ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00820027
Conditions: Pain, Postoperative
Sponsor: Organon and Co
Start date: 2008-12-15; Completion date: 2010-12-14
Enrollment: 776 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.

Detailed description:

Arms: arm 1: Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days. arm 2: Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days. arm 3: Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days. arm 4: Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.
Interventions: intervention 1: Etoricoxib 90 mg intervention 2: Etoricoxib 120 mg intervention 3: Ibuprofen 600 mg intervention 4: Matching Placebo for Etoricoxib 120 mg intervention 5: Matching Placebo for Etoricoxib 90 mg intervention 6: Matching Placebo for Ibuprofen intervention 7: Morphine intervention 8: Oxycodone
Intervention descriptions: intervention 1: One 90 mg tablet once daily intervention 2: Two 60 mg tablets once daily intervention 3: One tablet three times daily intervention 4: Two tablets once daily intervention 5: One tablet once daily intervention 6: One tablet three times daily intervention 7: As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection intervention 8: 5 mg as needed

Protocol documents:
Clinical trial NCT00375752
Conditions: Breast Neoplasms
Keywords: Breast cancer Anti tumor potential Letrozole Zoledronic acid Neoadjuvant treatment Hormone responsive breast cancer
Sponsor: Novartis Pharmaceuticals
Start date: 2006-06-01; Completion date: 2010-12-16
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety/efficacy of zoledronic acid when given by intravenous infusion every 4 weeks in addition to letrozole as endocrine therapy in postmenopausal patients with hormone responsive breast cancer

Detailed description:
Open-label, multicenter, randomized phase II trial over approx 6.5 months of neoadjuvant treatment with letrozole with or without zoledronic acid in postmenopausal patients with primary breast cancer. A total of approximately 850 patients were originally planned to be enrolled; primary study endpoint was the objective response rate (according to modified RECIST criteria) after 6 months of treatment. After the core study, patients willing to participate were followed-up for further 5 years.

Arms: arm 1: Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment arm 2: 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
Interventions: intervention 1: Letrozole intervention 2: Zolendronic Acid
Intervention descriptions: intervention 1: 2.5 mg.tablet. intervention 2: 4 mg or an adjusted dose based on renal function in 100 ml physiologic (o.9%) normal saline, (as an intravenous infusion over no less than 15 minutes)

Protocol documents:
Clinical trial NCT01059799
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-02-01; Completion date: 2010-12-16
Enrollment: 435 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Insulin degludec injected subcutaneously (under the skin) once daily. The doses will be individually adjusted intervention 2: Insulin glargine injected subcutaneously (under the skin) once daily. The doses will be individually adjusted

Protocol documents:
Clinical trial NCT00960063
Conditions: Neoplasms Solid Tumors Bone Cancer Kidney Tumor Neuroblastoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-11-11; Completion date: 2010-12-22
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1/1B, non-randomized, open-label, dose-escalation study of robatumumab (SCH 717454, MK-7454) administered in combination with chemotherapy in pediatric participants with solid tumors, to be conducted in conformance with Good Clinical Practices. This study will evaluate the safety, tolerability and dose-finding of robatumumab when administered in combination with temozolomide and irinotecan (Arm A); or cyclophosphamide, doxorubicin, and vincristine (Arm B), or ifosfamide and etoposide (Arm C).

The primary study hypothesis is that robatumumab can be safely administered in combination with chemotherapy regimens in pediatric participants with solid tumors.

Detailed description:

Arms: arm 1: Participants receive temozolomide 100 mg/m\^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m\^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle. arm 2: Participants receive vincristine 2 mg/m\^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m\^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m\^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle. arm 3: Participants receive ifosfamide 1800 mg/m\^2 per day IV PLUS etoposide 100 mg/m\^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
Interventions: intervention 1: Temozolomide intervention 2: Vincristine intervention 3: Ifosfamide intervention 4: Irinotecan intervention 5: Robatumumab intervention 6: Doxorubicin intervention 7: Cyclophosphamide intervention 8: Etoposide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol documents:
Clinical trial NCT01059812
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-02-01; Completion date: 2010-12-23
Enrollment: 424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with type 2 diabetes not optimally controlled on once or twice daily insulin with or without metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec/insulin aspart intervention 2: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Injected subcutaneously twice daily. Dose was individually adjusted. intervention 2: Injected subcutaneously twice daily. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT01244035
Conditions: Hypertension
Keywords: High blood pressure
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-08-19; Completion date: 2010-12-23
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This was designed as a two part study comprising sequential double-dummy, placebo controlled 3-period randomized crossover studies. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of different doses and dose regimens of MK-8266. Only Part I of the study was completed.

Detailed description:

Arms: arm 1: Treatment A in Period 1, Treatment B in Period 2, and Treatment C in Period 3 arm 2: Treatment A in Period 1, Treatment C in Period 2, and Treatment B in Period 3 arm 3: Treatment B in Period 1, Treatment C in Period 2, and Treatment A in Period 3 arm 4: Treatment B in Period 1, Treatment A in Period 2, and Treatment C in Period 3 arm 5: Treatment C in Period 1, Treatment A in Period 2, and Treatment B in Period 3 arm 6: Treatment C in Period 1, Treatment B in Period 2, and Treatment A in Period 3 arm 7: Treatment D in Period 1, Treatment E in Period 2, and Treatment F in Period 3 arm 8: Treatment D in Period 1, Treatment F in Period 2, and Treatment E in Period 3 arm 9: Treatment E in Period 1, Treatment F in Period 2, and Treatment D in Period 3 arm 10: Treatment E in Period 1, Treatment D in Period 2, and Treatment F in Period 3 arm 11: Treatment F in Period 1, Treatment D in Period 2, and Treatment E in Period 3 arm 12: Treatment F in Period 1, Treatment E in Period 2, and Treatment D in Period 3
Interventions: intervention 1: Treatment A intervention 2: Treatment B intervention 3: Treatment C intervention 4: Treatment D intervention 5: Treatment E intervention 6: Treatment F
Intervention descriptions: intervention 1: MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 2: MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 3: Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266. intervention 4: MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 5: MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266. intervention 6: Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.

Protocol documents:
Clinical trial NCT00903201
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Sponsor: GlaxoSmithKline
Start date: 2009-09-28; Completion date: 2010-12-29
Enrollment: 146 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis

Detailed description:
This proof of mechanism study aims to evaluate the safety, tolerability and pharmacodynamics of SB-656933 following 28 days of daily administration of 20 and 50 mg SB-656933 in patients with CF compared to placebo. The primary endpoints of the study will be the effect of SB-656933 on safety and tolerability (adverse events, vital signs, clinical laboratory assessments, 12-lead electrocardiograms, and urinalysis) following 28 days of dosing. Secondary endpoints will include levels of neutrophil elastase in induced sputum and other sputum markers of inflammation (e.g. myeloperoxidase, total protein), induced sputum cells (i.e. total sputum neutrophil counts, percent sputum neutrophils) and sputum microbiology. Other assessments will include lung function measurements (spirometry); serum and plasma markers of inflammation (e.g. fibrinogen, CC-16, CRP, MMP8, MMP9, SP-D, and CXCL-8), quality of life questionnaire, and population pharmacokinetics parameters of SB-656933

Arms: arm 1: 20 mg of SB656933 arm 2: 50 mg of SB656933 arm 3: Placebo
Interventions: intervention 1: SB656933 intervention 2: SB656933 intervention 3: Placebo
Intervention descriptions: intervention 1: 20 mg intervention 2: 50mg intervention 3: placebo

Protocol documents:
Clinical trial NCT00546351
Conditions: Painful Diabetic Neuropathy
Keywords: Lacosamide
Sponsor: UCB Pharma
Start date: 2004-05-01; Completion date: 2011-01-01
Enrollment: 621 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.

Detailed description:

Arms: arm 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Protocol documents:
Clinical trial NCT00623233
Conditions: Metastatic Breast Cancer Locally Advanced Breast Cancer
Keywords: Breast Neoplasm
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2011-01-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Detailed description:

Arms: arm 1: Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.

Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.
Interventions: intervention 1: Gemcitabine intervention 2: Bevacizumab
Intervention descriptions: intervention 1: Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity. intervention 2: Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event \[AE\], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.)

Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00699582
Conditions: Refractory Partial Seizures
Keywords: E2007 (perampanel) refractory partial seizures adjunctive therapy seizure frequency reduction in seizure frequency partial onset seizures safety concomitant AED(s)
Sponsor: Eisai Inc.
Start date: 2008-05-01; Completion date: 2011-01-01
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: E2007 (perampanel) intervention 2: E2007 (perampanel) intervention 3: Placebo
Intervention descriptions: intervention 1: 8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 2: 12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose. intervention 3: Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.

Protocol documents:
Clinical trial NCT00789555
Conditions: Perennial Allergic Rhinitis
Keywords: nasal allergy nasal spray seasonal allergy perennial allergy
Sponsor: Alcon Research
Start date: 2008-11-01; Completion date: 2011-01-01
Enrollment: 1260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).

Detailed description:

Arms: arm 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 2: Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 3: Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months
Interventions: intervention 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) intervention 2: Olopatadine nasal spray vehicle, pH 3.7 intervention 3: Olopatadine nasal spray vehicle, pH 7.0
Intervention descriptions: intervention 1: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 2: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 3: Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Protocol documents:
Clinical trial NCT00856544
Conditions: Arthritis, Rheumatoid
Keywords: Arthritis Rheumatoid Antirheumatic Agents Clinical Trial
Sponsor: Pfizer
Start date: 2009-05-01; Completion date: 2011-01-01
Enrollment: 795 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit. arm 4: Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Film coated tablet, 5 mg PO BID, 1 year intervention 2: Film coated tablet, 10 mg PO BID, 1 year intervention 3: Film coated tablet, 1 tablet PO BID, 3-6 months intervention 4: Film coated tablet, 1 tablet PO BID, 3-6 months

Protocol documents:
Clinical trial NCT00041080
Conditions: Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2003-02-01; Completion date: 2011-01-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125.

II. To compare the toxicities and complications of these treatments.

SECONDARY OBJECTIVES:

I. To determine whether changes in serum biomarker levels including VEGF and/or bFGF are independent of the randomization treatment.

II. To determine whether serum and plasma biomarker levels including VEGF and/or bFGF are associated with the duration of recurrence-free survival.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression (6 months or less vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral thalidomide once daily on days 1-28.

ARM II: Patients receive oral tamoxifen twice daily on days 1-28.

In both arms, courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may receive additional therapy beyond 1 year at the investigator's discretion.

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

Arms: arm 1: Patients receive oral thalidomide once daily on days 1-28. arm 2: Patients receive oral tamoxifen twice daily on days 1-28.
Interventions: intervention 1: tamoxifen citrate intervention 2: thalidomide intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00053846
Conditions: Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific
Keywords: dyspnea pulmonary complications unspecified adult solid tumor, protocol specific
Sponsor: University of Rochester
Start date: 2002-11-01; Completion date: 2011-01-01
Enrollment: 432 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Buspirone may be effective in reducing dyspnea (shortness of breath) in patients with cancer who are undergoing chemotherapy.

PURPOSE: Randomized clinical trial to study the effectiveness of buspirone in reducing shortness of breath in patients who are undergoing chemotherapy for cancer.

Detailed description:
OBJECTIVES:

* Assess the degree to which buspirone can decrease the sensation of dyspnea in patients with malignant disease.
* Estimate the incidence of dyspnea in patients seen in community oncology practice settings.
* Investigate interrelationships of fatigue, depression, anxiety, and patient report of dyspnea.
* Assess the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center (CCOP site). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning on day 7 of chemotherapy, patients receive oral buspirone once a day for 3 days and then twice daily for up to 28 days.
* Arm II: Patients receive oral placebo as in arm I. Dyspnea is assessed at baseline. Dyspnea, mood, fatigue, depression, anxiety, and quality of life are assessed within 5-7 days before chemotherapy and immediately following therapy.

PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this study.

Arms: arm 1: buspirone hydrochloride arm 2: Placebo
Interventions: intervention 1: buspirone hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period intervention 2: Placebo

Protocol documents: