ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00509041
Conditions: Malignant Mesothelioma
Keywords: advanced malignant mesothelioma epithelial mesothelioma recurrent malignant mesothelioma sarcomatous mesothelioma
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2007-08-01; Completion date: 2012-12-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with previously treated malignant mesothelioma.

Detailed description:
OBJECTIVES:

Primary

* To determine the rate of progression-free survival (PFS) at 24 weeks (or 5.5 months) in patients with malignant mesothelioma treated with dasatinib.

Secondary

* To determine the response rate (partial response \[PR\] and complete response \[CR\]) in patients with malignant mesothelioma treated with dasatinib.
* To determine the response duration in patients with malignant mesothelioma treated with dasatinib.
* To describe the overall survival (OS) of patients with malignant mesothelioma treated with dasatinib.
* To describe the toxicity profile of dasatinib in patients with malignant mesothelioma.
* To determine whether the amount of expression of EphA2 and PDGFRβ, as measured by immunohistochemistry from tumor specimens, correlates with PFS in patients with malignant mesothelioma.
* To determine whether plasma levels of VEGF and PDGFRβ, serum levels of CSF-1, and soluble mesothelin-related protein correlate with PFS in patients with malignant mesothelioma.
* To determine whether inhibition of Src phosphorylation in PBMC correlates with PFS.
* To assess inhibition of phosphorylation of Src, EphA2, and PDGFRβ in tumor tissue by dasatinib.

OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative studies. Tumor tissue samples are analyzed for EphA2 and PDGFRβ expression by immunohistochemistry. Tumor tissue samples may also be analyzed for phosphorylation of Src, EphA2, and PDGFRβ by western blot. Blood samples are analyzed for concentration of VEGF and PDGF by quantitative sandwich enzyme immunoassay technique; mesothelin-related protein level by Mesomark® assay; CSF-1 level by ELISA assay; and phosphorylation of Src by phospho-Src (pTyr418) human ELISA.

After completion of study treatment, patients are followed at least every 2 months for 1 year, then every 4 months for 1 year, then every 6 months for 1 year.

Arms: arm 1: Use of dasatinib in treatment of pts with previously treated malignant mesothelioma
Interventions: intervention 1: dasatinib
Intervention descriptions: intervention 1: 50 mg PO bid

Protocol documents:
Clinical trial NCT00520741
Conditions: Epilepsy
Keywords: Epilepsy Partial Onset Seizures Lacosamide Monotherapy Vimpat
Sponsor: UCB BIOSCIENCES, Inc.
Start date: 2007-08-01; Completion date: 2012-12-01
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.

Detailed description:
Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.

Arms: arm 1: Lacosamide 400 mg/day arm 2: Lacosamide 300 mg/day
Interventions: intervention 1: Lacosamide intervention 2: Lacosamide
Intervention descriptions: intervention 1: 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. intervention 2: 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.

Protocol documents:
Clinical trial NCT00545974
Conditions: Frontal Lobe Dementia Frontotemporal Lobe Dementia Semantic Dementia
Keywords: Randomized Double-Blind Placebo-Controlled memantine Namenda Frontotemporal Dementia Semantic Dementia FTD SD dementia behavioral decline cognitive decline
Sponsor: University of California, San Francisco
Start date: 2007-10-01; Completion date: 2012-12-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether memantine is effective in slowing the rate of behavioral decline in frontotemporal dementia.

The secondary objective of the study is to assess the safety and tolerability of long-term treatment with memantine in patients with frontotemporal dementia (FTD) or semantic dementia (SD). To determine whether memantine is effective in slowing the rate of cognitive decline in frontotemporal dementia. To evaluate whether memantine delays or decreases the emergence of parkinsonism in frontotemporal dementia.

The tertiary objective of the study is to determine whether treatment with memantine affects changes in weight

Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled trial of memantine 10 mg twice daily versus placebo, at a ratio of 1:1, to receive active drug or placebo. Screening and enrollment is planned to last approximately one year. A Data and Safety Monitoring Board, consisting of a clinical pharmacist and 3 neurologists will review all AE reports approximately every 3 months after study initiation. The DSMB will notify the principal investigator, the study sponsor and the CHR if significant concerns are raised by their review of the AE data. An interim analysis of efficacy data will be conducted after 50% of the targeted enrollment population has completed 26 weeks of drug treatment.

Including screening and off-drug follow up, each subject will participate in the study for approximately 34 weeks.

The entire study is anticipated to last 86 weeks if enrollment is completed within one year of study initiation.

The targeted enrollment is 140.

Arms: arm 1: Memantine 10mg BID arm 2: Placebo condition
Interventions: intervention 1: memantine intervention 2: Placebo pill
Intervention descriptions: intervention 1: memantine 10mg BID intervention 2: Placebo pill BID

Protocol documents:
Clinical trial NCT00548418
Conditions: Cervical Cancer
Sponsor: Washington University School of Medicine
Start date: 2007-02-01; Completion date: 2012-12-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the combination of topotecan, cisplatin and bevacizumab is effective in the treatment of recurrent or persistent cervical cancer

Detailed description:
Cervical cancer remains a major cause of morbidity and mortality in women. Chemoradiation has led to improvements in survival, but the prognosis for patients with recurrent, metastatic cervical cancer remains poor. There is the need for more effective treatments for the management of recurrent/persistent cervical cancer. Angiogenesis appears to play an important role in cervical cancer development and progression, therefore VEGF inhibition appears to be a rationale therapeutic strategy for cervical cancer. There is increasing evidence that combining an anti-angiogenic agent with either cytotoxic chemotherapy or radiation enhances anti-tumor activity. This study combines the current most active chemotheraputic regimen for cervical cancer (cisplatin + topotecan) with an anti-angiogenic agent.

Arms: arm 1: Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle

Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle

Bevacizumab 15 mg/kg day 1 of a 21 day cycle
Interventions: intervention 1: Topotecan intervention 2: Cisplatin intervention 3: Bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00555464
Conditions: Hemangioma
Keywords: hemangioma, steroid, prednisolone, vincristine
Sponsor: Medical College of Wisconsin
Start date: 2007-11-01; Completion date: 2012-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to determine the safety and efficacy of Prednisolone and Vincristine for treatment of large, complicated infantile hemangiomas. The diagnostic, therapeutic and response criteria experimentally determined in this study will be used as a framework for future infantile hemangioma studies.

Detailed description:
Infants with large hemangiomas are often treated systemically with oral steroids (Prednisolone) to prevent complications. The best treatment for hemangiomas is not known and there are no medications approved by the FDA for treatment of hemangiomas. Also, the best method to measure the response of hemangioma to treatment is not known. Patients enrolling on this study will be randomly assigned to receive either daily Prednisolone by mouth or weekly Vincristine in a vein. Response to treatment will be monitored by clinical exams every two weeks and by an MRI at study entry and six and twelve weeks later. Patients with evidence of progressive disease (larger hemangiomas) on the week 6 MRI will be switched to the other drug to complete a total of 12 weeks of therapy. Side effects of each medication will be monitored closely determined from histories, physical exams, blood tests and other studies as necessary. Participation in this study will last up to 12 weeks and follow up for protocol.

Arms: arm 1: Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas. arm 2: The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
Interventions: intervention 1: Vincristine intervention 2: Prednisone
Intervention descriptions: intervention 1: Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI. intervention 2: Prednisolone given at 3 mg/kg/day by mouth for 12 week

Protocol documents:
Clinical trial NCT00569530
Conditions: Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) Bronchopulmonary Dysplasia
Keywords: nitric oxide surfactant bronchopulmonary dysplasia prematurity neonates iNO Infasurf lung function ventilated infants
Sponsor: Roberta Ballard
Start date: 2008-01-01; Completion date: 2012-12-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Detailed description:
Surfactant dysfunction may contribute to the development of bronchopulmonary dysplasia (BPD) in persistently ventilated preterm infants. The investigators conducted a multi-center, randomized, blinded pilot study to assess the safety and efficacy of late administration of surfactant (Calfactant - high in protein B) in combination with prolonged inhaled nitric oxide in preterm infants \< 1000 grams birthweight (BW). Calfactant is one of several types of exogenous surfactant. Calfactant has the highest % of surfactant protein B of the different types.

Arms: arm 1: Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated. arm 2: Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.
Interventions: intervention 1: Infasurf (ONY Inc.) intervention 2: Sham
Intervention descriptions: intervention 1: Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14, if remains intubated. intervention 2: Sham instillation (no treatment) will be given to study infants on days 0, 3, 7, 10, and 14, if remains intubated.

Protocol documents:
Clinical trial NCT00577642
Conditions: Multiple Myeloma
Keywords: aminobisphosphonates
Sponsor: Massachusetts General Hospital
Start date: 2007-10-01; Completion date: 2012-12-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to define the time a molecule in the participants bones called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in the urine to determine the rate of bone breakdown. Tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. There is some laboratory data to suggest that they may work against myeloma. Participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

Detailed description:
* Each participant will receive a single dose of zoledronic acid intravenously after the screening procedures.
* Participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: Medical history update; physical exam; ECOG (Eastern Cooperative Oncology Group) Performance Status; blood tests; and urine tests.
* After 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.

Arms: arm 1: Single arm biomarker study after a single dose of zoledronic acid
Interventions: intervention 1: Zoledronic acid
Intervention descriptions: intervention 1: 4mg IV over at least 15 minutes or corrected for creatinine clearance x 1

Protocol documents:
Clinical trial NCT00588809
Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Promyelocytic Leukemia (M3) Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Recurrent Adult Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2007-12-01; Completion date: 2012-12-01
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II clinical trial is studying how well selumetinib works in treating patients with recurrent or refractory acute myeloid leukemia. Selumetinib may stop the growth of cancer by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate (includes complete response-CR, complete response with incomplete count recovery CRi, partial response-PR, and minor response-MR) to AZD6244 (selumetinib).

SECONDARY OBJECTIVES:

I. To determine the effects of AZD6244 in AML samples on p-ERK and evaluate the potential utility of p-ERK inhibition as a surrogate marker of biologic activity.

II. To correlate the effects of AZD6244 with the presence (or absence) of mutated RAS or FLT-3 at baseline.

III. To assess the safety profile of AZD6244 in patients with AML.

OUTLINE:

Patients receive selumetinib orally (PO) twice daily (BID) on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 52 weeks.

Arms: arm 1: Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: selumetinib
Intervention descriptions: intervention 1: Given PO

Protocol documents:
Clinical trial NCT00591825
Conditions: Phobias
Sponsor: University of Kansas Medical Center
Start date: 2006-03-01; Completion date: 2012-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The research team hopes to use brain imaging and mental testing to learn more about specific phobias and the treatment of phobia. When given directly prior to therapy sessions, D-cycloserine has been shown to enhance the effects of therapy. This study hopes to identify reasons why D-cycloserine has this effect by measuring brain activity.

Detailed description:
Exposure and Response Prevention (ERP) therapy has become the treatment of choice for specific phobias. ERP involves systematic and repeated exposure to a feared or anxiety-provoking stimulus, leading to habituation and extinction of the fear response. Animal models of fear extinction have shown that acute administration of D-cycloserine (DCS) prior to exposure to a feared stimulus enhances extinction of that fear. A recent study in human subjects with height phobia (a specific phobia) has also demonstrated that DCS facilitates the effects of ERP therapy. Current theories postulate that DCS facilitates fear extinction by enhancing the learning process and increasing consolidation of memories, but the neural mechanisms underlying this process are not understood. The proposed research aims to elucidate these mechanisms by using fMRI to measure brain activation during 1) symptom provocation and verbal learning two hours post-medication, and 2)repeated symptom provocation and verbal recognition one week post-medication. This research will also examine the effects of DCS on cognitive functioning using neuropsychological testing both two house and one week post-medication.

Arms: arm 1: Participants without phobia will be given one placebo administration. arm 2: Participants without phobia will be given one D-cycloserine (DCS) administration of 100mg. arm 3: Participants with phobia will be given one placebo administration. arm 4: Participants with phobia will be given one D-cycloserine (DCS) administration of 100mg.
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: D-cycloserine intervention 2: Placebo

Protocol documents:
Clinical trial NCT00605072
Conditions: Cognitive Impairment Hypertension Aging
Keywords: cognitive disorders angiotensin receptor blockers
Sponsor: University of Southern California
Start date: 2008-01-01; Completion date: 2012-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effects of blood pressure medications on cognition and blood flow in hypertensive elderly patients with cognitive impairment. The hypothesis is that treatment with an angiotensin receptor blocker (ARB) or an angiotensin-converting enzyme inhibitor (ACEI) will be associated with a slower rate of further cognitive decline, improved cerebral blood flow and its regulation, and preserved physical function as compared to treatment with a diuretic (HCTZ), independent of blood pressure level.

Detailed description:
There is mounting evidence that hypertension, which affects more than 65% of the US elderly population, accelerates cognitive decline and increases the risk of functional disability among older individuals. Hypertension is also associated with cerebral blood flow reduction and dysregulation which contribute to further cognitive and functional impairment. Drugs that inhibit angiotensin II (ACEI and ARB) are commonly used antihypertensives and may have a protective effect on cognitive function, cerebral blood flow and physical function compared to other antihypertensives such as hydrochlorothiazide (HCTZ).

A total of 100 individuals will be recruited for this pilot 3-arm randomized study to investigate the effects of: (i) 12 months treatment with candesartan (ARB) compared to hydrochlorothiazide (HCTZ) and (ii) 12 months treatment with lisinopril (ACEI) compared to HCTZ and (iii) to estimate the effect size difference between lisinopril and losartan on cognition, cerebral blood flow regulation, and functional measures in a sample of elderly hypertensive individuals with objective evidence of cognitive impairment.

Arms: arm 1: Angiotensin Receptor Blocker arm 2: Angiotensin-Converting Enzyme (ACE) Inhibitor arm 3: Hydrochlorothiazide (diuretic)
Interventions: intervention 1: candesartan intervention 2: lisinopril intervention 3: hydrochlorothiazide intervention 4: nifedipine, long acting intervention 5: metoprolol, long-acting
Intervention descriptions: intervention 1: orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months intervention 2: orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months intervention 3: orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months intervention 4: If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments intervention 5: If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg

Protocol documents:
Clinical trial NCT00616343
Conditions: Essential Tremor
Keywords: ET
Sponsor: Loma Linda University
Start date: 2003-06-01; Completion date: 2012-12-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Zonisamide is effective in reducing tremors in patients with Essential Tremor.

Detailed description:
The subjects will remain on their usual medication and a baseline assessment using the Fahn Tolosa Marin tremor rating scale will be performed and will be video taped.

Arms: arm 1: None
Interventions: intervention 1: Zonisamide
Intervention descriptions: intervention 1: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.

Protocol documents: