Kornimate/medical-research-clean huggingface dataset:
sensory and psychomotor profile in depression

Conditions: Major Depressive Disorder

Summary: despite a possible psychomotor retardation during a depressive episode, standardized psychomotor assessment is rare. so, other possible psychomotor disorders or neurological "soft signs" are not known in depression. the investigator propose in this study to explore the psychomotor characteristics of patients with a major depressive disorder from the realization of a psychomotor assessment in comparison with adult without depressive disorder (control). it will be specifically assess muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.


Eligibility criteria:
inclusion criteria: * major depressive disorder according to the dsm-5 * aged to 18 from 65 years old exclusion criteria: * psychiatric comorbidity (bipolar, addiction, eating disorder, personality disorder, obsessional compulsive disorder) * antipsychotic drug * taken care in psychomotor therapy previously * electroconvulsive therapy * medical history of neurologic disease, neurodevelopmental disorder, sensory disability * constraint hospitalization * under legal protection * pregnant * lack of consent

Keywords: depression psychomotor assessment sensory profile perception motricity
hv electrophysiology study in transcatheter aortic valve implantation patients

Conditions: Left Bundle Branch Block; Transcatheter Aortic Valve Replacement; Transcatheter Aortic Valve Implantation

Summary: tavi induced lbbb is a complication that occurs between 7 and 65 % of the cases, numbers that differ considerably between devices. there is an increased risk of progression to total av-block at follow-up, with the risk of brady-arrhythmic death. the aim of the study is to elucidate the anatomical location of the conduction pathology of a tavi induced lbbb. this could impact valve design and placement and thereby reduce the number of new lbbb induced by tavi in the future. furthermore, finding predictors for progression to a high degree av block in the follow-up (and thus an indication for permanent pacemaker) could improve management of post-operative conduction abnormalities and prevent the risk of brady-arrhythmic death.

a prospective, single center, non-randomized pilot study in which patients will undergo an electrophysiology (ep) study during the tavi procedure. all patients eligible for inclusion will undergo an electrophysiology (ep) study during the tavi procedure. for the purpose of ep measurements, a his-catheter will be placed at the beginning of the procedure and remain in the same location until the end of the procedure. continuous hv measurements will be collected, together with a continuous surface ecg, during the entire tavi procedure. the different steps in tavi procedure will be registered. during the study, patients will undergo regular electrocardiographic examinations at the outpatient clinic (before implantation, after implantation, before discharge and after 6 weeks, 6 and 12 months post-implantation). these are part of the standard healthcare after the tavi procedure. the research protocol has been approved by the ethical committee (metc).

Eligibility criteria:
inclusion criteria: * all patients must provide written informed consent exclusion criteria: * pre-existent lbbb * pre-existent sick sinus syndrome * pre-existent high-degree atrioventricular block * pre-existent permanent pacemaker * patients unable to provide written informed consent

Keywords: lbbb tavi
a prospective study to collect images in patients treated with iodine-131 as part of a european research project in radiation protection.

Conditions: Differentiated Thyroid Cancer

Summary: this trial is a prospective, non-interventional, monocentric study aiming to collect standard of care imaging of patients treated with iodine-131 for the determination of dosimetric studies. data from this study will be collected as part of an european research project called medirad. the overall objectives of this project are to enhance the scientific bases and clinical practice of radiation protection in the medical field, and more specifically to develop and implement the tools necessary to establish the range of absorbed doses delivered to healthy organs in patients undergoing thyroid ablation and the threshold absorbed dose required for thyroid ablation. this will enable patient specific treatment planning that will minimize risk to the patient while ensuring a successful outcome and will facilitate development of a large scale epidemiological study of the effect of low absorbed doses from irradiation of normal organs with internal sources of radionuclides. patients will be followed as part of their standard of care. imaging (spect/ct (single photon emission computed tomography-computerized tomography) and whole body scintigraphy) performed at 48 hours post iodine-131 treatment will be collected. measures of external gamma radiation will also be collected in the european database.


Eligibility criteria:
inclusion criteria: 1. patient with differentiated thyroid cancer (papillary or follicular) stage t1b, t2, t3a, nx-n0-n1, m0 (according to ajcc 8th edition, 2017) of intermediate risk of recurrence (according to 2015 ata risk stratification system) 2. patient is eligible to receive a therapeutic activity of 3.7 gbq of i-131 after total thyroidectomy or completion thyroidectomy 3. age ≥ 18 years old 4. patient affiliated to the french social security system 5. patient who has received an informed consent for the study exclusion criteria: 1. patient who has received an external radiotherapy within 6 weeks prior to i-131 treatment 2. patient who has received a systemic chemotherapy within 6 weeks prior to i-131 treatment 3. history of treatment with i-131 4. pregnant or breastfeeding women 5. any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures 6. patient protected by law

Keywords: differentiated thyroid cancer iodine-131 thyroidectomy
asian study to investigate safety and efficacy of optimized dosing of advagraf in kidney transplantation

Conditions: Kidney Transplantation

Summary: primary purpose of this study is to compare renal function between subjects receiving optimized dose advagraf® over 52 weeks after kidney transplantation and subjects receiving standard dose advagraf®. pilot results of safety and efficacy in optimized dose advagraf® over 52 weeks after kidney transplantation will also be obtained.


Eligibility criteria:
inclusion criteria: * end stage kidney disease and a suitable candidate for primary kidney transplantation or re-transplantation * receiving a kidney transplant from a deceased or living donor with compatible abo blood type * female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. and, male subject of childbearing potential should agree to maintain effective birth control during the study exclusion criteria: * receiving or having previously received an organ transplant other than a kidney * cold ischemia time of the donor kidney \> 24 hours * receiving a graft from a non-heart-beating donor other than of maastricht category 3 * significant liver disease * receiving a graft from a hepatitis c or b positive donor * requiring on-going dosing with a systemic immunosuppressive drug prior to transplantation (e.g. for lupus disease, fsgn etc) other than minimal levels of immunosuppressant following failure of a previous transplantation without nephrectomy * significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract mal absorption or active peptic ulcer * subject or donor known to be hiv positive * known allergy or intolerance to tacrolimus, macrolide antibiotics, steroids, lactose, basiliximab or mmf or any of the product excipient * subject has malignant tumor * currently participating in another clinical trial, and/or has taken an investigational drug within 12 weeks prior to the study * subject with a high immunological risk

Keywords: acute rejection advagraf renal function
warning signs of squamous cell carcinoma and prevention of scc by at risk organ transplant recipients

Conditions: Squamous Cell Carcinoma

Summary: using focus group and cognitive interviews with organ transplant recipients, the investigators developed interactive workbooks: a) prevention by sun protection b) early detection by skin self-examination (sse). the investigators hypothesis is if the patient learns by acquiring skills in a favorable environment, then the patient may reduce their anxiety, enhance self-efficacy and perform self-management by sse and sun protection. the investigators also evaluate existing internet sources of primary and secondary prevention of skin cancer for organ transplant recipients.


Eligibility criteria:
inclusion criteria: * people with a history of solid organ transplantation within the last 2 years * speaks english * can see to do sse, capable of seeing to read a newspaper * stable health, patients report a general state of well being exclusion criteria: * unable to speak english * insufficient vision to see their own skin as determined by their ability to read a newspaper * comorbid debilitating disease * dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level.

Keywords: sccs squamous cell carcinoma skin self exam sse organ transplant performance of sse with our written educational intervention time after organ transplantation to deliver intervention evaluate internation information
safety and pharmacokinetic study of lumacaftor/ivacaftor in participants 1 to less than 2 years of age with cystic fibrosis, homozygous for f508del

Conditions: Cystic Fibrosis

Summary: this study will evaluate the safety and pharmacokinetics (pk) of lumacaftor (lum) and ivacaftor (iva) in participants 1 to less than 2 years of age with cystic fibrosis (cf), homozygous for f508del (f/f).


Eligibility criteria:
key inclusion criteria: * participants will be 1 to less than 2 years of age on day 1 of the relevant part of the study * homozygous for f508del (f/f) key exclusion criteria: * any clinically significant laboratory abnormalities at the screening visit that would interfere with the study assessments or pose an undue risk for the participants * solid organ or hematological transplantation other protocol defined inclusion/exclusion criteria may apply.
lichen planus and mean platelet volum

Conditions: Lichen Planus, Oral

Summary: 70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included. the blood samples will be drawn between 08:00 and 09:00 am, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. the mpv and other hematologic parameters will be measured in a blood sample. a surgical biopsy will be performed for histopathological assessment.

70 patients with suspicious oral lichen planus; atrophic and bullous erosive forms will be included for conventional clinical examination under incandescent projected light. using biopsy as a gold standard, all patients will be biopsied. blood samples for all participants, the blood samples will be drawn between 08:00 and 09:00 am, after a fasting period of 12 hours, and analysis were performed within 2 hours of the sampling. the mpv and other hematologic parameters will be measured in a blood sample that will be collected in tubes containing edta. complete blood cell analysis will be performed in hematology laboratory, new kasr al-aini teaching hospital, faculty of medicine, cairo university. for reliable mpv measurement, the investigator will standardize the time delay between sampling and analysis to \<2 hours for all patients. biopsy preparation a surgical biopsy will be performed for histopathological assessment. all clinically identified lesions underwent biopsies where specimens will be placed in 10% buffered formalin for fixation. paraffin embedded material will be cut into 4 μm thick sections and will be stained with haematoxylin + eosin then submitted for histopathological evaluation by a senior oral pathologist blinded to the clinical findings. statistical analysis the collected data will be entered through the spss version 18.0 software. sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy were calculated for mpv. the results will be compared with histopathological results using chi-square test with p value set as \< 0.05.

Eligibility criteria:
inclusion criteria: * inclusion criteria is suspected oral lichen planus, age 18-60 exclusion criteria: * foreseeable missing opportunity of follow-up examination, pregnancy, heart-, pulmonary, liver- and kidney disease, chronic pain syndrome nursing, drug addiction, recent operations, and diseases like heart, metabolism, cns, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics

Keywords: oral lichen planus, mean platelet volume
effects of running shoe sole hardness on vibration and neuromuscular fatigue during a half-marathon run on a treadmill

Conditions: Healthy Volunteers

Summary: during running, each contact between the foot and the ground causes an impact. ground reaction forces (grf) are considered as an input into the musculoskeletal system. it involves a sudden deceleration in the lower limb packages (including muscles) which generates soft-tissue vibrations (stv). the body is able to attenuate soft-tissue vibrations (stv) but this capability decreases with fatigue. stv could be minimize by improving shoe midsole hardness.

only 4 studies have studied soft-tissue vibrations (stv) with a distance not exceeding 10 km and without evaluating the potential influence of the shoe. thus, the effects of shoe midsole hardness on soft-tissue vibrations (stv) and neuromuscular fatigue at the end of an intense and/or long run remains unknown. the purpose is to compare two shoes whose only midsole hardness differs during a half-marathon on soft-tissue vibrations (stv), neuromuscular fatigue and running kinetics. maybe the shoe ensuring a better stv damping of the medial gastrocnemius muscle would reduce neuromuscular fatigue and improve comfort.

Eligibility criteria:
inclusion criteria: * endurance runners doing a long run of at least 20 km once a week. * affiliated or beneficiaries of a social security plan. * have freely given their written consent. * not participating in a competition during the study period. * shoe size 37 to 46 exclusion criteria: * any subject who has been injured in the 3 months preceding the protocol * any subject with chronic joint pathologies (e.g., repeated sprains, patellar or ligament problems) or cardiac pathologies. * any subject with chronic or central neurological pathologies * any subject participating at the same time in another medical interventional experiment * any subject who has taken corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy). * any subject deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice, family habilitation). * any subject declaring to have taken products prohibited by the world anti-doping agency

Keywords: soft-tissue vibrations footwear endurance athletes running muscle weakness
cardiac diseases with pregnancy in benisuef localities

Conditions: Heart Disease Structural Disorder Abscess of Cardiac Septum

Summary: the aim of this work is to demonstrate the variation of cardiac diseases among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes


Eligibility criteria:
inclusion criteria * all pregnant ladies with cardiac diseases, valvular heart disease, congenital heart disease, ischemic heart disease, cardiomyopathy, arrhythmias , big and pulmonary hypertension, presenting with pregnancy regardless age, any concomitant diseases and type of heart disease will be enrolled. * a similar number of pregnant females free from previous mentioned cardiac diseases will be studied as controls. exclusion criteria:
developing a down syndrome health instrument

Conditions: Down Syndrome; Health, Subjective

Summary: although over 200,000 individuals with ds live in the united states, studies to date have focused on outcomes apart from health. the foundation for this proposal is based on the need to accurately measure health of all individuals - specifically, with ds - and the dearth of available tools for this population. creating such an instrument will provide a barometer of the current state of health for ds and hold use in future research. in this project, i propose to create an instrument that directly assesses health in ds - the down syndrome health instrument (dhi). more specifically, the aims of this proposal are: 1. to conduct focus groups among caregivers, individuals with ds, panels of experts on ds and primary care physicians, and cognitive interviews to refine a conceptual model of health for ds and create an item pool, 2. to administer the dhi and establish internal validity, reliability, and external validity of the dhi for use in clinical research, and 3. to test the usability of the dhi in two pilot settings: research and clinical. this instrument will measure patient-reported health in ds for the first time and allow measurement of health as an outcome which is not currently possible in this population. this can identify gaps in care, then direct and optimize interventions that will improve care.


Eligibility criteria:
inclusion criteria: * primary caregiver of an individual with ds (individual with ds age: \<22 years) * caregiver age: ≥18 years * fluent in written and spoken english * able to read and provide informed consent exclusion criteria: * physical or mental condition of caregiver that would prohibit self-administration of questionnaire * mosaic down syndrome: based on medical record review. if caregiver is uncertain or mosaicism is unknown, we will request additional records.

Keywords: health status
pipeline™ flex embolization device with shield technology™ clinical study

Conditions: Aneurysm

Summary: the objective of the study is to assess the incidence of safety outcomes in patients treated with pipeline™ flex embolization device with shield technology™.


Eligibility criteria:
inclusion criteria: 1. subject has provided written informed consent using the irb/ec-approved consent form and agrees to comply with protocol requirements. 2. age 18-80 years. 3. subject has already been selected for flow diversion therapy as the appropriate treatment. 4. subject has an unruptured target intracranial aneurysm (ia). 5. subject has a target ia located in the anterior or posterior circulation. exclusion criteria: 1. major surgery in the past 30 days. 2. any known contraindication to treatment with the pipeline™ flex embolization device with shield technology™ per instructions for use. 3. pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
rapid start vs. standard start antiretroviral therapy (art) in hiv

Conditions: HIV/AIDS

Summary: this study plans to learn about whether starting hiv treatment very soon after diagnosis is more beneficial than waiting until entering routine clinical care after diagnosis.

randomized two arm, multi-site (three sites), open label pilot study conducted with laboratory evaluation and visits at entry, 4 weeks, 12 weeks, 24 weeks, 48 weeks and 96 weeks with laboratory evaluations and assessment if participants remain engaged in care. participants will be randomly assigned with equal probability to one of two arms: arm a: same day antiretroviral therapy (art) with bictegravir/emtricitabine/tenofovir alafenamide (bic/f/taf) + new diagnosis package with laboratory evaluations and social work referral. arm b: standard initiation of art at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.

Eligibility criteria:
inclusion criteria: * men and women 15 years and older in colorado and 19 years and older in nebraska. a waiver of parental consent is planned for individuals 15-17 in accordance with colorado law which allows minors to consent for treatment for sexually transmitted infections, including hiv. * reactive hiv-1 on an approved fourth generation hiv-1 antibody/antigen test within 72 hours * any primary language with access to an interpreter by phone is included. exclusion criteria: * pregnancy or intention to become pregnant in the next two years after enrollment * symptomatic acute hiv (with fever, rash, influenza-like symptoms) * creatinine clearance \<30 ml/min by cockcroft-gault equation. (therapy initiated will be terminated promptly in individuals who are found to have creatinine clearance \<30 ml/min) * prior history of known hiv diagnosis * negative confirmatory hiv differentiation assays (therapy initiated will be terminated in individuals with negative tests and excluded from the primary analysis) * allergy to bictegravir, emtricitabine or tenofovir alafenamide * signs or symptoms of opportunistic infection with cryptococcal meningitis, tuberculosis or other infection that requires delay of initiation of antiretroviral therapy (up to the discretion of the site pi) * vulnerable populations including prisoners and individuals without decision making capacity * concommitant use of medications that are contraindicated with bictegravir, emtricitabine and tenofovir alafenamide including adefovir, carbamazepine, cladribine, dofetilide, fosphenytoin-phenytoin, oxcarbazepine, phenobarbital, primidone, rifampin, rifabutin, rifapentine, st. john's wort, tipranavir