Kornimate/medical-research-clean huggingface dataset:
covid-19 infection in after vaccination

Conditions: Covid19

Summary: coronavirus disease 2019 (covid-19), caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2), was first identified in wuhan, china. it rapidly spread, resulting a global pandemic in march 2020. globally, till 27 august 2021, there have been 214,468,601 confirmed cases of covid-19, including 4,470,969 deaths, reported to who. with the absence of curative treatment for covid-19 infection the development of safe and effective vaccines is critical to ending the covid-19 pandemic. the pfizer/biontech comirnaty vaccine was listed for who emergency use listing (eul) on 31 december 2020. the sii/covishield and astrazeneca/azd1222 vaccines (developed by astrazeneca/oxford and manufactured by the state institute of india and sk bio respectively) were given eul on 16 february. the janssen/ad26.cov 2.s developed by johnson \& johnson, was listed for eul on 12 march 2021. the moderna covid-19 vaccine (mrna 1273) was listed for eul on 30 april 2021 and the sinopharm covid-19 vaccine was listed for eul on 7 may 2021. the sinopharm vaccine is produced by beijing bio-institute of biological products co ltd, subsidiary of china national biotec group (cnbg). the sinovac-coronavac was listed for eul on 1 june 2021. as of 25 august 2021, a total of 4,953,887,422 vaccine doses have been administered. in large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed covid-19. however, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with sars-cov-2, the virus that causes covid-19. a vaccine breakthrough infection is defined as the detection of sars-cov-2 rna or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an fda-authorized covid-19 vaccine. a total of 10,262 sars-cov-2 vaccine breakthrough infections had been reported from 46 u.s. states and territories as of april 30, 2021. among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.


Eligibility criteria:
inclusion criteria: * • patients 18 years old and above of both genders. * received at least one dose of covid-19 registered vaccines. * diagnosed covid-19 positive after vaccination by real time pcr (confirmed case) or combined clinical and radiological diagnosis (possible case). exclusion criteria: • children less than 18 years. * cases non vaccinated with covid-19 registered vaccine

Keywords: covid-19 covid-19 vaccination post vaccination infection breakthrough covid-19 partially vaccinated fully vaccinated
a study to characterize puff topography with use of juul 5% electronic nicotine delivery systems (ends) in adult smokers

Conditions: Tobacco Use; Nicotine Dependence, Other Tobacco Product; Tobacco Smoking

Summary: a study to characterize puff topography with use of a juul 5% electronic nicotine delivery systems (ends) in adult smokers

this will be an open label study to evaluate puff topography in adult smokers using a juul 5% ends. up to 30 subjects will be enrolled and evaluated on day 1 and day 15. the duration of the study is 15 days with up to a 28 days screening window.

Eligibility criteria:
key inclusion criteria: 1. healthy, adult, male or female smoker, 21 to 65 years of age 2. has been a smoker for at least 12 months prior to screening. 3. currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day. 4. a female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study 5. provides voluntary consent to participate in this study documented on the signed informed consent form. key exclusion criteria: 1. has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ecg, or clinical laboratory results, in the opinion of the pi. 2. has a body mass index (bmi) \> 40 kg/m2 or \< 18 kg/m2 at screening. 3. has a history of drug or alcohol abuse within 24 months of day 1. 4. if female, the subject is pregnant, lactating, or intends to become pregnant during the time period from screening through the end of study.

Keywords: electronic nicotine delivery system (ends) ends puff topography
combination therapy between doxycycline, pentoxifylline, and nitazoxanide in sexually active men

Conditions: Sexually Transmitted Diseases

Summary: bacterial sexually transmitted infections (stis) have been steadily increasing in gay, bisexual, and other men who have sex with men (msm) over the past 2 decades. while that trend started prior to the introduction of human immunodeficiency virus (hiv) pre-exposure prophylaxis (prep) in 2012, hiv prep has been associated with increases in sexual contacts and decreases in condom use with an resultant acceleration in the increase of bacterial stis such as gonorrhea, syphilis, and chlamydia.

doxycycline is a moderate-spectrum, second-generation tetracycline that is generally well tolerated. it is rapidly and almost completely absorbed after oral administration. first introduced commercially in the 1960s, doxycycline has been used by millions to manage acne and as primary prophylaxis for scrub typhus, leptospirosis, malaria, and lyme disease. there are anecdotal reports of doxycycline used for syphilis prophylaxis among us and australian military personnel during the vietnam war. doxycycline is a first-line agent for treatment of chlamydia and an alternative regimen for syphilis.an open-label extension of the french national hiv research agency (france recherche nord \& sud sida-hiv hépatites \[anrs\]) intervention préventive de l'exposition aux risques avec et pour les gays (ipergay) hiv-prevention study continued participant access to hiv prep and examined doxycycline postexposure prophylaxis (doxy pep) in msm and transgender women without hiv \[17\]. participants (n = 232) were randomly assigned 1:1 to the intervention-doxycycline 200 mg within 24-72 hours of condomless sexual encounters up to 3 times per week-or to no prophylaxis. those taking doxy pep had lower sti incidence (hazard ratio, 0.57; p = .014). chlamydia trachomatis and syphilis diagnoses were significantly lower in the intervention arm, with a relative reduction of 70-73% in the intention-to-treat analysis.

Eligibility criteria:
inclusion criteria: * individuals aged \> 18 years were eligible for participation if they had a diagnosis of untreated gonorrhea and chlamydia. the untreated status was defined as no antibiotic taken in the previous 28 days to treat gonorrhea and chlamydia. exclusion criteria: * known contraindications or hypersensitivity to doxycycline, pentoxifylline, and nitazoxanide. gonorrhea with complications, such as pelvic inflammatory disease or epididymo-orchitis significant renal failure or hepatic failure.
prokinetic effect of selected nutraceuticals

Conditions: Pulmonary Tuberculosis; Gastro-Intestinal Disorder

Summary: anti-tuberculosis treatment (att) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. nutraceuticals are the cheapest natural sources with therapeutic effects. these natural medicines help in alleviating gastrointestinal disturbances. this study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

the aim of this study will be to evaluate if zingiber officinale, carum carvi, l, and mentha spicata l nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects. this randomized control interventional three arms trial will comprise three phases. patients will be randomized to zingiber officinale, carum carvi, l, and mentha spicata l nutraceuticals or placebo for three months. we will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. acid-fast bacillus (afb) for sputum, chest x-ray (cxr), and complete blood count (cbc) at baseline and after 3 months since the study started.

Eligibility criteria:
inclusion criteria: * newly diagnosed pulmonary tb patients (both genders) * age group 18-65 years * symptoms criteria (rome iv) exclusion criteria: * patients ˃ 18 years and ˂ 65 years. * patients registered with extra pulmonary disease
safety and efficacy on cell-based therapy in patients with recent large acute myocardial infarction

Conditions: Acute Myocardial Infarction; Heart Failure

Summary: the purpose of this study is to test bone marrow mononuclear cells for patients with recent heart attack who are at high risk of experiencing heart failure. this study drug is made of you own cells. studies similar to this one have suggested that the use of cell-based transfer after heart attack can improve the recuperation of the heart. the purpose of this study is to assess whether cell transfer can improve the healing of the heart after a heart attack.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age and no more than 80 years of age. * acute st-segment elevation mi * symptoms suggestive of acute mi * ≥ 2mm st-segment elevation in 2 or more precordial leads or ≥ 1mm in or more limb leads or new left bundle branch block * time from symptom onset to enrollment \< 120 hours * left ventricular dysfunction by contrast ventriculography or echocardiography * ef above 25 % and lower than 40% * focal wall motion akinesis or dyskinesis * clearly identifiable infarct artery * patent infarct artery (timi flow grade 2 or 3) of ≥ 2 mm in diameter following successful stent placement exclusion criteria: * planned treatment with bypass surgery or prior cabg * multi-vessel pci * prior myocardial infarction by history or presence of pathologic q-waves * active cardiogenic shock: mechanical ventilation, iabp, or vasopressors/inotropes * successful reperfusion \< 3 hrs from symptom onset * prior mi or significant chronic heart failure * pacemaker/defibrillator * contraindication to mri (metallic foreign body, claustrophobia, inability to lie flat) * significant hepatic dysfunction or renal insufficiency (estimated creatinine clearance\ 2.5 mg/dl) * baseline hematocrit \< 30 * pregnancy, or lactation/parturition within the past 30 days * active or planned treatment with chemotherapy * anticipated difficulty with 90-day follow-up * evidence of a serious, active infection in the opinion of the investigator including, but not limited to subjects who are hiv, hepatitis b or c positive * any known severe hematological disease, malignancy, systemic or life threatening disorder that would be incompatible with the trial * previous enrollment in this trial * participation in an investigational drug or device study within the past 30 days

Keywords: magnetic resonance imaging
personalized dual-target rtms for patients with refractory schizophrenia

Conditions: Schizophrenia; Transcranial Magnetic Stimulation; Functional Magnetic Resonance Imaging (fMRI)

Summary: the goal of this clinical trial is to evaluate the efficacy of personalized dual-target rtms for treating patients with refractory schizophrenia and to investigate its underlying neural mechanisms using functional mri. the main questions it seeks to address are: does the dual-target rtms protocol improve clinical symptoms in patients with refractory schizophrenia? what neural circuit changes, as assessed by functional mri, occur following rtms treatment? participants will: undergo personalized, dual-target rtms treatment daily for 3 weeks. complete baseline and post-treatment assessments, including clinical symptom scales (panss, hama, hamd) and neuropsychological tests (moca, dst, vft, stroop test, and avlt). have structural and resting-state functional mri scans before and after treatment. be monitored for any treatment-related adverse events.

this open-label clinical trial aimed to evaluate the efficacy and underlying neural mechanisms of a personalized dual-target rtms protocol for treating patients with refractory schizophrenia. patients with refractory schizophrenia were prospectively recruited and underwent 3 weeks of rtms treatment. before treatment, structural and resting-state functional mri data were collected from each patient. clinical symptom severity was assessed using the positive and negative syndrome scale (panss), hamilton anxiety rating scale (hama), and hamilton depression rating scale (hamd). for patients experiencing auditory verbal hallucinations, the auditory hallucination rating scale (ahrs) was also administered. additionally, a battery of neuropsychological tests was conducted, including the montreal cognitive assessment (moca), digit span test (dst), verbal fluency test (vft), stroop test, and chinese auditory verbal learning test (avlt). after completing the 3-week rtms treatment, clinical symptom severity, treatment-related adverse events, and structural and resting-state functional mri data were reassessed.

Eligibility criteria:
inclusion criteria: 1. diagnosed by independent psychiatrists using the structured clinical interview for the diagnostic and statistical manual of mental disorders, 4th edition; 2. disease duration longer than six years; 3. hospitalization two or more times; 4. aged 18-60 years; 5. a stable dosage of antipsychotic medication for at least four weeks before inclusion, and retention of this stable dose for the duration of the study. exclusion criteria: 1. accompanied by other mental illnesses or histories; 2. pregnant; 3. a history of severe head trauma or neurological disease; 4. focal brain lesions on t1- or t2-weighted fluid-attenuated inversion-recovery mri; 5. a history of rtms or electroconvulsive therapy in the six months prior to the study; and 6. metal objects in the head or any other contraindication to mri.

Keywords: schizophrenia transcranial magnetic stimulation dual-target
general anesthesia combined with epidural anesthesia mitigates the surgical stress-related immunosuppression in patients with colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of th1/th2 and treg/th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.


Eligibility criteria:
inclusion criteria: * patients with colorectal cancer(crc); * subjected to the fast-track processing of surgery; * between 18 and 75 years old. exclusion criteria: * american society of anesthesiologists(asa) grade \> iii; * bmi \> 30; * a history of abdominal surgery, endocrine or immune system dysfunction; * recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month; * previous contraindication to epidural anesthesia.

Keywords: anesthesia t-helper mdscs colorectal cancer fast track
further acute research of a subcutaneous implantable defibrillator (s-icd) system

Conditions: Ventricular Fibrillation; Ventricular Tachycardia

Summary: the purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (s-icd) system in patients who require an implantable cardioverter defibrillator (icd)for treating ventricular tachyarrhythmias. the s-icd electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an icd, but then the s-icd system will be removed entirely.

the objectives of this study are to further evaluate the s-icd system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an s-icd emulator and parasternal electrode during the implant procedure of a standard transvenous icd. the active emulator is not a powered medical device and all elements of the test system are removed following the testing. this acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Eligibility criteria:
inclusion criteria: * patients requiring icd therapy according to national centre for clinical excellence (nice) criteria are eligible * and patients who require replacement of an existing transvenous icd system are eligible exclusion criteria: * patients unable or unwilling to provide informed consent * any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study * females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study * participation in another investigational device trial at any time during the conduct of this study * patients with a serious medical condition and life expectancy of less than one year * patients with documented spontaneous and frequently recurring vt that is reliably terminated with anti-tachycardia pacing * patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant

Keywords: subcutaneous icd icd dft pacing threshold polarity
study of nuv-422 in combination with enzalutamide in patients with mcrpc

Conditions: Prostate Cancer; Prostatic Cancer; Cancer of Prostate; Cancer of the Prostate; Prostate Neoplasm; Castrate Resistant Prostate Cancer; Castration Resistant Prostatic Cancer; Castration Resistant Prostatic Neoplasms

Summary: nuv-422-04 is an open-label phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of nuv-422 in combination with enzalutamide. the study population is comprised of adults with mcrpc. patients will self-administer nuv-422 and 160 mg enzalutamide orally in 28-day cycles. patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.


Eligibility criteria:
inclusion criteria: 1. diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone 2. have radiographic or biochemical evidence of progression as determined by investigator per standard criteria 3. have no known active or symptomatic central nervous system (cns) disease 4. prior therapy with abiraterone required and: * for phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease * for phase 2 only: patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with cdk inhibitors 5. eastern cooperative oncology group performance status (ecog ps) ≤ 2 6. adequate bone marrow and organ function 7. eligible to receive enzalutamide 8. life expectancy of \> 6 months exclusion criteria: 1. history of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma) 2. have received chemotherapy, hormonal therapy (with the exception of ongoing lhrh analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of nuv-422 and enzalutamide 3. received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or \< 5 half-lives) for myelosuppressive agent prior to the first dose of nuv-422 and enzalutamide 4. requires medications that are known to be strong inducers and /or inhibitors of cyp3a4/5 enzymes, except enzalutamide * for phase 1b only: requires medications that are known to be moderate inducers and /or inhibitors of cyp3a4/5 enzymes, except enzalutamide 5. prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors 6. known allergy or hypersensitivity to enzalutamide

Keywords: phase 1 phase 2 metastatic castration-resistant prostate cancer nuv-422 enzalutamide xtandi cdk cdk inhibition cdk2/4/6
efficacy study of human cytomegalovirus (hcmv) hyperimmune globulin to prevent congenital hcmv infection

Conditions: Cytomegalovirus Infection

Summary: the aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (hcmv)-specific hyperimmune globulin administration to pregnant women suffering from primary hcmv infection for the prevention of intrauterine hcmv transmission.

hcmv is the leading infectious cause of mental retardation and deafness in infants with congenital hcmv infection. primary hcmv infections during pregnancy carry the highest risk of fetal infection and disease. no intervention of proven efficacy is available in case of primary hcmv infection in pregnancy. however, a study published in 2005 (nigro et al., nejm 353:1350-62, 2005) reported that in pregnant women with primary hcmv infection treated with hcmv-specific hyperimmune globulin (cytotect®, biotest) the risk of transmitting the infection to the fetus was reduced from 40% to 16%. unfortunately, since the study was conducted with inadequate controls, the actual efficacy of hyperimmune globulin could not be properly assessed. in the present randomized, double-blind, placebo-controlled, multicenter trial pregnant women with ascertained primary hcmv infection at 4-26 weeks of gestation will be randomized to receive cytotect® or placebo intravenously within 6 weeks after the presumed onset of infection. primary efficacy parameter will be the number of hcmv-infected newborns or fetuses.

Eligibility criteria:
inclusion criteria: * pregnant women (in vitro fertilization permitted) * \>= 18 years of age * primary hcmv infection at 5-26 weeks' gestation * \<= 6 weeks from presumed onset of infection * gestational age between 5-32 weeks' gestation * written informed consent exclusion criteria: * multiple pregnancy * history of hiv or hbv or hcv infection * known immunodeficiency or immunosuppression * congenital or acquired autoimmune disease * known intolerance to protein of human origin * known intolerance to immune globulin * history of adverse effects to vaccination * hypersensitivity to human immune globulin (pathological igg or iga deficiences) * renal failure * serious organic or psychiatric disease * lack of motivation to participate in the study * women unable to satisfy study requirements * women not willing or unable to provide written informed consent * women not willing to give consent to transmission of anonymised data

Keywords: human cytomegalovirus immune globulin congenital infection prevention pregnancy