ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01475370
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia WT1
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-01-24; Completion date: 2016-12-22
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OCV-501
Intervention descriptions: intervention 1: 1. Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001.
2. After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.

Protocol documents:
Clinical trial NCT01796470
Conditions: Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Diffuse Large B-cell Lymphoma Indolent Non-Hodgkin's Lymphoma
Keywords: GS-US-339-0103 SYK inhibitor PI3K inhibitor GS-9973 GS 9973 GS-1101 GS 1101 Cal-101 Cal 101 idelalisib leukemia lymphoma CLL MCL DLBCL iNHL FL MZL LPL SLL WM Waldenström's macroglobulinemia
Sponsor: Gilead Sciences
Start date: 2013-06-20; Completion date: 2016-12-22
Enrollment: 66 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
This study will evaluate the efficacy of the combination entospletinib and idelalisib in participants with relapsed or refractory hematologic malignancies. Participants will be enrolled who have one of the following hematological tumor types: chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), or indolent non-Hodgkin lymphomas (iNHL; including follicular lymphoma (FL) and lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).

Detailed description:

Arms: arm 1: Entospletinib plus idelalisib at one of 4 dose combinations (400 mg/100 mg; 600 mg/100 mg; 800 mg/100 mg; 800 mg/150 mg).

After discontinuation of entospletinib+idelalisib combination therapy, and following a washout period, participants may continue to receive entospletinib 400 mg monotherapy.
Interventions: intervention 1: Entospletinib intervention 2: Idelalisib
Intervention descriptions: intervention 1: Entospletinib tablets administered orally twice daily intervention 2: Idelalisib tablets administered orally twice daily

Protocol documents:
Clinical trial NCT02116361
Conditions: Depressive Disorder, Major
Sponsor: Allergan
Start date: 2014-04-22; Completion date: 2016-12-22
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.

Detailed description:

Arms: arm 1: Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. arm 2: OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. arm 3: Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. arm 4: OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA injected into protocol-specified areas on Day 1. intervention 2: Placebo (normal saline) injected into protocol-specified areas on Day 1.

Protocol documents:
Clinical trial NCT02294058
Conditions: Multiple Sclerosis
Keywords: MS RMS Multiple Sclerosis Relapsing Multiple Sclerosis
Sponsor: Celgene
Start date: 2014-12-03; Completion date: 2016-12-22
Enrollment: 1346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

Detailed description:

Arms: arm 1: Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months. arm 2: Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months. arm 3: Participants received ozanimod 1 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.
Interventions: intervention 1: Ozanimod intervention 2: Interferon beta-1a intervention 3: Placebo to ozanimod intervention 4: Placebo to interferon beta-1a
Intervention descriptions: intervention 1: Capsules for oral administration once a day intervention 2: Administered by intramuscular injection once a week intervention 3: Matching placebo capsules administered orally once a day intervention 4: Placebo intramuscular injection once a week

Protocol documents:
Clinical trial NCT02405442
Conditions: Crohn's Disease
Sponsor: Gilead Sciences
Start date: 2015-04-30; Completion date: 2016-12-22
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

Detailed description:

Arms: arm 1: Double-Blind Phase: Participants will receive 1 single-use prefilled syringe (PFS) of andecaliximab 150 mg and matching placebo coadministered at Weeks 0, 2, 4, and 6 and 2 single-use PFS of placebo coadministered at Weeks 1, 3, 5, and 7. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. arm 2: Double-Blind Phase: Participants will receive 1 single-use PFS of andecaliximab 150 mg and matching placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. arm 3: Double-Blind Phase: Participants will receive 2 single-use PFS of andecaliximab 150 mg coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for an additional 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks. arm 4: Double-Blind Phase: Participants will receive 2 single-use PFS of placebo coadministered weekly for 8 weeks. Open-Label Phase: Participants will be eligible to enroll in the Open-Label Phase to receive andecaliximab 150 mg weekly for 44 weeks. Extended Treatment Phase: Participants who complete Week 52 assessments will be eligible to enter into the Extended Treatment Phase to continue treatment with andecaliximab 150 mg for an additional 156 weeks.
Interventions: intervention 1: Andecaliximab intervention 2: Placebo
Intervention descriptions: intervention 1: Andecaliximab administered via subcutaneous (SC) injection intervention 2: Placebo to match andecaliximab administered via SC injection

Protocol documents:
Clinical trial NCT02460159
Conditions: Hypercholesterolemia Heterozygous Familial Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2015-06-23; Completion date: 2016-12-22
Enrollment: 135 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

Detailed description:

Arms: arm 1: one EZ 10 mg/Atorva 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks. arm 2: one EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
Interventions: intervention 1: EZ 10 mg/Atorva 20 mg FDC intervention 2: EZ 10 mg/Atorva 10 mg FDC
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02618616
Conditions: Psoriasis
Sponsor: Ziarco Pharma Ltd
Start date: 2016-01-11; Completion date: 2016-12-22
Enrollment: 129 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a PASI score of at least 10. Following run-in, subjects were randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

Detailed description:
This was a randomized, double blind, placebo controlled, parallel group study in 129 subjects with moderate to severe psoriasis with a Psoriasis Area and Severity Index (PASI) score of at least 10 and an Investigator's Global Assessment (IGA) of 3 (0-4 scale). Following run-in subjects received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks. Subjects attended the clinic at Baseline (Day 0) when they were reviewed and confirmed they met inclusion/exclusion criteria. Subjects were then randomized and received either oral 30 mg ZPL-3893787 once daily or placebo once daily for 12 weeks.

Arms: arm 1: Each subject was given 30 mg ZPL-3893787 capsules, to be taken orally once daily (OD) for 12 weeks. arm 2: Each subject was given 30 mg capsules of matching placebo, to be taken orally OD for 12 weeks.
Interventions: intervention 1: ZPL-3893787 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01414855
Conditions: Lymphoma, B-Cell
Sponsor: Genentech, Inc.
Start date: 2011-08-31; Completion date: 2016-12-23
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.

Detailed description:

Arms: arm 1: Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
Interventions: intervention 1: obinutuzumab intervention 2: cyclophosphamide intervention 3: doxorubicin intervention 4: prednisone intervention 5: vincristine
Intervention descriptions: intervention 1: 1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15. intervention 2: 750 mg/m\^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles. intervention 3: 50 mg/m\^2 IV, Day 1 of each 21-cycle, 6 cycles. intervention 4: 100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles. intervention 5: 1.4 mg/m\^2 IV, Day 1 of each 21-day cycle, 6 cycles.

Protocol documents:
Clinical trial NCT01870726
Conditions: c-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBM
Keywords: Glioblastoma multiforme (GBM), glioblastoma, Grade IV Astrocytoma, brain tumor, brain cancer, giant cell glioblastoma, gliosarcoma
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-09; Completion date: 2016-12-23
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study assessed the safety and the dose of the combination of INC280 and buparlisib (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In addition, the anti-tumor activity of INC280 single agent should have been assessed in patients with recurrent glioblastoma with c-Met alteration.

Detailed description:
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD and/or to identify the recommended phase II dose (RP2D) for the combination of INC280 and buparlisib, followed by the phase II part to assess the clinical efficacy of INC280 single agent and in combination with buparlisib (BKM120), and to further assess the safety of the combination. In addition, a surgical arm should have started concurrently with the phase II part, to determine the PK/PD profile of the study drug combination in patients undergoing tumor resection for recurrent glioblastoma after 7 to 10-days treatment.

RP2D was not declared due to a lack of efficacy of the combination in the phase Ib stage, and phase II was continued with INC280 monotherapy only.

Arms: arm 1: To estimate the safe dose of the combination INC280 and buparlisib arm 2: To estimate anti-tumor efficacy of INC280 single agent and in combination with buparlisib
Interventions: intervention 1: INC280 intervention 2: Buparlisib
Intervention descriptions: intervention 1: Phase Ib: INC280 was given at the starting dose of 200mg capsules twice daily with escalation to higher strengths.

Phase II: INC280 was given at the dose of 400mg (tablets) twice daily. intervention 2: Buparlisib was given at the starting dose of 50mg once daily with escalation to higher strengths.

Protocol documents:
Clinical trial NCT01227824
Conditions: Infection, Human Immunodeficiency Virus I
Keywords: integrase inhibitor HIV Infection raltegravir GSK1349572
Sponsor: ViiV Healthcare
Start date: 2010-10-19; Completion date: 2016-12-27
Enrollment: 828 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

Detailed description:
ING113086 is a Phase 3 randomized, double-blind, double dummy, active-controlled, multicenter, study conducted in approximately 788 HIV-1 infected ART-naïve subjects. Subjects will be randomized 1:1 one of the following treatment arms:

1. GSK1349572 50 mg once daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

   OR
2. 400 mg RAL twice daily (approximately 394 subjects) + fixed-dose dual NRTI therapy (either ABC/3TC or TDF/FTC)

Analyses will be conducted at 48 weeks and 96 weeks. Subjects randomized to receive GSK1349572 and who successfully complete 96 weeks of treatment will continue to have access to GSK1349572 through the study until either it is locally available, as long as they continue to derive clinical benefit.

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Arms: arm 1: GSK1349572 50mg once daily + raltegravir placebo twice daily + NRTI background therapy once daily arm 2: raltegravir 400mg twice daily + GSK1349572 placebo once daily + NRTI background therapy once daily
Interventions: intervention 1: GSK1349572 (dolutegravir) intervention 2: raltegravir intervention 3: GSK1349572 Placebo intervention 4: ABC/3TC intervention 5: TDF/FTC intervention 6: raltegravir Placebo
Intervention descriptions: intervention 1: GSK1349572 50 mg taken once daily with or without food intervention 2: raltegravir 400mg taken twice daily intervention 3: GSK1349572 placebo taken once daily intervention 4: Abacavir/Lamivudine background therapy once daily intervention 5: Tenofovir/emtricitabine background therapy once daily intervention 6: raltegravir placebo taken twice daily

Protocol documents:
Clinical trial NCT02562989
Conditions: Alzheimer's Disease Amnestic Mild Cognitive Impairment
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-10-19; Completion date: 2016-12-27
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of \[18F\]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT) deposition in the brain. Brain NFT deposition is a pathologic finding in Alzheimer's Disease (AD), with brain NFT density shown to correlate with the severity of cognitive impairment in AD. The objectives of the study include performing the following with respect to \[18F\]MK-6240 administered as a PET imaging agent: 1) assess safety and tolerability; 2) determine radiation safety profile; 3) determine optimal imaging protocol parameters for quantification of brain NFTs in AD; 4) compare tracer binding in brain PET scans from participants with AD, participants with amnestic mild cognitive impairment (MCI) and healthy elderly participants; and 5) evaluate intra-subject test-retest (T-RT) variability of tracer uptake in brain regions of interest.

Detailed description:

Arms: arm 1: Healthy young participants received a single intravenous (IV) dose of \~185 megabecquerel (MBq) \[18F\]MK-6240 in Part 1 of the study arm 2: Healthy elderly participants received a single IV dose of \~160 MBq \[18F\]MK-6240, in Part 2 of the study arm 3: AD and amnestic MCI participants received up to two IV doses of \~160 MBq \[18F\]MK-6240 in Part 2 of the study
Interventions: intervention 1: [18F]MK-6240, ~185 MBq intervention 2: [18F]MK-6240, ~160 MBq
Intervention descriptions: intervention 1: IV dose of \~185 MBq \[18F\]MK-6240 intervention 2: IV dose of \~160 MBq \[18F\]MK-6240

Protocol documents:
Clinical trial NCT01575834
Conditions: Postmenopausal Osteoporosis
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases
Sponsor: Amgen
Start date: 2012-03-15; Completion date: 2016-12-28
Enrollment: 7180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Detailed description:

Arms: arm 1: Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months. arm 2: Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
Interventions: intervention 1: Romosozumab intervention 2: Placebo intervention 3: Denosumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection once a month (QM) intervention 2: Administered by subcutaneous injection once a month (QM) intervention 3: Administered by subcutaneous injection once every 6 months (Q6M)

Protocol documents:
Clinical trial NCT01782313
Conditions: Recurrent Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: Northwestern University
Start date: 2013-03-06; Completion date: 2016-12-28
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for patients who have been diagnosed with soft tissue sarcoma that has spread (metastasized) or that is not eligible for removal by surgery. The purpose of this study is to determine how soft tissue sarcomas respond to treatment with an investigational drug called tivozanib. In some lab and clinical studies, tivozanib has been shown to interfere with the growth of some types of tumors. The study will also evaluate how safe the study treatment is by observing how many and what kind of adverse events (side effects) participants experience.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the progression-free survival (defined as complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) assessed at 16 weeks for patients treated with tivozanib.

SECONDARY OBJECTIVES:

I. Overall response rate (defined as CR + PR). II. Clinical benefit rate (CR + PR + SD). III. Overall survival (up to 2 years beyond progression). IV. Correlation of clinical outcome with antibodies for vascular endothelial growth factor receptor 1 (VEGFR1) and VEGFR2.

V. Assess Safety and tolerability.

OUTLINE:

Patients receive tivozanib orally (PO) daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity, or until discontinuation per patient preference or physician recommendation.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Arms: arm 1: Patients receive tivozanib PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: tivozanib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents: