Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of two hyperimmune equine anti sars-cov-2 serum in covid-19 patients

Conditions: Covid19

Summary: reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and sars-cov-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. during the previous sars-cov epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. these preparations were also successful in several animal models. taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of sars-cov-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "s" (spike) protein of the virus and the second group with a mixture "m" of the s1 (spike) proteins, the n (nucleoprotein) protein and a construct with epitopes of the s1, e (envelope) and m (membrane) proteins, generating two different pharmaceutical preparations. objective: evaluate the efficacy and safety of two hyperimmune equine serum anti-sars-cov-2 ("s" and "m") formulations as an addition to the standard therapeutic approach for hospitalized patients with covid-19 over 18 years of age with the presence of at least 2 risk factors and a symptom onset period not exceeding 10 days. a total of 52 patients will be included and randomly divided into two balanced groups. on day 1, all participants from each group will receive an intravenous infusion containing 10ml (one vial) of hyperimmune equine anti-sars-cov-2 serum labeled as a or b. patients will be evaluated clinically, general laboratory, sars-cov-2 serologies, sars-cov-2 viral load and cytokines level as well as pulmonary ultrasound. data will be collected for both groups on days 0 to 7, 10 and 14 or discharge after completion of treatment. the study will end for each participant on the day of discharge from the hospital.


Eligibility criteria:
inclusion criteria: * agreement to participate in the study by signing the prior informed consent. * age over 18 years. * inpatient with rt-pcr confirmation of sars-cov-2. * period of onset of symptoms related to covid-19 not greater than 10 days * presence of at least 2 documented risk factors * moderate and severe clinical presentation of the disease. exclusion criteria: * patients who did not sign the informed consent. * critical patient. * patient previously bitten by a snake that was treated with equine hyperimmune serum. * patients with covid-19 on an outpatient basis. * pregnant women. * patients in hemodialysis program. * patients who have already received plasma from a convalescent covid-19 patient. * patients who were classified prior to the diagnosis of covid-19 by the treating physician as having a reserved prognosis with a short lifespan.

Keywords: covid-19 anti-sars-cov-2 equine immunoglobulin passive immunotherapy neutralizing equine antibodies.
donepezil and cognitive training for alcohol use disorder (aud)

Conditions: Alcohol Use Disorder

Summary: the goal of the project is to evaluate whether donepezil + cognitive remediation therapy is superior to placebo in reducing heavy drinking in patients with alcohol use disorder in a double-blind, placebo-controlled trial.


Eligibility criteria:
inclusion criteria: 1. males and females 18-80 years of age 2. fluency in english and a 6th grade or higher reading level 3. meets the diagnostic and statistical manual of mental disorders (dsm-5) criteria for a current alcohol use disorder (subjects should have a primary alcohol use disorder \[aud\] diagnosis, but may have concurrent occasional use of other substances) 4. last alcohol use and at least one heavy drinking day within the past 30 days 5. willingness to attend follow-up assessments at 13 weeks 6. willingness to submit to urine toxicology screenings exclusion criteria: 1. lifetime diagnosis of a psychotic disorder, not induced by drug use 2. current treatment with opioids or benzodiazepines, which may affect new learning 3. involvement in a legal case that may lead to incarceration during the study period 4. residential plans that would interfere with participation 5. medical illness that may significantly compromise cognition (e.g., parkinson's, alzheimer's, huntington's chorea, moderate or greater tbi) 6. an uncorrected sensory impairment (hearing or sight) that would seriously interfere with cognitive training 7. pre-morbid intelligence quotient (iq) estimate below 70 8. unstable housing or lack of commitment to staying within a geographic area that would make follow-up unlikely 9. unwillingness to provide contact information of someone who can help study staff contact the subjects in the event that study staff are unable to maintain contact directly 10. allergy to donepezil 11. unstable cardiovascular disease or unstable medical condition-clinically determined by a physician 12. imminent suicidal or homicidal risk 13. pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
dexmedetomidine sedation versus general anaesthesia for inguinal hernia surgery in infants

Conditions: Neurodevelopmental Disorder; Bilateral Inguinal Hernia

Summary: this is a prospective randomized controlled trial comparing dexmedetomidine sedation with caudal anaesthesia, and general sevoflurane anaesthesia with caudal anaesthesia for inguinal herniotomies in neonates and infants below 3 months of age. the investigators will compare the efficacy and adverse events associated with each of these techniques and neurodevelopmental outcomes of the infants in each group at 6 months and 2 years of age.

several epidemiologic studies have suggested that children exposed to general anaesthesia (ga) in early childhood may be at increased risk of subsequent learning disabilities and behavioural problems. animal studies have shown that exposure to ga agents during critical neuro-developmental windows induces neuronal apoptosis. all commonly used anaesthetic agents induce neurotoxicity with the exception of dexmedetomidine, a highly specific alpha-2 agonist which has been shown to be neuroprotective. ga is the current standard of care for inguinal hernia repair in infants at kkh. the investigators recently demonstrated that dexmedetomidine sedation with caudal block is a feasible alternative for inguinal hernia repair in infants below 3 months of age. this prospective randomized controlled trial will compare the early and long-term outcomes of infants following inguinal hernia surgery using dexmedetomidine sedation with caudal block versus ga with caudal block. this study aims: 1. to compare the neurodevelopment at 6 months and 2years, of infants randomized to dexmedetomidine sedation with caudal block with those randomized to ga with caudal block for inguinal hernia surgery before 3 months of age. 2. to compare the efficacy of dexmedetomidine sedation with caudal block versus ga with caudal block for inguinal hernia surgery, in terms of duration of anaesthesia, duration of surgery and surgeon's satisfaction with intraoperative conditions.

Eligibility criteria:
inclusion criteria: * infants below 3 months of age ( corrected age 54 weeks) presenting for elective inguinal hernia repair in kkh. exclusion criteria: * history of prematurity younger than 28 weeks gestation, * requirement for cpap greater than 6 cmh20 at time of surgery * significant cardiac pathology or cardiac conduction defects * unusually large hernia sacs * any contraindication for caudal anesthesia * surgeon refusal on account of anticipated prolonged or difficult surgery.

Keywords: dexmedetomidine sedation general anaesthesia neurodevelopment infants neonates
a study on the effects of soulera herbal blend intake on chronic stress in healthy adults

Conditions: Chronic Stress

Summary: the purpose of the study was designed to evaluate the efficacy and safety of soulera herbal mix in powder form and its effects on anxiety and the biomarkers for chronic stress.


Eligibility criteria:
inclusion criteria: * healthy men and women between the ages of 21-65. * no concerns that would confound the study as determined by study physicians. * women must not be pregnant or become pregnant for the duration of the study. exclusion criteria: * the subject has a history of hypersensitivity to any of the compounds used in the study * the subject is pregnant or breast feeding. note: if the potential subject is a post-menarche female, a urine pregnancy test must be performed within 24 hours prior to study drug administration and confirmed negative in order for the potential subject to eb enrolled. * history of psychiatric illness or chronic stress or anxiety * hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results * individuals who are cognitively impaired or who are not able to give informed consent * any routine prescription medication that the study physician feels may cause drug interaction with soulera or alter the prescription medications' activity * previous participation in a clinical research trial within 30 days prior to randomization * the subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana * the subject uses or has used in the past 30 days any steroid formulation, be it topical like face cream, ocular as in an eye drop, nasal as in a spray, injection or pill. * the subject is a current smoker or uses tobacco products such as chewing tobacco. * the subject is actively engaging in the use of herbal medicine, traditional chinese medicine, ancient indian medicine, yoga, or ayurveda * the subject is a night-shift worker and therefore presumably has an altered cortisol diurnal rhythm and is also unable to comply with the required cortisol collection times of the study
confirm: magnetic resonance guided radiation therapy

Conditions: Gastric Cancer; Invasive Breast Cancer; in Situ Breast Cancer; Mantle Cell Lymphoma; Larynx Cancer; Bladder Cancer

Summary: this research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (mri) and chemotherapy to treat patients with gastric and breast cancer. the name of the radiation machine involved in this study is the mridian linear accelerator.

this is a master clinical protocol evaluating magnetic resonance (mr) image guided radiation in patients with gastric and breast cancer. in this research study, the investigators are researching if getting an mri during radiation is a feasible way to delivery radiation. in this research study, a mri done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located. the research study procedures include: * screening for eligibility * study treatment including evaluations * follow up visits * questionnaires this is a phase i/ii clinical trial. a phase i clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "investigational" means that the way the radiation treatment is delivered is being studied. this research study is a feasibility study, which means it is the first-time investigators at this institution are examining this type of mr-guided radiation. investigators at other hospitals and academic centers are already using this type of radiation. the u.s. food and drug administration (fda) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

Eligibility criteria:
inclusion criteria: * participants must have histologically or cytologically confirmed malignancy requiring radiation * age 18 years of older * ecog performance status ≤2 (karnofsky ≥60%, see appendix a) * ability to understand and the willingness to sign a written informed consent document. * any further criteria listed in the specific disease site cohort exclusion criteria * history of allergic reactions attributed to gadolinium-based iv contrast -- note: if patient will not receive contrast, this is not applicable and kidney function will not affect eligibility * severe claustrophobia or anxiety * participants who cannot undergo an mri * any other exclusion criteria listed in the specific disease site cohort

Keywords: gastric cancer invasive breast cancer in situ breast cancer lymphoma larynx bladder
virtual reality intervention for stress, resilience, and blood pressure management in black women - realist women study

Conditions: Stress; Hypertension

Summary: the realist women study wants to see if a special program using virtual reality can help black women deal with stress and improve black women's heart health. the study team wants to see if using virtual reality (vr) can help with stress of black women. the investigator will look at things like sleep, stress, and how well the vr works. the investigator also wants to know about any problems black women might have using virtual reality.


Eligibility criteria:
inclusion criteria: * self-identified as a black woman * at least 21 years of age * fluency in english * international classification of diseases (icd)10 diagnosis of hypertension * being a south florida resident * willing to be audio-recorded exclusion criteria: * history of psychosis disorders * absence of vision and cognitive impairment * absence of epilepsy disorders * absence of motion sickness.

Keywords: intersectional framework
correlation between reticulated platelets and major adverse cardiac and cerebrovascular events after noncardiac surgery

Conditions: Cardiac Death; Congestive Heart Failure; Angina Pectoris; Stroke; Pulmonary Embolism; Deep Vein Thrombosis

Summary: this is an observational study designed to monitor the course of the fraction of reticulated platelets and the correlation thereof to major adverse cardiac and cerebrovascular events after noncardiac surgery.

reticulated platelets (rp) are newly formed, immature platelets which in contrast to mature platelets have high granule content and a residual amount of mrna. an increased mean platelet volume (mpv) and the fraction of rp have been shown to be correlated to cardiovascular events like myocardial infarction or cardiovascular death. however, there are no trials so far investigating how surgery impacts the fraction of rp and how this fraction correlates with the outcome after noncardiac surgery. patients with an age above 18 years undergoing high-risk or intermediate-risk noncardiac surgery are to be included. the fraction of rp is to be investigated in routinely acquired blood samples preoperatively, postoperatively in the recovery room, as well as 24-72 hours after anaesthesia and surgery. a primary common endpoint are major adverse cardiac and cerebrovascular events (macces), as well as deep vein thrombosis and pulmonary embolism. macces are defined according to sabaté et al. as: cardiac death, cerebrovascular death, nonfatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina or stroke. secondary endpoints are lengths of hospital stay and intensive care stay as well as mortality after 3 months. all participants are to be contacted by phone three months after discharge and their health situation is to be determined. 1000 patients will be enrolled in a defined time frame of six months

Eligibility criteria:
inclusion criteria: * high-risk or intermediate-risk surgical patients undergoing noncardiac surgery * age ≥ 18 years * written informed consent exclusion criteria: * low-risk surgery * age \< 18 years

Keywords: reticulated platelets noncardiac surgery macces major adverse cardiac and cerebrovascular events outcome high-risk or intermediate-risk noncardiac surgery
surgical outcomes in patients with primary hyperparathyroidism and unclear preoperative localisation studies

Conditions: Primary Hyperparathyroidism

Summary: although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (mip) as the best option for patients with concordant preoperative studies. nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming bne as mandatory and others suggesting that a mini-invasive approach is still possible if combined with iopth monitoring. in our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between us and mibi scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.

this is an unicentric, retrospective study on patients who underwent surgery for php from january 2004 to june 2020 at our department of general and endocrine surgery, which is a tertiary referral centre for parathyroid disease. ethical approval was released from our local independent ethical committee. patients involved in the study subjects gave informed consent to the work. in our study, we included only patients who underwent both us and mibi preoperatively. the exclusion criteria were the association of total or partial thyroidectomy planned preoperatively for thyroid disease, reoperative surgery for persistent or recurrent php, and incomplete data or follow-up. the primary aims of this study were: * to identify predictive factors of unclear preoperative localisation studies. * to evaluate if a mini-invasive approach is feasible in this kind of patients, considering the incidence of persistent php as the main outcome. the secondary outcomes were: * to assess the role of iopth assay in patients with unclear localisation studies. * to evaluate the accuracy of preoperative localisation studies in our series, particularly in patients with discordant or negative us and mibi scan.

Eligibility criteria:
inclusion criteria: * patients with primary hyperparathyroidism exclusion criteria: * patients with concomitant thyroid disease
focused suicide prevention strategy for youth

Conditions: Suicide; Suicide, Attempted; Suicidal Ideation

Summary: this study evaluates whether a family-centered suicide prevention strategy, when added to usual care (f-sps + uc), is more effective than enhanced usual care (euc) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. half of the participants will be randomized to receive f-sps + uc and half will receive euc.

this is a rct of a patient- and family-centered suicide prevention intervention added to usual care (f-sps + uc) for adolescents aged 12 to 18 years who present to the emergency department (ed) with suicidal ideation or suicide risk behaviours. the investigators will determine whether the f-sps + uc intervention is more effective than enhanced usual care (euc) in reducing suicide-related behaviors in 128 youth at high-risk of suicide. f-sps is a 6-week, standardized, manualized outpatient program that teaches participants to the skills to manage suicidal thoughts and impulses effectively. the family component addresses conflictual relationships that may be present in the family as well as improving family communication. enhanced usual care consists of 6 weekly telephone calls to ensure that the participant has connected with community resources suggested by the ed team and provide additional resources as needed.

Eligibility criteria:
inclusion criteria: * ages 12 to18 years * youth presenting in the emergency department with acute suicidal ideation or suicide risk behaviour * siq-jr score ≥ 31 * parent or caregiver able to communicate in english, or is willing to communicate using a hospital-organized translator, and willing to participate in study * living in the greater toronto area and access to a telephone. exclusion criteria: * active psychosis or hypomania/mania * moderate to severe intellectual disability, autism.
psychological assessment of scoliosis patients undergoing surgical management

Conditions: Adolescent Idiopathic Scoliosis (AIS); Mental Health

Summary: working in partnership with montefiore-einstein's department of translational psychiatry, the study team investigators have designed a prospective randomized clinical trial (2:1) study for 45 ais patients (10-19 yrs.). this protocol includes a baseline assessment of mental health, pain, and function in ais patients utilizing validated patient reported outcome measures. the investigators will implement and test a structured perioperative psychological intervention program, based on the aim to decrease anxiety and pain treatment (adapt), which was developed based on evidence-based cognitive behavioral therapy (cbt) protocols for the management of pediatric pain and childhood anxiety disorders

working in partnership with montefiore-einstein's department of translational psychiatry, the investigators have designed a prospective randomized clinical trial (2:1) study for 45 ais patients (10-19 yrs.). this protocol includes a baseline assessment of mental health, pain, and function in ais patients utilizing validated patient reported outcome measures. the investigators will implement and test a structured perioperative psychological intervention program, based on the aim to decrease anxiety and pain treatment (adapt), which was developed based on evidence-based cognitive behavioral therapy (cbt) protocols for the management of pediatric pain and childhood anxiety disorders

Eligibility criteria:
inclusion criteria: * diagnosis of scoliosis prior to age 20 * healthy, non-obese aged 10-19 years, with a diagnosis of idiopathic scoliosis, undergoing elective posterior spinal fusion exclusion criteria: * diagnosis of scoliosis after age 20 * permanent cognitive impairment * pregnant or breastfeeding women * use of opioids in the last 6 months * liver or renal diseases and developmental delays