Kornimate/medical-research-clean huggingface dataset:
lescod: "lewy body screening in cognitive disorders"

Conditions: Alzheimer Disease; Lewy Body Disease

Summary: dementia with lewy body (dlb) is the second most common neurodegenerative dementia in autopsy series. however, dlb represents a small proportion of the clinical diagnoses in epidemiology registries. indeed alzheimer disease (ad) and dlb are often concomitant, they share many symptoms and only a small weight is given to non-motor symptoms in dlb diagnosis. dlb is at the end of a pathological spectrum overlapping with ad, explaining the poor diagnostic value of both diagnostic criteria. to date there is still a need for a tool able to discriminate patients with pure dlb from those expressing common signs with both ad and dlb and those with pure ad. the purpose of this study is to validate a semi quantitative scale designed to reflect the lewy bodies burden in patients with mild to moderate cognitive decline. the investigators hypothesized that the score obtained may differentiate between ad, dlb and patients fulfilling clinical criteria for both dlb an ad. this score could also be correlated with dopaminergic depletion assessed with \[18f\]fluorodopa pet/computed tomography and/or with potential biomarkers of add measured in cerebrospinal fluid. this clinical validation is a preliminary work preceding further studies correlating the lescod score with functional imaging features, prognosis and therapeutic response. thus, the expected outcomes involve an improvement in demented patients' care, as well as a better patient selection for further therapeutic studies


Eligibility criteria:
inclusion criteria: * be a woman or a male \>60 to \< 90 years * have sufficient visual and auditory acuity * be able to speak, read, hear and understand french language * be covered by health care insurance * have a reliable help/partner/informant/caregiver * have a mild to severe cognitive decline based on mmse (mini-mental state examination) score ( from 18 to 26) * give oral agreement to the assessment of the lescod scale during routine consultation * have performed neuropsychology tests and mri respectively within 6 and 12 months exclusion criteria: * has evidence of neurological or psychiatric disorder other than ad or dlb explaining cognitive decline * has received previously or currently neuroleptic treatment * has no reliable help/caregiver the day of the visit * refuses to give his/her oral agreement to the assessment of the lescod scale * has presence on mri of radiologic evidence of cerebrovascular disease (score fazekas 2)

Keywords: alzheimer disease lewy body disease
the follow study of speech functions in preschool children with cerebral palsy: clinical measures and acoustic analysis

Conditions: Cerebral Palsy

Summary: the aims of this study: 1. to investigate the difference in motor speech functions among children with cerebral palsy (cp) of different motor severities. 2. to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with cp of different motor severities. 3. the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with cp. 4. to identify the variables that can predict motor speech functions in children with cp.

mental impairment, language and speech disorders are the common associated problems in children with cp. previous studies focus on language and motor speech dysfunctions in children with cp at school-age child, adolescents and adults. few literatures identify the determinants for predicted the motor speech performance in these children. it is important issue to follow-up the language and motor speech functions in children with cp. these data will provide clinicians for outcome prediction and goal setting.the aims of this study: (1) to investigate the difference in motor speech functions among children with cp of different motor severities, and(2) to investigate the longitudinal in motor speech functions at 6 months follow-up phase among children with cp of different motor severities, and(3) the correlation between motor severity, personal factors, family factors, language ability and motor speech in children with cp, and(4) to identify the variables that can predict motor speech functions in children with cp.

Eligibility criteria:
inclusion criteria: 1. subjects between the ages of 4-8 years old children. 2. subjects which aged 7 years or older should sign a consent form by themself. 3. in line with the assessment, the case must be able to follow simple verbal commands, and can be done in a simple sentence description. 4. were diagnosed with spastic cerebral palsy. exclusion criteria: 1. physiological condition is unstable: included in three months for surgery or infection and other major diseases 2. there is progressive or degenerative symptoms or diseases (such as degenerative epilepsy), peripheral nerve injury, spinal cord injury. 3. visual perception or hearing problems, after correction difficult communicators. 4. other movement disorders patterns for children with cerebral palsy (athetoid type, offset type, etc.).

Keywords: cerebral palsy language acoustic motor speech follow-up
radiotherapy priming for car-t

Conditions: Diffuse Large B Cell Lymphoma

Summary: the remit trial will investigate radiotherapy as a preferred bridging method prior to tisagenlecleucel infusion in patients with relapsed or refractory diffuse large b cell lymphoma

the remit trial is an open label, single arm phase iia study investigating radiotherapy as preferred bridging method prior to tisagenlecleucel treatment in patients with relapsed or refractory diffuse large b cell lymphoma approved to receive cd19 car-t cells as per their licensed indication. the trial will recruit 20 patients who have been approved to receive tisagenlecleucel treatment and where the tumour is amendable to radiotherapy as per standard of care. trial subjects (patients) during a 14 day screening phase will have their metabolic tumour burden assessed by pet-ct and bridging radiotherapy will be planned. bridging radiotherapy will commence immediately after leukapheresis with dose adjustments according to disease burden and localisation. disease areas requiring effective long-term control will receive full dose radiotherapy, 20 - 30gy /5-15# and other areas will receive low dose radiotherapy, 4gy / 2# for optimal tumour debulking and priming effects. standard lymphodepletion will be given day -5 to day -3 followed by tisagenlecleucel infusion on day 0. a window of 14-21 days will be left from last dose of radiotherapy and day 0. patients will be followed up at 3 and 6 months after tisagenlecleucel infusion for a minimum of 12 months.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age ≥ 18 years 3. histologically proven dlbcl, including transformed follicular or marginal zone lymphoma 4. measurable disease on cross-sectional imaging that is at least 1.5cm in the longest diameter and measurable in two perpendicular dimensions 5. relapsed/refractory after 2 or more standard immuno-chemotherapies 6. approved to receive tisagenlecleucel as per the licenced indication 7. eastern cooperative oncology group (ecog) performance status 0-1 8. disease accessible for repeat biopsies (selected patients only) 9. disease amenable to radiotherapy as assessed by the treating clinical oncologist 10. willing and able to comply with the requirements of the protocol, including contraceptive advice as per the protocol exclusion criteria: 1. prior radiotherapy at location/dose that would interfere with application of radiotherapy or outcome measures in this trial 2. women who are pregnant or breast feeding 3. previous therapy with any genetically modified autologous or allogeneic t-cell immunotherapy, unless treated with doses of genetically modified autologous or allogeneic t-cell immunotherapy within an abandoned dosing cohort in a first in human dose-escalation phase i clinical trial
a longitudinal study of brain atrophy in ms patients over 5 years

Conditions: Multiple Sclerosis

Summary: the primary aim of this study is to evaluate the effect of using tysabri on changes in the brain using mri and on disease progression in patients with relapsing-remitting multiple sclerosis over 5 years.

this is a prospective, observational, single-blinded, longitudinal study of natalizumab effect on brain atrophy development and disability progression in multiple sclerosis patients over 5 years, which will evaluate originally treated patients with natalizumab who participated in a prospective 1- and 2-year vwmtr study. (zivadinov et al., 2011b) all subjects will be assessed at 5-year follow-up with the same clinical examinations and will obtain 1.5t mri examination on the same scanner that did not undergo any upgrade changes in the period of 5 years.

Eligibility criteria:
inclusion criteria: * participation in natalizumab 1-year follow-up study * participants were aged 18-65 * have clinically definite ms according to the polman criteria of either rr or rsp disease type * edss scores ≤6.5 * disease duration \<30 years * normal kidney function (creatinine clearance \>59 ml/min) * started therapy either with natalizumab or im interferon beta-1a (ifnβ-1a) * signed informed consent * normal kidney functioning (creatinine clearance \>59) * none of the exclusion criteria exclusion criteria: * a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to 5-year follow-up visit * nursing mothers or pregnant women who will need to undergo 5-year follow-up mri * unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol * any other reasons that, in the opinion of the investigator, indicate that the subject is unsuitable for enrollment into this study

Keywords: multiple sclerosis tysabri mri natalizumab
examining the relationship between the presence of kinesiophobia in stroke patients and balance, gait, pain, and social participation levels

Conditions: Kinesiophobia; Stroke

Summary: the aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level.

individuals aged 18-75 with post-stroke hemiplegia or hemiparesis, a minimum functional ambulation scale score of 2, and no major neurological or rheumatological pathology affecting the musculoskeletal system other than stroke (e.g., polyneuropathy, parkinson's, multiple sclerosis, rheumatoid arthritis, etc.), as well as those without diseases affecting balance (e.g., parkinson's, cerebral trauma, meniere's disease, ear infection, benign paroxysmal positional vertigo, multiple sclerosis), and not using medications that disrupt balance, will be included in the study. detailed medical histories will be obtained from all included patients and/or caregivers, and comprehensive musculoskeletal examinations will be conducted. patient information, including name, surname, age, gender, occupation, education level, marital status, body mass index, duration of illness, stroke type, affected side, dominant side, and comorbidities, will be recorded. all included patients in the study will be assessed by the same physician using the functional ambulation scale, community integration questionnaire , mini-bestest (mini-balance evaluation systems test), balance assessment on the hur smart balance device, the timed up and go test , tinetti balance and gait test, vas kinesiophobia scale., and tampa kinesiophobia scale.

Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 75 years old * having experienced post-stroke hemiplegia or hemiparesis * scoring at level 2 or above on the functional ambulation classification * being willing to participate in the study and signing the consent forms" exclusion criteria: * patients who cannot undergo mental evaluation, are unable to complete scales, are illiterate, or have aphasia * having major neurological or rheumatological pathologies affecting the musculoskeletal system other than stroke (polyneuropathy, parkinson's, multiple sclerosis, rheumatoid arthritis, etc.) * patients with diseases affecting balance (parkinson's, cerebral trauma, meniere's disease, ear infections, benign paroxysmal positional vertigo, multiple sclerosis, etc.) * patients using medications that may disrupt balance

Keywords: kinesiophobia stroke balance pain
advanced chronic myelogenous leukemia (cml) - follow on: study of bms-354825 in subjects with cml

Conditions: Myeloid Leukemia, Chronic, Accelerated Phase; Leukemia, Lymphoblastic, Acute, Philadelphia-Positive

Summary: this is a phase iii study of bms-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with philadelphia chromosome positive (ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (gleevec).


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * patients with philadelphia-positive (ph+) (or bcr/abl+) accelerated phase chronic myeloid leukemia, ph+ (or bcr/abl+) blast phase chronic myeloid leukemia, or ph+ (or bcr/abl+) acute lymphoblastic leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate * men and women, 18 years of age or older * adequate hepatic function * adequate renal function * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized * eastern cooperative oncology group (ecog) performance status score 0 - 2 exclusion criteria: * women who are pregnant or breastfeeding * a serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy * uncontrolled or significant cardiovascular disease * medications that increase bleeding risk * medications that change heart rhythms * dementia or altered mental status that would prohibit the understanding or rendering of informed consent * history of significant bleeding disorder unrelated to cml * concurrent incurable malignancy other than cml * evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy * prior therapy with bms-35425 * prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: accelerated phase chronic myeloid leukemia lymphoid blast phase chronic myeloid leukemia myeloid blast phase chronic myeloid leukemia philadelphia positive acute lymphoblastic leukemia
a blinded study evaluating the accuracy and safety of cyclotron-produced 99mtc in adult patients

Conditions: Hyperthyroidism

Summary: the purpose of this study is to evaluate technetium-99m (99mtc) pertechnetate produced by a cyclotron as a replacement for 99mtc pertechnetate obtained from a generator containing the parent isotope molybdenum-99 (99mo). 99mtc pertechnetate is currently used in nuclear medicine departments across the country. 99mo is produced by a number of ageing nuclear reactors across the world and severe shortages of the isotope have occurred in the past few years. cyclotron-produced 99mtc offers an alternative decentralized production method on a regional basis. since the manufacturing process is different, the safety and efficacy of cyclotron-produced 99mtc pertechnetate must be evaluated in human subjects to enable its routine clinical use.


Eligibility criteria:
inclusion criteria: * who performance status 0-2 * older than the age of majority in the province where the study is performed, and be able to consent to the project * ambulatory and able to lie supine for the duration of the examination. * able and willing to return for a subsequent visit within 7 days to undergo a repeat examination and participate in a follow-up phone call to monitor for adverse events. subject referred for nuclear medicine examination for one of the following indications: * biochemically documented hyperthyroidism, referred for scintigraphy to evaluate the differential diagnosis of hyperthyroidism or to plan radioiodine treatment. * referred for bone scintigraphy for the evaluation of metastases, fractures, or inflammatory conditions. subjects referred for a limited area (localized) bone scan are eligible, provided they agree to undergo a whole-body scan as part of the procedure. exclusion criteria: * pregnant, planning to become pregnant within 30 days * severe evolving health problems (unstable coronary disease, liver failure, heart failure, end-stage-renal failure, hospitalized subjects with severe medical conditions) that may confound the assessment of adverse events. for subjects evaluated for hyperthyroidism: * recent iodine-containing iv contrast administration (\< 6 weeks) * recent amiodarone usage (\< 8 weeks) for subjects evaluated for bone scintigraphy: • recent trauma occurring less than 24 hours prior to the first 99mtc bone scintigraphy examination, or between the first and second 99mtc bone scintigraphy examination. women who are breast-feeding are eligible to participate in this study, but must cease breast-feeding for 24 hours following the 99mtc examinations. they can draw their milk and discard it during this period, and use either formula or previously collected milk to feed their child.

Keywords: osteogenesis
follow up of patients after oral immunotherapy for cow's milk, eggs and peanuts

Conditions: Allergy

Summary: food allergy is a potentially life threatening condition. the current practice consists of elimination diet and injectable epinephrine in case of a reaction. recently, oral immunotherapy has emerged as a treatment for food allergy in milk eggs and peanuts. we conduct an oral immunotherapy program with \~500 patients so far. in this study we intent to follow patients who completed the program and assess their allergy status and quality of life.

food allergy is a potentially life threatening condition. the current practice consists of elimination diet and injectable epinephrine in case of a reaction. recently, oral immunotherapy (oit) has emerged as an treatment for food allergy in milk eggs and peanuts. since 4/2010,a clinical oit program for milk eggs and peanuts is performed at the institute fir allergy asthma and immunology at assaf harofeh medical center with \~500 patients so far. patients with ige-mediated food allergy that are \>4 years old are eligible. in this study we intent to follow patients who completed the program. patients will fill a questionnaire regarding current consumption of the allergenic food, adverse reactions experienced and treatments required including the use of epipen. patients underwent skim prick tests (spt) for the allergenic food prior to initiation and treatment and will undergo spt again upon entering the study. blood tests for ige, igg4, basophil activation and cytokines will be obtained. patients who are not consuming the allergenic food regularly will undergo an oral food challenge in clinic.

Eligibility criteria:
inclusion criteria: * age\>4 years old ige mediated allergy to milk eggs or peanuts completion of oit \>6 months ago exclusion criteria: * non approval to participate

Keywords: food consumption
changes in tear osmolarity over time with sustained use of theratears

Conditions: Dry Eye Syndrome

Summary: the objective of the study is to see if there is a change in tear osmolarity over time when moderate to severe dry eye subjects are treated with theratears® lubricating drops.

the hypothesis is that the measured tear osmolarity from study participants decrease with sustained use of a over-the-counter artificial tears, theratears® lubricating drops, over an eight week period. participant's dry eye symptoms would also improve with sustained use of theratears® lubricating drops.

Eligibility criteria:
inclusion criteria: 1. is at least 21 years of age and has full legal capacity to volunteer; 2. has read and signed the information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye; 5. has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye. exclusion criteria: 1. has taken part in another research study within the last 30 days; 2. planned contact lens wear during the course of the study; 3. staff at the investigational site or family member of site staff or family member of currently enrolled participant; 4. any subject that violates the washout period by using eye drops during the 72hrs washout period; 5. has any known ocular disease including active ocular infection, inflammation or allergy, especially salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome; 6. used restasis (or similar topical medication) within the last 6 months; 7. has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable; 8. is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary); 9. use of medications such as: systemic antihistamine (e.g., allegra®, benadryl®, claritin®, dimetapp®, unisom®, zyrtec®, etc.), isotretinoin (e.g., accutane®, roaccutane®, amnesteem®, claravis®, isotroin®, sotret®) or similar medications; 10. has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 11. has undergone ocular surgery(lasik, cataract, etc)within the last year.

Keywords: tear osmolarity keratitis sicca ocular surface disease theratears