Kornimate/medical-research-clean huggingface dataset:
effect of aprotinin on transfusion requirements in patients undergoing elective spinal fusion surgery

Conditions: Blood Loss, Surgical; Postoperative Hemorrhage

Summary: the objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation


Eligibility criteria:
inclusion criteria: * subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. one vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces. exclusion criteria: * subjects with previous exposure to aprotinin in the last 6 months. if the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. if no records are available, or if the subject received aprotinin, the subject should be excluded.- subjects with a known or suspected allergy to aprotinin. * subjects with sepsis or a known bone infection.- subjects with known bone malignancy. * subjects with a creatinine clearance less than 30ml/min as calculated by the cockcroft-gault formula. * subjects with a history of bleeding diathesis or known coagulation factor deficiency. * subjects with failure of a major organ system or any active significant medical illness that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study * subjects who refuse to receive allogenic blood products for religious or other reasons. * subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values \<24% or \<8 g/dl, respectively). * subjects who have participated in an investigational drug study within the past 30 days * subjects with a history of deep vein thrombosis or pulmonary embolism. * subjects who are pregnant or breast feeding. * women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening. * women of childbearing potential who are not using a reliable method of contraception. * planned use of other antifibrinolytic agents. * subjects on chronic anticoagulant treatment with vit k antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).

Keywords: bloodloss transfusion requirements in patients undergoing elective spinal fusion surgery
moxibustion plus cupping in convalescent patients with covid-19

Conditions: COVID-19; Convalescence

Summary: this trial is designed to evaluate the efficacy and safety of moxibustion plus cupping in the convalescence of covid-19.

moxibustion plus cupping may be effective and safe for convalescent patients with covid-19, but evidence is limited. the randomized clinical trial may help to provide evidence-based factors for improving the patients' symptoms in the convalescence of covid-19.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of the convalescence of covid-19 (defined by the chinese guideline for covid-19 in 2020 trial version 7). 2. 18-70 years old; 3. chest tightness/fatigue/shortness of breath/cough, with at least 2 of the above symptoms and the average vas score (last 48 hours) ≥ 40 points; 4. volunteers with informed consent; exclusion criteria: 1. surgery in the lung that affects lung function; 2. rely on mechanical ventilation to maintain lung function; 3. chronic lung diseases affecting lung function; 4. diseases affecting heart function; 5. severe basic diseases; 6. resting heart rate \> 120/min, systolic blood pressure \> 180mmhg, diastolic blood pressure \> 100mmhg; 7. unstable angina or myocardial infarction in the past 1 month; 8. severe obesity (bmi\>30kg/m2); 9. allergic constitution; 10. pregnant or lactating women; 11. disabled patients; 12. mentally ill patients; 13. participating in other clinical trials; 14. poor compliance or other complicate conditions according to the researchers.

Keywords: moxibustion covid-19 randomized clinical trial
ulipristal acetate versus gnrh analogue treatment before hysteroscopic resection of uterine leiomyoma

Conditions: Fibroid

Summary: the uterine leiomyoma is the most common female benign disease. submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (aub) and infertility. hysteroscopic removal of submucosal myomas improves this conditions. gnrh analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than gnrh agonists. upa significantly improved quality of life and pain reduction.

the uterine leiomyoma is the most common benign tumor of the female genital tract. the myomas are usually clinically apparent in 25% of patients. submucosal fibroid are about 10% of all uterine myoma; they distort the endometrial cavity causing heavy and/or irregular bleeding (aub) and infertility. according to the degree of myometrial penetration, the european society for gynaecological endoscopy (esge) classified submucosal myomas in type 0 (totally intracavitary fibroids), type i (\ 50% myometral penetration). hysteroscopic removal of submucosal myomas improves menorrhagia and aub. gnrh analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. a recent meta-analysis of data demonstrated that symptomatic relief in patients undergoing surgery was similar either following pre-operative gnrh-a administration or without gnrh-a administration, mainly due to the persistence of abnormal bleeding due to the protrusion of the myoma into the uterine cavity. in recent studies, ulipristal acetate treatment was able to control uterine bleeding associated with fibroids in more than 90% of cases. moreover, it controlled bleeding faster than gnrh agonists, with median times to amenorrhea of 5-7 days in patients receiving upa compared to 21 days in patients receiving a gnrh agonist. it was demonstrated that upa significantly improved also quality of life. pain, as measured by the visual analogue scale, showed a degree of relief similar to that achieved for postoperative pain with narcotic and non-narcotic analgesics. this pain reduction is related to the high amenorrhea rate during treatment (severe bleeding being responsible for uterine contractions and prostaglandin secretion). no sub-analysis have been conducted on submucosal fibroids but, according to our experience, this subgroup of myomas may be the one who most benefits from the administration of upa.

Eligibility criteria:
inclusion criteria: submucosal leiomyoma, symptoms of menomethrorragia, menstrual disorder, infertility, pelvic pain. exclusion criteria: intramural or subserosal leiomyomas, endometrial hyperplasia with atypia, history of uterine surgery

Keywords: fibroids gnrh analogue ulipristal acetate hysteroscopy
effect of colding of endotracheal tubes on sore throat

Conditions: Postoperative Sore Throat

Summary: postoperative sore throat (post) is a common and undesirable postoperative symptom that causes patient dissatisfaction. cold application is a non-invasive, non-pharmacological, cost-effective and effort-effective therapy for pain management. the aim of this study was to evaluate whether colding of ett can reduce sore throat, dysphagia and dysphonia after endotracheal intubation.

the incidence of postoperative sore throat (post) has been reported up to 62% following general anaesthesia.it is an undesirable events experienced by patients after general anaesthesia. various pharmacological agents have been applied to reduce post, such as lidocaine, ketamine, magnesium, corticosteroids or non-steroidal anti-inflammatory drugs. however, these agents may have some systemic and local side effects. therefore, various non-pharmacological applications have been investigated to reduce sore throat. cold application is a non-invasive, cost-effective and effort-effective therapy for pain management. although the mechanism is not clearly known, it increases the pain threshold, slows cellular metabolism, causes vasoconstriction, and reduces capillary permeability. therefore, we hypothesized that colding of endotracheal tube may decrease post associated with airway inflammation. the aim of this study was to evaluate whether colding of ett can reduce sore throat, dysphagia and dysphonia after endotracheal intubation. the goal of this study is to identify a simple, safe, and inexpensive perioperative intervention to reduce post operative sore throat. this study is a prospective, randomised study involving 116 subjects and they will assessed on the incidence and severity of sore throat, dysphagia and dysphonia at 1. 4. 12. 24. hours after removal of endotracheal tube. outcomes from this study can be extended to patients who will be receiving general anaesthesia using a endotracheal tube to reduce the incidence and severity of sore throat.

Eligibility criteria:
inclusion criteria: patients who were entubated with an ett. those who accept the research elective surgery patients in american society of anaesthesiologists (asa) i and ii class 18 years and over mallampati classification i and ii operation time more than 1 hour exclusion criteria: patients with sore throat and lower respiratory tract infection patients with a history of allergies

Keywords: endotracheal tube sore throat dysphagia
assess the safety and efficacy of the 4 channel nmes, pilot study

Conditions: Dysphagia

Summary: this study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. the purpose of this study is to investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

* design: prospective study * inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(n=9) * intervention: participants are divided into two group and applied electrical stimulation by a "synchronized electrical stimulation device(sesd)" in different protocol * main outcome measures: high-resolution manometry(hrm) parameters, videofluoroscopic parameters, eq-5d (euroqol-5d) questionnaire

Eligibility criteria:
inclusion criteria: * patient who do not belong to the criteria excluded for subjects aged 19 years or older * patient who is confirmed to be dysphagia by videofluoroscopy * patients who need clinical application of electrical stimulation therapy equipment for dysphagia. ex) stroke, cervical spinal cord injury * those voluntarily agreeing to the clinical trial exclusion criteria: * patient who refuse inspection, do not agree * simple "commend obey", first step is impossible * when instructions can not be executed due to dementia, psychiatric disorders, etc. * dysphagia occurs due to respiratory failure, neck surgery, etc., * pregnant women and lactating women

Keywords: stroke cervical spinal cord injury
impact of covid-19 infection during pregnancy on newborns and young children

Conditions: Pregnancy; Covid-19

Summary: this study aim is to assess impact of covid-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

all pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother. in positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured. occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Eligibility criteria:
inclusion criteria: * for pregnant women, all women who deliver in the chu st pierre, with oral consent. * for children follow up: children born to positive mothers and matched controls after written consent exclusion criteria: * none

Keywords: covid-19 pregnancy antibodies congenital sars infection breast milk
a study to assess growth in children with idiopathic short stature

Conditions: Idiopathic Short Stature

Summary: study 111-903 will generate baseline growth data in children with iss by collecting growth measurements and other variables of interest.


Eligibility criteria:
inclusion criteria: 1. participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent. 2. a height assessment corresponding to a height z-score of ≤ -2.25 sds in reference to the general population of the same age and sex, as calculated using the centers for disease control and prevention (cdc) growth chart (https://www.cdc.gov/growthcharts/zscore.htm). 3. participants who have either never received hgh, or who are currently receiving hgh treatment. 4. historic stimulation test result with serum or plasma gh level greater than 10 μg/l. 5. parent(s) or guardian(s) are willing and able to provide written, signed informed consent. exclusion criteria: 1. diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the medical monitor. 2. known presence of one or more pituitary hormone deficiencies 3. bone age advanced over chronological age by more than 3 years. 4. for hgh naïve participants, historic stimulation test result with serum or plasma gh level greater than 10 μg/l or serum igf-1 in the normal range for age (between -1.00 sds and +2.00 sds). 5. for participants currently on hgh treatment, historic results before gh treatment of stimulation test with serum or plasma gh level greater than 10 μg/l or serum igf-1 test between -1.00 sds and +2.00 sds. 6. have received an investigational product (ip) or investigational medical device for any purpose within 6 months before the screening visit. .
anticipation and detection of heart failure decompensation with automatic treatment of informations

Conditions: Heart Failure

Summary: heart failure (hf) is a serious chronic disease with frequent readmissions, some of which can be prevented by early action. the management of hf is complex: long, often difficult and costly. in france, nearly one million people suffer from hf and 120,000 new cases are diagnosed every year. with the aging population, this number will continue to evolve and become a real public health problem. within 10 to 20 years ahead, who projects that heart failure in either the 3 most common diseases in industrialized countries. the objective of the project is to test an intelligent platform for monitoring at home, using non-intrusive sensors, patients with heart failure, particularly those with stage ii and iii nyha. it will assist the medical automating the processing of information from these sensors to detect and report an early stage risk situations. patient monitoring, by a system of telemedicine tools associated with motivation and education helps significantly reduce the number of days of hospitalization becomes important when the patient is hospitalized for acute hf.


Eligibility criteria:
inclusion criteria: * population with heart failure stage ii and iii exclusion criteria: * population whose age is less than 18 years

Keywords: heart failure telemonitoring intrusive sensors intrusive devices heart failure stage ii heart failure stage iii heart disease
interest of virtual reality to reduce patient anxiety during the placement of a percutaneous implantable port catheter

Conditions: Anxiety; CIP

Summary: the vascular access unit (uav) of the lyon sud hospital center is the first unit within a french public establishment where the regional health agency (ars) has authorized that medical procedures for the installation of central venous access be performed by nurses. the installation of cip represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. in the uav, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. affected patients usually have a diagnosis of serious illness (oncology). virtual reality (vr) simulates the physical presence of the patient in an environment artificially generated by software. many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during cip placement under local anesthesia, without premedication. the medical device used is lumeen. it is a class i medical device software within the meaning of regulation (eu) 2017/745, ce marked. in the context of research, the relaxation module is used. this module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. it allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. the duration of an immersion can be adjusted according to the needs of the medical procedure..


Eligibility criteria:
inclusion criteria: * adult patient ≥18 years old * patient operated on an outpatient basis and available for a phone call between d+1 and d+5 * patient operated for a 1st pose of cip at the uav * patient whose anxiety measured by ens anxiety is at least 4/10 at entry * patient having signed the informed consent * patient affiliated to a social security exclusion criteria: * patient not sufficiently fluent in the french language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material; * patient with motion sickness; * patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol; * patient deprived of liberty or placed under guardianship or curators; * pregnant or breastfeeding women; * patient with a history of epilepsy ; * patient with a pacemaker or pacemaker; * patient with psychiatric disorders of a psychotic nature in the acute phase or visual hallucinations; * patient under anxiolytic treatment; * patient presenting wounds or infections on the level of the head not allowing the installation of the virtual reality helmet.

Keywords: virtual reality anxiety cip
the characteristics of prepulse inhibition in children and adolescents suffering from attention deficit disorder

Conditions: Attention Deficit Disorder

Summary: the purpose of this study is to show that prepulse inhibition test of acoustic startle response is an indicator of objective diagnostic characteristics of attention deficit disorder in children and adolescents. by demonstrating that prepulse inhibition test of acoustic startle response is impaired in children and adolescents suffering from attention deficit disorder in the relation to the normal function described in the literature. the investigators will try to prove our hypothesis by an experiment that consists of two phases: phase i (about 25 minutes): the patient will enter the room, will be asked to sit on a chair, and will be asked to look at a computer screen showing silent video of aquarium fish, then the patient will be connected to both the prepulse inhibition test device and the galvanic skin response device and pass the tests. phase ii (about 25 minutes): after completion of phase i, each participant will receive his daily regular dose of methylphenidate and after an hour and a half from taking the drug, will repeat the tests, both the prepulse inhibition test and the galvanic skin response test. duration of the entire experiment is 140 minutes (two hours and twenty minutes).


Eligibility criteria:
inclusion criteria: 1. between the ages of 7-18 2. diagnosed with attention deficit hyperactivity disorder according to diagnostic and statistical manual of mental disorders, fifth edition- clinical diagnostic interview was performed. 3. receive drug therapy with methylphenidate doses ranging from 0.3 mg / kg to 1 mg / kg. 4. the participant is treated with methylphenidate at least two months prior to the experiment. exclusion criteria: 1. autism. 2. chronic neurological diseases. 3. developmental delay. 4. psychotic or major effective disorder (psychotic state now or in the past, schizophrenia, schizoaffective, depression, bipolar disorder) 5. substance abuse. 6. mental retardation. 7. contraindicated for the treatment of methylphenidate. 8. hearing problems. 9. pregnancy week 20 and thereafter

Keywords: add adhd ppi