Kornimate/medical-research-clean huggingface dataset:
a study evaluating the latanoprost punctal plug delivery system (l-ppds) in subjects with ocular hypertension or open-angle glaucoma

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: the purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosed with bilateral oh or oag and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of oh or oag. * adequate iop control on topical prostaglandin monotherapy during the past 1 month. exclusion criteria: * functionally significant vision loss, or progressive field loss within the last year. * contact lens wear at any time during the treatment period. * keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or restasis®. * active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment. * subjects with ≥0.9 vertical cup or completely notched optic nerve head rim. * currently on chronic ocular topical medications * currently on any ophthalmic or systemic steroid therapy. * laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries. * history of macular edema * history of chronic/recurrent inflammatory eye disease. * history of a non-response to topical prostaglandin therapy. * subjects who have epiphora.
deep learning magnetic resonance imaging radiomics for diagnostic value of hepatic tumors in infants

Conditions: Hepatoblastoma; Hepatic Hemangioendothelioma

Summary: hepatic tumors in the perinatal period are associated with significant morbidity and mortality in affected patients. the conventional diagnostic tool, such as alpha-fetoprotein (afp) shows limited value in diagnosis of infantile hepatic tumors. this retrospective-prospective study is aimed to evaluate the diagnostic efficiency of the deep learning system through analysis of magnetic resonance imaging (mri) images before initial treatment.

hepatic tumors seldom occur in the perinatal period. they comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. it should be mentioned that alpha-fetoprotein (afp) is highly elevated during the first several months after birth even in normal infants, thus the diagnostic value of afp is limited for infantile patients with hepatic tumors. this study is a retrospective-prospective design by west china hospital, sichuan university, including clinical data and radiological images. a retrospective database was enrolled for patients with definite histological diagnosis and available magnetic resonance imaging (mri) images from june 2010 and december 2020. the investigators have constructed a deep learning radiomics diagnostic model on this retrospective cohort and validated it internally. a prospective cohort would recruit infantile patients diagnosed as liver tumor since january 2021. the proposed deep learning model would also be validated in this prospective cohort externally. the established model would be able to assist diagnosis for hepatic tumor in infants.

Eligibility criteria:
inclusion criteria: * age between newborn and 12 months * receiving no treatment before diagnosis * with written informed consent exclusion criteria: * clinical data missing * unavailable mri images * without written informed consent
cteph diagnosis europe - mri

Conditions: Pulmonary Hypertension

Summary: phase iii diagnostic trial to demonstrate that functional lung mri can replace vq-spect in a diagnostic strategy for patients with suspected cteph where positive findings are verified with catheter pulmonary angiography (cpa), or computed tomography pulmonary angiography (ctpa)

change-mri is a prospective, multicentre, comparative phase iii diagnostic study. the study aims to show via an in-place validation that mri can replace vq-spect as a screening test for chronic pulmonary embolism in the diagnostic algorithm for cteph. the diagnostic gold standard is catheter pulmonary angiography (cpa) or computed tomography pulmonary angiography (ctpa) with correction from the clinical outcome after 6-12 months.

Eligibility criteria:
inclusion criteria: * transthoracic echocardiography indicates pulmonary hypertension * patients with clinical suspicion for cteph, scheduled for spect * provided informed consent for the study * age \>18y exclusion criteria: * patient unable to undergo mri (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to mr i.v. contrast imaging agents) * women who are pregnant or breast feeding

Keywords: chronic thromboembolic pulmonary hypertension (cteph) mri spect
spyglass-guided lithotripsy versus eswl for pancreatic duct stones

Conditions: Pancreatic Duct Stone

Summary: overall stone clearance with endoscopic retrograde cholangiopancreatography (ercp) for pancreatic duct stones is a amjor problem, especially bigger size stones. after ercp failure, surgery was the only option but patients not suitable for surgery were treated through stenting. but had to undergo multiple ercps and show lower success rate. recently, spyglass and extracorporeal shock wave lithotripsy (eswl) have been applied for the treatment of huge stones. the present study aims to compare the efficacy and safety outcomes of spyglass-guided lithotripsy and eswl procedures for the removal of pancreatic duct stones.

eswl was first used for the removal of renal calculi and ureteral calculi however, now a day is being used for pancreatic duct stones and biliary calculi. it has the advantages of simple operation, lower cost, and higher safety. recent studies show that the procedure time for eswl is also shorter and the utilization rate of mechanical lithotripsy was effectively reduced with fewer complications. but it is difficult for eswl to break the stones larger than 3cm into small pieces. spyglass has been used in clinics for more than ten years. recently, a study reported difficult bile duct stones that were treated with spyglass-guided laser lithotripsy that shows promising results. compared with laser lithotripsy under x-ray monitoring, there is no significant difference in stone removal rate and complication rate between the two methods. however, the effect of lithotripsy under spyglass direct vision is better, which can break large stones into smaller pieces, thus making it easier to take stones. investigator conducted the current study to compare the therapeutic outcome and complications between spyglass direct vision lithotripsy and eswl procedures for the removal of large pancreatic duct stones.

Eligibility criteria:
inclusion criteria: * pancreatic duct sone * falied to eliminate through ercp only exclusion criteria: * pregnancy * refusal of written informed consent * patients not suitable for eswl/ spyglass * contraindications to ercp exist * complicated with acute pancreatitis or acute cholangitis * coagulation dysfunction#thrombocytopenia * patients after gastrointestinal reconstruction * allergic to drugs
study of 0444 gel in the treatment of inflammatory lesions of rosacea

Conditions: Inflammatory Rosacea

Summary: the aim of this trial is to assess the efficacy of metronidazole topical gel 1% in the treatment of inflammatory lesions of rosacea. treatment medication will be administered as follows: a thin film of gel will be applied and rubbed into the entire face once daily for a period of 70 days.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of rosacea * good health with the exception of rosacea * papsules and pustules minimum and maximum requirements exclusion criteria: * subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. * subjects who have any systemic or dermatological disorders with the exception of rosacea

Keywords: inflammatory rosacea rosacea
the association of transgelin-2, metallothionein-2 and ezrin with asthma

Conditions: Asthma

Summary: asthma is one of the most common chronic respiratory diseases. previous study found a series of differentially expressed genes and proteins (transgelin-2, metallothionein-2, ezrin) in asthmatic rat. the aim of the study is to investigate the changes and associations of these gene with asthma in human.

this study will investigate the changes and associations in asthma. in this project, the investigators will explore the changes of gene expression of transgelin-2, metallothionein-2 and ezrin in asthma and investigate their correlation with current diagnosis markers of asthma, including pulmonary function, fractional exhaled nitric oxide,eosinophil counts,immunoglobulin e, interleukin-5, etc.

Eligibility criteria:
inclusion criteria: 1. males or females, aged 14-75 years; 2. patients with a definite diagnosis of bronchial asthma; 3. the diagnosis of asthma according to the global initiative for asthma (gina), with positive bronchodilator responsiveness (reversibility) test; 4. healthy volunteers without respiratory symptoms such as cough, wheezing, chest tightness or dyspnea; 5. agree with all procedures in this trial by signing a written informed consent form. exclusion criteria: 1. patients with chronic obstructive pulmonary disease or other airway disease; 2. complicated with other severe primary diseases (including hypertension, cancer, hyperthyroidism, bronchiectasia, cardiac insufficiency) and conditions that would prevent participation in the trial or put the participant at risk; 3. women who are known to be pregnant or breastfeeding; 4. not willing to participate; 5. psychiatric history and neurological disorders can not work normally; 6. other conditions that the researcher considers inappropriate to participate in this study.
study to evaluate the qt / qtc interval prolongation potential of vericiguat

Conditions: Coronary Artery Disease

Summary: the primary objective of this study was to investigate whether there is a clinically meaningful effect on qtc change from baseline relative to placebo after administration of 10 mg at steady state in patients with stable cad (coronary artery disease).


Eligibility criteria:
inclusion criteria: * patients with stable cad (coronary artery disease) defined by: * clinically stable for at least 3 months * coronary artery stenosis in any of the 3 main coronary vessels * or history of myocardial infarction * sinus rhythm at screening * interpretable echocardiographic images * age: 30 to 80 years * body mass index (bmi): above/equal 18.0 and below/equal 36.0 kg/m² exclusion criteria: * ejection fraction (ef) below 30% at screening * progressive angina with symptoms of worsening of angina within the \<3 month * history of recent myocardial infarction or unstable angina * documented current relevant coronary stenosis ≥90% in any of the main 3 coronary vessels without bypass graft * symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months or patients with stroke at more than 3 months * insulin dependent diabetes mellitus * clinically significant and persisting cardiac ischemia * atrial fibrillation, pacemaker, defibrillator, second and third degree atrial-ventricular (av) block * known clinically relevant ventricular arrhythmias * clinically relevant heart failure with reduced left ventricular ejection fraction * significant valvular heart disease with moderate or severe aortic stenosis or any other significant stenosis; any other moderate or severe valvular failures * valve replacement * hypertrophic obstructive cardiomyopathy (hocm) * previous or imminent cardiac transplantation * known long qt syndrome or prolongation of the qt interval with ongoing proarrhythmic conditions * co-medication with drugs known to have qt prolonging effect * intolerance of fluoroquinolones, including moxifloxacin * history of serious adverse effects e.g. tendinitis and tendon rupture, arthralgia and effects on the peripheral and central nervous system while taking fluoroquinolones including moxifloxacin * history of tendon diseases or tendon injury caused by quinolones * treatment with fluoroquinolones, including moxifloxacin during the last 2 weeks * treatment with organic nitrates during the last 3 months * treatment with riociguat during the last 3 months * treatment with phosphodiesterase (pde)-5 inhibitors during the last 14 days * systolic blood pressure below 110 or above 160 mmhg at screening visit * diastolic blood pressure below 50 or above 100 mmhg at screening visit * heart rate below 50 or above 100 beats/min (taken from ecg measurement) at first screening visit * estimated glomerular filtration rate (egfr) below 30 ml/min/1.73m\*2

Keywords: vericiguat stable cad qt/qtc
development of a city-wide cohort of hiv-infected persons in care in the district of columbia: the dc cohort

Conditions: HIV; AIDS

Summary: the goal of the dc cohort is to establish a clinic-based city-wide longitudinal cohort that will describe clinical outcomes, and improve the quality of care for outpatients with human immunodeficiency virus/acquired immune deficiency syndrome (hiv/aids) in washington, dc.

all major community and academic clinics treating hiv-infected persons in the district of columbia (dc) will initially be included in the development of a city-wide "dc cohort" of hiv-infected persons in care, with consideration to be given subsequently to the inclusion of large private physician practices. socio-demographics, risk factors, treatments, diagnoses, labs and procedures documented in outpatient medical record systems will be included in the dc cohort database. routine reports will be generated every six months for sites comparing their participants' socio-demographics, clinical status, treatments, and outcomes to all other data in the dc cohort database, and other comparisons specifically requested by sites. all sites will be provided analytic support in research areas of interest.

Eligibility criteria:
inclusion criteria: * patient is receiving care for hiv at one or more of the twelve participating clinics in the dc cohort. * patient is either age 18 years or older, or seeks hiv care independently and is able to understand and sign informed consent. * patient is a minor who is consented by a parent or legal guardian. exclusion criteria: * patient is unable or refuses to provide informed consent. * minor children ages 12 through 17 who are unaware of their hiv status

Keywords: hiv aids co-morbidities
a study of liposomal trans crocetin, leaf-4l6715, in patients with acute respiratory distress syndrome due to covid-19, sepsis or other causes

Conditions: COVID19, Sepsis or Other Causes; Acute Respiratory Distress Syndrome

Summary: this is an open label phase ii study of treatment with leaf-4l6715 in patients who experience severe acute respiratory distress syndrome (ards) due to covid-19, sepsis or other causes. the purpose of this study is to evaluate the improvement in pao2/fio2 by more than 25% in patients treated with leaf-4l6715.

patient is treated with leaf-4l6715, a liposomal transcrocetin. the liposomal formulation allows for a gradual release of the free drug, thereby facilitating less frequent dosing. pharmacokinetic assessment will be carried out to identify an optimal dose and schedule.

Eligibility criteria:
inclusion criteria: 1. signed informed consent from the patient or patient's legal representative must be obtained prior to any procedures, as the likelihood of patients being able to provide consent is very limited 2. patients must be ≥ 18 years old 3. patient must have acute respiratory distress syndrome as defined, with a pao2/fio2 ratio of less than 200 mm hg 4. patient must be under artificial ventilation support (including patient under optiflowtm nasal high flow device or an equivalent device) 5. patient must have a life expectancy of at least 24 hours 6. patients should have normal liver function as defined by alt, ast and alkaline phosphate less than 3 uln for the institution 7. patient must have platelet count above \>100,000 cells/mm3, hemoglobin \> 8 g/dl and an absolute neutrophil count (anc) of \> 1000 cells/mm3 8. patients requiring dialysis due to renal impairment in cohort 3 exclusion criteria: 1. patient is enrolled in any other therapeutic clinical trial with the same endpoints. all observational studies or study with limited invasive methods (pharmacokinetic studies, monitoring of virus charges studies, biological monitoring studies ....) are allowed 2. patient is pregnant or breast-feeding 3. patient has a known hypersensitivity to crocetins, leaf-4l6715 or any of its excipients 4. patients with hemoglobinopathy 5. patients receiving extracorporeal membrane oxygenation (ecmo)
study to evaluate the persistence of the cellular and humoral immune response following vaccinations with glaxosmithkline (gsk) biologicals' candidate vaccines containing hbsag and different adjuvants in healthy adult volunteers

Conditions: Hepatitis B

Summary: the purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of gsk biologicals' investigational vaccine formulations containing hbsag (used as a model antigen) and an adjuvant.

subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (nct00508833) and who were enrolled in specific groups. all subjects were vaccinated in the study 287615 (nct00508833) according to a 0, 1, 10 month schedule. no new subjects were enrolled and no vaccine was administered in this long-term follow-up study. there was a single visit at year 4 at which blood samples for immunogenicity assays were taken.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol. * subjects who took part in and completed study 287615 (nct00508833). * written informed consent obtained from the subject. * healthy subjects as established by medical history before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling. * administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period. * pregnant or lactating female. * documented hiv-positive subject.

Keywords: hbsag persistence of the immune response adjuvants
ultrasonography in juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis, Oligoarthritis; Polyarticular Juvenile Rheumatoid Arthritis; Systemic Juvenile Idiopathic Arthritis

Summary: the purpose of this study is to analyse the usability of ultrasonography together with biomarkers in the investigation of patients diagnosed with juvenile idiopathic arthritis. the investigators hypothesize that serum and urine markers of cartilage and bone synthesis and degradation, together with ultrasound measurements of joint cartilage thickness, are useful tools in the early evaluation of jia patients, - as diagnostic, prognostic and monitoring methods.


Eligibility criteria:
inclusion criteria: * juvenile idiopathic arthritis: oligoarticular, polyarticular or systemic onset type. * informed consent from parents * between 5-15 years of age exclusion criteria: * other diagnoses that involves bones or cartilage * intraarticular steroid injections within 1 month of the trial investigation

Keywords: juvenile idiopathic arthritis ultrasonography cartilage cartilage biomarkers bone biomarkers
platelet rich fibrin combined with 1.2% atorvastatin for treatment of intrabony defects in chronic periodontitis

Conditions: Periodontitis

Summary: current study was designed to evaluate the combined efficacy of prf and 1.2% atv gel with open flap debridement (ofd) in treatment of intrabony defects in chronic periodontitis subjects.


Eligibility criteria:
inclusion criteria: the presence of 3- wall ibd ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph \[iopa\]) along with an interproximal probing depth (pd) ≥5 mm after phase i therapy (scaling and root planing \[srp\]) in asymptomatic teeth. exclusion criteria: 1) agressive periodontitis subjects; 2) systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) hematological disorders and insufficient platelet count (\<200,000/mm3); 5) pregnancy/lactation; and 6) smoking and tobacco use in any form 7) immunocompromised individuals.

Keywords: periodontitis surgery growth factors statins
urinary incontinence and other pelvic floor dysfunctions in trail runners

Conditions: Urinary Stress Incontinence

Summary: the pelvic floor is a crucial complex for many bodily functions, supporting the pelvic organs and contributing to urinary and anal continence, as well as sexual function. dysfunction of this structure can lead to a variety of disorders, including urinary incontinence (ui), a common problem in women. although the prevalence of ui in middle-aged women has been documented at between 20% and 30%, high-impact physical activities, such as certain sports and running, increase the risk of ui. according to the most recently published meta-analysis, the prevalence is 44% \[95%ci 30.2-57.8\]. although this subject is often taboo, it can have psychosocial consequences and affect sporting activities. only 31.7% of female runners talk to a health professional about it. trail running, a fast-growing discipline, differs from road running in its particular physical demands, which could influence the occurrence of pelvic floor disorders (pfd) and exercise-induced utis. the unique characteristics of trail running, such as the technical nature of the terrain, the steep gradients and the variety of distances, place intense demands on the female pelvi-perineal system. nevertheless, despite the growing popularity of this sport, little epidemiological data exists on the prevalence of stress uti and pelvic floor disorders among female trail runners.


Eligibility criteria:
inclusion criteria: * adult runner * residing in mainland france, or in french overseas departments and territories such as guadeloupe, martinique, french guiana, réunion, mayotte and new caledonia * practising trail running on a regular basis (defined pragmatically by the participant herself), whether or not affiliated to a club * able to complete the questionnaire online- exclusion criteria: * pregnant or have given birth in the last six months * does not understand french * a protected adult (guardianship or curatorship) or under court protection
identification and characterization of genetic variants in hereditary angioedema

Conditions: Hereditary Angioedema With C1 Esterase Inhibitor Deficiency

Summary: this project aims to analyse in an unbiased way the existence of genetic variants that contribute to explaining and predicting the differences in clinical expression between patients with hae.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) with hae-c1inh diagnosis (confirmed by mutation in serping1 gen or immunochemical study showing a decrease in c1inh function \<50% in two determinations together with a family history (symptomatic patients' group) * patients ≥ 22 years old with c1inh hereditary deficiency (confirmed by mutation of serping1 gene or immunochemical study showing a decrease in c1inh function \<50% in two determinations together with a family history) and who have not developed symptoms consistent with hae-c1inh * signed informed consent. exclusion criteria: * no confirmed c1inh deficiency. * inability to sign the informed consent. * presence of recurrent angioedema with histaminergic characteristics (response to treatment with antihistamines, glucocorticoids and/or epinephrine)