ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00673816
Conditions: Von Hippel-Lindau Syndrome
Keywords: Von Hippel Lindau Sunitinib Malate Sutent Von Hippel-Lindau Syndrome VHL
Sponsor: National Eye Institute (NEI)
Start date: 2008-05-01; Completion date: 2011-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will pilot the use of systemic sunitinib malate, a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet derived growth factor (PDGF), in five participants with Von Hippel-Lindau (VHL) to investigate its potential efficacy as a treatment for retinal angiomas. Participants will have visual dysfunction with either visual acuity loss or visual field loss from retinal angiomas secondary to genetically confirmed VHL. This open-label study will pilot the use of systemic sunitinib malate in five participants to investigate its potential efficacy as a treatment for retinal angiomas associated with VHL. Participants will receive nine months of sunitinib malate therapy (six cycles total - one cycle consists of 50 mg oral dose once daily for four weeks followed by a two week rest period). The primary outcome will be a change in the best-corrected visual acuity of more than or equal to 15 letters from baseline to the Week 36 visit. The secondary ocular outcomes will focus on retinal thickness and leakage of the retinal angioma at the Week 36 visit. Optical coherence tomography will document changes in retinal thickening and fluorescein angiography will be used to determine leakage of the retinal angioma.

Detailed description:

Arms: arm 1: Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).
Interventions: intervention 1: Sunitinib Malate
Intervention descriptions: intervention 1: Participants were expected to receive 9 months of sunitinib malate therapy administered in 6 cycles. Each cycle consisted of a daily oral dose of 50 mg sunitinib malate for 4 weeks followed by a 2-week rest period).

Protocol documents:
Clinical trial NCT00682643
Conditions: Rhinitis, Allergic, Perennial
Keywords: Perennial Allergic Rhinitis fluticasone furoate ocular safety
Sponsor: GlaxoSmithKline
Start date: 2008-06-01; Completion date: 2011-02-01
Enrollment: 550 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess long-term ocular safety of fluticasone furoate nasal spray in adult and adolescent subjects diagnosed with perennial allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: fluticasone furoate nasal spray intervention 2: vehicle placebo nasal spray
Intervention descriptions: intervention 1: fluticasone furoate nasal spray intervention 2: placebo

Protocol documents:
Clinical trial NCT00686881
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-01; Completion date: 2011-02-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

Detailed description:

Arms: arm 1: Participants receiving PegIFN-2b at 0.5 ug/kg subcutaneously (SC) once a week for up to 156 weeks. arm 2: Participants receiving SNMC 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for up to 156 weeks.
Interventions: intervention 1: Peginterferon alfa-2b (PegIFN-2b) intervention 2: Comparator: Stronger neo minophagen C (SNMC)
Intervention descriptions: intervention 1: PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks intervention 2: SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .

Protocol documents:
Clinical trial NCT00708175
Conditions: Bone Metabolism
Keywords: Glucose Metabolism Disorder Dysmetabolic Syndrome Type II Diabetes Diabetes Mellitus Lipoatrophic Postmenopausal
Sponsor: Takeda
Start date: 2008-05-01; Completion date: 2011-02-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of pioglitazone on bone metabolism in postmenopausal women with impaired fasting glucose.

Detailed description:
The World Health Organization has estimated that 30% of all women aged over 50 years (postmenopausal) have osteoporosis according to a definition of Bone Mineral Density at any site being more than 2.5 standard deviations below the mean for young healthy adult women.

A known risk factor for development of osteoporosis and fracture is diabetes mellitus, with correlations to duration of disease and poor glycemic control.

Pioglitazone is a thiazolidinedione developed by Takeda Pharmaceuticals for the treatment of type 2 diabetes. Preclinical studies to date on the bone effects of thiazolidinediones have not clearly identified a mechanism of bone loss. While there is evidence of increased bone fractures in postmenopausal diabetic females treated with a thiazolidinedione, the mechanism is not known. Initial studies with thiazolidinediones in humans have focused on short term exposure (12 to 14 weeks) and non-diabetic females. These studies have shown acute changes in circulating bone markers and bone density, but have been questioned because they may not represent bone metabolism in states of abnormal glucose metabolism. Impaired glucose tolerance has been identified not only as a risk factor for developing type 2 diabetes, but also at higher risk for known complications of diabetes. Examination of the effect of thiazolidinediones on bone metabolism in IGT patients will provide data in patients with abnormal glucose tolerance, but without the potential confounding effects of oral hypoglycemic medications to treat type 2 diabetes.

The primary objective of this study is to evaluate the effect of pioglitazone on bone mass and metabolism in postmenopausal women with impaired fasting glucose or impaired glucose tolerance. Total participation time in this study is approximately 1 year and six months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pioglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: Pioglitazone 30 mg, tablets, orally, once daily for 4 weeks, then increased to Pioglitazone 45 mg, tablets, orally, once daily for up to 48 weeks. intervention 2: Pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.

Protocol documents:
Clinical trial NCT00715624
Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1, metformin, insulin
Sponsor: Sanofi
Start date: 2008-07-01; Completion date: 2011-02-01
Enrollment: 496 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to basal insulin with or without metformin over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to basal insulin on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction at Week 24.

The secondary objectives are to assess the effects of lixisenatide when added to basal insulin on body weight, 2-hour postprandial plasma glucose (PPG) after standardized meal challenge test, percentage of patients reaching HbA1c less than 7 percent (%), percentage of patients reaching HbA1c less than or equal to 6.5%, fasting plasma glucose (FPG), change in 7-point self-monitored plasma glucose (SMPG) profiles, change in basal insulin and total insulin doses; to evaluate safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

Detailed description:
Patients who complete the 24-week main double-blind treatment would undergo a variable double-blind extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 25) for the last randomized patients.

Arms: arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 2-step initiation regimen of volume matching placebo: 10 mcg QD for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Placebo intervention 3: Basal Insulin intervention 4: Metformin intervention 5: Pen auto-injector
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: Dose to be kept stable. intervention 4: Metformin if given to be continued at stable dose (1.5 gram per day) up to the end of treatment. intervention 5: None

Protocol documents:
Clinical trial NCT00725504
Conditions: Pain
Sponsor: Stanford University
Start date: 2008-09-01; Completion date: 2011-02-01
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Our goals for this study involve using intravenous lidocaine as it is normally used in the Stanford Pain Management Center to assess the effect of intravenous lidocaine on chronic pain. Studies have been done determining the efficacy of intravenous lidocaine for treating pain but little research has been done to determine the effects of an intravenous lidocaine infusion on the different components of the pain experience. Our study will incorporate pain quality measures both before and during the infusions of lidocaine to determine changes in present pain intensity.

Detailed description:
Each patient will receive an intravenous infusion of lidocaine. Drug will be infused using a computer-controlled paradigm. This paradigm allows increasing plasma concentrations in a step-wise manner, keeping the concentration during each infusion step constant. Plasma concentrations will be increased gradually from 0 to 5 ug/ml in a method at the discretion of the medical team. This will be conducted according to standard medical practice for the infusion and the study procedures will not affect the infusion paradigm. Total infusion time is approximately 1-2 hours. During the course of the study, the primary outcome measure was changed from blood oxygenation level dependent (BOLD) signal to pain intensity.

Arms: arm 1: Each participant will receive an intravenous infusion of lidocaine. Plasma concentrations will be increased gradually from 0-5 µg/ml.
Interventions: intervention 1: Intravenous lidocaine
Intervention descriptions: intervention 1: Intravenous lidocaine administered up to 5 µg/ml.

Protocol documents:
Clinical trial NCT00758602
Conditions: Kidney Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2008-09-01; Completion date: 2011-02-01
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received mycophenolate mofetil (MMF) 0.75 to (-) 1 gram (g), orally (PO), twice daily (BID) from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 milligrams per kilogram (mg/kg), PO, BID to reach a target trough dose of 8-10 nanograms per milliliter (ng/mL) from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice. arm 2: Participants received MMF 0.75-1 g, PO, BID from Day 0 through Month 12. Participants also received tacrolimus 0.1-0.15 mg/kg, PO, BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to 0.05-0.08 mg/kg, PO, BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. Participants also received corticosteroids per center practice.
Interventions: intervention 1: mycophenolate mofetil intervention 2: tacrolimus, standard dose intervention 3: tacrolimus, low dose intervention 4: corticosteroids
Intervention descriptions: intervention 1: 0.75-1 g PO BID from Day 0 through Month 12 intervention 2: Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12. intervention 3: Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12. intervention 4: According to center's practice

Protocol documents:
Clinical trial NCT00760019
Conditions: Atherosclerosis
Keywords: vascular inflammation endothelium-dependent flow-mediated blood vessel function
Sponsor: Brigham and Women's Hospital
Start date: 2005-08-01; Completion date: 2011-02-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether reducing inflammation in blood vessels with an aspirin-like drug called salsalate will improve blood vessel function.

Detailed description:
To test the hypothesis that inhibition of I \[kappa\] B kinase \[beta\] (IĸKβ), an inflammatory mediator, by high dose salsalate, will restore insulin-mediated endothelium-dependent vasodilation in subjects with atherosclerosis.

Arms: arm 1: In this crossover study, this group was randomly allocated therapy with salsalate first, a 4 week washout, then 4 weeks of placebo therapy in a double-blinded fashion. arm 2: In this crossover study, this group was randomly allocated therapy with placebo first, a 4 week washout, then 4 weeks of salsalate therapy in a double-blinded fashion.
Interventions: intervention 1: salsalate intervention 2: placebo
Intervention descriptions: intervention 1: 1.5 grams orally 3 times daily intervention 2: matching placebo

Protocol documents:
Clinical trial NCT00764946
Conditions: Human Immunodeficiency Virus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2011-02-01
Enrollment: 209 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to test the safety and effect of twice daily raltegravir in a diverse cohort of patients currently infected with human immunodeficiency virus (HIV), where at least 50% are African American and at least 25% are female, either having received antiretroviral drugs before or not.

Detailed description:

Arms: arm 1: raltegravir
Interventions: intervention 1: Comparator: raltegravir
Intervention descriptions: intervention 1: 400 mg tablets taken twice daily. Total treatment period is 48 weeks.

Protocol documents:
Clinical trial NCT00768040
Conditions: Diabetic Macular Edema
Keywords: Diabetes Macular edema Aliskiren Diabetic retinopathy Diabetes mellitus type 1 Diabetes mellitus type 2
Sponsor: Novartis Pharmaceuticals
Start date: 2008-09-01; Completion date: 2011-02-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Detailed description:

Arms: arm 1: Aliskiren 300 mg once daily for 12 weeks arm 2: Matching placebo once daily for 12 weeks
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: 300 mg once daily intervention 2: Matching placebo once daily

Protocol documents:
Clinical trial NCT00768300
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis interstitial lung disease ambrisentan
Sponsor: Gilead Sciences
Start date: 2008-12-01; Completion date: 2011-02-01
Enrollment: 494 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ambrisentan intervention 2: Placebo
Intervention descriptions: intervention 1: Ambrisentan (5mg or 10 mg tablet) was administered orally once daily. intervention 2: Placebo to match ambrisentan was administered orally once daily.

Protocol documents:
Clinical trial NCT00772668
Conditions: Lymphoma Follicular Lymphoma Marginal Zone Lymphoma
Keywords: stage III grade 1 follicular lymphoma stage IV grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage IV grade 2 follicular lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma
Sponsor: University of Miami
Start date: 2009-09-25; Completion date: 2011-02-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells.

PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.

Detailed description:
OUTLINE:

* Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
* Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Arms: arm 1: Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

* Rituximab

  * Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
  * Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
* Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
* Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
* Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles
Interventions: intervention 1: Rituximab intervention 2: Bortezomib intervention 3: Cyclophosphamide intervention 4: Prednisone
Intervention descriptions: intervention 1: Administered intravenously during induction and maintenance therapy per protocol. intervention 2: Administered intravenously per protocol. intervention 3: Administered intravenously per protocol. intervention 4: Administered orally (PO) per protocol.

Protocol documents:
Clinical trial NCT00798694
Conditions: Glaucoma
Keywords: glaucoma impression cytology ocular surface changes prostaglandins
Sponsor: Wills Eye
Start date: 2008-11-01; Completion date: 2011-02-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.

Detailed description:
Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.

Arms: arm 1: Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. arm 2: Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Interventions: intervention 1: Xalatan intervention 2: Travatan Z
Intervention descriptions: intervention 1: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime intervention 2: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Protocol documents: