Kornimate/medical-research-clean huggingface dataset:
effect of low dose corticosteroids on perioperative markers of thrombosis and fibrinolysis in total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: one postoperative complication following unilateral or bilateral total knee arthroplasty is thrombosis (blood clot formation). in this prospective, double-blinded randomized controlled clinical trial, researchers are investigating the effect of steroids on biochemical markers of thrombosis. furthermore, elevated cellular markers of thrombosis (specifically il-6) have been linked to postoperative depression following total knee arthroplasty surgery. hence the investigators are also checking if use of hydrocortisone, a steroid, may help reduce the incidence of postoperative depression. other studies have shown that surgery causes some reaction in the body that is consistent with inflammation. when the inflammation is extensive, it may affect different parts of the body. it may also lead to clotting disorders and result in blood clots. in a previous study by this principal investigator (see reference 22, "use of low-dose steroids in decreasing cytokine release during bilateral total knee arthroplasty"), hydrocortisone was administered over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty. the investigator found lower levels of cellular markers consistent with inflammation (specifically the protein, il-6). steroid use also showed additional benefits, such as decreased pain and better range of motion at the knee. in this study, investigators recruit patients undergoing total knee arthroplasty surgery. patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a saline placebo. in addition to analyzing patients' blood samples for hydrocortisone's effect on clotting factors (i.e. il-6), investigators record patients' pain scores and patients' oral analgesic use. to assess patients' well-being, patients are contacted one month and 3 months following their surgeries and administered the patient health questionnaire (see reference 23, "the phq-9: validity of a brief depression severity measure.") arthroplasty.


Eligibility criteria:
inclusion criteria: * all patients undergoing unilateral or bilateral total knee replacement * age 50-90 exclusion criteria: * all patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively * patients who are smokers * patients under 50 years of age * patients over 90 years of age * patients with diabetes * patients with a prior history of corticosteroid intolerance * patients with previous complications of steroid use

Keywords: orthopedic procedures prostheses and implants joint prosthesis knee prosthesis arthroplasty, knee thromboembolism inflammation b-cell differentiation factor-2 differentiation factor-2, b-cell b-cell stimulatory factor-2 bsf-2 ifn-beta 2 mgi-2 interleukin-6 (il-6) steroids pregnenediones hydrocortisone physiological effects of drugs therapeutic uses
neuraxial labor analgesia and the incidence of postpartum depression

Conditions: Parturition; Analgesia, Obstetrical; Depression, Postpartum

Summary: postpartum depression (ppd) affects approximately 15% of women during the first year after giving birth, and is common across cultures. the etiology of postpartum depression is not totally clear. the severe pain experienced during childbirth was reported to be associated with the development of postpartum depression. the purpose of the present study is to evaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

postpartum depression (ppd) affects approximately 15% of women during the first year after giving birth, and is common across cultures. in postpartum chinese women, the reported incidence ranged from 6.5% to 29.5%. the etiology of postpartum depression is not totally clear. identified risk factors include previous maternal blues, unplanned pregnancy, lack of marital or social support, and previous psychiatric illnesses. furthermore, the severe pain experienced during childbirth was reported to be associated with the occurrence of postpartum depression. a recent study of the investigators found that use of epidural analgesia during labor was associated with decreased risk of postpartum depression. however, several limitations existed in that study and further evidence is needed to reconfirm the finding. the purpose of the present study is to reevaluate whether use of neuraxial labor analgesia can reduce the incidence of postpartum depression.

Eligibility criteria:
inclusion criteria: 1. primiparae between 18 and 34 years of age with term single cephalic pregnancy; 2. admitted to the delivery room during daytime working hours (from 8 am to 5 pm). 3. preparing to deliver vaginally. exclusion criteria: 1. history of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists); 2. presence of contraindications to epidural analgesia, which includes: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy. 3. other reasons that are considered unsuitable for study participation.

Keywords: primipara childbirth neuraxial labor analgesia postpartum depression
assessment of treatment with pulsehaler on patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of the study is to assess the safety and the effect of treatment by pulsehaler™ on patients with copd, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of pulsehaler™ by the patients.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * diagnosis established for at least 1 year; * post-bronchodilator fev1/fvc \< 0.7 * post bronchodilator fev1 \<70% predicted * age: 40 years or older * smoking cigarettes, at least 10py * patient signed the informed consent form exclusion criteria: * bullous emphysema (ruled out by recent ct) * hospitalization due to exacerbation of copd within the last 3 months * upper respiratory infection and/or exacerbation of copd in the last 4 weeks * systemic steroid treatment in the last 4 weeks * women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive. * severe cardiac disease, e.g., chf grade 3 or higher * acute mi within last 3 months * cabg within last 3 months * other severe systemic disease
monitoring and evaluation of a cognitive behavioral therapy program focused on attention and emotion regulation for children with fetal alcohol spectrum disorder

Conditions: Fetal Alcohol Spectrum Disorders; Hyperactivity Disorder; Attention Deficit

Summary: this is a multi-center, prospective, randomized, open-label, controlled trial with two parallel arms and blinded endpoint assessment. it aims yo compare the 6-month efficacy of a group cbt program versus body-mediated intervention (meditation) children (7-13 years) with adhd-associated fasd and emotional dysregulation via a measurement of the aggressive behaviors subscale score of the dysregulation profile subset of the cbcl scale.


Eligibility criteria:
inclusion criteria: * child with fetal alcohol spectrum disorder * child with attention deficit disorder with / without hyperactivity * child with a score upper than or equal to 180 points on the "aggressive behavior", "anxiety / depression" and "concentration problems" subscales of the cbcl * child followed in la reunion, montpellier or bordeaux university hospital * child whose parents are affiliated with social security * child who accepts to participate and whose parents have given their consent exclusion criteria: * non-french speaking child or parents / non-creole speaking child or parents * child who already participate to cbt or body mediation groups

Keywords: fasd adhd
whole milk intake and cardio-metabolic risk factors

Conditions: Lactose Malabsorption; Cardiovascular Disease

Summary: milk is the source of high-quality protein, calcium, and other vitamins and minerals. epidemiologic studies have linked high consumption of milk with risk of metabolic syndrome, t2dm, hypertension and obesity, which are independent risk factors of cardiovascular disease. however, milk contains disaccharide lactose, which may cause gastrointestinal problems in those adults with poor digestion. recent studies have shown that subjects with intolerance to lactose tend to reduce their consumption of milk. actually, consumption of 12g lactose (240ml milk) per day produces negligible symptoms in lactose intolerant. furthermore, a dairy-rich diet could improve lactose intolerance because of colonic adaption to it. lactose maldigestion would not be a restricting factor in milk intake. in general, the undigested lactose will be fermented by colonic bacteria into hydrogen, carbon dioxide, and short-chain fatty acids (scfa: acetate, propionate, and butyrate). the scfas may have beneficial effects on human glucose and lipid metabolism, and the lactose fermentation may change the intestinal flora profile. but there are few studies evaluating effect of milk intake on health of people with lactose malabsorption or intolerance.this trial intend to study the effect of whole milk on cardio-metabolic risk factors of healthy person with or without lactose maldigestion.


Eligibility criteria:
inclusion criteria: * aged above 18 years of age * able to give informed connect exclusion criteria: * unwilling to trial dietary intervention * pregnancy * known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease. * known gastrointestinal disease, such as irritable bowel syndrome(ibs), functional bowel disease and so on. * evidence of drug or alcohol abuse
de-escalation protocols in locoregionally advanced nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to explore the efficacy and safety of image guided de-escalation protocols in patients with locoregionally advanced nasopharyngeal carcinoma (npc). so the investigators studied whether toxicities reducing treatment with omitted concurrent chemotherapy after good response to induction chemotherapy would maintain survival outcomes while improving tolerability for patients with locoregionally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * histological diagnosis of nasopharyngeal carcinoma * stage iii or iva according to uicc/ajcc 8th staging system * age ≥18 * no prior anti-tumor treatment * karnofsky performance score (kps)≥70 * adequate blood supply * informed consent obtained exclusion criteria: * can not take contrast-mri imaging * pregnant * combined with other malignant tumor (except basal cell carcinoma of skin)

Keywords: nasopharyngeal carcinoma de-escalation
afatinib in subjects with kidney dysfunction

Conditions: Renal Insufficiency

Summary: the primary objective of the current study is to investigate the influence of moderate to severe renal impairment on the pharmacokinetics and safety of a single dose afatinib in comparison to a control group with normal renal function. the assessment of safety and tolerability will be an additional objective of this trial and will be evaluated by descriptive statistics.


Eligibility criteria:
inclusion criteria: * despite renal impairment (group 1 and 2) healthy males or females according to the investigators assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure (bp), pulse rate (pr)), 12-lead electrocardiogram (ecg), and clinical laboratory tests. * glomerular filtration rate (gfr), estimated according to: -- mdrd (modification of diet in renal disease)-formula: * egfr (estimated glomerular filtration rate) \[ml/min/1.73m²\]= 175 x serum creatinine-1.154 x age-0.203 (if male) * egfr\[ml/min/1.73m²\]= 175 x serum creatinine-1.154 x age-0.203 x 0.742 (if female) * 30 to 59 ml/min for moderate renal impairment group 1 * 15 to 29 ml/min for severe renal impairment group 2 * = 90 ml/min for healthy volunteers group 3 * age =18 and =79 years exclusion criteria: * any finding of the medical examination (including blood pressure (bp), pulse rate (pr) and electrocardiogram (ecg)) deviating from normal and of clinical relevance, e.g. repeated measurement of systolic blood pressure \ 140 mmhg, diastolic blood pressure \ 90 mmhg, repeated measurement of pulse rate \ 90 bpm. * any evidence of a clinically relevant concomitant disease. * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, dermatological or hormonal disorders. * relevant gastrointestinal tract surgery (except appendectomy). * diseases of the central nervous system (such as epilepsy, seizures) or psychiatric disorders or neurological disorders. * history of photosensitivity or recurrent rash. * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
a study of neurovax™, a novel therapeutic tcr peptide vaccine for pediatric multiple sclerosis

Conditions: Multiple Sclerosis

Summary: a phase i study of neurovax™, a novel therapeutic tcr peptide vaccine for pediatric multiple sclerosis to demonstrate safety \& efficacy

a multi-center phase i study of neurovax™, a novel therapeutic tcr peptide vaccine for pediatric multiple sclerosis to demonstrate safety \& efficacy 12 subjects with pediatric ms

Eligibility criteria:
inclusion criteria: * ages eligible for study: 5 years to 17 years * genders eligible for study: both * accepts healthy volunteers: no criteria * subject is between 5 and 17 years of age, inclusive * clinically diagnosed pediatric ms * definite pediatric ms by the revised mcdonald criteria (2005) (appendix a), with a pediatric ms course * expanded disability status scale (edss) \<= score 6.5 (appendix b) two or more documented clinical relapses of ms in the preceding 24 months or one documented clinical relapse of ms in the preceding 12 months prior to screening * laboratory values within the following limits: * creatinine 1 . 5 x high normal * hemoglobin exclusion criteria: * subjects currently prescribed campath or lemtrada

Keywords: multiple sclerosis pediatric ms neurovax vaccine therapeutic
involvement of the physician in primary prevention and pre-hospital management of stroke

Conditions: Stroke

Summary: stroke is a growing disease. it is the first pathology responsible for acquired handicap, the second of dementia and the second cause of death in the world. in france, they are the leading cause of death in women and the third cause in men. sequelae and disabilities also represent a significant financial cost for health insurance. the early management of the treatment improves the patient's vital and functional prognosis. the ability of the patient to identify the signs of stroke requiring urgent consultation and proper orientation are therefore crucial for further management. the most common signs that patients must recognize are muscle weakness or sudden paralysis of an arm, leg or half of the body, asymmetry of the face, tingling, numbness of a hemi-body, speech or understanding, loss of vision of an eye or hemifield, disorder of the coordination of a hemi-body. the variety of clinical pictures complicates primary prevention. in this context, a 2010-2014 national stroke action plan was undertaken with the aim, among other things, of developing information to prevent stroke and to limit its sequelae. in this plan, the attending physician must improve prevention in high-risk patients and be a link between the city and the hospital for follow-up. several questions arise: * are patients who are regularly followed by a general practitioner better educated on the signs of stroke / tia and thus more able to give an appropriate warning? * what is the profile of patients who have not been affected by the different modes of primary prevention? * what are the effective means of information and those desired


Eligibility criteria:
inclusion criteria: * patient whose age is ≥ 18 years * patient hospitalized in the neurology / neurovascular department within the ghpsj following a stroke (first episode or recurrence) * francophone patient exclusion criteria: * patient with previously labeled cognitive impairment * patient under tutorship or curatorship * patient deprived of liberty * patient unable to answer the questionnaire * patient opposing participation in the study
caesarean wound dressing removal study

Conditions: Surgical Wound; Surgical Wound Infection; Cesarean Section Complications

Summary: an open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.

the trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour. the primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) the secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery

Eligibility criteria:
inclusion criteria: 1. age 18-50 2. lower segment caesarean delivery 3. primary or repeat caesarean delivery 4. caesarean section in active phase of labour. 5. regional anaesthesia exclusion criteria: 1. upper segment or classical caesarean delivery 2. massive postpartum haemorrhage \> 1.5 litre 3. pre-delivery chorioamnionitis 4. skin closure using interrupted suture 5. acquired or congenital coagulation disorder 6. associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection. 7. inability to give consent

Keywords: wound dressing cesarean
virtual reality technology for cognitive functions of children with down syndrome

Conditions: Down Syndrome

Summary: the purpose of the study is to identify the effect of fully-immersive virtual reality technology on cognitive functions of children with down syndrome

intellectual disability is recognized as one of the most prominent features of ds which is the most common genetic cause of intellectual disability. cognitive functioning often changes across the lifespan and is moderated by several comorbid factors such as sensory impairments, seizures, autism, sleep disruption, and other medical and psychiatric conditions (grieco et al., 2015). there is encouraging evidence supporting the use of non-immersive virtual environments to provide useful learning, rehabilitation, and leisure experiences for people with intellectual disabilities. therefore, immersive vr applications may also be an effective way to improve motivation and engagement for children with ds in learning settings (michalski et al., 2022). therefore, this study aims to investigate the effect of full-immersive vrapeutic software gaming technology on cognitive functions of children with down syndrome

Eligibility criteria:
inclusion criteria: * diagnosed with down syndrome age from 6-10 years both genders will be included iq ranges from 50-69(mild intellectual disability) they will be able to understand the instructions able to walk independently exclusion criteria: * significant visual or hearing problems significant mental or psychological problems that interfere with understanding instructions musculoskeletal problems or fixed deformities in upper or lower limbs current hospitalization for urgent medical reasons

Keywords: down syndrome ds virtual reality vr
predicting response to crt using body surface ecg mapping

Conditions: Heart Failure

Summary: cardiac resynchronization therapy (crt) involves pacing the left and right side of the heart in order to improve the coordination of the contraction in patients with heart failure. current selection criteria incorporate the severity of the symptoms, the mechanical function of the heart and the time it takes the electrical stimulation to spread over the left ventricle (as assessed on the standard 12 lead electrocardiogram-ecg). unfortunately these criteria only seem to select approximately 70% of the patients who might respond to this invasive therapy. body surface ecg mapping is a new technique that assesses the electrical activation of the heart in more detail than the standard ecg. this study aims to determine whether this new technology may aid current selection criteria in predicting response to crt.


Eligibility criteria:
inclusion criteria: * age \>18 years old * fulfils established clinical criteria for crt implantation (with or without a defibrillator) * nyha class iii-iv heart failure (or nyha ii with nyha iii/iv symptoms in the preceding 12 months) * lvef \<35% (calculated using echocardiography or cardiac mr) at the time of implantation * qrs duration \> 130ms * optimal tolerated medical therapy for heart failure exclusion criteria: * severe, life threatening non cardiac disease * active malignant disease and recent (\<5 years) malignant disease * prior heart transplant * recent history of unstable angina, acute coronary syndrome or myocardial infarction within three months of enrolment into the study * pregnancy * failure to participate in consent process * atrial fibrillation * conventional pacemaker in situ * heart failure requiring constant intravenous therapy including diuretics and/or inotropes * recent revascularisation procedure i.e. coronary artery bypass grafting (cabg) or percutaneous coronary intervention (pci) within the last three months

Keywords: heart failure cardiac resynchronization therapy ecg imaging body surface mapping
energy requirements in mitochondrial disease

Conditions: Mitochondrial Disease; Chronic Metabolic Disorder

Summary: metabolic diseases and mitochondrial disorders are caused by genetic mutation which lead to disruptions in energy producing pathways in our body. enough energy or calories must be given in the diet to ensure normal growth and development. currently, energy needs for patients with metabolic and mitochondrial diseases are not measured, but is estimated using a mathematical equation based on healthy children. this may lead to under feeding or overfeeding of calories, and has negative nutritional implications. the clinical standard for measuring energy needs is the use of indirect calorimeter.the indirect calorimeter takes individualized measurements for each patient and therefore will enable dietitians and clinicians to provide sufficient calories in the diet to better manage the disease and promote normal growth and development. we believe daily energy requirements will vary within metabolic diseases (phenylketonuria) and mitochondrial disorders (mitochondrial fatty acid oxidation defect, polg1 mutation etc.). the objective of this preliminary study is to measure resting energy expenditure in children living with metabolic and mitochondrial conditions and data obtained will be used to generate future hypothesis and will form a basis for future studies.


Eligibility criteria:
inclusion criteria: * children(1-18y) who are diagnosed with either phenylketonuria (pku) or a mitochondrial disorder exclusion criteria: * children, less than 1y old, who are diagnosed with pku or a mitochondrial disorder, as it is difficult to perform indirect calorimeter on them. * children(1-18y) who are not diagnosed with pku or a mitochondrial disorder * children(1-18y) who are diagnosed with either pku or a mitochondrial disorder, but are currently experiencing illness such as fever, cold, vomiting or diarrhea

Keywords: polg1 mutation phenylketonuria