Kornimate/medical-research-clean huggingface dataset:
covered self-expandable metal stents for palliation of malignant biliary strictures: evaluation of a new type of stent

Conditions: Malignant Biliary Strictures

Summary: self-expandable metal stents for palliation of malignant biliary strictures

the comvi biliary stent (taewoong medical inc., seoul, korea), is a covered metallic stent with a expanded polytetrafluoroethylene (e-ptfe) membrane sandwiched between two wire layers and has a weaker axial force than other stents. patients with middle-distal malignant biliary stricture and with symptoms as jaundice, itching and pain.

Eligibility criteria:
inclusion criteria: * patients with malignant stenosis at the middle or lower third of the common bile duct inoperable and/or unresectable. * patients without liver metastases and 6 months life expectancy * patients at the first attempt of endoscopic biliary drainage. * negative history for biliary tract surgery. exclusion criteria: * patients with ampullary cancer. * patients with hilar and/or intra-hepatic ducts malignancy. * patients with haemobilia. * patients with acute cholangitis at the time of stenting. * patients with previous percutaneous, endoscopic or surgical biliary drainage.

Keywords: malignant strictures of the main biliary duct
extracorporeal life support in cardiogenic shock

Conditions: Acute Myocardial Infarction; Cardiogenic Shock

Summary: the aim of the study is to examine whether treatment with extracorporeal life support (ecls) in addition to revascularization with percutaneous coronary intervention (pci) or alternatively coronary artery bypass grafting (cabg) and optimal medical treatment is beneficial in comparison to no ecls in patients with severe infarctrelated cardiogenic shock with respect to 30-day mortality


Eligibility criteria:
inclusion criteria: * cardiogenic shock complicating ami (stemi or nstemi) plus obligatory: * planned revascularization (pci or alternatively cabg) * systolic blood pressure \ 30 min or catecholamines required to maintain pressure \>90 mmhg during systole * signs of impaired organ perfusion with at least one of the following criteria a) altered mental status, b) cold, clammy skin and extremities, c) oliguria with urine output \<30 ml/h * arterial lactate \>3 mmol/l * informed consent exclusion criteria: * resuscitation \>45 minutes * mechanical cause of cardiogenic shock * onset of shock \>12 h * severe peripheral artery disease with impossibility to insert ecls cannulae * age \ 75 years * shock of other cause (bradycardia, sepsis, hypovolemia, etc.) * other severe concomitant disease with limited life expectancy \<6 months * pregnancy * participation in another trial
community health workers against covid19

Conditions: Covid 19; Social Isolation; Mental Health Impairment

Summary: randomized controlled trial among patients from family practices at risk of psychosocial suffering due to social distancing measures. patients from the intervention group receive support from community health workers. contacted at least 8 times by community health workers. evolution of psychosocial wellbeing is evaluated by questionnaires at time 0 and after 6 weeks of intervention. psychosocial outcomes are compared between control and intervention groups. process evaluation will be done through in-depth interviews.

patients vulnerable for psychosocial suffering due to social distancing measures are recruited by family practitioners in the city of ghent. the recruited patients are randomly selected into a control and intervention group. based on the validated promis instruments, all participants are interviewed face to face on their mental and social health at time 0 and after 6 weeks of intervention. patients from the intervention group are contacted by community health workers after the first interview. community health workers offer emotional support to the patients through at least 8 contacts over 6 weeks. the control group receive care as usual and are offered support by community health workers after the second interview. in depth interviews (qualitative study) will be conducted among community health workers and patients after finalizing the post-intervention questionnaires. research questions: what are the psychosocial consequences of social distancing for at-risk groups? can community health workers reduce the psychosocial impact of physical distancing measures isolation? relevance: understanding community-based psychosocial support for vulnerable people during and after health crises. keywords: community health workers, psychosocial, health crises

Eligibility criteria:
inclusion criteria: * patients recruited by family practitioners based on anticipated psychosocial impact of physical distancing measures exclusion criteria: * patients with severe psychiatric diseases (psychosis, severe depression)

Keywords: community health workers randomized controlled trial psychosocial impairment
efficacy of a novel app-based migraine treatment platform - a pilot study

Conditions: Migraine Disorders

Summary: this study evaluates biofeedback delivered through a smartphone as a treatment for migraine in adolescents. three out of four participants will receive treatment as smartphone delivered biofeedback training, and one out of four participants will receive treatment as a sham-biofeedback app.

biofeedback is a behavioral treatment without known side effects. in biofeedback patients learn control over bodily reactions through feedback visualised on a screen. typical bodily reactions that are displayed is heart rate and muscle tension. biofeedback has for decades been considered as effective preventive treatment of migraine among children and adolescents. in spite of that, it is not available to most patients in need. this is most likely because it requires specialised stationary equipment and a trained therapist. in this project, the researchers have developed a new smartphone biofeedback app connected to wearable, wireless sensors measuring muscle tension, finger temperature and heart rate. the app and sensors will be used to deliver biofeedback treatment to adolescents suffering for migraine. the goal of the study is to investigate the effect of the biofeedback treatment and the sham-biofeedback treatment on migraine headaches.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine with or without aura according to ichd-3 * two to eight migraine attacks per month * written informed consent signed by guardians, or by adolescent if age between 16-18 years. exclusion criteria: * participant not speaking norwegian * reduced sensibility, hearing or vision to a degree that impairs proper use of the app * serious psychiatric or neurologic disease and * currently using migraine prophylaxis.

Keywords: biofeedback smartphone app
the behavioral and brain mechanism of igd

Conditions: Internet Gaming Disorder

Summary: this project aims to investigate whether anodal tdcs of dlpfc enhances cognitive regulation over craving an emotions.


Eligibility criteria:
inclusion criteria: * inclusion criteria for igds were: 1. a score of 67 or higher on the cias; 2. engagement in internet gaming for over 14 hours per week for a minimum of one year; and 3. reporting of internet gaming as their primary online activity; * inclusion criteria for hcs were: 1. a score \< 60 on the cias; 2. never having spent more than 2 hours per week engaged in internet gaming exclusion criteria: * for all participants: 1. current or history of use of illegal substances and gambling; 2. current or history of psychiatric or neurological illness; and 3. current use of psychotropic medications
combined antihypertensive therapy and sexual dysfunction

Conditions: Hypertension; Sexual Dysfunction

Summary: this randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs. the researchers hypothesize that: 1. both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension. 2. felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels. 3. oxidative stress decline after both combination regimens. felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.

the effects of hypertension and its pharmacotherapy on sexual function are well known in men,although this topic remains unexplored in women.there is evidence suggests that some classes of antihypertensive drugs such as diuretics and beta-blockers have more negative impact on male sexual function than other classes such as calcium channel blockers(ccbs) and angiotensin-converting enzyme inhibitors(acei).some data suggest that angiotensin ⅱ antagonists（arbs) not only do not exacerbate sexual function in males,but even improve it. treatment with multiple antihypertensive medications was often necessary to attain blood-pressure goals recommended by guidelines.more than two third of patients with 2 or 3 degree of essential hypertension require combination therapy at the beginning of treatment to avoid target organ damage and to minimize the accidence of adverse events. ccbs were recommended by both jnc-7 and esh / esc 2007 hypertension guidelines as the basic for the treatment of hypertension.the purpose of this study is to compare the impacts of different ccb-based antihypertensive drugs combination on sexual behavior in both male and female patients with essential hypertension,thus provide evidences for physicians to increase patients adherence to the treatment regimens beside lowing blood pressure.

Eligibility criteria:
inclusion criteria: * patients with essential hypertension. * initial hypertension, or without taking any antihypertensive for at least one month. * sexual active. exclusion criteria: * patients with secondary hypertension. * patients with malignant hypertension, coronary heart disease, diabetes, a history of syncope, bradycardia (heart rate \<45 beats / min), atrioventricular block(ⅱ or ⅲ degree), sick sinus syndrome, congestive heart failure, a history of cerebral vascular accidents, serious hepatic and kidney dysfunction, a history of serious mental illness, pregnant, taking oral exogenous estrogens (including contraceptives), hysterectomy, breastfeeding, a history of alcohol or drug abuse, having serious conflict with sexual partner, severity sexual dysfunction. * patients refuse to answer questions, refuse to fill in the questionaires,or do not willing to take blood examination.

Keywords: hypertension antihypertensive agents combination sexual dysfunction oxidative stress
efficacy and safety study to compare ibuprofen + caffeine with ibuprofen alone in the treatment of headache

Conditions: Headache

Summary: based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to: * evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone; * evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone. the hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.


Eligibility criteria:
inclusion criteria: * patients with ability to read, understand and sign the ic; * patients with symptoms of frequent episodic tension headache, mild to moderate; * patients with symptoms of migraine with or without aura, of mild to moderate intensity; * patients who have had between two and five headache attacks in the last 30 days; * patients who accept the condition of ingesting less than three cups of coffee per day and / or reduce the intake of any beverage that contains caffeine; * patients who accept the condition not to drink any beverage that contains caffeine for 24 hours after drug administration. * patients able to understand and maintain the clinical protocol. * patients who started or changed prophylactic treatment for headache 30 days before inclusion. * female patients of childbearing age must agree to undergo pregnancy testing through urine. exclusion criteria: * patients in whom headache began after 50 years of age; * patients with strong or disabling headaches; * patients with chronic daily headaches lasting up to 72 h or with cluster headaches not responsive to common analgesics; * patients with headaches occurring in 15 or more days per month; * patients with secondary headaches; * patients who overuse analgesics (acetylsalicylic acid up to 300 mg / day) or nsaids; * known hypersensitivity to components of both formulations of the drug test as the comparison; * known hepatic or renal diseases; * patients who are pregnant or intend to become pregnant or lactating; * patients with severe concomitant systemic diseases such as cancer, diabetes, congenital or acquired heart diseases, hematological diseases, convulsive disorders, autoimmune diseases, renal failure, severe infections, hormonal disorders, pulmonary disorders and peptic diseases; * history of alcoholism or substance abuse.

Keywords: headache migraine ibuprofen caffeine
awareness of osteoporosis in ankylosing spondylosis patients

Conditions: Osteoporosis; Osteoporosis Risk; Ankylosing Spondylitis

Summary: osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. ankylosing spondylitis patients are at increased risk for developing osteoporosis. identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. this study is aimed to investigate awareness and knowledge of osteoporosis in ankylosing spondylitis patients.

osteoporosis is a common disease of bone loss. the reduced bone strength predisposes an increased risk for fractures in older individuals. it can affect people from different ethnicity. many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin d, immobility, and chronic inflammation. patients with ankylosing spondylitis are at high risk of developing osteoporosis due to chronic inflammation and their medications. patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. this study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with ankylosing spondylitis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ankylosing spondylitis * must be between the ages of 18 and 99 * must give consent to participate in the study exclusion criteria: • not giving consent
gallex 4 - long-term extension study to evaluate tesaglitazar therapy in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this is a parallel-group, multi-center, long-term extension study from the gallant 4 study to monitor the safety and tolerability of oral tesaglitazar compared with glibenclamide in patients with type 2 diabetes for up to 100 weeks of treatment. the total duration, including treatment and follow-up, is 103 weeks.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are \>=18 years of age * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * completed the last two visits of randomized treatment period in gallant 4 exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * previous enrollment in this long-term extension study * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study

Keywords: patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study gallant 4
retrospective study of intracerebral hemorrhage patients in hospital parc taulí

Conditions: Intracerebral Hemorrhage

Summary: this is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. the study will review the data from about 500 patients attended during the last ten years in the neurology department of hospital parc taulí de sabadell. the aim is to measure the size of the lesion in neuroimage (tc and mri), the edema, the alterations in diffusion weighted images and to correlate this data with clinical parameters and analytical measurements. with this approach investigators plan to investigate the incidence of hematoma growth, the role of perilesional edema and diffusion changes, and the relation between neuroimaging findings and clinical outcome. the study also try to establish significant correlations between clinical and analytical data, the clinical outcome and and the magnitude of changes in neuroimaging.


Eligibility criteria:
inclusion criteria: * patients who have been attended at the hospital parc taulí for the last 10 years after presenting an intraparenchymal hemorrhage. * the patients have had to undergo a computed tomography at the admission and a cranial magnetic resonance during the hospitalization in the time course specified in point in the protocol * the patients must present in their clinical story the analytical determinations detailed in the protocol. exclusion criteria: * intracerebral hemorrhage secondary to head trauma * intracerebral hemorrhage secondary to neoplasm
rivastigmine in multiple sclerosis patients with cognitive impairment

Conditions: Multiple Sclerosis; Cognitive Impairment

Summary: this study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired multiple sclerosis (ms) patients. primary objective was the assessment of cognition by the selective reminding test (srt) -a subtest of the brief repeatable battery (brb) - after titration of 4 weeks and maintenance of 12 weeks. this double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.


Eligibility criteria:
inclusion criteria: 1. written informed consent to participate in the trial 2. males and females between 18 and 55 years of age; 3. definite diagnosis of multiple sclerosis as defined by 2005 revised mcdonald criteria 4. ms-subtype: clinical isolated syndrome (cis), relapsing remitting multiple sclerosis (rrms), secondary progressive multiple sclerosis (spms); 5. cognitive impairment 6. sufficient education to read, write and communicate comprehensibly exclusion criteria: 1. use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 2. women who are pregnant or breast feeding or who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception 3. with a physical or sensory disability that can subjectively prevent the patient from completing all study requirements 4. patients suffering any other type of concomitant psychiatric and/or neurological disorder other than ms which is known to affect cognition (e.g. severe depressive symptoms, cerebrovascular diseases, epilepsy). 5. patients suffering an acute relapse of ms in the previous 30 days (treated or not with intravenous or oral glucocorticoid regimens) prior to baseline. 6. with a history or current problem of drug-addiction and/or alcohol abuse. 7. known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes \[≥126 mg/dl or ≥7 mmol/l if fasting and ≥200 mg/dl or 11.1 mmol/l if random testing\] a patient should be further evaluated for diabetes mellitus) 8. with a history of severe or moderate-severe cranioencephalic trauma. 9. history or presence of any intolerance or contraindication for the application of rivastigmine (or for drugs with similar chemical structures) as listed in the current investigator's brochure and/or spc, i.e. severe liver insufficiency, pancreatitis, gastric ulcer, convulsions. 10. with a history in the past year or a current diagnosis of cerebrovascular disease (for instance, stroke, transient ischemic events, aneurysms). 11. severe depressive symptoms indicated by a score of more than ≥ 14 on the madrs at screening 12. history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin other protocol-defined inclusion/exclusion criteria may apply

Keywords: multiple sclerosis cognition rivastigmine patch
salivary interleukin-32, interleukin-10, interleukin-6 and tumor necrosis factor-alpha levels in children

Conditions: Early Childhood Caries

Summary: this study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (tnf-α) in saliva of children with early childhood caries.

fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. probing pocket depth (ppd), gingival index (gi) and plaque index (pi) will be recorded and saliva samples will be collected. interleukin-32, interleukin-10, interleukin-6 and tnf-α will be analyzed in saliva samples by elisa.

Eligibility criteria:
inclusion criteria: * children with untreated early chilhood caries * age between 3 and 6 years exclusion criteria: * having a systemic problem or mental retardation * children with treated caries

Keywords: early childhood caries
training of psychosocial skills based on cognitive behavioural therapy for patients with parkinson's disease

Conditions: Parkinson's Disease; Mild Cognitive Impairment

Summary: patients with parkinson's disease (pd) will be trained using a cognitive behavioral group-training-program to reduce stress and augment quality of life. an unspecific group with the same amount and frequency of meetings is used as a control group. for the evaluation of the training effects, scales to assess quality of life, analyses of psychopathological variations as well as neurocognitive tests will be used. protocol amendment in 1-2017: addition of fu year 3 and year 5.


Eligibility criteria:
inclusion criteria: * patients with idiopathic parkinson's disease according to united kingdom parkinson's disease brain bank criteria, being either cognitively normal, suffering from mild cognitive impairment or having mild dementia. patients must be able to give their written informed consent. exclusion criteria: * moderate or severe dementia (dms-iv, mini mental status (mms) \<24), other neurological or psychiatric diseases of the brain not related to pd, secondary parkinsonism, physical impairment hindering the adequate execution of the training, insufficient knowledge of german or pregnancy are exclusion criteria. deep brain stimulation (dbs) is no exclusion criterion.