Kornimate/medical-research-clean huggingface dataset:
a six-month follow-up study of participants with coronavirus disease 2019 (covid-19) previously enrolled in a ro7496998 (at-527) study

Conditions: COVID-19; Long COVID

Summary: this study will evaluate the long-term sequelae of covid-19 in patients diagnosed with covid-19 who previously enrolled in a ro7496998 (at-527) study (i.e. parent study nct04889040 \[cv43043\]), for approximately 6 months after the end of the parent study.


Eligibility criteria:
inclusion criteria: * participant was diagnosed with covid-19 and enrolled in a phase iii ro7496998 (at-527) covid-19 study exclusion criteria: * participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study. * any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Keywords: coronavirus disease 2019 covid-19 sars-cov-2 mild to moderate covid-19 long-covid observational
efficacy of autoppc for the treatment of obstructive sleep apnea syndrome (osas)

Conditions: Obstructive Sleep Apnea Syndrome

Summary: obstructive sleep apnea syndrome (osas) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. the most effective treatment consists in ventilation by mask with continuous positive airway pressure (cpap), that prevents collapse of the upper airway. however the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. thus, cpap treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autocpap) with the objective adjusted pressure to avoid airways obstruction with minimal pressure. different models of autocpap function with different signals and event detection algorithms with different modes of reaction to events. these machines are marketed with ce certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. these machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. thus these bench tests need to be supplemented by clinical studies. the investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. we develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. these clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. the perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.


Eligibility criteria:
inclusion criteria: * patients with obstructive sleep apnea syndrome and indication for autoppc exclusion criteria: * patients with copd, or evolutive heart disease patients with evolutive cancer patients already with ppc machine patients simultaneously included in another clinical study.
studying the clinical trial experiences of patients with mesothelioma

Conditions: Mesothelioma

Summary: medical research participation percentages haven't always been fully representative of a given demographic. the goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through. the data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future mesothelioma patients during clinical trials.


Eligibility criteria:
inclusion criteria: * must have a medical diagnosis of mesothelioma that has been confirmed by a physician. * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. exclusion criteria: * pregnant or lactating woman * patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. * known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Keywords: mesothelioma
foreseehome nrich registry

Conditions: Age-Related Macular Degeneration

Summary: this registry will compare functional and structural data of progression of intermediate amd (iamd) and conversion to neovascular amd (nv-amd) while monitored at home with the foreseehome monitoring system (fsh) and during routine care with spectral domain optical coherence tomography (sd-oct) and to validate the predictive value of a non-nv-amd fsh alerts.

the participants include those actively monitoring on the fsh program which requires diagnosis of intermediate amd and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. the process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing. the aim of the registry is to collect data up to 20,000 patients on the foreseehome program for at least one year. the data will be collected for approximately a period of 5 years. the registry will include clinics that provide direct care to the patients on the foreseehome device, and notal vision monitoring center. the registry aims to collect data from about 200 referring physicians. the registry will include structural and functional data for the patients active on the foreseehome device. the details of data points to be collected are mentioned below. data from participating sites will be collected in a de-identified manner and collected in the registry. patients will be assigned a patient id and will be collected in a sequential manner from each site. no data shall be acquired outside standard of care. not all data points for each patient are expected to be present. the following data points shall be shared in the registry: from notal vision monitoring center 1. patient id, date of birth (dob), gender, and testing eye from prescribing physician 2. visual acuity: visual acuity as measured during regular examination, in a period when the patient is active on the foreseehome program, shall be shared in the registry. maximum 2 visual acuity measurements shall be shared during one calendar year. 3. structural oct images: oct images (volume scans) acquired following a foreseehome alert shall be shared in the registry. 4. oct angiography (oct-a) images: oct-a images acquired following a foreseehome alert shall be shared in the registry 5. fluorescein angiography (fa): fa images acquired following a foreseehome alert visit shall be shared in the registry 6. diagnosis of wet-amd in case of foreseehome alert: the diagnosis related to status of patient's macular degeneration in both eyes shall be shared in the registry in case of an alert. 7. status of the eye after exiting the foreseehome program regarding conversion to wet-amd and its timing

Eligibility criteria:
inclusion criteria: * the participants include those actively monitoring on the fsh program which requires diagnosis of intermediate amd and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. exclusion criteria: * patients that are unable to establish a baseline
treatment of high and very high risk dyslipidemic patients for the prevention of cardiovascular events

Conditions: Dyslipidemia; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerotic Cardiovascular Disease

Summary: high and very high risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. this real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

suffering from hypercholesterolemia is a major health concern in europe. appropriate medical treatment lowers low density lipoprotein cholesterol and reduces the incidence of clinical cardiovascular events. despite the multiple available treatments, many patients remain inadequately treated or even untreated and some lipid-lowering drugs may be associated with an increase in events like side effects or increase in diabetes. as this is a non-interventional study, only data from routine clinical practice will be documented.

Eligibility criteria:
inclusion criteria: * very high risk and high risk dyslipidemic patients requiring lmts * not simultaneously participating in any interventional study * providing written informed consent for participation in the study (informed consent form) * life expectancy \> 1 year exclusion criteria: * not applicable; non-interventional study

Keywords: high-risk dyslipidemic low-density lipoprotein cholesterol cardiovascular disease lipid modifying therapies dyslipidemia hypercholesterolemia atherosclerotic cardiovascular disease
impairment of the cognitive flow in the development of a depressive disorder and suicidal ideas

Conditions: Suicide

Summary: the study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

the study consists in testing two big general hypotheses: * in the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements) * secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.

Eligibility criteria:
inclusion criteria: * patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters). * knowledge of the french language * patient who have signed of the form of consent, * patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode. exclusion criteria: * not compatible health with the signing of the protocol, * the not knowledge of the french language, * patient who have refused the protocol.

Keywords: suicidal patients;psychiatry
vidaza-dli pre-emptive azacitidine and donor lymphocyte infusions following allogeneic hematopoietic stem cell transplantation for high risk acute myeloid leukemia and myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion.


Eligibility criteria:
inclusion criteria: * patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor. high risk aml is defined as : * aml in cr1 with unfavorable cytogenetics defined by complex caryotype, autosomal monosomy combined or not with other cytogenetics abnormalities inv(3)/t(3,3), t(6;9), t(6;11), t(11;19), del(5q), del(7q). * aml in cr2 or greater remission prior allogeneic transplantation * aml in pr or relapse prior allogeneic transplantation * or patients with high risk myelodysplastic syndrome undergoing allogeneic transplantation with either a familial or an unrelated donor. high risk mds is defined as : * mds with intermediate-2 group and higher risk group according to ipss criteria * age 18 - 70 years. * availability of an hla identical family donor or unrelated donor with matching in 10/10 alleles (hla-a, b, c, drb1, dqb1) or maximum of 1 allele or antigen mismatch or family donor with maximum 1 allele mismatch. * conditioning regimen to allogeneic transplantation may be either myeloablative or reduced. * be able to understand and sign informed consent. * affiliation number to national health care system * men and women of childbearing potential must use effective contraception during and up to 3 months after treatment. exclusion criteria: * the presence of any one exclusion criteria renders the patient ineligible: * patient in full relapse post-transplant (\>20% blasts in the bone marrow) following allogeneic transplant * documented leukemic infiltration of cns/cerebrospinal fluid. * karnofsky performance score below 60%. * acute and chronic heart failure (nyha class iii or iv) or symptomatic ischemic heart disease. following allogeneic transplant * severe liver failure (bilirubin \>30 μmoles/l, sgpt \> 4 x upper limit of normal). * hepatic malignancy in advanced stage. * severe neurological or psychiatric disorders * acute gvhd grade ii-iii. patient with grade i gvhd may be included (see annex 1 for ghvd grade definition). * active uncontrolled infection. * denied informed consent. * treatment with other investigational drugs following allogeneic transplantation. * no effective contraception * lactating females * pregnant woman

Keywords: allogreffe, lam , mds azacitidine (vidazaò) injection de lymphocytes de donneur (dli)
prevalence and risk factors of epiretinal membrane in diabetic and non-diabetic patients

Conditions: Epiretinal Membrane

Summary: numerous terms have been used to describe epiretinal membrane (erm): macular pucker, epimacular membrane, surface-wrinkling retinopathy, cellophane maculopathy and preretinal macular fibrosis. it is, by definition, a fibrocellular tissue found on the inner surface of the retina. it is semi-translucent and proliferates on or above the surface of the internal limiting membrane. it causes blurring and metamorphopsia, while mild cases are often asymptomatic. erm presence can degrade the acuity and the quality of vision, thus affecting the quality of life. there is evidence that it also has an adverse impact to the treatment options for patients suffering from macular disorders. more specifically, regarding to diabetic retinopathy, erm seems to have a bidirectional etiopathogenetic relationship with its course and complications. the aim of this study is to know the prevalence of erm in the brussel's population, the risk factors predisposing to erm formation and if diabetic patients have a significantly higher prevalence of erm in comparison to general population.


Eligibility criteria:
inclusion criteria: -subjects examined in the general or diabetes screening consultations of the ophthalmology department of the chu brugmann hospital exclusion criteria: * women pregnant or breast-feeding * hypersensitivity to tropicamide * any macular pathology other than diabetic maculopathy * prior retinal photocoagulation * prior intravitreal injection * prior retinal surgery

Keywords: epiretinal membrane diabetes
siopen bioportal, an international registry linked to a virtual biobank for patients with peripheral neuroblastic tumours

Conditions: Neuroblastoma; Ganglioneuroblastoma; Ganglioneuroma

Summary: the siopen bioportal is a prospective non-therapeutic multi-centre international study aimed at developing an international registry linked to a virtual biobank for all the patients with peripheral neuroblastic tumor within countries of the siopen network. the overall aim of this study is to provide a gdpr-compliant framework to collect basic clinical annotations, biological and genetic features and information about the location on biospecimens for all the patients with a peripheral neuroblastic tumor including neuroblastoma, ganglioneuroblastoma and ganglioneuroma in the siopen network. this study will support data and sample management and intensify cross-borders data and sample sharing fostering translational and clinical research. the post-hoc hypothesis formulated based on the data generated in this study will be used as statistical basis for future precision medicine programs based on improved biological characterization, patient stratification and therapeutic management.


Eligibility criteria:
inclusion criteria: i-1. patients with pnt: ganglioneuroma or ganglioneuroblastoma or neuroblastoma, i-2. at the time of initial diagnosis of neuroblastic tumour, or at relapse/progression if not yet registered i-3. written patient informed consent, or parents or legal representative written informed consent and assent of the child, adolescent or young adult non-inclusion criteria: r-1. (adult) patients with olfactory neuroblastoma r-2. central nervous system (cns) neuroblastoma (as per the who classification)
effects of shock absorbing insoles on knee pain and walking in persons with knee osteoarthritis

Conditions: Osteoarthritis

Summary: osteoarthritis (oa) is a progressive, chronic disease affecting more than 20 million americans. there is no known cure for oa and management includes pain control and prevention of functional decline. purpose: to investigate the immediate effects of a shock absorbing insole (sai) placed in the shoe on knee pain, functional mobility and lower extremity biomechanics.

sixty adults (age 50+) with knee oa and pain will be recruited. a physician will diagnose the severity of knee oa through radiographs. participants will be tested in the kbr human performance lab on the campus of winston salem state university (wssu). participants will complete a demographic form and a survey about their knee pain and function. participants will be evaluated under two conditions: 1) with sai placed inside the shoe and 2) shoes alone. there are three walking tasks: 1) walking 25 feet at their usual pace; 2) walking 25 feet at a fast pace; 3) walking six minutes for distance; and a 4) biomechanical gait analysis. after each of the walks, participants will rate the amount of knee pain they experienced. during the biomechanical analysis, participants will walk down a 20 foot walkway while wearing reflective markers. eight cameras and a force plate embedded in the walkway will measure the amount of body movement and the forces applied to the leg joints during walking.

Eligibility criteria:
inclusion criteria: * 50 years of age or older * radiographic evidence of knee oa in the test extremity (k-l grading scale = 1 to 4) * knee pain (womac pain subscore of 4 or more and report moderate pain on at least 1 listed activity in the womac) on most days * able to speak, write, and understand english * able to walk 25 feet without an assistive device * must wear a shoe size available in the lab (women's 6-10 and men's 8-14) * able to attend two sessions of data collection within 14 days exclusion criteria: * currently wearing some type of foot orthosis (custom or over-the counter) * had lower extremity surgery of the test leg in the past 12 months * had a total knee replacement on the involved leg * had hip and/or ankle oa in the involved leg * had a neuromuscular disease disorder which affected their walking ability
evaluation of the pk of nrl972 following pre- and co-administration of ursodeoxycholic acid and cloxacillin

Conditions: Hepatic Cirrhosis

Summary: a study in healthy volunteers to determine whether different drugs metabolised by the liver have any effects on how nrl972 is processed within the body.


Eligibility criteria:
inclusion criteria: 1. males or females (females of non-childbearing potential or of childbearing potential while taking medically appropriate contraception) 2. caucasian 3. age: 21 - 40 years 4. bw 50 - 100 kg 5. bmi 20 - 26 kg.m-2 6. healthy based on the pre-study examination 7. willing and able to provide informed consent exclusion criteria: general - all subjects 1. previous participation in the trial 2. participant in any other trial during the last 90 days 3. donation of blood during the last 60 days or a history of blood loss exceeding 300 ml within the last 3 months 4. history of any clinically relevant allergy (including hypersensitivity to the trial medications) 5. presence of acute or chronic infection 6. presence or history of any relevant co-morbidity 7. resting systolic blood pressure \> 160 or \ 95 or \< 50 mmhg 8. clinically relevant ecg-abnormalities, prolonged qtc with \> 450 msec in males and \> 460 msec in females in particular 9. presence of any relevant abnormality in the laboratory safety tests, especially low haemoglobin, increased liver enzymes 10. positive serology for hbsag, anti hbc and anti hcv 11. positive hiv test 12. positive alcohol or urine drug test on recruitment (and upon admission) 13. history of alcohol and/or drug abuse and/or daily use of \> 30 gr alcohol 14. smoking more than 15 cigarettes/day or equivalent of other tobacco products 15. use of prohibited medication 16. suspicion or evidence that the subject is not trustworthy and reliable 17. suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard general - all females 18. positive pregnancy test 19. lactating 20. not using appropriate contraception in pre-menopausal women (note: under the conditions of the present study, women using hormonal contraceptives will be informed that this method is not sufficient during the study and that further i.e. mechanical methods \[condom, diaphragm with spermicidal gel\] should be us
practical pattern of surgical timing of childhood cataract in china

Conditions: Childhood Cataract

Summary: in the current study, the investigators analyzed the surgical rwd of 2,421 children with childhood cataracts from the childhood cataract program of the chinese ministry of health (ccpmoh) at the zhognshan ophthalmic center and proposed data-based clinical experience for the timings of cataract extraction and iol implantation.


Eligibility criteria:
inclusion criteria: * childhood cataracts present at the zoc at the first time age: 0-18 years exclusion criteria: * complicated with other type of cataracts

Keywords: surgical timing cataract extraction iol implantation childhood cataract real-world data