Kornimate/medical-research-clean huggingface dataset:
strengthening hope after icu discharge

Conditions: Critical Care

Summary: the goal of this clinical trial is to evaluate an interventional program that aims to strengthen hope in intensive care unit (icu) patients in the rehabilitation phase. the main questions it aims to answer are: to develop and implement a follow-up service to strengthen hope in icu patients, and to evaluate the effect on hope in a stepped wedge randomized trial. to identify possible predictive factors (facilitators and barriers) associated with hope. participants will be asked to take part in an icu follow-up service, a "hope intervention" consisting of digital individual- and group conversations. the program will address topics that are important for hope, such as active involvement, social relationships, believes and thoughts of the future. we will compare the level of hope between participants who have completed the "hope intervention" to those that have not yet completed the program.

the icu patient's situation is challenging as they are acutely ill over a prolonged period of time and receive life sustaining treatment in the icu. having hope and belief in a positive future, even when the prospects of such future are uncertain, may give strength and motivation and possibly improve the outcome in the rehabilitation phase. hope is scarcely described in icu patients. health care professionals need to learn how to best support icu patients and promote hope during the rehabilitation period. therefore, the main aim of the present study is to develop, implement and evaluate a follow up service to former icu patients to strengthen their hope using a stepped wedge cluster randomized control intervention trial (sw-crt). the secondary aim is to identify possible predictive factors associated with hope. the intervention will start after hospital discharge and will be carried out in group sessions.

Eligibility criteria:
inclusion criteria: * patients ≥18 years * icu patient for \> 48 hours * must be able to communicate verbally just after their icu stay and be able to handle digital meetings exclusion criteria: * patients with severe cognitive impairment * do not understand and speak norwegian * patients with major psychiatric challenges, suicidal attempts as a reason for icu stay * age over 85 years.

Keywords: critical care critical illness critical care outcomes post-icu hope intervention study
investigation of the effect of i-prf application on pain in alveolitis

Conditions: Alveolar Osteitis; Pain; Dry Socket

Summary: literature review showed that there are no studies on the use of i-prf in alveolitis cases. the aim of this study was to investigate the effect of i-prf on the treatment of alveolitis. the hypothesis of the study was that i-prf applied to alveolitis patients would reduce pain.

the present study will include 60 healthy patients over 18 years of age with alveolitis. 60 patients will be randomly divided into two groups: control and i-prf. after irrigation of the sockets, no substance will be applied to the control group, and i-prf will be applied to the study group. postoperative pain will be measured on the 3rd and 7th days.

Eligibility criteria:
inclusion criteria: healthy individuals without systemic disease patients with complete data and attending their appointments exclusion criteria: patients who smoke pregnant or breastfeeding female patients with bleeding disorders and diabetics patients currently or previously using bisphosphonates or receiving radiotherapy to the jaw patients unable to consent to participate in the study

Keywords: injectable platelet rich fibrine
suspected cases of carbon monoxide poisoning

Conditions: Carbon Monoxide Intoxication

Summary: the purpose of this study is to collect non-invasive opportunity sample data in suspected or known cases of carbon monoxide poisoning.


Eligibility criteria:
inclusion criteria: * known or suspected carbon monoxide poisoning. exclusion criteria: * less than 18 years of age
improving heart and metabolic health in people with severe mental illness through a long-term clinical trial

Conditions: Psychotic Disorders

Summary: cardiometabolic diseases are prevalent among individuals with psychotic disorders, significantly contributing to their shorter lifespan, reduced quality of life, and economic impact on individuals and society. to improve cardiometabolic health, effective and individualized interventions are crucial. psychosis outpatient clinics are ideal for these interventions due to regular patient visits and the availability of diverse health professionals. the investigators have developed and want to test a comprehensive intervention program to improve cardiometabolic health, enhance quality of life, and promote healthy lifestyles specifically for people with psychotic disorders at psychiatric outpatient clinics in gothenburg. this clinical trial aims to include 644 individuals with psychotic disorders from six outpatient clinics in the department of psychotic disorders at sahlgrenska university hospital in gothenburg. two outpatient clinics will provide the lagom-intervention, while the other clinics will serve as controls, offering "care as usual". the intervention group will receive multidisciplinary support integrated into the routine clinical procedures. the intervention includes regular follow-ups and use of motivational tools, including body composition analyzer and cardiovascular risk prediction algorithm (qrisk3). if the intervention effectively improves cardiometabolic health, enhances quality of life for this vulnerable group, and proves cost-effective, it can serve as a model program for implementation in region västra götaland.


Eligibility criteria:
inclusion criteria: 1. adults, ≥18 years, meeting icd-10 diagnostic criteria for any one of the schizophrenia spectrum disorders (f20-f25 or f28-f29). 2. has the ability to sign informed consent. exclusion criteria: 1. having an electrical medical implant like pacemaker or other mechanical implants. 2. pregnant women. 3. deemed unsuitable for inclusion at the discretion of the investigator. 4. previous participation in the clinical trial. 5. under treatment with compulsory care.

Keywords: psychotic disorders cardiometabolic diseases quality of life cost-effectiveness cardiometabolic risk indicators
respiratory variations for assessing blood withdrawal 2

Conditions: Dysmetabolic Syndrome; Hyperferritinemia; Obese

Summary: objectives: to investigate whether respiratory variations of the inferior vena cava (δivc) and internal jugular vein (δijv) diameters during standardized breathing (δivcst and δijvst) increase after a therapeutic bleeding in spontaneously breathing and obese patients with dysmetabolic hyperferricemia. design: prospective, monocentric study in the efs nord-de-france blood center. patients: obese patients with dysmetabolic hyperferricemia undergoing a therapeutic bleeding. interventions: the investigators performed ultrasound measures and collected clinical parameters before and after a therapeutic bleeding, during a standardized respiratory maneuver. main outcome and measures: the primary endpoint was the δivcst change induced by a 300 to 500ml therapeutic bleeding. the investigators measured the minimal and maximal ivc and ijv diameters during a standardized respiratory maneuver. δivcst and δijvst were calculated as follows: \[(maximal diameter - minimal diameter)/maximal diameter\].100.


Eligibility criteria:
inclusion criteria: * adult patients of \> or equal 18 years * dysmetabolic hyperferritinemia * undergoing a therapeutic blood withdrawal * health insured * obese (body mass index \> or equal 30kg/m²) exclusion criteria: * pregnancy * transthoracic echogenicity unsuitable for measuring the inferior vena cava diameters * clinical signs of active exhalation

Keywords: hyperferritinemia dysmetabolic hyperferritinemia obese blood withdrawal respiratory variations inferior vena cava internal jugular vein ultrasound ultrasonography echography
association between ferroptosis and epilepsy

Conditions: Epilepsy

Summary: epilepsy is one of the most common neurologic disorders seen in children, often characterized by recurring seizures. nearly 10.5 million children worldwide are estimated to have active epilepsy. children with epilepsy are more likely to have developmental health and developmental comorbidities such as depression, anxiety, attention deficit hyperactivity disorder, learning disabilities, and developmental delay compared to children without epilepsy. status epilepticus (se) is the most common life-threatening emergency neurological emergency in children and leads to hippocampal neuronal cell death. the animal model proved se-induced neuronal cell death in hippocampal ca1 and ca3 regions. classical drugs like carbamazepine or phenytoin often cause behavioral problems and side effects such as unsteady gait, depression, and irritability. in addition, classical medicine did not protect cognitive function and preferred to drive drug-resistant. therefore, it is necessary to develop a novel therapy to treat epilepsy. ferroptosis is a new type of cell death, usually accompanied by a large amount of iron accumulation and lipid peroxidation. it is widely accepted that glutamate-mediated neuronal hyperexcitation plays a causative role in eliciting seizures, and cystine/glutamate antiporter inhibition induces ferroptosis. hence, investigators hypothesize gpx4 dependent ferroptosis pathway may play a key role in eliciting seizures.

to investigate the possible association between gpx4 dependent ferroptosis pathway and epilepsy. investigators first obtained gene expression of gse25453 from geo (https://www.ncbi.nlm.nih.gov/geo), which contained ten medial temporal lobe epilepsy and ten adjacent non-seizure region tissues. then, investigators further the possible association between gpx4 dependent ferroptosis pathway and epilepsy in school-aged children. investigators obtained peripheral blood from 20 newly diagnosed untreated school-aged children (6 -12 years) and 20 age-matched healthy controls. three glutathione peroxidase 4 (gpx4）dependent ferroptosis pathway biomarkers were investigated: solute carrier family 7 member 11（slc7a11), gpx4, tumor protein 53 (p53). western blot and rt-qpcr were used to investigate the possible changes in these three biomarkers.

Eligibility criteria:
seizure group inclusion criteria: 1. aged between 6 and 12 years old 2. newly diagnosed untreated epilepsy exclusion criteria: 1. treated with medicine or another therapy 2. had history of cancer diseases 3. had history of endocrine diseases healthy control group inclusion criteria: 1. aged between 6 and 12 years old exclusion criteria: 1. had history of epilepsy 2. had history of cancer diseases 3. had history of endocrine diseases

Keywords: school-aged children ferroptosis epilepsy gpx4
first-in-human trial of single ascending dose, multiple ascending dose and malaria challenge model in healthy participants

Conditions: Healthy

Summary: the primary purpose of this study was to investigate the safety and tolerability of m5717 and to characterize the pharmacokinetics (pk) /pharmacodynamic relationship between m5717 pk and parasite clearance in healthy participants following infection with plasmodium falciparum.


Eligibility criteria:
inclusion criteria: * adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (bmi) between 19.0 kilogram per meter square(kg/m\^2) and 29.9 kg/m\^2. * healthy as assessed by the investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion. * other protocol defined inclusion criteria could apply. exclusion criteria: * participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders. * participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the investigator considers may affect the safety of the participant and/or outcome of the trial. * participants who have any history of malaria. * participants who have participated in a previous malaria vaccine trial. * participants who have participated in a previous human malaria challenge trial.

Keywords: healthy participants m5717 malaria plasmodium falciparum
efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: the purpose of this study was to observe the efficacy and safety of 400 μg twice daily of aclidinium bromide vs. placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * a diagnosis of stable moderate to severe copd as defined by gold (the global initiative for chronic obstructive lung disease) guidelines(http://www.goldcopd.org); a postbronchodilator fev1/forced vital capacity \[fvc\] ratio \< 70% and fev1 ≥ 30% to \<80% of the predicted value. * current or former cigarette smokers with a smoking history of at least 10 pack-years. exclusion criteria: * history or current diagnosis of asthma * patients who have been hospitalized for an acute copd exacerbation within 3 months prior to visit 1 * any respiratory tract infection (including the upper respiratory tract) or copd exacerbation in the 6 weeks before visit 1. * patients with any clinically significant respiratory conditions other than copd
metabolic syndrome and leptin level associated with fructose consumption in spain

Conditions: Healthy

Summary: a food frequency questionnaire (ffq), will be provided to 800 adults to assess overall fructose intake and this will be related to a number of features related to the metabolic syndrome, including serum leptin, characteristic features of metabolic syndrome (body mass index, waist circumference, plasma lipids, blood pressure, homa index,fasting glucose and fasting insulin levels) and other as: crp, fibrinogen, homocysteine and uric acid.


Eligibility criteria:
inclusion criteria: * adults, 18-70 years of age exclusion criteria: * diabetes * kidney failure * heart failure * cancer

Keywords: fructose leptin metabolic syndrome blood pressure inflammation relationship of fructose intake to leptin levels relationship of fructose to metabolic syndrome relationship of fructose to inflammation parameters relationship of fructose to blood pressure
effects of glp-1 agonists on cardiac steatosis evaluated by magnetic resonance imaging

Conditions: Type II Diabetes

Summary: type ii diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. the development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. thus glucagon-like peptide 1 (glp-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. it has also been demonstrated in a diabetic rat model that the administration of liraglutide, a glp-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. these beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.


Eligibility criteria:
inclusion criteria: * patient who has given his consent * adult patient over 50 years of age type ii diabetic treated without modification of the antidiabetic treatment during the previous 3 months * hba1c ≥ 7%. * patient for whom a decision to start a glp-1 agonist treatment has been made (liraglutide, semaglutide, dulaglutide). * at least one risk factor from among: * treated hypertension, * treated dyslipidemia, * history of obesity (bmi\>30 kg/m2) * active smoking (from 1 cigarette per day) or smoking cessation for less than 3 years, * coronary heredity (myocardial infarction or sudden death before age 55 in father/brother, myocardial infarction or sudden death before age 65 in mother/sister) exclusion criteria: - protected adult patient not affiliated to a national health insurance scheme pregnant or breastfeeding woman women who intend to become pregnant or of childbearing age and do not use adequate contraceptive methods. antidiabetic treatment of the incretin family (dpp4 inhibitor except sitagliptin) severe renal failure (clearance \<30ml/min according to cockroft due to gadolinium injection) claustrophobia / contraindication to mri (compatible non-mri implanted metallic material) history of hypersensitivity to gadoteric acid or gadolinium-based contrast agents and meglumine hypersensitivity to liraglutide, semaglutide, dulaglutide or any of the excipients history or presence of pancreatitis (acute or chronic) chronic inflammatory bowel disease diabetic gastroparesis dysthyroidism
prospective evaluation of adult pulmonary langerhans cell histiocytosis

Conditions: Adult Pulmonary Langerhans Cell Histiocytosis

Summary: study objectives: * to estimate the incidence of pulmonary deterioration in adult pulmonary langerhans cell histiocytosis * to assess the impact of tobacco discontinuation * study design multicentric prospective cohort study * main endpoint: pulmonary deterioration * sample size : 40 patients

study objectives to estimate the incidence of pulmonary deterioration in adult pulmonary langerhans cell histiocytosis to assess the impact of tobacco discontinuation study design multicentric prospective cohort study main endpoint: pulmonary deterioration sample size : 40 patients

Eligibility criteria:
inclusion criteria: * pulmonary langerhans cell histiocytosis diagnosed within the past 48 months exclusion criteria: * age \< 18 * deep pulmonary dysfunction (cpt\< 60%, fev1\< 30%, dlco\< 30%, partial pressure of oxygen in arterial blood (pao2)\< 60mmhg) * no informed consent or consent withdrawal
complement activation in the lysosomal storage disorders

Conditions: Fabry Disease; Gaucher Disease; Niemann-Pick Disease, Type C; Lysosomal Storage Diseases

Summary: the lysosomal storage disorders (lsds) are monogenic disorders associated with inflammation affecting multiple organs, and early death. few treatments are available that can modify the disease course, and there is an urgent need to identify new steps in pathogenesis that can be targeted therapeutically. the complement system is novel and highly plausible as a primary driver of inflammation and cellular injury in the lsds. this study assesses the complement activation state in patients with fabry disease (fd), gaucher disease (gd) and niemann-pick disease, type c (npc), with comparison to healthy controls. this has the potential for immense clinical benefit through targeted complement inhibition across the full spectrum of lysosomal storage disorders, in which key pathophysiological processes including the inflammatory response to lysosomally 'stored' materials are shared.

this is a single-centre, cross-sectional observational study in patients \>16 years of age diagnosed with fd, gd or npc. the research hypotheses of this study are: 1. that complement is excessively activated, including at the specifically complement c5 level, in patients with the lysosomal storage disorders fd, gd and npc. 2. that complement activation drives tissue injury in the lsds via downstream effector mechanisms including membrane attach complex (mac/c5b-9)-mediated cytotoxicity and c5ar-mediated inflammation. the study aims to show enhanced complement activation, including at the c5 level, in patients with fd, gd and npc compared to healthy controls. the research assays for this study include the primary outcome measure of plasma soluble c5b-9 (sc6b-9) levels measured using elisa. this assay measures the degree to which ongoing c5 activation is occurring in vivo based on sensitive detection in plasma of the key activation product c5b-9. the assay would be expected to show elevated plasma sc5b-9 levels in patients with the glycosphingolipidoses compared to disease-free controls, as was previously demonstrated in patient cohorts of atypical haemolytic uraemia syndrome (ahus) and c3 glomerulopathy (c3g). additional complement activation products will be assessed as secondary endpoints including plasma c3a and c5a levels by elisa, and intracellular leukocyte c5a concentration as a marker of systemic c5a generation and c5ar1 expression.

Eligibility criteria:
inclusion criteria: * all consenting patients with a prior diagnosis of fd, gd or npc will be included in the study. control participants will be healthy volunteers. exclusion criteria: * patients who are unable to provide consent or to perform a blood or urine test will be excluded.

Keywords: complement
a study to assess the drug-drug interaction of bms 663068 with methadone and also with buprenorphine/naloxone

Conditions: Infection, Human Immunodeficiency Virus

Summary: the study is being conducted to assess the effect of multiple doses of bms-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. target population: subjects on methadone maintenance therapy (for inclusion in part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening 3. male and female subjects with body mass index of 18 to 34 kg/m2, inclusive 4. women of child bearing potential (wocbp) with negative serum or urine pregnancy test and must not be breastfeeding 5. men and wocbp must agree to follow instructions for contraception exclusion criteria: 1. history of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse 2. any gastrointestinal (gi) surgery within 4 weeks of study drug administration that could affect its absorption 3. evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population. 4. history of allergy to any drugs, bms-663068, hiv attachment inhibitors, or related compounds