Kornimate/medical-research-clean huggingface dataset:
safety of direct oral anticoagulant during pregnancy

Conditions: Thromboembolic Disease

Summary: pregnancy is a major risk factor of thromboembolic disease (2 to 10 increased risk of thromboembolic event for pregnant women). this risk is related to the physiological changes inducing venous stasis and hypercoagulability. thromboembolic disease is the first preventable cause of death during pregnancy (in france 1.1 maternal death per 100 000 living births. the recommended treatment for pregnant women is low molecular weight heparin requiring subcutaneous injections daily. vitamin k antagonists are contraindicated due to a teratogenic risk. direct oral anticoagulants (doac) are easier to use. currently available preclinical and incidental exposure data on doac in pregnant women are very limited and insufficient to conclude on their safety. therefore, its use during pregnancy is currently contraindicated for the grounds of precaution. the use of reimbursement data from the système national des données de santé (national health data system) would provide more information on accidental exposure to doacs during pregnancy, thanks to its completeness. the primary objective of sacod is to compare the prevalence of adverse perinatal outcomes in pregnant women treated with a direct oral anticoagulant versus pregnant women treated with heparin and vitamin k antagonist. the secondary objectives of the sacod study are to i) determine the frequency of patients exposed to a direct oral anticoagulant during pregnancy according to pregnancy, ii) measure the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with a direct oral anticoagulant therapy, iii) compare the prevalence of adverse perinatal outcomes in pregnant women initiating treatment with direct oral anticoagulants compared with pregnant women treated with heparin and a vitamin k antagonist, iv) compare the prevalence of adverse perinatal outcomes in pregnant women with antiphospholipid syndrome treated with a direct oral anticoagulant versus pregnant women treated with heparin and anti-vitamin k, v) measure the incidence of thrombo-embolic episodes during pregnancy under anticoagulant treatment.


Eligibility criteria:
inclusion criteria: * pregnant women exposed to an anticoagulant exclusion criteria: * women not covered by national health insurrance
a trial to determine the feasibility and effectiveness of early multisensory stimulation intervention in patients in the trauma-neurosurgical intensive care unit (tnicu) following severe acquired brain injury

Conditions: Traumatic Brain Injury With Prolonged Loss of Consciousness

Summary: st. michael's hospital (smh) provides service to individuals with some of the most severe brain injuries and intensive care needs in canada. these patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention. it has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function. previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. however there is still not enough conclusive evidence to confirm whether the intervention is truly effective. the investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. the investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.


Eligibility criteria:
inclusion criteria: * at least 2 weeks post injury, no more than 8 weeks post injury * glasgow coma scale score of less than or equal to 9, or motor component score of 5 or less if patient intubated * no previous brain injury * no chronic/progressive neurological illness * no intracranial pressure monitor * no more than1 pre-existing sensory impairment (e.g. deafness, blindness) * functional level of english for patient and substitute decision maker (i.e. conversational english, work/education in english, completion of english as a second language course, etc.) * deemed medically appropriate as per nurse practitioner/md (e.g. no active seizures, no sedation, haemodynamically stable, etc.) exclusion criteria: patients who do not meet inclusion criteria above.

Keywords: multisensory stimulation
prospective pilot clinical trial of azithromycin treatment in respiratory syncytial virus (rsv)- induced respiratory failure in children

Conditions: Respiratory Syncytial Virus

Summary: this randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (picu). the study will include children with rsv infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

eligible participants include all children admitted to the picu at children's of alabama with a diagnosis of rsv infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (bipap) or high flow nasal cannula (hfnc) oxygen (ie, \>1 l/kg/min of flow, with 5 l/min flow for children weighing \<5 kg). during hospitalization, all patients will be treated according to the american academy of pediatrics guidelines for the management of bronchiolitis, primarily supportive care. participants will then be randomized according to a permuted-block design to receive either placebo (saline) or azm (fresenius kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. all biologic samples collected will be analyzed in the pi's lab at the university of alabama at birmingham. drug pharmacokinetics will be performed at the pharmaceutical sciences research institute of samford university, birmingham, al.

Eligibility criteria:
inclusion criteria: * admission to the picu with rsv infection * need for positive pressure ventilation (invasive and non-invasive) * randomization and drug/placebo initiation within 48 hours of admission to pediatric intensive care unit exclusion criteria: * azithromycin use within 7 days of picu admission * contraindication to azithromycin use including: * patients with electrocardiogram qt interval corrected for heart rate (qtc) ≥ 450 ms * patients with significant hepatic impairment (direct bilirubin \>1.5 mg/dl) * known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug * cardiac arrhythmia * history of pyloric stenosis * immunocompromised children (any cause) * current use of any medication known to cause qt prolongation

Keywords: rsv respiratory support icu azithromycin
development of a new family of hiv latency regulators (lras) targeting the tat viral protein

Conditions: HIV Infections

Summary: antiretroviral therapy (art) prevents hiv from multiplying. however, if people living with hiv stop taking art, the virus quickly reappears in their blood due to the random activation of hidden infected cells. these hidden cells contain hiv that is not active and do not produce the virus. these cells are a major challenge in finding a cure for hiv. one of the most promising ways to get rid of these hidden infected cells is by activating them with special drugs called latency-reversing agents (lras). this process, known as the "shock-and-kill" strategy, involves waking up the hidden virus ("shock" phase) so that it can be destroyed by the body's immune system or by the virus itself ("kill" phase). investigators are developing new lras that target and activate a viral protein called tat, which is necessary for the virus to start producing again and for reversing its dormant state.the lead compound, named d10, is the first of its kind to target the tat protein. this compound has been patented and has shown activity in activating the virus in lab-grown cells. now, investigators need to test its effectiveness on real target cells from people living with hiv.

20 ml of blood (5 tubes of 4 ml each) will be collected from 24 people living with hiv who are on art. the inclusion criteria for this study are: being hiv-positive, having an undetectable viral load for more than 12 months, and having a history of very low t-cd4 counts (nadir \< 200 cells/mm³). in the lab, investigators will isolate immune cells (pbmcs) from the blood using a special technique. these cells will then be placed in small wells and treated with lras for 18-20 hours. investigators will measure the virus produced in the cell supernatant using two methods: q-rt-pcr for viral rna and p24 elisa for viral protein. the results will be analyzed using conventional statistical methods.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older * hiv-positive * on art (antiretroviral therapy) * hiv-1 rna undetectable for more than 12 months * nadir cd4 count \< 200/µl exclusion criteria: * lack of antiretroviral treatment * immunosuppressive treatments * history of cancer less than 5 years old * pregnant or breast-feeding women * persons protected by law (under guardianship or curators), persons under court protection * participating in another research project with an ongoing exclusion period * refusal to participate in research * subject not affiliated to a social security scheme, or not benefiting from such a scheme.

Keywords: hiv-1 tat latency latency reversing agents transcription
outcomes in lower pole kidney stone management using mini-pcnl compared with retrograde intra renal surgery

Conditions: Kidney Stone

Summary: due to the anatomic characteristics of the lower calyx, lower pole stones are difficult to be eliminated through the ureter, even if the stones had been fragmented. retrograde intrarenal surgery (rirs) can be used to deal with lower pole stones of 1.0-2.0 cm, while percutaneous nephrolithotripsy (pcnl) is mainly used to deal with lower pole stones with larger diameter or when rirs failed to resolve the stone. this study was conducted to compare mini pcnl and retrograde intrarenal surgery (rirs) for the management of lower pole kidney stones in terms of efficacy.


Eligibility criteria:
inclusion criteria: * renal stone at lower pole of size 10mm -20mm exclusion criteria: * patients with positive urine culture, * patients with anatomical abnormalities determined by ultrasonography * uncontrolled diabetes (hba1c \>9%) * patients undergone previous renal surgery

Keywords: lower pole stone, mini pcnl, retrograde intrarenal surgery
dn-101 in combination with docetaxel in androgen-independent prostate cancer (aipc) (aipc study of calcitriol enhancing taxotere [ascent-2])

Conditions: Prostate Cancer

Summary: the primary objective of this study is: * to evaluate the effect of dn-101 in combination with docetaxel (ascent regimen) on survival in metastatic androgen-independent prostate cancer the secondary objectives of this study are: * to determine the effect of the ascent regimen on the rate of thromboembolic events (blood clots) * to determine the effect of the ascent regimen on prevention of skeletal-related events (fractures) * a separate sub-study will be conducted at selected study sites in north america to determine the population pk of dn-101.


Eligibility criteria:
inclusion criteria: * histopathologically or cytologically proven adenocarcinoma of the prostate * documented metastatic prostate adenocarcinoma * documented progression while on androgen ablation therapy detected by rising prostate specific antigen (psa) and/or imaging * age \>= 18 years * eastern cooperative oncology group (ecog) performance status \<= 2 * adequate hematologic, renal and hepatic function * life expectancy \>= 3 months exclusion criteria: * prior chemotherapy, except estramustine * prior chemotherapy with docetaxel * prior isotope therapy (e.g., strontium-89, samarium-153, etc.) * one or more contraindications to the use of corticosteroids * history of cancer-related hypercalcemia

Keywords: androgen-independent prostate cancer (aipc) prostate cancer dn-101 calcitriol taxotere docetaxel
dexmedetomidine use for sedation in patients submitted to tracheal surgery

Conditions: Postoperative Sedation

Summary: patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an intensive care unit (icu). patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing the neck was maintained in flexion through chin-to-chest sutures. infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation richmond agitation sedation scale, (rass) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.


Eligibility criteria:
inclusion criteria: * patients submitted to tracheal surgery * elective surgery * age ≥ 18 years exclusion criteria: * severe neurological disorder * visual or hearing impairment * acute cerebrovascular disease * mean arterial pressure (map) \<55 mmhg or hypotension requiring the use of inotropes/vasopressors * heart rate (hr) \<50 bpm * second and third degree atrioventricular block (av block) in the absence of pmk * sequential organ failure assessment (sofa) score \<2 index * hepatic failure * emergency surgery * pregnancy * patient refusal to give consent * inability to give consent * age ≤18 years * asa score ≥ iv.
utilizing continuous glucose monitoring to characterize and manage hyperglycemia in patients initiating alpelisib

Conditions: Metastatic Breast Cancer

Summary: this is a prospective, descriptive, single site, observational study in subjects receiving alpelisib for treatment of metastatic breast cancer. the purpose of the study is to characterize the impact of alpelisib on glucose control in patients with breast cancer using continuous glucose monitoring to measure glucose levels throughout the day and night. patients will follow a hyperglycemia prevention and management regimen aimed to diminish hyperglycemia known to occur in most oncology patients starting alpelisib. all patients will wear an abbott freestyle libre 2 system to obtain continuous glucose monitor (cgm) data (glucose measured every minute for 14 days). cgm will be placed at least 10 days prior to starting alpelisib and continue for at least 3 months while taking alpelisib.


Eligibility criteria:
inclusion criteria: 1. adults aged 18 or older with a diagnosis of metastatic breast cancer that are initiating treatment with alpelisib. 2. must be willing and able to comply with study visits and procedures. 3. must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/her2 negative cancer with the presence of a pik3ca mutation. 4. oncologist plans to use alpelisib until progression of disease or unacceptable toxicity. 5. patients must receive cancer care during alpelisib treatment phase with a healthpartners oncologist and be willing to see idc/healthpartners diabetes education for diabetes management. 6. must have a compatible smartphone, access to a compatible smartphone, or the ability to upload cgm reader from home or bring the reader in to a medical visit at least once a month for uploading, to allow for remote management of diabetes and data collection. 7. life expectancy of at least 3 months exclusion criteria: 1. known history of serious allergy to skin-adhesive material or previous cutaneous reaction to a continuous glucose monitor. 2. known currently uncontrolled diabetes, defined as the most recent hba1c over 10% or history of dka within 6 months prior to enrollment. 3. concurrent use of high-dose vitamin c, defined as ≥ 1g of oral vitamin c daily, or intravenous vitamin c infusions. 4. any other concurrent severe and/or uncontrolled medical condition that, in the opinion of the investigator, would cause unacceptable safety risk, compromise compliance with the protocol, or contraindicate participation in the study. one example being known requirement for high dose steroids at the time of possible enrollment into the study.

Keywords: hyperglycemia glucose management alpelisib
cannabidiol effects on blood alcohol level and intoxication

Conditions: Alcohol Use Disorder

Summary: the main objectives of this study were to test if 2 different doses of cannabidiol (compared to placebo) alter 1) breath alcohol concentration, 2) craving and subjective responses to alcohol or 3) cognitive performance following a standard dose of alcohol.

cannabidiol (cbd), is commonly found in the cannabis plant and has shown promise in treating alcohol use disorders (aud). in this within-subjects, placebo-controlled, crossover study, the investigators explored the effects of two doses (200mg and 30mg) of plant-based cbd (compared to placebo cbd) on blood alcohol level, subjective effects of alcohol, craving and cognition over the course 4 hours after subjects consume a standardized dose of alcohol. this pilot study was conducted at colorado state university and volunteers were recruited from the local community. 36 individuals completed at least 1 study session and 22 completed all three sessions. at each session they received either placebo 30mg oral cbd or 200mg oral cbd prior to being given a standard dose of alcohol. they then remained in our laboratory for 4 hours and completed cognitive testing using the nih toolbox cognitive battery, breath alcohol level measurements and self-reported intoxication ratings (using the the biphasic alcohol effects scale \[baes\] and the the subjective effects of alcohol scale \[seas\]) and reported their craving levels using the alcohol urge questionnaire (auq) every 30 minutes. they also provided 3 blood samples to measure blood-cbd levels at each session (prior to receiving the cbd, 25 minutes post-cbd ingestion and again 60 minutes later). study sessions were separated by at least one week.

Eligibility criteria:
inclusion criteria: * 21-60 years old * able to provide consent * willing to consume cbd during the study * report heavy drinking (\>5 drinks \[\>4 for women\] per occasion on at least 5 days/month in the past 3 months) * not cannabis/cbd naive (i.e. thc or cbd use at least once in the past year), do not use cannabis regularly (i.e., less than monthly over past year), and no past-month cannabis use. exclusion criteria: * a regular or recent cannabis user (i.e. they used cannabis more often than monthly during the past year or used cannabis in the past month) * were seeking treatment a substance use disorder (sud) including aud, taking medications to treat bipolar or psychotic disorders * using nicotine every day * taking blood thinning medications * reported having a major medical condition contraindicating alcohol or cbd use (e.g., liver disease or heart disease) * reported current suicidality * met criteria for psychotic disorder, bipolar disorder or a current major depressive episode, * reported using illicit drugs in the 30 days prior to beginning the study or tested positive for any illicit drugs * were pregnant, breastfeeding or trying to become pregnant.

Keywords: alcohol cannabidiol craving
evaluation of nutritional scores as predictive factors of postoperative outcome after pancreatic surgery

Conditions: Pancreatic and Peripancreatic Tumors

Summary: patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. after surgery, it will be evaluated which score predicts the best complications.

patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: nutritional risk screening score 2002; subjective global assessment; malnutrition universal screening tool; mini nutritional assessment and short nutritional assessment questionnaire. the postoperative outcome will be recorded, and the predictive value of each score will be calculated.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. all patients are informed orally about all aspects of the trial. all conditions leading to primary pancreatic resection are eligible. exclusion criteria: * patients undergoing minor pancreatic resections.

Keywords: pancreatic cancer pancreaticoduodenotomy nutritional assessment score malnutrition pancreatic surgery distal resection total resection oncology clinica trial