ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00328614
Conditions: Prostate Cancer
Keywords: Locally advanced prostate cancer positive lymph nodes
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2003-03-01; Completion date: 2011-06-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

Detailed description:
The likelihood of prostate cancer cells metastasizing to bone has an early and important influence on the natural history of prostate cancer. Bone-targeted therapy, when given sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs the progression of the disease in clinically non-metastatic prostate cancer patients.

The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam radiation therapy has never been previously evaluated in high risk clinically localized prostate cancer. Many patients with high-risk prostate cancer develop progressive disease within 2 years of therapy indicating that subclinical metastatic disease may be present at the time of initial diagnosis. In these high-risk patients, there may be a therapeutic benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153 EDTMP to treat localized and subclinical bony disease, respectively.

Arms: arm 1: Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 2: Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 3: Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 4: Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 5: Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy arm 6: Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Interventions: intervention 1: Samarium-153 intervention 2: Total Androgen Suppression (TAS) with Bicalutamide intervention 3: Total androgen suppression (TAS) with Goserelin Acetate intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD). intervention 2: Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. intervention 3: Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation. intervention 4: Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.

Protocol documents:
Clinical trial NCT00336856
Conditions: Colon Cancer Rectum Cancer
Keywords: Colon Cancer
Sponsor: University of Pittsburgh
Start date: 2006-06-01; Completion date: 2011-06-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Research Hypothesis: Subjects in the study population who are treated with cetuximab in combination with irinotecan will have higher response rates than subjects treated with irinotecan alone.

Detailed description:
Primary Objective:

·The primary aim of this study is to assess the response rate of patients with previously treated colorectal cancer (CRC) Number of Subjects: 31

Study Population:

Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC.

Test Product, Dose and Mode of Administration, Duration of Treatment:

Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.

Reference Therapy, Dose and Mode of Administration, Duration of Treatment: Irinotecan administered at a dose of 150a or 180 mg/m2 IV over 60 minutes every two weeks.

Arms: arm 1: Cetuximab will be administered at the dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks, IV over 2 hours at an infusion rate not to exceed 5 ml/min. Followed immediately by Irinotecan administered at a dose of 180 mg/m2 IV over 60 minutes every two weeks.
Interventions: intervention 1: Cetuximab intervention 2: Irinotecan
Intervention descriptions: intervention 1: The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks. intervention 2: The treatment will include cetuximab 500 mg/m² IV for 120 minutes followed by irinotecan 180 mg/m² or 60 minutes. The starting dose of irinotecan for patients who are 70 years old or greater, or who have had radiation therapy to the abdomen or pelvis, or whose level of functioning is poor (performance status of 2) will have a starting dose of 150 mg/m2 for irinotecan. All subsequent treatments will include cetuximab 500 mg/m² IV over 60 minutes and irinotecan 150 mg/m² or 180 mg/m2 intravenously over 60 minutes every 2 weeks.

Protocol documents:
Clinical trial NCT00362440
Conditions: HIV Lipodystrophy
Keywords: HIV lipodystrophy Leptin Fat wasting Pioglitazone Insulin resistance
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2006-08-01; Completion date: 2011-06-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by your fat cells). Our hope is that they will improve sugar and fat metabolism and positively affect the body fat changes you have noticed while taking HAART.

Detailed description:
Highly active antiretroviral therapy (HAART) induces profound and sustained suppression of human immunodeficiency virus (HIV) replication, and is thus very effective in reducing disease-associated morbidity and mortality in this patient population. However, HAART also results in the development of a lipodystrophic syndrome which is characterized by fat accumulation, fat wasting, or a combination of both, and similar to congenital forms of lipodystrophy, is associated with components of the metabolic syndrome, including insulin resistance (IR), fasting hypertriglyceridemia, and hypercholesterolemia.

Our study is a "proof of concept" study on the treatment of the HAART-induced metabolic syndrome, which builds upon and represents a direct extension of a study previously funded by the American Diabetes Association (ADA). If our clinical trial proves that a combination treatment of leptin and an insulin sensitizer has additive or synergistic effects in reversing the metabolic abnormalities of HIV positive patients with lipoatrophy, it could lead to the design of larger multi-center, randomized, placebo-controlled trial(s) aiming at establishing safety and efficacy of this treatment for the HAART-induced metabolic syndrome.

Arms: arm 1: Leptin replacement therapy arm 2: Diabetes treatment therapy
Interventions: intervention 1: Leptin intervention 2: Pioglitazone or metformin intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00373113
Conditions: Breast Neoplasms
Keywords: advanced breast cancer metastatic breast cancer treatment resistant treatment failure
Sponsor: Pfizer
Start date: 2006-11-01; Completion date: 2011-06-01
Enrollment: 482 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Detailed description:
Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Arms: arm 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles arm 2: 37.5 mg daily, continuous dosing
Interventions: intervention 1: Capecitabine intervention 2: Sunitinib malate
Intervention descriptions: intervention 1: 1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles intervention 2: 37.5 mg daily, continuous dosing

Protocol documents:
Clinical trial NCT00374244
Conditions: Schizophrenia
Keywords: schizophrenia pimozide clozapine
Sponsor: Yale University
Start date: 2004-01-01; Completion date: 2011-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life events and social activities), compared to placebo (an inactive substance, "sugar pill"), when added to clozapine in patients with schizophrenia.

The participant will be asked to come in once a week to meet with the research staff and study doctor. The participant will continue to see your regular clinician during this study for all normal appointments. The participant will remain on your current medications throughout the study. During the study you will be randomly selected to be put on a small dose of Pimozide or placebo.

Detailed description:
If you choose to participate, you will first have screening tests to find out if you are eligible. The study physician will do a number of tests including a physical examination, a routine medical history, lab tests for blood and urine, and EKG (to monitor your heart) and interviews about your physical and mental health.

At each visit you will complete an EKG (to monitor your heart), vital signs, and discuss how you are feeling with the research staff and doctor. Once a month, we will also conduct a slightly longer interview with you about your symptoms and draw one tube of blood to check your Clozapine level. At the beginning and end of the study, you will do some pencil and paper games called "Neurocognitive tests".

If you are interested in participating in this study, we will go over it in greater detail with you, including the possible benefits and risks associated with participating. We will make sure you understand the study before you begin. This study is completely voluntary, which means that you can choose to stop participating in the study at any time.

Arms: arm 1: placebo pimozide arm 2: active pimozide
Interventions: intervention 1: Pimozide intervention 2: placebo
Intervention descriptions: intervention 1: half of the subjects are randomized to the active drug group intervention 2: half of the subjects are randomized to placebo group

Protocol documents:
Clinical trial NCT00447057
Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
Keywords: nonsquamous
Sponsor: Eli Lilly and Company
Start date: 2007-03-01; Completion date: 2011-06-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Detailed description:

Arms: arm 1: Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm arm 2: Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm arm 3: Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm arm 4: Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm
Interventions: intervention 1: Pemetrexed intervention 2: Erlotinib intervention 3: Pemetrexed intervention 4: Erlotinib
Intervention descriptions: intervention 1: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity intervention 2: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle intervention 3: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity intervention 4: 150 mg given po, QD, starting on the first day of the first cycle

Protocol documents:
Clinical trial NCT00449033
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer (NSCLC) Cancer
Sponsor: Bayer
Start date: 2007-02-01; Completion date: 2011-06-01
Enrollment: 904 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Detailed description:
During follow-up, it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients' data are reported in the current CSR addendum, 6 in the sorafenib + GC group and 4 in the placebo + GC group, and as before all in the ITT (non-squamous) population.

Arms: arm 1: Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met. arm 2: Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m\^2 infusion (IV), followed by cisplatin 75 mg/ m\^2 IV; Day 8: gemcitabine 1250 mg/ m\^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo intervention 3: Gemcitabine intervention 4: Cisplatin
Intervention descriptions: intervention 1: Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV intervention 2: Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV intervention 3: Chemotherapy component; Gemcitabine 1250 mg/m\^2 IV intervention 4: Chemotherapy component; Cisplatin 75 mg/m\^2 IV

Protocol documents:
Clinical trial NCT00458952
Conditions: Pheochromocytoma Paraganglioma
Keywords: MIBG iobenguane iodine I 131 radiotherapy radiopharmaceutical dosimetry neuroendocrine tumor Ultratrace no carrier added metaiodobenzyl-guanidine
Sponsor: Molecular Insight Pharmaceuticals, Inc.
Start date: 2007-04-01; Completion date: 2011-06-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

Detailed description:
This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD. The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.

Arms: arm 1: Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6.
Interventions: intervention 1: Ultratrace Iobenguane (MIBG) I 131
Intervention descriptions: intervention 1: Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose

Protocol documents:
Clinical trial NCT00467896
Conditions: Pulmonary Hypertension
Keywords: PAH iloprost Ventavis Pulmonary Arterial Hypertension Actelion Pharmaceuticals Cotherix
Sponsor: Actelion
Start date: 2006-09-01; Completion date: 2011-06-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Detailed description:

Arms: arm 1: The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.
Interventions: intervention 1: Iloprost PD-6 intervention 2: Iloprost PD-15
Intervention descriptions: intervention 1: Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®. intervention 2: Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.

Protocol documents:
Clinical trial NCT00474955
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2011-06-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of \<15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants will be administered peginterferon alpha-2a \[Pegasys\] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of \<15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 180 micrograms or 135 micrograms sc weekly for 48 weeks

Protocol documents: