Kornimate/medical-research-clean huggingface dataset:
percutaneous endoscopic tracheal plug/unplug for cdh (congenital diaphragmatic hernia)

Conditions: Severe Congenital Diaphragmatic Hernia

Summary: congenital diaphragmatic hernia is an anatomically simple birth defect in which contents of the fetal abdomen migrate into the chest due to incomplete formation of the diaphragm. herniation of viscera into the chest prevents the fetal lungs from developing and growing to normal size. in the most severe cases, there is significant morbidity and mortality at birth. for these fetuses, fetal intervention may improve outcomes by enabling the lungs to grow enough in utero that they are capable of sustaining life after birth. this unblinded, non-randomized trial will assess the safety and efficacy of the use of the goldvalve balloon and minitorquer microcatheter to perform percutaneous temporary tracheal occlusion to treat severe cdh in utero. the primary outcome variable will be fetal lung growth due to successful 'plugging/unplugging' of the trachea, as determined by serial lung-head ratio (lhr) measurements. secondary outcome variables include maternal, fetal and neonatal variables, specifically neonatal survival at 90 days of life. for infants who survive beyond 90 days post-delivery, their families will be offered follow-up (up to 2 years of age and possibly beyond) in the long-term infant-to-adult follow-up evaluation (life) clinic at ucsf.


Eligibility criteria:
general subject population: pregnant women in the second trimester, at least 18 years of age, and of any and all ethnic backgrounds. inclusion criteria: * confirmed diagnosis of cdh * normal fetal echocardiogram * normal karyotype * fetal liver herniated into the left hemithorax * lung-head ratio (lhr) is 1.0 or less, calculated between 24-26 weeks' gestation * fetus is between 26 and 28 weeks' gestation * singleton pregnancy * mother meets psychosocial criteria * pre-authorization from third-party payor for fetal intervention, or ability to self-pay. exclusion criteria: * failure to meet all inclusion criteria * other congenital anomalies detected on ultrasound * contraindication to abdominal surgery or general anesthesia * allergy to latex * preterm labor, preeclampsia, or uterine anomaly (e.g., large fibroid tumor) * family unable or refuses to stay in san francisco for duration of the tracheal occlusion period and for the duration of the pregnancy as medically necessary.

Keywords: congenital diaphragmatic hernia lung-head ratio percutaneous tracheal occlusion fetal intervention
efficacy of endocell® vs conventional medium in the treatment of infertility

Conditions: Infertility

Summary: the aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (day 5) after co-culture on autologous endometrial cell culture (aecc) versus transfer of a single embryo at day 3 after culture in conventional medium. efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.


Eligibility criteria:
inclusion criteria: * women aged ≥ 18 and ≤ 36 * undergoing ovarian stimulation for an in vitro fertilization (ivf) or intra cytoplasmic sperm injection (icsi) * having experienced no more than 1 embryo transfer failure * with basal fsh level ≤ 12 iu/l within the 6 months prior to the study * endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation) * negative serology for hiv 1 and 2, hepatitis b and c, htlv 1 and 2, syphilis exclusion criteria: * hypersensitivity to one of the culture media components * oocyte donation, sperm donation * thawed embryos transfer * women with endometriosis grade iii and iv, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps * women affected by pathologies associated with any contraindication of being pregnant * abnormal gynaecologic bleeding of undetermined origin * uncontrolled thyroid (tsh dosage) or adrenal dysfunction * neoplasias, any pathologies of the endometrium or the cervix

Keywords: infertility cell culture aecc endocell ivf
covid-19 vaccine messaging, part 1

Conditions: Vaccination; COVID-19

Summary: this study tests different messages about vaccinating against covid-19 once the vaccine becomes available. participants are randomized to 1 of 12 arms, with one control arm and one baseline arm. we will compare the reported willingness to get a covid-19 vaccine at 3 and 6 months of it becoming available between the 10 intervention arms to the 2 control arms. study participants are recruited online by lucid, which matches census based sampling in online recruitment.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * us resident exclusion criteria: * younger than 18 years of age * non-us resident * do not consent

Keywords: messaging
field triage of older adults who experience traumatic brain injury

Conditions: Traumatic Brain Injury; TBI

Summary: our overall goal in this proposed study is to describe the current prehospital trauma triage process for older adult (age≥55) patients with suspected traumatic brain injury (tbi), to identify the effect of certain medications (anticoagulants and platelet inhibitors) on tbi-related need for trauma center services, and to identify novel tbi screening strategies that are feasible for use in the prehospital setting.

traumatic brain injury (tbi) is major source of disability and death for older adults. of particular concern is that older adults most frequently sustain tbis after low-mechanism injuries, such as falls from standing height, and frequently use anticoagulants and platelet inhibitors, which place them at risk for worse clinical outcomes. with the growth of the older adult population and the expanding use of anticoagulants and platelet inhibitors, tbi among older adults will continue to be a major source of morbidity and mortality unless methods are identified to improve outcomes in this unique population. building upon our long-standing and highly successful ems research laboratory that has specifically focused on the triage of injured patients and the prehospital care of older patients and employing a combination of qualitative and quantitative methods, we will collect data from a large, multi-county catchment area that includes multiple ems agencies, urban and rural environments, as well as trauma centers and non-trauma centers. in this study, we will: 1) identify candidate neurologic scales to maximize detection of high-risk older adult tbi patients; 2) characterize the current trauma triage process used by ems providers to identify older patients with suspected tbi and patients taking anticoagulants and/or platelet inhibitors; 3) assess the public health burden of tbi among older adult ems patients taking anticoagulants and/or platelet inhibitors; 4) assess the predictive ability of novel prehospital-based neurologic screening strategies to identify high-risk older adult tbi patients in the prehospital setting who require tbi-related trauma center care. findings from this study have the potential to shift clinical practice in the prehospital setting by informing future recommendations for the identification of tbi among older adults taking anticoagulants or platelet inhibitors.

Eligibility criteria:
inclusion criteria: * ems provider arriving with a patient who is injured \>=55 years old exclusion criteria: * no systematic exclusions

Keywords: tbi trauma traumatic brain injury
epigallocatechin gallate (egcg) as a flushing agent during full pulpotomy in mature permanent molars with irreversible pulpitis

Conditions: Irreversible Pulpitis

Summary: this study evaluates the effect of two flushing agents (epigallocatechin gallate (egcg) and sodium hypochlorite (naocl)) during full pulpotomy using two different calcium silicate-based materials (mta and premixed bioceramic putty) on postoperative pain, success rate and dentin bridge thickness in mature permanent mandibular molars with irreversible pulpitis. participants will be divided into four groups based on the flushing fluid and the pulp capping material to be used.


Eligibility criteria:
inclusion criteria: 1. patients of either gender between the age group of 20-40 years. 2. systemically healthy patient (asa i or ii). 3. mature permanent mandibular molars with: * extremely deep carious lesion (caries penetrating entire thickness of dentin). * clinical diagnosis of symptomatic irreversible pulpitis and normal periapical tissue. 4. patients who agree to provide written consent and attend for recall appointments. exclusion criteria: 1. non-restorable teeth with subgingival caries or badly broken teeth. 2. signs of pulpal necrosis; associated sinus tract or swelling. 3. negative response to pulp sensibility test. 4. poor periodontal support. 5. absence of pulp exposure following complete caries removal. 6. bleeding from the pulp could not be detected from one or more of the orifices indicating pulp necrosis. 7. failure to achieve haemostasis within 10 min following full pulpotomy.
irbesartan/hydrochlorothiazide and irbesartan in the treatment of mild to moderate hypertension

Conditions: Hypertension

Summary: study objectives : * to demonstrate the reduction in office blood pressure following a 8-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference. * to demonstrate the reduction in office blood pressure after 4-week regimen of irbesartan / hydrochlorothiazide using irbesartan as a reference. * to compare the response rate (defined as office systolic blood pressure/diastolic blood pressure reduce more than 10mmhg from week 0) of patients after 4-week and 8-week regimen of irbesartan / hydrochlorothiazide versus irbesartan. * to compare the proportion of patients requiring titration after 4-week regimen of irbesartan/hydrochlorothiazide versus irbesartan * to ascertain the safety and tolerability of irbesartan / hydrochlorothiazide versus irbesartan when administered once daily


Eligibility criteria:
inclusion criteria: * patients with mild to moderate hypertension with office diastolic blood pressure (dbp) 90-109 mmhg and/or systolic blood pressure (sbp) 140-179 mmhg * all women of child-bearing potential must have negative urine pregnancy tests within a week prior to initiation of therapy exclusion criteria: * females who are pregnant or breast feeding * office dbp ≥ 110 mmhg or office sbp ≥ 180 mmhg * history of significant cardiovascular diseases which includes: * acute myocardial infarction within six months or any ischemic heart disease requiring medication. * cerebrovascular disease * history of significant renal diseases including: * serum creatinine \> 3.0 mg/dl. * creatinine clearance \< 30 ml/min. * severe biliary cirrhosis and cholestasis * refractory hypokalemia, hypercalcemia * history of autoimmune disease, collagen vascular disease, multiple drug allergies, bronchospastic disease or other malignancies requiring current medication * hepatic disease as indicated by any of the following: * sgot or sgpt \>3 x upper limit of normal. * serum bilirubin \> 2 x upper limit of normal. * any other condition or therapy that, in the investigator's opinion, or as indicated in the product(s) label may pose a risk to the patient or interfere with the study objectives. * any other investigational drug given within 30 days of initiation of therapy, and participation in other clinical studies while enrolled in this protocol. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
endocrine disrupting chemicals and hormones in adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention-deficit/hyperactivity disorder (adhd) is a common neurodevelopmental disorder in children and adolescents. growth hormone and thyroid function are associated with both physical and neurocognitive development. endocrine disrupting chemicals (edcs) could disturb the normal function of endocrine systems, and further link to the pathophysiology of adhd. in addition, whether methylphenidate for treating adhd influences growth hormone and thyroid function of patients remains unclear.

therefore, this study aims (1) to investigate the prospective role of edcs, growth hormone and thyroid function in clinical manifestations of adhd; and (2) to determine the influence of pharmacotherapy on growth hormone and thyroid function among patients with adhd under a one-year methylphenidate treatment. methods: in this two-year study, we will recruit 120 patients with adhd (aged between 6 and 16) and 120 age- and gender-matched control subjects. blood (10 ml) and urine (10 ml) will be obtained from each participant to analyze the levels of edcs (phthalates, phenols and parabens), growth hormone and thyroid function (tsh, t3, free t4, t4, growth hormone, igf-1and igf-bp3). behavior symptoms (adhd-rs and snap-iv) and neuropsychological function (wisc, cpt and cata) of each participant will be assessed. patients with adhd will receive treatment in a clinical practice and then will be followed up for 12 months. at the 12th month, the same procedures as those performed at the baseline will be replicated for patients with adhd. this study will provide proof of the relationships of edcs, endocrine systems and adhd manifestations in clinical samples and further explain the biological pathogenesis of adhd. in addition, this study will elucidate the influence of adhd medications on growth hormone and thyroid function. such information may become an important reference for future research and safety of pharmacotherapy for patients with adhd.

Eligibility criteria:
inclusion criteria: * patients with adhd aged between 6 and 16. * the patients were either newly diagnosed with adhd or had an existing diagnosis but had not taken medication for adhd during the previous 6 months or more. exclusion criteria: * patients with a history of major physical or additional psychiatric diseases

Keywords: adhd endocrine disrupting chemicals growth hormone thyroid methylphenidate
prognostic implications of accuffrangio-guided pci in stemi

Conditions: Coronary Artery Disease; ST Elevation Myocardial Infarction

Summary: this is a prospective, single-center clinical trial. accuffrangio (arteryflow technology co., ltd., hangzhou, china) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. the aim of this study was to evaluate the diagnostic accuracy and prognostic implications of accuffrangio in patients with st-segment elevation myocardial infarction (stemi).


Eligibility criteria:
inclusion criteria: * 18 years and older * stemi patients with primary percutaneous coronary intervention within 24 hours with at least 1 non-ira * diameter stenosis of 50%-90% by visual estimate * reference vessel size \> 2 mm in stenotic segment by visual estimate exclusion criteria: * lvef ≤ 40% * egfr \< 60 ml/min * allergy to contrast media, adenosine * prior cabg
evaluate safety and effectiveness of xenosure® biological patch in the application of peripheral vascular repair

Conditions: Vascular Diseases

Summary: the purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of xenosure biologic patch. this trial is performed to meet the china fda regulation in this kind of device. the clinical trial will be performed solely inside china under gcp regulation and all applicable china regulations on medical device clinical trial.

the purpose of this trial is to collect safety and effectiveness data to support peripheral vascular indication of xenosure biologic patch. this trial is performed to meet the china fda regulation in this kind of device. the clinical trial will be performed solely inside china under gcp regulation and all applicable china regulations on medical device clinical trial. 144 subjects for peripheral vascular repair, including respective 72 subjects for the trial group and the control group.

Eligibility criteria:
inclusion criteria: - 1) any man or woman aged between 18\~80 years old 2) the expected lifetime of no less than 12 months 3) the subject can be considered for suturing with xenosure biological patch after the peripheral vascular repair surgery. the subject's targeted arterial diameter is less than 5mm or the arterial incision length is more than 4cm and less than 9cm. 4) physical conditions and vital signs meet requirements for the surgery. 5) the subjects and/or their guardians sign the written informed consent form. exclusion criteria: 1. patients with severe visceral diseases in heart, liver, kidney, etc. 2. patients have unstable vital signs and not suitable for the surgery indications 3. patients need vascular outflow stenting repair in the same location with xenosure® biological patch. 4. pregnant or lactating women 5. patients with severe allergic history (especially allergic to bovine materials) 6. patients with the past medical history of severe immunodeficiency disease 7. the subject has used or plans to use immunomodulatory drugs for more than half a year. 8. the subject with poor blood clotting function is defined as that pre-operative inr or aptt is prolonged over 30% than the reference value without drug intervention, or that blood platelet count is less than 100\*10\^9/l. 9. the subject has severe kidney disorders or diseases with the estimated glomerular filtration rate \[grf\]\<30ml/min/1.73m2. 10. the subject's alt or ast level is 2.5 times higher than the upper normal limit or the subject has active liver disease or icterus. 11. the subject has participated in another clinical study within 3 months or is participating in another clinical study now. 12. the investigator believes that the subject has other reasons unsuitable for inclusion. -
clinical assessment of perfusion techniques during repair of coarctation with aortic arch hypoplasia in infants

Conditions: Coarctation of Aorta

Summary: the purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.

three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)

Eligibility criteria:
inclusion criteria: * coarctation with severe aortic arch hypoplasia (distal aortic arch z-score \< -2) * coarctation of aorta with septal defects exclusion criteria: * coarctation with mild aortic arch hypoplasia (distal aortic arch z-score \> -2) * complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, shone's complex) * univentricular and duct-dependent heart defects * aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score \< -2.0) * left ventricular dysfunction (left ventricle ejection fraction \< 60%) * congenital renal or central nervous system anomalies * related infectious diseases * prematurity (gestational age \< 37 weeks)

Keywords: congenital heart disease coarctation of aorta aortic arch hypoplasia cerebral selective antegrade perfusion double arterial cannulation
metformin and pioglitazone effects on fetuin-a and osteoprotegrin concentrations in type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of t2dm. biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. these medications diminish or delay long term micro- and macrovascular complications associated with t2dm although at different rates. excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in t2dm subjects. given the shared pathway of insulin resistance/fetuin-a/opg in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive cad risk via direct and indirect amelioration of insulin resistance/fetuin-a/opg. the present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-a and opg in a group of iranian adults with newly diagnosed t2dm.


Eligibility criteria:
inclusion criteria: newly diagnosed type 2 diabetes patients based on american diabetes association criteria (2011) for diagnosis of diabetes exclusion criteria: previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions intake of glucocorticoids in the past one year major illnesses of heart, lung, kidney, and liver.

Keywords: fetuin-a opg metformin pioglitazone
effect of ofa in laparoscopic gastrectomy

Conditions: Postoperative Pain

Summary: the investigator will examine the effects of opioid free anesthesia in patients undergoing laparoscopic gastrectomy. the investigator expect that opioid free anesthesia will reduce postoperative pain and opioid consumption. and investigator will analyze the association between postoperative pain and patient's underlying psychological characteristics and pain sensitivity. the investigator anticipate that psychological characteristics and pain sensitivity may be realted to postoperative pain and opioid consumption.


Eligibility criteria:
inclusion criteria: * patients over 19 years who underwent laparoscopic gastrectomy for gastric cancer exclusion criteria: * patients with a history of allergic reactions to drugs * patients with a history of drug addiction * patients with chronic pain who require analgesics * patients with cancer other than the stomach * history of hospitalization for psychiatric disorders * patients with sleep apnea * preoperative pulse oximetry (spo2) \< 95 % * moderate or severe hepatic impairment * bradycardia (hr\<50bpm), hypotension, atrioventricular block, intraventricular or sinus block * body mass index over 35 kg/m2 * blood clotting disorders * pregnant/lactating women * cognitive impairment * unable to read consent form (eg illiterate, foreigner, etc.)
effect of vitamin d3 and omega-3fa on leptin and hba1c with vitamin d deficiency

Conditions: Vitamin D Deficiency

Summary: the combined effect of vitamin d3 and omega-3 supplements on serum leptin and glycated hemoglobin (hb a1c) levels in jordanian people with vitamin d deficiency.

nothing is published in the literature about effect of vitamin d3 (vd3) and omega-3 fatty acids (omega-3fa) on serum leptin and glycated hemoglobin ( hba1c) this study will be conducted to investigate effect of vd3 and omega-3fa alone and with each other on serum leptin and glycated hemoglobin (hb a1c) levels in jordanian people with vitamin d deficiency. this randomized, controlled clinical trial will be designed to test effects of 50,000 iu vd3 weekly and 1000 mg omega-3fa daily for eight weeks, separately and with each other, on on serum leptin and glycated hemoglobin (hb a1c) levels .

Eligibility criteria:
inclusion criteria: * jordanian people aged 25-55 * medical diagnosis of vitamin d deficiency ( vd \<25 ng/ ml) exclusion criteria: * blood disorders including * thalassemia * sickle cell disease

Keywords: vitamin d3 vitamin d deficiency leptin a1c omega-3 fatty acid