ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01643772
Conditions: Pain
Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Start date: 2011-05-01; Completion date: 2012-07-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A Single Dose PK Study of OxyNorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose PK Study of OxyNorm® immediate-release capsules 10mg in Chinese patients with pain.It will be a single center, open label, randomized, oral administration study.

Detailed description:
Single dose: The subjects will be randomized to receive a single dose of OxyNorm® immediate-release capsules 5, 10, and 20mg.

Multiple dose: The subjects will take 3 days OxyNorm® capsule 10mg, once every 6 hours, 10mg per dose. In the morning of the 4th day, the subjects will take single dose of OxyNorm® capsule 10mg. On the 5th day, all the subjects complete the study.

Arms: arm 1: Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting arm 2: Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting arm 3: Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting arm 4: Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning
Interventions: intervention 1: Oxycodone hydrochloride
Intervention descriptions: intervention 1: The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.

Protocol documents:
Clinical trial NCT01675622
Conditions: Cancer
Keywords: Cancer Pain
Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Start date: 2011-01-01; Completion date: 2012-07-01
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.

Detailed description:
To compare the efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Oxycodone intervention 2: Morphine
Intervention descriptions: intervention 1: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days intervention 2: Morphine tablets 10mg and 20mg, oral every 4-6 hours

Protocol documents:
Clinical trial NCT01675635
Conditions: Postoperative Pain
Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Start date: 2011-07-01; Completion date: 2012-07-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy and safety of oxycodone capsules compared with morphine tablets in hospitalized patients with moderate to severe pain following surgery.

Detailed description:
To evaluate the efficacy and safety of oxycodone immediate-release capsules compared with morphine immediate-release tablets in hospitalized patients with moderate to severe pain following surgery.

Arms: arm 1: To determine the efficacy and safety of OxyNorm Capsules. arm 2: To determine the efficacy and safety of Morphine tablet.
Interventions: intervention 1: OxyNorm Capsules intervention 2: Morphine tablet
Intervention descriptions: intervention 1: dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours intervention 2: dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.

Protocol documents:
Clinical trial NCT01981616
Conditions: Inflammatory Bowel Disease
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the rates of seroconversion to a hepatitis B vaccine series after a single 750 mg intravenous (IV) dose of vedolizumab or placebo. Secondary objectives are to determine the rates of seroconversion to an oral cholera vaccine series, assess change in anti-hepatitis B surface antibodies and assess the safety and tolerability of a single 750-mg IV dose of vedolizumab.

Detailed description:

Arms: arm 1: Vedolizumab 750 mg, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18. arm 2: Vedolizumab placebo-matching, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
Interventions: intervention 1: Vedolizumab intervention 2: Placebo intervention 3: Hepatitis B vaccine intervention 4: Oral cholera vaccine
Intervention descriptions: intervention 1: Vedolizumab for intravenous infusion intervention 2: Placebo intravenous infusion intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01998906
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2002-05-01; Completion date: 2012-07-01
Enrollment: 330 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.

Detailed description:

Arms: arm 1: Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m\^2), IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m\^2, IV; methotrexate 40 mg/m\^2, IV; and 5-fluorouracil 600 mg/m\^2, IV, on Day 1 of Cycles 8 through 10. arm 2: Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. arm 3: Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m\^2, IV, and paclitaxel 150 mg/m\^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m\^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.
Interventions: intervention 1: Trastuzumab intervention 2: Doxorubicin intervention 3: Paclitaxel intervention 4: CMF
Intervention descriptions: intervention 1: 8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17 intervention 2: 60 mg/m2 IV on Day 1 of Cycles 1 through 3 intervention 3: 150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7 intervention 4: CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10

Protocol documents:
Clinical trial NCT02024867
Conditions: Skin Disease, Bacterial Abscess
Keywords: Methicillin resistent Staphylococcus aureus Staphylococcus aureus
Sponsor: Lucy Holmes, MD
Start date: 2010-02-01; Completion date: 2012-07-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

Detailed description:
Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to assess for cure. Patients were contacted 1 month later to determine if they had developed another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).

Arms: arm 1: Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day arm 2: Oral Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
Interventions: intervention 1: Trimethoprim-Sulfamethoxazole
Intervention descriptions: intervention 1: 3 versus 10 days of drug

Protocol documents:
Clinical trial NCT02168387
Conditions: Atelectasis
Keywords: atelectasis continuous high frequency oscillator acetylcysteine dornase alfa
Sponsor: Duke University
Start date: 2010-12-01; Completion date: 2012-07-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (CHFO) is more successful at removing mucus than medications that thin out the mucus.

Detailed description:
Both of these therapies (CHFO and medication) are currently used in the Pediatric Intensive Care Unit and Pediatric Cardiac Intensive Care Unit. This research study is being done because the investigator is trying to learn if the mechanical removal of mucus with CHFO will effectively re-inflate the collapsed area of lung. Specifically, the study team will determine if CHFO can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood.

One of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine).

Thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the CHFO as compared with medications that thin out the mucus. CHFO and all the medications used in this study are part of the standard of care for atelectesis. However, there is no information on which combination works best and no one agrees that one approach is more effective than another. Usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.

Arms: arm 1: Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. arm 2: Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
Interventions: intervention 1: continuous high frequency oscillator (CHFO) intervention 2: Acetylcysteine intervention 3: dornase alfa
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02810873
Conditions: Breast Carcinoma
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2008-09-01; Completion date: 2012-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.

Detailed description:
OBJECTIVES:

I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.

II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).

III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.

OUTLINE: This is a dose-finding 2-stage study.

STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.

STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.

Arms: arm 1: STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan. arm 2: STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
Interventions: intervention 1: Positron Emission Mammography intervention 2: Positron Emission Tomography intervention 3: Fludeoxyglucose F-18 intervention 4: Copper Cu 64 TP3805
Intervention descriptions: intervention 1: Undergo PEM Positron Emission Mammography scan intervention 2: Undergo PET Positron Emission Tomography scan intervention 3: Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan intervention 4: Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan

Protocol documents:
Clinical trial NCT01334918
Conditions: Coronary Artery Disease (CAD)
Keywords: pharmacologic stress Coronary Artery Disease (CAD) regadenoson ischemia
Sponsor: Astellas Pharma Inc
Start date: 2011-04-26; Completion date: 2012-07-02
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare Multidetector Computed Tomography (MDCT) and Single Photon Emission Computed Tomography (SPECT) stress myocardial perfusion imaging (MPI) with regadenoson in order to detect the presence or absence of reversible defects.

Detailed description:
All participants will be randomized to one of two imaging sequences: rest/stress SPECT on Day 1 followed by stress/rest MDCT on Day 2 or stress/rest MDCT on Day 1 followed by rest/stress SPECT on Day 2. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent.

Arms: arm 1: Resting SPECT imaging was performed prior to regadenoson stress SPECT

imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection. arm 2: Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
Interventions: intervention 1: regadenoson intervention 2: technetium Tc99m sestamibi /technetium Tc99m tetrafosmin intervention 3: Contrast intervention 4: Single Photon Emission Computed Tomography intervention 5: Multidetector Computed Tomography
Intervention descriptions: intervention 1: Administered by intravenous bolus. intervention 2: Administered by intravenous infusion intervention 3: Administered by intravenous infusion. intervention 4: Procedure/Surgery intervention 5: Procedure/Surgery

Protocol documents:
Clinical trial NCT01521494
Conditions: Chronic Kidney Disease Requiring Hemodialysis
Keywords: Hemodialysis Hyperphosphatemia
Sponsor: Kissei Pharmaceutical Co., Ltd.
Start date: 2012-01-11; Completion date: 2012-07-03
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: PA21 intervention 2: PA21 intervention 3: PA21 intervention 4: PA21 intervention 5: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00301067
Conditions: Metastatic Melanoma
Keywords: stage IV melanoma recurrent melanoma
Sponsor: Northwestern University
Start date: 2005-01-30; Completion date: 2012-07-09
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Calcitriol may help temozolomide kill more tumor cells by making them more sensitive to the drug. Calcitriol may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the best dose of calcitriol, the side effects of calcitriol when given together with temozolomide, and to see how well they work in treating patients with metastatic stage IV melanoma.

Detailed description:
\* Phase I: Patients receive oral calcitriol on days 1 and 15 and oral temozolomide on days 2-8 and 16-22. Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity. Responding patients continue therapy for up to 6 courses in the absence of unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of calcitriol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

* Phase II: Patients receive temozolomide and calcitriol at the MTD as in phase I.

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

Arms: arm 1: Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.2 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days. arm 2: Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.3 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days. arm 3: Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days. arm 4: Temozolomide dose of 150 mg/m2 will be administered orally on days 2-8 and 16-22 every cycle where 1 cycle equals 28 days.

Calcitriol dose of 0.5 mcg/kg will be administered orally on days 1 and 15 every cycle where 1 cycle equals 28 days.
Interventions: intervention 1: Calcitriol intervention 2: Temozolomide
Intervention descriptions: intervention 1: The patient will receive calcitriol in capsule form by mouth on Days 1 and 15 of every cycle intervention 2: The patient will receive temozolomide in capsule form by mouth on Days 2-8 and 16-22 of each 28 study treatment cycle

Protocol documents:
Clinical trial NCT00457418
Conditions: Melanoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-20; Completion date: 2012-07-11
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to establish the pharmacokinetics of PEG-Intron, administered at a dose of 6 μg/kg/week for 8 weeks (induction treatment), followed by a dose of 3 μg/kg/week for up to 252 weeks (maintenance treatment), in patients with high risk melanoma.

Detailed description:

Arms: arm 1: 6 ug/kg/week, SC (first 8 weeks)

3 ug/kg/week, SC (252 weeks \[weeks 9-260\], maintenance)
Interventions: intervention 1: PEG-Intron
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01284634
Conditions: Fatty Liver
Keywords: Cannabidiol Fatty liver Diabetes Body fat
Sponsor: GW Research Ltd
Start date: 2011-05-03; Completion date: 2012-07-13
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of GWP42003 on liver triglyceride (liver fat) in participants with fatty liver disease (FLD).

Detailed description:
This study was conducted as a 10-week (eight-week treatment period and one-week safety follow-up), randomized, partially-blind study that evaluated the effect of GWP42003 in participants with raised liver triglycerides (liver fat ≥5%). Participants were clinically diagnosed with FLD and had liver fat levels ≥5% as measured by Magnetic Resonance Imaging/ Magnetic Resonance Scanning (MRI/MRS), or were willing to undergo MRI/MRS scan at the screening visit to confirm a liver fat content of ≥5%. Eligible participants entered the study at a screening visit (Day -10 to -2) and then returned for a fasted baseline visit (Day 1), a mid-treatment visit (Day 29) and an end of treatment visit (Day 57). Safety follow-up telephone calls took place throughout the treatment period up to Day 64 after completion of treatment or seven days after date of last dose/withdrawal.

Arms: arm 1: Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). arm 2: Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). arm 3: Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). arm 4: Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste.
Interventions: intervention 1: GWP42003 200 mg/day Dose intervention 2: GWP42003 400 mg/day Dose intervention 3: GWP42003 800 mg/day Dose intervention 4: Placebo
Intervention descriptions: intervention 1: GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). intervention 2: GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). intervention 3: GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14). intervention 4: Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).

Protocol documents: