ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00211185
Conditions: Lymphoma, T-Cell, Peripheral
Sponsor: Eisai Inc.
Start date: 2004-03-14; Completion date: 2009-12-23
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study of ONTAK and CHOP (chemotherapy drugs) to find out their ability to make Peripheral T-cell lymphoma disappear (for any period of time) and potentially lengthen life. The study will also compare what kind of side effects these drugs cause and how often they occur. The hypothesis is that patients with newly diagnosed peripheral T-Cell lymphoma, when given ONTAK + CHOP, will tolerate the treatment and will have a 20% improvement in response rate when compared to CHOP alone.

Detailed description:

Arms: arm 1: Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.
Interventions: intervention 1: Denileukin diftitox intervention 2: Cyclophosphamide intervention 3: Doxorubicin intervention 4: Vincristine intervention 5: Prednisone intervention 6: Pegfilgrastim
Intervention descriptions: intervention 1: Denileukin diftitox will be administered intravenously (IV) at a dosage of 18 micrograms/kilogram/day (ug/kg/d) on Days 1 and 2 of each 21-Day cycle for a total of 6 cycles, with a maximum of 8 cycles. intervention 2: Cyclophosphamide will be administered IV at a dosage of 750 milligrams/meter squared (mg/m\^2) on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles. intervention 3: Doxorubicin will be administered IV at a dosage of 50 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles. intervention 4: Vincristine will be administered IV at a dosage of 1.4 mg/m\^2 on Day 3 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles. intervention 5: Prednisone will be administered orally at a dosage of 100 mg on Days 3 to 7 of each 21-day cycle for 6 cycles, with a maximum of 8 cycles. intervention 6: Pegfilgrastim will be administered at a dosage of 6 mg subcutaneously on Day 4 to help prevent neutropenia. Alternatively, participants received filgrastim 5 ug/kg/d starting on Day 4 and continued until absolute neutrophil count (ANC) was less than 5000/millimeter squared (mm\^2) for 2 days post-nadir.

Protocol documents:
Clinical trial NCT00445068
Conditions: Multiple Myeloma
Keywords: Multiple myeloma adults LBH589 refractory
Sponsor: Novartis Pharmaceuticals
Start date: 2007-04-16; Completion date: 2009-12-25
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of LBH589B in adult patients with multiple myeloma who have received at least two prior therapies and are refractory to their last therapy. Patients must have received in prior therapy either bortezomib or lenalidomide

Detailed description:

Arms: arm 1: Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00669409
Conditions: Osteoarthritis, Knee
Keywords: monoclonal antibody
Sponsor: Pfizer
Start date: 2008-06-06; Completion date: 2009-12-25
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I). To evaluate the preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee in comparison with placebo (Part I and Part II).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: PF-04383119 (tanezumab) intervention 2: PF-04383119 (tanezumab) intervention 3: PF-04383119 (tanezumab) intervention 4: PF-04383119 (tanezumab) intervention 5: PF-04383119 (tanezumab) intervention 6: PF-04383119 (tanezumab)
Intervention descriptions: intervention 1: single dose of 10 mcg/kg IV intervention 2: single dose of 100 mcg/kg IV intervention 3: single dose of 200 mcg/kg IV intervention 4: single dose of 25 mcg/kg IV intervention 5: single dose of 50 mcg/kg IV intervention 6: single dose of Placebo IV

Protocol documents:
Clinical trial NCT00184717
Conditions: Foetal Growth Problem Small for Gestational Age
Sponsor: Novo Nordisk A/S
Start date: 2004-08-18; Completion date: 2009-12-28
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan.

In the main period, subjects will receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years).

Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.

Detailed description:

Arms: arm 1: In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime arm 2: In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime arm 3: No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period arm 4: In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period arm 5: In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
Interventions: intervention 1: somatropin intervention 2: somatropin
Intervention descriptions: intervention 1: 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge intervention 2: 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Protocol documents:
Clinical trial NCT00736879
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases
Sponsor: AstraZeneca
Start date: 2008-09-22; Completion date: 2009-12-29
Enrollment: 497 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in subjects with Type 2 Diabetes who are not well controlled on diet and exercise alone. The safety of this treatment will also be studied

Detailed description:

Arms: arm 1: Dapagliflozin: 1 mg arm 2: Dapagliflozin: 2.5 mg arm 3: Dapagliflozin: 5 mg arm 4: Placebo: 0 mg
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets, Oral, Once Daily, Up to 24 weeks intervention 2: Tablets, Oral, Once Daily, Up to 24 weeks

Protocol documents:
Clinical trial NCT00592553
Conditions: Duchenne Muscular Dystrophy Becker Muscular Dystrophy
Keywords: Duchenne muscular dystrophy Becker muscular dystrophy Nonsense mutation Premature stop codon DMD/BMD PTC124
Sponsor: PTC Therapeutics
Start date: 2008-02-29; Completion date: 2009-12-31
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
DMD/BMD is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of DMD/BMD in approximately 13 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 2b trial that will evaluate the clinical benefit of ataluren in boys with DMD/BMD due to a nonsense mutation. The main goals of the study are to understand whether ataluren can improve walking, activity, muscle function, and strength and whether the drug can safely be given for a long period of time.

Detailed description:
This study is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, efficacy and safety study, designed to document the clinical benefit of ataluren when administered as therapy of patients with DMD/BMD due to a nonsense mutation (premature stop codon) in the dystrophin gene.

Arms: arm 1: Participants will receive ataluren suspension orally 3 times a day (TID), 20 milligrams/kilogram (mg/kg) at morning, 20 mg/kg at midday, and 40 mg/kg at evening (total daily dose 80 mg/kg) for 48 weeks. arm 2: Participants will receive ataluren suspension orally TID, 10 mg/kg at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks. arm 3: Participants will receive placebo matched to ataluren orally TID at morning, midday, and evening for 48 weeks.
Interventions: intervention 1: Ataluren intervention 2: Placebo
Intervention descriptions: intervention 1: Ataluren will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to ataluren will be administered as the schedule specified in the respective arm.

Protocol documents:
Clinical trial NCT00642668
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-06-30; Completion date: 2009-12-31
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Detailed description:

Arms: arm 1: Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)

Protocol documents:
Clinical trial NCT00752219
Conditions: Complicated Intra-abdominal Infections
Sponsor: Pfizer
Start date: 2009-03-31; Completion date: 2009-12-31
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.

Detailed description:

Arms: arm 1: NXL104/ceftazidime + metronidazole arm 2: None
Interventions: intervention 1: ceftazidime/NXL104 + metronidazole intervention 2: meropenem
Intervention descriptions: intervention 1: IV TID intervention 2: IV TID

Protocol documents:
Clinical trial NCT00838526
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease GERD
Sponsor: Eisai Inc.
Start date: 2008-08-31; Completion date: 2009-12-31
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).

Detailed description:
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, RAB ER 50 mg (once daily) or Ranitidine 150 mg (twice daily).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rabeprazole ER intervention 2: Ranitidine
Intervention descriptions: intervention 1: 50 mg capsule, taken orally, once daily for 26 weeks. intervention 2: 150 mg capsule, taken orally, twice daily for 26 weeks.

Protocol documents:
Clinical trial NCT00402363
Conditions: Fibrillation, Atrial
Keywords: Lovaza Omega-3 fatty acids Omacor Paroxysmal atrial fibrillation
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2010-01-01
Enrollment: 663 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: omega-3-acid ethyl esters intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00423605
Conditions: Fibromyalgia
Keywords: FMS Fibro Pain Body Pain Tenderness Joint pain Stiffness Muscular Pain
Sponsor: Jazz Pharmaceuticals
Start date: 2006-12-01; Completion date: 2010-01-01
Enrollment: 560 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

Detailed description:
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Arms: arm 1: None
Interventions: intervention 1: Xyrem®
Intervention descriptions: intervention 1: flexible dosing

Protocol documents:
Clinical trial NCT00004146
Conditions: Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2000-03-01; Completion date: 2010-01-01
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Phase II trial to study the effectiveness of carboxyamidotriazole plus radiation therapy in treating patients who have newly diagnosed supratentorial glioblastoma multiforme.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate overall survival rate in patients administered CAI (carboxyamidotriazole) and radiation therapy to adults with newly diagnosed glioblastoma multiforme.

II. To determine the toxicity of CAI when combined with cranial irradiation. III. To estimate correlations between pharmacokinetic parameters, including steady state CAI concentration, with toxicity and/or drug activity in this patient population.

IV. To estimate duration of disease free progression with this treatment regime.

OUTLINE: This is a multicenter study.

Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.

Arms: arm 1: Patients receive induction therapy consisting of radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for survival.

Other: pharmacological study, radiation therapy
Interventions: intervention 1: radiation therapy intervention 2: carboxyamidotriazole intervention 3: pharmacological study
Intervention descriptions: intervention 1: Undergo radiotherapy intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00023712
Conditions: Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2001-11-05; Completion date: 2010-01-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of bortezomib in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the antitumor activity of bortezomib in patients with persistent or recurrent platinum-sensitive ovarian epithelial or primary peritoneal carcinoma.

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

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive bortezomib IV twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: bortezomib intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00087126
Conditions: Cervical Cancer
Keywords: recurrent cervical cancer cervical squamous cell carcinoma
Sponsor: Gynecologic Oncology Group
Start date: 2005-02-01; Completion date: 2010-01-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well topotecan works in treating women with persistent or recurrent cervical cancer.

Detailed description:
OBJECTIVES:

* Determine the antitumor activity of topotecan in patients with persistent or recurrent carcinoma of the cervix that failed higher priority treatment protocols.
* Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive topotecan IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 1-2 years.

Arms: arm 1: Topotecan weekly
Interventions: intervention 1: topotecan hydrochloride
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00123630
Conditions: Esophagitis
Keywords: eosinophilic esophagitis omalizumab
Sponsor: University of Utah
Start date: 2005-11-01; Completion date: 2010-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults.

The pathophysiology of EE appears to be an allergy/atopy mediated disease. A personal and family history of allergic diseases (food allergies, atopic dermatitis, asthma, allergic rhinitis or conjunctivitis) has been noted in 62-85% of patients with EE. The rising incidence of EE may be related to the worldwide allergy and asthma epidemic.

Current treatment of EE is directed at decreasing esophageal allergic inflammation. Oral and topical corticosteroids, cromolyn sodium, montelukast and elemental/elimination diets have all been shown to be effective. However, none of these treatments are directed at the specific pathophysiologic mechanism of EE and some have significant side effects.

The shared pathogenetic mechanisms of EE and asthma suggest that therapeutic strategies directed at asthma may also be effective for EE. Specifically those targeted at the allergic immune mechanisms involved with asthma may be effective. Omalizumab is a recently developed anti-IgE antibody that has been shown to decrease the use of inhaled and oral corticosteroids, reduce the frequency of asthma exacerbations, and improve asthma related symptoms in patients with allergic asthma. The objective of the study is to determine the efficacy of omalizumab in the treatment of eosinophilic esophagitis

Detailed description:
This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE level. Omalizumab or placebo will be administered subcutaneously every 4 weeks for 16 weeks. At study entry subjects will have EGD with biopsies performed to ensure the diagnosis and obtain tissue for histologic analysis. No dilation will be performed at this time. Baseline validated questionnaires for dysphagia, GERD, and atopy will also be administered. Blood will be drawn for baseline serum testing. Repeat questionnaires and rating of overall symptom improvement will be administered at 4 week intervals for the rest of the study period. At the end of the 16 week period, repeat endoscopy will be performed and biopsies taken. Esophageal dilation may be performed if clinically indicated at this time. Blood will also be drawn for repeat serum testing.

Arms: arm 1: placebo group arm 2: Xolair group
Interventions: intervention 1: omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: omalizumab dosed IV based on IgE level and weight every 2 - 4 weeks intervention 2: Placebo given IV once every 2-4 weeks based on weight

Protocol documents: