Kornimate/medical-research-clean huggingface dataset:
the effectiveness of adding braun anastomosis to standard child reconstruction after pancreatoduodenectomy

Conditions: Pancreatic Disease; Pancreatic Cancer; Delayed Gastric Emptying

Summary: the goal of this clinical trial (rembrandt) is to evaluate the effectiveness of adding an extra connection (i.e. 'braun anastomosis') after standard reconstruction in pancreatic head resection in reducing the incidence of delayed gastric emptying.

rationale/hypothesis: the addition of braun enteroenterostomy (be) reduces the incidence of delayed gastric emptying (dge) resulting in lower morbidity and healthcare costs after pancreatoduodenectomy. objective: to assess the effectiveness of adding be in reducing dge in patients undergoing open pancreatoduodenectomy. study design: a multicenter, patient and observer blinded, registry-based randomized controlled trial. study population: patients undergoing an open pancreatoduodenectomy for all indications. intervention: braun enteroenterostomy (be), or braun anastomosis, in addition to usual care. usual care/comparison: pancreatoduodenectomy with standard child reconstruction. main endpoints: 1. incidence of dge grade b/c (according to international study group of pancreatic surgery (isgps) 2. incidence of postoperative pancreatic fistulas (popf) grade b/c (according to isgps), anastomotic leak, complications, hospital length of stay, functional outcome at 12 months, in-hospital mortality, 30-day mortality, healthcare costs. sample size: 256 in total, 128 per arm nature and extent of the burden and risks associated with participation, benefit and group relatedness: patients undergoing open pancreatoduodenectomy have an increased risk of postoperative complications such as dge, popf and anastomotic leak. the addition of be, which is an anastomosis, could also result in a leak. however, this risk is diminishable compared to the risks of dge and dge related other complications like anastomotic leaks associated with standard pancreatoduodenectomy. moreover, previous cohort studies involving be do not describe an increased risk of adverse outcomes for be.

Eligibility criteria:
inclusion criteria: * undergoing open pancreatoduodenectomy * provided informed consent * age over 18 years exclusion criteria: * insufficient control of the dutch language to read the patient information and to fill out the questionnaires in dutch hospitals * previous bariatric surgery (such as roux-en-y gastric bypass, gastric sleeve) * pregnancy * bowel motility disorders * minimally invasive pancreatoduodenectomy * gastric outlet syndrome

Keywords: randomized controlled trial prospective studies braun anastomosis braun enteroenterostomy
treatment of melasma with yellow light compared to tranexamic acid

Conditions: Melasma

Summary: photobiomodulation (pbm) has been suggested as an alternative treatment for melasma, showed by the in vitro data, inhibition of the tyrosinase enzyme and reduction in the pigment content by autophagy. this treatment compares with tranexamic acid, where it acts on similar pathways of melanogenesis. a total of 54 female participants, phototype scale fitzpatrick ll - lv will be recruited which will be distributed among two groups: light + placebo home care cosmetic product and light sham + home care cosmetic product with tranexamic acid. the treatments will consist of 90 days, with application of photobiomodulation (pbm) once a week and application of the cosmetic product twice a day.

this is a controled, randomized, double blind, two arms clinical trial. the main objective of this study is to evaluate the effect of photobiomodulation with amber light in the treatment of melasma compared to the effect of tranexamic acid. the sample will be divided into 2 groups: group 1 will receive pbm with amber light emitting diode (led) (dmc e-light abr), 20 j/cm² and placebo topical cosmetic for use in home care; group 2 will receive pbm sham and topical cosmetic containing 5% liposomal tranexamic acid for use in home care. a total of 54 women with facial melasma, aged 35 to 50 will be included. the treatments will consist of 12 sessions, once a week for 3 months. the severity of melasma will be evaluated through the melasma area and severity index (masi index), the pigmentation of the epidermis will be evaluated by corneomelametry, photographic records and the quality of life questionnaire (melasqol-pb) will also be made.

Eligibility criteria:
inclusion criteria: * feminine gender * age between 35 to 50 years * phototypes l to lv of the fitzpatrick scale * facial melasma * healthy participants without clinical skin comorbidities (psoriasis, vitiligo, rosacea and dermatoses) exclusion criteria: * pre-existing systemic diseases, autoimmune diseases, digestive system disease * polycystic ovary * isotretinoin drug use (less than 6 months) * sequelae of an accident on the face that interferes with the facial treatment * undertakes any treatment for topical or oral melasma at the time of the research or less than 3 months ago * uses retinoic acid, vitamin a derivatives, photosensitizing drugs * skin pathologies on the face * glaucoma, cataract, cancer patients, pregnant women, lactating women * uses oral or intrauterine contraceptives (iud) * thyroid disorders * use of hormone replacement * bacterial, viral and fungal infections * tendency to form keloids

Keywords: low level laser therapy (lllt) melasma photobiomodulation tranexamic acid
imtap : impact of the suicide attempt on the nearly entourage in term of traumatic stress and medico-economic impact

Conditions: Suicide, Attempted; Relatives

Summary: with 11.000 deaths and 150.000 attempts each year in france, the suicide represents an important public health problem. for each death by suicide, one can count 6 "direct" bereaved people and 20 people in more indirect connection with this mourning (terra 2001). in term of impact, there is thus 300.000 people (annually) touched by the deaths by suicide and 3.750.000 people (annually) touched by the "suicide attempt" of a close relative. it seems indeed important to have public health data on this cascade repercussion of the suicide attempt. a suicide attempt propagates a suffering cascade on the various circles of the family and close entourage, which can be measured in term of traumatic stress and medico-economic impact. objective = to measure the medico-economic impact on the entourage, in the 3 months following the suicide attempt and at 1 year.

secondary objectives = to measure the impact of the suicide attempt in traumatic term of stress on the close relatives of committing suicide confronted with the suicidal scene to compare the evolution of consumption of care of the close relatives and of committing suicide to measure the evolution of the general health condition of the close relatives and of committing suicide the study participants (committing suicide it and the relatives) will be recontacted by telephone, after 3 months and to 1 year. consumption of care (number of consultations, drugs consumption) of the population of the close relatives of committing suicide will be compared with the data of the research institute and documentation in economy of health (irdes) on the french population (sample of 20.000 people, representative of 95% of the french households).

Eligibility criteria:
inclusion criteria for suicide attempter : * men or women * older than 18 years * survivor with an suicide attempt going back to less than 15 days inclusion criteria for close relations of committing suicide : * men or women * age more than 18 years * members of the entourage of committing suicide * living under the same roof as committing suicide it

Keywords: suicide
place of echocardiography in iv fluid therapy in patients with septic shock and left ventricular systolic dysfunction

Conditions: Shock, Septic; Ventricular Dysfunction, Left

Summary: iv fluid therapy remains an essential haemodynamic objective in the treatment strategy of septic shock. left ventricular systolic dysfunction secondary to sepsis is observed in 40% and up to 65% of the population concerned. however, the capacity of the various indices to predict the response to iv fluid therapy in septic shock with left ventricular systolic dysfunction have not been clearly defined. measurement of parameters reflecting filling pressures during transthoracic echocardiography (tte) is one of the methods used to evaluate cardiac function and estimate the filling reserve, but with no strong evidence. right heart catheterization with determination of cardiac output by pulmonary thermodilution can also be used to measure the various parameters commonly used to predict the response to iv fluid therapy. very few data are available with no reliable and clinically relevant data in this population with septic shock and left ventricular systolic dysfunction (lvef ≤ 40%) and the response to iv fluid therapy monitored by dynamic indices obtained by transpulmonary thermodilution and right heart catheterization. consequently, the capacity of the various indices of preload dependence to predict the response to iv fluid therapy in septic shock with left ventricular systolic dysfunction remains difficult to define.


Eligibility criteria:
inclusion criteria: * septic shock with cardiovascular dysfunction despite norepinephrine, * left ventricular systolic dysfunction defined by transthoracic echocardiography and lvef ≤ 40% * fluid challenge decided by the patient's attending physician according to the optimization of cardiac output in septic shock protocol, * iv fluid therapy with 500 ml of crystalloid solution. * haemodynamic monitoring decided by the patient's referring physician not involved in the study, according to the department's usual practice by transthoracic echocardiography and thermodilution monitoring. * sedated, on mechanical ventilation, and adapted to the ventilator. * patients who have received oral information and written documentation (with a copy filed in the medical records) on awakening. * the trusted person designated for each patient has received the same oral and written information. exclusion criteria: patients under the age of 18 years, pregnant women, patients under judicial protection or deprived of their freedom, amputation of one or both lower limbs contraindication to passive leg raising (e.g.: severe ic, etc.), cardiac tamponade or aortic dissection with uncontrolled active bleeding. no indication for iv fluid therapy

Keywords: echocardiography
chronic resveratrol supplementation in healthy humans

Conditions: Healthy

Summary: the effects of chronic resveratrol supplementation have yet to be investigated in healthy humans. it is hypothesised that the effects will be different to those seen in acute supplementation. this study will look specifically at cognitive performance, cerebral blood flow, subjective sleep, mood and health, blood pressure and plasma levels of resveratrol. it is hypothesized that these measures will be affected differently by acute and chronic supplementation.


Eligibility criteria:
inclusion criteria: * healthy * between 18-35 * at least enrolled on undergraduate degree programme * native english speaker exclusion criteria: * smoking * taking other medication/ supplements * pregnant/ breast feeding * high caffeine consumers * migraine sufferers

Keywords: cognitive performance cerebral blood flow subjective sleep subjective mood subjective health
evaluation of difficult airway with ultrasonography

Conditions: Difficult Intubation; Obesity

Summary: as a result of anatomical and physiological changes in obese patients, airway management can be challenging. ultrasound measurement of neck anterior soft tissues combined with recommended predictive tests may increase the ability to predict the difficult airway. in this study we planned to evaluate the measurement of neck anterior soft tissues by ultrasound in obese patients before anesthesia induction to anticipate difficult mask ventilation, difficult laryngoscopy, and intubation.

patients with bmi\> 30, schedule elective surgery under general anesthesia, and give consent will be included in the study. in the preoperative evaluation, demographic data of the patients, airway physical examination results (mouth opening, mallampati score, thyromental distance, neck circumference (from thyroid cartilage level), abnormal upper tooth presence, neck movement restriction\], presence of sleep apnea and stop-bang score will be recorded. in the patients taken on the operation table with supine position, ultrasound-guided soft tissue distances will be measured using ultrasound 6-13 hz linear probe. the distance between the hyoid bone-skin (dshb), the vocal cord anterior commissura-skin distance (dsac), the minimum distance of the trachea to the skin at the level of the suprasternal notch (dst), the distance between the thyroid isthmus and the skin (dsi), and the distance between the epiglottis and the skin (dse) will be measured and recorded. after standard monitoring and anesthesia induction, difficult mask ventilation will be evaluated with han scale \[(1) can be ventilated with a mask; 2) can be ventilated with the airway (with or without muscle relaxation); 3) difficult mask ventilation (insufficient, unstable, two practitioners are needed); 4) cannot be ventilated by mask\] and grade 3-4 will be recorded as difficult mask ventilation. difficult laryngoscopy will be evaluated with cormack lehane scale \[grade 1: vocal cords appear; grade-2: posterior commissura and epiglottis visible; grade-3: only epiglottis are seen; grade-4: glottic structures are not visible\] and grade 3-4 will be recorded as difficult laryngoscopy. difficult intubation will also be evaluated with the number and duration of intubation attempts with the macintosh blade. tracheal intubation will be performed by an anesthesiologist who has at least two years of experience and unaware of ultrasound measurements. the duration of intubation (the time from the first handling of the laryngoscope until the capnography trace appeared) and the number of trials will be recorded.

Eligibility criteria:
inclusion criteria: * patients planned to undergo general anesthesia for elective surgery * american anesthesiology association physical classification (asa) status i-iii * body mass index (bmi) above 30 exclusion criteria: * patients with neck mass * history of previous neck and thyroid surgery, trauma, arthritis, loss of teeth * history of difficult intubation * bearded patients * pregnant women

Keywords: difficult mask difficult laryngoscopy difficult intubation
early resuscitation in paediatric sepsis using inotropes

Conditions: Sepsis

Summary: septic shock in children still carries substantial mortality and morbidity. while resuscitation with 40-60 ml/kg intravenous fluid boluses remains a cornerstone of initial resuscitation, an increasing body of evidence indicates potential for harm related to high volume fluid administration. the investigators hypothesize that a protocol on early use of inotropes in children with septic shock is feasible and will lead to less fluid bolus use compared to standard fluid resuscitation. here, the investigators describe the protocol of the adrenaline in early sepsis resuscitation in children- a randomised controlled pilot study in the emergency department (andes child)


Eligibility criteria:
inclusion criteria: * 28 days and \<18 years * treated for sepsis * received at least 20 ml/kg fluid bolus in the last 4 hours and clinician decides to continue treating signs of shock * parental/caregiver consent prior to or after enrolment exclusion criteria: * preterm babies born \<34 weeks gestation that have a corrected age of \<28 days * received ≥ 40 ml/kg of fluid boluses during the 4 h pre-enrolment * inotrope infusion commenced pre-enrolment * lack of access (intraosseous, central venous or peripheral) to administer fluids and/or inotropes after 60min of enrolment * cardiomyopathy or chronic cardiac failure * chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment * known chronic renal failure (defined as requiring renal replacement therapy) * known chronic hepatic failure * palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation or ventilation) * cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of \>2min duration, or death is deemed to be imminent or inevitable during this admission. * major bleeding with haemorrhagic shock * sepsis is not likely to be the cause of shock * previous enrollment in andes-child

Keywords: pediatric sepsis septic shock inotropes adrenaline emergency department fluid child
pregnancy exposure registry for vumerity (diroximel fumarate)

Conditions: Multiple Sclerosis

Summary: the primary objectives of the study are to estimate the risk of major congenital malformations (mcms) in infants born to women with multiple sclerosis (ms) who were exposed to diroximel fumarate (drf) at any time from 2 weeks after the first day of their last menstrual period (lmp) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with mcms in women with ms who were exposed to drf at any time from 2 weeks after the first day of their lmp through the first trimester of pregnancy with the following: i) women with ms who were unexposed to disease modifying therapies (dmts) and, ii) women with ms who were exposed to other dmts (e.g., avonex and tysabri pregnancy registries). the secondary objective of the study is to evaluate pregnancy outcomes in women with drf exposure at any time from 2 weeks after the first day of their lmp through the end of pregnancy compared with the following: i) women with ms who were unexposed to dmts, ii) women with dimethyl fumarate (dmf) exposure, iii) women with ms who were exposed to other dmts (e.g., avonex and tysabri pregnancy registries), and iv) women without ms (e.g., women from external, general population comparators).


Eligibility criteria:
key inclusion criteria: * participant must have a diagnosis of ms * documentation that the participant was one of the following: 1. exposed to drf at any time from 2 weeks after the first day of their lmp (i.e., conception date) up through any time during pregnancy. (if exact exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure). 2. unexposed to any dmt during pregnancy, defined as having never received dmt therapy; discontinued treatment with drf at least 1 day before 2 weeks after the first day of their lmp (i.e., conception date); or discontinued a non registry-specified ms dmt more than 5 times its half-life prior to 2 weeks after the first day of their lmp (i.e., conception date) * participants with knowledge of the outcome of the pregnancy (e.g., pregnancy loss or live birth) key exclusion criteria: - none note: other protocol defined inclusion criteria may apply

Keywords: pregnancy relapsing forms of ms
a study of baked milk tolerance to treat eosinophilic esophagtis

Conditions: Eosinophilic Esophagitis

Summary: this research is being done to see if patients with milk-triggered eoe are able to tolerate baked milk in their diet and if there is a threshold amount of straight milk that is tolerable.


Eligibility criteria:
inclusion criteria: * diagnosed with eosinophilic esophagitis ≥ 15 eosinophils per hpf * going through or completed the six-food elimination diet, with milk only or milk plus one additional food identified as a trigger exclusion criteria: * patients with conditions known to be associated with esophageal eosinophilia, including crohn's disease, churg-strauss, achalasia, and hypereosinophilic syndrome * topical swallowed steroids within 8 weeks of study enrollment * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy
urine omics predicting io therapy responses in mrcc patients

Conditions: Metastatic Renal Cell Carcinoma

Summary: the study aims to identify urinary metabolite and protein markers that can predict anti-tumor efficacy and adverse events in subjects receiving io-based therapies for metastatic renal cell carcinoma.

this is a multi-center single-arm translational study where patients with mrcc who are to receive pre-determined io-based therapy will be invited to participate the study. after signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study via gs-ms/ms and/or lc-ms/ms to identify potential metabolite and protein markers that are able to predict efficacy and side effects of io-based therapies. all subjects in the first-line, maintenance after 1st line, second-line, or subsequent lines of io-based therapy will be invited and recruited, but those who have received any io-based therapy before the study can not be recruited.

Eligibility criteria:
inclusion criteria: 1. age \> 20 years 2. subjects diagnosed as advanced or metastatic renal cell carcinoma (a/mrcc) 3. subjects who are about to receive io-based therapy 4. ecog performance 0, 1, 2, and 3 5. life expectancy \>3 months 6. egfr \> 15 ml/min/1.73 m2 (stage iv chronic kidney disease or better) 7. willing to sign the informed consent form exclusion criteria: 1. subjects not willing to sign the informed consent form 2. subjects with active infection or active urinary tract infection, as shown by urinary wbc \> 5/hpf 3. subjects having co-existing other malignancies that need active treatment. those subjects with other malignancies that do not need active treatment are allowed to join the study. 4. subjects taking any immune-modulating agents, including but not limited to corticosteroid, immune-suppressants, etc. at the discretion of recruiting investigators 5. subjects who have taken any io-based therapy before. 6. subjects who have received other systemic anti-cancer therapies within 4 weeks of screening are not allowed. however, subjects who had a washout period of the above agents for \>4 weeks are allowed to enroll. subjects who have received or are receiving targeted therapy are allowed to join the study.

Keywords: renal cell carcinoma biomarkers clinical responses io-based therapies metabolomics proteomics urine
caverject user study

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to demonstrate the usability of the system.

demonstrate usability

Eligibility criteria:
inclusion criteria: age 40 to 70 exclusion criteria: prior syringe skills

Keywords: erectile dysfunction