Kornimate/medical-research-clean huggingface dataset:
concerns of children whose parents have cystic fibrosis

Conditions: Cystic Fibrosis

Summary: as more and more patients with cystic fibrosis (cf) become parents, we have studied parenting concerns in this serious chronic disease in a first study (mucopar) which is ongoing. the current study (mucokids) is an extension of the previous mucopar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has cf. this will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with cf. the collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

life expectancy has improved significantly in cystic fibrosis in recent years. from pediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. parent patients still face the risk of complications and death while their child is still young. however, there is very little data in the literature on parenting in cystic fibrosis. in a first study which is ongoing (43 patients out of the 50 planned have been included), we intended to study parenting, considering the sick parent's point of view. however, this question does not only concern parents and their spouses. it is also fundamental to take into account the experience of the children, to understand their experiences and their own needs in this context of serious illness of a parent with limited life expectancy. therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of children whose one parent has cf. children are eligible from the age of 6 if their parents agree. children will have semi-structured individual interviews or will participate in focus groups with the study psychologist in order to express their feelings, difficulties, expectations and needs in living with a parent who has cf. thematic analysis of the content will first be done separately for individual interviews and focus groups, and a global synthesis will be carried out.

Eligibility criteria:
inclusion criteria: * have a parent with cf cared at one of the 2 adult cf centres participating into the study * have the authorization of the parent with cf if the child is an adult and of both parents for subjects less than 18 years old * be ay least 6 years old * have a good level of french and good speaking skills for adolescents and adults * have a level of french and oral expression skills adapted to their age group for the youngest exclusion criteria: * psychiatric pathology (borderline state, bipolarity and other psychotic disorders) in their parents or themselves * serious somatic disease not related to cystic fibrosis in their parents or themselves

Keywords: cystic fibrosis parenthood child with a severely ill parent psycho-social qualitative study
physiological effects of gastric sleeve operation

Conditions: Obesity, Morbid; Bariatric Surgery

Summary: after gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. studies suggest that gut-hormone secretion is altered comparable to what is also seen after roux-en-y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. the purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and bmi. furter, a group of roux-en-y gastric bypass operated patients matched on pre-operative bmi, current bmi, sex and age will be included for comparison.


Eligibility criteria:
sg ang rygb group: inclusion criteria: * uncomplicated rygb or sg \> 12 month prior to inclusion * weight stable (+/- 3 month the last month) * written informed consent exclusion criteria: * diabetes (hba1c\>48 or fasting plasma-glucose\>6.1 mm) * pregnancy and/or breastfeeding * inadequately treated thyroid disease * serious heart or respiratory illness * haemoglobin \< 6,5 mm. un-operated control group: inclusion criteria: * written informed consent exclusion criteria: * prior rygb, sg or complicated upper gastrointestinal surgery * diabetes (hba1c\>48 or fasting plasma-glucose\>6.1 mm) * pregnancy and/or breastfeeding * inadequately treated thyroid disease * serious heart or respiratory illness * haemoglobin \< 6,5 mm.

Keywords: gastric sleeve gastric bypass
sudden cardiac death stratification in myotonic dystrophy type 1 patients

Conditions: Myotonic Dystrophy 1; Sudden Cardiac Death

Summary: the aim of the study is to evaluate if the electrophysiological study (eps) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (icd), in inducible patients, is able to improve survival in comparison with conventional therapy (conv strategy) in myotonic dystrophy type 1 patients with conduction disorders.

trial design: this is a double-arm prospective observational study. patient population: to be included in the study, dm1 patients had to have at least 18 years old, lvef \>35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive eps evaluation, according to the current guidelines. the following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. all eligible dm1 patients underwent eps for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently icd implantation. non-inducible dm1 patients did not receive an icd and underwent pacemaker implantation. endpoints: the primary endpoint was all-cause mortality. secondary end-points were sudden death (sd), death due to cardiac arrhythmias, icd interventions and arrhythmic events in implanted patients.

Eligibility criteria:
inclusion criteria: * md1 diagnosis genetically confirmed * lvef \>35% on two-dimensional echocardiography * permanent pacing indication according to the current guidelines exclusion criteria: * electrolyte imbalance * thyroid disorders * prior cardiac surgery * prior cardiac arrest * prior spontaneous sustained ventricular arrhythmias

Keywords: arrhythmias electrophisiological study primary prevention
study of the safety and efficacy of su-011,248 in adult patients with advanced kidney cancer

Conditions: Kidney Neoplasms

Summary: the primary goal of the study is to evaluate the effectiveness and safety of su-011,248 as a treatment for metastatic kidney cancer.


Eligibility criteria:
inclusion criteria: * eligible patients must be at least 18 years of age with a diagnosis of metastatic kidney cancer. * the patient's kidney cancer must have gotten worse during/after previous cytokine-based therapy was given. * any side effects from prior therapy must have subsided, and blood and urine tests must show adequate bone marrow, liver, and kidney function exclusion criteria: * prior treatment with any systemic therapy other than 1 prior cytokine-based treatment regimen; * prior surgical resection of or irradiation to the only site of measurable disease; * ongoing severe hematuria; * other active second malignancy; * cardiovascular diseases or conditions within the last 12 months; * known brain metastases; * known hiv-positive or aids-related illness; * pregnant or breast-feeding women; * current participation in other clinical trials; * other severe acute or chronic medical conditions.
does bupivacaine in laparoscopic portals reduce post surgery pain in tubal ligation by electrocoagulation?

Conditions: Pain

Summary: the use of bupivacaine , an anesthesic, in laparoscopic portals is recommended in some surgeries. in the ase of tubal ligation by electrocoagulation, where pain is reduced, there is no evidence of this benefit. the objective of this study is to verify the degree of pain after laparoscopic tubal ligation surgery in patient who received bupivacaine 0.5% in the portal, or placebo

in order to conduct this study, the internal and external validation were considered. the author will use different gynecological teams, with different expertise to perform the laparoscopic tubal ligation, but using the same surgical and anesthesic technique. second year residents, during their rotation, and medical staff will perform the surgery. anesthesic technique: intravenous remifentanil 0.1-0.5 micrograms/kg/min intravenous propofol target controlled or sevoflurane intermittent ventilation using o2 40 - 100%, with or without compressed air. before incision: 5ml of bupivacaine 0.5% or saline solution 0.9% from the aponeurosis until the skin in the end of the procedure: intravenous 4mg of dexamethasone + 40mg of tenoxican post-operation prescription: npo util well awake, then free according to patient´s tolerance if nausea/vomit: metoclopramide 10mg iv if pain: dipyrone 1g iv qid if pain is intense: morphine 3mg iv 3/3 h if pain persists: morphine 1mg h/h after hospital discharge: if pain: sodium diclofenac 50mg tid

Eligibility criteria:
inclusion criteria: * all patients schedule for laparoscopic tubal ligation exclusion criteria: * not willing to consent * use of analgesic within 12 hours prior the surgery * known allergy or contraindications to bupivacaine, dipyrone, porphine, or sodium diclofenac

Keywords: pain tubal ligation bupivacaine laparoscopy
effectiveness of permethrin impregnated underwear in preventing louse proliferation in infected homeless

Conditions: Body's Louses

Summary: homelessness, also name the fourth world, is a growing public health problem worldwide. previous studies showed that up to 30% of the homeless people reported pruritus that often results in itchy lesions, which expose them to bacterial skin infections. the investigators therefore conducted a randomized, double-blind, placebo-controlled trial to test the hypothesis that a single oral dose of ivermectin was effective in significantly reducing the prevalence of pruritus in a sheltered homeless population.


Eligibility criteria:
inclusion criteria: * patient homeless person " individual who has no regular access to a conventional residence ", appearing during the period of study at reception centers (forbin or madrague ville) and being in the habit of wearing there (at least 4 times a week), * male genital organ and feminine, * of more than 18 years old, * presenting of the prurit, hurts of scratching or the louses * wishing to change his underwear, * having given his lit(enlightened) consent exclusion criteria: * woman presenting a sexually transmitted infection (infection with gonococcus, with chlamydia trachomatis, with trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results of which will be known only secondarily. * pregnant woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy. * woman removing her consent during the study. * lost sight woman. * woman deprived of freedom, judicial or administrative; * woman hospitalized for quite other reason that looks for her(it); * woman hospitalized in a sanitary establishment or social in the other purposes that the research; * major woman except state to express its consent
a 5-week trial of pd 0332334 and alprazolam extended release compared to placebo in patients with generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the safety and efficacy of pd 0332334 compared to placebo in the treatment of generalized anxiety disorder in an adult population


Eligibility criteria:
inclusion criteria: * healthy males or females with a diagnosis of generalized anxiety disorder (gad) (diagnostic and statistical manual-iv \[dsm-iv\], 300.02). * ham-a total score ≥20 and item #1 on the ham-d (depressed mood score) ≤2 at both screening and baseline/randomization. exclusion criteria: * current diagnoses (within the 6 months) of major depressive disorder; obsessive compulsive disorder; panic disorder; posttraumatic stress disorder; anorexia; bulimia; caffeine-induced anxiety disorder; * any of the following past or current diagnoses: schizophrenia; psychotic disorder; delirium, dementia, bipolar or schizoaffective disorder; cyclothymic disorder; dissociative disorders; antisocial or borderline personality disorder * current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.
multiple sclerosis, menstrual cycle and physical acivity

Conditions: Multiple Sclerosis

Summary: this study aims to identify moderating variables that modify satisfaction with physical activity practice throughout the menstrual cycle (mc) in women with and without multiple sclerosis (ms) during high-intensity interval training (hiit) and strength training sessions, and to compare the acute effects of different types of physical activity sessions in women with and without ms. this study used a randomized crossover trial study and single-blind performed by women with ms, matched 1:1 based on age, lifestyle factors and country of residence, with women without ms to analyse the effect of physical activity practise on satisfaction, functionality, fatigue, and inflammatory profile throughout mc. participants will visit the facilities approximately 10 times (4 preliminary familiarization visits and 6 visits to carry out a physical activity session in each phase of the mc) over a period of 3-4 months. evaluation will comprise clinical, nutritional and psychological interviews including different variables such as satisfaction on physical activity; visual analogue scale of fatigue; abdominal obesity and anthropometric variables; dietary and nutritional monitoring; bioimpedance analysis; blood profile of hormone, inflammatory and cognitive function blood profile; neuromuscular strength, voluntary activation, and contractile properties; functional assessment (spasticity, knee angles, gait speed, walking endurance, balance, sit-to-stand test, timed up and go test); rating of perceived exertion; pain; muscle oxygen saturation; lactate; heart rate variability; quality of sleep and life; and body temperature. during the luteal phase, women with ms are expected to exhibit different acute responses to hiit and strength training sessions compared to women without the disease.


Eligibility criteria:
inclusion criteria: * women aged between 18-40 years; * women with a menstrual cycle length of ≥ 21 days and ≤ 35 days of natural menstruation; * absence of iron deficiency anaemia (serum ferritin \> 20 μg/l, hemoglobin \> 115 μg/l, transferrin saturation \> 16%) * being in a stable phase of the disease, * to ambulate autonomously for more than 100 meters exclusion criteria: * a score \ 6 on the expanded disability status scale (edss); * experienced a relapse in the 12 months prior to enrolment; * received corticosteroid treatment in the previous 2 months; * participated in a structured exercise programme in the past 6 months; * secondary amenorrhoea (absence of ≥ 3 consecutive periods despite not being pregnant and having previous menstruation); * used or currently use hormonal contraceptives for 3 months before recruitment * reported musculoskeletal or neurological injuries not associated with ms, recent surgical interventions, or pregnancies in the previous year, * have unrelated diseases to ms

Keywords: strength training high-intensity interval training physical activity satisfaction quality of life
blood glucose control with a software-algorithm in intensive care unit (icu) patients

Conditions: Critical Illness

Summary: hyperglycemia is common in critically ill patients and associated with an adverse outcome. recently, large randomized controlled trials have demonstrated that tight glycaemic control (tgc) reduces morbidity and mortality in this population. based on this emerging evidence intensive insulin therapy is currently finding its way into the critical care practice. in the meantime numerous insulin infusion protocols, which are based on frequent bedside glucose monitoring, have been implemented. recent reviews comparing different types of protocols describe widely ranging practice and difficulties in achieving tgc despite extensive efforts of the intensive care unit (icu) staff. a fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. the primary objective of the current study is to investigate the performance (efficacy) of a control algorithm for glycaemic control in icu patients for the whole length of icu stay.


Eligibility criteria:
inclusion criteria: * age: \> 18 years of age * stay in the icu expected to be \> 120 h * blood glucose \> 110 mg/dl or patient on insulin treatment exclusion criteria: * patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency. * known or suspected allergy to insulin * any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures) * moribund patients likely to die within 24 hours

Keywords: algorithm tight glycemic control glucose control intensive care insulin icu
gemox combined with donafenib and tislelizumab in biliary tract cancer

Conditions: Biliary Tract Carcinoma

Summary: study design: prospective, single-arm, single-center study; primary endpoint: safety; secondary endpoints: disease control rate, overall response rate, conversion rate, overall survival; main characteristics of enrolled patients: patients with initially unresectable biliary tract cancer; interventions: combination of gemcitabine, oxaliplatin, donafenib and tislelizumab; sample size: 10 patients; treatment until: 1. successfully conversed to resectable disease 2. progressed disease 3. intolerable toxicity 4. patient requests withdrawal research process: in this study, patients who met the inclusion criteria were evaluated at the end of every 2 circles of treatment (6 weeks), up to surgical treatment or disease progression. safety evaluation: evaluate adverse reactions according to ctcae 4.0; follow up: 12 months after the last case was enrolled.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years and ≤80 years; 2. ecog physical condition score: 0\~1; 3. histologically or cytologically confirmed malignant tumor of epithelial origin in the biliary system; 4. preoperative imaging assessment of the disease stage was iii/iv; 5. the main organs function well, and the examination indicators meet the following requirements: routine blood tests: hemoglobin ≥90 g/l (no blood transfusion within 14 days); neutrophil count ≥1.5×10\^9/l; platelet count ≥80×10\^9/l; biochemical examination: total bilirubin ≤2×uln (upper normal value); alt or ast ≤ 2.5×uln; endogenous creatinine clearance ≥ 50 ml /min (cockcroft-gault formula); 6. sign the informed consent voluntarily; 9. good compliance, and family members willing to cooperate with follow-up. exclusion criteria: 1. patients with other uncured malignant tumors; 2. pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period; 3. previous antitumor therapy for the disease in this study; 4. participated in clinical trials of other drugs within one month; 5. patients with a known history of other systemic serious diseases before screening; 6. long-term unhealed wounds or incomplete healing fractures; 7. previous organ transplantation history; 8. abnormal coagulation function; 9. screening for overactivity/venous thrombosis events in the previous year, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 10. having a history of abuse of psychotropic substances and being unable to quit or having mental disorders; 11. a history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 12. concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.
impact of sarcopenia index on postoperative pulmonary complication in elderly patients undergoing opcab

Conditions: Coronary Artery Occlusive Disease

Summary: retrospective data collection. the aim of this study is to determine the effect of preoperative sarcopenia index on postoperative pulmonary complications in elderly patients undergoing off-pump coronary artery bypass graft surgery.


Eligibility criteria:
inclusion criteria: * patients who were 65 years of age or older at the time of surgery(off-pump coronary artery bypass graft surgery) * serum cystatin c and creatinine test results were valid within one week before surgery exclusion criteria: * patients with chronic renal failure (estimated glomerular filtration rate less than 60) * patients with acute kidney injury * patients with respiratory tract infection within 1 month before surgery
role of circulating micrornas in pathogenesis of aneurysms of the abdominal and thoracic aorta - study "micro aaa"

Conditions: Aortic Aneurysm

Summary: the objective of this study is to establish whether patients with aortic aneurysm, compared to general population, have higher levels of selected mirnas and whether there is significant association between the level of mirna in circulating blood and the size of the aortic aneurysm or the risk of its rupture.

aneurysm of the abdominal and thoracic aorta represents a major cause of cardiovascular morbidity and mortality. the course of this condition can stay asymptomatic for long, and its first manifestation can be acute rupture of the aneurysm sac with life-threatening bleeding. detection of patients at risk and their early treatment significantly reduce the percentage of this potentially lethal complications. aortic diseases are most often degenerative processes with a varying involvement of genetic predisposition. in literature, a substantial number of genes were proved to affect the metabolism of the vessel wall and to determine production of structural proteins, which were associated with the vascular pathologies. pathophysiologic mechanisms of lesions of the aortic wall have not been completely understood. among other, they include endothelial dysfunction, chronic inflammation of the vessel wall, apoptosis of smooth muscle cells and degradation of the extracellular matrix, resulting in the loss of integrity of layers of the vessel wall and decrease in its strength, which leads to dilation, rupture or dissection. apart from mutations in genes coding the structural proteins of the vessel wall, many other potential biomarkers were proposed for early diagnosis of aortic aneurysm. these include microrna (mirna), one-fibre chains of non-coding ribonucleic acid which are several nucleotides long and are involved in the gene expression through the mechanism of inhibition of mrna translation or increase in its degradation. recently, association of levels of these mirnas to presence and growth of aortic aneurysms has been described.

Eligibility criteria:
inclusion criteria: study population: * signed informed consent for participation to the study; * age above 18 years; * presence of untreated thoracic or abdominal aortic aneurysm (taa or aaa); * ct-verified diagnosis of aaa/taa including measurement of the maximum diameter of the aneurysm. control population: * signed informed consent for participation in the study; * age above 18 years; * absence of a thoracic or abdominal aortic aneurysm (taa or aaa). exclusion criteria: * life expectation above one year; * history of myocardial infarction or unstable angina pectoris 1 month ago.