ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01842841
Conditions: Gaucher Disease
Sponsor: Shire
Start date: 2013-03-13; Completion date: 2014-10-08
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1 Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1 Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher disease present with acute neurological deterioration, which leads to early death. Those with Type 3 disease typically display a more sub-acute neurological course, with later onset and slower progression.

The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.

Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type 1 Gaucher disease.

Detailed description:
Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB) that leads to progressive accumulation of glucocerebroside within macrophages and subsequent tissue and organ damage; typically of the liver, spleen, bone marrow, and brain.

Gaucher disease has been designated in the list of Specified Rare and Intractable Diseases by Specified Disease Treatment Research Program of Ministry of Health, Labor and Welfare (MHLW) as one of "lysosomal storage diseases" since 2001. Gaucher disease is also designated in the Medical Aid Program for Specified Categories of Chronic Pediatric Diseases.

The prevalence of mutations and the phenotype of patients with Gaucher disease in Japan differs from that in non-Japanese populations. Some patients with type 1 Gaucher disease in Japan have more severe and progressive disease compared to non-Japanese patients and the disease is characterized by an earlier onset of symptoms.

Velaglucerase alfa, a highly-purified form of the naturally occurring enzyme glucocerebrosidase, has been developed as an enzyme replacement therapy for Gaucher disease for the symptoms (anemia, thrombocytopenia, hepatomegaly, splenomegaly, and bone manifestation).

The primary objective of this study is to evaluate the long-term safety of every other week (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.

Arms: arm 1: 15 to 60 U/kg, EOW via intravenous infusion
Interventions: intervention 1: velaglucerase alfa
Intervention descriptions: intervention 1: 15-60 U/kg, EOW

Protocol documents:
Clinical trial NCT01920594
Conditions: Surgical Procedures
Keywords: GSK1278863 Thoracic Aortic Aneurysm Repair
Sponsor: GlaxoSmithKline
Start date: 2013-10-31; Completion date: 2014-10-08
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that GSK1278863 will reduce neurologic, renal, and/or cardiac ischemia in patients undergoing elective descending thoracic aorta/thoracoabdominal aortic aneurysm (DTA/TAAA) repair, a population known to be at high risk for ischemic events from their underlying pathology and the surgical complexity required to address their disease. Approximately 160 subjects will be stratified according to intervention type (surgical or endovascular repair, with the latter limited to 50% of the total study population) and randomized in a 1:1 fashion to treatment with GSK1278863 (300 milligrams \[loading dose\] followed by 100 milligrams \[mg\]/day x 4 days) or placebo starting prior to planned repair, through postoperative day 3. The duration of participation in this study is expected to be approximately 4 to 8 weeks from screening to follow-up.

Detailed description:

Arms: arm 1: Subject will receive GSK1278863 300mg on Day-1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100mg once daily for 4 days starting from Day 0. arm 2: Subject will receive GSK1278863 matching placebo on Day-1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 matching placebo once daily for 4 days starting from Day 0.
Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: White, round biconvex, film coated tablet with unit dose strength of 100 mg for oral administration intervention 2: White, round biconvex, film coated GSK1278863 matching placebo tablet for oral administration

Protocol documents:
Clinical trial NCT01036594
Conditions: Prostate Cancer
Keywords: Ketoconazole Dexamethasone
Sponsor: University of California, San Francisco
Start date: 2009-12-11; Completion date: 2014-10-09
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is an open label, phase II, single center trial of ketoconazole/dexamethasone to determine if the administration of ketoconazole/dexamethasone, after disease progression with ketoconazole/hydrocortisone slows or reverses disease progression in men with progressive prostate cancer.

Detailed description:

Arms: arm 1: po = oral tid = 3 times per day qam = every morning qom = every evening bid = twice daily

1 cycle = 28 days

* Ketoconazole: 200mg during first week of study (run-in phase), then 400mg po tid
* Hydrocortisone 20mg po qam and 10mg po qpm: If participant has ≥ 30% Prostate-specific antigen (PSA) decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by Prostate Specific Antigen Working Group (PSAWG) criteria) is documented. After that, drug will be discontinued. If participant has \< 30% PSA decline at 12 week evaluation, participant goes off study. arm 2: * Ketoconazole: 400mg po tid
* Dexamethasone 0.5mg po bid: If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression (by RECIST criteria OR by PSAWG criteria) is documented.
Interventions: intervention 1: Ketoconazole intervention 2: Hydrocortisone intervention 3: Dexamethasone
Intervention descriptions: intervention 1: 200mg during first week of study (run-in phase), then 400mg po tid intervention 2: Hydrocortisone 20mg po qam and 10mg po qpm

If participant has ≥30% PSA decline at 12 week evaluation, treatment continues until progressive disease (by RECIST criteria OR by PSAWG criteria) is documented. After that, drug will be discontinued. If participant has \<30% PSA decline, patient goes off study. intervention 3: Dexamethasone 0.5mg po bid

If ≥ 30% PSA decline (Prostate-specific antigen) at 12 week evaluation, administration starts when disease progression (by RECIST criteria OR by PSAWG criteria) is documented.

Protocol documents:
Clinical trial NCT01195415
Conditions: Recurrent Pancreatic Carcinoma Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2010-06-01; Completion date: 2014-10-10
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies vismodegib and gemcitabine hydrochloride in treating patients with advanced pancreatic cancer. Vismodegib may stop the growth of pancreatic cancer by blocking blow flow to the tumor. Gemcitabine hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib and gemcitabine hydrochloride may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To obtain tumor biopsies before and after therapy with GDC-0449 (vismodegib) to evaluate the effect of inhibition of hedgehog signaling on pancreatic cancer stem cells by: evaluating the tumor for number and percentage of pancreatic cancer stem cells before and after treatment with GDC-0449.

SECONDARY OBJECTIVES:

I. To assess progression free survival (PFS) at 3 months following treatment with GDC-0449 and gemcitabine (gemcitabine hydrochloride).

II. To assess response rate to treatment and overall survival in patients with advanced pancreas cancer treated with GDC-0449 alone and in combination with gemcitabine.

III. To evaluate the toxicity of GDC-0449 alone and in combination with gemcitabine.

OUTLINE:

Patients receive vismodegib orally (PO) once daily (QD) on days 1-28 and gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Arms: arm 1: Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Gemcitabine Hydrochloride intervention 2: Laboratory Biomarker Analysis intervention 3: Vismodegib
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given PO

Protocol documents:
Clinical trial NCT01948986
Conditions: Renal Impairment Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-10-01; Completion date: 2014-10-16
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the effect of renal impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and in healthy participants with normal renal function.

Detailed description:

Arms: arm 1: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with normal renal function arm 2: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with mild renal impairment arm 3: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with moderate renal impairment arm 4: Ertugliflozin (15 mg), oral, administered in participants with T2DM and with severe renal impairment arm 5: Ertugliflozin (15 mg), oral, administered in participants with healthy participants and with normal renal function
Interventions: intervention 1: Ertugliflozin
Intervention descriptions: intervention 1: Single oral administration of 3 X 5 mg tablets.

Protocol documents:
Clinical trial NCT01451203
Conditions: Rheumatoid Arthritis
Keywords: Cimzia Early RA Certolizumab Pegol
Sponsor: Astellas Pharma Inc
Start date: 2011-10-11; Completion date: 2014-10-20
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of radiographically confirmed joint damage progression over a one-year period as a primary endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be discontinued, and the subjects will be monitored for one more year (the follow-up period) to investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory purposes.

Detailed description:
This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Arms: arm 1: Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards arm 2: Participants who certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
Interventions: intervention 1: Placebo intervention 2: CZP intervention 3: methotrexate (MTX)
Intervention descriptions: intervention 1: Subcutaneous (SC) intervention 2: SC intervention 3: oral

Protocol documents:
Clinical trial NCT01732510
Conditions: Atopic Dermatitis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-12-21; Completion date: 2014-10-20
Enrollment: 65 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 3-part study to assess the safety, tolerability, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MK-8226 in participants with moderate to severe atopic dermatitis. Part 1 (multiple rising dose study) objectives were to find the maximum tolerated dose (MTD) of MK-8226 and to assess safety and PK. Part 2 objectives were to determine safety, PK, and preliminary efficacy. Part 3 objectives were to further define safety and PK, and explore MK-8226 PK/PD to model the optimal dose range for future studies. The study was terminated early due to business reasons on 08 May 2014; final results from an analysis for Part 1 (efficacy, PK, safety, immunogenicity) and Part 2 (safety, immunogenicity) are summarized.

Detailed description:
Part 1 of the study is a multiple rising dose assessment of the safety, tolerability, and pharmacokinetics of MK-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period.

Part 2 of the study is an assessment of the safety, tolerability, and efficacy of MK-8226 for 12 weeks followed by a 20-week off-treatment follow-up period.

In Part 3 of the study, participants will be treated with MK-8226 for a period of 12 weeks followed by a 20-week off-treatment follow-up period to evaluate pharmacokinetic and pharmacokinetic correlations to assist with modeling the dose range planned for further studies.

Arms: arm 1: MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks. arm 2: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 3: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 4: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 5: Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. arm 6: MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks. arm 7: Placebo administered IV every 2 weeks for a period of 12 weeks.
Interventions: intervention 1: MK-8226 intervention 2: Placebo
Intervention descriptions: intervention 1: MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks. intervention 2: Placebo administered IV every 2 weeks for a period of 12 weeks.

Protocol documents:
Clinical trial NCT01345058
Conditions: Epilepsy
Keywords: Epilepsy antiepileptic drug polytherapy
Sponsor: Brigham and Women's Hospital
Start date: 2011-08-01; Completion date: 2014-10-21
Enrollment: 56 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to determine whether a combination of low dose lacosamide and levetiracetam is more effective than high dose levetiracetam in patients who have failed low dose levetiracetam.

Detailed description:

Arms: arm 1: Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. arm 2: Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
Interventions: intervention 1: lacosamide intervention 2: levetiracetam
Intervention descriptions: intervention 1: Lacosamide maximum of 200 mg/day, to be titrated as follows:

* Week 1: 50 mg twice a day
* Beginning Week 2: 100 mg twice a day. intervention 2: Low dose ≤1500 mg/day, High dose \>1500 mg/day

Protocol documents:
Clinical trial NCT01657019
Conditions: Binge Eating Disorder
Sponsor: Shire
Start date: 2012-08-21; Completion date: 2014-10-21
Enrollment: 604 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lisdexamfetamine dimesylate
Intervention descriptions: intervention 1: 50 or 70 mg administered orally, once a day for 52 weeks

Protocol documents:
Clinical trial NCT01746420
Conditions: Lateral Epicondylitis
Keywords: elbow
Sponsor: BioMimetic Therapeutics
Start date: 2012-12-12; Completion date: 2014-10-21
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether recombinant human platelet-derived growth factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis elbow).

Detailed description:
Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study

Study Center(s): 6

Number of Subjects: 100

Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age

Study Drug, Dose, Regimen:

Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB

Duration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB)

Duration of Follow-up: 24 weeks (6 months) post-operative follow-up

Arms: arm 1: Dose A - sodium acetate buffer (0 mg rhPDGF-BB) arm 2: Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB arm 3: Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB arm 4: Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB arm 5: Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
Interventions: intervention 1: rhPDGF-BB Injection intervention 2: Placebo
Intervention descriptions: intervention 1: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection intervention 2: sodium acetate buffer (0 mg rhPDGF-BB)

Protocol documents:
Clinical trial NCT02126826
Conditions: Osteoarthritis
Sponsor: Boehringer Ingelheim
Start date: 2014-05-28; Completion date: 2014-10-21
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
* To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
* To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
* The assessment of pharmacodynamics in OA patients

Detailed description:

Arms: arm 1: Multiple Rising Doses Placebo to BI 1026706 arm 2: Multiple Rising Doses BI 1026706
Interventions: intervention 1: BI 1026706 intervention 2: Placebo to BI 1026706
Intervention descriptions: intervention 1: Multiple Rising Doses (oral solution, tablet) intervention 2: Multiple Rising Doses (oral solution / tablet, identical to active treatment)

Protocol documents:
Clinical trial NCT01222351
Conditions: Late Onset Alzheimer Disease
Keywords: Alzheimer's disease Positron emission tomography Biomarker Brain amyloid plaque load
Sponsor: New York State Psychiatric Institute
Start date: 2010-12-01; Completion date: 2014-10-22
Enrollment: 161 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. The driving hypothesis of the study is that amyloid beta in the brain as measured by positron emission tomography positivity is associated with the onset of cognitive decline associated with late onset Alzheimer's disease.

Detailed description:
This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain is associated with decline in cognition over the 10 years prior to the PET scan.

Arms: arm 1: BAY 94-9172 PET/CT
Interventions: intervention 1: BAY 94-9172 (Florbetaben)
Intervention descriptions: intervention 1: Measure of brain amyloid load using BAY 94-9172 PET/CT

Protocol documents:
Clinical trial NCT01510184
Conditions: Diffuse Large B-cell Lymphoma Follicle Center Lymphoma
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2012-04-19; Completion date: 2014-10-23
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Detailed description:

Arms: arm 1: Participants received rituximab 250 milligram per meter square (mg/m\^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m\^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter \[μL\] to 149,000/μL). arm 2: Participants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease.
Interventions: intervention 1: Zevalin intervention 2: Y-90-Zevalin intervention 3: Rituximab intervention 4: In-111 Zevalin
Intervention descriptions: intervention 1: Zevalin administered intravenous infusion. intervention 2: Y-90-Zevalin administered by intravenous infusion. intervention 3: Rituximab administered by intravenous infusion. intervention 4: In-111-Zevalin administered by intravenously.

Protocol documents: