ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00931918
Conditions: Non-Germinal B-Cell-like (GCB) Diffuse Large B-cell Lymphoma (DLBCL)
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2009-10-01; Completion date: 2015-08-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.

Detailed description:
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP \[rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\] with or without VELCADE®.

The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:

* RCHOP
* Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone\]

Participants received treatment for up to six, 21-day cycles.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.

Arms: arm 1: RCHOP \[rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. arm 2: Vc-RCHOP \[bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone\] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m\^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m\^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m\^2 IV infusion, doxorubicin 50 mg/m\^2 IV injection and vincristine 1.4 mg/m\^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
Interventions: intervention 1: Bortezomib intervention 2: Rituximab intervention 3: Cyclophosphamide intervention 4: Doxorubicin intervention 5: Vincristine intervention 6: Prednisone
Intervention descriptions: intervention 1: Bortezomib IV intervention 2: Rituximab IV intervention 3: Cyclophosphamide IV intervention 4: Doxorubicin IV solution intervention 5: Vincristine IV intervention 6: Prednisone tablet

Protocol documents:
Clinical trial NCT00939484
Conditions: Adult Medulloblastoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-06-01; Completion date: 2015-08-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vismodegib works in treating adult patients with recurrent or refractory medulloblastoma. Vismodegib may slow the growth of tumor cells and may be an effective treatment for medulloblastoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To estimate the efficacy of GDC-0449 (vismodegib) treatment for adult patients with recurrent or refractory medulloblastoma, as measured by the objective response rates for patients without (Stratum A) and with (Stratum B) evidence of activation of Sonic Hedgehog (SHH) signaling pathway tumors.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of GDC-0449 administered on a once daily schedule.

II. To estimate the duration of objective response and progression-free survival (PFS).

III. To characterize the pharmacokinetics (plasma and cerebrospinal fluid) of GDC-0449 in adults with refractory medulloblastoma.

IV. To document pathologic and genomic methods to identify CNS tumors with activation of the PTCH/SHH pathway.

V. To describe the objective responses observed in patients whose pathologic assessment of tumor result in unknown (Stratum C) evidence of activation of Sonic Hedgehog (SHH) signaling pathway tumors.

OUTLINE: This is a multicenter study. Patients are stratified according to PTCH/Sonic Hedgehog signaling pathway activation (inactivated vs activated vs unknown).

Patients receive vismodegib orally (PO) once daily on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 12 months.

Arms: arm 1: Patients receive vismodegib PO once daily on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Pharmacological Study intervention 2: Vismodegib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT00994604
Conditions: Asthma COPD
Sponsor: Johns Hopkins University
Start date: 2009-10-01; Completion date: 2015-08-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine whether broccoli sprout extract can effect lung function measurements in individuals with asthma and COPD.

Detailed description:
Asthma afflicts 23 million people, results in nearly 13 million ambulatory physician encounters, and 440,000 hospitalizations annually. The economic burden for 2010 is estimated to run $20.7 billion.

Although steroids are the mainstay of treatment, they do not "cure" the disease. While inflammation may be the inciting factor, other mechanisms must play a crucial role in this process. Elevated oxidative stress could cause the kind of chronic inflammation associated with asthma, and could provide an explanation for recurrent asthma attacks. Cigarette smoke, both primary and secondary exposure, worsens the oxidative stress balance in the airways. Thus, the continuing focus on simply treating the inflammation is a barrier to progress. It is critical to examine other factors, such as abnormal oxidative stress through specific pathways that may affect airway inflammation and asthma attacks.

One compound, that repairs oxidative stress pathways, is sulforaphane, a food compound found in vegetables, including broccoli sprouts. Preliminary data demonstrate that broccoli sprout extract (BSE), rich in sulforaphane, improves airflow measures in asthmatics.

We plan to examine whether the airflow abnormalities in asthma, and the exacerbation from cigarette smoke, can be prevented by the administration of BSE, and determine the primary inflammatory and oxidative stress signaling pathways involved in the protection provided by BSE.

Arms: arm 1: This a before and after treatment study. The subjects will consumer broccoli sprout extract (BSE) for two weeks (14d). Lung function and Chest CT will be performed before and after BSE consumption.
Interventions: intervention 1: broccoli sprout extract
Intervention descriptions: intervention 1: consumption of broccoli sprout extract for 2 weeks

Protocol documents:
Clinical trial NCT01097395
Conditions: Hepatitis C Virus
Keywords: ribavirin pharmacokinetics Hepatitis C virus
Sponsor: University of Colorado, Denver
Start date: 2010-02-01; Completion date: 2015-08-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.

Detailed description:

Arms: arm 1: 1000 mg daily in patients weighing \<75 kg and 1200 mg daily in patients weighing ≥ 75 kg arm 2: Dose adjusted based on first dose AUC0-12
Interventions: intervention 1: ribavirin
Intervention descriptions: intervention 1: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12

Protocol documents:
Clinical trial NCT01120275
Conditions: Acral Lentiginous Malignant Melanoma Lentigo Maligna Malignant Melanoma Nodular Malignant Melanoma Recurrent Melanoma Solar Radiation-related Skin Melanoma Stage IV Melanoma Superficial Spreading Malignant Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-10-01; Completion date: 2015-08-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with stage IV melanoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the six-month progression-free survival and one-year overall survival probability in Stage IV melanoma patients treated with RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097).

SECONDARY OBJECTIVES:

I. To investigate in a preliminary manner the relationship between Notch activation status and gene expression profile of tumor and clinical outcomes from patients in this study.

II. To study the effects of the investigational therapy on T cell function, which will provide a basis for subsequent trials combining Notch blockade with immunomodulatory therapy for advanced melanoma.

III. To assess the response rate (confirmed and unconfirmed complete and partial responses).

IV. To assess toxicity.

OUTLINE: This is a multicenter study.

Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Some patients undergo blood collection at baseline and during study for analysis of T-cell function by flow cytometry and ELISA. Tumor tissue samples from biopsy or surgery are also analyzed for Notch activation by IHC and qRT-PCR.

After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for 2 years.

Arms: arm 1: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: gamma-secretase/Notch signalling pathway inhibitor RO4929097 intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01121939
Conditions: Neuroendocrine Carcinoma
Keywords: advanced neuroendocrine Gastrointestinal Bevacizumab Avastin Pertuzumab Omnitarg 2C4 Sandostatin Octreotide
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-05-01; Completion date: 2015-08-01
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase II trial will be to define the activity of a VEGF inhibitor

bevacizumab, HER1/HER2 inhibitor pertuzumab, and sandostatin for patients with

advanced neuroendocrine cancers. In particular, the efficacy of bevacizumab and

pertuzumab treatment is of great interest. The primary endpoint of this trial will be

response rate. Toxicity and progression-free survival will be obtained and evaluated.

Detailed description:
* To determine overall response rate of patients with low grade neuroendocrine cancer when treated with the combination of bevacizumab, pertuzumab and sandostatin LAR®.
* To determine the disease control rate (objective response + stable disease), time to treatment progression, progression-free survival, and overall survival in patients with advanced low grade neuroendocrine cancer when treated with bevacizumab, pertuzumab and Sandostatin LAR® treatment.
* To define the toxicity and safety of the combination of bevacizumab, pertuzumab and Sandostatin LAR® when used in patients with advanced low grade neuroendocrine cancer.

Arms: arm 1: combination of bevacizumab, pertuzumab, and sandostatin for patients with advanced neuroendocrine cancers
Interventions: intervention 1: Bevacizumab intervention 2: Pertuzumab intervention 3: Sandostatin LAR® Depot
Intervention descriptions: intervention 1: 15 mg/kg IV Day 1. The first dose should be administered over

90 minutes. If no adverse reactions occur after the initial dose, the second dose should

be administered over a minimum of 60 minutes. If no adverse reactions occur after the

second dose, all subsequent doses should be administered over a minimum of 30

minutes. Bevacizumab will be infused prior to pertuzumab. intervention 2: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Otherwise, pertuzumab should be infused over 60 minutes. Patients should be observed for 30 minutes after completing the pertuzumab infusion.

If a patient misses a dose of pertuzumab for 1 cycle (i.e., 2 sequential cycles or administrations are 6 weeks or more apart), a re-loading dose (840 mg) of pertuzumab should be given. If re-loading pertuzumab is administered, subsequent doses of 420 mg will then be given every 3 weeks, starting 3 weeks later. intervention 3: 30 mg will be given every 28 days by IM injection. The dose of sandostatin may be increased, at the discretion of the treating physician, if necessary to control symptoms related to tumor secretion of vasoactive peptides.

Protocol documents:
Clinical trial NCT01122901
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2010-12-01; Completion date: 2015-08-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with recurrent or progressive glioblastoma. Gamma-secretase/Notch signalling pathway inhibitor RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. 6-month progression-free survival (PFS6). (Group A) II. Efficiency of neurosphere generation after pretreatment with RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097). (Group B)

SECONDARY OBJECTIVES:

I. Radiographic response rate. (Group A) II. Toxicities associated with this regimen. (Group A) III. Overall survival. (Group A) IV. Expression levels of Notch pathway components and downstream targets. (Group B) V. Tumor propagation. An extension of lifespan by 50% in tumor bearing mice (mice bearing fresh tumor tissue). (Group B) VI. Patient event-free survival in correlation with expression levels of Notch pathway components and downstream targets.

VII. 6-month progression-free survival (PFS6). VIII. Toxicities associated with this regimen. IX. Overall survival.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

GROUP A: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 orally (PO) once daily (QD) on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

GROUP B (surgical resection indicated): Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 as in Group A.

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

Arms: arm 1: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.
Interventions: intervention 1: gamma-secretase/Notch signalling pathway inhibitor RO4929097 intervention 2: therapeutic conventional surgery intervention 3: pharmacological study intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Undergo surgery intervention 3: Correlative studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT01138475
Conditions: Gastric Bypass Parathyroid Hormone
Keywords: PTH Gastric bypass surgery vitamin D paricalcitol
Sponsor: Kerstyn C. Zalesin, M.D.
Start date: 2010-07-01; Completion date: 2015-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy of paricalcitol, cholecalciferol, and placebo in the reduction of parathyroid hormone in patients after Roux-en-Y gastric bypass surgery (RYGB). Assess changes, if any, in measures of self-assessed well-being attributable to paricalcitol after RYGB. Evaluate the rates of hypercalcemia, kidney stones, gastrointestinal side effects, and other organ system adverse effects of paricalcitol, cholecalciferol, and placebo in patients after RYGB

Detailed description:

Arms: arm 1: This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). arm 2: This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group). arm 3: This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).
Interventions: intervention 1: Paricalcitol intervention 2: Cholecalciferol intervention 3: Placebo
Intervention descriptions: intervention 1: 1 microgram by mouth daily for 6 weeks intervention 2: 5000 IU (international units) by mouth daily for 6 weeks intervention 3: Inactive substance, one capsule daily for 6 weeks

Protocol documents:
Clinical trial NCT01151410
Conditions: Hypertension
Keywords: Pediatric hypertension primary hypertension secondary hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-01; Completion date: 2015-08-01
Enrollment: 208 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).

Detailed description:

Arms: arm 1: Patients will receive one of the following doses based on the their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg arm 2: Patients will receive one of the following doses based on their weight: Low weight (≥20 to \<50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to \<80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Interventions: intervention 1: Aliskiren intervention 2: Enalapril
Intervention descriptions: intervention 1: Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg

Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg

High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg intervention 2: Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg

Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg

High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg

Protocol documents: