Kornimate/medical-research-clean huggingface dataset:
establishing new treatment approaches for amblyopia: perceptual learning and video games

Conditions: Amblyopia

Summary: amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. this study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia.

amblyopia, a developmental abnormality that impairs spatial vision, is a major cause of vision loss, resulting in reduced visual acuity and reduced sensitivity to contrast. our previous findings (see publications) show that the adult amblyopic brain is still plastic and malleable, suggesting that active approach is potential useful in treating amblyopia.the goal of this project is to assess the limits and mechanisms of neural plasticity in both normal and amblyopic spatial vision. this study uses psychophysical measures to study neural plasticity in both adults and children with amblyopia. research participants will be asked to practice a visual discrimination task (perceptual learning) or to play video games with the amblyopic eye for a period of time. a range of visual functions will be monitored during the course of treatment.

Eligibility criteria:
inclusion criteria: * adults and children with normal vision or amblyopia * amblyopia: interocular va difference of 0.1 logmar or more exclusion criteria: * any ocular pathological conditions, nystagmus

Keywords: perceptual learning video games visual plasticity amblyopia treatment pathophysiology of amblyopia vision training stereoacuity strabismus
prebiotics in patients with non-alcoholic liver disease

Conditions: Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Summary: the purpose of this present study is to evaluating whether prebiotics - itf (inulin/ofs 75/25) is effective in treating patients with non-alcoholic liver disease.

the study will include 60 patients with non-alcoholic fatty liver disease (nafld) which will randomize to two groups, receiving either itf (inulin/oligofructose-ofs 75/25) or maltodextrin (placebo). the trial will last for 26 weeks: stage 1-run-in period: subjects will be followed to ascertain weight maintenance. stage 2- randomized intervention period: subjects will be assigned to receive 16 gram/day of itf or maltodextrin. both itf and placebo will be provided in identical opaque packages and both subjects and researchers will be blinded to the content. after signing informed (-2 week) consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. at week 0, week 12 and week 24 all the following tests will be performed: vital signs: blood pressure, anthropometric measurements, body composition determined by bioelectrical impedance analysis (bia). biochemical blood tests: liver function tests fasting glucose insulin \& lipid profile, crp (an inflammation marker), scfa, bcaa, and lbp and fgf 19. fecal samples: fecal samples will be used for microbiota composition analysis, and ba analysis. assessment of liver status at week 0 and 24 by using magnetic resonance spectroscopy (1h-mrs), steatotest and nashtest (fibromax™) and by liver enzymes for evaluating steohepatitis.

Eligibility criteria:
inclusion criteria: * diagnosis of nafld based on fatty infiltration detection by ultrasonography and alanine aminotransferase levels of (alt) ≥ 30 u/l male ≥ 19 u/l females. * over-weight (bmi ≥ 27 kg/m2) who fulfill the criteria of the national cholesterol education program (ncep) metabolic syndrome * willing to sign informed consent to participate in the study * patients without diabetes or with well-controlled diabetes (hba1c \< 7.5%) who are treated by diet ± metformin exclusion criteria: * pregnancy * uncontrolled diabetes * diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse, presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric surgery * serious medical conditions * evidence of another etiology for chronic liver disease such as: hepatitis b, hepatitis c, hiv, autoimmune diseases and metabolic diseases, medications with known hepatotoxicity.

Keywords: inulin, ofs (oligofructose)
intervention study of drugs in patients osteopenia and osteoporosis

Conditions: Osteoporosis; Osteopenia, Osteoporosis

Summary: this is a 12 months, randomized, multicenter, open-label, parallel-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in china to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies.

this is a 12 months,randomized, multicenter, open-label, pragmatic-group study in postmenopausal women and male aged 50 years or old with osteoporosis or osteopenia in china to evaluate the efficacy and safety of different anti-osteoporpsis intervention strategies, including * group1: basic treatment group (elemental calcium 600mg/ day + vitamin d 1000iu/day) * group2: basic treatment+ anti-osteoporosis drug group (alendronate, zoledronate, tripopeptide, denosumab, activated vitamin d, menatetrenone soft capsules according to the patient's condition) * group3: basic treatment + non-drug treatment group(diet, exercise, rehabilitation therapy). eligibility for participation will be determined by medical history, physical examination, and laboratory results obtained during a screening visit. about 180 postmenopausal women and elderly male with osteoporosis or osteopenia will be included in this study. all subjects will be given informed consent before starting any examination and test. the following data of all subject will be collected: liver and kidney function, hba1c, fasting blood glucose, fasting lipid profile, serum calcium, serum phosphate, parathyroid hormone, 25-hydroxy vitamin d, bone turnover markers(btms) (inculding serum procollagen type i n-propeptide, serum c-terminal telopeptide of type i collagen,osteocalcin and alkaline phosphatase), thoracic and lumbar spine x-ray, bone mineral density(bmd) by dual energy x-ray. then they will be randomized into three groups at a 1:1 ratio. every group will be given calcium carbonate and vitamin d. in the group 2, the medication will be decided by the doctor according to the patients' condition. particularly, denosumab has not been approved for male adaptation, we will sign an additional informed consent. all subjects will be followed by visiting clinic every three months and complete the examinations to assess the safety and efficacy. safety indexes: liver and kidney function, urine routine test and 24-h urine calcium. efficacy indexes: bmd change, btms changes and fracture reduction. all subjects will be followed 12 months and data will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities * postmenopausal women and male aged 50 years or old * osteoporosis by dxa or fragility fracture history * osteopenia with more than one osteoporotic risk factors exclusion criteria: * secondary osteoporosis * renal insufficiency (ccr\< 35ml/min) * new fractures \< 3 months, prior bilateral hip fractures or surgical replacement. * other medication contraindications * malignant tumors * mobility-impaired individuals

Keywords: anti-osteoporosis therapy men postmenopausal women
ultrasound-assisted bilateral transversus abdominis plane block for open prostatectomy

Conditions: Prostatectomy; Transversus Abdominis Plane Blockade; Pain

Summary: the purpose of this study is to compare the quality of a transversus abdominis plane blockade with an intravenous pain therapy with opioids. due to the relatively low side effect profile and comparably few contraindications, this method offers a good option, to be a standard procedure or better alternative in the treatment of pain in surgery of the prostate.


Eligibility criteria:
inclusion criteria: * patients at the age of 18 and above, who need an open prostatectomy * written consent exists exclusion criteria: * american society of anaesthesiologists (asa) classification \> iii * allergy to local anaesthesia * contraindications to one of the applied methods * previous surgery on the abdominal wall * chronic pain patients * myasthenia gravis * alcohol dependence * increased intraocular pressure * lacking willingness to save and hand out data within the study * participation in another trial according to the german drug law * accommodation in an institute due to an official or judicial order

Keywords: general anaesthesia epidural catheter intravenous pain therapy
impact of interface with/without oral appliance of sleep apnea treatment

Conditions: Obstructive Sleep Apnea

Summary: cpap is the most effective treatment of obstructive sleep apnea. oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. the present investigation evaluates if cpap compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. eligible patients are those demonstrating a low compliance when using an oro-nasal mask during cpap therapy. patients will be treated with automatic cpap with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

participating subjects will be currently treated by cpap and low compliance will be assessed according to machine report download demonstrating 3h or less of cpap usage per night.

Eligibility criteria:
inclusion criteria: * normal nasal breathing * dentition allowing for use of an oral appliance * absence of mandibular joint pathology * patients requiring the use of a facial mask during capp titration due to presence of mouth leaks with a nasal/prong interface * patients using cpap less than 3 hours/day as prescribed following cpap titration exclusion criteria: * clinical instability * smoking cessation * current weight loss strategy * marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy) * severe cardio-metabolic co-morbidity

Keywords: cpap compliance leaks respiratory disturbances index quality of life
efficacy and safety of hydroxychloroquine and azithromycin for patients with moderate to severe covid-19

Conditions: COVID-19

Summary: this is an exploratory study to evaluate the efficacy of hydroxychloroquine (400 mg bid on d1 and 400 mg/day on d2 to d5) and azithromycin (500 mg/ 5 days) to treat moderate to severe covid-19 pneumonia.

this is an exploratory, open label, multi-center study to evaluate the efficacy of hydroxychloroquine (hcq) (400 mg bid on d1 and 400 mg/day on d2 to d5) and azithromycin (azt) (500 mg/ 5 days) to treat moderate to severe covid-19 pneumonia. we aim to demonstrate decrease in hospital related complications among patients who are hospitalized with moderate or severe covid-19 by treating them with hcq and azt on top of standard care compared to patients who receive standard care only. patients hospitalized with confirmed diagnosis of covid-19 will receive the treatment. patients that do not fulfill the inclusion/exclusion criteria or that is not willing to participate in the study will be invited to consent the use of their data as part of a "control" group.

Eligibility criteria:
inclusion criteria: 1. informed consent from patient or legal representative. 2. male or female, aged ≥ 18 years; 3. laboratory confirmation of 2019-ncov infection by reverse-transcription polymerase chain reaction (rt-pcr) from any diagnostic sampling source; 4. at least one of the characteristic symptoms of covid-19 5. hospitalized for up to 36h with non-invasive ventilation or up to 24h with invasive ventilation. 6. negative result for pregnancy test (if applicable). exclusion criteria: 1. participating in another rct in the past 12 months; 2. known allergy to hcq or chloroquine 3. any contraindication to htc or azt, including retinopathy and prolonged qt, 4. severely reduced lv function 5. severely reduced renal function; 6. pregnancy or breast feeding 7. any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
socio-psychological status of healthcare workers during sars-cov2 pandemic

Conditions: Depression, Anxiety

Summary: the aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the sars-cov2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.

severe acute respiratory syndrome - corona virus 2 (sars-cov2) was detected by the chinese center for disease control and prevention on 7 january 2020 in a patient with atypical pneumonia in wuhan, china, via a nasopharyngeal swab. on march 11, 2020, the world health organization declared it a "pandemic". sars-cov2 quickly turned into a global epidemic, with a total of 134,957,021 confirmed cases and 2,918,752 deaths reported in april 2021.since sars-cov2 is a highly contagious disease, the risk of infection in healthcare workers is quite high. in one of the earliest studies in wuhan, 29 percent of patients (40 out of 138) were reported to be healthcare workers. a report from the american centers for disease control and prevention (cdc) stated that a total of 9,282 healthcare workers were diagnosed with covid-19, including 27 deaths, between february 12 and april 9, 2020. eleven to nineteen percent of covid-19 cases have been identified as healthcare professionals.as the investigators have seen in studies of sars or ebola outbreaks, the sudden onset of an immediately life-threatening epidemic can place an extraordinary amount of pressure on healthcare workers. increased workload, physical fatigue, inadequate personal equipment, nosocomial transmission, and having to make ethically difficult decisions can have dramatic effects on their physical and mental health. the weight of working conditions together with the risk of illness of their social environment and families can cause mental health problems such as fear and anxiety in healthcare workers.when an effective vaccination program is in place, population uptake should be as high as possible to achieve herd immunity. vaccination hesitancy, defined as a delay in acceptance or rejection of vaccination despite the availability of vaccination services, is one of the barriers to this. it is a complex special case that varies with time, place, and vaccines. it is influenced by factors such as peace of mind, convenience, and trust. vaccine hesitations have been identified as one of the ten global health threats of 2019.the aim of our study is to investigate the presence of depression, anxiety and fear in healthcare workers during the sars-cov2 pandemic process, to evaluate their work and social life situations, as well as to evaluate the perspectives of the entire population towards hospital admission, surgery decision and vaccination.

Eligibility criteria:
inclusion criteria: * all healthcare workers aged between 18-65 who works at siran government hospital exclusion criteria: * participants who did not agree to participate in the study * uncooperative participants

Keywords: depression anxiety healthcare workers
validation of multidimensional assessment of thymic states (mathys): a study in a population of bipolar patients treated with olanzapine

Conditions: Bipolar Disorder I or II

Summary: a non randomized study to validate the mathys scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from bipolar disorder i or ii, and treated with olanzapine.


Eligibility criteria:
inclusion criteria: 1. patients must meet diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) disease diagnostic criteria for bipolar disorder * currently or most recently in a manic episode (single manic episode or most recent episode manic) or * currently or most recently in a hypomanic episode or * currently or most recently in a mixed episode or * currently or most recently in a major depressive episode * and confirmed by the module d of the scid (semi-structured interview). 2. patients must be more than 18 of age at visit 0. exclusion criteria: 1. a valid current or lifetime dsm-iv-tr axis i or ii diagnosis which could interfere, at the investigator's opinion, with the evaluation. 2. patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.
midura-study (neuro-patch in duraplasty)

Conditions: Meningioma; Tumor, Brain; Chiari Malformation; Vascular Malformation; Hydrocephalus; Tethered Cord; Dural Fistula; Craniotomy; Spinal Surgery; Duraplasty

Summary: the aim of this study is to collect systematically and proactively data regarding the performance of neuro-patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer


Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * duraplasty using neuro-patch® according to the instructions for use exclusion criteria: * use in infected regions * use in open cerebrocranial traumata * use in open spina bifida * known hypersensitivity to implant materials * pregnancy * representation by a legal guardian or under involuntary commitment

Keywords: duraplasty dural substitute synthetic graft neuro-patch®
a study for efficacy and safety of live biotherapeutic mrx4dp0004 to treat covid-19

Conditions: COVID-19

Summary: this is a randomised, double-blind, placebo controlled study to evaluate the efficacy and safety of mrx-4dp0004 in patients with covid-19. 90 hospitalised patients will be enrolled and randomised (2:1) to receive mrx-4dp0004 or placebo for up to 14 days. mrx-4dp0004 is an immunomodulating live biotherapeutic product (lbp) which is expected to prevent or reduce the hyperinflammatory response to sars-cov-2 infection without impairing viral clearance.


Eligibility criteria:
inclusion criteria: * willing and able to sign the consent form * suspected or confirmed covid-19 as defined by: 1. positive rna test for sars-cov-2 or 2. presenting with symptoms of covid-19 as determined by the investigator, and 3. a score of 4 or 5 on the who ordinal scale for clinical improvement, and 4. oxygen saturation of \<95% on room air, and 5. chest x-ray with evidence of covid-19 e.g. ground-glass opacities * requires admission to hospital * able to swallow oral capsules exclusion criteria: * known valvular heart defects, pulmonary hypertension or heart failure * known to have cystic fibrosis * gi fistula or malabsorption syndrome * known allergy to ampicillin, clindamycin and imipenem * any other condition which, in the opinion of the investigator, would prevent full participation in the study or would interfere with the evaluation of the study endpoints * antibiotic treatment at enrolment or within 2 days prior * pregnant or breastfeeding females * unable or unwilling to follow contraception requirements * concurrent participation in another interventional clinical trial at enrolment or within 30 days prior

Keywords: mrx-4dp0004 coronavirus live biotherapeutic product sars-cov-2 immunomodulatory
the role of antidepressants or antipsychotics in preventing psychosis

Conditions: Psychotic Disorder

Summary: this is a randomized, controlled pilot study comparing the antidepressant fluoxetine with the second generation antipsychotic aripiprazole in approximately 10 subjects aged 12-25 at risk for developing psychosis. our primary hypotheses are that compared to aripiprazole, fluoxetine will be better tolerated and will lead to greater improvement in symptoms at the end of 6 months of treatment.


Eligibility criteria:
inclusion criteria: * 12-25 years of age (inclusive) * able to understand and speak english * have at least one sub-threshold positive psychotic symptom that is moderate, moderately severe, or severe exclusion criteria: * lifetime diagnosis of an axis i psychotic disorder: schizophreniform disorder; schizophrenia; schizoaffective disorder; bipolar disorder; or major depression with psychotic features * current psychosis * current diagnosis of major depressive disorder, single episode or recurrent, severe without psychotic features * lifetime diagnosis of substance abuse or dependence (excluding nicotine) * current stimulant treatment * any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine, including history of neurological, neuroendocrine or other medical condition known to affect the brain * estimated intelligence quotient \< 70
sunsmart intervention in schools

Conditions: Melanoma

Summary: a prevention study to improve sun exposure behaviors in children after an educational classroom-based intervention.

this study aims to demonstrate that learning about sun exposure using a more classroom-based intervention will motivate classroom students to reduce exposure at a critical life period and will create lifetime learned sun exposure behaviors. students' sun exposure behaviors will be assessed prior to the educational intervention. the educational intervention consists of three educational sessions and one lab lesson. at the conclusion of the intervention, students' sun exposure behaviors will be assessed again via a post-intervention questionnaire.

Eligibility criteria:
inclusion criteria: * any children between grades 4 and 8 enrolled in one of the participating schools. exclusion criteria: * no exclusions, but children or their parents may opt out of participating.

Keywords: sunscreen sun exposure behaviors baseline assessments follow-up assessments knowledge
prasugrel versus high dose clopidogrel in patients with stable coronary artery disease and high platelet reactivity while on chronic clopidogrel treatment

Conditions: Coronary Artery Disease (CAD)

Summary: clopidogrel administration is considered standard of care in patients with stable coronary artery disease post pci. however , a significant proportion of patients is considered clopidogrel resistant and this is shown to be accompanied by future adverse events. the hypothesis of the study is to define among consecutive outpatient clinics individuals with stable coronary artery disease being on chronic clopidogrel treatment, those that are clopidogrel resistant, as assessed with the verifynow point of care assay. clopidogrel resistant patients will be randomized in a 1:1 fashion to either prasugrel 10mg or clopidogrel 150mg daily. platelet reactivity will be assessed at day 14, when treatment crossover will be performed without a washout period. at day 28 platelet reactivity will be assessed as well.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * patients with history of coronary artery disease under chronic (≥ 6 months) clopidogrel treatment * high on-clopidogrel platelet reactivity (≥235 platelet reactivity units as assessed with the verifynow assay) * written informed consent exclusion criteria: * history of bleeding diathesis * history of active bleeding within 6 months before randomization * chronic oral anticoagulation treatment * contraindications to antiplatelet treatment * known platelet function disorders * acute coronary syndrome within 30 days before randomization * cardiogenic shock * planned percutaneous coronary intervention in the next 30 days * cancer * haemodialysis * platelet count \< 100000/μl * hematocrit \< 30% * high likelihood of being unavailable on the day 28 visit * history of stroke * known allergy to clopidogrel and/or prasugrel

Keywords: coronary angioplasty clopidogrel resistance prasugrel