Kornimate/medical-research-clean huggingface dataset:
imatinib mesylate in treating patients with recurrent or refractory fibromatosis

Conditions: Desmoid Tumor

Summary: rationale: imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. purpose: this phase i/ii trial is studying the side effects of imatinib mesylate and to see how well it works in treating patients with recurrent or refractory aggressive fibromatosis.

objectives: primary * determine the non-progression rate in patients with recurrent or refractory aggressive fibromatosis after 3 months of treatment with imatinib mesylate. secondary * determine the non-progression rate in patients after being treated with this drug for 12 months. * determine the toxic effects of this drug in these patients. * determine the tolerance to this drug in these patients. * determine the response rate in patients treated with this drug * determine progression free and overall survival of patients treated with this drug. * determine the quality of life of patients treated with this drug. * correlate clinical, biological, and genomic markers with response and long-term stable disease in patients treated with this drug. outline: this is a multicenter study. patients receive oral imatinib mesylate once daily for up to 12 months in the absence of disease progression or unacceptable toxicity. quality of life is assessed periodically. projected accrual: a total of 39 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed aggressive fibromatosis (desmoid tumor) * relapse or disease progression despite surgery, chemotherapy, radiotherapy, or any other treatment * tumors must meet the following criteria: * ineligible for complete surgical resection by carcinological exeresis or surgery would cause severe mutilation * cannot be treated with curative radiotherapy * measurable disease by recist criteria * no prior malignancy patient characteristics: * not pregnant or nursing * fertile patients must use effective contraception during and for 6 months after completion of study treatment * absolute neutrophil count \> 1,000/mm\^3 * platelet count \> 100,000/mm\^3 * bilirubin \< 1.5 times upper limit of normal (uln) * sgot and sgpt \< 2.5 times uln * creatinine ≤ 2.5 times normal * no severe liver failure * no chronic somatic or psychiatric illness that would preclude study compliance * no known hypersensitivity to imatinib mesylate or one of its components * no geographical, social, or psychological reason that would inhibit follow-up prior concurrent therapy: * see disease characteristics * no concurrent immunomodulators\* * no concurrent hormonal treatments\* if used for fibromatosis * no concurrent cytotoxic drugs\* * no concurrent nonsteroidal anti-inflammatory drug\* if used for fibromatosis * allowed if used as an analgesic 3 months prior to disease progression * no concurrent participation in another therapeutic investigational trial note: \*if disease progression has occurred during this treatment, then the treatment must have ended ≥ 1 month prior to study entry

Keywords: desmoid tumor
chloroquine for glioblastoma.

Conditions: Glioblastoma

Summary: adjuvant chloroquine to the conventional treatment for glioblastoma; a randomized, single-blind, placebo-controlled, phase i/ii trial.


Eligibility criteria:
inclusion criteria: histologically confirmed glioblastoma adequate hematologic, hepatic, and renal function karnofsky performance status score ≥ 70% life expectancy ≥ six weeks exclusion criteria: abnormal severe un-controlled medical conditions
photon/proton radiation therapy for oropharyngeal cancers

Conditions: Oropharyngeal Cancers

Summary: the purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

this is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Eligibility criteria:
inclusion criteria: * biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue). * stage-grouping: * stage i (t1n0) * stage ii (t2n0) * favorable stage iii (t1n1/t2n1) and selected stage iv (t1-t2 early n2b)2 or less lymph node and 2 or less cm diameter lymph node * unfavorable stage iii and selected stage iv (any t, n2c/n3) * surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies. * will receive treatment with proton radiation. exclusion criteria: * evidence of distant metastasis. * previous irradiation for head and neck cancer.

Keywords: oropharyngeal cancer proton radiation outcomes
gastric decompression after sub-total gastrectomy

Conditions: Gastric Cancer

Summary: the purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to billroth ii or according roux.

a silastic naso-gastric tube (rusch® distributed by teleflex medical srl) is used in the naso-gastric/jejunal tube group

Eligibility criteria:
inclusion criteria: * all people subjected to subtotal gastrectomy for distal gastric adenocarcinoma. exclusion criteria: * people undergoing enteral nutrition through naso-jejunal tube

Keywords: naso-gastric/jejunal tube sub-total gastrectomy gastric cancer decompression discomfort complications
decrease implantation site infection : a randomized controlled trial

Conditions: Infection

Summary: cardiovascular implantable electronic device (cied) infections have been increasing out of proportion to the number of devices implanted the investigators investigated recent trends and possible causes of the increasing numbers of cardiovascular implantable electronic device infections.

there are many studies on the preventive use of antibiotics or povidone iodine to cardiovascular implantable electronic device (cied) infections. but, studies of posterior pocket capsule removal is still limited. the investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.

Eligibility criteria:
inclusion criteria: * scheduled for cardiac devices replacement exclusion criteria: * under the age of 18 * take an antibiotic * history of infection within 30 days

Keywords: infection prevention cardiac devices
preventing eating disorders by improving mental health literacy in chinese adolescents

Conditions: Eating Disorders; Mental Health Literacy

Summary: mental health literacy (mhl) is necessary for the prevention, detection, and treatment of eating disorders, whereas the mhl about eating disorders is inadequate in china. thus, the current study aimed to improve the mhl for eating disorders among chinese adolescents via a brief online intervention.


Eligibility criteria:
inclusion criteria: * middle school students exclusion criteria: -
pharmacists' intervention in patients using novel oral anticoagulants：a study on behavioral patterns

Conditions: Anticoagulants; Intention; Behavioral Symptoms

Summary: novel oral anticoagulant drugs (noacs) are now increasingly used in clinical practice. although there are outstanding advantages of noacs, there are also some shortcomings in use. the behavioral pattern of patients using novel oral anticoagulant drugs can directly affect the effect of anticoagulant therapy. however, at present, there is no study on behavioral patterns of compliance and cognition in patients using noacs in china. there are few reports on the management outcomes of noacs anticoagulant therapy as well. above all, exploring whether pharmacists change behavioral patterns in patients using noacs is of great significance to improve the effectiveness and safety and to prove the value of pharmacists who provide pharmaceutical care.

the study is a prospective randomized controlled trial. patients who will use noacs are prospectively divided into routine group and pharmacist intervention group. for the intervention group, pharmacists regularly provide telephone and outpatient follow-up combined with patient medication education, establishing database system, telephone reminder, etc. at the 12-week follow-up, behavioral patterns of compliance, self-anxiety, depression status and satisfaction with the pharmacist service will be evaluated in both groups. pharmacodynamic substitution indicators and endpoints will be collected as well. clinical data is designed to be collected from 400 patients, 200 patients each group. data will be recorded by epidata dual-track, analyzed by spss19.0 software. p\<0.05 is considered significant.

Eligibility criteria:
inclusion criteria: 1. outpatients or inpatients with anticoagulation indications of novel oral anticoagulant drugs (noacs). 2. new prescriptions for noacs, or previous prescriptions for noacs, not received any intervention by pharmacists before. 3. written informed consent was obtained from patients or their families. exclusion criteria: 1. patients who did not use novel oral anticoagulants. 2. patients who had received interventions from pharmacists, such as medication education. 3. written informed consent was not obtained from patients or their families.
safety and maintenance study of entocort for children with crohn's disease

Conditions: Crohn's Disease

Summary: a safety for maintenance of entocort ec for children with mild to moderate crohn's disease.

a multicenter, open label, non-comparative study to evaluate the safety of entocort ec as a maintenance treatment for crohn's disease in paediatric subjects aged 5 to 17 years, inclusive

Eligibility criteria:
inclusion criteria: * all male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit. * all subjects must weight \>= 15 kg at the time of enrollment. * subjects must have been diagnosed and treated for active crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology and have a pcdai \<= 10 exclusion criteria: * subjects who have had any previous intestinal resection proximal to and including the ascending colon. * subjects with evidence of active crohn's disease (pcdai \> 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications. * subjects with morning cortisol level \<150 nmol/l (5.4 ug/dl) or dhea-s below normal range for age and gender (note: subjects from the induction protocol with abnormal morning cortisol/dhea-s levels at visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that entocort 6 mg is an appropriate therapy option.

Keywords: crohn's disease
improved efficacy of selective laser trabeculoplasty with the addition of rocklatan post-treatment vs artificial tears post-treatment

Conditions: Glaucoma

Summary: a randomized, single-site, parallel-group, prospective study of patients who are candidates for slt, to study the effect of iop change with rocklatan vs artificial tears.


Eligibility criteria:
inclusion criteria: * patients 18 years and older * documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. diagnosis of primary open angle glaucoma must be supported by the following: * 24-2 sita faster within the last 6 months - with a mean deviation of 0 to -12 db, excluding patients that meet severe criteria by having defects involving fixation or in two hemispheres. * oct rnfl and optic nerve examination within the last 6 months * diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary rnfl, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the rnfl/gca on examination or imaging * progressive thinning on sd-oct of 7 microns in inferior and superior quadrants or \>4 micron loss in global rnfl thickness * deviation from this isnt rule (inferior, superior, nasal and temporal order of rnfl thickness with the inferior rnfl quadrant being the thickness) * candidate for bilateral slt * post-washout, post-slt iops between 28-10 * gonioscopy findings of schafer grade iii and iv exclusion criteria: * patients md \<-12, hvf defects in both hemispheres or involving fixation * medication conditions that prevent slt * prior use of rho kinase inhibitor * previous slt performed on either eye * prior migs implanted in either eye * prior or current intolerance of a rho kinase inhibitor * uncontrolled iop on maximum tolerated medical therapy; unable to washout * narrow angles or other angle abnormalities * history of corneal disease or dystrophy, including endothelial dysfunction * history of corneal edema * current or history of intra-ocular infection or inflammation * history of retinal diseases that will could affect diagnostic testing * anticipated use of intra-ocular or topical steroids not associated with the study protocol * current participation of study drugs or devices or within 6 months prior to screening * pregnant or planning to be pregnant throughout the study * any condition in the opinion in the investigator that would potentially confound the results of this study
changing lifestyle in osa males who suffer metabolic syndrome and impotence: is there a response?

Conditions: Obstructive Sleep Apnea; Erectile Dysfunction; Metabolic Syndrome

Summary: the problems like metabolic syndrome and sexual impotence in males with obstructive sleep apnea are common. continuous passive airway pressure (cpap) is an authorized treatment for this type of apnea but still the recommendations of changing lifestyles are the suggested cornerstone therapies especially in obese males

forty males with metabolic syndrome, sexual impotence (erectile dysfunction), and obstructive sleep apnea will be randomized to control group (cpap will be applied in this group that will contain 20 males, cpap will be applied five days weekly during night-sleeping for 4 hours for 12 weeks ) and study 20-patient group (also cpap will be applied with the same protocol of control group plus lifestyle changes that will contain 3-session per-week 40-minute treadmill exercising and low-caloric/dietary 12-week restriction)

Eligibility criteria:
inclusion criteria: * moderate and severe obstructive sleep apnea * erectile dysfunction (mild and moderate) * metabolic syndrome men exclusion criteria: * cardiac patients * psychiatric men * autoimmune diseased men * renal diseased men
clinical evaluation of the sequredx t21 test in high risk pregnancies

Conditions: Down Syndrome; Fetal Aneuploidy

Summary: whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the sequredx trisomy 21 test.


Eligibility criteria:
inclusion criteria: * pregnant woman 18 years of age or older at 10 - 22 weeks gestation inclusive * subject has one or more high risk indicator for fetal chromosome 21 aneuploidy * subject provides signed and dated informed consent * subject agrees to provide a whole blood sample exclusion criteria: * fetal demise at the time of the blood draw * previous specimen donation under this protocol

Keywords: down syndrome fetal aneuploidy trisomy noninvasive prenatal test
ipratropium spray for drooling saliva in parkinson's disease

Conditions: Parkinson's Disease

Summary: a phase ii double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with parkinson's disease.

background: excessive drooling of saliva (sialorrhoea) is a common complication of parkinson's disease (pd). unfortunately current medications, which rely on anticholinergic properties, often induce systemic side effects, such as confusion, hallucinations or urinary retention. aim: we therefore hypothesise that local application of an anticholinergic aerosol spray into the mouth would reduce sialorrhea in pd without inducing systemic side-effects. method: a double blind, randomised, placebo-controlled cross-over trial of the muscarinic antagonist, ipratropium bromide in patients with bothersome drooling in idiopathic parkinson's disease. all patients are recruited from the movement disorders clinic, toronto western hospital and informed consent is obtained. patients are randomised to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micorgram per metered dose) or matching placebo, up to a maximum of 4 times per day, in a double-blind, cross-over design using randomisation tables. total treatment length is two weeks for each limb of the study with a 1-2 week wash out period. the primary outcome measure is an objective measure of saliva production. dental rolls are inserted into the mouth for 5 min and the patient instructed not to swallow and sit upright. the weight of dental rolls before and after insertion is calculated as a measure of saliva production. the secondary outcome measures are subjective measure of saliva where patients or caregivers record the level of saliva production each day for the 2 weeks of each treatment using validated subjective rating scales which assess drooling severity and frequency. in addition, parkinsonism is rated using the updrs parts i - iv and adverse events are recorded. the scores for measured saliva production following ipratropium bromide and placebo treatment will be compared using appropriate paired t-tests. results from the scales assessing the subjective measures of saliva production and updrs ratings will be compared via paired non-parametric wilcoxon matched pairs test. 20 patients will be recruited.

Eligibility criteria:
inclusion criteria:male and female patients with idiopathic pd and who are currently experiencing bothersome drooling (united parkinson's disease rating scale (updrs) item 6, rating of 2 or higher) will be eligible for this study. patients must be on a stable medication regimen for the preceding one-month run-in period. in addition, patients or a caregiver must be able to complete a daily record card, and patients must be able to tolerate an oral dental roll for 5-minute periods for saliva measurements. - exclusion criteria: patients taking acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents, history of glaucoma, clinically significant urinary outflow obstruction or urinary retention, active psychosis or hallucinations, and allergy to peanuts or soybeans. -

Keywords: sialorrhoea
technology-supported physical activity intervention for metastatic breast cancer survivors: fit2thrivemb

Conditions: Metastatic Breast Cancer; Obesity

Summary: this study will test the feasibility and acceptability of increasing pa in metastatic breast cancer (mbc) patients using a smartphone app, fitbit and coaching.

the primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mhealth intervention to increase pa in metastatic breast cancer (mbc) patients using a two-arm randomized control trial (rct). we will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. inactive mbc patients will be assigned to fit2thrivemb or education control. participants assigned to the fit2thrivemb will receive the fit2thrivemb smartphone app, fitbit, and coaching calls. participants in the education control will be asked to download the app cancer.net from the american society of clinical oncology, will receive educational materials and calls during the intervention period and the fitbit following completion of 12 week assessments.

Eligibility criteria:
inclusion criteria: * female; ≥18 years of age * diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify). * fluent in spoken and written english * own a smartphone * have access to the internet to complete assessments * self-report engaging in \<150 minutes of moderate to vigorous pa per week. exclusion criteria: * untreated brain metastases * uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to pa participation * current enrollment in another dietary or pa trial

Keywords: inactivity breast cancer metastatic breast cancer quality of life sedentary
trial comparing 2 diagnostic strategies for preoperative localization of parathyroid adenoma in primary hyperparathyroidism:temp / ct with tc99m-sestamibi or pet / ct with f18-choline in first intention

Conditions: Parathyroid Adenoma; Hyperparathyroidism; F18-choline

Summary: the investigators hypothesize that positron emission tomography with fluorocholline (f18-choline pet) will reduce the proportion of unnecessary invasive surgery decisions and that the higher cost of positron emission tomography versus mibi scintigraphy (tc99m-sestamibi ) will be offset by lower cost in terms of type. surgery performed wisely and complications.


Eligibility criteria:
inclusion criteria: * patient 18 years old * patient presenting with primary hyperparathyroidism and for whom an excisional surgery is planned * for women of childbearing age, negative pregnancy test at baseline * biological assessment confirming the diagnosis of primary hyperparathyroidism (high serum pth and calcium concentrations) * affiliation to a social security scheme * patient having signed his written consent exclusion criteria: * patient deprived of liberty, under tutorship or curatorship * hypersensitivity to tecnescan sestamibi * any associated medical or psychological condition that could compromise the patient's ability to participate in the study * pregnant or lactating woman * history of parathyroid surgery * patient with multiple endocrine neoplasia 1 (nem1) * known hypersensitivity to fluorocholine or to any of the excipients (sodium chloride, water for injections)
brain activity in epilepsy

Conditions: Epilepsy

Summary: prospective interventional study with implantation of micro-electrodes to study the brain networks in epilepsy at high spatiotemporal resolution.

the goal of this trial is to study brain activity in epilepsy at high spatiotemporal resolution. apart from the epileptogenic network (dysfunctional areas), the investigators will study human brain function. the use of micro-electrode arrays allows to study the human brain a high spatiotemporal resolution, even at the single neuron level. scientific objectives of the current project: * to record neural signals from macro-electrodes and delineate the epileptogenic network and study brain function during specific tasks. * to record neural signals from micro-electrodes and delineate the epileptogenic network and study brain function during specific tasks. * identifying pivotal regions for bmi applications and developing online decoding algorithms. * comparing neural recordings to fmri activity

Eligibility criteria:
inclusion criteria: * age ≥18 yo * epilepsy patients undergoing intracranial electrode placement. * able to understand the procedure involved and to consent. exclusion criteria: * age \< 18 yo * pregnancy