Kornimate/medical-research-clean huggingface dataset:
ltfu for all cell and gene therapy studies

Conditions: Hepatocellular Carcinoma; Prostate Cancer

Summary: master ltfu study will monitor the long-term safety and tolerability of cell or gene therapy study participants from astrazeneca for up to 15 years post last cell or gene therapy treatment.

this is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other astrazeneca cell or gene therapy studies for up to 15 years.

Eligibility criteria:
inclusion criteria: 1. the participant has received a cell or gene therapy in another astrazeneca protocol. 2. provision of signed and dated, written informed consent before any study-specific procedures. exclusion criteria: not applicable -

Keywords: cell therapy gene therapy long term follow up ltfu hepatocellular carcinoma prostate cancer
cardiomems heart sensor allows monitoring of pressure to improve outcomes in nyha class iii heart failure patients

Conditions: Heart Failure, Congestive

Summary: this is a prospective, multi-center, randomized, single-blind clinical trial conducted in the united states (us). the objective of the study is to evaluate the safety and efficacy of the hf pressure measurement system in reducing heart failure (hf) related hospitalizations in a subset of subjects suffering from hf.


Eligibility criteria:
inclusion criteria: 1. diagnosis of hf ≥ 3 months, with either preserved or reduced lvef 2. diagnosis of nyha class iii hf (historical assessment documented at screening visit) 3. subjects with reduced lvef must be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ace-i or arb. beta blockers and ace-i (or arb) doses should be stable for one month prior to study entry. 4. at least 1 hf hospitalization within 12 months of screening visit 5. subjects with pulmonary artery branch diameter sized between 7mm and 15mm (implanted vessel) exclusion criteria: 1. subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis 2. subjects, in the investigator's opinion, unable to tolerate a right heart catheterization 3. subjects who have had a major cardiovascular event (e.g., myocardial infarction, stroke) within 2 months of screening visit 4. subjects with cardiac resynchronization device (crt) implanted ≤ 3 months prior to enrollment 5. subjects with a glomerular filtration rate (gfr) \<25 ml/min who are non-responsive to diuretic therapy or who are on chronic renal dialysis 6. subjects likely to undergo heart transplantation within 6 months of screening visit 7. subjects with congenital heart disease or mechanical right heart valve(s) 8. subjects with known coagulation disorders 9. subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel
addressing involuntary movements in tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to determine whether fixed-doses of an investigational drug, sd-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.


Eligibility criteria:
inclusion criteria: * history of using a dopamine receptor antagonist for at least 3 months * clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening * subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications * have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months * history of being compliant with prescribed medications * able to swallow study drug whole * be in good general health and is expected to attend all study visits and complete study assessments * female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study exclusion criteria: * currently receiving medication for the treatment of tardive dyskinesia * have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias * have a serious untreated or undertreated psychiatric illness * have recent history or presence of violent behavior * have unstable or serious medical illness * have evidence of hepatic impairment * have evidence of renal impairment * have known allergy to any component of sd-809 or tetrabenazine * has participated in an investigational drug or device trial and received study drug or device within 30 days * have acknowledged use of illicit drugs * have a history of alcohol or substance abuse in the previous 12 months

Keywords: dyskinesias movement disorders central nervous system diseases nervous system diseases neurologic manifestations signs and symptoms
smartphone intervention for overdose and covid-19

Conditions: Substance Use Disorders; Overdose; COVID-19

Summary: this study will examine if the use of a smartphone application called thrive4life connect can help people who use drugs lower their risk of overdose and learn more about covid-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.

the mobile health system used in this study, called thrive4life connect, has been developed for use in harm reduction settings with prior funding from the national institute on drug abuse. thrive4life connect is based on the addiction comprehensive health enhancement support system (a-chess) and facilitates brief, behavioral interventions targeting knowledge gaps, motivation, and social connectedness. this app is being used in another study at university of wisconsin-madison (registered to nct04268173). the proposed study will develop new intervention content for assessing and increasing vaccine confidence and lowering overdose risk. the feasibility and preliminary efficacy will be tested using a pilot, pre-post study design with 60 people who have injected drugs in the past week and used opioids in the past 30 days. the investigators will examine feasibility outcomes based on study recruitment, retention, and intervention completion. changes in knowledge about covid-19 and overdose, motivation to reduce risk, and behavioral outcomes including overdose risk behaviors and vaccine uptake will be examined to establish preliminary efficacy.

Eligibility criteria:
inclusion criteria: * 18 years old or older * willing to attend in person study encounters at any of the following vivent health locations: milwaukee, appleton, and eau claire * used opioids to get high in the past 30 days * injected drugs at least 2 times in the past 7 days * express interest in reducing their overdose risk exclusion criteria: * none in addition to the inclusion criteria
diagnostic evaluation of dementia with lewy bodies using a multimodal approach

Conditions: Lewy Bodies Disease; Alzheimer Disease; Cognitive Impairment

Summary: dementia with lewy body disease (dlb) is the second leading cause of degenerative cognitive disorder after alzheimer's disease (ad). its variable clinical expression makes diagnosis difficult. to date, there is no validated dlb diagnostic biomarker, despite several biomarkers in development (eeg, mri, biology). studies have shown that an improvement in diagnostic performance could be obtained by combining different modalities biomarkers using machine learning. the aim of this research is to identify the best combination of multimodal biomarkers for the diagnosis of dlb (eeg, mri, biology, cognitive scores), using a machine learning approach applied to a clinical cohort.

study population: observational prospective cohort study including over 24 months at the ghu ap-hp. nord lariboisière, cognitive neurology center : 50 probable dlb patients, 50 ad patients, and 30 control subjects with subjective cognitive impairment but without any element in favor of neurodegenerative disorders. total clinical dataset n= 130. act : * 32-electrode eeg (resting state, passive auditory and active visual task). * 4 dry electrode eeg cap simultaneously with the 32-electrode eeg expected results: improved dlb diagnosis performance using a combination of multimodal biomarkers (eeg, cognitive scores, plasma, brain mri).

Eligibility criteria:
inclusion criteria for dlb ant ad patients: * neuropsychological assessment possible (good level in french language, absence of visual/auditory deficit limiting the cognitive assessment) * dementia with lewy bodies according to the revised criteria of mc keith 2017 or probable ad defined according to mckhann 2011 criteria including csf biomarkers (an abnormal level of beta-amyloid 1-42 protein \[ab42\] or a pathological ab42/ab40 ratio and an abnormal level of phosphorylated tau \[p-tau\]) inclusion criteria for control patients: * neuropsychological assessment possible (good level in french language, absence of visual/auditory deficit limiting the cognitive assessment) * mmse (mini-mental state examination) greater than or equal to 28, normal memscreen test results, normal brain mri and normal neurological examination exclusion criteria (for all) : * contraindication to mri * other neurological or psychiatric or toxic/iatrogenic disorders that may account for the cognitive impairment or for eeg abnormalities * any unstable medical pathology and/or that may account for the cognitive impairment

Keywords: eeg mri plasma biomarkers
functional assessments in vision impairment

Conditions: Retinitis Pigmentosa (RP); Diabetic Retinopathy (DR); Age Related Macular Degeneration (AMD); Glaucoma; Retinal Dystrophy

Summary: the aim of the research project is to validate the use of a novel functional assessment tool designed to document how participants with a vision impairment complete activities of daily living in a real world environment.

there is currently no multisensory tool to assess functional vision in people with a vision impairment. this study is designed to capture and assess the reliability and validity of a novel tool developed by multi-disciplinary experts in ophthalmology, optometry, orthoptics, orientation and mobility (o\&m) specialists, and people with lived experience of low vision. the tool is designed to be used in both clinical and in interventional clinical trial setting, to provide functional vision assessment measures within real-world outcomes. the development of this tool is at a critical junction in time where a range, of interventions are being developed for people with low vision including bionic eyes, and gene and cell therapies. the fda requires trials to show real world functional outcomes in addition to traditional endpoints, hence a tool like the atomm may have wide use and implications. this study will recruit participants with varying levels of vision impairment to assess the reliability of the atomm.

Eligibility criteria:
inclusion criteria: 1. willing to provide signed informed consent. 2. be available for study visits. 3. willing to comply with study assessments. 4. in good general health and ambulant. 5. aged over 18 years of age. 6. have a vision impairment caused by any ocular condition which affects independent mobility. 7. agree to allow the research team into their home and local environments. 8. participate in assessments in public settings exclusion criteria: 1. significant co-morbidities which prohibit involvement in study visits. 2. anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. 3. cognitive deficiencies, including dementia or progressive neurological disease. 4. have a psychiatric condition that, in the investigator's opinion, precludes compliance with the protocol including past or present psychoses and bipolar disorder. 5. deafness or significant hearing loss. 6. inability to converse in english.
modified "providence" pedi cast-sling vs.cast and sling

Conditions: Fractures, Bone; Pediatric ALL

Summary: examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.


Eligibility criteria:
inclusion criteria: * patients aged 0-18 years old who were evaluated in the pediatric emergency department (ed) by the orthopaedic resident on call * patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast. exclusion criteria: * open fractures * fractures at multiple levels (e.g. wrist and elbow fracture) * fractures requiring immediate/urgent surgery * patients requiring admission for any reason * bivalved lac's for any reason
study to evaluate the effects of xxs on oxidative stress in patients with mild or moderate hyperlipidemia

Conditions: Oxidative Stress

Summary: given preliminary data in animal (proprietary data) have shown that xxs (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with xxs in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.


Eligibility criteria:
inclusion criteria: * persons who have provided written consent * persons aged over 18 years * presenting ldl levels between 1.30 and 1.90 g/l and/or triglyceride levels between 1.5 and 3 g/l exclusion criteria: * persons without national health insurance cover * pregnant or breastfeeding women * adults under guardianship * patients with diabetes (insulin-dependent diabetes (idd) or non-insulin-dependent diabetes nidd) * patients with coronary artery disease * patients with atherosclerosis * hdl\>0.80 g/l * receiving treatment with lipid-lowering agents (statins, fibrates, ezetimibe or ω3) * consuming vitamin supplements (a, c, e...) * consuming oligoelements or minerals (se, zn, ca...) * renal insufficiency (creatinine clearance \< 30 ml/min calculated according to the modification of the diet in renal disease (mdrd))
the effect of theophylline in the treatment of bronchiectasis

Conditions: Bronchiectasis

Summary: theophylline was well recommended in the treatment of chronic obstructive pulmonary disease (copd) and asthma. however, there is no supporting evidence for their efficacy in the treatment of bronchiectasis. our hypothesis is that theophylline will play a role in bronchiectasis. our purpose is to examine the efficacy and safety of 24 weeks treatment with theophylline in subjects with non-cystic fibrosis bronchiectasis.

for the reasons of lack of sufficient clinical trial evidences, there are no standard therapy recommendations for bronchiectasis. currently the treatments for bronchiectasis are mostly based on experience gained from the treatment of copd and cystic fibrosis(cf). the aims of treatment for bronchiectasis are to improve the health-related quality of life, to slow down the decrease of lung function, to reduce the exacerbation frequence and the mortality. the mechanism of treatment are including: treating the underlying disease; improving drainage of sputum; anti-infection; anti-inflammation; treating airway obstruction. a review written by peter j. barnes describes that as a bronchodilator in copd, theophylline may relax human airways smooth muscle, have an anti-inflammation rols, and have an additional effect on mucociliary clearance. besides, theophylline can improve the activity of histone deacetylase, which will reverse the resistant of corticosteroids. we hypothesis that theophylline will have the same effect in subjects with ncf-bronchiectasis as in subjects with copd. our trial may give an evidence of using theophylline in treatment of bronchiectasis.

Eligibility criteria:
inclusion criteria: * patients between 18-70 years old with non-cf bronchiectasis ,free from acute exacerbations for at least 3 months.stable phase of the disease. exclusion criteria: * patients with a cigarette smoking history of more than 10 packs-year. patients with copd. patients with traction bronchiectasis due to advanced fibrosis. patients with known intolerance for theophylline. patients with asthma. patients with other disease disturbing outcomes of the trials. patients without consent.

Keywords: bronchiectasis theophylline therapeutic uses hdac hat random placebo study
ultrasound assessment of neck muscles and balance in male patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis; Balance Assessment; Balance; Spondylarthropathies; Spondylitis, Ankylosing

Summary: the aim of this study is to evaluate the relationship between ultrasonographic measurements of the cervical muscles and balance parameters in patients diagnosed with ankylosing spondylitis (as)

this study aims to investigate the relationship between cervical multifdus and longus colli muscles and balance function in male patients diagnosed with ankylosing spondylitis (as) according to the modified new york criteria. a total of 38 as patients under regular follow-up at the istanbul physical medicine and rehabilitation training and research hospital rheumatology clinic, along with 38 age-matched healthy male volunteers, will be included. ultrasonographic imaging will be performed to assess the thickness and of the cervical multifidus and longus colli muscles.the hur smartbalance btg4 (hur-labs oy, kokkola, finland) balance platform will be used to measure postural sway, weight distribution, and the limit of stability (los) through a computerized system.the berg balance scale (bbs), the timed up and go (tug) test,the single-leg stance test will be conducted, measuring the ability to maintain posture while standing on one leg. disease activity and functional assessment in as patients will be conducted by using the bath ankylosing spondylitis functional index (basfi), the bath ankylosing spondylitis metrology index (basmi) additionally, the bath ankylosing spondylitis disease activity index (basdai) will be used to measure disease activity and quality of life will be assessed with ankylosing spondylitis quality of life questionnaire (asqol).cervical muscle strength measurement will be performed using a hand-held dynamometer, which will objectively assess isometric cervical flexion and extension strength.

Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * diagnosed with ankylosing spondylitis according to the modified new york criteria (for patient group). * cognitive ability sufficient to understand and follow test instructions. exclusion criteria: * orthopedic disorders affecting the spine or lower limbs. * cardiovascular disorders. * neurological disorders. * visual or auditory impairments. * history of surgery involving the spine or lower limbs. * psychiatric disorders. * cognitive impairment. * clinical signs or symptoms of cervical radiculopathy.

Keywords: ankylosing spondylitis balance deep cervical muscles
the effect of using smart phone application for enhancing adherence to home exercise

Conditions: Knee Osteoarthritis

Summary: background: knee osteoarthritis (oa) is a serious condition and requires good adherence to interventions such as exercises to achieve optimal management. the use of smart phone technologies could be such a strategy to enhance adherence to the home exercise program (hep) thus improve pain, physical function and lower limb strength. the study aimed to examine the effect of using an innovative smart phone app on enhancing the adherence to home exercise programs among female older adults with knee oa in saudi arabia and the effectiveness of this hep which delivered through an app, on pain and physical function. methodology: 40 females aged 50 years or older with knee oa (20 per study arm) recruited to a randomized control trial that uses a parallel study design. all participants assessed and received an education and a set of a home exercise program for knee oa, participants randomized into the app arm (experimental group) received their hep in the smart phone application. participants randomized to the other arm (control group) received hep in a paper hand-out. after enrolment, the study outcomes were assessed at week three and week six. the primary outcomes were self-reported adherence, anprs, and ar-womac.


Eligibility criteria:
inclusion criteria: * female older adults aged 50 and above. * diagnosed with unilateral or bilateral chronic knee oa (diagnosed ≥ six months). * mild to moderate pain intensity (score ≤ 7 on the arabic numeric pain rating scale). * ambulate independently. * literate, familiar to use smart mobile phone or tablet. * no previous exercising within the last six months. exclusion criteria: * comorbidities that affect their health and wellness (neurological conditions, unstable cardiopulmonary conditions, mental disorders with score \< 24 on mini-mental state examination) * waiting for surgical intervention. * recent trauma (fall/ accident).
efficacy of transfer factor to prevent upper respiratory tract infections in healthy adults

Conditions: Upper Respiratory Tract Infections Due to Influenza or Rhinovirus

Summary: the goals of our study are to critically evaluate if a healthy population supplemented with transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. in this study we will give either transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. the frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. saliva samples will be collected weekly and assessed for salivary iga secretion rate. data from this study will establish the efficacy of transfer factor to support a healthy immune system.


Eligibility criteria:
inclusion criteria: * males and females (18 - 40) who are in good health exclusion criteria: * subjects who are allergic to eggs (on which the supplement is based). if a volunteer is not sure if they are allergic to eggs or milk. those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, bmi above 40 kg/m2, consumption of \>12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. women who are pregnant or lactating will also be excluded from the study.
advanced social relations training

Conditions: Autism; Autism Spectrum Disorder

Summary: advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (iq) ≥ 80. there will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. the protocol will be carried out once a week for a duration of 45 minutes. the aim is to enhance communication and social skills within the group. a total of 23 sessions are planned. from the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. at the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing. the last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them.


Eligibility criteria:
inclusion criteria: * diagnosis of autism * intelligence quotient ≥ 80 exclusion criteria: * presence of other medical disorders

Keywords: autism children social relation awareness on social media communication social stories