Kornimate/medical-research-clean huggingface dataset:
safety of liposom with citalopram in elderly patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine if liposom forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from major depressive disorder (mdd).

the effects of phospholipid liposomes when associated with antidepressant drugs are very interesting. in addition to an improvement of somatic symptoms of depression, measured with the hamilton rate scale for depression, liposomes are able to reduce the latency of onset of the antidepressant activity of drugs like amitriptyline, clomipramine, and trazodone. these results indicate that phospholipids can be used as an adjuvant to antidepressant therapy, also allowing specific antidepressant drug dose reduction. thus, the hypothesis is that combination therapy would not only lead to greater efficacy, but also to a more rapid onset of therapeutic response. the addition of liposom forte may be clinically important since it may ensure the use of lower citalopram doses, thereby reducing the risk of adverse events, and this may prove to be important, especially in elderly people.

Eligibility criteria:
inclusion criteria: 1. meets dsm-v criteria for major depressive disorder 2. score of ≥ 16 in the ham-d 3. score of ≥ 23 on the mini-mental state exam (mmse-2) 4. aged ≥ 65 and \< 85 years 5. patients able to understand the study procedures and to comply with protocol requirements 6. patients legally able to give written informed consent to the trial (signed and dated by the subject) exclusion criteria: 1. any contraindication for treatment or intolerance to liposom forte or citalopram 2. congenital long qt syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the qt interval 3. history of psychiatric disorder other than major depressive disorder, including history of substance use disorder 4. presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder 5. severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders) 6. diabetes mellitus type i and ii 7. acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation 8. treated with long acting injectable (lai) antipsychotics within 6 months prior to study entry 9. treated with any antipsychotics, antidepressant, food supplements or over-the-counter cns-active medications (e.g, st. john's wort, melatonin, selective serotonin reuptake inhibitors \[ssris\], serotonin and norepinephrine reuptake inhibitors \[snris\], monoamine-oxidase inhibitors \[maois\], or other antidepressants) within 4 weeks prior to the first administration of study medication 10. ongoing or planned psychotherapy or other psychological treatment during the study period
evaluation of central macular thickness in femtosecond laser-assisted cataract surgery

Conditions: Age Related Cataracts; Cystoid Macular Edema

Summary: the investigational device is an approved femtosecond laser (fsl) device with an integrated imaging system to perform certain steps of the cataract procedure. the fsl will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. cataract surgery will be performed in subjects who have signed an informed consent form. macula thickness will be measured with spectralis oct on screening date. postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination, retinal oct imaging and quantitative autofluorescence.


Eligibility criteria:
inclusion criteria: * bilateral age-related cataract necessitating lens extraction and posterior iol implantation * age 40 and older (females of childbearing age will be interviewed if pregnancy is possible) exclusion criteria: * corneal abnormality * preceding ocular surgery or trauma * uncontrolled glaucoma * proliferative diabetic retinopathy * macular degeneration * iris neovascularization * history of uveitis/iritis * microphthalmus * recurrent intraocular inflammation of unknown etiology * blind fellow eye * uncontrolled systemic or ocular disease
viusid administration in subjects with chronic inflammatory syndrome under hemodialysis treatment

Conditions: Chronic Inflammatory Syndrome

Summary: the purpose of the study is to determine whether viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with chronic inflammatory syndrome under hemodialysis treatment. the duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. all patients enrolled in the study will be receiving the standard treatment for chronic inflammatory syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. efficacy assessment will be carried out 12 weeks after the end of viusid or placebo treatment.


Eligibility criteria:
inclusion criteria: * subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months * signed informed consent exclusion criteria: * patients with chronic terminal nephropathy previously treated with peritoneal dialysis * receptors of a renal graft * patients with malignant neoplastic conditions * pregnant women

Keywords: dietary supplement hemodialysis chronic inflammatory syndrome viusid
the effect of animal-assisted intervention

Conditions: Animal Model; Pediatric; Emergencies; Fear; Nursing Caries

Summary: the aim of the study is to examine the effect of animal-assisted practice on fear in children admitted to the emergency room.

children's fears about the hospital are traumatic and confront us as a hindering factor in their growth and development.bringing the child to the emergency room and not knowing what will happen there creates great fear in him. children already have different fears according to different age groups and developmental stages. these; separation from family, pain and suffering, change in body image (losing body parts), etc. the state of fear can lead to a worsening of the child's existing illness and symptoms. in addition to being separated from the family, being separated from peers, not being able to play games, staying away from school if going to school, etc. they have concerns.

Eligibility criteria:
inclusion criteria: * to be followed for at least 2 hours in the pediatric emergency room, * age range is 5-7, * not afraid of the goldfish to be used in the research, * not allergic to fish and fish feed, * does not have physical, auditory, visual and cognitive barriers to feeding (feeding), * no speech or communication disorder that will prevent the parent and child from communicating, * parent and child's willingness to participate in the research exclusion criteria: * patients who are not admitted to the pediatric emergency room, patients who do not fit the age range of 5-7, who stay less than 2 hours, * afraid of goldfish, allergic to fish food, preventing feeding, having physical, auditory, visual and cognitive disabilities, * patients with speech and communication disorders that will prevent parents and children from communicating, * parent and child not willing to participate in the research.
fatigue prevalence, severity, and state of treatment in germany

Conditions: Cancer-related Fatigue

Summary: fatigue is a major concern during and after cancer therapy with severe impact on quality of life. yet, sound comparable data on fatigue prevalence, severity, and impact on daily life across different tumor entities is lacking. furthermore, little is known about the current state of screening, counselling and treatment of fatigue. thus, the fix-study aims to assess such data to identify patient groups with especial need for an improved fatigue management and treatment. a minimum of n=3000 patients about equally distributed about the 16 most common tumor entities shall be recruited between year 1 and 2 after primary cancer diagnosis via the cancer registry baden-württemberg. data on fatigue (eortc qlq-fa12, bfi), quality of life (eortc qlq-c30), depression and anxiety (paq-4), and information about screening and treatment of fatigue will be assessed via self-reported questionnaires. clinical data regarding tumor and treatment characteristics will be derived from the cancer registry. this trial is imbedded in a larger research agenda on fatigue and will provide the basis for the development of an individually-tailored fatigue program.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * diagnosed with a primary tumor of one of the following malignant neoplasms (including in-situ carcinoma): stomach (c16, d00.2), colon (c18, d01.0), rectum (c19-20, d01.1-1.2), liver (c22, d01.5), pancreas (c25, d01.7), lung (c33-34, d02.1-2.2), malignant melanoma (c43, d03), breast (c50, d05, female only), cervix or ovaries (c53, d06), endometrium (c54.1, d07.0), ovaries (c56), prostate (c61), kidney (c64), bladder (c67, d09.0), non-hodgkin lymphoma (c82-88), leukemia (c91-c95) * time since first diagnosis is at least 1 year, maximal 2 years * able to understand and follow the study protocol. exclusion criteria: • any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor, except non-malignant, unspecified, or in-situ neoplasm of skin (c44 or d0.4)
the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale

Conditions: Chronic Cor Pulmonale

Summary: this study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,nt-probnp,pao2 and paco2.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic cor pulmonale and admit to hospital exclusion criteria: * pneumothorax or mediastinal emphysema * active tuberculosis * install a cardiac pacemaker * acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents. * pregnancies * end-stage patients (expected survival time less than 6 months)
hydromorphone for icu-analgesia in patients with non-mechanical ventilation

Conditions: Hydromorphone; Analgesia; ICU

Summary: hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. the study will further explore the continuous pumping-dose of hydromorphone for icu non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for icu non-mechanical ventilation patients.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * non-mechanical ventilation patients with expected icu stay time \>24h * people with moderate to severe pain who need immediate analgesic treatment (nrs ≥ 4 or bps ≥ 5 points, cpot ≥ 3); exclusion criteria: * pregnancy； * can not get pain score from patients * allergy to drugs * ....
development and effects of a structural education program in adult kidney transplant recipients

Conditions: Chronic Kidney Disease

Summary: kidney transplantation is the treatment of choice for patients with end-stage renal disease. the purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. patients are randomly assigned to an educational program or to a standard care control group. the education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, hba1c, glomerular filtration rate, quality of life (qol) and knowledge are measured in both groups after 6, 12 and 24 months. the investigators postulate that the education group will have superior outcomes compared to the control group.


Eligibility criteria:
inclusion criteria: * being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation exclusion criteria: * severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

Keywords: education program kidney transplantation renal transplantation evaluation
sli maneuver and respiratory morbidities

Conditions: Respiratory Distress Syndrome

Summary: purpose: the investigators hypothesis is that, as compared to the only ncpap-applied group, application of sli maneuver followed by respiratory support with ncpap immediately afterwards in preterm infants at high risk for rds would reduce the need for intubation and mechanical ventilation in early period and ultimately will improve respiratory outcomes.

primary outcome measures: surfactant need, intubation and mechanical ventilation needs within the first 72 hours of life in sli (sustained lung inflation) maneuver-applied preterm infants and non-sli-applied preterm infants. secondary outcome measures: * heart rate, fractional inspiratory oxygen, cpap pressure and oxygen saturation within the first 72 hours of life in preterm infants * total non-invasive, invasive respiratory support time * the presence of and the degree of bpd (bronchopulmonary dysplasia) * premature morbidities such as pda (patent ductus arteriosus), ivh (intraventricular hemorrhage), nec (necrotizing enterocolitis), rop (retinopathy of prematurity) * feeding intolerance, reaching birth weight and transition to full oral feeding time study design randomization group 1: group that received sli maneuver immediately after birth followed by ncpap. group 2: group that received ncpap after birth. following the oral and nasal aspirates, sli at 25 cm h2o pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm ncpap at h2o pressure will be applied. patients will be observed for 5-10 seconds in terms of cardiorespiratory functions following sli maneuver. if respiratory failure continues during ncpap (such as apnea, gasping) and/or heart rate is \> 60 / min but \ 60 / min but \<100 / min persists after the second sli maneuver, resuscitation will be applied in line with the guidelines of american academy of pediatrics. the control group of infants will receive ncpap support at 5 cm h2o pressure and be supported in line with the guidelines of american academy of pediatrics.

Eligibility criteria:
inclusion criteria: * preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days will be included. exclusion criteria: 1. presence of major congenital anomaly, 2. patients with hydrops fetalis and pulmonary hypoplasia 3. consent not provided or refused
impact of high fiber snacks on adiposity, glucose regulation and appetite

Conditions: Obesity

Summary: the primary objective of the proposed research is to determine the influence of 8 weeks of twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat 120kcal muffin on components of obesity (waist circumference \[waist measurement\], serum glucose \[blood sugar\], triglycerides \[fats in the blood\] and hdl-cholesterol, and blood pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight and obese individuals. a total of 48 children aged 10-16 years will be randomly assigned to groups and provided with twice daily 120 kcal servings of either dried apples or muffins for 8 weeks of feeding. prior to initiating the feeding trial and again after 8 weeks, blood samples will be collected and analyzed. during each visit to the lab, subjects will be weighed in minimal clothing, tested for body composition using dual energy x-ray absorptiometry (dxa), bioelectrical impedance (bia) and air displacement plethysmography (bod pod) and blood pressure, and measured for waist circumference. one 24-hour recall will be performed prior to initiation of the study; one recall will be performed throughout the feeding period, and one at the end of the 8 weeks. dietary intake of energy, macronutrients, vitamins and minerals will be assessed to determine diet quality. all food records will be analyzed using the nutritionist pro (first databank) software. the potential benefits of the study include determining the effects of consistent snacking and particular snack foods on metabolism and weight management. there are no major risks to subjects in this study. there are minimal risks when performing venipuncture (blood draws) including bruising, perforation of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of needles, and infection. this study will hopefully allow more understanding and insight into the diet of children and the effect of it on body makeup and blood sugar. it is hypothesized that the twice a day apple snack group will have decreased waist circumference, body adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at the end of 8 weeks.


Eligibility criteria:
inclusion criteria: * must be between age 10-16 * must be overweight or obese according to growth charts exclusion criteria: * regular consumers of apples (one per day) * supplement users other than multivitamin

Keywords: apple high fiber body composition children
gender-specific associations between quality of life and leukocyte telomere length

Conditions: Apparently Healthy People Aged 55 and Over

Summary: quality of life (qol) is an important factor for successful aging. telomere length is an indicator of cellular aging and cumulative biological stress and is thus related to health status and survival. however, the relationship between qol and telomere length has not yet been examined. in this study we investigated the relationship between leukocyte telomere length (ltl) and qol. however, the relationship between overall qol and ltl has not previously been investigated. therefore, this study was conducted to examine the relationship between ltl and qol. qol was measured by the korean version of the 36-item short-form health survey (sf-36), which is a multidimensional scale consisting of subjective evaluation.


Eligibility criteria:
inclusion criteria: * married couple * apparently healthy subjects above 55 years exclusion criteria: * subjects who had experienced hormone therapy * subjects who had been diagnosed with dementia, parkinson's disease, stroke, ischemic heart disease, congestive heart failure, arrhythmia, depression, cancer, thyroid disorders, or chronic renal disease
sakurabead used as resorbable embolic for genicular artery embolization

Conditions: Osteo Arthritis Knee; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis

Summary: an open label, prospective, two-arm, multicenter, randomized controlled trial comparing sakurabead genicular artery embolization (gae) with a control (corticosteroid injection).

to compare safety and efficacy of sakurabead with corticosteroid injection for the treatment of pain secondary to knee osteoarthritis. treatment will be performed on a total of approximately 89 patients who will be followed up for a period of 2 years.

Eligibility criteria:
inclusion criteria: 1. subject is able and willing to provide written informed consent, and 2. clinical diagnosis of knee oa, and 3. moderate to severe knee pain (womac pain ≥ 10), and 4. pain refractory to at least 3 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or intra-articular injections), and 5. kellgren-lawrence grade 1, 2 or 3 on radiograph of the knee, and 6. age ≥ 40 years and \< 80 years, and 7. able to comply with all treatments and follow-up visits. exclusion criteria: 1. severe knee oa (kellgren-lawrence grade 4), or 2. current infection of target joint, or 3. life expectancy less than 36 months, or 4. known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or 5. rheumatoid or known serologic diagnosis of autoimmune arthritis, or 6. prior knee replacement surgery in the target knee, or 7. pain score of \>3 nrs on the non-target knee, or 8. an acute internal derangement of the target knee, or 9. history of uncorrectable coagulopathy, or 10. prior iodinated contrast reaction resulting in anaphylaxis, or 11. active pregnancy as demonstrated by urine or serum β-hcg, or lactating female, or planning pregnancy in the following 12 months, or 12. has undergone an invasive treatment (including but not limited to: corticosteroid injection, hyaluronic acid injections, nerve ablation) in the target knee within the past 3 months, or 13. contraindication to mri, or 14. at the discretion of the principal investigator

Keywords: genicular artery embolization gae knee embolization knee oa knee osteoarthritis
evaluation of a novel mobile phone application ( optibp) for blood pressure monitoring

Conditions: Technology

Summary: evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )

the purpose of the study is to compare the blood pressure values measured by a novel smartphone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff). all patients admitted to the emergency department at erasme hospital brussels, belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry). the optibp application is a mobile application installed on a smartphone which is a non-invasive data-logger intended to acquire physiological data from patients. by applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure (+ heart rate), as well as patient's heart rate. after having compared that the blood pressure in both arms are similar ( maximum of 10 mmhg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position). the patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff). then, the values obtained by the two methods will be compared to confirm the reliability of the data obtained with the novel mobile application. the goal is therefore to compare blood pressure values as obtained by the analysis of the data recorded by the optibp mobile application, against simultaneous measurements provided by the oscillometric brachial cuff

Eligibility criteria:
inclusion criteria: * patients (men or women) older than 18 years old admitted to the emergency department and in relatively good conditions to be able to participate in the study. * informed consent as documented by signature exclusion criteria: * minor patients * patients unable to participate due to the illness. * patients that cannot sign informed consent * patients extremely painful at the arrival (not possible for him to stay in a supine position). * blood pressure difference between the two arms \>10mmhg * unstable patients requiring an urgent management