ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01101022
Conditions: ADHD Specifically With Executive Function Impairment
Sponsor: Shire
Start date: 2010-05-19; Completion date: 2010-11-29
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: SPD489 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks) intervention 2: 1 capsule per day, daily throughout the double-blind treatment period (10 weeks)

Protocol documents:
Clinical trial NCT00922116
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2009-04-30; Completion date: 2010-11-30
Enrollment: 191 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention descriptions: intervention 1: sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)

Protocol documents:
Clinical trial NCT00088465
Conditions: Schizophrenic Disorders Schizoaffective Disorder
Sponsor: Eli Lilly and Company
Start date: 2004-08-01; Completion date: 2010-12-01
Enrollment: 931 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

* Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
* Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
* Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Detailed description:

Arms: arm 1: Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Interventions: intervention 1: Intramuscular olanzapine depot
Intervention descriptions: intervention 1: 45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.

Protocol documents:
Clinical trial NCT00162032
Conditions: Kawasaki Disease
Sponsor: Lantheus Medical Imaging
Start date: 2005-08-01; Completion date: 2010-12-01
Enrollment: 445 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.

Detailed description:
The purpose of this clinical research study is to determine how well CARDIOLITE® rest and stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion. The safety of CARDIOLITE® rest and stress heart imaging will also be studied.

Arms: arm 1: Children 4-11 years of age, intervention Sestamibi arm 2: Adolescents 12-16 years of age, intervention Sestamibi
Interventions: intervention 1: Sestamibi
Intervention descriptions: intervention 1: Sestamibi

Protocol documents:
Clinical trial NCT00343291
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer Malignant pleural effusions
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2010-12-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin chemotherapy.

Detailed description:

Arms: arm 1: Cycles 1-6:

* Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
* Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle
* Paclitaxel 200 mg/m² on day 1 of every 3 week cycle
* Carboplatin area under curve (AUC=6 min\*mg/mL) on day 1 of every 3 week cycle

Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met arm 2: Cycles 1-6:

* Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week
* Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle

Cycles 1-3:

* Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles
* Carboplatin AUC=6 min\*mg/mL on day 1 of each 3 week cycle for the first 3 cycles

Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Interventions: intervention 1: Cetuximab intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin
Intervention descriptions: intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously

Protocol documents:
Clinical trial NCT00761579
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone Antipsychotics Agents
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-04-01; Completion date: 2010-12-01
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER). The total study duration will be approximately of 48 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of paliperidone for 48 weeks, dose ranging from 3 to 12 milligram). Efficacy of the participants will primarily be evaluated by Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.

Arms: arm 1: Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
Interventions: intervention 1: Paliperidone
Intervention descriptions: intervention 1: Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.

Protocol documents:
Clinical trial NCT00793624
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2009-02-01; Completion date: 2010-12-01
Enrollment: 906 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.

Detailed description:

Arms: arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: 12mcg inhaled twice daily from the Aerolizer inhaler arm 4: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Interventions: intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Formoterol intervention 4: Placebo intervention 5: Placebo
Intervention descriptions: intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 4: Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 5: Placebo for comparison Formoterolon safety and efficacy in COPD patients

Protocol documents:
Clinical trial NCT00852397
Conditions: Acute Coronary Syndrome
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2010-12-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.

Detailed description:
Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Apixaban intervention 2: Apixaban intervention 3: Placebo
Intervention descriptions: intervention 1: Apixaban 2.5 mg tablet BID for 24 weeks intervention 2: Apixaban 5.0 mg tablet BID for 24 weeks intervention 3: Placebo tablet for 24 weeks

Protocol documents:
Clinical trial NCT00958438
Conditions: Gout
Keywords: Intercritical Gout Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout
Sponsor: Regeneron Pharmaceuticals
Start date: 2009-07-01; Completion date: 2010-12-01
Enrollment: 248 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15. arm 3: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Interventions: intervention 1: Placebo intervention 2: Rilonacept intervention 3: Rilonacept
Intervention descriptions: intervention 1: Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks. intervention 2: Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks. intervention 3: Rilonacept 320 mg SC loading dose followed by Rilonacept 160 mg/2 mL SC injections once a week for 16 weeks.

Protocol documents:
Clinical trial NCT01074268
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2010-02-01; Completion date: 2010-12-01
Enrollment: 456 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.

The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted. intervention 3: Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.

Protocol documents:
Clinical trial NCT00073749
Conditions: Lymphoma, B-Cell
Keywords: B-Cell Non-Hodgkin's Lymphoma
Sponsor: Pfizer
Start date: 2003-08-01; Completion date: 2010-12-01
Enrollment: 79 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).

Detailed description:

Arms: arm 1: Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
Interventions: intervention 1: Inotuzumab ozogamicin [CMC-544]
Intervention descriptions: intervention 1: CMC-544, IV, dose escalation trial

Protocol documents:
Clinical trial NCT00073983
Conditions: Sarcoma
Keywords: recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor chondrosarcoma recurrent osteosarcoma
Sponsor: Sarcoma Alliance for Research through Collaboration
Start date: 2006-10-01; Completion date: 2010-12-01
Enrollment: 54 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the objective response rate in patients with recurrent osteosarcoma or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel.

Secondary

* Determine the time to progression in patients treated with this regimen.
* Assess the toxicity of this regimen in these patients.
* Compare the pharmacokinetics of this regimen vs gemcitabine alone in these patients.
* Obtain tumor samples for cDNA microarray analysis of gene expression and development of cell lines and xenotransplantation models.

OUTLINE: This is a nonrandomized, multicenter study.

Patients are stratified according to diagnosis recurrent osteosarcoma vs recurrent Ewing's sarcoma vs unresectable or locally recurrent chondrosarcoma).

Patients receive gemcitabine intravenously over 90 minutes on days 1 and 8 and docetaxel intravenously over 1 hour on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 9 and continuing until blood counts recover. Patients may receive pegfilgrastim SC on day 9 (once per course) as an alternative to G-CSF. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Optional blood samples are collected at baseline and periodically during study for pharmacokinetics studies. Optional tumor tissue samples from biopsy or surgical resection are analysed for cDNA microarray analysis of gene expression.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A maximum of 120 patients (40 per stratum) will be accrued for this study within 17-24 months.

Interventions: intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: docetaxel intervention 4: gemcitabine hydrochloride intervention 5: microarray analysis intervention 6: laboratory biomarker analysis intervention 7: pharmacokinetic study
Intervention descriptions: intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: docetaxel intervention 4: gemcitabine hydrochloride intervention 5: microarray analysis intervention 6: laboratory biomarker analysis intervention 7: pharmacokinetic study

Protocol documents:
Clinical trial NCT00109031
Conditions: Cancer Lymphoma Leukemia
Keywords: Cancer Oncology
Sponsor: Swedish Orphan Biovitrum
Start date: 2005-01-01; Completion date: 2010-12-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).

Detailed description:

Arms: arm 1: Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 2: Palifermin 180 μg/kg on Day -1 and matched placebo on Days -2 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 3: Palifermin 180 μg/kg on Day -2 and placebo on Days -1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0. arm 4: Palifermin 180 μg/kg on Day -3 and placebo on Days -1 and -2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Interventions: intervention 1: palifermin intervention 2: Total Body Irradiation intervention 3: Cyclophosphamide intervention 4: Etoposide intervention 5: Placebo
Intervention descriptions: intervention 1: Administered as one daily intravenous bolus. intervention 2: To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days. intervention 3: Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2 intervention 4: Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction. intervention 5: Administered as one daily intravenous bolus.

Protocol documents:
Clinical trial NCT00118144
Conditions: Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2010-12-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.

SECONDARY OBJECTIVES:

I. Determine the progression-free and overall survival of patients treated with this drug.

II. Determine the time to disease progression in patients treated with this drug.

III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).

Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for survival.

Arms: arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
Interventions: intervention 1: bortezomib
Intervention descriptions: intervention 1: Given IV

Protocol documents: