Kornimate/medical-research-clean huggingface dataset:
polarstem retrospective multicenter study

Conditions: Osteoarthritis

Summary: the primary purpose of this study is to demonstrate the polarstem™ ti/ha cumulative femoral stem revision rate at 10 years. the secondary purpose of this study is to provide 10 years of safety and effectiveness data of polarstem™ ti/ha in terms of radiographic and clinical performance

this is a multicenter retrospective longterm clinical outcome study conducted in up to 6 hospitals in france. 502 subjects who have undergone tha with polarstem™ from 2002 to 2005 will be enrolled in this study and clinical and radiographically followed up for at least 10 years. subjects who have not reached the 10-year post surgery timepoint will be invited to a 10-year post-operative follow-up visit to obtain the clinical and radiographic outcome measures.

Eligibility criteria:
inclusion criteria: 1. subject required and received primary total hip arthroplasty between 2002 and 2005. 2. subject received the polarstem™ ti/ha unilateral or bilateral, due to severe hip joint damage resulting from arthrosis, degenerative disease, traumatic events, inflammatory or rheumatoid processes. 3. subject received the non-cemented polarsystem (polarstem™ ti/ha in combination with polarcup™). 4. subject was aged between 18 and 75 at time of surgery. 5. signed informed consent (icf). exclusion criteria: 1. subject received the cemented polarstem™. 2. previously failed endoprosthesis and/or thr components in relevant hip. 3. medical or mental health conditions which could impair the stubject's ability or willingness to comply with the study.

Keywords: total hip arthroplasty tha
intensive faciltiation of swallowing in patients with severe dysphagia after acquired brain injury

Conditions: Deglutition Disorders

Summary: this study is a randomized controlled trial (rct). patients after severe acquired brain injury (abi) were randomised in addition to the individual daily rehabilitation program to intensive facial oral tract therapy (f.o.t.t.®) (intervention group) or unspecific treatment: washing face, brushing teeth, without facilitating swallowing (control group). the duration of the intervention period was 15 working days (3 weeks). the intervention in both groups was twice a day.

the f.o.t.t.® approach uses structured tactile input and facilitation techniques in meaningful everyday life context, aiming for improving function in the face and oral tract that is as normal as possible. the goal is maximum participation in daily life. the treatment encourages learning of helpful functional movements or patterns of movement for safe swallowing, protection of airway, oral hygiene, eating, drinking, breathing, voice and articulation.

Eligibility criteria:
inclusion criteria: * patients with dysphagia caused by severe abi exclusion criteria: * congenital brain damage, psychiatric diagnosis, history of head and neck cancer, agitated behaviour, need for tracheostomy tube
vibratory perturbation-based pinch task training for stroke patients

Conditions: Stroke Rehabilitation

Summary: the investigator assumed that perturbed-event-induced vibrotactile cueing enable more precision arm movement adjustment, sensory function and dexterity improvement in the spastic arm. thus the specific aim of the study was to develop a vibrotactile therapy system that can provide vibrotactile feedback through the pinch performance of the hand when countering mechanically induced perturbations and also analyzed training effects of the perturbation-based pinch task training system on the sensorimotor performance of the hands for stroke patients.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of unilateral cerebral infarction or hemorrhage 2. be able to perform a pinch task with the thumb and index finger 3. with premorbid right-handedness exclusion criteria: 1. subject has a uncontrolled hypertension 2. subject has major cognitive-perceptual deficits 3. subject has other brain disease

Keywords: stroke perturbation-based training task-specific motor training recovery of function
rasburicase treatment for chemotherapy or malignancy-induced hyperuricemia in asthma/allergy patients

Conditions: Leukemia; Lymphoma; Tumor Lysis Syndrome; Hyperuricemia

Summary: this is a multi-center trial for rasburicase in children at high risk of tumor lysis syndrome who have a history of asthma/atopy. the main purpose of this study is to establish the safety of this drug in patients with a history of asthma or severe allergies.

because they were excluded from most of the clinical trials of non-recombinant urate oxidase and rasburicase, the safety of rasburicase in this population is not known, though preliminary data indicates that the drug is safe. the primary objective of this study is to estimate the proportion of grade 3 or 4 allergic reactions to rasburicase in patients with a history of asthma or severe allergy (to antigens other than rasburicase or other urate oxidases) treated with rasburicase for the prevention or treatment of malignancy or chemotherapy-induced hyperuricemia. patients at risk of tumor lysis syndrome with a history of asthma/atopy will be treated with rasburicase according to standard practice and observed for allergic reactions.

Eligibility criteria:
inclusion criteria: * a diagnosis of hematologic malignancy. * existing hyperuricemia or high risk of developing hyperuricemia of malignancy. * the treating clinician plans to treat the patient with rasburicase. a patient is only eligible for rasall if the clinician has already decided to use rasburicase. rasburicase should not be given in order to make a patient eligible for this non-therapeutic observational study. * no prior exposure to rasburicase or other urate oxidase. * a history of asthma or significant allergy. exclusion criteria * wheezing or an active hypersensitivity reaction at entry. * hypersensitivity to aspergillus proteins.

Keywords: leukemia
bridging the gap: using video art to document the human face of disease & predict quality of life assessments in brain tumor patients

Conditions: Brain Tumors; Quality of Life; Animal Assisted Therapy

Summary: the goal of this study is to explore whether facial expression changes in visual portraits correlate with quality of life (qol) questionnaire responses before and after pet therapy sessions and to compare scores of qol questionnaires before and after pet therapy.

through this pilot study, the investigators propose to create new intersections between video art and clinical care by photographing and videotaping patients with brain tumors before, during and after pet therapy sessions. this exploratory scholarship has two equally compelling goals. first, the artistic component of the project aims to create compelling slow motion video portraits of patients' willing to share their experiences of what it is like to confront such a grave illness. the goal is to put a human face on disease and share the endurance of the human spirit through art. second, the scientific component will assess the potential of using facial video portraits as a novel and innovative way to measure quality of life (qol) in lieu of questionnaires in brain tumor patients. in addition, the project will evaluate the effects of pet therapy on the qol of these patients.

Eligibility criteria:
inclusion criteria: * patients with brain tumors * willingness to participate in a brief pet therapy session with a dog * willingness to allow photographs, pictures and audio used in an art exhibit exclusion criteria: * allergy to dogs * concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
analysis of bpa concentration in serum in women of reproductive age with autoimmune thyroid disease

Conditions: Hypothyroidism; Hyperthyroidism; Hashimoto Disease; Graves Disease

Summary: the aim of the study is to assess the relationship between the concentration of bisphenol a in serum and selected parameters of thyroid function in women of reproductive age with thyroid dysfunction - hashimoto's disease and graves' disease.


Eligibility criteria:
inclusion criteria: * graves' disease or hashimoto's disease (positive thyroid autoantibody) * control group: thyroid autoantibody negative, normal thyroid function * women aged 18 to 45 in both the control group and experimental group exclusion criteria: * pregnancy and lactating women * previous or planned treatment with 131i or thyroidectomy * the use of drugs affecting the thyroid function (lithium, amiodarone, interferon a, sodium nitroprusside, sunitinib, sorafenib, iodine contrast, antibiotics / antifungals / antivirals (for at least 4 weeks prior to recruitment to the study), which do not result from the treatment of thyroid disease (levothyroxine, thyreostatic drugs, glucocorticoids) * active malignancy * other autoimmune diseases * other endocrine diseases * patients with severe liver, kidney or heart failure

Keywords: bisphenol a bpa hashimoto's disease graves' disease
the effects of resveratrol and acute exercise on endothelial function in postmenopausal women

Conditions: Endothelial Dysfunction

Summary: this pilot study plans to learn more about the aging of blood vessels and arteries in women. as women age and go through menopause, their risk for cardiovascular disease increases. also with aging and menopause, levels of the reproductive hormone estradiol decline. hormone replacement therapy to restore estradiol levels does not protect women from cardiovascular disease, so lifestyle changes, such as regular exercise, are recommended to reduce disease risk. however, there are differences between men and women in their response to exercise. in older men, exercise improves the health of their arteries, but in postmenopausal women, exercise does not provide this benefit. the purpose of this pilot study is to determine whether low estradiol levels in postmenopausal women are responsible for the poor vascular response to exercise. in this study the investigators will also test whether treatment with resveratrol, a plant compound found in red wine, improves postmenopausal women's response to exercise. the investigators hypothesize that acute treatment with estrogen or resveratrol will improve vascular responses to an acute bout of exercise.


Eligibility criteria:
inclusion criteria: * between the ages of 50-70 and at least 1 year beyond menopause; * resting blood pressure \<140/90 mmhg; * plasma glucose concentrations \<110 mg/dl under fasting conditions; * bmi \< 35; * ldl cholesterol \< 160 mg/dl; * sedentary or recreationally active (\<3 days of vigorous aerobic exercise); * no use of ocs, ht, or other medications that might influence cardiovascular function; * nonsmokers; * no use of vitamin supplements, blood thinners or nsaids, or willing to stop use one month prior to and for the duration of the study; * not taking any other medications that would interact with e2 patch or resveratrol to confound interpretation of results. exclusion criteria: * history of or active e2-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia (≥ 150 mg/dl), and cvd; * known allergy to transdermal patch, or resveratrol; * history of stomach ulcer or bleeding; * other contraindications to ht or resveratrol. * other conditions for which individuals will be excluded from the study include: diabetes, active infection, history of seizures or disease that affects the nervous system or an abnormal resting ecg.
comparison of morphine and fentanyl/midazolam in intensive care unit

Conditions: Respiratory Failure

Summary: hypothesis: morphine infusion decreases time to mechanical ventilation weaning and extubation, as compared to the combination of fentanyl and midazolam in critically-ill patients.


Eligibility criteria:
inclusion criteria: * adults admitted to icu requiring mechanical ventilation informed consent exclusion criteria: * less than 18 years old * consent denial

Keywords: sedation critical care morphine fentanyl analgesic based sedation
efficacy and safety of tralokinumab administered by an autoinjector in adults and adolescents with moderate to severe atopic dermatitis (injecztra)

Conditions: Atopic Dermatitis

Summary: the purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (sc) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (ad).

this is a single-arm, phase 3 trial designed to evaluate the efficacy and safety of tralokinumab when administered by an autoinjector in adults and adolescent subjects with moderate-to-severe ad. at baseline, the subjects will receive an initial sc dose of 600 mg tralokinumab. for the rest of the treatment period, all subjects will self-administer a dose of 300 mg tralokinumab every other week for 14 weeks.

Eligibility criteria:
inclusion criteria: * age 12 years and above. * subject able and willing to self-administer tralokinumab with device a. * diagnosis of ad as defined by the hanifin and rajka (1980) criteria for ad. * history of ad for ≥1 year. * a recent history (within 1 year before the screening visit) of inadequate response to treatment with topical medication or for whom topical treatments are otherwise medically inadvisable. * ad involvement of ≥10% body surface area at screening and baseline. * an easi score of ≥12 at screening and ≥16 at baseline. * an iga score of ≥3 at screening and at baseline. * applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline. exclusion criteria: * active dermatologic conditions that may confound the diagnosis of ad or would interfere with assessment of treatment. * use of tanning beds or phototherapy within 4 weeks prior to baseline. * treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to baseline. * treatment with topical corticosteroids, topical calcineurin inhibitors, topical phosphodiesterase 4 inhibitors, or topical janus kinase inhibitors within 2 weeks prior to baseline. * receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin e) including dupilumab or investigational biologic agents 3 to 6 months prior to baseline. * active skin infections within 1 week prior to baseline. * clinically significant infection within 4 weeks prior to baseline. * a helminth parasitic infection within 6 months prior to the date informed consent is obtained. * tuberculosis requiring treatment within 12 months prior to screening. * known primary immunodeficiency disorder.
evaluation of cloudcare in the treatment of type 1 diabetes

Conditions: Type 1 Diabetes

Summary: cloudcare is an ehealth application to help health care professionals (hcp) in the management/treatment of type 1 diabetes. the application will automatically check all uploaded glucose parameters from patients glucose monitoring devices and present all these data in a categorized way (using a so called dashboard) to the hcp. in this way the hcp has a direct overview of the condition of her/his patients, and can determine which data request direct action towards the patient and which data do not. it is expected that this system improves outcome and patient experience. in this study this expectation will be studied by measuring the effect of cloudcare on patients' treatment satisfaction, glucose control, hcp satisfaction and the impact on costs.

diabeter offers a conformité européenne (ce) marked ehealth application called cloudcare. this is a customizable care management and decision support system that uses algorithms and automation to help triage clinically relevant cases from all incoming data transmission (data uploads) and improve clinical workflows. this should complement existing clinical care models, like face-to-face meetings. the cloudcare application offers the health care professional (hcp) a better and accurate oversight of the patient's condition, which enables the hcp to contact the patient in a timely manner. cloudcare enables improved use of clinically relevant data by both patients and care team and is expected to improve outcomes and patient experience. this prospective cohort study aims to estimate the effect of the cloudcare application in daily practice on patients' treatment satisfaction, glycaemic control ('glucometric'), hcp satisfaction and the impact on costs.

Eligibility criteria:
inclusion criteria: * willing to sign the study informed consent form prior to any data collection for this study * clinical diagnosis, based on investigator assessment, of type 1 diabetes and using insulin with or without metformin for at least 6 months. * age between 16 and 75 years old. * use of multiple daily injections of insulin (mdi, with a basal insulin injection and bolus injections) or continuous subcutaneous insulin infusion (csii) with flash or continuous glucose monitoring (fgm/cgm), but without cloudcare for at least three months. * receiving cloudcare as part of their standard care for at least 6 months. exclusion criteria: * patients with type 1 diabetes on glucose lowering treatments other than insulin with or without metformin. * any known factor, condition, or disease that might interfere with study conduct or interpretation of the results, as deemed by the investigator.

Keywords: cohort prospective observational
acid-sensing ion channel and migraine disease proof of concept study on the efficacy of amiloride in the prophylaxis of migraine aura

Conditions: Migraine With Aura

Summary: recent data suggest involvement of acid-sensing ion channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. the implication of acid-sensing ion channels is discussed through acid-sensing ion channel-1 which is the most expressed acid-sensing ion channel channel subtype in the central nervous system. in a mouse model, cortical spreading depression is inhibited by different acid-sensing ion channel blockers including amiloride which is a non-selective blocker of the acid-sensing ion channel-1 channel. from a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. the apam study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. this is a randomized crossover study versus placebo conducted in 3 french headache centers.


Eligibility criteria:
inclusion criteria: * diagnosis of migraine with aura code * at least 1 aura with aura per month in the 3 months prior to inclusion * no prophylactic antimigraine treatment for at least 1 month prior to inclusion * for women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study * signature of written informed consent * patient affiliated with social security exclusion criteria: * existence of contraindication to taking amiloride: * known hypersensitivity to the molecule * hyperkalemia (potassium level (\> 5.5 mmol / l)) * use of another hyperkalemic diuretic or potassium salts * renal insufficiency (clearance \<60 ml / min) * severe hepatocellular insufficiency * in combination with lithium, converting enzyme inhibitors, angiotensin ii inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes * cardiovascular and renal history, for subjects over 75 years old * patient, who from an investigator's point of view would not be compliant to the procedure of the study * pregnant or lactating patient * patient under trusteeship, under guardianship, protected by law

Keywords: migraine aura amiloride acid-sensing ion channel
optimized supervised education program for peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: peripheral arterial disease (pad) is a frequent and serious chronic disease witch is undertreated. the recommended management of pad include pharmacological approach and lifestyle modifications. patient education help to reach this outcome. our study propose to compare patient education management with physical activity coaching to usual care.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 years * with peripheral arterial disease * who accept to follow a patient education program exclusion criteria: * permanent limb ischemia * revascularisation programmed in the 6 next months * other severe prognostic disease * difficulties to obtain patient consent because of language or understanding

Keywords: peripheral arterial disease patient education physical activity coaching lifestyle modifications walking capacity 6 minutes walking test
role of anterior segment optical coherence tomography in infectious keratitis

Conditions: Infective Keratitis

Summary: to evaluate the role of anterior segment optical coherence tomography in follow up of infectious keratitis and assessment of response to treatment.

50 patients with proven infectious keratitis clinically will be included in the study. the following will be performed for all patients in initial visit and follow up: * slit lamp examination and photography. * visual acuity assessment. * anterior segment optical coherence tomography. 1. the central corneal thickness (cct) (extracted from pachymetry map), 2. minimal corneal thickness (mct) (extracted from pachymetry map) 3. corneal thickness at the site of the lesion (ctl) (extracted from pachymetry map or the sum of stl+ cetl) 4. stromal thickness at the center of the lesion (stl) stromal lesion (extracted from stromal map) 5. corneal epithelial thickness over the stromal lesion (cetl) at the center of the lesion (extracted from epithelial map)

Eligibility criteria:
inclusion criteria: * any case with infectious keratitis (any age) either received medical treatment or not, attending to our department will be included in the study. exclusion criteria: * cases with healed infectious keratitis. * cases presented from the start with severe corneal affection and melting.
diversity analysis of vaginal microbiota on women with high-risk human papillomavirus infection

Conditions: Papillomavirus Infections

Summary: since other genital infections enhance hiv susceptibility by inducing inflammation, the investigators study the relationship between the vaginal microbiota composition and the risk of hpv infection, cervical cytological abnormalities.

persistent infection with oncogenic human papillomavirus (hpv) is necessary but not sufficient for the development of cervical cancer. additional factors correlated with hpv persistence include immunodeficiency caused by hiv, smoking, use of oral contraceptives and, more recently reported, vaginal dysbiosis. in a state of dysbiosis, there is a marked reduction of lactobacillus and a high diversity of bacteria, with increased abundance of anaerobic bacterial species. based on this, the investigators are going to analyze the changes of microbiota in women with high-risk hpv and the cervical lesions. and the investigators hope to figure out the difference and change in microbiota to realize the tanning of cervical lesions.

Eligibility criteria:
inclusion criteria: clinical diagnosis of hr-hpv results. exclusion criteria: clinical diagnosis of vaginitis, immune disease, malignancy history of cervical lesions pregnancy clinical diagnosis of other serious systemic primary diseases, such as severe liver and kidney dysfunction severe mental illness