ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00424749
Conditions: Churg-Strauss Syndrome
Keywords: Antineutrophil cytoplasmic antibody associated vasculitis Glomerulonephritis Rituximab
Sponsor: Fernando Fervenza
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.

Detailed description:
Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.

Arms: arm 1: 375 mg/m\^2/week for 4 weeks
Interventions: intervention 1: Rituximab intervention 2: Prednisone
Intervention descriptions: intervention 1: Patients received 4 weekly doses of rituximab 375 mg/m\^2. intervention 2: Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months

Protocol documents:
Clinical trial NCT00433017
Conditions: Macular Degeneration Choroidal Neovascularization
Keywords: Age-related macular degeneration AMD Choroidal neovascularization Verteporfin Ranibizumab
Sponsor: Novartis
Start date: 2007-05-01; Completion date: 2009-07-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

Detailed description:

Arms: arm 1: Verteporfin (6 mg/m\^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA). arm 2: Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
Interventions: intervention 1: Verteporfin Photodynamic Therapy intervention 2: Ranibizumab intervention 3: Placebo
Intervention descriptions: intervention 1: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of the infusion. intervention 2: Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection intervention 3: As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.

Protocol documents:
Clinical trial NCT00437125
Conditions: Major Depressive Disorder Idiopathic Parkinson Disease
Sponsor: Eli Lilly and Company
Start date: 2007-03-01; Completion date: 2009-07-01
Enrollment: 151 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study aims to assess the tolerability of duloxetine, 60mg once daily, in open label fashion, in depressed patients with Parkinson's disease during 12 weeks treatment.

Detailed description:

Arms: arm 1: Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Interventions: intervention 1: Duloxetine hydrochloride
Intervention descriptions: intervention 1: Duloxetine 30 milligram (mg) once daily (QD) orally (PO) for 1 week, then duloxetine 60 mg QD PO for 11 weeks

Protocol documents:
Clinical trial NCT00442117
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will be an open-label, parallel-group comparison of Mometasone Furoate Dry Powder Inhaler (MF-DPI) 200 mcg once daily in the evening with two puffs vs. Budesonide Dry Powder Inhaler (BUD-DPI) 200 mcg twice daily with two puffs each time in patients previously treated with inhaled corticosteroids (ICS) or without ICS with diagnosed mild persistent or moderate persistent asthma (classified as Global Initiative For Asthma, 2005) in the previous 4 weeks. The primary efficacy endpoint is percent change from baseline in FEV1.

Detailed description:

Arms: arm 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) arm 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day)
Interventions: intervention 1: mometasone furoate dry powder inhaler intervention 2: Budesonide DPI
Intervention descriptions: intervention 1: MF DPI 200 mcg, two puffs once daily PM (total of 400 mcg/day) for 12 weeks. intervention 2: Budesonide (BUD) DPI 200 mcg, two puffs twice daily (total of 800 mcg/day) for 12 weeks.

Protocol documents:
Clinical trial NCT00443053
Conditions: Thrombosis, Venous
Keywords: superficial vein thrombosis superficial thrombophlebitis fondaparinux deep vein thrombosis venous thromboembolism treatment thrombosis
Sponsor: GlaxoSmithKline
Start date: 2007-03-01; Completion date: 2009-07-01
Enrollment: 3002 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Detailed description:
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fondaparinux 2.5mg or placebo
Intervention descriptions: intervention 1: Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Protocol documents:
Clinical trial NCT00447278
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2007-03-01; Completion date: 2009-07-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder \[ADHD\]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

Detailed description:

Arms: arm 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension arm 2: Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
Interventions: intervention 1: Atomoxetine intervention 2: Other standard therapy for ADHD
Intervention descriptions: intervention 1: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension intervention 2: Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension

Protocol documents:
Clinical trial NCT00459810
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2007-02-01; Completion date: 2009-07-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel poliglumex, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estradiol may kill prostate cancer cells that no longer respond to hormone therapy. Giving paclitaxel poliglumex together with estradiol may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the response rate in patients treated with this regimen.
* Determine the time to PSA progression and measurable disease progression in patients treated with this regimen.
* Determine time to death from all causes in patients treated with this regimen.
* Correlate levels of serum estradiol, serum cathepsin B, and bone turnover markers with PSA response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive transdermal estradiol continuously (patches changed every 7 days) until the PSA level rises. Patients whose PSA increases above baseline or PSA decreases \< 10% after 4 weeks of estradiol therapy or whose serum PSA reduction is \< 50% after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy. These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1. Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Interventions: intervention 1: transdermal estradiol intervention 2: paclitaxel poliglumex
Intervention descriptions: intervention 1: Transdermal estradiol given 0.2mg/day for duration of study. intervention 2: Paclitaxel poliglumex (PPX) is a macromolecular polymer-drug conjugate of paclitaxel. PPX was given every 28 days, at a dose of 150 mg/m2

Protocol documents:
Clinical trial NCT00462345
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15. Participants also received methylprednisolone 100 mg, IV, 30 minutes before the infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate greater than or equal to (≥) 5 mg/week, PO, folate greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
Interventions: intervention 1: rituximab intervention 2: Methotrexate intervention 3: Corticosteroid or NSAID intervention 4: Folate
Intervention descriptions: intervention 1: 1000 mg i.v. on Days 1 and 15 intervention 2: 10 to 25 mg/week p.o. or parenteral from Day 1 through Week 24 intervention 3: ≤10 mg/day prednisone p.o., or equivalent corticosteroid, or NSAIDs p.o. from Day 1 through Week 24 intervention 4: ≥5 mg/week, once daily or b.i.d. from Day 1 through Week 24

Protocol documents:
Clinical trial NCT00477672
Conditions: Parkinson's Disease Psychosis
Keywords: Parkinson's disease, psychotic disorders
Sponsor: ACADIA Pharmaceuticals Inc.
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

Detailed description:

Arms: arm 1: Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks arm 2: Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks arm 3: Placebo tablet, once daily by mouth, 6 weeks
Interventions: intervention 1: Pimavanserin tartrate (ACP-103) intervention 2: Pimavanserin tartrate (ACP-103) intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg, tablet, once daily by mouth, 6 weeks intervention 2: 40 mg, tablet, once daily by mouth, 6 weeks intervention 3: tablet, once daily by mouth, 6 weeks

Protocol documents:
Clinical trial NCT00479037
Conditions: Osteoporosis
Keywords: postmenopausal women with primary osteoporosis
Sponsor: Nycomed
Start date: 2007-04-01; Completion date: 2009-07-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Full Length Parathyroid Hormone, PTH(1-84) intervention 2: Strontium Ranelate
Intervention descriptions: intervention 1: Once daily subcutaneous injection in the abdomen by self administration intervention 2: The daily dose of 2 g (one sachet) strontium ranelate was to be mixed in a glass of water and taken immediately after mixing at bedtime at least 2 hours before or after intake of calcium, any food or drinks, other than water

Protocol documents:
Clinical trial NCT00481078
Conditions: Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-05-01; Completion date: 2009-07-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying carboplatin, paclitaxel, and vorinostat to see how well they work compared with carboplatin, paclitaxel, and a placebo in treating patients with stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel together with vorinostat is more effective than giving carboplatin and paclitaxel together with a placebo in treating non-small cell lung cancer

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the response rate associated with the combination of vorinostat, carboplatin, paclitaxel versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC.

SECONDARY OBJECTIVES:

I. To determine the time to progression and overall survival for the two regimens.

II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel for patients with advanced NSCLC.

III. To understand mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood, archived tumor tissue, and paired biopsies in consenting patients.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to gender and brain metastasis (present vs absent). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral vorinostat (SAHA) once daily on days 1-14 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3.

Arm II: Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.

In both arms, treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3. arm 2: Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
Interventions: intervention 1: vorinostat intervention 2: paclitaxel intervention 3: carboplatin intervention 4: placebo intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given PO intervention 5: Correlative studies

Protocol documents:
Clinical trial NCT00482274
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2007-05-01; Completion date: 2009-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

* Determine the time to PSA recurrence in patients receiving this treatment.
* Determine the time to metastatic disease in patients receiving this treatment.
* Determine the time to androgen independent state in patients receiving this treatment.
* Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

After completion of study therapy, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Interventions: intervention 1: docetaxel
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.

Protocol documents:
Clinical trial NCT00486265
Conditions: Acute Myelogenous Leukemia
Keywords: Phase I Phase II acute myelogenous leukemia AML cancer
Sponsor: AstraZeneca
Start date: 2007-07-01; Completion date: 2009-07-01
Enrollment: 47 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).

For enrollment information see the Central Contact information below

Detailed description:

Interventions: intervention 1: AZD4877
Intervention descriptions: intervention 1: intravenous infusion administered on days 1, 2 and 3

Protocol documents:
Clinical trial NCT00486720
Conditions: Myelodysplastic Syndromes Blood Disease Bone Marrow Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2009-07-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy, safety and tolerability of vorinostat in patients with lower risk Myelodysplastic Syndrome (MDS).

Detailed description:

Arms: arm 1: vorinostat 400 mg arm 2: vorinostat 200 mg
Interventions: intervention 1: vorinostat intervention 2: vorinostat
Intervention descriptions: intervention 1: vorinostat 400 mg by mouth (P.O.) capsules once daily (q.d.). Treatment in 21 day cycles for up to 8 cycles. intervention 2: vorinostat 200 mg by mouth (P.O.) capsules three times daily (t.i.d.). Treatment in 21 day cycles for up to 8 cycles.

Protocol documents:
Clinical trial NCT00492752
Conditions: Carcinoma, Hepatocellular
Sponsor: Bayer
Start date: 2005-10-01; Completion date: 2009-07-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is

* Find out if patients receiving Sorafenib will live longer
* Find out if Sorafenib has any effect on patient reported outcomes
* Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases
* Determine the pharmacokinetics (PK) in patients with liver cancer

Detailed description:

Arms: arm 1: Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment. arm 2: Placebo tablets matching in appearance were orally administered bid (twice daily).
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: multikinase inhibitor; Sorafenib 400 mg (orally) twice daily intervention 2: Matching placebo (orally) twice daily

Protocol documents: