at Screening and Baseline. Within the lower baseline platelet count cohort (less than 40 x 10\^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher baseline platelet count cohort (from 40 to less than 50 x 10\^9/L), subjects will be randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for 5 days.

Detailed description:
This study will consist of Prerandomization Phase and Randomization Phase. The Prerandomization Phase includes a Screening Period (Day -28 to Day -1) and a Baseline Period (Day 1). During the Prerandomization Phase, participants will be divided into two cohorts based on the platelet count: Low Platelet Count Cohort and High Platelet Count Cohort. Participants in Low Platelet Count Cohort will be randomized to receive one of the four treatments: Placebo, Avatrombopag 20 mg, Avatrombopag 40 mg, or Avatrombopag 60 mg. Participants in High Platelet Count Cohort will be randomized to receive one of the three treatments: Placebo, Avatrombopag 20 mg, or Avatrombopag 40 mg.

The Randomization Phase includes the Treatment Period and the Follow-up Period. The Follow-up Period comprises 3 visits: Visit 4 (5 to 8 days after last dose of study drug \[Study Day 10 to 13\]), Visit 5 (12 to 15 days after last dose of study drug \[Study Day 17 to 20\]), and 30 days after receiving the last dose of study drug.

Arms: arm 1: 20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) once daily on Days 1 through 5 arm 2: 40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) once daily on Days 1 through 5 arm 3: 60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5 arm 4: Placebo (3 x 20-mg matching placebo tablets) once daily on Days 1 through 5
Interventions: intervention 1: avatrombopag intervention 2: Placebo
Intervention descriptions: intervention 1: E5501 (avatrombopag) 20-mg tablets intervention 2: Placebo matching 20-mg tablets

Protocol documents: