ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00141921
Conditions: Pediatric Plaque Psoriasis
Keywords: Immunex Amgen Pediatric, plaque psoriasis clinical trial
Sponsor: Amgen
Start date: 2005-08-11; Completion date: 2017-08-16
Enrollment: 182 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric patients with moderate to severe psoriasis.

Detailed description:
This study was a multicenter, open-label extension study for pediatric patients who participated in Study 20030211 (NCT00078819).

Arms: arm 1: Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT00528957
Conditions: HIV Infections
Keywords: Phase 3 Randomized, Open-Label Treatment-Experienced Highly Active Antiretroviral Therapy HIV Tenofovir DF Pediatrics
Sponsor: Gilead Sciences
Start date: 2006-12-28; Completion date: 2017-08-16
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tenofovir DF intervention 2: Zidovudine intervention 3: Stavudine
Intervention descriptions: intervention 1: Tenofovir DF (oral powder or tablet): 300-mg tablets for participants \> 37 kg; 8-mg/kg oral powder (up to 300 mg) for participants ≤ 37 kg. During the extension phase, participants whose weight increases to \> 37 kg may be switched from the oral powder to the tenofovir DF tablet. intervention 2: Zidovudine as prescribed by the investigator prior to study entry (pediatric participants \< 30 kg: 1 mg/kg/dose given every 12 hours; pediatric participants ≥ 30 kg: 30 mg twice daily). intervention 3: Stavudine as prescribed by the investigator prior to study entry (pediatric participants 6 weeks to 12 years of age: 160 mg/m\^2 every 8 hours; pediatric participants \> 12 years of age: 300 mg twice daily).

Protocol documents:
Clinical trial NCT01307423
Conditions: Psoriatic Arthritis
Keywords: psoriasis Arthritis Psoriatic Arthritis inflammation skin condition inflammatory cells apremilast CC-10004 phosphodiesterase type 4
Sponsor: Amgen
Start date: 2010-12-09; Completion date: 2017-08-16
Enrollment: 529 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Detailed description:
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Arms: arm 1: Apremilast 20mg twice daily, orally arm 2: Apremilast 30mg twice daily, orally arm 3: Placebo + 20mg Apremilast tablets administered twice daily arm 4: Placebo + 30mg Apremilast tablets administered twice daily
Interventions: intervention 1: Apremilast 20mg intervention 2: Apremilast 30mg intervention 3: Placebo
Intervention descriptions: intervention 1: Apremilast 20mg twice daily, orally intervention 2: Apremilast 30mg twice daily, orally intervention 3: Placebo

Protocol documents:
Clinical trial NCT01540409
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51
Sponsor: Sarepta Therapeutics, Inc.
Start date: 2012-02-27; Completion date: 2017-08-16
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to assess the ongoing efficacy, safety, and tolerability of an additional 212 weeks of treatment with eteplirsen injection in Duchenne muscular dystrophy (DMD) subjects who have successfully completed the 28 week eteplirsen study: Study 4658-us-201. This study will also evaluate the correlation between biomarkers for DMD and the clinical status of participating DMD subjects.

Detailed description:
This is an open label, multiple dose extension study to assess the ongoing efficacy, safety, and tolerability of weekly intravenous (IV) infusions of eteplirsen in DMD subjects who have successfully completed Study 4658-us 201.

Subjects will have the opportunity to enroll in this study during the last visit of Study 4658-us-201 (Week 28). Eligible subjects will receive once weekly IV infusions of eteplirsen (50 or 30 mg/kg) for an additional 212 weeks. Subjects will receive the same dose of eteplirsen they received in Study 4658-us-201. Subjects will thereafter continue to receive once weekly IV infusions of eteplirsen for up to an additional 72 week period (through week 284). If commercial eteplirsen becomes available during this additional 72 week period, participation in the study will be discontinued as subjects transition to commercial eteplirsen.

Safety, efficacy, pharmacokinetic (PK), and biomarker assessments will be performed at scheduled visits; adverse events (AEs) and concomitant medications and therapies will be continuously monitored.

If review of data from this open label study suggests that continued treatment with eteplirsen is warranted, this study may be extended by protocol amendment or subjects who successfully complete this study may have the opportunity to participate in a separate follow on, open label eteplirsen study.

Arms: arm 1: Multiple-Dose Extension Study
Interventions: intervention 1: AVI-4658 (Eteplirsen)
Intervention descriptions: intervention 1: Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.

Protocol documents:
Clinical trial NCT02415595
Conditions: Infection, Human Immunodeficiency Virus
Sponsor: ViiV Healthcare
Start date: 2015-05-12; Completion date: 2017-08-21
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

Detailed description:

Arms: arm 1: BMS-955176 at 60 mg active dose per day + BMS-955176 placebo matching 120 mg + efavirenz (EFV) placebo matching 600 mg + tenofovir/emtricitabine (TDF/FTC) 300/200 mg per day, orally arm 2: BMS-955176 placebo matching 60 mg + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC 300/200mg per day, orally arm 3: BMS-955176 at 60mg active dose per day + BMS-955176 at 120mg active dose per day + EFV placebo matching 600mg + TDF/FTC at 300/200mg per day, orally arm 4: BMS-955176 placebo matching 60mg + BMS-955176 placebo matching 120mg + EFV at 600mg per day + TDF/FTC 300/200mg per day
Interventions: intervention 1: BMS-955176 intervention 2: EFV intervention 3: TDF/FTC
Intervention descriptions: intervention 1: HIV Maturation Inhibitor intervention 2: EFV intervention 3: TDF/FTC

Protocol documents:
Clinical trial NCT01285609
Conditions: Lung Cancer - Non Small Cell Squamous
Sponsor: Bristol-Myers Squibb
Start date: 2011-01-16; Completion date: 2017-08-22
Enrollment: 1289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Detailed description:
The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Arms: arm 1: Ipilimumab + Active Chemo Backbone

Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses arm 2: Placebo + Active Chemo Backbone

Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)

Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses

Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses
Interventions: intervention 1: Ipilimumab intervention 2: Placebo intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02310789
Conditions: Cystic Fibrosis
Sponsor: Richard Barry Moss
Start date: 2015-07-31; Completion date: 2017-08-23
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Clinical studies of lumacaftor + ivacaftor (combo therapy) produced better FEV1 (forced expiratory volume in 1 second) improvements than ivacaftor alone, without further improvement in sweat chloride results.

To help understand why sweat chloride was unresponsive, the investigators will use a newly developed sweat secretion test that provides accurate, in vivo readout of CFTR (cystic fibrosis transmembrane conductance regulator) function in the sweat gland secretory coil.

The investigators devised a protocol to determine if short courses of ivacaftor (3.5 days) will produce significant increases in WT (Wild-Type, i.e. normal) CFTR open probability by measuring CFTR-dependent sweating (C-sweat) in subjects with WT CFTR.

Detailed description:
Cystic fibrosis (CF) is a genetic disease caused by malfunctioning of a protein called CFTR.

CF affects various organs including the sweat glands and the lungs. An FDA approved drug called ivacaftor helps some people with CF, and laboratory tests show that it produces further improvement when combined with an investigational drug called lumacaftor. However, results from clinical tests of the two drugs used together gave mixed results: lung function improved but sweat gland function did not improve. This study will measure CFTR-dependent sweat rate to test the hypothesis that CFTR in the normal sweat glands might be functioning at peak efficiency, and so can't be improved further with ivacaftor, thus accounting for the apparent discrepancy between lung function and sweat gland results. CFTR-dependent sweat rate is important to understanding CF because it is a very accurate measure of CFTR function.

Arms: arm 1: Participants will receive ivacaftor orally for 3 days, followed by 35 days off drug. Participants will repeat this cycle then receive ivacaftor for 3 additional days. For sweat testing, participants will receive β-adrenergic cocktail to stimulated sweating, at both 1% stimulation strength and full stimulation strength. Each participant will also receive pilocarpine nitrate 5% administered by Macroduct sweat stimulator device. Sweat stimulation testing will be done on- and off-ivacaftor.
Interventions: intervention 1: Ivacaftor intervention 2: β-Adrenergic cocktail intervention 3: Pilocarpine Nitrate 5% intervention 4: Macroduct sweat stimulator
Intervention descriptions: intervention 1: 150mg administered orally twice daily. intervention 2: Administered subcutaneously to induce sweating. Cocktail composed of atropine (280µM), isoproterenol (160µM), and aminophylline (20 mM). intervention 3: Administered subcutaneously using Macroduct sweat stimulator device. intervention 4: None

Protocol documents:
Clinical trial NCT00866697
Conditions: Ovarian Cancer
Keywords: fallopian tube cancer pazopanib anti-angiogenesis ovarian cancer primary peritoneal cancer tyrosine kinase inhibitors gynecologic cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2009-05-26; Completion date: 2017-08-24
Enrollment: 940 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.

Detailed description:
This was a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO (International Federation of Gynecology and Obstetrics) Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that had not progressed (i.e., complete response (CR), partial response (PR), stable disease (SD) after completing their first-line chemotherapy for advanced ovarian cancer. Approximately 900 subjects were to be enrolled into the study. Study was closed following 3rd overall survival (OS) interim analysis as planned per protocol, which confirmed futility.

Arms: arm 1: matched placebo tablet administered orally once daily for up to 24 months arm 2: Pazopanib tablet administered orally at 800 mg once daily for up to 24 months
Interventions: intervention 1: Pazopanib intervention 2: Placebo
Intervention descriptions: intervention 1: Pazopanib 800 mg tablet daily for 104 weeks (24 months) intervention 2: Matching placebo 800 mg tablet daily, for 104 weeks (24 months).

Protocol documents:
Clinical trial NCT00782067
Conditions: Leukemia
Keywords: Aggressive systemic mastocytosis mast cell leukemia C-Findings tyrosine kinase inhibitor KIT mutation AHNMD Systemic Aggressive
Sponsor: Novartis Pharmaceuticals
Start date: 2008-10-13; Completion date: 2017-08-24
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the efficacy and safety of twice daily (bid) oral midostaurin in patients with Aggressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) with or without an Associated Hematological clonal Non-Mast cell lineage Disease (AHNMD).

Detailed description:

Arms: arm 1: Midostaurin was administered at a dose of 100 mg twice daily (bid) in continuous cycles of 28 days until disease progression, intolerable toxicity or withdrawal due to any cause, whichever occurred first.
Interventions: intervention 1: Midostaurin (PKC412)
Intervention descriptions: intervention 1: Midostaurin was provided as 25 mg soft gelatin capsules for oral administration.

Protocol documents:
Clinical trial NCT00988156
Conditions: Partial Epilepsy in Children and Adolescents
Keywords: Epilepsy Partial Refractory Children Adolescents Adjunctive Randomised Double-blind Placebo-controlled Parallel-group
Sponsor: Bial - Portela C S.A.
Start date: 2007-12-07; Completion date: 2017-08-24
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.

Detailed description:
Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.

This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.

The primary analysis variables are:

* The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)
* The relative reduction in standardised seizure frequency

Arms: arm 1: To receive Eslicarbazepine acetate in addition to concomitant therapy arm 2: To receive placebo in addition to concomitant therapy
Interventions: intervention 1: Eslicarbazepine acetate (BIA 2-093) intervention 2: Eslicarbazepine acetate
Intervention descriptions: intervention 1: Part I - 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

The recommended target dose of double-blind study treatment will be 20mg/kg/day.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year. intervention 2: Part I: 8-week observational baseline period followed by a 6-week double-blind titration period, a 12-week double-blind maintenance period, a double-blind tapering-off period, and a 4-week observational period.

Part II: At the end of part I, there is an option to enter a long-term open-label extension period to receive Eslicarbazepine acetate for 1 year.

Protocol documents:
Clinical trial NCT02826798
Conditions: Cytomegalovirus Infections
Keywords: VBI-1501A VBI-1501 prophylactic vaccine virus diseases cytomegalovirus (CMV) cytomegalovirus infections cytomegalovirus vaccines Herpesviridae Infections Phase 1 Human Herpesvirus 5 (HHV5) Vaccines, virus-like particle (VLP) enveloped virus-like particle (eVLP)
Sponsor: VBI Vaccines Inc.
Start date: 2016-06-23; Completion date: 2017-08-24
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.

Detailed description:
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.

Arms: arm 1: 0.5µg CMV vaccine with adjuvant arm 2: 1.0µg CMV vaccine with adjuvant arm 3: 2.0 µg CMV vaccine with adjuvant arm 4: 1.0µg CMV vaccine without adjuvant arm 5: Buffer/sucrose used for VBI-1501 suspension
Interventions: intervention 1: VBI-1501A 0.5 μg intervention 2: VBI-1501A 1.0 μg intervention 3: VBI-1501A 2.0 μg intervention 4: VBI-1501 1.0 μg intervention 5: Placebo
Intervention descriptions: intervention 1: VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 2: VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 3: VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 4: VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168 intervention 5: buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.

Protocol documents:
Clinical trial NCT02268214
Conditions: Type 1 Diabetes Mellitus
Keywords: Dapagliflozin Efficacy Safety Add on to insulin Oral Antidiabetic Type 1 diabetes
Sponsor: AstraZeneca
Start date: 2014-11-11; Completion date: 2017-08-25
Enrollment: 833 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

Detailed description:
Study Classification: Safety, Efficacy and Pharmacokinetics/dynamics

Arms: arm 1: Dapagliflozin 5 mg tablet orally, once daily for 52 weeks arm 2: Dapagliflozin 10 mg tablet orally, once daily for 52 weeks arm 3: Placebo tablet orally, once daily for 52 weeks
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo for dapagliflozin
Intervention descriptions: intervention 1: Tablets intervention 2: Tablets

Protocol documents:
Clinical trial NCT02601469
Conditions: Plaque Psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2015-09-04; Completion date: 2017-08-25
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Detailed description:
1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis
2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS

Arms: arm 1: administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
Interventions: intervention 1: DSXS
Intervention descriptions: intervention 1: twice daily for 28 days

Protocol documents:
Clinical trial NCT01311687
Conditions: Multiple Myeloma
Keywords: Myeloma Multiple Myeloma Relapsed Multiple Myeloma Relapsed and Refractory Multiple Myeloma Refractory Myeloma Resistant Multiple Myeloma Treatment-resistant Multiple Myeloma Pomalidomide Lenalidomide-resistant Bortezomib-resistant
Sponsor: Celgene
Start date: 2011-03-11; Completion date: 2017-08-29
Enrollment: 455 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

Detailed description:

Arms: arm 1: Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression. arm 2: Participants received 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day treatment cycle until disease progression.
Interventions: intervention 1: pomalidomide intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 4 mg pomalidomide capsules administered orally intervention 2: 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally

Protocol documents: