ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02164539
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GSK573719 asthma UMEC FF GSK2829332 persistent obstruction GW685698 Fluticasone Furoate COPD umeclidinium bromide
Sponsor: GlaxoSmithKline
Start date: 2014-07-01; Completion date: 2015-07-18
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the dose-response of 4 doses of umeclidinium bromide in combination with fluticasone furoate compared with fluticasone furoate monotherapy in chronic obstructive pulmonary disease participants with an asthmatic component. The fluticasone furoate/umeclidinium bromide treatments will also be compared to the once-daily inhaled corticosteroid/long-acting beta agonist combination fluticasone furoate/vilanterol.

Detailed description:

Arms: arm 1: Eligible subjects will enter a 4-week run-in period and will receive fluticasone propionate/salmeterol. Subjects will then be randomized to receive fluticasone furoate 100 mcg, fluticasone furoate/umeclidinium bromide 100/15.6 mcg, fluticasone furoate/umeclidinium bromide 100/62.5 mcg, fluticasone furoate/umeclidinium bromide 100/125 mcg, fluticasone furoate/umeclidinium bromide 100/250 mcg, or fluticasone furoate/vilanterol 100/25 mcg, respectively for 4 weeks arm 2: Subjects completing Treatment Phase A will be randomized to receive either fluticasone furoate/umeclidinium bromide100/250 mcg or fluticasone furoate/umeclidinium bromide/vilanterol 100/250/25 mcg for 1 week. arm 3: Subjects completing Treatment Phase B will be randomized to receive either the same treatment as in Treatment Phase B, or the same treatment minus the umeclidinium bromide component, for 1 week.
Interventions: intervention 1: FF intervention 2: UMEC intervention 3: VI
Intervention descriptions: intervention 1: Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister) intervention 2: Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) intervention 3: Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)

Protocol documents:
Clinical trial NCT01547390
Conditions: Preeclampsia
Keywords: preeclampsia Aspirin
Sponsor: Washington University School of Medicine
Start date: 2012-03-01; Completion date: 2015-07-20
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial to estimate the efficacy of low dose aspirin for preventing preeclampsia in women identified as high risk. The investigators hypothesize that the risk of preeclampsia in women identified by a first trimester multiparameter predictive model to be at high risk will be significantly reduced by initiating low dose aspirin early in pregnancy.

Detailed description:
This will be a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in women identified in the first trimester to be at high risk. We will also obtain maternal blood, cord blood and placenta specimen for basic science studies to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a cost-benefit analysis to determine the cost effectiveness of screening and using aspirin prophylaxis for screen positive women.

Rationale for Design: The randomized control trial is the 'gold standard' of research design. Other designs such as case-control, retrospective cohort and prospective cohort are limited by potential bias and confounding. Randomly assigning subjects to different interventions minimizes selection bias. The random assignment also results in groups that are likely to be similar with regards to important confounding variables. This minimizes confounding by both measured and unmeasured factors. While random allocation does not guarantee the groups will be identical, it does ensure that any differences between them are due to chance alone. Finally, randomization produces groups that are random samples of the population. This permits use of standard statistical tests that are based on probability theory.

Arms: arm 1: Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first arm 2: placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Interventions: intervention 1: Aspirin intervention 2: placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01928186
Conditions: Estrogen Receptor Positive HER2/Neu Negative Male Breast Carcinoma Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Sponsor: University of Washington
Start date: 2011-09-01; Completion date: 2015-07-20
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Detailed description:
PRIMARY OBJECTIVES:

I. Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.

SECONDARY OBJECTIVES:

I. Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.

II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.

OUTLINE:

Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.

Arms: arm 1: Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Interventions: intervention 1: Fluorothymidine F-18 intervention 2: Positron Emission Tomography intervention 3: Laboratory Biomarker Analysis intervention 4: Run-in (short pre-surgery course) of endocrine-targeted therapy
Intervention descriptions: intervention 1: Undergo FLT PET intervention 2: Undergo FLT PET intervention 3: Correlative studies intervention 4: Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.

Protocol documents:
Clinical trial NCT03453684
Conditions: Surgical Site Infection Vancomycin
Sponsor: University of Colorado, Denver
Start date: 2012-12-01; Completion date: 2015-07-20
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

Detailed description:
Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. The Investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics.

Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time.

Arms: arm 1: Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision
Interventions: intervention 1: Administration of Vancomycin
Intervention descriptions: intervention 1: Intravenous Vancomycin Administration

Protocol documents:
Clinical trial NCT02260193
Conditions: Anemia End Stage Renal Disease
Keywords: anemia end stage renal disease chronic kidney disease CKD dialysis chronic renal insufficiency renal impairment erythropoietin kidney oral anemia treatment hemoglobin hypoxia-inducible factor HIF hypoxia-inducible factor propyl-hydroxylase inhibitor HIF-PHI pharmacokinetics
Sponsor: Akebia Therapeutics
Start date: 2014-09-10; Completion date: 2015-07-22
Enrollment: 94 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and tolerability of orally administered AKB-6548 in participants with end stage renal disease undergoing chronic hemodialysis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: AKB-6548 intervention 2: AKB-6548 intervention 3: AKB-6548
Intervention descriptions: intervention 1: Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 2: Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol. intervention 3: Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.

Protocol documents:
Clinical trial NCT01966003
Conditions: Non-small Cell Lung Cancer Metastatic
Sponsor: Amgen
Start date: 2013-11-11; Completion date: 2015-07-23
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

Detailed description:

Arms: arm 1: Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles. arm 2: Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel intervention 3: ABP 215 intervention 4: Bevacizumab
Intervention descriptions: intervention 1: Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W intervention 2: Administered 200 mg/m² IV Q3W intervention 3: Administered 15 mg/kg Q3W by IV infusion intervention 4: Administered 15 mg/kg Q3W by IV infusion

Protocol documents:
Clinical trial NCT01838876
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Depression
Sponsor: Forest Laboratories
Start date: 2013-04-29; Completion date: 2015-07-27
Enrollment: 442 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).

Detailed description:

Arms: arm 1: Cariprazine, flexible dose (titrated to a dose of 3.0 milligrams (mg) adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability), oral administration, once daily plus antidepressant drug therapy (ADT) for 26 weeks.
Interventions: intervention 1: Cariprazine intervention 2: Antidepressant Therapy (ADT)
Intervention descriptions: intervention 1: Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration. intervention 2: ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug

Protocol documents:
Clinical trial NCT02359045
Conditions: Relative Bioavailability AUC Cmax Pharmacokinetics
Keywords: Omega-3-carboxylic acids, Phase I, Healthy Subjects, Pharmacokinetics, Relative bioavailability
Sponsor: AstraZeneca
Start date: 2015-02-12; Completion date: 2015-07-27
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be used as basis for choice of formulation for further pharmaceutical development.

Detailed description:
To assess the relative bioavailability of the different omega-3-carboxylic acids prototype capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted conditions.

Arms: arm 1: Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1), D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fasted condition. arm 2: Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) or D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fed condition.
Interventions: intervention 1: D1400147 intervention 2: D14000136 intervention 3: D14000137 intervention 4: Epanova®
Intervention descriptions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C intervention 4: Treatment D

Protocol documents:
Clinical trial NCT01023308
Conditions: Multiple Myeloma
Keywords: Myeloma DACi Bortezomib Combination Panobinostat LBH589D relapsed Velcade® Combination,
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-21; Completion date: 2015-07-30
Enrollment: 767 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Panobinostat intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Placebo
Intervention descriptions: intervention 1: Panobinostat was administered 3x week ( 2 weeks on 1 week off) intervention 2: Bortezomib was administered 2 x week ( 2weeks on 1 week off) intervention 3: Dexamethasone was adminstered on day of Bortezomib and the day after Bortezomib administration intervention 4: Placebo was administered 3x week ( 2 weeks on 1 week off)

Protocol documents:
Clinical trial NCT01483690
Conditions: Acute Lymphoblastic Leukemia Precursor B-Cell Lymphoblastic Leukemia Precursor T-Cell Lymphoblastic Leukemia
Keywords: Relapse Lymphoblastic Leukemia Decitabine Vorinostat Refractory Acute Childhood Pediatric ALL
Sponsor: Therapeutic Advances in Childhood Leukemia Consortium
Start date: 2011-12-01; Completion date: 2015-07-31
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a pilot study using decitabine and vorinostat before and during chemotherapy with vincristine, dexamethasone, mitoxantrone, and peg-asparaginase in pediatric patients with acute lymphoblastic leukemia (ALL).

Detailed description:
Decitabine is a demethylating agent and vorinostat is a HDAC inhibitor. The use of demethylating agents and HDAC inhibitors in combination have been previously shown to have synergistic effects in altering neoplastic pathways of cancer cells and be well tolerated in human clinical studies. With the ability of decitabine and vorinostat to alter the abnormal cellular pathways of leukemic blasts and essentially turn off anti-apoptotic proteins, the leukemia cells have become primed for cytotoxic cell kill via chemotherapeutic agents. This study will ask the question as to whether or not the combination of decitabine and vorinostat followed by chemotherapy is feasible and whether it can positively impact outcome in patients with relapsed or refractory acute lymphoblastic leukemia.

Arms: arm 1: Decitabine 15 mg/m2/day given IV over 1 hour on days 1 through 7 and days 15 through 21.

Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 3 through 10 and days 17 through 24 arm 2: Decitabine 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.

Vorinostat: 180 mg/m2/day (Max dose=400 mg daily) given orally on days 2 through 7 and days 16 through 21
Interventions: intervention 1: Decitabine intervention 2: Vorinostat intervention 3: Vincristine intervention 4: Dexamethasone intervention 5: Mitoxantrone intervention 6: Pegaspargase intervention 7: Methotrexate
Intervention descriptions: intervention 1: 10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19. intervention 2: 180 mg/m2/day (Max dose=400mg daily) given orally on days 2 through 7 and days 16 through 21. intervention 3: 1.5 mg/m2/day (Max dose 2 mg) given IV push on days 10, 17, 24 and 31. intervention 4: 20 mg/m2/day divided BID given orally on days 8 through 12 and 22 through 26. intervention 5: 10 mg/m2/day given on days 8 and 9 as a short IV infusion over 5-15 minutes; do not infuse over less than 3 minutes intervention 6: 2500 international units/m2/day IM or IV on days 10 and 24. intervention 7: Given intrathecally to all patients the dose defined by age below.

* 8 mg for patients age 1-1.99
* 10 mg for patients age 2-2.99
* 12 mg for patients 3-8.99 years of age
* 15 mg for patients \>9 years of age

CNS 1 or 2 patients get doses on day 8, 22 and 35 and CNS 3 patients should get doses on day 8, 15, 22, 29 and 35

Protocol documents:
Clinical trial NCT01995266
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-02-28; Completion date: 2015-07-31
Enrollment: 218 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

Detailed description:

Arms: arm 1: Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and

Daclatasvir 60mg tablet by mouth once daily for 24 weeks
Interventions: intervention 1: Asunaprevir intervention 2: Daclatasvir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: