ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00735696
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer Lung NSCLC
Sponsor: Eli Lilly and Company
Start date: 2009-01-01; Completion date: 2012-01-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the progression-free survival (PFS) rate at 6 months of ramucirumab administered in combination with paclitaxel and carboplatin as first-line therapy for Stage IIIB or IV non-small cell lung cancer

Detailed description:
Non-small cell lung cancer (NSCLC) accounts for 75-80% of all lung cancers. The advanced stages are associated with poor survival rates, a median survival rate of approximately 3.9 months if left untreated.

Angiogenesis is a process for wound healing and restoring blood flow to tissues after injury. It is the physiological process involving the growth of new blood vessels from pre-existing vessels. Angiogenesis may be promoted by growth factors and in diseases such as cancer, where growth factors are over expressed, the body loses the ability to maintain a balanced angiogenesis. This may embellish the existing supplies of blood; potentially increasing the delivery of oxygen and nutrients supplies for cancer growth and survival.

Ramucirumab is an angiogenesis inhibitor; and is believed to block the promotion of the growth factor to form new blood vessels, thus reducing the blood supply to the cancer cells.

Arms: arm 1: Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle).

In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.
Interventions: intervention 1: Ramucirumab intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: 10 milligrams per kilogram (mg/kg), intravenous (IV) infusion, on Day 1 of each 21-day cycle. intervention 2: 200 milligrams per meter squared (mg/m\^2), administered intravenously (IV) following the ramucirumab infusion, on day 1 of each 21-day cycle, for up to six cycles. intervention 3: Administered after paclitaxel, as an intravenous infusion (IV), over 30 minutes on day 1 of each 21-day cycle, for up to six cycles. The dose to be administered is calculated based on the participant's actual body weight at time of treatment and the area under the curve (AUC) dosing. The target AUC for carboplatin treatment is AUC=6.

Protocol documents:
Clinical trial NCT00738699
Conditions: Ovarian Cancer
Keywords: ovarian cancer relapsed ovarian cancer refractory ovarian cancer
Sponsor: Morphotek
Start date: 2008-09-01; Completion date: 2012-01-01
Enrollment: 415 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer

Detailed description:
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

Arms: arm 1: MORAb-003 (Farletuzumab) Plus Paclitaxel arm 2: Placebo Plus Paclitaxel
Interventions: intervention 1: MORAb-003 (farletuzumab) intervention 2: 0.9% Saline intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. intervention 2: Placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles. intervention 3: None

Protocol documents:
Clinical trial NCT00742235
Conditions: Healthy Subjects Vitamin D Deficiency
Sponsor: Massachusetts General Hospital
Start date: 2007-07-01; Completion date: 2012-01-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.

Detailed description:

Arms: arm 1: Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses) arm 2: Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level \>32 ng/ml
Interventions: intervention 1: ergocalciferol
Intervention descriptions: intervention 1: Ergocalciferol 50,000 IU given every other day for 5 total doses

Protocol documents:
Clinical trial NCT00752973
Conditions: Pediculosis
Keywords: Head Lice
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2008-09-01; Completion date: 2012-01-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Detailed description:

Arms: arm 1: MALG treatment
Interventions: intervention 1: MALG (malathion) Treatment
Intervention descriptions: intervention 1: MALG applied for 30 minutes

Protocol documents:
Clinical trial NCT00771056
Conditions: B-Cell Chronic Lymphocytic Leukemia
Keywords: untreated
Sponsor: Northwell Health
Start date: 2008-07-01; Completion date: 2012-01-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine 400mg po daily for up to one year. They will be monitored for disease status as well as adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at baseline and every 6 months or sooner if the patient develops any visual disturbances.

Detailed description:
This is a single-center, open-label, single arm Phase 2 study evaluating the feasibility, and efficacy of treating CLL subjects with hydroxychloroquine. The study schema and schedule of events are as follows:

Prior to beginning hydroxychloroquine:

* Blood samples to be taken.
* Baseline tests confirming diagnosis of CLL as defined above (if not already obtained in records)
* Physical exam performed
* Either six months prior or 4 weeks within starting HCQ ophthalmologic exam documented
* Days 1-365 subject takes hydroxychloroquine 400mg/day
* At 2 weeks: CBC and chemistry
* Every 4 weeks: CBC, chemistry, history (including the inquiry about the presence or absence of visual symptoms) and physical exam.
* Starting at 4 weeks: blood samples taken for laboratory companion studies taken at office visit every 8 weeks.
* At 6 months (+ or - 30 days): subject will have follow up ophthalmologic exam). This will also be done in the presence of any visual/ocular symptoms.

All subjects must meet the selection criteria for registration in this study. All subjects must have a peripheral blood sample submitted. It is estimated that approximately 70 subjects will be screened. The anticipated accrual period is 12 months.

Arms: arm 1: Hydroxychloroquine 400 mg po daily for up to one year.
Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: 400mg by mouth daily x 1 year

Protocol documents:
Clinical trial NCT00800540
Conditions: Glaucoma
Keywords: glaucoma ocular perfusion pressure ocular blood flow open angle glaucoma requiring more than one IOP-lowering medication
Sponsor: Alcon Research
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.

Detailed description:

Arms: arm 1: AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. arm 2: COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
Interventions: intervention 1: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension intervention 2: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
Intervention descriptions: intervention 1: Fixed combination ophthalmic suspension intervention 2: Fixed combination ophthalmic solution

Protocol documents:
Clinical trial NCT00802945
Conditions: Tumor Breast Cancer
Sponsor: Nektar Therapeutics
Start date: 2008-10-01; Completion date: 2012-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.

Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.

Detailed description:

Arms: arm 1: NKTR-102 arm 2: NKTR-102
Interventions: intervention 1: NKTR-102 intervention 2: NKTR-102
Intervention descriptions: intervention 1: NKTR-102 given on a q14 day schedule intervention 2: NKTR-102 given on a q21 day schedule

Protocol documents:
Clinical trial NCT00822094
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia Adult First Relapse AML Acute Myelogenous leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia
Sponsor: Jazz Pharmaceuticals
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

Detailed description:
This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Arms: arm 1: First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion arm 2: First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice
Interventions: intervention 1: CPX-351 intervention 2: Intensive Salvage Therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00823264
Conditions: Phenytoin Toxicity
Keywords: Anticonvulsants Toxicology multidose charcoal phenytoin
Sponsor: Emory University
Start date: 2008-08-01; Completion date: 2012-01-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from the blood. This is theorized to occur as charcoal absorbs phenytoin from across the intestines and then is secreted in the stool. Patients will be selected to receive either charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to follow their level. The different groups will then be compared to see if multidose charcoal does indeed increase the elimination of phenytoin from the body.

Detailed description:
See above

Arms: arm 1: Patients will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels drop below 25 ug/cc arm 2: Will not receive activated charcoal. Serum levels will be followed.
Interventions: intervention 1: Activated Charcoal
Intervention descriptions: intervention 1: 50 grams by mouth every 4 hours until serum phenytoin level is less than 25.

Protocol documents:
Clinical trial NCT00842335
Conditions: Advanced Solid Tumors
Keywords: solid tumors angiogenesis inhibitor dose escalation maximum tolerated dose JI-101
Sponsor: Jubilant Innovation Ltd.
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study, the first clinical trial of JI-101, is to determine the maximum tolerated dose of JI-101 when given orally to patients with solid tumors. Safety, tolerability, pharmacokinetics, pharmacodynamics, and the effects of the drug on tumor metabolism will also be studied. JI-101 is an inhibitor of new blood vessel growth that may provide benefit to patients with solid tumors that have failed standard therapeutic regimens.

Detailed description:
JI-101 is a compound being developed for the treatment of patients with solid tumors; specifically patients for which no approved therapy or standard of care is available or have solid tumors and have failed standard of care therapy. JI-101 is an inhibitor of vascular endothelial growth factor receptor 2 (VEGFR2), platelet-derived growth factor receptor beta (PDGFRβ), and EphB4 receptor, each of which plays an important role in driving vascularization (angiogenesis and vasculogenesis) during normal development and tumorigenesis. JI-101 inhibits the growth of new blood vessels, which in turn, may slow or prevent the growth of tumors. The purpose of this open label study is to treat patients with advanced solid tumors, with increasing doses of JI-101, thereby providing information about the maximum tolerated dose (MTD). The study will also examine safety, tolerability, pharmacokinetics, pharmacodynamics, and may evaluate the effects of the drug on tumor metabolism. During this dose-escalation study, at least two patients will be dosed at each dose level (cohort). The patients must complete 21 days of dosing and safety results will be reviewed prior to any patients being assigned the next higher dose level. A continuous reassessment method will be utilized to escalate JI-101 doses between cohorts. Doses will be increased, with an anticipated high dose of 800mg per day. If the MTD is not reached, an optimal biologic dose (OBD) will be determined based on the highest doses that are tolerable with acceptable efficacy. The cohort at MTD or OBD will be expanded to include up to 30 patients with solid tumors to further explore the safety and tolerability of orally-administered JI-101.

Arms: arm 1: None
Interventions: intervention 1: JI-101
Intervention descriptions: intervention 1: JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication

Protocol documents:
Clinical trial NCT00851084
Conditions: Colorectal Neoplasms Neoplasm Metastasis
Keywords: Angiogenesis Colon cancer Rectal cancer Oxaliplatin
Sponsor: Sanofi
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study.

Secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept.

This study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints.

Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given FOLFOX6 treatment.

Detailed description:

Arms: arm 1: modified FOLFOX6 chemotherapy regimen arm 2: modified FOLFOX6 chemotherapy regimen in combination with aflibercept
Interventions: intervention 1: aflibercept intervention 2: oxaliplatin intervention 3: 5-FU intervention 4: Folinic Acid
Intervention descriptions: intervention 1: administration: IV infusion intervention 2: administration: IV infusion intervention 3: administration: IV infusion intervention 4: administration: IV infusion

Protocol documents:
Clinical trial NCT00853073
Conditions: Glaucoma
Keywords: failing blebs failing express shunt avastin bevacizumab glaucoma prior trabeculectomy Express shunt placed under a scleral flap subsequent filtration failure
Sponsor: Wills Eye
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.

Detailed description:
To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.

Arms: arm 1: subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. arm 2: patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.
Interventions: intervention 1: bevacizumab intervention 2: balanced salt solution
Intervention descriptions: intervention 1: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure intervention 2: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure

Protocol documents:
Clinical trial NCT00853333
Conditions: Pain
Keywords: Pain Propofol Dexmedetomidine Midazolam Effects of sedation on pain perception.
Sponsor: University of Alabama at Birmingham
Start date: 2008-11-01; Completion date: 2012-01-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose to evaluate the potential effect of sedation on pain perception in two ways, by asking for a participant's pain rating(subjective) and by evaluating a subject's brain activation using fMRI(objective).

Detailed description:
We propose to contrast and compare the effect of propofol and midazolam, two GABA-related sedative drugs, and dexmedetomidine, an alpha-2 adrenergic agonist, on pain perception in human volunteers by asking a participant to rate their pain and by evaluating a subject's brain activation using fMRI.

Arms: arm 1: Administration via an IV arm 2: Administration via an IV arm 3: Administration via an IV
Interventions: intervention 1: dexmedetomidine intervention 2: midazolam intervention 3: propofol
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00853905
Conditions: Glaucoma
Keywords: open angle glaucoma (POAG) angle closure glaucoma (PACG) pigmentary glaucoma pseudoexfoliation glaucoma neovascular glaucoma traumatic glaucoma
Sponsor: Wills Eye
Start date: 2009-02-01; Completion date: 2012-01-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.

Detailed description:
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.

Arms: arm 1: glaucoma surgery with 0.2cc Triesence adjunct. arm 2: glaucoma surgery with balanced salt solution, the standard technique.
Interventions: intervention 1: Triesence intervention 2: balanced salt solution BSS
Intervention descriptions: intervention 1: At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound. intervention 2: At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.

Protocol documents: