Kornimate/medical-research-clean huggingface dataset:
validation of velocity curvature index as a diagnostic biomarker tool for assessment of large vessel stroke

Conditions: Stroke; Acute Ischemic Stroke

Summary: this study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (probe), non-significant risk (nsr) device study including up to 420 evaluable subjects measured with the study device(s) and up to 40 non-evaluable subjects for the training phase.

the purpose of this study is to collect robust data from novaguide 2 intelligent ultrasound system to validate the velocity curvature index (vci) as a diagnostic biomarker tool to drive clinical decision making for assessing cerebral vascular occlusions confirmed by standard of care computed tomography angiography (cta) imaging.

Eligibility criteria:
inclusion criteria: 1. subject aged 18 years and older referred for evaluation of possible stroke. 2. subject receives computed tomography angiography (cta) imaging for the assessment of stroke. 3. subject or legally authorized representative has the ability to provide informed consent and comply with the protocol. exclusion criteria: 1. head ct findings consistent with acute primary intracranial hemorrhage (ich), etc. 2. subjects with occlusions in the distal or posterior circulation arteries. 3. subjects who underwent partial or full craniotomy 4. additional intracranial pathologies present (tumor, hydrocephalus, etc.) 5. anticipated insufficient time to acquire a complete tcd scan as described by the protocol 6. subjects who have a physical limitation preventing placement of the system.
intravitreal celecoxib for chronic uveitis

Conditions: Inflammation

Summary: intraocular delivery of celecoxib will be an effective means to treat inflammation and macular edema and prevent structural complications and vision loss in patients with chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects.

specific aims i: test the safety of intraocular injection of 1mg and 4mg celecoxib in patients who have chronic inflammation or macular edema who are unable to tolerate corticosteroids due to their side effects. ii: test the efficacy of intraocular 1mg and 4mg celecoxib in treating inflammation or structural complications of inflammation (macular edema) in patients who are unable to tolerate corticosteroids due to their side effects. after investigational new drug application and vanderbilt institutional review board approval, celecoxib will be compounded by the investigational drug service of the vanderbilt medical center and packaged in individual sterile single use syringes for intraocular injection within 2 hours of preparation. pharmaceutical grade celecoxib will be obtained from the drug manufacturer (pfizer) with certificate analysis and compounded in sterile dimethyl sulfoxide following strict sterile technique.

Eligibility criteria:
inclusion criteria: * chronic inflammation and/or macular edema despite maximal medical treatment unable to tolerate corticosteroids due to side effects aphakic or pseudophakic subjects exclusion criteria: * 15 years or younger have active ocular infection pregnancy phakic subjects

Keywords: macular edema
the association among headache severity, head posture, cervical muscle endurance, and neck disorders in individuals with migraine

Conditions: Migraine Disorders

Summary: to determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine.

headache is a general health problem that can be seen in different age groups, is common, depends on many factors, and has a lot of individual and socioeconomic effects. it is stated that the rate of individuals who experience a headache at least once in their lifetime is very high in the general population. migraine is one of the most common types of primary headache. neck pain and cervical dysfunctions in individuals with migraine have been the subject of many studies. it is seen that studies examining the relationship between cervical region musculoskeletal system disorders and headache in different types of headaches are increasing day by day. this study aims to determine the relationship among headache severity, head posture, cervical muscle endurance and neck disorders in individuals with migraine. in addition, the relationship between these parameters and quality of life will be examined.

Eligibility criteria:
inclusion criteria: * having been diagnosed with migraine at any time in his life and complaining of headache, * not having any diagnosed chronic disease, * no past or present mental illness, * individuals who can speak, read and write turkish. exclusion criteria: * having any neurological, psychiatric or cognitive disorder, * individuals who cannot speak, read or write turkish.

Keywords: headache head posture neck disorders migraine cervical endurance
the development of younger siblings of children with autism now at 10 years of age

Conditions: Autism Spectrum Disorders

Summary: background: autism is a complex developmental disorder involving difficulties in verbal and nonverbal communication, social-emotional functioning, and markedly restricted interests and activities. strong evidence from research conducted with family members of children with autism supports the role of genetic factors in its etiology. thus, some family members are characterized by the broad autism phenotype (bap) which involves a clinical picture of milder but qualitatively similar difficulties. working hypothesis and aims: researchers recently initiated prospective longitudinal studies investigating the early developmental profiles of young siblings of children with autism (sibs-a). such longitudinal sibs-a study is currently conducted at the hebrew university and includes the oldest siblings studied to date. our main aim is to identify siblings who manifest any autism or bap characteristics. methods: two groups, sibs-a (n = 42) and siblings of children with typical development (sibs-td, n = 62), were seen at ages 4, 14, 24, 36, 54 months and 7 years. we plan to continue the investigation at age 10 years, a time when school related abilities and social/emotional competences are more consolidated and to investigate the developmental trajectories of children's abilities from age 4 months to 10 years using growth curve analyses. expected results: we expect that compared to sibs-td, significantly more 10-year-old sibs-a will display difficulties related to asd or bap related difficulties. we also expect to identify different patterns of stability and/or change in the development of children's abilities from age 4 months to 10 years, between the two groups. importance: this study provides a useful approach for the examination of the main research hypothesis regarding the development of sibs-a. one of the main advantages of using the growth curve analysis is the identification of early predictive markers for future development. probable implications to medicine: this research has significant implication for early identification and the search into the causes of autism and the bap, as well as for implementation of early treatment and prevention programs. by highlighting expressions of asd and the bap in siblings, we may identify early clinically predictive behavioral markers associated with their onset and contribute to the investigation of underlying genetics mechanisms.


Eligibility criteria:
inclusion criteria: inclusion criteria for the sibs: * a group comprised intact families who had a child with autism. inclusion criteria for families in the sibs-td group: * intact families with a newborn and an older child who exhibited typical development with no history of any learning and/or emotional difficulties according to parental report

Keywords: neurodevelopmental disorders autism spectrum disorders broader autism phenotype siblings cognitive language and social emotional development to identify siblings who manifest any autism or broader autism phenotype characteristics
long term administration of inhaled mannitol in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. the results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. it is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. an open label phase of 26 weeks duration will follow the blinded 26 week phase. during the open label phase all subjects will receive active treatment.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent to participate in this study in accordance with local regulations 2. have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 meq/l) and/or genotype with two identifiable mutations consistent with cf, accompanied by one or more clinical features consistent with the cf phenotype) 3. be aged \> 6 years old 4. have fev1 \>40 % and \< 90% predicted 5. be able to perform all the techniques necessary to measure lung function exclusion criteria: 1. investigators, site personnel directly affiliated with this study, or their immediate families. immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted. 2. be considered "terminally ill" or eligible for lung transplantation 3. have had a lung transplant 4. be using nebulized hypertonic saline in the 4 weeks prior to visit 1 5. have had a significant episode of hemoptysis (\>60 ml) in the three months prior to enrolment 6. have had a myocardial infarction in the three months prior to enrolment 7. have had a cerebral vascular accident in the three months prior to enrolment 8. have had major ocular surgery in the three months prior to enrolment 9. have had major abdominal, chest or brain surgery in the three months prior to enrolment 10. have a known cerebral, aortic or abdominal aneurysm 11. be breast feeding or pregnant, or plan to become pregnant while in the study 12. be using an unreliable form of contraception (female subjects at risk of pregnancy only) 13. be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0 14. have a known allergy to mannitol 15. be using beta blockers 16. have uncontrolled hypertension - systolic bp \> 190 and / or diastolic bp \> 100 17. have a condition or be in a situation which in the investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study 18. be 'mannitol tolerance test positive' -

Keywords: cystic fibrosis mannitol mucoactive
effects of vitamin d-enriched mushrooms on vitamin d status and immune function and inflammatory status in adults

Conditions: Vitamin D Deficiency

Summary: we propose to assess the effects of including vitamin d-enriched mushrooms as part of participants' usual eating pattern primarily on 25(oh) vitamin d2 status and secondarily on immune function and inflammatory status.

we hypothesize that consuming vitamin d-enriched mushrooms daily for 12 weeks will prevent decreases in serum 25-hydroxy-vitamin d2 concentrations. secondarily, we hypothesize consuming vitamin d-enriched mushrooms daily for 12 weeks will improve clinical indicators of inflammatory status and alter/enhance immune status and immune cell function. this short-term randomized, controlled trial will provide important data to inform the plausibility, focus, and design of longer-term intervention trials, consistent with the mushroom council's research agenda regarding health-promoting effects of vitamin d-enriched mushrooms.

Eligibility criteria:
inclusion criteria: * bmi: 25.0-34.9 kg/m\^2 * total cholesterol \<240 mg/dl * low density lipoprotein cholesterol \< 160 mg/dl * triglycerides \<300 mg/dl * fasting glucose \< 110 mg/dl * systolic/diastolic blood pressure \< 140/90 mmhg * body weight stable for 3 months prior (+- 3 kg) * stable physical activity regiment 3 months prior * medication use stable for 6 months prior * non-smoking * non-diabetic * not acutely ill * females not pregnant or lactating * willing to refrain from taking vitamin d supplements or any supplements containing vitamin d * no history of bariatric surgery * not extremely or severely depressed (beck's depression inventory score \<= 30) * agree not to donate blood for at least one month prior to, during, and for one month after the study * agree not to travel to sunny locations during the study period * agree to forgo any tanning bed or other tanning procedures during the study * willing and able to consume mushrooms and travel to testing facilities exclusion criteria: * age \ 70 * bmi \ 35kg/m2 * total cholesterol \>240 mg/dl, low-density lipoprotein cholesterol \>160 mg/dl, triglycerides \>300mg/dl, fasting glucose \>110 mg/dl * systolic/diastolic blood pressure \>140/90 mm hg * body weight changes in previous 3 months (±3 kg) * changes in physical activity regimen in the previous 3 months * medication changes in the previous 6 months * extremely or severely depressed (beck's depression inventory score \>30) * unwilling to refrain from taking vitamin d supplements or any supplements containing vitamin d * regiment of megadosing vitamin d * unwilling to not to travel to sunny locations during the study period * unwilling to forgo any tanning bed or other tanning procedures during the study * history of bariatric surgery * consuming a restricted diet (such as keto, gluten free, high protein, low carb, etc.) * smoking * diabetic * acute illness * females pregnant or lactating * unwilling to not to donate blood for at least one month prior to, during, and for one month after the study * allergic to mushrooms or bread

Keywords: mushroom immune function vitamin d2 randomized controlled trial
efficacy of egb761 in patients suffering from friedreich ataxia

Conditions: Friedreich Ataxia

Summary: the purpose of this protocol is to determine the efficacy of egb 761 120 mg bid versus placebo in patients suffering from friedreich ataxia


Eligibility criteria:
inclusion criteria: * friedreich ataxia diagnosis confirmed by evidenced mutation expansion of frataxin gene * ambulatory patient, with depressed tendon reflexes and pyramidal syndrome associated or not to a loss of position or vibration senses or dysarthria * patient able to perform the tests of the study exclusion criteria: * severe cardiac disease as assessed by echocardiography performed at least within 6 months before screening or during the wash out period (4 weeks) * absolute contra-indication to nuclear magnetic resonance spectroscopy(nmr) examination: iron and any magnetic objects implanted in the whole body, e.g. some neurostimulators, cardiac pace-makers, vascular clips and other implanted orthopaedic prosthesis * patient who did not deplete at baseline phosphocreatine (pcr) pool by more than 30 % during the exercise bout * any continuous use of the following forbidden medications: * other antioxidant such as idebenone, coenzyme q, vitamin e/c taken for less than 4 weeks prior study treatment start (ie for antioxidant drugs a mandatory wash-out period of 4 weeks prior study drug start has to be observed), * any other vasodilators * tranquilizer such as benzodiazepine, meprobamate or buspirone, and/or antidepressant (only one), at non stable dose
randomized controlled trial of standard erp and oc-go

Conditions: Obsessive-Compulsive Disorder

Summary: phase ii of this study will examine the efficacy of the oc-go application via a randomized controlled trial comparing standard exposure and response prevention (erp) treatment for pediatric obsessive compulsive disorder (ocd) to exposure/response prevention (erp) augmented with oc-go. a cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard erp will receive oc-go augmented erp for the second half of treatment, and vice versa. efficacy will be investigated in a sample of 32 children with ocd.

this project seeks to refine and assess oc-go, a hipaa-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (ebt) for ocd, a common and impairing condition, and provider ability to effectively implement ebts. oc-go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. use of oc-go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of ebts, and therapist confidence and expertise.

Eligibility criteria:
inclusion criteria: * ages 9-17 years old * primary diagnosis of ocd based on diagnostic interview (adis) * cgi-severity score \> 3 exclusion criteria: * anti-ocd medication/unstable dose (with changes expected during the study) * significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low iq, etc.) precluding the child's ability to complete all study procedures
efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of long covid-19

Conditions: Long COVID-19

Summary: to explore the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of long covid-19


Eligibility criteria:
inclusion criteria: 1. the age ranges from 18 to 85 (inclusive), regardless of gender. 2. patients with confirmed sars-cov-2 infection, according to the consensus of the chinese diagnostic criteria for covid-19 (tentative tenth edition). 3. patients with symptoms of long covid-19 3 months from the onset of covid-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases. 4. be expected to live longer than 1 year. 5. volunteer to participate in this clinical study and sign the written informed consent. exclusion criteria: 1. those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation. 2. t lymphocyte abnormality, hiv positive. 3. highly allergic or have a history of severe allergy. 4. pregnant and lactating women. 5. patients with severe autoimmune disease history; 6. patients with uncontrolled chronic diseases or serious complications; 7. patients with malignant tumors; 8. patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism; 9. patients with severe organ dysfunction 10. other situations that the researchers think are not suitable for participating in this study
close assessment and testing for chronic graft versus host disease, catch study

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (gvhd) develops after stem cell transplantation. performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic gvhd.

outline: patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cgvhd onset. patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cgvhd onset. patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cgvhd onset. patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cgvhd onset. patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cgvhd onset. patients also complete surveys and have their medical records reviewed. after completion of study, patients are followed up periodically.

Eligibility criteria:
inclusion criteria: * adults age 18 or older * scheduled for allogeneic hct from any donor for any indication, with a risk of cgvhd of \> 25% (see below in exclusion criteria for treatment plans with a cgvhd risk \< 25%) * ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site * ability to communicate in english or spanish, to allow completion of patient surveys and clear communication with the study team exclusion criteria: * receipt of umbilical cord blood, bone marrow with post-transplant cyclophosphamide (peripheral blood with post-transplant cyclophosphamide is allowed), anti-thymocyte globulin, alemtuzumab, or ex-vivo t-cell depletion. these patients are excluded because they have a cgvhd risk of \< 25% * hematologic malignancy with active disease at the time of transplant. minimal residual disease is allowed * hematopoietic cell transplant co-morbidity index \> 4 based on parameters known at time of enrollment * prior allogeneic transplant * prior autoimmune disease with ongoing symptoms * history of noncompliance * inability to comply with study requirements due to geographic, logistic, social or any other factors
warfarin and coronary calcification project

Conditions: Coronary Calcification

Summary: the purpose of the study is to assess whether the use of warfarin, a commonly used anticoagulation drug, is associated with increased amounts of coronary artery calcification. studies in animals and preliminary but small retrospective studies in humans have suggested a possible link to increased tissue calcification with use of this drug. the researchers will investigate this by assessing the amount of calcification seen in the coronary arteries using a specialized computed tomography (ct) scan (electron-beam ct) and assessing to see if the amount is influenced by the amount of time a patient has been taking warfarin. the researchers will exclude patients with known coronary artery disease, chronic kidney disease or hyperparathyroidism.


Eligibility criteria:
inclusion criteria: * age 18 years of age or older * patients referred to begin or already treated with warfarin anticoagulation therapy. exclusion criteria: * known prior myocardial infarction or coronary heart disease * history of advanced chronic kidney disease manifested by serum creatinine\>2 or calculated glomerular filtration rate (gfr)\<30 * history of hyperparathyroidism * current hypercalcemia * current hyperphosphatemia * uncertain duration of warfarin therapy * lack of records documenting international normalized ratio (inr) during therapy

Keywords: coronary calcification vitamin k dependent proteins warfarin