ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00833482
Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) HIV Infections
Sponsor: Bristol-Myers Squibb
Start date: 2009-09-01; Completion date: 2011-02-01
Enrollment: 185 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study assesses the effects of voriconazole, 200 mg, administered twice daily (BID), on the steady-state pharmacokinetics of atazanavir administered as atazanavir/ritonavir, 300/100 mg once daily (QD), in healthy participants with functional CYP2C19 alleles. The study also reviews the effects of atazanavir/ritonavir, 300/100 mg QD, on the pharmacokinetics of voriconazole, 200 mg, BID in healthy participants with functional CYP2C19 alleles.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Voriconazole intervention 2: Atazanavir intervention 3: Ritonavir
Intervention descriptions: intervention 1: Treatment A: Participants with functional CYP2C19 alleles (EM) received oral tablets of voriconazole, 400 mg, twice daily (BID), on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a light meal. Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose. Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30. intervention 2: Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Treatment B in participants who were poor metabolizers of CYP2C19 (PMs): PM participants received oral tablets of atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30. intervention 3: Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.

Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30. Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.

Protocol documents:
Clinical trial NCT00838162
Conditions: Human Immunodeficiency Virus Type 1
Keywords: Human immunodeficiency virus type 1 HIV-1 HIV-1 treatment-naive TMC310911 Protease inhibitor Ritonavir Antiviral Activity HIV Infections Treatment Naive
Sponsor: Tibotec Pharmaceuticals, Ireland
Start date: 2009-06-01; Completion date: 2011-02-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antiviral activity as measured by the change in viral load from baseline in the 14 days following initiation of treatment with 4 different dose regimens of TMC310911 co-administered with ritonavir.

Detailed description:
This is an open-label (all people know the identity of the intervention) and randomized (study medication assigned by chance) study in treatment-naive human immunodeficiency virus type 1 (HIV-1)-infected participants (participants who had not been treated with a therapeutic HIV vaccine within 1 year prior to enrollment and who had never been treated with an antiretroviral \[ARV\] medication indicated for the treatment of HIV-infection or ARVs for treatment of hepatitis B infection with anti-HIV activity prior to screening). In this study approximately 32 participants will be enrolled and randomly assigned to receive 4 different dose regimens co-administered with ritonavir (8 participants in each dosing regimen). The trial will consist of a screening period (maximum 6 weeks), a treatment period with TMC310911 (2 weeks), and a follow-up period (4 weeks). Safety evaluation will include assessment of adverse events, clinical laboratory tests, vital sign measurements, physical examinations and electrocardiograms.

Arms: arm 1: TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 2: TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 3: TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14 arm 4: TMC310911 300 mg + ritonavir 100 mg once daily on Days 1 to 14
Interventions: intervention 1: TMC310911 75 mg twice daily intervention 2: TMC310911 150 mg twice daily intervention 3: TMC310911 300 mg twice daily intervention 4: TMC310911 300 mg once daily intervention 5: Ritonavir 100 mg twice daily intervention 6: Ritonavir 100 mg once daily
Intervention descriptions: intervention 1: TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14. intervention 2: TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14 intervention 3: TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14 intervention 4: TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14 intervention 5: Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14 intervention 6: Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14

Protocol documents:
Clinical trial NCT00839800
Conditions: Asthma
Keywords: Asthma Symbicort Turbuhaler
Sponsor: AstraZeneca
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 2091 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Detailed description:

Arms: arm 1: Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed arm 2: Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Interventions: intervention 1: Symbicort Turbuhaler intervention 2: Terbutaline Turbuhaler
Intervention descriptions: intervention 1: 160/4.5 µg intervention 2: 0.4 mg

Protocol documents:
Clinical trial NCT00841204
Conditions: Precancerous Condition
Sponsor: National Cancer Institute (NCI)
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether sulindac is more effective than a placebo in preventing melanoma in individuals with many moles and abnormal moles.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.

SECONDARY OBJECTIVES:

I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.

II. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.

III. To assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.

OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.

ARM I: Participants receive oral sulindac twice daily.

ARM II: Participants receive oral placebo twice daily.

In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Blood and tissue samples are collected at baseline and/or after completion of study therapy and analyzed for sulindac and metabolite levels via high performance liquid chromatography tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF expression via immunohistochemistry assays.

After completion of study therapy, participants are followed for 2 weeks.

Arms: arm 1: Participants receive oral sulindac twice daily for 8 weeks arm 2: Participants receive oral placebo twice daily for 8 weeks
Interventions: intervention 1: sulindac intervention 2: placebo intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Inactive agent intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT00845039
Conditions: Colon Cancer Rectal Cancer
Keywords: Tumors Antibodies, Monoclonal Colorectal Neoplasms Metastatic K-RAS Wild-Type Carcinoma of the Colon or Rectum
Sponsor: Eli Lilly and Company
Start date: 2009-05-01; Completion date: 2011-02-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan and cetuximab in participants with metastatic colorectal cancer (CRC).

Detailed description:
The purpose of this study is to determine the value of adding IMC-A12 to irinotecan + cetuximab in improving progression-free survival (PFS) at 18 weeks from the date of randomization for participants with metastatic Kirsten Rat Sarcoma (K-RAS) wild-type CRC that has progressed on an oxaliplatin/bevacizumab-containing regimen.

Arms: arm 1: Participants in Treatment Group 1 will receive intravenous infusions of Cetuximab 500 milligrams per square meter (mg/m²) and Irinotecan 180 mg/m². arm 2: Participants in Treatment Group 2 will receive intravenous infusions of Cetuximab 500 mg/m², IMC-A12 10 milligrams/kilogram (mg/kg) and Irinotecan 180 mg/m².
Interventions: intervention 1: Cetuximab intervention 2: Irinotecan intervention 3: IMC-A12 (cixutumumab)
Intervention descriptions: intervention 1: Cetuximab 500 mg/m² every 14 days until disease progression or participant intolerance intervention 2: 180 mg/m² every 14 days until disease progression or participant intolerance intervention 3: IMC-A12 10 mg/kg every 14 days until disease progression or participant intolerance

Protocol documents:
Clinical trial NCT00853762
Conditions: Relapsing Multiple Sclerosis
Sponsor: EMD Serono
Start date: 2009-03-01; Completion date: 2011-02-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study (28851) is a long-term follow-up study of subjects enrolled in ATAMS study 28063 (NCT00642902). The aim of this study is to monitor the safety and tolerability of atacicept administered for up to 5 years to subjects with relapsing multiple sclerosis (RMS).

This extension study consists of two parts. Part A will be double blind and Part B will be open label. During Part A, subjects initially randomized to atacicept will continue to receive the atacicept dose to which they have been randomized in study 28063 (ATAMS) once a week subcutaneously (under the skin). Subjects randomized to placebo in ATAMS will receive atacicept at 150 mg once a week subcutaneously during Part A. Once the results of ATAMS are available and the atacicept dose with the best benefit / risk ratio has been identified, all subjects will be switched to this dose and will continue the extension study open-label (Part B). Throughout the study, subjects and investigators will remain blinded with respect to initial and part A treatment allocation/dose.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Atacicept 25 mg intervention 2: Atacicept 75 mg intervention 3: Atacicept 150 mg intervention 4: Atacicept 150 mg
Intervention descriptions: intervention 1: Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study will continue with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study. intervention 2: Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study will continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study. intervention 3: Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study will continue with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study. intervention 4: Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study will continue with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.

Protocol documents:
Clinical trial NCT00856635
Conditions: Optic Neuritis
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective of the study is to determine whether glatiramer acetate 20 mg once daily reduces the amount of axonal loss in the optic nerve after a first event of acute optic neuritis compared to placebo patients and to generate data supporting the potential neuroprotective effect of glatiramer acetate in a human in vivo model of axonal loss.

Detailed description:

Arms: arm 1: Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months. arm 2: Participants received placebo subcutaneous injection once a day for up to 6 months.
Interventions: intervention 1: Glatiramer Acetate intervention 2: placebo
Intervention descriptions: intervention 1: 20 mg injected daily subcutaneously intervention 2: injected daily subcutaneously

Protocol documents:
Clinical trial NCT00857584
Conditions: Bipolar Disorder Bipolar Depression
Keywords: Bipolar disorder Bipolar depression quetiapine sertraline
Sponsor: AstraZeneca
Start date: 2009-05-01; Completion date: 2011-02-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.

Detailed description:

Arms: arm 1: Lithium or valproate at stable doses within seric therapeutic levels arm 2: Lithium or valproate at stable doses within seric therapeutic levels
Interventions: intervention 1: Extended release quetiapine (quetiapine XR) intervention 2: Sertraline intervention 3: adequate mood stabilizer
Intervention descriptions: intervention 1: Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.

Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. intervention 2: Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.

Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study. intervention 3: An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).

Protocol documents:
Clinical trial NCT00863434
Conditions: Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia
Sponsor: University of Washington
Start date: 2009-02-01; Completion date: 2011-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with cytarabine may kill more cancer cells.

PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with cytarabine works in treating patients with acute myeloid leukemia with minimal residual disease

Detailed description:
PRIMARY OBJECTIVES:

I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual (MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission by morphology.

SECONDARY OBJECTIVES:

I. To determine the duration of complete remission after this treatment to minimize MRD.

OUTLINE:

Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily (QD) on days 1-5 and clofarabine intravenously (IV) over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: clofarabine intervention 2: cytarabine intervention 3: filgrastim
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given SC

Protocol documents:
Clinical trial NCT00876187
Conditions: Low Back Pain
Keywords: randomized controlled trial monoclonal antibody nerve growth factor naproxen
Sponsor: Pfizer
Start date: 2009-06-15; Completion date: 2011-02-01
Enrollment: 1359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of multiple doses of tanezumab administered every 8 weeks in treating chronic low back pain. Tanezumab is a monoclonal antibody directed against human nerve growth factor.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Tanezumab 20 mg IV intervention 2: Placebo for naproxen intervention 3: Tanezumab 10 mg IV intervention 4: Placebo for naproxen intervention 5: Tanezumab 5 mg IV intervention 6: Placebo for naproxen intervention 7: Placebo for tanezumab intervention 8: Naproxen intervention 9: Placebo for tanezumab intervention 10: Placebo for naproxen
Intervention descriptions: intervention 1: 2 IV administrations of tanezumab 20 mg at an 8 week interval intervention 2: Oral placebo for naproxen twice a day for 16 weeks intervention 3: 2 IV administrations of tanezumab 10 mg at an 8 week interval intervention 4: Oral placebo for naproxen twice a day for 16 weeks intervention 5: 2 IV administrations of tanezumab 5 mg at an 8 week interval intervention 6: Oral placebo for naproxen twice a day for 16 weeks intervention 7: 2 IV administrations of placebo for tanezumab at an 8 week interval intervention 8: Oral naproxen 500 mg twice a day for 16 weeks intervention 9: 2 IV administrations of placebo for tanezumab at an 8 week interval intervention 10: Oral placebo for naproxen twice a day for 16 weeks

Protocol documents:
Clinical trial NCT00879229
Conditions: Idiopathic Pulmonary Fibrosis Pulmonary Hypertension
Keywords: Idiopathic Pulmonary Fibrosis Pulmonary Hypertension PH IPF Ambrisentan ERA Endothelin Receptor Antagonist Cardiovascular
Sponsor: Gilead Sciences
Start date: 2009-07-01; Completion date: 2011-02-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Detailed description:

Arms: arm 1: Participants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks arm 2: Participants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment at the initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 4 weeks.
Interventions: intervention 1: Ambrisentan intervention 2: Placebo
Intervention descriptions: intervention 1: Ambrisentan (5 mg or 10 mg tablet) administered orally once daily. intervention 2: Placebo to match ambrisentan administered orally once daily.

Protocol documents:
Clinical trial NCT00914589
Conditions: Acquired Bleeding Disorder Cardiac Surgery Requiring Cardiopulmonary Bypass
Sponsor: Novo Nordisk A/S
Start date: 2009-07-01; Completion date: 2011-02-01
Enrollment: 479 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Canada, Asia, Europe and USA. The aim of this clinical trial is to investigate the effect and safety of rFXIII on transfusion needs in patients undergoing heart surgery.

Detailed description:

Arms: arm 1: Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. arm 2: Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute. arm 3: Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
Interventions: intervention 1: catridecacog intervention 2: catridecacog intervention 3: placebo
Intervention descriptions: intervention 1: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 2: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute intervention 3: Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute

Protocol documents: