Kornimate/medical-research-clean huggingface dataset:
a study of hh-120 nasal spray in close contacts of those diagnosed with covid-19

Conditions: COVID-19; SARS-CoV-2 Infection

Summary: this study is to evaluate the efficacy of post-exposure prevention and safety of hh-120 nasal spray in participants who are caregivers of hospitalized patients infected with sars-cov-2. hh-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the sars-cov-2 infected patients or confirmed infection of the participant, whichever occurs first.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 18 or above; * caregivers of hospitalized children who are infected with sars-cov-2; * negative qrt-pcr nucleic acid test result during the screening; * willing and able to give written informed consent. exclusion criteria: * those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study; * female subjects who are positive for human chorionic gonadotropin (β-human chorionic gonadotropin, β-hcg) or are breastfeeding; * have used antiviral drugs with a therapeutic effect on covid-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, bamlanivimab, etesevimab, bebtelovimab, casirivimab and imdevimab, sotrovimab), convalescent plasma, hydroxychloroquine, paxlovid (nimatevir/ritonavir), azvudine, baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives); * those who have participated in clinical trials of sars-cov-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening; * those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) factors, etc.) have allergies or hypersensitivity reactions; * those who have received the covid-19 vaccine within 2 weeks before the study drug administration or plan to receive the covid-19 vaccine during the study; * those who cannot tolerate with nasal spray treatment; * any other circumstances that the researchers deemed not suitable for participating in the study.
one, two, or three istents for the reduction of intraocular pressure in open-angle glaucoma subjects

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: the purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (iop) lowering effect of one, two, or three istent devices in eyes of subjects previously on two anti-glaucoma medications.


Eligibility criteria:
inclusion criteria: * diagnosed with primary open-angle glaucoma (poag) * subject on two topical hypotensive medications exclusion criteria: * traumatic, uveitic, neovascular, or angle closure glaucoma * fellow eye already enrolled

Keywords: open angle glaucoma surgery glaucoma, open-angle ocular hypertension eye diseases
the observe protocol

Conditions: Major Depression Disorder

Summary: this observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either spravato® or iv ketamine. this can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. this 5-year, 6-site study will enroll 450 total patients. the sites will comprise 3 academic medical centers and 3 community psychiatric practices.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, an individual must meet the following criteria: 1. recently started treatment (within 75 days of screening visit) with iv ketamine or spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial madrs score ≥ 25) trd (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. these patients are referred to as treatment-continuing subjects. or 2. scheduled to receive standard clinical treatment with iv ketamine or spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial madrs score ≥ 25) trd (refractory to two or more antidepressant trials) without psychotic features. these patients are referred to as treatment-initiating subjects. in addition, in order to be eligible, an individual must meet all of the following additional criteria: 3. adult ages 18 or older 4. provision of signed and dated informed consent form prior to any study procedures 5. stated willingness to comply with all study procedures and availability for the duration of the study exclusion criteria: an individual who meets any of the following criteria will be excluded from participation in this study: 1. diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder) 2. other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis 3. active or recent (within 12 months) substance use disorder (other than nicotine)
impact of a dolutegravir-based regimen on early mortality of aids patients

Conditions: Severely Immunocompromised HIV Patients

Summary: the current available antiretroviral (arv) agents make possible a successful treatment of virtually all hiv-infected patients, but some problems related to early mortality are still of concern, mainly in resources-limited settings. there are several published reports showing that such patients are at a significantly higher risk of death during the first months of treatment, in comparison with the observed outcomes in developed countries. one of the consistently detected risks for early mortality across these reports is the baseline low cd4 count, although it does not seem to be the only reason for such outcome. in brazil and other developing countries, there is still a large proportion of aids patients who are diagnosed with aids, or only seek health care for hiv infection late in the course of disease. dolutegravir (dtg), the first hiv-1 integrase inhibitor, is a potent and safe arv drug. the available evidence suggest it promotes a faster decline in hiv-1 plasma viremia, and a higher increase in cd4 cells count, in comparison with those in efavirenz (efv) arm. the investigators propose to compare the impact of dtg versus efv in the early mortality rates for severely ill (cd4+ cells count \<50 cells/mm3) patients starting arv therapy.


Eligibility criteria:
inclusion criteria: * patients with confirmed hiv-1 infection (positive western blot or plasma hiv-1 rna \>1,000 copies/ml) * no previous use of any arv drug (drug-naïve patients) * presence of clinical symptoms according to rio de janeiro / caracas´ aids definition (asthenia, cachexia/wasting, cough, dermatitis, persistent, diarrhea, fever, lymphadenopathy, candidiasis, oral, or hairy leukoplasia, central nervous system dysfunction, herpes zoster in individual younger than 60 years of age)), and/or any active aids-defining condition * baseline cd4+ cells count equal or lower than 50 cells/mm3 * age equal or higher than 18 years * hiv-1 plasma viral load ≥ 1,000 copies of hiv-1 rna/ml exclusion criteria: * undetectable plasma viral load at screening * cd4 cells count\>50 cells/mm3 * asymptomatic individuals
evaluating precision of therapy - milrinone

Conditions: Congenital Heart Disease

Summary: children with congenital heart disease have significant morbidity including low cardiac output syndrome and subsequent organ dysfunction that may be prevented by optimization of circulatory function. more than half of these children receive milrinone. clinical evaluation cannot distinguish between patients with sub-therapeutic, therapeutic, and toxic milrinone drug levels. consequently children who require pharmacologic circulatory support may be receiving sub-optimal dosing, and children who do not need milrinone may be receiving milrinone unnecessarily. the primary objective of this study is to determine if optimizing milrinone levels with therapeutic drug monitoring in critically ill children following cardiac surgery improves clinical outcomes and reduces the duration of milrinone infusion. this study hypothesizes that optimizing milrinone levels with therapeutic drug monitoring in critically ill children following cardiac surgery will improve clinical outcomes and reduce the duration of milrinone infusion.

the proposed trial is a pilot of an open label, randomized trial of milrinone therapeutic drug monitoring in patients \ 10 years to ensure equal distribution of these age ranges in each group for pharmacokinetic analysis. for the intervention group, sampling for milrinone levels will occur at 0 hours (upon arrival to icu with routine admission blood collection) and approximately every 6- 8 hours (whenever the line is accessed for routine blood work). the last sample will be taken 6-8 hours after cessation of infusion, or if the patient leaves the icu, or the maximum amount of blood sampling has been reached or after 7 days for children weighing more than 8 kgs (or 5 days for children weighing less than 8 kgs), which ever comes first. follow-up will be exclusively during the period of hospitalization in the icu until icu discharge. an optional algorithm with a proposed titration for milrinone will be provided for use at the discretion of the treating team. clinical outcomes will be measured as a composite outcome of dysrhythmia, lcos and death.

Eligibility criteria:
inclusion criteria: * admitted to a pediatric (0 - 18 years) intensive care unit following cardiopulmonary bypass (cpb) and surgery for congenital heart disease. * clinical decision by treating team to start milrinone infusion. * anticipated to receive milrinone infusion for more than 24hs. this limit will increase the proportion of sicker children in the sample, increasing the power of the study. * has an arterial line, and a central venous line defined as radiologically confirmed line * informed consent obtained exclusion criteria: * premature infants (\<36 weeks post-conceptual age) or weight less than 2.0 kg. * failure to provide consent

Keywords: congenital heart disease pediatrics milrinone cardiopulmonary bypass therapeutic drug monitoring
model of predicting biochemical recurrence after radical prostate cancer based on pre-treatment psma pet / mr image features

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate the predictive value of preoperative 18f-psma-1007 pet/mr in the predictive effect of biological recurrence (bcr) after radical prostatectomy (rp) for localized prostate cancer (pca).

construct a predictive model for biochemical recurrence (bcr) in patients after radical prostatectomy using imaging parameters from preoperative 18f-psma-1007 pet/mri, and compare the predictive performance of this model with existing clinical models. data from three centers will be collected, with datasets from two centers used as the training set for the selection of predictive factors and model construction, while the dataset from the remaining center will serve as the validation set to assess the predictive performance of the model for bcr after prostatectomy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. histologically confirmed prostate cancer without other types of malignancy - exclusion criteria: 1.surgery or endocrine therapy is performed prior to the examination -

Keywords: pet/mr prostate cancer biochemical recurrence multicenter
auricular acupuncture for the treatment of post-tonsillectomy pain

Conditions: Recurrent Tonsillitis; Peritonsillar Abscess; Obstructive Sleep Apnea

Summary: the goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.


Eligibility criteria:
inclusion criteria: * any adult patient who meets criteria and is scheduled for tonsillectomy exclusion criteria: * any patient with prior use of acupuncture * individuals under age 18 * tonsillectomy performed with other surgical procedures, i.e uppp, adenoidectomy, * patients with a known personal or family history of a bleeding disorder will be excluded. * patients with a history of kidney or liver problems will also be excluded. * patients found to be pregnant will be excluded from participation. * patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.

Keywords: tonsillectomy acupuncture
thromboelastography in in patients with sepsis

Conditions: Shock, Surgical; Systemic Inflammatory Response Syndrome

Summary: methods: the study is an observational prospective trial that includes 150 patients 18 or older admitted to our icu because of severe sepsis or septic shock as defined by the american college of chest physicians/ society of critical care medicine consensus conference. patients whose primary reason for hospital admission is sepsis or patients developing sepsis after elective invasive procedure will be included. only patients with known former primary coagulation/hypercoagulability disorder wil be excluded. procedure: within 12 hours of admission to the intensive care unit (icu) blood will be drawn for the following: blood count, glucose, urea, creatinine, liver function tests, prothrombin time, partial thromboplastin time, ddimer, fibrinogen and teg (thromboelastography) assay will be performed. these blood tests will be also drawn on day 2 and 4 of admission. on day one, another 3 cc of blood will be drawn and frozen in -80 degrees for levels of coagulation factors: i, ii, v, vii, viii, ix, x, xi, xii, xiii, antithrombin iii, protein c, s. demographic data will be collected according to patient chart, and the acute physiologic and chronic health evaluation (apache) ii score will be assessed after 24 hours. vital signs will be collected from monitors. informed consent will be waved due to lack of any intervention and the general condition of patients unable to sign an informed consent. control group will include 10 healthy individuals. end point: the primary end point is to determine the common hypercoagulable/coagulation disorders according to teg. the secondary end point is to determine whether teg results have prognostic implications on this group of severe septic patients.


Eligibility criteria:
inclusion criteria: * all patients age 18 years or older admitted to icu whose primary reason for admission was sepsis or suffering sepsis or septic shock after elective surgical procedure exclusion criteria: * patients suffering primary disease affecting the coagulation system
risk factors for post-operative respiratory complications in patients at risk for osa

Conditions: Respiratory Complications

Summary: this study investigates the incidence of postoperative respiratory complications (prcs) including: oxygen desaturation events, tracheal re-intubations within 48 hours of surgery, and failure to wean from ventilator within 48 hours of surgery - in patients with and without risk factors for osa undergoing elective, non-cardiac surgery (ncs).

324 subjects will be enrolled into one of two groups: increased or not increased risk for osa, n=162 patients per group. preoperative assessments of osa status, mallampati score (an assessment for mouth and throat morphology), stop-bang test (assessment for risk of osa), and medical history will be used to determine patient group assignment. all subjects will receive standard general anesthesia and monitoring as a part of standard of care whether or not she/he will participate in the study, including ecg, arterial pressure, spo2, bis, blood pressure (bp), heart rate (hr), and respiratory rate (rr), all of which will be continuously recorded and data will be saved for every three minutes during induction using standard monitors. standard monitoring assessments in pacu will be used, and patients with increased perioperative risk for osa will be closely monitored for hypoxemia and other complications. the nellcor pulse oximetry sensor will be applied in pacu and continuously monitor the patient's oxygen saturation and respiratory rate for the first 48 hours postoperatively. at the end of the 48 hours, the device will be removed, and the de-identified data will be transferred to a computer with analysis software and examined for patterns in respiratory distress in both patient groups. data collected from the nellcor bedside respiratory patient monitoring system on pulse and oxygen saturation, as well as data on clinically significant events, such as prcs, acute respiratory failure, tracheal reintubation, hypoxemia, chf, mi, a-fib, and delirium will be analyzed to understand the effects of osa on postoperative recovery

Eligibility criteria:
inclusion criteria: * male or female , 18 to 75 years of age * asa i, ii or iii * capable and willing to consent * participants literate in english language exclusion criteria: * asa iv or v * patients with severe visual or auditory disorder * illiteracy * chronic obstructive pulmonary disease * restrictive lung diseases * benzodiazepines use * patients who were undergoing surgical procedures involving the upper airway, including tonsillectomy, septoplasty, uvuloplasty, uvulopalatoplasty, uvulopharyngoplasty, or uvulopalatopharyngoplasty, as these procedures were most likely to have been indicated to cure the primary disease process (osa) * cardiac surgeries * neurosurgeries (brain) * any condition, which in the opinion of the investigator would make subject ineligible for participation in the study such as history of unstable cardiovascular, pulmonary, renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality (hyperthyroidism, unstable diabetes type i/ii)
the framingham study: examining dna markers and links to diseases

