ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00088166
Conditions: Brain Edema Brain Tumor
Keywords: peritumoral brain edema edema malignant brain tumor astrocytoma brain tumor dexamethasone Decadron
Sponsor: Celtic Pharma Development Services
Start date: 2004-05-01; Completion date: 2008-03-01
Enrollment: 200 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of XERECEPT® to dexamethasone (Decadron) a common treatment for symptoms of brain swelling (edema). This study is specifically aimed at patients who require chronic high doses of dexamethasone to manage symptoms.

Detailed description:
XERECEPT® is not a potential treatment for cancer, but may reduce the edema associated with tumors and as a result, decrease neurological symptoms.

Arms: arm 1: Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking. arm 2: Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
Interventions: intervention 1: hCRF intervention 2: placebo hCRF
Intervention descriptions: intervention 1: hCRF ; open-label dexamethasone that the patient is currently taking intervention 2: placebo hCRF 2mg/day and open-label dexamethasone that they are taking

Protocol documents:
Clinical trial NCT00089648
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2004-12-01; Completion date: 2008-03-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib
Intervention descriptions: intervention 1: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol

Protocol documents:
Clinical trial NCT00174785
Conditions: Atrial Fibrillation Atrial Flutter
Keywords: Mortality, Hospitalization
Sponsor: Sanofi
Start date: 2005-06-01; Completion date: 2008-03-01
Enrollment: 4628 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).

To assess that dronedarone is well tolerated in this population.

Detailed description:
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

Arms: arm 1: Dronedarone 400mg tablets twice daily (bid) arm 2: matching placebo tablets
Interventions: intervention 1: dronedarone (SR33589) intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) intervention 2: oral administration (tablets)

Protocol documents:
Clinical trial NCT00924443
Conditions: Acute Myeloid Leukemia
Keywords: acute myelogenous leukemia acute myeloid leukemia clolar evoltra clofarabine untreated acute leukemia adult acute leukemia
Sponsor: Genzyme, a Sanofi Company
Start date: 2004-06-01; Completion date: 2008-03-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.

Detailed description:
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.

Arms: arm 1: Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
Interventions: intervention 1: clofarabine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00052078
Conditions: Anxiety Disorders Social Phobia Generalized Anxiety Disorder
Keywords: Phobic Disorders Anxiety, Separation
Sponsor: Johns Hopkins University
Start date: 2003-01-01; Completion date: 2008-03-01
Enrollment: 488 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This randomized, controlled trial compared the efficacy of the medication sertraline (Zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

Detailed description:
Anxiety disorders are among the most common conditions affecting children and adolescents. These disorders impair school, social, and family functioning. When left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. Previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. This study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo.

During Phase I of this two-phase study, 488 participants were randomly assigned to receive sertraline (Zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. Phase II involved a 6-month maintenance period for participants.

Arms: arm 1: Participants received sertraline for 12 weeks. arm 2: Participants received cognitive behavioral therapy for 12 weeks arm 3: Participants received both sertraline and CBT for 12 weeks. arm 4: Participants received a placebo pill for 12 weeks.
Interventions: intervention 1: Sertraline (SRT) intervention 2: Cognitive Behavioral Therapy (CBT) intervention 3: Placebo
Intervention descriptions: intervention 1: Participants were treated with sertraline. intervention 2: Participants received CBT. intervention 3: Participants were treated with a placebo pill.

Protocol documents:
Clinical trial NCT00054028
Conditions: Recurrent Breast Cancer Stage IIIB Breast Cancer Stage IV Breast Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2002-12-01; Completion date: 2008-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the best dose of suramin when given together with paclitaxel in treating women with stage IIIB-IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Suramin may increase the effectiveness of paclitaxel by making tumor cells more sensitive to the drug.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the dose of suramin in combination with paclitaxel (TXT) that results in suramin plasma concentrations approaching 10-50 uM over the duration, when TXT in the plasma is at therapeutically significant levels, in women with stage IIIB or IV breast cancer. (Phase I) II. Determine the objective response rate in patients treated with this regimen. (Phase II)

SECONDARY OBJECTIVES:

I. Determine the pharmacokinetics of low-dose suramin in these patients. (Phase I) II. Determine the time to tumor progression in patients treated with this regimen. (Phase II) III. Determine the 1-year survival of patients treated with this regimen. (Phase II)

OUTLINE: This is a phase I, dose-escalation study of suramin followed by a phase II multicenter study.

PHASE I: Patients receive low-dose suramin intravenously (IV) over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for the phase I study within 9 months. A total of 28 patients will be accrued for the phase II study within 18-24 months.

Arms: arm 1: PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.

PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above.
Interventions: intervention 1: suramin intervention 2: paclitaxel intervention 3: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00079937
Conditions: Asthma
Keywords: allergic asthma atopic omalizumab immunoglobulin E IgE anti-IgE
Sponsor: Novartis Pharmaceuticals
Start date: 2004-04-01; Completion date: 2008-03-01
Enrollment: 628 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A substance called immunoglobulin E (IgE), which is naturally produced by our body, has a key role in generating asthma attacks. In patients with allergies, there is an exaggerated production of IgE in response to specific substances such as pollens. Omalizumab is a new drug that inactivates IgE. This study tested the safety and efficacy of omalizumab against asthma attacks in children with allergic asthma.

Detailed description:
This study was designed to provide one year efficacy and safety data for subcutaneous (SC) omalizumab, compared to placebo in children (6 to \< 12 years) with moderate to severe persistent asthma who have inadequate asthma control despite treatment according to National Heart, Lung and Blood Institute (NHLBI) step 3 or 4 (at least medium dose inhaled corticosteroids with or without other controller asthma medications).

Arms: arm 1: Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks. arm 2: Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
Interventions: intervention 1: Omalizumab intervention 2: Placebo intervention 3: Fluticasone
Intervention descriptions: intervention 1: The omalizumab dose administered, based on the patient's body weight and total serum IgE level at Screening, and the number of injections and injection volume was determined from the dosing tables in the protocol. Omalizumab 75 to 375 mg was administered subcutaneous (SC) every 2 or 4 weeks depending on the dose. intervention 2: Placebo was administered subcutaneous (SC) every 2 or 4 weeks depending on the dosing schedule in the protocol. intervention 3: Patients entered the study using their current formulation of any inhaled steroid (proprietary drug and device) ≥ 200 μg/day equivalent of fluticasone administered with a dry-powder inhaler.

Protocol documents:
Clinical trial NCT00089999
Conditions: Neoplasms, Breast
Keywords: lapatinib advanced metastatic breast cancer GW572016 ErbB2
Sponsor: GlaxoSmithKline
Start date: 2004-06-01; Completion date: 2008-03-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.

Detailed description:

Interventions: intervention 1: Lapatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00101647
Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic myelogenous leukemia (CML): Accelerated phase
Sponsor: Bristol-Myers Squibb
Start date: 2004-12-01; Completion date: 2008-03-01
Enrollment: 197 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure

Protocol documents:
Clinical trial NCT00101816
Conditions: Chronic Myeloid Leukemia Blast Crisis
Keywords: Myeloid blast phase Chronic Myeloid Leukemia (CML)
Sponsor: Bristol-Myers Squibb
Start date: 2004-12-01; Completion date: 2008-03-01
Enrollment: 124 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are currently in the myeloid blast phase of chronic myeloid leukemia (CML) and who are either resistant to or intolerant of imatinib mesylate. Another purpose of the study is to see what side effects this drug may have on subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: Tablets, Oral, 70 mg, twice daily, Until disease progression or intolerable toxicity, switch to the roll-over study or study closure.

Protocol documents:
Clinical trial NCT00103844
Conditions: Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia
Keywords: Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia
Sponsor: Bristol-Myers Squibb
Start date: 2005-02-01; Completion date: 2008-03-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Detailed description:

Arms: arm 1: Active Comparator arm 2: Active Comparator
Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks intervention 2: Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Protocol documents:
Clinical trial NCT00105196
Conditions: Major Depressive Disorder
Keywords: Single or recurrent non-psychotic episode of Major Depressive Disorder
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2005-03-01; Completion date: 2008-03-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole+ ADT intervention 2: Placebo+ ADT
Intervention descriptions: intervention 1: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks intervention 2: Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks

Protocol documents:
Clinical trial NCT00110357
Conditions: Cancer Refractory Solid Tumor
Sponsor: Eli Lilly and Company
Start date: 2005-08-01; Completion date: 2008-03-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to establish the maximum tolerated dose and recommended Phase II dose of Erbitux™ in combination with Irinotecan in pediatric and adolescent patients with refractory solid tumors.

Detailed description:

Arms: arm 1: 1-12 years old arm 2: 13-18 years old
Interventions: intervention 1: Cetuximab + Irinotecan intervention 2: Cetuximab + Irinotecan
Intervention descriptions: intervention 1: Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 16 or 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days. intervention 2: Intravenous (IV) cetuximab 75 - 250 mg/m2 depending on dose escalation for MTD, weekly; irinotecan was administered at a dose of 20 mg/m2 or per dose escalation, administered x5 days x2 weeks, separated by 2 days off, every 21 days.

Protocol documents:
Clinical trial NCT00110994
Conditions: Cancer Melanoma
Sponsor: Bayer
Start date: 2005-04-01; Completion date: 2008-03-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double blind, placebo controlled, multicenter, phase II study to compare the anti-tumor activity as measured by progression-free survival (PFS) and the tolerability of Sorafenib in combination with Dacarbazine (DTIC) versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy. A total of approximately 98 subjects will be randomized to receive DTIC + Sorafenib or DTIC + Placebo.

Detailed description:

Arms: arm 1: Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period. arm 2: Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m\^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo intervention 3: Dacarbazine
Intervention descriptions: intervention 1: Sorafenib, 400 mg, 2 tablets (200 mg each) po (per os) bid (twice daily) Study days 1-21 intervention 2: Placebo, 2 tablets, po (per os) bid (twice daily) Study days 1-21 intervention 3: Dacarbazine, 1000 mg/m\^2 intravenous on Study Day 1

Protocol documents:
Clinical trial NCT00112905
Conditions: Adenocarcinoma of the Bladder Distal Urethral Cancer Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Regional Transitional Cell Cancer of the Renal Pelvis and Ureter Squamous Cell Carcinoma of the Bladder Stage III Bladder Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Urethral Cancer Associated With Invasive Bladder Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2008-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sorafenib works in treating patients with progressive regional or metastatic cancer of the urothelium. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the 4-month progression-free survival rate, response rate and toxicity of BAY 43-9006 in patients with progressing regional or metastatic transitional cell carcinoma (or mixed histologies containing a component of TCC) of the urothelium who have progressed on one and only one prior systemic chemotherapy regimen for metastatic disease.

SECONDARY OBJECTIVES:

I. To determine the time to disease progression and overall survival with BAY 43-9006.

II. To evaluate the frequency of polymorphisms in drug metabolizing enzymes and to correlate these polymorphisms with variations in BAY 43-9006 pharmacokinetics.

III. To evaluate the frequency of raf kinase mutations in tumor specimens and correlate these with response rate.

IV. To evaluate serum VEGF levels as potential markers of angiogenesis inhibition by BAY 43-9006.

V. To evaluate markers of apoptosis and kinase inhibition in peripheral blood mononuclear cells as potential biomarkers of BAY 43-9006 activity.

VI. To determine if there are proteins differentially translated from the genome in patients who respond to treatment with BAY 43-9006 versus patients who do not respond to BAY 43-9006.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-56. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-56. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Optional correlative studies

Protocol documents: