Kornimate/medical-research-clean huggingface dataset:
increasing insulin resistance as a predictor of impending bacteremia

Conditions: Acquired ICU Bacteremia

Summary: insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of blood glucose regulation and increased insulin resistance. in sepsis there is an extreme activation of inflammatory mediators and of counter-regulatory hormones, such as cortisol, glucagon and catecholamines, which increase hepatic gluconeogenesis on the one hand, and increase the peripheral resistance to insulin on the other hand. disorder in the regulation of blood glucose level causes increased mortality and morbidity among intensive care unit patients with sepsis, as well as an increase in the duration of hospitalization and its financial expenses. there are a number of parameters used in the intensive care unit to diagnose the development of sepsis within the unit, such as an increase or decrease in body temperature, an increase in crp level, white blood cell count, pro-calcitonin level, etc it is possible that an increase in insulin resistance can also be used as a predictor of sepsis. it should be noted that almost all patients hospitalized in the intensive care unit are treated with a continuous infusion of insulin to balance their blood glucose level, including patients who are not diagnosed with diabetes prior to their hospitalization in the unit. this is in light of the increase in insulin resistance for the reasons listed above among patients in critical condition, and also due to the need to maintain blood glucose values in the range of 140-180 mg/dl, since high blood glucose values among patients hospitalized in the intensive care unit are associated with increased morbidity and mortality. we would therefore like to investigate whether an increase in insulin resistance, as expressed in an increase in the patient's insulin intake, can predict the development of sepsis secondary to bacteremia in the intensive care unit.


Eligibility criteria:
inclusion criteria:patients aged 18-100, diabetic and non-diabetic, admitted to the general intensive care unit from january 2013 to january 2021 (inclusive) for any reason, required during their hospitalization a continuous infusion of insulin, and developed during their hospitalization acquired bacteremia after more than 48 hours from icu admission. - exclusion criteria:patients who did not receive a continuous insulin infusion, patients with bacteremia of non-pathogenic bacteria (contamination), patients who developed bacteremia less than 48 hours after icu admission, patients who received drugs that might influence insulin resistance (steroids, glucagon) or patients with other reasons that might explain an increase in insulin resistance other than infection. -

Keywords: acquired bacteremia, insulin resistance
a novel smartphone application for "smart" knee osteoarthritis trials

Conditions: Osteoarthritis, Knee

Summary: the overarching goal is to develop a mhealth app that can use smartphone embedded sensors to objectively collect physical function data in individuals with knee osteoarthritis (koa) in the context of daily life.

the goal is to develop a mhealth app using smartphone embedded sensors to objectively collect physical function data in individuals with knee osteoarthritis (koa) in the context of daily life. it will be performed technical development of an internet-interactive app to collect, analyze and transfer the subjects' data. as a proof-of-concept, the mhealth app will execute algorithms that automate deployment of three well-established physical function tests. in a laboratory setting, it will be evaluated usability, acceptability and reliability of the mhealth app compared with traditional performance tests among focus groups of individuals with koa. it will then evaluate its usability and acceptability when used in the participants' home environments. as an early indicator of construct validity, it will be examined if the physical function test measurements can detect diurnal variation in the impact of koa.

Eligibility criteria:
inclusion criteria: * male or female subjects at least 50 years old with symptomatic knee osteoarthritis * english speaker * be able to walk 20 meters without an assistive device, such as a cane, walker or crutches. * have an iphone 6 or higher with internet connection. \* confirmation of knee osteoarthritis will be based on american college of rheumatology (acr) classification criteria: exclusion criteria: * prior surgery on either knee within 6 months of enrollment * received corticosteroid injection in the knee within 3 months of enrollment * evidence or history of any other inflammatory arthritis (rheumatoid arthritis, gout, psoriatic arthritis).

Keywords: chronic diseaase technology pain function
how does platelet dose impact clinical outcomes after prp treatment?

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine which platelet rich plasma (prp) injection dosage provides the most improvement in a patient's knee pain level at 26 weeks post-injection.

knee osteoarthritis (oa) is a chronic progressive disease affecting more than 20% of people older than 45 years. a myriad of different treatments have been proposed in the scientific literature, and current treatment options include conservative and surgical procedures in which the main objective is to relieve pain and improve function. conservative nonsurgical interventions include weight management, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs (nsaids), corticosteroid and hyaluronic acid injections. although these agents have been beneficial in the short term, there is a lack of evidence that such interventions alter the progression of oa. more recently, platelet-rich plasma (prp), a biological therapy, has become an emerging treatment option to improve the status of the joint for patients with oa. prp is an autologous blood product that is injected into the knee joint, which contains an elevated concentration of platelets above that of whole blood. however, the optimal prp preparation is still unknown. studies are needed that investigate optimal platelet count and how that is related to clinical outcome. this study is designed as a double-blind randomized controlled study, where enrolled subjects are randomized to one of five treatment groups (in blocks of 10): 1. a total prp injection dose of less than 5 billion platelets; 2. a total prp injection dose between 5 and \<10 billion platelets; 3. a total prp injection dose between 10 and \<20 billion platelets; 4. a total prp injection dose of \>20 billion platelets; and 5. a saline injection control each patient will be asked to complete a questionnaire at baseline, 6, 12, and 26 weeks. after patients have completed all the study questionnaires, the investigators will pull the results from the blood analysis, so that blood composition levels can be correlated with any pain improvements that are felt. the purpose of the study is to establish if there is a relationship between the injection dosage a patient receives and knee pain level (based on the pain scores from the self-reported questionnaire).

Eligibility criteria:
inclusion criteria: * 40-80 years of age * previous diagnosis of unilateral, primary osteoarthritis of the knee * knee pain; duration of symptoms \> 4 weeks * k-l grade 0-4 exclusion criteria: * under 40 years of age; over 80 years of age * bilateral knee pain * duration of symptoms \< 4 weeks * nsaid or clopidogrel use in the last 7 days * high risk of a thrombotic event if discontinuing nsaid or clopidogrel for four weeks. * steroid use in the last 6 weeks * active diagnosis of leukopenia/anemia/thrombocytopenia

Keywords: osteoarthritis osteoarthritis, knee arthritis platelet rich plasma
anais, a spanish version of the dafne programme

Conditions: Diabetes Mellitus, Type 1

Summary: anais is a therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. participants are randomised in two groups, to attend the training course immediately (immediate anais) or a year later (delayed anais). the main outcome was hba1c at one year.

anais (alimentación normal con ajuste de insulina) is a spanish version of the dafne programme, performed in patients with type 1 diabetes. anais is a randomised, controlled, parallel trial. anais is a group-based, therapeutic education programme for type 1 diabetes based on a flexible insulin regime adjusted to the patient's food intake. participants with type 1 diabetes and an hba1c between 7 and 10% were recruited from the outpatient clinics in a tertiary care center. they were randomised (opaque, sealed envelopes, 2:1 ratio) to attend the training course immediately (immediate anais) or a year later (delayed anais). the main outcome was hba1c at one year. secondary outcomes included lipids, weight, hypoglycemic events, treatment satisfaction, quality of life and self-defined objectives.

Eligibility criteria:
inclusion criteria: we considered patients to be eligible if they were aged over 18 years, had type 1 diabetes, had an hba1c between 7-12%, (or hba1c \< 7% with a history of severe hypoglycemia), duration of diabetes of more than two years without advanced complications and ability to understand written and spoken spanish. exclusion criteria: exclusion criteria included severe psychiatric illness, pregnancy, or other circumstances that, according to the investigators' criteria, could interfere with study completion.

Keywords: type 1 diabetes education programme quality of life dietary freedom patient empowerment
comparison of tumor efficacy safety in laparoscopic resection of gastrointestinal stromal tumors between favorable and unfavorable site

Conditions: GIST of Stomach; Gastric Cancer; Surgery; Complication

Summary: participants with gastrointestinal stromal tumors(gist) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of gist and that of unfavorable site under the currently standard surgical therapy.

participants with gastrointestinal stromal tumors(gist) were divided into favorable and unfavorable sites according to the anatomical site of the tumor, and this study aims to validate the overall postoperative morbidity and mortality rates between favorable site receiving laparoscopic resection of gist and that of unfavorable site under the currently standard surgical therapy. main end of study: 3-year disease free survival rate

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old 2. primary gastric lesion confirmed pathologically gist by endoscopic biopsy. preoperative endoscopy, ultrasound endoscopy or computer tomography, magnetic resonance suspected gist, and then postoperative pathology confirmed as the original gist 3. written informed consent 4. expected r0 resection by laparoscopy 5. performance status of 0 or 1 on the ecog (eastern cooperative oncology group) scale 6. asa (american society of anesthesiology) class i to iii 7. maximum tumor diameter ≤10cm exclusion criteria: 1. pregnant and lactating women 2. suffering from a severe mental disorder 3. history of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. history of previous gastric surgery (including esd/emr for gastric cancer) 5. rejection of laparoscopic resection 6. history of other malignant disease within the past five years 7. history of unstable angina or myocardial infarction within the past six months 8. history of a cerebrovascular accident within the past six months 9. history of continuous systematic administration of corticosteroids within one month 10. requirement of simultaneous surgery for another disease 11. emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer 12. fev1\<50% of the predicted values 13. maximum tumor diameter \>10cm

Keywords: gist laparoscopic resection early complication mortality tumor sites
proof of concept study on pitolisant effect on autism spectrum disorders in children and adolescents

Conditions: Autism Spectrum Disorder

Summary: proof of concept, multicenter, randomized, double-blind, placebo-controlled, parallel-group, study to investigate the effect, safety, tolerability and pharmacokinetics of pitolisant in male children and adolescents with autism spectrum disorders.

first clinical study to assess the effect of bf2.649 in male children and adolescent with a diagnosis of autism spectrum disorders according to dsm-5 criteria and confirmed by the autism diagnostic observation schedule (ados-2) or autism diagnostic interview-revised (adi-r) over a 12-weeks period.

Eligibility criteria:
inclusion criteria: * participants and their parent(s)/legal guardian(s) are willing and able to give informed assent and consent for participation in the study. * male children and adolescents aged from 6 to 17 inclusive for the duration of study participation. * diagnosis of autism spectrum disorders (asd) as per the diagnostic and statistical manual of mental disorders (dsm-5) criteria confirmed by the autism diagnostic observation schedule (ados-2) or the autism diagnostic interview-revised (adi-r). * intelligence quotient (iq) ≥ 70 using wechsler intelligence scale. * social responsiveness scale second edition (srs-2) total t-score ≥ 66 at screening and baseline. exclusion criteria: * previous genetic diagnosis of asd-known "syndromic" asd (e.g., fragile x syndrome, angelman syndrome, prader-willi, rett's syndrome, tuberous sclerosis, dup15q syndrome). * history of suicidal behavior or suicidal ideation in the past 12 months, or a positive answer to questions 4 or 5 on the columbia-suicide-severity rating scale (c-ssrs) at screening and/or baseline, and/or is a significant risk for suicidal behavior per investigator judgement. * history or current diagnosis of epilepsy or any seizure occurring after the age of 5. * clinically significant deviation from normal on 12-lead ecg that results in an active medical problem, per investigator judgement or, with a corrected qt interval by fridericia (qtcf) \> 450ms at screening. * severe hepatic impairment (child pugh c) or with any other hepatic significant abnormality in the physical examination or alanine aminotransferase (alat) or aspartate aminotransferase (asat) ≥ 2x upper limit of normal (uln) for age at laboratory results.
a study to assess efficacy, safety of kae609 in adult patients with acute malaria mono-infection

Conditions: Cure Rate

Summary: this study will assess efficacy, safety , tolerability and pk in uncomplicated adult malaria patients with acute p. falciparum infection after single dose with kae609 at 75 mg, 150mg, 225mg and 300mg/day

the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study. cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. after approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a data monitoring committee(dmc). consensus agreement of dmc is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Eligibility criteria:
inclusion criteria: * male and female patients aged 20 to 60 years * presence of mono-infection of p. falciparum * weight between 40 kg to 90 kg exclusion criteria: * patients with signs and symptoms of severe/complicated malaria * mixed plasmodium infection * presence of other serious or chronic clinical condition requiring hospitalization. * severe malnutrition * significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study

Keywords: parasitemia
comparison of two daily disposable lenses

Conditions: Refractive Ametropia; Myopia

Summary: the purpose of this study was to compare the clinical performance of the new dailies® aquacomfort plus® freshtech (dacp freshtech) contact lenses to an already marketed daily disposable contact lens, dailies® aquacomfort plus® (dacp).

subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.

Eligibility criteria:
inclusion criteria: * at least 3 months of soft contact lens wearing experience; * wears habitual lenses at least 5 days per week and at least 8 hours per day; * uses digital devices (computer, tablet, and/or smart phone) for an average of 4 hours per day; * experiences eye fatigue at least once per week attributable to digital device use with habitual lenses; * is willing to not use rewetting/lubricating drops during the period of study product exposure; * other protocol-specified inclusion criteria may apply. exclusion criteria: * routinely sleeps in contact lenses; * known pregnancy at time of enrollment; * binocular vision issues or issues of eye alignment; * any eye infection, inflammation, disease or abnormality that contraindicates contact lens wear; * use of medications as specified in the protocol; * ocular surgery within the past 12 months; * other protocol-specified exclusion criteria may apply.

Keywords: eye strain eye fatigue
treatment of vesico-vaginal fistula by a robot assisted laparoscopy : results of a multicentric series (ffvlaro)

Conditions: Vesico-vaginal Fistula

Summary: robot-assisted vesico-vaginal fistula (vvf) repair was described a few years ago as an alternative to the open approach to minimize the morbidity of this surgery. very little series have reported the results of robotic vvf repair. the objective of this work was to evaluate the results of robotic vvf repair.


Eligibility criteria:
inclusion criteria: * presence of a vesico-vaginal fistula exclusion criteria: -
intelligent approach to traditional chinese medicine for insomnia

Conditions: Insomnia

Summary: insomnia is a very common health issue, affecting over 40% of the population in chinese-speaking regions. the impact of insomnia on society, economy, mental health, and physical health is significant, with previous research indicating that insomnia is associated with an increased risk of high blood pressure, heart disease, anxiety, and depression, which can ultimately lead to a decline in quality of life. treatment for insomnia includes non-pharmacological and pharmacological interventions, with clinical practice often utilizing sedative medications for sleep, but with side effects such as dependency, tolerance, daytime drowsiness, and withdrawal symptoms, which make it challenging for patients to find suitable medical treatment. traditional chinese medicine (tcm) approaches insomnia by first conducting a thorough assessment based on individualized patterns (differentiation of body constitution) and evaluating insomnia-related symptoms, followed by an examination of tongue and pulse to determine the correct treatment plan, which may involve acupuncture, herbal medicine or a combination of both (integrative treatment). due to the complex nature of insomnia, a definitive diagnosis requires neuroimaging and other measures during sleep studies to assess brain wave activity, if possible, to understand the cognitive impact.

in the treatment of insomnia, chinese medicine first assesses the individual's constitution and symptoms related to insomnia, before incorporating auricular acupuncture and pulse diagnosis. subsequently, different syndrome types are identified and treated with acupuncture or traditional chinese medicine (dialectical treatment). since insomnia is often subjective, a definitive diagnosis may require overnight monitoring of brain waves and other parameters in a sleep laboratory. smart imaging methods can help detect special reaction areas of ear points, while pulse diagnosis equipment can provide objective auxiliary diagnosis and classification of insomnia through pulse wave digital conversion analysis. previous studies have demonstrated the effectiveness of auricular point stimulation in treating insomnia, and this study aims to enhance the therapeutic outcomes for primary insomnia by combining chinese medicine techniques.

Eligibility criteria:
inclusion criteria: * major mental illnesses include schizophrenia, bipolar disorder, major depression, dementia, apnea, restless legs syndrome, alcohol and substance abuse, organic psychosis and those with major physiological illnesses that affect sleep. exclusion criteria: * as per the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) published by the american psychiatric association, insomnia is characterized.

Keywords: auricular points, chinese medicine pulse diagnosis
deep brain stimulation of the globus pallidus in huntington's disease

Conditions: Huntington's Disease

Summary: this is a single centre, controlled phase i study, which evaluates safety and efficacy of stimulation of lower caudal two contacts (gpi) vs. upper cranial two contacts (gpe) in huntington´s disease (hd).

a total of 6 hd patients will be selected out of an existing larger hd patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. the preoperative clinical status will be evaluated twice including the united huntington disease rating scale (uhdrs), neuropsychological, neurophysiologic and neuroradiological assessments. at 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place. all patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the globus pallidus, two contacts reaching the gpe, two the gpi within both hemispheres. surgery will be done under general anesthesia, the implantation of the stimulator (kintera®) will take place in the same procedure. postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests. we expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal deep brain stimulation (dbs) on motor symptoms of hd.

Eligibility criteria:
inclusion criteria: * clinically symptomatic and genetically confirmed huntington disease (number of cag repeats\>= 36) * age: \> 18 * moderate stage of the disease (uhdrs motor\>= 30) * predominant movement disorder * compliance of the patient, stable cognition during a 6 months phase prior to inclusion (mds\>/= 120) * signed informed consent exclusion criteria: * advanced disease, precluding the ability to give informed consent * very early stage of disease causing minor disability * severe comorbidity that could compromise the life prognostic or preclude general anaesthesia or immunosuppression * mattis dementia rating scale \< 120 * psychiatric or personality disturbances that might compromise the follow-up * participation at another trial (in particular transplantation) * severe cortical atrophy seen on ct and mri

Keywords: globus pallidus huntington's disease deep brain stimulation movement disorders