ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00111761
Conditions: Colorectal Cancer
Keywords: Immunex Panitumumab ABX-EGF Abgenix
Sponsor: Amgen
Start date: 2002-07-01; Completion date: 2008-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if panitumumab, in combination with irinotecan, leucovorin, and 5-fluorouracil (5-FU) is safe and efficacious in patients with metastatic colorectal cancer.

Detailed description:
Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).

Secondary Objective(s) To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer).

To assess the pharmacokinetics (PK) of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer. (Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen, and the PK of irinotecan (IR) and its active metabolite SN-38 when IR is given in combination with ABX-EGF, leucovorin (LV), and 5-fluorouracil (5-FU) in subjects with metastatic colorectal cancer)

Arms: arm 1: Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil (5-FU)and leucovorin (IFL chemotherapy regimen) arm 2: Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
Interventions: intervention 1: Irinotecan intervention 2: Panitumumab intervention 3: 5-Fluorouracil intervention 4: Leucovorin
Intervention descriptions: intervention 1: Part 1: 125 mg/m\^2 IV infusion once a week on weeks 1 through 4 of each 6-week treatment cycle. Part 2: 180 mg/m\^2 IV infusion every other week until disease progression or unable to tolerate. intervention 2: Intravenous (IV) infusions of panitumumab 2.5 mg/kg once a week delivered in 6-week cycles. intervention 3: Part 1: IV bolus 500 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: IV bolus 400 mg/m\^2 and infusional 2400-3000 mg/m\^2 over 46 hours once every other week until disease progression or unable to tolerate. intervention 4: Part 1: IV bolus 20 mg/m\^2 on weeks 1 through 4 of each 6-week cycle. Part 2: 400 mg/m\^2 every other week until disease progression or unable to tolerate.

Protocol documents:
Clinical trial NCT00113529
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2004-10-01; Completion date: 2008-10-01
Enrollment: 42 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

Detailed description:

Arms: arm 1: Phase 1 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib; 50 mg Sunitinib + 250 mg Gefitinib

Phase 2 - 37.5 mg Sunitinib 4/2 Schedule + 250 mg Gefitinib
Interventions: intervention 1: Gefitinib + Sunitinib
Intervention descriptions: intervention 1: Until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00118287
Conditions: de Novo Myelodysplastic Syndromes Previously Treated Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes
Sponsor: Fred Hutchinson Cancer Center
Start date: 2005-04-01; Completion date: 2008-10-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept.

II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease.

III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response.

OUTLINE:

Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: azacitidine intervention 2: etanercept
Intervention descriptions: intervention 1: Given SC or IV intervention 2: Given SC

Protocol documents:
Clinical trial NCT00122317
Conditions: Paroxysmal Hemoglobinuria, Nocturnal
Keywords: transfusion dependent paroxysmal nocturnal hemoglobinuria hemolytic
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2005-05-01; Completion date: 2008-10-01
Enrollment: 187 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

Detailed description:
An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies.

Arms: arm 1: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks
Interventions: intervention 1: eculizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00139659
Conditions: Asthma Diabetes Mellitus
Sponsor: Pfizer
Start date: 2003-01-01; Completion date: 2008-10-01
Enrollment: 288 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Inhaled Insulin intervention 2: Subcutaneous Insulin
Intervention descriptions: intervention 1: Inhaled insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or NPH insulin, or a single bedtime dose of insulin glargine. intervention 2: Subcutaneous short-acting insulin with dose adjusted according to premeal blood glucose plus oral antidiabetic agent(s) and/or either once or twice daily doses of either Ultralente or neutral protamine hagedorn (NPH) insulin, or a single bedtime dose of insulin glargine.

Protocol documents:
Clinical trial NCT00145704
Conditions: Osteopenia
Keywords: osteopenia growth hormone deficiency pediatric malignancy
Sponsor: State University of New York - Upstate Medical University
Start date: 2002-06-01; Completion date: 2008-10-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.

Detailed description:
Adult patients with Dexa scan (bone scan) z-scores \< -1.0 (meaning low bone density) in at least one site will be selected for randomization. All patients who qualify for randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase (BSAP) and n-terminal telopeptides of collagen (NTX) levels. Recent bloodwork obtained as part of their ongoing long-term Pediatric Oncology and/or Endocrine clinic follow-up evaluation will be reviewed to exclude any baseline correctable confounding causes of osteopenia (low bone density). All women of childbearing potential will have a pregnancy test.

For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1(Insulin like growth factor) monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.

Arms: arm 1: No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months. arm 2: Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months
Interventions: intervention 1: bisphosphonate therapy (risedronate) intervention 2: Vitamin D supplement intervention 3: Calcium
Intervention descriptions: intervention 1: Bisphosphonate therapy given to patients with growth hormone deficiency intervention 2: Vitamin D given to patients with growth hormone deficiency intervention 3: calcium supplement given to patients with growth hormone deficiency

Protocol documents:
Clinical trial NCT00168324
Conditions: Macular Edema Retinal Vein Occlusion
Sponsor: Allergan
Start date: 2004-10-01; Completion date: 2008-10-01
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Detailed description:

Arms: arm 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180. arm 2: 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180. arm 3: Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Interventions: intervention 1: 700 µg Dexamethasone intervention 2: 350 µg Dexamethasone intervention 3: Sham Injection
Intervention descriptions: intervention 1: 700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180. intervention 2: 350 µg Dexamethasone intravitreal implant administered on Day 0. intervention 3: Sham injection on Day 0.

Protocol documents:
Clinical trial NCT00174447
Conditions: Schizophrenia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2001-10-01; Completion date: 2008-10-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Open label extension study of Ziprasidone, evaluation of safety of long term use of ziprasidone

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ziprasidone
Intervention descriptions: intervention 1: Dosage may subsequently be adjusted according to clinical status, only at each protocol visit and step by step between 40, 60 and 80 mg bid

Protocol documents:
Clinical trial NCT00176605
Conditions: Prostate Cancer
Keywords: prostate cancer recurrent prostate cancer stage IV prostate cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2005-05-01; Completion date: 2008-10-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Based on data supporting the use of cyclophosphamide and etoposide both as single agents in combination and a Phase I study showing acceptable toxicity with a chronic dosing regimen, we propose a Phase II clinical trial. This protocol establishes a model that will test the hypothesis that the use of etoposide and cyclophosphamide early in the course of prostate cancer progression, when fewer tumor cells are present, will have greater anti-tumor activity. We plan to treat patients with stage D0 prostate cancer to assess toxicity and anti-tumor activity.

Detailed description:

Arms: arm 1: Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy. Total duration of therapy is 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Therapy will continue in this alternating manner for 24 weeks. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.
Interventions: intervention 1: Etoposide intervention 2: Cyclophosphamide
Intervention descriptions: intervention 1: 50 mg per day of Etoposide orally for 21 consecutive days. Etoposide will be alternated with oral cyclophosphamide. The drug is administered at night just prior to bed. Week 1 of each cycle will begin with etoposide. intervention 2: 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration of cyclophosphamide at this dose has been well tolerated

Protocol documents:
Clinical trial NCT00182689
Conditions: Extensive Stage Small Cell Lung Cancer Recurrent Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-07-01; Completion date: 2008-10-01
Enrollment: 89 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sorafenib works in treating patients with extensive stage small cell lung cancer. Sorafenib may stop the growth of small cell lung cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the efficacy of BAY 43-0006 in previously-treated, platinum-sensitive and platinum-refractory patients with measurable disease and extensive stage small cell lung cancer (E-SCLC) in terms of response rate (confirmed and unconfirmed, complete and partial).

SECONDARY OBJECTIVES:

I. To assess the qualitative and quantitative toxicities of BAY 43-9006 in this patient population.

II. To assess overall survival in this group of patients treated with BAY 43-9006.

III. To collect specimens via the Lung Cancer Specimen Repository Protocol (S9925) in order to perform exploratory analyses of the relationship between selected markers and patient outcomes.

OUTLINE: This is a multicenter study. Patients are stratified according to platinum sensitivity status (platinum sensitive vs platinum refractory).

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 2 years from study entry.

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00191191
Conditions: Non-small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2004-10-01; Completion date: 2008-10-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Pemetrexed 500 mg/m2 arm 2: Pemetrexed 1000 mg/m2
Interventions: intervention 1: Pemetrexed 500 mg/m2 intervention 2: Pemetrexed 1000 mg/m2
Intervention descriptions: intervention 1: 500 mg/m2, intravenous (IV), every 21 days, one year from registration date intervention 2: 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date

Protocol documents:
Clinical trial NCT00191451
Conditions: Breast Cancer
Sponsor: Eli Lilly and Company
Start date: 2004-04-01; Completion date: 2008-10-01
Enrollment: 150 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two or three drugs listed above when given in combination can help patients with metastatic breast cancer. How long the treatment will stop the growth of the cancer.

Detailed description:

Arms: arm 1: Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. arm 2: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). arm 3: Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients).
Interventions: intervention 1: Gemcitabine intervention 2: Carboplatin intervention 3: Herceptin
Intervention descriptions: intervention 1: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion) intervention 2: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion). intervention 3: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion).

Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion).

Protocol documents:
Clinical trial NCT00196313
Conditions: Dysmenorrhea
Keywords: cyclic pelvic pain dysmenorrhea oral contraceptives
Sponsor: Duramed Research
Start date: 2005-05-01; Completion date: 2008-10-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 13 weeks of treatment with the option to extend blinded therapy for an additional 13 weeks. The overall study duration will be 6-9 months. Patients will be required to record menstrual pain in a daily diary.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 1 tablet daily by mouth intervention 2: 1 tablet daily by mouth

Protocol documents:
Clinical trial NCT00197106
Conditions: Asthma
Keywords: salmeterol/fluticasone combination Asthma bronchial hyperresponsiveness Children symptom control
Sponsor: GlaxoSmithKline
Start date: 2005-06-01; Completion date: 2008-10-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.

Detailed description:
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.

Arms: arm 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg arm 2: fluticasone propionate 2 x 100 mcg
Interventions: intervention 1: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg intervention 2: fluticasone propionate 2 x 100 mcg
Intervention descriptions: intervention 1: comparator intervention 2: comparator

Protocol documents:
Clinical trial NCT00235391
Conditions: Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis
Keywords: Deferasirox Congenital Anemias Anemias Red Blood Cell Disorders Chronic Iron Overload Transfusional Iron Overload Iron Chelators Oral Iron Chelators Thalassemia Sickle Cell Disease Diamond Blackfan Anemia Myelofibrosis ICL670A
Sponsor: Novartis Pharmaceuticals
Start date: 2005-10-01; Completion date: 2008-10-01
Enrollment: 1683 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.

Detailed description:

Arms: arm 1: Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Starting dose was determined by the frequency of blood transfusions and recommended initial daily dose of deferasirox is 20 mg/kg body weight for patients receiving blood transfusion, 10 mg/kg for patients receiving less frequent transfusion/exchange transfusion and 30 mg/kg for patients receiving more frequent blood transfusions.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: 125 mg, 250 mg and 500 mg tablets. Dosage was calculated based on participant's body weight. Tablets were dispersed in water, orange or apple juice and taken orally once a day.

Protocol documents: