Kornimate/medical-research-clean huggingface dataset:
a combination study to determine the safety and efficacy of panzem ncd with avastin in metastatic carcinoid tumors

Conditions: Carcinoid Tumor

Summary: this single center, open-label study will evaluate the safety and efficacy of panzem (2-methoxyestradiol, 2me2) nanocrystal dispersion (ncd) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.


Eligibility criteria:
inclusion criteria: * histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor * measurable disease, according to recist, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral ct to be greater than or equal to 1 cm in diameter * 18 years or older laboratory data to include (next 7 bullet points): * aspartate aminotransferase(ast)and alanine aminotransferase (alt)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present) * total bilirubin less than or equal to 2 mg/dl * serum creatinine less than or equal to 1.5 mg/dl * total white blood cell count greater than 3,500/mm3 * absolute neutrophil count greater than or equal to 1,500/mm3 * international normalized ratio less then or equal to 1.5 * platelets greater than or equal to 100,000/mm3 * agree to use effective contraceptive methods * have an ecog performance status of less than 2 * life expectancy of greater than 12 weeks * ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions exclusion criteria: * pregnant or nursing, or refusal to use appropriate birth control * an active infection * have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure * have apparent central nervous system metastasis or carcinomatous meningitis * have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer * be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and coumadin * have current or a history of severe bleeding * uncontrolled / severe hypertension * previous history of nephrotic syndrome * urine protein: creatinine ratio greater than or equal to 1.0 at screening * have received radiotherapy or chemotherapy within the previous 4 weeks * participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks * have had major surgery within 4 weeks or plan to undergo elective surgery during treatment * additional uncontrolled serious medical condition or psychiatric illness * have any condition that is likely to interfere with regular follow-up
acute feedback on left ventricular lead implantation location for cardiac resynchronization therapy

Conditions: Heart Failure; Resynchronization Therapy; Assessment of Acute CRT Response

Summary: exploratory, prospective, interventional, non-randomized single-center research study to compare metrics derived from 2 or 3-d reconstructions of lead movement, bioimpedance and vcg to augmentation of left ventricular contractility (lv dp/dt max) at different pacing configurations in patients undergoing a crt-implant. pacing sites and contractility data will be compared to pre operative cardiac ultrasound and mri metrics.


Eligibility criteria:
inclusion criteria: * subject is indicated for crt or crt-d device according to current applicable esc/aha guidelines * subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting \> 30 seconds during the last 2 weeks prior to inclusion). no documented af-episodes allowed during the last 2 weeks prior to inclusion. * subject receives optimal heart failure oral medical therapy (ace inhibitor and/or arb and beta blockers), and is on a stable medication scheme for at least 2 months prior to enrollment. * subject (or the legal guardian) is willing to sign informed consent form exclusion criteria: * permanent atrial fibrillation/ flutter or tachycardia * rbbb * recent myocardial infarction (mi), within 40 days prior to enrollment. subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days prior to enrollment * post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year * implanted with a left ventricular assist device (lvad), or has reasonable probability (per investigator's discretion) of receiving a lvad in the next year * on chronic renal dialysis, or with severe renal disease (defined as estimated glomerular filtration rate (equation provided by modification of diet in renal disease study): (egfr) \< 30 ml/min/1.73m2) * on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week) * severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period) * complex and uncorrected congenital heart disease * mechanical heart valve * breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control * enrolled in one or more concurrent studies that would confound the results of this study * already implanted with pacemaker (crt, crt-d, icd) and needs replacement

Keywords: heart failure bundle branch block crt response
bleeding prediction in patients following cardiac surgery using whole blood aggregometry and thromboelastometry

Conditions: Heart Disease; Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease

Summary: use of whole blood impedance aggregometry and rotational thromboelastometry can reveal useful data about platelet function and viscoelastic properties of blood clot in patients undergoing cardiac surgery. the purpose of this study is to clarify whether it is possible to predict patients on excessive risk of perioperative bleeding using whole blood impedance aggregometry and rotational thromoelastometry. antiplatelet therapy is the cornerstone in treatment of patients with coronary artery disease. another research goal is to determine the degree of response to antiplatelet therapy before and after surgery and to investigate whether patients by level of response to antiplatelet therapy before surgery have a higher risk of perioperative bleeding.


Eligibility criteria:
inclusion criteria: 1. \> 18 years old 2. elective cardiac surgery patients 3. coronary artery disease 4. aortic valve disease 5. mitral valve disease 6. ascendent aorta aneurysm 7. combine coronary and valve disease 8. cardiac surgery procedures using cardiopulmonary bypass exclusion criteria: 1. missing consent 2. patients with emergent cardiac surgical procedures 3. patients on antiplatelet therapy other than aspirin or clopidogrel 4. patients with inaccurate antiplatelet therapy administration documentation 5. missing data 6. off-pump procedures 7. patients younger than 18 years old 8. patients with severe mental disorders 9. intrinsic coagulopathy

Keywords: cardiac surgery aggregometry thromboelastometry platelet function bleeding antiplatelet therapy
latent iron deficiency at birth influences auditory neural maturation in late preterm and term infants

Conditions: Latent Iron Deficiency at Birth

Summary: this study evaluates auditory neural maturation by auditory brainstem evoked response in late preterm and term infants with in utero iron deficiency compared with neonates with normal in utero iron status.

iron is an essential nutrient for brain development. during early human development, iron is required for multiple neurodevelopmental processes. to meet the iron requirements of a developing brain, active transfer of iron occurs across the placenta during the last trimester of pregnancy and therefore most term infants have iron replete status at birth. however, maternal iron deficiency during pregnancy, a global health problem, can negatively affect the fetal iron status. in addition, prematurity, maternal diabetes mellitus, preeclampsia, maternal smoking, and intrauterine growth restriction during pregnancy have also been associated with decreased iron transfer to the fetus often leading to in utero iron deficiency. cord serum ferritin (sf) level at birth provides a good measurement of fetal tissue iron storage concentration and is therefore often used to evaluate in utero iron status. the absolute and interpeak latencies on auditory brainstem evoked response (abr) are often used as surrogate outcome measures for neural maturation in the neonates. the absolute latencies for each of these abr waves and the interpeak latencies (ipl, i-iii, iii-v, and i-v) are influenced by the degree of myelination, neuronal development, synaptic function, and axonal growth in the auditory nervous system. the absolute latencies and ipl decrease as the auditory neural system matures with age in neonates. although iron is essential for auditory neural maturation during the perinatal period, there is a paucity of data regarding the concomitant effect of in utero iron deficiency on auditory neural maturation in late preterm and term infants. the present prospective study is planned with an objective to determine the association of in utero iron deficiency as evaluated by cord ferritin with auditory neural maturation at birth in ≥ 34 weeks ga infants.

Eligibility criteria:
inclusion criteria: * neonates born between 34 - 42 weeks of gestation at sir ganga ram hospital, new delhi exclusion criteria: infants with * craniofacial anomalies * chromosomal disorders, * hemolytic disease (coomb's positive), * multiple gestation, * history of third trimester maternal infections, * clinical chorioamnionitis, * apgar score \< 5 at 5 minutes, * torch infections (toxoplasmosis, other infections, rubella, cytomegalovirus infection and herpes simplex), * clinical or culture proven sepsis, * admission to the neonatal intensive care unit, * infants on whom cord blood not collected and on whom abr could not be performed
hepcidin after intravenous iron treatment

Conditions: Iron Deficiency (Without Anemia)

Summary: the aim of this study is to investigate the hepcidin hormone response after intravenous iron administration.

intravenous iron is often administered when peroral iron is insufficient to correct iron-deficiency or not tolerated. few studies have shown a relationship between pretherapeutic serum hepcidin levels and response to intravenous iron infusion: the lower the pre-infusion hepcidin level, the fewer red blood cell concentrates were used to correct anaemia. however, there are no studies investigating hepcidin levels after intravenous iron supplementation. furthermore, some studies showed an increase in hepcidin 24 hours after ingesting oral iron supplements, impairing the iron uptake the next day. however, how long hepcidin is increased after intravenous iron administration is unknown. prolonged serum hepcidin concentrations after an iron infusion would reduce intestinal iron absorption and continued, simultaneous oral iron therapy would be pointless. this study investigates whether and how serum hepcidin concentrations change after intravenous iron therapy. women with iron deficiency (serum ferritin below 30ng/ml) without anaemia (hemoglobin \>117g/l) receive 500mg iron (ferinject®) intravenously. serum hepcidin levels are measured before therapy (day 0) 2 days (day 2) and 7 days (day 7) after infusion.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * iron-deficiency (serum ferritin \<30ng/ml) * female gender * premenopausal * age \>18 years * body mass index (bmi) in normal range (18-25 kg/m²) * the participant is linguistically and cognitively able to understand the study procedure exclusion criteria: * anaemia (hemoglobin \<117g/l) * allergy or contraindications for iron infusions * anamnestic current pregnancy * breastfeeding * chronic inflammatory diseases (e.g. colitis) * liver disease (alanine transaminase (alt) \>35 u/l) * increased c-reactive protein (crp) (\>5mg/l) * intake of dietary supplements containing iron (last 7 days)
effect of perinatal emotional management on maternal emotion and delivery outcomes

Conditions: Perinatal Problems; Mental Depression; Complications; Cesarean Section

Summary: pregnancy or childbirth is a kind of persistent and strong source of stress for pregnant women. prenatal and intrapartum negative emotions not only damage the mental health of pregnant women, but also have a negative impact on the mode of delivery, labor, postpartum complications and neonatal outcomes . due to considerations for the effect on the fetus, there is concern of the use of drug treatment for depression during pregnancy. therefore, psychological interventions have an important role. according to the who global survey in asia 2007-08, china had the highest overall rate of caesarean section (46.2%), and also had the highest rate of caesarean section without indication (11.7%). the embarrassing "first in the world" of caesarean section rate was causing widespread concern in china. recently, the chinese government has launched a project named "promoting the rate of natural childbirth and protecting the health of mother and child", trying to reduce the cesarean section rate especially that without medical indication. therefore, examining if emotional management is effective in reducing negative emotions of pregnant women as well as decreasing the rate of cesarean section is an important research question. our study aims to help the pregnant women control their anxiety, depressive feelings and other negative emotions by "emotional self-management group training" and we examine if this can reduce the incidence of depression and improve delivery outcomes.

this study tried to explore the effectiveness of prenatal emotional management on pregnant women' delivery outcomes. all participants filled the questionnaire (phq-9) at the baseline assessment. then they were randomly assigned into the emotional management (em) group and the usual care (uc) group. the baseline evaluation began at 31 weeks of pregnancy and the mother was followed up to 42 days postpartum. each subject received the em package in the em, and the uc was given only routine prenatal care. phq-9 and edinburgh postnatal depression scale（epds）were used for assessment.

Eligibility criteria:
inclusion criteria: 1. never have a baby before, 2. with single fetus, head position and normal pelvic measurements, 3. were receiving regular antenatal care, 4. were able to schedule and fulfill questionnaires independently. exclusion criteria: 1. situation with pregnancy complications, 2. surgical history of diseases, 3. current or previous history of any kind of mental disorders.

Keywords: psychological intervention, prenatal period, cesarean section rate, stage of labor
montelukast for acute bronchiolitis and postbronchiolitis viral induced wheezing

Conditions: Bronchiolitis; Wheezing; Cough

Summary: the aim of the current study is to evaluate the effect of montelukast in treatment of acute bronchiolitis and postbronchiolitis viral induced wheezing of infants 3 to 12 months of age in bandar abbas children' hospital.

all the patients will be evaluated at the baseline, during hospitalization (daily) and at 2 months and 6 months after starting the intervention.

Eligibility criteria:
inclusion criteria: * infant in 3-12 months of age with first episode of wheezing or bronchiolitis * written informed consent by parents exclusion criteria: * previous wheezing episode or confirmed asthma or bronchiolitis * recent bronchodilator use * immune deficient * immunosuppressive drug use * croup or pneumonia diagnosis * loss of follow up

Keywords: bronchiolitis postbronchiolitis wheezing montelukast
traditional rehabilitation versus rehabilitation with the imoove® device for spinal musculoskeletal disorders

Conditions: Lower Back Pain

Summary: the main objective of this study is to evaluate in patients with chronic low back pain (lasting for more than 3 months and not postoperative) the effect of an instrumental rehabilitation using the i-moove ® device compared to a conventional physiotherapy rehabilitation for ambulatory postural stability (mean and standard deviation of excursions from the center of gravity) without visual control, 6 weeks after the start of the rehabilitation protocol. we focus on the relative variation between the values obtained on day 0 versus 6 weeks, via measures performed on a force platform. the results will be stratified into 3 age groups (18-39 years, 40-60 years and over 60 years).

the secondary objectives of this study are to evaluate and compare the two physical therapy techniques at 6 weeks and 6 months after the start of the rehabilitation protocol in terms of: a - improving postural stability and visual control on an unstable surface (with and without visual control) b - improving levels of abdominal strength (ito test) and erector spinae (sørensen test) c - the impact of back pain on daily life using questionnaires (dallas, québec, fabq and tampa questionnaires/scores) d - improvement of pain (visual analog scale),

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 6 months of follow-up * patients with pain in the lumbar spine (low back pain) for at least 3 months, not in connection with an operation exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient will have difficulties with follow-up (the patient is about to move, or isn't motivated) * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * the patient has already participated in a dynamic physical therapy program * the patient has a contraindication for a treatment used in this study * the patient has had surgery in the past year * the patient has a pathology that can interfere with the physical therapy regimen (heart failure, respiratory failure, major orthopedic problems)

Keywords: proprioception
southeast asian brugada syndrome cohort

Conditions: Brugada Syndrome

Summary: brugada syndrome (brs) is the leading cause of sudden death in young asian adults including thailand. this syndrome may be hereditary and involve mutations in certain genes. aim of the study is to identify the relationship between genetic variants and the diagnosis/clinical severity of patients with brs.

this cohort study recruits brs patients with confirmed brugada type 1 ecg and healthy volunteers in thailand. data collection consists of demographic, clinical data, ecg and blood sample for genetic studies. genotyping was done by whole genome sequencing and snp array then compared between cases and controls. each brs patient will be followed up prospectively for symptoms and aicd shock. subsequently, the study will analyze relationship between genetic variants and clinical data against clinical severity of brs patients.

Eligibility criteria:
inclusion criteria: * thai nationality * the patient has at least one of confirmed brugada type 1 ecg in at least one of right precordial leads (v1 or v2) with or without pharmacologic provocative testing. the confirmed ecg is standard 12 lead ecg or brugada lead exclusion criteria: * the patient has other cardiac diseases such as ischemic heart disease, valvular heart disease, congenital heart disease, myocarditis and pericarditis * the patient has type 2 or type 3 brugada ecg without type 1 ecg during pharmacologic provocative testing and/or brugada lead * the patient had one time of brugada type 1 ecg during drug use without reproducibility

Keywords: brugada syndrome genetics epidemiology thai southeast asia
effect of lithium therapy on long covid symptoms

Conditions: Long COVID

Summary: this study will assess low-dose lithium's effects on several different symptoms experienced by long covid patients.

in this double-blind, placebo-controlled study, 50 patients with long covid will be randomly assigned to either low-dose oral lithium or placebo therapy for three weeks. after the double-blind study phase, all patients will be provided with lithium therapy for two additional weeks. study visits will occur at baseline and after the three-week double-blind study phase.

Eligibility criteria:
1. documented or self-reported positive test for covid-19 ≥4 weeks prior to enrollment. 2. no fever for ≥4 weeks prior to enrollment. 3. reports fatigue and/or brain fog (i.e. concentration or memory impairment) for ≥4 weeks prior to enrollment on the pasc-specific symptom questionnaire beginning after infection with covid-19. 4. fatigue severity scale (fss) score ≥28 or brain fog severity scale (bfss) score ≥28 at baseline. 5. beck depression inventory ii score \<24. 6. no change in any psychoactive or steroid medications for ≥30 days. 7. no plan to change any psychoactive, steroid or diuretic medication for ≥5 weeks and not planning on obtaining a covid vaccine within the next 5 weeks. 8. not using any long covid therapies felt to be worsening the patient's symptoms or starting a long covid therapy within the next 5 weeks. 9. no history of fibromyalgia, chronic fatigue syndrome or progressive cognitive disorder prior to covid-19 infection. 10. no active medical, psychiatric or social problems that would interfere with completing the study procedures in the opinion of the investigator. 11. no use of tobacco or marijuana products for \>6 months and no current alcohol abuse (≥4 drinks/day) or illicit drug use. 12. not receiving or applying for disability payments or workman's compensation for long covid. 13. not pregnant or nursing or planning to get pregnant over the next two months.

Keywords: lithium, long covid
a study of escalating doses of itacitinib administered orally in patients with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a study of itacitinib in patients with chronic plaque psoriasis. this study will evaluate safety and efficacy parameters of itacitinib.


Eligibility criteria:
inclusion criteria: * subjects with chronic plaque psoriasis aged 18 to 75 who have had insufficient response to topical agents, and who meet the psoriasis assessment expectations as defined in the study protocol exclusion criteria: * females who are pregnant or breastfeeding * men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively * subjects treated with leflunomide or other biological therapies to treat psoriasis and all jak-stat inhibitors within 12 weeks prior to first dose of study drug