ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01119898
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Arthritis NSAIDs Topical NSAID Diclofenac PENNSAID
Sponsor: Mallinckrodt
Start date: 2010-08-02; Completion date: 2011-02-16
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life.

OA can occur in any joint, but usually affects the hands, knees, hips or spine.

The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.

Detailed description:

Arms: arm 1: Diclofenac sodium 2.0% w/w arm 2: The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Interventions: intervention 1: PENNSAID Gel intervention 2: Vehicle
Intervention descriptions: intervention 1: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks intervention 2: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

Protocol documents:
Clinical trial NCT00883896
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis ACR Methotrexate Interleukin-22
Sponsor: Pfizer
Start date: 2009-06-18; Completion date: 2011-02-18
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Detailed description:

Arms: arm 1: Part 1: Placebo arm 2: Part 1: 100 mg ILV-094 SC Q4W arm 3: Part 1: 100 mg ILV-094 SC Q2W arm 4: None arm 5: Part 2: 200 mg ILV-094 SC Q2W
Interventions: intervention 1: Placebo intervention 2: ILV-094 intervention 3: ILV-094 intervention 4: Placebo intervention 5: ILV-094
Intervention descriptions: intervention 1: Part 1: Placebo SC administration every 2 weeks X 10 weeks. intervention 2: Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks. intervention 3: Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks. intervention 4: Part 2: Placebo SC administration every 2 weeks X 10 weeks intervention 5: Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks

Protocol documents:
Clinical trial NCT01090024
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-03-01; Completion date: 2011-02-18
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients.

Detailed description:

Arms: arm 1: Patients receiving two capsules twice daily arm 2: Patients receiving four capsules in the morning arm 3: Patients receiving four capsules in the evening arm 4: Patients receiving four capsules twice a day
Interventions: intervention 1: BI 671800 intervention 2: Placebo
Intervention descriptions: intervention 1: BI 671800 intervention 2: Placebo matching BI 671800

Protocol documents:
Clinical trial NCT01133990
Conditions: Colorectal Cancer
Sponsor: Eisai Inc.
Start date: 2010-03-04; Completion date: 2011-02-18
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects.

The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

Detailed description:
The primary purpose for Phase 1b: to determine the maximum tolerated dose (MTD) of E7820 recommended for Phase 2 when administered in combination with the FOLFIRI regimen (irinotecan, leucovorin, and 5-fluorouracil \[5-FU\]) in participants with locally advanced or metastatic colorectal cancer (mCRC) who have failed first-line therapy. Phase 2: to evaluate the safety and tolerability of E7820 administered in combination with the FOLFIRI regimen, compared with FOLFIRI alone and FOLFIRI plus bevacizumab, in patients with locally advanced or mCRC who have failed first-line therapy.

Arms: arm 1: The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 and Day 15 of each 28-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional). The 5-FU IV bolus (400 mg/m2) and CIV infusion (2400 mg/m2) over 46 hours is repeated on Days 15 and 16 of each cycle. arm 2: E7820 is administered orally in tablet form once daily, every day of each 28-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Phase II portion, the dose will be the MTD recommended Phase IB dose in combination with FOLFIRI, as determined during the Phase Ib portion of the study. arm 3: Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle
Interventions: intervention 1: FOLFIRI intervention 2: E7820 intervention 3: Bevacizumab
Intervention descriptions: intervention 1: FOLFIRI will be administered as IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m\^2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump. The 5-FU IV bolus (400 mg/m\^2) and CIV infusion (2400 mg/m\^2) over 46 hours is repeated on Days 15 and 16 of each cycle. intervention 2: E7820 will be administered orally in tablet form once daily, every day of each 28-day treatment cycle. intervention 3: Bevacizumab will be administered at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle.

Protocol documents:
Clinical trial NCT01127178
Conditions: Solid Tumors
Sponsor: Eisai Inc.
Start date: 2010-03-29; Completion date: 2011-02-24
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) of poly (ADP-Ribose) polymerase inhibitor E7016 when used with temozolomide (TMZ) in patients with advanced solid tumors and gliomas.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: E7016 + TMZ
Intervention descriptions: intervention 1: Single-Dose PK Period (single oral dose of E7016 on Day -7) in the Dose-Escalation Component; Multiple-Dose Treatment Cycles (7 days of oral E7016 + 5 days of oral TMZ) added in Cycle 1 of the Dose-Escalation Component and in Cycles 1 through 6 of the Expansion Component.

Protocol documents:
Clinical trial NCT00988247
Conditions: Rhinitis, Allergic, Perennial
Keywords: Rhinitis, Allergic, Perennial BDP-HFA Hay fever Allergic rhinitis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-10-31; Completion date: 2011-02-28
Enrollment: 529 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.

Detailed description:

Arms: arm 1: During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. arm 2: During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Placebo Nasal Aerosol
Intervention descriptions: intervention 1: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 30-weeks (or 52-weeks, depending upon investigator site). intervention 2: Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).

Protocol documents:
Clinical trial NCT00065468
Conditions: Carcinoma, Renal Cell Kidney Neoplasms
Keywords: Advanced Renal Cell Carcinoma Kidney Cancer
Sponsor: Pfizer
Start date: 2003-07-01; Completion date: 2011-03-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Interferon Alfa intervention 2: CCI-779 intervention 3: Interferon Alfa and CCI-779
Intervention descriptions: intervention 1: Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter. intervention 2: 25 mg of CCI-779 given Intra Venously once per week intervention 3: 15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week

Protocol documents:
Clinical trial NCT00154102
Conditions: Epidermal Growth Factor Receptor (EGFR) Expressing Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer EGFR Irinotecan cetuximab first-line treatment
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-05-01; Completion date: 2011-03-01
Enrollment: 1221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Giving combination chemotherapy together with cetuximab as first treatment after diagnosis of a metastatic colorectal cancer ('1st-line' treatment) may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with cetuximab is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of cetuximab in combination with a standard and effective chemotherapy (5-Fluorouracil (5FU)/Folinic acid (FA) plus irinotecan) for metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone on patient expressing the epidermal growth factor (EGF) receptor.

Patients expressing this EGF Receptor will be randomly assign in one of the 2 groups to either receive the combination chemotherapy alone or with cetuximab (open-label study) and will then be treated until progression of the disease or unacceptable toxicity occur. Regular efficacy assessments (every 8 weeks) based on imaging will be performed throughout the study together with regular safety assessments (e.g. safety labs). An independent Safety Board of experts will also monitor safety data.

After participant discontinuation from the trial, regular updates on further treatments and survival status will be requested from the investigator.

The entire study (from the first patient entering the study to the last collect of follow-up information) is 4-5 years long.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab intervention 2: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Intervention descriptions: intervention 1: Cetuximab intravenous infusion of 400mg/m\^2 for the first infusion then weekly intravenous infusion of 250mg/m\^2. Number of Cycles: until progression or unacceptable toxicity develops intervention 2: Bi-weekly Irinotecan infusion of 180mg/m\^2, Folinic Acid infusion of 400mg/m\^2 (racemic) or 200mg/m\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\^2 followed by a 46-hour continuous infusion of 2400mg/m\^2 Number of Cycles: until progression or unacceptable toxicity develops

Protocol documents:
Clinical trial NCT00395018
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B Virus, Liver Transplant
Sponsor: Bristol-Myers Squibb
Start date: 2007-04-01; Completion date: 2011-03-01
Enrollment: 109 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: entecavir
Intervention descriptions: intervention 1: Tablets, Oral, 1 mg, once daily, up to 72 weeks

Protocol documents:
Clinical trial NCT00831415
Conditions: Major Depressive Disorder
Keywords: Open-label Long-term extension study
Sponsor: Pfizer
Start date: 2009-03-01; Completion date: 2011-03-01
Enrollment: 304 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).

The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.

Detailed description:

Arms: arm 1: DVS SR
Interventions: intervention 1: desvenlafaxine succinate sustained release tablets
Intervention descriptions: intervention 1: 25-mg or 50-mg DVS SR tablets taken orally, once daily, at the same time each day. 100 mg dose will be supplied as 2 tablets of 50-mg tablet.

Protocol documents:
Clinical trial NCT00831441
Conditions: Acute Coronary Syndrome
Keywords: NOS
Sponsor: Bristol-Myers Squibb
Start date: 2009-03-01; Completion date: 2011-03-01
Enrollment: 7484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Apixaban intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, twice daily, until study end intervention 2: Tablets, Oral, 0 mg, twice daily, until study end

Protocol documents:
Clinical trial NCT00887224
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Sponsor: Pfizer
Start date: 2009-06-01; Completion date: 2011-03-01
Enrollment: 874 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Desvenlafaxine succinate sustained release 50 mg intervention 2: Desvenlafaxine succinate sustained release 25 mg intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg tablet, once daily. 5 months open-label duration for all enrolled subjects; additional 6 months double-blind duration for randomized subjects assigned to this arm. intervention 2: 25 mg tablet for taper, once daily for 1 week intervention 3: Matching placebo tablet, once daily. 6 months double-blind duration for randomized subjects assigned to placebo.

Protocol documents:
Clinical trial NCT00095836
Conditions: Head and Neck Cancer
Keywords: recurrent thyroid cancer stage III follicular thyroid cancer stage III papillary thyroid cancer stage IV follicular thyroid cancer stage IV papillary thyroid cancer anaplastic thyroid cancer thyroid gland medullary carcinoma
Sponsor: Massachusetts General Hospital
Start date: 2003-03-01; Completion date: 2011-03-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the all-measurable-disease response rate in patients with iodine-refractory locally advanced or metastatic thyroid cancer treated with gefitinib.

Secondary

* Determine the toxicity of this drug in these patients.
* Determine progression-free and overall survival of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: Gefitinib
Intervention descriptions: intervention 1: Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00096447
Conditions: Recurrent Endometrial Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-11-01; Completion date: 2011-03-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the 6-month progression-free survival of patients with recurrent or persistent endometrial carcinoma treated with lapatinib.

II. Determine the nature and degree of toxicity of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine the objective response rate in patients treated with this drug. II. Determine the duration of progression-free survival and overall survival in patients treated with this drug.

III. Determine the effects of prognostic factors, such as initial performance status and tumor grade, in patients treated with this drug.

OUTLINE: This is a multicenter study.

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

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-82 patients will be accrued for this study within 30-67 months.

Arms: arm 1: Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lapatinib ditosylate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00097448
Conditions: Sudden Deafness
Keywords: sudden hearing loss unilateral sudden sensorineural hearing loss sudden sensorineural hearing loss sudden unilateral hearing loss
Sponsor: Massachusetts Eye and Ear Infirmary
Start date: 2004-12-01; Completion date: 2011-03-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Detailed description:
Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.

Arms: arm 1: Nineteen days of oral prednisone arm 2: Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
Interventions: intervention 1: prednisone intervention 2: methylprednisolone sodium succinate
Intervention descriptions: intervention 1: Oral, 19 days intervention 2: Four intratympanic injections delivered to the middle ear over 2 weeks

Protocol documents: