Kornimate/medical-research-clean huggingface dataset:
functional outcome after cardiac arrest

Conditions: Out of Hospital Cardiac Arrest

Summary: descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. patients showing sign of awakening very early are considered in a good outcome group. nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning. we aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. prognosis factors will be studied in the acute phase.

Eligibility criteria:
inclusion criteria : * age 18 to 85 * out of hospital cardiac arrest ; cardiac arrest in the er is eligible * glasgow coma score ≥ 12 within 15 days after onset * living in the parisian area exclusion criteria : * no social security * neurological condition (multiple sclerosis, parkinson disease, ams, stroke) priori to the cardiac arrest * psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders * deafness and blindness * neoplasia * premorbid limitation of autonomy. * difficulties in speaking and writing the french language

Keywords: cerebral anoxia functional outcome
combined local anesthetic blockade and neuromodulation vs local anesthetic blockade only for analgesia after below-knee amputation: rct

Conditions: Amputation

Summary: this multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve blockade compared to the standard of care, i.e., local anesthetic blockade only using safe stimulation parameters in a condition associated with high postoperative pain state, i.e. a patient undergoing lower limb amputation.

the primary aim of this pilot trial is to evaluate the feasibility, safety, and analgesic efficacy of the hybrid technique (combined pns and la-based pnb) compared to that of pnb during the hospital course in patients undergoing below-knee amputations. the secondary aims are to estimate analgesia and opioid-sparing effects at later timepoints of 3, 6, and 12 months following the surgery.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age * undergoing below-knee amputation exclusion criteria: * chronic opioid use (daily use within the two weeks before surgery and duration of use of more than four weeks of \> 30 mg of oxycodone per day or \> 50 of morphine milligrams per day) * neuromuscular deficit of the target nerve(s) * compromised immune system or concurrent risk of infection based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection). * implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or another implantable neurostimulator whose stimulus current pathway may overlap * history of bleeding disorder or chronic antiplatelet or anticoagulation therapies (other than aspirin) that require to be restarted within the first three postoperative days * allergy to study medications or devices (including occlusive dressings, bandages, tape, etc.) * incarceration * pregnancy * chronic pain for more than three months of any severity in an anatomic location other than the surgical site * anxiety disorder * history of substance abuse * inability to consent

Keywords: peripheral nerve stimulation neuromodulation peripheral nerve block post-amputation pain below-knee amputation
sits-ivt in patients >80 years study

Conditions: Ischaemic Stroke

Summary: a non-interventional post-approval study on safe implementation of treatment in stroke - international stroke thrombolysis register (sits-istr) existing data of intravenous recombinant tissue plasminogen activator (rt-pa) (0.9 mg/kg) in acute ischaemic stroke patients over 80 years, treated according to the summary of product characteristics (smpc) in european countries.


Eligibility criteria:
inclusion criteria: * patients over 80 years old presenting with acute ischaemic stroke symptoms for which thrombolysis treatment was initiated within 4.5 hours after stroke onset according to smpc are included. * patients over 80 years who received thrombolysis according to smpc for acute ischaemic stroke (ais) within 4.5 hours after stroke onset during the period (approximately 3 years) prior to july 2018 are included. exclusion criteria: * contraindication(s) to the use of iv thrombolysis per local smpc. * documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of index event and for the duration of the data collection.
white matter connections and memory: the strategic study

Conditions: Stroke; Cognitive Impairment; Memory Impairment

Summary: in patients who have had a stroke, memory problems are common. some patients with memory problems improve over the first year after stroke, but recovery is unpredictable. the strategic study assesses patients with recent stroke and follows them up after one year. the study uses cognitive testing and advanced mri to understand the brain's mechanism for recovery from memory problems and to identify factors that may predict later recovery.

memory breakdown in older age is a major challenge for medical research, with an increasing burden in personal, societal and fiscal terms. stroke is an important cause. memory depends on widespread networks in the brain which are bound together by white matter connections, which essentially act as the wiring of brain networks. this project uses a technique called diffusion tensor mri to investigate these connections and their relationship to brain function and patterns of memory impairment after stroke. previous research showed that a tract called the fornix was most important in the healthy brain and in ageing. however, in individuals at an early stage of memory decline alternative pathways became disproportionately more important. this led to the idea that individuals with early memory decline might be especially vulnerable to injury to these alternative tracts from stroke. the purpose of this project is to test this idea. the project focuses on patients with recent stroke. participants undergo mri, including diffusion tensor mri, and in-depth testing of memory and other cognitive functions. the pattern of damage to temporal lobe connections in the brain will be assessed and related to the impact of brain infarction on memory. analysis will determine how undamaged tracts contribute to recovery over one year. finally, cutting edge computational image analysis techniques will be applied to try and predict memory profile in more detail and extract maximum information about prognosis from brain images.

Eligibility criteria:
inclusion criteria: * aged over 50 years * recent ischaemic stroke * english is first language exclusion criteria: * previous large artery infarct * major neurological or psychiatric condition * moderate to severe head injury (mayo classification) * dementia * severe cardiac failure * active malignancy

Keywords: diffusion tensor imaging
a epidemiological survey of preoperative pain perception and postoperative pain in chinese population

Conditions: Pain; Surgery

Summary: object: every person's pain perception and possible postoperative pain is different. as the investigators know, they are affected by many factors. however, the investigators don't know whether the smoking factors, alcohol factors, surgery type, education background, etc. will affect individual pain perception and possible postoperative pain in chinese population. this study was conducted to investigate the power of these possible affect factors. method: patients receiving elective surgery under general anesthesia were recruited into this study. the investigators measured their preoperative pressure pain threshold (ppt) and pressure pain tolerance (pto)and also investigated the patient's personal information of smoking factors, alcohol factors, surgery type, education background, etc. in addition, we retrospectively investigated the visual analog scale (vas) during patient-controlled analgesia (pca) treatment 0 to 48 h after operation as well as the pca press frequency and drug consumption of those patients who received pca administration.

patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or pregnancy or at the lactation period.

Eligibility criteria:
inclusion criteria: * aged 18 to 70 * the right hand is handedness * agreed to participate the research * not with known chronic disease * not taking analgesics within 3 months exclusion criteria: * history of chronic pain diseases * diabetes mellitus * severe cardiovascular diseases * kidney or liver diseases * alcohol or drug abuse * pregnancy or at lactation period * disagree to participate to the research

Keywords: pain perception postoperative pain demography smoking alcohol
a study to learn how safe and tolerable vonsetamig is in adult patients with chronic kidney disease (ckd) who need kidney transplantation and are highly sensitized to human leukocyte antigen (hla)

Conditions: Chronic Kidney Disease (CKD)

Summary: the purpose of this study is to determine whether vonsetamig will safely decrease anti-hla antibodies to allow for kidney transplantation. vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to hla. the study is looking at several other research questions, including: * side effects that may be experienced from taking vonsetamig * how vonsetamig works in the body * how much vonsetamig is present in the blood * if vonsetamig works to lower levels of antibodies to hla


Eligibility criteria:
key inclusion criteria: 1. has chronic kidney disease (ckd) requiring hemodialysis, and awaiting kidney transplant on the united network for organ sharing (unos), with a cpra ≥99.9%, or those with a cpra \>98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol 2. adequate hematologic and adequate hepatic function as defined in the protocol 3. willing and able to comply with clinic visits and study-related procedures key exclusion criteria: 1. current or active malignancy not in remission for at least 1 year 2. central nervous system (cns) pathology or history of cns neurodegenerative or movement disorders 3. patients who have had their spleen removed, including patients with functional asplenia 4. patients who have received a stem cell transplantation within 5 years 5. use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger) 6. total plasma igg \<300 mg/dl at screening 7. continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration 8. received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration 9. received cyclophosphamide, rituximab, obinutuzumab, other anti-cd20 or b cell-depleting agents, or proteasome inhibitors or anti-cd38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration 10. prior treatment with any anti-bcma antibody (including antibody drug conjugate or bsab) or bcma-directed car-t cell therapy, as described in the protocol 11. has received a covid-19 vaccination, as described in the protocol note: other protocol defined inclusion / exclusion criteria apply

Keywords: kidney transplant hemodialysis desensitization human leukocyte antigen (hla)
evaluation of use of plastic bags to prevent neonatal hypothermia-part iv

Conditions: Hypothermia

Summary: the overall hypothesis is that plastic bags used in combination with who thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine who thermoregulation care alone. part v is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. this study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). the axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. with an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility criteria:
inclusion criteria: * infant admitted to the nicu * current weight less than 2,000g * being removed from incubator exclusion criteria: * abdominal wall defect or myelomeningocele * major congenital anomalies * blistering skin disorder

Keywords: hypothermia newborn incubator plastic bag normothermia
clinical validation of the blood pressure measuring device withings bpm pro 2 (wihyp-gp)

Conditions: Hypertension

Summary: the aim of the study is to assess the accuracy of the automatic oscillometric bp measuring device at the brachial level, the withings bpm pro 2, in the general population


Eligibility criteria:
inclusion criteria: * patient older than 18 years; * patient who signed the informed consent form; * patient followed-up at site (in-patient or out-patient); * patient with arm circumference between 22 cm and 42 cm. exclusion criteria: * patient unable to give a consent or understand properly protocol information; * patient suffering from arrhythmia; * patient with poor quality of korotkov sounds; * patient for whom k5 sounds are absent; * patient wearing an implantable electric medical device (pacemaker,...); * patient with both upper arms suffering from open wound and/or damaged skin.
nuvent™ revision study

Conditions: Chronic Rhinosinusitis

Summary: this is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the nuvent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age. 2. subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery. 3. subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia. 4. subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the investigator. 5. subject is willing and able to comply with protocol requirements. exclusion criteria: 1. subject is pregnant or breastfeeding. 2. subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the investigator. 3. subject has sinonasal tumors. 4. subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint. 5. subject lacks capacity to consent to participation in this research himself/herself.
split-face tolerability comparison between metrogel® 1% vs finacea® 15% in subjects with healthy skin

Conditions: Skin Manifestations

Summary: the purpose of this study is to compare the tolerability of metrogel® 1% to finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility criteria:
inclusion criteria: * healthy male and female adults (ages 18 years or older) * subjects with healthy skin as determined by the clinical grader exclusion criteria: * subjects with a degree of skin pigmentation that interferes with the reading of skin reactions * subjects with known allergy to one of the components of the study drugs (refer to the package inserts for metrogel® 1% and finacea® gel 15%) * subjects who have participated in another investigational drug or device research study within 30 days of enrollment * subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids * subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids * subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated * subjects who foresee unprotected and intense uv exposure during the study (mountain sports, uv radiation, sunbathing, etc.)
acitretin and etanercept in psoriasis

Conditions: Psoriasis

Summary: to determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

this study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved pasi 75. they will be given acitretin 25 mg/day. the combined treatment will occur over 6 months. subjects' progress will be assessed monthly, based on the improvement of their pasi and pga scores.

Eligibility criteria:
inclusion criteria: * adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 \[moderate\] or higher) who are on etanercept 50 mg sq once weekly and have not achieved pasi 75 after 12 weeks or more of treatment with etanercept * all patients on etanercept have been tested for tb before initiation of etanercept exclusion criteria: * patients \ 80 years old * patients who are not on etanercept 50 mg sq once weekly * women of childbearing potential (note: women of non-childbearing potential, meaning surgically sterile \[bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation\] or post-menopausal for at least 2 years, are eligible) * inability to understand consent or comply with study requirements * uncontrolled hypertriglyceridemia * patients with severely impaired hepatic function * patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests * systemic psoriasis therapies or puva within the past 2 weeks * uvb or topical psoriasis therapies (other than emollients/moisturizers and otc shampoos) within the past 1 week * patients with epilepsy or multiple sclerosis

Keywords: psoriasis etanercept acitretin
development and validation of a sputum biomarker mrna panel for the diagnostic work-up of asthma 4.

Conditions: Asthmatic Patients

Summary: the main objectives of the study are: 1. to unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency the investigators have developed a non-invasive technique based on mrna analysis of induced sputum that enables us to study airway inflammation in detail. this technique forms the basis for our current project based on the following hypotheses: 1. different molecular asthma phenotypes exist: a th2 phenotype and a non th2 phenotype as reported by woodruff and colleagues (woodruff pg et al). sputum mrna cytokine levels can be used to diagnose th2 asthma and discriminate this from non-th2 asthma. 2. based on our previous research and preliminary data that non-th2 asthma can be further divided in th17 asthma and th1+th2 asthma; besides these, a fourth group without th2, th17 or th1 characteristics also exist. 3. these subgroups have different responses to anti-microbial therapy with potential anti-inflammatory potency (macrolides).


Eligibility criteria:
inclusion criteria: * severe asthmatics (gina step 4 or step 5 (without anti-ige)) exclusion criteria: * viral/fungal/bacterial infection +fever (\<1 month) * asthma exacerbation (\<3 months) * other respiratory disease (cf, ciliary dyskinesia,bronchiectasis)
neurofeedback for tourette syndrome

Conditions: Tourette Syndrome; Chronic Tic Disorder

Summary: the aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fmri) scanning, and will try to learn to control activity in the region during these feedback sessions. in separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.


Eligibility criteria:
inclusion criteria: * diagnosis of tourette syndrome or chronic tic disorder * currently active tics * aged 11-19 * ability to execute most common tics without moving head while lying on back exclusion criteria: * blindness (because feedback is provided visually) * lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder. * presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment. * neurological conditions affecting central nervous system, with the exception that predisposition to migraine will not be grounds for exclusion * change in medication in the month prior to beginning the study * unwillingness to keep medication stable over the course of the intervention * full braces (but some retainers are ok) * claustrophobia of a degree that they cannot comfortably be scanned * if common tics involve dramatic changes in breathing that could alter blood oxygenation measurements * inability to keep head still while executing most common tics * inability to keep head still in mock scanner * inability or unwillingness to understand or follow the instructions * pregnancy or possible pregnancy * subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.

Keywords: neurofeedback biofeedback real-time fmri rt-fmri functional connectivity fmri