Kornimate/medical-research-clean huggingface dataset:
serum hepcidin in pregnant women and the association with pregnancy outcome

Conditions: Anemia

Summary: hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. the increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. firstly, investigator examines the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women will be tested.

this is a mono-center, observational, controlled study with 2 parallel groups (obese versus non-obese pregnant women). the study will be conducted at the university hospital of basel, department of obstetrics and antenatal care. a total of n=188 healthy pregnant women (expected 40% with bmi ≥ 30 kg/m2) will be recruited in the first trimester in our outpatients' department in order to have a total of 169 evaluable women, considering a drop-out rate of 10%. serum hepcidin, iron and hematological parameters will be measured at 11-14, 24-28, 32-36 weeks of gestation and at labor. the blood pressure, weight, weight gain, bmi and smoking status will be examined at all visits. blood samples will be measured in the university hospital of basel, department of laboratory medicine. recruitment will begin in january 2019.

Eligibility criteria:
inclusion criteria: * women with a bmi ≥ 18.5 kg/m2, * maternal age ≥ 18 years, * singleton pregnancy, * gestational age at recruitment: 11-14 of gestational weeks, * written informed consent. exclusion criteria: * pregnant women with a bmi\< 18.5 kg/m2, * congenital anomaly of fetus, * severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
star-life registry: starflo glaucoma implant clinical experience program

Conditions: Open Angle Glaucoma

Summary: starflo is a novel suprachoroidal glaucoma drainage device (gdd), bleb-free, exhibiting anti-fibrotic properties. release of this ce marked implant has been limited to leading glaucoma centers in europe.

this clinical experience program is being initiated to expand the surgical and clinical practice knowledge about the use of starflo for reducing intraocular pression (iop) in patients suffering from open angle glaucoma in a real world population of patients. this program is designed to be an international multicenter observational study. patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery. the aim of this program is to document the patient's benefit following implantation of the starflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.

Eligibility criteria:
inclusion criteria: * patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with starflo implant from 2011 * patients who have signed a data release form exclusion criteria: * patients who did not sign a data release form

Keywords: glaucoma drainage device starflo
mediterranean diet as treatment for normal weight women with pcos

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of pcos. thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely mediterranean diet and standardized normocaloric diet in normal weight women with pcos.

pcos is the most common endocrine disorder of reproductive age women, that is often characterized by chronic anovulation, hyperandrogenism and insulin resistance. the central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. no data are available for the best therapeutical approach for metabolic dysfunction of pcos. in addition, although insulin resistance is a crucial pathogenetic factor for pcos and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with pcos benefit or did not from lifestyle change program including diet without calorie-restriction. although there are not studies focused on the effectiveness and safety of mediterranean diet in pcos, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in pcos population and, in particular, on long-term pcos-related health risk. in this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with pcos.

Eligibility criteria:
inclusion criteria: polycystic ovary syndrome (using eshre/arsm 2007 criteria), 18 ≤bmi ≤ 25 exclusion criteria: age \ 35 years, bmi less than 18 and higher than 25, pregnancy, hypothyroidism, hyperprolactinemia, cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months, neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea). -

Keywords: mediterranean diet ovarian cysts treatment ovarian diseases normocaloric diet
a virtual parent-led support group for parents of children and youth with eating disorders: a mixed methods feasibility study examining acceptability, cost and parent outcomes

Conditions: Eating Disorders

Summary: there is a gap in the literature about the feasibility and implementation of parent-led support groups for parents who have children or adolescents with eating disorders. in this study, we will be observing the experiences of 40 parents in ontario who will virtually participate in one of 3 parent-led support groups for parents of children and youth with eating disorders. parents will be expected to attend the virtual sessions twice a month over the course of six months. we hope to evaluate the acceptability, cost, and parental outcomes of the parent-led support groups via surveys before, during, and after the study, as well as using a post-study interview.


Eligibility criteria:
inclusion criteria: * have the capacity to write, speak and understand english, in order to participate in the sessions * have access to the internet/computer to participate in the sessions * must have a child or adolescent with an eating disorder. exclusion criteria: * don't have the capacity to write, speak and understand english * don't have access to the internet/computer * don't have a child or adolescent with an eating disorder

Keywords: eating disorder parent support group
study evaluating safety, tolerability, and efficacy of intravenous ap-sa02 in subjects with s. aureus bacteremia

Conditions: Bacteremia; Staphylococcus Aureus; Staphylococcus Aureus Bacteremia; Bacteremia Staph; Bacteremia Due to Staphylococcus Aureus

Summary: phase 1b/2a, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous ap sa02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to staphylococcus aureus

this study will be conducted in two phases: phase 1b will to evaluate the safety and tolerability of multiple ascending intravenous (iv) doses of ap-sa02 or placebo as an adjunct to best available therapy (bat) compared to bat alone in subjects with sa bacteremia (sab). phase 2a will evaluate the efficacy, safety, and tolerability of multiple doses of ap-sa02 or placebo as an adjunct to bat compared to bat alone in subjects with complicated sab.

Eligibility criteria:
key inclusion criteria: * a hospitalized female or male ≥ 18 years old * positive blood culture for staphylococcus aureus (sa) * source of sa infection controlled, or a plan for source control, if relevant * not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if or reproductive potential key exclusion criteria: * concomitant growth of organisms besides sa * left-sided infectious endocarditis by modified duke criteria * known or suspected brain abscess or meningitis * known allergy to phage products

Keywords: bacteriophage phage bacteremia staphylococcus aureus staphylococcus sab
effect of cyclosporine and remote ischemic preconditioning in reperfusion ischemia injury on tetralogy fallot patients with correction surgery

Conditions: Myocardial Injury; Cardiac Surgery

Summary: the study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on mda, calcium cytosol concentration, and mitochondrial edema in tetralogy fallot patients undergoing corrective surgery.

forty patients undergoing tetralogy fallot corrective surgery were randomized to ripc and cyclosporine (n=20) and control (n=20). cyclosporin was administered 2 hour pre induction of anesthesia with the dose of 3 mg/kg body weight intravenously. ripc was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmhg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval. blood samples from coronary sinus and biopsies from the myocardial infundibulum were obtained three times at the condition of pre ischemic, ischemic, and reperfusion. mda was measured from the blood samples, meanwhile calcium cytosol concentration and mitochondrial edema was measured from the biopsy samples.

Eligibility criteria:
inclusion criteria: * tetralogy fallot patient that is undergoing correction surgery * has an ideal anatomy for corrective surgery, namely: pulmonary artery size within normal limits (according to the kirklin table), mc goon ratio\> 1.5, nakata index\> 200, normal coronary artery ostium and good biventricular function. exclusion criteria: * patient refuses the procedure * patient with acute kidney injury * patient without lower extremity * patient with cyclosporin allergy

Keywords: ripc cyclosporine ischemia reperfusion injury mda calcium cytosol tetralogy fallot mitochondrial edema infundibulum
abatacept versus adalimumab head-to-head

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive


Eligibility criteria:
inclusion criteria: * moderate to severe rheumatoid arthritis (ra) according to american college of rheumatology (acr) criteria * methotrexate failure * naive to ra biologics * ≤5 years duration of disease * disease activity score-28 c-reactive protein (das28 crp) ≥ 3.2 * willingness to self-inject subcutaneous (sc) drug exclusion criteria: * previous or current medical conditions that are warnings against the use of tumor necrosis factor (tnf)-blocking agents * history of active or chronic hepatitis * cancer in the last 5 years * history of severe chronic or recurrent bacterial or viral infections * risk of tuberculosis * current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
acute effects of oral ketone ester on cardiac function in patients with covid-19

Conditions: COVID-19

Summary: based on chinese studies, cardiac injury occurs in 20-30% of hospitalized patients and contributes to 40% of deaths. there are many possible mechanisms of cardiac injury in covid-19 patients and increased myocardial oxygen demand and decreased myocardial oxygen supply are likely contributors to increased risk of myocardial infarction and heart failure. interventions reducing the risk of cardiac injury are needed. ketone bodies, such as 3-hydroxybutyrate and acetoacetate, can maintain atp production in the heart and brain during starvation. it has been suggested that ketone bodies are more efficient substrates of energy metabolism than glucose, with a lower oxygen consumption per atp-molecule produced. in addition, the reduction in hospitalizations due to heart failure observed in type 2 diabetes patients treated with sodium-glucose cotransporter 2 inhibitors, is suggested to be partly attributable to increased levels of 3-hydroxybutyrate. infusion with 3-hydroxybutyrate reaching a plasma level of approximately 3 mm had acute beneficial hemodynamic effects in patients with heart failure and in healthy controls in a study by nielsen et al. improved haemodynamics and reduced systemic oxygen consumption might be of great benefit in patients with covid-19. the primary endpoint is left ventricular ejection fraction. secondary endpoints are conventional echocardiography parameters, peripheral blood oxygen saturation, venous blood oxygen saturation and urine creatinine clearance. the study population are twelve previously hospitalized patients with covid-19 the study design is a randomized placebo-controlled double-blinded crossed-over acute intervention study.


Eligibility criteria:
inclusion criteria: - patients previously hospitalized at hospitals of greater copenhagen and the zealand region with a laboratory confirmed diagnosis of covid-19 \> 18 years of age. exclusion criteria: * persons not able to cooperate * persons unable to understand and sign "informed consent" * diagnosis with chronic obstructive pulmonary disease * diagnosis with asthma * active treatment with sodium-glucose transporter 2 inhibitors * egfr \< 15 ml/min/1.73m2 * insulin-dependent diabetes
pharmacokinetic study of al-60371 otic suspension in pediatric subjects following tympanostomy tube surgery

Conditions: Otitis Media

Summary: the purpose of this study is to describe the pharmacokinetics of al-60371 otic suspension following two posologies of bilateral ototopical doses in pediatric subjects immediately after bilateral tympanostomy tube surgery.


Eligibility criteria:
inclusion criteria: * requires bilateral myringotomy and tympanostomy tube insertion; * provides informed consent (parent/legal guardian); * signs assent form where applicable (subject); * accompanied by parent/legal guardian at each visit; * other protocol-defined inclusion criteria may apply. exclusion criteria: * menarcheal females; * current or recent history of any disease which, in the opinion of the principal investigator, may place the subject at risk or interfere with study; * use of excluded medications within one week prior to surgery and for the duration of the study; * requires another surgical procedure in addition to the myringotomy; * clinically relevant otic condition which, in the opinion of the principal investigator, would preclude the safe administration of the study medication; * participation in any other investigational study within 30 days before entry into this study or along with this study; * known or suspected allergy or hypersensitivity to any active or inactive ingredient in the test article; * other protocol-defined exclusion criteria may apply.

Keywords: ear tubes tympanostomy tubes otitis media at the time of tympanostomy tube surgery omtt
mind-body skills groups for the treatment of war-related trauma in adults in gaza

Conditions: Posttraumatic Stress Disorder

Summary: the objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adults in gaza will result in improvement of posttraumatic stress symptoms and depression, and will increase posttraumatic growth compared to a control group.


Eligibility criteria:
inclusion criteria: * having experienced a political violence or war-related criterion a stressor * meeting the american psychiatric association (dsm-iv tr) criteria for ptsd according to screening scores on the ptsd checklist- civilian version exclusion criteria: * former psychosocial or medical treatment for mental health conditions * significant cognitive impairment
strenght training in osteoporosis prevention

Conditions: Osteopenia or Osteoporosis

Summary: the study involves 120 women over the age of 50. all participants in the study take part in high-intensity strength training for 10 months. in addition, half of the participants receive vitamin d3 at a dose of 4,000 iu/day. the investigators hypothesize that training combined with vitamin d3 supplementation will be more effective in preventing osteoporosis than training alone.


Eligibility criteria:
inclusion criteria: * age over 50 * female exclusion criteria: * ongoing cancer, * unstabilized cardiovascular disease, * cognitive disorders, * radiological treatment in the last 12 months, * other contraindications to undertaking high-intensity strength training, * diseases affecting the skeleton such as: paget's disease, type i diabetes mellitus, * taking medications affecting skeletal conditions including: long-term therapy with corticosteroids, thiazides, antiretroviral drugs, * contraindications to taking vitamin d including: hypercalcemia, nephrolithiasis, sarcoidosis, lack of cholecalciferol hydroxylase activity in the liver and kidneys.

Keywords: strenght training vitamin d3 osteoporosis osteopenia
immunogenicity and thrombotic potential of circulating protamine-heparin complexes in cardiac surgery patients

Conditions: Thrombocytopenia; Antibodies Drug Specific

Summary: the primary aim of this study was to describe the prevalence and time course of the occurrence of protamine/heparin antibodies in patients undergoing cardiac surgery on cardiopulmonary bypass. the second aim was to identify triggers of immunization. the third aim of this study was to evaluate a potential clinical impact of protamine/heparin antibodies and their platelet-activating properties leading to thromboembolism and other adverse outcomes.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * cardiac surgery on cardiopulmonary bypass exclusion criteria: * cardiac surgery without cardiopulmonary bypass * age \< 18 years * no written consent

Keywords: thrombin generation protamine
endoscopic multispectral imaging for the early detection of barrett's neoplasia

Conditions: Barrett's Esophagus; Intraepithelial Neoplasia

Summary: the overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of barrett's-associated neoplasia (high grade dysplasia or cancer). the investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. the goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of barrett's esophagus.


Eligibility criteria:
inclusion criteria: * 18 years or older * known or suspected barrett's esophagus with intraepithelial neoplasia(hgd/cancer) exclusion criteria: -

Keywords: barrett's esophagus intraepithelial neoplasia cross polarized reflectance examination vital-dye enhanced fluorescence examination
early sodium intake in preterm newborns

Conditions: Hyponatremia; Premature

Summary: hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. sodium imbalances impact in newborns outcome. there is controversy about the time of initiation and the requirements of sodium in premature infants. hypothesis: early (24 hours of life) sodium supplementation (5meq/kg/day) prevents the develop of hyponatremia in preterm infants.

this study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the newborn intensive care unit at children hospital in saltillo coahuila mexico. infants receive at 24 hours of life; sodium (5meq/kg/day) versus less than 1meq/kg/day. weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.

Eligibility criteria:
inclusion criteria: * preterm infants \<35 weeks gestation exclusion criteria: * urinary malformations * congenital abdominal wall defect * intestinal atresia / obstruction * congenital heart defect

Keywords: preterm infant sodium hyponatremia
assess the efficacy and safety of asc-01 in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy and the safety of asc-01 (aripiprazole/sertraline combination) compared to sertraline monotherapy in patients with major depressive disorders who have responded incompletely to sertraline monotherapy.


Eligibility criteria:
inclusion criteria: * patients who are either inpatients or outpatients. * patients who are able to understand necessary information for giving consent to undergo examinations, observations, and evaluations specified in this clinical protocol, and who are able to give written consent based on a full understanding of the trial. * patients who have been given a diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent" according to the dsm-5 and who have a current episode of major depression that has been continuing for at least 8 weeks * patients with a ham-d 17 total score of 18 or more at the screening period evaluation exclusion criteria: * female patients of childbearing potential who wish to become pregnant during the trial period or within 4 weeks after completion or discontinuation of the trial * pregnant or breast-feeding female patients, or female patients who may be pregnant * patients judged to be intolerant to all antidepressant (including drugs not used for their current episodes of major depression) based on their treatment history * patients who have had electroconvulsive therapy * patients who have enrolled in a clinical trial of other drugs or medical devices within 1 month before the time of informed consent * patients who have a medical history suggesting a risk of developing serious adverse events or symptoms that may hinder efficacy/safety evaluation (eg, symptoms of fibromyalgia, or premenstrual syndrome etc that overlap with depressive symptoms) * patients with complications or a history of diabetes mellitus, or patients who have been judged to be diabetic * fasting blood glucose level ≥ 126 mg/dl * 2-hour glucose level in 75-g oral glucose tolerance test (ogtt) ≥ 200 mg/dl * non-fasting blood glucose level ≥ 200 mg/dl * hba1c \[ngsp level\] ≥ 6.5% * patients who are undergoing treatment for thyroid disease (except for patients whose disease has been stabilized with drug therapy for 3 months or longer before the time of informed consent) * patients who have a history of neuroleptic malignant syndrome or serotonin syndrome * patients who have a history of seizure disorder (eg, epilepsy)