ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01877668
Conditions: Psoriatic Arthritis
Keywords: psoriatic arthritis radiographic changes active comparator tofacitinib
Sponsor: Pfizer
Start date: 2014-01-20; Completion date: 2015-12-18
Enrollment: 422 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Tofacitinib 5 mg BID intervention 2: Tofacitinib 10 mg BID intervention 3: Adalimumab intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months intervention 2: Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months intervention 3: Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months intervention 4: Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months intervention 5: Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Protocol documents:
Clinical trial NCT01981954
Conditions: Neurogenic Detrusor Overactivity Pediatric
Keywords: Solifenacin succinate suspension Efficacy Safety
Sponsor: Astellas Pharma Europe B.V.
Start date: 2013-09-25; Completion date: 2015-12-18
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.

Detailed description:
In some children with a severe form of spina bifida (which is the consequence of a spinal cord defect), the bladder muscle (detrusor) contracts strongly and without warning (also known as neurogenic detrusor overactivity) and the urethra (the passage connecting the bladder with outside) does not relax. Though these children cannot void, urine leakage can happen when the overactive contractions are strong, and/or the pressure in the bladder is so high that it overcomes the closed urethra (overflow at high filling bladder pressure). This high bladder pressure puts these children at risk for kidney damage and can decrease the quality of the bladder. Therapy was aimed to decrease the high filling bladder pressure and the overactive detrusor contractions.

Arms: arm 1: Children aged 6 months to less than 5 years were treated with sequential titrated doses of solifenacin up to 12 weeks in the Titration period after which a fixed dose of solifenacin was given for at least 40 weeks in the Fixed-dose assessment period. Children received solifenacin once daily during these 2 periods.
Interventions: intervention 1: Solifenacin succinate
Intervention descriptions: intervention 1: Oral suspension

Protocol documents:
Clinical trial NCT02753075
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Start date: 2015-09-08; Completion date: 2015-12-18
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the longitudinal efficacy of two experimental oral rinses, one containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice daily brushing with a standard fluoride toothpaste.

Detailed description:

Arms: arm 1: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 1 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 2: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Experimental Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks. arm 3: Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 ml of Placebo Oral Rinse 2 for 1 minute. This regimen will be performed twice daily for 8 weeks.
Interventions: intervention 1: Experimental Oral Rinse 1 intervention 2: Experimental Oral Rinse 2 intervention 3: Placebo Oral Rinse intervention 4: Fluoride toothpaste
Intervention descriptions: intervention 1: Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5 intervention 2: Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5 intervention 3: Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5 intervention 4: Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate

Protocol documents:
Clinical trial NCT02502734
Conditions: Asthma
Keywords: inhaled corticosteroids pediatric subjects asthma fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2015-09-07; Completion date: 2015-12-21
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will be conducted to evaluate the effect of once daily treatment with fluticasone furoate (FF) on lower leg growth in pediatric subjects with persistent asthma by using knemometry. Approximately 65 paediatric asthmatic subjects, aged 5 to 11 years (inclusive), will be screened to achieve 60 randomised and 50 evaluable subjects. Subjects meeting the eligibility criteria will enter the 2 week run-in period. After completing run-in period, each subject will be randomly allocated to one of two treatment sequences: inhaled fluticasone furoate followed by placebo or placebo followed by inhaled fluticasone furoate. Each treatment will be administered via the ELLIPTA™ dry powder inhaler. The two treatment periods will be separated by a two-week wash-out period. Subjects completing two treatment period will enter into 7 days follow-up period. ARNUITY™ ELLIPTA (FF) is approved in the US for adults and adolescents aged 12 and above.

ARNUITY and ELLIPTA are a registered trademarks of the GlaxoSmithKline group of companies.

Detailed description:

Arms: arm 1: Subjects will receive oral inhalation of FF 50 μg administered via ELLIPTA, once daily (OD) for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo administered via ELLIPTA, OD for 14 days +/- 4 days in Period 2. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed. arm 2: Subjects will receive oral inhalation of placebo administered via ELLIPTA OD for 14 days +/- 4 days in Period 1 followed by receive oral inhalation of FF 50 μg administered via ELLIPTA, OD for 14 days +/- 4 days. The two treatment periods will be separated by a two-week wash-out period. Additionally all subjects will be provided salbutamol inhaler to be used for symptomatic relief of asthma symptoms during both the run-in and treatment periods as needed.
Interventions: intervention 1: Fluticasone furoate intervention 2: Placebo intervention 3: Salbutamol
Intervention descriptions: intervention 1: FF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA. intervention 2: Placebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA. intervention 3: Salbutamol will be provided as a inhaler.

Protocol documents:
Clinical trial NCT01950273
Conditions: Lymphoma, Follicular
Sponsor: Boehringer Ingelheim
Start date: 2013-09-27; Completion date: 2015-12-22
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL).

The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

Detailed description:

Arms: arm 1: BI695500, once a week for 4 weeks (4 administrations in total) arm 2: MabThera, once a week for 4 weeks (4 administration in total)
Interventions: intervention 1: BI 695500 intervention 2: MabThera
Intervention descriptions: intervention 1: BI695500, once a week for 4 weeks (4 administrations in total) intervention 2: MabThera, once a week for 4 weeks (4 administrations in total)

Protocol documents:
Clinical trial NCT02298192
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2014-11-21; Completion date: 2015-12-23
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, North America and the United States of America.

The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/liraglutide
Intervention descriptions: intervention 1: For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.

Protocol documents:
Clinical trial NCT02461563
Conditions: Hepatitis C Virus Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-06-23; Completion date: 2015-12-23
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate safety, pharmacokinetics (PK), and the ability of MK-1075 to suppress viral load (VL) in HCV-infected participants during 7 days of once daily dose administration. The primary hypothesis is at a once-daily dose that is sufficiently safe and well tolerated in HCV-infected participants, the mean maximum HCV RNA (log10 IU/mL) reduction is at least 3 log10 IU/mL as compared to baseline following multiple dose oral administration of MK-1075 in HCV genotype 1 (GT1) and genotype 3 (GT3) infected participants.

Detailed description:

Arms: arm 1: Fasted GT1 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 2: Fasted GT1 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 3: Fasted GT1 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 4: Fasted GT3 participants are administered 200 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 5: Fasted GT3 participants are administered 400 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days arm 6: Fasted GT3 participants are administered 800 mg MK-1075 in tablet form, orally, once daily for 7 consecutive days
Interventions: intervention 1: 200 mg MK-1075 intervention 2: 400 mg MK-1075 intervention 3: 800 mg MK-1075
Intervention descriptions: intervention 1: Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days intervention 2: Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days intervention 3: Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days

Protocol documents:
Clinical trial NCT01876251
Conditions: Breast Cancer Metastatic
Keywords: Breast cancer metastatic docetaxel PF-03084014
Sponsor: Pfizer
Start date: 2013-11-04; Completion date: 2015-12-24
Enrollment: 30 participants; Allocation: ; Intervention model: 

Brief summary:
This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.

Detailed description:

Arms: arm 1: PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m\^2
Interventions: intervention 1: PF-03084014 intervention 2: PF-03084014 intervention 3: PF-03084014 intervention 4: Docetaxel intervention 5: Docetaxel
Intervention descriptions: intervention 1: Tablet, 10 mg, twice a day intervention 2: Tablet, 50 mg, twice a day intervention 3: Tablet, 100 mg, twice a day intervention 4: Solution for IV infusion 75 mg/m\^2, every 3 weeks intervention 5: Solution for IV infusion 100 mg/m\^2, every 3 weeks

Protocol documents:
Clinical trial NCT02231164
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Start date: 2014-10-14; Completion date: 2015-12-24
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.

Detailed description:

Arms: arm 1: patients to receive backbone chemotherapy and placebo arm 2: patients to receive backbone chemotherapy and nintedanib
Interventions: intervention 1: docetaxel intervention 2: docetaxel intervention 3: placebo intervention 4: nintedanib
Intervention descriptions: intervention 1: intravenous chemotherapy drug intervention 2: intravenous chemotherapy drug intervention 3: oral placebo intervention 4: oral experimental therapy

Protocol documents:
Clinical trial NCT02549040
Conditions: Human Immunodeficiency Virus-1 (HIV-1)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-09-21; Completion date: 2015-12-24
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to evaluate and compare the relative bioavailability of different doravirine (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.

Detailed description:

Arms: arm 1: After a minimum 10 hour overnight fast, participants received a single oral dose during each of 5 periods. During Period 1, participants received Treatment B: Doravirine Type 1 dose (150 mg tablet \[40% drug loaded granule\]). During Period 2, participants received Treatment A: Doravirine 100 mg film coated tablet. During Period 3, participants received Treatment C: Doravirine Type 2 dose (150 mg tablet \[30% drug loaded granule\]). During Period 4, participants received Treatment D: Doravirine Type 3 dose (150 mg tablet \[50% drug loaded granule\]. During Period 5, participants received Treatment E: Doravirine Type 4 dose (100 mg tablet \[30% drug loaded granule\]). Each period was separated by a 14 day washout.
Interventions: intervention 1: Treatment A: Doravirine 100 mg film coated tablet intervention 2: Treatment B: Doravirine 150 mg tablet (40% drug loaded granule) intervention 3: Treatment C: Doravirine 150 mg tablet (30% drug loaded granule) intervention 4: Treatment D: Doravirine 150 mg tablet (50% drug loaded granule) intervention 5: Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)
Intervention descriptions: intervention 1: Single doravirine 100 mg film coated tablet administered orally at the start of Period 2 intervention 2: Single doravirine NF Type 1 dose (150 mg tablet \[40% drug loaded granule\]) administered orally at the start of Period 1 intervention 3: Single doravirine NF Type 2 dose (150 mg tablet \[30% drug loaded granule\])administered orally at the start of Period 3 intervention 4: Single doravirine NF Type 3 dose (150 mg tablet \[50% drug loaded granule\])administered orally at the start of Period 4 intervention 5: Single doravirine NF Type 4 dose (100 mg tablet \[30% drug loaded granule\]) administered orally at the start of Period 5

Protocol documents:
Clinical trial NCT01420081
Conditions: Endometrial Neoplasms
Keywords: uterine neoplasms endometrial uterine cancer PI3K mTOR PI3K/mTOR recurrent metastatic
Sponsor: Pfizer
Start date: 2012-01-19; Completion date: 2015-12-25
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the individual safety and efficacy of two dual PI3K/mTOR inhibitors in patients with recurrent endometrial cancer.

Detailed description:
The study was prematurely discontinued due to lack confidence in the Stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. The decision to terminate the study was made on January 23, 2014. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Arms: arm 1: PI3K Basal, IV Compound arm 2: PI3K Activated, Oral Compound arm 3: Japanese lead in cohort, IV compound
Interventions: intervention 1: PF-05212384 intervention 2: PF-05212384 intervention 3: PF-05212384
Intervention descriptions: intervention 1: 154mg IV weekly intervention 2: 154mg IV weekly intervention 3: 154mg IV weekly

Protocol documents:
Clinical trial NCT01498887
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Remitting Multiple Sclerosis Fingolimod Early multiple sclerosis Naive patients
Sponsor: Novartis Pharmaceuticals
Start date: 2011-12-24; Completion date: 2015-12-26
Enrollment: 347 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study assessed the efficacy of fingolimod in patients with short duration relapsing-remitting multiple sclerosis who had not been previously treated with disease-modifying therapies (DMTs), versus patients with the same disease duration who had previously received first-line DMTs.

