ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00468169
Conditions: Head and Neck Cancer
Keywords: Cetuximab Erbitux locally advanced head neck cancer neoplasms squamous carcinoma lymphoepithelioma
Sponsor: University of Chicago
Start date: 2006-07-01; Completion date: 2012-11-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.

Detailed description:

Arms: arm 1: Cetuximab \[250mg/m2 (day 1, weekly x10)\] + FHX (5-FU \[CI: 600mg/m2/day; days 0-5 (120h total) every other week x5\], Hydroxyurea \[500 mg PO BID, days 0-5 (=11 doses), every other week x5\] and twice-daily radiation \[150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)\]). Total duration is 10 weeks. arm 2: Cetuximab \[250 mg/m2 (day 1, weekly x7)\] + PX (Cisplatin \[100mg/m2 (week 1 \& 4 on day 1 (or 2))\], Accelerated fraction radiotherapy with concomitant boost \[AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)\]). Total duration: 7 weeks.
Interventions: intervention 1: Cetuximab intervention 2: 5-FU intervention 3: Hydroxyurea intervention 4: Twice-daily radiation intervention 5: Cisplatin intervention 6: Accelerated fraction radiotherapy with concomitant boost
Intervention descriptions: intervention 1: 250mg/m2(day 1, weekly x 10); intervention 2: 600 mg/m2/day; days 0-5 (120 h total) every other week x 5 intervention 3: 500 mg PO BID, days 0-5 every other week x 5 intervention 4: 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks) intervention 5: 100 mg/m2, week 1 and 4 on day 1 (or 2) intervention 6: 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks.

Protocol documents:
Clinical trial NCT00493636
Conditions: Breast Cancer
Keywords: Breast Cancer
Sponsor: Accelerated Community Oncology Research Network
Start date: 2007-06-01; Completion date: 2012-11-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.

Detailed description:

Arms: arm 1: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) arm 2: Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Interventions: intervention 1: Gemcitabine intervention 2: Sorafenib intervention 3: Placebo intervention 4: Capecitabine
Intervention descriptions: intervention 1: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle intervention 2: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) intervention 3: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) intervention 4: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Protocol documents:
Clinical trial NCT00499694
Conditions: Prostate Cancer
Keywords: stage IV prostate cancer recurrent prostate cancer adenocarcinoma of the prostate
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2007-10-01; Completion date: 2012-11-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.

Detailed description:
OBJECTIVES:

Primary

* Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab.

Secondary

* Determine the toxicity of this regimen in these patients.
* Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen.
* Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen.

OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 28-42 days.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Arms: arm 1: Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)

Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
Interventions: intervention 1: bevacizumab intervention 2: satraplatin
Intervention descriptions: intervention 1: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days) intervention 2: 80 mg/m(2), Orally, Days 1-5, every 35 days

Protocol documents:
Clinical trial NCT00550732
Conditions: Mycoses
Keywords: Triazoles
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-12-01; Completion date: 2012-11-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.

Detailed description:
In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.

Arms: arm 1: Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
Interventions: intervention 1: Posaconazole
Intervention descriptions: intervention 1: Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.

Protocol documents:
Clinical trial NCT00560391
Conditions: Multiple Myeloma
Sponsor: Bristol-Myers Squibb
Start date: 2008-05-01; Completion date: 2012-11-01
Enrollment: 35 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.

Detailed description:

Arms: arm 1: Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 15 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 2: Participants received a combination of dasatinib, 70 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 3: Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 20 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 4: Participants received a combination of dasatinib, 100 mg QD, lenalidomide, 25 mg QD, and dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22, in 28-day cycles. arm 5: Participants received a combination of dasatinib, lenalidomide, and dexamethasone in varying doses in 28-day cycles.
Interventions: intervention 1: Dasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg intervention 2: Dasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg intervention 3: Dasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg intervention 4: Dasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg intervention 5: Dasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Intervention descriptions: intervention 1: Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 2: Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 3: Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 4: Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. intervention 5: Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.

Protocol documents:
Clinical trial NCT00606086
Conditions: Genotype 1 Chronic Hepatitis C
Keywords: Hepatitis, HCV, Liver disease, HepC
Sponsor: GlobeImmune
Start date: 2007-12-01; Completion date: 2012-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The GI-5005 therapeutic vaccine in combination with standard of care or standard of care alone will be injected under the skin of HCV subjects. Patients will be monitored for safety, immune responses and any therapeutic benefits related to the injections including EVR, ETR, and SVR.

Detailed description:

Arms: arm 1: GI-5005 monotherapy continuing on to triple therapy arm 2: Standard of care alone
Interventions: intervention 1: GI-5005 intervention 2: Pegylated Interferon and Ribavirin
Intervention descriptions: intervention 1: 40YU, subcutaneous intervention 2: Pegylated interefron is an injection and ribavirin is an oral tablet

Protocol documents:
Clinical trial NCT00623506
Conditions: Traumatic Brain Injury
Keywords: TBI Pregnenolone Cognition
Sponsor: Durham VA Medical Center
Start date: 2008-01-01; Completion date: 2012-11-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres. Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al. 2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al. 2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following TBI.

Detailed description:
See brief summary

Arms: arm 1: Pregnenolone arm 2: Placebo
Interventions: intervention 1: Pregnenolone intervention 2: Placebo
Intervention descriptions: intervention 1: Placebo for two weeks (during placebo lead-in), then:

Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID) intervention 2: Placebo for two weeks (placebo lead in), then:

Placebo equivalent to Pregnenolone arm: 100 mg in divided doses (50 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 300 mg in divided doses (150 mg, PO, BID) Placebo equivalent to Pregnenolone arm: 500 mg in divided doses (250 mg, PO, BID)

Protocol documents:
Clinical trial NCT00635700
Conditions: Psychosis Prodrome
Keywords: psychosis schizophrenia prodrome ziprasidone placebo
Sponsor: Yale University
Start date: 2008-03-01; Completion date: 2012-11-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine whether ziprasidone is superior to placebo over 24 weeks for patients with the psychosis prodrome.

Detailed description:

Arms: arm 1: Patients will be treated with Ziprasidone for 6 months arm 2: Patients will be treated with placebo for 6 months
Interventions: intervention 1: ziprasidone intervention 2: placebo
Intervention descriptions: intervention 1: 20-160 mg/d intervention 2: placebo

Protocol documents:
Clinical trial NCT00659360
Conditions: Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Rhabdomyosarcoma Dermatofibrosarcoma Protuberans Endometrial Stromal Sarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Uterine Sarcoma Stage III Adult Soft Tissue Sarcoma Stage III Uterine Sarcoma Stage IV Adult Soft Tissue Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2008-02-01; Completion date: 2012-11-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
OBJECTIVES:

I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.

II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks.

Arms: arm 1: Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00668200
Conditions: Paget's Disease of the Bone Hypocalcemia
Keywords: Paget's hypocalcemia zoledronic acid serum calcium
Sponsor: Novartis Pharmaceuticals
Start date: 2008-05-01; Completion date: 2012-11-01
Enrollment: 81 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.

Detailed description:

Arms: arm 1: 5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.
Interventions: intervention 1: Reclast (ZOL446, zoledronic acid) intervention 2: Calcium intervention 3: Vitamin D
Intervention descriptions: intervention 1: 5 mg i.v. annually ("real-life, physician prescribed") intervention 2: 1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation) intervention 3: 800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration

Protocol documents:
Clinical trial NCT00721734
Conditions: Multiple Myeloma Renal Insufficiency
Keywords: Myeloma Renal Insufficiency Proteasome Hematological carfilzomib PR-171
Sponsor: Amgen
Start date: 2008-11-01; Completion date: 2012-11-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the influence of renal impairment on carfilzomib in patients with Multiple Myeloma (MM).

Detailed description:

Arms: arm 1: Carfilzomib, 15 mg/m², was administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles.

If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
Interventions: intervention 1: Carfilzomib
Intervention descriptions: intervention 1: Carfilzomib was administered intravenously (IV) at a rate of approximately 10 mL/minute.

Protocol documents:
Clinical trial NCT00724984
Conditions: Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin
Keywords: PCI-24781 Lymphoma Hodgkin Disease Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral
Sponsor: Pharmacyclics LLC.
Start date: 2008-07-01; Completion date: 2012-11-01
Enrollment: 55 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The first part of the study will determine the highest dose of study drug that can be taken without causing serious side effects in patients with lymphoma. The appropriate dose determined from the first part of the study will be used in the second part of the study to assess disease response in 2 different types of lymphoma patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PCI-24781
Intervention descriptions: intervention 1: Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart ("BID"), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).

Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I.

Protocol documents:
Clinical trial NCT00729807
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
Sponsor: University of Maryland, Baltimore
Start date: 2008-07-01; Completion date: 2012-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as pentamidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well pentamidine works in treating patients with relapsed or refractory melanoma.

Detailed description:
OBJECTIVES:

Primary

* To determine the response rate in patients with relapsed or refractory melanoma that expresses wild-type p53 and S100 calcium binding protein B (S100B) treated with pentamidine.

Secondary

* To observe the effect of this drug on the expression of S100B and p21 in tumor biopsy samples.
* To observe the effect of this drug on S100B detectable in serum.
* To observe the time to progression in these patients.
* To assess the toxicities associated with the administration of this drug in these patients.

OUTLINE: Patients receive pentamidine IV over 2 hours 5 days a week for 2 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative laboratory studies. Samples are assessed for p53 status and S100B, p53, and p21 expression by immunohistochemistry, polymerase chain reaction, western blotting, luminescence assay, and ELISA.

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

Arms: arm 1: None
Interventions: intervention 1: pentamidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00736073
Conditions: Pancreatitis
Keywords: pancreatitis
Sponsor: Duke University
Start date: 2007-08-01; Completion date: 2012-11-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if giving Aprepitant 4 hours before and for two days after ERCP decreases the risk of developing pancreatitis after ERCP.

Detailed description:
This study involves taking a drug Aprepitant by mouth 4 hours before the ERCP and once a day for two days after the ERCP, in an attempt to reduce the risk of pancreatitis caused by ERCP. Pancreatitis, or injury and inflammation of the pancreas, is the most common complication of ERCP and occurs in approximately 6 out of every 100 patients undergoing ERCP. It may result in pain and lead to hospitalization and, in some cases, a need for further procedures such as surgery.

Aprepitant is a medication that is currently used to prevent nausea and vomiting in some patients caused by chemotherapy for the treatment of cancer. It is also approved for the prevention of post-operative nausea and vomiting. There is theoretical evidence from animal studies that the way in which Aprepitant works in the body may prevent pancreatitis.

Arms: arm 1: aprepitant arm 2: Placebo
Interventions: intervention 1: aprepitant intervention 2: Placebo
Intervention descriptions: intervention 1: one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose intervention 2: one dose of placebo (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose

Protocol documents: