Kornimate/medical-research-clean huggingface dataset:
preschool bronchial remodeling and risk of exacerbation

Conditions: Preschool Severe Asthma

Summary: bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (rbm), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (bsm) mass. we identified using latent class analysis two classes of patients. compared to the second class, the first class was characterized by an increase in rbm thickness, blood vessel count, bsm mass and a decrease in rbm-bsm distance, mucus gland mass and bronchial fibrosis. we then hypothesized that this first latent class identified children at risk of asthma exacerbations.

asthma is the most frequent chronic disease in children. severe asthma is characterized by airway hyperresponsiveness, bronchial inflammation and bronchial remodeling 1. bronchial remodeling is an abnormal tissue repair process of the bronchial wall components which can include epithelial abrasion, thickening of the reticular basement membrane (rbm), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (bsm) mass. at preschool age (before 6 years old), asthmatic children constitute a heterogeneous population and several classifications have been proposed to identify distinct phenotypes according to the chronology of asthma 2, the triggers of asthma 3, the trajectory of lung function as measured by forced expiratory volume in 1 second (fev1) 4 or according to a combination of clinical and inflammatory variables 5. more recently, we demonstrated for the first time using latent class analysis (lca) that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data). indeed, we identified two latent classes of patients. compared to the second class, the first latent class was characterized by an increase in rbm thickness, blood vessel count, bsm mass and a decrease in rbm-bsm distance, seromucosal gland mass and bronchial fibrosis (unpublished data). since, previous studies showed that bronchial remodeling could have negative impact on the patients' outcomes, we therefore hypothesized that the latent classes identified from the bronchial remodeling data in severe preschool asthmatic children included in the "p'tit asthme" study (nct02806466) could identify children at risk of asthma exacerbations requiring systemic corticosteroids therapy.

Eligibility criteria:
inclusion criteria: * to have been previously included in the "p'tit asthme" study (nct02806466) * to have performed bronchoscopy with analyzable biopsies * to have been asthmatic at the inclusion in the p'tit asthme study (nct02806466) exclusion criteria: • to refuse the use of children data as expressed by representatives of parental authority

Keywords: exacerbation children asthma bronchial remodeling wheezing
contribution of acupuncture on pain related to the screening of premature retinopathy (rop) by digital camera

Conditions: Laser Stimulation

Summary: pain management in premature infants is essential because they are exposed to repeated minor painful procedures such as screening for premature retinopathy (rop). acupuncture has shown its analgesic effectiveness in many studies. laser acupuncture is a simple, fast, side-effect-free method, but no study exists on the contribution of acupuncture in the management of pain caused by the examination of the fundus in addition to conventional therapies (suction, glucose g30%, anaesthetic eye drops) which are not sufficiently effective. hypothesis: laser acupuncture is a medical device that would reduce the pain and discomfort of premature newborns when examining the fundus with a digital camera.

randomized, single-centre, randomized, double-blind, randomized, controlled clinical trial in two parallel groups, acupuncture versus placebo as an add-on to the usual analgesic strategy (glucose g 30%/suction and administration of a drop of anesthetic eye drops). the main objective is to evaluate the contribution of acupuncture versus placebo as an add-on to the g30% glucose solution 2 minutes before the examination associated with the instillation of a drop of oxybuprocaine administered 1 minute before the start of the examination on pain assessed at the first eye fundus (fo) by the score premature infant pain profile (pipp) measured before the start of the examination (baseline) and on 30 seconds after the examination of both eyes.

Eligibility criteria:
inclusion criteria: * premature from 23+0 to 30sa+6d regardless of birth weight with 1st fo for rop screening; * premature birth weights \< 1250g with a 1st fo for rop screening; * informed consent of the holder(s) of parental authority; * child benefiting from a social security system exclusion criteria: * analgesic or sedative drug treatment (benzodiazepines, morphine and related) within 48 hours of the examination. * known chromosomal abnormality
a first-in-human study of ly2409021 in healthy participants and participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to determine the safety of ly2409021 in healthy participants and participants with diabetes. the study drug is given as single oral doses. each participant can receive up to 3 doses, with a minimum 7 day washout between dosing periods. side effects will be documented. this study is approximately 9 weeks long, not including screening. screening is required within 6 weeks prior to the start of the study.


Eligibility criteria:
inclusion criteria: for all participants: * must be either a male, or a female who cannot become pregnant, who is either healthy or have type 2 diabetes mellitus (t2dm) but not taking medication for diabetes * have an hemoglobin a1c (hba1c) value of less than or equal to 10% at screening * have blood and urine laboratory test results that are acceptable for the study for healthy participants: * have a screening body mass index (bmi) of 18.5 to 29.9 kg/m\^2 inclusive * have a fasting blood glucose between 3.0-5.2 millimoles/liter (mmol/l) at screening * have plasma glucose, two hours after ingesting an oral 75 g glucose load, less than 7.8 mmol/l for participants with type 2 diabetes mellitus (t2dm): * have a screening body mass index (bmi) of 18.5 to 35 kg/m\^2 inclusive * must weigh 45 kg or more at screening * have a fasting blood glucose less than 11.1 mmol/l at screening * have plasma glucose, two hours after ingesting an oral 75 g glucose load, greater than or equal to 11.1 mmol/l exclusion criteria: for all participants: * have participated in a study with a new drug in the last 30 days * have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study * have hypertension requiring more than single-agent therapy, or blood pressure greater than 140/90 millimeters of mercury (mmhg) on monotherapy * are allergic to ly2409021 or similar drugs * have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 ml of beer, or 150 ml of wine, or 45 ml of spirits) * intend to use other over-the-counter or prescribed medicines during 7 or 14 days respectively before the study, or during the study. medicines for high cholesterol and high blood pressure are allowed if you have diabetes. * have a significant blood disorder and/or donated blood (450 ml or more) in the last 3 months for participants with t2dm: * have signs of having serious problems with diabetes (for example, severe eye problems, poorly healing skin) * have a history of being in a coma due to low blood sugar
magnetic resonance-guided high-intensity focused ultrasound (mr-hifu) used for mild hyperthermia

Conditions: Healthy Participants; Pelvic Neoplasms; Soft-tissue Sarcoma; Bladder Cancer; Cervical Cancer; Rectal Cancer

Summary: this study will help to elucidate the treatment sites in the extremities and pelvis for which mr-guided hifu heating is feasible, which has the potential to be beneficial for patients with conditions at those sites (soft tissue sarcoma, cervical cancer, etc.). the investigators anticipate that successful completion of this study will lead to clinical trials in those feasible sites of interest to determine the safety and efficacy of administering therapeutic levels of heat for hyperthermia or other applications.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * willing and able to provide informed consent * patients only: must have a tumor in extremity muscle tissue or in the pelvis. exclusion criteria: * contraindications for mri (e.g., unsafe mri implanted devices, shrapnel, history of metal fragments in eyes, neurostimulators, excessive size and weight, claustrophobia) * pregnant
postoperative periprosthetic fractures in hip fracture patients: exeter vs anatomic sp2 lubinus stem

Conditions: Femoral Neck Fractures; Periprosthetic Fractures

Summary: recent studies have indicated a high incidence of postoperative periprosthetic femoral fracture in elderly patients treated with two commonly used cemented polished, tapered femoral stems. the aim of this study was to compare the prevalence and incidence rate of ppf in a cohort of elderly with femoral neck fractures (fnf) treated with either a collarless, polished, tapered stem (exeter) or an anatomic matte stem (lubinus sp 2). patients and methods in a multicentre retrospective cohort study 2529 patients 60 years and above, with a fnf as indication for primary surgery with a cemented hip arthroplasty were included. patients were treated either with a polished tapered exeter stem or a matte anatomic lubinus sp12 stem according to the surgeons preference or to the praxis of the present department. the incidence of perprosthetic femoral fractures hip-related complications and repeat surgery were assessed at a minimum follow-up of 2 years postoperatively.


Eligibility criteria:
inclusion criteria: * femoral neck fracture * treated with hip arthroplasty with exeter or sp2 stem exclusion criteria: * patological fracture * other typ of stem
efficacy and safety of favipiravir in covid-19 patients in indonesia

Conditions: Infectious Disease; SARS-CoV Infection; Covid19

Summary: the benefit of the research is to provide information regarding the efficacy and safety of favipiravir plus the standard of care (soc) for mild-moderate covid-19 patients to be a reference for policy recommendations regarding the use of favipiravir as an antiviral drug for the treatment of covid-19.

pre-screening is assessing patients who meet the inclusion and exclusion criteria. screening was carried out to assess whether the subjects met the inclusion and exclusion criteria. randomization was performed to determine the study drug allocation. the research subjects were inpatients at selected hospitals and at the time of recruitment, the time was called d1. the next day is called d2 and so on follow-up will be carried out from the first day of recruitment, taking medication up to a maximum of 19 days for test drugs and 11 days for soc drugs. recording of clinical and laboratory manifestations will be carried out from recruitment until the patient returns from the hospital. all results will be recorded in a case report form, and if a case of clinical and laboratory manifestations is found to be severe, it will be written on the adverse case report form and reported immediately according to standard gcp procedures. subjects may also drop out of the study due to discontinuation of follow-up or a protocol violation

Eligibility criteria:
inclusion criteria: 1. adult patients 18 years - 59 years 2. confirmation of covid-19 based on the results of the real time pcr (rtpcr) examination for sars-cov-2 less than 7 days before the first day of taking the drug 3. patients with mild-moderate clinical manifestations were admitted to the hospital designated by the physician according to the operational definition of the study protocol 4. have not received covid-19 antiviral therapy 5. consciously and voluntarily participate in research exclusion criteria: 1. pregnant and lactating women 2. allergy history to favipiravir and standard hospital drugs 3. patients with uric acid examination values above normal male\> 7 mg / dl; women\> 5.7 mg / dl 4. patients with a history of prolonged ecg / arrhythmia / qt disorders 5. cannot swallow drug

Keywords: favipiravir covid19 sars-cov2
covid-19 long immunité imagerie (cliim)

Conditions: COVID Long-Haul

Summary: covid-long pathology affects a large number of patients, and represents a major medical, economic and societal challenge. to date, we have no objective criterion for a definitive diagnosis, nor any predictive tool for monitoring the evolution of covid-long. based on recruitment from the infectious diseases department of nice university hospital, the investigator's team wants to conduct an innovative pathophysiological study to better define the disease and identify specific biomarkers that could subsequently be used as a diagnostic tool for covid-long. 120 participants will be initially included for the model learning phase: 60 controls in the cl- cohort and 60 patients in the cl+ cohort. then 80 patients (40 cl+ and 40 cl-) will be enrolled for the model validation phase.


Eligibility criteria:
for cl+ patients inclusion criteria: * case definition in line with who delphi process exclusion criteria: * history of chronic fatigue syndrome diagnosed before or after covid. * history of progressive psychiatric pathology. * history of acute covid requiring admission to intensive care and mechanical ventilation. * no social security affiliation. for control (cl-) inclusion criteria: * history of acute covid-19, mild, moderate or severe (episode at least 3 months at the time of inclusion). * absence of persistent symptoms more than 3 months after first covid symptoms (or mild not affecting daily activities). exclusion criteria: * history of progressive psychiatric pathology. * history of acute covid requiring admission to intensive care and mechanical ventilation. * no social security affiliation. * pregnant or breast-feeding.
norwegian stoma trial

Conditions: Rectal Cancer; Ileostomy; Complications; Quality of Life; Complication,Postoperative

Summary: the norwegian stoma trial is an open-label multicenter trial investigating the use of stomas, both diveriting and permanent, in the surgical treatment of rectal cancer. the objective is to compare the chosen strategy to surgical complications, health realted quality of life and length of stay.

in this national, multicenter study the study group will investigate whether patients with rectal adenocarcinoma undergoing a resection with an anastomosis will benefit from a diverting stoma or not, by studying how choice of surgery affects complications. in addition the study group will investigate complication rates and hrqol among patients receiving a permanent colostomy and compare this to patients who have received an anastomosis. the investigators know that there are different approaches to the use of stomas (both permanent and diverting) between different hospitals. the investigators aim to discover potential differences in complication rates, length of stay and hrqol among these patients and compare this to the chosen strategy. health related quality of life will be measured using the eortc cr 29 and eortc cr 30 questionnares. bowel function will also be monitored using the lars (low anterior resection syndrome) score.

Eligibility criteria:
inclusion criteria: * age 18 years or older * verified rectal adenocarcinoma by biopsy * tumor located in the rectum with lower border of the tumor located 15 cm or less from the anal verge. * given informed consent exclusion criteria: * advanced tumor stage requiring exenterative surgery beyond a convetional apr or tme. * stage iv disease * synchronous colon cancer necessitating a total colectomy * other concomitant disease(s) which will complicate participation. * unwillingness to give informed consent
esophageal calibration during laparoscopic fundoplication reduces dysphagia

Conditions: Dysphagia

Summary: gastro esophageal reflux is the most common benign disease of the esophagus and laparoscopic nissen fundoplication became the standard surgical treatment of this disease. although being almost transient postoperative dysphagia is still a common complaint following this procedure. the aim of this study is to investigate the effect of inserting a soft structured and blunt mounted 39 f orogastric tube to postoperative dysphagia.


Eligibility criteria:
inclusion criteria: * grade 3 or more esophagitis * hiatal hernia larger than 3 centimeters * acide suppression therapy history longer than 2 years exclusion criteria: * story of endoscopic mucosal resection for barret's mucosa

Keywords: laparoscopic nissen fundoplication esophageal calibration postoperative dysphagia
chronic obstructive pulmonary disease and pulmonary hypertension: prevalence and quality of life

Conditions: Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to determine the prevalence of pulmonary hypertension (ph) among patients suffering from chronic obstructive pulmonary disease (copd) and to assess the quality of life in those patients with concomitant ph compared to copd patients without ph and those only suffering from pulmonary arterial hypertension (pah) respectively.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * known or newly diagnosed copd or pah * written informed consent * present long-term oxygen treatment is no exclusion criterion exclusion criteria: * age \< 18 years * right-heart catheterization not reasonable * pregnancy, lactation * life expectancy \<12 months due to any diseases aside from copd * any medical, psychological or other condition, which limits the patient's ability to provide informed consent * no written informed consent provided * current participation in another clinical trial

Keywords: pulmonary hypertension chronic obstructive pulmonary disease prevalence quality of life
telemedicine efficacy in medication adherence in post-ischemic stroke patients

Conditions: Stroke; Compliance, Patient; Compliance, Treatment; Compliance, Medication

Summary: telemedicine is an incipient resource to support the stroke system of care in colombia. several studies had demonstrated that patients benefit by implementing telestroke, for instance, providing timely and appropriate neurological consultation, diminishing accessible barriers, improving medication adherence for secondary prevention and facilitating linkages between patient and physician, especially for those in rural or neurologically underserved areas. hypothesis: the use of telemedicine improves medication adherence in post-ischemic stroke. study design: this is a randomized, single-blind, clinical trial to assess the efficacy of telemedicine, over medication adherence in post-ischemic stroke subjects from colombia. population: eighty-four post-ischemic stroke subjects, subjects of both genders, over 18 years old, with a first stroke will be included. ethical aspects: the study will be conducted according to the helsinki declaration, the good clinical practices guidelines and the colombian legislation. prior to entering the study, patients must sign a written or oral informed consent that has been approved by the institutional ethics committee of fundación cardiovascular de colombia. overall objective: this study aims to determine the efficacy of telemedicine on pharmacological adherence in post-ischemic stroke participants. focus of study: adherence to secondary stroke prevention medication.


Eligibility criteria:
inclusion criteria: * first ischemic stroke. * lived in urban areas. * available access to permanent internet at home, in work on mobile dispositive, computers or tablets. * patients who gave their written informed consent. exclusion criteria: * diagnosis of neurodegenerative diseases such as dementia and parkinson's disease. * diagnosis of diseases-terminal to prevent tracking. * diagnosis of psychiatric illnesses such as major depressive disorder (mdd) or others. * global cognitive impairment or previous diagnosis of dementia.

Keywords: stroke consultation telemedicine recovery rehabilitation
virtual reality; the effect on pain reduction during an external version.

Conditions: Pain

Summary: summary rationale: the use of an external cephalic version (ecv) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections. literature about the effectivity of virtual reality (vr) on acute pain reduction seems promising. objective: the primary objective of this study is to explore the effect of vr on pain during ecv. secondary objectives are the rate of successful ecv procedures and to explore tolerability, feasibility and patient satisfaction of vr use. study design: the study concerns a non-blinded, single centre, randomised controlled trial. study population: eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the zuyderland medical centre location heerlen. intervention: the study population will be randomly divided into the intervention group (vr-group) or the standard care group. the intervention group can choose for an immersive guided relaxation vr experience or an interactive vr experience during the external version additional to the usual standard care. the participants randomised to the standard care group receive the usual standard care given during external version. main study parameters/endpoints: the primary outcome is pain measured on a numeric rating scale (nrs). a total of 42 patients have to be included in each group. this means that a total of 84 women will have to be included in the study. nature and extent of the burden and risks associated with participation, benefit and group relatedness: each participating woman is asked to complete a questionnaire after using vr and the degree of pain perception is questioned on the basis of a 0-10 score (nrs). the study population experiences a very small medical risk when participating to this study. they can experience side-effects of vr for example dizziness or nausea and in rare cases epileptic insults.


Eligibility criteria:
inclusion criteria: * written and orally given informed consent * 18 years and older * native dutch speaker * singleton pregnancy in breech position * scheduled ecv exclusion criteria: * contraindication for ecv * chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' \[16\]. the pain is not due to an obstetrical problem. * chronic use of pain medication (opioids) * alcohol or drug abuse * known car sickness * epileptic insults in previous history * psychotically seizures in previous history * claustrophobic * blindness * history of mental illness * patients in strict isolation (mrsa) * age \<18 years * twin pregnancy * no native dutch speaker