ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00684203
Conditions: Atherosclerosis Myocardial Ischemia Myocardial Infarction
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-01; Completion date: 2007-10-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population.

Detailed description:
The study drug (loading dose) is administered at least 1 hour before catheterization for diagnostic imaging or percutaneous coronary interventions (PCI). The incidence of bleeding is thought to be an important index to assess the safety of this drug, therefore thrombolysis in myocardial infarction (TIMI) is evaluated.

Arms: arm 1: Vorapaxar 20 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 2: Vorapaxar 20 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 3: Vorapaxar 40 mg loading dose + daily 1 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 4: Vorapaxar 40 mg loading dose + daily 2.5 mg maintenance dose + standard of care (Aspirin + Ticlopidine) arm 5: Placebo loading dose + daily placebo maintenance dose + standard of care (Aspirin + Ticlopidine)
Interventions: intervention 1: Vorapaxar intervention 2: Placebo intervention 3: Aspirin intervention 4: Clopidogrel
Intervention descriptions: intervention 1: Oral tablets; single 20-mg or 40-mg loading dose on first day followed by daily 1-mg or 2.5-mg maintenance dose for 59 days intervention 2: Oral tablets; matching placebo for SCH 530348 loading and maintenance doses for 59 days intervention 3: Loading dose of 75-325 mg on Day 1, then 75-100 mg once daily for 60 days. intervention 4: 100 mg two or three times daily for 60 days.

Protocol documents:
Clinical trial NCT00684593
Conditions: Psoriasis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2007-10-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.

Detailed description:

Arms: arm 1: Navarixin 30 mg administered orally once daily for 28 days. arm 2: Matching placebo to Navarixin administered orally once daily for 28 days.
Interventions: intervention 1: Navarixin 10 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Navarixin capsules orally, once daily for 28 days. intervention 2: Matching placebo capsules to Navarixin orally, once daily for 28 days.

Protocol documents:
Clinical trial NCT00858988
Conditions: Tropical Enteropathy
Sponsor: Washington University School of Medicine
Start date: 2007-09-01; Completion date: 2007-10-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether rifaximin is effective in the treatment of tropical enteropathy in a population of African children at high risk for this disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg of rifaxin for 7 consecutive days, twice daily intervention 2: twice daily for 7 consecutive days

Protocol documents:
Clinical trial NCT00974350
Conditions: Postoperative Pain Hernia Surgery
Keywords: Post-operative pain hernia surgery opioid
Sponsor: Durect
Start date: 2007-01-01; Completion date: 2007-10-01
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.

The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.

Detailed description:

Arms: arm 1: 2.5 mL SABER-Bupivacaine/Once arm 2: 5.0 mL SABER-Bupivacaine/Once arm 3: 2.5 mL or 5.0 mL SABER-Placebo/Once
Interventions: intervention 1: SABER-Bupivacaine intervention 2: SABER-Bupivacaine intervention 3: SABER-Placebo
Intervention descriptions: intervention 1: Injectable Extended Release Solution; 2.5 mL SABER-Bupivacaine/Once intervention 2: Injectable Extended Release Solution; 5.0 mL SABER-Bupivacaine/Once intervention 3: Injectable Solution; 2.5 or 5.0 mL SABER-Placebo/Once

Protocol documents:
Clinical trial NCT01090752
Conditions: Diabetes Hypertension
Keywords: diabetes blood pressure pioglitazone sodium insulin resistance, renal function, sodium, pioglitazone
Sponsor: University Hospital, Geneva
Start date: 2005-10-01; Completion date: 2007-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Detailed description:
Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.

Arms: arm 1: placebo-controlled, randomized, cross-over study arm 2: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
Interventions: intervention 1: Pioglitazone intervention 2: Metformin
Intervention descriptions: intervention 1: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance intervention 2: placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance

Protocol documents:
Clinical trial NCT01351090
Conditions: Postoperative Pain
Sponsor: American Regent, Inc.
Start date: ; Completion date: 2007-10-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA).

The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ketorolac tromethamine intervention 2: Ketorolac tromethamine intervention 3: Placebo
Intervention descriptions: intervention 1: 10 mg Intranasal (2 x 100 uL of a 5% solution) intervention 2: 30 mg Intranasal (2 x 100 uL of a 15% solution) intervention 3: Intranasal

Protocol documents:
Clinical trial NCT00281684
Conditions: Toothache
Keywords: Acute Pain Dental Pain Vanilloid VR1 TRPV1 Inflammation
Sponsor: GlaxoSmithKline
Start date: 2005-12-07; Completion date: 2007-10-03
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is a multi centre, randomised, single-blind, parallel group, placebo-controlled, single oral dose study with a positive control arm. Patients previously scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon completion of surgery, e.g. prior to established pain, patients will be randomised to treatment (SB-706598, placebo or co-codamol) and dosed with the study medication

Detailed description:

Arms: arm 1: Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days. arm 2: Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days. arm 3: Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days. arm 4: Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.
Interventions: intervention 1: SB705498 400 mg intervention 2: SB705498 1000 mg intervention 3: Placebo intervention 4: Co-Codamol
Intervention descriptions: intervention 1: SB705498 400 mg intervention 2: SB705498 1000 mg intervention 3: Placebo intervention 4: Co-Codamol

Protocol documents:
Clinical trial NCT00453479
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: muscarinic receptor, bronchodilators Chronic obstructive pulmonary disease,
Sponsor: GlaxoSmithKline
Start date: 2007-03-28; Completion date: 2007-10-11
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK233705 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease. This is a randomised, double-blind, placebo-controlled, dose ascending, parallel group study to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of twice daily inhaled doses of GSK233705B for 7 days, in COPD subjects.

Detailed description:

Interventions: intervention 1: GSK233705B
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00308282
Conditions: Arthritis, Rheumatoid
Sponsor: Eli Lilly and Company
Start date: 2006-03-28; Completion date: 2007-10-18
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LY2127399 intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks. intervention 2: IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks.

Protocol documents:
Clinical trial NCT00220337
Conditions: Painful Diabetic Neuropathy
Keywords: Painful diabetic neuropathy Lacosamide
Sponsor: UCB Pharma
Start date: 2004-12-21; Completion date: 2007-10-31
Enrollment: 371 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.

Detailed description:

Arms: arm 1: Open label active treatment
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Protocol documents:
Clinical trial NCT00684567
Conditions: Glioblastoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-09-27; Completion date: 2007-10-31
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.

Detailed description:

Arms: arm 1: It is the only arm of the study. Subjects receive a combination of radiotherapy and temozolomide, and then temozolomide monotherapy.
Interventions: intervention 1: Radiotherapy intervention 2: Temozolomide
Intervention descriptions: intervention 1: Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher. intervention 2: During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.

Protocol documents:
Clinical trial NCT00081770
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-03-01; Completion date: 2007-11-01
Enrollment: 4469 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.

Detailed description:
PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:

Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials

REBETOL Dosage (for Use With PegIntron):

Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight \>65-85 kg Daily Dose 1000 mg; Screening 2 Weight \>85-105 kg Daily Dose 1200 mg; Screening 2 Weight \>105-125 kg Daily Dose 1400 mg

The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week

COPEGUS Dosage (for Use With PEGASYS):

Screening 2 Weight \<75 kg Daily Dose 1000 mg; Screening 2 Weight \> or = 75 kg Daily Dose 1200mg

NOTE: Double Blind for PegIntron; Open Label for REBETOL, PEGASYS and COPEGUS

NOTE: REBETOL is the Schering-Plough brand name for ribavirin. COPEGUS is the Hoffman-La Roche brand name for ribavirin.

Arms: arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up arm 3: PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
Interventions: intervention 1: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 2: PegIntron (peginterferon alfa-2b; SCH 54031) intervention 3: REBETOL (ribavirin; SCH 18908) intervention 4: PEGASYS (peginterferon alfa-2a) intervention 5: COPEGUS (ribavirin)
Intervention descriptions: intervention 1: 1.5 ug/kg/week subcutaneously (SC) for 48 weeks intervention 2: 1.0 ug/kg/week SC for 48 weeks intervention 3: weight based dose 800-1400 mg/day orally (PO) for 48 weeks intervention 4: 180 ug/week SC administered for 48 weeks intervention 5: 1000-1200 mg/day PO for 48 weeks

Protocol documents:
Clinical trial NCT00195260
Conditions: Neoplasms
Keywords: Solid tumors
Sponsor: Pfizer
Start date: 2004-10-01; Completion date: 2007-11-01
Enrollment: 151 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Detailed description:

Arms: arm 1: Dose finding study of monotherapy bosutinib in patients with advanced solid tumors. arm 2: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 3: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 4: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
Interventions: intervention 1: bosutinib intervention 2: bosutinib intervention 3: bosutinib intervention 4: bosutinib
Intervention descriptions: intervention 1: Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen. intervention 2: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen. intervention 3: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen. intervention 4: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen.

Protocol documents:
Clinical trial NCT00267189
Conditions: Liver Transplantation
Keywords: Liver transplantation, everolimus, calcineurin inhibitor, renal function
Sponsor: Novartis Pharmaceuticals
Start date: 2005-11-01; Completion date: 2007-11-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.

Detailed description:

Arms: arm 1: Reduced CNI dose + everolimus (1.5 mg twice daily (b.i.d)) ± steroids arm 2: Standard CNI dose ± MPA/AZA ± steroids
Interventions: intervention 1: Everolimus intervention 2: Calcineurin inhibitors (CNI) intervention 3: Mycophenolate acid (MPA)/ Azathioprine (AZA) intervention 4: Steroids
Intervention descriptions: intervention 1: 1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00104052
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-02-01; Completion date: 2007-11-01
Enrollment: 107 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.

Detailed description:
This global, multicenter, open-label Phase 3 study will evaluate the safety, efficacy and tolerability of PEG-Intron plus REBETOL in previously untreated pediatric subjects, ages 3 through 17 years, with chronic hepatitis C.

Arms: arm 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study participation).
Interventions: intervention 1: peginterferon alfa-2b (PEG2b) (SCH 54031) intervention 2: ribavirin (SCH 18908)
Intervention descriptions: intervention 1: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks. intervention 2: 15 mg/kg/day for up to 48 weeks

Protocol documents: