ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01864148
Conditions: Multiple Sclerosis
Sponsor: Biogen
Start date: 2013-08-01; Completion date: 2016-03-01
Enrollment: 419 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

Detailed description:

Arms: arm 1: BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72.

Avonex once-weekly intramuscular (IM) injection up to Week 84. arm 2: BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84. arm 3: BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84. arm 4: BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84. arm 5: Placebo once every 4 weeks IV infusion up to Week 72.

Avonex once-weekly IM injection up to Week 84.
Interventions: intervention 1: BIIB033 intervention 2: Placebo intervention 3: Avonex
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00030264
Conditions: Neurofibromatosis Type 1 Precancerous Condition
Keywords: plexiform neurofibroma neurofibromatosis type 1
Sponsor: Children's Hospital of Philadelphia
Start date: 2001-02-01; Completion date: 2016-03-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining methotrexate with vinblastine may be effective treatment for neurofibromatosis type 1 associated with progressive plexiform neurofibromas.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas.

Detailed description:
OBJECTIVES:

* Determine the effect of chronic vinblastine and methotrexate on time to disease progression in children or young adults with progressive plexiform neurofibroma associated with neurofibromatosis type 1.
* Determine the objective response rate in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.

OUTLINE: Patients are stratified according to tumor status (severely debilitating and/or life-threatening vs cosmetically disfiguring).

Patients receive methotrexate and vinblastine IV weekly for 26 weeks and then every 2 weeks for 26 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months during study participation.

Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 3 years.

Arms: arm 1: Methotrexate and Vinblastine will be given once a week for the first 26 weeks and then every two weeks for the next 26 weeks or until disease progression (whichever occurs first).
Interventions: intervention 1: Methotrexate intervention 2: Vinblastine
Intervention descriptions: intervention 1: Methotrexate will be given at a dose of 30mg/m2/week intramuscular (IM) or intravenous (IV) for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first) intervention 2: Vinblastine will be given at a dose of 6mg/m2/week intravenous (IV) for for the first 26 weeks, then every 2 weeks for the next 26 weeks or until disease progression (whichever occurs first). Maximum actual dose may not exceed 10mg.

Protocol documents:
Clinical trial NCT00509821
Conditions: Glioblastoma Multiforme
Sponsor: Eli Lilly and Company
Start date: 2007-10-01; Completion date: 2016-03-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the protocol was to induce a novel radiochemotherapy with enzastaurin as first-line treatment regimen in glioblastoma: Participants with active, unmethylated MGMT promoter were treated with enzastaurin before, concomitant, and after radiotherapy to determine safety and PFS at 6 months (PFS-6) in phase II.

Detailed description:

Arms: arm 1: Enzastaurin given orally (PO) once daily (QD). 1125 mg loading dose D(-)7 then 500 mg PO,QD with concomitant radiotherapy. arm 2: Enzastaurin 1125 mg loading dose D(-)7 then 250 mg twice daily (BID) PO, with concomitant radiotherapy.
Interventions: intervention 1: Enzastaurin 500 milligram (mg) Once Daily (QD) intervention 2: Enzastaurin 250 mg Twice Daily (BID)
Intervention descriptions: intervention 1: 1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment. intervention 2: 1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment.

Protocol documents:
Clinical trial NCT00515528
Conditions: Melanoma
Keywords: metastatic melanoma
Sponsor: University of Chicago
Start date: 2007-04-23; Completion date: 2016-03-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if an experimental melanoma vaccine can produce an immune response in patients with metastatic melanoma, and if combining this vaccine with the drug Ontak can improve these immune responses. It is also hoped that this will lead to tumor shrinkage.

Detailed description:
This is an open-label, randomized phase II, single institution study comparing administration of a 4-peptide melanoma vaccine alone or post-Ontak, in patients with metastatic melanoma.

Treatment:

1. Cohort A: Vaccine alone. Patients will receive immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously on day 1. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression.
2. Cohort B: Ontak plus vaccine. Patients will receive Ontak (18 mcg/kg) intravenously on day -4 for one dose. On day 0, they will receive the first immunization with an emulsion of 4 melanoma peptides (250 mcg each)/GM-CSF/Montanide injected intradermally/subcutaneously. A second vaccination will be given 2 weeks later and a third vaccination 2 weeks after that. Patients will be re-evaluated around week 6 and can continue courses of 3 vaccinations (one every 2 weeks) until disease progression. However, no further Ontak will be given.

Duration: Patients may remain on study until disease progression, unacceptable toxicity, patient choice to withdraw, or physician decision to discontinue therapy (due to intervening illness, poor patient compliance, or other situation that would increase patient risk).

Arms: arm 1: Subjects received vaccine immunization injected intra-dermally or subcutaneously on day 1. The vaccine was an emulsification consisting of 250 mcg each of the following peptides: Melan-A, gp100, MAGE-3, and NA17 as well as GM-CSF 125 mcg and Montanide. A second and third vaccination was given at 2 weeks and 4 weeks after the first. If there was no evidence of cancer progression, additional courses of three vaccinations administered at 2 week intervals were administered until disease progression. arm 2: Subjects in Vaccine plus Ontak received the same vaccination strategy as Vaccine alone group but additionally received a single dose of denileukin diftitox(18 mcg/kg) 4 days prior to the first vaccine administration
Interventions: intervention 1: 4-peptide melanoma vaccine intervention 2: Ontak
Intervention descriptions: intervention 1: Experimental cancer vaccine given as a shot under the skin once every two weeks intervention 2: A single dose of Ontak given as an intravenous infusion over 30 minutes, 4 days before the first vaccine is given.

Protocol documents:
Clinical trial NCT00597727
Conditions: Food Hypersensitivity
Keywords: Peanut Allergy Sublingual immunotherapy
Sponsor: University of North Carolina, Chapel Hill
Start date: 2008-01-01; Completion date: 2016-03-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

Detailed description:
In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention.

The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is primarily designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Secondarily, the study is designed to evaluate the efficacy of extended maintenance dosing of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT. Mechanistic studies will be completed concurrently as exploratory endpoints to understand changes in the allergic immune response related to peanut SLIT.

Arms: arm 1: Blinded subjects who received peanut sublingual drops for the initial 12 month blinded phase of the study. arm 2: Blinded subjects who received placebo sublingual drops for the initial 12 month blinded phase of the study. arm 3: After completing the blinded phase of the study, subjects receiving Blinded Peanut SLIT continued on extended maintenance open-label peanut SLIT for the duration of the study. Subjects receiving Blinded Placebo SLIT were crossed over and underwent the 12 month buildup protocol on open label peanut SLIT and then continued on extended maintenance treatment for the duration of the study. arm 4: Subjects who were unblinded prematurely during the blinded phase of the study and then re-enrolled as an open label cohort. arm 5: Subjects from the original phase 1 study of peanut SLIT (NCT00429429) who were rolled over into the current protocol as an open label peanut SLIT cohort.
Interventions: intervention 1: Peanut SLIT intervention 2: Placebo SLIT
Intervention descriptions: intervention 1: Liquid peanut protein drops diluted in glycerin which are dosed under the tongue. intervention 2: Liquid glycerin without peanut which are dosed under the tongue.

Protocol documents:
Clinical trial NCT00717366
Conditions: Renal Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-07-01; Completion date: 2016-03-01
Enrollment: 64 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.

Detailed description:

Arms: arm 1: Participants will receive methoxy polyethylene glycol-epoetin beta (MIRCERA) IV injection at a starting dose based on an intermediate conversion factor from their previous Erythropoiesis-stimulating Agent (ESA) dose (4 \* previous weekly epoetin dose \[international units {IU}\]/250 or 4 \* previous weekly darbepoetin alfa dose \[micrograms {mcg}\]/1.1) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with hemoglobin (Hb) level within ± 1 grams per deciliter (g/dL) of their baseline Hb level and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks. arm 2: Participants will receive MIRCERA IV injection based on a high conversion factor from their previous ESA dose (4 \* previous weekly epoetin dose \[IU\]/125 or 4 \* previous weekly darbepoetin alfa dose \[mcg\]/0.55) once every 4 weeks for 20 weeks. Participants who will complete the 20 weeks of treatment with Hb within ± 1 g/dL of their baseline Hb and within the target range of 10-12 g/dL will enter an optional 52-weeks safety extension period. During this period, the participants will continue to receive MIRCERA IV injection once every 4 weeks.
Interventions: intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta
Intervention descriptions: intervention 1: Will be administered IV, every 4 weeks.

Protocol documents:
Clinical trial NCT00875836
Conditions: Marijuana Dependence
Keywords: Marijuana Buspirone Contingency management Motivational enhancement therapy
Sponsor: Medical University of South Carolina
Start date: 2009-09-01; Completion date: 2016-03-01
Enrollment: 175 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Marijuana is the most commonly used illicit drug, yet few clinical trials have evaluated pharmacotherapy treatments for marijuana dependence. This study will evaluate the efficacy of buspirone for reducing marijuana use in marijuana-dependent adults. A contingency management (CM) intervention and motivational enhancement therapy (MET) will be incorporated to encourage study engagement and retention. It is hypothesized that buspirone combined with MET and CM will reduce the percent of marijuana-positive urine drug screen results in marijuana-dependent individuals as compared to a placebo treatment combined with MET and CM.

Detailed description:

Arms: arm 1: Buspirone arm 2: Placebo
Interventions: intervention 1: Buspirone intervention 2: Placebo
Intervention descriptions: intervention 1: Flexible dose, up to 60 mg daily intervention 2: Flexible dose, up to 60 mg daily

Protocol documents:
Clinical trial NCT00896025
Conditions: Acute Liver Failure Fulminant Hepatic Failure
Keywords: Liver disease
Sponsor: University of Texas Southwestern Medical Center
Start date: 2008-12-01; Completion date: 2016-03-01
Enrollment: 255 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This proposed study is a multi-center open label study to determine if N-acetylcysteine has any survival benefits in patients with acute liver failure.

Detailed description:
Patients admitted to study sites with carefully defined criteria for acute liver failure and who are thought not to have acetaminophen toxicity, mushroom poisoning, pregnancy-related liver failure, or malignancy will be eligible. Each patient will receive intravenously in solution of 5% dextrose in water containing N-acetylcysteine, beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, and in declining doses over a total of 72 hours. Care of patients and consideration of transplantation or other clinical decisions will not be affected by the study or the use of study drug.

Arms: arm 1: Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous N-acetylcysteine infusion for a total of 72 hours. arm 2: Each eligible Acute Liver Failure patient for whom the investigator chooses not to utilize N-acetylcysteine may serve as a control and receives standard of care.
Interventions: intervention 1: N-acetylcysteine
Intervention descriptions: intervention 1: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.

NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.

i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour

ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours

iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours

iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours

v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours

Protocol documents:
Clinical trial NCT01001442
Conditions: Multiple Myeloma
Keywords: Multiple myeloma Relapsed Refractory
Sponsor: Biotest Pharmaceuticals Corporation
Start date: 2010-08-01; Completion date: 2016-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.

Detailed description:
Phase I/IIa, open-label, 3 + 3 multi-dose escalation study. The Phase I part of the study was to include the dose escalation cohort; a conventional dose escalation design, following 3 + 3 rules was chosen to define the MTD.

The Phase IIa part was to include the MTD/recommended phase II dose (RPTD) expansion cohort in which descriptive statistical methods for evaluation of response, time to event endpoints, and safety were to be performed.

35 subjects in the Safety population, 34 subjects in the ITT and PP populations.

Arms: arm 1: BT062 was to be administered as single-dose IV infusions via a 0.22 μm in-line filter preferably in a forearm vein, according to medically accepted procedures on Days 1, 8, and 15 of each 28-day cycle. Alternatively BT062 may have been administered through a central venous line or a peripherally inserted central catheter (PICC). Other administration routes were only to be allowed after approval from Biotest. Each subject was to be monitored carefully for the effects of exposure to BT062. No subject was to have received more than 3 doses of BT062 per 28-day treatment cycle.
Interventions: intervention 1: BT062
Intervention descriptions: intervention 1: intravenous administration

Protocol documents:
Clinical trial NCT01013740
Conditions: Cancer
Keywords: Neoplasms, Breast
Sponsor: Novartis Pharmaceuticals
Start date: 2009-11-25; Completion date: 2016-03-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.

Detailed description:
Approximately 105 subjects will be enrolled in the study and randomized 2:1 to one of the following regimens Arm A (n=70): Lapatinib 1250 mg orally once daily continuously plus Vinorelbine 20mg/m2 intravenously (IV) on day 1 and 8, every third week, or Arm B (n=35): Lapatinib 1250 mg orally once daily (QD) continuously plus Capecitabine 2000 mg/m2/day orally in 2 doses 12 hours apart on days 1-14 every third week. Randomization will be stratified according to the following variables: 1) Prior receipt of therapy for metastatic breast cancer (Yes or No), and 2) Site of metastatic disease (Visceral/Soft tissue or Bone-only). Subjects will receive randomized study treatment until disease progression or discontinuation of study treatment due to unacceptable toxicity, withdrawal of consent, lost to follow up, or death. All subjects who discontinue study treatment without documented progression will continue to be followed for progression according to protocol-schedule until new anti-cancer therapy is initiated and/or progression or death is documented. Survival data will be collected for all subjects to ensure a minimum of 18 months survival data. This study will include a safety run-in phase for approximately the first 30 subjects (20 randomized to lapatinib and vinorelbine; 10 to lapatinib and capecitabine).

Arms: arm 1: Lapatinib + Vinorelbine arm 2: Lapatinib + Capecitabine
Interventions: intervention 1: Vinorelbine intervention 2: Lapatinib intervention 3: Capecitabine
Intervention descriptions: intervention 1: Vinorelbine intervention 2: Lapatinib intervention 3: Capecitabine

Protocol documents:
Clinical trial NCT01078974
Conditions: Waldenstrom's Macroglobulinemia
Keywords: WM pomalidomide dexamethasone rituximab
Sponsor: Steven P. Treon, MD, PhD
Start date: 2010-05-01; Completion date: 2016-03-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pomalidomide is a newly discovered drug that may stop cancer cells from growing abnormally. Pomalidomide may also stimulate the immune system to fight the cancer cells and possibly improve the effectiveness of dexamethasone and rituximab to fight the Waldenstrom's Macroglobulinemia (WM) cancer cells. This drug have been used in multiple myeloma and information from these other research studies suggests that Pomalidomide may help to reduce or prevent the growth of cancer cells.

Detailed description:
* Participants will be given a study drug-dosing calendar for each treatment cycle. Each treatment cycle lasts 28 days during which time participants will take Pomalidomide orally once a day. Dexamethasone and rituximab will be administered intravenously on weeks 1, 2, 3, 4 and on weeks 12, 13, 14, 15.
* Since we are looking for the highest dose of Pomalidomide in combination with dexamethasone and rituximab which can be administered safely without severe or unmanageable side effects, not everyone who participates will receive the same dose of the study drug. The dose participants will get will depend on the number of participants who have been enrolled in the study and how well they have tolerated their doses.
* As long as there is no evidence that the participant's Waldenstrom's Macroglobulinemia has progressed, they can continue to receive Pomalidomide for up to 52 weeks. Participants will be asked to return to the clinic for follow-up tests at least every three months for four years.

Arms: arm 1: Drug: pomalidomide Taken orally once a day

Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
Interventions: intervention 1: pomalidomide intervention 2: dexamethasone intervention 3: rituximab
Intervention descriptions: intervention 1: Taken orally once a day intervention 2: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15 intervention 3: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15

Protocol documents: