ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00683046
Conditions: Acute Myelogenous Leukemia Lymphoid Leukemia Chronic Myelogenous Leukemia Malignant Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Myeloproliferative Disorder Anemia, Aplastic Myelodysplastic Syndromes
Keywords: Relapsed or refractory acute myelogenous or lymphoid leukemia. Acute myeloid or lymphocytic leukemia in first remission at high-risk for recurrence.Chronic myelogenous leukemia in accelerated phase or blast-crisis. Chronic myelogenous leukemia in chronic phase Chronic myelogenous leukemia in accelerated phase or blast-crisis Recurrent or refractory malignant lymphoma or Hodgkin's disease. Chronic lymphocytic leukemia, relapsed or with poor prognostic features. Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. Severe aplastic anemia after failure of immunosuppressive therapy. Myelodysplastic syndromes (including PNH) Multiple myeloma at high risk for disease recurrence.
Sponsor: University of Chicago
Start date: 2001-11-01; Completion date: 2014-12-01
Enrollment: 204 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

1. To evaluate disease free survival after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.
2. To evaluate the incidence and severity of acute and chronic GVHD after Campath 1H-based in vivo T-cell depletion, in patients with hematologic malignancies undergoing non-myelo-ablative stem cell transplantation.
3. To evaluate engraftment and chimerism after Campath 1H-based in vivo T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Fludarabine intervention 2: Melphalan intervention 3: Stem cells intervention 4: Campath
Intervention descriptions: intervention 1: Fludarabine 30 mg/m2 intravenously daily at the same time over 30 minutes on days -7,-6,-5,4,-3,. intervention 2: Melphalan 140 mg/m2 IV on day -2. intervention 3: Stem cell infusion on day 0. intervention 4: Campath, 20 mg IV on day -7, 6, -5, -4, and -3.

Protocol documents:
Clinical trial NCT00755079
Conditions: Spinal Cord Injury
Keywords: spinal cord injury beta-2 agonist respiratory muscle strength pulmonary function test
Sponsor: US Department of Veterans Affairs
Start date: 2007-04-01; Completion date: 2014-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.

Detailed description:

Arms: arm 1: group of persons with spinal cord injury will receive blinded placebo capsule arm 2: group of persons with spinal cord injury will receive blinded beta-2 adrenergic agonist capsule
Interventions: intervention 1: extended release beta-2 adrenergic agonist intervention 2: placebo
Intervention descriptions: intervention 1: Albuterol extended release belongs to a class of drugs known as bronchodilators. It works in the airways by opening breathing passages and relaxing muscles. intervention 2: An ambiguous sheathing capsule will be placed over a lactose placebo pill. The placebo will have no effect on pulmonary function.

Protocol documents:
Clinical trial NCT00771901
Conditions: Insulin Resistance Diabetes Obesity
Keywords: obesity insulin resistance type II diabetes
Sponsor: Washington University School of Medicine
Start date: 2008-02-01; Completion date: 2014-12-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Normally, the hormone insulin works to help keep blood sugar normal. However, as a person gains weight, insulin does not work as well and blood sugar tends to be a little higher than normal. This is called "insulin resistance".

Two investigational drugs (not approved by the Food and Drug Administration) for the treatment of high lipid levels or insulin resistance are being examined in this study: one drug is called tauroursodeoxycholic acid (TUDCA), the other is called sodium phenylbutyrate (PBA). This study is designed to test if TUDCA and/or PBA is effective in people who are obese with insulin resistance and high lipids. We hypothesize that pharmacologically-induced decreases in ER stress will improve insulin action and hepatic lipid metabolism in obese subjects.

Detailed description:
A 4-week randomized, controlled trial will be conducted to evaluate the following specific aims in obese subjects:

Determine the effect of treatment with TUDCA or PBA on:

1. Body fat distribution: a) intrahepatic triglyceride (IHTG) content, b) intramyocellular triglyceride (IMTG) content, and c) intra-abdominal fat content, assessed by using magnetic resonance spectroscopy and magnetic resonance imaging.
2. In vivo insulin sensitivity in adipose tissue (suppression of lipolysis), liver (suppression of glucose production), and skeletal muscle (stimulation of glucose uptake), assessed by using the hyperinsulinemic-euglycemic clamp procedure in conjunction with stable isotope tracer infusion.
3. VLDL-triglyceride (TG) and VLDL-apolipoprotein-B100 (apoB-100) secretion rates, assessed by stable isotopically labeled tracer infusion methods.
4. Skeletal muscle intracellular insulin signaling, fatty acid oxidation, and markers of inflammation, assessed by evaluating skeletal muscle biopsies ex vivo.
5. Adipose tissue insulin signaling, ER stress, and inflammation, assessed by evaluating adipose tissue biopsies ex vivo.

Arms: arm 1: Subjects will be given a placebo rather than tauroursodeoxycholic acid. arm 2: Subjects will receive tauroursodeoxycholic acid for four weeks. arm 3: Subjects will receive sodium phenylbutyrate for four weeks.
Interventions: intervention 1: tauroursodeoxycholic acid intervention 2: placebo intervention 3: sodium phenylbutyrate
Intervention descriptions: intervention 1: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner. intervention 2: 7 pills daily for 4 weeks intervention 3: 20g/day for four weeks.

Protocol documents:
Clinical trial NCT00771953
Conditions: Lung Cancer Non Small Cell Lung Cancer
Keywords: apricoxib docetaxel pemetrexed Stage IIIb or Stage IV
Sponsor: University of Maryland, Baltimore
Start date: 2008-11-01; Completion date: 2014-12-01
Enrollment: 109 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine the anti-tumor activity of the combination of apricoxib + either docetaxel (AP/DC) or pemetrexed (AP/PE) compared with placebo + either docetaxel (P/DC) or pemetrexed (P/PE) as measured by progression free survival in patients with Stage IIIb (pleural effusion)or Stage IV non-small cell lung cancer (NSCLC).

Detailed description:
Patients diagnosed with advanced non-small cell lung cancer that has not responded to platinum-based chemotherapy are eligible to particvpate in this study.

Current standard treatments for this type of lung cancer are generally not effective in preventing the cancer from growing. The purpose of this study is to see if adding the drug apricoxib to standard chemotherapy is effective in treting NSCLC. Apricoxib is an investigational drug. Investigational means that it is not approved by the Food and Drug Administration (FDA). Laboratory studies suggest that apricoxib may be useful in the treatment of cancer . This is seen particularly when it is combined with chemotherapy drugs. However, this has not been proven in humans.

Laboratory evidence indicates that apricoxib may benefit patients whose disease over-produces a substance called COX-2. COX-2 can be detected in the urine as a substance called PGE-M (prostaglandin E metabolite). It is thought that patients who have a PGE-M level in the urine that decreases by at least half after taking apricoxib may benefit more than patients whose urine PGE-M decreases by less than half after apricoxib.

This study evaluated whether adding apricoxib to standard chemotherapy treatment will improve outcomes in patients with non-small cell lung cancer whose urine PGE-M decreases at least 50% after taking apricoxib. Apricoxib or placebo was added to either docetaxel or pemetrexed treatment.

Arms: arm 1: Apricoxib 400mg once a day arm 2: Placebo once a day
Interventions: intervention 1: apricoxib intervention 2: Placebo intervention 3: Docetaxel or Pemetrexed
Intervention descriptions: intervention 1: Oral apricoxib tablets will be provided as white or off-white film-coated tablets available in 100mg strength to be taken every day intervention 2: Oral placebo tablets will be provided as white or off-white film-coated tablets to be taken every day intervention 3: Docetaxel 75mg/m2 or Pemetrexed 500mg/m2 given as an IV infusion every 21 days. TheTreating physician will determine chemotherapy drug as per his usual practice.

Protocol documents:
Clinical trial NCT00791648
Conditions: Acute Kidney Injury Post-Operative Delirium Icu Delirium Acute Renal Failure Delirium
Keywords: aki delirium statin short-term cardiac
Sponsor: Vanderbilt University Medical Center
Start date: 2009-07-01; Completion date: 2014-12-01
Enrollment: 653 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim1a: Statin naive patient's scheduled for cardiac surgery will be randomized to 80mg atorvastatin or placebo on the day prior to surgery and then 40mg daily thereafter until hospital discharge to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Aim1b: Patients using statins preoperatively will be randomized to atorvastatin 80mg or placebo on day of surgery and 40mg or placebo on postop day 1 with resumption of preoperative statin therapy on postop day 2 to test the hypothesis that short-term atorvastatin use decreases:

1. acute kidney injury following cardiac surgery.
2. postoperative delirium following cardiac surgery.

Endpoints include glomerular filtration, urine and plasma markers of renal dysfunction, markers of oxidative stress, mitochondrial function, systemic inflammatory markers, delirium, dialysis, stroke, myocardial infarction, time to extubation, ICU length of stay, and death.

Detailed description:

Arms: arm 1: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1. arm 2: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.

Aim 2 control: placebo the day of cardiac surgery and postop day 1.
Interventions: intervention 1: atorvastatin intervention 2: placebo
Intervention descriptions: intervention 1: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.

Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1. intervention 2: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.

Aim 2 control: placebo the day of cardiac surgery and postop day 1.

Protocol documents:
Clinical trial NCT00815516
Conditions: Candidiasis
Keywords: candidiasis candida Neonate candidemia Micafungin Mycamine amphotericin B deoxycholate
Sponsor: Astellas Pharma Global Development, Inc.
Start date: 2013-02-01; Completion date: 2014-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.

Detailed description:
Neonates and young infants will be stratified by estimated gestational age and by world region

Arms: arm 1: Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination. arm 2: Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
Interventions: intervention 1: micafungin intervention 2: amphotericin B deoxycholate
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Administered by intravenous infusion

Protocol documents:
Clinical trial NCT00831480
Conditions: Kidney Cancer
Keywords: Renal cell carcinoma Everolimus Neoadjuvant advanced kidney cancer
Sponsor: Linda C. Higgins
Start date: 2011-04-01; Completion date: 2014-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma - RCC).

Since 2002, Everolimus has been studied in more than 2500 patients with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Various studies, in animals such as in mice with cancer and in humans with cancer have shown that Everolimus can slow the growth of cancer.

Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed at the same dose.

Detailed description:
Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell carcinoma. Following initial kidney tumor biopsy, everolimus is administered for 3-5 weeks before cytoreductive nephrectomy and everolimus is then resumed and continued until tumor progression or intolerable toxicities. Any correlation of tumor tissue biomarker changes from initial biopsy to nephrectomy specimen with long-term progression-free survival will be determined. This trial may enable the identification of factors predictive of significant benefit from everolimus administered as first-line therapy by employing the neoadjuvant therapy paradigm.

Arms: arm 1: All subjects will take everolimus
Interventions: intervention 1: everolimus
Intervention descriptions: intervention 1: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.

Protocol documents:
Clinical trial NCT00844714
Conditions: Endothelial Function Rheumatoid Arthritis Inflammation
Keywords: endothelial function rheumatoid arthritis cardiovascular risk rituxan therapy
Sponsor: University of California, San Francisco
Start date: 2009-11-01; Completion date: 2014-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this investigation is to determine the effects of Rituxan therapy in individuals with rheumatoid arthritis on endothelial function and other markers of endothelial function

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Rituxan
Intervention descriptions: intervention 1: 1000mg rituxan by intravenous infusion will be given on day 1 and day 15 of the study

Protocol documents:
Clinical trial NCT00856375
Conditions: Colorectal Cancer
Keywords: colorectal cancer Colorectal cancer, second line
Sponsor: Nektar Therapeutics
Start date: 2008-12-01; Completion date: 2014-12-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.

Detailed description:
NKTR-102 (Topoisomerase I Inhibitor Polymer Conjugate) is a polyethylene glycol (PEG) conjugate of irinotecan. Irinotecan is a topoisomerase I inhibitor approved worldwide. In the US, irinotecan is indicated as a component of first-line therapy in combination with 5 fluorouracil (5 FU) and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Second-line therapy for colorectal cancer typically involves cetuximab and irinotecan. However, growing evidence indicates that cetuximab (or other EGFR inhibitors) is not appropriate therapy for patients with mutant KRAS. For these patients, irinotecan may be appropriate as a single agent, and a new therapy that could improve upon efficacy and safety would provide an important option for the treatment of advanced colorectal cancer.

Arms: arm 1: NKTR-102 IV every 3 weeks arm 2: irinotecan IV every 3 weeks
Interventions: intervention 1: NKTR-102 intervention 2: irinotecan
Intervention descriptions: intervention 1: IV every 3 weeks intervention 2: IV every 3 weeks

Protocol documents:
Clinical trial NCT00883779
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-04-01; Completion date: 2014-12-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Platinum chemotherapy (cisplatin or carboplatin) intervention 3: erlotinib [Tarceva] intervention 4: gemcitabine
Intervention descriptions: intervention 1: po on days 15-28 of each 4 week cycle until disease progression intervention 2: cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles intervention 3: 150mg po on days 15-28 of each 4 week cycle until disease progression intervention 4: 1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles

Protocol documents:
Clinical trial NCT00891046
Conditions: Systemic Juvenile Idiopathic Arthritis
Keywords: Flare arthritis IL-1beta antagonist systemic juvenile idiopathic arthritis CHAQ steroids ACR pediatric response Systemic juvenile idiopathic arthritis with active flare
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2014-12-01
Enrollment: 270 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Detailed description:

Arms: arm 1: Canakinumab
Interventions: intervention 1: Canakinumab
Intervention descriptions: intervention 1: Canakinumab

Protocol documents:
Clinical trial NCT00943306
Conditions: Familial Hypercholesterolemia
Keywords: Homozygous Familial Hypercholesterolemia MTP Apheresis lomitapide Homozygous Familial Hypercholesterolemia (HoFH)
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2009-10-29; Completion date: 2014-12-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a long term follow on study to assess the continued long term safety and efficacy of lomitapide in patients with homozygous familial hypercholesterolemia.

Detailed description:
This was a phase III open label clinical trial to evaluate the long-term efficacy and safety of lomitapide at the maximum tolerated dose (for each patient) established during the clinical trial 733-005/UP1002. Subjects completing the 78-week treatment period in study 733-005/UP1002 who have not met any of the stopping criteria will be eligible to participate in 733-012. The treatment period continued until a decision was made by the local competent authority regarding marketing authorization. Lomitapide will be given orally once daily. Patient specific doses will be carried forward from 733-005/UP1002, but will not exceed the maximum tolerated dose the patient received during 733-005 /UP1002. The maximum dose for any patient was 80 mg/day. There was no reference therapy in this trial. The effects of the study drug were compared to baseline data (from 733-005/UP1002). Concomitant lipid-lowering therapy including plasmapheresis or LDL apheresis is permitted.

Note that hereafter, Week 0 in Study 733-005/UP1002 will be referred to as Baseline and Week 48 in Study AEGR-733-012 will be referred to as Week 126 (of overall treatment).

Arms: arm 1: Maximum tolerated dose of lomitapide in addition to existing lipid lowering therapy including plasmapheresis or lipid apheresis.
Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: 5-60 mg po every day

Protocol documents: