ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00269152
Conditions: Non-Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2005-12-01; Completion date: 2013-07-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: carboplatin
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles intervention 2: 75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles intervention 3: area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles

Protocol documents:
Clinical trial NCT00302133
Conditions: Bipolar Disorder Alcohol Dependence
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Sponsor: University of Miami
Start date: 2006-05-01; Completion date: 2013-07-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Detailed description:
Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.

Arms: arm 1: Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate arm 2: Placebo comparator one capsule daily for 12 weeks add on to valproate
Interventions: intervention 1: Naltrexone hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Naltrexone hydrochloride 50 mg capsule daily for 12 weeks intervention 2: Placebo arm

Protocol documents:
Clinical trial NCT00320710
Conditions: Breast Cancer
Keywords: Breast cancer zoledronic acid bone metastases
Sponsor: Novartis Pharmaceuticals
Start date: 2006-02-01; Completion date: 2013-07-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This study is prospective, double-blind, stratified, multi-center, and two-arm.

Detailed description:

Arms: arm 1: Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks. arm 2: Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind. arm 3: Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were swithced to the zoledronic acid q 4 weeks according to a study amendment.
Interventions: intervention 1: Zoledronic acid intervention 2: Placebo
Intervention descriptions: intervention 1: 4mg IV intervention 2: Placebo to zoledronic acid

Protocol documents:
Clinical trial NCT00323882
Conditions: Prostate Cancer Neoplasm Metastasis
Keywords: Prostate Cancer Oncology Prostate Cancer Metastatic Hormone PSA Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Sponsor: Bristol-Myers Squibb
Start date: 2006-01-01; Completion date: 2013-07-01
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MDX-010
Intervention descriptions: intervention 1: selected dose administered IV every 3 weeks

Protocol documents:
Clinical trial NCT00348790
Conditions: Brain and Central Nervous System Tumors Sarcoma
Keywords: adult grade I meningioma adult grade II meningioma adult grade III meningioma adult malignant hemangiopericytoma adult anaplastic meningioma adult papillary meningioma adult melanocytic lesion recurrent adult brain tumor
Sponsor: Northwestern University
Start date: 2006-05-01; Completion date: 2013-07-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with recurrent or progressive meningioma.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of vatalanib, in terms of radiographic improvement and clinical improvement, in patients with recurrent or progressive meningioma.

Secondary

* Determine the 6-month progression-free survival of these patients.
* Describe the response rate and overall survival of these patients.
* Determine the safety of vatalanib in these patients.
* Correlate the response rates with expression of vascular endothelial growth factor, epidermal growth factor receptor, platelet-derived growth factor, and HER2.
* Develop exploratory data concerning surrogate markers of angiogenic activity in vivo using magnetic resonance perfusion.

OUTLINE: Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days for 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Arms: arm 1: Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.

Patients who are responding may remain on study treatment for 12 months.
Interventions: intervention 1: vatalanib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00350701
Conditions: Diabetes Mellitus Type 2
Keywords: DM type 2 Hypogonadism Testosterone AndroGel
Sponsor: University at Buffalo
Start date: 2006-07-01; Completion date: 2013-07-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is to study the effect of replacing testosterone on different inflammatory cells in type 2 diabetics with low testosterone levels.

Detailed description:
Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress. Hypogonadism( low testosterone) is also associated with increased levels of inflammatory mediators and atherosclerosis.

This project is about studying the effect of testosterone replacement on different inflammatory cells in blood and urine. It will also compare the dose dependent effect on inflammatory cells. This also involves comparing level of inflammation in hypogonadic diabetic males treated with testosterone with those not treated with any replacement therapy.

This study involves applying AndroGel for 8 wks and studying effects during this time and thereafter.

Arms: arm 1: androgel 5g arm 2: androgel 10g arm 3: placebo
Interventions: intervention 1: androgel intervention 2: androgel 10g intervention 3: placebo
Intervention descriptions: intervention 1: androgel 5g intervention 2: androgel 10g intervention 3: placebo

Protocol documents:
Clinical trial NCT00367341
Conditions: Major Depressive Disorder
Keywords: Depression, Treatment, Imaging
Sponsor: Emory University
Start date: 2006-08-01; Completion date: 2013-07-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
While there are many effective options for treating a major depressive episode, there are no clinical markers that predict the likelihood of remission with an initial trial of either an antidepressant medication or psychotherapy. More critically, there are also no reliable predictors that might anticipate failure to such standard treatments either alone or in combination. This project will characterize imaging-based brain subtypes that distinguish groups of depressed patients who later remit or not to SSRI pharmacotherapy or cognitive behavior therapy (CBT), respectively. To define these subtypes, a prospectively-treated cohort of 100 patients will be randomized to receive either escitalopram (s-CIT) or CBT for the first 12 weeks, with non-remitters to either first treatment crossed over to receive an additional 12 weeks of treatment with combined treatment. Non-remitters to both treatments will thus define a relatively treatment resistant third subgroup. Resting-state 18F-fluoro-deoxyglucose (FDG) positron emission tomography (PET) scans will be acquired prior to initiating antidepressant therapy, with pre-treatment scan patterns associated with three possible outcomes (CBT remission, s-CIT remission, and non-remission to both) assessed using multivariate analytic methods. A second PET scan, acquired early in the treatment course, will be used to assess the likelihood of response to the specific treatment first assigned. The proposed studies are a first step towards defining brain-based biomarkers predictive of differential treatment outcome in major depression; most critically, patterns distinguishing patients at risk for treatment resistance. Identification of such biomarkers has additional implications for future testing of novel therapies in patients with distinct brain signatures, including development of evidence-based treatment algorithms for individual patients.

Detailed description:
SPECIFIC AIMS Aim 1. To define baseline regional glucose metabolic patterns (measured using FDG PET) associated with differential clinical remission to each of two well-established, randomly delivered first-line antidepressant treatments-the SSRI escitalopram (s-CIT) or cognitive behavioral therapy (CBT) with cross-over treatment for non-remitters (sequential course of treatment model).

Aim 2. To define metabolic change patterns, occurring early in the course of both s-CIT and CBT, associated with successful and unsuccessful clinical remission to each intervention.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: escitalopram intervention 2: Cognitive Behavioral Therapy (CBT)
Intervention descriptions: intervention 1: Participants will receive treatment with escitalopram for 12 weeks. intervention 2: CBT will include 16 1 hour sessions provided over 12 weeks.

Protocol documents:
Clinical trial NCT00445263
Conditions: CORONARY DISEASE
Keywords: CORONARY DISEASE
Sponsor: Hospital Avicenne
Start date: 2007-03-01; Completion date: 2013-07-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The acute coronary syndrome (ACS) without ST elevation is a frequent pathology. The main evolutionary risk of these patients is the coronary thrombosis and its self complications. The platelets aggregation plays a major role in the physiopathology of the ACS. The therapeutic arsenal of the anti-thrombosis essentially resting on aspirin and heparin has been reinforced lately by the inhibitors of the glycoprotein anti GP IIb/IIIa. The profit of these products in the ACS with or without ST elevation, associated or not to coronarography, has clearly been demonstrated. This profit is more marked when patients are at high risk of complications. Thus, the use of an anti GP IIb/IIIa is recommended among patients at "high risk" for whom a coronarography is planned, in the last international recommendations of the European Cardiology Society (ESC), the American Heart Association and the American College of Chest Physician. Otherwise, some authors have proposed An early invasive strategy based on coronarography with discordant results. The ideal delay of realization of this coronarography is unknown. It varies according to the studies between 2.5 hours to 48 hours. Once again, patients at high risk seem to benefit the more of such a strategy if it is set precociously.

Objective To compare an invasive strategy associating an early administration of tirofiban and a coronarography achieved in the 6 hours after the randomization to a conservative strategy in a population of high risk patients with ACS without ST elevation.

Design Multicentric, prospective, randomized study.

Detailed description:
Patient's selection Patient of more than 18 years with a ACS defined by a thoracic pain of more than 20 minutes that occurred during the last 24 hours, anomalies on EKG and one of the following criteria : diabetes; recurrence of coronary pain; precocious pain post-myocardial infarction; falling of the ST segment of \> 1 mm; transient elevation of the ST segment \> 1 mm; elevation of the I troponin, T troponin or CPK MB; hemodynamic instability; ventricular arrhythmia; TIMI score \> 5

Therapeutic modes All patients receive : aspirin, clopidogrel, enoxaparine. Trinitrin and analgesics are at the clinician's appreciation. Besides, either they receive an anti GP IIb/IIIa: tirofiban (Agrastat®) and are oriented in cardiology to have a coronarography in the six hours or they are oriented in cardiology to receive the classical treatment, guided by the investigations searching for signs of myocardial ischemia.

Arms: arm 1: Tirofiban and coronarography within 6 hours arm 2: Coronarography after 6 hours
Interventions: intervention 1: TIROFIBAN intervention 2: CORONAROGRAPHY
Intervention descriptions: intervention 1: intravenous infusion intervention 2: standard procedure of coronarography

Protocol documents:
Clinical trial NCT00490490
Conditions: Lymphoma, Non-Hodgkin
Sponsor: Stanford University
Start date: 2007-01-01; Completion date: 2013-07-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).

Detailed description:
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam

Arms: arm 1: Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)
Interventions: intervention 1: Bexxar (tositumomab) intervention 2: External beam radiotherapy (XRT) intervention 3: Potassium Iodide (KI)
Intervention descriptions: intervention 1: Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy. intervention 2: Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study. intervention 3: Potassium iodide (KI) will be administered as:

* Saturated solution potassium iodide (SSKI) 4 drops orally 3-times-a-day,
* Lugol's solution 20 drops orally 3-times-a-day, OR
* KI tablets 130 mg orally once per day KI treatment will start at least 24 hours prior to tositumomab, and continue daily for 14 days following the last dose of tositumomab

Protocol documents:
Clinical trial NCT00529191
Conditions: Type 1 Diabetes
Keywords: Type I Diabetes (T1DM) Atorvastatin (Lipitor) Insulin Pancreas Beta Cells
Sponsor: Children's Hospital of Philadelphia
Start date: 2007-07-01; Completion date: 2013-07-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

Detailed description:
Type 1 diabetes is an autoimmune disease that is characterized by destruction of the insulin-producing beta cells of the pancreas. T1DM therapy requires insulin administration, either by multiple daily injections or by insulin pump. However, in many patients, blood sugar control remains suboptimal and complications develop that shorten life expectancy and severely impact quality of life. At the time of diagnosis, most patients still have significant residual beta cell function. Previous research has shown that weakening the immune system's attack on the pancreatic beta cells may help to preserve or potentially increase insulin production.

Preliminary studies have shown that members of the statin family of medications, including atorvastatin (Lipitor®), preserve beta cell function in a mouse model of type 1 diabetes. These finding suggest that use of atorvastatin in combination with insulin therapy may delay and potentially reverse the destruction of beta cells in patients who have recently developed type 1 diabetes. Atorvastatin (Lipitor®) is approved for use in adults and children (\>10 years of age) who have elevated blood cholesterol levels. This study will examine whether atorvastatin (Lipitor®) may also help the body preserve insulin production in patients with newly diagnosed (within 8 weeks) type 1 diabetes.

Patients will be randomly assigned to take either atorvastatin (Lipitor®) or placebo. Two out of every 3 patients will receive atorvastatin and 1 out of 3 will get placebo. As this is a double-blinded study, neither the care team nor the patient will know if they are actually taking atorvastatin (Lipitor®). Patients who have given consent to participate in the study and pass the required screening tests will take the assigned treatment every day for 12 months. All patients will begin taking 10 mg once daily, the recommended starting dose. After 4 weeks, the dose will be increased to 20 mg. In addition to a high standard of diabetes care and the medication, patients will have blood tests during 7 visits over an 18 month period.

Arms: arm 1: Two out of every three patients will receive atorvastatin. arm 2: One out of three subjects will receive a placebo.
Interventions: intervention 1: Atorvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months intervention 2: One out of three subjects will receive a placebo.

Protocol documents:
Clinical trial NCT00530816
Conditions: Multiple Myeloma
Sponsor: Amgen
Start date: 2007-09-01; Completion date: 2013-07-01
Enrollment: 164 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the best overall response rate, safety and tolerability of carfilzomib in patients with relapsed or refractory multiple myeloma.

Detailed description:
Two groups of patients with multiple myeloma were initially studied: bortezomib-naïve and bortezomib-treated. Following Amendment 2, only bortezomib-naïve patients were enrolled. Study results were reported in 2 parts, depending on whether a patient received prior bortezomib.

Arms: arm 1: Participants received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.

Starting with Amendment 3, if all doses in Cycle 1 were well-tolerated the dose was escalated to 27 mg/m² IV for subsequent cycles.
Interventions: intervention 1: carfilzomib
Intervention descriptions: intervention 1: Intravenous (IV) injection over 2 to 10 minutes twice weekly for three weeks followed by 12 days of rest.

Protocol documents: