Kornimate/medical-research-clean huggingface dataset:
a clinical trial of 23-valent pneumococcal polysaccharide vaccine

Conditions: Pneumococcal Infections

Summary: this an open phase ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by sinovac biotech co., ltd.the purpose of this study is to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.

this study is an open phase ⅳ clinical trial to evaluate the immunity persistence after single dose of 23-valent pneumococcal polysaccharide vaccine.the experimental vaccine was manufactured by sinovac biotech co., ltd,the control vaccine was manufactured by chengdu institute of biological products co., ltd..a total of 600 subjects including 450 subjects in the experimental group and 150 subjects in the control group who participated in the second stage of phase ⅲ clinical trial (pps)will be enrolled .based on the age at the time of enrollment in the phase ⅲ study, there will be 150 participants in each age group (2-17 years old group, 18-60 years old group and ≥61 years old) in the experimental group and 50 participants in each age group in the control group .3.0-3.5ml of venous blood will be collected from all subjects after enrollment.

Eligibility criteria:
inclusion criteria: * subjects who participated in the second stage of phase ⅲ clinical trial (pps); * the subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8-17 years, both subjects and guardians need to sign the informed consent form); * proven legal identity. exclusion criteria: * have received any pneumococcal vaccine after participating the phase iii clinical trial of 23-valent pneumococcal polysaccharide vaccine ; * history of invasive disease caused by streptococcus pneumoniae after participating the phase iii clinical trial of 23-valent pneumococcal polysaccharide vaccine; * autoimmune disease or immunodeficiency / immunosuppression was known after participating the phase iii clinical trial of 23-valent pneumococcal polysaccharide vaccine; * history of immunosuppressive therapy after participating the phase iii clinical trial of 23-valent pneumococcal polysaccharide vaccine; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
impact of remote vital signs monitoring in people using long-term oxygen therapy

Conditions: ILD; COPD

Summary: assess quality of life of patients using prolonged oxygen therapy

adult participants of both sexes with copd and pid, prolonged oxygen use, will be evaluated after being informed about the study, agreeing and signing the informed consent form. participants will be randomized to a control group and a group monitored for 90 days. the monitored group will receive a wearable device to monitor vital signs of heart rate and oxygen saturation and the control group will receive a pulse oximeter. both groups will be monitored through the cell phone application.

Eligibility criteria:
inclusion criteria: * patients with a clinical, radiological and/or anatomopathological diagnosis of copd and ild according to the 2020 ats/jrs/alat guidelines; * age over 18 years; * clinical stability (absence of exacerbations or hospitalizations related to the underlying disease) for at least 6 weeks; * patients who are on optimized drug therapy, including long-term home oxygen therapy (ltot) * have a smartphone compatible with the monitoring device; * signing of the icf to participate in the study. exclusion criteria: * presence of other concomitant lung diseases; * myocardial infarction within four months prior to the start of the study, unstable angina or severe heart disease (nyha functional class iii-iv) and/or decompensated. * patients who received a lung transplant during the study * living outside the coverage area or moving out of state

Keywords: quality of life monitoring remote ild copd
fundus oculi and erectile dysfunction

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ed.

the purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ed. in this monocentric, prospective, observational case-control study 40 eyes of 40 patients affected by erectile dysfunction and 20 healthy age-matched controls will be enrolled. patients will undergo dva examination at baseline and 6 months after pde5i therapy. healthy subjects will be examined with dva at baseline only.

Eligibility criteria:
inclusion criteria: * subjects with erectile dysfunction diagnosis (organic and psychogenic); * subjects with erectile dysfunction diagnosis defined by iief score ≤ 25 * subjects with stable partner for at least 6 months and sexually active. * subjects aged between 40 - 60 years; * signature of informed consent for patients exclusion criteria: * subjects with ed secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia); * subjects with a diagnosis of ed post-traumatic and iatrogenic, since after pelvic surgery; * subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses; * subjects smoking; * individuals with uncontrolled systemic diseases; * all persons who do not confirm at least one criterion for inclusion.

Keywords: erectile dysfunction ed fundus oculi retinal vascularization international index of erectile function questionnaire iief dynamic vessel analyzer dva phosphodiesterase type 5 inhibitor pde5is
drug interaction study of fimasartan/amlodipine/hydrochlorothiazide in healthy male subjects

Conditions: Drug-Drug Interaction

Summary: the purpose of this study is to evaluate the drug interaction and safety of fimasartan/amlodipine and hydrochlorothiazide in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * a healthy male adults aged 19-50 years exclusion criteria: * history or presence of clinically significant medical or psychiatric condition or disease. * hypersensitivity to ingredient of ip and other medication, food. * participation in any other study within 3months. * history of whole blood donation within 2months and apheresis 1month.
efficacy and safety of niuliva® for the prevention of hepatitis b virus recurrence in newly orthotopic liver transplant recipients

Conditions: Hepatitis B; Liver Transplantation

Summary: the aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of niuliva (hepatitis b virus immune globulin) in the prophylaxis of hepatitis b virus (hbv) reinfection in patients submitted to liver transplantation due to hbv-induced liver disease by reaching and maintaining certain hepatitis b antibody (hbsag) levels considered as protective during the first six and twelve months post-transplantation.


Eligibility criteria:
inclusion criteria: * male or female. * patients from 18 to 70 years of age (both included). * serum hbv dna-negative determined by dna pcr-amplification assay just prior to anhepatic phase visit. * serum hbeag negative just prior to anhepatic phase visit. * patients who are to undergo liver transplantation due to liver disease associated to hbv. * the patient agrees to participate and comply with all the aspects of the protocol, including blood sampling, for the total duration of the study. * signed informed consent. exclusion criteria: * patients who have already experienced a liver transplantation even for reasons not related to hbv infection. * patients with unknown serum hbv replication status (data on hbeag and hbv dna). * patients with known allergies to any component of niuliva®. * history of serious adverse events (saes) or frequent adverse events (aes) related to the administration of human blood-derived products. * patient with unknown viral status for hcv, hav, hiv type 1 and type 2 * patients with selective iga deficiency. * any haemostatic abnormality contraindicating i.v. injection according to the investigator's judgment. * patient suffers from any acute or chronic medical, surgical or psychiatric condition or laboratory abnormality that may increase the risk associated with the study participation or investigational product administration, or may interfere with the interpretation of the study results. * known abuse of alcohol, drugs or other chemical substances; or has done so in the past 6 months. * breast-feeding women or pregnant women at the time of inclusion or who are expecting to be pregnant within the next 7 months after inclusion. * subject has participated in any other investigational study within the last 3 months. * existing possibility that the patient may be treated with other products containing specific anti-hepatitis b immunoglobins (other than niuliva®) in a period of 13 months. * subject is incapable of giving consent personally.

Keywords: hepatitis b hbv orthotopic liver transplantation liver transplantation recurrence reinfection protective titers hbsab hepatitis b virus immune globulin niuliva
study of safety, tolerability, and efficacy of secukinumab in subjects with moderate to severe nail psoriasis

Conditions: Moderate to Severe Nail Psoriasis

Summary: this purpose of this study was to demonstrate the efficacy of secukinumab versus placebo on nail psoriasis and to assess long-term efficacy, safety and tolerability of secukinumab.


Eligibility criteria:
inclusion criteria: * subjects with chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization, including significant nail involvement, defined as nail psoriasis severity index (napsi) score ≥16 and number of fingernails involved ≥4 and psoriasis area and severity index (pasi) score ≥12 and body surface area (bsa) score ≥10% * candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy exclusion criteria: * forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of hallopeau, erythrodermic and guttate psoriasis) * drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium) * ongoing inflammatory skin diseases other than psoriasis or any other disease affecting the fingernails which may potentially confound the evaluation of study treatment effects * ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (cs), uv therapy). washout periods do apply * prior exposure to secukinumab (ain457) or any other biological drug directly targeting il-17 or the il-17 receptor * exposure to any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer * history of hypersensitivity to constituents of the study treatment * other protocol-defined inclusion/exclusion criteria do apply

Keywords: moderate nail psoriasis severe nail psoriasis psoriasis secukinumab
cerebrotendinous xanthomatosis (ctx) prevalence study

Conditions: Cerebrotendinous Xanthomatosis (CTX)

Summary: iiopathic bilateral cataracts occur in many children with cerebrotendinous xanthomatosis (ctx) so the opportunity to use contact with health care providers in connection with pediatric cataract evaluation and treatment is a promising avenue for disease detection and prevention.

this is an observational, multicenter study to determine the prevalence of cerebrotendinous xanthomatosis (ctx) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Eligibility criteria:
inclusion criteria: 1. the patient has a diagnosis of idiopathic bilateral cataracts 2. between the ages of 2 to 21 years at the time of diagnosis exclusion criteria: 1. the patient has a diagnosis of cataracts with known etiology other than ctx 2. the patient has a diagnosis of ctx 3. the patient has cataracts caused by cataractogenic treatments 4. the patient has taken or is currently taking cholic acid or chenodeoxycholic acid 5. the patient has participated in an interventional clinical trial in the past 30 days 6. the patient and/or their parent/legal guardian, in the opinion of the investigator, is unable to adhere to the requirements of the study

Keywords: cerebrotendinous xanthomatosis ctx prevalence study ctx idiopathic bilateral cataracts cataracts bilateral cataracts early-onset idiopathic bilateral cataracts observational study ophthalmology
faecal microbiota analysis in neurotypical and autism syndrome disorder siblings

Conditions: Autism Spectrum Disorder; Autism

Summary: this study aims to accurately characterise the gut microbiota composition of faeces of children with asd and compare it with the gut microbiota composition of their neurotypical siblings. in addition it aims to also characterise the metagenome and metabolome of the faeces of both asd and neurotypical siblings.


Eligibility criteria:
inclusion criteria: * children of both sexes who are diagnosed with asd and under the care of esneft who have a neurotypical sibling (either full or half sibling), who share their living environment. this is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible. * aged 3 years to 10 years old (at time of consent) * parent/guardian able to consent to participate * parent/guardian able to complete required surveys (or with accommodated adjustments) exclusion criteria: * use of antibiotics in the previous 4 weeks * not under the care of esneft * children \ 10 years old * children that don't have half or full siblings * parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented
wolman/cesd natural history chart review and longitudinal follow-up

Conditions: Wolman Disease; Cholesterol Ester Storage Disease; Acid Cholesteryl Ester Hydrolase Deficiency, Type 2

Summary: the purpose of this study are: to characterize and understand the natural history of disease progression in wd and cesd, and to provide historical controls for wd and cesd for developing clinical treatment trials. the hypothesis is that the variability and clinical progression in wd and cesd is large and represents a continuum of severities from a lethal infantile to near normal adults with only "fatty livers".

this is a single institution historical cohort study of patients with wolman (wd) or cholesteryl ester storage disease (cesd). retrospective data will be collected and abstracted from the medical records of both living and deceased patients. additionally prospective data from living patients will be collected and abstracted annually until the end of the study. literature sources will be used as secondary source data and will be screened to minimize/eliminate duplicative reports.

Eligibility criteria:
inclusion criteria: * male or female of any age; * a clinical diagnosis of wd or cesd as defined by: * documented lal enzyme deficiency or * lal gene mutations or * a clinical course and tissue biopsy consistent with cesd or wd; * written informed consent

Keywords: wolman disease cholesteryl ester storage disease enzyme deficiency natural history medical records review
open-label study of topotecan and pazopanib in advanced solid tumors

Conditions: Solid Tumours

Summary: to determined what dose of topotecan can be safely given with daily pazopanib.

a phase i open-label study of the safety, tolerability, and pharmacokinetics of two schedules of oral topotecan in combination with pazopanib in subjects with advanced solid tumors

Eligibility criteria:
inclusion criteria - * signed, written informed consent. * at least 18 years of age. * ecog performance status 0 or 1. * subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy. * able to swallow and retain oral medications. * females are eligible to enter and participate in this study providing adequate established contraception is being practiced. exclusion criteria * had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) * received an investigational drug within 30 days or 5 half-lives (whichever is longer). * received prior treatment with pazopanib/investigational anti-angiogenic compounds. * presence of uncontrolled infection. * pregnant or lactating. * poorly controlled hypertension (sbp of ? 140 mmhg, or dbp of ? 90 mmhg. * class iii or iv heart failure as defined by the new york heart association (nyha) functional classification system.- * arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months. * any unresolved bowel obstruction or diarrhea ? grade 1. * received an allogeneic bone marrow transplant. * known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan. * any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study. * psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. * clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations.

Keywords: pazopanib phase i topotecan advanced solid tumors
japanese assessment of indication based programming

Conditions: Heart Failure; Arrhythmias, Cardiac

Summary: the purpose of this clinical investigation is to assess the programming behavior of the physicians in the patient cohort. furthermore, the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications will be evaluated by comparing parameters determined by the feature ibp to daily life programming chosen by physicians.


Eligibility criteria:
inclusion criteria: * implanted with a single or dual chamber icd or crt-d device approved in japan capable of using the ibp feature. * geographically stable patients who are available for follow-up at a study center . * age 20 years or above. * patients, who do receive all leads that are supposed to be used with a certain type of device (i.e. no dual chamber icd / crt-d device without an atrial lead or crt-d devices with only one ventricular lead). exclusion criteria: * inability or refusal of the patient to give approval to collect/store/process personal health information at the sponsor. * pregnant women or women, planning to become pregnant . * any kind of previous crm device therapy (no replacements, no upgrades, no new implants after complete system removals ). * enrolment in another clinical trial or clinical investigation without prior notification of the sponsor . * estimated life expectancy of less than six months per judgment of the physician.

Keywords: cardiac resynchronization therapy heart failure pathologic processes heart diseases tachycardia cardiovascular diseases ventricular flutter tachycardia, ventricular ventricular fibrillation arrhythmias, cardiac ease of use
prevention of postoperative bleeding in subcapital femoral fractures

Conditions: Hip Fracture; Blood Loss

Summary: the main hypothesis of this clinical trial is that the use of intra-articular tranexamic acid and the fibrin glue plus usual hemostasis will reduce at least a 25% the postoperative blood loss with respect to usual hemostasis in patients undergoing subcapital femoral fractures.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patients with unilateral subcapital femoral fracture * patients requiring hip replacement (total or partial) * signed informed consent from the patient or legal representative exclusion criteria: * known allergy to fibrin glue and tranexamic acid * multiple fractures * pathological fractures * contraceptives or estrogen therapy * use of blood salvage during surgery * history compatible with thromboembolic disease: * cerebral vascular accident * ischemic heart disease (myocardial infarction, angina ) * deep vein thrombosis * pulmonary embolism * peripheral arterial vasculopathy * patients with thrombogenic arrhythmias * patients with cardiovascular stents * prothrombotic alterations in coagulation

Keywords: hip fractures clinical trial randomized fibrin glue tranexamic acid blood loss
study of the efficacy and safety of medi4893

Conditions: Staphylococcus Aureus Pneumonia

Summary: clinical trial looking at safety and efficacy of medi4893 in prevention of pneumonia caused by staphylococcus aureus in high-risk patients


Eligibility criteria:
inclusion criteria: * colonized with staphylococcus aureus, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. exclusion criteria: * staphylococcal disease at randomisation; lung injury score consistent with pneumonia; current lung disease; chronic tracheostomy patients; currently receiving systemic anti-staphylococcal antibiotics; moribund patients.
biomarkers for early screening of gestational diabetes mellitus

Conditions: Gestatiaonl Diabetes Mellitus; Early Pregnancy

Summary: gestational diabetes mellitus (gdm) refers to the abnormal glucose metabolism first detected during pregnancy. it is estimated that approximately 7% of pregnant women worldwide and their offspring are affected by gdm. the incidence of gdm in china is as high as 18.9%. a number of studies have shown that gdm complicates 3%-25% of pregnancies and poses serious health and life threats to the mother and child. in fact, due to the lack of physical activity during pregnancy and the decrease of insulin sensitivity compared with non-pregnancy, the optimal time for intervention has long been lost until the diagnosis of gdm in the second trimester. however, it is a pity that no authoritative screening method for gdm in early pregnancy has been established, and the pathogenesis of gdm is still unclear. this study intend to search for biomarkers used for screening of gdm in early pregnancy and explore the pathogenesis of gdm, so as to provide new ideas for prevention measures and treatment targets of gdm.


Eligibility criteria:
inclusion criteria: * maternal age: 20-49 years * plan to have routine prenatal examinations and give birth in the research center * willing to cooperate with the hospital to follow up exclusion criteria: * have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, aids, etc. * fetus has a known deformity or genetic defects * incomplete clinical data