ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00554515
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Kidney Renal Cell Metastatic interleukin-2 select
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2006-11-01; Completion date: 2013-10-31
Enrollment: 123 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
High-dose interleukin 2 (Proleukin, Novartis) (IL-2) is approved by the U.S Food and Drug Administration (FDA) for the treatment of metastatic kidney cancer and is a standard treatment of this disease. At the present time, IL-2 is the only therapy for kidney cancer that can produce a remission of disease that lasts after treatment is completed. However, most patients who receive IL-2 do not benefit and all patients experience potentially dangerous side effects.

Recent research has suggested that certain patients may respond better to IL-2 than others. The Cytokine Working Group is currently conducting a clinical trial that aims to identify and confirm this research and narrow the application of IL-2 to those patients most likely to benefit.

Detailed description:
OBJECTIVES:

Primary

* To determine, in a prospective fashion, if the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "good" pathologic predictive features is significantly higher than a historical, unselected patient population.

Secondary

* To determine, in a prospective fashion, the response rate to high-dose IL-2 for patients with metastatic renal cell carcinoma and "poor" pathologic predictive features and to compare this response rate to the response rate of patients with "good" pathologic predictive features.
* To determine if components of other predictive and prognostic models (e.g MSKCI or UCLA criteria) can help to further define the optimal population to receive high-dose IL2 for metastatic renal cell carcinoma.
* To identify features of the baseline immune function (arginine, arginase, T cell zeta chain) of patients with metastatic renal cell carcinoma that are associated with response to high-dose IL-2.
* To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most.

Arms: arm 1: Participants received high-dose (HD) IL2, 600,000 IU/kg/dose (Prometheus Laboratories Inc.) i.v. every 8 hours for 5 days (maximum of 14 doses) beginning on day 1 and again on day 15. One course generally consisted of 5 days of treatment, 9 days of rest, 5 more days of treatment, and 9 weeks of rest, followed by up to two additional courses of HD IL2 for patients who benefited and tolerated most of the planned IL2 doses. A treatment delay of up to 4 weeks was allowed for resolution of side effects between courses. Patients were eligible to receive a maximum of three courses of treatment.
Interventions: intervention 1: HD IL2
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00731549
Conditions: Schizophrenia
Keywords: Aripiprazole IM Depot Schizophrenia Intramuscular
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2008-12-01; Completion date: 2013-11-01
Enrollment: 1081 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.

Detailed description:
This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247).

This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.

During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.

Arms: arm 1: Active Treatment of aripiprazole IM depot (300mg or 400mg)
Interventions: intervention 1: Aripiprazole IM Depot
Intervention descriptions: intervention 1: 300mg or 400mg

Protocol documents:
Clinical trial NCT01063907
Conditions: Multiple Myeloma
Keywords: Leukemia Immunoproliferative Disorder Neoplasma by Histologic Type Immune System Diseases Hematologic Diseases Blood Protein Disorders Paraproteinemias Multiple Myeloma Hematologic Disorders Leukemia, Chronic, B-cell Leukemia, B-cell Leukemia, Chronic Neoplasms, Plasma Cell Monoclonal Gammopathy of unknown significance (MGUS)
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2010-03-01; Completion date: 2013-11-01
Enrollment: 95 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM).

The primary objectives:

* To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I);
* To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II).

The secondary objectives:

* To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only);
* To evaluate for preliminary evidence of efficacy (Phase I);
* To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).

Detailed description:
This is a multicenter, open label, dose escalation, Phase I / II study in subjects with relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up to 101 subjects treated in the study. Study centers in the USA and the UK will participate in Phase I and II. Centers in the Philippines will be participating in Phase II only. The planned enrollment period is 22 months and the planned study duration is 28 months.

Arms: arm 1: Cohort 1: KW 2478 130 mg/m\^2 and Bortezomib 1.0 mg/m\^2 arm 2: Cohort 2: KW 2478 130 mg/m\^2 and Bortezomib 1.3 mg/m\^2 arm 3: Cohort 3: KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2 arm 4: Cohort 4: KW 2478 175 mg/m\^2 and Bortezomib 1.3 mg/m\^2 arm 5: KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2
Interventions: intervention 1: KW-2478 intervention 2: Bortezomib
Intervention descriptions: intervention 1: Administered Days 1, 4, 8 and 11 of a 21 day cycle intervention 2: Administered on Days 1, 4, 8 and 11 of a 21 day cycle

Protocol documents:
Clinical trial NCT01533935
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2013-11-01
Enrollment: 291 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.

Detailed description:

Arms: arm 1: patient will receive olodaterol 5 mcg once daily arm 2: placebo comparator for tiotropium + olodaterol arm 3: patient will receive tiotropium 5 mcg once daily arm 4: patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily arm 5: patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily
Interventions: intervention 1: Placebo intervention 2: Tiotropium + Olodaterol intervention 3: tiotropium + Olodaterol intervention 4: Tiotropium intervention 5: Olodaterol intervention 6: Respimat
Intervention descriptions: intervention 1: placebo matching tiotropium + olodaterol intervention 2: Tiotropium 2.5 mcg + olodaterol 5 mcg once daily intervention 3: tiotropium 5 mcg + olodaterol 5 mcg once daily intervention 4: tiotropium intervention 5: Olodaterol 5 mcg once daily intervention 6: Respimat inhaler

Protocol documents:
Clinical trial NCT01612676
Conditions: Septic Shock
Sponsor: Ferring Pharmaceuticals
Start date: 2012-06-01; Completion date: 2013-11-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

Detailed description:

Arms: arm 1: FE 202158
Interventions: intervention 1: FE 202158
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02641379
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-05-01; Completion date: 2013-11-01
Enrollment: 737 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (\>) 500 individuals.

Detailed description:

Arms: arm 1: Participants will receive PEG-IFN (180 microgram \[mcg\]), subcutaneously (sc), once weekly for 24 weeks and Ribavirin 1000-1200 milligram per day (mg/day) (\<75 kilogram (kg); \>75 kg) for 24 weeks. arm 2: Participants will receive PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) till week 24; if patient is still HCV RNA positive. Treatment will be stopped if participant is HCV RNA negative at week 24 -treatment with PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) till week 72 arm 3: Participants will receive PEG-IFN (180 mcg), sc, once weekly for 48 weeks and Ribavirin 1000-1200 mg/day (\<75kg; \>75 kg) for 48 weeks. arm 4: Participants will receive PEG-IFN (180 mcg), sc, once weekly for 72 weeks and Ribavirin 1000-1200 mg/day (\<75 kg; \> 75 kg) for 72 weeks.
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\\n intervention 2: Ribavirin is available as 200 mg tablets

Protocol documents:
Clinical trial NCT00061932
Conditions: Adenocarcinoma of the Gastroesophageal Junction Diffuse Adenocarcinoma of the Stomach Intestinal Adenocarcinoma of the Stomach Mixed Adenocarcinoma of the Stomach Recurrent Gastric Cancer Stage IIIB Gastric Cancer Stage IIIC Gastric Cancer Stage IV Gastric Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-04-01; Completion date: 2013-11-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II trial is studying how well bortezomib with or without irinotecan works in treating patients with gastroesophageal junction or stomach cancer that can not be removed by surgery. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate for the combination of irinotecan and PS 341 in patients with previously untreated adenocarcinoma of the stomach or GEJ.

II. To determine the response rate for PS341 in patients with previously treated adenocarcinoma of the stomach or GEJ.

III. To determine the toxicities and recovery from toxicities for patients receiving PS 341 alone or in combination with irinotecan IV. To perform GeneChip analysis on biopsy specimens prior to and subsequent to treatment with PS341 to determine changes in patterns of gene expression

OUTLINE: Patients are stratified (stratum 2 closed to accrual as of 9/19/2006) according to prior chemotherapy for advanced disease (yes vs no).

STRATUM 1 (Previously untreated patients): Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.

STRATUM 2 (Previously treated patients) (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.

In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8. arm 2: (closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.
Interventions: intervention 1: bortezomib intervention 2: irinotecan
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00066222
Conditions: Lung Cancer
Keywords: limited stage small cell lung cancer
Sponsor: Radiation Therapy Oncology Group
Start date: 2003-06-01; Completion date: 2013-11-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the response rate of patients with limited stage small cell lung cancer treated with cisplatin and etoposide combined with accelerated high-dose thoracic radiotherapy.
* Determine the progression-free and overall survival in patients treated with this regimen.
* Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.

Arms: arm 1: Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Interventions: intervention 1: Cisplatin intervention 2: Etoposide intervention 3: Radiation therapy
Intervention descriptions: intervention 1: 60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64. intervention 2: 120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66. intervention 3: Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.

Protocol documents:
Clinical trial NCT00068341
Conditions: Breast Cancer
Keywords: stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage II breast cancer
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2003-07-01; Completion date: 2013-11-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Detailed description:

Arms: arm 1: see intervention description arm 2: please see intervention description arm 3: please see intervention description
Interventions: intervention 1: trastuzumab intervention 2: carboplatin intervention 3: docetaxel intervention 4: trastuzumab
Intervention descriptions: intervention 1: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV intervention 2: Cycle 1-8 Day 1 or 2 AUC = 6 IV intervention 3: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV intervention 4: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV

Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV

Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

Protocol documents:
Clinical trial NCT00068445
Conditions: Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific
Keywords: neurotoxicity pain unspecified adult solid tumor, protocol specific
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2004-02-01; Completion date: 2013-11-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.

Detailed description:
OBJECTIVES:

* Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.
* Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.
* Determine the toxic effects of lamotrigine in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms (1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

Arms: arm 1: Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity.

Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.

Patients are followed at 3-7 days. arm 2: Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks.

Treatment continues for 10 weeks in the absence of unacceptable toxicity.

Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.

Patients are followed at 3-7 days.
Interventions: intervention 1: lamotrigine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00227539
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
Sponsor: University of Washington
Start date: 2005-07-01; Completion date: 2013-11-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before, during, and after chemotherapy) may help doctors predict a patient's response to treatment and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well PET works in predicting response in patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without surgery for stage I, stage II, or stage III non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in predicting radiological and pathological response in patients treated with pemetrexed disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung cancer (NSCLC).

Secondary

* Determine the safety of cisplatin and pemetrexed disodium in these patients.
* Determine the radiographic response rate, duration of response, and time to progression in patients treated with cisplatin and pemetrexed disodium.

OUTLINE: This is a multicenter study.

* Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen, and pelvis. Patients receive fludeoxyglucose F 18 (\^18FDG) IV followed by 45 minutes of rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at three points during the study: 4 weeks prior to treatment, after the first cycle of treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical resection of the tumor.
* Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: cisplatin intervention 2: pemetrexed disodium intervention 3: adjuvant therapy intervention 4: therapeutic conventional surgery intervention 5: fludeoxyglucose F 18
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents: