ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00853385
Conditions: Rheumatoid Arthritis
Keywords: oral DMARD JAK inhibitor clinical trial
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 717 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: CP 690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo intervention 5: Biologic TNFi
Intervention descriptions: intervention 1: tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months intervention 2: tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months intervention 3: placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months intervention 4: tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months intervention 5: placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months

Protocol documents:
Clinical trial NCT00862251
Conditions: Cardiovascular Disorder Diabetes Mellitus
Keywords: cardiovascular disorder
Sponsor: Organon and Co
Start date: 2009-04-01; Completion date: 2011-03-01
Enrollment: 808 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin 10 mg.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ezetimibe (+) simvastatin intervention 2: simvastatin 40 mg or atorvastatin 20 mg intervention 3: Rosuvastatin intervention 4: atorvastatin 10 mg or simvastatin 20 mg
Intervention descriptions: intervention 1: ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks. intervention 2: simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. intervention 3: rosuvastatin 10 mg tablets, taken once daily for six weeks. intervention 4: All patients will take atorvastatin 10 mg tablets OR simvastatin 20 mg tablets, taken once daily in a 6-week screening/stabilization period prior to randomization.

Protocol documents:
Clinical trial NCT00871403
Conditions: Lung Cancer, Non-Small Cell
Keywords: GW786034 pazopanib pemetrexed cisplatin non-small cell lung cancer NSCLC
Sponsor: GlaxoSmithKline
Start date: 2009-07-01; Completion date: 2011-03-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: Investigational treatment (pazopanib and pemetrexed) arm 2: Standard treatment (pemetrexed and cisplatin)
Interventions: intervention 1: pazopanib and pemetrexed intervention 2: pemetrexed and cisplatin
Intervention descriptions: intervention 1: oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m\^2 once every 3 weeks, then pazopanib 800 mg once daily intervention 2: pemetrexed IV 500 mg/m\^2 and cisplatin IV 75 mg/m\^2 once every 3 weeks

Protocol documents:
Clinical trial NCT00877370
Conditions: Acute Kidney Failure
Keywords: ertapenem continuous hemodialysis pharmacokinetics
Sponsor: University of Michigan
Start date: 2009-02-01; Completion date: 2011-03-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine how much ertapenem is removed by continuous hemodialysis.

Detailed description:
Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. A pharmacokinetic evaluation will be made to determine what is the most appropriate dose for this drug in patients receiving CVVHD to achieve pharmacokinetic and pharmacodynamic goals.

Arms: arm 1: subjects will receive ertapenem while receiving CVVHD
Interventions: intervention 1: ertapenem
Intervention descriptions: intervention 1: One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained.

Protocol documents:
Clinical trial NCT00883493
Conditions: Acute Bipolar Depression
Keywords: Acute bipolar depression Lithium carbonate quetiapine fumarate MADRS
Sponsor: AstraZeneca
Start date: 2009-04-01; Completion date: 2011-03-01
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Detailed description:

Arms: arm 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. arm 2: Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Interventions: intervention 1: Quetiapine fumarate XR intervention 2: Lithium carbonate
Intervention descriptions: intervention 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. intervention 2: Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Protocol documents:
Clinical trial NCT00884273
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2009-08-01; Completion date: 2011-03-01
Enrollment: 182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dose) with respect to mean percentage reduction in prostate volume.

The hypothesis was that degarelix could decrease prostate size at least as effectively as the combination of a GnRH agonist with an anti-androgen for flare protection.

Detailed description:

Arms: arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. arm 2: Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.

On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.
Interventions: intervention 1: Degarelix intervention 2: Goserelin intervention 3: Bicalutamide
Intervention descriptions: intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. intervention 2: Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively. intervention 3: On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin.

Protocol documents:
Clinical trial NCT00884949
Conditions: MPS IV A
Keywords: Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
Sponsor: BioMarin Pharmaceutical
Start date: 2009-04-01; Completion date: 2011-03-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, open-label study is designed to assess safety, dose-response using pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).

Detailed description:

Arms: arm 1: Within-patient Dose-Escalation
Interventions: intervention 1: BMN 110
Intervention descriptions: intervention 1: Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:

* Weeks 1-12: 0.1 mg/kg/week
* Weeks 13-24: 1.0 mg/kg/week
* Weeks 25-36: 2.0 mg/kg/week

Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.

Protocol documents:
Clinical trial NCT00886834
Conditions: Contraception
Keywords: IUD insertion Nulliparous women Contraception Family Planning IUD insertion in nulliparous women
Sponsor: University of Utah
Start date: 2009-04-01; Completion date: 2011-03-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.

Detailed description:
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Because of misoprostol's known ability to cause cervical dilation, some family planning providers use this drug to facilitate insertion. While there is a wealth of data on the use of misoprostol prior to many procedures requiring cervical dilation there is minimal objective evidence assessing its effect on provider ease of insertion or patient comfort during IUD insertion in nulliparas. The goal of this project is to evaluate whether misoprostol relative to placebo prior to IUD insertion in nulliparous women eases insertion and decreases pain. The results of this trial will be contributed to a prospective meta-analysis on the subject.

Arms: arm 1: Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. arm 2: Pills which are identical to the study drug in appearance, taste, and smell.
Interventions: intervention 1: Misoprostol intervention 2: Placebo
Intervention descriptions: intervention 1: 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion. intervention 2: Pills which are identical to the study drug in appearance, taste, and smell.

Protocol documents:
Clinical trial NCT00891020
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 886 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.

Detailed description:

Arms: arm 1: Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion. arm 2: Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion. arm 3: Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: Nonbiologic DMARDs of investigator's choice
Intervention descriptions: intervention 1: 8 mg/kg intravenous every 4 weeks for 24 weeks intervention 2: 4 mg/kg every 4 weeks for 24 weeks intervention 3: Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed

Protocol documents:
Clinical trial NCT00905632
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2009-05-01; Completion date: 2011-03-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.

Detailed description:

Arms: arm 1: BI 207127 low dose tid + SOC arm 2: BI 207127 middle dose tid + SOC arm 3: BI 207127 high dose tid +SOC arm 4: Placebo tid +SOC
Interventions: intervention 1: BI 207127 middle dose +SOC intervention 2: BI 207127 high dose+SOC intervention 3: Placebo + SOC intervention 4: BI 207127 low dose + SOC
Intervention descriptions: intervention 1: BI 207127 middle dose tid + SOC intervention 2: BI 207127 high dose tid +SOC intervention 3: Placebo tid +SOC intervention 4: BI 207127 low dose tid + SOC

Protocol documents:
Clinical trial NCT00915590
Conditions: Corneal Neovascularization
Sponsor: Reza Dana, MD
Start date: 2009-04-01; Completion date: 2011-03-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.

Detailed description:
Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema, lipid deposition, and inflammation that may alter visual acuity and is a leading cause of monocular visual impairment and blindness. Additionally, it results in the loss of immune response across the cornea, thereby worsening the prognosis of a subsequent penetrating keratoplasty (PK). Growth of new blood and lymphatic vessels from preexisting vessels are mediated by members of the vascular endothelial growth factor (VEGF) family. This study is designed to investigate whether Interleukin-1-Receptor Antagonist is a drug that is both safe and effective in blocking VEGF pathways, stopping new growth, and reducing old vessel growth.

Arms: arm 1: It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra. arm 2: It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
Interventions: intervention 1: Placebo intervention 2: IL-1Ra
Intervention descriptions: intervention 1: Custom eye drop eye three times a day in both eyes for a period of 6 weeks intervention 2: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks

Protocol documents:
Clinical trial NCT00915876
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease Vitamin D
Sponsor: Amy Barton Pai
Start date: 2009-03-01; Completion date: 2011-03-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. The type of Vitamin D being used in this study (paricalcitol) is Food and Drug Administration (FDA) approved to treat high parathyroid hormone levels. The purpose of this study is to find out if paricalcitol has other benefits beyond its ability to lower parathyroid hormone levels such as improving the blood vessels reaction to stress and decreasing blood levels of substances that may increase blockages in the blood vessels.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Paricalcitol intervention 2: Placebo
Intervention descriptions: intervention 1: paricalcitol 1 mcg QD x 8 weeks intervention 2: Placebo for Paricalcitol 1 mcg QD x 8 weeks

Protocol documents:
Clinical trial NCT00928512
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, RA, ACR, inflammatory joints
Sponsor: Novartis Pharmaceuticals
Start date: 2009-07-01; Completion date: 2011-03-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

Detailed description:

Arms: arm 1: Secukinumab 25mg s.c. q4wk arm 2: Secukinumab 75mg s.c. q4wk arm 3: Secukinumab 150mg s. c. q4wk arm 4: Secukinumab 300mg s.c. q4wk arm 5: Secukinumab Placebo s.c. q4wk
Interventions: intervention 1: Secukinmab intervention 2: Placebo
Intervention descriptions: intervention 1: Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. intervention 2: Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously.

Protocol documents:
Clinical trial NCT00946920
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2009-06-01; Completion date: 2011-03-01
Enrollment: 859 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Degarelix intervention 2: Goserelin acetate
Intervention descriptions: intervention 1: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations). intervention 2: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Protocol documents: