ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02638259
Conditions: Rheumatoid Arthritis
Keywords: Biosimilars Rheumatoid Arthritis Etanercept
Sponsor: Sandoz
Start date: 2015-02-21; Completion date: 2017-06-12
Enrollment: 376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

Detailed description:
Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared.

An additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients

Arms: arm 1: Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2). arm 2: Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).
Interventions: intervention 1: GP2015
Intervention descriptions: intervention 1: Enbrel comparator

Protocol documents:
Clinical trial NCT02669667
Conditions: Safety Healthy Subjects
Keywords: MEDI9314 Safety Tolerability Pharmacokinetics Immunogenicity
Sponsor: MedImmune LLC
Start date: 2016-02-18; Completion date: 2017-06-12
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to assess the safety and tolerability of MEDI9314 in healthy adult subjects

Detailed description:
This is a phase I study to assess the safety, tolerability pharmacokinetics, and immunogenicity of MEDI9314 following single dose administration to healthy subjects

Arms: arm 1: single dose of MEDI9314 or placebo arm 2: single dose of MEDI9314 or placebo arm 3: single dose of MEDI9314 or placebo arm 4: single dose of MEDI9314 or placebo arm 5: single dose of MEDI9314 or placebo arm 6: single dose of MEDI9314 or placebo
Interventions: intervention 1: MEDI9314 intervention 2: placebo
Intervention descriptions: intervention 1: single dose of MEDI9314 intervention 2: single dose of placebo

Protocol documents:
Clinical trial NCT02415608
Conditions: Aggressive Systemic Mastocytosis Mast Cell Leukemia Systemic Mastocytosis
Sponsor: Jason Robert Gotlib
Start date: 2015-03-01; Completion date: 2017-06-14
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 2 trial studies ibrutinib to see how well it works in treating patients with systemic (affecting the entire body) mastocytosis that has spread to other parts of the body and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is a disease in which too many mast cells (a type of immune system cell) are found throughout the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVE:

Evaluate the response rate to ibrutinib in patients with advanced systemic mastocytosis (SM) (aggressive systemic mastocytosis \[ASM\] or mast cell leukemia \[MCL\], or SM-associated hematologic non-mast cell disorder \[AHNMD\]) by the end of 6 cycles (6 months).

SECONDARY OBJECTIVES:

* Evaluate the tolerability and safety profile of ibrutinib in patients with advanced SM.
* Evaluate the pharmacokinetic (PK) profile of ibrutinib in a subset of patients with advanced SM.
* Evaluate changes in histopathology (blood and bone marrow) of patients with advanced SM in response to ibrutinib therapy.
* Evaluate changes in mastocytosis related symptom scores and quality-of-life (QOL) using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF).
* Evaluate the duration of response (DoR) and time to response (TTR).
* Evaluate progression-free survival (PFS) and overall survival.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1 to 28. Treatment repeats every 28 days for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving an unconfirmed or confirmed clinical improvement (CI), partial response (PR), or complete response (CR) by the end of course 6 will be permitted to continue maintenance courses of ibrutinib on an ongoing basis until loss of response/progressive disease, or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 6 months thereafter.

Arms: arm 1: Participants receive ibrutinib daily on days 1 to 28, at 420 mg/day in 28-day cycles arm 2: Participants receive ibrutinib daily on days 1 to 28, at 560 mg/day in 28-day cycles
Interventions: intervention 1: Ibrutinib
Intervention descriptions: intervention 1: Given orally in 28-day cycles

Protocol documents:
Clinical trial NCT02489968
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2015-05-12; Completion date: 2017-06-16
Enrollment: 880 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A will evaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg + linagliptin. All analyses will be carried out separately for these study parts. The objective of Part A is to investigate the efficacy, safety and tolerability of the fixed dose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin 10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM (Type 2 Diabetes Mellitus) who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placebo after 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safety and tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared with empagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanese patients with T2DM who have insufficient glycaemic control after 16 weeks of treatment with empagliflozin 25 mg alone once daily. The study is designed to show superiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mg plus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will be followed by a 28 week extension treatment period to evaluate further efficacy and safety up to 52 weeks.

Detailed description:

Arms: arm 1: patient to receive a tablet containing low dose empagliflozin and linagliptin once daily arm 2: patient to receive a tablet containing low dose empagliflozin once daily arm 3: patient to receive a tablet containing high dose empagliflozin and linagliptin once daily arm 4: patients to receive a tablet containing high dose empagliflozin once daily
Interventions: intervention 1: empagliflozin 10 mg + linagliptin 5 mg intervention 2: empagliflozin 10 mg intervention 3: empagliflozin 25 mg + linagliptin 5 mg intervention 4: empagliflozin 25 mg intervention 5: Placebo
Intervention descriptions: intervention 1: empagliflozin low dose + linagliptin once daily intervention 2: empagliflozin low dose once daily intervention 3: empagliflozin high dose + linagliptin once daily intervention 4: empagliflozin high dose once daily intervention 5: None

Protocol documents:
Clinical trial NCT02742441
Conditions: Plaque Psoriasis
Sponsor: Therapeutics, Inc.
Start date: 2016-06-01; Completion date: 2017-06-16
Enrollment: 409 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study (Study 310) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Detailed description:

Arms: arm 1: 122-0511 Foam, topically applied twice daily

Intervention: Drug: 122-0551 Foam arm 2: Vehicle Foam, topically applied twice daily

Intervention: Drug: Vehicle Foam
Interventions: intervention 1: 122-0551 Foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Topical Foam containing active drug intervention 2: Topical Foam containing no active drug

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT02456740
Conditions: Migraine
Keywords: Migraine Headache Prevention Prophylaxis
Sponsor: Amgen
Start date: 2015-07-17; Completion date: 2017-06-19
Enrollment: 955 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.

Detailed description:
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial consisted of four phases: screening (≤ 3 weeks of initial screening and a 4-week baseline phase); the double-blind treatment phase (24 weeks) in which participants received placebo or erenumab 70 mg or 140 mg daily; the active-treatment phase, in which participants underwent repeat randomization and were assigned to receive 70 mg or 140 mg of erenumab (28 weeks); and a safety follow-up phase (12 weeks).

Arms: arm 1: Participants received placebo once a month (QM) by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. arm 2: Participants received erenumab 70 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded. arm 3: Participants received erenumab 140 mg QM by subcutaneous injection on day 1 and weeks 4, 8, 12, 16, and 20 in the 24-week double-blind treatment phase. At week 24, participants were re-randomized to receive either erenumab 70 mg or erenumab 140 mg, administered QM at weeks 24, 28, 32, 36, 40, 44, and 48, with actual dose blinded.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month intervention 2: Administered by subcutaneous injection once a month

Protocol documents:
Clinical trial NCT01697358
Conditions: Failed Back Surgery Syndrome Back Pain Pain in Leg, Unspecified
Keywords: FBSS post laminectomy syndrome SCS RCT back pain
Sponsor: MedtronicNeuro
Start date: 2013-01-08; Completion date: 2017-06-20
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

Detailed description:
The study has a multi-center, prospective, randomized (1:1), open-label, parallel-group design of two alternative treatments:

* SCS group (SCS+OMM)
* OMM group

Arms: arm 1: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead plus an individual Optimal Medical Management (OMM) treatment plan arm 2: The investigator and subject will determine an individual Optimal Medical Management (OMM) treatment plan
Interventions: intervention 1: Spinal Cord Stimulation (SCS) intervention 2: Optimal Medical Management (OMM)
Intervention descriptions: intervention 1: Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group. intervention 2: The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.

Protocol documents:
Clinical trial NCT02607735
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Infection
Sponsor: Gilead Sciences
Start date: 2015-11-11; Completion date: 2017-06-21
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy.

Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

Detailed description:

Arms: arm 1: SOF/VEL/VOX for 12 weeks arm 2: Placebo to match SOF/VEL/VOX for 12 weeks arm 3: SOF/VEL/VOX for 12 weeks for eligible participants initially randomized to receive placebo
Interventions: intervention 1: SOF/VEL/VOX intervention 2: Placebo
Intervention descriptions: intervention 1: 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food intervention 2: Tablet administered orally once daily with food

Protocol documents:
Clinical trial NCT02217475
Conditions: Nonalcoholic Steatohepatitis
Sponsor: Tobira Therapeutics, Inc.
Start date: 2014-09-18; Completion date: 2017-06-22
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

Detailed description:

Arms: arm 1: CVC 150 mg tablet in Years 1 and 2. arm 2: Placebo-matching CVC tablet in Year 1 then CVC 150 mg tablet in Year 2. arm 3: Placebo-matching cenicriviroc (CVC) tablet in Years 1 and 2.
Interventions: intervention 1: Cenicriviroc intervention 2: Placebo
Intervention descriptions: intervention 1: CVC 150 mg, administered orally once daily and taken every morning with food. intervention 2: Placebo administered orally once daily and taken every morning with food.

Protocol documents:
Clinical trial NCT02568683
Conditions: Non-Hodgkin Lymphoma
Keywords: DLBCL Relapsed Refractory
Sponsor: Gilead Sciences
Start date: 2016-02-11; Completion date: 2017-06-22
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study is to evaluate the safety of ENTO with VCR in participants with relapsed or refractory B-cell NHL.

Detailed description:

Arms: arm 1: Participants will be enrolled sequentially in a 3 + 3 dose escalation design to receive escalating dose of ENTO+VCR at dose levels 1 to 4 with the objective of defining the maximum tolerated dose (MTD) or recommended dose for the dose expansion stage. Following the determination of the MTD of the dose levels 1 to 4 (or concurrently with the opening of dose level 4), the safety of administering ENTO with VCR when administered as a 4-day prolonged continuous infusion may be evaluated in the continuous infusion dose escalation level (dose level C1) with the objective of investigating the schedule of dosing ENTO when administered with VCR as a continuous infusion. arm 2: Based on the tolerability, safety, and efficacy data from the dose escalation phase, participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) may receive VCR+ENTO. arm 3: Based on the tolerability, safety, and efficacy data from the dose escalation phase, participants with relapsed or refractory B-cell NHL (non-DLBCL) may receive VCR+ENTO.
Interventions: intervention 1: Entospletinib intervention 2: Vincristine
Intervention descriptions: intervention 1: ENTO spray dried dispersion tablets administered orally twice daily while in a fasted state intervention 2: VCR administered intravenously

Protocol documents:
Clinical trial NCT02421510
Conditions: Type 1 Diabetes Mellitus
Keywords: High level of sugar (glucose) in the blood
Sponsor: Lexicon Pharmaceuticals
Start date: 2015-05-01; Completion date: 2017-06-23
Enrollment: 782 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Detailed description:

Arms: arm 1: Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. arm 2: Sotagliflozin 200 milligram (mg) (one 200 mg tablet and one placebo tablet), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, before the first meal of the day for 24 weeks followed by a 28-week extension period.
Interventions: intervention 1: Sotagliflozin intervention 2: Sotagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: High dose Sotagliflozin, once daily, before the first meal of the day intervention 2: Low dose Sotagliflozin,once daily, before the first meal of the day intervention 3: Placebo, once daily, before the first meal of the day

Protocol documents:
Clinical trial NCT02102204
Conditions: Hyperparathyroidism, Secondary
Keywords: Secondary Hyperparathyroidism (SHPT), chrominc kidney disease (CKD), hemodialysis
Sponsor: Amgen
Start date: 2014-03-25; Completion date: 2017-06-26
Enrollment: 902 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Detailed description:
This is a multicenter, single-arm, extension study in which adults with secondary hyperparathyroidism currently receiving hemodialysis and previously treated in Amgen studies 20120231 (NCT01785875), 20120334 (NCT01576146), or 20120360 (NCT01896232) will continue to be treated with etelcalcetide until approximately 2.5 years after the first participant was enrolled.

Arms: arm 1: Participants received etelcalcetide three times a week (TIW) by bolus injection at the end of hemodialysis. The minimum etelcalcetide dose in this study was 2.5 mg and the maximum dose was 15 mg. Etelcalcetide dose was titrated to maintain parathyroid hormone levels within 2x to 9x the upper limit of normal based on the reference range of the assay used at the individual study center.
Interventions: intervention 1: Etelcalcetide
Intervention descriptions: intervention 1: Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.

Protocol documents:
Clinical trial NCT01919398
Conditions: Neoplasm Metastasis
Sponsor: Eli Lilly and Company
Start date: 2013-08-01; Completion date: 2017-06-28
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to assess the safety and tolerability of LY2940680 up to the global recommended dose in Japanese participants with advanced solid cancers.

Detailed description:

Arms: arm 1: Cohort 1: 100 mg LY2940680 administered orally daily in 28-day cycles. Cohort 2: 200 mg LY2940680 administered orally daily in 28-day cycles. Cohort 3: 400 mg LY2940680 administered orally daily in 28-day cycles.

Treatment with LY2940680 continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
Interventions: intervention 1: LY2940680
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT01575873
Conditions: Steroid-induced Osteopor, Glucocorticoid-induced Ostepor
Keywords: GIOP, Glucocorticoid, osteporosis, denosumab, BMD, Bone Mineral Density
Sponsor: Amgen
Start date: 2012-03-28; Completion date: 2017-06-29
Enrollment: 795 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-year study to evaluate the effect of denosumab versus risedronate in adults with glucocorticoid-induced osteoporosis.

Detailed description:

Arms: arm 1: Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months. arm 2: Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
Interventions: intervention 1: Denosumab intervention 2: Placebo for risendronate intervention 3: Risendronate intervention 4: Placebo for denosumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection once every 6 months intervention 2: Administered orally once a day intervention 3: Administered orally once a day intervention 4: Administered by subcutaneous injection once every 6 months

Protocol documents: