ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00138151
Conditions: Cervical Cancer
Keywords: recurrent cervical cancer stage IVB cervical cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2001-03-01; Completion date: 2010-11-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving isotretinoin and interferon alpha-2b together with paclitaxel may reduce drug resistance and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving isotretinoin and interferon alpha-2b together with paclitaxel works in treating patients with stage IV, recurrent, or persistent cervical cancer.

Detailed description:
OBJECTIVES:

* Determine the response in patients with stage IVB, recurrent, or persistent cervical cancer treated with isotretinoin, interferon alpha-2b, and paclitaxel.

OUTLINE: This is a multicenter study.

Patients receive oral isotretinoin and interferon alpha-2b subcutaneously once daily on days 1-4 and paclitaxel IV over 3 hours on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study.

Arms: arm 1: * Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle
* Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle
* Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days
Interventions: intervention 1: recombinant interferon alpha-2b intervention 2: isotretinoin intervention 3: paclitaxel
Intervention descriptions: intervention 1: Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle intervention 2: Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle intervention 3: Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days

Protocol documents:
Clinical trial NCT00217672
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: Translational Oncology Research International
Start date: 2005-05-01; Completion date: 2010-11-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether giving docetaxel together with bevacizumab is more effective than docetaxel alone in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with bevacizumab works compared to docetaxel alone as first-line therapy in treating women with stage IV breast cancer.

Detailed description:
This trial began as a 2-arm study with a docetaxel-alone arm. When bevacizumab became widely available, it was converted to a 1-arm open-label trial of docetaxel/bevacizumab. Patients enrolled in the docetaxel-alone arm were permitted to cross over to docetaxel/bevacizumab. Patients received bevacizumab 15 mg/kg and docetaxel 75 mg/m2 intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal.

Arms: arm 1: docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.

Bevacizumab: 15 mg/kg IV every 3 weeks. Subjects continue on study until disease progression, unacceptable toxicity, or withdrawal of patient consent. arm 2: docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
Interventions: intervention 1: bevacizumab intervention 2: Docetaxel
Intervention descriptions: intervention 1: Patients receive bevacizumab 15 mg/kg intravenously (I.V.) every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.

Protocol documents:
Clinical trial NCT00274781
Conditions: Leukemia Myelodysplastic Syndromes
Keywords: refractory anemia with excess blasts in transformation refractory anemia with excess blasts chronic myelomonocytic leukemia secondary acute myeloid leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes de novo myelodysplastic syndromes
Sponsor: The Cleveland Clinic
Start date: 2004-02-01; Completion date: 2010-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving arsenic trioxide together with gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of arsenic trioxide and gemtuzumab ozogamicin to achieve complete and partial remissions in patients with advanced myelodysplastic syndromes.

Secondary

* Determine the efficacy of this regimen, in terms of 50% decrease in Red Blood Cell (RBC) transfusion requirements and change in hemoglobin concentration from baseline in patients treated with this regimen.
* Determine the platelet, neutrophil, bone marrow, and cytogenic response in patients treated with this regimen.
* Determine the response duration in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Determine the safety and toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive arsenic trioxide IV over 1 hour once daily on days 1-5 in week 1 and then twice weekly in weeks 2-12. They also receive gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 12 weeks during study treatment, and then 4 weeks after the completion of study treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Arms: arm 1: Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m\^2 D8 for 1 or 2 Cycles of 12 Weeks each
Interventions: intervention 1: arsenic trioxide intervention 2: gemtuzumab ozogamicin
Intervention descriptions: intervention 1: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12). intervention 2: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion

Protocol documents:
Clinical trial NCT00284180
Conditions: Breast Neoplasms Breast Cancer
Keywords: Breast Neoplasms Breast Cancer Vinflunine Vinca Alkaloid Javlor
Sponsor: SCRI Development Innovations, LLC
Start date: 2006-01-01; Completion date: 2010-11-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research study involves the anti-cancer medication trastuzumab and the investigational drug vinflunine. The purpose of this trials is to see if trastuzumab and vinflunine used in combination or vinflunine alone is effective in the treatment of metastatic breast cancer

Detailed description:
If the tumor is HER2neu positive, eligible patients will receive trastuzumab and vinflunine intravenously (IV) every 3 weeks.

If the tumor is HER2neu negative, eligible patients will receive vinflunine intravenously (IV) every 3 weeks.

Patients whose cancer does not grow or decreases in size may continue to receive treatment until cancer progression. Evaluation of cancer will be every 9 weeks.

Arms: arm 1: Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days arm 2: Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2.
Interventions: intervention 1: Vinflunine intervention 2: Trastuzumab
Intervention descriptions: intervention 1: Novel second generation vinca alkaloid intervention 2: Anti-HER2 monoclonal antibody

Protocol documents:
Clinical trial NCT00287872
Conditions: Multiple Myeloma
Keywords: stage II multiple myeloma stage III multiple myeloma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2004-09-01; Completion date: 2010-11-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.

Detailed description:
OBJECTIVES:

* Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma.
* Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen.
* Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation.
* Determine the time to response in patients treated with this regimen.
* Assess the quality of life of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide\* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity.

NOTE: \*For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only.

Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment.

After completion of study treatment, patients are followed every 3 months.

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

Arms: arm 1: The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
Interventions: intervention 1: bortezomib intervention 2: thalidomide
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00308113
Conditions: Duchenne Muscular Dystrophy
Keywords: Muscular dystrophy Duchenne CoQ10 prednisone
Sponsor: Cooperative International Neuromuscular Research Group
Start date: 2007-04-01; Completion date: 2010-11-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will help determine if CoQ10 and prednisone, alone and as a combination decrease the decline in cardiopulmonary and skeletal muscle function that occurs in the wheelchair confined phase of DMD. Participants who are enrolled in this study should not have taken any corticosteroids within the last six months. This is a 13-month, prospective, randomized study comparing a daily prednisone arm (0.75mg/kg/day), a CoQ10 arm (serum of greater than 2.5 ug/mL) and a combination arm (prednisone and CoQ10) with an enhanced standard of care arm in wheelchair confined males age 10 to 18 years with an established DMD diagnosis.

Detailed description:
Duchenne muscular dystrophy (DMD) is the most common form of muscular dystrophy affecting 1:3500 male births worldwide. Despite an increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains largely supportive. Improvement in the treatment of DMD will depend upon the development of better therapies. Affected boys become symptomatic at 3 to 5 years of age with proximal leg weakness that impairs mobility, ability to get up from a squat, and precludes a normal ability to run. By 8 years of age, some affected boys begin to lose the ability to walk and resort to a wheelchair for mobility. This shift from the ambulant to non-ambulant phase occurs in all boys with a diagnosis of DMD by age 12 years. In this study, participants will be randomized into groups after being screened to determine eligibility. Participants will then be followed for a 12-month investigation period.

Arms: arm 1: CoenzymeQ10 taken once a day each morning by mouth. arm 2: Prednisone taken once a day each morning by mouth arm 3: CoenzymeQ10 and prednisone each taken once a day in the morning by mouth. arm 4: Enhanced standard of care.
Interventions: intervention 1: Prednisone intervention 2: Coenzyme Q10
Intervention descriptions: intervention 1: Prednisone 0/75 mg/kg/day. intervention 2: serum levels of greater or equal to 2.5 micrograms/mL.

Protocol documents:
Clinical trial NCT00331344
Conditions: Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage IV Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-04-01; Completion date: 2010-11-01
Enrollment: 100 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities of the combination of ixabepilone, mitoxantrone hydrochloride, and prednisone in patients with hormone-refractory metastatic prostate cancer that progressed during or after taxane-based chemotherapy. (Phase I) II. Assess the efficacy, as measured by reduction in prostate-specific antigen, of this regimen in these patients. (Phase II)

SECONDARY OBJECTIVES:

I. Evaluate the overall safety of this regimen as second-line chemotherapy in these patients.

II. Evaluate the objective response rate in patients treated with this regimen.

OUTLINE: This is a multicenter, phase I, open label, dose-escalation study of mitoxantrone hydrochloride and ixabepilone followed by a phase II study.

PHASE I: Patients receive mitoxantrone hydrochloride intravenously (IV) over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of mitoxantrone hydrochloride and ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PHASE II: Patients receive mitoxantrone hydrochloride and ixabepilone at the MTD determined in phase I and prednisone as in phase I.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Patients receive mitoxantrone hydrochloride IV over 30 minutes and ixabepilone IV over 3 hours on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 21 days for ≥ 3 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: mitoxantrone hydrochloride intervention 2: ixabepilone intervention 3: prednisone
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given orally

Protocol documents:
Clinical trial NCT00373685
Conditions: Osteoarthritis
Keywords: GI events in patients with moderate GI risk treated with NSAIDS
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-10-01; Completion date: 2010-11-01
Enrollment: 8067 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.

Detailed description:

Arms: arm 1: dosing as per USPI label arm 2: None
Interventions: intervention 1: Celecoxib intervention 2: Any commercially available NSAID with the indication for osteoarthritis
Intervention descriptions: intervention 1: open-label intervention 2: dosing as per USPI label related to the chosen commercially marketed NSAID

Protocol documents:
Clinical trial NCT00404079
Conditions: Low Back Pain
Keywords: Chronic low back pain
Sponsor: Ullevaal University Hospital
Start date: 2006-12-01; Completion date: 2010-11-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Low back pain (LBP) is the most frequent cause of sick leave and disability pension, and degenerative and osteoarthritic (OA) changes is a significant cause of pain and disability. Some indications exist for symptomatic and possible cartilage-structurmodifying effect on knee- and hip-osteoarthritis with glucosamine sulphate (GS). The OA process in the lumbar spine is most likely to OA processes in knees and hips, hence GS could have comparable symptomatic and structural effect on lumbar OA.

Study hypothesis: No difference in treatment effect exists between oral intake of GS- or placebo-capsules for patients' with chronic low back pain measured with Roland Morris Disability Questionnaire.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Glucosamine sulphate intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intake of 1500 mg glucosamine sulfate(from Pharma Nord) daily for 6 months intervention 2: Oral intake of 3 placebo capsules (similiar looking to the glucosamine sulfate capsules)daily for 6 months

Protocol documents:
Clinical trial NCT00423683
Conditions: Cancer Thromboembolism
Keywords: Cancer thromboembolism
Sponsor: Northwell Health
Start date: 2007-01-01; Completion date: 2010-11-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.

Detailed description:
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without an inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms. Patients will be equally randomized to receive either Arixtra with or without placement of an Inferior Vena Cava (IVC) filter. Fifty three patients are expected to be enrolled in each arm. Patients will be monitored for 90 days after study enrollment. Monitoring will include telephone calls and physician visits and repeat radiologists if the patient is symptomatic of a Deep Vein thrombosis (DVT). This will also include completion of a quality of life questionnaire.

Arms: arm 1: Arixtra Alone arm 2: Arixtra + filter
Interventions: intervention 1: Arixtra alone intervention 2: Arixtra + filter
Intervention descriptions: intervention 1: Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt) intervention 2: Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Protocol documents: