ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00602797
Conditions: Recurrent Non-Small Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer
Sponsor: University of Nebraska
Start date: 2007-12-17; Completion date: 2014-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well vinorelbine tartrate and paclitaxel works in treating older patients with non-small cell lung cancer that has spread to other placed in the body. Drugs used in chemotherapy, such as vinorelbine tartrate and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES: I. To assess the safety and efficacy of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. II. To assess the response rate of a combination of vinorelbine and paclitaxel administered weekly to elderly patients with advanced non-small cell lung cancer. III. To assess the quality of life of elderly patients with advanced non-small cell lung cancer during administration of weekly paclitaxel and vinorelbine. OUTLINE: Patients receive vinorelbine tartrate intravenously (IV) over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks. Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

Arms: arm 1: Patients receive vinorelbine tartrate IV over 6-10 minutes and paclitaxel IV over 1 hour once weekly for 6 weeks.
Interventions: intervention 1: Paclitaxel intervention 2: Quality-of-Life Assessment intervention 3: Questionnaire Administration intervention 4: Vinorelbine Tartrate
Intervention descriptions: intervention 1: Given IV intervention 2: Ancillary studies intervention 3: Ancillary studies intervention 4: Given IV

Protocol documents:
Clinical trial NCT00622388
Conditions: Lymphoma, Large-Cell, Diffuse
Sponsor: GlaxoSmithKline
Start date: 2007-12-01; Completion date: 2014-08-01
Enrollment: 81 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Detailed description:

Arms: arm 1: 8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
Interventions: intervention 1: Ofatumumab
Intervention descriptions: intervention 1: 8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Protocol documents:
Clinical trial NCT00638651
Conditions: Healthy
Keywords: Tattoos Black/blue tattoos
Sponsor: University of Miami
Start date: 2008-02-01; Completion date: 2014-08-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo removal will be compared to a laser removal alone.

Detailed description:
Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age which contains black and/or blue ink in areas that can be covered. Exclusion criteria includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast feeding state, immunosuppressed patients, history of autoimmune or connective tissue disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin, aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.

Arms: arm 1: The tattoo will be treated with laser and imiquimod 5% cream arm 2: The tattoo will be treated with laser and placebo topical cream
Interventions: intervention 1: 1064 nm Nd:YAG laser intervention 2: Imiquimod, 5% cream
Intervention descriptions: intervention 1: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy intervention 2: 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month

Protocol documents:
Clinical trial NCT00642460
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2008-05-01; Completion date: 2014-08-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients \>=30kg, or 12mg/kg for patients \<30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which, for patients who meet specific criteria, an optional alternative dosing schedule decreasing the study drug administration frequency will be introduced. Anticipated time on study treatment is up to 5 years.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: Placebo intervention 3: Non-steroidal anti-inflammatory drugs (NSAIDs) intervention 4: methotrexate intervention 5: corticosteroids
Intervention descriptions: intervention 1: 8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule. intervention 2: iv every 2 weeks for 12 weeks intervention 3: as prescribed intervention 4: as prescribed intervention 5: orally, as prescribed

Protocol documents:
Clinical trial NCT00691938
Conditions: Leukemia, Myeloid, Acute Myelodysplastic Syndromes
Keywords: LBH589 Decitabine panobinostat histone deacetylase methylation hypomethylation
Sponsor: Washington University School of Medicine
Start date: 2008-06-01; Completion date: 2014-08-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.

Detailed description:
To address the need for less toxic, more effective treatments for older patients with advanced MDS and AML, the purpose of this Phase 1-2 single institution study is to evaluate the safety and efficacy of LBH 589 and decitabine administered in combination.

Decitabine is an epigenetic modifier of gene expression that has been shown to be well-tolerated in this population at the dose schedule proposed in this study, with reasonable efficacy. Although its precise mechanism of action is incompletely understood, it is postulated to work by reactivating the expression of key tumor suppressor genes silenced in tumor cells by reversing a pattern of hypermethylation of promotor elements.

LBH389 is likewise an epigenetic modifier that inhibits the deacetylation of both histones and non-histone proteins, including HSP90 and p53. Although clinical experience with LBH589 in AML is limited, aberrant histone deacetylase activity has been previously shown to play a significant role in the pathogenesis of AML. The addition of LBH589 to a decitabine regimen of previously established efficacy and tolerability will allow us to evaluate the hypothesis that two epigenetic modifiers that are believed to work through distinct mechanisms of action may act together to improve the responses of patients treated with decitabine alone, without significant additional toxicity.

Arms: arm 1: LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 2: LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 3: LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 4: LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 5: LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 6: LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle. arm 7: LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was Level 5B.

Decitabine 20 mg/m\^2 IV on days 1-5 in a 28 day cycle.
Interventions: intervention 1: LBH589 intervention 2: Decitabine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00769067
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer advanced second or third line
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2014-08-01
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Erlotinib intervention 2: PF-00299804
Intervention descriptions: intervention 1: Continuous oral dosing at 150 mg daily. intervention 2: Continuous oral dosing at 45mg daily

Protocol documents:
Clinical trial NCT00796120
Conditions: Sarcoma
Keywords: Sarcomas Trabectedin Doxorubicin Ifosfamide YONDELIS
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2008-11-01; Completion date: 2014-08-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Detailed description:
This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.

Arms: arm 1: Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. arm 2: Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.
Interventions: intervention 1: Trabectedin intervention 2: Doxorubicin intervention 3: Ifosfamide
Intervention descriptions: intervention 1: Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression. intervention 2: Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression. intervention 3: Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.

Protocol documents:
Clinical trial NCT00825734
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Sorafenib Nexavar Ixabepilone Ixempra
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-03-01; Completion date: 2014-08-01
Enrollment: 83 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study, patients with metastatic HER2-negative breast cancer will receive treatment with ixabepilone and sorafenib until disease progression or unacceptable toxicity occurs. The Phase I portion of this study will determine the maximum tolerated doses (MTDs) of sorafenib and ixabepilone that may be used in combination for first- or second-line treatment of MBC. The MTDs identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy and safety of the combination of sorafenib and ixabepilone in patients who have received at least one prior chemotherapy treatment in either the adjuvant or neoadjuvant setting or following one prior MBC chemotherapy in MBC patients who had not received prior adjuvant or neoadjuvant breast cancer chemotherapy. This will be one of the initial trials investigating the use of this treatment combination for MBC.

This trial will be conducted under the leadership of the Sarah Cannon Research Institute (SCRI) Oncology Research Consortium, a community-based, multi-center, clinical trial organization.

Detailed description:

Arms: arm 1: Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m\^2) arm 2: Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m\^2) arm 3: Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m\^2)
Interventions: intervention 1: Sorafenib intervention 2: Ixabepilone
Intervention descriptions: intervention 1: Dose Level 1 - Sorafenib PO BID (200mg) Dose Level -1 - Sorafenib PO BID (200mg) Dose Level 1a - Sorafenib PO BID (400mg) intervention 2: Dose Level 1 - Ixabepilone IV every 21 days (40mg/m\^2) Dose Level -1 - Ixabepilone IV every 21 days (32mg/m\^2) Dose Level 1a - Ixabepilone IV every 21 days (32mg/m\^2)

Protocol documents:
Clinical trial NCT00887822
Conditions: Gastric Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-03-01; Completion date: 2014-08-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of bevacizumab in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin in participants who have not received prior chemotherapy for advanced or metastatic gastric cancer. Participants will be randomized to one of two treatment groups Bevacizumab + Capecitabine/Cisplatin (experimental arm) or Placebo + Capecitabine/Cisplatin (control arm).

Detailed description:

Arms: arm 1: Participants will receive bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m\^2) orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity. arm 2: Participants will receive placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m\^2 orally twice daily (total daily dose 2000 mg/m\^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
Interventions: intervention 1: Bevacizumab intervention 2: Placebo intervention 3: Capecitabine intervention 4: Cisplatin
Intervention descriptions: intervention 1: 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle intervention 2: Placebo matched to bevacizumab on Day 1 of every 3-week cycle intervention 3: 1000 mg/m\^2 orally twice daily on Days 1-14 of every 3-week cycle intervention 4: 80 mg/m\^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles

Protocol documents:
Clinical trial NCT00924404
Conditions: Chronic Sinusitis
Keywords: Xylitol vs. Saline nasal washes sinusitis
Sponsor: University of Iowa
Start date: 2009-05-01; Completion date: 2014-08-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Is a xylitol nasal rinse better or worse than saline on patient satisfaction.

Detailed description:
In this pilot study, the investigators plan to compare the efficacy of twice daily xylitol nasal rinse with saline rinse which is the current standard, on outcomes such as quality of life and exacerbations.

Arms: arm 1: isotonic xylitol for sinus rinse arm 2: saline for sinus rinse
Interventions: intervention 1: Xylitol intervention 2: Saline
Intervention descriptions: intervention 1: 5% solution for sinus rinse intervention 2: saline for sinus rinse

Protocol documents:
Clinical trial NCT00938431
Conditions: Epilepsy
Keywords: Lacosamide Vimpat Children Epilepsy Seizures Anti-epileptic
Sponsor: UCB Pharma
Start date: 2009-11-01; Completion date: 2014-08-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).

Detailed description:
Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Arms: arm 1: Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day arm 2: Cohort 2 (Age 12 - 17 years); 12 mg/kg/day. arm 3: Cohort 3 (Age 2 - 4 years); 12 mg/kg/day. arm 4: Cohort 4 (Age 5 - 11 years); 12 mg/kg/day. arm 5: Cohort 5 (Age 1 month to \< 2 years); 12 mg/kg/day
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide oral solution (syrup) 10 mg/mL or 15 mg/mL

Protocol documents:
Clinical trial NCT00979940
Conditions: Coronary Artery Disease
Keywords: atorvastatin clopidogrel percutaneous intervention periprocedural myonecrosis
Sponsor: Indiana University School of Medicine
Start date: 2008-11-01; Completion date: 2014-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.

Detailed description:

Arms: arm 1: Patients do not receive Atorvastatin prior to PCI in cath lab arm 2: Atorvastatin 80mg po given prior to PCI in cath lab
Interventions: intervention 1: Atorvastatin
Intervention descriptions: intervention 1: Atorvastatin 80mg po given one time before PCI in cath lab.

Protocol documents:
Clinical trial NCT01010568
Conditions: Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: CLL SLL Bendamustine Ofatumumab
Sponsor: Georgetown University
Start date: 2010-04-01; Completion date: 2014-08-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Detailed description:

Arms: arm 1: Ofatumumab and Bendamustine
Interventions: intervention 1: Ofatumumab and Bendamustine
Intervention descriptions: intervention 1: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Protocol documents:
Clinical trial NCT01011413
Conditions: HIV Infections
Keywords: HIV Antiretroviral Therapy (ART) Efavirenz (EFV) Dose reduction
Sponsor: Kirby Institute
Start date: 2011-08-01; Completion date: 2014-08-01
Enrollment: 636 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical data suggests that the standard dose of the anti-HIV medication, efavirenz (EFV), could be reduced without compromising its effectiveness. Lower drug doses could have fewer side effects and would make EFV more affordable. The purpose of this study is to compare the safety and effectiveness, over 96 weeks, of standard (600mg) versus reduced dose (400mg) EFV in controlling HIV as part of initial combination antiretroviral therapy.

Detailed description:
In this international, multicenter trial, 630 HIV infected patients who have not received any previous treatment for their HIV-infection will be enrolled. Participants will be randomized equally (1:1) to receive Truvada (tenofovir and emtricitabine) with either the standard or reduced dose of EFV. Neither the study doctor nor the participant will know which treatment the participant is receiving. Physical examinations, laboratory analyses and questionnaires will be performed at the 11 study visits at screening, baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. The primary aim of this study is to compare between treatment groups the proportion of patients with undetectable HIV viral load (HIV RNA \< 200 copies/mL) after 48 weeks. Information on immune function, drug adherence, resistance to antiretrovirals, quality of life, mental state and HIV-related conditions will also be collected. Blood samples will be collected for future testing. Interim analyses will be performed when the first 125 participants in each treatment group reach week 24 and when all participants reach week 24. These interim analyses will provide an early check that the reduced dose of EFV suppresses HIV infection as effectively as the standard dose of EFV. A follow-up analysis will be performed when all participants reach week 96.

Arms: arm 1: Eligible patients will be centrally randomised to receive tenofovir (TDF) (300mg qd)/emtricitabine (FTC) (200mg qd) + EFV (600mg qd; 3 x 200mg qd) arm 2: Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).
Interventions: intervention 1: Efavirenz 600mg intervention 2: Efavirenz 400mg
Intervention descriptions: intervention 1: 3 x EFV 200 milligram (mg) tablets once daily intervention 2: 2 x EFV 200 milligram (mg) tablets plus 1x matched EFV placebo tablet once daily

Protocol documents: