ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00908310
Conditions: Chronic Kidney Disease Renal Insufficiency
Keywords: CKD - Chronic Kidney Disease GBCA - Gadolinium-based contrast agent GFR - Glomerular Filtration Rate MRI - Magnetic Resonance Imaging NSF - Nephrogenic Systemic Fibrosis Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.
Sponsor: GE Healthcare
Start date: 2009-05-01; Completion date: 2013-09-01
Enrollment: 213 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Omniscan
Intervention descriptions: intervention 1: OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Protocol documents:
Clinical trial NCT00939822
Conditions: Alzheimer's Disease
Sponsor: University of Wisconsin, Madison
Start date: 2009-03-01; Completion date: 2013-09-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the research is to see how simvastatin affects a substance in the body called beta-amyloid. Beta-amyloid is found in the brain and in the liquid around the brain and spinal cord. High amounts of beta-amyloid may be associated with a greater risk of getting Alzheimer's disease. This study will see if simvastatin can lower the amount of beta-amyloid in the spinal fluid. This study will also see if simvastatin affects memory and thinking, blood flow in the brain, and blood vessel function. The investigators hope that future studies show whether simvastatin might prevent memory loss and decrease the chance of developing Alzheimer's disease.

Detailed description:
Studies show that some medicines that lower cholesterol may reduce the risk of developing Alzheimer's disease, but this has not yet been proven in humans. We are looking for individuals to participate in this study to see if a cholesterol-lowering medication, called simvastatin affects blood flow to the brain, blood vessel function and a substance in the spinal fluid related to the changes in Alzheimer's disease.

The SHARP study included 88 adults ages 40-72 with parental history of documented Alzheimer's disease. The study had 9 visits over the course of 18 months. Participants had fasting blood tests collected, completed a medical history questionnaire and medication side effect review, underwent lumbar puncture procedure, completed memory testing, and had ultrasound and MRI procedures. Participants were randomly assigned to receive either simvastatin or a placebo each night for 18 months.

Arms: arm 1: 40 mg. Simvastatin/day arm 2: Matching Placebo
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: 40 mg Simvastatin/day intervention 2: Matching Placebo

Protocol documents:
Clinical trial NCT00997373
Conditions: Endometrial Carcinoma
Keywords: Endometrial Cancer Endometrial Carcinoma Aromatase Inhibitor Letrozole Femara
Sponsor: University of California, Davis
Start date: 2009-10-01; Completion date: 2013-09-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Some cases of endometrial cancer are dependent on estrogen for their growth. Letrozole blocks estrogen production in the body. The purpose of this study is to determine if the investigators can predict which patients might benefit from Letrozole treatment by studying the many different forms of the estrogen receptor molecule that exist within the cancer tissues. To participate in this study, the patients must be 40 years of age or older and have biopsy-proven endometrial carcinoma, either well differentiated or moderately differentiated forms. Also, to be eligible to participate in this study, the patients need to be healthy enough to have a hysterectomy. If the patients are less than age 60, they will need a blood test (FSH) to confirm that they have gone into menopause.

Detailed description:

Arms: arm 1: letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy. arm 2: no treatemtn prior to hysterectomy
Interventions: intervention 1: Letrozole
Intervention descriptions: intervention 1: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks

Protocol documents:
Clinical trial NCT01003301
Conditions: Cat Allergy
Keywords: cat allergy
Sponsor: Johns Hopkins University
Start date: 2009-10-01; Completion date: 2013-09-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells.

Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.

Detailed description:
This is a randomized, placebo-controlled, double-blind, parallel group design study that includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All subjects will be cat allergic.

Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to treatment and another challenge after 2 months of treatment or when their blood basophils become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1 active:placebo), will not undergo nasal challenges. This group will participate in an ancillary study in which the effects of omalizumab on gene expression profiles in peripheral blood cells will be studied.

Arms: arm 1: Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma. arm 2: This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks. intervention 2: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.

Protocol documents:
Clinical trial NCT01051570
Conditions: Prostate Cancer
Keywords: hormone-resistant prostate cancer recurrent prostate cancer stage IV prostate cancer adenocarcinoma of the prostate
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2010-02-01; Completion date: 2013-09-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus 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. Giving carboplatin together with everolimus and prednisone may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin together with everolimus and prednisone works in treating patients with metastatic prostate cancer that progressed after docetaxel.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the time to progression (TTP) achieved with carboplatin and everolimus in patients with castrate resistant metastatic prostate cancer that progressed after docetaxel-based chemotherapy.

Secondary

* To evaluate the safety of this regimen.
* To assess the PSA response rate in patients treated with this regimen.
* To evaluate the overall survival (OS) outcome in these patients.
* To investigate the association of TTP and PSA response rate with correlative markers, such as phospho mTOR, pAKT, and p70S6.
* To evaluate the pharmacokinetics of this regimen.
* To explore the association of TTP, OS, and circulating tumor tumor cell count.

OUTLINE: Patients receive carboplatin IV over 30-60 minutes on day 1, oral prednisone twice daily on days on days 1-21, and oral everolimus once daily on days 2-21 of course 1 and on days 1-21 of subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Blood and tumor tissue samples are collected periodically for pharmacodynamic, pharmacokinetic, and biomarker analysis.

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

Arms: arm 1: Carboplatin: AUC=4 by Calvert's formula (max dose 600 mg)\*IV over 30-60 min, Day 1 of a 21 day cycle

RAD 001: 5 mg Orally daily, starting from Day 2 continuously

Prednisone 5 mg Orally twice daily, continuously
Interventions: intervention 1: carboplatin intervention 2: RAD 001 intervention 3: prednisone intervention 4: laboratory biomarker analysis intervention 5: pharmacological study
Intervention descriptions: intervention 1: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle intervention 2: 5 mg orally starting on Day 2 then continuous intervention 3: 5 mg orally twice a day starting on Day 1 then continuous intervention 4: Samples will be collected from archival tissue. intervention 5: Samples will be collected Cycle 1, day 1, 2 \& 8 and Cycle 2, Day 1 \& 2

Protocol documents:
Clinical trial NCT01078389
Conditions: Joint Damage
Keywords: Gout Hyperuricemia Uric Acid Drug Therapy
Sponsor: Takeda
Start date: 2010-03-01; Completion date: 2013-09-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.

Detailed description:
Gout is caused by high levels of uric acid in the body, and is associated with a broad range of comorbidities including heart disease, chronic kidney disease and additional risk factors like obesity and high blood pressure. Hyperuricemia, which is defined as an elevation in serum urate levels, develops into gout when urate crystals form from supersaturated body fluids and settle in joints and other organs. Urate-lowering therapy is used to treat hyperuricemia in patients with gout.

Current treatments focus on initiating urate-lowering therapy in hyperuricemic gout patients who have experienced multiple acute gout flares within the past year. However, joint damage caused by crystal deposition may occur much earlier than previously considered. Monosodium urate crystals have been found present in the joints of people with hyperuricemia who do not have any symptoms. The presence of monosodium urate crystals would indicate that after the crystals form, they stay within the joint if serum urate levels are not reduced. Lowering uric acid levels and maintaining them may reduce acute gout flare episodes and possibly halt or reduce joint damage in patients with gout.

This study will evaluate the effect of febuxostat on joint damage in hyperuricemic patients with early gout. All patients will receive gout flare prophylaxis for the first 6 months of the study. Gout flares may also be treated throughout the study.

A variety of imaging techniques are in use to evaluate gout. Plain radiographs (x-rays), Magnetic Resonance Imaging (MRI) and Dual Energy Computed Tomography (DECT) will be utilized in this study. The modified Sharp/Van Der Heijde scoring method (named after Drs. Sharp and Van Der Heijde) for assessment of x-rays has been validated in patients with chronic gout and will be used in this study for evaluating erosion and joint space narrowing. Participants are expected to have 15 visits which will include plain radiographic examinations at 5 visits, 3 Magnetic Resonance Imaging (MRI) examinations and 3 DECT procedures at selected sites.

Arms: arm 1: Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months. arm 2: Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
Interventions: intervention 1: Febuxostat intervention 2: Placebo for Febuxostat
Intervention descriptions: intervention 1: Febuxostat capsules intervention 2: Febuxostat placebo-matching capsules

Protocol documents:
Clinical trial NCT01103245
Conditions: Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders
Keywords: Glucose Insulin
Sponsor: Vanderbilt University Medical Center
Start date: 2010-03-01; Completion date: 2013-09-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on glucose metabolism in humans.

Detailed description:
The purpose of this study is to determine the effects of mineralocorticoid receptor (MR) antagonism and renin inhibition on fasting blood glucose and glucose-stimulated insulin secretion in humans.

Arms: arm 1: Hydrochlorothiazide (HCTZ) 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg (ALI 150) daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 300mg ((ALI 300) for 1 month arm 2: HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25mg (SPL 25) daily for one month arm 3: HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 25 mg (SPL 25) daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 50 mg daily for one month arm 4: HCTZ 12.5mg daily for 1 month

then HCTZ 12.5mg daily plus Spironolactone 25 mg daily for 1 month

then HCTZ 12.5mg daily plus Aliskiren 150 mg daily and Spironolactone 25 mg daily for one month
Interventions: intervention 1: Hydrochlorothiazide (HCTZ) intervention 2: Aliskiren 150 mg (ALI 150) intervention 3: Spironolactone (SPL 25) intervention 4: Aliskiren 300 mg (ALI 300) intervention 5: Spironolactone 50 mg (SPL 50)
Intervention descriptions: intervention 1: HCTZ 12.5mg daily intervention 2: Aliskiren 150mg daily intervention 3: spironolactone 25mg daily intervention 4: Aliskiren 300mg daily intervention 5: Spironolactone 50 mg daily

Protocol documents:
Clinical trial NCT01177735
Conditions: Multiple Myeloma
Keywords: Pomalidomide multiple myeloma relapsed
Sponsor: University of Arkansas
Start date: 2011-10-01; Completion date: 2013-09-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide. Patient accrual is 30 over a 2 year period.

Primary objective:

* To determine progression-free survival (PFS) after initiation of pomalidomide therapy

Secondary objective:

* To determine the response rate (CR, n-CR, VGPR) and duration of response after pomalidomide therapy.
* To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation of daily pomalidomide dosing.
* To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation 3 concurrent days of exposure to lenalidomide.
* To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6 month examinations.

Detailed description:
Pomalidomide is a 2nd generation immunomodulatory agent (IMiD®) with greater efficacy than lenalidomide and with a similar toxicity spectrum. Phase I trials have shown that pomalidomide 1 to 5 mg is well-tolerated1,2.

TT3 has been remarkably successful in the management of newly diagnosed MM, inducing CR rates of \>60% and 4-year estimates of overall and event-free survival of 85% and 75%. Of those achieving CR, estimated 4-year CR rate is 85%. TT3 maintenance has been with either VTD in 2003-33 or VRD in 2006-66, so that pomalidomide's role in overcoming refractoriness to lenalidomide can be assessed.

Pharmacogenomic investigations comparing GEP data obtained at baseline and 48hr post-treatment have been performed in case of thalidomide, dexamethasone, lenalidomide, bortezomib and melphalan3. Thus, as most patients on TT3 had baseline and 48-hr GEP investigations performed after bortezomib, the opportunity exists to investigate, at the time of relapse, not only a re-challenge with bortezomib with 48hr GEP but also pomalidomide's effect.

This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide.

Arms: arm 1: None
Interventions: intervention 1: Pomalidomide
Intervention descriptions: intervention 1: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.

Protocol documents:
Clinical trial NCT01180894
Conditions: Trauma ICU Anemia
Keywords: Trauma Anemia Iron Erythropoeisis
Sponsor: Denver Health and Hospital Authority
Start date: 2011-06-01; Completion date: 2013-09-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical trial is to determine whether intravenous iron supplementation of anemic, critically ill trauma patients improves anemia and reduces the need for a red blood cell transfusion.

Detailed description:
Nearly all trauma patients admitted to an intensive care unit (ICU) are anemic (low red blood cell counts). Anemia is an independent risk factor for poor outcomes, including infection, impaired wound healing, and death. Current therapies for ICU anemia are unsatisfactory: Red blood cell (RBC) transfusion is associated with an increased risk of immune suppression, infection, and organ failure. Furthermore, use of both hemoglobin replacement products and erythropoietin are limited by expense as well as unfavorable side effect profiles.

One principal cause of anemia in trauma ICU patients involves disturbances in iron metabolism. Iron is necessary to make RBCs, and a lack of iron delivered to the bone marrow results in anemia. Trauma causes diversion of iron from the bone marrow into storage, where it cannot participate in the generation of RBCs. This diversion of iron is caused by inflammatory proteins released as a result of tissue injury.

Previous work by the principal investigator among ICU patients suggested a benefit to oral iron supplementation administered in dosages similar to those used in a standard multivitamin. However, many patients were not able to tolerate oral medications, and this study was not specific to trauma patients. Additional research has suggested that intravenous iron supplementation is effective in treating anemic patients with other inflammatory conditions, such as cancer and inflammatory bowel disease. However, the benefit of intravenous iron supplementation has never been tested among anemic ICU patients, including trauma patients.

The current clinical trial will evaluate the risk/benefit profile of intravenous iron supplementation among anemic trauma ICU patients. The study will take place over several academic trauma centers with a long history of participation in translational research.

Anemia remains a devastating complication of trauma. Current treatment options are limited. Intravenous iron supplementation represents a targeted, cost-effective solution to this pervasive problem, the efficacy of which remains undefined.

Arms: arm 1: 100 mg IV TIW arm 2: Pacebo - Normal Saline
Interventions: intervention 1: Iron sucrose intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg IV TIW intervention 2: None

Protocol documents:
Clinical trial NCT01230710
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2013-09-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: Participants received erlotinib 150 mg orally once a day for 48 weeks.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: Erlotinib was supplied as tablets.

Protocol documents:
Clinical trial NCT01241240
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2011-03-01; Completion date: 2013-09-01
Enrollment: 192 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. arm 2: Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Interventions: intervention 1: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy) intervention 2: Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Intervention descriptions: intervention 1: One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks. intervention 2: One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.

Protocol documents: