Kornimate/medical-research-clean huggingface dataset:
a phase ⅳ clinical trial of the recombinant hepatitis e vaccine (escherichia coli)(coadministration with recombinant hepatitis b vaccine)

Conditions: Hepatitis E; Hepatitis B

Summary: this is a open label, randomized phase vi study, to assess the safety and immunogenicity of co-administration of hepatitis e vaccine with hepatitis b vaccine. the concomitant group (n =300) received hepatitis b vaccine concomitantly with hepatitis e vaccine at day 1 and months 1 and 6; the nonconcomitant group (n =150) received hepatitis e vaccine at at day 1 and months 1 and 6. another nonconcomitant group (n=150) received hepatitis b vaccine at at day 1 and months 1 and 6. anti-hev igg and hbsab were determined. injection-site and systemic adverse events (aes) were monitored for 30 days after any vaccination; serious aes were monitored throughout the study.


Eligibility criteria:
inclusion criteria: * healthy people aged over 18 years old on the day of enrollment * negative in hbsag,hbsab and hbcab. * judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations. * able to understand this study information and willing to comply with all study requirements. * willing to participate in this study and sign informed consent form. exclusion criteria: * pregnant or breastfeeding or planning on getting pregnant in the future 7 months * use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period * received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, exceptlocal treatment. * administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period. * administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study. * had a fever (axillary temperature over 38°c) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. * plan to participate in any other clinical trial during the study period * administration of hev vaccine before the study. * immunodeficiency (such as hiv carriers), primary disease of important organs, malignant tumor,or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). * history of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
physical rehabilitation and chronic kidney disease

Conditions: Sarcopenia; Chronic Kidney Disease; Older

Summary: older patients with chronic renal failure suffer from sarcopenia. loss of muscle function is associated with increased morbidity and mortality. currently few treatment are available. the aim of this study is to evaluate the impact of physical rehabilitation in this population on muscle performance and quality of life.


Eligibility criteria:
inclusion criteria: * man or woman * age over 70 years * ckd stage 3b, 4 or 5 or a dfg \<45ml / min according to ckd-epi formula * an sppb (short physical performance battery test )\<10 * having received a complete and loyal information and having given his written and informed consent. * ability to rehabilitate exclusion criteria: * subject not presenting previous inclusion criteria * general condition not compatible for the realization of physical rehabilitation * patient protected under the terms of the law. * inability to respect the follow-up of the study for geographical, social or psychological reasons. * depression or other psychiatric disorder * refusal to participate in the study * absence of affiliation to the social security system * subject in a exclusion period of an other study

Keywords: sarcopenia chronic kidney disease older
cardiac progenitor cell infusion to treat univentricular heart disease (perseus)

Conditions: Hypoplastic Left Heart Syndrome; Single Right Ventricle; Single Left Ventricle

Summary: the purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

following the safety verification of the phase i study (ticap trial) that has been implemented and completed, the efficacy will be verified in this phase ii clinical study. the rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. preclinical and phase i studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion. the efficacy of cell transplantation is assessed as the primary endpoint of the phase ii clinical study. the improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac mri, which are conducted before and after treatment, are assessed as the evaluation items. the absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.

Eligibility criteria:
inclusion criteria: 1. age: age is 0 year or more and 20 years or less at the time of enrollment. 2. the patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries. 3. the ventricular ejection fraction \<60%. exclusion criteria: 1. cardiogenic shock 2. a patient with unstoppable extracorporeal circulation 3. a patient with lethal, uncontrollable arrhythmia 4. a patient with a complication of coronary artery disease 5. a patient with a complication of brain dysfunction due to circulatory failure 6. a patient with malignant neoplasm 7. a patient with a complication of serious neurologic disorder 8. a patient with high-grade pulmonary embolism or pulmonary hypertension 9. a patient with high-grade renal failure 10. a patient with multiple organ failure 11. active infection (including endocarditis) 12. sepsis 13. active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)

Keywords: univentricular heart
prp use in diabetic patients undergoing cesarean section

Conditions: Diabetes, Gestational; Wound Complication

Summary: this study will investigate the effectiveness of prp in wound healing among diabetic patients undergoing elective cesarean sections

in this balanced, randomized, and controlled prospective study, 100 pregnant ladies at full term diabetic patients will be admitted to minia university hospital. the patients will be randomly assigned into two groups. the intervention group will receive prp at surgery, whereas the control group will receive the usual care. all patients will be evaluated at baseline, one week, two weeks, four weeks and eight week after the cesarean section.

Eligibility criteria:
inclusion criteria: * the inclusion criteria will be a fixed factor along with age(18 y:45 y),diabetic patients(any type of diabetes),elective delivery,average body mass index(bmi) (17 : 24.9),non previously scared uterus ,single pregnancy exclusion criteria: * the exclusion criteria will be younger ages below 18 years ,older ages above 45 years, emergency caesarean delivery, previous scared uterus, underweight bmi below 17, overweight bmi above 24.9, no other medical problems, associated other diseases, and multiple pregnancy
covid-19 and diabetes in west of algeria

Conditions: Coronavirus Infections; Diabetes Mellitus; Prevalence; Risk Factors; Patient Outcome Assessment; Severe Acute Respiratory Syndrome

Summary: by jan 7, 2020, chinese scientists had isolated a novel coronavirus, from patients with virus-infected pneumonia. the who designated later this virus as covid-19 (coronavirus disease 2019). this exponential pandemic coronavirus infection is responsible for severe forms in 15 to 20%, for critical ill requiring ventilation in 5% and for mortality in 2%. algeria was part of the 13 top priority countries identified by who based on their direct links and volume of travel to the infected provinces in china. it is known that some predisposing conditions lead to a worse outcome with coronavirus. in china, the overall case-fatality rate was 2.3%, but was higher in patients with diabetes (7.3%). in italy, the most common comorbidities associated with death from covid-19 were hypertension (73.8%) and diabetes (33.9%). the us centers for disease control and prevention suggests diabetes is the most common comorbidity in covid-19 cases. in the largest cohort nhs england study, death from covid-19 was strongly associated with uncontrolled diabetes (after full adjustment, hr 2.36). the west algerian corodiab-13 study aims is (1) to assess the prevalence of diabetes among hospitalized patients with covid-19, (2) to describe the phenotypic characteristics of patients with diabetes, and (3) to identify the parameters specific to the diabetic which are associated with severe forms. in the future, this study will provide answers for two main questions 1. why diabetics are more at risk of developing covid-19 infection? 2. why diabetics are at high risk of developing severe forms?


Eligibility criteria:
inclusion criteria: * patients admitted in a hospital center since 1th april 2020 * patients with covid19 with biological proof (specific pcr) or with clinical and radiological diagnosis. * patient with diabetes known before the admission * new onset diabetes discovered at admission (plasma glycaemia value strictly greater than 2 g/l at any time) exclusion criteria: * pregnant * active cancer * dementia * minors, adults under guardianship, protected persons * significant disability (the modified rankin scale more than 2 prior admission)

Keywords: covid-19 diabetes risk factors severe illness outcomes
the predictive value of retinal vascular signs for intracranial artery stenosis (rvs-icas)

Conditions: Intracranial Stenosis

Summary: intracranial artery stenosis (icas) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the asian population. however, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. this study aims to evaluate the predictive value of retinal vascular signs for intracranial artery stenosis (icas) and explore a new screening method.

intracranial atherosclerosis stenosis (icas) is a leading cause of ischemic stroke worldwide, contributing to the global burden of stroke, particularly in the asian population. compared with the other stroke subtypes, patients with icas particularly the degree of stenosis≥50% had more severe stroke, stayed longer in the hospital and higher risk of recurrent ischemic events. however, there is no non-invasive, easy to popularize and economic for intracranial artery stenosis in mass population screening. retinal imaging has great advantages including share the same embryological origin, anatomic features, and physiological properties with brain, non-invasive, easy to popularize, inexpensive and possess good economic benefits. therefore, investigators design this study to assess the predictive value of retinal vascular signs for intracranial artery stenosis (icas) and hope to explore a new screening method.

Eligibility criteria:
inclusion criteria: 1. age≥35 2. accept tcd examination and fundus examination 3. signed informed consent exclusion criteria: 1. non-atherosclerotic stenosis, such as arteritis, moyamoya disease, arterial dissection, vascular malformation, etc., which were clearly diagnosed. 2. intracranial space-occupying lesions 3. jugular vein and intracranial venous lesions 4. patients with severe cardiac, hepatic, renal disease. 5. life expectancy of less than 1 year due to co-morbid conditions. 6. known pregnancy (or positive pregnancy test), or breast-feeding. 7. pathological myopia fundus changes 8. glaucoma 9. refractive medium turbidity affects fundus observation 10. anterior macular membrane of both eyes 11. papilledema, optic neuritis and optic neuropathy 12. patients who have had internal eye surgery in the last six months (including fundus laser) 13. previous history of internal eye trauma 14. poor image quality of fundus and images 15. any condition which, in the judgment of the investigator, might increase the risk to the patient.
dynamic airway ct is diagnostic for tracheomalacia in children

Conditions: Tracheomalacia

Summary: the purpose of this pilot interventional study is to evaluate the use of dynamic airway computed tomography (da-ct) for diagnosis of tracheomalacia in children 0-18 years for whom flexible bronchoscopy has been performed. the primary aims are to evaluate the diagnostic accuracy, image quality, and radiation exposure of da-ct as a potential noninvasive alternative to the gold standard of flexible bronchoscopy in the diagnosis of tracheomalacia. the results from this pilot study will help to estimate sample size for a larger-scale study with more precise estimates of da-ct diagnostic potential.


Eligibility criteria:
inclusion criteria: * participants 0-18 years old, with * clinically indicated flexible bronchoscopy has been performed exclusion criteria: * pregnancy or breastfeeding * unable to undergo ct scanning without sedation * patients with tracheostomy

Keywords: tracheomalacia in children
longterm observational study in subjects treated with aa4500 in aux-cc-854, 856, 857, 858 & 859

Conditions: Dupuytren's Disease

Summary: the purpose of study aux-cc-860 is to assess the durability of response of the aa4500 treatment regimen. this study will also evaluate long-term safety and progression of disease in joints.

phase 3 non-treatment study in which year 2 to year 5 year follow-up of subjects who received aa4500 in the 9-month open-label studies (aux-cc-854 and aux-cc-856) or the 12-month double-blind with open-label extension studies (aux-cc-857/aux-cc-858 and aux-cc-859). after completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.

Eligibility criteria:
inclusion criteria: to be eligible for this study a subject had to: * have received at least one injection of aa4500 in one of the auxilium sponsored studies (aux-cc-854, aux-cc-856, studies aux-cc-857/aux-cc-858, or aux-cc-859) and have at least one fixed-flexion contracture measurement after treatment with aa4500 * be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator * voluntarily sign and date an informed consent agreement approved by the institutional review board/independent ethics committee (irb/iec) exclusion criteria: * none

Keywords: advanced dupuytren's disease muscular diseases musculoskeletal diseases contracture joint diseases connective tissue diseases dupuytren's contracture
safety/efficacy of antibiotic steroid combination in treatment of blepharitis and/or keratitis and/or conjunctivitis

Conditions: Blepharitis; Conjunctivitis; Keratitis

Summary: safety and efficacy of antibiotic steroid combination compared with individual administration in the treatment of bacterial ocular inflammation and infection (blepharitis and/or keratitis and/or conjunctivitis).

antibiotic/steroid combination compared to individuals components 8 days of treatment.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of blepharitis and/or keratitis and/or bacterial conjunctivitis exclusion criteria: * uncontrolled glaucoma or intraocular hypertension * wear contact lens during the study * patients with sight in a single eye * suspicious of viral, fungic infection * use of any other ophthalmic drugs during the study * use of immunosuppressant therapy * known or suspected allergy or hypersensibility to any component of study medication

Keywords: moxifloxacin dexamethasone ocular inflammation ocular infection
interactive psychopharmacologic effects of alcohol and nicotine in humans

Conditions: Alcohol Consumption; Tobacco Use

Summary: the purpose of this study is to characterize the interactive effects of acute intravenous (iv) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.


Eligibility criteria:
inclusion criteria: * male or female, 21 to 50 years old. exclusion criteria: * alcohol or nicotine naive

Keywords: alcohol, nicotine
pharmacodynamics, pharmacokinetics, safety and tolerability of ultra low doses of dapagliflozin in healthy subjects

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the pharmacodynamics (pd), pharmacokinetics (pk), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy men and women * wocbp who are using acceptable method of contraception * women who are not nursing exclusion criteria: * history of gi disease * any gi surgery that could impact study drug absorption * glucosuria at screening or day -2 * abnormal liver function tests (alt, ast or total bilirubin \> 10% above uln) * history of current or recurrent uti * history of diabetes mellitus * history of chronic or recurrent vulvovaginal mycotic infections * estimated creatinine clearance (clcr) \< 80 ml/min using cockroft-gault formula * history of allergy to sglt2 inhibitors or related compounds
lumbosacral transitional vertebra prevalence among egypt population and its association with lumbar degeneration

Conditions: Lumbosacral Anomalies

Summary: retrospective cross sectional study study setting: cases will be recruited from the recorded data system at the department of diagnostic radiology, assiut university.

* study subjects: 1. inclusion criteria: * all patients underwent msct kub from 2022 till 2023 * age between 20-50 years old 2. exclusion criteria: * all cases below 20 and above 50 . * previous history of lumbar spine surgery; * non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures; * images with poor quality 3. sample size calculation: the study will include all patients underwent kub ct in assuit university hospital. objective of this research study will be accomplished through the following consecutive steps: * patient enrolment and sample collection: sample are patients underwent msct kub at our hospital , assuit university at one year. lumbosacral spine will be assessed for lstv ,the patient images will be divided into two groups ,one which has lstv as cases and other group with normal spine as control. both groups will be assessed for associated disc degeneration ,facet arthropathy sacroiliac joint degeneration ,paravertebral muscle volume and will be compared with control.

Eligibility criteria:
inclusion criteria: * • all msct kub studies from 2022 till 2023 * age between 20-50 exclusion criteria: * all cases below 20 and above 50 . * previous history of lumbar spine surgery; * non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures; * images with poor quality
analysis of the posterior wall fracture of the acetabulum

Conditions: Acetabular Fracture

Summary: assessement,evaluation of postoperativ reduction of posterior wall acetabular fractures in assiut university hospital

posterior wall fracture of the acetabulum resemble 30% of acetabular fracture,surgical treatement is the 1st choice now for most of these fractures as it aimes to restore joint conjuroity and decreases the possibelities of osteoarthrities of the hip joint,in this study investigators will make analysis and assessement of the quality of postoperative reduction which is the main indicator of outcome of acetabular fractures in adult patients in assiut university hospitsls

Eligibility criteria:
inclusion criteria: * adult patients of both sexes with posterior acetabular wall fracture either isolated or associated with other fractures exclusion criteria: * other types of acetabular fractures not associated with posterior wall fracture
monopolar and bipolar current rfa knife in poem

Conditions: Esophageal Motility Disorders

Summary: per oral endoscopic myotomy (poem) is performed for various esophageal muscular disorders, including achalasia and other spastic esophageal conditions. it is performed with the standard endoscope and involves dissecting the esophageal muscle sphincter. the procedure is typically completed using standard monopolar energy, which are effective, but can be associated with post-procedural pain. more importantly, frequent exchange of various instruments are required in order to cut the right layers and to stop bleeding. the speedboat-rsd is fda approved for dissection of various tissue within the gastrointestinal tract tract but only a few studies have evaluated its use in poem. currently, the investigators have been performing egd with poem procedures using speedboat-rsd as a standard of care procedure. the investigators would like to compare the performance of the standard monopolar erbe knife to the bipolar speedboat-rsd knife in poem. the investigators hypothesize the bipolar knife will allow for efficient completion of the poem procedure with less post procedural pain.

per oral endoscopic myotomy (poem) is performed for various esophageal motility disorders, including achalasia and other spastic esophageal conditions. it is performed with the standard endoscope and involves dissection of the esophageal submucosa followed by cutting of the esophageal muscle. the procedure is typically completed using standard monopolar cutting knives, which are effective, but can be associated with inadvertent thermal injury and post-procedural pain due to dissemination of higher voltage. more importantly, frequent exchange of various instruments are required in order to inject within the submucosa and to coagulate bleeding vessels. the speedboat-rsd has an integrated injection needle for submucosal injection and uses bipolar radiofrequency energy (brf) and microwave energy to dissect tissue/coagulate vessels. in essence, injection, submucosal dissection, cutting, and coagulation can all occur with one knife (2). it is fda approved for submucosal dissection (esd) and myotomy within the gastrointestinal tract but only a few studies have evaluated its use in poem (3). currently, the investigators have been performing egd with the poem procedure using speedboat-rsd as a standard of care procedure. the investigators would like to compare the performance of the standard monopolar erbe knife to the bipolar speedboat-rsd knife in poem. the investigators hypothesize the bipolar knife will allow for efficient completion of the poem procedure with less post-procedural related pain.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years of age * able to sign consent - planned poem procedure for all indications exclusion criteria: * pregnant patients * prisoners * unable to sign consent

Keywords: achalasia dysphagia per-oral endoscopic myotomy bipolar electrocautery