ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00410124
Conditions: Metastatic Renal Cell Carcinoma
Keywords: advanced kidney cancer everolimus kidney cancer oral therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2006-11-01; Completion date: 2011-10-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.

Detailed description:

Arms: arm 1: The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day. arm 2: Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
Interventions: intervention 1: RAD001 intervention 2: Placebo
Intervention descriptions: intervention 1: The dose of RAD001 was 10 mg/day. Patients were instructed to take two tablets (5 mg each) by mouth every day. intervention 2: None

Protocol documents:
Clinical trial NCT00440310
Conditions: Liver Metastases Colorectal Neoplasms Neoplasm Metastasis Neoplasm Recurrence, Local
Keywords: Liver neoplasms Liver metastases MCRC Litx™ LS11 Colorectal cancer with recurrent liver metastases
Sponsor: Light Sciences Oncology
Start date: 2007-02-01; Completion date: 2011-10-01
Enrollment: 483 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the overall survival and progression free survival of patients treated with Litx™ + chemotherapy versus chemotherapy alone in the treatment of Colorectal Cancer with recurrent liver metastases, and to demonstrate the safety of Litx™ therapy.

Litx™ consists of a light-activated drug, talaporfin sodium (LS11, Light Sciences Oncology, Bellevue, Washington), and a light generating device, composed of light-emitting diodes (LEDs), that is energized by a power controller and percutaneously placed in the target tumor tissue inside the body.

Detailed description:
Randomized, stratified, two arm study:

* Litx™ and chemotherapy arm (FOLFOX4 or FOLFIRI)
* Chemotherapy only arm (FOLFOX4 or FOLFIRI)

For patients who have progressed on FOLFIRI, they will be treated with Litx™ plus FOLFOX4 versus FOLFOX4 alone; and for patients who have progressed on FOLFOX, they will be treated with Litx™ plus FOLFIRI versus FOLFIRI alone.

Stratification upon enrollment by chemotherapy and tumor sum of the longest diameter (SLD) (SLD \< 4 cm or SLD ≥4 cm but ≤7.5 cm).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Talaporfin sodium intervention 2: Percutaneous placement of device in liver metastases intervention 3: Interstitial light emitting diodes intervention 4: FOLFOX4 regimen intervention 5: FOLFIRI regimen
Intervention descriptions: intervention 1: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes). intervention 2: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions. intervention 3: 200 J/cm per Light Source at 20 mW/cm light energy intervention 4: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin intervention 5: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan

Protocol documents:
Clinical trial NCT00449072
Conditions: Rhinitis, Allergic, Perennial
Sponsor: Sanofi
Start date: 2007-03-01; Completion date: 2011-10-01
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months.

The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo:

* the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal \[HPA\] axis function)
* the rate of treatment-emergent-adverse-events (TEAE)
* global efficacy rated by the investigator and the participant separately
* the rate of use of rescue medication during the study

Detailed description:
The study consisted of:

* a 4- to 6-month screening/baseline period
* a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1
* a 2-month follow-up period (up to Day 420+/-5 days)

Arms: arm 1: 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered

* Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle
* Placebo in the double-blind treatment period

All participants were provided Children's Claritin® Syrup as a rescue medication. arm 2: 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered

* Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle
* Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period

All participants were provided Children's Claritin® Syrup as a rescue medication.
Interventions: intervention 1: Placebo intervention 2: Placebo intervention 3: TAA-AQ, Nasacort® AQ intervention 4: Claritin®
Intervention descriptions: intervention 1: Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration intervention 2: Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period intervention 3: 110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period intervention 4: Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label

Protocol documents:
Clinical trial NCT00480740
Conditions: Cardiac Transplant Patent Ductus Arterious Atrial Septal Defect Bidirectional Cavopulmonary Anastomosis
Keywords: Dexmedetomidine Congenital heart disease pharmacokinetics pharmacodynamics pediatric Bidirectional cavopulmonary anastomosis Fontan physiology Cardiac transplant
Sponsor: Children's National Research Institute
Start date: 2006-12-01; Completion date: 2011-10-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the pharmacokinetics, pharmacodynamics, and pharmacogenomics of dexmedetomidine in the following three pediatric patient populations: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Detailed description:
While opioid analgesia is currently the mainstream for management of pain in the perioperative setting, it often leads to significant morbidity, including opioid tolerance and hyperalgesia. Looking at ways to decrease the need for opioids with the use of adjunct medications allows for the long-term goal of decreasing physiologic tolerance in children. This is especially relevant in the pediatric congenital heart population.

Dexmedetomidine is in a class of drugs known as alpha-2 agonists and is known to provide analgesia, attenuate opioid tolerance and inhibit the sympathetic stress response. While there are numerous published case studies of dexmedetomidine validating its effectiveness and safety, the pharmacologic and pharmacodynamic profile has not been established.

This study will examine the hemodynamics, pharmacokinetics, and pharmacogenomics of dexmedetomidine in patients with congenital heart disease. The dose-ranging effect of dexmedetomidine will also be investigated. The three groups being studied will be: patients with bi-directional cavopulmonary anastomosis or a Fontan procedure, patients who have had a cardiac transplant, and patients with otherwise normal physiology who are undergoing closure of a patent ductus arteriosis or atrial septal defect.

Comparison: Compare both invasive and noninvasive hemodynamic parameters at baseline sevoflurane and during maintenance dosing on dexmedetomidine. The pharmacokinetics of dexmedetomidine in the pediatric population following escalating loading doses and continuous infusion at timed intervals will be estimated. The efficacy of dexmedetomidine will be estimated by the amount of rescue doses of propofol that are given.

Arms: arm 1: diagnostic cardiac catheterization in children with a transplanted heart arm 2: diagnostic cardiac catheterization in children with a transplanted ventricle arm 3: diagnostic cardiac catheterization in children with normal cardiac physiology
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization

Protocol documents:
Clinical trial NCT00482014
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-05-01; Completion date: 2011-10-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.

Detailed description:

Arms: arm 1: Pemetrexed + Carboplatin arm 2: Pemetrexed + Cisplatin
Interventions: intervention 1: pemetrexed intervention 2: cisplatin intervention 3: carboplatin intervention 4: radiation therapy
Intervention descriptions: intervention 1: Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles

Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles

Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase intervention 2: Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles intervention 3: Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter\*minute (mg/mL\*min), administered intravenously, Days 1, 8, 22, 29 and 43

Phase 2 - dosed at AUC 5 mg/mL\*min, administered intravenously, every 21 days for 3 cycles intervention 4: Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51

Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45

Protocol documents:
Clinical trial NCT00485303
Conditions: Prostatic Neoplasms Prostate Cancer
Keywords: Prostatic Neoplasms Prostate cancer Abiraterone acetate CB7630 Prednisone
Sponsor: Cougar Biotechnology, Inc.
Start date: 2007-06-01; Completion date: 2011-10-01
Enrollment: 58 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

Detailed description:
This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

Arms: arm 1: Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.
Interventions: intervention 1: Abiraterone acetate intervention 2: Prednisone
Intervention descriptions: intervention 1: Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity. intervention 2: Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Protocol documents:
Clinical trial NCT00500682
Conditions: Chronic Kidney Disease
Keywords: Kidney Diseases
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-07-01; Completion date: 2011-10-01
Enrollment: 1020 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1\) To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD), on time to first occurrence of any event of the triple composite outcome of initiation of dialysis, kidney transplant or doubling of serum creatinine (sCr) when compared with placebo; 2) To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD; 3) To evaluate the effects of AST-120 versus placebo, on other measures of renal function.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: AST-120
Intervention descriptions: intervention 1: 9g /day (3 times a day) intervention 2: 9g /day (3 times a day)

Protocol documents:
Clinical trial NCT00524121
Conditions: Esophageal Cancer
Keywords: adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer
Sponsor: Roswell Park Cancer Institute
Start date: 2006-03-01; Completion date: 2011-10-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess the overall survival of older patients with stage I-IV squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction treated with erlotinib hydrochloride in combination with radiotherapy.

Secondary

* Assess the proportion of patients achieving mucosal complete response after treatment with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Assess the effect of this regimen on dysphagia control, performance status, and overall quality of life of these patients.
* Investigate the correlation between smoking status and overall survival of these patients.
* To correlate the Epidermal growth factor receptor (EGFR) and phosphor Epidermal growth factor receptor (pEGFR) expression by IHC and EGFR mutation status with clinical outcomes.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5 days a week in weeks 1-4 or 5 days a week for the first 5.5 weeks.

Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin, vimentin, cytokeratin, phospho-S6, and Ki67.

After completion of study treatment, patients are followed at 30 days and annually thereafter.

Arms: arm 1: Patients receive oral erlotinib hydrochloride once daily for 1 year
Interventions: intervention 1: erlotinib hydrochloride intervention 2: immunohistochemistry staining method intervention 3: radiation therapy
Intervention descriptions: intervention 1: Oral intervention 2: Correlative Study intervention 3: Radiation Treatment

Protocol documents:
Clinical trial NCT00527423
Conditions: Macular Degeneration
Keywords: VEGF Trap-Eye Macular Degeneration AMD Neovascular Age-Related Macular Degeneration
Sponsor: Regeneron Pharmaceuticals
Start date: 2007-08-01; Completion date: 2011-10-01
Enrollment: 157 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Detailed description:
Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Arms: arm 1: None
Interventions: intervention 1: VEGF Trap Eye
Intervention descriptions: intervention 1: Intravitreal injection

Protocol documents:
Clinical trial NCT00581048
Conditions: Allergic Asthma
Keywords: Asthma Allergy Atopy Vitamin E GSTP1 Oxidative stress
Sponsor: Vanderbilt University
Start date: 2006-12-01; Completion date: 2011-10-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Asthma is a common respiratory disease of unknown etiology which currently affects approximately 7.5 % of the adult population ( ). Asthma is an inflammatory disorder of the airways. Airway inflammation is evident not only in patients with fatal asthma but also in mild asthmatics ( ). Oxidant stress, defined as inadequately controlled generation of toxic reactive oxygen species (ROS) in the cells or tissues is a common feature of inflammation, and has also been documented in asthma ( , ). However, the current understanding of the relationship between the inflammation and the oxidant stress in asthmatic airways is poor. Does oxidant stress contribute to the expression of asthmatic phenotypes independently of inflammation? If so, could asthmatics benefit from supplementation of antioxidants? These questions have been nagging us since our laboratory provided credible evidence of oxidant injury in the airways of allergic asthmatics ( ). The purpose of our study is to more precisely determine 1/ the pathophysiologic role of oxidative stress, and 2/ usefulness of antioxidant therapy using vitamin E in allergic asthma.

Detailed description:

Arms: arm 1: 1500 units daily for 16 weeks
Interventions: intervention 1: Natural source d-α-tocopheryl acetate
Intervention descriptions: intervention 1: 1500 units daily for 16 weeks

Protocol documents:
Clinical trial NCT00591734
Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma Everolimus RAD001 Bevacizumab
Sponsor: SCRI Development Innovations, LLC
Start date: 2008-01-01; Completion date: 2011-10-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-randomized, open label Phase II study comparing bevacizumab and everolimus in the treatment of metastatic melanoma.

Detailed description:
All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients will receive 6 weeks of treatment, followed by re evaluation. Patients with objective response or stable disease will continue treatment until disease progression.

During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks.

Fifty-five patients will be enrolled in this multi-centered study

Arms: arm 1: All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
Interventions: intervention 1: Bevacizumab intervention 2: Everolimus
Intervention descriptions: intervention 1: 15 mg/kg of bevacizumab intravenously (IV) once every 3 weeks. intervention 2: 10 mg by mouth daily

Protocol documents: