ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00332644
Conditions: Nicotine Dependence
Sponsor: University of Wisconsin, Madison
Start date: 2004-09-01; Completion date: 2010-08-01
Enrollment: 1504 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.

Detailed description:
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.

Arms: arm 1: nicotine patch alone treatment arm 2: nicotine lozenge alone treatment arm 3: nicotine patch + lozenge combination treatment arm 4: bupropion alone treatment arm 5: bupropion + nicotine lozenge combination treatment arm 6: placebo control (no active medication) treatment
Interventions: intervention 1: nicotine patch intervention 2: nicotine lozenge intervention 3: nicotine patch + nicotine lozenge intervention 4: bupropion intervention 5: bupropion + lozenge intervention 6: placebo
Intervention descriptions: intervention 1: used according to FDA package label intervention 2: used according to FDA-approved package directions intervention 3: dosage of both according to FDA-approved dosing schedule intervention 4: dosage according to FDA-approved instructions intervention 5: dosage according to FDA approved standard instructions intervention 6: dosage same as active drug conditions

Protocol documents:
Clinical trial NCT00332709
Conditions: Osteoporosis Postmenopausal
Keywords: Breast cancer postmenopausal bone mineral density Zoledronic acid Letrozole extended adjuvant treatment. Postmenopausal women with primary hormone receptor positive breast cancer
Sponsor: Novartis
Start date: 2006-01-01; Completion date: 2010-08-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an infusion.

This trial did not recruit patients in the United States.

Detailed description:

Arms: arm 1: Letrozole orally 2.5 mg/day for 3 years arm 2: Letrozole orally 2.5mg/day for 3 years; Zoledronic acid 4mg every 6 months by infusion
Interventions: intervention 1: Letrozole intervention 2: Zoledronic acid
Intervention descriptions: intervention 1: 2.5 mg/day for 3 years intervention 2: 4 mg every 6 months

Protocol documents:
Clinical trial NCT00356122
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung non-small cell chemotherapy tumor advanced recurrent metastatic Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Sanofi
Start date: 2006-07-01; Completion date: 2010-08-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to see how well three investigational drugs worked together in preventing progression of the disease. This study provided a new combination of chemotherapy drugs - docetaxel and oxaliplatin - as first line therapy in the treatment of lung cancer. The therapy included bevacizumab that may prevent or slow down the blood supply to the tumor and may also prevent tumor growth. The three investigational drugs are United States Food and Drug Administration (FDA) approved.

Detailed description:
The planned treatment duration for each participant is six 21-day treatment cycles of combination therapy; non-progressing participants will continue on bevacizumab monotherapy until progression. After discontinuation or after completion of all study treatments, all participants will be contacted every 3 months for a maximum of 2 years from first treatment to document overall survival and record new anticancer treatment (chemotherapy or biologic).

Arms: arm 1: Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
Interventions: intervention 1: Docetaxel intervention 2: Oxaliplatin intervention 3: Bevacizumab
Intervention descriptions: intervention 1: 70 mg/m\^2 administered intravenously (IV) on Day 1 for Cycles 1-6 (the treatment cycle is 3 weeks) intervention 2: 100 mg/m\^2 administered IV on Day 1 for Cycles 1-6 intervention 3: 15 mg/kg administered IV on Day 1 for Cycles 1-6, and every 3 weeks during maintenance therapy for a total treatment of one year, until disease progression or death due to any cause, whichever occurs first.

Protocol documents:
Clinical trial NCT00433329
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension bosentan sildenafil combination therapy Compass 3
Sponsor: Actelion
Start date: 2007-03-01; Completion date: 2010-08-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An open label, non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute walk distance (6 MWD) of ≥380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters.

Detailed description:

Arms: arm 1: Oral bosentan 62.5 mg twice daily (BID) first 4 weeks, followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated, with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
Interventions: intervention 1: Bosentan intervention 2: Sildenafil
Intervention descriptions: intervention 1: Oral bosentan 62.5 mg BID first 4 weeks followed by 24 weeks of 125 mg BID if the 62.5 mg BID dose was well tolerated intervention 2: Oral sildenafil 20 mg TID in patients who do not reach the 6-MWT distance threshold at Week 16

Protocol documents:
Clinical trial NCT00442702
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2007-09-01; Completion date: 2010-08-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera. arm 2: Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
Interventions: intervention 1: Mircera intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: Starting dose of 120, 200 and 360 micrograms administered by subcutaneous injection once a month. intervention 2: As prescribed, subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling specifications.

Protocol documents:
Clinical trial NCT00454142
Conditions: Recurrent Lymphoepithelioma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx
Sponsor: National Cancer Institute (NCI)
Start date: 2007-08-01; Completion date: 2010-08-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with stage IV or recurrent nasopharyngeal cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the efficacy of pazopanib hydrochloride in patients with stage IV or recurrent nasopharyngeal carcinoma.

II. Determine the progression-free survival of patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine the effect of this drug on angiogenesis inhibition using dynamic contrast-enhanced computed tomography (CT) scan.

V. Determine the pharmacokinetic profile of this drug in these patients. VI. Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit rate and pharmacokinetics.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 12 months.

Arms: arm 1: Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Pharmacological study will be done on Day 1 and Day 28. Computed tomography will be done at baseline and day 28.
Interventions: intervention 1: pazopanib hydrochloride intervention 2: pharmacological study intervention 3: computed tomography
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00462072
Conditions: Rheumatoid Arthritis Psoriatic Arthritis Psoriasis Crohn's Disease
Sponsor: University of Rochester
Start date: 2007-03-01; Completion date: 2010-08-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Specific Aim 1. To determine the transcriptome of peripheral blood mononuclear cells isolated monocytes and target tissues in IMIDs.

Specific Aim 2. To analyze the change in gene expression profiles in patients with Crohn's disease, psoriatic and rheumatoid arthritis before and after infliximab therapy.

Detailed description:
Our hypothesis is that hematopoietic stem cells are very sensitive to elevated levels of TNFa, which potentiates their differentiation into myeloid effector cells. During their migration from the bone marrow to the end organ, these cells express a unique set of genes that function to prime these cells to respond to critical differentiation signals. Elucidation of this transcriptome through microarray analysis will provide insight into novel drug targets and a formal understanding of the biochemical and molecular genetic events linking IMIDs. To test our hypothesis, will determine the transcriptome in peripheral blood mononuclear cells and isolated monocytes from 20 normal healthy donors, 10 patients with psoriatic arthritis, 10 patients with psoriasis, 10 patients with Crohn's disease and 10 patients with rheumatoid arthritis. The transcriptome will also be examined in inflamed intestinal tissue from patients with Crohn's disease, psoriatic skin and synovial tissue from patients with rheumatoid and psoriatic arthritis.

Interventions: intervention 1: Infliximab
Intervention descriptions: intervention 1: Subjects will be on a stable dose of methotrexate 12.5 to 20 mg per week and will be started on infliximab 5 mg/kg.

Protocol documents:
Clinical trial NCT00465972
Conditions: HIV Infections Insomnia
Keywords: HIV Insomnia Cytokines Adherence
Sponsor: Duke University
Start date: 2007-03-01; Completion date: 2010-08-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use in patients who are HIV positive and suffer from insomnia.

Detailed description:
Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.

Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.

Arms: arm 1: Placebo arm 2: Doxepin arm 3: Temazepam
Interventions: intervention 1: Doxepin intervention 2: Temazepam intervention 3: Placebo
Intervention descriptions: intervention 1: Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length intervention 2: Temazepam capsule 15 mg po nightly x duration of study intervention 3: Placebo capsule nightly for duration of study

Protocol documents:
Clinical trial NCT00477204
Conditions: Type 1 Diabetes Mellitus Dyslipidemia
Keywords: Type 1 Diabetes Mellitus dyslipidemia adolescents
Sponsor: University of Colorado, Denver
Start date: 2007-05-01; Completion date: 2010-08-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to establish the safety of ezetimibe/simvastatin and simvastatin in adolescents with Type 1 Diabetes and to determine the amount of decrease in LDL-cholesterol.The study hypothesizes that simvastatin and ezetimibe/simvastatin will be safe in adolescents with Type 1 Diabetes and will lower LDL-cholesterol at 6 months.

Detailed description:
Cardiovascular disease is the leading cause of death in people with type 1 diabetes mellitus (T1DM) and since atherosclerosis begins in childhood, data to inform clinicians as to appropriate dyslipidemia treatment in this high-risk population are of great public health importance. In this trial of lipid-lowering medications (Zocor \[simvastatin\], a statin, compared to Vytorin \[ezetimibe/simvastatin\], a combination of a statin and Zetia, a medication that blocks cholesterol absorption) will be performed in patients ages 12-18 years with LDL ≥ 130 mg/dl, consistent with current ADA guidelines. The study hypothesizes that Zocor and Vytorin will be safe in adolescents with T1DM and will lower LDL-cholesterol at 6 months compared to baseline. In a two-arm design, Vytorin will lower LDL-c more than monotherapy with Zocor.

Arms: arm 1: Zocor(simvastatin)(20 mg)daily for 6 months along with Placebo (sugar pill)of active comparator (Vytorin \[simvastatin\] + Zetia \[ezetimibe\]. arm 2: Vytorin(simvastatin \[Zocor} + ezetimibe \[Zetia\])(20 mg)daily for 6 months along with placebo (sugar pill)of comparator (Vytorin \[simvastatin\]).
Interventions: intervention 1: Simvastatin intervention 2: Ezetimibe/Simvastatin
Intervention descriptions: intervention 1: simvastatin 20 mg daily intervention 2: Ezetimibe (10mg)/Simvastatin (20mg)

Protocol documents:
Clinical trial NCT00502307
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Carcinoma AV-951 tivozanib
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2007-10-01; Completion date: 2010-08-01
Enrollment: 272 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase 2 trial is evaluating the antineoplastic activity of tivozanib (AV-951) in treating patients with recurrent or metastatic renal cell cancer. Tivozanib (AV-951) is a VEGF-receptor tyrosine kinase inhibitor, and may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description:
Approximately 200 patients will be enroled into the initial, 16 week, open-label period using 1.5 mg/day dosing. Patients will receive tivozanib (AV-951) continuously for 3 weeks followed by 1 week off study drug. Patients will undergo disease assessment at baseline and after Cycles 2 and 4 and response will be determined by RESIST criteria.

After the initial, 16 week open-label period, disease status will be assessed and compared to baseline using modified RECIST criteria:

* Patients with greater than or equal to 25% tumor shrinkage will continue on their current dose of tivozanib (AV-951)
* Patients with less than 25% tumor change (growth or shrinkage) will be randomly assigned to double-blind tivozanib (AV-951) or matching placebo for 12 weeks
* Patients with greater than or equal to 25% tumor growth will be discontinued

Arms: arm 1: Tivozanib (AV-951) administered as a solid dosage form daily for three weeks per month arm 2: solid oral capsule containing excipients dosed daily for three weeks per month
Interventions: intervention 1: Tivozanib (AV-951) intervention 2: Placebo comparator
Intervention descriptions: intervention 1: solid oral dosage form taken daily for three weeks per one month cycle intervention 2: solid oral capsule containing excipients dosed daily for three weeks per month

Protocol documents:
Clinical trial NCT00514137
Conditions: Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-09-01; Completion date: 2010-08-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sunitinib works in treating patients with relapsed multiple myeloma. Sunitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the number of responses in patients with relapsed multiple myeloma treated with sunitinib (sunitinib malate).

SECONDARY OBJECTIVES:

I. To assess the toxicity of sunitinib malate in patients with relapsed multiple myeloma.

II. To assess time to progression after initial response to sunitinib malate.

OUTLINE:

Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3-6 months for up to 3 years.

Arms: arm 1: Patients receive 37.5 mg oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Oral 37.5 mg each day of the 6-week cycle (continuous dosing).

Protocol documents:
Clinical trial NCT00515619
Conditions: Epilepsy
Sponsor: UCB Pharma
Start date: 2004-12-01; Completion date: 2010-08-01
Enrollment: 376 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this trial is to determine safety and efficacy of Lacosamide under long term therapy.

Detailed description:

Arms: arm 1: 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: 50 mg and 100 mg tablets up to 800 mg/day as twice day (BID) dosing throughout the trial

Protocol documents: