Kornimate/medical-research-clean huggingface dataset:
does environmental factors affect accuracy in pre-hospital non-invasive temperature measurement?

Conditions: Hypothermia

Summary: the aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting.

the aim of this study is to assess the impact of different environmental factors on the ability for a thermistor-based epitympanic thermometer to accurately read the temperature of a normothermic individual and thereby estimate their feasibility and reliability in the austere pre-hospital setting. healthy volunteers will be recruited. as reference value for core temperature we will use a standard rectal probe (mon-a-therm, general purpose temperature probe 12fr/ch, covidien) attached to an external monitor. the study will be in a field setting in the mountains of hemsedal, norway. for measuring the epitympanic temperature we will use the metraux thermometer (walpoth, galdikas et al. 1994). the metraux thermometer is widely used in pre-hospital care in norway and internationally. the ear-sensor will after induction of anaesthesia be inserted according to the manufacturers specifications in the auditory canal and activated. the sensor is two tiny and soft metal wires covered in a plastic wrapping integrated in a soft rubber earplug. the depth of the measuring point is pre-set from the manufacture to be approximately 10 mm from the tympanic membrane. the display will then show the epitympanic temperature in real-time. the volunteers will be exposed to four different scenarios. 1. ambient air with no protection of head/measuring site. 2. ambient air with local protection of measuring site. 3. snow in the ear-canal before placing the thermometer (to resemble avalanche conditions). 4 cold water in the ear canal (to resemble water immersion/submersion). the temperature will be measured in degrees celsius. a baseline will be established before exposing the volunteers to the different environmental factors. after exposure the temperature will be recorded every 15 seconds for a total of 10minutes.

Eligibility criteria:
inclusion criteria: * adult 18-60 years * no medication * healthy, no chronic illness * no acute illness on study day * no pathology in ear canal on otoscopy exclusion criteria: * pathology in ear canal * non-consent

Keywords: hypothermia pre-hospital epitympanic temperature
clinical-pathological characterization and outcomes of metastatic urothelial cancer in latin america

Conditions: Recurrent/Metastatic Urothelial Cancers

Summary: the lacog 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in latin america.


Eligibility criteria:
inclusion criteria: 1. age at least 18 years; 2. histological confirmation of urothelial carcinoma (include mixed urothelial histology); 3. diagnosis of recurrent or metastatic (stage iv) urothelial carcinoma during the period of january 2016 to july 2018; 4. site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records; 5. availability of tumor sample (ffpe/slides) from primary tumor or metastatic site at the time of registration. exclusion criteria: 1. synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers); 2. pure non-urothelial carcinoma histology.

Keywords: metastatic recurrent urothelial cancers renal pelvis ureter bladder urethra
continuous glucose monitoring in prediabetes

Conditions: Pre-diabetes

Summary: the objective of this project is to develop a behavioral intervention that combines wearable continuous glucose monitoring (cgm) with smartphone feedback and educational video clips generated by artificial intelligence (ai) software to improve glycemic control among individuals with pre-diabetes. the goal is to prevent transition to type 2 diabetes.

video narratives will be provided by latino community health workers, known as promotores de salud (pds), who will wear and experience the continuous glucose monitoring (cgm) system and its glycemic variability feedback. study 1 (g1) is a phase 0 intervention development study, enrolling a sample of 20 spanish- and/or english-speaking pds who test positive for pre-diabetes via a finger prick screening. participants will wear cgm devices for 20 days, during which they will record daily narratives about their experiences with the cgm feedback and their glucose variability. structured interviews between staff and participants will explore the benefits and barriers of cgm use. these recorded video clips will serve as the foundation for educational cinematic smartphone videos for future interventions. artificial intelligence (ai) tools will be used to translate the text, audio, and video clips into various languages for broad dissemination. blood glucose levels in mg/dl will be recorded continuously over the wear period.

Eligibility criteria:
inclusion criteria: * prediabetes by finger prick blood a1c% * willingness to wear cgm sensor * latino community health worker exclusion criteria: * currently pregnant * less than 18 years of age, which is adult in california * diagnosed with any disorder that interferes with glucose * influential medical disorder/event affecting ability to participate in study * incompatible smartphone device not pairing with dexcom g6 app

Keywords: prediabetes glucose management feedback narrative education artificial intelligence contingency-shaped learning
impact of anti-cytomegalovirus treatment in the management of relapsing ulcerative colitis requiring vedolizumab therapy

Conditions: Ulcerative Colitis, Unspecified

Summary: ulcerative colitis (uc) is an inflammatory bowel disease that can require the use of anti-tnf alpha therapy. when anti-tnf alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. the efficacy of vedolizumab has been assessed in a phase 3 study (gemini i), with response rates of 41.1% with vedolizumab vs 25.5% with placebo. cytomegalovirus (cmv) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). a recent meta-analysis supports the use of valganciclovir in case of cytomegalovirus (cmv) reactivation in active ulcerative colitis (uc). moreover, a study showed that the risk of cmv reactivation seems to be more important with vedolizumab than with anti tnf, and the risk of colectomy is higher in case of cytomegalovirus (cmv) reactivation (p\<0.05).

the hypothesis of this study is in ulcerative colitis (uc) patients with tissue cytomegalovirus (cmv) reactivation ; not responding to anti-tnf or without anti-tnf ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.

Eligibility criteria:
inclusion criteria: * patient with moderate to severe active ulcerative colitis (uc) defined by a mayo score greater than 5 * patient with an inflammatory outbreak of ulcerative colitis (uc) : * without anti-tnf * under anti-tnf (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure). * having rectosigmoidoscopy with an endoscopic mayo score≥ 2 with 2 biopsies of the inflammatory tissue * presence of a cytomegalovirus (cmv) infection in the inflammatory tissue (viral load greater than 5 iu / 100000 cells by qpcr) * patient with a negative pre-treatment assessment including hiv, hbv, hcv, hcv serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by rifinah or rimifon * signed informed consent exclusion criteria: * patient with severe acute colitis * patient treated by ciclosporin or prograf * patient with human immunodeficiency virus (hiv)+, hepatitis b, hepatitis c, tuberculosis * clostridium difficile infection. * patient with intolerance or contraindications to current therapy * pregnant or starts breastfeeding * patient who received a live vaccine in the month preceding the study * patients with severe renal insufficiency defined by creatinine clearance \<30ml/minute, or hemodialysed

Keywords: ulcerative colitis (uc) cytomegalovirus (cmv) vedolizumab valganciclovir anti-tnf mayo score
bilateral synchronous simultaneous stone surgery

Conditions: Kidney Calculi; Nephrolithotomy, Percutaneous; Ureteroscopy

Summary: advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. to avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (bssss) has been popularized in recent years. our aim is to evaluate the preliminary outcomes of bssss in patients undergoing supine percutaneous nephrolithotomy (pcnl) and retrograde intrarenal surgery (rirs).


Eligibility criteria:
inclusion criteria: * patients scheduled for kidney stone surgery according to european association urology, urolithiasis guidelines * patients with bilateral kidney stones exclusion criteria: * none
rectus femoris thickness measurement in unilateral transtibial amputated prosthesis users

Conditions: Amputation, Traumatic

Summary: knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation. it is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis. therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process. muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy x-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases. the first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests. the second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.

bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound. bilateral knee extension strength was measured via handheld dynamometer (jamar, bolingbrook, il, usa). functional strength and walking were assessed by step-up-over (suo) and walk-across (wa) tests of neurocom balance master® device (neurocom international, clackamas, or, usa).

Eligibility criteria:
inclusion criteria: 1. unilateral transtibial amputation on the right side 2. using the prosthesis for more than 1 year 3. able to use the prosthesis without pain and discomfort 4. able to walk without a walking aid exclusion criteria: 1. presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.) 2. ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.) 3. taking medication that is known to affect balance

Keywords: amputees quadriceps musclemuscle strength muscle strength
active-control randomised trial comparing 4-factor prothrombin complex concentrate with frozen plasma in cardiac surgery

Conditions: Bleeding Cardiac Surgery Patients

Summary: this is a multicentre, active-control randomized, prospective, phase 3 study in adult cardiac surgery patients. approximately 500 patients will be randomized at approximately 12 hospitals.

patients will be randomized to receive either 4-factor pcc (octaplex) or frozen plasma (fp). the study will compare the hemostatic treatment response to octaplex versus fp, defined as effective if no additional systemic or surgical hemostatic intervention is required from 60 minutes to 24 hours after initiation of the first treatment dose. the study will include adult (≥18 years old) patients who undergo cardiac surgery with cardiopulmonary bypass (cpb) and require coagulation factor replacement due to bleeding post-cpb and after adequate reversal of heparin with protamine (as assessed by the surgical staff based on clinical and laboratory criteria) during surgery, and who have a known (e.g., as indicated by inr) or suspected coagulation factor deficiency.

Eligibility criteria:
inclusion criteria: 1. adult (≥18 years old) patients undergoing any index cardiac surgery employing cpb 2. coagulation factor replacement with pcc or fp ordered in the operating room for: 1. management of bleeding, or 2. anticipated bleeding in a patient who has been on-pump for \>2 hours or has undergone a complex procedure (e.g., aortocoronary bypass \[acb\] plus aortic valve replacement) 3. coagulation factor deficiency, either known to exist (e.g., as indicated by elevated extem clotting time \[ct\] or inr) or suspected based on the clinical situation 4. patients who have given written informed consent. in united states patients will provide informed consent prior to surgery. in canada, informed consent will be obtained after surgery, in accordance with article 3.7a of the 2018 tri- council policy statement on the ethical conduct for research involving humans. exclusion criteria: 1. undergoing heart transplantation, insertion or removal of ventricular assist devices (not including intra-aortic balloon pump \[iabp\]) or repair of thoracoabdominal aneurysm 2. critical state immediately before surgery with high probability of death within 24 hours of surgery (e.g., acute aortic dissection, cardiac arrest within 24 hours before surgery) 3. severe right heart failure (clinical diagnosis ± echocardiography) 4. known contraindications to heparin 5. pcc required for reversal of warfarin or direct oral anticoagulant (doac; dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to or during surgery 6. known thromboembolic event (tee) within 3 months prior to surgery 7. history of severe allergic reactions to pcc or fp 8. individuals who have immunoglobulin a (iga) deficiency with known antibodies against iga 9. refusal of allogeneic blood products 10. known pregnancy 11. currently enrolled in other interventional clinical trials
a study comparing pf-05089771 ts tablet to pf-05089771 ts oral dispersion in the fasted state and to pf-05089771 ts tablet in the fasted and fed state

Conditions: Pain

Summary: the primary purpose of this study is to estimate the relative bioavailability and food effect of a pf-05089771 tablet.


Eligibility criteria:
inclusion criteria: * healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years exclusion criteria: * evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen. * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * screening supine blood pressure ≥140 mm hg (systolic) or ≥90 mm hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. single 12-lead ecg demonstrating qtc \>450 msec or a qrs interval \>120 mseca at screening. if qtc exceeds 450 msec, or qrs exceeds \>120 mseca the ecg should be repeated two more times and the average of the three qtc or qrs values should be used to determine the subject's eligibility.
anlotinib in combination with durvalumab as sequential therapy of thoracic radiotherapy after induction chemotherapy for extensive-stage small cell lung cancer:a single arm study

Conditions: Anlotinib; Durvalumab; Small Cell Lung Cancer

Summary: anlotinib in combination with durvalumab as sequential therapy of thoracic radiotherapy after induction chemotherapy for extensive-stage small cell lung cancer:a single arm study


Eligibility criteria:
inclusion criteria: - the subjects volunteered to join the study and signed the informed consent form. they had good compliance and cooperated with the follow-up; patients between 18-75 years old; extensive small cell lung cancer confirmed by histopathology (according to veterans administration lung study group, valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide \[complete remission (cr), partial remission (pr) or stable (sd) according to recist1.1 standard\]; the time interval between the first trt and the end of the last chemotherapy should be less than or equal to 6 weeks; the life expectancy shall be at least 3 months; ecog score: 0-1 exclusion criteria: - small cell lung cancer patients with other pathological types of tumor species; patients with pathological fracture in bone metastasis of small cell lung cancer; patients with central nervous system metastasis; patients who have received chest radiotherapy before; patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; imaging (ct or mri) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
analysis of the impact of a temporo-spatial reorientation tool on the speed of improvement of confusional syndrome

Conditions: Attention Disorder

Summary: confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. there are patient-specific predisposing factors and precipitating factors. elderly people, due to their comorbidities, are more at risk. confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. the health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 european countries in 2011. the occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality. the gold standard for making the diagnosis of delirium is the use of the dsm-5 criteria, but their use is time-consuming and requires that staff be trained in their use. the 4 "a" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes. concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. a tool to help with temporo-spatial reorientation (la rob'gazette) has been set up in the medical care and geriatric rehabilitation (smrg) departments of the hus


Eligibility criteria:
inclusion criteria: * patient aged 75 and over * hospitalized at the hus in the smrg department during the period from january 1, 2021 to april 31, 2023 * passed at least a 4at during hospitalization * absence of written opposition in the patient's medical file (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes. exclusion criteria: - presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.

Keywords: attention disorder confusion syndrome attentional disorders disorganization of cognitive functions
muscle metabolic function in older adults with different vitamin d status before and after exercise

Conditions: Vitamin D Deficiency

Summary: this is a small pilot aerobic training trial designed to examine differences between normal-high and low vitamin d levels and 7-days of aerobic training on local vo2 measured by non-invasive hybrid diffuse optical spectroscopy.


Eligibility criteria:
inclusion criteria: * 65-75 years of age exclusion criteria: * currently have or have a history of cardiovascular or pulmonary disease that would preclude the involvement in the performance of exercise. * uncontrolled diabetes or hypertension. * history of neurological conditions related to spinal derangement, disk disease, peripheral neuropathies, tremor and rigidity * history of leg/hip trauma, inflammation, infection rhabdomyolysis, or leg surgery in the past 3 months * have a diagnosis of osteoporosis (as determined by dxa) * participated in a resistance or aerobic training program in the last 3 months * engage in more than 1 hr/week of vigorous activity * body mass index \>29 * on hormone replacement therapy

Keywords: muscle metabolic function vitamin d status 25(oh)d older adults
study evaluating cci-779 in relapsing multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: to evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral cci-779 administered to subjects with relapsing ms who completed study 3066a2-205-ww.


Eligibility criteria:
inclusion criteria: * subjects with relapsing-remitting ms or secondary progressive ms with relapses. * successful completion of study 3066a2-205-ww with no major protocol violations. exclusion criteria: * pregnancy or lactation. * clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ecg) performed at the last visit of study 3066a2-205-ww (day 252). * any adverse events or findings observed in study 3066a2-205-ww that in the opinion of the investigators would preclude the subject's entry into the extension study. please refer to section 16.2 'discontinuation and withdrawal of subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066a2-205-ww.

Keywords: multiple sclerosis