ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01449630
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2011-10-24; Completion date: 2012-04-02
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a phase I study of LY3031207 in healthy subjects. The purposes of this study are to look at safety, how well the study drug is tolerated, and how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Subjects will participate in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Participants received escalating doses of 5 mg (milligrams), 25 mg, 75 mg, 225 mg, 450 mg and 900 mg of LY3031207 capsule orally. arm 2: Single dose of placebo administered orally in up to two occasions separated by at least a 3 week wash-out period between each dose. arm 3: Single 400mg dose of celecoxib administered orally on one occasion.
Interventions: intervention 1: LY3031207 intervention 2: Placebo intervention 3: Celecoxib
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT00622505
Conditions: Multiple Myeloma
Keywords: Multiple myeloma zoledronic acid skeletal complications bone
Sponsor: Novartis Pharmaceuticals
Start date: 2007-11-07; Completion date: 2012-04-03
Enrollment: 121 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.

Detailed description:

Arms: arm 1: Participants received 4 milligrams (mg) or a reduced dose, i.e., 3.5 mg, or 3.3 mg or 3.0 mg of Zoledronic acid as an IV infusion over a minimum of 15 minutes, every 4 weeks or every 12 weeks for up to 96 weeks based on the participants most recent urine N-telopeptide of type 1 collagen (NTx) measurement (greater than or equal to \[≥\] 50 nanomoles per millimoles \[nmol/mmol\] creatinine or \<50 nmol/mmol creatinine, respectively).
Interventions: intervention 1: zoledronic acid
Intervention descriptions: intervention 1: Zoledronic acid concentrate (4 mg/5 milliliters \[ml\]) was diluted in 100 mL sterile 0.9% calcium-free sodium chloride or 5% dextrose injection, administered IV, either 4 or 12 weeks for 96 weeks.

Protocol documents:
Clinical trial NCT01096849
Conditions: Complicated Urinary Tract Infection Acute Pyelonephritis
Keywords: urinary tract infection UTI cUTI pyelonephritis AP ACHN-490
Sponsor: Achaogen, Inc.
Start date: 2010-07-13; Completion date: 2012-04-03
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multi-center, multi-national, double-blind, randomized, comparator-controlled study of plazomicin administered intravenously compared with levofloxacin, a standard approved intravenous therapy for complicated urinary tract infection (cUTI) and acute pyelonephritis (AP).

Detailed description:

Arms: arm 1: Patients received two intravenous (IV) infusions daily for 5 consecutive days: 10 milligrams per kilogram (mg/kg) plazomicin followed by placebo. arm 2: Patients received two IV infusions daily for 5 consecutive days: 15 mg/kg plazomicin followed by placebo. arm 3: Patients received two IV infusions daily for 5 consecutive days: placebo followed by 750 milligrams (mg) levofloxacin.
Interventions: intervention 1: levofloxacin intervention 2: plazomicin intervention 3: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00321464
Conditions: Bone Metastases
Keywords: Fractures Compressions Bisphosphonates Bone metastases Breast cancer Skeletal Radiation Surgery to Bone
Sponsor: Amgen
Start date: 2006-04-01; Completion date: 2012-04-04
Enrollment: 2049 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Denosumab intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes intervention 2: Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

Protocol documents:
Clinical trial NCT01380184
Conditions: Cancer, Advanced
Keywords: Relapsed cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-07-05; Completion date: 2012-04-05
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Part 1 of the study will assess the pharmacokinetics, safety, and tolerability of ridaforolimus (MK-8669) after administration of single and multiple 40 mg doses in Chinese participants with advanced cancer. Part 2 of the study is optional; participants can continue to receive the study treatment in a weekly regimen of daily oral doses of ridaforolimus 40 mg for five consecutive days followed by two days off-treatment.

Detailed description:

Arms: arm 1: In Part 1 (Days 1-19), participants received ridaforolimus (MK-8669) 40 mg via oral enteric-coated tablet on Day 1; followed by no study treatment on Days 2-7; followed by two weekly sequences (Days 8-19) consisting of 5 consecutive days of ridaforolimus 40 mg and 2 consecutive days off study treatment. Following Part 1, participants underwent at least a 2-day study treatment washout prior to starting Part 2. In Part 2, participants received a weekly treatment regimen consisting of 5 consecutive days (Days 1-5) of ridaforolimus 40 mg via oral enteric-coated tablet and 2 consecutive days (Days 6-7) off study treatment. This weekly treatment regimen was repeated every subsequent week for the remainder of participation in Part 2.
Interventions: intervention 1: ridaforolimus
Intervention descriptions: intervention 1: 4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)

Protocol documents:
Clinical trial NCT00773838
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-12-01; Completion date: 2012-04-09
Enrollment: 143 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the clinical activity of vorinostat in combination with bortezomib in participants with relapsed or refractory multiple myeloma after at least 2 prior treatment regimens. The primary objective is to define the objective response rate (RR) associated with the administration of vorinostat in combination with bortezomib to patients with relapsed and refractory multiple myeloma after at least 2 prior treatment regimens. The primary hypothesis of the study is the administration of vorinostat in combination with bortezomib will result in a clinically meaningful rate of objective response.

Detailed description:
The protocol has been amended to indicate that the Final Analysis is designated as the time when the primary endpoint of 29 responders has been met, or the time when all participants have discontinued treatment or have been enrolled in the study for at least 6 months (if the primary endpoint is not reached by this time). Following the Final Analysis, participants will be allowed to continue study treatment in an extension as long as they have not met the criteria for discontinuation, and will be followed for overall survival and serious AEs.

Arms: arm 1: Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
Interventions: intervention 1: Vorinostat intervention 2: Bortezomib intervention 3: Dexamethasone
Intervention descriptions: intervention 1: Four 100 mg vorinostat capsules orally, once daily (QD) by mouth on Days 1-14 of each 21-day treatment cycle. intervention 2: Bortezomib 1.3 mg/m\^2, IV injection QD on Days 1, 4, 8, and 11 of each 21-day treatment cycle. intervention 3: Five 4 mg Dexamethasone tablets orally, QD on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle if PD is observed after 2 treatment cycles or if NC to disease is observed after 4 treatment cycles.

Protocol documents:
Clinical trial NCT01405911
Conditions: Glucose Intolerance
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-08-16; Completion date: 2012-04-09
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to evaluate the safety, efficacy, and dose level of sitagliptin (MK-0431/ONO-5435) used once daily (qd) in Japanese participants with impaired glucose tolerance who have inadequate glycemic control using diet and exercise therapy.

Detailed description:

Arms: arm 1: Participants will take one tablet of placebo for sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. arm 2: Participants will take one tablet of sitagliptin 25 mg and one tablet of placebo for sitagliptin 50 mg orally once daily for 8 weeks. arm 3: Participants will take one tablet of sitagliptin 50 mg and one tablet of placebo for sitagliptin 25 mg orally once daily for 8 weeks.
Interventions: intervention 1: Placebo for Sitagliptin 25 mg intervention 2: Placebo for Sitagliptin 50 mg intervention 3: Sitagliptin 25 mg intervention 4: Sitagliptin 50 mg
Intervention descriptions: intervention 1: 1 tablet orally once daily before breakfast for 8 weeks intervention 2: 1 tablet orally once daily before breakfast for 8 weeks intervention 3: 1 tablet orally once daily before breakfast for 8 weeks intervention 4: 1 tablet orally once daily before breakfast for 8 weeks

Protocol documents:
Clinical trial NCT00345839
Conditions: Secondary Hyperparathyroidism Chronic Kidney Disease
Keywords: Cinacalcet HCl Cinacalcet AMG 073 Sensipar Mimpara Calcimimetic Hemodialysis CKD Secondary hyperparathyroidism (HPT)
Sponsor: Amgen
Start date: 2006-08-22; Completion date: 2012-04-10
Enrollment: 3883 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis.

Detailed description:
Secondary HPT is common in people with CKD. Patients with secondary HPT often have high parathyroid hormone (PTH) levels and may develop large parathyroid glands in the neck. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. Other problems from secondary HPT may include increases in blood levels of calcium and phosphorus. These may cause calcium to deposit in body tissues. Calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. New evidence suggests that secondary HPT is associated with cardiovascular disease and increased death risk. The purpose of this study is to evaluate the effects of cinacalcet (cinacalcet HCl or Sensipar®/Mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (CKD) patients with secondary hyperparathyroidism (HPT) who are receiving dialysis. These events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cinacalcet intervention 2: Placebo
Intervention descriptions: intervention 1: Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg daily (QD), once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention. intervention 2: Possible doses: 30, 60, 90, 120, and 180 mg using tablet strengths of 30, 60, or 90 mg. Sequential titration starting at 30 mg QD, once every 4 weeks for the first 20 weeks and once every 8 weeks after Week 20. Titration increases or decreases based on PTH values, serum calcium, and safety. Daily dosing unless temporary hold criteria or withdrawal criteria is met, or until study completion; estimated 2.5 to 4 years of intervention.

Protocol documents:
Clinical trial NCT01466985
Conditions: HIV-1 Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-21; Completion date: 2012-04-10
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety, tolerability, pharmacokinetics, and antiretroviral activity of doravirine (MK-1439) as monotherapy in antiretroviral therapy (ART)-naïve, HIV-1-infected participants.

Detailed description:

Arms: arm 1: Participants will receive oral doses of doravirine 25 mg or placebo once daily for 7 days. arm 2: Panel B (doravirine 200 mg or placebo once daily for 7 days) will initiate upon satisfactory review of safety and tolerability from Panel A, and all safety, tolerability and pharmacokinetic data from the study MK-1439-001. arm 3: Panel C is optional. If conducted, the dose will be confirmed after review of data from prior panels.
Interventions: intervention 1: Doravirine intervention 2: Placebo
Intervention descriptions: intervention 1: Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg). intervention 2: Placebo tablets once daily for 7 days.

Protocol documents:
Clinical trial NCT01394211
Conditions: Estrogen Receptor-positive Breast Cancer Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Male Breast Cancer Recurrent Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer
Sponsor: University of Arizona
Start date: 2011-07-13; Completion date: 2012-04-12
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving pazopanib hydrochloride and anastrozole before surgery works in treating patients with stage II-III estrogen receptor-positive breast cancer. Pazopanib hydrochloride and anastrozole may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pazopanib hydrochloride and anastrozole together before surgery may make the tumor smaller and reduce the amount of normal cells that have to be removed

Detailed description:
OBJECTIVES:

I. To determine the pathologic complete response (pCR) rate at surgery.

SECONDARY OBJECTIVES:

I. To evaluate alternative measurements of anti-tumor activity: proportion of patients achieving sustained decrease in antigen KI-67 (ki-67) at 12 weeks of therapy with anastrozole plus pazopanib (pazopanib hydrochloride); proportion of patients achieving down-staging to a pathologic stage 0 or 1 at surgery.

II. To assess qualitative and quantitative toxicity of this combination, with special emphasis on the frequency of events grade 3 or greater, or the occurrence of unexpected toxicities.

OUTLINE:

Patients receive pazopanib hydrochloride\* orally (PO) once daily (QD) and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo definitive surgery.

NOTE: \*Pazopanib hydrochloride is stopped 7-14 days before surgery.

Arms: arm 1: Patients receive pazopanib hydrochloride\* PO QD and anastrozole PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients then undergo therapeutic conventional surgery.

NOTE: \*Pazopanib hydrochloride is stopped 7-14 days before definitive surgery.
Interventions: intervention 1: anastrozole intervention 2: pazopanib hydrochloride intervention 3: therapeutic conventional surgery
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Undergo definitive surgery

Protocol documents:
Clinical trial NCT00867165
Conditions: Primary Hypercholesterolemia
Keywords: heterozygous familial hypercholesterolemia nonfamilial hypercholesterolemia
Sponsor: Organon and Co
Start date: 2009-05-21; Completion date: 2012-04-13
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children \>=6 to \<=10 years old with primary hypercholesterolemia. The study will also evaluate the effect of ezetimibe on total cholesterol (TC), apolipoprotein B (Apo B), high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and triglycerides (TG). The safety of ezetimibe in this subject population will also be evaluated.

Detailed description:

Arms: arm 1: Ezetimibe 10-mg tablet once daily for 12 weeks arm 2: Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
Interventions: intervention 1: ezetimibe intervention 2: Placebo
Intervention descriptions: intervention 1: oral tablets: ezetimibe 10 mg once daily for 12 weeks intervention 2: oral tablets: placebo to match ezetimibe 10 mg; administered once daily during the 5-week, single-blind, placebo run-in and diet stabilization period and 12-week double-blind treatment period

Protocol documents:
Clinical trial NCT01128179
Conditions: Chronic Kidney Disease
Sponsor: Shire
Start date: 2010-12-06; Completion date: 2012-04-16
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lanthanum carbonate intervention 2: Placebo
Intervention descriptions: intervention 1: 1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks intervention 2: Matching placebo chewable tablets administered 3 times a day for 12 weeks

Protocol documents:
Clinical trial NCT01346969
Conditions: Reduction in Hypertrophic Skin Scarring
Keywords: Skin scarring cicatrix breast scar
Sponsor: Pfizer
Start date: 2011-06-01; Completion date: 2012-04-16
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing skin scarring in subjects undergoing revision of scars from prior surgery. The study will also evaluate the safety and tolerability of EXC 001 and placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: EXC 001 intervention 2: EXC 001 intervention 3: EXC 001 intervention 4: EXC 001
Intervention descriptions: intervention 1: Single-dose administered by injection four different times intervention 2: Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1 intervention 3: Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2 intervention 4: Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3

Protocol documents:
Clinical trial NCT01362348
Conditions: Macular Degeneration
Keywords: Age-related Macular Degeneration
Sponsor: GlaxoSmithKline
Start date: 2011-07-07; Completion date: 2012-04-16
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD.

Detailed description:
MD7114987 is a Phase 2a study designed to determine whether pazopanib eye drops have the potential to reduce retinal edema and maintain or improve visual acuity in persons with a previously untreated subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) and to further characterize the safety and tolerability of pazopanib eye drops administered over a 12-week period.

Arms: arm 1: pazopanib topical ocular administration
Interventions: intervention 1: pazopanib eye drops
Intervention descriptions: intervention 1: 10 mg/mL (1 drop) four times daily

Protocol documents:
Clinical trial NCT00768664
Conditions: Head and Neck Neoplasms
Keywords: recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
Sponsor: Pfizer
Start date: 2008-11-04; Completion date: 2012-04-18
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-00299804
Intervention descriptions: intervention 1: 45 mg by continuous oral dosing

Protocol documents:
Clinical trial NCT01052779
Conditions: Iron Deficiency Anemia Kidney Disease
Keywords: Iron deficiency anemia Chronic kidney disease Feraheme Ferumoxytol Iron sucrose IDA CKD Venofer
Sponsor: AMAG Pharmaceuticals, Inc.
Start date: 2010-03-01; Completion date: 2012-04-19
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Detailed description:

Arms: arm 1: Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g). arm 2: Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
Interventions: intervention 1: Ferumoxytol intervention 2: Iron Sucrose
Intervention descriptions: intervention 1: IV Ferumoxytol intervention 2: IV Iron Sucrose

Protocol documents: