ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00215683
Conditions: Prostate Cancer
Keywords: Prostate Cancer Androgen ablation therapy
Sponsor: Ferring Pharmaceuticals
Start date: 2005-02-01; Completion date: 2009-11-01
Enrollment: 137 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an extension study for the study FE200486 CS12 (NCT00819156). Each participant was to be treated until he was discontinued or withdrawn from the study, or a marketing authorization for degarelix had been obtained.

The study was terminated when all ongoing participants had been treated for at least 5 years (including one year in the main study).

Detailed description:
Participants who completed the main FE200486 CS12 study initially continued with the same dose in the FE200486 CS12A extension study. After a protocol amendment all study participants were treated with 160 mg (40 mg/mL).

The data include data from the participants who participated in both the main study (FE200486 CS12; NCT00819156) and the extension study FE200486 CS12A.

Arms: arm 1: Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL). arm 2: Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL). arm 3: Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. After a protocol amendment in January 2006 all study participants were treated with 160 mg (40 mg/mL).
Interventions: intervention 1: Degarelix
Intervention descriptions: intervention 1: Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 28 days until the end of the study.

Protocol documents:
Clinical trial NCT00284154
Conditions: Carcinoma, Small Cell Lung Cancer
Keywords: Extensive stage Relapsed
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-01-01; Completion date: 2009-11-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.

Detailed description:
Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once every three weeks (21 days). This three week treatment period is called a cycle. Patients whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of vinflunine. Evaluation will be conducted every other cycle.

Arms: arm 1: Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
Interventions: intervention 1: Vinflunine
Intervention descriptions: intervention 1: 320mg/m2 every 21 days as a 15-20 minute infusion

Protocol documents:
Clinical trial NCT00305942
Conditions: Carcinoma, Small Cell
Keywords: Lung Cancer Carcinoma, Small Cell
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-03-01; Completion date: 2009-11-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

Detailed description:
Eligible patients will receive treatment with carboplatin and topotecan.

Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

Arms: arm 1: Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

\- Cycles are repeated every 21 days for \> 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
Interventions: intervention 1: Topotecan intervention 2: carboplatin
Intervention descriptions: intervention 1: Topotecan 4mg/m2 IV on days 1, 8. intervention 2: Carboplatin AUC=5 IV day 1 only .

Protocol documents:
Clinical trial NCT00314574
Conditions: Asthma
Keywords: Persistent Asthma EXTRA Xolair Difficult Breathing
Sponsor: Genentech, Inc.
Start date: 2005-12-01; Completion date: 2009-11-01
Enrollment: 850 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.

Detailed description:

Arms: arm 1: The subcutaneous dose of Xolair administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study. arm 2: The subcutaneous dose of placebo administered in this study was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.

Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.

Participants were permitted to use albuterol as rescue medicine throughout the study.
Interventions: intervention 1: omalizumab (Xolair) intervention 2: placebo intervention 3: corticosteroids intervention 4: long-acting beta-agonists
Intervention descriptions: intervention 1: Omalizumab (Xolair) was administered by subcutaneous (SC) injection every 2 or 4 weeks. Xolair was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that were reconstituted with Sterile Water for Injection (SWFI), USP. intervention 2: Placebo was administered by subcutaneous (SC) injection every 2 or 4 weeks. Placebo contained the same ingredients as the lyophilized formulation of Xolair,excluding omalizumab. intervention 3: Minimum dose of 500 µg of fluticasone dry-powder inhaler or its equivalent ex-valve dose twice a day. intervention 4: 50 µg salmeterol twice daily or 12 µg formoterol twice daily.

Protocol documents:
Clinical trial NCT00322348
Conditions: Advanced Breast Cancer
Keywords: oncology cancer breast cancer
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2009-11-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival at 24 weeks.

Secondary Objectives are to compare the safety and tolerability profile of ZOLADEX 10.8 mg and ZOLADEX 3.6 mg by assessment of adverse events (AEs)and to assess goserelin PK in Japanese and Caucasian participants who have received ZOLADEX 10.8 mg by assessment of goserelin plasma concentration time profiles

Recruitment into the study has been permanently stopped as of 24 December 2007 due to slow recruitment. 98 (vs the planned 260) patients were randomised into the study and will be followed as per protocol for 2 years

Detailed description:

Arms: arm 1: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks arm 2: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Interventions: intervention 1: Goserelin acetate intervention 2: Goserelin acetate
Intervention descriptions: intervention 1: 3.6 mg intramuscular depot injection given every 4 weeks intervention 2: 10.8 mg intramuscular depot injection given every 12 weeks

Protocol documents:
Clinical trial NCT00350792
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-08-01; Completion date: 2009-11-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed and Carboplatin in elderly patients with advanced non-small cell lung cancer

Detailed description:

Arms: arm 1: Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles.

Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.
Interventions: intervention 1: pemetrexed intervention 2: carboplatin
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 6 cycles intervention 2: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles

Protocol documents:
Clinical trial NCT00365417
Conditions: Breast Cancer
Keywords: NSABP Doxorubicin Cyclophosphamide Bevacizumab Capecitabine Docetaxel Breast cancer Locally advanced Neoadjuvant Locally advanced breast cancer
Sponsor: NSABP Foundation Inc
Start date: 2006-08-01; Completion date: 2009-11-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate:

* How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors
* Side effects from adding bevacizumab to chemotherapy
* Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart
* If receiving bevacizumab will have any effect on how patients recover from surgery
* Side effects of the combinations of drugs used in this study

Detailed description:
Initial trials of neoadjuvant chemotherapy administered for locally advanced tumors, including those in breast cancer, demonstrated therapy could induce sufficient tumor regression to allow for the resection of otherwise unresectable tumors. Subsequent demonstration of the equivalence of lumpectomy to mastectomy in patients with operable breast cancer, stimulated interest in the concept of using preoperative chemotherapy to reduce large, but operable, primary tumors to allow for lumpectomy in women who would otherwise require a mastectomy. Given the data from previous studies, it is appropriate to continue development of sequential doxorubicin/cyclophosphamide/docetaxel regimens to improve on clinical and pathologic response rates. FB-4 is a Phase II, single arm study for women with locally advanced human epidermal growth factor receptor 2 (HER2)-negative breast cancer diagnosed by core needle biopsy. The primary aim of the study is to determine the pathologic complete response rate in the breast following neoadjuvant chemotherapy combined with bevacizumab.

Arms: arm 1: None
Interventions: intervention 1: Bevacizumab intervention 2: Doxorubicin intervention 3: Cyclophosphamide intervention 4: Capecitabine intervention 5: Docetaxel
Intervention descriptions: intervention 1: 15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles intervention 2: 60 mg/m\^2 IV every 21 days x 4 cycles intervention 3: 600 mg/m\^2 IV every 21 days x 4 cycles intervention 4: Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles intervention 5: Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles

Protocol documents:
Clinical trial NCT00369265
Conditions: Laryngopharyngeal Reflux
Keywords: Gastroesophageal reflux Laryngitis Hoarseness Dysphonia Proton pump inhibitor
Sponsor: American Institute for Voice and Ear Research
Start date: 2006-08-01; Completion date: 2009-11-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Lansoprazole 30mg taken twice daily is effective in the treatment of laryngitis due to gastroesophageal reflux.

Detailed description:
The investigators propose to study the effect of Lansoprazole 30 mg bid therapy vs. placebo in patients who present with symptoms characteristic of reflux laryngitis. The efficacy of Lansoprazole 30 mg bid in healing and improving reflux laryngitis will be determined. For the purpose of this study, healed reflux laryngitis will be defined as an improvement or resolution of arytenoid erythema and improvement in symptoms. Improved reflux laryngitis will be defined as improvement in any two of the following areas: arytenoid erythema; voice quality as assessed by the patients or health care provider; or, improvement/resolution of related symptoms (throat clearing, cough, etc.). The impact of Lansoprazole 30 mg bid therapy on quality of life will be evaluated in a preliminary fashion.

Arms: arm 1: Lansoprazole 30 mg Twice Daily arm 2: placebo
Interventions: intervention 1: Lansoprazole intervention 2: Sugar pill
Intervention descriptions: intervention 1: Lansoprazole 30mg twice daily intervention 2: placebo twice daily

Protocol documents:
Clinical trial NCT00370552
Conditions: Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2007-03-01; Completion date: 2009-11-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if ixabepilone plus bevacizumab is effective in shrinking or stopping the growth of cancer when given as first-line chemotherapy in participants with metastatic breast cancer. The study will also assess the safety of this combination treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg intervention 2: Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg intervention 3: Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg
Intervention descriptions: intervention 1: Ixabepilone,16 mg/m\^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. intervention 2: Ixabepilone, 40 mg/m\^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity (After Cycle 4, dose reduction to 32 mg/m\^2 was to be implemented for all subsequent cycles.) Bevacizumab, 15 mg/kg, administered as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity. intervention 3: Paclitaxel, 90 mg/m\^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00372489
Conditions: Chronic Renal Failure Chronic Kidney Disease Anemia
Keywords: anemia chronic kidney disease CKD chronic renal failure CRF dialysis erythropoietin EPO erythropoiesis stimulating agent ESA Hematide™ hemodialysis hemoglobin Hb Hgb Omontys peginesatide red blood cell red blood cell production
Sponsor: Affymax
Start date: 2006-09-01; Completion date: 2009-11-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of peginesatide treatment in an earlier study.

Detailed description:
Anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The presence and severity of anemia are related to the duration and extent of kidney failure. Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure.

Erythropoiesis stimulating agents have been established as a treatment for anemia in subjects with chronic kidney disease, and have improved the management of anemia over alternatives such as transfusion. Peginesatide is a parenteral formulation developed for the treatment of anemia associated with chronic kidney disease. Peginesatide binds to and activates the human erythropoietin receptor, and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents (ESAs).

Study participants had received at least 24 weeks of peginesatide dosing in a previous Affymax-sponsored study (NCT00228449) and were to receive doses of peginesatide for approximately 54 months. However, the Sponsor ended the study early.

Arms: arm 1: None
Interventions: intervention 1: peginesatide
Intervention descriptions: intervention 1: Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.

Protocol documents:
Clinical trial NCT00372567
Conditions: Gastrointestinal Stromal Tumor
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2009-11-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.

Detailed description:
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sunitinib malate intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: 37.5 mg daily intervention 2: 800mg daily

Protocol documents:
Clinical trial NCT00379899
Conditions: Chronic Kidney Disease End Stage Renal Disease Coronary Artery Calcification Vascular Calcification Calcification Cardiovascular Disease Chronic Renal Failure Hyperparathyroidism Kidney Disease Nephrology Secondary Hyperparathyroidism
Keywords: calcification vascular calcification coronary vascular calcification chronic kidney disease end stage renal disease dialysis
Sponsor: Amgen
Start date: 2006-09-01; Completion date: 2009-11-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the absence of cinacalcet, in subjects with chronic kidney disease receiving hemodialysis

Detailed description:

Arms: arm 1: Standard of care, without use of cinacalcet.
Interventions: intervention 1: cinacalcet
Intervention descriptions: intervention 1: Low dose vitamin D with cinacalcet

Protocol documents:
Clinical trial NCT00380718
Conditions: Non-small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-11-01; Completion date: 2009-11-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and toxicity of pemetrexed dosing that is tailored to individual patient tolerance in patients with advanced non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pemetrexed
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m2), intravenous (IV) in the first cycle. Acceptable toxicity\* in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 with unacceptable toxicity every 3 week in subsequent cycles till progression of disease.

\*Toxicity acceptable if none of the following toxicities recorded at any time during Cycle 1: Platelets \<50 x 10\^9/L; absolute neutrophil count \<1.0 x 10\^9/L; Stomatitis/pharyngitis/esophagitis/diarrhea Grade \>2; Skin Grade \>2; Serum bilirubin \>3.0 x upper limit of normal (ULN); alanine aminotransferase/aspartate aminotransferase \>10 x ULN; Other non-hematologic toxicities Grade \>2 (except nausea, vomiting).

Protocol documents: