Kornimate/medical-research-clean huggingface dataset:
use of a hand-held digital cognitive aid in simulated cardiac arrest.

Conditions: Cardiac Arrest

Summary: cardiac arrest is one of the most stressful situations to be managed. our first study (max, accepted for publication bja) clearly showed that it could not be compared to other urgent and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly improved with the help of a digital cognitive aid. the present study exclusively deals with the management of cardiac arrest (recovery ward, or in the delivery room.) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

" errare humanum est ", to err is human. this latin saying attributed to seneca shows that since the dawn of time, human beings are aware that managing complex situations will always be an inexhaustible source of mistakes. this is particularly true in anesthesia and intensive care in which situations are often complex and stressful, thus leading to mistakes or inadequate management. improvement might arise from the use of cognitive aids. in a first study (max, accepted for publication bja) the investigators designed a smartphone application including 5 scenarios of anesthesia and intensive care crises (malignant hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader managing the crises. technical and non technical skills were improved in 4 out of 5 scenarios. cardiac arrest (ventricular fibrillation) clearly happened to be a different situation compared to other crises, and no improvement could be measured with our cognitive aid. the present study exclusively deals with the management of cardiac arrest (man in recovery ward, pregnant woman in the delivery room) with the second generation of our digital cognitive aid, and explores new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand of the leader.

Eligibility criteria:
inclusion criteria:• * resident physicians training in anesthesia/intensive care (same specialization in france), year 1 to 5 (out of 5) * to be familiar with our simulation centre (at least passed once as a resident) exclusion criteria: * no experience in simulation training

Keywords: cognitive aid
frailty prevalence in surgical european patients. european prospective cohort stufy of the prevalence of frailty in surgical patients.

Conditions: Frailty

Summary: european prospective one day cohort study. analysis of the prevalence of frailty and predefined 30-day postoperative complications in adult patients undergoing emergency or elective surgery.


Eligibility criteria:
inclusion criteria: * patients over the age of 18 who will undergo emergency or elective surgery with an intended hospital stay of more than 24 hours and any type of anesthesia. exclusion criteria: * outpatient (ie. day case) surgery, obstetric analgesia or anesthesia, organ transplant surgery, cardiac surgery, neurosurgery.
anti-inflammatory effects of macrolide treatment in influenza lower respiratory tract infections

Conditions: Influenza; Lower Respiratory Tract Infection

Summary: influenza lower respiratory tract infection (lrti) is a major cause of morbidity and mortality worldwide. while viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. in this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza lrti. its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.

objectives: (1) we aim to investigate the anti-inflammatory effects of macrolide treatment in patients with influenza lrti and the impact on viral clearance. (2) to investigate the impact of macrolide treatment on influenza symptom and disease resolution. design: a randomized, open-label, multicenter study. settings: acute medical facilities in 3 general public hospitals in hong kong. subjects, sampling and intervention: adult (\>/=18 years) patients hospitalized for virologically confirmed influenza lrti who fulfill the inclusion/exclusion criteria will be randomized to receive (1) azithromycin 500 mg p.o. for 5 days (in addition to antiviral, as part of usual care), or (2) no azithromycin (ie, antiviral alone, part of usual care) after informed consent. serial blood samples will be collected for cytokine/inflammatory response assays. serial nasopharyngeal swabs will be collected to assess for viral clearance. symptoms, clinical progress, radiography and adverse events will be monitored.

Eligibility criteria:
inclusion criteria: 1. established influenza a or b infection by virologic tests 2. age \>/=18 years 3. present within 4 days from illness onset 4. clinical evidence of lrti and require hospital care 5. require antiviral (oseltamivir) treatment 6. able to provide written, informed consent. exclusion criteria: 1. patients on immunosuppressants 2. pregnant or lactating woman 3. known hepatic failure, end-stage renal failure, cardiac arrhythmia (e.g. prolonged corrected qt interval \>450 msec) 4. known contraindications to azithromycin (e.g. allergic reaction) 5. lack of consent for study.

Keywords: influenza macrolide anti-inflammatory
safety and efficacy study of intracystic tara-002 for the treatment of lymphatic malformations in participants 6 months to less than 18 years of age

Conditions: Lymphatic Malformation

Summary: this is a phase 2a/b single arm open label study to evaluate the safety, reactogenicity, and efficacy of intracystic injection of tara-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations. the phase 2a safety lead-in, age de-escalation study is designed to establish the safety of tara-002 in older participants 6 years to less than 18 years before proceeding to younger participants 2 years to less than 6 years, then 6 months to less than 2 years. the phase 2b is an expansion study in which enrollment of participants will be initiated after safety has been established in each cohort during the phase 2a safety lead-in study. each participant will receive up to 4 injections of tara-002 spaced approximately 6 weeks apart.


Eligibility criteria:
inclusion criteria: * male or female participants 6 months to less than 18 years of age at the time of informed consent/assent form was signed * participants whose parent/lar(s) have voluntarily given written consent and participants who provided assent (if applicable) after the study has been explained to them * participants with macrocystic lm or mixed cystic lm (≥ 50% macrocystic disease measured by volume) of the head/neck/mediastinum according to the issva 2018 criteria (issva 2018) measured via lm imaging at screening to confirm, upon central review, the diagnosis of macrocystic or mixed cystic lm * participants who may have had surgical or sclerotherapy treatment for their lm, but not within six months of the consent/assent form being signed exclusion criteria: * penicillin allergy * vascular tumors or combined vascular malformations * microcystic lm or mixed cystic lm with predominant microcystic features * lms of the orbit (orbital lm) as target cyst for more information on eligibility criteria, please contact the sponsor.

Keywords: macrocystic lymphatic malformations mixed-cystic lymphatic malformations
baclofen in the treatment of muscle cramps in patients with cirrhosis

Conditions: Muscle Cramps; Liver Cirrhosis

Summary: patients with cirrhosis often experience muscle cramps with varying severity. the mechanism of their occurrence is not yet understood. muscle cramps in patients with cirrhosis are associated with significantly diminished quality of life. the aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. patients with cirrhosis often experience muscle cramps with varied frequency and severity. the exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes. although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. several agents as vitamin e, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking. baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. it was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough. the aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps in patients with liver cirrhosis.

Eligibility criteria:
inclusion criteria: * cirrhosis * muscle cramps( ≥3 cramps per week ) exclusion criteria: * allergy to baclofen * renal impairment * pregnant and lactating women * peripheral vascular disease * peripheral neuropathy * medications as calcium channel blockers, conjugated estrogens and naproxen.
effects of apelin on the lung circulation in pulmonary hypertension

Conditions: Pulmonary Arterial Hypertension; Heart Failure

Summary: the purpose of this study is to determine the effects of apelin on the lung circulation. the investigators hypothesise that apelin will relax the lung blood vessels and improve the pumping ability of the heart.

apelin is an endogenous peptide with physiological actions in the cardiovascular system and is abundantly expressed in the pulmonary vasculature. pre-clinical models and preliminary clinical data indicate that apelin deficiency may mediate or contribute to the pathogenesis of pulmonary hypertension and heart failure. apelin causes peripheral vasodilatation and increased cardiac contractility. the investigators will determine the effects of apelin on the pulmonary circulation in 3 groups; healthy control, people with pulmonary arterial hypertension and people with pulmonary hypertension due to heart failure. each subject will receive both apelin infusion and saline placebo infusion in a crossover design. the infusions will be given in a random order which the subject and the investigator will be blinded to. the investigators hypothesise that apelin will have more marked pulmonary haemodynamic effects than that observed in the systemic circulation. moreover, the investigators propose that apelin will have a marked vasodilatory effect on the human pulmonary vasculature and reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension or pulmonary hypertension due to left heart disease.

Eligibility criteria:
pulmonary arterial hypertension inclusion criteria: * pulmonary arterial hypertension which is idiopathic, heritable, associated with connective tissue disease or associated with drugs/toxins * mean pulmonary artery pressure \>/= 25mmhg * pulmonary capillary wedge pressure \< 15 mmhg * normal/reduced cardiac output * stable * who functional class ii - iv exclusion criteria: * significant left ventricular dysfunction * chronic lung disease (fev1 \< 60% or abnormal ct) * chronic thromboembolic pulmonary hypertension heart failure inclusion criteria: * stable on treatment for 3 months prior to study * nyha grade ii - iv * ejection fraction \ 5.5 cm and/or shortening fraction \< 20% * tricuspid regurgitant velocity \>/= 3.0 m/s healthy volunteers inclusion criteria: * mean pulmonary artery pressure \< 25 mmhg * tricuspid regurgitant velocity \< 2.5 m/s exclusion criteria: * obstructive coronary artery disease all subjects exclusion criteria: * bleeding diathesis * women of childbearing potential without pregnancy test * systolic blood pressure \> 190 mmhg or \< 100 mmhg * malignant arrhythmias * renal or hepatic failure * haemodynamically significant valvular heart disease * severe or significant co-morbidity * pacemaker * already taking part in another trial * lack of informed consent

Keywords: pulmonary hypertension heart failure apelin haemodynamics pulmonary vascular resistance cardiac output
a study of safety and efficacy of pet-adapted treatment with nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin, etoposide (nice-40) in patients with relapsed/refractory hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: nivolumab is an anti-pd-1 antibody highly effective in patients with relapsed/refractory classical hodgkin lymphoma. a pet-adapted regimen of nivo combined with ice as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r chl patients. this study evaluates the safety and efficacy of pet-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (nice-40) in patients with relapsed/refractory hodgkin lymphoma.


Eligibility criteria:
inclusion criteria: * diagnosis: histologically confirmed hodgkins lymphoma * relapsed or refractory disease after the first line of treatment * age 18-70 years old * ejection fraction greater than 50% * ecog 0-2 status * signed informed consent * no severe concurrent illness exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * severe organ failure: creatinine more than 2 norms; alt, ast more than 5 norms; bilirubin more than 1.5 norms * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign an informed consent * active or prior documented autoimmune disease requiring systemic treatment.

Keywords: nivolumab ifosfamide carboplatin etoposide
optimizing the number of systematic cores during a mri target biopsy

Conditions: Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate

Summary: this is a multicentre, paired-cohort, prospective, controlled study. the patient with a suspicion of pca and a concomitant positive mpmri (defined as presence of one lesion pi-rads ≥ 3) will receive a mri-tbx (4 target cores). during the same session, subsequently to mri-tbx, patient will receive a systematic sampling with 6-core s-bx followed by 14-core s-bx, for a total of 20-core systematic cores, in addition to 4 mri-tbx cores. procedure will be performed by the same operator. each single core will be stored in a dedicated cassette and sequentially numbered. we hypothesize that the proportion of cspca (defined as prostate cancer with gleason score ≥ 3+4) detected by 6-cores s-bx will be no less than that detected by 20-cores s-bx, both performed in addition to mri-tbx. assessing the optimal number of systematic cores to take in addition to mri-tbx cores in men undergoing a mri-tbx would provide a useful clinical information for every day clinical practice. moreover, the possibility to decrease the number of systematic cores taken during a mri-tbx, hence reducing the overall number of cores taken during a biopsy, would reduce the length of the diagnostic procedure, potentially reduce the probability of infections/sepsis and reduce the overdiagnosis of clinically insignificant pca.


Eligibility criteria:
inclusion criteria: * male patients, aged between 18 and 80 years old with suspicion of prostate cancer * presence of a positive mpmri of the prostate (visible lesion pi-rads ≥ 3) * serum psa ≤ 20ng/ml * suspected stage ≤ t2 on rectal examination (organ confined prostate) * fit to undergo a prostate biopsy * able to understand and willing to sign a written informed consent document exclusion criteria: * prior positive prostate biopsy * prior treatment of the prostate * prostate volume \<30 ml at mpmri of the prostate * more than one lesion at mpmri of the prostate * contraindication to prostate biopsy
specs: safe pediatric euglycemia in cardiac surgery

Conditions: Heart Defects, Congenital; Hyperglycemia

Summary: critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. this study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.

children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. a synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. insulin is most commonly used to treat people with diabetes, but it is also used in hospitals to control blood glucose levels in patients. previous studies of adult intensive care unit (icu) patients have shown that patients whose blood sugar levels are maintained at normal levels with the use of insulin contract fewer infections and are released more quickly from the icu than patients who do not maintain normal blood glucose levels. this study will use a continuous blood glucose monitoring system to detect changes in blood glucose levels. intravenous insulin infusions will be used to then safely maintain normal blood glucose levels. the purpose of this study is to determine if maintaining normal blood glucose levels during an icu stay will help decrease the incidence of infections and improve surgical recovery in young children following heart surgery. this study will enroll children who are undergoing heart surgery that requires a cardiopulmonary bypass procedure. participants will be randomly assigned to either a control group or the treatment group. all participants will receive usual care while in the icu and will undergo continuous glucose monitoring. participants in the treatment group will receive intravenous insulin infusions to keep their blood glucose within the normal range. while in the icu, blood will be collected from all participants once a day for the first 3 days and then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and immune function. on days 1 and 5 following surgery, participants who are on a ventilator will have their breath measured to monitor heart function and energy use. thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site. children who enroll in the study will be asked to participate in follow-up neurodevelopmental evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic control in the icu.

Eligibility criteria:
inclusion criteria: * undergoing heart surgery with cardiopulmonary bypass * recovering in the cardiac icu exclusion criteria: * enrolled in another interventional clinical trial with related study outcomes

Keywords: congenital heart defects insulin euglycemia normoglycemia
spinal cord injury - assessing tolerability and use of combined rehabilitation and neuroaid

Conditions: Spinal Cord Injury

Summary: saturn investigates the promising role of neuroaid in patients with spinal cord injury and will provide important information on the feasibility of conducting larger controlled trials.

saturn is a prospective cohort study of patients with moderately-severe to severe spinal cord injury, defined as american spinal injury association impairment scale a and b, who are treated with open-label neuroaid for 6 months in addition to standard care and followed for 24 months. anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 using a secured online system and will include information on demographics, main diagnostics, neurological and functional state, treatment compliance, concomitant therapies, and side effects, if any.

Eligibility criteria:
inclusion criteria: * male or female * age 18 to 65 years * diagnosed with spinal cord injury between 3 days and 4 weeks * american spinal injury association impairment scale a or b * informed consent for inclusion into the database is obtained exclusion criteria: * non survivable injury * multiple significant trauma (i.e. significant intracranial and extracranial injuries including limb fractures) that would limit observation of recovery from spinal cord injury * other conditions that would limit clinical assessment of outcomes (e.g. dementia, demyelinating disease, autoimmune disease, etc) * refusal of treatment or contraindication to neuroaid
effects of ligands on human hair follicles grafted onto scid mice

Conditions: Alopecia

Summary: the purpose of this study is to determine if immunophilin ligands may have the potential to reverse hair loss.

preliminary experiments in c57bl/6j mice showed that immunophilin ligand fk506 and its non-immunosuppressive analogs, gp11046 and gp11511 were capable of promoting telogen to anagen transition. since gp11046 and gp11511 possess the neurotrophic properties of fk506 without its immunosuppressant capability, the neural action of these immunophilin ligands may play an important role in the hair cycle. this finding has significant clinical implications in that immunophilin ligands may have the potential to reverse alopecia. to further investigate this possibility we propose to explore the response of transplanted miniaturized scalp hair follicles to topically applied immunophilin ligands.

Eligibility criteria:
inclusion criteria: * healthy men ages 18-65 with hamilton type iv or v alopecia exclusion criteria: * individuals who do not meet the inclusion criteria.