Kornimate/medical-research-clean huggingface dataset:
effects of levosimendan in patients eligible for aortic valve replacement with left ventricular hypertrophy

Conditions: Diastolic Dysfunction; Left Ventricular Hypertrophy

Summary: this is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. patients receive infusion of either levosimendan or placebo 4 hours prior to surgery and until the end of surgery.

levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic dysfunction. outcome measures will be obtained at some of the following: * approximately 4 hours prior to surgery. baseline. start of levosimendan/placebo infusion * immediately before surgery * after induction of anaesthesia and before "knife time" = start of surgery. * at the end of surgery: levosimendan infusion will stop. * approximately 4 hours after surgery immediately before extubation. * approximately 21 hours after surgery * approximately 96 hours after surgery (day 4) * 6 months after surgery outcome measures are comprised of invasive measurements, blood samples, transthoracic echocardiography and transoesophageal echocardiography focusing on measures of systolic and diastolic function of the heart. interim analysis will be conducted after 30 included patients.

Eligibility criteria:
inclusion criteria: * eligible for aortic valve replacement * ef \> 45% * left ventricular posterior wall \> 12mm * sinus rhythm exclusion criteria: * concomitant bypass operation * severe mitral insufficiency * active endocarditis * insufficient ultrasound opportunity * systolic blood pressure \< 100 mmhg * moderate-severe renal failure * allergy to levosimendan * lack of patient consent pregnancy or status of lactating * fertile women who do not use relevant anticonception

Keywords: levosimendan heart failure inotropics diastolic dysfunction left ventricular hypertrophy aortic valve stenosis
calcium phosphate versus pmma cement in thoracolumbar fractures

Conditions: SPINAL Fracture

Summary: patients at the age of 50 or older presenting with thoracolumbar fractures including segments th 6-l5 and a3/a4 fractures according to the ao spine fracture classification after the acute trauma and planned surgery within 3 weeks following trauma will be asked to participate in a randomized trial in which they will receive either calciumphosphate (cap) or polymethylmethacrylate (pmma) as part of a standardized treatment approach. regardless of the group patients are randomized to, all participating patients undergo the same surgical procedure except for the preparation and administration of bone cement. the study participation period for each patient is 1 year from the date of the surgery and includes 4 defined time points that include follow-up clinical visits for imaging and progress checks at 6 weeks, 3 months, 6 months and 12 months after surgery. at each follow-up visit, a combination of questionnaires and radiological imaging will be performed to assess general health status, disability level and pain control, as well as objective results of the surgery. the main outcome measure will be the loss of correction rate that will be measured through the bi-segmental cobb angle presented in the ct-scan.


Eligibility criteria:
inclusion criteria: * written consent of the participant after being informed * acute trauma (surgery within three weeks following trauma) * thoracolumbar fractures including segments th 6-l5 * a3/a4 fractures according to the ao spine fracture classification * patient age ≥ 50 years * minimum follow up 1 year exclusion criteria: * presence of neurological deficits at the time of surgery * pathological fractures (bone metastases) * traumatic brain injury * ankylosing spondylitis as a comorbidity * pregnancy

Keywords: spinal fractures fractures polymethyl methacrylate pmma bone cements calciumphosphate thoracolumbar fractures dorsal instrumentation burst fractures balloon kyphoplasty
impact of endothelial and leukocyte senescence in circulatory shock states

Conditions: Shock; Cardiovascular Diseases; Infection

Summary: circulatory shocks (cs) are life-threatening, acute organ dysfunction. advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease. the investigators hypothesize that cs with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections. the aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a cs. it will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a cs, likely to guide new management strategies to prevent their occurrence.


Eligibility criteria:
inclusion criteria: * circulatory shock * patient with health care insurance exclusion criteria: * patients' refusal to participate in clinical research * pregnant woman * breastfeeding woman * a patient with a protective order

Keywords: shock cardiovascular diseases infection
an acute human intervention with flavonoid to investigate absorption, metabolism and excretion

Conditions: Pharmacokinetics of Flavonoids in Humans

Summary: the era of general dietary recommendations for the whole population may be coming to an end, as it is becoming apparent that we are all unique and do not respond in the same way to the same foods. within a decade it is believed that doctors will be able to take profiles of their patients, identify specific diseases for which they are at risk and create personalised nutrition plans accordingly. at the university of east anglia, uk the investigators are interested in particular food compounds known as flavonoids which can be found in foods such as chocolate, orange juice and blackberries (cob). the study will determine if factors such as age, gender, genetics and the bacteria present in our guts contribute to variability between individuals in their absorption, metabolism and excretion of flavonoids.

the study will recruit men and women who are aged either 18-30 or 65-77 years and are generally healthy.on arriving at the study day we will collect a blood sample. breakfast will then be supplied in the form of a food or drink that will contain freezedried powder from orange juice, chocolate and blackberry. after breakfast further blood samples will be taken at several time points throughout the day. urine and faeces samples will also be collected. these biological samples will be tested for flavonoid absorption, metabolism and excretion as well as influence of genetic make-up of individuals and the gut microflora harboured in faecal samples.

Eligibility criteria:
inclusion criteria: * male or female * caucasian of european origin * age either between 18-30 years or between 65-77 years exclusion criteria: * bmi \ 30 kg/m2 * smokers or nicotine users * high (above 140/90 mmhg ) or low (less than 90/60 mmhg) blood pressure * having any existing medical conditions or significant past medical history likely to affect study measurements e.g., type 2 diabetes, cardiovascular, renal, liver or gastrointestinal diseases * unsatisfactory biochemical, haematological or urinary assessment, indicating abnormal; renal or liver function, full blood profile, impaired glucose handling, deranged lipids or measurements considered to be counter indicative of the study by the clinical advisor * taking any prescribed medication that could interact with the enzymes involved in the metabolism of flavonoids * taking flavonoid containing supplements or other dietary supplements for one month prior to the study (and duration of the study intervention) * known allergies to the intervention foods * consume more alcoholic beverages on average than 21 units/wk for men, or 14 units/wk for women (the uk department of health recommendations) * pregnant, breast feeding, or planning a pregnancy (or having fertility treatment) * unable to provide informed consent to participate in the study

Keywords: absorption metabolism excretion flavonoids polyphenols genes gut-microflora
a pharmacokinetics study to investigate the effect of vemurafenib on digoxin in patients with brafv600 mutation-positive metastatic melanoma

Conditions: Malignant Melanoma, Neoplasms

Summary: this open-label, multi-center, three-period, one sequence study will investigate the effect of vemurafenib on the pharmacokinetics of digoxin in patients with unresectable brafv600-mutation positive metastatic melanoma or other malignant tumor type that harbors a v600-activating mutation of braf without acceptable standard treatment options. patients will receive multiple doses of vemurafenib in periods b and c and a single dose of digoxin in periods a and c. eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (nct01739764). the anticipated time on study treatment is approximately 36 days.


Eligibility criteria:
inclusion criteria: * male or female patients \>= 18 years old * patients with either unresectable stage iiic or stage iv metastatic melanoma positive for the brafv600 mutation or other malignant tumor type that harbors a v600-activating mutation of braf, as determined by results of cobas® 4800 braf v600 mutation test or a dna sequencing method, and who have no acceptable standard treatment options * eastern cooperative oncology group (ecog) performance status 0 to 2 * life expectancy \>= 12 weeks * full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment * adequate hematologic and end organ function * female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective methods of contraception * negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential exclusion criteria: * prior treatment with vemurafenib or other braf inhibitor within 42 days of first dose of study drug * prior anti-cancer therapy within 28 days before the first dose of study drug * history of clinically significant cardiac or pulmonary dysfunction * history of symptomatic congestive heart failure of any new york heart association class or serious cardiac arrhythmia requiring treatment * history of myocardial infarction within 6 months prior to first dose of study drug * current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living * history of congenital long qt syndrome or qtc \> 450 ms * current digoxin therapy or anticipated requirement to take digoxin therapy during the study * active central nervous system lesions * uncontrolled or poorly controlled diabetes * current severe, uncontrolled systemic disease
role of enhancing serotonin receptors activity for sleep apnea treatment in patients with sci

Conditions: Spinal Cord Injury; Sleep Disordered Breathing

Summary: the purpose of this study is to look at the effect of exciting using drugs to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (sci) during sleep. during this part of the study participants will be asked to take buspirone (buspar) (15-50mg per day), trazodone (100mg per day) and a placebo in a random fashion, each for a 2 week period (drug period) of time followed by two weeks without drugs (washout period). the drugs will not be taken all at the same time, but each will be taken separately for two weeks followed by a night study to look at the effect the medication/placebo pill has on the way the body responds during sleep.

randomized placebo controlled cross-over study. each subject will be studied on three separate occasions: (1) buspirone vs. trazodone vs. placebo for 2 weeks; the patients will be blinded to whether they are taking trazodone or placebo; buspirone cannot be blinded because it is dosed twice a day and is up titrated during the two weeks of administration. the initial dose of buspirone is 15 mg daily (7.5 mg bid.). to achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached. after the two week treatment a sleep study will be repeated. trazodone will be given at 100 mg dose before bed-time. (2) cross over medication for two weeks will be followed by a second sleep study followed by two weeks washout. (3) cross over medication for two weeks will be followed by another sleep study. to assess the clinical effect of the drug on breathing during sleep a qualitative polysomnography will be performed for 2 hours the same night after taking the drug/placebo. this will allow the determination of ventilatory changes and the determination of the number of respiratory events (apnea/hypopnea index).

Eligibility criteria:
inclusion criteria: * adults with sci (\>6months after spinal cord injury) at the t6 level/above exclusion criteria: * pregnant and lactating females * heart failure, vascular disease, or stroke * advanced chronic obstructive pulmonary disease (copd), liver disease, and chronic kidney disease * bmi \>38 kg/m2 * mechanical ventilation dependence * the following medications are not allowed (potential interaction with buspirone or inhibition of the cyp3a4 system): * cimetidine * ketoconazole * ritonavir * itraconazole * erythromycin * diltiazem * verapamil * monoamine oxidase (mao) inhibitors \[such as marplan, nardil, parmate, emsam\] * other prohibited concomitant medications include haloperidol, trazodone, or triazolam
implementation of physical exercise at the workplace (irma09) - laboratory technicians

Conditions: Musculoskeletal Disorders; Stress

Summary: musculoskeletal disorders and stress of employees remain a major problem in many occupations. the aim of this study is to investigate the effect of an individually tailored bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical exercises (reference group) on musculoskeletal pain, work disability, and stress in lab technicians with a history of work-related musculoskeletal pain.


Eligibility criteria:
inclusion criteria: * laboratory technician * pain intensity \>= 3 (scale of 0-10) * pain duration \>= 3 months * pain frequency \>= 3 days per week exclusion criteria: * life threatening disease * pregnancy
can postpartum depression be prevented with care

Conditions: Sleep Quality, Depression, Postnatal Care, Single-Blind Method, Fatigue, Social Support

Summary: this study was designed to eliminate postpartum insomnia and fatigue and reduce the risk of postpartum depression through the maintenance of structural, personal, and social integrity with holistic care under the guidance of levine's conservation model for primiparous puerperal women who experience fatigue and are at risk of developing depression. : a single-blind pretest-posttest randomized controlled study. women were called to the hospital on the 7th postpartum day and randomly assigned by a computer program to either the intervention group (n=56) or the control group (n=56). participants did not know which group they were in.

a nursing care program was prepared for the intervention group under the guidance of levine's conservation model. this program was applied with 7 home visits between the 8th and 80th postpartum days. face-to-face training and training booklets were provided in home visits. as of the fourth home visit, pilates exercises were performed. the women in the control group received routine care. pretest and posttest data were collected with a personal data sheet, visual analogue scale for fatigue, postpartum physical symptom severity scale, postpartum sleep quality scale, edinburgh postpartum depression scale, and postpartum support scale. sleep quality improved for the primiparous puerperal women of the intervention group. they had reduced postpartum fatigue and increased energy; maintained their structural, personal, and social integrity; and had decreased risk of developing postpartum depression with the holistic care provided (all p\<0.001). a negative correlation was detected between the support subscale posttest total score from the postpartum support scale and the posttest scores of the edinburgh postpartum depression scale for the women of the intervention group (r=-0.303; p\<0.05)

Eligibility criteria:
inclusion criteria: * primiparous; * reading and understanding turkish; * normal term delivery; * no risky situations during pregnancy or delivery; * high score (≥65 points) from the visual analogue scale to evaluate fatigue severity (vas-f), * score of ≥12 points from the edinburgh postpartum depression scale (epds); * episiotomy; * hemoglobin value of at least 10.0 mg/dl; * no current or past history of psychiatric illness. exclusion criteria: * inability to communicate * unwillingness to participate in the research.
ultrasound to detect evidence for retinal detachment in retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. this research study will use ultrasound to examine the eye for retinal changes of prematurity.

retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of \< 28 weeks and a birth weight \<1500 g. these evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity. b-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation. we will use a simple water bath enclosure for a standard 20 mhz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. we will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (rop) between the two techniques existed.

Eligibility criteria:
inclusion criteria: premature birth exclusion criteria: * none

Keywords: retinopathy of prematurity ultrasound eye
turkish version of pain modulation index

Conditions: Chronic Pain

Summary: in order to assess the validity and reliability of the turkish version of pain modulation index, 125 volunteers with chronic pain were enrolled in the study. test and re-test method was used to assess reliability and correlation analyses with pain detect, visual analog scale pain and central sensitization inventory scores were used to assess validity of the questionnaire. turkish version of the pain modulation index was found to be a valid and reliable tool for evaluating chronic pain.

pain modulation index is a questionnaire that was developed in english for the assessment of chronic pain for qualities consistent with central sensitization. the english version of the questionnaire was translated into turkish by two physicians than back translated into english by two separate bilingual translators. initially 10 volunteers were asked to answer this first version of the questionnaire and report any difficulties in understanding the items. their feedback was used to give the questionnaire its final shape. for the validation stage, patients that were diagnosed as having chronic non-cancer pain with more than 3 months duration were enrolled into the study. they answered the questions twice, 15 days apart. in addition to the turkish version of the pain modulation index, on the first visit, they were also asked to answer pain detect and central sensitization inventory. their answers were analysed to assess the validity and reliability of the turkish version of pain modulation index.

Eligibility criteria:
inclusion criteria: * presence of chronic non-cancer pain of more than 3 months duration exclusion criteria: * illiteracy * refusal to take part in the study
new formulations of propafenone to treat atrial fibrillation

Conditions: Atrial Fibrillation

Summary: propafenone is a currently used medicine to treat atrial fibrillation and is a mixture of two compounds, (r)-propafenone and (s)-propafenone. in this study, the investigators will randomize participants to (r)-propafenone, (s)-propafenone, or placebo.

atrial fibrillation is a common cardiac arrhythmia that needs development of more effective medications. propafenone is a medicine currently used to treat atrial fibrillation and is a mixture of two compounds, (r)-propafenone and (s)-propafenone. the investigators have discovered that purified (r)-propafenone may be more effective than (s)-propafenone for treatment of atrial fibrillation, and that (s)-propafenone reduces the efficacy of (r)-propafenone when administered as a mixture. this study will compare the ability of (r)-propafenone, (s)-propafenone, and placebo to suppress the induction of atrial fibrillation in participants undergoing an atrial fibrillation ablation procedure.

Eligibility criteria:
inclusion: 1. history of atrial fibrillation 2. greater than or equal to 18 years of age 3. scheduled to undergo an atrial fibrillation ablation procedure 4. able to provide written informed consent exclusion: 1. long-standing persistent atrial fibrillation at the time of ablation (greater than 1 year of a continuous atrial fibrillation episode) 2. is in atrial fibrillation or atrial flutter the morning of the ablation procedure 3. the presence of any of the following in a patient without a permanent pacemaker for implantable cardiac defibrillator 1. sick sinus syndrome indicated by the inability to previously tolerate an antiarrhythmic drug due to bradycardia 2. sinus bradycardia with a heart rate less than 50 beats per minute at the time of study drug administration 3. right bundle branch block, left bundle branch block, or bifascicular block 4. pr-interval \> 280ms, or history of 2nd or 3rd degree atrioventricular block 4. concomitant use of cyp3a4 and cyp2d6 inhibitors 5. previous surgical or catheter ablation for atrial fibrillation or cox-maze procedure 6. amiodarone use within 3 months prior to enrollment 7. antiarrhythmic drug (other than amiodarone) within 5 half-lives prior to atrial fibrillation ablation 8. expected life span \< 1 year 9. creatinine clearance \<30 ml/min 10. reversible cause of atrial fibrillation (ie. thyrotoxicosis) 11. unrevascularized coronary artery disease 12. canadian class iv angina 13. left ventricular ejection fraction \<40% 14. new york heart association class iii or iv symptoms 15. previous heart transplantation 16. planned heart transplantation or ventricular assist device 17. cardiac/thoracic surgery \<6 months prior to enrollment 18. severe asthma or chronic obstructive pulmonary disease 19. breastfeeding

Keywords: ablation
patient perception study for al-4943a

Conditions: Allergic Conjunctivitis

Summary: to evaluate patient perceptions of al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.


Eligibility criteria:
inclusion criteria: * history of allergic conjunctivitis within last 24 months * active signs and symptoms of ocular allergies exclusion criteria: * severe or serious ocular condition, ocular surgical intervention, ocular infection

Keywords: allergic conjunctivitis