ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00816361
Conditions: Cancer
Sponsor: MedImmune LLC
Start date: 2009-03-09; Completion date: 2012-09-11
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.

Detailed description:

Arms: arm 1: Participants received MEDI-573 0.5 milligram per kilogram (mg/kg) as a 60-minute intravenous (IV) infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 2: Participants received MEDI-573 1.5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 3: Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 4: Participants received MEDI-573 10 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 5: Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 6: Participants received MEDI-573 30 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 7: Participants received MEDI-573 45 mg/kg as a 90-minute IV infusion once every 21 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 8: Participants received MEDI-573 5 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal. arm 9: Participants received MEDI-573 15 mg/kg as a 60-minute IV infusion once every 7 days until unacceptable toxicity, documentation of disease progression, or other reason for participant withdrawal.
Interventions: intervention 1: MEDI-573
Intervention descriptions: intervention 1: Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.

Protocol documents:
Clinical trial NCT01281124
Conditions: Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2011-01-12; Completion date: 2012-09-12
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the ability of 5-azacytidine to cause DNA hypomethylation and re-expression of silenced tumor suppressor genes when stratified for high or low expression of mir29a, b, and c.

SECONDARY OBJECTIVES:

I. To compare the molecular studies (mir29 expression and tumor suppressor gene methylation) between archival tissue, fresh biopsy pre-treatment samples, and post-treatment fresh samples.

II. To determine the overall response rate by CT (RECIST 1.1 criteria) and PET (EORTC PET response criteria), PFS, and OS of patients treated with azacytidine in the second- or third-line setting.

III. To correlate the blood microRNA profiles (and changes in microRNA profiles) with response to azacytidine.

OUTLINE:

Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tissue and blood sample collection at baseline and periodically during study treatment for correlative studies. After completion of study treatment, patients are followed up for 12 weeks.

Arms: arm 1: Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Azacitidine intervention 2: Diagnostic Laboratory Biomarker Analysis intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Given subcutaneously intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01247922
Conditions: Ependymoma
Keywords: Pediatric Ependymoma Ependymoma Tarceva Erlotinib
Sponsor: OSI Pharmaceuticals
Start date: 2011-05-23; Completion date: 2012-09-13
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were allowed to participate in this study to assess the safety profile of single-agent erlotinib in participants with recurrent or refractory pediatric ependymoma.

Detailed description:
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollment of patients in that study and Study OSI-774-206 was permanently closed.

Arms: arm 1: Participants who received erlotinib in a continuous oral dose of 85 mg/m\^2 per day until dose modification, interruption or study discontinuation occurred.
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: continuous oral Erlotinib 85 mg/m\^2 per day

Protocol documents:
Clinical trial NCT01559259
Conditions: Pain
Keywords: ibuprofen acetaminophen pain molar extraction
Sponsor: Pfizer
Start date: 2012-04-10; Completion date: 2012-09-13
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the overall analgesic efficacy of three different fixed dose ibuprofen plus acetaminophen formulations compared to ibuprofen alone and to placebo.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Ibuprofen/acetaminophen intervention 2: Ibuprofen/acetaminophen intervention 3: Ibuprofen/acetaminophen intervention 4: Ibuprofen intervention 5: Placebo
Intervention descriptions: intervention 1: Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg intervention 2: Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg intervention 3: Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg intervention 4: Two caplets of ibuprofen 200 mg intervention 5: Two caplets of placebo

Protocol documents:
Clinical trial NCT01376323
Conditions: Diabetes Mellitus, Type 2
Keywords: Safety Dose Ranging Efficacy
Sponsor: GlaxoSmithKline
Start date: 2011-07-13; Completion date: 2012-09-17
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this combined, two part study is to evaluate the safety and glucose lowering effects of GSK256073 when administered to diabetic subjects for 12 weeks.

Detailed description:
The study will be conducted at centers in Europe and the United States. The study is being conducted in two parts. Part A (n = 90 subjects) will provide a preliminary evaluation of 12 weeks of treatment. Initiation of part B (n = 210 additional subjects) will be dependent on the results observed in part A. The emerging data from part A will be used to guide selection of the doses in Part B. Up to 8 dose levels of GSK256073 may be included in part B. The emerging exposure response relationships from the part A interim analysis will be used to guide dose selection.

Each subject enrolled in the study will undergo screening procedures, a 2 week placebo run-in period, baseline assessments, randomization, a twelve week treatment period, and a 2 week follow-up period. Following completion of the baseline visit and randomization into the study, subjects will return to the clinic for safety and efficacy assessments at Weeks 3, 6, 9, and 12. A subject's total participation in the study will last up to approximately 20 weeks. Subjects will continue their current prescribed regimen of metformin (glucophage) monotherapy and will monitor fasting blood glucose levels daily using a glucometer.

Arms: arm 1: GSK256073 1mg capsule taken orally twice a day arm 2: GSK256073 2 x 1mg capsule taken orally once a day arm 3: GSK256073 5mg capsule taken orally twice a day arm 4: GSK256073 2 x 5mg capsule taken orally once a day arm 5: GSK256073 10mg capsule taken orally twice a day arm 6: GSK256073 2x 10mg capsule taken orally once a day arm 7: GSK256073 25mg capsule taken orally twice a day arm 8: GSK256073 2x 25mg capsule taken orally once a day arm 9: Matching placebo capsules taken orally either once a day or twice a day arm 10: Commercially available Sitagliptin 100mg capsules taken once a day
Interventions: intervention 1: GSK256073 1mg intervention 2: GSK256073 5mg intervention 3: GSK256073 10mg intervention 4: GSK256073 25mg intervention 5: Placebo intervention 6: Sitagliptin 100mg
Intervention descriptions: intervention 1: GSK256073 1mg capsule intervention 2: GSK256073 5mg capsule intervention 3: GSK256073 10mg capsule intervention 4: GSK256073 25mg capsule intervention 5: placebo capsule intervention 6: Sitagliptin 100mg capsule

Protocol documents:
Clinical trial NCT01357850
Conditions: Heart Failure, Congestive
Sponsor: GlaxoSmithKline
Start date: 2010-09-15; Completion date: 2012-09-18
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, resulting in increased myocardial efficiency and increased exercise capacity. A positive result, defined as either statistically significant effects on one or more of the efficacy endpoints or as an overall signal suggesting a clinically relevant effect on myocardial physiology, would provide evidence for potential progression into further development in a chronic heart failure population.

Detailed description:

Arms: arm 1: GSK716155 (3.75mg) arm 2: GSK716155 (15mg) arm 3: GSK716155 (30mg) arm 4: GSK716155-matcued placebo
Interventions: intervention 1: GSK716155 intervention 2: Placebo
Intervention descriptions: intervention 1: GSK716155 intervention 2: Placebo

Protocol documents:
Clinical trial NCT01527188
Conditions: Allergic Rhinitis Due to House Dust Mite
Keywords: HDM allergic rhinitis
Sponsor: Stallergenes Greer
Start date: 2010-12-08; Completion date: 2012-09-19
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Detailed description:

Arms: arm 1: 100 IR house dust mites allergen extract tablet arm 2: 300 IR house dust mites allergen extract tablet arm 3: 500 IR house dust mites allergen extract tablet arm 4: Placebo tablet
Interventions: intervention 1: 100 IR house dust mites allergen extract tablet intervention 2: 300 IR house dust mites allergen extract tablet intervention 3: 500 IR house dust mites allergen extract tablet intervention 4: Placebo tablet
Intervention descriptions: intervention 1: One sublingual tablet daily during 6 months intervention 2: One sublingual tablet daily during 6 months intervention 3: One sublingual tablet daily during 6 months intervention 4: One sublingual tablet daily during 6 months

Protocol documents:
Clinical trial NCT01299376
Conditions: Hypertension
Keywords: Essential hypertension Antihypertensive agents Blood pressure Uncontrolled hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-01-24; Completion date: 2012-09-20
Enrollment: 286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study has two parts. In the first part, the efficacy and safety MK-0954E (losartan potassium 50 mg \[L50\] (+) hydrochlorothiazide 12.5 mg \[H12.5\] (+) amlodipine besylate 5mg \[A5\]) will be evaluated and compared to the efficacy and safety of MK-0954H (L50/H12.5) in Japanese participants. In the second part, the safety and tolerability of long-term use of open-label MK-0954E in participants with hypertension will be evaluated. The primary hypothesis is that MK-0954E is more effective in lowering mean trough sitting diastolic blood pressure (SiDBP) after 8 weeks of treatment compared to MK-954H (L50/H12.5 mg) in Japanese participants with essential hypertension who are not adequately controlled following a 8-week treatment with filter period study drug of MK-954H.

Detailed description:

Arms: arm 1: One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open label extension. arm 2: One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension
Interventions: intervention 1: L50/H12.5/A5 intervention 2: L50/H12.5 intervention 3: Placebo to L50/H12.5/A5 intervention 4: Placebo to L50/H12.5
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT02013817
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2005-10-11; Completion date: 2012-09-24
Enrollment: 43 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of intense combination treatment including MabThera/Rituxan (rituximab), followed by MabThera/Rituxan maintenance therapy in patients with B-cell CLL who are naive to chemotherapy. The anticipated time on study treatment is 2.5 years.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: fludarabine intervention 3: cyclophosphamide
Intervention descriptions: intervention 1: Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8 intervention 2: Every 4 weeks, 6 cycles intervention 3: Every 4 weeks, 3 cycles

Protocol documents:
Clinical trial NCT01294384
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2011-05-01; Completion date: 2012-09-25
Enrollment: 305 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Detailed description:

Arms: arm 1: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. arm 2: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. arm 3: 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Interventions: intervention 1: carboxymethylcellulose sodium based New Eye Drop Formulation 1 intervention 2: carboxymethylcellulose sodium based New Eye Drop Formulation 2 intervention 3: carboxymethylcellulose sodium based Eye Drops
Intervention descriptions: intervention 1: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. intervention 2: 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. intervention 3: 1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Protocol documents:
Clinical trial NCT01422304
Conditions: Neuromuscular Blockade Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Blood Coagulation Antithrombotic Agents
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-12; Completion date: 2012-09-26
Enrollment: 1198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on coagulation parameters in participants undergoing hip fracture surgery or joint (hip/knee) replacement surgery with neuromuscular blockage induced by rocuronium or vecuronium.

Detailed description:
Participants will be randomized to sugammadex or usual care in a 1:1 ratio.

Arms: arm 1: Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive sugammadex and placebo to neostigmine, and participants assigned to planned spontaneous recovery will receive sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure. arm 2: Prior to randomization, participants will be assigned to planned active reversal or planned spontaneous recovery by the anesthesiologist according to the recovery method the anesthesiologist would have chosen if the participant were not in the study. In this treatment arm, participants assigned to planned active reversal will receive neostigmine and placebo to sugammadex, and participants assigned to planned spontaneous recovery will receive placebo to sugammadex. Study drug will be administered after the last dose of rocuronium or vecuronium and after wound closure.
Interventions: intervention 1: Sugammadex intervention 2: neostigmine and glycopyrrolate or atropine intervention 3: Placebo to neostigmine intervention 4: Placebo to sugammadex
Intervention descriptions: intervention 1: Sugammadex 4 mg/kg intravenously intervention 2: Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels intervention 3: Normal saline (NaCl 0.9%) intervention 4: Normal saline (NaCl 0.9%)

Protocol documents:
Clinical trial NCT01388491
Conditions: Hemostasis Oral Contraceptive
Keywords: Contraception Hemostasis Blood Coagulation
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2011-10-31; Completion date: 2012-09-30
Enrollment: 293 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the impact of DR-102, a 28-day oral contraceptive compared to a standard 28-day oral contraceptive regimen on hemostatic parameters in healthy women.

Detailed description:

Arms: arm 1: 21 days of combination active pills (containing 150 mcg desogestrel \[DSG\]/20 mcg ethinyl estradiol \[EE\]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles arm 2: 21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
Interventions: intervention 1: desogestrel/ethinyl estradiol and ethinyl estradiol intervention 2: desogestrel/ethinyl estradiol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00239356
Conditions: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2003-03-01; Completion date: 2012-10-01
Enrollment: 119 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country

Protocol documents:
Clinical trial NCT00452673
Conditions: Advanced Breast Cancer
Sponsor: Bristol-Myers Squibb
Start date: 2007-06-01; Completion date: 2012-10-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn about the safety and efficacy of Dasatinib in combination with Capecitabine for patients with advanced breast cancer, and who have received treatment with a taxane and an anthracycline

Detailed description:

Arms: arm 1: Twice a day (BID) for 2 weeks of a 3-week cycle arm 2: BID for 2 weeks of a 3-week cycle arm 3: BID for 2 weeks of a 3-week cycle arm 4: 2 weeks of a 3-week cycle
Interventions: intervention 1: Dasatinib intervention 2: Capecitabine
Intervention descriptions: intervention 1: Tablets, Oral, 50 mg or 70 mg twice a day (BID), 100 mg once per day (QD). Treatment may continue until disease progression intervention 2: Tablets, Oral, 660 - 1250 mg/m\^2 twice a day (BID). Treatment may continue until disease progression.

Protocol documents:
Clinical trial NCT00486954
Conditions: Neoplasms, Gastrointestinal Tract
Keywords: lapatinib paclitaxel ErbB2 Gastric cancer Advanced gastric cancer
Sponsor: GlaxoSmithKline
Start date: 2007-07-01; Completion date: 2012-10-01
Enrollment: 273 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
EGF104578 is two-part study (Pilot part/Randomized part).Pilot part is designed to find the optimal (best) doses of lapatinib and paclitaxel when given together,Randomized part is designed to evaluate the overall survival in patients receiving lapatinib and paclitaxel compared to patients receiving only paclitaxel.

Detailed description:

Arms: arm 1: 6 pills of lapatinib at 250 mg each once daily and infusion of paclitaxel at 80 mglm2 weekly arm 2: Infusion of paclitaxel at 80 mglm2 weekly
Interventions: intervention 1: Lapatinib intervention 2: Paclitaxel
Intervention descriptions: intervention 1: 6 pills at 250 mg each once daily intervention 2: Infusion at 80 mg/m2 weekly

Protocol documents: