Kornimate/medical-research-clean huggingface dataset:
time from onset of fever to administration of antibiotics in neutropenic fever patients

Conditions: Febrile Neutropenia; Fever

Summary: this trial uses an interview and a survey to gather information from cancer patients about the onset of their fever and the administration of antibiotics. collecting information from patients may help doctors to assess the relationship between time to antibiotic administration and inhospital cause specific death, intensive care unit admission, hospital length of stay, and positive blood cultures.

primary objectives: i. to assess the prognostic value of the length of time between the time onset of fever and first antibiotic administration on cause specific 14 day mortality rate. secondary objectives: i. to assess the associations of the length of time between the time onset of fever and first antibiotic administration with intensive care unit (icu) admission, icu length of stay, length of hospitalization and percentage of patients with positive blood cultures. outline: patients respond to a survey and participate in an interview with study staff about their fever and when they started feeling unwell.

Eligibility criteria:
iinclusion criteria: --\> 18 years of age * temperature above 38.0 documented * anc\< 500/mm3 exclusion criteria: --age \<18
single ascending doses study with gnbac1 in healthy male volunteers

Conditions: Multiple Sclerosis

Summary: this is a phase i, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, pk, and immunogenicity of gnbac1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.


Eligibility criteria:
main inclusion criteria: * healthy male volunteers * negative urine drug screen * have signed the informed consent. main exclusion criteria: * history of serious adverse reactions or hypersensitivity to any drug. * use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.

Keywords: temelimab
intracept: prospective, randomized, multi-center study intraosseous basivertebral nerve ablation for treatment of clbp

Conditions: Chronic Low Back Pain

Summary: prospective, open-label, 1:1 randomized controlled trial of basivertebral nerve (bvn) ablation arm vs standard care control for the treatment of vertebrogenic chronic low back pain (clbp). participants in the the bvn ablation arm will receive radiofrequency ablation of the bvn using the intracept procedure for treatment of up to 4 vertebral bodies (l3 to s1). participants in the standard care control arm will continue on non-surgical standard care and will be offered optional crossover after 12 months of follow-up with follow-up of 6 months post crossover treatment. the study had a pre-specified interim analysis with stopping rules for superiority when approximately 60% of the randomized participants have completed their 3-month primary endpoint study visit. an independent data safety management board (dsmb) reviewed the interim analysis results and recommended stopping enrollments for superiority and offering early crossover to the control arm participants.

participants in the bvn ablation arm will be followed for 24 months following treatment. bvn ablation arm participants will be approached to participate in a sub study of 3 additional years of follow-up at their 24 month visit (total of 5 years of follow-up). control arm subjects who were originally to be offered optional crossover treatment after the 12 month follow-up visit were offered crossover per the dsmb recommendation at a mean of 176.5 days.

Eligibility criteria:
inclusion criteria: * skeletally mature subjects at least 25 years of age * chronic lower back pain for at least 6 months * failure to respond to at least 6 months of non-operative conservative management exclusion criteria: * radicular pain * current or history of spinal infection * modic changes at vertebral bodies other than l3 to s1 * contraindication to mri * pregnant, lactating or plan to become pregnant in next year * has life expectancy of less than 2 years * compensated injuries or ongoing litigation regarding back pain/injury, or financial incentive to remain impaired
acupuncture for phantom limb pain

Conditions: Phantom Limb Pain

Summary: phantom pain is a common complication following limb amputation, and is thought to result from a system of pathophysiological mechanisms - peripheral, spinal, central and psychological. treatment is primarily medical, using antidepressant and anticonvulsant medications. at present, there is no evidence-based approach for the management of phantom limb pain (plp). acupuncture is an ancient chinese treatment during which thin needles (diameter 0.20-0.30mm) are inserted into various points on the skin. studies of this treatment have found significant benefit in a number of conditions with chronic pain. we propose a randomized, double-blind, placebo/sham -controlled study to evaluate whether acupuncture is an effective and safe modality for preventing and reducing plp in patients following lower limb amputation. patients requiring lower limb amputation (above-ankle) will be randomized into two groups, for real or placebo/sham acupuncture treatment. both groups will be treated twice-weekly with a standardized (as opposed to individualized) acupuncture treatment protocol, using either true or placebo needles at sham acupuncture points, for a period of four weeks (eight treatments). the primary outcome to be evaluated will be plp at 4 weeks, using a site-specific numerical rating pain scale (ss-nrs). secondary outcome measures to be evaluated are: stump pain (ss-nrs); analgesic use (tramadol, 100mg tablet); and depressive symptoms, using the beck depression score. blinding of the participants will be evaluated using a validation of blinding questionnaire at the end of the treatment period.


Eligibility criteria:
inclusion criteria: * patients of either gender * age 18 years and older * scheduled for lower single limb amputation (above or below knee) * ability to comply with study protocol exclusion criteria: * patients requiring limb amputation due to trauma * patients displaying symptoms of overt axis-1 psychopathology such as schizophrenia or substance abuse * inability to comply with the study protocol * previous experience with acupuncture treatment; current use of complementary or alternative medical treatments.

Keywords: acupuncture amputation phantom limb pain
withdrawal of pharmacological treatment in patients responding to cardiac resynchronization therapy:

Conditions: Heart Failure

Summary: the purpose of this randomized trial is to investigate the effect of the complete removal of pharmacological treatment in patients responding to cardiac resynchronization therapy with recuperated lvef in terms of imaging parameters (changes in lvef and lv volume), as well as, clinical parameters that translate into worsening of heart failure.


Eligibility criteria:
inclusion criteria: 1. patient with a crt device for at least one year due to the presence of lbbb and lvef \<40% of non-ischemic origin 2. current lvef ≥50% and normal volumes in two consecutive echocardiographic studies, separated at least 3 months, and the last one performed in the previous 6 months. 3. normally functioning crt device with stimulation\> 95%. 4. nyha functional class i-ii. 5. absence of admissions for hf in the last year. 6. nt-probnp \<450pg/ml in sinus rhythm and \<900pg/ml in patients with atrial fibrillation, in the previous 6 months. 7. pharmacological treatment with beta-blockers, aceis/aiira/rnai with or without mra. 8. older than 18 years. 9. patients who have given their informed consent in writing. exclusion criteria: 1. previous episode of sustained ventricular tachycardia/recovered sudden death/appropriate shock (in the case of a patient with an implantable cardioverter-defibrillator associated with crt). 2. uncontrolled arterial hypertension (figures\> 140/90 mmhg). 3. need to use beta-blockers at the medical discretion for other indications such as heart rate (hr) control in atrial fibrillation (in the absence of ablation of the atrioventricular node) or to control other supra or ventricular arrhythmias. 4. severe valve disease. 5. diabetic or hypertensive with microalbuminuria or proteinuria. 6. renal failure with creatinine clearance \<30ml/min/1.73m2. 7. fertile women who are neither using contraceptives nor surgically sterilized; pregnant or lactating women. 8. patients are currently participating in a clinical trial or have participated in the past 30 days.
prostate cancer screening: a pilot study

Conditions: Prostate Cancer

Summary: prostate cancer (pca) is the second most frequently diagnosed tumour and the third most lethal among men in europe. the lack of precise tools and examinations to precisely diagnose pca has caused overtreatment of indolent and low-aggressive pca, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. the present trial aims to study a new pathway to early diagnose pca with magnetic resonance imaging (mri) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.

men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial psa test. those cases with psa ≥ 3 ng/ml will be invited to undergo a urologic examination with computed risk assessment and an mri, which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer. then, only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness.

Eligibility criteria:
inclusion criteria: * age between 55-65 years; * asymptomatic or paucisymptomatic from a urological point of view; * no previous prostate biopsy; * living in the asl to5 (piedmont, italy); * signed written informed consent. exclusion criteria: * positive oncologic anamnesis for prostate cancer; * previous biopsy or prostate surgery; * previous radiotherapy of the pelvis; * any contraindication to mri examination; * claustrophobic or uncollaborative subjects.

Keywords: prostate cancer psa risk calculator magnetic resonance imaging prostate biopsy
impact of tdcs on cannabis craving in schizophrenia

Conditions: Schizophrenia; Cannabis Use Disorder

Summary: this study aims to evaluate the tdcs's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.

the authors set up this randomized, double-blind multicenter study. 7 centers are participating in this research. after randomisation, the patient will have either the placebo or stimulation sessions, by tdcs, 5 session per day, for 5 days. the authors use the marijuana craving questionnaire (mcq) scale to determine the variation in cannabis craving and measure the impact of treatment on craving, as primary outcome. secondary objectives include assessing the effect of tdcs on the general psychopathology of schizophrenia, cannabis and tobacco addiction, and on cognitive tests assessing attention and risk taking this study will be the first known multicenter study assessing tdcs impact on cannabis craving in schizophrenia.

Eligibility criteria:
inclusion criteria: 1. patients (male or female) aged 18-65 2. patients with schizophrenia according to dsm 5 criteria with comorbid diagnosis of "cannabis use disorder" 3. stabilized patients: total score = 80 at initial panss score and = 3 at the following panss points: * conceptual disorganization * distrust * hallucinatory behaviour * unusual content of thought 4. patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients) 5. reported cannabis use greater than three times per week in the past three years 6. signed consent to participate in research 7. affiliation to a french social security scheme 8. patient fluent in the french language exclusion criteria: 1. presence of any other psychiatric disorder, as per dsm-5 criteria. 2. pregnancy, possible pregnancy due to lack of contraception, breastfeeding. 3. currently active suicidal or self-injurious ideation (suicidal or not) 4. patients with serious medical codition 5. other "moderate" to "severe" addictions, according to dsm 5 criteria (excluding tobacco and coffee). 6. contraindications to tdcs (presence of intracranial metal material, intracranial hypertension, etc.). 7. subjects already treated by tdcs 8. patients under legal guardianship (except under curatorship) 9. patients under safeguard of justice

Keywords: cannabis use disorder schizophrenia cannabis craving
the acute effect of exercise on appetite appetite-regulating hormones and inflammation in children

Conditions: Obesity

Summary: this study describes the effect of acute high intensity exercise at 70% vo2peak on inflammation, stress, appetite hormones and appetite in lean and obese children and adolescents.

in summary, exercise does induce a variety of metabolic mechanisms on a central and peripheral level, related to appetite other than solely gut peptides. the literature points towards a rather loose coupling when it comes to high intensity exercise and the suppression of food intake, without a clear explanation of the cause of exercise induced anorexia. this study is aimed to investigate high-intensity exercise and its effects on appetite and satiety hormones, inflammation, stress and eating behaviors on appetite and food intake. the objective of the current study is to investigate the factors contributing to exercise-induced anorexia in lean and obese children, and maximize its translation into post-exercise suppression of food intake and promotion of negative energy balance particularly in obese children. it is hypothesized that high-intensity exercise would promote a greater suppression of food intake through suppression of appetite ratings via physiological mechanisms depending on stress and inflammation rather than gut peptides.

Eligibility criteria:
inclusion criteria: * 11 normal weight and 11 obese boys will be recruited for the study. lean and obese boys aged 10-18 years, born full-term and with a normal body weight at birth, will be included in the study exclusion criteria: * dieters and individuals with lactose intolerance, allergies to milk and dairy products and gastrointestinal problems will be excluded from the study.
physical activity and metabolic risk factors in postmenopausal women

Conditions: Postmenopausal Women

Summary: hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. this study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women. in this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. the investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. differences from baseline to follow-up will be calculated and compared across groups. results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.


Eligibility criteria:
inclusion criteria: * have one or more metabolic risk variables as defined by the atp iii (2001) * age between 35 and 64 years * absence of known heart disease * resting bp: 130 \< sbp \< 160 and 85 \< dbp \< 100 * currently physical inactive (\< 30 min of physical activity per week) exclusion criteria: * none of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.

Keywords: physical activity metabolic syndrome postmenopausal women exercise training
microcurrent and aerobic exercise effects on abdominal fat

Conditions: Obesity, Abdominal

Summary: the purpose of this study was to analyze microcurrent short and long term effects used with aerobic exercise on abdominal fat.

nutritional patterns have been changed during xxi century with sugar and fat's high proportions that allied to sedentarism increased body fat. there is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. women with their abdominal adipocytes (visceral fat) show an increased lipolitic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. the most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 mn. nevertheless aerobic exercise practice reduce globally lipidic sources and not locally . electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. this technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat . abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.

Eligibility criteria:
inclusion criteria: * age between 18 and 30 years * presenting a normal to pre-obese body mass index (18.5 - 29.9 kg/m2) * moderate physical activity level (between 600 and 3000 metabolic-minute/week (met-min/week)) scored by international physical activity questionnaire (ipaq) exclusion criteria: * submitted to other fat reduce procedure * to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise * to present any contra indications to microcurrent and/or aerobic exercise * to take medication that influence lipid metabolism, and to be pregnant

Keywords: abdominal fat metabolic syndrome microcurrent aerobic exercise
a prospective trial to compare deep inspiratory breath hold (dibh) with prone breast irradiation

Conditions: Breast Cancer

Summary: this phase ii trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

patients attend a simulation visit and undergo two ct scans, one in the prone position and one in the supine position with dibh. within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with dibh or in the prone position daily for 15-30 consecutive days as per physician's prescription

Eligibility criteria:
inclusion criteria: * any woman with biopsy proven left breast dcis or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist exclusion criteria: * previous radiation to the ipsilateral breast * all pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study

Keywords: radiation prone position supine position dibh invasive breast carcinoma ductal breast carcinoma in situ