Detailed description:

Arms: arm 1: Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months. arm 2: Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Interventions: intervention 1: Fingolimod (FTY720)
Intervention descriptions: intervention 1: Hard gelatin capsules containing 0.5 mg of fingolimod.

Protocol documents:
Clinical trial NCT01475825
Conditions: Hypercholesterolemia Heterozygous Familial
Sponsor: Kastle Therapeutics, LLC
Start date: 2011-12-01; Completion date: 2015-12-29
Enrollment: 309 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective:

Determine whether mipomersen (ISIS 301012) significantly reduces atherogenic lipid levels in patients with severe heterozygous familial hypercholesterolemia (severe HeFH), defined as low-density lipoprotein cholesterol (LDL-C) levels ≥200 mg/dL plus the presence of coronary heart disease (CHD)/risk equivalents or LDL-C levels ≥300 mg/dL regardless of the presence of CHD/risk equivalents (referred to as Cohort 1) compared to placebo. Two different mipomersen dosing regimens will be studied: subcutaneous (SC) mipomersen 200 mg once weekly versus placebo, and SC mipomersen 70 mg thrice weekly versus placebo.

Secondary Objectives:

* Determine whether there are qualitative differences between the safety profiles of the 2 dosing regimens and placebo in Cohort 1, patients with HeFH with LDL-C levels ≥160 mg/dL and \<200 mg/dL plus the presence of CHD/risk equivalents (referred to as Cohort 2), and the overall study population
* Determine whether there are qualitative differences between the tolerability of the 2 dosing regimens and placebo in Cohort 1, Cohort 2, and the overall study population
* Further characterize the pharmacokinetics (PK) of the 2 dosing regimens in Cohort 1, Cohort 2, and the overall study population
* Determine whether the 2 mipomersen dosing regimens significantly reduce atherogenic lipid levels in Cohort 2 compared to placebo
* Obtain additional data regarding ongoing safety and efficacy of mipomersen in patients with FH and inadequately controlled LDL-C who complete the primary efficacy assessment visit (PET) in the Blinded Treatment Period and continue treatment in Open-Label Continuation Period

Detailed description:
The study consisted of a Screening period of up to 4 weeks, Blinded Treatment Phase of 60 weeks, Open-Label Continuation Period of 26 weeks, and Post-Treatment Phase of 24 weeks.

Study Design, masking - Study treatment was blinded (double-blinded) through the Primary Efficacy Assessment Visit in the Blinded Treatment Period. Study treatment was open-label in the Open-Label Continuation Period.

Arms: arm 1: Subcutaneous injection of mipomersen 200 mg once weekly arm 2: Placebo matching subcutaneous injection once weekly. arm 3: Subcutaneous injection of mipomersen 70 mg thrice weekly. arm 4: Placebo matching subcutaneous injection thrice weekly.
Interventions: intervention 1: mipomersen sodium 200 mg intervention 2: Placebo intervention 3: mipomersen sodium 70 mg
Intervention descriptions: intervention 1: Subcutaneous mipomersen 200 mg once weekly intervention 2: Placebo vehicle for subcutaneous injection. intervention 3: Subcutaneous mipomersen 70 mg thrice weekly

Protocol documents:
Clinical trial NCT01414244
Conditions: Diarrhea-Predominant Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome Glutamine Intestinal Permeability
Sponsor: Tulane University
Start date: 2010-11-01; Completion date: 2015-12-30
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection.

Detailed description:
In a double-blind trial, eligible adults with post-infectious IBS with increased intestinal permeability were randomly assigned to receive either glutamine (5 g three times daily) or placebo for eight weeks. The primary end point was the proportion of patients who had a reduction of ≥50 on the Irritable Bowel Severity Scoring System (IBS-SS).

Arms: arm 1: Glutamine arm 2: Whey protein powder
Interventions: intervention 1: Glutamine
Intervention descriptions: intervention 1: Drug

Protocol documents: