Kornimate/medical-research-clean huggingface dataset:
an observational study to describe the adherence to the seom algorithm for the treatment of hyponatraemia in spain

Conditions: Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion

Summary: in 2014, the spanish sociedad española de oncología médica (seom) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (siadh) in oncology patients was developed. since it is hypothesised that the adherence to the seom algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the seom algorithm and its impact on patient outcomes


Eligibility criteria:
inclusion criteria: * provision of patient informed consent unless a) not required by local regulations, b) it would represent a non-reasonable effort or c) if the source patient is deceased or untraceable. * female and/or male oncology patients aged 18 years and over * patients who have experienced at least one occurrence of hyponatraemia secondary to the siadh. exclusion criteria: * a patient cannot take part in this study if participating in any clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Keywords: hyponatremia siadh oncologic patients
prophylaxis with caspofungin in high-risk liver transplantation

Conditions: Liver Transplantation; Fungal Infection

Summary: this is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. it is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per european organization for research and treatment of cancer/mycoses study group \[eortc/msg\] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. it is also expected that the incidence of serious drug-related adverse events will be less than 25%.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * patient has received an orthotopic liver transplantation * patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation * for women of childbearing potential, patient must have a negative serum or urine pregnancy test exclusion criteria: * any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug. * documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment. * abnormal laboratory values as defined per protocol. * allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal. * patient not expected to survive at least 5 days. * patient is pregnant or breast feeding.

Keywords: liver transplantation invasive fungal infection invasive aspergillosis prophylaxis caspofungin
effects of preventive treatment for respiratory syncytial (rs) virus infection during infancy on later atopic asthma in preterm infants

Conditions: Atopic Asthma; Recurrent Wheezing

Summary: the primary objective of the study is to determine whether the incidence of atopic asthma after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for respiratory syncytial (rs) virus infections during the infancy. the secondary objective is to determine whether the incidence of recurrent wheezing after three years old may be suppressed in the children who were born as preterm infants and prophylactically treated with palivizumab for rs virus infections during the infancy.


Eligibility criteria:
inclusion criteria: * infants born july \~ december 2007 at 33\~35 weeks of gestation * infants administered at least 3 doses of palivizumab during the first 6 months of life (palivizumab treated) * infants not administered any doses of palivizumab during the first 6 months of life (palivizumab untreated) exclusion criteria: * intrauterine growth retardation (less than -2.5sd) * infants with chronic lung disease (cld) or other respiratory disease * infants received mechanical ventilation * infants with chronic heart disease (chd) or congenital anomaly (such as immunodeficiency)

Keywords: atopic asthma recurrent wheezing preterm infants palivizumab respiratory syncytial virus rsv
phototherapeutic keratectomy (ptk) with mitomycin in adenoviral opacities

Conditions: Keratitis; Corneal Opacity

Summary: the present study was designed to evaluate the treatment of adenoviral corneal opacities with ptk and mitomycin c.

epidemic keratoconjunctivitis is a very common disease, some patients developed a complication after the infection wich is corneal infiltration. topical treatment sometimes helps to avoid loss of visual acuity. therefore recurrence of the opacities after topical drops is observed. when corneal fibrosis occur is difficult to achieve visual rehabilitation with topical approach. this study evaluate pre and postoperative data of patients with subepithelial fibrosis caused by adenoviral infiltrates submitted to phototherapeutic keratectomy (ptk) using mitomycin c.

Eligibility criteria:
inclusion criteria: * visual acuity worse than 20/40, caused by central subepithelial fibrosis exclusion criteria: * pregnancy, age less than 18 years-old or more than 80 years-old. * diabetes, autoimmune diseases, corneal thickness less tha 400 micron.

Keywords: ptk corneal opacity mitomycin
an eye tracking study of affective disorder patients with suicide risk

Conditions: Major Depressive Disorder; Bipolar Disorder; Suicide

Summary: this research tries to investigate the validity and reliability of eye-tracking technologies by using different paradigms (eg. free-view, pro-saccade and anti-saccade) which served as a novel way of evaluating suicide risk among affective disorder patients including bipolar and unipolar depression. all the participants including health control will be assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual,dsm-iv diagnosis of depression or bipolar disorder * bdi-ii\>20(suicide and disorder control group); bdi-ii\<13，no history of depression(health control) * informed consent * suicide attempt in the past 6 months(suicide risk group) exclusion criteria: * current or past substance abuse, psychotic disorder,obsessive compulsive disorder , post-traumatic stress disorder, in the past 6 months * history of epilepsy or head trauma * eye disorders * history of electroconvulsive therapy in the past 4 weeks.

Keywords: eye-tracking eye movement saccade
watchman left atrial appendage system for embolic protection in patients with atrial fibrillation

Conditions: Atrial Fibrillation; Stroke

Summary: this is a multi-center, prospective, randomized study, stratified by center, comparing the watchman device to long term warfarin therapy, demonstrating that the treatment arm is non-inferior to the control arm. this study was amended to allow for a non-randomized arm and increased enrollment.

the watchman device is designed to be permanently implanted distal to the ostium of the left atrial appendage (laa) to trap potential emboli before they exit the laa.

Eligibility criteria:
inclusion criteria: * patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (af) * eligible for long term warfarin * chads score \>= 1 \[congestive heart failure (chf), history of high blood pressure, 75 years of age or older, diabetes, prior stroke or transient ischemic attack (tia)\] exclusion criteria: * contraindicated for warfarin * contraindicated for aspirin or clopidogrel (plavix) * congestive heart failure (chf) class 4 * implanted mechanical valve * atrial septal or patent foramen ovale (pfo) device * platelets \< 100,000 or hemoglobin \< 10 * left ventricular ejection fraction (lvef) \< 30%

Keywords: atrial fibrillation af a fib stroke coumadin warfarin blood thinning medication transient ischemic attack (tia) watchman left atrial appendage laa isolation laa occlusion
contraband™: fih safety & feasibility study (rm-20-01)

Conditions: Heart Failure, Left Sided

Summary: the contraband™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy. contraband™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries, causing a local reduction in the internal diameters of these arteries, and resulting in an elevation in systolic right ventricular pressure. this may result in repositioning the interventricular septum to a more normal anatomical position, and supporting it with a "counter-pressure" during systole of the left ventricle. this study is a first-in-human, early feasibility, multi center, prospective, interventional, open-label, single-arm study.


Eligibility criteria:
inclusion criteria: 1. age is 18 - 85 years old 2. chronic (\> 3 months) systolic heart failure 3. symptomatic left heart failure stage c (nyha ii\*-iva) 4. lvef 20 - 40% 5. patients on optimal tolerated medical therapy for at least one month. if subject is on device therapy, if icd for at least 1 month, if crt/pacemaker, for at least 3 months. 6. provide a personally signed and dated inform consent form, and able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule. exclusion criteria (selected): 1. serum nt-probnp \<300 2. significant rv dysfunction with tapse \<17 3. pulmonary hypertension (spap \> 45 mmhg by echo or mpap \> 20 mmhg by rhc) 4. anatomical pathology or constraints preventing appropriate access/implant of contraband™ 5. restrictive cardiomyopathy or myocarditis 6. patients with congenital heart disease and/or mechanical heart valve(s) 7. any severe valve disease (grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5) 8. hemodynamic instability: hypotension (systolic pressure \<90 mmhg) or requirement for inotropic support or mechanical hemodynamic support 9. active bacterial endocarditis or previous history of sbe (subacute bacterial endocarditis) 10. any planned cardiac surgery or interventions within the next six (6) months 11. need for coronary artery revascularization 12. myocardial infarction or any percutaneous cardiovascular intervention within 1 month 13. cardiovascular surgery, or carotid surgery within 3 months 14. acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (egfr \< 30) 18. leukopenia (wbc \< 4000 cells/μl), anemia (hgb \< 9 g/dl), thrombocytopenia (platelets \< 150,000 cells/μl) or any known blood clotting disorder

Keywords: pulmonary artery banding
actigraphy and neonatal abstinence syndrome

Conditions: Neonatal Abstinence Syndrome

Summary: the aim of our study is to analyse the correlation between actigraphy and lipsitz scoring system in neonatal opioid abstinence syndrome.

neonatal opioid abstinence syndrome occurs after birth when opioids were used by the mother during pregnancy. many scoring systems, like lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. the majority of items in these scores are motor skills items. actigraphy allows to measure objectively the newborn motricity. we will analyse the correlation between actigraphy and lipsitz scoring system in four groups of newborns.

Eligibility criteria:
inclusion criteria: * newborn \> 32 weeks of gestation + 0 day exclusion criteria: * perinatal asphyxia * 5- minute apgar score \< 7 * ante or post-natal brain injury diagnosis * upper arm motor deficit * hospitalization in intensive care unit * neonatal respiratory distress
aromasin® as adjuvant treatment in postmenopausal women with invasive, estrogen receptor positive early breast cancer

Conditions: Breast Neoplasms

Summary: this non-interventional study will be conducted in several eastern european countries to assess the safety, tolerability and efficacy of aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how aromasin® is used in routine clinical practice, to assess adherence to prescribed aromasin® treatment and to understand reasons for its early discontinuation.

the study prematurely discontinued on october 11, 2011 due to slow enrollment. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * postmenopausal females, defined as one from the next : 1. natural menopause ≥1 year, 2. surgical ovariectomy, 3. chemotherapy-induced amenorrhoea ≥ 2 years. * patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * patients who are disease-free after 2 to 3 years of adjuvant tamoxifen treatment. * patients whose tumour was estrogen receptor positive (er+). * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients for whom aromasin® treatment is contraindicated (see smpc). * metastatic breast cancer or a contra lateral tumour. * other concomitant adjuvant endocrine therapy. * other concomitant antineoplastic treatment. * participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Keywords: hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
the effect of deep tissue massage on respiratory parameters in people with asthma

Conditions: Massage; Asthma Patients

Summary: bronchial asthma, as a chronic inflammatory disease of the respiratory tract, significantly reduces the quality of life of patients. standard treatment includes pharmacotherapy, but a holistic approach, including manual therapies, can support pharmacological therapy, reducing the need for drugs. the aim of the research is to verify whether deep tissue massage (dtm) techniques applied to the chest significantly affect respiratory parameters in people with asthma. the study is the next stage of the study conducted on healthy people. after obtaining positive results in the study involving people not suffering from respiratory diseases, the next step is to examine people with, in this case, bronchial asthma. it is important to determine whether the use of this form of manual therapy can bring benefits in the context of improving respiratory functions, reducing respiratory muscle tension and relieving subjective symptoms associated with asthma, such as shortness of breath or limitations in everyday functioning. the hypothesis assumes that dtm techniques can have a bigger effect on the respiratory system than classic massage (cm). the study is a randomized controlled trial, where participants will be randomly assigned to one of two groups: the study group (subjected to dtm) or the control group (subjected to cm). before and after the massage intervention, participants will undergo spirometry to assess the changes in respiratory parameters. the obtained data will then be analyzed for effects on respiratory parameters and differences between both groups.


Eligibility criteria:
inclusion criteria: * diagnosed with bronchial asthma * stable health condition, allowing participation in the study * informed consent to participate in the study exclusion criteria: * acute or chronic comorbidities that may affect the results (e.g. copd, heart failure, cancer) * any chest surgery performed within the last 6 months * contraindications to massage (e.g. skin infections, wounds) * pregnancy * participation in other clinical trials in the last 3 months

Keywords: deep tissue massage spirometry asthma respiratory parameters
effect of valsartan on lipid subfractions in hypertensive patients with metabolic syndrome

Conditions: Hypertension; Metabolic Syndrome

Summary: the purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.


Eligibility criteria:
inclusion criteria: * male or female outpatients \>= 18 years of age at visit 1 * hypertension (systolic blood pressure \>= 140 mmhg and \ = 90 mmhg and \< 105 mmhg * elevated triglycerides * metabolic syndrome as defined by adult treatment panel iii criteria exclusion criteria: * mssbp \>= 170 mmhg and/or msdbp \>= 105 mmhg at any time between visit 1 and visit 2 * diabetes mellitus * patients treated with lipid lowering drugs in the last 6 weeks prior to visit 1 * a history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure nyha ii - iv other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, metabolic syndrome, lipid subfractions
posture in abdominopelvic training in women sui

Conditions: Female Stress Incontinence

Summary: measure effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with sui. 42 women aged between 46-75 with sui and stress-predominant mixed urinary incontinence. there were randomly assigned two groups of different treatment. quality of life was measured by questionnaires: incontinence questionnaire short form (iciq-iu-sf) and king's health questionnaire (khq) global punctuation and incontinence impact. treatment satisfaction was measured by vas scale.

the aim of this study was compare the effect of postural correction in abdominopelvic exercises on the improvement of the quality of life in patients with stress urinary incontinence (sui). was a randomized 2-treatment parallel design study. the sample consist in 42 women aged between 46-75 with stress urinary incontinence (sui) and stress-predominant mixed urinary incontinence (ium). they were randomly assigned to two groups: group 1 (n=21) who received abdomino-pelvic training, and group 2(n=21) who received the above treatment, guidelines about postural correction. both groups received 12 treatment sessions in first session information regarding clinical and demographical aspects will be collected. to evaluate results of postural correction combined with abdominopelvic exercise women was assessed:at initial session, post- intervention and 3 months post-intervention treatment.quality of life was measured by spanish validation questionnaires: international continence questionnaire short form (iciq-iu-sf) and king's health questionnaire (khq) global punctuation and incontinence impact. treatment satisfaction was measured by visual analogic scale (vas).

Eligibility criteria:
inclusion criteria: * sui or stress-predominant mixed ui * diagnosed via clinical assessment and urodynamic study * estrogenic deficit.: perimenopause, menopause, postmenopause exclusion criteria: * grade 3-4 prolapse, * functional alterations (barthel scale \> 85 points), * neurological or cognitive alterations (mini mental examination \> 24 points) * other predominant type of urinary incontinence.

Keywords: stress urinary incontinence abdominopelvic exercise quality of life
the effect of eprosartan on hormones and kidney function in patients with essential hypertension

Conditions: Essential Hypertension

Summary: we, the investigators at holstebro hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.


Eligibility criteria:
inclusion criteria: * age 18 - 65 years. * body mass index less or equal to 30 kg/m2. * women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal. * arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmhg systolic or above 80 mmhg diastolic. exclusion criteria: * history of myocardial infarction. * history of stroke. * heart failure. * endocrine organ disease. * lung disease. * clinically significant abnormal biochemical screening of the blood regarding: b-hemoglobin, p-sodium, p-potassium, p-creatinine (under 200 µmol/l will be accepted), p-albumin, p-bilirubin, p-alaninaminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose. * clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/l will be accepted). * renovascular hypertension. * malignant disease. * alcohol abuse. * usage of medical drugs besides antihypertensives or statins. * drug abuse. * pregnancy or breast feeding. * known intolerance or allergic to eprosartan or sodium nitroprusside. * blood donation within 1 month of the start of the study.
health effects following use of lead free ammunition used with hk416

Conditions: Lung Function Tests; Markers of Inflammation

Summary: the purpose of this study is to determine whether use of lead free ammunitions cause more respiratory problems than use of lead containing ammunitions.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * active respiratory disease
prophylaxis trial in high risk allogenic stem cell transplant recipients with graft vs. host disease

Conditions: Mycoses

Summary: this trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (poz) vs. fluconazole in the prophylaxis against development of invasive fungal infections (ifi).

this study is designed to determine the safety, tolerance and efficacy of poz used as prophylaxis of ifi in high-risk subjects with grade ii-iv acute graft vs. host disease (gvhd) or extensive chronic gvhd. the primary objective is to assess the efficacy of sch56592 vs fluconazole in preventing proven or probable ifi within the time period from randomization to 16 weeks after the start of treatment with study drug.

Eligibility criteria:
inclusion criteria: * hematopoietic progenitor cell transplant subjects with chronic or grade ii-iv acute gvhd being treated with high dose immunosuppressive therapy. * one of the following to the subject's prior immunosuppressive regimen: 1. at least 1mg per kg per day of methylprednisolone or equivalent, 2. antithymocyte globulin (atg) for the therapy of acute gvhd, 3. tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.

Keywords: allogenic stem cell transplantation fungal infections
ultraslow swl versus slow swl for ureteric stones with high attenuation value

Conditions: Ureteric Stone

Summary: ultraslow full-power swl versus slow power-ramping swl in ureteric stones with high attenuation value

to evaluate the efficacy of ultraslow rate of swl versus slow rate, power ramping swl

Eligibility criteria:
inclusion criteria: * single upper ureteric stone less than or equal to 2 cm * radio-opaque stone * high attenuation value (≥ 1000 hu) stone exclusion criteria: * abnormal renal anatomy * renal insufficiency * solitary kidney * coagulopathies * uncontrolled hypertension * renal artery or aortic aneurysm * active urinary tract infection * pregnancy * severe skeletal malformations (spinal deformity) precluding proper stone localization

Keywords: ureteric stone swl high density stones ultraslow swl slow swl ramping pause