Kornimate/medical-research-clean huggingface dataset:
assessment of the sub-gonal arterial revascularization of the lower limbs in critical ischemia by venous allograft stored at + 4 ° c (erav)

Conditions: Venous Allogeneic Transplant; Occlusive Peripheral Arterial Disease

Summary: the main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of occlusive peripheral arterial disease (opad) in critical ischemia, in the absence of usable great saphenous vein.


Eligibility criteria:
inclusion criteria: * man or woman over 18 (under effective contraception, hormonal contraceptive or intrauterine device, if premenopausal). * patient with critical ischemia of the lower limb (stage 4-5-6 according to the rutherford classification) requiring revascularization by sub-gonal bypass * patient eligible and scheduled for bypass in venous allograft stored at + 4 ° c with distal anastomosis below the knee * patient without usable autologous great saphenous vein * subject affiliated or beneficiary of a social security scheme * patient having received the appropriate information concerning the objectives and procedures of the study and having declared his non-objection. exclusion criteria: * use of unscheduled allografts * patient requiring composite bypass in agv + autologous venous material or prosthesis * patient requiring replacement of infected prostheses * patient with acute ischemia * patient with severe coagulation disorders * patient classified physical status score 4 * patient participating in another clinical trial * potential allergy to the graft * protected patients: adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision * pregnant or breastfeeding woman
the resistance mechanism of trastuzumab deruxtexan in her2 positive breast cancer patients.

Conditions: HER2-positive Breast Cancer

Summary: this study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in her2 positive breast cancer patients.


Eligibility criteria:
inclusion criteria: * her2 positive breast cancer * stage iv disease * treated with t-dxd * available ffpe samples exclusion criteria: * tnbc breast cancer * hormone receptor positive breast cancer * non-available ffpe samples * treated except t-dxd
omega-3 supplements to reduce antisocial behaviour in young offenders

Conditions: Antisocial Behavior

Summary: the study aims to examine the effects of providing omega-3 supplements on young offenders' antisocial behaviour. participants will be randomized into three groups: (1) omega-3, (2) placebo and (3) treatment as usual. self report and correctional officer ratings of behaviour will be assessed at 0 months (baseline), 3 months (end of supplementation), 6 months and 12 months. the investigators hypothesize that omega-3 supplementation will reduce antisocial behaviour among the young offenders.

this study follows up on two prior omega-3 supplementation randomized controlled trial (rct) conducted on young offenders - one in the uk (gesch et al. 2002) and the netherlands (zaalberg et al. 2009).

Eligibility criteria:
inclusion criteria: * admission into young offender's institution exclusion criteria: * allergy to fish and fish products * serious mental illness and intellectual disability * ability to read and write at the level required to complete self report questionnaires
diffusion-weighted mri in staging patients with localized prostate cancer

Conditions: Adenocarcinoma of the Prostate; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Summary: this pilot clinical trial studies how well diffusion-weighted magnetic resonance imaging (mri) works in staging patients with prostate cancer that has not spread to nearby lymph nodes or other parts of the body. new imaging techniques, such as diffusion-weighted mri, may be a less invasive way of predicting the stage and grade of prostate cancer.

primary objectives: i. to determine the sensitivity and specificity of diffusion-weighted mri for pathologic t3 stage prostate cancer using a 3 tesla (3t) magnet with a surface coil. outline: patients undergo diffusion-weighted mri of the pelvis.

Eligibility criteria:
inclusion criteria: * biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features: * gleason \>= 7 * \> 50% biopsy cores + * prostate-specific antigen (psa) \>= 10 * interested in undergoing a radical prostatectomy as definitive management for prostate cancer * no clinical or radiographic evidence for distant metastatic disease * in subjects with psa \ 20, a bone scan must document lack of concern for bone involvement exclusion criteria: * ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor * history of claustrophobia * pacemaker or other implanted metal objects which would make subject ineligible for mri, per standard criteria * unable to give written informed consent
a novel care pathway in women with "low-risk" gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: this study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (gdm), and the implementation of a new low-impact care pathway for women with low-risk gdm. the study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with gdm that are at low-risk of dietary therapy failure.


Eligibility criteria:
inclusion criteria: * women able to understand and sign the study consent form * singleton pregnancy * planning to give birth to at st. michael's hospital * diagnosed with gdm between 24-32 weeks' gestation based on a positive gct or gtt result as defined by the canadian diabetes association clinical practice guidelines exclusion criteria: * women with preexisting diabetes (type 1 or 2 diabetes) * multiple gestation, or a diagnosis of gdm before 24 weeks' or after 32 weeks' gestation * not continuing care at st. michael's hospital after the dip clinic visit
varicose vein in patients under the age of 40

Conditions: Varicose Veins

Summary: varicose veins are a result of valvular insufficiency and presented with twisted, enlarged veins. they not only cause cosmetic concerns but also lead to limb edema, skin pigmentation/lipodermatosclerosis, and even venous ulcers. this disease affects a large percentage of the population. although there have been several researches on the risk factors for varicose veins and the outcomes of alternative therapies , there is currently limited data focusing on varicose veins in young patients. in this case-control study, we wanted to assess the risk factors for varicose veins in patients under the age of 40, as well as their long-term results of surgery.


Eligibility criteria:
inclusion criteria: 1. great saphenous varicose veins (gsvv) with saphenous vein reflux \>0.5s. 2. lower extremity venography excluding iliac vein compression; 3. treated by great saphenous vein stripping and ambulatory phlebectomy. 4. the patient had a minimum follow-up of five years. exclusion criteria: 1. secondary varicose veins (defined as varicose veins caused by deep vein thrombosis, iliac venous compression or venous injury etc.); 2. small saphenous veins; 3. treated by endovenous ablation/laser or sclerotherapy alone.
testosterone replacement in men with non-metastatic castrate resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine whether prostate cancer growth can be slowed in patients who receive androgel® 1% at 10 gram dose.

the primary objective of the study is to determine the effect of testosterone replacement on time to disease progression and time to clinical cancer progression. the secondary objectives are to describe the effect of testosterone replacement on patient-reported quality of life (fact-p, fact-fatigue and specific measures from the expanded prostate cancer index (epic): sexual and hormonal assessments), and hand-grip strength; to describe changes in total testosterone, free testosterone, and psa levels; to explore ar levels in circulating tumor cells as a marker of treatment benefit.

Eligibility criteria:
inclusion criteria: * prostate cancer * patient must have received primary definitive local therapy to the prostate (surgery and/or radiotherapy) * patient was surgically or pharmacologically castrated at least 6 months prior to starting the study * patient must have had a previous trial of anti-androgen therapy * patient must have a rising psa * no evidence of distant metastatic disease * ecog performance status \< 2 * age \>18 years * patients must have normal hepatic function exclusion criteria: * patients with a history of any previous cytotoxic therapy or radionuclide therapy (such as rhenium, strontium, or samarium) * patients may not be receiving any other investigational agents * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * patients receiving renal dialysis * patients with significant pulmonary disease who have received chronic or pulse steroid therapy within the last 3 months prior to randomization will be excluded * patients who have known hypersensitivity to any of the androgel ingredients, including testosterone that is chemically synthesized from soy

Keywords: prostate cancer testosterone replacement androgel prostatic cancer prostatic neoplasms
providing emotional support around the point of multiple sclerosis diagnosis: prelims 2

Conditions: Multiple Sclerosis

Summary: emotional support following multiple sclerosis (ms) diagnosis is not part of the current service provision. however, research has identified a need for this as poor adjustment to diagnosis has been linked to higher levels of psychological distress. a previous study, named 'providing emotional support around the point of ms diagnosis' (prelims), explored how best to provide support. people with ms completed a self-help workbook, alongside receiving support from ms nurses. the workbook is based on a psychological therapy called acceptance and commitment therapy and was developed through focus groups of people with ms, relevant stakeholders, and clinical expertise. in this study, issues were found with parts of the workbook content and delivery. nurses found it difficult to facilitate this alongside their usual ms nurse care and felt psychological distress was not within their remit. in this study, the investigators will * explore how effective the prelims workbook is at reducing distress from ms diagnosis, when delivered by a psychology practitioner (trainee clinical psychologist) * compare delivery by a psychology practitioner with the data from the nurse delivered prelims trial to explore which is more effective * explore experience of the prelims-2 intervention and potential improvements. the investigators will recruit between three and seven people from an ms clinic who have received an ms diagnosis in the last year and consent to taking part. participants will meet with a psychology practitioner (over the phone or online) once a week for four weeks, alongside completing the workbook. the investigators will also ask participants to complete questionnaires to examine their levels of psychological distress. interviews will then be conducted to get feedback for refining the workbook. the overall study will last a year


Eligibility criteria:
inclusion criteria: 1. aged 18 and/or over. 2. received a new diagnosis of ms within the last twelve months, confirmed by a consultant neurologist. 3. scores ≥18 on the msis-psy. exclusion criteria: 1. unable or willing to give informed consent. 2. individuals currently receiving psychological therapy, to ensure any change cannot be attributed to another intervention. 3. individuals who have had a prior diagnosis of psychological distress, e.g., depression or anxiety disorder, to ensure participants are as homogenous as possible. the intervention is aimed at distress specifically related to receiving an ms diagnosis. 4. unable to speak and read english (as all measure used have been standardised and validated in english, and the workbook is only available in english). 5. unable to use/do not have access to a telephone or a computer with internet connection

Keywords: acceptance and commitment therapy
radiosurgery for glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: conventional radiation for 6 weeks is not well tolerated by the elderly. shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (kps\<70). fractionated cyberknife radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life. to assess the tolerability of cyberknife radiosurgery for high grade gliomas in elderly with poor performance status. secondary: assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.

conventional radiation for 6 weeks is not well tolerated by the elderly. shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (kps\<70). fractionated cyberknife radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.

Eligibility criteria:
inclusion criteria: 1. histopathologically confirmed newly diagnosed glioblastoma multiforme or anaplastic glioma (who grade iii) by surgical excision or biopsy. 2. patient must recover from the effects of surgery, post-operative infection, or other complications. 3. therapy should start within 5 weeks of surgery 4. must have an estimated survival of \> 8 weeks. 5. kps \< 70. 6. age \> 65 years. 7. must have a pre- and post operative contrast enhanced mri scans 8. laboratory values within the following limits: anc (absolute neutrophil count) \>/= 1500 cell/ul platelets \>/= 100x 10(3)/ul, hemoglobin \>/= 9g/dl, serum creatinine ≤ 1.5mg/dl., serum total bilirubin \ /= 3g/dl. - exclusion criteria: 1. histology grade less than anaplastic glioma ( who grade iii). 2. recurrent malignant glioma. 3. tumor involving the brain stem. 4. any detected tumor foci beyond the cranial vault. 5. major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy. 6. prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \> 5 years. 7. prior chemotherapy for the current disease. -
pilot study of ono-5129 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ono-5129 in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. fasting blood glucose 126-250mg/dl 2. hba1c 6.5-11% exclusion criteria: 1. previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization 2. history of myocardial infarction, coronary artery surgery 3. other eligibility criteria as specified in the study protocol

Keywords: ono-5129 type 2 diabetes mellitus
study of predictors of response to anti epilepsy in epilepsy

Conditions: Seizure

Summary: pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. however, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome p450 and less generalised adverse events. however, their metabolism could be more complexe (i.e. the less known uridine 5'-diphospho-glucuronyltransferase (ugt) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. the goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.

the goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug with their specific metabolism pathways) from a cohort of 1000 patients. the response to the antiepileptic drugs modification will be analyse 3 months after the modification, with the analysis of the number of seizures, the quality of life, the clinical global impression, the adverse events, the systematic dosage of all the molecules (residual concentration just before the taken) and the pharmacogenetic analysis of the main metabolism pathways and the main pharmacodynamic targets.

Eligibility criteria:
inclusion criteria: * epileptic patients who required a treatment adaptation exclusion criteria: * patients unable to give reliable information and without caregiver * pregnancy * severe comorbidity, which would impede interpretation

Keywords: epilepsy pharmacoresistant antiepileptic drug pharmacokinetic pharmacodynamic pharmacogenetic
acute effects of wine consumption on healthy volunteers

Conditions: Healthy, Postprandial

Summary: the purpose of this study is to investigate whether red and white wine consumption has acute effects on postprandial biochemical markers related to platelet aggregation, inflammation and oxidative stress compared to water or 12.5% ethanol aqueous solution consumption.

the last few years, epidemiologic studies indicate that regular moderate consumption of alcohol is associated with lower risk of coronary heart disease and heart attack, as well as with lower mortality. more specific, a j or u-shaped association between alcohol consumption and the incidence of coronary heart disease have been suggested, which means that there was lower disease risk in moderate alcohol consumers than in abstainers or heavy drinkers. the scientific interest was focused on wine after the term "french paradox" was introduced, in order to describe the epidemiological observation that the french suffer a relatively low incidence of coronary heart disease, despite having a diet relatively rich in saturated fats. the paradox was attributed to the moderate consumption of red wine by french. even though many clinical studies have occurred since then, only few of them report the postprandial effect of wine, mainly focusing on the study of oxidative stress markers and endothelium dysfunction. also, a limited number of publications refer to the postprandial wine effect upon platelet aggregation, which is an indicative marker for inflammation / thrombosis and atherosclerosis. the limited clinical evidence prompted us to investigate the postprandial effect of wine consumption upon platelet aggregation, inflammation and oxidation markers, by undertaking a clinical study of crossover design. the subjects randomly consumed 4ml of drink \[robola or cabernet sauvignon or 12.5% ethanol or water\]/kg of individual, parallel with a standardized meal, which consisted of 30.8% carbohydrates, 12.0% proteins and 53.1% fat. the meal total energy was 787.2 kcal.

Eligibility criteria:
inclusion criteria: * healthy * non-obese exclusion criteria: * smokers * those who reported slimming or any other dietary regime * abstainers from alcohol consumption * heavy drinkers * athletes * subjects who were on medication, such as aspirin, that may have an impact on platelet aggregation or surgical events that may have affected the study outcomes * participants with a known diagnosis of either hypertension or diabetes * subjects on medication

Keywords: wine inflammation oxidative stress randomized control trial postprandial intervention platelet aggregation haemostasis robola cabernet sauvignon alcohol paf metabolism
taste physiology in healthy, normal-weight volunteers

Conditions: Exploratory Behavior

Summary: taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. the receptors found on the tongue are also found in the entire gut. the correlation of stimulation of these gut receptors and brain activity has not yet been examined. the objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.


Eligibility criteria:
inclusion criteria: * right-handed healthy males * body-mass index of \< 25 * age 18-45 years * no drugs * non-smoking exclusion criteria: * smoking * substance abuse * regular intake of medications (except for oral contraceptives) * medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia * history of gastrointestinal disorders * food allergies, glutamate intolerance * body piercings that cannot be removed