Conditions: Vascular Diseases

Summary: since 1948, residents of framingham, massachusetts, have participated in a program that collects blood samples and clinical data to provide a rare and valuable database for scientific research. the purpose of this study is to support this national resource by aiding in its research capacity. specifically, researchers in this study will (1) investigate heart, lung, and blood diseases; stroke; memory loss; joint disease; bone loss; deafness; cancer; blood vessel diseases and other health conditions, and (2) examine dna and its relationship to risk of developing these disease and health conditions. approximately 330 families have participated in the framingham study. participants will be required to undergo a four-hour exam and to take that exam every two years thereafter. during the exam, the framingham investigators will (1) interview participants about medical status, health issues, and lifestyles; (2) perform a regular physical exam; (3) obtain blood and urine samples and administer a glucose-tolerance test; (4) supervise a brisk six-minute treadmill walk; (5) administer an ultrasound procedure; and (6) review and obtain copies of medical and hospital records. participants will also be asked to complete a questionnaire at home regarding dietary and health habits.

many studies have shown that hematocrit (hct) levels are associated with cerebrovascular disease, cardiovascular disease (cvd), peripheral vascular disease, as well as all-cause mortality. twin studies have shown that hct variation is largely determined by genetic factors with heritability estimated as 40% - 65%. so far, no linkage analysis in humans between hct and dna markers have been reported. the purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (qtl) involved in controlling hct levels. in the framingham study, a 10cm genome scan (about 400 markers) has been conducted in 330 families. hct was measured in the original cohort and framingham offspring. these data provide us the opportunity to undertake linkage analyses using variance component method to map quantitative trait loci (qtl) of hct.

Eligibility criteria:
* inclusion /exclusion criteria the study population will include the members of the 330 framingham study families with genome scan.

Keywords: genetics populations cvd risk gene mapping epidemiology framingham study vascular diseases
empagliflozin outcome trial in patients with chronic heart failure with reduced ejection fraction (emperor-reduced)

Conditions: Heart Failure

Summary: the aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.


Eligibility criteria:
inclusion criteria: * male or female patient age \>= 18 years at screening. for japan only: age \>= 20 years at screening * patients with chronic hf (chronic heart failure) nyha (new york heart association classification) class ii-iv and reduced ef (ejection fraction) (lvef (left ventricular ejection fraction) \<=40%) and elevated nt-probnp (n-terminal of the prohormone brain natriuretic peptide) * if ef \>= 36% to \ = 2500 pg/ml or patients without af (atrial fibrillation/atrial flutter) and nt-probnp \>= 5000 pg/ml for patients with af * if ef \>= 31% to \ = 1000 pg/ml for patients without af and nt-probnp \>=2000 pg/ml for patients with af * if ef\ = 600 pg/ml for patients without af and nt-probnp \>=1200 pg/ml for patients with af * ef ≤ 40% and hospitalization for heart failure in the past 12 months: ntprobnp ≥ 600 pg/ml for patients without af and nt-probnp \>= 1200 pg/ml for patients with af * appropriate dose of medical therapy for hf consistent with prevailing local and international cv (cardiovascular) guidelines, stable for at least 1 week prior to visit 1 * appropriate use of medical devices such as cardioverter defibrillator (icd) or a cardiac resynchronization therapy (crt) consistent with prevailing local or international cv guidelines * signed and dated written icf (informed consent form) * further inclusion criteria apply exclusion criteria: * myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or tia (transient ischaemic attack) in past 90 days prior to visit 1 * heart transplant recipient, or listed for heart transplant * acute decompensated hf * systolic blood pressure (sbp) \>= 180 mmhg at visit 2. * symptomatic hypotension and/or a sbp \< 100 mmhg * indication of liver disease * impaired renal function, defined as egfr (estimated glomerular filtration rate) \< 20 ml/min/1.73 m2 (ckd-epi (chronic kidney disease - epidemiology collaboration equation)) or requiring dialysis * history of ketoacidosis * current use or prior use of a sglt (sodium-glucose co-transporter)-2 inhibitor or combined sglt-1 and 2 inhibitor * currently enrolled in another investigational device or drug study * known allergy or hypersensitivity to empagliflozin or other sglt-2 inhibitors * women who are pregnant, nursing, or who plan to become pregnant while in the trial * further exclusion criteria apply
mazindol for cocaine abuse - 2

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate high and low dose mazindol for cocaine abuse.


Eligibility criteria:
please contact site for information.

Keywords: cocaine-related disorders