ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00365456
Conditions: Osteoporosis
Keywords: Lumbar Spine Bone Mineral Density (BMD)
Sponsor: Takeda
Start date: 2006-07-01; Completion date: 2011-08-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Parathyroid Hormone (PTH) intervention 2: Risedronate
Intervention descriptions: intervention 1: Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen. intervention 2: Orally once weekly as one 35 mg tablet.

Protocol documents:
Clinical trial NCT00382031
Conditions: Head and Neck Cancer Squamous Cell Cancer
Sponsor: Genmab
Start date: 2006-11-01; Completion date: 2011-08-01
Enrollment: 286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer

Detailed description:
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.

Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.

Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.

Arms: arm 1: Zalutumumab in combination with Best Supportive Care arm 2: Best Supportive Care
Interventions: intervention 1: Zalutumumab intervention 2: Control
Intervention descriptions: intervention 1: Individual dose titration weekly i.v doses intervention 2: Best Supportive Care

Protocol documents:
Clinical trial NCT00385697
Conditions: Type 1 Diabetes Mellitus
Keywords: Randomized Double Blind Parallel Group Controlled Clinical Trial
Sponsor: MacroGenics
Start date: 2006-10-01; Completion date: 2011-08-01
Enrollment: 554 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels.

Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

Detailed description:
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

Arms: arm 1: Full dose of teplizumab IV for 14 days, repeated at Week 26 arm 2: One third full dose of teplizumab IV for 14 days, repeated at Week 26 arm 3: Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26 arm 4: Placebo IV dosing daily for 14 days repeated at Week 26 arm 5: Full dose of teplizumab IV for 14 days, repeated at Week 26
Interventions: intervention 1: Teplizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Daily IV dosing for 14 days, repeated at Week 26 intervention 2: Daily IV dosing for 14 days, repeated at Week 26

Protocol documents:
Clinical trial NCT00385996
Conditions: Carcinoma, Non-small Cell Lung
Keywords: Carcinoma,non-small cell lung preoperative Tarceva Response rate
Sponsor: Weill Medical College of Cornell University
Start date: 2006-10-01; Completion date: 2011-08-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

Detailed description:
Tarceva® (erlotinib) is a drug that blocks a receptor called the Epidermal Growth Factor Receptor (EGFR) on certain cells including tumor cells. Blocking this receptor has been shown to shrink tumors in some patients. Tarceva®(erlotinib) is approved for commercial use by the U.S. Food and Drug Administration for treatment of Non-Small Cell Lung Cancer (NSCLC) after failure of at least one chemotherapy treatment. However, it is not approved for the first treatment of Non-Small Cell Lung Cancer (NSCLC), which is the treatment used in this study.

Patients with early stage non-small cell lung cancer will receive daily Tarceva® (erlotinib) at 150 mg/day for 3 weeks followed by surgical resection at week 4. High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva® (erlotinib). Post-operative 2-year treatment with Tarceva® (erlotinib) will be offered to patients who had at least a 50% (half) decrease in size of their tumor after treatment with Tarceva® (erlotinib)and/or patients with tumors that were found to have the receptor, Epidermal Growth Factor Receptor (EGFR), on their tumor cells at the time of their surgery.

Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II. Patients who receive post-operative chemotherapy will begin Tarceva (erlotinib)no sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery. Follow-up for recurrence and survival will continue for 2 years.

Arms: arm 1: Erlotinib 150mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.
Interventions: intervention 1: Tarceva (Erlotinib)
Intervention descriptions: intervention 1: Patients will receive daily erlotinib at 150 mg/day for 3 weeks followed by surgical resection at week 4 then daily Tarceva® at 150 mg/day for 2 years for those patients who had a response rate of at least 50% tumor volume reduction and/or have EGFR-positive tumor tissue determined by IHC and/or FISH.

Protocol documents:
Clinical trial NCT00390221
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: MS multiple sclerosis
Sponsor: Biogen
Start date: 2008-02-01; Completion date: 2011-08-01
Enrollment: 621 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.

Detailed description:

Arms: arm 1: Participants will receive 3 subcutaneous (SC) injections of placebo every 4 weeks for up to 52 weeks. arm 2: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks. arm 3: Participants will receive 3 SC injections every 4 weeks for up to 52 weeks.
Interventions: intervention 1: BIIB019 (Daclizumab High Yield Process) intervention 2: Placebo
Intervention descriptions: intervention 1: SC injection intervention 2: Placebo SC injection

Protocol documents:
Clinical trial NCT00393068
Conditions: Esophageal Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2007-02-01; Completion date: 2011-08-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if adding two targeted drugs (bevacizumab and erlotinib) further improves the response to chemotherapy (5-FU, paclitaxel, carboplatin) and radiation therapy in patients with operable esophageal cancer.

Side effects (toxicity) information will also be collected.

Detailed description:
Surgical removal has been the standard treatment for operable esophageal cancer. However, recent studies have shown improved results when patients receive a short course of chemotherapy and radiation therapy prior to surgery.

Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).

Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.

Arms: arm 1: Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).

Surgery will be performed approximately 12-14 weeks after beginning this combined treatment.
Interventions: intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin intervention 5: 5-FU intervention 6: Radiation therapy intervention 7: Surgery
Intervention descriptions: intervention 1: Erlotinib intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin intervention 5: 5-FU intervention 6: Radiation therapy intervention 7: Surgery

Protocol documents:
Clinical trial NCT00404755
Conditions: Major Depressive Disorder Dysthymia
Keywords: Depression
Sponsor: New York State Psychiatric Institute
Start date: 2006-07-01; Completion date: 2011-08-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.

Detailed description:
Preliminary data suggest that depressed patients with increased left hemispheric laterality of perceptual processing are unlikely to improve during 6 weeks' treatment with placebo, while being very responsive to either imipramine or fluoxetine. Depressed patients who do not show evidence of poor right hemispheric functioning respond significantly more often to placebo than those with poor right hemispheric functioning , and do not show an advantage of drug over placebo. 100 patients will be tested with verbal and nonverbal dichotic tests, and then treated sequentially with bupropion, escitalopram, and imipramine. Preferential hemisphere for auditory processing will be correlated with treatment outcome.

Arms: arm 1: escitalopram 10 mg/d for 1 week, then increasing by 10 mg/week if tolerated and not remitted to maximal dose of 40 mg/d arm 2: bupropion extended release (XL) 150 mg/d for a week, then 300 mg/d for a week and then 450 mg/d; all dose increases if tolerated and not remitted arm 3: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then by 50 mg/week to a maximum dose of 300 mg/d; all dose increases if tolerated and not remitted
Interventions: intervention 1: escitalopram intervention 2: bupropion intervention 3: imipramine
Intervention descriptions: intervention 1: Escitalopram: wk 1: 10 mg/d; wks 2-3: 20 mg/d; wk4: 30 mg/d; wks 5-6: 40 mg/d intervention 2: bupropion XL 150 mg/d increasing as tolerated and not remitted by 150 mg/d to maximal dose of 450 mg/d intervention 3: imipramine 50 mg/d increasing twice weekly by 50 mg/increase to 200 mg/d, then 50 mg increase/week to 300 mg/d; all dose increases if tolerated and not remitted

Protocol documents:
Clinical trial NCT00414453
Conditions: Neuropathic Pain Chronic Pain Multiple Sclerosis
Keywords: Neuropathic pain Chronic pain Multiple sclerosis Central neuropathic pain Peripheral neuropathic pain Opioid analgesic Lidocaine
Sponsor: University of Rochester
Start date: 2007-01-01; Completion date: 2011-08-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will determine whether treatment with an extended-release opioid or topical lidocaine is effective in relieving distal symmetric lower extremity burning pain associated with multiple sclerosis (MS). If treatment with topical lidocaine is efficacious, it will have important implications for understanding this chronic pain syndrome, which is widely assumed to be caused by central nervous system pathology.

Detailed description:
This study is a single-center, double-blind, 15-week, 3-period crossover clinical trial. Subjects will complete each of the following 5-week long periods (unless they withdraw from the trial): 1) placebo pills and topical lidocaine patches, 2)extended-release oxycodone pills and placebo(vehicle) patches, and 3)placebo pills and placebo patches. Sixty subjects will be randomized to one of 6 treatment sequences. It is expected that this trial will take approximately 2 years to complete.

Arms: arm 1: 5% lidocaine patch used as intervention placebo patch used with extended release oxycodone or with placebo pills and placebo patches a randomized subjects given extended release oxycodone and placebo patches during this treatment placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group period
Interventions: intervention 1: Lidocaine patch 5% intervention 2: Extended-release oxycodone intervention 3: Placebo extended-release oxycodone pills intervention 4: Placebo lidocaine patches
Intervention descriptions: intervention 1: lidocaine 5% patch; 12 hours on, 12 hours off intervention 2: extended-release oxycodone titrating schedule intervention 3: placebo pills with titrating schedule intervention 4: used with extended release oxycodone group; used with placebo pills/placebo patches

Protocol documents:
Clinical trial NCT00435370
Conditions: Smoking Cessation Schizophrenia
Sponsor: Baylor College of Medicine
Start date: 2006-11-01; Completion date: 2011-08-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive symptoms in Chinese people with schizophrenia.

Detailed description:
Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. In considering the high rate of cigarette smoking among people with schizophrenia, it is also likely that they smoke. People with schizophrenia who smoke tend to experience improved cognition, and tobacco withdrawal has been associated with deterioration of cognition. This suggests that nicotine may improve cognitive deficits or medication side effects in people with schizophrenia.

Auditory sensory gating, a neural mechanism thought to reflect sensory information processing and affect cognition, is diminished in people with schizophrenia. Auditory sensory gating has been associated with the 7 nicotinic acetylcholine receptor, a brain receptor that is important for cognition and can be activated by nicotine. Activation of this receptor using an agonist medication, such as tropisetron, may produce the same positive effect that nicotine has on cognition. This study will determine the effectiveness of using tropisetron as supplemental therapy to the atypical neuroleptic risperidone in people with schizophrenia.

Participants in this 12-week double blind study will be randomly assigned to receive either tropisetron or placebo. All participants will also follow a 6-mg risperidone regimen. Study visits will occur every 2 weeks throughout the study and final outcome assessments will include cognitive functioning and treatment safety and effectiveness.

Arms: arm 1: Tropisetron (10mg/day) + risperidone(6mg/day) arm 2: Placebo + risperidone (6mg/day)
Interventions: intervention 1: Tropisetron intervention 2: Placebo intervention 3: Risperidone
Intervention descriptions: intervention 1: 10 mg/day intervention 2: placebo intervention 3: 6mg/day

Protocol documents:
Clinical trial NCT00436969
Conditions: Glenohumeral Osteoarthritis
Keywords: Orthovisc Osteoarthritis Shoulder Randomized
Sponsor: DePuy Mitek
Start date: 2006-12-01; Completion date: 2011-08-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

Detailed description:
This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.

Arms: arm 1: Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). arm 2: Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.
Interventions: intervention 1: Orthovisc intervention 2: Control
Intervention descriptions: intervention 1: Orthovisc injection intervention 2: Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Protocol documents:
Clinical trial NCT00444587
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-03-01; Completion date: 2011-08-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Second line chemotherapy intervention 2: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: As prescribed intervention 2: 6mg/kg iv every 3 weeks

Protocol documents:
Clinical trial NCT00468910
Conditions: Colon Cancer Precancerous Condition Rectal Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-03-01; Completion date: 2011-08-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.

SECONDARY OBJECTIVES:

I. Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.

II. Assess the effect of this drug on rectal prostaglandin levels in these patients.

III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.

IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.

ARM II: Patients receive oral placebo once daily.

In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.

Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline (during prestudy colonoscopy) and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity (including plasma cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers associated with antineoplastic alteration (including apoptosis and cell proliferation). UGT1A6 genotyping analysis is also performed.

After completion of study treatment, patients are followed at 3 months.

Arms: arm 1: Patients receive oral acetylsalicylic acid (aspirin) once daily. arm 2: Patients receive oral placebo once daily.
Interventions: intervention 1: acetylsalicylic acid intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative study

Protocol documents:
Clinical trial NCT00475423
Conditions: Idiopathic Thrombocytopenic Purpura
Sponsor: Hoffmann-La Roche
Start date: 2007-05-01; Completion date: 2011-08-01
Enrollment: 122 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15

Protocol documents: