ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01484496
Conditions: Systemic Lupus Erythematosus
Keywords: Subcutaneous Lupus Systemic Lupus Erythematosus SLE Belimumab Autoimmune Disease Antibodies
Sponsor: Human Genome Sciences Inc., a GSK Company
Start date: 2011-11-16; Completion date: 2015-10-01
Enrollment: 839 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Detailed description:
This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Arms: arm 1: Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months. arm 2: Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Interventions: intervention 1: Placebo intervention 2: Belimumab 200 mg SC intervention 3: Standard therapy
Intervention descriptions: intervention 1: Placebo intervention 2: Belimumab 200 mg SC intervention 3: Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.

Protocol documents:
Clinical trial NCT01511107
Conditions: Acute Otitis Media
Keywords: acute otitis media ear infection antimicrobial therapy antimicrobial resistance
Sponsor: Alejandro Hoberman
Start date: 2012-01-01; Completion date: 2015-10-01
Enrollment: 520 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome. This is a Phase 2b multicenter, randomized, double-blind, placebo-controlled clinical trial in 600 children aged 6 through 23 months comparing the efficacy of consistent reduced-duration antimicrobial treatment (5 days) with that of consistent standard-duration treatment (10 days) for each episode of AOM developing during a single respiratory season (October 1 through May 31).

Detailed description:
Eligible subjects will be randomized at the enrollment visit and will have a telephone call in the course of therapy, and a subsequent visit at the end of therapy. Thereafter, they will be followed through the end of the respiratory season, and their parents will be encouraged to bring their child when concerned about a potential recurrence of AOM. At each recurrence subjects will receive the treatment regimen (either standard- or reduced-duration) to which they were randomized at study entry (consistent treatment strategy).

The recruitment of eligible children with AOM of varying degrees of severity from various primary care practices in 2 separate geographic regions, i.e. Western Pennsylvania and Kentucky, representing urban, suburban and rural demographics will enhance generalizability of study findings and encourage translation to clinical practice.

Arms: arm 1: amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 10 days arm 2: amoxicillin-clavulanate, 90/6.4 mg/kg/day, 2 divided doses, 5 days plus placebo, 2 divided doses, 5 days
Interventions: intervention 1: Amoxicillin-Clavulanate, 10 days intervention 2: Amoxicillin-Clavulanate, 5 days
Intervention descriptions: intervention 1: Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10 intervention 2: Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5

Plus

Placebo Days 6-10

Protocol documents:
Clinical trial NCT01560260
Conditions: Carney Complex Chondrosarcoma Gastrointestinal Stromal Tumor Paraganglioma
Sponsor: National Cancer Institute (NCI)
Start date: 2012-03-01; Completion date: 2015-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well linsitinib works in treating younger and adult patients with gastrointestinal stromal tumors. Linsitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate to treatment with OSI-906 (linsitinib) 150mg BID in patients with advanced wild-type (WT) gastrointestinal stromal tumor (GIST).

SECONDARY OBJECTIVES:

I. To determine the clinical benefit rate (CBR) (stable disease \[SD\] \>= 9 months, partial response \[PR\], or complete response \[CR\]) in patients with advanced WT GIST treated with OSI-906.

II. To determine the response duration, progression free survival (PFS), and overall survival (OS) in patients with advanced WT GIST treated with OSI-906.

III. To determine the tolerability and adverse event profile of OSI-906 in patients with advanced GIST.

IV. To explore patterns of protein expression in serum and tumor tissues as predictors of response and progression-free survival (PFS) in advanced WT GIST treated with OSI-906.

V. To evaluate the metabolic response to OSI-906 using fludeoxyglucose F 18 (FDG)-positron emission tomography (PET).

VI. To determine if tumor metabolic response correlates with anatomic response and clinical benefit.

VII. To measure changes in tumor metabolism by FDG-PET qualitatively and semi-quantitatively with standard uptake value (SUV) and tumor body ratio (TBR) from baseline to first computed tomography (CT)-response evaluation and correlate the findings with size changes as defined by conventional cross-sectional imaging scans.

VIII. To investigate correlations between glucose, insulin, and candidate tumor tissue and blood biomarkers with FDG-PET metabolic response.

OUTLINE:

Patients receive linsitinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days, every 12 weeks for 2 years, and then annually thereafter.

Arms: arm 1: Patients receive linsitinib 150mg orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Linsitinib intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01565083
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-04-01; Completion date: 2015-10-01
Enrollment: 213 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.

Detailed description:

Arms: arm 1: Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle (1 cycle = 21 days) as a loading dose of 840 milligrams (mg), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg per kilogram (mg/kg), followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (will be administered after trastuzumab) on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg per meter-squared (mg/m\^2) followed by 30-35 mg/m\^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab will be administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles). arm 2: Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg/kg, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs is well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg will be administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Interventions: intervention 1: Pertuzumab intervention 2: Trastuzumab intervention 3: Vinorelbine
Intervention descriptions: intervention 1: Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle. intervention 2: Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle. intervention 3: A dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.

Protocol documents:
Clinical trial NCT01610297
Conditions: Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major
Keywords: hematopoietic stem cell transplantation, beta-thalassemia major, deferasirox, iron overload
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-01; Completion date: 2015-10-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a prospective, single-arm, multicenter, national, phase II clinical study. The purpose of this Phase II study was to examine the safety and efficacy of deferasirox to decrease iron overload (IOL) in the posttransplant period in patients with beta-thalassemia major.

Detailed description:

Arms: arm 1: Oral dose of ICL670 at 10 mg/kg daily
Interventions: intervention 1: ICL670
Intervention descriptions: intervention 1: Oral dose of ICL670 at 10 mg/kg daily

Protocol documents:
Clinical trial NCT01622569
Conditions: Bilateral Nasal Polyposis
Sponsor: Optinose US Inc.
Start date: 2013-11-19; Completion date: 2015-10-01
Enrollment: 323 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of intranasal administration of 100, 200, and 400 μg of fluticasone propionate twice a day delivered by the OptiNose device with placebo in subjects with bilateral nasal polyposis. Two co-primary endpoints will be used in the study: reduction of nasal congestion/obstruction symptoms at the end of Week 4 of the double-blind treatment phase measured by the 7 day average instantaneous AM diary symptom scores, and reduction in total polyp grade (sum of scores from both nasal cavities) over the 16 weeks of the double-blind treatment phase as determined by the Lildholdt scale score measured by nasoendoscopy.

Detailed description:
This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study designed to assess the efficacy and safety of intranasal administration of 3 doses of OPN-375 (100, 200, and 400 µg bid) in subjects with bilateral nasal polyposis and nasal congestion.

This study consisted of 3 phases. After signing informed consent, subjects who met eligibility criteria at Visit 1 (screening) entered the study.

1. Pretreatment phase (single-blind, placebo, run-in): 7 to up to 14 days duration, to determine disease status eligibility and to ensure the subject was able to comply with study procedures prior to randomization and enrolment in the double-blind treatment phase.
2. Double-blind treatment phase: 16 weeks duration with 6 scheduled visits starting with Visit 2, Day 1 (baseline) when eligible subjects were randomized by balance allocation to 1 of 4 treatment groups and ending at Visit 7 (Week 16).
3. Open-label extension phase: 8 weeks duration with 1 scheduled visit (Visit 8 \[Week 24\]).

Arms: arm 1: Double-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 2: Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 3: Double-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks arm 4: Double-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks

Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Delivered via Optinose Exhalation Delivery System

Protocol documents:
Clinical trial NCT01623310
Conditions: Nasal Polyps
Sponsor: Optinose US Inc.
Start date: 2013-09-01; Completion date: 2015-10-01
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study designed to assess the safety of intranasal administration of 400 μg of fluticasone propionate twice a day delivered by the OptiNose device in subjects with chronic sinusitis with or without nasal polyps. The study consists of an up-to-7-day pretreatment phase followed a 12-month open-label treatment phase. The duration of each subject's participation is approximately 53 weeks.

Detailed description:

Arms: arm 1: OPN-375 400 μg BID for 12 months
Interventions: intervention 1: Fluticasone Propionate
Intervention descriptions: intervention 1: Using Optinose Exhalation Delivery System

Protocol documents:
Clinical trial NCT01625000
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Acute Schizophrenia Mental Disorder Psychotropic Drugs Dopamine Agents Risperidone Central Nervous System Agents
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2015-10-01
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214 relative to placebo in patients with acute exacerbation of schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: MP-214 3mg intervention 2: MP-214 6mg intervention 3: MP-214 9mg intervention 4: Risperidone 4mg intervention 5: Placebo
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks. intervention 2: Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks. intervention 3: Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks. intervention 4: Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks. intervention 5: Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.

Protocol documents:
Clinical trial NCT01629615
Conditions: Breast Cancer
Keywords: breast cancer metastatic triple negative breast cancer BKM120 SOLTI PI3K inhibitor
Sponsor: SOLTI Breast Cancer Research Group
Start date: 2012-06-01; Completion date: 2015-10-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the clinical activity of BKM120 in patients with metastatic triple-negative breast cancer.

Detailed description:
This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory study of single agent BKM120 in the treatment of metastatic triple negative breast cancer patients.

Patients will first undergo screening, tumor measurement and collection of available tumor block from the primary tumor and/or a metastatic site. Available tumor block is required in all patients per inclusion criteria. Analysis of this tumor block will be used for correlation of predictive markers and clinical response in order to define potential subpopulation that benefit from BKM120.

Following confirmation of eligibility criteria, subjects will be enrolled. BKM120 will then be administered in a 100mg dose, orally, once daily, in a continuous schedule. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations.

Treatment with BKM120 will continue until disease progression, unacceptable toxicity that precludes any further treatment, and/or discontinuation of the treatment by investigator or patient decision.

Arms: arm 1: None
Interventions: intervention 1: BKM120
Intervention descriptions: intervention 1: BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression

Protocol documents:
Clinical trial NCT01660906
Conditions: Chronic Phase Chronic Myeloid Leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2012-12-01; Completion date: 2015-10-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study proposes to evaluate the number of chronic, Grade 1 or 2, non-hematologic Adverse Events (AEs) that reduce in grade or resolve at 3 months after switching therapy from imatinib to dasatinib.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: tablets, oral, 100 mg, Once daily, Up to12 months on study,

Protocol documents:
Clinical trial NCT01677988
Conditions: Adenocarcinoma of Head of Pancreas
Keywords: NEOADJUVANT FOLFIRINOX CHEMOTHERAPY LOCALIZED PANCREATIC HEAD ADENOCARCINOMA RADIATION THERAPY
Sponsor: Medical University of South Carolina
Start date: 2012-07-01; Completion date: 2015-10-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.

Detailed description:

Arms: arm 1: Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection
Interventions: intervention 1: Neo-adjuvant Chemotherapy intervention 2: Chemoradiation intervention 3: Surgical Resection
Intervention descriptions: intervention 1: 1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)

   1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
   2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation. intervention 2: 1. Chemoradiation may be administered at selected approved CTN sites.
2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.

   1. Unresectable → Off study. Subsequent treatment per patient's primary MD.
   2. Resectable → Continue to Registration #3 for Surgical Resection intervention 3: 1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD)
2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies

Protocol documents:
Clinical trial NCT01687257
Conditions: Hepatitis C Cirrhosis Portal Hypertension With or Without Liver Decompensation
Sponsor: Gilead Sciences
Start date: 2012-07-01; Completion date: 2015-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

Detailed description:

Arms: arm 1: Participants will receive SOF+RBV for 48 weeks. arm 2: Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.
Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: SOF 400 mg tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01704651
Conditions: Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords: Ovary Ovarian Fallopian Peritoneal Cancer Gynecological Female
Sponsor: Jamie N. Bakkum-Gamez
Start date: 2013-01-01; Completion date: 2015-10-01
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Detailed description:

Arms: arm 1: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days. arm 2: Perioperative administration of placebo, at same dosing interval as study drug.
Interventions: intervention 1: Alvimopan intervention 2: Placebo
Intervention descriptions: intervention 1: Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. intervention 2: Perioperative administration of placebo, at same dosing interval as study drug.

Protocol documents: