Kornimate/medical-research-clean huggingface dataset:
high-dose selenium supplementation in patients with left ventricular assist

Conditions: Ventricular Dysfunction, Left

Summary: this planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. the sos-lvad trial can be assigned to the clinical phase iii. the aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (cpb) and lvad implant. the investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the icu and a decrease of postoperative morbidity and mortality. before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.


Eligibility criteria:
inclusion criteria: * patients with chronic left ventricular heart failure, who undergo lvad implant surgery (including other heart surgery) * full aged, contractually capable, male and female patients * patients that are capable and willing to understand and obey the instructions of the study staff. * signed informed consent exclusion criteria: * selenium intoxication * patients with contraindications to the planned intervention, due to diseases * severe exacerbation of comorbidities such as renal failure requiring dialysis or liver dysfunction (defined as bilirubin \>2mg/dl) * known hypersensitivity to the trial medication (selenase® 300 rp, selenase® t), to any of the constituents of the solution or to the placebo * patients that are not contractually capable; patients accommodated to a facility by court order or public authority * pregnancy or lactation period * women at reproductive age, without suitable contraception * patients in a relationship of dependency or in employment with the head of study's * underaged * no signed informed consent * simultaneous participation in another clinical trial

Keywords: heart failure cardiac surgery ventricular assist device selenium
application of atp infusions in palliative home care

Conditions: Cancer; Palliative Care; Survival; Quality of Life

Summary: palliative care in cancer aims at alleviating the suffering of patients. a previous study in patients with advanced non-small-cell lung cancer showed that adenosine 5'-triphosphate (atp) infusions had a favourable effect on fatigue, appetite, body weight, muscle strength, functional status, quality of life, and survival. based on these promising results, the present study was designed 1. to evaluate whether the beneficial effects of atp administration observed in patients with advanced lung cancer would also be present in pre-terminal cancer patients of different tumour types, and 2. to test the feasibility of application of atp infusions in a home care setting.


Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed cancer * medical treatment options restricted to supportive care * a life expectancy \< 6 months * world health organization (who) performance status 1 or 2 * suffering from at least one of the following complaints: fatigue, weight loss \> 5% over the last 6 months, or anorexia exclusion criteria: * symptomatic angina pectoris * symptomatic heart failure * any form of atrioventricular (av) block (assessed by electrocardiogram) * life expectancy \< 4 weeks * concurrent palliative chemotherapy * cognitive dysfunction, and other diseases hampering adequate follow up
demonstration of bioequivalence of empagliflozin and metformin given in one tablet compared to the intake of single tablets

Conditions: Healthy

Summary: the primary objective of this trial is to establish bioequivalence of two fdc tablets and the single tablets when administered together after a high fat high caloric meal.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects exclusion criteria: 1. any relevant deviation from healthy conditions
evaluation of an investigational lubricant eye drop on lipid layer thickness

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the effects of an investigational lubricant eye drop on tear film lipid layer thickness of dry eye patients.


Eligibility criteria:
inclusion criteria: * patients (minimum age 18) meeting specific criteria for dry eye. exclusion criteria: * use of topical ocular drops within 12 hours of the study visit; or use of topical ocular ointment within 36 hours of the study visit. in addition, cannot use any topical ocular drugs during study period. * history or evidence of ocular or systemic medical conditions and/or medications that would confound the evaluation.

Keywords: lipid layer thickness
an ahei dietary intervention to reduce pain in women with endometriosis

Conditions: Endometriosis

Summary: the investigators are conducting this study to examine if a healthy diet based on the alternative healthy eating index (ahei) influences pain symptoms, quality of life, and inflammatory markers measured in blood samples in women with endometriosis who are currently experiencing pain symptoms.


Eligibility criteria:
inclusion criteria: * female * aged 18-45 * laparoscopically-confirmed endometriosis * premenopausal (at least one period in the past 6 months) * vas pain score of at least 7 out of 10 in the previous 3 months * score below 75 on the ahei-2010 exclusion criteria: * postmenopausal * pregnant * have had a hysterectomy or oophorectomy * have chronic illnesses that are known to affect gastrointestinal absorption of nutrients (celiac disease, crohn's disease, ulcerative colitis, or cystic fibrosis) * a history of kidney stones, cancer (except basal cell carcinoma), or diabetes

Keywords: diet
pdms outcome after intensive care, organdysfunction and monitoring

Conditions: Pleural Effusion; Blood Pressure

Summary: the objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure.

the close monitoring of patients after cardiac surgery is regarded as standard. however, little is currently known about the influence on patient-related outcome parameters. recently it has already been shown that intraoperative variability of blood pressure during heart surgery has a postoperative effect on 30-day mortality. the aim of this retrospective study is to investigate the effects of different hemodynamic measurements and management after cardiac surgery on patient-specific outcome parameters.

Eligibility criteria:
inclusion criteria: 1. in-patients of the charité universitätsmedizin berlin 2. at least 18 years old 3. female or male sex 4. cardiosurgical intervention (ops 5.35 and 5.36) between 01/06 and 12/13. 5. post-operative monitoring of anesthesiological intensive care unit exclusion criteria: 1. previous cardiosurgical interventions during the same hospital stay. 2. incomplete documentation
malignant pleural effusion: pleur-x vs. chemical pleurodesis in vats

Conditions: Malignant Pleural Effusion

Summary: this is a prospective randomized study whose aim is to compare the efficacy of the permanent thoracic catheter (pleur-x) versus chemical pleurodesis in videothoracoscopy (vats) in the treatment of malignant pleural effusion at the first diagnosis.patients with malignant pleural effusion for whom there is indication of surgery and who agree to participate in the study will be randomized 1: 1 in the pleur-x arm (arm 1) or in the chemical pleurodesis arm (arm 2). the arm 1 provides for the installation of a permanent drainage under local anesthesia while the arm 2 provides a pleurodesis with talc in vats under general anesthesia. both procedures are standard of care.

before the study procedure the patients will be requested to perform some examination as physical and radiological examination. patients will also complete questionnaires for quality of life assessment (eortc qlq 30) and symptoms (vas for pain). patients will then be randomized into one of the two arms. for patients included in arm 1, a permanent drainage (pleur-x) is provided under local anesthesia performed on an outpatient basis while for patients included in arm 2 a pleurodesis with talc in vats is planned under general anesthesia. arm 2 patients will be hospitalized for 5 days. patients will then be followed up to 3 months after surgery. during this period a medical examination will be required at 1 week, 4 weeks and 3 months after the intervention during which the patient will be asked to complete questionnaires for the evaluation of quality of life (eortc qlq 30) and symptoms (vas for pain ). a chest radiograph will be performed after four weeks to evaluate the primary parameter. adverse events will be collected throughout the study period.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, \<80 years * first diagnosis of malignant pleural effusion * indication to treat the malignant pleural effusion with surgery * informed informed consent exclusion criteria: * previous surgeries on the same hemitorace * pregnant women * trapped lung syndrome * patients with estimated life expectancy \< 4-8 weeks
identification and differentiation of thyroid nodules by acoustic imaging and viscoelastic parameters

Conditions: Thyroid Gland Carcinoma

Summary: this study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters.

primary objectives: i. identification of thyroid nodules by vibro-acoustography - determine detection rate. ii. evaluate the specificity of va in differentiating malignant and benign of thyroid nodules - compare the result to that of ultrasound (us). iii. assess diagnostic value of shear wave ultrasound vibrometry (sduv) and comb push shear elastography (cuse) in differentiation of thyroid nodules - correlate sduv and cuse results to pathology. iv. test and compare the results shear wave imaging with new fda approved ultrasound device called supersonic imagine aixplorer. v. assess diagnostic value of shear wave ultrasound vibrometry (sduv) and comb push shear elastography (cuse) in differentiation of palpable and sonographically detectable cervical lymph nodes or non-thyroidal neck masses. vi. assess the diagnostic values of ultrasound quantitative microvessel imaging for differentiation of thyroid nodules and cervical lymph nodes. vii. assess the response to alcohol ablation on patients with recurrent thyroid cancer on thyroid bed or new lymph nodes on neck. outline: this is an observational study. patients undergo ultrasound imaging on study.

Eligibility criteria:
inclusion criteria: * \* male and female patient volunteers ages 8 and up who are suspicious for thyroid cancer * patients who have palpable and sonographically detectable lymph nodes or nonthyroidal neck masses and are referred to radiology department or endocrinology for fine-needle aspiration biopsy (fnab) * patients 18 and up who were previously diagnosed with thyroid cancer and treated with thyroidectomy and recently diagnosed as having recurrence nodes on thyroid bed or on their neck exclusion criteria: * because thyroid cancer is rare under the age of 8 years, children younger than this age are excluded from the study * having fnab or surgical biopsy on thyroid in less than two weeks for thyroid nodule detection group * having fnab or surgical biopsy on cervical lymph nodes or non- thyroidal masses for this group of patients
coronary flow rate measurement in t-grafts

Conditions: Coronary Heart Disease

Summary: is the surgical treatment of patients with coronary heart disease using the t-graft technique an adequate solution that provides a sufficient myocardial flow reserve? a magnetic resonance examination (mri) is required.


Eligibility criteria:
inclusion criteria: * coronary heart disease * age \> 18 ys * ejection fraction \> 45% exclusion criteria: * myocardial infarction * re-intervention

Keywords: patients scheduled for bypass grafting
budesonide / formoterol in treatment of exacerbations of copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether the budesonide+formoterol combination is effective in the treatment of exacerbations of copd with a main emphasis on investigating the effects on inflammation and a secondary emphasis on clinical efficacy


Eligibility criteria:
inclusion criteria: * smoking-induced copd according to ats criteria * fev1 \ 0.7 liter at exacerbation * fev1/ivc ratio \<88% of predicted for men and \<89% for women exclusion criteria: * history of asthma * known hypersensitivity to the study drugs * serious concomitant diseases * pregnancy or lactating * abnormal chest x-ray or blood gasses
hummus for health: dietary quality and health outcomes in toddlers

Conditions: Obesity

Summary: the goal of this study is to examine the effect of increasing children's intake of fiber and unsaturated fat, through daily servings of hummus and vegetables, on their microbiome profile.

population: the investigators will recruit 104 children ages 12-24 months from daycare centers in the houston and surrounding areas. study design: the study will be conducted at daycare centers and will consist of three phases - a 'lead in period' (two weeks) where baseline measurements will be taken followed by an 'introductory period' (three weeks) where the new food will be introduced on three days during snack time for three weeks. the introductory phase will be followed by the 'intervention period' (three weeks) where children will receive daily servings of hummus and vegetables. lead in period (two weeks): two 24-hour dietary recalls will be conducted on each child (parent-report); one 24-hour dietary recall (over a weekend) will be conducted on each parent (self-report). three dirty diapers will be collected within the time span of a week for microbiome analysis. introductory period (three weeks): since children typically take several introductions of a new food to accept it, and the investigators wish to ensure a high acceptance of hummus, the investigators will spend three weeks introducing the food. the food will be provided on three days during snack time for three weeks. prior to introducing the food, children will receive a 'lesson' involving information about vegetables using a combination of songs, rhymes and craft activities. following the lesson, hummus and vegetables will be provided in the hummus group; vegetables only in the control group. hummus will be provided in a pre-packaged 2 ounce serving cup; vegetables will conform to age-appropriate servings designated by the american academy of pediatrics (aap) and will consist of soft vegetables (e.g., winter squash) and lightly steamed, but chilled, hard vegetables (e.g., carrots, broccoli). intervention period (three weeks): similar to the introductory period, a serving of either hummus and vegetables or vegetables only will be provided to the children during snack time. the food will be provided daily for three weeks. in the final week of the intervention period, two 24-hour dietary recalls (one weekday and one weekend) will be conducted on the child (parent-report). in addition, one weekend 24-hour dietary recall will be conducted on the parent (self-report). three dirty diapers will be collected on the child during the final week for microbiome analysis.

Eligibility criteria:
inclusion criteria: * children between the ages of 12 and 24 month old. * children attending daycare at least 3 days a week. * children with a parental-report of being hummus-naive. exclusion criteria: * any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption. * children with parent-reported antibiotic use in the previous 6 months.

Keywords: gut microbiota obesity toddlers fiber unsaturated fats
fetal viability estimation in egypt

Conditions: Premature Birth; Miscarriage

Summary: due to the discrepancy between the egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.


Eligibility criteria:
inclusion criteria: * pregnant females age from 18- 40 years old * preterm delivery before completing 38 weeks of gestation * singleton or multiple gestation * fetuses with congenital anomalies exclusion criteria: * refusal to get enrolled in the study

Keywords: miscarriage fetal viability prematurity
persistent dyspnea in post covid_19 and pulmonary function

Conditions: covid_19 Patients

Summary: covid-19 has a high spread rate, millions of people have been infected around the world. patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (icu)

covid-19 has a high spread rate, millions of people have been infected around the world. patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (icu) many patients with mild or severe covid-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection. post-covid-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering covid-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis. dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post covid-19 syndrome. also, persistent dyspnea in post covid-19 infection is frequent, it is so far, of unknown mechanism. cardiopulmonary exercise test (cpet) is currently the gold standard technique in the differential diagnosis of dyspnea. cardiopulmonary exercise testing (cpet) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.

Eligibility criteria:
inclusion criteria: * confirmed or clinically and radiologically highly suspected covid19-infection * symptom duration at least 12 weeks following first occurrence of symptoms * patients with dyspnea score 2, 3 and 4 on mmrc * no other disease that better could explain the symptoms (dyspnea) than covid-19 exclusion criteria: * age \<18 * pregnant women * terminally ill patients * active covid-19 infection * previous known severe pulmonary or heart disease * inability to perform pulmonary function or cardiopulmonary exercise tests.

Keywords: post covid_19,dyspnea, cardiopulmonary exercise
oxytocin treatment in neonates and infants with prader-willi syndrome

Conditions: Prader-Willi Syndrome

Summary: prospective, randomized, placebo-controlled, double-blind part of the phase iii trial to assess the safety and efficacy of 4 weeks oxytocin (ot) administration on oral and social skills in neonates/infants with prader-willi syndrome (pws) aged less than 3 months at inclusion. phase iii clinical trial.


Eligibility criteria:
inclusion criteria: 1. male or female neonate or infant, with pws genetically confirmed. 2. age \<92 days (plus a tolerance of up to 8 days maximum) (for preterm infants, born before 37 weeks amenorrhea, corrected age will be applied). 3. signed informed consent obtained from the parents/holders of parental authority. 4. parents willing and able to comply with all study procedures. exclusion criteria: * 1. neonate or infant currently admitted to the emergency care unit for ongoing life-threatening comorbidities like severe respiratory, cardiovascular or neurological abnormalities. 2. neonate or infant with prolongation of the qt interval. 3. neonate or infant without medical insurance. 4. neonate or infant with hypersensitivity to oxytocin or excipients of the product. 5. neonate or infant with concomitant treatment prolonging qt interval 6. neonate or infant with family history of genetic pathology causing qt interval prolongation. 7. neonate or infant with hypokalemia (clinically relevant at the discretion of the doctor). 8. neonate or infant participating simultaneously in another interventional study. 9. neonates or infants whose parents' situations may jeopardize the interpretation of the results. 10. neonates or infants whose parents' refuse video recording, required to respond to the primary objective of the study.
bed rest after preterm premature rupture of the membranes

Conditions: Preterm Premature Rupture of Membrane

Summary: antepartum bed rest is widely prescribed after preterm premature rupture of the membranes (pprom), although its effectiveness to prevent preterm birth has not been demonstrated. this pilot randomized controled trial (rct) aims to access the impact of bed rest in maternal and neonatal outcomes in pregnancies complicated by premature rupture of the membranes.

aims - to access the impact of bed rest in latency time to delivery, chorioamnionitis incidence and other maternal and neonatal outcomes in pregnancies complicated by pprom, thus enabling proper sample size calculation for future powered rct. study population and sample size - eligible patients included those with single pregnancies with pprom at 24+0-33+6 weeks of gestation who were admitted to and delivering at our tertiary center. pprom was diagnosed on the basis of patient's history and sterile speculum examination with visualization of amniotic fluid pooling in the vagina and/or leaking from the cervical canal. exclusion criteria included indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress), fetal malformations, multiple gestation, and maternal immunosuppressive disease. considering future sample size calculation based upon assumed differences between groups regarding latency and infection, we aimed a sample of 30 participants. randomization - a pilot unblinded randomized controlled trial (rct) in a 1:1 allocation ratio between two groups (complete bed rest versus activity restriction after pprom). simple random allocation sequence was generated by the investigators and implemented by sequentially numbered sealed envelopes. participants were enrolled by physicians after hospital admission and written informed consent was obtained before randomization. the trial was conducted in a single tertiary center of the portuguese national health system after approval by its ethical committee. statistical analysis - an intention-to-treat analysis was performed with a significance level of 5%.

Eligibility criteria:
inclusion criteria: * single pregnancies and * pprom at 24+0-33+6 weeks of gestation and * admitted to our tertiary center. exclusion criteria: * indication for immediate delivery on admission (chorioamnionitis, placenta abruption, cord prolapse, signs of fetal hypoxia/distress) * fetal malformations * multiple gestation * maternal immunosuppressive disease