ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01396447
Conditions: Depression, Bipolar
Keywords: Bipolar I disorder Bipolar depression Depression Bipolar disorder
Sponsor: Forest Laboratories
Start date: 2011-07-26; Completion date: 2014-01-10
Enrollment: 584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

Detailed description:

Arms: arm 1: Participants received placebo orally once a day for 8 weeks. arm 2: Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period. arm 3: Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period. arm 4: Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Interventions: intervention 1: Placebo intervention 2: Cariprazine
Intervention descriptions: intervention 1: Placebo was supplied in capsules. intervention 2: Cariprazine was supplied in capsules.

Protocol documents:
Clinical trial NCT01542632
Conditions: Healthy
Keywords: safety and immunogenicity of dengue vaccine
Sponsor: Takeda
Start date: 2012-02-01; Completion date: 2014-01-10
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 1 study to compare the safety, tolerability and immunogenicity of different dose schedules of subcutaneously (SC) administered dengue vaccine in healthy adults and to compare the immunogenicity of different dose schedules of the vaccine.

Blood samples were obtained for safety labs on Days 0, 7, 14, 90, 97, 104 and measurement of viremia at baseline \[during the screening period or on day of vaccination (Day 0)\], and then on Days 7, 9, 11, 14, 17, 21, 90, 97, and 104. Blood samples for measurement of dengue neutralizing antibodies in serum were obtained at baseline \[during the screening period or on day of vaccination (Day 0)\], then on Days 30, 90 and 120.

The entire duration for each individual subjects participation was approximately 5 months including recruitment and collection of data for primary outcomes (through Day 120).

Detailed description:

Arms: arm 1: Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and placebo, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. arm 2: TDV, 0.5 mL, subcutaneous injection in one arm and TDV 0.5 mL, subcutaneous injection in the other arm on Day 0. Placebo, 0.5 mL, subcutaneous injection on Day 90. arm 3: TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90. arm 4: TDV new formulation, 0.5 mL, subcutaneous injection in one arm and new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. arm 5: TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90. arm 6: 1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
Interventions: intervention 1: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) intervention 2: TDV New Formulation intervention 3: Placebo intervention 4: New Formulation Placebo
Intervention descriptions: intervention 1: TDV subcutaneous injection intervention 2: TDV New Formulation subcutaneous injection intervention 3: Placebo subcutaneous injection intervention 4: New Formulation placebo subcutaneous injection

Protocol documents:
Clinical trial NCT01817582
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye Disease
Sponsor: Bausch & Lomb Incorporated
Start date: 2013-05-17; Completion date: 2014-01-10
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.

Detailed description:

Arms: arm 1: Participants will administer lotemax gel 0.5 % BID in both eyes (OU) for 2 weeks, then administer both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administer restasis emulsion 0.05% BID OU for 8 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day). arm 2: Participants will administer lotemax gel 0.5% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day). arm 3: Participants will administer restasis emulsion 0.05% BID OU for 12 weeks. Participants will also receive preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Interventions: intervention 1: Lotemax intervention 2: Restasis intervention 3: Soothe® Lubricant Eye Drops
Intervention descriptions: intervention 1: Lotemax gel will be administered as per the dose and schedule specified in the arms. intervention 2: Restasis emulsion will be administered as per the dose and schedule specified in the arms. intervention 3: None

Protocol documents:
Clinical trial NCT03733470
Conditions: Emphysema
Sponsor: Eric A. Hoffman
Start date: 2011-06-29; Completion date: 2014-01-13
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.

Detailed description:
Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.

Arms: arm 1: 8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. arm 2: 11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.
Interventions: intervention 1: Sildenafil study group
Intervention descriptions: intervention 1: One dose of 20 mg Sildenafil will be given one hour before CT imaging.

Protocol documents:
Clinical trial NCT01756898
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis eczema
Sponsor: Daiichi Sankyo
Start date: 2012-11-28; Completion date: 2014-01-14
Enrollment: 370 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.

Detailed description:

Arms: arm 1: Oral administration of low dose ASB17061 taken once daily for 28 consecutive days. arm 2: Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days. arm 3: Oral administration of high dose ASB17061 taken once daily for 28 consecutive days. arm 4: Oral administration of placebo taken once daily for 28 consecutive days.
Interventions: intervention 1: 5 mg ASB17061 intervention 2: Placebo intervention 3: 10 mg ASB17061 intervention 4: 20 mg ASB17061
Intervention descriptions: intervention 1: Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days. intervention 2: Oral administration of placebo taken once daily for 28 consecutive days. intervention 3: Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days. intervention 4: Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.

Protocol documents:
Clinical trial NCT01611883
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2012-07-02; Completion date: 2014-01-16
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.

Detailed description:

Arms: arm 1: 10 mg oral dose once daily for 24 weeks arm 2: Placebo to match ezetimibe orally once daily for 24 weeks
Interventions: intervention 1: Ezetimibe intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg oral dose once daily for 24 weeks intervention 2: Placebo to match ezetimibe orally once daily for 24 weeks.

Protocol documents:
Clinical trial NCT00861913
Conditions: Recurrent Melanoma Stage IV Cutaneous Melanoma AJCC v6 and v7
Sponsor: National Cancer Institute (NCI)
Start date: 2009-04-03; Completion date: 2014-01-16
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Pazopanib hydrochloride 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.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the anti-tumor activity and safety profile of single agent Pazopanib (pazopanib hydrochloride).

SECONDARY OBJECTIVES:

I. To assess the impact of Pazopanib on circulating levels of vascular endothelial growth factor (VEGF).

II. To examine the association between tumor response and B-Raf and N-Ras mutations.

III. To examine pre/post-treatment expression levels of VEGF, vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, and Ki67.

IV. To correlate baseline and changes in p-ERK levels in the tumor with response.

V. To determine pazopanib steady-state trough plasma concentrations (Css,min) and the relationships between Css,min and the PD effects and toxicities of pazopanib.

VI. To examine the associations of common polymorphisms in CYP1A2, CYP2C8, UGT1A1, ABCB1, and ABCG2 with the PK and PD of pazopanib.

VII. To Assess Progression Free Survival. VIII. To Assess Overall Survival.

OUTLINE: This is a multicenter study.

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

Patients undergo tumor tissue biopsy at baseline and blood sample collection at baseline and on days 14, 28, and 42 for research studies. Tumor tissue samples are analyzed by DNA sequencing, ELISA, western blotting, and immunoperoxidase staining. Blood samples are analyzed for pharmacodynamics, pharmacokinetics, and pharmacogenetics by high-performance liquid chromatography with tandem mass spectrometry.

After completion of study treatment, patients are followed periodically for up to 5 years.

Arms: arm 1: Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Pazopanib Hydrochloride intervention 3: Pharmacological Study
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given orally intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01667107
Conditions: Fungal Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-01-23; Completion date: 2014-01-16
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.

Detailed description:

Arms: arm 1: Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole. arm 2: Posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
Interventions: intervention 1: Posaconazole intervention 2: Calogen®
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01435759
Conditions: Major Depressive Disorder
Sponsor: Shire
Start date: 2011-05-31; Completion date: 2014-01-17
Enrollment: 1197 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. 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 SPD489 help patients with depression who are also 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 arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg intervention 2: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg intervention 3: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg intervention 4: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg intervention 5: Antidepressant + Placebo
Intervention descriptions: intervention 1: Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks intervention 2: Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks intervention 3: Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks intervention 4: Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks intervention 5: oral, once daily for 8 weeks

Protocol documents:
Clinical trial NCT01691521
Conditions: Asthma
Keywords: safety SB-240563 efficacy placebo eosinophils mepolizumab Severe refractory asthma
Sponsor: GlaxoSmithKline
Start date: 2012-10-08; Completion date: 2014-01-18
Enrollment: 580 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate two dose regimens of mepolizumab \[75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks\] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

Detailed description:

Arms: arm 1: Mepolizumab 75 mg will be administered intravenously approximately every 4 weeks with the last dose at week 32. Subjects in the Mepolizumab IV arm will receive mepolizumab 75 mg intravenously and placebo SC once every 4 weeks with the last dose at Week 28 (total of 8 doses) arm 2: Subjects in the Mepolizumab SC arm will receive mepolizumab 100 mg SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses) arm 3: Subjects in the Placebo arm will receive matching placebo SC and placebo IV once every 4 weeks with the last dose at Week 28 (total of 8 doses)
Interventions: intervention 1: Mepolizumab IV intervention 2: Mepolizumab SC intervention 3: IV Placebo intervention 4: SC Placebo
Intervention descriptions: intervention 1: Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28 intervention 2: Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28 intervention 3: Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28 intervention 4: Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28

Protocol documents:
Clinical trial NCT01979445
Conditions: Coronary Artery Disease (CAD)
Keywords: CAD
Sponsor: The Medicines Company
Start date: 2013-12-02; Completion date: 2014-01-20
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
There are two separate objectives in this study:

1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued
2. To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.

Detailed description:

Arms: arm 1: Prasugrel 60 milligram (mg) administered orally 30 min after the discontinuation of cangrelor infusion on Day 1 (2.5 hours \[hrs\] after initiation of cangrelor infusion). arm 2: Clopidogrel 600 mg administered orally within 5 min after the discontinuation of the cangrelor infusion on Day 1 (2 hrs after initiation of cangrelor infusion). arm 3: Clopidogrel 600 mg administered orally 1.5 hrs after the initiation of cangrelor infusion on Day 1. arm 4: Clopidogrel 600 mg administered orally 1 hr after the initiation of cangrelor infusion on Day 1.
Interventions: intervention 1: Cangrelor intervention 2: Clopidogrel intervention 3: Prasugrel
Intervention descriptions: intervention 1: Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1. intervention 2: Clopidogrel 600 mg single oral dose intervention 3: Prasugrel 60 mg single oral dose

Protocol documents:
Clinical trial NCT00553644
Conditions: Recurrent Mantle Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2007-11-15; Completion date: 2014-01-21
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well bortezomib and lenalidomide work in treating patients with mantle cell lymphoma that has come back after a period of improvement (refractory) or is not responding to treatment (refractory). Bortezomib may also stop the growth of cancer cells by blocking some proteins needed for cell growth. Lenalidomide may stimulate the immune system to kill cancer cells and may also block the growth of new blood vessels necessary for cell growth. Giving bortezomib with lenalidomide may be an effective treatment for relapsed or refractory mantle cell lymphoma.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the overall response (complete response \[CR\] and partial response \[PR\]) rate and the complete response (CR) rate to bortezomib + lenalidomide therapy in patients with relapsed or refractory mantle cell lymphoma.

SECONDARY OBJECTIVES:

I. To determine the time to progression after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma.

II. To determine the disease-free survival and overall survival after therapy with bortezomib + lenalidomide in patients with relapsed or refractory mantle cell lymphoma.

OUTLINE:

Patients receive induction therapy comprising bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide orally (PO) once daily (QD) on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually for 2 years.

Arms: arm 1: Patients receive induction therapy comprising bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib IV on days 1 and 8 and lenalidomide PO QD on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Bortezomib intervention 2: Laboratory Biomarker Analysis intervention 3: Lenalidomide
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given PO

Protocol documents: