Kornimate/medical-research-clean huggingface dataset:
implementation of finnish prehospital stroke scale to emergency medical services

Conditions: Recognition of Thrombectomy Candidate

Summary: the investigators have developed a simple prehospital stroke scale (fpss), containing 5 dichotomized items to recognize both large and small artery thrombi of the brain. fpss is implemented to both emergency medical services and later, to emergency response centers. the efficacy of the scale and possible improvement of both the patient flow and treatment results will be evaluated.

finnish prehospital stroke scale, fpss, was developed for prehospital setting for prediction of large vessel occlusions (lvos) and stroke in common. it contains four stroke signs used universally in emergency medical services (emss) and emergency response centers (ercs): 1) facial weakness, 2) extremity weakness, 3) speech disturbance, 4) visual disturbance. additionally, it contains only one item 5) conjugated gaze deviation, while all the items are presented in dichotomized form. in an earlier, retrospective cohort of 856 code stroke patients, the sensitivity of fpss for lvos was highest for thrombi of areas with the documented cost effectiveness of endovascular treatment: internal carotid artery (ica) and m1 segment of middle cerebral artery (72 % and 82 %). the overall specificity of fpss for the lvos was 91 %. for its simplicity it is easy to implement in ems and erc as a single score predicting both thrombolysis and thrombectomy candidates. in the present study accuracy of fpss will be studied prospectively. fpss is launched 5/18 in ems in an area with a population of more than a million, containing districts of five central hospitals capable for thrombolysis and one university hospital capable for endovascular treatment. during 2019-20 fpss will be launched in two ercs triaging stroke patients in the study area. the hypotheses that are tested are: 1. fpss is accurate to detect ica and m1 thrombi in ems setting 2. the use of fpss shortens door-in-door-out (dido) delay patients arriving to central hospitals and redirected to university hospital for thrombectomy. 3. the use of fpss aids to triage lvo-patients straight to a center capable for thrombectomy 4. fpss is accurate in the detection of ica and m1 thrombi in erc setting 5. the effect of fluent triage of lvo is seen in overall shortened recanalization delay and better outcomes as lower modified rankin scores (mrs) in 3 months control compared recanalization delays and 3 month mrs during the pre-implementation period.

Eligibility criteria:
inclusion criteria: * acute ischaemic stroke * prehospital susipicion of large vessel occlusion exclusion criteria: - stroke mimic

Keywords: stroke conjugated eye deviation prehospital stroke scale large vessel occlusion
a study of av-101 (dry powder inhaled imatinib) in patients with pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: impahct: inhaled imatinib pulmonary arterial hypertension clinical trial is a phase 2b/phase 3 study to evaluate the safety and efficacy of av-101 (dry powder inhaled imatinib) in patients with pulmonary arterial hypertension (pah). the phase 2b part of the study will assess three doses to establish an optimal dose for the phase 3 part of the study. the phase 2b primary endpoint will be the placebo corrected change in pulmonary vascular resistance (pvr). the phase 3 primary endpoint will be the placebo corrected change in 6-minute walk distance (6mwd) after 24 weeks of treatment.


Eligibility criteria:
key inclusion criteria * pah belonging to one of the subgroups: 1. i/hpah, pah-ctd, 2. pah due to drugs and/or toxins/chemicals (having been in the care of the investigator for at least one year with no relapses of drug or toxin/chemical abuse), 3. hiv associated or 4. pah due to repaired congenital heart disease (at least 1 year since repair) * world health organization (who) functional class ii, iii or iv symptoms * stable concomitant background therapy of at least one pah approved medications * able to walk a distance of at least 100 m but no more than 475 m during the screening 6-minute walk tests. key exclusion criteria * pulmonary hypertension (ph) belonging to groups 2 to 5 * a history of left-sided heart disease * pregnant or breast-feeding females additional criteria may apply, per protocol

Keywords: pulmonary arterial hypertension lungs pulmonary pah av-101 imatinib impahct
novel serum biomarkers for identifying plaque erosion in acs and predicting prognosis

Conditions: Plaque Rupture; Acute Coronary Syndromes

Summary: the goal of this observational study is to find novel serum biomarkers for the accurate diagnosis of plaque erosion (pe) from acute coronary syndrome (acs) and help predicting the prognosis of pe. the main question it aims to answer is • whether novel serum biomarkers could facilitate the non-invasive diagnosis and prognosis prediction of pe ? participants will be contacted at 1,2,5 year after the diagnosis of pe-acs or other reasons of acs.


Eligibility criteria:
inclusion criteria: people presenting with an acute coronary syndrome (acs)-either non-st-segment elevation myocardial infarction (nste-acs); or st-segment elevation myocardial infarction (ste-acs), and subsequently underwent emergent coronary angiography followed by percutaneous coronary intervention (pci). culprit leisions were tested using optical coheren tomograpgy and pathological diagnosis(pe or pr) were validated by 2 independent experienced core lab members. exclusion criteria: * patients younger than 18 years or older than 85 years * patients in cardiogenic shock * prior coronary artery bypass grafting, * patients with corornary stent thrombosis * patients with left main coronary disease * patients with congestive heart failure * patients with life-threatening arrhythmia * patients with thrombocytopenia patients with significant hepatic or renal impairment * patients with septicemia, leukopenia, active inflammatory or malignant disease * other factors compromising high-quality optical coherence tomography (oct) imaging (e.g., severe vessel tortuosity or calcification, persistent no-reflow, lesions in distal segments, or an indeterminate culprit lesion) * individuals unable to provide informed consent were also excluded.

Keywords: plaque erosion plaque rupture acute coronary syndrome
detection of periapical lesions on dental panoramic radiographs based on artificial intelligence

Conditions: Periapical Diseases

Summary: dental periapical damages can have various reasons and is reflected by a radiolucent lesion on complementary imaging: angulated retro-alveolar (ra) radiographs, dental panoramic radiographs, and three-dimensional imaging such as computed tomography (ct) or cone-beam computed tomography (cbct). for the radiographic detection of these deep periodontal lesions, the dental panoramic represents a first approach commonly performed with relatively low radiation. the investigation can be followed by retroalveolar radiology imaging that are more localized and more precise. however, using these techniques, the detection rates of these lesions are low (20% and 36% respectively), it is necessary to use three-dimensional tomographic investigation to be more discriminating (69%). the gold standard imaging for detection of these lesions is cbct followed by retroalveolar radiography (\~2x less sensitive than cbct) and panoramic radiography (\~2x less sensitive than ra). although not a full-thickness radiograph, the dental panoramic has the advantage of being more commonly performed while being less radiating than cbct and giving a global view of the dental arches on a single image. the detection of periapical lesions is done after a clinical assessment and a visual appreciation of the complementary examinations. the aim of this project is to improve the detection of periapical lesions, by developing an algorithm able to identify them on a panoramic dental radiograph. this algorithm is based on a deep learning system trained with reference data including panoramic dental imaging and cbct with an acquisition interval of less than 3 months. the model is based on a previous work, will improve the quality of the initial data (using cbct), using innovative artificial intelligence algorithms (transfer learning).

the final objective of the research is to improve the early diagnosis of periapical lesions, which would allow a better and faster care of these lesions namely at early stages. this represents a major public health interest since these lesions can be responsible for multiple local and regional pathologies (osteomyelitis, cervico-facial cellulitis, thrombophlebitis, cerebral abscesses...) or even more serious general pathologies (cardiac pathologies, cardiovascular diseases, diabetes, renal diseases, tendinopathies...). for certain target groups such as the military and high-level athletes, this research would make it possible to improve the assessment carried out before medical aptitude or club transfer.

Eligibility criteria:
inclusion criteria: * patients who have had cbct and panoramic dental imaging with less than 3 months between the two examinations exclusion criteria: * patients who refused to participe in the study.

Keywords: tomography dental injury artificial intelligence periapical lesions
palbociclib (pd-0332991) combined with fulvestrant in hormone receptor+ her2-negative metastatic breast cancer after endocrine failure (paloma-3)

Conditions: Metastatic Breast Cancer

Summary: the study is a randomized, double blind, placebo controlled, phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (faslodex®) over fulvestrant alone in prolonging pfs in women with hr+, her2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. the safety between the two treatment arms will also be compared. during study treatment, pre- and perimenopausal women must be receiving therapy with the lhrh agonist goserelin (zoladex® or generic).


Eligibility criteria:
inclusion criteria: * women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy * confirmed diagnosis of hr+/her2- breast cancer * any menopausal status * progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy * on an lhrh agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (zoladex ®) at time of randomization. * measurable disease defined by recist version 1.1, or bone-only disease * eastern cooperative oncology group (ecog) ps 0-1 * adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures * patient must agree to provide tumor tissue from metastatic tissue at baseline exclusion criteria: * prior treatment with any cdk inhibitor, fulvestrant, everolimus, or agent that inhibits the pi3k-mtor pathway * patients with extensive advanced/metastatic, symptomatic visceral disease, or known uncontrolled or symptomatic cns metastases * major surgery or any anti-cancer therapy within 2 weeks of randomization * prior stem cell or bone marrow transplantation * use of potent cyp3a4 inhibitors or inducers

Keywords: palbociclib (pd-0332991) fulvestrant goserelin hormone receptor-+ her2-negative prior endocrine treatment any menopausal status paloma-3
young blind child melatonin treatment study

Conditions: Blindness

Summary: the primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. melatonin will be measured in urine, for children under the age of 3. sleep and behavioral questionnaires will be completed by parents and/or teachers. this study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. a second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.

Eligibility criteria:
inclusion criteria: * age 1-20 years * blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health. exclusion criteria: * abnormal heart, lung, kidney, liver disease or a primary sleep disorder, * significant clinical abnormalities (other than blindness), * use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).

Keywords: melatonin circadian rhythms sleep sleep disorders
evaluate the efficacy of bgg492 as adjunctive treatment in patients with refractory partial onset seizures

Conditions: Partial Onset Seizures

Summary: this study will assess the efficacy of bgg492 as adjunctive treatment in patients with refractory partial onset seizures


Eligibility criteria:
inclusion criteria: * outpatients ≥ 50 kg (110 lb) of weight * a diagnosis of epilepsy (≥ 2 years prior to screening) with partial seizures with or without secondarily generalized seizures * uncontrolled partial seizures despite having been treated with at least two different aeds within the last 2 years prior to screening. * treated with a stable dose of 1-2 aeds * at least 4 partial seizures during the 4-week baseline period and at least 4 partial seizures during the 4 weeks prior to the baseline period. * no 28-day seizure-free period during the 8 weeks preceding randomization * positive biomarker screening exclusion criteria: * presence of only non-motor simple partial seizures * history of psychogenic seizures * absences, myoclonic seizures e.g. in the context of primary generalized epilepsy; * previous history of lennox-gastaut syndrome * pregnant or nursing (lactating) women * status epilepticus or seizure clusters, according to the judgement of the investigator, occurring within 52 weeks prior to randomization other protocol-defined inclusion/exclusion criteria may apply

Keywords: partial onset seizure seizure frequency nervous system diseases central nervous system diseases cns brain diseases neurologic manifestations adjunctive treatment aeds antiepileptic drug
the effects of dppis on cognitive function of diabetic patients

Conditions: Cognitive Impairment

Summary: this is a single-center, randomized controlled clinical trial with a parallel-group design conducted at minia university hospital.

all patients admitted to diabetes clinics of minia university hospital, will be screened for the eligibility criteria. diabetic patients (aged above 50 years) with uncontrolled diabetes on oral hypoglycemic drugs. 105 patients will be enrolled and randomized into three groups. group i=35 t2dm patients given dpp4is group ii=35 t2dm patients given dpp4is and metformin. group iii=35 patients will be given placebo (only adjust their drugs to control blood glucose level)

Eligibility criteria:
inclusion criteria: type-2 diabetic adult subjects (above 50 years old) who had uncontrolled (a1c=8-9 %) blood glucose levels with an oral hypoglycemic drug at the screening visit were eligible to participate. exclusion criteria: those with type1 diabetes or ketoacidosis, end organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female), liver cell failure (elevated alanine transaminase (alt) and aspartate transaminase (ast) ≥ 2 folds), and heart failure, previous history of pancreatitis, and pregnant or lactating females were excluded from the study.

Keywords: cognitive dpp-4 inhibitors diabetes depression
the western norway mental health interface study on referral letters

Conditions: Mental Disorders

Summary: the main object to this trial is to study the function of referral letters as a mean to coordinate the care process for adult people when referred from primary care to specialised mental health care. the study will explore if and to what degree the quality of these referral letters can be improved, and the potential improvement's impact on defined patient-, professional and organisational related outcomes. according to medical research council guidelines for evaluating complex interventions, a stepwise design with the use of both qualitative and quantitative methods will be used to conduct a controlled intervention study.

the study is based on a stepwise progression including four steps. within step one group interview with four mixed groups of health professionals (both primary and specialised care), patient representatives and managers will be conducted. the groups will give input on firstly, what information they think is important to include in the referral letters, and secondly, what impact they think improved referral letters can have for the organisation and care within specialised mental health care. within step two a validated check-list to assess the quality of referral letters will be developed. within step three outcome measures will be developed and tested. both step two and three will make use of the results from step one in addition to existing literature and testing. step four is the intervention study where measures from the former steps will be used.

Eligibility criteria:
inclusion criteria: * referral letters send from a gp to public specialised mental health care * referrals for elective assessment or treatment exclusion criteria: * referral letters send from other health personnel * referrals for acute care (within 24 hours)

Keywords: health service coordination referral letters mental health adults
patient management during major abdominal surgery: an oxygen consumption protocol compared to standard approach

Conditions: Hemodynamic Instability

Summary: this study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. during general anesthesia metabolic needs of the body are markedly reduced and increase in co may not be necessary. in addition, excessive fluid administration has been related to worse post-operative outcomes. we divide patients into three groups: the standard treatment group, the nice protocol group and the intervention group. in this group we use the v-aco2/cao2-cvo2 as marker of tissue ability to increase their oxygen consumption in response to increased o2 delivery, and based on this index the administration of fluid. the principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.


Eligibility criteria:
inclusion criteria: * patients aged \> 18 years * acquisition of written informed consent * major abdominal surgery (major gastrointestinal surgery: dcp, gastrectomy, miles, emicolectomy; gynecologic surgery: oncologic surgery) surgery times ≥ 3 hours exclusion criteria: * absolute contraindication to cvc placement * pregnant women * hepatic surgery * laparoscopic surgery * major vascular surgery * dialysis treatment and kidney transplant surgery * severe heart failure (ef ≤ 35%) * emergency surgery

Keywords: co2 gap oxygen consumption stroke volume optimization
prospective clinical study to assess the safety and efficacy of versius, in transoral robotic surgery

Conditions: Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma, Unknown Primary

Summary: this is a single-arm, single site, multi-surgeon prospective feasibility study for transoral robot assisted surgery (tors) with the versius surgical system. versius is a robotic system designed to help in the accurate control of surgical instruments for minimal access ("keyhole") surgery. in tors procedures surgical instruments are inserted through the mouth/throat to remove sick tissue rather than through skin incisions. the primary objective of this study will be to evaluate the safe use and performance of the versius in transoral surgeries. pre-clinical work has been conducted to ensure tors with versius is viable and safe; this will be one of the first in-human studies of tors with versius. this study will focus specifically on patients with cancerous tumours of the oropharynx (the mouth/throat) that need to be surgically removed. the safety of versius for tors will be mainly assessed by the rate of complications/adverse events up to 30 days after surgery, and the performance will be mainly assessed by the number of tors cases successfully completed with versius (i.e. without having to switch to another surgical technique).


Eligibility criteria:
inclusion criteria: 1. patient and disease factors deemed suitable for robotic-assisted trans oral robotic surgery (tors) procedure using the versius surgical system 2. aged 18 or over with signed, written informed consent 3. histologically confirmed squamous cell carcinoma of the oropharynx {uicc/ajcc tnm (7) stage t1-3, n0-n2b / tnm (8) t1-3, n0-1 disease} or histologically confirmed squamous cell carcinoma in 1 or more cervical lymph nodes, with no discernible primary tumour (cancer unknown primary) 4. patients considered fit for surgery and potential adjuvant treatment (who performance status 0-2) 5. multidisciplinary team (mdt) decision to treat with primary surgery 6. surgical site and anatomical factors allowing access and freedom of operating using versius surgical system exclusion criteria: 1. t4 tumours, or t1-t3 where transoral surgery is not considered feasible due to anatomy, location, or disease factors; these may include (but not limited to) tumour visualisation, endophytic growth pattern and resulting defect functional concerns 2. disease / anatomical factors limiting access and freedom of operating using versius surgical system 3. patients with distant metastatic disease as determined by pre-operative staging 4. uicc/ajcc tnm (7) stage n2c-n3 disease; tnm (8) n2-3 disease 5. american society of anaesthesiologists (asa) class iv or above 6. who performance status 3 or above 7. unwilling or unable to sign an informed consent form 8. morbid obesity (bmi ≥40) 9. active pregnancy 10. medical contraindication for general anaesthesia 11. patient participation in an interventional clinical study within 30 days prior to screening, and up to 45 days post-surgery 12. patients with a history of radiotherapy to the head or neck

Keywords: tors robotic surgery transoral robotic surgery