ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01362140
Conditions: MDS
Keywords: Randomized Darbepoetin alfa Myelodysplastic Syndromes Placebo-controlled low risk MDS intermediate-1 risk MDS International Prognostic Scoring System
Sponsor: Amgen
Start date: 2011-12-21; Completion date: 2017-09-14
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

Detailed description:
This study consists of a 3-week screening period, a 24-week double-blind treatment period, and a 48-week active treatment period and the long-term follow-up period.

An end of treatment period (EOTP) visit occurs at week 25, or 3 weeks after last dose of investigational product (IP) for participants who withdraw from the study. After entering the active treatment period, an end of active treatment period (EOATP) visit occurs at week 72 / 73, or 3 weeks after the last dose of darbepoetin alfa.

Long-term follow-up (LTFU) will occur every 26 weeks (± 4 weeks) from the EOATP visit (or EOTP visit if the participant does not enter the active treatment period) and will continue for a minimum of 3 years from the first dose of IP. Follow-up may occur through clinic visit or telephone contacts. Information on the participant's survival and progression to AML status will be collected during LTFU.

Arms: arm 1: Participants received darbepoetin alfa 500 µg every three weeks (Q3W) for 24 weeks in the double-blind treatment period, and continued to receive darbepoetin alfa 500 µg Q3W during the active treatment period for an additional 48 weeks. arm 2: Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks during the double-blind treatment period. From week 25 participants received darbepoetin alfa 500 µg Q3W during the active treatment period for 48 weeks.
Interventions: intervention 1: Darbepoetin alfa intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection every 3 weeks intervention 2: Administered by subcutaneous injection every 3 weeks

Protocol documents:
Clinical trial NCT02626520
Conditions: Ductal Adenocarcinoma of Pancreas Adenocarcinoma of Ampulla
Sponsor: Essentia Health
Start date: 2016-05-11; Completion date: 2017-09-14
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients diagnosed with pancreatic cancer without clinically detectable metastatic disease will be treated with standardized systemic chemotherapy, followed by chemoradiation, and then surgical resection for those with resectable or borderline resectable disease. The primary endpoint is disease-free survival at 1 yr from initiation of treatment.

Detailed description:
Patients with ductal adenocarcinoma of the pancreas (or ampulla) that have received no prior therapy and have no clinically detectable metastatic disease will be enrolled. Management will be driven by resectability status as defined by the American College of Surgeons. All patients will be defined at entry as Resectable, Borderline Resectable or Locally Advanced (Unresectable).

All patients will be treated initially with gemcitabine and nanoparticle albumin bound paclitaxel (nab-paclitaxel) every 14 days for 4 cycles. Patients classified as Resectable, who have CA19-9 below 180 and CA-125 below 30 will then proceed to resection. All other patients will get 5-fluorouracil as 46 hr infusion given with leucovorin and irinotecan (FOLFIRI-3) every 14 days x 4 cycles.

All patients without progression will then receive chemoradiation consisting of external beam radiotherapy (40 Gy in 20 fractions given over 4 weeks). During radiation all patients will receive radiosensitizing radiotherapy as: 5-fluorouracil at 225 mg/m2 5 days per week, Mitomycin-C at 3 mg.m2 on d1, 8, 15 \& 22; Cisplatin at 10 mg/m2 on d2, 9, 16, 23 and unfractionated heparin at 6,000 units/m2 daily in divided doses from day 1 to day 28.

After approximately 4 weeks to recover from chemoradiation, all patients with Resectable or Borderline Resectable disease will undergo definitive surgery.

Adjuvant therapy with FOLFIR-3 for an additional 6 cycles will be offered to all patients post-operatively.

Patients will then be actively followed every 3 to 6 months in keeping with National Comprehensive Cancer Network (NCCN) guidelines for 2 yrs, and then followed for recurrence, late toxicity and vital status every 6 months through 5 years.

Arms: arm 1: Systemic chemotherapy followed by definitive surgery without pre-operative or post-operative radiotherapy. arm 2: Systemic chemotherapy followed by chemoradiation, followed by definitive surgery
Interventions: intervention 1: Gemcitabine and nanoparticle albumin bound paclitaxel intervention 2: 5-fluorouracil and irinotecan intervention 3: Preoperative chemoradiation intervention 4: Definitive resection
Intervention descriptions: intervention 1: Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles intervention 2: FOLFIRI.3 given every 14 days x 4 cycles intervention 3: Pre-operative chemoradiation to 40 Gy in 20 fractions intervention 4: Definitive surgical resection of primary tumor

Protocol documents:
Clinical trial NCT01496157
Conditions: Prostate Cancer
Keywords: Primary Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-09-11; Completion date: 2017-09-17
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC), as a PET imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available. Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (CT, bone scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived prediction of pathologic stage).

Detailed description:

Arms: arm 1: Patients will be imaged with 18F-DCFBC
Interventions: intervention 1: 18F-DCFBC
Intervention descriptions: intervention 1: A bolus of 10 mCi (370 MBq) \[9-11 mCi (333-407 MBq)\] of 18F-DCFBC will be injected into the IV line by slow IV push.

Protocol documents:
Clinical trial NCT01973569
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Denosumab RANKL RANK AMG 162 joint damage Developmental Phase III
Sponsor: Daiichi Sankyo
Start date: 2013-10-01; Completion date: 2017-09-19
Enrollment: 679 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.

Detailed description:
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.

Arms: arm 1: denosumab administered subcutaneously every 6 months arm 2: denosumab administered subcutaneously every 3 months arm 3: placebo administered subcutaneously to match denosumab
Interventions: intervention 1: denosumab intervention 2: placebo
Intervention descriptions: intervention 1: denosumab administered subcutaneously intervention 2: placebo administered subcutaneously to match denosumab

Protocol documents:
Clinical trial NCT01753713
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: Manmeet Ahluwalia, MD
Start date: 2012-12-20; Completion date: 2017-09-20
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial studies how well dovitinib works in treating patients with recurrent or progressive glioblastoma. Dovitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

Anti-angiogenic Therapy Naive Patients: To determine 6 month progression-free survival (PFS6) in anti-angiogenic therapy (including anti-vascular endothelial growth factor (VEGF) therapy or bevacizumab) naive patients with recurrent glioblastoma (GBM) in patients treated with dovitinib

Anti-angiogenic Therapy Patients: To estimate time to progression in patients with recurrent or progressive Glioblastoma who have progressed on anti-angiogenic therapy (including anti-VEGF therapy).

SECONDARY OBJECTIVES:

1. To evaluate the side effect profile of dovitinib in both patient populations.
2. To evaluate the efficacy of dovitinib as measured by objective response rate (ORR) in both patient populations.
3. To estimate time to percentage of patients free from progression at 6 months (PFS-6)in patients with recurrent or progressive Glioblastoma who have progressed on antiangiogenic therapy (including anti-VEGF therapy). (Anti-angiogenic Therapy Patients)
4. To estimate time to progression in anti-angiogenic therapy (including anti-VEGF therapy or bevacizumab) naiVe patients with recurrent glioblastoma (GBM) in patients treated with dovitinib. (Anti-angiogenic Therapy Naive Patients)
5. To evaluate the overall survival (OS) in both patient populations.

EXPLORATORY OBJECTIVES:

To explore association between clinical outcome and potential biomarkers that may include microparticles, PlGF, PDGF-AA, PDGF-AB, PDGF-BB, SDF-1a, thrombospondin-1, Ang1, and Il-6, IL-8 and FGF.

OUTLINE:

Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Arms: arm 1: Patients who have progressed without anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. arm 2: Patients who have progressed on anti-angiogenic therapy. Patients receive dovitinib orally (PO) 5 days a week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: dovitinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01633060
Conditions: Metastatic Breast Cancer
Keywords: BKM120 fulvestrant breast cancer metastatic locally advanced AI treated mTOR inhibitor PI3K PIK3CA PTEN HER2- HR+
Sponsor: Novartis Pharmaceuticals
Start date: 2012-10-03; Completion date: 2017-09-21
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

Detailed description:
Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016, Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study was terminated.

Arms: arm 1: BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol. arm 2: BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Interventions: intervention 1: Fulvestrant intervention 2: BKM120 intervention 3: BKM120 matching placebo
Intervention descriptions: intervention 1: Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter) intervention 2: BKM120 100 mg once daily intervention 3: BKM120 matching placebo, once daily

Protocol documents:
Clinical trial NCT02170025
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis delta F508 Safety Tolerability Sweat Chloride Pharmacokinetics
Sponsor: Bayer
Start date: 2014-09-30; Completion date: 2017-09-22
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assessment of the safety, tolerability and early signs of efficacy of three times a day orally administered BAY63-2521 in adult delta F508 homozygous Cystic Fibrosis patients not on treatment with Orkambi

Detailed description:
The study consists of two parts. The first part is double-blind, randomized and placebo-controlled. The second part has an open-label study design. In part 1 patients on Orkambi or other CFTR-modulators are excluded. In part 2 patients on Orkambi are allowed to be included under certain conditions.

Arms: arm 1: Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient. arm 2: Participants received matching placebo tid.
Interventions: intervention 1: Riociguat (Adempas, BAY63-2521) intervention 2: Placebo
Intervention descriptions: intervention 1: Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient. intervention 2: Participants received matching placebo tid.

Protocol documents:
Clinical trial NCT02296424
Conditions: Systemic Juvenile Idiopathic Arthritis (SJIA)
Keywords: Juvenile Rheumatoid arthritis (JRA) chronic systemic inflammatory disorder painful joints inflammation of the synovial membrane auto-immune rheumatoid disease reactive rheumatoid arthritis Systemic Juvenile Rheumatoid arthritis (SJRA)
Sponsor: Novartis Pharmaceuticals
Start date: 2014-11-17; Completion date: 2017-09-25
Enrollment: 182 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Detailed description:
This two-part open-label study was to assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The study was also to collect long term safety and tolerability data on SJIA patients treated with canakinumab.

Arms: arm 1: All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab was administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continued to maintain inactive disease for 24 additional weeks, canakinumab was administered at 1mg/kg every 4 weeks. If the patient continued to maintain inactive disease for another 24 additional weeks, canakinumab treatment was discontinued. arm 2: All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
Interventions: intervention 1: ACZ885 150 mg (Canakinumab)
Intervention descriptions: intervention 1: Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Protocol documents:
Clinical trial NCT02334527
Conditions: Metastatic Urothelial Carcinoma (UC)
Keywords: metastatic urothelial carcinoma (UC) LCCC 1406 Lineberger palbociclib
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2015-03-17; Completion date: 2017-09-28
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy.

Detailed description:
This multicenter phase II trial will evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma (UC) with cyclin-dependent kinase inhibitor 2A (CDKN2A) (also referred to as p16) loss and positive Retinoblastoma (Rb) expression after failure of first-line chemotherapy. The study will enroll up to 40 patients to identify 36 evaluable patients, using a Simon's two-stage design, with a primary endpoint of progression free survival (PFS) at 4 months (PFS4). Secondary objectives include estimating median PFS, overall survival (OS), response rate (RR) and exploratory objectives include an evaluation of molecular predictors of response and resistance.

Arms: arm 1: Palbociclib
Interventions: intervention 1: Palbociclib
Intervention descriptions: intervention 1: 125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off.

Protocol documents:
Clinical trial NCT02116582
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: MDV3100 Xtandi Abiraterone Metastatic Castration-Resistant Prostate Cancer Enzalutamide
Sponsor: Astellas Pharma Europe B.V.
Start date: 2014-05-23; Completion date: 2017-09-29
Enrollment: 215 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.

Detailed description:

Arms: arm 1: Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
Interventions: intervention 1: Enzalutamide
Intervention descriptions: intervention 1: Participants received 160 mg of enzalutamide (soft capsules) orally once daily.

Protocol documents:
Clinical trial NCT02932462
Conditions: Scalp Psoriasis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2016-03-01; Completion date: 2017-09-29
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study

Detailed description:
This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis

Arms: arm 1: DSXS 1535 topical product arm 2: Vehicle
Interventions: intervention 1: DSXS intervention 2: Placebo
Intervention descriptions: intervention 1: topical product intervention 2: topical product

Protocol documents:
Clinical trial NCT01701583
Conditions: Chronic Urticaria
Keywords: Chronic Idiopathic Urticaria CIU Urticaria Chronic Hives Xolair
Sponsor: University of Colorado, Denver
Start date: 2013-04-01; Completion date: 2017-10-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study looks at changes in cell proteins in people with chronic hives treated with omalizumab.

Detailed description:
The purpose of this study is to evaluate for changes in the proteins produced in white blood cells (basophils) in patients with chronic hives who are treated with and respond to omalizumab.

Arms: arm 1: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
Interventions: intervention 1: Omalizumab
Intervention descriptions: intervention 1: Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.

Protocol documents:
Clinical trial NCT01893801
Conditions: Stage IV Pancreatic Cancer
Keywords: pancreatic cancer pancreatic adenocarcinoma Stage IV pancreatic cancer pancreas pancreatic
Sponsor: Pancreatic Cancer Research Team
Start date: 2013-05-01; Completion date: 2017-10-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).

Detailed description:
This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response (complete response-CR, partial response-PR, stable disease-SD and progressive disease-PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS (overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE (v4.0, May 2009).

Arms: arm 1: This is a phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel 125mb/m2, cisplatin 25mg/m2, and gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.
Interventions: intervention 1: nab-paclitaxel intervention 2: Cisplatin intervention 3: gemcitabine
Intervention descriptions: intervention 1: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle intervention 2: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle intervention 3: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Protocol documents: