Kornimate/medical-research-clean huggingface dataset:
in situ immune parameters and their prognostic role on the survival of patients with glioblastoma

Conditions: Glioblastoma

Summary: glioblastoma (gbm) is the most frequent brain tumor. currently survival is poor and few treatments are available. recent data show that there is no immune privilege of the central nervous system (cns) and that gbm are invaded by effector cd8 t cells, letting us hypothesis that gbm growth is dependent of immunosurveillance. the aim of this study is to better understand the antitumor immune response against gbm to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of gbms that could benefit from an immunotherapy approach. to achieve this goal, gbm tumor samples and a blood sample will be collected during the initial tumor resection. the sites involved in the recruitment of the patients will be the neurosurgical teams in brussel, dijon, nantes and padova.

primary objective : the primary objective is to determine for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters secondary objectives : to identify the best combination of in vivo immune parameters that is predictive of 1-year overall survival to determine the impact of immune parameters on overall survival create a collection of biological samples

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed, brain tumor 2. gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron. 3. subjects ≥18 and ≤75 years of age at surgery 4. patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study. 5. confirmation of the diagnosis of grade iv gbm by the local pathologist with an independent neuropathologist who will review this diagnosis 6. primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent temozolomide chemotherapy. 7. tumor biopsy for biological analysis has to be performed before using ultrasonic surgery exclusion criteria: 1. patient with other type of primary brain tumor or metastases 2. patients with only biopsy performed for the diagnosis 3. subjects under guardianship, curatorship or judicial protection 4. female subjects who are pregnant or breast-feeding

Keywords: immunotherapy tumors and blood samples
immunogenicity and reactogenicity of mpl adjuvanted recombinant hepatitis b- vaccine and engerix™-b in adult non-responders

Conditions: Hepatitis B

Summary: the purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis b vaccine with that of engerix™-b when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * age: older than 18 years of age. * documented non-responders 2 to 5 months after having received 4 doses of a hepatitis b vaccine * good physical condition as established by clinical examination and history taking at the time of entry. * female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * written informed consent obtained from the subjects exclusion criteria: * positive at screening for anti-hbv antibodies * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * any acute disease at the moment of entry. * chronic alcohol consumption. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * simultaneous participation in any other clinical trial. * previous vaccination with an mpl containing vaccine. * administration of immunoglobulins 6 months before and during the whole study period * vaccination one month before and one month after each dose of the study vaccine

Keywords: hepatitis b engerix™-b recombinant hepatitis b vaccine adjuvant
chronic pain after inguinal hernia repair

Conditions: Inguinal Hernia; Chronic Pain

Summary: chronic pain after inguinal hernia repair has become a major concern. although tension-free lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. the necessity of mesh-fixation using sutures, could be causative. however, current data do not provide evidence whether suture fixation in lichtenstein repair might be the reason for chronic postoperative pain. a newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. thereby the rate of chronic postoperative pain could be decreased. two techniques of inguinal hernia repair will be evaluated: 1. open anterior mesh repair using conventional lichtenstein technique (sutures for mesh-fixation) 2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation) postoperative pain will be evaluated by visual analog scale and mc gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.


Eligibility criteria:
inclusion criteria: * primary unilateral inguinal hernia * 18 years and older exclusion criteria: * bilateral hernia * recurrent hernia * incarcerated hernia * malignant disease within the last 5 years * not able to understand the questionaire
effects of virtual reality exercises on individuals with peripheral artery disease

Conditions: Peripheral Arterial Disease(PAD)

Summary: the aim of this study is to investigate the effects of virtual reality exercises on lower extremity skin temperature, arterial stiffness, gait parameters and enjoyment of exercise in individuals with peripheral arterial disease.

the number of studies conducted in individuals with peripheral arterial disease (pad) is quite small. in the only existing study, it was found that the application of a walking program on a treadmill in a virtual environment created with virtual reality increased the walking distance of individuals with intermittent claudication. in this direction, our study was planned to determine the effect of exercise program with virtual reality application on skin temperature, arterial stiffness, gait parameters and exercise enjoyment in individuals with pad. the study group will receive an exercise program with x-box 360 kinecttm game console (x-box 360, microsoft, united states) for 50 minutes a day, 2 days a week for 12 weeks, and the control group will receive only a home exercise program. lower extremity skin temperature will be evaluated with a thermal camera (flir e53, flir systems, wilsonville, oregon, usa), arterial stiffness will be evaluated with an arterial stiffness meter (sphygmocorxcel device), gait parameters will be evaluated with a wearable movement analysis system (g-walk), 6 minute walk test and walking impairment questionnaire. enjoyment of physical activity will be evaluated with the short version of physical activity enjoyment scale assessments will be made as initial assessment before the exercise program, interim assessment at week 6 and final assessment at week 12.

Eligibility criteria:
inclusion criteria: * being diagnosed with pad * being between 18-65 years of age * ankle-brachial index less than 0.9 * not having a lower extremity injury or surgery that would prevent participation in the exercise program exclusion criteria: * history of cardiovascular events less than 3 months before the start of the study * uncontrolled severe hypertension (systolic blood pressure ≥ 180 mmhg or diastolic blood pressure ≥ 110 mmhg) * uncontrolled diabetes mellitus (glycemic index ≥ 290) * critical limb ischemia * balance problems * vertigo * history of epilepsy * dementia * chronic diseases that may be contraindications for exercise

Keywords: virtual reality exercise arterial stiffness gait analysis skin temperature
scgs as a proxy for determining the cognitive status of older adults

Conditions: Mild Cognitive Impairment; Dementia; Alzheimer Disease; Healthy Aging; Cognitive Decline

Summary: detecting memory problems early is crucial for treating conditions like mild cognitive impairment (mci), which often leads to dementia. currently, doctors use tests in clinics to check for these issues. however, there's a growing need for better methods to monitor our cognitive skills over time. computer games emerge as a cost-effective solution for assessing the brain functions of older adults. in our study, we are investigating the potential of computer games to reflect the cognitive skills of older adults. we developed the vibrantminds platform, featuring five games: whack-a-mole, bejeweled, mahjong solitaire, word search, and memory game. we have evaluated these games for ease of use, enjoyment, and their impact on brain functions. now, our goal is to determine whether these games can offer valuable insights into the cognitive skills of older adults. we are collecting demographic data, game-playing data, and cognitive test results. our analysis will determine the correlation between game data, cognitive test outcomes, and demographic information. additionally, we will assess both the perceived and observed engagement of older adults as they play the games.


Eligibility criteria:
inclusion criteria: * reside in calgary and/or edmonton, alberta, canada * sufficient english language skills to converse in english with research staff exclusion criteria: * moderate or severe limitations in the control or movement of the upper extremity (e.g., severe arthritis, amyotrophic lateral sclerosis, multiple sclerosis) * visual and hearing impairments * attention deficit

Keywords: serious computer game computer games vibrantminds
the effect of lateral tilt on ventilation distribution in lungs assessed by electrical impedance tomography

Conditions: Lung Collapse

Summary: prevention of lung inhomogeneity is an essential part of preventive strategy in neurocritical care, reducing the risks of secondary brain damage from hypoxemia, hypo/hypercapnia or pneumonia.

in the monocentric, intervention, prospective, randomized study, the investigators will examine the effect of lateral tilting (routinely used in critical care) on the lung inhomogeneity that will be analyzed by electrical impedance tomography (eit) in the unconscious patients with acute primary brain disease and artificial pulmonary ventilation. two types of lateral tilting will be compared: manual positioning of body by nurse versus the bed tilting (15° lateral tilt, original company (linet) and product brand name (eleganza 5).

Eligibility criteria:
inclusion criteria: * primary brain disease * hospitalization in neurocenter, neurointensive care unit * age\>18 years * unconsciousness * artificial pulmonary ventilation exclusion criteria: * intracranial hypertension * history of primary lung disease * the terminal stage of the disease * refractory hemodynamic instability

Keywords: lung inhomogeneity lung collapse atelectasis mechanical ventilation eit bed tilting positioning neurocritical care unconsciousness acute brain disease preventive strategy
efficacy of a tea catechin sports drink for enhancing exercise-induced fat loss

Conditions: Overweight; Obesity

Summary: the primary objective of this trial is to evaluate the influence of consuming a tea catechin containing sports beverage on body fat mass during exercise-induced weight loss among overweight and obese men and women.

the study will include two screening/baseline visits and six treatment visits over 12 weeks. during the treatment phase of the study, subjects will be instructed to consume one bottle of sports drink (500 ml) daily (total consumption of tea catechins in the active group = 540 mg/d). subjects will be asked to maintain a constant energy intake throughout the study period. three-day diet records will be collected and analyzed at weeks 0, 6, and 12 to evaluate consistency of energy intake. all subjects will engage in an exercise program with a goal of maintaining 180 min/week of low- to moderate-intensity exercise (e.g., walking and other aerobic activities, 4-6 days per week). three of the weekly exercise sessions will be supervised and 1-3 will be unsupervised. subjects will be asked to wear a pedometer and record their daily physical activity (steps) each night in a physical activity diary. diaries will be collected at each visit and used to evaluate exercise compliance. dual energy x-ray absorptiometry (dexa) and computed tomography (ct) scans will be performed at baseline (week 0) and at the end of the treatment (week 12). additionally, body weight and abdominal circumference will be assessed at every clinic visit during the study. it is anticipated that subjects will expend 1000-1800 kcal per week above their baseline level in deliberate physical activity. accordingly, the control group is expected to lose 1.5 to 2.8 kg of body fat during the 12-week treatment period

Eligibility criteria:
inclusion criteria: * men and women 21 to 65 years of age, inclusive * waist circumference ≥ 87 cm for women and ≥ 90 cm for men at screening * total cholesterol ≥ 200 mg/dl * provide written informed consent and authorization for protected health information exclusion criteria: * volunteers with body mass index ≥ 40.0 kg/m2 or \< 25.0 kg/m2; * recent weight loss of more than 4.5 kg; * recent use of any weight loss medications, supplements, or programs; * history of weight-reducing surgery or an eating disorder * pregnancy

Keywords: green tea, polyphenols, weight loss, body fat
acute and chronic effects of a botanical extract on anxiety, perceived stress, mood and cortisol in healthy adults

Conditions: Mood Disorders

Summary: mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide. in recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials. however, only few studies looked at the effects of these botanicals on mood in healthy subjects. the aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.

the chronic effect of the active product on mood, anxiety, perceived stress, quality of life and cortisol secretion \& metabolism will be assessed through validated questionnaires and urine collection after 2, 4 and 8 weeks of daily supplementation. the acute effect of the product will be assessed after a single dose and exposure to an acute psychological stressor. before, during and after the stressor, saliva samples will be collected and subjective levels of anxiety and mood will be measured. in addition, galvanic skin response (gsr) and heart rate (hr) will be measured throughout the stressor session.

Eligibility criteria:
inclusion criteria: * with non-pathological feelings of anxiety and/ or stress in daily life: * subjects self-reporting low mood; * total score ≥ 40 at the profile of mood state (poms 2); * score \< 16 at the generalized anxiety disorder 7-item (gad-7) questionnaire * score ≤ 10 at the patient health questionnaire 9-item (phq-9) * not meeting the diagnosis criteria for any mental disorder * body mass index (bmi) in the normal range: 18.5 ≥ bmi ≤ 30 kg/ m2 * for non-menopausal women: using effective contraception/pregnancy is not physiologically possible. * subject showing no difficulty for salivary sampling * subjects capable of and willing to comply with the protocol and to give their written informed consent main exclusion criteria: * diagnosis of psychological pathology within the previous 3 years * diagnosis of cognitive pathology * anxiolytic or antidepressant treatment, within the previous 3 months * event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks * menopausal transition * high blood pressure * subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology * usual corticoid treatment/ steroidal anti-inflammatory treatment * unbalanced thyroid disease * high physical activity practice * tobacco consumption * subjects consuming any food supplement * excessive alcohol or caffeine use * consumption of recreational drugs * subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.

Keywords: mood anxiety stress dietary supplement botanical
xeltis hemodialysis access graft (axess) us study

Conditions: End Stage Renal Disease

Summary: a multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the axess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (egfr) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.


Eligibility criteria:
inclusion criteria: 1. subjects with end-stage renal disease (esrd) who require placement of an avg in the upper extremity to start (within the first 6 months of follow-up) or maintain hemodialysis therapy and are deemed unsuitable for fistula creation by the investigational surgeon. 2. at least 18 years of age at screening. 3. suitable anatomy (e.g. a target vein with a minimum diameter of 4mm) for the implantation of an axess graft 4. the patient has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent. 5. the patient has been informed and agrees to pre- and post-procedure follow-up. 6. life expectancy of at least 12 months. exclusion criteria: 1. history or evidence of severe cardiac disease (nyha functional class iv and/or ef \<25%), myocardial infarction within 6 months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina. 2. uncontrolled or poorly controlled diabetes in the opinion of the investigator. recommended standards of a1c level \<8% / 183 mg/dl / 10.2 eag. 3. abnormal blood values (e.g., leukopenia with white blood cell count (wbc) \<4,000/mm³ and/or anemia with hemoglobin \<8g/dl and/or thrombocytopenia \<100,000/mm³) that could influence patient recovery and or/ graft hemostasis. 4. reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, international normalized ratio (inr) \>1.5 or prothrombin time (pt) \>18 seconds. 5. any active local or systemic infection. 6. known heparin-induced thrombocytopenia. 7. known active bleeding disorder and/or any coagulopathy or thromboembolic disease. 8. allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically. 9. anticipated renal transplant within 6 months. 10. known or suspected central vein obstruction on the side of planned graft implantation. 11. previous dialysis access graft in the operative limb, unless the axess graft can be placed more proximally than the previously failed graft. 12. previous enrollment in this study. 13. subject is participating in another study. 14. a female who is breastfeeding or of childbearing potential with a positive pregnancy test or not using adequate contraception. 15. any other condition which, in the judgment of the investigator, would preclude adequate evaluation for the safety and performance of the study conduit. intra-operative exclusion criteria: 1. unsuitable anatomy to implant the axess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
efficacy and safety of tocilizumab for tao

Conditions: Tocilizumab; Thyroid Associated Ophthalmopathy

Summary: this study aims to evaluate the efficacy and safety of tocilizumab treating thyroid associated ophthalmopathy.

thyroid associated ophthalmopathy(tao) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. in tao pathogenesis, orbital fibroblasts are activated by autoantibodies against the thyrotropin receptor tshr and the insulin-like growth factor-1 receptor. the fibroblasts then secrete interleukin-6 (il-6), macrophage chemoattractant protein-1, and transforming growth factor-ß. in orbital preadipocyte fibroblasts, il-6 increases expression of the thyrotropin receptor tshr, and the orbital volume is relative to il-6 mrna expression. thus, il-6 may have several roles in the pathogenesis of tao. tocilizumab, a recombinant humanized igg1 monoclonal antibody against il-6 receptors, is fda-approved for the treatment of rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis with a good toleration. the investigators carry this perspective cohort study to evaluate the efficacy of tocilizumab in tao.

Eligibility criteria:
inclusion criteria: age 18-70 years old * clinical diagnosis of thyroid-associated ophthalmopathy * euthyroid status at least 1 months before baseline. * no previous specific therapy for tao, except for local measures * written informed consent is obtained exclusion criteria: * uncontrolled diabetes or hypertension * renal or hepatic insufficiency. * infectious diseases (hiv, hbv,tb and so on) * history of mental/psychiatric disorder * other ocular diseases or fundus diseases. * any previous systemic medications or surgery for the treatment of tao * pregnant or lactating females. * intolerability of tocilizumab

Keywords: thyroid associated ophthalmopathy tocilizumab
evaluation of retinal and vascular features in coats disease after intravitreal injections of ranibizumab

Conditions: Coats Disease

Summary: this study evaluates the retinal and vascular features in patients affected by coats disease under the effects of ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography

coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment. ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. the optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. the study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of ranibizumab in coats disease.

Eligibility criteria:
inclusion criteria: * age older than 18 years * diagnosis of coats disease * treatment-naïve with ranibizumab * absence of other vitreoretinal and vascular retinal diseases * absence of diabetes exclusion criteria: * age younger than 18 years * no diagnosis of coats disease * previous treatments with ranibizumab * presence of vitreoretinal and vascular retinal diseases * presence of diabetes