ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00766467
Conditions: Malignant Glioma
Keywords: armodafinil Nuvigil fatigue
Sponsor: Eudocia Quant Lee, MD
Start date: 2008-09-01; Completion date: 2014-07-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.

Detailed description:
* Since no one knows for certain if armodafinil improves fatigue in brain tumor patients undergoing radiation therapy, participants will be randomized into one of two study groups. Half of the participants will receive armodafinil and the other half will receive pills with no medicine (placebo). Neither the participant or the study doctor will know what group they are in.
* Participants will be given a study medication-dosing calendar and will take either the study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days 8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days from the radiation start date.
* Participants will be evaluated via documented clinician telephone call and self-administered questionnaires on days 1, 8, 22, 43 and 57.

Arms: arm 1: Armodafinil arm 2: Placebo
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Taken orally once a day in the morning. Dose will change depending upon level of fatigue intervention 2: Placebo taken once a day in the morning

Protocol documents:
Clinical trial NCT00802841
Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic Myelogenous Leukemia CML Chronic Phase Suboptimal Response
Sponsor: Novartis Pharmaceuticals
Start date: 2009-05-01; Completion date: 2014-07-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

Detailed description:
The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.

Arms: arm 1: Participants received 400 mg nilotinib twice daily (BID). arm 2: Participants received 600 mg imatinib once daily (QD).
Interventions: intervention 1: nilotinib intervention 2: imatinib
Intervention descriptions: intervention 1: Supplied as 200 mg tablets intervention 2: Supplied as 100 mg and 400 mg tablets

Protocol documents:
Clinical trial NCT00859131
Conditions: End Stage Renal Disease
Sponsor: Medical University of South Carolina
Start date: 2009-03-01; Completion date: 2014-07-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).

Detailed description:
A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.

Arms: arm 1: Subjects receiving Thymoglobulin as induction agent in renal transplantation arm 2: subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Interventions: intervention 1: Rabbit Antithymocyte globulin intervention 2: Daclizumab
Intervention descriptions: intervention 1: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4 intervention 2: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Protocol documents:
Clinical trial NCT00915603
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Paclitaxel Bevacizumab Everolimus
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-07-01; Completion date: 2014-07-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic breast cancer. Patients will be randomized (1:1) to receive either paclitaxel/bevacizumab/everolimus (Treatment Arm 1) or paclitaxel/ bevacizumab/placebo (Treatment Arm 2). Patients will be evaluated for response to treatment every 8 weeks; responding and/or stable patients will continue treatment, with re-evaluations every 8 weeks, until tumor progression or

intolerable toxicity occurs. Outcomes will be assessed for each treatment arm

separately. This trial is not intended to compare treatment arms primarily. Any such analyses are exploratory and will be conducted without adjustment for multiple hypothesis testing.

Detailed description:

Arms: arm 1: Systemic Therapy arm 2: Systemic Therapy
Interventions: intervention 1: Everolimus intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Placebo intervention 5: Bevacizumab intervention 6: Paclitaxel
Intervention descriptions: intervention 1: Everolimus 10mg PO daily continuously for all 28 days of a cycle intervention 2: Bevacizumab 10mg/kg IV Days 1 and 15 of 28 day cycle intervention 3: Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction. intervention 4: Placebo PO daily continuously for all 28 days of a cycle intervention 5: Bevacizumab 10mg/kg IV days 1 and 15 of 28 day cycle intervention 6: Paclitaxel 90mg/m2 1-hour IV infusion Days 1, 8 and 15 of 28 day cycle. Patients will receive standard pre-medication before each paclitaxel treatment to prevent a hypersensitivity reaction.

Protocol documents:
Clinical trial NCT00955721
Conditions: Cholangiocarcinoma Biliary Tract Cancer Gallbladder Cancer
Keywords: Cholangiocarcinoma Biliary Tract Cancer Gallbladder Cancer
Sponsor: University of Miami
Start date: 2009-08-01; Completion date: 2014-07-01
Enrollment: 9 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there is no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.

Detailed description:
The purpose of this study is to build on the efficacy of the GEMOX regimen by adding Sorafenib in the treatment of Biliary Tract Cancer. Since there are no data on the combination of these three agents, the investigators plan to evaluate the safety in a run-in phase I portion in order to define the recommended phase II dose (RPTD). The phase II trial will enroll 40 patients at the RPTD level within 2 years in order to provide a preliminary estimate of progression-free survival (primary endpoint of the trial) in the target population.

Arms: arm 1: Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib.

* Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
* Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
* Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops. arm 2: Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:

* Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.
* Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.
* Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.
Interventions: intervention 1: Gemcitabine intervention 2: Oxaliplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Intravenously (IV) on Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops. intervention 2: Intravenously (IV) on Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops. intervention 3: Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops.

Protocol documents:
Clinical trial NCT00972335
Conditions: Intracranial Meningioma
Keywords: Avastin RAD001 Meningioma Bevacizumab Everolimus Brain
Sponsor: SCRI Development Innovations, LLC
Start date: 2010-01-01; Completion date: 2014-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this multicenter, Phase II trial, the investigators plan to evaluate the activity of the combination of bevacizumab and everolimus in patients with recurrent, progressive meningioma following maximal treatment with surgical resection and local radiation therapy. Although these patients are relatively rare, there is currently no established standard of treatment for a disease that causes a great deal of morbidity, and that is eventually fatal.

Detailed description:

Arms: arm 1: Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.

Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study
Interventions: intervention 1: Everolimus intervention 2: Bevacizumab
Intervention descriptions: intervention 1: This drug will be dosed at 10 mg orally DAILY for the duration of the study. intervention 2: This drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study.

Protocol documents:
Clinical trial NCT00982423
Conditions: Heart Failure Kidney Dysfunction
Keywords: heart failure heart failure with and without kidney dysfunction
Sponsor: Mayo Clinic
Start date: 2009-07-01; Completion date: 2014-07-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators' objective is to define the effects of decreasing the furosemide dose on heart, kidney and humoral function in people with compensated heart failure and kidney dysfunction and also in people with compensated heart failure without kidney dysfunction. Secondly, to define the humoral activation in both groups.

Detailed description:
The broad objective of this protocol is to advance our understanding of the pathophysiological mechanisms of human Cardiorenal Syndrome (CRS) with a specific emphasis upon the biological interaction between diuretic therapy, the renin-angiotensin-aldosterone-system (RAAS) and cyclic 3'-5'-guanosine monophosphate (cGMP) pathway.

Arms: arm 1: Subjects received their clinically prescribed dose of furosemide for a 3 week stabilization period, then were assessed for cardiorenal and humoral function. Subjects then had a 50% reduction of the furosemide dose for a 3 week stabilization period, and were assessed for cardiorenal and humoral function again.
Interventions: intervention 1: Furosemide
Intervention descriptions: intervention 1: Subjects received their clinically prescribed dose of furosemide for a 3 week stabilization period, then were assessed for cardiorenal and humoral function. Subjects then had a 50% reduction of the furosemide dose for a 3 week stabilization period, and were assessed for cardiorenal and humoral function again.

Protocol documents:
Clinical trial NCT01005576
Conditions: Severe Thalassemia
Keywords: Thalassemia Alemtuzumab Hematopoietic cell transplant non-myeloablative
Sponsor: Washington University School of Medicine
Start date: 2010-01-01; Completion date: 2014-07-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to determine if blood cell transplants, with either bone marrow or cord blood from unrelated donors, are effective in children with severe thalassemia and if this treatment approach has acceptable risks and side effects.

This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine, Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation. The primary hypothesis is that this regimen will promote stable engraftment of unrelated donor hematopoietic cells, support normal erythropoiesis, and result in an event free survival of \> 75% of children with thalassemia major.

Detailed description:

Arms: arm 1: Hydroxyurea days -50 to -21 Alemtuzumab days -21 to -19 Fludarabine days -8 to -4 Thiotepa day -4 Melphalan day -3 Stem cell infusion day 0
Interventions: intervention 1: Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
Intervention descriptions: intervention 1: Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion

Protocol documents:
Clinical trial NCT01016015
Conditions: Metastatic Osteosarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Osteosarcoma Stage III Adult Soft Tissue Sarcoma Stage IV Adult Soft Tissue Sarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-11-01; Completion date: 2014-07-01
Enrollment: 178 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well temsirolimus and cixutumumab works in treating patients with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Giving temsirolimus with cixutumumab may be an effective treatment for soft tissue or bone sarcoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the proportion of patients progression-free at 12 weeks (progression free survival \[PFS\], defined as Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) with (A) Insulin-like growth factor (IGF)-1receptor (R)+ soft tissue sarcomas; (B) IGF-1R+ bone tumors; or (C) IGF-1R(-) sarcomas, who are treated weekly with intravenous A12 (cixutumumab) and temsirolimus.

SECONDARY OBJECTIVES:

I. To determine the overall response rate (defined as CR + PR). II. To determine the overall survival. III. To determine the correlation of clinical outcome with pre- and post-treatment IGF-1R pathway related markers in plasma (pre and post therapy), archived tissue, and pre- and post-treatment tumor biopsies.

OUTLINE:

Patients receive cixutumumab intravenously (IV) over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Cixutumumab intervention 2: Laboratory Biomarker Analysis intervention 3: Temsirolimus
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given IV

Protocol documents:
Clinical trial NCT01016678
Conditions: Migraine
Sponsor: Premiere Research Institute
Start date: 2010-03-01; Completion date: 2014-07-01
Enrollment: 104 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.

Detailed description:
There are two primary treatment comparisons for this study: 1) the percentage of subjects' pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET versus placebo across attacks.

The following alternative hypothesis will be tested to see if there is a difference in the proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all attacks, OR there is a difference in the proportion of subjects who are sustained pain free at 24 hours with TREXIMET versus placebo at all attacks.

Arms: arm 1: One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo. arm 2: This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet. arm 3: Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug. arm 4: One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet. arm 5: One fifth of the subject will treat all their migraines with Active Treximet.
Interventions: intervention 1: Treximet intervention 2: Placebo
Intervention descriptions: intervention 1: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period. intervention 2: Dummy pill comparator

Protocol documents:
Clinical trial NCT01022424
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: ADPKD Tolvaptan OPC-41061
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2009-11-01; Completion date: 2014-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.

Detailed description:

Arms: arm 1: Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Interventions: intervention 1: OPC-41061
Intervention descriptions: intervention 1: Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Protocol documents:
Clinical trial NCT01048099
Conditions: Breast Cancer
Keywords: Breast Cancer Metastatic PRO Onc Assay FISH Testing HER Negative HER Overexpression HER Activation
Sponsor: SCRI Development Innovations, LLC
Start date: 2011-01-01; Completion date: 2014-07-01
Enrollment: 283 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2 overexpression/activation by the PRO Onc Assay.

Detailed description:
This two-part trial is designed to evaluate the clinical significance of the PRO Onc assay when used in patients with metastatic HER2-negative breast cancer. The first part of this study will determine the incidence of HER overexpression/activation, as determined by the PRO Onc assay, in patients previously judged to have HER2-negative breast cancer by FISH analysis. Blood specimens will be obtained from patients with HER2-negative breast cancer; CTCs will then be isolated and tested for HER2 overexpression/activation using the PRO Onc Assay. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay. If the incidence of HER2 overexpression/activation, as determined by the PRO Onc Assay, is \>10%, the study will proceed to Part 2. Part 2 of this study will assess the efficacy of HER2-targeted therapy in a group of patients with HER2-negative breast cancer who are identified as having HER2 overexpression/activation by the PRO Onc Assay. Patients will be treated with either trastuzumab or pertuzumab. Patients who progress during the first 8 weeks will have HER2-targeted treatment discontinued and will be removed from study. After 8 weeks, patients who have stable disease will be allowed to add chemotherapy to HER2-targeted therapy. Patients who have an objective response to single-agent, HER2-targeted therapy after 8 weeks will continue single-agent therapy.

Arms: arm 1: Blood specimens tested for circulating tumor cells followed by systemic treatment based on assay results with either trastuzumab or pertuzumab
Interventions: intervention 1: PRO Onc Assay and Treatment intervention 2: Trastuzumab intervention 3: Pertuzumab
Intervention descriptions: intervention 1: Patients with HER2-negative metastatic breast cancer will be identified, and blood specimens will be obtained from each participant. The PRO Onc Assay will be performed on CTCs isolated from these specimens. When clinically indicated, fine needle aspiration biopsy will also be obtained and submitted for the PRO Onc Assay. intervention 2: 8 mg/kg IV loading dose, followed by 6 mg /kg IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks intervention 3: 840 mg IV loading dose, followed by 420 IV every 3 weeks until progressive disease or unacceptable toxicity with evaluations performed every 8 weeks

Protocol documents: