ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00086411
Conditions: Tobacco Use Disorder
Keywords: light smokers, smoking cessation treatment programs
Sponsor: University of Pennsylvania
Start date: 2003-09-01; Completion date: 2009-06-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare two different types of Food and Drug Administration (FDA) approved smoking cessation medications (nicotine patch or bupropion) used in conjunction with two levels of counseling. It was hypothesized that the higher level of counseling would have the highest rates of treatment completion and highest rates of abstinence.

Detailed description:
The study compared a minimal level counseling model to a higher level counseling model plus one of two types of FDA approved smoking cessation products (bupropion or the nicotine patch)used to achieve long term abstinence among lighter smokers. Each participant received both products under blinded conditions meaning that neither the participant nor the counselor knew which product was real or a placebo. The primary goal was to determine the combination or combinations of high or low intensity counseling and pharmacotherapy (either bupropion or the nicotine patch) that were most effective for lighter smokers. The main hypothesis was that higher level counseling would contribute to improved outcomes meaning that more counseling would be associated higher abstinence rates following the completion of treatment and at longer term follow-up.

Arms: arm 1: bupropion and MM counseling with placebo patch arm 2: bupropion and Mayo counseling with placebo patch. arm 3: patch and MM counseling with placebo pills arm 4: patch and Mayo counseling with placebo pills
Interventions: intervention 1: nicotine transdermal system intervention 2: bupropion intervention 3: Medication Management intervention 4: Mayo Counseling intervention 5: placebo patch intervention 6: placebo bupropion
Intervention descriptions: intervention 1: starting with 21 or 14mg dependent on number of cigarettes per day smoked upon entry in the study; titrated down over 8 weeks. intervention 2: 150 mg/day X 3 days 300mg/day for 60 days Total 9 weeks intervention 3: Brief manual based therapy; four 15 minute session over 10 weeks. intervention 4: Manual based therapy; Weekly 30 minute sessions for 10 weeks intervention 5: placebo patch containing no nicotine intervention 6: placebo pills

Protocol documents:
Clinical trial NCT00095563
Conditions: High-grade Salivary Gland Carcinoma High-grade Salivary Gland Mucoepidermoid Carcinoma Low-grade Salivary Gland Carcinoma Low-grade Salivary Gland Mucoepidermoid Carcinoma Recurrent Adenoid Cystic Carcinoma of the Oral Cavity Recurrent Salivary Gland Cancer Salivary Gland Acinic Cell Tumor Salivary Gland Adenocarcinoma Salivary Gland Adenoid Cystic Carcinoma Salivary Gland Malignant Mixed Cell Type Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2004-09-01; Completion date: 2009-06-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of lapatinib in treating patients who have recurrent and/or metastatic adenoid cystic cancer or other salivary gland cancers. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the antitumor activity of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands using objective response rates (partial and complete responses).

SECONDARY OBJECTIVES:

I. To determine the duration of objective response, rate and duration of stable disease, progression-free, median and overall survival rates of GW572016 in recurrent and/or metastatic adenoid cystic carcinoma of the salivary glands.

II. To estimate the antitumor activity of GW572016 in other epidermal growth factor receptor (EGFR)- and/or erbB2-overexpressing malignant tumors of the salivary glands using objective response rates (partial and complete responses).

III. To document the safety and tolerability of GW572016 in these patient populations

TERTIARY OBJECTIVES:

I. To investigate if differences in baseline levels of EGFR and/or erbB2 expression, and receptor phosphorylation status in tumor specimens predict outcome to therapy.

II. To investigate if the inhibitory effects of GW572016 on EGFR and/or erbB2 pathway activation in tumor specimens correlate with clinical outcome.

III. To determine the steady state levels of GW572016 achieved, and their correlation with clinical and laboratory correlative endpoints.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

Patients are followed for survival

Arms: arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Interventions: intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00122954
Conditions: Multiple Sclerosis Depression
Keywords: Fatty Acids, Omega-3 Fish Oils Complementary Therapies
Sponsor: Oregon Health and Science University
Start date: 2005-07-01; Completion date: 2009-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether fish oil can reduce depression in people with multiple sclerosis (MS) who are mild to moderately depressed and are currently taking antidepressant medication.

Study hypothesis: Three months of fish oil supplementation will improve depression scores on the Montgomery-Asberg depression rating scale (MADRS) or Beck Depression Inventory (BDI) better than placebo.

Detailed description:
Depression occurs in 50% to 60% of all individuals with MS. Evidence suggests that the omega-3 fatty acids in fish oil supplements can significantly reduce depression with a low risk of side effects. Therefore, fish oil supplements may be a safe adjunctive therapy to improve the therapeutic benefits of antidepressants. This study will determine the effectiveness of fish oil supplements in reducing depression in MS patients who are taking antidepressant medication.

This study will last 3 months. Participants will be randomly assigned to receive either fish oil supplements or placebo daily for 3 months. At the end of 3 months, participants who show an improvement in their depressive symptoms will have the option to continue their treatment for an additional 3 months. Participants will do no respond to treatment will be excused from the study. All participants will remain on their antidepressants and MS medication throughout the study. Participants will have weekly study visits. At each visit, participants will be asked about their general health, and self-report scales will be used to assess depressive symptoms. Medication adherence will be monitored by pill counts and through red blood cell fatty acid analysis. Blood collection will occur at study start and at study completion.

Arms: arm 1: Fish oil concentrate arm 2: Placebo oil
Interventions: intervention 1: Fish oil concentrate intervention 2: Placebo
Intervention descriptions: intervention 1: fish oil concentrate at a daily dose of 6 grams (2.1 gram EPA and 1.5 gram DHA). intervention 2: soybean oil with 1% fish oil at a daily dose of 6 grams

Protocol documents:
Clinical trial NCT00158184
Conditions: Opioid-Related Disorders Substance-Related Disorders
Keywords: Opiate Opioid Abuse Liability Abuse Potential
Sponsor: New York State Psychiatric Institute
Start date: 2004-06-01; Completion date: 2009-06-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.

Detailed description:
Prescription opioid abuse is becoming an increasingly widespread and serious public health concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of first-time users of prescription opioid medications for non-medical reasons reached 2 million in the year 2000, a number that has quintupled since 1984. Despite this trend, little experimental research has been directed towards understanding who may be abusing these medications, and under what conditions. The study will examine the reinforcing, subjective, performance, and physiological effects of oxycodone. Because it is not clear who is abusing prescription opioids, the medication effects will be compared in drug abusers and non-drug abusers.

Arms: arm 1: Recreational users of prescription opioids. Participants in this arm received the 3 interventions (0, 15, and 30 mg oxycodone) at random. arm 2: Participants with a history of prescription opioid use, but who did not abuse them. Participants in this arm received the 3 interventions (0, 15, and 30 mg) at random.
Interventions: intervention 1: oxycodone 15 mg intervention 2: oxycodone 30 mg intervention 3: Placebo 0 mg
Intervention descriptions: intervention 1: 15 mg/70 kg oxycodone administered once per day, orally. intervention 2: 30 mg/70 kg oxycodone administered once per day, orally. intervention 3: 0 mg placebo dose administered once a day, orally.

Protocol documents:
Clinical trial NCT00183729
Conditions: Depression
Keywords: Major depressive disorder Rehabilitating Elderly Apathy
Sponsor: Eric Lenze
Start date: 2005-08-01; Completion date: 2009-06-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

Detailed description:
Depression is a serious medical illness that is often difficult to diagnose and treat. It occurs in people of all ages, but is often overlooked in older adults. Depression frequently co-occurs with other serious illnesses, and may be mistaken by both patients and health care givers as a normal consequence of the illness. However, these misconceptions toward depression contribute to the underdiagnosis and undertreatment of depressive disorders in older people. In turn, depression may hinder a patient's recovery from an illness. This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or a cardiopulmonary condition.

This double-blind study will last for 12 months. Participants will be randomly assigned to receive either placebo or memantine, which is a drug that is often used to treat Alzheimer's disease. Both memantine and placebo will be administered to participants for 12 weeks. All participants will be followed for an additional 40 weeks. Outcome measurements will include participants' depressive symptoms, motivation, and learned helplessness. In addition, medication side effects, functional outcome, and incidence of major depressive disorder will be measured. All measurements will be taken at Week 12 and Month 12.

Arms: arm 1: Memantine for 12 weeks arm 2: Placebo for 12 weeks
Interventions: intervention 1: Memantine intervention 2: Placebo
Intervention descriptions: intervention 1: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day. intervention 2: Placebo distribution is planned to mimic the active drug.

Protocol documents:
Clinical trial NCT00193596
Conditions: Neoplasms, Unknown Primary
Keywords: Neoplasms, Unknown Primary
Sponsor: SCRI Development Innovations, LLC
Start date: 2003-09-01; Completion date: 2009-06-01
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Detailed description:
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

* Paclitaxel + Carboplatin + Etoposide
* Irinotecan + Gemcitabine

Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Arms: arm 1: Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1

Carboplatin area under the curve (AUC) 6.0 IV, day 1

Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10

Regimen A was repeated at a 21-day interval arm 2: Irinotecan 100 mg/m2 IV, days 1 and 8

Gemcitabine 1000 mg/m2 IV, days 1 and 8

Regimen B was repeated at a 21-day interval
Interventions: intervention 1: Etoposide intervention 2: Gemcitabine intervention 3: Irinotecan intervention 4: Paclitaxel intervention 5: Carboplatin
Intervention descriptions: intervention 1: 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A intervention 2: 1000 mg/m2 IV, days 1 and 8, in regimen B intervention 3: 1000 mg/m2 IV days 1 and 8 in regimen B intervention 4: 200 mg/m2 by 1-hour IV infusion, day 1, regimen A intervention 5: Area under the curve (AUC) 6.0 IV, day 1, regimen A

Protocol documents:
Clinical trial NCT00205504
Conditions: Metabolic Syndrome X Insulin Resistance Obesity Cardiovascular Diseases
Keywords: Inflammatory markers, oral contraceptions, obesity, metabolic syndrome X
Sponsor: Virginia Commonwealth University
Start date: 2005-06-01; Completion date: 2009-06-01
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Oral contraceptives (OCs) are the most widely used method of reversible birth control. However, the long-term cardiovascular safety of the widely used low-dose OCs (ethinyl-estradiol \< 50 mcg) is still debated. Although cardiovascular events are rare in young women whether they use OCs or not, the risks of myocardial infarction and ischemic stroke are increased among users of OCs who have conventional cardiovascular risk factors such as use of tobacco, diabetes or hypercholesterolemia. However, the risk of cardiovascular events in OC users with emerging cardiovascular risk factors (such as obesity and the metabolic syndrome) have not been investigated. Recently, the metabolic syndrome has been linked with the risk of cardiovascular disease. The syndrome is a clustering of risk factors in a single individual, and its underlying cause may be insulin resistance. Whether the metabolic syndrome predicts a higher cardiovascular risk in OC users has not been studied. This is a critical problem because the metabolic syndrome is prevalent in 24% of adults. Until the cardiovascular risks in users of OC are clearly defined, the appropriate use of OC with the least harm would not be possible.

The investigator's long-term goal is to understand the best way to prevent and treat cardiovascular disease in women. The objective of this particular project is to obtain pilot data on the extent to which the metabolic syndrome and obesity affects glucose metabolism and cardiovascular risks in women taking OCs. The researchers hypothesize that women with metabolic syndrome and obese women will have worsened glucose metabolism and elevated cardiovascular risks associated with OC use, when compared to normal weight women without the metabolic syndrome. Results of this study will clarify the risk factors for cardiovascular events in women taking OCs, and will serve as pilot data for a National Institutes of Health (NIH) proposal. Once the cardiovascular risk factors of OC users are understood, clinicians can make better informed decisions about contraceptive choices for their patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ortho Tri Cyclen
Intervention descriptions: intervention 1: Ortho Tri Cyclen, one tablet daily, for 6 cycles

Protocol documents:
Clinical trial NCT00211809
Conditions: Body Dysmorphic Disorder
Keywords: Body Dysmorphic Disorder SRIs Cognitive Behavioral Therapy
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2008-09-01; Completion date: 2009-06-01
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The research project is a controlled pilot study of the efficacy of cognitive-behavioral therapy (CBT) as an adjunct to serotonin reuptake inhibitor (SRI) pharmacotherapy in body dysmorphic disorder (BDD). This study assesses the efficacy of CBT in comparison to relaxation and stress management training (RSMT), an active control treatment

Detailed description:
In total, 20 BDD patients aged 16 through 65 will participate. To be eligible they must meet DSM-IV criteria for BDD, have a score of 20 or greater on the BDD modification of the Yale Brown Obsessive-Compulsive Scale (BDD-YBOCS) and be on a stable, therapeutic does of an SRI (at least 12 weeks on the SRI with 8 weeks at a therapeutic dose: acceptable medications (therapeutic daily doses) are citalopram (40mg), clomipramine (150mg), fluoxetine (40mg), fluvoxamine (150mg), paroxetine (40mg), sertraline (50mg), and venlafaxine (150mg).

Arms: arm 1: Participants with body dysmorphic disorder
Interventions: intervention 1: Cognitive Behavioral Therapy intervention 2: Venlafaxine
Intervention descriptions: intervention 1: standard psychiatric evaluation intervention 2: start dose of 37.5 mg/day and increased to a minimum of 150mg/day, generally over the first 4 weeks and then maintained at that dose for 8 weeks.

Protocol documents:
Clinical trial NCT00252564
Conditions: Metastatic Colorectal Cancer
Sponsor: US Oncology Research
Start date: 2005-09-01; Completion date: 2009-06-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the rates of Progression-Free Survival (PFS) at 12 months for patients treated with Bev-FOLFOX versus patients treated with FOLF-CB for first line treatment of metastatic colorectal cancer.

Detailed description:
This is a Phase III, open label, nonblinded study. A total of 240 eligible patients will be randomized on a 1:1 basis to either treatment Arm.

In this trial, we will compare the efficacy, safety, and tolerability of this novel combination of biweekly infusional 5-FU/leucovorin plus cetuximab and bevacizumab (FOLF-CB) to the current standard of care, biweekly infusional 5-FU/leucovorin plus oxaliplatin and bevacizumab (Bev-FOLFOX). For practical purposes, this study will be a head to head comparison of oxaliplatin versus cetuximab, since the other components of both regimens will be the same.

Arms: arm 1: (Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via "T" connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.

Bevacizumab --\> oxaliplatin and LV --\> bolus 5-FU --\> infusional 5-FU

Dosing on Days 1 and 15 of each 28-day cycle arm 2: (FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.

Cetuximab --\> bevacizumab --\> LV --\> bolus 5-FU --\> infusional 5-FU
Interventions: intervention 1: Bevacizumab intervention 2: Oxaliplatin intervention 3: Leucovorin intervention 4: Fluorouracil intervention 5: Cetuximab
Intervention descriptions: intervention 1: 5 mg/kg over 30 minutes on Days 1 and 15 intervention 2: 85 mg/m2 on Days 1 and 15 intervention 3: 400 mg/m2 on Days 1 and 15 intervention 4: 400 mg/m2, IV bolus followed by: 1200 mg/m2/day via 24-hour continuous infusion, for 2 consecutive days (total 5-FU infusion dose = 2400 mg/m2 over the 48 hour period) intervention 5: 400 mg/m2 over 2 hours (Cycle 1 Day 1 only) All subsequent doses (Day 8, 15, 22 of Cycle 1 and Days 1, 8, 15, 22 other cycles)250 mg/m2 over 1 hour

Protocol documents:
Clinical trial NCT00256204
Conditions: Parkinson's Disease
Keywords: Parkinson's Rasagiline Mesylate
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2005-11-01; Completion date: 2009-06-01
Enrollment: 1174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 2 phase study to evaluate disease progression in Parkinson's disease patients taking rasagiline

Detailed description:

Arms: arm 1: 1mg early start active treatment arm (72 weeks active)followed by 1mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) arm 2: 2mg early start active treatment arm (72 weeks active)followed by 2mg 36 week delayed start active treatment arm (36 weeks placebo followed by 36 weeks active) arm 3: Each arm is followed by 36 weeks of placebo
Interventions: intervention 1: Rasagiline Mesylate intervention 2: Rasagiline Mesylate intervention 3: Placebo
Intervention descriptions: intervention 1: tablet, 1mg once daily intervention 2: tablet, 2mg once daily intervention 3: Placebo

Protocol documents:
Clinical trial NCT00259610
Conditions: Rheumatoid Arthritis
Keywords: RA painful joints swollen joints
Sponsor: University of Alabama at Birmingham
Start date: 2004-05-01; Completion date: 2009-06-01
Enrollment: 755 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better

Detailed description:
The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have become increasingly apparent and investigators continue to gain insight into the pathogenesis of this disease. Recent evidence suggests that treatment earlier in the disease process with more aggressive approaches results in superior long-term outcomes compared to less intensive treatment regimens. Specifically, there is growing interest in the possibility that early "aggressive" treatment with combinations of DMARDs as initial treatment in efforts to potentially reduce the proportion of patients that advance to severe disability.

Arms: arm 1: methotrexate (MTX) + etanercept arm 2: methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ) arm 3: methotrexate (MTX) or MTX + Etanercept arm 4: methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
Interventions: intervention 1: methotrexate intervention 2: sulfasalazine intervention 3: hydroxychloroquine intervention 4: etanercept
Intervention descriptions: intervention 1: varies intervention 2: varies intervention 3: varies intervention 4: varies

Protocol documents: