ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00617123
Conditions: Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-07-01; Completion date: 2010-10-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).

Detailed description:

Arms: arm 1: Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year arm 2: Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
Interventions: intervention 1: Vorapaxar 2.5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Vorapaxar 2.5 mg oral tablet intervention 2: matching placebo oral tablet

Protocol documents:
Clinical trial NCT00620035
Conditions: Contraception
Sponsor: Organon and Co
Start date: 2007-03-01; Completion date: 2010-10-01
Enrollment: 301 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.

Detailed description:

Arms: arm 1: Radiopaque Etonogestrel Implant (drug) inserted with the Next Generation Applicator (NGA)

The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and

2 mm in diameter which is placed at the inner side of the non-dominant upper-arm

about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains

approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.

The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year.
Interventions: intervention 1: Radiopaque Etonogestrel Implant
Intervention descriptions: intervention 1: One implant inserted for a 3-year treatment period

Protocol documents:
Clinical trial NCT00663026
Conditions: Alzheimer Disease
Keywords: antibody immunotherapy
Sponsor: Pfizer
Start date: 2008-11-01; Completion date: 2010-10-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the safety and effectiveness of bapineuzumab for the treatment of mild to moderate Alzheimer disease. Subjects will be in the study for six months and will receive subcutaneous injections once per week.

Detailed description:

Arms: arm 1: 5 mg/week arm 2: 10 mg/week arm 3: Placebo
Interventions: intervention 1: bapineuzumab intervention 2: bapineuzumab intervention 3: placebo
Intervention descriptions: intervention 1: 5 mg bapineuzumab subcutaneous injection once per week for 6 months intervention 2: 10 mg bapineuzumab subcutaneous injection once per week for 6 months intervention 3: Placebo subcutaneous injection once per week for 6 months

Protocol documents:
Clinical trial NCT00681109
Conditions: Posterior Blepharitis
Sponsor: Reza Dana, MD
Start date: 2008-01-01; Completion date: 2010-10-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.

Detailed description:

Arms: arm 1: 2.5% IL-1Ra arm 2: Artificial Tear arm 3: 5% IL-1Ra
Interventions: intervention 1: 2.5% IL-1Ra intervention 2: Placebo intervention 3: 5% IL-1Ra
Intervention descriptions: intervention 1: 2.5% custom made topical IL-1Ra three times a day in both eyes for three months intervention 2: custom eye drop to be applied three times a day in both eyes for three months intervention 3: 5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months

Protocol documents:
Clinical trial NCT00686036
Conditions: Prostate Cancer
Keywords: prostate cancer hormone treatment
Sponsor: Genzyme, a Sanofi Company
Start date: 2008-05-01; Completion date: 2010-10-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.

Detailed description:

Arms: arm 1: 300 mg orally, once daily for up to 18 months arm 2: orally, once daily for up to 18 months
Interventions: intervention 1: vandetanib intervention 2: Placebo
Intervention descriptions: intervention 1: 300 mg orally, once daily for up to 18 months intervention 2: None

Protocol documents:
Clinical trial NCT00686972
Conditions: Bariatric Surgery
Keywords: Bariatric Surgery Glucose Regulation Cardiac Function Body Composition
Sponsor: Johns Hopkins University
Start date: 2007-05-01; Completion date: 2010-10-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.

Detailed description:
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.

Arms: arm 1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Interventions: intervention 1: GLP-1
Intervention descriptions: intervention 1: 5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.

Protocol documents:
Clinical trial NCT00687219
Conditions: Hepatitis C, Chronic Liver Cirrhosis
Keywords: hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-06-01; Completion date: 2010-10-01
Enrollment: 102 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to evaluate the efficacy and safety of combination therapy with peginterferon alfa-2b 1.0 µg/kg/week subcutaneous (SC) + ribavirin administered for 48 weeks in participants with chronic hepatitis C and type C compensated liver cirrhosis. Participants who are hepatitis C virus ribonucleic acid (HCV-RNA) positive after 24 weeks of treatment will be discontinued from therapy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Peginterferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: Administered at 1.0 µg/kg/week SC for 48 weeks intervention 2: Administered based on body weight and hemoglobin value at Screening: 600-1000 mg/day for subjects with hemoglobin value at screening \>=14g/dL, and 400-800 mg/day for subjects with hemoglobin value at screening \>=12g/dL and \<14g/dL; treatment duration is 48 weeks

Protocol documents:
Clinical trial NCT00688103
Conditions: Rheumatoid Arthritis
Sponsor: Japan Biological Agent Study Integrated Consortium
Start date: 2005-06-01; Completion date: 2010-10-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.

1. Etanercept alone treatment group (25mg, twice/week, s.c.)
2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)

Detailed description:

Arms: arm 1: etanercept (25mg, twice/week, s.c.) arm 2: etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)
Interventions: intervention 1: ETN Alone intervention 2: ETN+MTX
Intervention descriptions: intervention 1: etanercept (25 mg, twice/week, s.c.) intervention 2: etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)

Protocol documents:
Clinical trial NCT00695903
Conditions: Endocarditis, Bacterial Infective Endocarditis
Keywords: Gram-positive bacterial infections Staph Aureus Bacteremia MRSA Infective Endocarditis Right-sided Infective endocarditis SABIE SAIE RIE
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2008-09-17; Completion date: 2010-10-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA), including right-sided infective endocarditis (RIE).

Detailed description:
Patients who meet all inclusion criteria and exhibit none of the exclusion criterial will be randomized to one of two treatment arms:

1. daptomycin Intravenously (IV) 10 mg/kg every 24 hours
2. vancomycin IV dosed to maintain trough levels of 15 to 20 μg/mL.

The suggested duration of therapy with daptomycin or vancomycin will be 28 days (or up to 42 days if clinically indicated). Dose adjustments for both drugs will be made by an unblinded pharmacist at each site. To minimize the duration with which patients are treated with antibacterial agents effective against S. aureus prior to enrollment, patients with suspected MRSA bacteremia will be enrolled pending definitive culture results. Suspected MRSA bacteremia will be defined clinically or as initial blood cultures that grow Gram-positive cocci and that were obtained from a patient at increased risk for methicillin-resistant S. aureus infections. However, only patients with confirmed MRSA bacteremia or right-sided infective endocarditis will remain in the study and be evaluated for efficacy. During treatment, regular assessments will be performed. An End-of Therapy (EOT) will be performed 1-3 days after stopping therapy or upon Early Termination (ET). All patients will have a post therapy visit for Test of Cure (TOC) performed 35-49 days following last dose of study drug.

Arms: arm 1: Daptomycin 10 mg/kg IV every 24 hours arm 2: Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL
Interventions: intervention 1: daptomycin intervention 2: vancomycin
Intervention descriptions: intervention 1: daptomycin 10 mg/kg IV every 24 hours intervention 2: Vancomycin 15 mg/kg IV, dosed to maintain trough serum concentrations of 15 to 20 μg/mL

Protocol documents:
Clinical trial NCT00707655
Conditions: Head and Neck Cancer Squamous Cell Carcinoma
Sponsor: Genmab
Start date: 2008-09-01; Completion date: 2010-10-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety of zalutumumab in combination with radiotherapy as the treatment of patients with head and neck cancer who are not eligible for platinum based chemotherapy.

Detailed description:
This is an open label, multi-center, phase I/II dose-escalation clinical trial investigating the safety of zalutumumab in combination with radiotherapy. The safety of zalutumumab doses in combination with radiotherapy (RT) will be investigated using 3 patient cohorts in a dose-escalation / de-escalation design based on Dose Limiting Toxicity (DLT). The dose-escalation starts at 8 mg/kg zalutumumab in combination with RT. Initially, three patients will be treated at a dose level and observed for DLTs. If none of the three patients experience a DLT, then the next cohort of three patients is treated at the next higher dose of zalutumumab. If one of three patients treated at a dose level experience a DLT, then three more patients are treated at the same dose level. If two or more of the three patients experience DLTs, then the next cohort of three patients should be treated at the next lower dose of zalutumumab, unless at least six patients on that dose have already been dosed. Furthermore, if 1 or fewer DLTs are observed among six patients at a given dose level, then the next cohort of three patients is treated at the next higher dose of zalutumumab. The maximum tolerated dose will be decided by Genmab based on the recommendations made by the IDMC on the basis of their review of the aggregated safety data.

Arms: arm 1: Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected. arm 2: Zalutumumab in combination with radiotherapy for 8 weeks. The treatment period of 8 weeks is followed by a 3 week follow-up period where all adverse events are collected and then additionally a 2 year follow-up period where only serious adverse events are collected.
Interventions: intervention 1: Zalutumumab
Intervention descriptions: intervention 1: Eight weekly infusions

Protocol documents:
Clinical trial NCT00711009
Conditions: Human Immunodeficiency Virus Infection
Keywords: Human Immunodeficiency Virus infection
Sponsor: Abbott
Start date: 2008-07-01; Completion date: 2010-10-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

Detailed description:

Arms: arm 1: lopinavir/ritonavir 400/100 milligram (mg) tablet twice-daily + co-formulated emtricitabine/tenofovir disoproxil fumarate 200/300 mg once-daily arm 2: lopinavir/ritonavir 400/100 mg tablet twice-daily + raltegravir 400 mg twice-daily
Interventions: intervention 1: lopinavir/ritonavir (LPV/r) intervention 2: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) intervention 3: raltegravir (RAL)
Intervention descriptions: intervention 1: LPV/r 400/100 mg BID intervention 2: FTC/TDF 200/300 mg QD intervention 3: RAL 400 mg BID

Protocol documents:
Clinical trial NCT00717574
Conditions: Deep Sedation Anesthesia, General
Keywords: depth of sedation nitrous oxide general anesthesia anesthesia indices
Sponsor: University of Oklahoma
Start date: 2008-03-01; Completion date: 2010-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesizes that adding 60% nitrous oxide to a steady state sevoflurance or propofol anesthetic will lead to a decrease in both BIS and Entropy indices during a constant level of surgical stimulus

Detailed description:
Nitrous oxide is a widely used general anesthetic pas. It is often used in addition to a second, more potent agent. BIS and Entropy are depth of anesthesia monitors in clinical use. There are conflicting reports about the usefulness of these monitors when nitrous oxide is used as a part of the anesthetic regimen. While some studies demonstrate a decrease in BIS and Entropy, this study aims to investigate the effects of adding nitrous oxide to a sevoflurane or a propofol based anesthetic on BIS and Entropy indices.

Arms: arm 1: Sevoflurane based general anesthesia arm 2: Propofol based general anesthesia
Interventions: intervention 1: Sevoflurane group intervention 2: Propofol group
Intervention descriptions: intervention 1: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture. intervention 2: Addition of 60% nitrous oxide for 20 minutes duration, then back to 1:1 oxygen/air mixture.

Protocol documents:
Clinical trial NCT00726180
Conditions: Breast Cancer
Keywords: Breast cancer Women w/Her2 positive ERnegative not metastasized
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2008-07-01; Completion date: 2010-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making hormonal therapies a therapeutic option and possibly improving their overall prognosis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: trastuzumab (Herceptin®)
Intervention descriptions: intervention 1: About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.

Protocol documents:
Clinical trial NCT00745498
Conditions: Proliferative Diabetic Retinopathy Vitreous Hemorrhage
Keywords: Proliferative diabetic retinopathy vitrectomy bevacizumab vitreous hemorrhage
Sponsor: Seoul National University Bundang Hospital
Start date: 2008-06-01; Completion date: 2010-10-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effect of pre- and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Detailed description:
Postoperative vitreous hemorrhage(VH) is a common complication after vitrectomy for proliferative diabetic retinopathy. Persistent or recurrent VH can delay visual rehabilitation and give patients much trouble. There have been efforts to lower the incidence of postoperative VH such as using intraoperative gas tamponade and preoperative bevacizumab injection. Bevacizumab(Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative intravitreal bevacizumab (IVB) injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful.Our hypothesis is that preoperative bevacizumab injection could reduce postoperative VH by way of decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative VH by inhibiting the vessel formation after surgery.

To prove our hypothesis, we started the prospective randomized comparative study to determine the effect of pre- and intra-operative IVB injection on postoperative vitreous hemorrhage after diabetic vitrectomy.

Arms: arm 1: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 1 to 14 days before vitrectomy arm 2: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy arm 3: Patients will not receive bevacizumab before nor during vitrectomy
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml)

Protocol documents:
Clinical trial NCT00746252
Conditions: Bipolar Disorder
Keywords: bipolar children antipsychotic side effect
Sponsor: University of Maryland, Baltimore
Start date: 2008-06-01; Completion date: 2010-10-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn more about weight gain and related side effects when children are treated with antipsychotic medicine for mood disorders.

Detailed description:
This protocol is a six month, randomized, open label trial of risperidone versus aripiprazole in antipsychotic naive youth (7 - 12 years old) who have been identified by their clinical treatment provider as needing antipsychotic treatment of a bipolar disorder.

This study proposes to monitor changes in metabolic parameters (body mass index percentile, % body fat, insulin resistance, and lipid levels) over the course of six months treatment with aripiprazole or risperidone in youth with a bipolar spectrum disorder. We will also assess possible mechanisms of second generation antipsychotic induced weight gain by monitoring physical activity and hunger/appetite changes over the course of treatment.

Arms: arm 1: risperidone arm 2: aripiprazole
Interventions: intervention 1: risperidone intervention 2: aripiprazole
Intervention descriptions: intervention 1: Children will have a flexible dose titration based on their unique response to the medication (assessed using clinical global improvement scores). Children will be treated for six months using daily, bid dosing. intervention 2: children will have a flexible dosing titration based on their unique response (assessed using clinical global improvement scores). Children will be treated with daily medication for six months.

Protocol documents:
Clinical trial NCT00746811
Conditions: Primary Hypercholesterolemia
Keywords: cholesterol hypercholesterolemia omega 3
Sponsor: Provident Clinical Research
Start date: 2010-01-01; Completion date: 2010-10-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are to assess the effects of 4 g/d P-OM3, compared with placebo, on LDL-C and other aspects of the fasting lipid profile in subjects with primary hypercholesterolemia.

Detailed description:
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or P-OM3 for the first 6 week phase followed by the study product they did not receive during the first phase (P-OM3 or placebo) for the second 6 weeks.

Arms: arm 1: P-OM3 (4 g/d) for the first six weeks of treatment. Placebo (soy oil) for the second six weeks of treatment. arm 2: Placebo (soy oil) for the first six weeks of treatment. P-OM3 (4 g/d) for the second six weeks of treatment.
Interventions: intervention 1: P-OM3 intervention 2: Placebo
Intervention descriptions: intervention 1: 4 grams/day - 4 one gram capsules intervention 2: 4 grams/day - 4 one gram capsules

Protocol documents: