ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01884350
Conditions: Non-valvular Atrial Fibrillation
Sponsor: Bristol-Myers Squibb
Start date: 2013-10-15; Completion date: 2016-01-20
Enrollment: 1217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

Detailed description:
SPAF=Stroke Prevention in Atrial Fibrillation

ISTH=International Society on Thrombosis and Hemostasis

Primary Purpose: Other: To measure adherence to the study medication using an electronic monitoring device over the first 24 weeks on study medication

Arms: arm 1: Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information arm 2: Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program
Interventions: intervention 1: Apixaban
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00112437
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2005-06-24; Completion date: 2016-01-20
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 1-year base study with a 1-year extension to examine the effects of a new experimental medication (odanacatib \[MK-0822\]) on postmenopausal osteoporosis. This study will enroll approximately 375 postmenopausal women, and randomly assign them to 4 different doses of odanacatib or to placebo. Measurements performed during the study include: bone mineral density scans, spine x-rays, laboratory blood and urine tests, height measurements and optional bone biopsies (at the end of 2 years).

Detailed description:
Study Extension:

Participants who completed 12 months of the base study and 12 months of the first extension were invited to continue in three additional extensions: MK0-822-004-10, which extended the study to 36 months, MK-0822-004-20 (NCT00112437) which extended the study to 60 months, and MK-0822-004-30 (NCT00112437), which extended the study to 120 months.

* In the first extension, participants continued to receive the same treatment they received in the 12-month base study.
* In the second extension, participants were re-randomized to odanacatib 50 mg OW or placebo OW for 12 months.
* In the third extension, participants who were initially randomized to odanacatib 3 mg or placebo OW in the base study received odanacatib 50 mg weekly in Years 4 and 5; all other participants remained on the same treatment they were during Year 3.
* In the fourth extension, all participants received odanacatib weekly in Years 6-10.

Study arms for extensions include only odanacatib 50 mg and placebo for the first two extensions and odanacatib 50 mg only for the third extension.

Extension Studies:

MK-0822-004-10 (NCT00112437) Extension: Participant has participated in and completed 24 months of treatment in the base study

MK-0822-004-20 (NCT00112437) Extension: Participant participated in and completed 36 months of treatment in base and extension studies.

MK-0822-004-30 (NCT00112437) Extension: Participant participated in and completed 60 months of treatment in the base and extension studies.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Odanacatib intervention 2: Odanacatib intervention 3: Odanacatib intervention 4: Odanacatib intervention 5: Vitamin D3 intervention 6: Calcium Carbonate intervention 7: Placebo
Intervention descriptions: intervention 1: Odanacatib 3 mg, once weekly for 24 months intervention 2: Odanacatib 10 mg, once weekly for 24 months intervention 3: Odanacatib 25 mg, once weekly for 24 months intervention 4: Odanacatib 50 mg, once weekly for 24 months intervention 5: Vitamin D3, two 2800 IU weekly throughout the study intervention 6: Participants who have a calcium intake less than 1000 mg/day will receive daily calcium supplements providing 500 mg of elemental calcium. intervention 7: Placebo to Odanacatib 3 mg, 10 mg, 25 mg, or 50 once weekly for 24 months

Protocol documents:
Clinical trial NCT01849276
Conditions: Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Minimally Differentiated Myeloid Leukemia (M0) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Erythroleukemia (M6a) Adult Pure Erythroid Leukemia (M6b) Blastic Phase Chronic Myelogenous Leukemia Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia
Sponsor: Northwestern University
Start date: 2015-03-11; Completion date: 2016-01-21
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine if metformin in combination with cytarabine is safe and effective. Participants in this research study have acute myeloid leukemia (AML) that has come back after initial treatment or has not gone away with initial therapy.There is evidence that metformin directly kills leukemia cells. Laboratory data have also shown that combinations of metformin with cytarabine are more efficient than each agent alone in killing leukemia cells in the laboratory.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of metformin (metformin hydrochloride) in combination with cytarabine in relapsed/refractory AML.

II. Define the dose limiting toxicity (DLT) of metformin in combination with cytarabine in relapsed/refractory AML.

SECONDARY OBJECTIVES:

I. Remission rate. II. Overall survival (OS). III. Disease-free survival (DFS). IV. Length of remission.

OUTLINE: This is a dose-escalation study of metformin hydrochloride in combination with Cytarabine.

Patients receive metformin hydrochloride orally (PO) twice daily (BID) on days 1-15 and cytarabine intravenously (IV) over 3 hours BID on days 4-10.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 5 years.

Arms: arm 1: Patients receive metformin hydrochloride orally twice a day on days 1-15 and cytarabine IV over 3 hours twice on days 4-10.
Interventions: intervention 1: metformin hydrochloride intervention 2: cytarabine intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given IV intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT02637999
Conditions: Chronic Hepatitis D Infection
Sponsor: Hepatera Ltd.
Start date: 2014-02-13; Completion date: 2016-01-21
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized open-label substudy of daily Myrcludex B (MXB) plus pegylated interferon-alpha-2a (PEG-INF-a) in patients with hepatitis B e antigen (HBeAg) negative chronic hepatitis B virus (HBV) co-infected with hepatitis delta virus (HDV).

Detailed description:
The study is designed to evaluate safety and efficacy of MXB in a subset of HBV infected patients who are co-infected with HDV. Hepatitis delta represents the most severe form of chronic viral hepatitis and there is no approved treatment option available for patients infected with both HBV and HDV.

24 patients will be randomised into 3 arms: pre-treatment with MXB followed by PEG-INF-a treatment versus a combination of both drugs versus PEG-INF-a.

Prolonged blockade of HBV entry into hepatocytes should also block infection with HDV particles (which uses hepatitis B surface antigen (HBsAg) as its envelope) and thus provide a therapeutic option for this otherwise hardly treatable disease. PEG-INF-a is used for the treatment of chronic hepatitis delta. The study endpoints are virological response (HBsAg, hepatitis delta virus ribonucleic acid (HDV RNA), hepatitis B virus deoxyribonucleic acid (HBV DNA)), as well as safety and tolerability and drug immunogenicity.

Arms: arm 1: Myrcludex B 2mg daily for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL weekly for 48 weeks arm 2: Myrcludex B 2mg daily and PEG IFN alfa-2a 180 µg/0.5 mL weekly for 24 weeks, followed by PEG IFN alfa-2a 180 µg/0.5 mL weekly for 24 weeks arm 3: PEG IFN alfa-2a 180 µg/0.5 mL once weekly for 48 weeks
Interventions: intervention 1: PEG IFN alfa-2a intervention 2: Myrcludex B
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01913535
Conditions: Treatment Resistant Depression
Keywords: Depression Treatment Resistant Depression Antidepressant Major Depression MDD
Sponsor: Massachusetts General Hospital
Start date: 2013-09-12; Completion date: 2016-01-22
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Detailed description:
This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.

Arms: arm 1: Patients in this arm will receive CERC-501 10.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) arm 2: Patients in this arm will receive CERC-501 20.0 mg/day for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2) arm 3: Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 10.0 mg/day for 3 days (in Phase 2) arm 4: Patients in this arm will receive placebo for 3 days (in Phase 1) and CERC-501 20.0 mg/day for 3 days (in Phase 2) arm 5: Patients in this arm will receive placebo for 3 days (in Phase 1) and for 3 subsequent days (in Phase 2)
Interventions: intervention 1: CERC-501 intervention 2: Placebo
Intervention descriptions: intervention 1: Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).

High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).

For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.

For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days. intervention 2: For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).

For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.

For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days.

Protocol documents:
Clinical trial NCT01923363
Conditions: Obesity
Keywords: pharmacokinetics obesity piperacillin-tazobactam combination product pharmacodynamics piperacillin/tazobactam
Sponsor: Loma Linda University
Start date: 2014-02-25; Completion date: 2016-01-23
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.

Detailed description:

Arms: arm 1: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Then, they will be switched to higher dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
Interventions: intervention 1: Piperacillin/Tazobactam Standard Dose to High Dose
Intervention descriptions: intervention 1: Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.

Protocol documents:
Clinical trial NCT00723255
Conditions: Recurrent Endometrial Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2008-09-01; Completion date: 2016-01-25
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects of giving bevacizumab together with temsirolimus and to see how well it works in treating patients with recurrent or persistent endometrial cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving bevacizumab together with temsirolimus may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the activity of bevacizumab and temsirolimus, in terms of 6-month progression-free survival (PFS) and objective tumor response, in patients with recurrent or persistent endometrial cancer.

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

SECONDARY OBJECTIVES:

I. To determine the duration of PFS and overall survival of patients treated with this regimen.

II. To determine the effects of prognostic factors (i.e., performance status, histological subtype, and grade) in patients treated with this regimen.

TERTIARY OBJECTIVES:

I. To compare the proportion of patients with objective tumor response and PFS at 6 months receiving the combination of bevacizumab and temsirolimus with those for the single agents bevacizumab and temsirolimus using historical controls.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years, then every 6 months for 3 years, for a total of 5 years.

Arms: arm 1: Patients receive bevacizumab IV on days 1 and 15 and temsirolimus IV on days 1, 8, 15, and 22.
Interventions: intervention 1: bevacizumab intervention 2: temsirolimus
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT01927341
Conditions: Metastatic Colorectal Cancer
Keywords: MEK162, panitumumab, mutant RAS, wild-type RAS, metastatic colorectal cancer, adult mCRC patient
Sponsor: Pfizer
Start date: 2013-11-19; Completion date: 2016-01-25
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.

Detailed description:

Arms: arm 1: Phase Ib: Dose escalation. arm 2: Patients with mutant RAS mCRC who have not been pretreated with an EGFR inhibitor (EGFRi), including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy. arm 3: Patients with acquired mutant RAS mCRC who have been pretreated with anti-EGFR monoclonal antibody therapy, but have not been pre-treated with EGFR tyrosine kinase inhibitor therapy. arm 4: Patients with WT RAS mCRC who have been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy. arm 5: Patients with WT RAS mCRC who have not been pretreated with an EGFRi, including EGFR tyrosine kinase inhibitor therapy and/or anti-EGFR monoclonal antibody therapy.
Interventions: intervention 1: MEK162 intervention 2: Panitumumab
Intervention descriptions: intervention 1: Tablet for oral use, 45 mg (three 15 mg tablets), BID intervention 2: Intravenous infusion, 20mg/ml concentrate solution for infusion, Q2W (Days 1 and 15 of every cycle)

Protocol documents:
Clinical trial NCT01351623
Conditions: Multiple Myeloma
Keywords: PR-171 (CARFILZOMIB) Chemotherapy 10-228
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2011-05-09; Completion date: 2016-01-26
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new drug called carfilzomib. It is a type of drug called a proteasome inhibitor. Proteasome breaks down proteins that are no longer useful to the cell. When the proteasome is turned off by a drug (like carfilzomib), useless proteins cannot be broken down. Instead the proteins build up and cause the cell to die. Myeloma cells make a lot of protein and are especially in need of a functional proteasome to survive.

Carfilzomib is not approved for use by the Food and Drug Administration to treat myeloma. It is considered an experimental drug. Previous studies have shown that carfilzomib is safe to use. This study will look at what the effects, good and/or bad, carfilzomib has on myeloma.

Detailed description:

Arms: arm 1: A single arm, open-label, single institution phase 2 clinical trial is planned.
Interventions: intervention 1: Carfilzomib
Intervention descriptions: intervention 1: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.

Protocol documents:
Clinical trial NCT01898598
Conditions: Basal Cell Carcinoma
Sponsor: Hoffmann-La Roche
Start date: 2014-01-23; Completion date: 2016-01-26
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

Detailed description:

Arms: arm 1: Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks. arm 2: Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
Interventions: intervention 1: Placebo intervention 2: Vismodegib
Intervention descriptions: intervention 1: Participants will receive matching placebo to vismodegib for 12 weeks. intervention 2: Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks

Protocol documents:
Clinical trial NCT02055352
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Novartis Pharmaceuticals
Start date: 2014-05-30; Completion date: 2016-01-26
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

Detailed description:

Arms: arm 1: Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study. arm 2: Fixed combination of fluticasone and salmeterol
Interventions: intervention 1: Budesonide intervention 2: Fluticasone intervention 3: Indacaterol intervention 4: Salmeterol
Intervention descriptions: intervention 1: Budesonide 400 mcg twice a day via Breezhaler® device intervention 2: Fluticasone 250 mcg twice daily via Accuhaler® device intervention 3: Indacaterol 150 mcg once daily via Breezhaler® device intervention 4: Salmeterol 50 mcg twice daily via Diskus® device

Protocol documents:
Clinical trial NCT02378961
Conditions: Hepatitis C Virus Infection
Sponsor: Gilead Sciences
Start date: 2015-02-16; Completion date: 2016-01-26
Enrollment: 128 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis) arm 2: GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis) arm 3: GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis) arm 4: GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis) arm 5: VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis) arm 6: GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis) arm 7: VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
Interventions: intervention 1: VOX intervention 2: SOF/VEL
Intervention descriptions: intervention 1: 100 mg tablet(s) administered orally once daily with food intervention 2: 400/100 mg FDC tablet administered orally once daily with food

Protocol documents: