Kornimate/medical-research-clean huggingface dataset:
sleep related memory consolidation in children with age related focal epilepsy.

Conditions: Benign Epilepsy With Centro Temporal Spikes (BECTS); Atypical Benign Partial Epilepsy (ABPE); Epileptic Encephalopathy With Continuous Spike and Waves During Sleep (ECSWS)

Summary: age related focal epilepsies in children encompasses, according to the ilae criteria, benign epilepsy with centro temporal spikes (bects), atypical benign partial epilepsy (abpe) and epileptic encephalopathy with continuous spike and waves during sleep (ecsws). these non structural epilepsies are associated with interictal sleep spike and waves activated by sleep. moreover, high prevalence of learning disorders occur in children with age related epilepsies. a correlation is suspected between learning disorders and sleep activation of spike and waves. the investigators suppose that learning dysfunction is linked to loss of information during sleep of epileptic children, unlike for control patients. as sleep allows memory consolidation of words learned during wakefulness, an epileptic activity during sleep may disrupt this consolidation, leading to a loss of information. hypothesis: the investigators hypothesize a disruption of memory consolidation after one night in children affected with abpe and ecsws (severe group) compared to memory consolidation in children affected with bects (benign group), and control group. primary purpose: to demonstrate that the deficit of delayed recall in 15 word learning test after one night is higher for the "severe group", compared to the "benign group" and the control group. secondary purposes: * to study the evolution over time of memory consolidation * to evaluate the correlation of the deficit of delayed recall with executive dysfunction, clinical factors of epilepsy, neurophysiological factors of epilepsy, and sleep architecture


Eligibility criteria:
inclusion criteria: principal: * normal psychomotor development * informed consent signed by both parents and subject if able * affiliated to social security regimen specific patients from "severe" and "benign" groups: * focal age related epilepsy: bects, abpe, ecsws (ilae criteria) * children hospitalized for their follow-up * normal neuroimaging control group -children hospitalized for a non neurologic disease exclusion criteria: principal: psychiatric trouble (dsm v) sensorial trouble without correction poor command of french language minor under care specific patients from "severe" and "benign" groups: * degenerative disease * abnormal neuroimaging * mental deficiency control group * neurologic trouble * abnormal sleep eeg * intellectual deficiency

Keywords: memory consolidation epilepsy childhood benign epilepsy with centro temporal spikes (bects) epileptic encephalopathy with continuous spike and waves during sleep (ecsws)
safety and efficacy of the lvis and lvis jr devices in the endovascular treatment of intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: a french, multicenter, prospective, observational, "real life" assessment of the safety and efficacy of lvis and lvis jr devices in the treatment of intracranial aneurysms

this is a multicenter observational study. treatment and follow-up visits will be done as per standard of care. the purpose of this study is to collect data on safety of the devices used since the french reimbursement. 130 patients will be enrolled over an 18-month recruitment period. all patients will be followed for at least 12 months.

Eligibility criteria:
inclusion criteria: * patient with an intracranial aneurysm for which an endovascular treatment is indicated with the device lvis or lvis jr, either scheduled or emergency (" bail-out stenting ") * patient or patient's legally authorized representative has been informed about the study and does not oppose the collection of his/her personal data exclusion criteria: * none

Keywords: aneurysm endovascular
study of cyh33 in combination with endocrine therapy with or without palbociclib in patients with hr+, her2- advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a multicenter, open-label, phase ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of cyh33 administered orally in combination with standard-of-care et ± cdk4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (hr+), human epidermal growth factor receptor 2 negative (her2-) breast cancer. patients will be enrolled in two stages, including dose exploration phase (stage 1) and dose expansion phase (stage 2) of each cohort.


Eligibility criteria:
main inclusion criteria: 1. provide informed consent voluntarily. 2. male and female patients ≥ 18 years of age. 3. patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer. 4. in case of women, both premenopausal and postmenopausal patients can be enrolled in the study. 5. confirmed diagnosis of hr+, her2- breast cancer. 6. for stage 1 dose exploration phase, patients with or without pik3ca mutation may be enrolled; for stage 2 dose expansion phase, patients with pik3ca mutations are required. 7. patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy. 8. patient has measurable disease per recist v1.1. 9. ecog ≤ 1. 10. patient must have adequate organ and bone marrow function. main exclusion criteria: 1. previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment. 2. previously received treatment with any pi3kα inhibitor, akt inhibitor, or mtor inhibitor. 3. radical radiation therapy within 4 weeks prior to the first dose of the study treatment. 4. patient with an established diagnosis of diabetes mellitus. 5. any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance. 6. patient with clinically significant cardiovascular disease.

Keywords: pik3ca mutant advanced breast cancer
effects of auditory stimulation on sleep and memory in schizophrenia

Conditions: Schizophrenia

Summary: the investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. the investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. the investigators will study healthy subjects and outpatients with schizophrenia.


Eligibility criteria:
inclusion criteria: for healthy controls: * male and female subjects * 18-50 years of age * proficient in english for schizophrenia patients: * male and female schizophrenia outpatients * 18-50 years of age * proficient in english * able to give informed consent exclusion criteria: * pregnant females * current use of psychotropic medications (healthy controls only) * a history of head injury resulting in prolonged loss of consciousness or other neurological sequelae * iq \<85 * neurological disorder (including seizure disorder) * significant hearing or vision loss * current substance abuse or dependence (nicotine abuse or dependence is not exclusionary) * any unstable chronic medical condition that affects sleep * diagnosed sleep disorder

Keywords: sleep memory schizophrenia auditory stimulation
treatment of necrotizing vasculitides for patients older than 65 years

Conditions: Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Polyarteritis Nodosa

Summary: the aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.

systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly. although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients. preliminary data indicate that systemic necrotizing vasculitides (snv) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects. in this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (cyc then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).

Eligibility criteria:
inclusion criteria: * newly diagnosed wg, mpa, pan without hbv infection, or css * patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol. * within or after the 65th of anniversary * age ≥ 65 years exclusion criteria: * any cytotoxic drug within previous year * co-existence of another systemic autoimmune disease, e.g., sle, ra * virus-associated vasculitides * hiv positivity * malignancy (usually excluded unless approved by the trial coordinator) * age \< 65 years * inability to give informed consent

Keywords: systemic necrotizing vasculitides corticosteroids; azathioprine; mycophenolate mofetil; cyclophosphamide elderly patients randomized controlled trial
efficacy study of a cosmetic lotion in the treatment of androgenetic alopecia in males and females

Conditions: Androgenetic Alopecia

Summary: the purpose of this study is to determine whether the hair loss prevention lotion named mexis, m.p.a.f., m6s patent is effective in the treatment of androgenetic alopecia.

this study verifies whether the tested product has any efficacy in the treatment of androgenetic alopecia. * the evaluated product (hair loss prevention lotion) is called:mexis, mpaf, m6s patent. * 20 volunteers both men and women suffering from hair loss both in parties and over the entire scalp with age between 18 and 70 years have been selected for this test . * samples of the product have been applied following their usual use: as they are. * on the selecting volunteers have been used: 1. the pull test by pulling with fingers of some hair and counting them to estimate the evolution of the pathology. 2. a sebum-meter to check the presence of scales on the scalp. 3. a polarized light video-camera to check the redness of the scalp and to have a picture of hair and scalp. * volunteers were also asked about: * fluffiness * sheen * itching * presence of scales on scalp * oily hair * product's acceptability * the readings are taken at 0 time (basal value), after 15 days (t15), 30 days (t30), 45 days (t45), 45 days (t45), 60 days (t60) and 90 days (t90) by the experimenter in the medical studio. then they analyzed and reported in a graph. * summarizing tables and graphs of the data were taken during experimentation.

Eligibility criteria:
inclusion criteria: * good state of general health * suffering from hair loss * no pharmacological treatment in progress * promise not to change the usual daily routine * no atopy in the anamnesis exclusion criteria: * illness * good state of hair * pharmacological treatment in progress * denial of the continuance of the usual daily routine * atopy in the anamnesis

Keywords: baldness androgenetic alopecia alopecia
study of the combination of velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with newly diagnosed non-germinal center b-cell subtype of diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this is a randomized, open-label, active-control, parallel-group, multicenter, multinational phase 2 study of the efficacy and safety of velcade, rituximab, cyclophosphamide, doxorubicin, and prednisone (vr-cap) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (r-chop) in patients with newly diagnosed non-germinal center b-cell (non-gcb) subtype of diffuse large b-cell lymphoma (dlbcl)


Eligibility criteria:
inclusion criteria: * male or female patients 18 years or older. * newly diagnosed non-gcb subtype of dlbcl (stage ii, iii or iv). * at least 1 measurable site of disease. * eastern cooperative oncology group (ecog) performance status 0-2 * female subjects must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; and have a negative pregnancy test at screening. * male subjects must agree to use a double barrier method of birth control exclusion criteria: * prior treatment with velcade. * prior extended radiotherapy or chemotherapy for lymphoma * more than 150 mg/m2 of prior doxorubicin * major surgery within 3 weeks of study. * peripheral neuropathy or neuralgia of grade 2 or worse. * active cns lymphoma * diagnosed or treated for a malignancy other than nhl, with some exceptions * pregnant or breast feeding * active systemic infection * documented of suspected human immunodeficiency virus (hiv)/aids * uncontrolled or severe cardiovascular disease * known allergies, hypersensitivity or intolerance to study drugs * serious medical condition that could interfere with study * concurrent treatment with another investigational agent
the effect of an experimental gel based on copaiba oil resin in reducing post-bleaching tooth sensitivity

Conditions: Tooth Bleaching Pain

Summary: this randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing copaiba oil resin in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. the volunteers of this study were randomized into 3 different groups - gc (placebo); gn (potassium nitrate and sodium fluoride); gco (copaiba oil resin). the dental elements of the gco received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. the gc and gn groups also received the application of a placebo gel and a nitrate potassium and sodiun fluoride gel, respectively, under the same conditions described for the experimental gel. subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide. post-bleaching sensitivity was collected through a form composed of the visual analogue scale (vas). color measurement was performed at two times: baseline (ti) and one week after the 3rd bleaching session (tf).


Eligibility criteria:
inclusion criteria: * good oral hygiene * absence of active caries lesions * never undergone bleaching therapy * not present dental hypersensitivity * don't be a smoker * don´t be pregnant * present at least 28 teeth in the oral cavity exclusion criteria: * volunteers undergoing orthodontic treatment, * presence of periodontal disease * dental cracks or fractures * restorations and prostheses on anterior teeth * extensive molar restorations * gastroesophageal disorders * severe internal dental darkening * presence of dentinal exposure in anterior and / or posterior teeth.
psychological mobile app for patients with aml

Conditions: AML; Acute Myeloid Leukemia

Summary: this research study is evaluating whether a psychological mobile application (app), is efficacious in reducing anxiety and depression symptoms and improving quality of life for patients diagnosed with acute myeloid leukemia (aml) compared to a physical health promotion app.

patients with a new diagnosis of aml often confront a sudden and life-threatening diagnosis, requiring an immediate disruption of their life and an urgent 4-6 week hospitalization to initiate intensive chemotherapy. during this hospitalization, they endure substantial physical symptoms due to the side-effects of intensive chemotherapy, which negatively impacts their quality of life. patients with aml also experience significant psychological distress as they struggle with the abrupt onset of illness, uncertainty regarding their prognosis, physical and social isolation during their hospitalization, and complete loss of independence. from our prior studies, we learnt that the use of dreamland, a psychological mobile app, was feasible to integrate in the care of patients with aml receiving intensive chemotherapy and has promising efficacy for improving patients' physical and psychological symptoms and their quality of life. in this project, the study doctors want to compare the effectiveness of dreamland versus cerena in improving the patient experience when diagnosed with aml. cerena is a mobile app that provides medical information about how to best take care of one´s health. using this research, the study doctors hope to find out the best way to help patients cope with the diagnosis and treatment for aml. the study will use questionnaires to measure patient's quality of life, physical symptoms, mood, and the participant sense of control over their situation. study questionnaires will be completed in the hospital or clinic. the participants will also have the option of completing these questionnaires remotely through a secure web link or through a mailed paper copy. blue note therapeutics, inc. is supporting this research study by providing funding. blue note therapeutics is a digital health technology company that focuses on the health needs of patients with a cancer diagnosis.

Eligibility criteria:
inclusion criteria: * hospitalized patients (aged 18 years or older) with a new diagnosis of aml * receiving treatment with either a) intensive chemotherapy (7+3) or modification of this regimen on a clinical trial, or b) a similar intensive regimen requiring prolonged 3-6-week hospitalization * ability to comprehend and speak english as the mobile apps are only available in english exclusion criteria: * patients with a diagnosis of acute promyelocytic leukemia * patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

Keywords: aml acute myeloid leukemia
user evaluation of the invasive component of the cnoga tensortip combo glucometer (cog)

Conditions: Diabetes Mellitus

Summary: open label, prospective, comparative, multi-center study. all participants will get an introduction to the invasive component of the tensortip cog by means of the instructions for use in english language only (incl. an illustrated short manual) and will be asked to perform a reading without further device training. thereafter, a healthcare professional will perform an additional reading with the reference method (ysi 2300 stat plus). in addition, blood will be drawn for determination of hematocrit. in the study, a minimum of 10 test strip vials that cover a minimum of 3 strip lots will be used. in addition multiple devices will be employed. after completion of the study the study participants will be given a questionnaire to fill out.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes or healthy * subjects who are able to complete informed consent form (by him/herself or by his/her guardian); * 18 years old and above; exclusion criteria: * does not meet inclusion criteria; * subjects with any other severe disease in the discretion of the investigator * not capable to read english user instructions at the discretion of the patient * pregnancy or nursing mothers * any condition that may prevent participants from successful participation in the trial (in discretion of the investigator) * illiteracy
comparison between ultra-low-dose computed tomography and lung mri in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to compare the performances of ultra-low dose computed tomography (ct) and lung magnetic resonance imaging (mri) for morphological assessment of cystic fibrosis-related lung disease and to compare their performances to conventional low dose ct

cystic fibrosis (cf) is a recessive autosomal disease caused by mutations in the cystic fibrosis transmembrane conductance regulator (cftr) gene that encodes for an epithelial chloride channel involved in ion and fluid transport. cf is the most common inherited disease in caucasians and disease severity mainly depends on the degree of lung involvement, which can lead to terminal respiratory failure disease monitoring of cf-related lung disease rely on functional assessment and complimentary morphological assessment. conventional low-dose chest computed tomography (ct) is currently the gold standard for the morphological assessment of cf-related lung disease but ultra-low dose chest ct and high-resolution magnetic resonance imaging (mri) of the lung using ute sequences have been recently developed and allow important radiation reduction of radiation dose exposure. however the performances of these 2 competing imaging methods remains to be compared.

Eligibility criteria:
inclusion criteria: * age ≥ 18 year-old * diagnosis of cystic fibrosis provided by genetic and swear test * chest ct acquisition performed as part of the standard follow-up * patient with social security or health insurance * informed consent exclusion criteria: * mri contraindication * orthopnea * inability to hold breath for 17 seconds * no spirometry planned the same day * lung transplant patient

Keywords: magnetic resonance imaging multidetector computed tomography
discharge counseling and medication therapy management (mtm) services after discharge for heart failure patients

Conditions: Heart Failure

Summary: readmission to a hospital shortly after discharge is a common and costly problem. in the united states patients with a diagnosis of heart failure currently experience an elevated 30 day readmission rate of approximately 20%. by providing patients with medication related counseling at discharge by a pharmacist, home medications at discharge, and seeing the patient again in a pharmacist-run medication therapy management (mtm) clinic 7 days after discharge, the study anticipates achieving its primary goal of showing a reduction in the readmission rate. secondary goals are: 1) to determine patients understanding of the medication they are taking, 2) to evaluate satisfaction with the comprehensive discharge counseling service, and 3) determine the number of interventions made and benefit of the mtm clinic.

the active arm of this study (medication related hospital discharge counseling by a pharmacist, home medications, and 7 day follow-up visit at a pharmacist run mtm clinic) is available to all subjects. to study the primary goal of reducing the 30 day readmission rate the data obtained from the active arm subjects will be compared to a match group of hospitalized patients that were previously discharged with a diagnosis of heart failure. the data for all secondary study goals will be obtained directly from the active arm subjects.

Eligibility criteria:
inclusion criteria: * heart failure with high risk for readmission. * enroll in study prior to hospital discharge. exclusion criteria: -

Keywords: heart failure medication therapy management
a single-dose study of mk6349 in patients with type 2 diabetes (6349-002)

Conditions: Type 2 Diabetes Mellitus

Summary: a single dose study to assess the safety, tolerability, pharmacokinetics and pharmacokinetics of mk6349 in type 2 diabetics.


Eligibility criteria:
inclusion criteria: * subject is a non-smoking male or female (females must be postmenopausal, had a tubal ligation or a hysterectomy) between 18 to 55 years of age * subject has type 2 diabetes and is currently being treated with diet and exercise alone or with less than 3 oral diabetes drugs exclusion criteria: * subject is on insulin or a ppar agonist medication * subject has type 1 diabetes