ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01959230
Conditions: Hyperemia
Keywords: Ocular redness
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-11-07; Completion date: 2013-12-20
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy and safety of brimonidine tartrate ophthalmic solution 0.025% with its vehicle for the treatment of ocular redness in a population of adult and geriatric participants with ocular redness.

Detailed description:

Arms: arm 1: Participants will apply 1 drop of brimonidine tartrate ophthalmic solution 0.025% into each eye 4 times daily for up to 4 consecutive weeks. arm 2: Participants will apply 1 drop of the vehicle of brimonidine tartrate ophthalmic solution into each eye 4 times daily for up to 4 consecutive weeks.
Interventions: intervention 1: Brimonidine Tartrate intervention 2: Vehicle intervention 3: Sodium Fluorescein intervention 4: Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP
Intervention descriptions: intervention 1: Ophthalmic solution to be applied as directed. intervention 2: Ophthalmic solution to be applied as directed. intervention 3: For use as needed during the study for evaluating corneal damage. intervention 4: For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.

Protocol documents:
Clinical trial NCT01436149
Conditions: Major Depressive Disorder
Sponsor: Shire
Start date: 2011-10-27; Completion date: 2013-12-23
Enrollment: 1262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions:

* How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it?
* Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant?
* How much SPD489 should be given to patients with depression who are also taking an antidepressant?
* How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 (Lisdexamfetamine dimesylate ) intervention 2: Placebo
Intervention descriptions: intervention 1: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks intervention 2: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks

Protocol documents:
Clinical trial NCT02044419
Conditions: Healthy
Keywords: Comparative Bioavailability lomitapide
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2013-10-30; Completion date: 2013-12-23
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To compare the relative bioavailability of lomitapide when administered by sprinkling the contents of a 20 mg capsule of lomitapide in applesauce or in mashed banana to a single oral intact capsule dose of 20 mg lomitapide in healthy subjects.

Detailed description:

Arms: arm 1: Contents of single 20 mg capsule of lomitapide sprinkled in applesauce arm 2: Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana arm 3: Intact capsule of 20 mg lomitapide
Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01852812
Conditions: Perennial Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2013-06-07; Completion date: 2013-12-24
Enrollment: 87 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.

Detailed description:

Arms: arm 1: Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) arm 2: Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks arm 3: Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
Interventions: intervention 1: Montelukast Oral Granules (OG) intervention 2: Montelukast Chewable Tablets (CT)
Intervention descriptions: intervention 1: Montelukast 4 mg in one sachet intervention 2: Montelukast 5 mg in one tablet

Protocol documents:
Clinical trial NCT00702884
Conditions: Esophageal Cancer
Keywords: recurrent esophageal cancer stage IIIA esophageal cancer stage IIIB esophageal cancer stage IIIC esophageal cancer stage IV esophageal cancer
Sponsor: Tony Bekaii-Saab
Start date: 2008-06-30; Completion date: 2013-12-30
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with relapsed or refractory esophageal or gastroesophageal junction cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the progression-free survival rate (complete response, partial response, and stable disease as defined by RECIST criteria \[Response Evaluation Criteria in solid Tumors\]) at 24 weeks in patients with relapsed or refractory esophageal or gastroesophageal junction cancer treated with sunitinib malate.

Secondary

* To explore the predictive role of a hybrid imaging protocol that combines PET/CT (Positron emission tomography) scan simultaneously with dynamic contrast-enhanced MRI.
* Correlate quantitative changes in mean vessel density, alterations in tumor cell proliferation, and apoptosis in tumor biopsy specimens with clinical outcome in these patients.
* To evaluate the objective response as defined by RECIST criteria, median overall survival, and median progression-free survival of these patients.
* To evaluate the toxicities of sunitinib malate in these patients.

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

Patients undergo blood and tumor tissue sample collection periodically for correlative laboratory studies. Tumor tissue samples are assessed by immunohistochemistry and TUNEL for detection and quantitation of mean vessel density, proliferating tumor cells, and apoptosis. Tumor tissue samples are also assessed by immunohistochemistry for MAPK levels. Blood samples are analyzed by ELISA for VEGF, PlGF, sVEGFR2, and sVEGFR3 levels. Patients also undergo PET/CT scan and dynamic contrast-enhanced MRI periodically for correlative studies.

After completion of study treatment, patients are followed for at least 6 months.

Arms: arm 1: Sunitinib 37.5 mg daily for a 4 week cycle
Interventions: intervention 1: sunitinib malate
Intervention descriptions: intervention 1: Sunitinib 37.5 mg daily for a 4 week cycle

Protocol documents:
Clinical trial NCT01901185
Conditions: Rheumatoid Arthritis Psoriatic Arthritis
Sponsor: Amgen
Start date: 2013-06-11; Completion date: 2013-12-30
Enrollment: 77 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the ability of people with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) to use an experimental autoinjector to self inject etanercept (Enbrel®).

Detailed description:
Study participants need to have been self-administering etanercept for greater than or equal to 6 months prior to screening. You will be in this study for about 9 weeks. This includes a 4-week screening period and a 5-week treatment period.

Arms: arm 1: Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
Interventions: intervention 1: Etanercept / Autoinjector A
Intervention descriptions: intervention 1: Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).

Protocol documents:
Clinical trial NCT01664247
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-10-01; Completion date: 2013-12-31
Enrollment: 346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: placebo intervention 3: liraglutide
Intervention descriptions: intervention 1: Administered s.c. (under the skin) once daily. Dose individually adjusted. intervention 2: Administered s.c. (under the skin) once daily. Dose individually adjusted. intervention 3: Administered s.c. (under the skin) once daily. Dose: 1.8 mg.

Protocol documents:
Clinical trial NCT01984398
Conditions: Bioequivalence
Sponsor: Repros Therapeutics Inc.
Start date: 2013-12-31; Completion date: 2013-12-31
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal

Detailed description:
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers, and to determine and compare the safety of a single dose each of two formulations of 12.5 mg and 25 mg Androxal administered to healthy male volunteers.

Arms: arm 1: 12.5 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation arm 2: 25 mg Androxal formulation A and 12.5 mg Androxal formulation B, a single dose of each formulation
Interventions: intervention 1: 12.5 mg Androxal Formulation A intervention 2: 12.5 mg Androxal Formulation B intervention 3: 25 mg Androxal Formulation A intervention 4: 25 mg Androxal Formulation B
Intervention descriptions: intervention 1: Single dose of 12.5 mg Androxal formulation A intervention 2: Single dose of 12.5 mg Androxal Formulation B intervention 3: Single dose of 25 mg Androxal formulation A intervention 4: Single dose of 25 mg Androxal formulation B

Protocol documents:
Clinical trial NCT01389323
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2011-09-01; Completion date: 2014-01-01
Enrollment: 448 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the rates of sustained virologic response in each cohort (Black-African Americans, Latinos) in this study to historical rate.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Daclatasvir intervention 2: Peg-Interferon Alfa-2a intervention 3: Ribavirin
Intervention descriptions: intervention 1: Tablet, Oral, 60 mg, once daily, 24 weeks intervention 2: Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response intervention 3: Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response

Protocol documents:
Clinical trial NCT01485887
Conditions: Major Depressive Disorder
Keywords: Venlafaxine ER long-term extension Japan
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2012-01-01; Completion date: 2014-01-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 3, flexible-dose, open-label, multi-center study. The subjects who complete the week 8 visit in the prior double-blind study (B2411263) will be eligible to participate in this study. This study consists of 10 month treatment phase and 1-3 week tapering phase. The 2 follow-up visits will be evaluated after 2 weeks and 4 weeks of last study medication dosing.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Venlafaxine ER
Intervention descriptions: intervention 1: Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration

Protocol documents:
Clinical trial NCT01673919
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-02-01; Completion date: 2014-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg iv every 4 weeks, 104 weeks

Protocol documents:
Clinical trial NCT02446990
Conditions: Coronary Artery Disease
Sponsor: Institut de Recherches Internationales Servier
Start date: 2009-09-01; Completion date: 2014-01-01
Enrollment: 19102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivabradine intervention 2: Placebo
Intervention descriptions: intervention 1: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months. intervention 2: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.

Protocol documents:
Clinical trial NCT00094861
Conditions: Dysphagia Non-Small Cell Lung Cancer Lung Cancer
Keywords: dysphagia palifermin, KGF chemoradiotherapy NSCLC, non-small cell lung cancer lung cancer supportive care clinical trial consolidation chemotherapy radiotherapy
Sponsor: Swedish Orphan Biovitrum
Start date: 2005-01-01; Completion date: 2014-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).

Detailed description:
During the acute dysphagia evaluation phase (the period lasting from the administration of the first dose of investigational product through Week 12 (or up to Week 16 if dysphagia is not resolved to CTCAE v3.0 grade ≤ 1 by Week 12) participants underwent acute dysphagia assessments twice weekly. All participants were followed for disease progression, second primary tumors, other malignancies, and overall survival until death or loss to follow-up during the long term follow-up (still ongoing).

Arms: arm 1: Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:

* standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
* paclitaxel 50 mg/m\^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
* carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).

Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m\^2 and carboplatin dosed at AUC 6.0. arm 2: Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:

* standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy
* paclitaxel 50 mg/m\^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)
* carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).

Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m\^2 and carboplatin dosed at AUC 6.0.
Interventions: intervention 1: Palifermin intervention 2: Placebo intervention 3: Radiotherapy intervention 4: Paclitaxel intervention 5: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00387127
Conditions: Neoplasms, Head and Neck
Keywords: Neck Cancer Locally advanced head and neck cancer locally advanced Head and Neck cancer lapatinib EGFR/ErbB2 inhibitor Head Cancer
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2014-01-01
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II study comparing the effects of lapatinib versus placebo when administered concurrently with cisplatin and radiotherapy followed by 1 year monotherapy with lapatinib or placebo. The study is designed to evaluate and compare the two treatment groups with respect to complete response rate at 6 months following chemoradiation completion.

Detailed description:

Arms: arm 1: 1500mg lapatinib orally daily arm 2: orally daily
Interventions: intervention 1: Lapatinib oral tablets intervention 2: radiotherapy intervention 3: cisplatin chemotherapy
Intervention descriptions: intervention 1: Lapatinib is administered orally once daily. intervention 2: Radiotherapy is given either as conventional fractionation using Two-dimensional (2D) or conformal techniques, or as Intensity Modulated Radiation Therapy (IMRT). Radiation therapy will be standardised throughout the study. Radiation therapy is given only once daily, with a dose/fraction not exceeding 2.5Gy, to a total dose of 65 Gy (IMRT) or 70 Gy (2D or 3D RT) to the gross site of disease . intervention 3: Cisplatin is administered intravenously at a dose of 100mg/m2 on days 1, 22 and 43 of radiotherapy (approximately Study Days 8, 29 and 50).

Protocol documents:
Clinical trial NCT00410813
Conditions: Breast Cancer Metastatic Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer bone metastases
Sponsor: SWOG Cancer Research Network
Start date: 2007-03-01; Completion date: 2014-01-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This randomized phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone.

Detailed description:
OBJECTIVES:

* Compare the progression-free survival of patients with stage IV bone metastasis-predominant breast cancer treated with 1 of 2 treatment schedules of dasatinib.
* Compare the response rate (complete and partial, confirmed and unconfirmed) in patients treated with these regimens.
* Compare the MUC-1 antigen response rate (CA 15-3 or CA 27-29) in patients treated with these regimens.
* Compare the circulating tumor cell response rate in patients treated with these regimens.
* Compare the anti-osteoclast activity, as measured by changes in bone turnover markers, in patients treated with these regimens.
* Compare the frequency and severity of toxicities of these regimens in these patients.
* Compare the pain profiles of these patients and explore changes over time.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral dasatinib once daily.
* Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity.

Blood samples are acquired from patients once weekly in weeks 1, 4, 8, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers.

Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks 8, 16, and 24.

After completion of study treatment, patients are followed every 3-6 months for up to 2 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Arms: arm 1: Patients receive oral dasatinib once daily. arm 2: Patients receive oral dasatinib twice daily.
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: given orally

Protocol documents: