ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00597493
Conditions: Recurrent Glioblastoma Multiforme
Keywords: Recurrent Glioblastoma Multiforme GBM Glioblastoma Sorafenib Temozolomide Brain Tumor Recurrent GBM Temodar Gliosarcoma Glioma Nexavar
Sponsor: Duke University
Start date: 2007-09-01; Completion date: 2010-12-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
PURPOSE AND OBJECTIVES:

Primary Objective To evaluate the activity of Sorafenib plus protracted, daily temozolomide in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month PFS.

Secondary Objectives To evaluate the safety and toxicity of combination therapy using Sorafenib plus temozolomide; To determine the pharmacokinetics of Sorafenib when combined with temozolomide in patients on and not on concurrent EIAC medications.

Detailed description:
STUDY ACTIVITIES AND POPULATION GROUP:

This is an open-label, non-randomized, single center phase 2 trial. A treatment cycle will consist of 4 weeks of therapy.

Sorafenib will be administered at a set dose of 400 mg (2 x 200 mg tablets) twice daily, without food (at least 1 hour before or 2 hours after eating). Temozolomide will be administered at a set dose of 50 mg/m2 once daily without food (at least 1 hour before or 2 hours after eating).

Thirty-two (32) patients will be enrolled in this single-stage study.

DATA ANALYSIS AND RISK/SAFETY ISSUES:

After 16 patients with recurrent GBM are treated, an interim analysis will be conducted. If 6 or more patients have experienced unacceptable toxicity, accrual of patients in this patient group will be terminated. Otherwise, patient accrual will continue. If 9 or more of the total 32 patients experience unacceptable toxicity, the treatment regimen will be considered to have an unacceptable toxicity profile. The type I and II error rates associated with this testing are 0.053 and 0.053, respectively.

Arms: arm 1: Subjects receive 400mg of Sorafenib twice daily and 50mg/m\^2 of Temozolomide once daily

Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changes in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure
Interventions: intervention 1: Sorafenib and Temozolomide
Intervention descriptions: intervention 1: Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).

Protocol documents:
Clinical trial NCT00598585
Conditions: Chronic Fatigue Syndrome
Sponsor: Charles Drew University of Medicine and Science
Start date: 2002-07-01; Completion date: 2010-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)

Detailed description:
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.

Arms: arm 1: sidenafil arm 2: placebo
Interventions: intervention 1: Sildenafil (Viagra) intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation. intervention 2: Placebo pills 3X/day for 6 weeks

Protocol documents:
Clinical trial NCT00604565
Conditions: End Stage Renal Disease (ESRD)
Keywords: Hemodialysis
Sponsor: Charles Drew University of Medicine and Science
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In maintenance hemodialysis patients, regular administration of parenteral iron by addition of soluble ferric pyrophosphate (SFP) to the dialysate, when compared to conventional dialysate, is effective in preventing the development of iron deficiency, thereby maintaining hemoglobin level; is clinically safe and does not lead to oxidative stress or inflammation.

Detailed description:

Arms: arm 1: dialysate with added soluble ferric pyrophosphate (SFP) arm 2: standard dialysate without soluble ferric pyrophosphate (SFP)
Interventions: intervention 1: soluble ferric pyrophosphate (SFP) intervention 2: placebo
Intervention descriptions: intervention 1: Subjects will be randomized to undergo dialysis with either Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL).

Control concentrate lacking SFP (C-HD) does not contain SFP (total iron = 0) intervention 2: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)

Protocol documents:
Clinical trial NCT00605267
Conditions: Breast Cancer
Keywords: Breast Cancer Breast Neoplasms Tumors or cancer of the human BREAST Tumor or cancer of the human MAMMARY GLAND
Sponsor: AstraZeneca
Start date: 2007-10-01; Completion date: 2010-12-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

Detailed description:

Arms: arm 1: Tamoxifen arm 2: Anastrazole (Arimidex)
Interventions: intervention 1: Tamoxifen intervention 2: Anastrazole (Arimidex) intervention 3: Goserelin acetate (Zoladex)
Intervention descriptions: intervention 1: 20 mg once daily oral dose intervention 2: 1 mg once daily oral dose intervention 3: 3.6mg/month depot injection

Protocol documents:
Clinical trial NCT00606021
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed plus best supportive care with best supportive care alone as maintenance therapy following first-line treatment with a pemetrexed-cisplatin combination in patients with advanced non-squamous non-small cell lung cancer.

A total of approximately 100 patients are planned to be enrolled, and following completion of four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive care alone).

Detailed description:

Arms: arm 1: Pemetrexed: 500 milligrams per square meter (mg/m²) , intravenous (IV), Day 1 of each 21-day cycle for 6 cycles

Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician. arm 2: Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Interventions: intervention 1: pemetrexed intervention 2: Best Supportive Care
Intervention descriptions: intervention 1: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles intervention 2: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.

Protocol documents:
Clinical trial NCT00613366
Conditions: Contraception
Keywords: intrauterine device cervical dilation nulliparous women pain management
Sponsor: Oregon Health and Science University
Start date: 2007-06-01; Completion date: 2010-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an intrauterine device for contraception reduces pain in women who have never delivered a baby.

Detailed description:
The investigators intend to conduct a randomized double blind study at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette.

Subjects will be approached only after deciding to get an intrauterine. When the participants return for intrauterine device placement, at 90 minutes prior to the procedure half will receive misoprostol and half will receive placebo. The subjects will be asked to rate their level of pain at specific points during the insertion. Providers will be asked to mark whether or not additional dilation was required as well as their perceived ease of intrauterine device placement.

Arms: arm 1: Cervical preparation with misoprostol prior to intrauterine device insertion arm 2: Cervical preparation with placebo prior to intrauterine device insertion
Interventions: intervention 1: Misoprostol intervention 2: Magnesium Oxide
Intervention descriptions: intervention 1: Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes. intervention 2: Place 2 tablets between the teeth and cheek and allow to dissolve for 30 minutes.

Protocol documents:
Clinical trial NCT00620555
Conditions: Epilepsies, Partial
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-05-01; Completion date: 2010-12-01
Enrollment: 65 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: gabapentin
Intervention descriptions: intervention 1: Orally administered gabapentin

Protocol documents:
Clinical trial NCT00622284
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2008-02-01; Completion date: 2010-12-01
Enrollment: 1560 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5.0 mg daily) compared to glimepiride given for 104 weeks as add-on therapy to preferably \> 1500 mg metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control

Detailed description:

Arms: arm 1: patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride arm 2: patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)
Interventions: intervention 1: Placebo identical to BI 1356 5mg intervention 2: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg intervention 3: BI 1356 intervention 4: Glimepiride
Intervention descriptions: intervention 1: Placebo tablet once daily intervention 2: Placebo tablets once daily intervention 3: 5mg, once daily in the morning for 104 weeks intervention 4: 1mg or 2mg or 3mg or 4mg in the morning for 104 weeks

Protocol documents:
Clinical trial NCT00622427
Conditions: ADHD With Sleep Onset Insomnia
Sponsor: University of Alabama at Birmingham
Start date: 2008-02-01; Completion date: 2010-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Primary: We hypothesize a clinically significant improvement in sleep latency, sleep-onset and total sleep time measures in adults with ADHD when given a trial of Ramelteon compared to placebo. Secondary:We expect that Ramelteon will show statistically significant improvements vs. placebo in measures of daytime sleepiness and with no decrement in daytime functioning, including such specific items as focus and social and occupational functioning.

Detailed description:
Method: 8-week, randomized, double-blind, placebo-controlled crossover trial of Ramelteon in adult ADHD subjects who suffer from initial insomnia.

Arms: arm 1: 8 mg tablets every night for 2 weeks, then a 2 week washout,then crossover to placebo tablets for 2 weeks. arm 2: placebo tablets for every night for 2 weeks, then a 2 week washout, followed by 8 mg tablets every night for 2 weeks.
Interventions: intervention 1: Ramelteon intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg tablets every night for 2 weeks intervention 2: placebo tablets for every night for 2 weeks

Protocol documents:
Clinical trial NCT00661388
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-08-01; Completion date: 2010-12-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Eligible participants will be administered C.E.R.A subcutaneously, every 4 weeks for 44 weeks. The initial dose of C.E.R.A. will be 1.2 micrograms/kilogram. Subsequent doses will be adjusted to maintain the individual participant's hemoglobin within the target range of 10.0 and 12.0 grams/deciliter.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: sc every month (starting dose 1.2 micrograms/kg)

Protocol documents:
Clinical trial NCT00667589
Conditions: Hand-foot Skin Reaction Rash
Keywords: sorafenib rash hand foot skin reaction
Sponsor: Northwestern University
Start date: 2008-06-01; Completion date: 2010-12-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate treatments for a rash caused by sorafenib.

Detailed description:
This study will compare compare the effectiveness of four creams (urea 40% cream, fluocinonide 0.05% cream, tazarotene 0.1% cream, and Udderly smooth® Udder Cream) in treating hand-foot skin reaction (HFSR), a rash caused by sorafenib.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: urea 40% cream intervention 2: fluocinonide 0.05% cream intervention 3: tazarotene 0.1% cream intervention 4: bland emollient cream (Udderly smooth® Udder Cream)
Intervention descriptions: intervention 1: urea 40% cream applied twice per day to affected areas intervention 2: fluocinonide 0.05% cream applied twice per day to affected areas intervention 3: tazarotene 0.1% cream applied twice per day to affected areas intervention 4: bland emollient cream applied twice per day to affected areas

Protocol documents:
Clinical trial NCT00672854
Conditions: Parenteral Nutrition
Keywords: parenteral nutrition lipid emulsion nosocomial infection mortality endothelial function inflammatory markers oxidative stress immune function autonomic nervous system insulin sensitivity carbohydrate metabolism
Sponsor: Emory University
Start date: 2008-11-01; Completion date: 2010-12-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions.

Detailed description:
This study compares the effect of a soybean oil-based versus an olive oil-based lipid emulsion in healthy volunteers and in critically ill patients. In healthy volunteers, your blood sugar levels, blood vessel function, and your ability to fight infections will be examined. In ICU patients, we examines whether use of the olive oil-based lipid emulsion may decrease the risk of infection and hospital complications.

Arms: arm 1: Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based) arm 2: Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based)
Interventions: intervention 1: ClinOleic 20% Intravenous Emulsion intervention 2: Intralipid, 20% Intravenous Emulsion
Intervention descriptions: intervention 1: ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake. intervention 2: It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection

Protocol documents:
Clinical trial NCT00676897
Conditions: Septic Shock
Keywords: statin, sepsis, septic shock, simvastatin
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2008-02-01; Completion date: 2010-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Simvastatin will attenutat IL-6 levels and lead to a more rapid shock reversal than placebo

Detailed description:

Arms: arm 1: Simvastatin 40 mg PO or NGT arm 2: Placebo
Interventions: intervention 1: Simvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Simvastatin 40mg PO or NGT intervention 2: Corn Starch

Protocol documents:
Clinical trial NCT00686517
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2003-12-01; Completion date: 2010-12-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

Detailed description:

Arms: arm 1: pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks arm 2: pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks arm 3: pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks
Interventions: intervention 1: Pegylated interferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: 1.5 ug/kg/week SC for 12 or 24 weeks intervention 2: Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Protocol documents:
Clinical trial NCT00686777
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-01-01; Completion date: 2010-12-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.

Detailed description:

Arms: arm 1: Pegylated Interferon alfa-2b was administered to participants at 1.5 μg/kg subcutaneously once weekly for 48 weeks. Ribavirin was administered orally every day after morning and evening meals for 48 weeks at 400 mg/day.
Interventions: intervention 1: Pegylated Interferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: Pegylated Interferon alfa-2b 1.5 ug/kg SC once weekly for 48 weeks intervention 2: Ribavirin 400 mg/day orally

Protocol documents:
Clinical trial NCT00695188
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis MTX polyglutamates clinical outcome
Sponsor: Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
Start date: 2008-05-01; Completion date: 2010-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective is to determine whether erythrocyte polyglutamate levels are associated with objective clinical response in patients with rheumatoid arthritis after oral administration of low-dose methotrexate.The secondary aim of this study is to compare the efficacy and safety of standard dose methotrexate versus a higher starting dose.

Detailed description:
The folate antagonist methotrexate (MTX) is currently one of the most widely used drugs for the treatment of rheumatoid arthritis (RA).Although MTX is very effective and well tolerated, the major drawback is the large interpatient variability in the clinical response.MTX is intracellularly converted by folylpolyglutamate synthetase (FPGS) to methotrexate polyglutamates (MTXPGs), which enhance the intracellular retention of MTX. Furthermore, the γ-linked sequential addition of glutamic acid residues inhibits finals steps in the de novo purine and pyrimidine biosynthesis, resulting in anti-proliferative and anti-inflammatory effects.76 adult, MTX-naive patients who fulfill the American College of Rheumatology criteria (ACR) for RA with a Disease Activity Score in 28 joints (DAS-28) \> 3.2 are enrolled at two sites in Vienna (Austria).Clinical status is assessed by the number of joint counts and the Health Assessment Questionnaire (HAQ).Patients are randomly assigned to receive either a standard dose or a higher starting dose of 25 mg orally. In week 5, a subcutaneous dose of 25 mg is administered to each patient to get a reference level (bioavailability of 100%).The patients participate for 16 weeks, in which blood samples are collected at weeks 1, 2, 5, 6, 10 and 11 to perform pharmacokinetic analyses and metabolite measurements.The determination of erythrocyte MTXPG-levels is performed by using a HPLC technique.The primary outcome is the objective clinical response (measured in a rheumatic score, DAS-28), secondary outcome parameters are quality of life and routine laboratory parameters used in rheumatology. This clinical outcome will be correlated with MTX pharmacokinetics in blood, MTXPG kinetics in erythrocytes, and their impact on the folate pathway.

Arms: arm 1: Escalating dose arm 2: 25 mg
Interventions: intervention 1: methotrexate intervention 2: methotrexate
Intervention descriptions: intervention 1: oral administration Escalating dose (15, 20, 25 mg) intervention 2: 25 mg oral administration

Protocol documents: