Kornimate/medical-research-clean huggingface dataset:
development of novel imaging and molecular biomarkers of fibrosis in patient with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: prospective multicenter interventional non-randomized cross-sectional study. ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings. this study aims to develop novel imaging and molecular biomarkers of fibrosis, through the use of intestinal ultrasound and shear wave elastography, using histologic specimens obtained by endoscopic biopsies as reference standard.


Eligibility criteria:
inclusion criteria: * adult, 18 years of age and older, * established diagnosis (\> three months) of ulcerative colitis, * performing colonoscopy, according to current standards of care and ecco guidelines, * ability to understand and comply with the study procedure and sign an informed consent form exclusion criteria: * pregnancy, * presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare), * inability to undergo intestinal ultrasound within the time set by the study, * poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen. * subjects who needs to change therapy
long term safety and tolerability of nva237 versus tiotropium in japanese patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily nva237, using tiotropium as an active control, in japanese patients with moderate to severe chronic obstructive pulmonary disease (copd) .


Eligibility criteria:
inclusion criteria: * patients with moderate to severe stable copd (stage ii or stage iii) according to the gold guideline 2008. * current or ex-smokers who have a smoking history of at least 10 pack years. * patients with a post-bronchodilator fev1 ≥30% and \< 80% of the predicted normal, and postbronchodilator fev1/fvc \< 0.7 at visit 2 (day -7) exclusion criteria: * pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception * patients requiring long term oxygen therapy * patients who have had a lower respiratory tract infection within 6 weeks prior to visit 1 * patients with concomitant pulmonary disease * patients with a history of asthma * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions * patients with a known history and diagnosis of alpha-1 antitrypsin deficiency * patients in the active phase of a supervised pulmonary rehabilitation program * patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents * other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd nva237
vascular response of orsiro vs. xience drug-eluting stents for treating coronary bifurcation lesions

Conditions: Coronary Artery Disease

Summary: this study aims to compare vessel response and clinical outcomes of a biodegradable-polymer, ultra-thin strut, drug-eluting stent (orsiro, biotronik) and a durable-polymer, thin-strut, drug-eluting stent (xience, abbott) for the treatment of coronary bifurcation lesions with two-stent double-kissing crush technique. how the differences in stent platforms affect vessel healing process will be examined by optical coherence tomography.

patients with true coronary bifurcation lesions (medina \[1, 1, 1\] or \[0, 1, 1\]) will be enrolled and randomized to undergo two-stent double kissing crush technique with orsiro or xience. pre-intervention and post-stenting optical coherence tomography will be performed during the index procedure. another parallel prospective registry will enroll patients with bifurcation lesions treated with provisional one-stent strategy. all subjects will receive coronary angiography and optical coherence tomography follow-up at 3 and 12 months.

Eligibility criteria:
inclusion criteria: 1. patients who are at least 20 years old and present with acute or chronic coronary syndrome. 2. patients who are suitable for pci with des implantation and provide written informed consent. 3. patients with coronary bifurcation lesion amenable to be treated with 2-stent double-kissing (dk) crush technique. 4. target vessels suitable for oct examination. 5. women of childbearing potential must have a negative pregnancy (serum and/or urine) test within 7 days prior to index procedure in accordance with the institutional standard of care. female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test. exclusion criteria: 1. patient who are not suitable candidates for use of dual antiplatelet therapy (dapt) 2. estimated glomerular filtration rate \< 45 ml/min/1.73 m2 3. liver cirrhosis 4. life expectancy \< 1 year 5. planned surgery within 3 months 6. pregnancy, breast-feeding, or plan to be pregnant in the coming 12 months 7. target bifurcation lesion involved in chronic total occlusion or the culprit vessel of st-elevation myocardial infarction

Keywords: drug-eluting stents coronary bifurcation lesions double-kissing crush technique optical coherence tomography
a preliminary study of the effectiveness and tolerability of aripiprazole in bipolar depression

Conditions: Bipolar Depression

Summary: the specific aim of this study is to obtain preliminary evidence of the acute effectiveness and tolerability of aripiprazole in the treatment of bipolar depression.


Eligibility criteria:
inclusion criteria: * subjects must have bipolar i, ii or nos disorder as defined by dsm-iv-tr; must have clinical significant depressive symptoms and have failed one or more mood stabilizer trials; may or may not be receiving antimanic or mood stabilizing medications; subjects or legally authorized representative must sign the informed consent document after the nature of the trial has been fully explained; if female, subjects must be postmenopausal, surgically incapable of childbearing or practicing medically acceptable effective method(s) of contraception. exclusion criteria: * subjects who do not have bipolar disorder by dsm-iv criteria; subjects with current dsm-iv axis i diagnosis of delirium, dementia, amnesia or other cognitive disorders or a psychotic disorder; subjects with serious general medical illness; subjects who are allergic to or have demonstrated hypersensitivity to aripiprazole; women who are pregnant or nursing; subjects who have received an experimental drug or used an experimental device within 30 days; subjects who have a history of neurologic malignant syndrome.

Keywords: adults bipolar depression bipolar disorder bipolar i bipolar ii depression
the usefulness of myocardial work index in extracorporeal membrane oxygenation patients

Conditions: Echocardiography; Mechanical Circulatory Support; Myocardial Failure; Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication

Summary: investigation of the potential prognostic role of non-invasive myocardial work in patients receiving veno-arterial extracorporeal membrane oxygenation therapy.

the study aims to examine the prognostic role of non-invasive myocardial work in veno-arterial extracorporeal membrane oxygenation therapy patients. subjects with cardiogenic shock regardless of etiology will be enrolled 48-72 hours after the initiation of mechanical circulatory support. it is hypothesized that non-invasive myocardial work may be an independent prognosticator of the outcome.

Eligibility criteria:
inclusion criteria: * 18 years or older age * severe cardiogenic shock requiring the initiation of va-ecmo therapy * stabile hemodynamic state and oxigenation with va-ecmo and vasoactive support * informed written consent (due to the nature of the study, from a legally eligible relative of the patient) exclusion criteria: * younger than 18 years of age * unstable hemodynamic state or suboptimal oxigenation despite established va-ecmo and vasoactive support * severe neurological damage or confirmed brain death at the time of enrollment which squarely indicates therapy limitation and poor short-term outcome * transesophageal echocardiography is contraindicated * suboptimal echocardiographic window

Keywords: echocardiography myocardial work index cardiogenic shock extracorporeal membrane oxygenation therapy
development of a computer-aided polypectomy decision support

Conditions: Adenomatous Polyps

Summary: quality components of colonoscopy include the detection and complete removal of colorectal polyps, which are precursors to crc. however, endoscopic ablation may be incomplete, posing a risk for the development of "interval cancers". the investigators propose to develop a solution based on artificial intelligence (ai) (cadp computer-aided decision support polypectomy) to solve this problem.this research project aims to develop cadp, a computer decision support solution (cds) for the ablation of colorectal polyps from 1 to 20 mm.

this research project aims to develop cadp, a computer-based decision support (cds) solution for the removal of colorectal polyps ranging from 1-20 mm. the investigators will use a video and image dataset of polypectomy procedures to train the cadp model; thus, it can provide real-time overlaid video feedback for polypectomy procedures based on five specific metrics: 1) estimation of polyp size; 2) prediction of morphology and histology; 3) suggestion of an appropriate resection accessory and technical approach based on the characteristics, size, and histology of the polyp according to current guidelines; 4) image overlay, based on semantic image segmentation technology, showing the extent of the lesion and suggestion of an appropriate resection margin contour around the polyp to ensure its complete removal; 5) post-resection analysis to identify any remnant polyp tissue or insufficient resection margin that may increase this risk. the investigators will collect a set of images and video data from live polypectomy procedures to leverage recent advances in ai technology to train deep learning models. this dataset will be obtained prospectively from a cohort of adults (ages 45-80) undergoing screening, diagnostic, or surveillance colonoscopies. to train the cadp solution, the investigators will obtain the corresponding completeness of resection status using the yield of post-resection margin biopsies. the dataset will be divided into two groups, the training, and the cadp test, respectively.

Eligibility criteria:
inclusion criteria: * signed informed consent * age 45-80 years * indication to undergo a lower gi endoscopy. exclusion criteria: * known inflammatory bowel disease * active colitis * coagulopathy * familial polyposis syndrome; * poor general health, defined as an american society of anesthesiologists (asa) physical status class \>3 * emergency colonoscopies

Keywords: polyps detection artificial intelligence adenoma detection polyps classification computer decision support
detecting the changes of swallowing function in oral cancer patients

Conditions: Swallowing Function

Summary: the evidence of swallowing changes in tongue cancer patients is still limited. this study aimed to investigated the swallowing changes in these patients by using the videofluoroscopy (vfss) and high resolution impedance manometry (hrim).

objective: to investigated the swallowing changes in tongue cancer patients by using the videofluoroscopy (vfss) and high resolution impedance manometry (hrim). methods: 1. patients are fulfilled tongue cancer diagnosis; 2.they will undergo vfss and hrim examinations before or after surgery if they experience discomfort while swallowing.

Eligibility criteria:
inclusion criteria: * patients elective received oral cancer surgery and suitable to receive mandibular-lip split or pull-through resection surgeries exclusion criteria: * 1. patients had major underlying disease, ex: heart, brain, lung, liver disease * 2. coagulopathy * 3.pregnancy * 4. the patients could not have good compliance

Keywords: dysphagia swallowing
effectiveness of foam rolling on selected muscle groups on jumping

Conditions: Hypertension

Summary: an experiment elucidating the immediate effect of foam rolling of the posterior chain on reactive force performance that will represent multiple jumps over low obstacles. the measurements will be performed using the optojump device, which will provide data on the time of foot contact with the ground and the jump height. the angles of the torso inclination to the vertical will also be measured during jumping.

fifteen women were selected for this experiment in the form of a randomized crossover study. measurements were taken by leg jumps over 5 obstacles 125 cm apart. the pre-test was performed twice with a two-minute rest between each trial. immediately after finishing the second trial, a randomly selected half of the probands performed posterior chain facilitation using a foam roller, facilitating first the left leg, then the right leg and finally spinal erectors. rolling was performed with a sense of maximal intensity and at a high rolling speed across the full length and width of the muscle with both cranial and caudal rolling directions. facilitation was performed on each muscle group in the distoproximal direction. immediately following the intervention, a post-test was performed a total of 3 times, 1 minute after the intervention, 3 minutes after the intervention and 5 minutes after the intervention. the control measurement was performed the same way as the intervention, but the control group of probands rested in a resting sitting position for 4 minutes instead of foam rolling. after one week, a second measurement followed, where the original control group underwent the intervention measurement and vice versa. the optojump instrument (microgate, bolzano, italy) was used to obtain the resistance and flight phase data. a video recording (gopro hero 9) was taken of the skipping procedure, from which photographs were taken over each obstacle at the moment of the greatest trunk tilt (the junction of the trochanter major and the external auditory canal exit) from the vertical axis.

Eligibility criteria:
inclusion criteria: * women * age range 18-30 years * regular training at least 3 times a week * training with a minimum duration of 1.5 hours * valid medical sports examination * experience with jumping over hurdles * having a problem with maintaining the physiological position of the torso when running exclusion criteria: * injuries * acute illnesses * chronic disease * musculoskeletal limitations * during convalescence

Keywords: smr plyometrics jumps over hurdles posterior myofascial chain
efficacy of a new resurfacing hip prosthesis

Conditions: Osteoarthritis, Hip

Summary: the purpose of this study is to compare the articular surface replacement (asr) prosthesis placed by the conventional positioning method and the asr prosthesis placed by 'computer assisted surgery' (cas) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. the hypothesis is that this variation is larger with the conventional positioning method than when cas is used.

for patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. however, because of the life expectation and high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution. an alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. the articular surface replacement (asr) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (cas). the hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when cas is used. this study will compare the results of those who had an asr prosthesis placed by the conventional positioning method with those patients in whom the asr prosthesis was placed using cas.

Eligibility criteria:
inclusion criteria: * men aged ≤ 60 years, and women aged ≤ 55 years * presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery exclusion criteria: * evident osteoporosis * active local or systemic infection * clinical manifestation of vascular deficiency of the lower extremity * pathological condition of the acetabulum * presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, legg-calve- perthes disease * rheumatoid arthritis * extreme varus position (neck-shaft angle \< 110º) * presence of femoral cyst \> 1 cm in diameter * previous hip surgery * presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year * presence of a thr at the contra lateral site less than 6 months post- operatively or patients with a thr at the contra lateral site with a poor function of the hip * bmi\> 30 kg/m2 * renal deficiency (creatine \> 115 μmol/l for men and \> 90 μmol/l for women) * medically proven metal allergy * request of patient to correct an existing leg length discrepancy * head-neck ratio \< 1 * use of steroids, and/or immunosuppressive medication * alcoholism * patients from which it is not sure that they will be able to attend the follow-up measurements * insufficient command of the dutch language, spoken and/of written

Keywords: "resurfacing hip" [mesh] "conventional position method" "surgery, computer-assisted" [mesh]
nutritional intervention program in malnourished patients admitted for heart failure

Conditions: Heart Failure; Malnutrition; Nutritional Intervention; Mortality

Summary: the purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.


Eligibility criteria:
inclusion criteria: * patients admitted for heart failure * \> 18 years old * malnutrition determined by mna test (\< 17 points) exclusion criteria: * if is not possible to perform a nutritional assessment * planned pci or cabg to correct heart failure etiology
tolerability, pharmacokinetics and dopamine ß-hydroxylase (dßh) inhibition profile of bia 5-453

Conditions: Hypertension; Chronic Heart Failure

Summary: the purpose of this study is to assess the safety and tolerability of bia 5-453 after single oral doses

single centre, randomised, double-blind, placebo-controlled study of single ascending doses in 10 sequential groups of 8 healthy young male volunteers. within each group (n=8), 6 volunteers were randomised to receive bia 5-453 and the remaining 2 volunteers were randomised to receive placebo. a volunteer participated only in a single period.

Eligibility criteria:
inclusion criteria: 1. a signed and dated informed consent form before any study-specific screening procedure was performed. 2. aged between 18 and 45 years, inclusive. 3. healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ecg). 4. nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must have been able to abstain from smoking during the inpatient stay. 5. have a high probability for compliance with and completion of the study. exclusion criteria: medical history 1. any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease. 2. acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1. 3. history of drug abuse within 1 year before study day 1. 4. history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day (12.5 cl glass of 10° \[10%\] wine = 12 g; 4 cl of aperitif, 42° \[42%\] whiskey = 17 g; 25 cl glass of 3° \[3%\] beer = 7.5 g; 25 cl glass of 6° \[6%\] beer = 15 g 5. history of any clinically important drug allergy. physical and laboratory findings 6. an automatic ecg qtc interval reading at screening or enrolment \>450 ms. 7. positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. 8. positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma \[3,4-methylenedioxy-methamphetamine; ecstasy\]). prohibited treatments 9. prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (imp) administration. 10. consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 72 before study day -1. 11. use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before imp administration. 12. donation of blood (ie 450 ml) within 90 days before study day 1.
therapy of preconditioned autologous bmmscs for patients with ischemic heart disease

Conditions: Myocardial Infarction; Acute Myocardial Infarction; Ischemic Cardiomyopathy

Summary: the purpose of the present study is to evaluate the efficacy of the preconditioned autologous bone marrow mesenchymal stem cells for patients with ischemic heart diseases.


Eligibility criteria:
inclusion criteria: * age under 75; * clinical diagnosis of acute myocardial infarction, chronic myocardial infarction and ischemic cardiomyopathy * nyha (new york heart association) grade: iii-iv, lvef (left ventricular ejection fraction): 25-50%; * no infection diseases including hbv (hepatitis b virus), hcv (hepatitis c virus ), syphilis and aids; * no psychiatric illnesses and speaking dysfunction; * informed consent. exclusion criteria: * more than 75 years old; * lvef\<24%; * unstable hemodynamics, shock; * severe infection; * patients have tumor or other lethal diseases (expectation of life\<6 months); * radiation patients; * hematopoietic malignancy including haemophiliacs; * anemia (hb\<100g/l); * the other clinical trial participants within one month; * abnormal increasing of the blood biochemical indicators that is not explained by the conditions; * informed refusal.