ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00350142
Conditions: Pancreatic Cancer
Keywords: Stereotactic Body Radiotherapy (SBRT) pancreas cancer locally advanced local control Gemcitabine
Sponsor: Albert Koong
Start date: 2006-04-01; Completion date: 2008-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the efficacy of treating locally advanced pancreatic cancer using Stereotactic Body Radiotherapy (using Trilogy) and Gemcitabine

Detailed description:
In this study, we propose to combine stereotactic body radiotherapy (SBRT) with standard gemcitabine chemotherapy. We hypothesize that earlier administration of systemic chemotherapy may prolong the interval to distant progression and improve overall survival in these patients. In this study, we will treat pancreatic cancer patients with locally advanced disease with 3 weeks of gemcitabine, followed by Trilogy(TM) SBRT and additional gemcitabine. 30 patients will be accrued to this study at Stanford University Medical Center, the only site participating in this research study. Treatment on this protocol requires placement of 3-5 gold (99.9% pure) fiducials for targeting purposes. Four to 7 days after placement of the fiducials, patients will then undergo a 4D pancreatic protocol CT scan through the upper abdomen. In addition, an FDG PET scan is required for treatment planning purposes. This imaging set will be processed for radiosurgery, using a modified linac based radiation treatment planning system (EclipseTM). An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy prescribed to the isodose line that completely surrounds the gross pancreatic tumor volume (GTV) as defined by the contrast CT. Following SBRT, patients will be monitored clinically and radiographically.

Arms: arm 1: Patients will have a 4D pancreatic protocol CT and a FDG PET scan scan, both for planning purposes. An SBRT treatment plan will be developed based on tumor geometry and location. All patients will receive a single fraction of 25 Gy dose of Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine.
Interventions: intervention 1: Stereotactic Body Radiotherapy intervention 2: Gemcitabine intervention 3: 4D pancreatic protocol CT scan intervention 4: FDG PET scan
Intervention descriptions: intervention 1: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator intervention 2: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes intervention 3: Patients will undergo this imaging procedure prior to treatment for planning purposes. intervention 4: Patients will have this imaging procedure along with a CT scan to map the tumor and facilitate treatment planning.

Protocol documents:
Clinical trial NCT00353522
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2006-07-01; Completion date: 2008-10-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will investigate the efficacy and safety of RO4607381 in patients with coronary heart disease, or CHD risk equivalent. After a pre-randomization phase of 5-12 weeks, patients will be randomized to receive either RO4607381 (900mg po) or placebo po daily for 24 weeks, with concomitant atorvastatin 10-80mg daily, and changes in cholesterol level and lipoprotein metabolism will be measured. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Dalcetrapib 900mg po daily for 24 weeks arm 2: Placebo po daily for 24 weeks
Interventions: intervention 1: Placebo intervention 2: dalcetrapib
Intervention descriptions: intervention 1: po daily for 24 weeks intervention 2: 900mg po daily for 24 weeks

Protocol documents:
Clinical trial NCT00355472
Conditions: Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL)
Keywords: Adult T-Cell Leukemia ATL Adult Peripheral T-Cell Lymphoma PTCL
Sponsor: Kyowa Kirin Co., Ltd.
Start date: 2007-02-01; Completion date: 2008-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Detailed description:
This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

Arms: arm 1: KW-0761
Interventions: intervention 1: KW-0761
Intervention descriptions: intervention 1: IV administration at 4 escalating dose levels.

Protocol documents:
Clinical trial NCT00357110
Conditions: Breast Cancer
Keywords: Breast neoplasms breast cancer early breast cancer oncology cancer breast cancer micrometastasis fulvestrant
Sponsor: AstraZeneca
Start date: 2006-04-01; Completion date: 2008-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Detailed description:

Arms: arm 1: Anastrozole monotherapy arm 2: Anastrozole + Fulvestrant
Interventions: intervention 1: Fulvestrant intervention 2: Anastrozole
Intervention descriptions: intervention 1: intramuscular injection intervention 2: 1 mg oral tablet

Protocol documents:
Clinical trial NCT00363766
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to estimate the time to progressive disease for patients who receive LY573636-sodium (hereafter referred to as LY573636) after two previous treatments for metastatic non-small cell lung cancer. Patients will receive an intravenous infusion of study drug once every 21 days. Computed tomography (CT)-scans will be done before the first dose and then after every other treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LY573636-sodium
Intervention descriptions: intervention 1: A loading dose to target 420 micrograms/milliliter (µg/mL) maximum concentration (Cmax) or 380 µg/mL Cmax followed by a lower chronic dose to maintain Cmax within these target ranges, intravenous, every 21 days until disease progression.

Protocol documents:
Clinical trial NCT00367055
Conditions: Type 2 Diabetes Mellitus
Keywords: Beta cell function Type 2 diabetes Combination treatment
Sponsor: GlaxoSmithKline
Start date: 2004-10-01; Completion date: 2008-10-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It has been shown in previous study that progressive glycemic deterioration was associated with progressive loss of b-cell function, measured by the decrease in plasma insulin levels, irrespective of the therapy used (diet, sulfonylureas or metformin).There is growing evidence that thiazolidinediones could have a positive action on the b-cell function. But it has not yet been demonstrated that they could protect from a deterioration in insulin secretion in the long term. So, it appears interesting to study the long term evolution of the b-cell function and the possible protection with rosiglitazone in patients with type 2 diabetes showing evidence of loss of b-cell function with metformin alone.

Detailed description:

Interventions: intervention 1: rosiglitazone-metformin intervention 2: Metformin intervention 3: metformin+ gliclazide
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00380588
Conditions: Biliary Tract Cancer
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine alone by comparison in patients with advanced biliary tract cancer

Detailed description:

Arms: arm 1: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.

Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. arm 2: Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
Interventions: intervention 1: gemcitabine intervention 2: cisplatin
Intervention descriptions: intervention 1: 1000 milligrams per square meter (mg/m2), intravenous (IV) intervention 2: 25 milligrams per square meter (mg/m2), intravenous (IV)

Protocol documents:
Clinical trial NCT00380692
Conditions: Autistic Disorder Attention Deficit Disorder With Hyperactivity
Sponsor: Eli Lilly and Company
Start date: 2006-10-01; Completion date: 2008-10-01
Enrollment: 97 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).

Detailed description:

Arms: arm 1: atomoxetine 0.5 mg/kg/day every day (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks arm 2: placebo every day (QD), by mouth (PO) for 8 weeks

Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00383708
Conditions: Acromegaly
Sponsor: Ipsen
Start date: 2006-10-01; Completion date: 2008-10-01
Enrollment: 125 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main aim of this study is to assess the efficacy of the co-administration of lanreotide Autogel 120 mg (administered via deep sub-cutaneous injections every 28 days) and pegvisomant (administered at 40 to 120 mg per week via sub-cutaneous injection given once or twice a week) on IGF-1 levels over 28 weeks in acromegalic patients. The primary endpoint will be the percentage of acromegalic patients with normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment period.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: lanreotide (Autogel formulation) intervention 2: Pegvisomant
Intervention descriptions: intervention 1: 120 mg administered via deep subcutaneous injection every 28 days over 28 weeks. intervention 2: Administered at 40 to 120 mg per week via subcutaneous injection once or twice a week over 28 weeks.

Protocol documents:
Clinical trial NCT00385593
Conditions: Asthma, Bronchial
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 654 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Detailed description:

Interventions: intervention 1: Symbicort (budesonide/formoterol) Turbuhaler intervention 2: Conventional treatment
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00394589
Conditions: Rheumatoid Arthritis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-03-01; Completion date: 2008-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether increasing either the infusion dose or infusion frequency in patients presenting with a disease flare after an initial response to infliximab results in a significant improvement in disease activity.

Subjects responding to an initial infliximab treatment regimen, who flare during continuation of treatment at 3 mg/kg administered every 8 weeks, will be randomly assigned to one of 3 different dosing regimens of infliximab and will be treated for 4 or 5 consecutive infusions for a total duration of 24 weeks. The infliximab control group and the infliximab increased dose group are evaluator and subject-blinded. The increased frequency group is not blinded. Clinical assessments of disease activity will be based the European League Against Rheumatism (EULAR) criteria for response. Safety parameters will be assessed at every infusion.

A disease flare is defined by an increase in DAS28 with 0.6 or more at screening, when compared to the DAS28 score measured immediately prior to the last Remicade® infusion and depends upon the actual score as well. Since prior to enrollment, the subject received Remicade® as per routine clinical practice, the days on which infusions were administered and assessments are done during the induction period do not have to be exactly at Week 2, 6 and 14.

* Drug: Infliximab Control (double-blinded)
* Drug: Infliximab Increased Dose (double-blinded)
* Drug: Infliximab Increased Frequency (open-label)

Detailed description:

Arms: arm 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks arm 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab, every 8 weeks arm 3: Continuation of infliximab 3 mg/kg every 8 weeks
Interventions: intervention 1: Infliximab Increased Frequency intervention 2: Infliximab Increased Dose intervention 3: Infliximab Control
Intervention descriptions: intervention 1: Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks for 24 weeks intervention 2: 3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks for 24 weeks intervention 3: Continuation of infliximab 3 mg/kg every 8 weeks for 24 weeks

Protocol documents:
Clinical trial NCT00396253
Conditions: Dysfunctional Hemodialysis Catheters
Keywords: HD TNKase Hemodialysis Catheter clearance
Sponsor: Genentech, Inc.
Start date: 2006-11-01; Completion date: 2008-10-01
Enrollment: 223 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase III, open-label study conducted at 44 centers in the United States, Canada, and Puerto Rico. 223 subjects who required hemodialysis (HD) and had a dysfunctional HD catheter were enrolled in the study.

Detailed description:
The study consisted of four visits that corresponded to consecutive HD sessions for each patient, as well as one follow-up visit. Patients could receive up to three treatments with open-label tenecteplase during the study: one or two treatments during an initial treatment course, and eligible patients whose catheter became dysfunctional again within 21 days of the first visit received an additional treatment as part of a retreatment (RT) course.

At Visit 1, patients eligible at the beginning of HD had 2 mL (2 mg) of tenecteplase instilled into each of the two lumens of the HD catheter. After a dwell time of 1 hour, study drug was withdrawn and all subjects underwent HD. The duration of the HD session was not fixed by the study protocol, but rather by the site's HD practice, physician orders, and individual patient response during the session. Patients who did not experience treatment success at the end of Visit 1 had 2 mL (2 mg) of tenecteplase instilled into each lumen of their catheter as part of the initial treatment course. The treatment was left to dwell for an extended time, until the second HD session at Visit 2 (up to 72 hours later). Patients who received extended-dwell tenecteplase had the treatment withdrawn from their catheter at the beginning of Visit 2. Patients underwent HD as prescribed or to the extent possible.

Patients who had treatment success at Visit 1 or Visit 2 and had a recurrence of catheter dysfunction within 21 days of Visit 1 and met the re-treatment eligibility criteria had 2 mL (2 mg) of tenecteplase instilled into each lumen, followed by a 1-hour dwell time at re-treatment Visit 1.

Arms: arm 1: At each treatment, subjects had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Subjects could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all subjects at Visit 1. At the end of hemodialysis at Visit 1, eligible subjects had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
Interventions: intervention 1: Tenecteplase
Intervention descriptions: intervention 1: 2 mL (2 mg) of reconstituted lyophilized tenecteplase instilled into each lumen of the HD catheter.

Protocol documents:
Clinical trial NCT00397839
Conditions: Male Osteoporosis
Keywords: male osteoporosis osteoporosis bisphonates bone
Sponsor: Hoffmann-La Roche
Start date: 2007-01-01; Completion date: 2008-10-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibandronate intervention 2: placebo
Intervention descriptions: intervention 1: Ibandronate orally (tablet) at a dose of 150 mg once per month intervention 2: Placebo orally (tablet) at a dose of 150 mg once per month

Protocol documents:
Clinical trial NCT00401960
Conditions: Endocarditis, Bacterial
Keywords: Enterococcus Daptomycin Endocarditis
Sponsor: Weill Medical College of Cornell University
Start date: 2006-09-01; Completion date: 2008-10-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious.

Patients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:

1. Safety.

   1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.
   2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.
2. Efficacy.

   1. Clinical efficacy.

      * Time to clearance of bacteremia
      * Cure at 6 weeks following completion of antibiotic therapy
      * Mortality at 6 weeks following completion of antibiotic therapy
   2. Microbiologic efficacy.

      * Peak and trough serum bactericidal titers
      * The minimum bactericidal concentration of Enterococci to daptomycin

We expect to enroll 40 patients over 2 years.

Detailed description:

Arms: arm 1: Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving arm 2: Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician
Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis

Protocol documents:
Clinical trial NCT00410046
Conditions: Ankylosing Spondylitis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.

Detailed description:

Arms: arm 1: Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
Interventions: intervention 1: Enbrel (etanercept)
Intervention descriptions: intervention 1: Etanercept 50 mg SC injection once weekly

Protocol documents:
Clinical trial NCT00412958
Conditions: Vitrectomy
Sponsor: ThromboGenics
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Detailed description:

Arms: arm 1: 25µg of ocriplasmin intravitreal injection arm 2: 75µg of ocriplasmin intravitreal injection arm 3: 125µg of ocriplasmin intravitreal injection arm 4: Intravitreal injection of placebo
Interventions: intervention 1: Ocriplasmin 25µg intervention 2: Ocriplasmin 75µg intervention 3: Ocriplasmin 125µg intervention 4: Placebo
Intervention descriptions: intervention 1: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin. intervention 2: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin. intervention 3: Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin. intervention 4: Intravitreal injection of placebo

Protocol documents: