Kornimate/medical-research-clean huggingface dataset:
coronary heart disease as measured by coronary calcium score among individuals with chronic traumatic spinal cord injury

Conditions: Spinal Cord Injuries; Heart Diseases

Summary: this study includes male subjects age 45 to 70, who have sustained a traumatic spinal cord injury (sci) at least 10 years prior. subjects will be interviewed for demographic data, including heart disease risk factors. a blood test for cholesterol levels will be drawn. a ct scan of arteries of the heart will be performed to determine the presence of coronary calcium, a marker of subclinical coronary heart disease. scoring of coronary calcium or coronary calcium score (ccs) is automated by the ct scanner. each subject's framingham risk score will be calculated; this is an individuals 10 year risk of having a coronary heart disease event (significant symptoms). in addition, it will be determined if subjects are being treated for diagnosed dyslipidemia (high cholesterol) according to the national cholesterol educational program (ncep) guidelines. the proposed pilot study aims to better understand the problem of coronary heart disease in individuals with spinal cord injury, specifically ccs in sci, when compared to the general population.


Eligibility criteria:
inclusion criteria: * male * spinal cord injury due to externally inflicted trauma * \> or = 10 years post injury * american spinal injury association (asia) scale a,b, or c * 45 to 70 years of age * communication and comprehension sufficient for compliance with all testing procedures * voluntary informed consent exclusion criteria: * spinal cord injury of non-traumatic etiology * injury \< 10 years prior to enrollment * known coronary heart disease

Keywords: spinal cord injury coronary artery calcium dyslipidemia
adherence to oral therapies in advanced breast and prostate cancers

Conditions: Breast Cancer; Prostate Cancer

Summary: adotac is a pilot study, open, prospective, single-center, one-arm. the 200 patients will be included. patient is included at day 0. the included patient will have the opportunity to complete the self-questionnaires either at the icl on day 0, or at home up to 10 days after the date of inclusion in the study. blood samples are collected the day of enrolment (day 0) in order to measure the following biological markers: ferritin, serum iron, tsat, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.


Eligibility criteria:
inclusion criteria: * adult over 18 years old. * patient with inoperable advanced breast cancer treated with oral endocrine therapy and/or targeted therapy and patient with inoperable advanced prostate cancer treated with oral hormonal therapy and/or targeted therapy. * oral anticancer medications started for at least 3 months. * with a performance status ≤ 3. * patient has understood, signed and dated the consent form. * patient covered by the social security system. exclusion criteria: * patient with early breast cancer or localized prostate cancer. * patient with life expectancy \< 3 months. * patient in progression * undergoing intravenous or oral cytotoxic chemotherapy (capecitabine, cyclophosphamide, vinorelbine). * patient who has not yet started oral anticancer therapies or who has started for less than 3 months. * patient unable to read or speak french. * patient already included in another therapeutic trial with an experimental molecule. * persons deprived of their liberty or under guardianship (including curatorship).
effect of icodextrin on the treatment outcome of peritoneal dialysis patients during acute peritonitis

Conditions: Peritonitis

Summary: the objective of the present study is to evaluate the a prior hypothesis that treatment with icodextrin during acute peritonitis would improve the treatment outcomes of peritonitis complicating peritoneal dialysis. the safety and effectiveness of icodextrin for decreasing glucose exposure, extent and severity of peritonitis will be evaluated in the setting of acute peritonitis complicating peritoneal dialysis among patients who are not receiving icodextrin.


Eligibility criteria:
inclusion criteria: * aged 18 or older on peritoneal dialysis, who develop clinical evidence of peritonitis * stable peritoneal dialysis with baxter connection system * willingness to give written consent and comply with the study protocol exclusion criteria: * already on icodextrin dialysate prior to acute presentation with peritonitis * known allergy or hypersensitivity to icodextrin, starch or have a glycogen storage disease * participation in another interventional study within last 30 days of randomization * history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures

Keywords: peritoneal dialysis peritonitis capd end-stage renal disease peritonitis outcome and ultrafiltration
effect of egb761® on brain glucose metabolism in three groups of elderly defined by cognitive functions

Conditions: Alzheimer's Disease; Cognitive Impairment

Summary: the aim of the study is to evaluate the effect of egb761®, in comparison to placebo, on cerebral glucose metabolism, in three groups of elderly patients: newly diagnosed mild alzheimer's disease (ad), memory complaint patients with cognitive impairment (mc) and memory complaint patients cognitively normal (cne). the first phase includes four weeks treatment with egb761® for all groups, with change in brain glucose metabolism at month 1 using 18 fdg-pet, as primary endpoint which will be followed by an open 17 months follow-up (fu) period with egb761® treatment in mc and cne patients.


Eligibility criteria:
inclusion criteria: * group specific inclusion criteria: cognitively normal elderly (cne) * spontaneous memory complaint by patient, * mini-mental state exam score ≥ 28. * clinical dementia rating = 0. * no diagnostic and statistical manual of mental disorders, fourth edition (dsmiv) criteria for dementia. memory complaints (mc) : * spontaneous memory complaint by patient * mini-mental state exam score ≥ 25 * clinical dementia rating 0.5. * no dsmiv criteria for dementia. mild alzheimer's disease (ad): * mini mental status examination (mmse) between 20 and 28 (inclusive). * clinical dementia rating ≥ 1.0 * dsmiv criteria for dementia. * national institute of neurological and communicative diseases and stroke / alzheimer's disease and related disorders association(nincds/adrda) criteria for probable ad. * newly diagnosed patients without treatment by cholinesterase inhibitors or memantine. * ≥ 65 years of age, both sex * geriatric depression scale (gds) \< 15 * informed consent signed by the patient or, if necessary by legal representative exclusion criteria: * contraindication to magnetic resonance imaging (mri) and/or positron-emission tomography (pet) scan * forbidden concomitant medications (cholinesterase inhibitors and memantine, specific psychoactive medications,e.g., neuroleptics, chronic anxiolytics including meprobamate, or sedative hypnotics other than benzodiazepines, monoamine oxidase inhibitors (maois) including selective maois. drugs acting on cerebral nervous system, antidiabetes medications , antioxidants medications, medications known to interfere with cognitive evaluations * significant neurological disease and psychiatric disorders/psychotic feature * significant medical illness

Keywords: mild alzheimer's disease (ad) patients memory complaint patients with cognitive impairment (mc) memory complaint patients cognitively normal (cne)
analyzing the composition of tears and blood for discovery of novel signatures of aggressive prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.


Eligibility criteria:
inclusion criteria: 1. male, 35-85 years old 2. patients who present for the evaluation of an abnormal exam or test (elevated psa, abnormal dre, etc.) 3. patients who present for the evaluation of a palpable nodule or induration on prostate exam 4. patients who meet the requirements of group 1, 2, or 3 of the protocol exclusion criteria: 1. patient \ 85 years of age 2. concurrent eye infection or trauma, including active conjunctivitis 3. abnormal production of tears (too much or too little) 4. any other conditions the pi or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment 5. atypia on prostate biopsy report
total genotype score, growth, maturation and loading exposure as risk factors for injury in elite male youth football

Conditions: Fractures in Children; Apophysitis; Muscle Strain; Ligament Injury; Tendon Injuries; Genetic Predisposition

Summary: a total genotype risk score was generated based on the findings of previous research for non-contact injury, non-contact muscle injury, tendon injury, ligament injury, fracture injury and apophysitis injury. this score was then compared with the incidence of injury between those with high, medium and low risk scores for each injury. the influence of different rates of growth, stages of physical maturation and loading exposure were then also included in the risk model to see if any interaction effects could be observed between genetic risk score and susceptibility to injury in different categories of growth, maturation and loading exposure.


Eligibility criteria:
inclusion criteria: * elite male football players exclusion criteria: * female * non-elite
upper airway of women with obstructive sleep apnea after bariatric surgery

Conditions: Sleep Apnea; Obesity

Summary: evaluation of upper airway with magnetic resonance and polysomnographic at the pre and post operative of 23 women having undergone bariatric surgery (with the y-roux technique) for treatment of obesity.

the the present study aims at describing the modifications occurring in the upper airway (ua) and the impact of such modifications on the severity of obstructive sleep apnea after bariatric surgery in women who have obstructive sleep apnea (osa). the hypothesis is that the massive weight loss after bariatric surgery on osa women could modify the ua more intensely than previously reported by other therapies for weight loss and that the menopause status may influence the likely reshaping of ua after bariatric surgery.

Eligibility criteria:
inclusion criteria: * patients with a recommendation and considered apt for bariatric surgery by the multi-professional group * aged between 18 and 70 * with a residual (after the 16-week period) bmi above 35 kg/m2 * polysomnographic obstructive sleep apnea diagnosis: apnea-hypopnea index (ahi) above 5 events per hour associated with a co-morbidity and/or complaints of snoring. exclusion criteria: * patients with body weight above 180 kg - for the impossibility of having a magnetic resonance (mr) * carrying metal artifacts which contraindicate the performing of mr * patients with a history of pharyngeal or neoplasia in the head and neck region * patients affected by gross craniofacial deformities * pregnant women * previous ua surgery for osa * patients undergoing any other treatment for osa.

Keywords: sleep apnea obesity bariatric surgery
safety and efficacy of bgs649 in male obese subjects with hypogonadotropic hypogonadism

Conditions: Hypogonadotropic Hypogonadism

Summary: the purpose of this study is to evaluate the safety and efficacy of bgs649 in male obese subjects with hypogonadotropic hypogonadism. all subjects will be treated for a maximum of 24 weeks. some subjects who complete 24 weeks of treatment will be invited to participate in a 6-month blinded safety extension study (protocol mbgs206). the study is planned to enroll 268 subjects.


Eligibility criteria:
inclusion criteria: * adult male subject aged 18 to 65 years inclusive * bmi \> 30 kg/m2 and \< 50 kg/m2 * serum total testosterone concentration below the normal range * lh levels below the upper limit of normal * oestradiol levels within or above the normal range of approved assay * at least two symptoms of androgen deficiency present for at least 2 months prior to the first screening visit, with at least one of these being a sexual dysfunction exclusion criteria: * evidence of clinically significant endocrinopathy at screening that may interfere with the study assessments * other types of hypogonadotropic hypogonadism or primary hypogonadism * any other pituitary or hypothalamic disease

Keywords: hypogonadotropic hypogonadism testosterone
transplantation of autologous adipose derived stem cells (adscs) in spinal cord injury treatment

Conditions: Acute Spinal Cord Injury

Summary: this study is designed to assess the safety and effect of autologous adipose derived stem cell (adscs) transplantation in acute spinal cord injury patients. 1. to assess the safety of autologous adscs transplantation in acute spinal cord injury and the complication after adscs transplantation. 2. to evaluate the effect of adscs isolation and expansion procedure. 3. to determine if functional outcome is improved following adscs transplantation in acute spinal cord injury patient, using pre-transplantation spinal cord function as the control.

the research has carried out in phase ii which is designed as randomized controlled trials. selection of patients began in feb,2013, 48 patients are divided in two group according to a 2:1 ratio (the number of candidates as treated: the candidates as control). the effectiveness of preliminary trial are evaluated by assessing frankel/asia motor grade, measuring electrophysiological parameters, enhanced mri and urinary and bowel function.

Eligibility criteria:
inclusion criteria: * must be able to give voluntary (patients may not be able to write) consent. * must be able to understand study information provided to him. * patients with complete spinal cord \< 2 weeks in acute category * the level of spinal cord injury must be categorized at a level in terms of asia impairment scale. * age should be between 19-60 years * both male and female exclusion criteria: * support respiration by machine * melanoma within 5 years * infectious diseases including hiv and hepatitis b, c * brain damage or multiple trauma * body temperature higher 38 ℃ or acute disorder * anemia or thrombocytopenia * angina , myocardial infarction , heart disease , embolic disease , chronic renal failure, glomerular disease and chronic obstructive pulmonary disease. * congenital or acquired immunodeficiency disorder * muscular dystrophy or muscle stiffness * non-conscious or voice disorders * treatment with cytotoxic drugs ( immunosuppressive drugs , corticosteroids and cytotoxic drugs) during the clinical trials . * participating in another clinical trial within 3 months * other serious disease or disorder can seriously affect the ability to participate in research. * women who are pregnant or lactating . * allergy to antibiotics and anesthetics . * do not agree to participate in research

Keywords: acute spinal cord injury, adipose derived stem cells
impact of the therapeutic education on the quality of life of the child suffering of food allergy ige-mediated

Conditions: IgE Mediated Food Allergy

Summary: the purpose of the study is to determine whether therapeutic education can improve the quality of life of the child from 8 to 12 years old suffering of food allergy. this study also show us if therapeutic education has an effect on the quality of life of child's family.

food allergy affects 5 - 6% of children. the major risk is anaphylaxis by ingestion of the forbidden allergen. the child and his family have to learn to deal with this risk. therapeutic education can help the children to take care of their allergy. food allergy limits the child socialisation, leads to anxiety/fear, and impairs health-related quality of life. in the day of today, there is no cure treatment. also, improve the quality of life is one of the goals of the food allergy management. the impact of therapeutic education on quality of life has never been studied. we intend to study the impact of therapeutic education on the quality of life of children from 8 to 12 years old with ige mediated food allergy. our hypothesis is the quality of life can be improved by therapeutic education.

Eligibility criteria:
inclusion criteria: * ige mediated food allergy * child from 8 to 12 years old (included) * family who can have an internet access * children which parents have received study's information * child who can have a medical examination before inclusion (art. l.1121-11 du csp). * patients who have a medical insurance. exclusion criteria: * non ige mediated food allergy * child with chronic disease, except asthma and atopic dermatitis * patients who already had a therapeutic education for food allergy * patient already included in another study

Keywords: food allergy children and families therapeutic education quality of life
no reflow phenomenon incidence and predictors

Conditions: No Reflow Phenomenon; STEMI

Summary: background no reflow phenomenon is described in up to 65% of patients undergoing primary percutaneous coronary intervention for st elevation myocardial infarction (stemi). it is known to be associated with worse outcomes but predictors of no reflow are not clearly described. objectives a single centre case-control observational study of patients presenting with acute myocardial infarction appropriate for ppci comparing baseline clinical, biochemical and angiographic characteristics between patients with no reflow phenomenon and those without. aiming to establish incidence for the uk population. secondary outcomes will be to gain further insight into those presenting with stemi for ppci and develop a risk model to guide management and clinical outcomes of patients to 30days. methods this study will prospectively recruit all consecutive patients attending a single centre for primary percutaneous coronary intervention for stemi. angiographic assessment of the recanalised epicardial vessel will be used to diagnose no reflow (reduced timi flow or blush grade). baseline demographic, angiographic and biochemical characteristics and outcomes at 30days for reflow and no reflow cohorts will be statistically assessed and compared with logistic regression.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * presenting with st elevation myocardial infarction * appropriate for primary percutaneous coronary intervention exclusion criteria: * primary percutaneous coronary intervention not performed eg due to non- flow- limiting coronary artery disease * unsuccessful pci * thrombolysis * patients who do not survive the procedure to leave the catheterisation laboratory
long-term observational study to evaluation the safety of furestem-ra inj(k0202)

Conditions: Rheumatoid Arthritis

Summary: long-term observational study to evaluation the safety of furestem-ra inj(k0202)

a multi-center, open, long-term follow-up study to evaluate the efficacy and safety of furestem-ra inj. in patients with moderate to severe rheumatoid arthritis: 5-year results from the k0202 extension study

Eligibility criteria:
inclusion criteria: 1. subject who enrolled k0202 clinical trial(parent study) and has been given more than one medication. 2. subjects who understand and voluntarily sign an informed consent form exclusion criteria: 1. any other condition which the investigator judges would make patient unsuitable for study participation
virtual reality vs. standard-of-care for comfort during immunizations in children

Conditions: Vaccination

Summary: children need routine immunizations which can be a painful procedure associated with pain and anxiety. this is particularly true of children visiting the children's hospital to visit relatives during flu season. no topical anesthetic or oral analgesia is commonly used. virtual reality (vr) is an immersive experience using sight, sound, and position sense. using vr may enhance distraction during the painful procedure and may reduce attention to pain. this study will randomize children (6 - 16 years old) to receive virtual reality or standard of care while receiving immunizations. investigators will measure pain, anxiety and satisfaction.


Eligibility criteria:
inclusion criteria: 1. children age 6 to 16 years 2. patients arriving to the immunization clinic for immunization. 3. parents will sign a consent form and children will sign an assent form exclusion criteria: 1. children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) 2. facial features or injury prohibiting wearing the vr goggles 3. vr system may interfere with immunization

Keywords: virtual reality pain anxiety
99mtc sestamibi spect/ct vs 18f fluorocholine pet/ct

Conditions: Parathyroid Adenoma

Summary: this study proposes the use of a well-established pet isotope, fluorine-18 (18f), bound to choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mtc sestamibi spect/ct


Eligibility criteria:
inclusion criteria: 1. suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone) 2. negative or equivocal 99mtc sestamibi spect/ct 3. able to provide written consent 4. total bilirubin ≤ 1.5 x upper limit of normal (uln) 5. alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 5 xuln 6. karnofsky performance status of \>50 (or ecog/who equivalent) 7. women must not be pregnant per the department of radiology policy on imaging in potentially pregnant and pregnant women. exclusion criteria: 1. less than 18 years old at the time of radiotracer administration 2. creatinine clearance (calculated using cockcroft-gault formula, or measured) \ 1.5 x uln 3. qtcf \>470 msec on electrocardiogram (ecg) or congenital long qt syndrome
safety evaluation of gene therapy in leber hereditary optic neuropathy (lhon) patients

Conditions: Leber Hereditary Optic Neuropathy

Summary: the purpose of this study is to evaluate the safety and tolerability profile of ascending doses of gs010 in leber hereditary optic neuropathy (lhon) patients.


Eligibility criteria:
inclusion criteria: documented diagnosis of lhon based on a genetic test confirming the presence of the g11778a mutation in the mitochondrial nd4 age 18 years old or older at the time of study entry (informed consent signature) visual acuity ≤ 1/10 of the less functional eye exclusion criteria: any known allergy or hypersensibility to one of the product used during the trial contraindication to ivt surgery (anaemia hb \<8g/dl, severe cardiovascular disease, severe coagulopathy...) disorder of the ocular humors and of the internal retina involving visual disability glaucoma presence of other pathology whose symptoms or associated treatments might affect the retina or the optic nerve vascular retinal occlusion narrow angle contra-indicating pupillary dilation other cause of optic neuropathy (inflammatory conditions or exposure to toxins...) patients presenting known mutation of other genes implicated in pathological retinal conditions