Kornimate/medical-research-clean huggingface dataset:
polyglucosamine l112 in overweight and obese subjects

Conditions: Obesity

Summary: this research proposes as its main purpose to evaluate the effectiveness of the intake of polyglucosamine at a dose of 3 g / day on weight loss in a group of subjects suffering from overweight and mild obesity (bmi between 25 and 32 kg / m2). and with weight\> 75 kg


Eligibility criteria:
inclusion criteria: * weight \> 75 kg * absence of previous diet therapy attempts * no fluctuation of at least 3 kg in the previous 3 months * beck depression inventory score \< 20 pt * binge eating scale score \< 27 pt exclusion criteria: * allergy to shellfish * pregnancy or breast feeding * presence of cardiopathies, nephropathies, liver diseases, bronchopneumopathies, haemopathies, dermopathies, chronic-degenerative diseases of the central nervous system * presence of active peptic ulcer, ulcerative colitis, crohn's disease, celiac disease, inflammatory bowel disease * symptomatic cholelithiasis * previous or current neoplasms * epilepsy * obesity secondary to endocrinopathies or genetic syndromes * significant motor disability or mental retardation * major depressive disorder, bulimia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder (i or ii), schizophrenia * previous history or current diagnosis of drug abuse or alcoholism * changing in smoking habits or quitting smoking in the last 6 months * current use or in the last 3 months of psychoactive drugs or current use or in the last 12 months of drugs affecting body weight or appetite

Keywords: obesity polyglucosamine body composition inflammation
assessment of cardiac fixation during pet using a new drug within amyloid cardiac injuries.

Conditions: Cardiac Amyloidosis

Summary: to estimate distribution's parameters of 18f-flutemetamol (vizamyl®) fixation on myocardium for patients with amyloid cardiac injuries.

hypothesis had been performed that pet with 18f-flutemetamol (vizamyl®) could lead an early diagnostic. indeed, this tracer had been recently used to highlight inter-cerebral beta-amyloid plaques on patients with alzheimer disease. because this labelling is performed on amyloid deposits, this tracer would lead to view and to quantify amyloid deposits within cardiac amyloid injuries. results of this pet will be combined with scan examinations for a better anatomic tracking.

Eligibility criteria:
inclusion criteria: * patients followed for amyloidosis with proved cardiac injury or strongly suspected: * cardiac echography with typical signs of amyloid injury, * anatomical result confirming presence of amyloid deposits at cardiac or peripheral level * signature of informed consent form, * affiliation to a social security system exclusion criteria: * patient who suffers from another pathology which could lead cardiac injury (coronary disease, valvular disease, other pathology of deposit), * pregnancy and lactating women, * absence of effective contraception, * irradiating examination performed within the last 12 months or scheduled within the next 12 months, * unable patient physically, mentally or legally to provide informed consent, * patient under a system of legal protection
covid-19 infection in hemodialysis patients

Conditions: COVID-19 Infection in Hemodialysis Patients

Summary: dialysis patients have a higher risk of infectious complications including complications from the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) which causes covid-19. there have been several reports describing the effect of co¬vid-19 in the dialysis population.

a report of hospitalized covid-19 patients from wuhan, china, showed that hemodialysis patients had worse outcomes compared to controls without kidney failure. in addition, the hemodialysis covid-19 patients developed serious complications such as shock, acute respiratory distress syndrome (ards), arrhythmias, and acute cardiac injury at a higher rate. in a population of hospitalized dialysis patients in new york city, there was a 31% mortality rate and 75% of those who required mechanical ventilation died. these complications are due to some of their underlying comorbidities and difficulties of keeping adequate social distancing as recommended by cdc guidelines. we aim to identify all hemodialysis patients who will be admitted from october 1, 2021 to septemper 30, 2022. patients who tested positive for covid-19 by a polymerase chain reaction (pcr) or highly suspected (corad 4-5) according to radiological finding, will be selected and followed until discharge from hospital to determine who will develop complications and who will need ventilatory support. also, the rate of death will be monitored. therefore, the current study is aiming to better understand the hemodialysis patients' characteristics profile that makes them susceptible for complications and death.

Eligibility criteria:
inclusion criteria: * all hemodialysis patients who defined as patient receiving maintenance dialysis prior to admission and diagnosed with covid-19 infection either highly suspicious radiological findings (corad 4-5) or proved by pcr for covid-19. exclusion criteria: 1. all patients diagnosed covid-19 other than hemodialysis patients. 2. hemodialysis patients with chest infection other than covid-19.
cardiovascular clinical project to evaluate the regenerative capacity of cardiocell in patients with no-option critical limb ischemia (n-o cli)

Conditions: Critical Limb Ischemia

Summary: the main objective of the circulate project is to compare the clinical outcomes of cardiocell administration in treatment of ischemic damages of cardiovascular system with control group, who will be treated by the administration of placebo during the sham procedure.

it is planned to enroll 105 patients into n-o cli trial with randomization into active (cardiocell) therapy and sham procedure/placebo administration with 2:1 ratio. the primary research question of this project is to check if the administration of cardiocell could improve the clinical outcomes in patients with n-o cli. there are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe in each studied indication and way of cardiocell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.

Eligibility criteria:
inclusion criteria: * patients able to walk * male and female patients, aged 18-80 years * no-option cli (definition: exhausted revascularization options including surgery or endovascular treatment) in rutherford stage 4-5 * in case of bilateral n-o cli, the limb with shorter claudication distance will be treated * presence of adequate inflow (patent iliac and common femoral arteries) * run-off through at least one (even partially seen) below-the-knee (btk) artery * signed informed consent exclusion criteria: * malignancy * moderate or severe immunodeficiency * acute or chronic bacterial or viral infectious disease * soft tissue disease or local infection in a place of required artery puncture * pregnancy or breastfeeding * any objective or subjective reason for inability to attend follow-up visits * females of childbearing potential, who does not want to use a highly effective method of contraception * females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test * participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project * life expectancy \< 1 year * any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
a comparison of strategies to prepare severely calcified coronary lesions

Conditions: Calcified Coronary Artery Disease (Grade 3)

Summary: the objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a super high-pressure nc ptca balloon (opn nc) or a scoring ptca balloon (nse alpha) after unsuccessful lesion preparation with conventional nc balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (synergy everolimus-eluting stent (ees)).


Eligibility criteria:
inclusion criteria: * age above 18 years and consentable; * persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia; * angiographically-proven coronary artery disease; * de novo lesion in a native coronary artery; * target reference vessel diameter between 2.25 and 4.00 mm by visual estimation; * calcification of the target lesion as determined by angiography (grade 3); * unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional nc balloon angioplasty * written informed consent. exclusion criteria: * myocardial infarction (within 1 week); * limited long-term prognosis due to other conditions; * target lesion is in a coronary artery bypass graft; * target lesion is an in-stent restenosis; * target lesion is aorto-ostial; * target vessel thrombus.
a follow-up study to evaluate the long-term safety and efficacy in participants who received cs-101 injection

Conditions: Beta-Thalassemia

Summary: this is a study to evaluate the long-term safety and efficacy of cs-101 in participants who received cs-101 in study cs -101-01 (nct06291961),no investigational drug product will be administered in the study.

this is a study to evaluate the long-term safety and efficacy of cs-101 in participants who received cs-101 in study cs -101-01 (nct06291961). subjects in the cs-101-01 study will be entered into long-term follow-up of this study up to 15 years post-infusion at the completion of the last (12-month) follow up visit after treatment with cs-101 injection.

Eligibility criteria:
inclusion criteria: * participants must have received cs-101 infusion in cs-101-01 study * participants (or his or her legally appointed and authorized representative or guardian) must sign and date informed consent form (icf) and, where applicable, an assent form exclusion criteria: * there are no exclusion criteria
prevention of acute mountain sickness by intermittent hypoxia

Conditions: Acute Mountain Sickness

Summary: acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (ams). the aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent ams.


Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * altitude exposure above 2000 m 8 weeks prior or during the study

Keywords: acute mountain sickness intermittent hypoxia acclimatization
g-poem vs peg-j in gastroparesis patients

Conditions: Gastroparesis

Summary: study design: a randomized non-blinded controlled clinical trial with two study arms (g-poem and peg-j). treatment success is measured using the gcsi at baseline before intervention and six months after intervention with a possible cross-over after six months of follow-up. study population: 50 patients with therapy refractory gp on dietary advices, prokinetics and possibly tube feeding (gastric rest) who have already been referred for additional treatment options in the form of peg-j/ g-poem. intervention: group 1 will receive g-poem treatment and group 2 will receive peg-j treatment. main study parameters/endpoints: a clinically meaningful treatment success six months after g-poem treatment, measured using the gcsi-score defined as a decrease of 1 or more point.


Eligibility criteria:
inclusion criteria: * patients with gp * 13c octanoic acid test or gastric scintigraphy (minimal 4-hour measurement) within the past twelve months * 18 years old exclusion criteria: * \< 18 years old * medical history of stomach surgery in which resection of antrum and/ or pylorus took place * medical history of surgical or laparoscopic pyloromyotomy * gastric bypass * current opioid use * pregnancy
can a nasal decongestant test predict treatment outcomes in seasonal allergic rhinitis?

Conditions: Seasonal Allergic Rhinitis

Summary: we hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. these latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.


Eligibility criteria:
inclusion criteria 1. males and females between 18 and 60 years of age. 2. history of grass and/or ragweed allergic rhinitis. 3. positive skin or rast test to grass, trees and/or ragweed antigen. 4. symptomatic at time of entry into study. exclusion criteria 1. women of childbearing potential not using the contraception method(s) (birth control pills, depo provera, double barrier) as well as women who are pregnant or breastfeeding. 2. patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 3. use of any other investigational agent in the last 30 days. 4. absence of nasal symptoms. 5. smoking. 6. uri at the time of screening.
a phase 3 study to evaluate the efficacy and safety of pegcetacoplan in adults at high risk of delayed graft function (dgf) following kidney allograft transplantation

Conditions: Delayed Graft Function; End Stage Renal Disease; Deceased Donor Kidney Transplant

Summary: a phase 3 study to evaluate the efficacy and safety of pegcetacoplan in adults at high risk of delayed graft function (dgf) following kidney allograft transplantation


Eligibility criteria:
inclusion criteria: 1. aged at least 18 years 2. have end-stage kidney disease and be on the waiting list for a kidney transplant from a deceased donor. 3. be on dialysis at the time of your transplant and produce very little urine (less than 200 ml per day). you must have been on dialysis for at least 3 months. 4. be receiving your first or second kidney transplant from a deceased donor. if this is your second transplant: 1. it cannot be due to a serious infection or a serious blood clot in your previous transplant. 2. your calculated panel reactive antibody (cpra) level must be below 50%. 5. be getting a donor kidney that meets the study's specific requirements. 6. be at low to medium risk of transplant rejection, and be scheduled to receive: 1. a medication called atg as part of your transplant procedure. 2. steroids (corticosteroids) as part of your treatment at the time of screening. 3. a medication called tacrolimus (or a similar drug) after your transplant, according to usual medical practice. 7. have received certain vaccines before starting the study treatment, specifically: 1. pneumococcal (s. pneumoniae) 2. meningococcal (n. meningitidis types a, c, w, y, and b) 3. haemophilus influenzae type b if you haven't had these vaccines, you may still qualify if you're medically shown not to respond to them and your doctor has a plan to give you preventive antibiotics, with the sponsor's approval. exclusion criteria: 1. have taken part in another medical research study or used an experimental drug, treatment, or device in the past 30 days (or longer, depending on the drug). 2. have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs. 3. weigh less than 20kg or more than 120kg at screening. 4. have or had recently had any of the following infections: 1. hepatitis b or hepatitis c (unless treated and no longer active). 2. hiv (human immunodeficiency virus) at any time. 5. have had cancer in the past 5 years, unless it was: 1. a small, treated skin cancer (like basal or squamous cell), or 2. a very small kidney cancer that was found early and treated. 6. have received any other organ transplant (except for one previous kidney transplant), or are scheduled for a transplant involving more than one organ.
analgesic stimulation non-invasive of the motor cortex

Conditions: Neuropathic Chronic Pain

Summary: prevalence of neuropathic pain raise to 6.9 % in the general population and can reach more than 58 % for patients that carry a lesion of the spinal cord. this pathological condition stays a major health problem, particularly as the efficacity of available treatments is currently limited. only 30 to 40% of patients are relieved of more than 50% of their pain by a pharmacological approach. in case of failure, drug treatments or in addition of these ones, stimulation of the motor cortex is a therapeutic path proposed by tsubokawa since the beginning of 1990s, but that found its place for neuropathic drug-resistant pain management only since a decade. neurophysiologic mechanisms of the analgesic efficacity of the motor cortex stimulation are still little understood. this stimulation can be realised in a chronic and invasive way with implanted electrodes. this process allow a lasting relief for about half of operated persons, without the possibility to identify clinical selection criterion reliable for potentially responding patients for this technique. recently, two electrophysiological non invasive techniques have been developed, allowing to get an analgesic stimulation of the motor cortex: the repetitive transcranial magnetic stimulation (rtms) and the direct current transcranial magnetic stimulation (tdcs). the main goal of this study is to compare the importance of analgesic effect of tdcs in chronic drug-resistant neurophysiologic pains to the one get thanks to a reference method of stimulation non invasive of the motor cortex, the rtms whose analgesic effect is already validated by data of the literature.


Eligibility criteria:
inclusion criteria: * persons affiliated to national social security. * patients that have given their signed free consent. * patients from 18 to 80 years, men or women, carriers of a chronic neuropathic pain (since more than a year ; evn \> 2during week s0) drug resistant, unilateral, involving at least the superior member and/or hemi-face, whose analgesic treatment is stable from at least one month. * patients whose drug resistance conduce their referent algologist (specialist in pain medicine) to study the possibility to propose them alternative therapeutic solutions nonpharmacological and to start a pre-surgical examination. exclusion criteria: * history of drug addiction, migraine, epilepsy. * presence of ferromagnetic intracranial equipment or a stimulating implanted (pace-maker, stimulation of basal ganglia, vagus nerve stimulator). * introduction of a new analgesic treatment since at least a month. * pregnant, parturient or breastfeeding women. the absence of effective contraception during all the study for patients of childbearing age. * persons deprived of liberty by judicial or administrative decision, person under legal protection. * counter-argument to mri.

Keywords: pain analgesic stimulation motor cortex
respiratory knowledge portal computer and phone application to improve quality of mechanical ventilation by reducing the number of ventilator associated events, injury created by the ventilator and unsafe setting of alarms.

Conditions: Ventilation; ARDS; Respiratory Failure; Mechanical Ventilation; Ventilator-induced Lung Injury (VILI); Quality Improvement; Ventilator Associated Events

Summary: ventilator associated events (vae) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the icu. vae have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. icu teams are encouraged to follow best practice protocols to help liberate and prevent vaes. yet, compliance with protocols in most icus is suboptimal for multiple reasons. with the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (bmdi) such as capsule (utmb's bmdi system), software systems have been developed to help identify variances in the standard of care. automation in near real-time ventilator data feedback has been shown to reduce the incidences of vaes. this quality improvement project will leverage vyaire's respiratory knowledge portal (rkp) to collect and store meaningful data regarding ventilator-associated events (vae), alarm policy compliance, ventilator weaning, and lung protective analytics. goals: 1. to collect quality metrics utilizing rkp from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis. 2. provide the rkp tool to the icu team to determine if the use of rkp's webportal and messenger zebra phone app improves quality of mechanical ventilation and outcomes. 3. to determine a return on investment (roi) for a software system like rkp.


Eligibility criteria:
inclusion criteria: 1. subjects requiring invasive mechanical ventilation. 2. subjects is in one of the monitored galveston campus icus. 3. ages 0-100 exclusion criteria: 1. is in an icu not monitored by rkp. 2. adults on high frequency ventilation (pediatric patients are not excluded). 3. any patient requiring ecmo.

Keywords: computer aided mechanical ventilation mechanical ventilation quality mechanical ventilation mechanical ventilation safety ventilator monitoring application
coroflex® isar neo pmcf study

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: international, multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of coroflex® isar neo coronary stent system to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with coroflex® isar neo coronary stent system sirolimus eluting stent.

the objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the coroflex® isar neo coronary stent system sirolimus eluting stent in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: coroflex® isar neo is intended to be used for * patients must be at least 18 years of age and * the patient must fulfill the standard recommendations for percutaneous coronary intervention (pci) based on the last european society of cardiology (esc) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment and * patients with novo lesion length 2-4 mm and * informed consent signed exclusion criteria: * patients with express refusal by the patient to participate in the study. * patients pregnant women and lactating women. * patients with acute coronary syndrome (acs) in a situation of cardiogenic shock (killip 4). * patients with contraindications or hypersensitivity to sirolimus. * patients with a life expectancy of less than 2 years. * patients included in other clinical trials.

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) drug eluting stent