Kornimate/medical-research-clean huggingface dataset:
cardiovascular safety of xenon in general anaesthesia, in patient with cardiovascular risk in non cardiac surgery

Conditions: Elevated Cardiac Risk; Coronary Arteries Disease Risk

Summary: the primary objective is to show non inferiority in cardiac safety (i.e myocardial necrosis-mn- assessed by positive cardiac troponin i -ctni- ultrasensitive assay) of a xenon based general anesthesia procedure in patients with elevated cardiac risk scheduled for atherosclerotic vascular surgery (i.e patient with coronary arteries disease risk) when compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.

the primary endpoint is defined as an increase above the 99th percentile of highly sensitive cardiac troponin i (ctni) at any time during the 72 h post operatively. time frame 3 days post-op; key secondary endpoint(s) are routine (local laboratory) dosage of standard cardiac troponin i (ctni) at d1 (24h) and d3 (72 h) post operatively, and also in case of any suspicion of myocardial infarction , routine cardiac safety monitoring.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * scheduled for atherosclerotic vascular elective surgery with presumed fast-track, * cardiac ischaemic risk supported by: * history of myocardial infarction older than 1 month and/or * documented stable angina (asymptomatic ± medical treatment) and/or * history of coronary revascularisation, and/or * surgical risk index ("lee" index) ≥ 3. * written informed consent exclusion criteria: * unstable angina within the last 30 days, * non controlled arterial hypertension . * severe cardiac heart failure (nyha iv) * severe chronic obstructive pulmonary disease * patient already randomized in another ongoing clinical trial * patient with recent myocardial infarction (m.i) (less than one month ) * patient already included in a clinical trial * history of hypersensitivity to study drugs( i.e xenon, propofol, sevoflurane, desflurane, isoflurane) * malignant hyperthermia * documented elevated intracranial pressure * preeclampsia or eclampsia * pregnancy and lactation * presumed uncooperativeness or legal incapacity

Keywords: xenon cardiac safety cardiovascular risk non cardiac surgery atherosclerotic vascular surgery
microcephaly genetic deficiency in neural progenitors

Conditions: Microcephaly

Summary: the purpose of this study is to: i. compare neuroradiological phenotype and cognitive functioning of mcph patients caused by aspm mutations already characterized and published (passemard et al. 2009a) with other mcph-related patients (patients with mcph1, wdr62, cdk5rap2, cep 152, cenpj, stil, or pcnt mutations) ii. describe the neuro-radiological and cognitive phenotype of microcephalic patients suffering from fanconi anemia, and compared them to subjects with: * fanconi anemia but normal ofc (head circumference) * mcph patients * healthy control subjects our hypothesis is that mutations in genes responsible of microcephaly impact differentially cortical brain development and functioning

phenotyping study on 2 different cohorts of rare disease affected patients: * group1: mcph (including different mcph subtypes) * group2: fanconi anemia (with or without microcephaly) inclusion criteria: common to each group: * age \> 3 years * access to french "social security" * no contraindication for mri group1: * primary microcephaly without gross malformation within or extra nervous central system * ofc \< -2sd at birth and \< -3 sd after age 6months * mutation in one mcph gene group2: proven fanconi anemia with: * positive chromosome breakage blood test * one of the 3 following elements: fancd2 positive test fibroblast sensitivity to mitomycin mutation in one fanc gene control subjects: * no antecedent * normal education aims: 1. description of neurological, neuropsychological and radiological phenotype for each group 2. phenotype comparison: * groups 1\&2 * group1 or 2 with control subjects * different mcph subtypes within group1 * with or without microcephaly within group2 3. epidemiological data on these rare diseases in our population protocol: patients from both groups and control subjects will be evaluated in cic for 1 day ½. they will be examined by a child neurologist and a geneticist. all of them will have cranial mri (1.5tesla). neuropsychological assessment will be performed (wechsler scales) for patients and control subjects.

Eligibility criteria:
inclusion criteria: patients aged ≥ 3 years: * microcephalic phenotype consistent with mcph (recruitment already done as part of a network gis-rare diseases institute). mcph patients have already been selected in the cohort "robert debré." * holders of a fanconi anemia characterized in terms of cytogenetics, enzyme and/or molecular (patients in the cohort "saint louis" followed by the krc rare aplastic anemia) * healthy controls aged ≥ 5 years siblings of patients with fanconi anemia exclusion criteria: patients with fanconi anemia: * bone marrow \< 3 years * post-transplantation neurological complications * developmental, genetic or environmental additional pathology

Keywords: mcph fanconi anemia
colonic polyp size measurement with artificial intelligence

Conditions: Colon Polyp; Artificial Intelligence

Summary: primary objective of the study is to evaluate if the novel virtual polyp sizing tool accuracy in determining the size class of polyps among diminutive (0-5 mm), small (6-9 mm) and large (10 mm and above).


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older undergoing colonoscopy * ability to provide written, informed consent (approved by ec) and understand the responsibilities of trial participation. exclusion criteria: * patients with known contra-indications to colonoscopy * patients who perform an emergency colonoscopy.
diagnosis and clinical presentation of iliac graft-enteric fistula: a case report

Conditions: Case-report; Diagnosis; Digestive System Fistula; Gastrointestinal Hemorrhage; Iliac Graft-Enteric Fistula

Summary: abstract introduction: aorto-enteric fistula (aef) is a life-threatening complication arising from abnormal connections between the gastrointestinal tract and major arteries. one uncommon type, iliac artery-enteric fistula (ief), can occur following vascular interventions such as arterial stent-graft placement. case presentation: we report the case of a 47-year-old male presenting with hematemesis and abdominal pain, who was diagnosed with an iliac graft-enteric fistula. timely recognition and management were crucial for a favorable outcome. clinical discussion: diagnosing aefs remains challenging, requiring a multidisciplinary approach and high clinical suspicion. while computed tomography angiography (cta) is commonly used for diagnosis, its sensitivity may be limited, emphasizing the importance of integrating clinical history and findings. management strategies vary based on etiology and patient status, with surgery being pivotal. conclusion: aorto-enteric fistula, which can arise from a thrombosed graft, presents diagnostic challenges due to its rare formation. in patients with a history of vascular interventions and gastrointestinal bleeding, aef should be considered. this case underscores the need for heightened awareness among healthcare professionals regarding aef diagnosis and management to reduce severe morbidity, mortality, and prolonged hospital stays.


Eligibility criteria:
inclusion criteria: n/a exclusion criteria: n/a

Keywords: case-report; ct scan; diagnosis; digestive system fistula; gastrointestinal hemorrhage; iliac graft-enteric fistula.
study of navigation skills in cerebral palsy for assessment and rehabilitation in immersive virtual reality

Conditions: Cerebral Palsy

Summary: spatial navigation refers to the ability to maintain a sense of direction/location while moving around the environment so to find one's way. it includes abilities such as orienting in complex environments,perceiving distance and planning routes to distant locations as well as mentally representing the reciprocal relations of landmarks in space (lawton, 2010; wolbers \& hegarty 2010. spatial navigation involves the precision in encoding multisensorial (visual, vestibular, proprioceptive)experiences, as well as to form mental representations to be used to guide behavior (bianchini et al.,2014). cerebral palsy (cp) is a neurodevelopmental disorder characterized by movement and posture disorders causing activity limitation. impairment in many other functions is common in cp including visual spatial competences and spatial organization. in this study the investigators meant to explore the navigation and learning strategies in children with cp.


Eligibility criteria:
inclusion criteria:. * diagnosis of bilateral cp; * age between 8 and 14 years old; * severity of motor impairment classified in levels i, ii and iii, according to the gross motor function classification system (gmfcs) (palisano et al., 1997) * or according to the manual ability classification system (macs) (eliasson et al., 2006); * ability to follow instructions. exclusion criteria: * severe muscle spasticity and/or contracture, * a diagnosis of severe learning disability, * behavioral problems, * visual or hearing difficulties that would affect the feasibility of proposed activities and/or compliance
bioequivalence study of rivaroxaban in japanese healthy adult male subjects

Conditions: Embolism, Atrial Fibrillation and Venous Thrombosis

Summary: the objectives of this study are to establish the bioequivalence between rivaroxaban tablet 10mg and rivaroxaban granule formulation 10mg, and to assess the safety and tolerability of rivaroxaban 10mg in healthy adult male subjects.


Eligibility criteria:
inclusion criteria: * japanese healthy male subjects * 20 to 40 years of age * 17.6 to 26.4 kg / m² of body mass index (bmi) exclusion criteria: * subject with incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * subject with a history of relevant diseases of vital organs, of the central nervous system or other organs, eg instable coronary heart disease, heart failure, liver failure, kidney failure, hypotension, or history of stroke or myocardial infarction * subject with known coagulation disorders (eg von willebrand's disease, hemophilia) * subject with known disorders with increased bleeding risk (eg periodontosis, hemorrhoids, acute gastritis, peptic ulcer) * subject with known sensitivity to common causes of bleeding (eg nasal)
comparison between pads with cold solution of magnesium sulfate or cold water postpartum perineal pain and healing

Conditions: Women After Delivery With Perineal Pain

Summary: perineal pain after delivery is common and is caused by local bruising or episiotomy. the pain may last for several days or months. thus, several analgesic methods are offered. topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. yet, the efficacy of this treatment was not tested sufficiently in a clinical trials. in the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery. women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (nrs) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.


Eligibility criteria:
inclusion criteria: * woman after spontaneous or operative vaginal delivery * perineal pain score of at least 2 nrs exclusion criteria: * women after cesarean delivery * refuse to participate * under 18 years of age * magnesium sulfate treatment not related to the study * contraindication for magnesium sulfate treatment * workers of the local obstetric department
china type ii inflammatory skin disease clinical research and standardized diagnosis and treatment project

Conditions: Atopic Dermatitis Eczema; Prurigo Nodularis

Summary: in order to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases, the national clinical center for skin and immune diseases established a standardized diagnosis and treatment center for type 2 inflammatory skin diseases to systematically and effectively understand the current treatment status of patients with type 2 inflammatory skin diseases, as well as the efficacy and safety of various treatment methods during practices, so as to further improve the diagnosis and treatment level of type 2 inflammatory skin diseases and help patients with type 2 inflammatory skin diseases.


Eligibility criteria:
inclusion criteria: 1. patients from the medical units that has passed the data review of the national clinical center for skin and immune diseases (see the study sites for data collection for details); 2. patients diagnosed with type 2 inflammatory skin diseases (dermatitis/eczema, urticaria, pemphigoid, prurigo nodularis). exclusion criteria: 1. patients who fail to provide informed consent form; 2. patients who cannot complete the questionnaire independently or under the guidance of investigators
phase iii long-term extension trial to assess safety and efficacy of cyb003 in mdd (extend)

Conditions: Major Depressive Disorder

Summary: this is a long- term extension of the double-blind trials approach (cyb003-002) and embrace (cyb003-003). its aim is to examine the safety and long-term efficacy of cyb003 in participants with mdd.


Eligibility criteria:
inclusion criteria: * has successfully completed either cyb003-002 approach or cyb003-003 embrace and received both dose administrations of trial medication * has continued the same antidepressant medication at the stable dose/day throughout cyb003-002 approach or cyb003-003 embrace * has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form * participants capable of producing sperm must use a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of ip, if their partner is a person of childbearing potential. in addition, their partner of childbearing potential must continue to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) throughout the trial until 12 weeks after the participant's final dose of ip * participants of childbearing potential (pocbp) who have a partner capable of producing sperm must agree to continue to use a highly effective method of contraception (i.e., failure rate of less than 1% when used consistently and correctly) in combination with the use of a condom plus spermicide (where publicly available) during the trial and for 12 weeks after their final dose of ip * female participants must have a negative pregnancy test at baseline (the end of trial \[eot\] visit in the approach or embrace trial), and prior to dose administration on the dosing day exclusion criteria: * newly developed symptoms of schizophrenia spectrum or other psychotic disorders that manifested in the approach or embrace trial * significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the c-ssrs at baseline or has experienced an adverse event (ae) of suicide ideation/attempt or self-harm in cyb003-002 approach or has had a \>1 point change in item 1 or 2 of the c-ssrs from screening in cyb003-002 approach * clinically relevant arrhythmia or vital sign changes noted during any of the dosing sessions in the approach or embrace trial * presence of clinically significant ecg abnormalities noted during the approach or embrace trials or at the baseline of extend * sensitivity or suspected sensitivity to cyb003 noted in the approach or embrace trial * positive urine test for drugs of abuse, or alcohol breath test prior to dosing. * unwilling to consent to audio and video recording of psychological support and dosing sessions

Keywords: major depressive disorder mdd psilocybin psychedelic cyb003 depression cyb003-002 long-term extension cyb003-003
a closed loop, doctor to patient, mobile application for depression in people with multiple sclerosis

Conditions: Multiple Sclerosis; MS; Depression

Summary: the researchers want to find out if an electronic application called ms catch can enhance patients' and doctors' experiences during and in between clinical visits. ms catch is a smartphone-based tool which allows patients to enter their mood related symptoms at regular intervals, which is then available to their neurologist in their electronic medical record. the neurologist is also able to view additional information from their medical record, and receives alerts for changes reported by the patient that raise concern for the patient's mental health.

ms-catch (care technology to ascertain, treat, and engage the community to heal depression in patients with multiple sclerosis) is a behaviorally informed, digital health, closed-loop-intervention that brings longitudinal mood reporting into the point of care. it consists of a simple tool used by the patient to improve mood reporting. this then triggers real-time alerts delivered to the clinician, who can access a comprehensive dashboard featuring risk factors and interventions to be considered, as well as resources local to the patient. this dashboard launches straight from the patient's electronic health record (ehr). ms-catch was designed using extensive human-centered design in all phases of development, and hipaa compliant redcap for electronic data capture. while the tool requires institutional approvals to launch within the ucsf ehr, the design elements could be readily repurposed using these technologies to support other institutions' requirements. each individual care component and visualization was then developed and refined using extensive stakeholder engagement and an eye to the com-b (capability, opportunity, and motivation to change behavior) principles of behavioral change, in order to promote behaviors likely to improve depression reporting, screening, comprehensive treatment and follow through.

Eligibility criteria:
inclusion criteria: * diagnosis of ms (relapsing or progressive) by 2017 mcdonald criteria18 * ages 18 to 80 * phq-9 score of 5-19 * any ms therapy, or no treatment * california resident to enable clinical telemedicine visits if warranted during the study visit exclusion criteria: * cognitive dexterity or visual impairment (typically defined as corrected acuity less than 20/70) that, in the opinion of the study neurologist (rb), would put the participant at risk or limit their ability to adhere to the study protocol * inability to provide informed consent * psychotic disorders: bipolar disorder, schizophrenia, schizoaffective disorder * substance abuse that in the treating neurologist's perspective could influence the patient's safety on study or adherence to study protocol * another co-morbid cns diagnosis eg. tbi

Keywords: ms multiple sclerosis depression depressed
influence of sagittal imbalance of the spine on gait pattern in adult spinal deformity

Conditions: Adult Spinal Deformity

Summary: this study intends to investigate the changes in gait pattern in adult spinal deformity (asd) patients with sagittal imbalance. it will investigate the gait kinematics in patients who have a mismatch of their spinopelvic parameters, and a positive sagittal balance. the investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate a pathological gait pattern.

with an ageing population, asd presents as a significant health issue with increasing incidence. most of the earlier literature concentrated on radiographic measurements of the deformity in the coronal plane, and its surgical correction. however, recent publications have demonstrated that sagittal spinopelvic alignment plays a critical role in pain and disability in patients with asd, and is a primary determinant of health related quality of life measures. there is substantial evidence that restoration of these parameters after spinal reconstructive surgery is correlated with good clinical outcome. maintenance of the ideal sagittal alignment allows an individual to maintain an erect posture with minimal energy expenditure. when there is progressive loss of lumbar lordosis, compensatory mechanisms involving the pelvis, hips and knees occur to extend adjacent segments of the kyphotic spine to allow for compensation of anterior translation of the axis of gravity. however, this compensatory mechanism may potentially result in adverse effect. one of the main disabilities in asd patients with sagittal imbalance is their decreased walking tolerance. the change in the spinal alignment along with these compensatory mechanisms may result in an inefficient gait worsening their walking tolerance. few studies in the literature have investigated the changes in gait pattern in patients with sagittal imbalance. of those, the patient group was heterogeneous, and the only criterion of sagittal imbalance was a positive sagittal vertical axis (sva), which the investigators now know is not a complete assessment of the sagittal alignment. the investigators propose to study the change in gait pattern in individuals with abnormal spinopelvic parameters, and how this may affect their quality of lives.

Eligibility criteria:
inclusion criteria: all patients diagnosed with asd, fulfilling the following radiographic criteria based on whole spine lateral film are eligible for recruitment: * sva bigger than 47mm * pelvic tilt (pt) bigger than 22deg * pelvic incidence (pi) - lumbar lordosis (ll) bigger than 11deg exclusion criteria: * if the aetiology of the asd of the patient is neuromuscular origin * other pathologies that may affect their gait such as previous trauma or surgeries to the pelvis or the lower limbs and joint replacements * inability to walk without aids for short distances

Keywords: asd
the use of propranolol for the prevention of worsening of esophageal varices in patients with isolated gastric varices

Conditions: Liver Cirrhoses; Portal Hypertension; Gastric Varix

Summary: balloon-occluded retrograde transvenous obliteration (brto) has been effective method to manage gastric varices. however, more than one third of patients after brto treatment experienced worsening of esophageal varices. the present study was designed to evaluate the effect of post-brto propranolol adminstration on the change of esophageal varices.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of liver cirrhosis 2. clinical diagnosis of isolated gastric varices 3. the presenec of spontaneous portosystemic shunt exclusion criteria: 1. contradictions to propranolol 2. balloon occluded retrograde transvenous obliteration was failed
recreational diving practice for stress management

Conditions: Psychological Stresses

Summary: within the components of scuba diving there are similarities with meditation and mindfulness techniques. perceived stress is known to be diminished during meditation practice. this study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

background: within the components of scuba diving there are similarities with meditation and mindfulness techniques. perceived stress is known to be diminished during meditation practice. this study evaluates the benefits of scuba diving on perceived stress and mindful functioning. method: a recreational diving group, composed of 37 subjects, was compared with a multisport control group, composed of 30 subjetcs, on perceived stress, mood, well-being and mindfulness by answering auto-questionnaires before and after a one-week long course. for the diving group, stability of the effects was evaluated one month later using similar auto-questionnaires.

Eligibility criteria:
inclusion criteria: * more than 18 * registered at a leisure sports club exclusion criteria: * they were undergoing medical treatment for psychological issues at the time of the study * they had taken part in a stress management program prior to recruitment for the current study