Kornimate/medical-research-clean huggingface dataset:
cap-teer: cerebral protection during transcatheter edge-to-edge repair

Conditions: Mitral Regurgitation; Functional Mitral Regurgitation; Degenerative Mitral Valve Regurgitation

Summary: transcatheter edge-to-edge repair of the mitral valve (m-teer) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. however, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices. this prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected m-teer.

subjects with indications for m-teer and who meet study eligibility criteria will be randomized 1:1 to one of two treatment arms: 1) intervention: cerebral protection device with m-teer or 2) control: unprotected m-teer. enrolled subjects will undergo a diffusion weighted magnetic resonance imaging (dw-mri) at baseline and at 72 hours, to evaluate any new cerebral lesions. enrolled subjects will be followed for 30 days. the study aims to address: * to determine whether the total amounts of new brain lesion assessed by diffusion weighted magnetic resonance images at 72 hours is comparable between the experimental group and the control group. * to assess the effectiveness and safety of cerebral protection device in the prevention of perioperative cerebrovascular events after m-teer * to explore the correlation between the volume/number/location of new brain lesions and changes in neurocognitive function * to evaluate the histopathological features of the captured fragments and their relevance to clinical features

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria: general inclusion criteria * age ≥18 years * severe mitral regurgitation (3+ to 4+) * symptom status: nyha functional class ≥ ii * subjects scheduled to receive the m-teer per the current approved indications for use * subjects agreed to join the study and complete follow-up exclusion criteria: potential subjects will be excluded if any of the following criteria apply: general exclusion criteria * contraindication to mri * cabg, pci, tavr, crt or crt-d within the prior 30 days * aortic or tricuspid valve disease requiring surgery or transcatheter intervention * copd requiring continuous home oxygen therapy or chronic outpatient oral steroid use * cerebrovascular accident within prior 30 days * severe symptomatic carotid stenosis (\>70% by ultrasound) * carotid surgery or stenting within prior 30 days * hemodynamic instability requiring inotropic support or mechanical heart assistance * need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. * contraindication for transesophageal echocardiography * life expectancy \< 1 year * pregnant or planning pregnancy within next 12 months * participation in another interventional trial * patients who are not able to give consent or complete the follow-up
a study of safety, tolerability, pharmacodynamics, and pharmacokinetics of kan-101 in celiac disease (aced-it)

Conditions: Celiac Disease

Summary: this study is to evaluate the pharmacodynamic (pd), safety, tolerability, pharmacokinetic (pk), and plasma biomarker response of kan-101 in participants with celiac disease (ced).

the study is a 3-part, multicenter phase 1b/2 study of kan-101 in participants with celiac disease (ced) on a gluten free diet (gfd). the 3 parts include: * part a - open-label, multiple ascending dose * part b - double-blind, placebo-controlled, parallel design * part c - double-blind, placebo-controlled, parallel design part a is a phase 1b, open-label, multiple ascending dose (mad) study design to assess the safety, tolerability, and pharmacokinetics (pk) of kan-101 in adult participants (18 to 70 years inclusive) with histology-confirmed ced. up to 12 participants who meet study inclusion/exclusion criteria will receive 1 of 2 dose levels of kan-101. the overall study duration will be about 56 days, including up to 28 days of screening, 7 days of treatment and 21 days of follow up. there will be a gluten challenge test (gc) on day 15. parts b and c are phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response following gc, safety, tolerability, and pk of kan-101 in adult participants with histology-confirmed ced. approximately 16 participants (4 participants per dose group) will be enrolled in part b and 104 participants (26 participants per dose group) enrolled into part c. participants will be randomized 1:1:1:1 and stratified by participation in a biopsy substudy to 4 treatment groups: placebo and 3 treatment groups with kan-101 doses based on information obtained from part a.

Eligibility criteria:
inclusion criteria: * previous diagnosis of celiac disease based on histology and positive celiac serology * hla-dq2.5 genotype * gluten-free diet for at least 12 months * negative or weak positive for transglutaminase iga and negative or weak positive for dgp-iga/igg during screening exclusion criteria: * refractory celiac disease * hla-dq8 genotype * previous oral gluten challenge within 12 months * selective iga deficiency * diagnosis of type-1 diabetes * active gastrointestinal diseases * history of dermatitis herpetiformis

Keywords: celiac disease hla-dq2.5 gluten free diet
evaluating the ease of application, removal, and comfort of gradusox™

Conditions: Ease of Applying and Removing, and Comfort, of Compression Stockings

Summary: the aims of this study are to evaluate the comfort, and ease of application and removal, of gradusox™ compression stockings compared to standard compression stockings of the same compression class.

after being informed about the study, all participants giving written informed consent will be randomised by closed envelope randomisation to either a) gradusox on their right leg and sigvaris on their left leg, or b) sigvaris on their right leg and gradusox on their left leg. at day 1, participants will attend the clinic and be fitted with their stockings and given an evaluation form. the evaluation form has four sections to be completed on day 1, day 2, day 4 and day 8 of the study. each section asks multiple choice questions related to the comfort and ease of applying and removing each stocking.

Eligibility criteria:
inclusion criteria: * adults aged 18 and over. * have known previous venous insufficiency that has been treated. * have no known current contraindication to the wearing of graduated compression hosiery. * have an ankle brachial pressure index (abpi) between 0.8-1.2. * have no active ulceration. * are physically able to apply and remove hosiery kits safely. * have had successful surgery at the whiteley clinic and have had at least one follow-up to show no residual venous disease. exclusion criteria: * under the age of 18. * have known arterial insufficiency (an abpi of below 0.8). * have active ulceration. * be physically unable to put stocking on their own legs. * have signs of recent lower limb trauma, active infection, ongoing untreated venous disease, significant ankle oedema. * unable to give informed consent. * pregnant. * fragile skin that may be damaged whilst trying to apply or remove compression stockings. * previous dvt or complicated varicose veins that were not able to be completely treated and left residual venous reflux disease.
a study of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis

Conditions: Acute Exacerbation of Chronic Bronchitis

Summary: a multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis

the patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. experimental group: on the basis of conventional therapy,xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: on the basis of conventional therapy,xiyanping injection simulation(0.9% normal saline) 10-20ml/d, the treatment method is the same as the experimental group.

Eligibility criteria:
inclusion criteria: * 1.18-75 years, males or females; * 2.patients met the acute exacerbation of chronic bronchitis diagnosis; * 3.patients with bronchitis were acute attacked 2-6 days,who had a history of chronic bronchitis more than 2 years. * 4. patients compliance is good, written informed consent was obtained from all participants before the study. exclusion criteria: * 1.patients had a history of andrographolide sulfonate or andrographolide allergy. * 2.pregnancy, lactation, and absence of contraception in women of fertile age. * 3.judging by the researchers, past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases * 4.after checking, patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases * 5.patients using systemic steroids or other immunosuppressive therapy * 6.patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases * 7.patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year. * 8.patients were participated in any study of drug trials in the last 30 days. * 9.according to the researchers' judgment, anyone who are not suitable for the study.
enhancing exercise training for adults with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study aims to find a new way to get individuals living with copd to become and stay active during and after an exercise intervention. in this study, individuals living with copd will participate in an online exercise intervention. the exercises included in this intervention are based in individuals' activities of daily living. additionally, during this intervention, individuals with copd will participate in peer support sessions and will be taught and encouraged to discuss eight behaviour change techniques that have been shown to help support increased participation in physical activity and/or exercise. the goal of this study is to test out this new protocol and determine if it is feasible to recreate on a larger scale and if it is acceptable for the copd community.


Eligibility criteria:
inclusion criteria: individuals must be at least 18 years of age, have no diagnosed cognitive impairment, have a copd diagnosis (any stage), be medically able to participate in exercise (confirmed by healthcare professional in the past 2 years), have access to a computer with a camera and internet, and speak english or french. exclusion criteria: less than 18 years of age, diagnosed with a cognitive impairment, not diagnosed with copd by a medical professional, unable to participate in exercise or unconfirmed in the past 2 years from a medical professional, no access to a computer and internet.

Keywords: exercise peer support behavior change
monitoring of regional lung ventilation by chest electrical impedance in the course of extubation

Conditions: Respiratory Disease

Summary: the electrical impedance tomography (eit) is a non-invasive exam. this exam performed on the lung continuously produces cross-sectional images of lung function. it may be relevant in lung description.

the aim is to follow the patients after extubation for the lung description. eit exam is performed before extubation, during follow-up visits and 48h after extubation

Eligibility criteria:
inclusion criteria: 1. age\> 65 years 2. invasive mechanical ventilation time greater than 48 hours 3. known or suspected chronic obstructive pulmonary disease 4. known or suspected heart failure 5. success in the spontaneous ventilation and extubation test scheduled by the doctor in charge 6. patient or trusted person who has been informed of the study and has consented to participate exclusion criteria: 1. pregnant women, minor patients 2. patients under extracorporeal circulatory assistance (ecmo) 3. refusal of the patient 4. contraindications to the realization of the phrenic nerve stimulation technique: * pacemaker, implantable cardiac defibrillator and other pacemakers * spinal implants, thoracic drains ... * copper allergy * epileptic patients 5. patients performing uncontrolled body movements 6. contraindications to the realization of the technique of electrical imaging tomography: * breast circumference not between 70 cm and 150 cm. * body mass index (bmi) greater than 50 * impossibility of placing the ct belt at the level of the chest skin (lesions, bandages, dressings, chest drains ...) * patients with unstable spinal lesions or fractures * allergy to tomography belt materials: silicone, brass, stainless steel * pacemaker, implantable cardiac defibrillator and other pacemakers 7. patients under legal protection (tutorship / guardianship)
effect of zinc supplementation on appetite and growth in primary malnourished children

Conditions: Appetite Disorders

Summary: zinc supplementation effect on appetite and growth of malnourished children

the investigators will do s. zinc and letting before and after zinc supplementation

Eligibility criteria:
inclusion criteria: * primary malnourished exclusion criteria: * zinc supplementation in the previous 3 months children with chronic disease
a possible therapeutic role for adenosine during inflammation

Conditions: Endotoxemia

Summary: the adenosine receptor is known for its anti-inflammatory actions and could therefore be a potential target in the treatment of sepsis and septic shock. stimulation of the adenosine receptor could potentially lead to a decrease in inflammation and tissue damage. under normal conditions adenosine is formed either by an intracellular 5'nucleotidase, which dephosphorylates amp, or by the hydrolysis of s-adenosylhomcysteine by hydrolase. an alternative pathway of amp degradations is provided by the cytosolic enzyme amp deaminase (ampd), which catalyses the irreversible deamination of amp to inosine monophosphate and ammonia. in humans four ampd isoforms have been described, named after the source from which they were initially purified; m (muscle), l (liver), e1 and e2 (erythrocyte), encoded by ampd1, ampd2 and ampd3. approximately 15-20% of caucasian and african american individuals are heterozygous or homozygous for the 34c\>t variant of ampd1. we hypothesize that healthy volunteers who have the polymorphism for ampd1 have a less severe inflammatory response to lps and show less (severe) organ failure. this hypothesis is based on the expected higher levels of adenosine in patients with the ampd1 polymorphism. this hypothesis is strengthened by the fact that patients with coronary artery disease and the ampd1 polymorphism show improved cardiovascular survival (anderson jl et al. j am coll cardiol 2000; 36: 1248-52) possibly based on higher adenosine levels by reduced ampd activity. furthermore the polymorphism predicts improved clinical outcome in patients with heart failure (loh e et al. circulation 1999) also based on a hypothetical elevation of adenosine. we hypothesize that: the c34t-polymorphism of the enzyme amp-deaminase leads to a decreased inflammatory respons and thereby a decrease of lps-induced tissue damage. a second hypothesis is based on the antagonism of the adenosine receptor, by caffeine; antagonism of the adenosine receptor by caffeine leads to an increased lps-induced inflammatory reaction and an increase in (subclinical) tissue damage?


Eligibility criteria:
inclusion criteria: * healthy male volunteers exclusion criteria: * drug-, nicotine-, alcohol abuses * tendency towards fainting * relevant medical history

Keywords: endotoxin adenosine caffeine ampd1 polymorphism
a ph2b to evaluate tildacerfont in the reduction of glucocorticoid steroid doses in adult cah

Conditions: Congenital Adrenal Hyperplasia

Summary: an investigation of the ability of tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic cah subjects up to 76 weeks of treatment. optional open label extension up to 240 weeks.

this is a study that will evaluate the ability of tildacerfont to reduce the glucocorticoid steroid dose used by adult cah subjects. the first 24-weeks will be a double-blind, placebo controlled, comparison of tildacerfont vs placebo. the following 52-weeks will allow all subjects to move to open label tildacerfont to continue to reduce steroid dose where appropriate, and observe long term safety. subjects will be offered a long term open label extension up to 240 weeks.

Eligibility criteria:
inclusion criteria: * male and female subjects over 18 years old, inclusive * has a documented historical diagnosis of classic cah due to 21-hydroxylase deficiency based on genetic mutation in cyp21a2 and/or documented elevated 17-ohp and currently treatment with hc, hc acetate, prednisone, prednisolone, methylprednisolone (or a combination of the aforementioned gcs) * has been on a stable, supraphysiologic dose of gc replacement for ≥1 month before screening. * for subjects with the salt-wasting form of cah, subject has been on a stable dose of mineralocorticoid replacement for ≥1 month before screening exclusion criteria: * has a known or suspected diagnosis of any other known form of classic cah (not due to 21-hydroxylase deficiency) * has a history that includes bilateral adrenalectomy or hypopituitarism * has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other crf1 receptor antagonist * shows clinical signs or symptoms of adrenal insufficiency

Keywords: cah adrenal disorder congenital adrenal hyperplasia
intravenous ntg to preserve gastric microcirculation during gastric tube reconstruction

Conditions: Esophageal Neoplasms; Microcirculation

Summary: the aim of the present study was to investigate if ntg, administered intravenously during gastric tube reconstruction, could preserve gastric fundus tissue blood flow and oxygenation and reduce the incidence of postoperative leakage.

complications of oesophagectomy and gastric tube reconstruction are leakage and stenosis, which may be due to compromised microvascular blood flow (mbf) in the gastric tissue. we recently demonstrated that peri-operatively decreased mbf could be improved by topical administration of nitro-glycerine ntg). in this present study we investigate the effect of intravenous ntg on gastric microcirculation. this single centre, prospective, double blinded study randomized thirty-two patients scheduled for esophagectomy into two groups. the intervention group received intravenous ntg during gastric tube reconstruction, as the control group received normal saline. baseline values of mbf, microvascular haemoglobin o2 saturation (μhbso2), and microvascular haemoglobin concentration (μhbcon) were determined at the gastric fundus before and after gastric tube construction and after pulling up the gastric tube to the neck.

Eligibility criteria:
inclusion criteria: * planned esophagectomy with gastric tube reconstruction * written informed consent * asa i and ii exclusion criteria: * younger than 18

Keywords: nitroglycerine gastroesophageal anastomosis microvascular bloodflow microvascular hemoglobinsaturation
effect of protein intake during hemodialysis on blood pressure and arterial stiffness indices

Conditions: End Stage Renal Disease; Hypotension During Dialysis; Protein Malnutrition; Arterial Sclerosis

Summary: open label, randomized, cross-over clinical study comparing the acute effect of high versus low protein meals during dialysis on intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices on maintenance hemodialysis patients.

a series of demographic, anthropometric and clinical data will be collected prior to enrollment. the intervention will last 3 consecutive weeks. eligible subjects will be randomised to one group (high or low protein meals during dialysis) for one week (3 dialysis sessions). second week will be a wash out period (patients will not consume meals during dialysis) and during the third week randomised subjects will cross over to the other study group. every meal will provide 1/3 of daily recommended energy and protein intake (35 kcal/kg body weight/day, 0.7 gr protein/kg body weight/day for low protein meals and 1.5 gr protein/kg body weight/day for high protein meals). all the meals will be prepared in the hospital's kitchen and will be personalized to each patient's preferences. the meal will be given one hour after the start of the session and should be consumed completely during dialysis. patients will be evaluated for the following parameters during their midweek dialysis session: 1. intradialytic blood pressure 2. 24-hour ambulatory blood pressure 3. arterial stiffness indices (central aortic blood pressure, pulse wave velocity, augmentation index) 4. hemodialysis adequacy 5. nutritional status intradialytic blood pressure, 24-hour ambulatory blood pressure and arterial stiffness indices will be evaluated with the use of the brachial cuff-based oscillometric device mobil-o-graph ng (iem, stolberg, germany). urea reduction ratio (urr) and kt/v (standard and equilibrated) will be used as measures for dialysis adequacy. possible changes in patients nutritional status will be assessed using the malnutrition-inflammation score (mis).

Eligibility criteria:
inclusion criteria: * patients to have provided informed written consent * patients undergoing maintenance hemodialysis for at least 3 months prior to enrollment * ability to self-ingest food during the dialysis session exclusion criteria: * history of malignancy or any other clinical condition associated with very poor prognosis * hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months * patients receiving parenteral nutrition * body mass index (bmi) of \>40 kg/m2 * bilateral functioning or non-functioning arteriovenous fistula (avf) and/or arteriovenous graft (avg) used as dialysis access * patients with major amputations (eg lower limbs) * women during pregnancy or lactation * patients with unsuccessful 24-hour ambulatory recording of blood pressure with mobil-o-graph device, in accordance with the current european society of hypertension guidelines.
sildenafil citrate for the treatment of established pre-eclampsia

Conditions: Pre-eclampsia

Summary: to determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia


Eligibility criteria:
inclusion criteria: * subjects with pre-eclampsia defined as new hypertension with a diastolic bp of \> or = 90 mmhg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with \>500 mg/24 hr proteinuria. subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement. * gestational age 24-34 w * singleton pregnancy exclusion criteria: * where urgent delivery is indicated * where the fetus is suspected to have a structural or chromosomal abnormality