ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00574080
Conditions: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2006-07-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Add three drugs, bortezomib, thalidomide, and dexamethasone (VTD) to the high dose chemotherapy regimen immediately before transplant (DPACE/Melphalan) to try to improve myeloma response and acquire longer survival for participants.

Detailed description:

Arms: arm 1: DPACE Induction, Melphalan/DPACE Transplant 1, BEAM Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases arm 2: DPACE Induction, Melphalan/DPACE + VTD Transplant 1, BEAM + VTD Transplant 2, DPACE Consolidation, Dexamethasone Maintenance with Interim dexamethasone between treatment phases
Interventions: intervention 1: Interim/Maintenance Dexamethasone intervention 2: Induction/Consolidation Dexamethasone intervention 3: Induction/Consolidation Cisplatin intervention 4: Induction/Consolidation Adriamycin intervention 5: InductionConsolidation Cyclophosphamide intervention 6: Induction/Consolidation Etoposide intervention 7: Induction Pegfilgrastim intervention 8: Transplant 1 Dexamethasone intervention 9: Transplant 1 Cisplatin intervention 10: Transplant 1 Adriamycin intervention 11: Transplant 1 Cyclophosphamide intervention 12: Transplant 1 Etoposide intervention 13: Transplant 1 Melphalan intervention 14: Transplant 1 and 2 Pegfilgrastim intervention 15: Autologous Peripheral Blood Stem Cell Transplant (ASCT) intervention 16: Transplant 2 Carmustine intervention 17: Transplant 2 Etoposide intervention 18: Transplant 2 Cytarabine intervention 19: Transplant 2 Melphalan intervention 20: Transplant 2 Dexamethasone intervention 21: Transplant 1 and 2 Bortezomib intervention 22: Transplant 1 and 2 Thalidomide
Intervention descriptions: intervention 1: 20 mg Days 1-4 every 3 weeks in the interim between treatment phases and during maintenance intervention 2: 40 mg Days 1-4 intervention 3: 10 mg/m2 by continuous infusion Days 1-4 intervention 4: 10 mg/m2 by continuous infusion Days 1-4 intervention 5: 400 mg/m2 by continuous infusion Days 1-4 intervention 6: 40 mg/m2 by continuous infusion Days 1-4 intervention 7: 6 mg Days 6 and 13 intervention 8: 20 mg Days -4, -3, -2, -1 and +4, +5, +6, and +7 intervention 9: 20 mg/m2 by continuous infusion Days -3 and -2 intervention 10: 20 mg/m2 by continuous infusion Days -3 and -2 intervention 11: 800 mg/m2 by continuous infusion Days -3 and -2 intervention 12: 80 mg/m2 by continuous infusion Days -3 and -2 intervention 13: 50 mg/m2 Days -2 and -1 intervention 14: 6 mg Day +6 intervention 15: Day 0 intervention 16: 300 mg/m2 Day -5 intervention 17: 200 mg/m2 Days -5, -4, -3, -2 intervention 18: 400 mg/m2 Days -5, -4, -3, -2 intervention 19: 140 mg/m2 Day -1 intervention 20: 20 mg Days -5, -4, -3, -2, +4, +5, +6, +7 intervention 21: 1 mg/m2 Days -4, -1, +3, +7 intervention 22: 200 mg Days -4 to +5

Protocol documents:
Clinical trial NCT00574405
Conditions: Diabetes Mellitus
Keywords: Insulin pump Beta cell
Sponsor: Arkansas Children's Hospital Research Institute
Start date: 2005-04-01; Completion date: 2011-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Type I diabetes (T1DM) is the second most common chronic illness effecting children in the USA. Worldwide, Type I diabetes is increasing in incidence, and its underlying etiology remains elusive. Nevertheless, recent data supports the notion that early and intensive management of Type I diabetes can 1) decrease long-term complications of diabetes; and 2) may significantly improve beta cell function and insulin secretion over ensuing years. To this end, we propose using insulin pump therapy to preserve and/or enhance residual endogenous B-cell secretory capacity among patients with newly diagnosed Type 1 DM. Furthermore, we anticipate that early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple daily injection (MDI) therapy, and will be well-tolerated by the patient. These data will provide important pilot information to explore the potential role of intensive insulin pump therapy in the treatment of children newly diagnosed with Type I diabetes. The specific aim of this study is to test the following hypothesis: Early use of insulin pump therapy is effective in preserving or enhancing residual endogenous pancreatic B-cell secretory capacity among patients with newly diagnosed T1DM: Moreover, early use of an insulin pump will improve glycemic control beyond that achieved with standard multiple injection therapy, and will be well-tolerated by the patient.

Detailed description:

Arms: arm 1: MDI = 3-4+ insulin injections/day, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®). arm 2: CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.
Interventions: intervention 1: MDI (split-mix NPH insulin + regular insulin or Lantus + Novolog® [or Humalog®]) intervention 2: CSII (Animas Corporation insulin pump, model IR 1200)
Intervention descriptions: intervention 1: MDI = 3-4+ insulin injections/day, using NPH + regular insulin or Lantus + insulin lispro; 12 month treatment duration. intervention 2: CSII (insulin pump), using Animas Corporation insulin pump, model IR 1200.

Protocol documents:
Clinical trial NCT00580840
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Joint Disease Arthritis Certolizumab pegol Cimzia
Sponsor: UCB Pharma
Start date: 2007-12-01; Completion date: 2011-03-01
Enrollment: 333 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Detailed description:
Subjects with a stable methotrexate (MTX) dose enter the run-in period in which certolizumab pegol (CZP) will be administered at a dose of 400 mg (2 injections) at Weeks 0, 2, and 4 and at a dose of 200 mg with placebo (1 injection placebo, 1 injection CZP) at Weeks 6, 8, 10, 12, 14 and 16. The dose of MTX should be stable for at least 2 months prior to the Baseline visit and will remain stable throughout the trial, unless there is a need to reduce the dose for reasons of toxicity.

At the Week 18 visit, subjects who were ACR20 (American College of Rheumatology 20% Improvement) responders at Week 16 will be randomized in a double-blinded way to receive either 400 mg CZP given every 4 weeks and placebo given every 4 weeks given as two injections (alternating CZP and placebo every two weeks) plus MTX, 200 mg CZP and placebo administered every 2 weeks (one injection of each) plus MTX, or Placebo administered as two injections every 2 weeks plus MTX. Non-responders will be withdrawn from the study.

Arms: arm 1: 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) arm 2: 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) arm 3: Placebo administered as two injections every 2 weeks
Interventions: intervention 1: Certolizumab pegol intervention 2: Certolizumab pegol intervention 3: Placebo
Intervention descriptions: intervention 1: 400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) intervention 2: 200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) intervention 3: placebo (saline) administered as two injections every 2 weeks

Protocol documents:
Clinical trial NCT00594230
Conditions: Myelodysplastic Syndromes (MDS)
Keywords: Myelodysplastic Syndromes (MDS) Refractory LBH589
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-01-01; Completion date: 2011-03-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a single arm Phase II study.

Detailed description:
LBH589 (20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.

Arms: arm 1: Treatment with LBH589 (Panobinostat) 20 mg arm 2: Treatment with LBH589 (Panobinostat) 30 mg
Interventions: intervention 1: Panobinostat
Intervention descriptions: intervention 1: Panobinostat(20 mg or 30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.

Protocol documents:
Clinical trial NCT00598650
Conditions: Dementia With Lewy Bodies (DLB)
Keywords: Lewy Body Disease Dementia Clinical Trial Phase II E2020 donepezil hydrochloride
Sponsor: Eisai Co., Ltd.
Start date: 2008-02-01; Completion date: 2011-03-01
Enrollment: 160 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E2020
Intervention descriptions: intervention 1: Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.

Protocol documents:
Clinical trial NCT00625872
Conditions: Growth Hormone Therapy Infant, Small for Gestational Age
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2011-03-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.

Detailed description:

Arms: arm 1: Somatropin for 12 months arm 2: In the first 6 months no intervention, afterwards Somatropin for 12 months
Interventions: intervention 1: Somatropin intervention 2: Somatropin
Intervention descriptions: intervention 1: Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months. intervention 2: Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.

Protocol documents:
Clinical trial NCT00633087
Conditions: Prostate Cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2006-11-01; Completion date: 2011-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects will be asked to participate in this clinical trial to examine the safety of 2-deoxyglucose (an agent which is quite similar to glucose) in the treatment of solid tumors and hormone refractory prostate cancer. This agent works by blocking the metabolism of glucose in the cells of the body. Although all cells require glucose for metabolism, it is believed that cancer cells require significantly more glucose than normal cells to grow. Therefore, even slight effects of glucose metabolism in cancer cells might result in the shrinkage of certain cancers. This agent has been given to humans before and has only caused mild nausea, vomiting and glucopenia (low blood sugar) at the doses given in these studies. This study will further examine the safety of 2-deoxyglucose in the treatment of advanced solid tumors and hormone refractory prostate cancer. The information obtained in this study will be used to design future clinical studies with 2-deoxyglucose. Subjects will be asked to take an oral solution of 2-deoxyglucose daily, by mouth, while on this study. They will be asked to have CT Scans, Bone Scans, and optional PET (Positron Emission Tomography) Scans prior to starting this study. PET scans will also be performed shortly after the start of the study and after 2 cycles (6 weeks) of therapy. Subjects will be asked to have a comprehensive physical examination and blood work prior to the start of the study. During the first 2 cycles of the study subjects will be asked to have blood drawn at different time intervals for the first 2 days of each cycle. While on the study, they will be asked to return to the clinic at intervals of 1 week for a physical examination and blood tests. Subjects will also be asked to have CT Scans and Bone Scans at intervals of 9 weeks while on the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 2-deoxyglucose
Intervention descriptions: intervention 1: 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.

Protocol documents:
Clinical trial NCT00654238
Conditions: Metastatic Differentiated Thyroid Cancer Metastatic Poorly Differentiated Thyroid Cancer Metastatic Anaplastic Thyroid Cancer Metastatic Medullary Thyroid Cancer
Keywords: Thyroid Cancer Anaplastic Medullary sorafenib
Sponsor: University of Pennsylvania
Start date: 2006-02-01; Completion date: 2011-03-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.

Detailed description:

Arms: arm 1: This is a single arm study.
Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: 400mg PO BID daily

Protocol documents:
Clinical trial NCT00671853
Conditions: Bipolar Disorder Anxiety Anxiety Disorders Substance Use Disorders
Keywords: Bipolar Disorder Anxiety Anxiety Disorders Substance Use Disorders
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2008-04-01; Completion date: 2011-03-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.

Detailed description:
120 subjects aged 18 and up with Diagnostic and Statistical Manual -IV Generalized Anxiety Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized. Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs without SUD. Potential participants will be recruited by means of Institutional Review Board -approved advertising or from the clinical psychiatric infrastructure.

This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine sustained-release monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. Subjects will be assessed weekly for mood changes and side effects.

Arms: arm 1: Quetiapine XR arm 2: Placebo for quetiapine XR
Interventions: intervention 1: Quetiapine XR intervention 2: Placebo for quetiapine XR
Intervention descriptions: intervention 1: Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day intervention 2: Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day

Protocol documents:
Clinical trial NCT00683787
Conditions: Gastric Cancer
Keywords: recurrent gastric cancer stage IV gastric cancer adenocarcinoma of the stomach
Sponsor: Roswell Park Cancer Institute
Start date: 2008-05-01; Completion date: 2011-03-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given together with or without vandetanib.

PURPOSE: This randomized phase II trial is studying docetaxel to see how well it works compared with docetaxel given together with vandetanib in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.

Detailed description:
OBJECTIVES:

Primary

* To test the hypothesis that the addition of a targeted agent, such as vandetanib, to standard chemotherapy with docetaxel will result in incremental responses in patients with metastatic gastric or gastroesophageal junction cancer.

Secondary

* To assess progression-free survival and overall survival of patients treated with this regimen.
* To study the toxicity profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to clinical site. Patients are randomized to 1 of 3 treatment arms.

* Arm I: Patients receive docetaxel IV once every 3 weeks.
* Arm II: Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily.
* Arm III: Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.

In all arms, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 2 months for 5 years.

Arms: arm 1: Patients receive docetaxel IV once every 3 weeks. arm 2: Patients receive docetaxel IV as in arm I and oral vandetanib (100 mg) once daily. arm 3: Patients receive docetaxel IV as in arm I and oral vandetanib (300 mg) once daily.
Interventions: intervention 1: docetaxel intervention 2: vandetanib
Intervention descriptions: intervention 1: Given IV once every 3 weeks intervention 2: Oral vandetanib once daily

Protocol documents:
Clinical trial NCT00701311
Conditions: Prostatitis Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Keywords: Prostatitis Pelvic pain
Sponsor: Kenneth Peters, MD
Start date: 2008-06-01; Completion date: 2011-03-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life. Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. We plan to study the use of CC-10004 in men with CP/CPPS.

Detailed description:
Prostatitis is the most common urologic diagnosis in men under the age of 50 and the third most common diagnosis in older men. In Chronic Prostatitis (CP) or Chronic Pelvic Pain Syndrome (CPPS), men have lower urinary tract symptoms, pelvic pain, sexual dysfunction and decreased quality of life.

Little is known about the cause of CP/CPPS. Likewise, no definitive therapy exists for CP/CPPS. Unlike bacterial prostatitis, where a clear infecting organism can be determined, CP/CPPS is not always treated with antibiotics.

Due to the significant inflammatory nature of CP/CPPS, most prior therapies have focused on targeting the inflammation. CC-10004 in several studies has shown to be an inhibitor of inflammatory mediators, and may decrease the pain experienced from CP/CPPS.

Arms: arm 1: Study drug CC-10004 20mg taken orally twice a day.
Interventions: intervention 1: CC-10004
Intervention descriptions: intervention 1: CC-10004 20 mg per day

Protocol documents:
Clinical trial NCT00703937
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2008-07-01; Completion date: 2011-03-01
Enrollment: 708 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Detailed description:

Arms: arm 1: 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). arm 2: SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Standard Medical Care (SMC) for the treatment of IDA
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00704028
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2008-06-01; Completion date: 2011-03-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Detailed description:

Arms: arm 1: 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. arm 2: As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Interventions: intervention 1: Ferric Carboxymaltose intervention 2: Iron Dextran
Intervention descriptions: intervention 1: 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg. intervention 2: As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Protocol documents:
Clinical trial NCT00704353
Conditions: Anemia
Sponsor: American Regent, Inc.
Start date: 2008-06-01; Completion date: 2011-03-01
Enrollment: 735 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent

Detailed description:

Arms: arm 1: 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. arm 2: Per product label
Interventions: intervention 1: Ferric Carboxymaltose intervention 2: Standard Medical Care (SMC)
Intervention descriptions: intervention 1: 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. intervention 2: Per product label

Protocol documents: