Kornimate/medical-research-clean huggingface dataset:
epidemiological and demographic data from 150 patients diagnosed with coronavirus disease 2019 pneumonia

Conditions: Corona Virus Infection; Pneumonia; Acute Respiratory Failure

Summary: in this study, the investigator examined epidemiological and demographic characteristics, risk factors and 28-day mortality of patients admitted to the intensive care unit with the diagnosis of coronavirus disease 2019 pneumonia.

the patients with intensive care requirements were admitted from emergency department and coronavirus disease 2019 wards to our units. the criteria for intensive care requirement was identified as oxygen saturation\ 30/min or pao2/fio2(partial oxygen pressure/fraction of inspired oxygen) \<300 despite conventional oxygen treatment of 5lt/min. primary objective was the effect of defined data on 28-day mortality, and secondary objective was the impact of lymphocyte count, lactate dehydrogenase, ferritin, d-dimer and procalcitonin levels, and sofa(sequential organ failure assessment) score on prognosis, which are among the risk factors determined by previous studies. all data were evaluated and recorded using the standardized international severe acute respiratory and emerging infection consortium (isaric) case report forms, complemented by electronic records of the hospital, nurse observation records, and missing information was completed by telephone interviews with patients' relatives.

Eligibility criteria:
inclusion criteria: * the study was planned retrospectively, cross-sectionally and observationally with 193 patients hospitalized between 16 march 2020 and 15 may 2020 in five different coronavirus disease 2019 intensive care units in two campuses of our hospital. exclusion criteria: * health workers, patients hospitalized less than 24 hours, patients with negative polymerase chain reaction tests, and patients who returned to intensive care unit after discharge were excluded from the study.

Keywords: coronavirus disease 2019 pneumonia
addressing personalized needs in clostridioides difficile infection

Conditions: Clostridioides Difficile Infection

Summary: beyond is aiming to demonstrate how by enrichment of the available specify score, patients at great likelihood for cdi with unfavorable outcome are early detected

in a previous project, following gwas analysis of the dna and measurement of serum biomarkers coming from 134 patients a prediction score named specify was developed. the specify score comprises four elements: low hemoglobin, increased urea, increased il-8 and carriage of g alleles of rs2091172. the score has 80% positive predictive value and 95.8% specificity for the early detection of unfavorable outcome but the sensitivity is low. unfavorable outcome is defined as any of: presentation or progression into severe cdi, relapse; and death. stool samples of day 1 before start of therapy of the patients are stored refrigerated. microbiome analysis will be done aiming to the integration of the shannon diversity index to the already developed score in order to improve sensitivity.

Eligibility criteria:
inclusion criteria: * age more than or equal to 18 years * both genders * diarrhea defined as at least 3 episodes of unformed stools in the last 24hours according to the bristol stool chart * presence of c.difficile in stool. this is defined as any stool sample positive for the presence of glutamate dehydrogenase (gdh) and for the presence of toxin a and/or b. exclusion criteria: • no exclusion criteria apply

Keywords: clostridioides difficile microbiome prediction unfavorable outcome
dose-ranging study of recombinant human papillomavirus virus 16/18 bivalent vaccine

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Summary: this is a phase ii clinical study of the novel recombinant hpv 16/18 bivalent vaccine expressed in e. coli. the primary purpose of this study is to evaluate which dosage of the hpv vaccine can induce higher antibody and at the same time caused less adverse events. the secondary purpose of this study is to to evaluate the safety and immunopersistence of the study vaccine.

totally 1600 healthy women of 18-25 years of age were enrolled. the participants were randomly stratified into 4 groups and receive different dosage of human papillomavirus (hpv) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule. the women were actively monitored for adverse events for 1 month after each injection. severe adverse events during the trial were followed up. serum samples from all the subjects would be collected on day 0, 7m, 24m, 48m and 72m to evaluate the immunogenicity and immuno-persistency.

Eligibility criteria:
inclusion criteria: * written informed consent from the subject prior to enrolment; * female between, and including, 18 and 25 years of age at the time of enrolment; * subjects must be free of obvious health problems; * not pregnant and having no plan for pregnancy; exclusion criteria: * pregnant or breastfeeding or having plan for pregnancy during the whole study (month 0-7); * previous vaccination against hpv; * having severe allergic history or other immunodeficiency; * chemotherapy and other immunosuppressive agents using;

Keywords: human papilloma virus 16 human papilloma virus 18 vaccine cervical intraepithelial neoplasia cervical cancer
jab-3068 activity in adult patients with advanced solid tumors

Conditions: Advanced Solid Tumor; Esophageal Squamous Cell Carcinoma; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma

Summary: to evaluate the safety and tolerability of jab-3068 administered in investigational regimens in adult participants with advanced solid tumors.

to assess the safety and tolerability and determine the recommended phase 2 dose (rp2d) of jab-3068 in combination with pd1 inhibitor in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: * written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses. * participant must be ≥18 years of age at the time of signature of the informed consent form (icf). * eastern cooperative oncology group (ecog) performance status score of 0 or 1. exclusion criteria: * history (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated stage i non-melanoma skin cancer * known serious allergy to experimental drugs * brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs
evaluation of breathe niov system on work of breathing in chronic obstructive lung disease patients

Conditions: Chronic Obstructive Lung Disease

Summary: the breathe ventilator is a lightweight, wearable ventilator that has received u.s. fda clearance for use in patients with respiratory difficulty. the investigators believe that the breathe niov system will reduce the work of the diaphragm and breathing by providing added tidal volume and oxygen. this will be a study in 14 patients with severe-to-very severe chronic obstructive lung disease (copd) to assess their work of breathing while using the niov system as measured by esophageal and stomach pressures.


Eligibility criteria:
inclusion criteria: 1. subject is \>18 years of age at time of consent. 2. subject has diagnosis of severe copd (gold stage iii or iv) as demonstrated by a fev1 \< 50% predicted and fev1/fvc ratio \< 70% predicted. 3. subject has increased inspiratory muscle work of breathing as evidenced by palpable sternocleidomastoid muscle contraction during inspiration exclusion criteria: 1. subject has acute exacerbation of copd - within 1 week of acute hospitalization 2. subject has respiratory rate at rest \> 28/min 3. subject requires \> 5 l/min nasal o2/min to maintain o2sat \> 90% 4. subject has severe dyspnea at rest 5. subject has swallowing disorders or chronic aspiration, prior esophageal surgery, or any other condition that would place the subject at risk during balloon placement. 6. subject has history of pneumothorax secondary to lung bullae. 7. subject is too cognitively impaired to give subjective ratings for visual analog scale 8. subject has sensitivity or an allergy to lidocaine 9. subject has known history of oxygen intolerance.

Keywords: copd
a randomized, double-blind, multicenter, sham-controlled, safety and efficacy study of conbercept in patients with mcnv

Conditions: Choroid Neovascularization Secondary to Degenerative Myopia

Summary: this study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.


Eligibility criteria:
inclusion criteria: 1. patients give fully informed consent and are willing and able to comply with all study procedures. 2. in the study eye: * myopia of equal to or greater than -6.00d,and axial length ≥26.5mm. * diagnosis of active subfoveal, juxafoveal, or extrafoveal cnv secondary to high myopia. * visual impairment due to cnv secondary to high myopia. * bcva score ≥24 and ≤73 etdrs letters (approximately 20/40\~ 20/320 snellen equivalent). * ocular media of sufficient quality to obtain fundus and oct images. 3. the bcva score of fellow eyes ≥ 19 etdrs letters (approximately 20/400 snellen equivalent) exclusion criteria: 1. current vitreous hemorrhage in either eye. 2. intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye. 3. active infectious ocular inflammation in either eye. 4. fibrosis or atrophy involving the center of foveal in the study eye. 5. any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition. 6. the lesion size ≥30 mm2 in the study eye. 7. any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results. 8. uncontrolled glaucoma or cup/disk ratio \> 0.8 in the study eye. 9. aphakia (excluding artificial lens) in the study eye. 10. serious amblyopia and amaurosis in the fellow eye.
foxp1 syndrome: the seaver autism center for research and treatment is characterizing foxp1-related neurodevelopmental disorders using genetic, medical, and neuropsychological measures.

Conditions: FOXP1; Mental Retardation With Language Impairment and With or Without Autistic Features; Autism Spectrum Disorder

Summary: foxp1, also known as forkhead-box protein p1, is a transcription factor protein belonging to the fox gene family. disruptions in the foxp1 gene cause a phenotype characterized by global developmental delay, speech deficits, mild dysmorphic features, and traits of autism spectrum disorder. this study seeks to characterize foxp1-related neurodevelopmental disorders using a number of genetic, medical and neuropsychological measures.

subjects with a variant in the foxp1 gene will be asked to complete a battery of developmental, behavioral and medical assessments to better characterize gene-related neurodevelopmental deficits. this series of assessments takes place over the course of a three-day period. it includes the autism diagnostic observation schedule (ados), parent interviews regarding developmental history and behavior, a psychiatric evaluation, a neurology assessment, as well as a clinical genetic evaluation that includes a physical and vitals exam. affected individuals, as well as biologically related siblings, will also undergo a series of sensory assessments, including a research eeg, visual evoked potential, and an eyetracking assessment. family members present for the visit will also be asked to provide a blood and/or saliva sample for research genetics.

Eligibility criteria:
inclusion criteria: * eligible participants must have a documented variant affecting the foxp1 gene that the research team determines to be likely or definitely pathogenic. * eligible participants must be at least 2 years of age. exclusion criteria: * none

Keywords: foxp1 intellectual disability autism spectrum disorder global developmental delay neurodevelopmental deficits developmental disability
a maintenance and long-term extension study of the efficacy and safety of upadacitinib (abt-494) in participants with crohn's disease who completed the studies m14-431 or m14-433

Conditions: Crohn's Disease

Summary: a multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered janus kinase 1 inhibitor, in adult participants with crohn's disease.


Eligibility criteria:
inclusion criteria: for substudy 1: * participant who achieve clinical response in study m14-431 or study m14-433. * participant completes study procedures in the parent study. the final endoscopy for studies m14-431 or m14-433 may be missing, if the endoscopy cannot be performed during the covid-19 pandemic. for substudy 2: * participant completes substudy 1. the week 52 endoscopy may be missing, if the endoscopy cannot be performed during the covid-19 pandemic. * participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy. exclusion criteria: for substudies 1 and 2: * participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during studies m14-431 and m14-433 or substudy 1 or 2 of study m14-430 that in the investigator's judgment makes the participant unsuitable for this study. * participant at the final visit of m14-431 or m14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. participants with serious infections undergoing treatment may be enrolled but not dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment. * participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of studies m14-431, m14-433 or substudy 1 of study m14-430 (week 52).

Keywords: upadacitinib abt-494 extension study efficacy safety crohn's disease maintenance study
study of icp-723 in patients with advanced solid tumors or primary central nervous system tumors

Conditions: Advanced Solid Tumors Harboring NTRK Fusion; Primary Central Nervous System Tumors Harboring NTRK Fusion

Summary: a multi-center, non-randomized, open-label phase 2 basket clinical trial to evaluate icp-723 in patients with advanced solid tumors or primary central nervous system tumors


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0-1; 2. patients with advanced solid tumors or primary central nervous system (cns) tumors harboring ntrk gene fusions as detected by the designated central laboratory, who received no previous ntrk inhibitor treatment; 3. at least one measurable lesion as per recist1.1 criteria, or for primary cns tumors, at least one measurable lesion as per rano or inrc criteria. 4. organ functions meet the clinical criteria exclusion criteria: 1. patients with unstable primary central nervous system (cns) tumors or cns metastasis. 2. patients with abnormal qtc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator. 3. patient with recent anti-tumor and other treatment as stated in the protocol. 4. grade 1 or higher toxicities attributed to any previous treatment not yet recovered. 5. other conditions considered unsuitable for participation in this trial at the discretion of the investigator
electronic medical record alerts to optimize medical therapy in heart failure and reduced ejection fraction

Conditions: HFrEF - Heart Failure With Reduced Ejection Fraction

Summary: optimal-hf is a pragmatic, cluster randomized, single-blind intervention trial that will be conducted at an outpatient clinic in argentina. the trial will assess the effectiveness of an individualized-based alert system compared to usual care in improving gdmt optimization at 90 days in patients with hfref.


Eligibility criteria:
patients inclusion criteria: * eligible patients will include those with an ef ≤ 40% on their most recent echocardiogram, age \> 18, and an outpatient cardiology encounter during the study period. * age 18 or over exclusion criteria: * under optimal medical treatment * palliative care, or undergoing hemodialysis will be excluded cardiologist inclusion criteria: cardiologists from an outpatient clinic at a cardiovascular center in buenos aires will be selected for potential participation in the study. exclusion criteria cardiologists belonging to the heart failure service
postmarketing surveillance to investigate the safety and efficacy information of alesion® tablet

Conditions: Rhinitis, Allergic, Perennial

Summary: study to investigate the safety and efficacy information of alesion® tablet under the proper use in daily clinical practice after new treatment guideline for allergic rhinitis, bronchial asthma, eczema, dermatitis, urticaria, pruritus, prurigo and psoriasis vulgaris with itching


Eligibility criteria:
inclusion criteria: all the patients who: * haven't treatment experience of epinastine product; * have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, prurigo, urticaria, psoriasis with itching, bronchial asthma exclusion criteria: * alesion® tablet is contraindicated for the patients with history of hypersensitivity to any ingredients of alesion® tablet in package insert. however, it is unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. and this survey is drug utilization study to observe actual use in any patients. therefore exclusion criteria is not set in the protocol
a trial of hrs-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy

Conditions: Obstructive Hypertrophic Cardiomyopathy

Summary: the purpose of this phase ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of hrs-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy


Eligibility criteria:
inclusion criteria: 1. understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (icf) 2. male or female aged 18-55（adult healthy volunteers）or 18-85 (ohcm patients). 3. body mass index (bmi) between 19 and 28 kg/m2. 4. normal electrocardiogram (ecg) exclusion criteria: 1. history of persistent tachyarrhythmia and syncope; 2. a history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy); 3. positive results of hepatitis b surface antigen, hepatitis c antibody, syphilis antibody and human immunodeficiency virus antibody.
pharmacokinetics of aminocaproic acid in scoliosis surgery

Conditions: Scoliosis

Summary: this study will evaluate the pharmacokinetics of antifibrinolytic drug epsilon-aminocaproic acid (eaca) in children undergoing posterior spinal fusion surgery (psf) at the children's hospital of philadelphia (chop) who receive eaca at the standard dose reported in the literature for this population and currently in use at chop.

posterior spinal fusion surgery (psf) can be associated with significant blood loss, and perioperative transfusion is common. various strategies have been employed to decrease intraoperative blood loss and reduce transfusion in children undergoing psf. the intraoperative administration of the antifibrinolytic drug epsilon-aminocaproic acid (eaca) is one such strategy that has been shown to be effective in this regard. this study will evaluate the pharmacokinetics of eaca in children undergoing psf at chop who receive eaca at the standard dose reported in the literature for this population and currently in use at chop.

Eligibility criteria:
inclusion criteria: 1)males or females age 8 to 18 years 2)subjects undergoing posterior spinal fusion surgery 3)subjects in whom aminocaproic acid administration is planned by the anesthesiology team 4)parental/guardian permission (written informed consent) and when appropriate, child assent. - exclusion criteria: 1. wards of the state are not eligible 2. subjects with a history of abnormal renal function -

Keywords: pediatrics scoliosis pharmacokinetics hemorrhage orthopedic surgery
the preventive effect of shenfu injection on myocardial dysfunction in sepsis

Conditions: Septic Cardiomyopathy; Septic Shock

Summary: this study focuses on improving heart function in patients with life-threatening blood infections (septic shock). when the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function. this multicenter clinical trial aims to evaluate whether adding shenfu injection - a traditional chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can: 1. prevent myocardial dysfunction during septic shock 2. accelerate cardiac recovery if complications occur 3. improve overall survival and clinical outcomes the randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with shenfu injection.


Eligibility criteria:
inclusion criteria: * 1. patients clinically diagnosed with septic shock must meet the diagnostic criteria of sepsis 3.0; * 2. age ≥ 18 years. exclusion criteria: * 1. pregnant or breastfeeding women; * 2. individuals with a history of allergies or known hypersensitivity to ginseng and aconite injection or its components; * 3. severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, hiv, etc.; * 4. severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (new york heart association \[nyha\] class iv); * 5. any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma; * 6. use of ginseng and aconite injection for less than 48 hours; * 7. patients expected to die within 48 hours; * 8. patients deemed unsuitable for this study by the investigator.

Keywords: septic shock cardiac dysfunction shenfu injection myocardial protection randomized controlled trial