ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00765063
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcers Neuroischaemic
Sponsor: Pfizer
Start date: 2008-10-01; Completion date: 2010-10-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.

Detailed description:

Arms: arm 1: Active study treatment
Interventions: intervention 1: Fragmin
Intervention descriptions: intervention 1: Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium

Protocol documents:
Clinical trial NCT00766532
Conditions: Breast Cancer Osteoporosis Osteopenia Fracture
Sponsor: University of Wisconsin, Madison
Start date: 2009-01-01; Completion date: 2010-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Research Question: Do Aromatase Inhibitors Decrease Intestinal Calcium Absorption?

Study Design: Postmenopausal women with early stage breast cancer initiating aromatase inhibitor adjuvant therapy will participate in this two-month study. The primary study outcome is the change in intestinal calcium absorption following such therapy. Secondary outcomes are the changes in bone resorption markers and musculoskeletal signs and symptoms after initiation of therapy.

We will interview women and review their medical records to determine eligibility. Eligible subjects will undergo two calcium absorption studies. The first study will determine their baseline calcium absorption, and the second study will occur after taking an aromatase inhibitor daily for at least 6 weeks. Women will present to the research unit in the early morning and receive an oral and intravenous stable calcium tracer with breakfast. Over the next 24 hours, we will collect all urine for measurement of its calcium content. During each inpatient stay, we will assess musculoskeletal symptoms by questionnaire and joint examination. Each woman will complete a four-day diet diary twice during the study.

Detailed description:

Arms: arm 1: aromatase inhibitor therapy for six weeks
Interventions: intervention 1: Aromatase Inhibitor
Intervention descriptions: intervention 1: Any aromatase inhibitor started as initial adjuvant therapy

Protocol documents:
Clinical trial NCT00770146
Conditions: Hypercholesterolemia Coronary Heart Disease
Sponsor: Kastle Therapeutics, LLC
Start date: 2008-11-01; Completion date: 2010-10-01
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).

Detailed description:
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for CHD.

Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of CHD or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in patients with high cholesterol who are at high risk for CHD and who are already on the maximally tolerated dose of statin.

This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up period. Participants who finished treatment or who discontinued prematurely from the study for any reason were assessed for safety for 24 weeks after the last study drug dose.

Arms: arm 1: Participants received placebo subcutaneous injection once a week for 26 weeks. arm 2: Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Interventions: intervention 1: Mipomersen sodium intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg/mL intervention 2: 1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).

Protocol documents:
Clinical trial NCT00780910
Conditions: Chronic Hepatitis C
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2008-11-01; Completion date: 2010-10-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in patients with (Genotype 1) hepatitis C, who relapsed after previous treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 intervention 2: Ribavirin intervention 3: Peginterferon Alfa-2b
Intervention descriptions: intervention 1: 750 mg every 8 hours for 12 weeks intervention 2: 600 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5 mcg/kg/week for 24 weeks

Protocol documents:
Clinical trial NCT00793598
Conditions: Viruria
Keywords: CMX001 Kidney transplant HSCT transplant BK Virus Post kidney transplant patients with BK virus viruria > 10^4 Post HSCT transplant patients with BK virus viruria > 10^4
Sponsor: Chimerix
Start date: 2009-11-01; Completion date: 2010-10-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus viruria.

Detailed description:
This was a randomized, double-blind, multiple-dose placebo-controlled study of oral brincidofovir (BCV) in hematopoietic stem cell transplant and renal transplant recipients with BK virus infection.

Subjects received blinded study medication for a total of 5 doses in 1 of the following regimens:

* 10 mg BCV administered twice weekly (BIW) on Days 0, 3, 7, 10, 14.
* 20 mg BCV administered once weekly (QW) on Days 0, 7, and 14 and placebo administered on Days 3 or 10.
* Placebo administered BIW on Days 0, 3, 7, 10 ,14.
* 40 mg BCV administered QW on Days 0, 7, 14, 21, and 28.
* Placebo administered QW on Days 0, 7, 14, 21, and 28.

Arms: arm 1: Under Amendments 1 and 2, subjects received 1 of 2 dose regimens of brincidofovir, as follows:

* 20 mg BCV once weekly (QW) on Days 0, 7, and 14; or
* 10 mg BCV twice weekly (BIW) BIW on Days 0, 3, 7, 10, and 14.

Under Amendment 3, subjects received 40 mg BCV QW for a total of 5 doses on Days 0, 7, 14, 21, and 28. arm 2: Under Amendments 1 and 2, subjects received placebo twice weekly (BIW) for a total of 5 doses on Days 0, 3, 7, 10, and 14.

Under Amendment 3, subjects received placebo once weekly (QW) for a total of 5 doses on Days 0, 7, 14, 21, and 28.
Interventions: intervention 1: Placebo intervention 2: Brincidofovir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00794664
Conditions: Hypercholesterolemia Coronary Heart Disease
Sponsor: Kastle Therapeutics, LLC
Start date: 2009-01-01; Completion date: 2010-10-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

Detailed description:
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for coronary heart disease (CHD).

Mipomersen is an antisense drug that reduces a protein in the liver cells called apolipoprotein B (Apo-B). Apo-B plays a role in producing low density lipoprotein cholesterol (LDL-C) (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High LDL-C is an independent risk factor for the development of coronary heart disease (CHD) or other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of heart attacks and other major adverse cardiovascular events. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.

Arms: arm 1: Weekly subcutaneous injections for 26 weeks arm 2: 200 mg weekly subcutaneous injections for 26 weeks
Interventions: intervention 1: Mipomersen intervention 2: Placebo
Intervention descriptions: intervention 1: 200 mg (1 mL), weekly subcutaneous injections for 26 weeks intervention 2: 1 mL weekly subcutaneous injections for 26 weeks

Protocol documents:
Clinical trial NCT00795717
Conditions: Cardiovascular Disease HIV Infection
Keywords: HIV cardiovascular risk atherogenic lipid profile brachial artery reactivity omega three fatty acids
Sponsor: Tufts University
Start date: 2008-07-01; Completion date: 2010-10-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether fish oil supplementation with Lovaza, formally known as Omacor will result in a significant reduction in serum triglyceride (TG), an increase in high density lipoproteins(HDL), and an improvement of endothelial dysfunction.

Detailed description:
This is a randomized, double blind, placebo controlled, cross-over, clinical trial to determine the effect of fish oil supplementation with Lovaza® on triglyceride levels in HIV-infected subjects on HAART with elevated serum triglycerides. The sample size is 40 subjects. The total duration of the study is 28 weeks, with 12-week treatment periods separated by a 4-week washout. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Arms: arm 1: Lovaza, dietary counseling arm 2: Placebo, dietary counseling
Interventions: intervention 1: Lovaza intervention 2: Placebo
Intervention descriptions: intervention 1: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks. intervention 2: 2 capsules given twice daily

Protocol documents:
Clinical trial NCT00796003
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic syndrome MDS Decitabine JNJ-30979754
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2008-07-01; Completion date: 2010-10-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS).

Detailed description:
This is an open-label (both physician and patient know the name and dosage of drug), multi-center study. This study consists of two parts, Phase I and Phase II. In Phase I, approximately 9 participants will be enrolled ie, 3 participants for dose level 1 (15 mg/m2 of JNJ-30979754) and 6 participants for dose level 2 (20 mg/m2 of JNJ-30979754). Once the tolerability of 20 mg/m2 is confirmed additional 30 participants will be included to receive 20 mg/m2 and approximate total participants in Phase II will be 36. This study will include screening period (within 14 days prior to the day of initial administration of Cycle 1) and dosing period (1 cycle consists of administration of study medication for first 5 consecutive days + rested for 23 days; ie, total 28 days). Cycles will be reapeated in participants in whom decitabine was expected to be effective. Safety evaluations will include assessment of adverse events, vital signs, body weight, clinical laboratory tests: hematology, blood biochemistry and urinalysis, cardiopulmonary function tests: ECG, chest X ray and oximeter analysis.

Arms: arm 1: JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 arm 2: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1 arm 3: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
Interventions: intervention 1: JNJ-30979754 15 mg/m2 intervention 2: JNJ-30979754 20 mg/m2
Intervention descriptions: intervention 1: JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. intervention 2: Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants.

Protocol documents:
Clinical trial NCT00796705
Conditions: Rheumatoid Arthritis
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Start date: 2008-11-01; Completion date: 2010-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.

Detailed description:
Over the past 10 years, advancements in biotechnology have revolutionized Rheumatoid Arthritis (RA) therapeutics with biologically-derived immunomodulating compounds. Tumor Necrosis Factor (TNF) alpha inhibitors constitute the largest class of these new biologic therapies. The purpose of this study is to determine the effectiveness of switching to an alternative TNF-alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA who have had inadequate clinical response to the study drugs etanercept and adalimumab.

This study will last approximately 16 weeks. Participants will be randomized into two arms and receive injections once per week for 12 weeks. Participants in the adalimumab arm will receive alternating subcutaneous adalimumab and adalimumab placebo injections. Participants in the etanercept arm will receive subcutaneous etanercept injections.

This study consists of thirteen study visits after randomization. Study visits will occur on a weekly basis for 12 weeks prior to a follow-up visit at Week 16. A vital signs measurement and adverse event assessment will occur at each visit. A physical exam, assessment of tender and swollen joints, medication assessment, and blood collection will occur at Weeks 4, 8, 12, and 16.

Arms: arm 1: 1 sub-cutaneous (SQ) injection of adalimumab or 1 SQ injection of placebo will be given in a blinded and alternating fashion for a total of 12 weeks arm 2: Participants will receive 1 SQ injection of etanercept each week for 12 weeks
Interventions: intervention 1: Adalimumab intervention 2: Adalimumab placebo intervention 3: Etanercept
Intervention descriptions: intervention 1: 40 mg injection of adalimumab administered subcutaneously intervention 2: 1.0 ml .9% saline placebo administered subcutaneously intervention 3: 50 mg dimeric fusion protein administered subcutaneously

Protocol documents:
Clinical trial NCT00823472
Conditions: in Vitro Fertilization Ovulation Induction
Keywords: embryonic structures sperm injections, intracytoplasmic IVF GnRH antagonist ovarian stimulation cycle day 2 versus cycle day 5
Sponsor: UMC Utrecht
Start date: 2009-01-01; Completion date: 2010-10-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background of the study:

Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity.

Objective of the study:

The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day.

Study design:

Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment.

Intervention:

One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist.

Primary study parameters/outcome of the study:

Primary outcome parameter is number of top embryos per ovum pick up.

Secondary study parameters/outcome of the study:

Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Mild stimulation
Intervention descriptions: intervention 1: Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm

Protocol documents:
Clinical trial NCT00828204
Conditions: Multiple Sclerosis
Sponsor: Biogen
Start date: 2009-01-01; Completion date: 2010-10-01
Enrollment: 95 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study was to evaluate the safe and effective use of the single-use autoinjector for the intramuscular (IM) delivery of liquid Avonex® (interferon beta-1a) in participants with multiple sclerosis (MS).

Detailed description:
The Main Study was a 4-week treatment period which consisted of 1 Avonex manual injection using a prefilled syringe, followed by 3 Avonex injections using the single-use autoinjector. The Extension Study was designed to provide continuation of treatment with the Avonex single-use autoinjector to eligible participants who completed the Main Study for up to an additional 12 weeks, and to obtain additional safety and preference data for the Avonex single-use autoinjector.

Participants were enrolled under the initial study protocol (Initial Subject Subset); the study was subsequently suspended. Changes were made to the protocol (including modifications to the autoinjector needle), and additional participants were enrolled (Main Subject Subset).

Arms: arm 1: Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.

In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.
Interventions: intervention 1: single-use autoinjector with a prefilled liquid Avonex syringe intervention 2: Avonex prefilled syringe via manual IM injection intervention 3: BG9418 (interferon beta-1a)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00835185
Conditions: Metastatic Colorectal Cancer
Keywords: Antibodies, Monoclonal Colorectal Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2007-08-01; Completion date: 2010-10-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if IMC-11F8 in combination with chemotherapy is effective in treating colorectal cancer (CRC).

Detailed description:
The purpose of this study is to evaluate the anti-tumor activity (best overall response) of the anti-epidermal growth factor receptor (EGFR) monoclonal antibody IMC-11F8 administered in combination with mFOLFOX-6 chemotherapy regimen in treatment-naive, locally-advanced or metastatic CRC participants.

Arms: arm 1: Participants will receive IMC-11F8 (necitumumab) once every 2 weeks in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA)
Interventions: intervention 1: IMC-11F8 (necitumumab) intervention 2: Oxaliplatin intervention 3: Folinic acid (FA) intervention 4: 5-FU
Intervention descriptions: intervention 1: IMC-11F8 800 milligrams (mg) intravenous (IV) infusion over 50 minutes on Day 1 intervention 2: Oxaliplatin 85 milligrams per meter square (mg/m²) IV infusion over 2 hours on Day 1 intervention 3: FA 400 mg/m² IV infusion bolus injection intervention 4: 5-FU 400 mg/m² as a bolus followed by 2400 mg/m² IV continuous infusion over 46 hours

Protocol documents:
Clinical trial NCT00845065
Conditions: Hepatitis C, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-02-01; Completion date: 2010-10-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa-

2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the

addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with

peginterferon alfa-2a/ribavirin.

Detailed description:

Arms: arm 1: Peginterferon alfa-2a (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by placebo (800 mg three times a day \[TID\] PO, using placebo matching SCH 503034 200-mg capsules) + peginterferon alfa-2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up. arm 2: Peginterferon alfa-2a (180 μg/week subcutaneously \[SC\]) plus ribavirin (1000 to 1200 mg/day orally \[PO\]) for 4 weeks followed by boceprevir (800 mg three times a day \[TID\] PO, using SCH 503034 200-mg capsules) + peginterferon alfa-2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks

with 24 weeks post-treatment follow-up.
Interventions: intervention 1: Boceprevir intervention 2: Placebo intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: 800 mg, using SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 2: 800 mg, using placebo matching SCH 503034 200-mg capsules, three times a day (TID) orally (PO) for 48 weeks intervention 3: Peginterferon alfa-2a, pre-filled syringes, given 180 μg/week subcutaneously (SC) for 48 weeks intervention 4: Ribavirin 200-mg capsules, weight-based dosing

* \<75 kg, 1000 mg/day orally (PO), divided twice daily (BID)
* \>=75 kg, 1200 mg/day PO, divided BID

for 48 weeks

Protocol documents: