Kornimate/medical-research-clean huggingface dataset:
fetal clavicular measurement to predict fetal macrosomia

Conditions: Macrosomia, Fetal; Large for Gestational Age; Shoulder Dystocia

Summary: macrosomia is associated with increased risks for both the mother and the baby, including complications during delivery, injuries, and even death. the accurate diagnosis of macrosomia is often difficult before birth. there are a number of factors that can increase the risk of macrosomia, such as maternal obesity, diabetes, and excessive weight gain during pregnancy. there are also a number of different techniques that can be used to try to predict macrosomia, but none of them are perfect. the aim of this study is to evaluate sensitivity of measuring fetal clavicle length in third trimester compared with biacromial diameter and hadlock formula iv for prediction of fetal macrosomia.

two terms are applied for fetal overgrowth, large for gestational age (lga) meaning fetal birth weight (bw) more than 90th percentile for specific gestational age while macrosomia is an absolute value regardless of gestational age which historically defined as 4000-4500 gm. those two groups have increased risks for neonatal and maternal complications compared to general population and increase sharply when bw \>4500gm, the risks of macrosomia are continuum without threshold defining safe and risky outcome, some authors classify macrosomia into 3 grades, grade 1 (4000gm-4499gm), grade 2(4500-4999), grade 3 (≥5000gm). despite its implications, the accurate diagnosis is after birth and its prenatal prediction is poor although published formulas for estimating fetal weight shows correlation with bw, however the variability of the estimate is up to 20% with most of formulas, meta-analysis of 29 studies showed sensitivity of 56% and specificity of 92% in predicting bw ≥ 4000gm accuracy of ultrasound decreases with increasing bw, bw\>4500 accurate prediction is only 33-44 % of cases. given the poor predictability of macrosomia, variety of other techniques and formulas are investigated, neither repeated us examination nor growth curves improves predictability, youssef's formula measuring biacromial diameter (distance by between both acromial processes which joins clavicles at acromioclavicular joints) and macrosomic specific formula seems to be predictive. in study evaluating clavicle length for shoulder dystocia, it found that measuring clavicle was significant for macrosomia however the limitation is small sample size and its comparison with other fetal biometrics may be needed.

Eligibility criteria:
inclusion criteria: * singleton pregnancy. * gestational age between 37-42 weeks. * accepting to be included in the study. exclusion criteria: * congenital fetal malformation affecting birth weight or affecting clavicle.

Keywords: macrosomia hadlock clavicle large for gestational age lga clavicle measurement youssef's formula biacromial diameter estimated fetal weight. efw ultrasound
incidence of late haemorrhage after invasive gastroenterological endoscopic manoeuvre in patients treated with anticoagulants compared to non-anticoagulated patients

Conditions: Bleeding

Summary: patients on oral anticoagulant therapy with vitamin k antagonists (avks; warfarin and acenocoumarol) and direct oral anticoagulants (doacs; apixaban, dabigatran, edoxaban and rivaroxaban), are advised to consider discontinuing treatment in anticipation of invasive manoeuvres. guidelines and expert consensus recommend, in clinical conditions with a high risk of bleeding, to suspend oral anticoagulant treatment with doacs 2 or 3 days before the procedure, depending on the glomerular filtrate, to suspend warfarin from day -5 and acenocoumarol from day -4, and to introduce heparins from day -3 after discontinuation of avks (so-called 'bridging therapy') for manoeuvres with a high risk of bleeding. in manoeuvres with a low bleeding risk it is possible not to suspend the anticoagulant or to reduce its intensity. obviously, the patient's intrinsic haemorrhagic and thrombotic risk (antiplatelet intake, renal insufficiency, hepatopathy, age, mechanical valve prosthesis, oncological condition, etc.) must also be taken into account in the overall assessment of pre-procedural preparation. gastroenterological endoscopic manoeuvres are generally considered to be at low haemorrhagic risk even if biopsy is planned, but are at high haemorrhagic risk if polypectomy or mucosectomy is planned. the most complex problem arises at the time of re-introduction of anticoagulant post-procedure. in fact, studies evaluating this specific aspect are very few and heterogeneous and mostly retrospective. the variables that are associated with an increased risk of bleeding are: the number and site of polypectomies, the diameter of the polyps, and local haemostasis techniques. late haemorrhages (\>24 hours) are of concern because the patient is generally at home and because, by the time the eschar falls out (varying between 4 and 10 days post-procedure), they have already resumed anticoagulation. however, there are no prospective studies of sufficient number to clarify whether the reintroduction of anticoagulation modifies the haemorrhagic risk, when is the time of greatest risk after the procedure, and which variables associated with the patient and the procedure most modify the haemorrhagic risk.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * expected endoscopic manoeuvre among those listed below * egds ± biopsy/polypectomy * colonoscopy ± biopsy/polypectomy * echoguided endoscopy ± biopsy/polypectomy * double-balloon enteroscopy * ercp (endoscopic retrograde cholangio-pancreatography) ± sphincterotomy exclusion criteria: * age \< 18 years * known active neoplasms of the gastroenteric tract * gastrointestinal procedures performed as an emergency * patients with an intrinsic haemorrhagic diathesis (e.g. known plateletopenia \< 50,000/mmc) * patients on antiplatelet treatment with clopidogrel or other thienopyridines

Keywords: endoscopic gastroenterological manoeuvre
v-a ecmo auto mode registry

Conditions: Heart Failure

Summary: abiomed impella v-a ecmo auto mode - observational study

the overall objective of this study is to collect data during routine impella usage in an ecpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated impella mode to run in conjunction with a va ecmo system for continued assessment and development of the underlying algorithms in different clinical settings. the primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the v-a ecmo auto mode algorithm for the impella pump. this is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the aic out of the operational console data.

Eligibility criteria:
inclusion criteria: * patients with ongoing or planned ecpella therapy exclusion criteria: * age \< 18 years * treatment with other than va ecmo setup * treatment with impella cp® heart pump only
study of the safety and efficacy of elagolix in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this study will assess the potential impact of elagolix on disordered pituitary and ovarian hormones in women with polycystic ovary syndrome (pcos).

this is a phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of elagolix in women with pcos. pcos is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. this study will help determine if elagolix can impact disordered hormonal dynamics in women with pcos and at what dosage.

Eligibility criteria:
inclusion criteria: * participants with clinical diagnosis of pcos. * participants with a body mass index (bmi) of 18.5 to 38 kg/m\^2 at time of screening. exclusion criteria: * participants with newly diagnosed medical condition requiring intervention that has not been stabilized at least 30 days prior to baseline. * participants with a significant medical condition that require intervention during the course of study participation (such as anticipated major elective surgery). * participants with an unstable medical condition (including, but not limited to, uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

Keywords: polycystic ovary syndrome hormone elagolix
pain sensitivity in acute inflammatory pain

Conditions: Healthy Volunteers Are Studied

Summary: pain is a complex experience influenced by gender and genetics, and, by psychosocial and sensory experiences. pain sensitivity is thus highly variable between individuals. in the present study we evaluate individuals´ pain perception in response to a number of different pain stimuli in 100 healthy volunteers (50 females and 50 males). the data will allow us to assess pain sensitivity, to predict pain responses and to investigate gender related differences in pain perception. a second aim is to evaluate the robustness of the different pain-tests since the tests are repeated with an interval of 2-4 weeks.

pain perception is affected by physiological, psychological, existential and demographic factors. in the present study psychophysiological, psychological, genetic and demographic components in pain perception are evaluated in healthy volunteers (n = 100). psychophysical assessments following induction of a first degree burn injury (47.0 c, 420 s, 12.5 sq.cm, lower leg) include: * pain during induction of burn injury * thermal thresholds * tactile thresholds * electrical thresholds * areas of secondary hyperalgesia * pressure algometric assessments * assessment of diffuse noxious inhibitory control (dnic) efficiency * assessment of (dnic) using cold pressor test psychological assessments include: * hads (hospital anxiety and depression scale) * pcs (pain catastrophizing scale) * vulnerability score genetics include: - a118g snp demographics include: * gender * height * weight

Eligibility criteria:
inclusion criteria: * healthy * psychomotor ability to perform the tests * cognitive ability to perform the tests exclusion criteria: * smoker * body mass index \> 28 * participation in drug studies \< 4 weeks prior to inclusion * chronic pain * chronic intake of analgesics * drug or alcohol abuse * intake of analgesics \< 48 hours prior to study * females not on contraceptive therapy (intra-uterine device or p-pill) * lesion in the assessment area

Keywords: burn injury cold pressor test gender pain pain sensitivity pain prediction psychometrics quantitative sensory testing
ventilation-perfusion (v/q) ratio and alveolar surface area in preterm infants

Conditions: Bronchopulmonary Dysplasia

Summary: to non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * congenital or chromosomal anomalies
implementing dementia care management into routine care in the region siegen-wittgenstein

Conditions: Dementia; Dementia Alzheimers; Mild Cognitive Impairment; Care Management

Summary: dementia care management (decm) is an evidence-based model of care in germany. it has proven its efficacy and cost-effectiveness. however it has not been implemented into routine care so far. the aim of this trial is to implement dementia care management into routine care in a selected region in germany and evaluate the process of implementation as well as the effect of dementia care management on participants. recruited in regular routine care n=60 people with cognitive impairment and/ or their cares will receive dementia care management provided by specifically trained and qualified dementia care managers for 6 months. data will be assessed and analysed prior to the implementation, immediately after having received the intervention and at a later time point. the effect of the intervention on person-oriented health care outcomes wil be analysed as well as factors associated with that.


Eligibility criteria:
inclusion criteria: * person with cognitive impairment living in household * living in the region of siegen-wittgenstein * written informed consent exclusion criteria: * institutionalisation of person with cognitive impairment * lacking sufficient communication skills
evaluation of impaired microcirculation during septic shock with contrast enhanced ultrasound

Conditions: Sepsis

Summary: microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. without adequate therapy that may lead to multi-organ failure and death. therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). the aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. for this purpose, the method is applied to 24 subjects during and after septic shock. it will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. as well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.


Eligibility criteria:
inclusion criteria: * septic shock exclusion criteria: * myocardial infarction

Keywords: sepsis septic shock contrast-enhanced ultrasound microcirculation
effects of augmented renal clearance on pharmacokinetic and pharmacodynamic properties of levetiracetam in subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: this study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. the patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.


Eligibility criteria:
inclusion criteria: * patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment * presentation to university of colorado hospital within 48 hours of subarachnoid hemorrhage * adults ages 18 to 89 years * anticipated length of stay ≥ 48 hours * informed consent provided by the patient or patient's designated medical proxy exclusion criteria: * pregnancy * patients receiving renal replacement therapy * brain death or imminent brain death expected ≤48 hours * patient with history of nephrectomy or renal transplant

Keywords: augmented renal clearance
thick cornea with high back elevation

Conditions: Corneal Thickness Measurement

Summary: to follow up cases of thick cornea with high back elevation by pentacam.

the cornea plays a crucial role in refraction and so help in good visual acuity. with its thickness and back elevation being essential parameters in diagnosing and managing corneal diseases such as keratoconus. the normal human cornea has a central thickness of approximately 540-550 µm. the periphery is generally thicker, reaching up to 700 µm. corneal thickness is influenced by genetics, hydration, and intraocular pressure.thick cornea (\> 540 µm): seen in conditions such as corneal edema and fuchs' dystrophy. thin cornea (\< 500 µm): observed in keratoconus, lasik-induced thinning, and corneal ectasia. back corneal elevation is assessed using corneal topography or tomography, typically referenced to a best-fit sphere (bfs). in normal cases, back corneal elevation is usually ≤12 µm above the bfs, indicating a structurally healthy cornea without signs of ectasia. susceptible elevation ranges between 12-20 µm, which may be an early indicator of corneal instability, such as subclinical keratoconus. therefore, it should be evaluated alongside other parameters, including pachymetry, anterior curvature, and biomechanical properties. abnormal back corneal elevation is generally considered \>20 µm, particularly if localized or asymmetric, and is strongly associated with corneal ectatic disorders such as keratoconus, pellucid marginal degeneration, or post-lasik ectasia. this abnormal elevation is often accompanied by other risk factors, including increased posterior corneal curvature, corneal thinning, and significant asymmetry, necessitating further assessment and monitoring. many cases of thick cornea are associated with high back elevation and this discourage refractive surgery in such cases so in investigator's study the investigator will follow up these cases to determine if these corneas are considered normal corneas or not.

Eligibility criteria:
inclusion criteria: any patient can interact with pentacam. both genders: include both males and females. patients with thick cornea (\>540 µm) with high back elevation. exclusion criteria: * patients with any eye disease (significant cataract or unstable glaucoma) * uncontrolled external disease such as blepharitis , moderate to severe dry eye and allergy. * patient with ocular disease such as uveitis, post herpetic infection and corneal opacity
a phase i study of dexmedetomidine bolus and infusion in corrective infant cardiac surgery: safety and pharmacokinetics

Conditions: Transposition of the Great Arteries; Tetralogy of Fallot; Ventricular Septal Defect

Summary: the purpose of this phase i study is to determine the safety of a drug called dexmedetomidine (dex) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. this study will also design and validate a dosing schema for the use of dex as described above.


Eligibility criteria:
inclusion criteria: 1. male or female, age 0 to 180 days at the time of surgery. 2. diagnosis of: d-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus) 3. scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass. exclusion criteria: * 1. less than 37 completed weeks' gestational age at birth for the neonatal age group (0-21 days); less than 36 completed weeks' gestational age at birth for the infant age group (22-180 days). 2. enrollment in the phn collaborative learning study, if tetralogy of fallot 91-180 days of age only. 3. known or suspected hepatic dysfunction; ast and alt \>3x upper limit of normal at the time of screening within 72 hours of operation. 4. known or suspected renal dysfunction; serum creatinine \> 0.8 mg/dl after 7 days of age, \>1.2 mg/dl if \<7 days of age, within 72 hours of operation. 5. preoperative administration of dex or clonidine within 72 hours of operation. 6. major congenital anomaly(ies) outside the cardiovascular system that in the investigator's opinion would potentially affect safety or pharmacokinetics. 7. preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis. 8. planned period of deep hypothermic circulatory arrest. 9. history of second or third degree heart block. 10. sinus or junctional bradycardia below 80 bpm sustained for greater than 15 minutes within 72 hours of operation. 11. junctional rhythm sustained for greater than 15 minutes within 72 hours of operation. 12. hypotension defined as mean arterial blood pressure below 35 mm hg for 0-21 day old neonatal patients, and below 40 mm hg for 22-180 day old infant patients sustained for greater than 15 minutes within 72 hours of operation. 13. history of cardiac arrest or ecmo cannulation.

Keywords: pediatric corrective cardiac surgery
human papilloma virus vaccination in girls with cystic fibrosis (vaccin-hpv-muc2)

Conditions: Mucoviscidosis

Summary: background the main risk factor for cervical cancer is the infection by human papillomavirus (hpv). vaccination against hpv, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. despite this, vaccination coverage against hpv remains low in france. a proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of hpv carriage and cervical pathology. an over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. particular attention to vaccination should therefore be included in this population. objectives of the study the main objective of the study is to estimate the frequency of hpv vaccination in young girls with cf over 9 years and followed in a pediatric cf center. the secondary objectives are to know: * the type of vaccine used (bivalent / quadrivalent / nonavalent) * the proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses) * reasons for non-use of vaccination study design the study will last 12 months. it is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire. population * young girls aged 9 years or older with cystic fibrosis * followed in a pediatric or mixed cf center in the france (rhone-alpes auvergne region and ile de france region) * with parents who did not object to participation in the study number of subject: 62 patients expected results * knowledge of hpv vaccination coverage in young girls with cf. * sensitization of patients, their parents and health professionals to hpv vaccination. understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.


Eligibility criteria:
inclusion criteria: * young girls aged 9 years or older * patients with cystic fibrosis * patients followed in a pediatric or mixed cf center in the france (rhone-alpes auvergne region and ile de france region) * patients with parents who did not object to participation in the study exclusion criteria: -patients who refuse to answer to the self-administrated questionnaire

Keywords: mucoviscidosis human papilloma virus vaccination young girl