ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00899574
Conditions: Breast Cancer Breast Neoplasms
Keywords: toll-like receptor toll-like receptor agonist recurrent breast cancer breast cancer metastasized to skin and/or chestwall immunomodulator
Sponsor: NYU Langone Health
Start date: 2009-05-01; Completion date: 2013-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).

Detailed description:
TLR agonists are novel agents for cancer therapy which modify the immune response. Imiquimod, a synthetic TLR7 agonist has proven immunomodulatory activity when applied topically, leading to clearance of human papilloma virus (HPV)-induced genital warts and primary skin malignancies. Its effects will now be examined in breast cancer metastatic to the skin. If effective, it will add a relatively non-toxic approach to the treatment armamentarium for this patient population frequently resistant to conventional therapies.

Arms: arm 1: Each treatment cycle consists of 8 weeks.

Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.

Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.
Interventions: intervention 1: Imiquimod
Intervention descriptions: intervention 1: Each treatment cycle consists of 8 weeks.

Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.

Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.

Protocol documents:
Clinical trial NCT00912509
Conditions: Infectious Keratitis
Keywords: infectious keratitis cross linking corneal ulcer corneal infection collagen cross linking
Sponsor: Price Vision Group
Start date: 2009-05-01; Completion date: 2013-06-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.

Detailed description:

Arms: arm 1: 30 minute treatment with UVX light arm 2: 45 minute treatment with UVX light
Interventions: intervention 1: riboflavin intervention 2: UVX Light
Intervention descriptions: intervention 1: riboflavin 0.1% is applied every 2 minutes for 30 minutes intervention 2: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%

Protocol documents:
Clinical trial NCT00918645
Conditions: Metastatic Cancer Prostate Cancer
Keywords: stage IV prostate cancer recurrent prostate cancer bone metastases
Sponsor: University of California, Davis
Start date: 2009-09-01; Completion date: 2013-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Diagnostic procedures, such as radionuclide imaging using calcium-41 (41Ca) chloride aqueous solution, may help predict progressive disease in patients with prostate cancer and bone metastasis.

PURPOSE: This clinical trial is studying how well calcium-41 (41Ca) chloride aqueous solution works in diagnosing patients with prostate cancer and bone metastasis.

Detailed description:
OBJECTIVES:

Primary

* To measure the pharmacokinetics of a single oral dose of calcium-41 (41Ca) chloride aqueous solution (\^41Ca) over 18 months in patients with hormone-refractory prostate cancer and bone metastasis.
* To correlate the \^41Ca-tracer kinetics with time to disease progression, skeletal-related events, and death.

Secondary

* To correlate modulations in baseline urinary \^41Ca clearance with changes in clinically relevant disease parameters, including isotope bone scan data and PSA.
* To combine bone turnover assessments with \^41Ca and collagen/bone cell biomarkers with clinical imaging techniques, especially isotope bone scans, to provide improved stratification of disease stage.

OUTLINE: Patients receive oral calcium-41 (41Ca) chloride aqueous solution (\^41Ca) on day 1. Some patients also receive oral calcium-46 (46Ca) chloride aqueous solution (\^46Ca).

Urine and blood specimens are collected periodically for 18 months. Blood samples are assayed for bone collagen residues, bone alkaline phosphatase, and PSA. Urine specimens are assessed for \^41Ca/Ca. Isotope bone scintigraphy is use to measure radioactivity.

After completion of study treatment, patients are followed up periodically for 3 years.

Arms: arm 1: None
Interventions: intervention 1: 41 Ca
Intervention descriptions: intervention 1: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.

Protocol documents:
Clinical trial NCT00939029
Conditions: Smokeless Tobacco Use
Keywords: tobacco use smokeless tobacco chewing tobacco snuff nicotine replacement tobacco dependence tobacco cessation tobacco abstinence
Sponsor: Mayo Clinic
Start date: 2010-07-01; Completion date: 2013-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

Detailed description:
Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.

A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (\> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (\> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.

Arms: arm 1: 2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks arm 2: 2 patches (containing non active ingredients) per day for 8 weeks
Interventions: intervention 1: nicotine replacement therapy (nicotine patches) intervention 2: placebo NRT
Intervention descriptions: intervention 1: 2- 21 mg patches per day for 8 weeks intervention 2: 2 placebo patches (containing no active ingredient)per day for 8 weeks

Protocol documents:
Clinical trial NCT00942968
Conditions: Cancer
Sponsor: Pfizer
Start date: 2009-06-01; Completion date: 2013-06-01
Enrollment: 338 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the long term tolerability and safety of dalteparin in subjects with cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: dalteparin
Intervention descriptions: intervention 1: Daily subcutaneous injection 200IU/kg dalteparin

Protocol documents:
Clinical trial NCT00945334
Conditions: Constipation-predominant Irritable Bowel Syndrome
Keywords: Constipation predominant Irritable Bowel Syndrome
Sponsor: Mark Pimentel, MD
Start date: 2009-08-01; Completion date: 2013-06-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.

Detailed description:

Arms: arm 1: Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days arm 2: Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days
Interventions: intervention 1: Neomycin intervention 2: Placebo intervention 3: Rifaximin
Intervention descriptions: intervention 1: 500 mg po bid for 14 days intervention 2: placebo for 14 days tid intervention 3: 550 mg po tid

Protocol documents:
Clinical trial NCT00948090
Conditions: Lymphoma
Keywords: Hodgkin Lymphoma Non-Hodgkin's Lymphoma Bone marrow transplant stem cell transplant busulfan cyclophosphamide etoposide
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2010-01-01; Completion date: 2013-06-01
Enrollment: 207 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a study for the outcome and safety of individualized busulfan dosing with cyclophosphamide and etoposide for patients preparing for a stem cell transplant to treat Non-Hodgkin or Hodgkin's Lymphoma.

Detailed description:
Evaluation of progression-free survival, transplant related mortality, overall survival, and overall response rate, in subjects with NHL and HL receiving an IV busulfan-based conditioning regimen with PK-guided IV busulfan dosing, followed by autologous HSCT as well as comparison to those receiving carmustine, etoposide, cytarabine, and melphalan (BEAM) conditioning regimen (and its variants) obtained from registry data in the Center for International Blood and Marrow Transplant Research (CIBMTR) Assessment of the safety profile of a BuCyE conditioning regimen with PK-directed dosing of IV busulfan will also be completed.

Arms: arm 1: Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant
Interventions: intervention 1: IV Busulfan, Cyclophosphamide and Etoposide (BuCyE Regimen)
Intervention descriptions: intervention 1: Pk-directed IV Busulfan (based on test dose method) for 4 days followed by Etoposide 1400mg/m2 QD for one day and Cyclophosphamide 2.5 g/m2 QD for two days followed by autologous stem cell transplant.

Protocol documents:
Clinical trial NCT00962598
Conditions: Depressive Disorder, Major
Keywords: Adolescents Major Depressive Disorder Proton Magnetic Resonance Spectroscopy Immune System Activation Omega-3 Fatty Acids
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2006-01-01; Completion date: 2013-06-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of a 10-week Omega-3 Fatty Acid treatment phase on brain chemistry of adolescents with major depressive disorder (MDD) using proton magnetic resonance imaging.

Detailed description:
This study rests on a confluence of findings showing that: 1) Major depressive disorder (MDD), is a major public health concern that often emerges in adolescence; which entails 2) pathophysiological abnormalities in fronto-striatal structures resulting in death and atrophy of glia and neurons; 3) omega-3 fatty acids (FA) effects on brain function in adolescent MDD can be assessed by proton magnetic resonance spectroscopy (1H MRS); and, 4) it is critical that commonly used complementary and alternative medicines such as omega-3FA that have face validity be tested for their neurobiological effect in MDD.

Using 1H MRSI, this study examines the effects of Omega-3FA on striatal and anterior cingulate cortex (ACC) concentrations of the neurocellular biomarkers total choline (tCho), total creatine (tCr), and γ-aminobutyric acid (GABA, ACC only) in adolescent MDD. Hypotheses are: 1) relative to placebo, omega-3FA treatment will result in significant reductions of striatal and ACC tCho and tCr concentrations, and increased ACC GABA; 2: Regardless of treatment condition (placebo or Omega-3FA), MDD adolescents who are improved at the end of 10-week treatment will exhibit a significant decrease in striatal and ACC tCho and tCr concentrations, and increases in ACC GABA relative to unimproved adolescents.

Arms: arm 1: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. arm 2: The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.
Interventions: intervention 1: Omega 3 Fatty Acids intervention 2: Corn oil
Intervention descriptions: intervention 1: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks. intervention 2: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell.

Protocol documents:
Clinical trial NCT00965094
Conditions: Chronic Renal Failure
Sponsor: Novartis Pharmaceuticals
Start date: 2009-12-01; Completion date: 2013-06-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.

Detailed description:

Arms: arm 1: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. arm 2: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
Interventions: intervention 1: Everolimus intervention 2: Tacrolimus (FK506) intervention 3: Basiliximab intervention 4: Enteric Coated Mycophenolate Sodium (EC-MPS) intervention 5: Corticosteroids
Intervention descriptions: intervention 1: One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL) intervention 2: Capsules 0.5 mg, 1 mg. Dosing according to blood level. intervention 3: One vial containing 20 mg lyophilisate. 2 x 20 mg \[day 0 (2 hrs prior to Tx) and day 4 post Tx\] to be applied as 10 sec. bolus injection, i.v. intervention 4: One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day) intervention 5: Used according to Israeli standards. A minimum dose of 5mg \[prednisone, or equivalent, was used throughout the study period.

Protocol documents:
Clinical trial NCT00999830
Conditions: Multiple Myeloma
Sponsor: Innate Pharma
Start date: 2009-09-01; Completion date: 2013-06-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two dose regimens of IPH2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy.

Detailed description:
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR, which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells.The primary objective of the study is to evaluate the clinical activity of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a stable partial or very good partial response (PR or VGPR).

Arms: arm 1: One infusion of IPH2101 every 4 weeks at the dose of 0.2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles. arm 2: One infusion of IPH2101 every 4 weeks at the dose of 2 mg/kg by intravenous route over 1 hour, for 4 or up to 8 cycles.
Interventions: intervention 1: IPH2101
Intervention descriptions: intervention 1: One infusion of IPH2101 every 4 weeks

Protocol documents:
Clinical trial NCT01002573
Conditions: Fever
Keywords: Pediatric Fever
Sponsor: Cumberland Pharmaceuticals
Start date: 2010-07-01; Completion date: 2013-06-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.

Detailed description:
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Arms: arm 1: Ibuprofen, 10 mg/kg arm 2: Acetaminophen, 10mg/kg
Interventions: intervention 1: ibuprofen intervention 2: acetaminophen
Intervention descriptions: intervention 1: Ibuprofen, 10 mg/kg intervention 2: Acetaminophen, 10mg/kg

Protocol documents:
Clinical trial NCT01005875
Conditions: Hepatocellular Carcinoma Liver Cancer
Keywords: Hepatocellular carcinoma HCC Liver Cancer adult primary hepatocellular carcinoma
Sponsor: University of Alabama at Birmingham
Start date: 2009-11-01; Completion date: 2013-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.

Detailed description:

Arms: arm 1: Radiation therapy, stereotactic body radiation therapy followed by Sorafenib
Interventions: intervention 1: Sorafenib intervention 2: Stereotactic Body Radiotherapy (SBRT)
Intervention descriptions: intervention 1: Nexavar in bottles of 120 tables intervention 2: SBRT

Protocol documents:
Clinical trial NCT01020448
Conditions: Prostate Cancer
Keywords: Locally advanced or metastatic Prostate Cancer
Sponsor: Ipsen
Start date: 2009-11-01; Completion date: 2013-06-01
Enrollment: 339 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Triptorelin (Decapeptyl®)
Intervention descriptions: intervention 1: One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.

Protocol documents:
Clinical trial NCT01023178
Conditions: Ovarian Failure, Premature
Sponsor: Stanford University
Start date: 2007-02-01; Completion date: 2013-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To directly compare the safety (by laboratory evaluation) and efficacy (feminization and growth) of three commonly used estrogen preparations in adolescent patients with ovarian failure, either due to congenital causes (Turner syndrome) or medical therapies. We hypothesize that transdermal estrogen will have equivalent efficacy and a more favorable safety profile in comparison with conventional oral estrogen replacement.

Detailed description:
Treatment with transdermal 17beta(17β) estradiol resulted in higher estradiol levels and more effective feminization compared to oral conjugated equine estrogen but did not result in an otherwise different biochemical profile in this limited number of heterogeneous patients. OBE (oral beta estradiol) and TBE (transdermal beta estradiol) provide safe and effective alternatives to OCEE (oral conjugated equine estrogen) to induce puberty in girls, but larger prospective randomized trials are required.

Arms: arm 1: 17Beta Estradiol - transdermal arm 2: Conjugated estrogens arm 3: 17beta Estradiol
Interventions: intervention 1: 17beta Estradiol intervention 2: Conjugated estrogens intervention 3: 17Beta Estradiol - transdermal intervention 4: Progesterone, micronized
Intervention descriptions: intervention 1: Oral pill given daily at increasing doses every 6 months for 18 months. intervention 2: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months intervention 3: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months intervention 4: Given starting at 18 months

Protocol documents: