Kornimate/medical-research-clean huggingface dataset:
efficacy of hfnc versus niv for prevent reintubation in sepsis patients

Conditions: Post Extubation Respiratory Failure; Re-intubation; Septic Shock; Severe Sepsis

Summary: post extubation respiratory failure occur in 30% of extubated patients. more than 50% of them required reintubation. noninvasive positive pressure ventilation (niv) had been reported as an effective tool to prevent post extubation respiratory failure. recently, high flow oxygen nasal cannula (hfnc) had been successfully used to prevent post extubation respiratory failure and prevent reintubation in comparable with niv among post cardiothoracic surgery and high risk for reintubated patients. there was no information about hfnc versus niv in prevention of reintubation among severe sepsis or septic shock patients.

post extubation respiratory failure occur in 30% of extubated patients. more than 50% of them required reintubation. noninvasive positive pressure ventilation (niv) had been reported as an effective tool to prevent post extubation respiratory failure. recently, high flow oxygen nasal cannula (hfnc) had been successfully used to prevent post extubation respiratory failure and prevent reintubation. the results from recent randomized controlled trials, comparing hfnc with niv for prevent post extubation respiratory failure among post cardiac surgery and high risk patients, showed no significant different in the treatment outcome.comparable with niv among post cardiothoracic surgery and high risk for reintubated patients. about 40-85% of severe sepsis/septic shock patients developed acute respiratory failure, required endotracheal intubation. according to the nature of patients population, usually eldery, multiple co-morbid condition and high apache ii score, sepsis patients were considerred as high risk for reintubation, after extubated. there was no information about hfnc versus niv in prevention of reintubation among severe sepsis or septic shock patients.

Eligibility criteria:
inclusion criteria: * diagnosis of sepsis or septic shock according to the third international consensus definitions for sepsis and septic shock (sepsis-3) * depended on mechanical ventilator for more than 48 hours * plan for extubation due to successful weaning exclusion criteria: * patient with tracheostomy * recent upper abdominal surgery * wound at face that prohibit face-mask application * patient or 1st degree relative not agree to participate trial * physician prefer either niv or hfnc for the patient

Keywords: sepsis septic shock severe sepsis extubation reintubation noninvasive positive pressure ventilation high flow oxygen nasal cannula
the multistrain probiotic omni-biotic® active for upper respiratory tract infections in older people

Conditions: Acute Upper Respiratory Tract Infection

Summary: the goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic omni-biotic® active to shorten the incidence and duration of acute upper respiratory tract infections (urtis) in older people. the main questions it aims to answer is: * is the multistrain probiotic omni-biotic® active effective in reducing the incidence of urtis in older people? * is the multistrain probiotic omni-biotic® active effective in reducing the duration of urtis in older people? * is the multistrain probiotic omnibiotic® active effective in changing selected immunological blood parameters in older people? researchers will compare the probiotic group and the placebo group to see if the incidence or duration of urtis are significant among the groups.


Eligibility criteria:
inclusion criteria: * 65 years or older at the signing of the written consent form * ability of participant to eat independently * ability of participant to adhere to all procedures of the clinical study exclusion criteria: * participants experienced an exacerbation of an existing chronic disease * participants experienced an exacerbation of metabolic diseases, * participants with mental incapacity to understand instructions * participants were prescribed long-term usage of antibiotics. * participants that changed their eating habits or consumed any probiotics 14 days * participants with markedly abnormal results of blood tests were excluded.
mosaic trial for stem cell transplant recipients

Conditions: Hematologic Malignancy; Stem Cell Transplant; Bone Marrow Transplant; Leukemia; Lymphoma; Multiple Myeloma; Myelodysplastic Syndromes

Summary: the goal of this clinical trial is to learn if using an intervention website (mosaic) improves selected patient-reported outcomes in adult blood cancer patients undergoing allogeneic or autologous stem cell transplant, compared to using an educational website (control group). patients will be recruited prior to their scheduled transplant, then randomized to use one of these two study websites throughout the study. they will complete five assessments during the study: one before transplant (baseline) and four after transplant (2, 4, 6, and 8 month follow-ups). the main questions this trial aims to answer are: 1. compared to patients using the control group website, do patients using the intervention website report greater improvements in general psychological distress, cancer treatment-related distress, physical symptoms, and health-related quality of life? 2. are these benefits at least partially explained by improvements in perceived preparedness, self-efficacy, and approach coping and/or reductions in avoidant coping and perceived stress? 3. do some patients benefit more from using the intervention website than others? specifically, we will examine whether patients' primary language (english/spanish) and their initial psychological distress are related to the benefit they get from using the intervention website. we will also explore effects of sex, race, ethnicity, and transplant type.


Eligibility criteria:
inclusion criteria: * diagnosed with a hematologic cancer according to medical records * scheduled for or preparing for scheduling of an allogeneic or autologous stem cell transplant at one of our study sites * aged 18 or older (no upper limit) * english or spanish proficient * interested in using a website to learn about stem cell transplant * ability to understand and willingness to sign an informed consent document and comply with all study procedures exclusion criteria: * currently participating in a behavioral intervention targeting distress, health-related quality of life, or symptoms * undergoing the first in a planned tandem stem cell transplant * unable to provide meaningful consent (severe cognitive impairment or language difficulties)
pharmacodynamic differences between branded and unbranded remifentanil molecules

Conditions: Pain

Summary: unbranded drug molecules are produced after the patent of a given drug has expired. unbranded molecules of remifentanil have been marketed in colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. the investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.

introduction. several remifentanil products are commercialized in colombia while these have never been compared in a clinical setting. objective. the aim of this study was to investigate the pharmacodynamic profile of the innovative molecule of remifentanil (group o = ultiva®) and two unbranded molecules (group a = remifentanil laboratorios chalver de colombia s.a. and group b = fada remifentanilo) registered in colombia. methods. the investigators carried out a double-blind, randomized, controlled trial. the branded molecule of remifentanil (group o, n=29) was compared against the two unbranded molecules (group a, n=29; group b, n=32) during anesthetic induction and tracheal intubation in adult patients american society of anesthesiology physical status classification = i without predictors for difficult airway. the target controlled infusion (tci) doses evaluated were 6, 8 and 10 ng/ml with the minto model. induction was complemented with propofol 5 mg/ml (tci) with the schneider model and rocuronium 0.6 mg/kg. the primary outcome was defined as the difference in mean arterial pressure and heart rate pre-intubation (tci equilibrium) and post-intubation (maximum measurement within 5 minutes).

Eligibility criteria:
inclusion criteria: * patients requiring orotracheal intubation * 18-50 years old * body mass index \<31 kg/m2 * written informed consent exclusion criteria: * pregnancy * risk of difficult airway * history of opioid use

Keywords: remifentanil propofol pharmacodynamic total intravenous anesthesia orotracheal intubation heart rate mean arterial pressure cooper intubation condition score
assessment of neurological manifestations in gaucher disease patients

Conditions: Gaucher Disease

Summary: the current work aims to detect the frequency and types of neurological disorders in patient diagnosed as gaucher disease in assiut university children's hospital

gaucher disease, the most common lysosomal storage disorder, caused by reduced activity of acid β-glucosidase and mutations in the gba1 gene. this leads to the accumulation of its normal substrate, glucocerebroside, in tissue macrophages, affecting the hematological, visceral, bone and neurologic systems. the determination of deficient β-glucocerebrosidase activity in leukocytes or fibroblasts by enzymatic assay is the gold standard for the diagnosis of gaucher disease. clinically, gaucher disease is classified into three major forms based upon the absence or presence and rate of progression of neurological manifestations : type 1 (non-neuronopathic), type 2 (acute neuronopathic), and type 3 (subacute neuronopathic). the ngd forms are gaucher disease type 2 (gd2) and gaucher disease type 3 (gd3). gd2 is the acute neuronopathic form and has an early onset cns involvement, typically manifesting in the first 6 months of life and leading to death by age 2 years, although patients may live up to age 4 years or beyond with supportive medical care. gd3, or the chronic neuronopathic form, has a slightly later onset, cns symptoms typically manifesting months to years after birth, and has a much slower neurological progression than is seen in gd2. gd3 is the predominant form of gaucher disease. phenotypically, there is a wide spectrum of visceral and neurological manifestations. enzyme replacement therapy has been shown to be effective in reducing glucocerebroside storage burden and diminishing the deleterious effects caused by its accumulation. enzyme replacement is effective in managing the visceral disease; however, treating the neurological manifestations has proved to be more challenging. currently, there is no agreement on a definition of ngd, other than one by exclusion ("the presence of neurological involvement in a patient with biochemically proven gaucher disease, for which there is no explanation other than gaucher disease")

Eligibility criteria:
inclusion criteria: * diagnosis of gaucher disease exclusion criteria: * not meeting inclusion criteria
observational study of type 1 and type 2 diabetes patients having switched from human premixes to novomix®30

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this observational study is to evaluate the blood glucose control (hba1c) using novomix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in romania.


Eligibility criteria:
inclusion criteria: * type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician). exclusion criteria: * subjects currently being treated with biphasic insulin aspart 30 * subjects who were previously enrolled in this study * subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients * women who are pregnant or have the intention of becoming pregnant within next 6 months * children below 10 years of age
empowering health: acute psychological effects of an electromyostimulation-whole-body-workout

Conditions: Depression

Summary: the study investigates the acute psychological effects of a whole-body-workout using electromyostimulation (ems) in participants with depression and healthy individuals.

ems-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. therefore ems could lower the barrier to physical activity. the present study focusses on acute psychological effects of an ems workout - especially with regard to the reduction of depressive symptoms. physical activity is notably important for patients with depression and shows multiple positive psychological and physical effects. but due to disease-related factors like lethargy, physical activity is far too rarely implemented. therefore ems-whole-body-workouts could provide an opportunity to generate positive psychological effects through a less (subjective) cost-intense strength training.

Eligibility criteria:
inclusion criteria: * subject familiarized with experimental procedure and had given written informed consent * depression, according to icd-10 * bdi-ii score ≥ 14 * able to understand german * reachability of participant for the two training sessions exclusion criteria: * contraindications for physical exercise * contraindications for ems-use * current ems-use * pregnancy * borderline personality disorder * bipolar disorder * schizophrenia * anorexia nervosa, bulimia nervosa * dementia * acute suicidality * substance dependencies with actual consumption (except nicotine)

Keywords: physical activity physical exercise mental disorder depression mental health health behaviour electromyostimulation ems strength training
accuracy of pulse oximeters with profound hypoxia

Conditions: Healthy Volunteers

Summary: the aim of this project is to test the accuracy of pulse oximeters during mild, moderate and severe hypoxia. this is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a laboratory hemoximeter). the data obtained is submitted by pulse oximeter manufacturers to the fda for device approval.

the study will include at least 10 subjects (up to 14 if needed to reach the 200 necessary data points to meet the iso 80601-2-61:2017). per fda guidance, at least 2, or 15% of the subjects will have dark skin.

Eligibility criteria:
inclusion criteria: 1. the subject is male or female, aged ≥18 and \<50. 2. the subject is in good general health with no evidence of any medical problems. 3. the subject is fluent in both written and spoken english. 4. the subject has provided informed consent and is willing to comply with the study procedures. exclusion criteria: 1. the subject is obese (bmi\>30). 2. the subject has a known history of heart disease, lung disease, kidney or liver disease. 3. diagnosis of asthma, sleep apnea, or use of cpap. 4. subject has diabetes. 5. subject has a clotting disorder. 6. the subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation. 7. the subject has any other serious systemic illness. 8. the subject is a current smoker. 9. any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. 10. the subject has a history of fainting or vasovagal response. 11. the subject has a history of sensitivity to local anesthesia. 12. the subject has a diagnosis of raynaud's disease. 13. the subject has unacceptable collateral circulation based on exam by the investigator (allen's test). 14. the subject is pregnant, lactating or trying to get pregnant. 15. the subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. 16. the subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
effect of oculomotor exercise on writing capabilities on autism

Conditions: Autism

Summary: autism spectrum disorders (asd)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (dsm-iv). in addition to these core deficits, asd is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. it is therefore not surprising that handwriting difficulties are frequently reported in children with asd.

handwriting is a functional skill that profoundly affects children's academic and psychosocial development. difficulties in acquiring and applying these skills subsequently lead to problems such as slow writing and illegible written .such difficulties may have implications on the child's successful participation in school and play activities, potentially leading to problems in academic performance and lowered self-esteem .therefore, students with handwriting difficulties are especially prone to frustration, disappointment, and under achievement. the aim of our study is to improve handwriting quality of children with asd.

Eligibility criteria:
inclusion criteria: * mild autism (score 55-71) on gilliam autism rating scale (gars-3). * intelligence quotient (iq) score 70-100. * writing difficulties exclusion criteria: * middle ear disorders * physical or mental conditions that may affect handwriting (e.g., seizures) * uncorrected visual or hearing impairments.
study of the efficacy of losartan on aortic dilatation in patients with marfan syndrome

Conditions: Marfan Syndrome

Summary: the purpose of this study is to evaluate if losartan limits aortic dilatation in patients with marfan syndrome.

aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy inclusion criteria : 10 years or older marfan syndrome according to international criteria signed informed consent non inclusion : previous surgery of the ascending aorta, or surgery planned non echogenicity contre-indication lactose pregnancy on going or planned within 3 years breast feeding participation in another clinical study non member of the social security or cmu number of subjects : the number of subjects (150 per group) is derived from the study from shores et al (1994) demonstrating the benefit of beta-blockade in marfan patient and uses a decrease by half of the aortic dilatation with losartan follow-up is 3 years, after inclusion period of 2 years. a total of 5 years is expected methods : randomised double blind vs placebo study. all french centres de competence for marfan syndrome and the centre de reference are participating in the study. end points : main endpoint is evolution of normalised aortic diameter. secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life.

Eligibility criteria:
inclusion criteria: * 10 years or older * marfan syndrome according to international criteria signed informed consent exclusion criteria: * previous surgery of the ascending aorta, or surgery planned * non echogenicity * contre-indication lactose * pregnancy on going or planned within 3 years * breast feeding * participation in another clinical study * non member of the social security or cmu

Keywords: marfan syndrome angiotensin ii type 1 receptor blockers aortic aneurysm, thoracic
direct superior approach (dsa) vs posterior approach (pa) in tha

Conditions: Surgery; Surgical Incision; Patient Satisfaction

Summary: total hip arthroplasty (tha) is a highly effective treatment for patients with symptomatic hip osteoarthritis. the surgical approach in tha is important as it influences postoperative clinical recovery, functional outcomes, and implant positioning \[1\]. the evolution of surgical techniques in tha has led to the development of minimally invasive surgery, which is performed through smaller skin incisions, reduced soft tissue disruption and greater muscle preservation \[2-10\]. this prospective, randomised control study compares clinical and radiological outcomes in tha performed using the standard posterior approach (pa) and its less invasive modification, the direct superior approach (dsa). the study will include 80 patients with hip osteoarthritis undergoing tha. following informed consent, patients will be randomised to one of the two treatment groups, and undergo tha using either the pa or dsa. the control group includes patients undergoing tha through the pa while the investigation group includes patients undergoing tha with the dsa. a further 25 patients randomly selected from each treatment group will undergo radiosteriometric analysis (rsa) to assess differences in early implant migration between pa and dsa groups. clinical and radiological outcomes of interest will be recorded by blinded observers at regular intervals for 2 years after surgery. the findings of this study will enable an improved understanding of differences in postoperative clinical recovery, functional outcomes, and implant positioning in tha performed using the dsa compared to the pa approach.


Eligibility criteria:
inclusion criteria: * patient has hip osteoarthritis requiring primary tha * patient and surgeon are in agreement that tha is the most appropriate treatment * patient is fit for surgical intervention following review by surgeon and anaesthetist * patient age: patients 18-80 years of age inclusive * gender: male and female * patient must be capable of giving informed consent and agree to comply with the postoperative review program * patient must be a permanent resident in an area accessible to the study site * patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken exclusion criteria: * patient is not suitable for primary tha e.g. patient requires revision surgery for previously failed tha * patient is not medically fit for surgical intervention * patients under the age of 18 or over 80 years of age * patient is immobile or has another neurological condition affecting musculoskeletal function * patient is already enrolled on another concurrent clinical trial * patient is unable or unwilling to sign the informed consent form specific to this study * patient is unable to attend the follow-up programme * patient is non-resident in local area or expected to leave the catchment area postoperatively

Keywords: total hip arthroplasty direct superior approach minimally invasive surgery implant position osteoarthritis posterior approach radiostereometric analysis