Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy and safety of three different doses of bay1817080 compared to placebo in patients with chronic cough

Conditions: Refractory and/or Unexplained Chronic Cough

Summary: researchers in this study want to find the optimal therapeutic dose of drug bay1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, rucc). study drug bay1817080 is a new drug under development for the treatment of long-standing cough. it blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. this prevents the urge to cough. researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. observation for each participant will last about 18 weeks in total. participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age at the time of signing the informed consent. * a cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough. * persistent cough for at least the last 8 weeks before screening. * women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose. * capable of giving signed informed consent. exclusion criteria: * smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years. * ongoing or previous exposure to inhalational toxic fumes (e.g., ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening. * respiratory tract infection within 4 weeks before screening. * history of chronic bronchitis. * systolic blood pressure ≥ 160 mmhg and/or diastolic blood pressure ≥ 100 mmhg at screening visit. * positive sars-cov-2 virus rna and/or serology igg tests at screening visit.

Keywords: rucc chronic cough p2x3 receptor antagonist
glucarpidase effect on severe delayed hdm-clearance in children treated with high-dose mtx in all

Conditions: Acute Lymphoblastic Leukemia (ALL)

Summary: early intervention in children and adolescents who experience delayed mtx-clearance and renal dysfunction in all treatments with the enzyme glucarpidase which rapidly hydrolyses mtx to non-toxic metabolites to avoid life threatening complications.

the nopho all-2008 protocol is a treatment and research protocol that aims to improve the overall outcome of nordic children and adolescents with all in comparison with the all-2000 protocol and with the aim to reduce and prevent toxic treatment complications with high-dose methotrexate (hd-mtx). the specific and primary objectives of the randomized study is: 1. early intervention in children and adolescents who experience delayed mtx-clearance and renal dysfunction with the enzyme glucarpidase which rapidly hydrolyses mtx to non-toxic metabolites and lowers the serum concentration to avoid life threatening complications. glucarpidase should be given if the 24 hour levels of mtx is \> 250 µm, 36 hour levels \> 30 µm or 42 hours levels \> 10 µm together with a reduced kidney function. glucarpidase treatment should take place within 48 hours from the start of hd-mtx treatment. 2. to evaluate if the early intervention with glucarpidase reduce the number of days the patients have to stay at the hospital. 3. evaluate the reduction of health costs of early intervention in patients with delayed mtx-clearance and renal dysfunction.

Eligibility criteria:
inclusion criteria: children and adolescents who experience delayed mtx-clearance and renal dysfunction during high-dose methotrexate treatment in nopho all-2008. exclusion criteria: children and adolescents with earlier anaphylactic reaction to glucarpidase. pregnant patients.

Keywords: drug: glucarpidase
genetic association mapping of malaria resistance in anopheles gambiae

Conditions: Malaria

Summary: this is a study of the genetics of malaria transmission by the mosquito vector in africa, anopheles gambiae. the study focuses on the mosquito vector, not the human subjects infected with malaria. dna extracted from infected mosquitoes will be analyzed genetically by microsatellite and single-nucleotide polymorphisms (snps) to identify mosquito genes that control mosquito resistance to malaria parasites.

a standard diagnostic blood smear from a drop of blood will be carried out on 20 study subjects once per month. one malaria-positive subject from among the 20 will be asked to donate 5cc of blood, also no more frequently than once per month. the blood will be placed in a water-jacketed heated membrane feeding device that will be positioned on top of a cage of mosquitoes. the mosquitoes are attracted to the warmth and drink the blood through the artificial skin-like membrane. the goal of the research is to study the infected mosquitoes. no studies will be carried out on the human subjects. the point of human subjects involvement is to obtain the naturally malaria-infected blood for feeding of mosquitoes. after blood feeding, the mosquitoes are held in an environmental chamber for one week, at which time they are dissected to count numbers of malaria parasites developing on the mosquito stomach wall. this number constitutes the quantitative phenotype, and we extract genomic dna from the carcass for genetic marker typing, which constitutes the genotype. genetic linkage analysis identifies markers near genes that control parasite number, thus resistance or susceptibility to parasite infection.

Eligibility criteria:
inclusion criteria: * 5-10 years old, and general good health exclusion criteria: * outside age group * specific diagnosable health problems * general poor health
sleep hygiene education in individuals with fibromyalgia; sleep quality, pain and depression

Conditions: Fibromyalgia

Summary: objective: this semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia. patients and methods: a sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. data was collected using the pittsburgh sleep quality index, the visual analog scale, and the beck depression inventory.

objective: this semi-experimental study was conducted to determine the effect of sleep hygiene education on sleep quality, pain, and depression in individuals with fibromyalgia. background: sleep problems, pain, and depression are common health issues in individuals with fibromyalgia. however, studies on sleep hygiene education to address these problems are limited in the literature. methods: a sample of 70 individuals with fibromyalgia (35 experimental, 35 control) were included in the study. data was collected using the pittsburgh sleep quality index, the visual analog scale, and the beck depression inventory.

Eligibility criteria:
inclusion criteria: the inclusion criteria for the study were as follows: * being 18 years of age or older, * having a diagnosis of fibromyalgia (fm) for at least 3 months, * being reachable, * agreeing to participate in the study, * not receiving treatment for depression, * not having received similar education on sleep hygiene, * having a vas pain score \>3, * having a psqi score \>5. exclusion criteria: additionally, the exclusion criteria for the study were as follows: * having a diagnosis of fm for less than 3 months, * using sleep medication, * having chronic illnesses that could interfere with sleep such as chronic obstructive pulmonary disease (copd) or asthma, * working on night shifts.

Keywords: sleep hygiene sleep quality pain depression fibromyalgia
competency-based assessment in musculoskeletal ultrasound

Conditions: Musculoskeletal Diseases

Summary: early diagnosis and rapid treatment initiation are of most importance to prevent joint damage in patients with arthritis. musculoskeletal ultrasound (msus) is becoming an integrated part of rheumatology routine care and is more sensitive than clinical examination for detecting synovitis even in the early stage of disease. however, msus is highly operator dependent and competences are needed to ensure correct image interpretation. traditionally competences are evaluated on how many examinations the trainees have performed, but the gold standard has now shifted towards competency-based education where objective assessment tools are the key element. a previous study has developed a scale for assessment of ultrasound competence, the objective structured assessment of ultrasound skills (osaus). although expert consensus supports evidence of content validity of the assessment instrument, it is not known if the osaus scale can discriminate differences in performance scores between different levels of msus experience in rheumatology in a reliable way.


Eligibility criteria:
inclusion criteria: * physicians working at the rheumatology departments in denmark: 1. novices: no or little experience with msus (less than 100 examinations). 2. intermediates: participated and completed at least one formal ultrasound course and more than 100 examinations (less than 1000 msus examinations). 3. physicians with a long experience in msus doing the procedure almost daily and providing teaching and/or research within this field (more than 1000 examinations). exclusion criteria: * no informed consent * novices/intermediates: extensive experience in msus

Keywords: training ultrasound medical education
low-dose ticagrelor in chinese acs patients undergoing pci

Conditions: Acute Coronary Syndrome

Summary: dual antiplatelet therapy (dapt) with aspirin and p2y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (cad). clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet p2y(12) adenosine diphosphate (adp) receptor. ticagrelor is an oral, reversibly-binding, direct-acting p2y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (acs). guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for acs patients. the previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. one-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in chinese patients with stable cad. but the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * after half-dose ticagrelor (loading dose 90mg, and then 45mg bidpo.) treatment for 3 days, the platelet aggregation is effectively inhibited by light transmission aggregometry method and thromboela-stogram. * planned to undergo pci recently * planned to dapt for 1 year after pci exclusion criteria: * taken adenosine diphosphate (adp) receptor antagonists within 2 weeks * platelet count \<100g/l; * a history of bleeding tendency; * aspirin, ticagrelor or clopidogrel allergies; * severe liver injury.
redopoem : failure of a first poem

Conditions: Achalasia

Summary: observational study, measurement of efficacy in the cohort.

achalasia is a motor disorder of the esophagus with a prevalence of 1/10000. multiple treatments have been proposed, including endoscopic dilation, botulinum toxin injection and surgery using the heller myotomy technique. these techniques are moderately effective and/or carry the risk of per- and post-procedural complications. poem has been available since 2008, with 80-90% efficacy and 90% safety, and no serious complications have been reported. in the event of failure of a first poem, a second poem, known as "redopoem", can be proposed. several studies show efficacy of between 76% and 96% and a safety of between 80% and 86%, with only one serious adverse event reported, and no deaths. however, the studies carried out involved small numbers of patients, generally around 50, the vast majority in asian countries. the aim of this study was therefore to evaluate the efficacy and safety of redopoem reported in patients from several expert centers in europe.

Eligibility criteria:
inclusion criteria: * adult patient * diagnosis of achalasia based on clinical criteria according to eckardt score, manometry, and radiology when available. * failure after poem (eckardt score \> or equal to 4 in consultation) treated with a new poem. * no active digestive neoplasia. exclusion criteria: * technical failure of redopoem * person not affiliated to a social security scheme * language barrier preventing fair collection of non-opposition.

Keywords: achalasia redopoem poem per-oral endoscopic myotomy retrospective multicenter efficacy
evaluation of a three dimensional functional metabolic imaging and risk assessment system in classifying women for likelihood of breast cancer

Conditions: Breast Cancer

Summary: the purpose of the study is to assess the effectiveness of mira in classifying women with dense breast tissue for supplemental breast mri. to assess the effectiveness of mira for correctly classifying women with breast cancer and to evaluate the safety of the device. in women above 30 years old who are undergoing mri or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.


Eligibility criteria:
inclusion criteria: * women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (mri and/or mammography) or * women who are between 30 to 79 years of age and scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or mri) performed at the clinical site that participates in the study. exclusion criteria: 1. contraindication to bilateral mammography or mri. 2. subjects who are unable to read, understand and execute the informed consent procedure. 3. subjects who have had mammography, ultrasound or mri examination performed on the day of the study prior to mira scan. 4. subjects who have significant existing breast trauma. 5. subjects who have undergone lumpectomy/mastectomy. 6. subjects who have undergone breast reduction or breast augmentation. 7. subjects who have undergone any other type of breast surgery. 8. subjects who have large breast scar / breast deformation. 9. subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study. 10. subjects who have a temperature \> 37.8c degrees on the day of the mira imaging. 11. subjects who are pregnant or lactating. 12. subjects who have had placement of an internal breast marker. 13. subjects with known raynaud's disease. 14. subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session. 15. subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices. 16. inmates or mentally disabled individuals. 17. subjects with a bi-rads category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy). 18. subjects who participated in the calibration phase will not be able to participate in the testing phase. 19. subjects currently participating in another investigational clinical study. 20. subjects undergoing breast mr for pre-staging. 21. subjects with known mastitis
exploring of serum biomarkers of delirium after cardiovascular surgery

Conditions: Delirium

Summary: the incidence of postoperative delirium in patients after cardiovascular surgery is very high, which seriously affects the short-term and long-term prognosis of patients, but its mechanism is not clear. recent studies have found that lactic acid participates in the process of sepsis by inducing histone lactatation in macrophages. histone h3 lysine 18 lactylation (h3k18la) is significantly associated with the severity of disease and inflammatory response. inflammation plays an important role in postoperative delirium. we therefore hypothesized that macrophage h3k18la also plays a role in postoperative delirium. at the same time, the latest literature shows that the early markers of alzheimer's disease (ad), such as aβ, exosomes and phosphorylated tau, etc. \[5\], can also be detected in the serum of ad patients. given the obvious correlation between alzheimer's disease and postoperative delirium \[6\], we hypothesized that serum biomarkers of ad could also be used as serum biomarkers for postoperative delirium. the objectives of this study were to investigate the correlation between h3k18 in serum monocytes and postoperative delirium and its severity in patients undergoing cardiovascular surgery. meanwhile, we also detect the serum levels of biomarkers of ad, such as aβ, tau and exosomes etc., in patients undergoing major cardiac surgery. we aim to find the serum biomarkers of delirium after major cardiac surgery, so as to provide a more convenient diagnostic basis for the prevention of postoperative delirium.


Eligibility criteria:
inclusion criteria: patients who receive cardiovascular surgery * patients participated voluntarily and signed informed consent exclusion criteria: * past medical history of neurological and psychiatric diseases; severe visual or hearing impairment;

Keywords: delirium biomarker cardiovascular surgery h3k18la exosome phospho-tau aβ
continuous positive airway pressure and acetazolamide to treat sleep apnea syndrome patients at altitude

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the purpose of the study is to investigate the effect of nasal continuous positive airway pressure in combination with acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude.


Eligibility criteria:
inclusion criteria: * obstructive sleep apnea syndrome, successfully on cpap therapy * residence at low altitude (\< 800 m) * obstructive apnea/hypopnea index \>20/h and a complaint of excessive daytime sleepiness before introduction of cpap therapy * \> 15 oxygen desaturations/h (\> 3% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without cpap exclusion criteria: * sleep disorders other than osa * more than mild cardiovascular disease, unstable cardiovascular disease * any lung disease, pulmonary hypertension * chronic rhinitis * treatment with drugs that affect respiratory center drive (benzodiazepines or other sedatives or sleep inducing drugs, morphine or codeine derivates), stimulants (modafinil, methylphenidate, theophylline) * internal, neurologic or psychiatric disease that interfere with sleep quality * previous intolerance to moderate or low altitude (\< 2600 m) * exposure to altitudes \> 1500m for \> 1 day within the last 4 weeks before the study

Keywords: apnea sleep altitude hypoxia treatment cpap
study of the relation between the fat infiltration of the multifidus muscle and the lumbar foraminal stenosis, by 2d and 3d segmentation

Conditions: Low Back Pain; Degenerative Condition, Neurologic

Summary: the aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. the investigators will analyse lumbar mri of patients previously included in a database of patients suffering from low back pain. foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2d and 3d manuel segmentation, semi-automatic segmentation. correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.


Eligibility criteria:
patients suffering from low back pain and candidate to a spine surgery included in a database previously constituted, for who the following parameters are available: lumbar 3d mri with t2 weighted sequences, informed consent.
dissect-n post market data collection registry

Conditions: Thoracic Aortic Dissection

Summary: dissect-n is a post-market registry designed to assess real-world safety and effectiveness of valiant navion thoracic stent graft system in the treatment of thoracic aortic dissections in real world practice.

dissect-n is a prospective, observational, global, multi-center, post-market registry designed to assess real-world safety and effectiveness of valiant navion thoracic stent graft system in the treatment of thoracic aortic dissections in real world practice.

Eligibility criteria:
inclusion criteria: * subject is ≥18 years old * subject was treated in the last 7 days, or is intended to be treated, with the valiant navion thoracic stent graft system for a dissection in the thoracic aorta * subject is willing to comply with standard of care clinical follow-up * subject or legal representative or consultee, as applicable has consented for study participation and signed the approved informed consent exclusion criteria: * subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this study. * subject is pregnant (not an exclusion if allowed per local regulatory requirements, pregnancy test to be performed where required) * subject has an active covid-19 infection or relevant history of covid-19. relevant history of covid-19 is defined as availability of a positive covid-19 test with sequela or hospitalization for treatment of covid-19. subjects with a positive covid-19 test who were asymptomatic or had mild symptoms should be excluded only if the positive test was less than 3 months prior to enrollment.