Kornimate/medical-research-clean huggingface dataset:
evaluation of the reproducibility of the measurement of the qsm signal (quantitative susceptibility mapping)

Conditions: White Matter Hyperintensity; Multiple Sclerosis

Summary: many central nervous system pathologies have an inflammatory component, often associated with an accumulation of disability and more severe tissue damage. in multiple sclerosis, the inflammatory process is in part characterized by the activation of microglia, an entity of the innate inflammatory system, as well as a breakdown of the blood-brain barrier. during inflammation, activated microglia may contain high levels of iron, characterizing its activated state.

several mri imaging tools are known to be highly sensitive to tissue iron content and have become the method of choice to study brain iron, including in a pathological context such as multiple sclerosis. quantitative magnetic susceptibility mapping (qsm) is an emerging technique to access non-invasively the iron content in brain tissue. for some years this technique has been used in ms to characterize white matter lesions. changes in the qsm value of the lesions have made it possible to describe lesions surrounded by an iron ring. susceptibility mri has also been proposed to highlight lesions according to their chronology. the study of reproducibility is of particular importance when using qsm in longitudinal studies or in therapeutic trials. a better understanding of intra- and inter-subject variation in qsm measurements may also allow a more accurate estimate of the number of subjects needed to detect changes in studies. in order to be widely applied to various pathologies, it is therefore necessary to evaluate its reproducibility by estimating the intra- and inter-subject variability for future dissemination in clinical and pharmaceutical studies. in this project, the invstigators propose to study the reproducibility of qsm acquisition.

Eligibility criteria:
inclusion criteria: * subject over 18 years old * consent to participate in the study * beneficiary of a social protection scheme * healthy volunteers: consent to be informed if an unexpected anomaly is revealed by the imagery. * patients: with ms defined according to mcdonald's revised criteria for spatial dissemination and temporal or clinical or radiological temporal dissemination and who should benefit from mri in the imaging department exclusion criteria: * absolute contraindication to 3t mri * realization of an injected mri (gadolinium) in the previous year * patient benefiting from a legal protection measure * pregnant or breastfeeding woman * for healthy volunteers: history of neurological pathology or neurological pathology in progress
investigation on safety, tolerability and pharmacokinetics of single and multiple doses of a long-acting glp-1 analogue (semaglutide) in an oral formulation in healthy male subjects

Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate the safety, tolerability and pharmacokinetics (the effect of the investigated drug on the body) of single and multiple doses of a long-acting glp-1 analogue (semaglutide) in an oral formulation in healthy male subjects.


Eligibility criteria:
inclusion criteria: * male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and laboratory safety tests performed during the screening visit, as judged by the investigator * body mass index (bmi) between 20 and 30 kg/m\^2 * glycosylated haemoglobin (hba1c) below 6.0% (only in part b) exclusion criteria: * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (gi), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing. occasional use of paracetamol or acetylsalicylic acid is permitted
carotid sinus massage in trendelenburg position for headache relief

Conditions: Migraine; Tension-Type Headache

Summary: headaches significantly impact patients' quality of life, with tension-type headaches and migraines being among the most prevalent types. there is growing evidence suggesting that blood pressure regulation and baroreceptor activity play a role in headache pathophysiology. carotid sinus massage (csm), particularly when combined with the modified trendelenburg position, may modulate autonomic nervous system activity to relieve headache symptoms. an initial open-label pilot study (n = 17) was completed, and the results were published in a preprint server for health sciences, the medical research archive (medrxiv), demonstrating the feasibility, safety, and promising preliminary efficacy of csm+t. based on these findings, a follow-up randomized, sham-controlled, parallel-arm trial will further evaluate the efficacy of the treatment.

this protocol includes two study phases: 1. pilot phase (completed): a single-arm, open-label pilot study was conducted in 17 participants to assess the feasibility and safety of csm+t for the relief of headaches. results have been published in medrxiv and support continued investigation. 2. parallel-arm phase (planned): a randomized, sham-controlled, parallel-arm clinical trial will now be implemented to evaluate efficacy. this phase will enroll 18 participants (9 per arm) to detect a clinically meaningful difference in headache relief with 80% power (α = 0.05, two-sided), accounting for potential attrition.

Eligibility criteria:
inclusion criteria: * participants must be at least 16 years of age. * must have a diagnosis of one of the following, according to the international classification of headache disorders (ichd-3): * migraine * tension-type headache * mixed headache * the headache episode must have started within the past 24 hours. exclusion criteria: * any contraindication to carotid sinus massage, including: * carotid bruits * recent myocardial infarction * history of stroke * known or suspected carotid artery stenosis * any contraindication to the trendelenburg position, including: * increased intracranial pressure * respiratory distress * congestive heart failure * history of syncope * history of cardiac arrhythmias

Keywords: carotid sinus massage trendelenburg autonomic nervous system
effect of ticagrelor on adenosine-induced coronary flow reserve in patients with microvascular angina

Conditions: Microvascular Angina

Summary: this study is undertaken to determine if ticagrelor augments adenosine-induced coronary flow reserve (cfr), ameliorates clinical symptomatology and exercise tolerance in patients with mva

considering the reduced cfr and increased platelet aggregability in patients with mva, together with the augmented effect on adenosine-mediated coronary blood flow and potent antiplatelet effect of ticagrelor, we speculate that ticagrelor can promisingly ameliorate the coronary microvascular function in patients with mva.

Eligibility criteria:
inclusion criteria: for inclusion in the study subjects should fulfill the following criteria: 1. provision of informed consent prior to any study specific procedures 2. female or male aged 18-80 years 3. a diagnosis of stable primary mva based on the presence of * a history of typical effort angina, * exercise-induced st-segment depression\>1 mm, * normal or near-normal (coronary artery stenosis\<50%) coronary angiography, * absence vasospastic angina * a coronary flow reserve (cfr) \<2.5 in the left anterior descending coronary artery as assessed by coronary blood flow (cbf) response to adenosine at transthoracic doppler echocardiography * suboptimal control of symptoms on conventional anti-ischemic therapy, as indicated by the occurrence of \>1 episode per week of angina exclusion criteria: ubjects should not enter the study if any of the following exclusion criteria are fulfilled: 1. concomitance with any of the cardiac condition below * significant （\>50%）coronary plaque disease * coronary artery spasm at angiography or other evidence of vasospastic angina * valvular or other structural heart disease * uncontrolled hypertension * abnormal echocardiographic examination including left ventricular hypertrophy 2. no previous consumption of the ticagrelor 3. no apparent contraindications to ticagrelor administration. * history of intracranial hemorrhage * active bleeding * severe hepatic impairment: ast and alt are greater than 3 times of the upper limit. bilirubin is greater than the upper limit. * hypersensitivity (e.g. angioedema) to ticagrelor or any component of the product * severe copd or asthma

Keywords: ticagrelor coronary flow reserve
use of pedometers to measure and increase walking among patients with esrd

Conditions: End-stage Renal Disease

Summary: randomized controlled trial using pedometers to increase physical activity among patients on dialysis.


Eligibility criteria:
inclusion criteria: * on hemodialysis for ≥ 3 months * able to walk * able to give informed consent and willing to participate exclusion criteria: * unable to walk * unable to understand directions or give informed consent

Keywords: dialysis end-stage renal disease
electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: the investigators evaluated clinical tolerance, biological tolerance, feasibility and efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10 patients with facioscapulohumeral muscular dystrophy, the third most common inherited myopathy.

autosomal dominant fshd is characterized by selective pattern of muscle involvement. weakness and atrophy typically involve facial and shoulder girdle muscles, and progressively anterior forearm and foreleg muscles and pelvic girdle muscles. the physiopatholgical mechanism of this disease, due to a deletion of repeated units named d4z4 located on 4q35, is still controversial. up to date, no curative therapy is available for these patients. we proposed in the present study to test feasibility, clinical and biological tolerance and efficacy of shoulder muscle training by electrostimulation in a group of fshd patients. 10 patients displaying classical fshd phenotype participate to this study consisting in daily session of shoulder girdle and quadriceps muscles electrostimulation of 23 minutes for a period of 5 months. we evaluated: clinical tolerance by daily pain and fatigue analogic scales, biological tolerance by measuring ck; feasibility: by measuring the monthly score of participation to sessions; the efficacy by manual muscle testing, quantitative muscle assessment, fatigue severity scale.

Eligibility criteria:
inclusion criteria: * 18 to 75 years old patient * fshd diagnosis confirmed by molecular biology * fshd clinical phenotype including shoulder girdle and quadriceps involvement * patient with vignos scale ≤ 5 (patient able to walk) * patient with health insurance * patient that could be followed for at least 6 months exclusion criteria: * patient with monolateral or bilateral scapular omopexia * patient that has already had electrostimulation training * patients with ck values \> 5 time normal values * patient that has not signed informed consent * patient with cancer, collagenopathies or others joint diseases * pregnancy and breast-feeding * patient on guardianship or trusteeship. * patient actively participating to other biomedical researches or whose exclusion period is not ended * patient with a formal contraindication to the protocol detected by inclusion examinations

Keywords: facioscapulohumeral muscular dystrophy electrostimulation training
new dosages of inflammatory markers for the early diagnosis of nosocomial bacterial infections of the newborn

Conditions: Nosocomial Infection

Summary: this study aims to evaluate new dosage of inflammatory markers or new inflammatory markers for the diagnosis of nosocomial bacterial infection. we made the hypothesis that these new dosages or new inflammatory markers could be more useful than dosage of inflammatory markers already used in clinical practice (especially the use of a combination of interleukins (6 or 8) and c-reactive protein for the management of newborns with a clinical suspicion of nosocomial bacterial infection and especially could allow to avoid excessive treatment with antibiotics


Eligibility criteria:
inclusion criteria: * newborns \> 72 hours of life hospitalized in neonatal intensive or intermediate care unit presenting a clinical suspicion of nbi exclusion criteria: * early post-operative period ( surgery of less than 48 hours) * multiple malformations * newborn already included in the study for a previous septic events * newborn treated with antibiotics in the last 24 hours

Keywords: late onset neonatal sepsis nosocomial bacterial infection inflammatory markers multiplex dosage
prospective evaluation of a scoring system in patients newly diagnosed with crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with crohn's disease.


Eligibility criteria:
inclusion criteria: all patients with crohn's disease who * have been newly diagnosed (initial diagnosis not more than 6 weeks previously) and * are as yet untreated (permitted medications are a maximum of 10 days of 5-aminosalicylates (5-asa) or glucocorticosteroids and antibiotics for non-intestinal indications) and * have consented to the documentation of their patient data and * agree to the up to 5-year documentation of the course of disease exclusion criteria: * pre-treatment with 5-asa \> 10 days * treatment with steroids \> 10 days * treatment with antibiotics, immunosuppressants or biological agents \> 10 days
sizing of the perceval® sutureless aortic valve prosthesis using the ct: a feasibility study

Conditions: Aortic Valve Stenosis

Summary: this study is to analyse if the size of the valve can be determined with a preoperative ct scan of the heart in order to prepare the valve preoperatively to save time.

patients with severe aortic stenosis undergo aortic valve replacement (avr). one approach to reduce trauma and operation time is the implantation of a sutureless valve to reduce aortic cross-clamp time due to the missing necessity of suturing the valve. until now, sizing of the valve was determined intraoperatively using the measuring devices provided by the product manufacturer. due to the implantation mechanism, the valve has to be collapsed after determination of the size. this is consuming time and can seriously delay the procedure. this study is to analyse if the size of the valve can be determined with a preoperative ct scan of the heart in order to prepare the valve preoperatively to save time.

Eligibility criteria:
inclusion criteria: * implantation of a sorin perceval ® sutureless valve * availability of preoperative ct scan exclusion criteria: * denial of consent * missing preoperative ct scan * bad quality of preoperative ct scan

Keywords: perceval® sutureless aortic valve prosthesis aortic valve stenosis aortic valve replacement preoperative ct scan of the heart
repeated gon injections in cch

Conditions: Cluster Headache

Summary: background: - the effect of repeated gon-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. as such, (repeated) gon-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. objectives: - the primary objective is to determine if repeated gon-injection result in effective control of cluster headache attacks for more days compared to placebo in chronic cluster headache. eligibility: - patients will be selected from the lumc (leiden university medical center) and cwz (canisius wilhelmina hospital) chronic cluster headache populations, diagnosed based upon the ichd-3. design: - bi-centre, randomized, double-blind, placebo-controlled retention trial with a maximum follow-up of one year.

a single injection of the greater occipital nerve (gon) with corticosteroids ('gon-injection') has been shown to be efficacious for the prophylactic treatment of cluster headache, with only mild, local side effects and often has its effect within days. it is a low-cost and safe treatment option; however, the beneficial effects are limited to weeks to months. this makes the injection suitable for episodic cluster headache, where periods with headache attacks last weeks to months. however, the effect of repeated gon-injections has never been studied in a double-blind randomized trial as a prophylactic therapy in a well-documented group of chronic patients. as such, (repeated) gon-injection has not yet found its place in current (inter)national treatment protocols for chronic cluster headache. the injection is often only used as a last-resort treatment in a very limited number of headache centres in a trial-and-error approach with a treatment interval varying between 3 and 6 months. it is, therefore, not known what chronic cluster headache patients can expect from this treatment. hypothesis: repeated gon-injections are a safe, well-tolerated, convenient, and cost-effective therapy to rapidly and long-term reduce the attack frequency in chronic cluster headache.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤ 70 years * chronic cluster headache (international classification of headache disorders - third edition; ichd-3) * ictal pain must be always at the same side * ≥4 weekly attacks of cluster headache in the prospective one-month baseline observation period * on a stable regimen of cluster headache prophylactics for \>4 weeks prior to onset of study treatment and agreeing not to increase the dose and not starting a new cluster prophylactic during the study period exclusion criteria: * contra-indication against, or current use of, corticosteroids * occipital nerve stimulation (ons) * use of anticoagulation medication or a known bleeding disorder * inability to use an electronic diary to monitor individual attacks and other items * other headaches if the patient cannot reliably distinguish them from attacks of cluster headache * current use of prophylactic medication for other headaches * pregnancy

Keywords: gon-injection
assessment of the safety and performance of a lumbar belt

Conditions: Low Back Pain

Summary: decathlon has developed the lumbar belt soft 300 and mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain. the objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved decathlon lumbar belt range of products to demonstrate safety and performance of these devices in a real-world setting. outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr), clinical evaluation report (cer) on decathlon lumbar belt soft 300/ mid 500 devices and support peer-reviewed publications on products performance and safety.


Eligibility criteria:
inclusion criteria: * subject is aged ≥18 years old * subject has a medically-confirmed common subacute or chronic low back pain * subject performs regular physical activity * the current condition of his/her back allows the subject to pursue a usual physical activity * subject has been informed and is willing to sign an informed consent form * subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (12 weeks) * subject is affiliated to the french social security regime exclusion criteria: * subject has undergone a surgical treatment for his/her back * subject presents associated neurologic signs (equina syndrome, radiculopathy, sciatica...) * subject presents signs of specific low back pain (i.e. low back pain is a symptom of an underlying condition): presence of red flags * subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent * subject has worn a support (lumbar or sacroiliac hip belt) during sports sessions in the last month * subject has any medical condition that could impact the study at investigator's discretion * subject has a known hypersensitivity or allergy to the components of the devices (elastodiene, elastane, polyamide, polyethersulfone \[pes\]) * adult subject to a legal protection measure
study to assess umbralisib plus ublituximab in participants with treatment naïve follicular lymphoma

Conditions: Follicular Lymphoma; Small Lymphocytic Lymphoma

Summary: this is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve follicular lymphoma (fl) and small lymphocytic lymphoma (sll).

the study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve fl and sll. ublituximab will be administered through cycle 12, while umbralisib will be administered through cycle 24. after this time, participants will be followed for progression free survival (pfs).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of fl or sll. * measurable disease that requires treatment * eastern cooperative oncology group (ecog) performance status ≤ 1 exclusion criteria: * currently or previously received treatment for their lymphoma * received wide field radiotherapy within 28 days or limited field radiation within 14 days of cycle 1 day 1 * evidence of hepatitis b virus, hepatitis c virus or known human immunodeficiency virus (hiv) infection

Keywords: treatment naïve