ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00033514
Conditions: Breast Cancer
Keywords: stage IV breast cancer recurrent breast cancer
Sponsor: Jonsson Comprehensive Cancer Center
Start date: 2001-08-01; Completion date: 2011-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

Detailed description:
OBJECTIVES:

* Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of 01/2004)
* Determine the safety profile of this regimen in these patients.
* Determine the rate and duration of objective response in patients treated with this regimen.
* Determine the pharmacologic behavior of this regimen in these patients.
* Determine time to disease progression and duration of survival in patients treated with this regimen.
* Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients.

OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of 01/2004).

Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of this study.

Arms: arm 1: please see intervention description
Interventions: intervention 1: trastuzumab intervention 2: erlotinib hydrochloride
Intervention descriptions: intervention 1: Day 1 4mg/kg IV 2 mg/kg IV weekly. intervention 2: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.

Protocol documents:
Clinical trial NCT00153166
Conditions: Arterial Occlusive Disease Intermittent Claudication Insulin Resistance
Keywords: peripheral arterial disease intermittent claudication
Sponsor: Brigham and Women's Hospital
Start date: 2004-01-01; Completion date: 2011-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will test the hypothesis that inflammation and insulin resistance contribute to reduced walking distance in subjects with intermittent claudication by impairing vascular reactivity and skeletal muscle metabolic function.

Detailed description:
People with peripheral arterial disease (PAD), an important clinical manifestation of atherosclerosis, often suffer symptoms of intermittent claudication that impair their walking ability and adversely affect their quality of life. People with PAD are also at increased risk for adverse cardiovascular events, including myocardial infarction, stroke and death. Unfortunately, medical therapies directed to the functional and limb-threatening manifestations are limited. Little attention has been paid to the biologic processes that cause PAD, and to atherogenic mechanisms that may preferentially affect the peripheral circulation.

Vascular inflammation and insulin resistance are two important and interdependent conditions that are associated with atherosclerosis. Subjects in this trial (160 adults with stable intermittent claudication who are not taking insulin or insulin-sensitizing medications, such as thiazolidinediones) will be randomized in a placebo-controlled, parallel design manner, to atorvastatin 80 mg orally daily (to reduce inflammation) and pioglitazone 45 mg orally once daily (to improve insulin sensitivity). Forty healthy adult subjects, age and gender-matched to a subset of the study group, will be enrolled to serve as a control population. Primary and secondary study endpoints include: treadmill walking time, endothelium-dependent vasodilation, and insulin-mediated skeletal muscle glucose uptake.

Arms: arm 1: Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo. arm 2: Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo. arm 3: Randomized to either atorvastatin and pioglitazone, atorvastatin/placebo, pioglitazone/placebo, or placebo/placebo.
Interventions: intervention 1: atorvastatin and pioglitazone intervention 2: atorvastatin/placebo intervention 3: pioglitazone/placebo intervention 4: placebo/placebo
Intervention descriptions: intervention 1: atorvastatin 80 mg orally once daily (to reduce inflammation) and pioglitazone 30 mg orally once daily (to improve insulin sensitivity) intervention 2: atorvastatin 80 mg orally once daily and matching placebo orally twice daily intervention 3: pioglitazone 30 mg orally once daily and matching placebo orally once daily intervention 4: placebo orally three times daily

Protocol documents:
Clinical trial NCT00232583
Conditions: Type 2 Diabetes Mellitus
Keywords: TYpe 2 diabetes mellitus Newly diagnosed Beta-cell function
Sponsor: University of Texas Southwestern Medical Center
Start date: 2003-11-01; Completion date: 2011-12-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Detailed description:
This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Arms: arm 1: Metformin 1000mg/BID and Insulin Novolog 70/30 per protocol titration arm 2: Metformin 1000mg/BID, Pioglitazone 45 mg and glyburide per protocol titration
Interventions: intervention 1: Metformin intervention 2: Insulin intervention 3: Metfomin intervention 4: Pioglitazone intervention 5: glyburide
Intervention descriptions: intervention 1: Metformin 1000mg/BID intervention 2: Insulin Novolg 70/30 per protocol titration intervention 3: Metformin 1000mg/BID intervention 4: Pioglitazone 45mg intervention 5: Glyburide per protocol titration

Protocol documents:
Clinical trial NCT00243074
Conditions: Advanced Malignant Mesothelioma Epithelial Mesothelioma Recurrent Malignant Mesothelioma Sarcomatous Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-11-01; Completion date: 2011-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is study how well AZD2171 works in treating patients with malignant pleural mesothelioma that cannot be removed by surgery. AZD2171 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. Determine the objective confirmed, complete, and partial response rates in patients with unresectable malignant pleural mesothelioma treated with AZD2171.

SECONDARY OBJECTIVES:

I. Determine the clinical benefit, in terms of objective response and stable disease rates, in patients treated with this drug.

II. Determine the 1-year median overall survival and progression-free survival in patients treated with this drug.

III. Determine the frequency and severity of toxic effects in patients treated with this drug.

IV. Correlate, preliminarily, pre- and post-treatment plasma vascular endothelial growth factor and soluble vascular cell adhesion molecule with clinical outcomes in patients treated with this drug.

V. Correlate, preliminarily, circulating endothelial cells with clinical outcomes in patients treated with this drug.

VI. Correlate variants of genes in the pathway targeted by this drug and variants of genes involved in the development of hypertension with the antiangiogenic property of this drug in these patients.

OUTLINE:

Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 5 years from study entry.

Arms: arm 1: Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cediranib maleate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00245856
Conditions: Deep-Vein Thrombosis
Keywords: Upper Extremity Deep-Vein Thrombosis DVT Fragmin Deep-Vein Thrombosis Thrombosis
Sponsor: University of Oklahoma
Start date: 2002-09-01; Completion date: 2011-12-01
Enrollment: 67 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.

Detailed description:
Upper extremity deep-vein thrombosis (DVT) is an increasingly common clinical problem and has been found to cause important pulmonary embolism in up to 36% of cases including fatal embolism. The major risk factor for development of DVT is presence of a central venous catheter in which up to 30% of patients may develop venous thrombosis. Peripherally inserted central catheters or (PICC) lines have been more frequently used in order to avoid the morbidity of central venous catheter insertion. There is little data on the incidence of DVT with these catheters, or effective treatment regimen.

The purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months. About 100 patients will be enrolled in this study at the University of Oklahoma.

All patients with upper extremity DVT will be screened. Each will have a complete baseline and risk factor assessment.

All patients will receive active study drug for a period of 3 months with reassessment of upper extremity DVT by ultrasound.

All patients will participate for a period of 12 months with follow up visits at 5-7 day, and 1, 3, 6, 12 months.

Arms: arm 1: Participants received dalterparin followed by warfarin or received dalterparin monotherapy for the treatment of upper extremity DVT
Interventions: intervention 1: Dalteparin sodium injection intervention 2: Warfarin
Intervention descriptions: intervention 1: 200units/kg subcutaneous daily for one month, followed by 150units/kg subcutaneous daily for two additional months or 200 units/kg subcutaneously daily for 5 days followed by warfarin. intervention 2: Titrated to INR 2-3 through study month 3

Protocol documents:
Clinical trial NCT00305578
Conditions: Bipolar Depression
Keywords: Bipolar Depression Incomplete Response
Sponsor: Indiana University School of Medicine
Start date: 2005-08-01; Completion date: 2011-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. Subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.

Detailed description:
Hypothesis/Objectives:

H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical Global Improvement (CGI) scale compared to patients augmented with placebo.

H2: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement of scores on the Selective Reminding Test (SRT), the Digit Span Test, the Stroop Test, and Trail Making Test (TMT) than patients augmented with placebo.

Study Population:

We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from the outpatient Mood Disorders Clinic and by advertisement.

Arms: arm 1: Placebo daily arm 2: Daily dose Memantine
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study. intervention 2: No active medication, only placebo

Protocol documents:
Clinical trial NCT00313781
Conditions: Prostatic Neoplasms
Keywords: randomized non-comparative efficacy
Sponsor: Pfizer
Start date: 2006-05-01; Completion date: 2011-12-01
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To test the efficacy of CP-751,871 combined with docetaxel and prednisone in the treatment of prostate cancer that is refractory to hormone therapy

Detailed description:

Arms: arm 1: For patients treated with docetaxel and prednisone only, who progress during treatment, CP-751,871 will be added to the regimen to test reversibility of chemoresistance. arm 2: None
Interventions: intervention 1: CP-751,871 intervention 2: docetaxel intervention 3: prednisone intervention 4: docetaxel intervention 5: prednisone
Intervention descriptions: intervention 1: CP-750,871 is administered intravenously at a dose of 20 mg/kg on day 1 of each 21-day cycle (for patient convenience and logistical management, the dose of CP-751,871 may be deferred up to 7 days). intervention 2: Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. intervention 3: Prednisone is administered at a dose of 5 mg twice daily. intervention 4: Docetaxel is administered IV on day 1 of each 21-day cycle, at a dose of 75 mg/m2. intervention 5: Prednisone is administered at a dose of 5 mg twice daily.

Protocol documents:
Clinical trial NCT00318812
Conditions: Anemia Renal Failure
Keywords: Randomized controlled trial (RCT) Prospective Studies ferric oxide, saccharated Peptides Heme Iron Erythropoietin, Recombinant Ferritin Transferrin Treatment Outcome
Sponsor: Ottawa Hospital Research Institute
Start date: 2007-05-01; Completion date: 2011-12-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.

Detailed description:
Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.

Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.

Arms: arm 1: Heme Iron Polypeptide 11mg PO tid for 6 months arm 2: Venofer q month IV x 6 months
Interventions: intervention 1: Heme Iron Polypeptide (Proferrin) intervention 2: Iron sucrose (Venofer)
Intervention descriptions: intervention 1: Heme iron polypeptide 11mg po tid for 6 months intervention 2: Iron sucrose infusion IV q month x 6 months

Protocol documents:
Clinical trial NCT00325572
Conditions: Autism Pervasive Developmental Disorder
Sponsor: Milton S. Hershey Medical Center
Start date: 2006-11-01; Completion date: 2011-12-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers.

The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study.

The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.

Detailed description:

Arms: arm 1: Participant will receive oral zinc and vitamin C supplementation based on the child's weight. Blood levels of zinc, copper, liver and renal function as well as blood counts will be measured. Copper to zinc ratio will be calculated at 6 and 16 weeks arm 2: Participant will receive placebo liquid with volume based on child's weight to match the amount given to participants in the experimental group.
Interventions: intervention 1: oral zinc and vitamin C supplements intervention 2: oral Placebo
Intervention descriptions: intervention 1: Each child will be provided separate suspensions containing zinc and vitamin C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation intervention 2: Each child will be provided separate Placebo suspensions C to be taken twice per day. The dose will be based on the child's weight and be titrated by checking copper/zinc ratio at 6 weeks of treatment. Monitoring of liver, renal functions and CBC will occur at the end of supplementation

Protocol documents:
Clinical trial NCT00344682
Conditions: Depressive Disorder
Keywords: memantine Namenda augmentation add-on depression MDD (major depressive disorder) unipolar depression NMDA ketamine uncompetitive NMDA receptor antagonist
Sponsor: University of Massachusetts, Worcester
Start date: 2006-06-01; Completion date: 2011-12-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is evaluating the efficacy and safety of the drug memantine (trade name NAMENDA) as an augmentation agent for the treatment of depression in people who are not fully responding to antidepressant medications.

Detailed description:
\- Objective

The objective of this study is to evaluate the efficacy and safety of 20 mg of memantine administered once daily as an augmentation agent for subjects who have been taking antidepressants for at least 1 month but who have experienced an incomplete or absent therapeutic response.

\- Background

Memantine is a moderate affinity, uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist that is approved for the treatment of moderate-to-severe dementia of the Alzheimer's type. It has been commercially available in 23 countries worldwide since 1982.

There are reports in the published literature that suggest NMDA receptors may be involved in the etiology of depressive disorders. The NMDA antagonist ketamine has been shown to have antidepressant effects in a placebo-controlled clinical trial (Berman et al., 2000). Uncompetitive NMDA receptor antagonists, including memantine, have been shown to exhibit antidepressant-like activity in animal models of depression (Moryl et al., 1993, Papp and Moryl 1994). Animal studies also support the possibility that uncompetitive NMDA receptor antagonists may work synergistically in combination with antidepressants in animal models of depression (Rogoz et al., 2001). Some authors have hypothesized a role for NMDA receptors in the therapeutic effects of numerous antidepressants (Skolnick et al., 1996).

\- Study Design and Duration

This is a randomized, single site, double-blind, placebo-controlled, parallel-group study in outpatients. The study consists of an 8-week double-blind treatment period. Approximately 25 patients will be randomized to each treatment group (memantine or placebo) for a total of approximately 50 patients.

Arms: arm 1: memantine (5-20mg a day) arm 2: placebo (5-20mg a day)
Interventions: intervention 1: memantine intervention 2: Placebo
Intervention descriptions: intervention 1: memantine 5mg - 20mg PO daily intervention 2: 5mg - 20mg PO daily over 8 weeks

Protocol documents: