Kornimate/medical-research-clean huggingface dataset:
treatment of epidermolysis bullosa dystrophica by polyphenon e (epigallocatechin 3 gallate)

Conditions: Epidermolysis Bullosa Dystrophica

Summary: dystrophic epidermolysis bullosa hereditaria are genodermatosis responsible for formation of cutaneous bullous lesion arising spontaneously or after mechanical trauma. these lesions are due to mutation on gene col7a1 coding for collagen vii. there is no treatment available. cares are consisting to dress lesions and to protect the skin. the investigators have recently observed on patients having residual expression of collagen vii that phenotype severity is modulated by activation degree of dermic metalloproteinase. the investigators have also observed that epigallocatechin-3-gallate (polyphenon e®) could be regulated this activity. the primary purpose of this study is to assessing the efficacity of polyphenon e to decrease the number of cutaneous bullosa after four month of treatment. the primary outcome measure is the rate of patient presenting a decrease of 20% or more of the number of cutaneous bullosa. secondary outcomes are: severity of mucosa impairment, affected cutaneous surface, the average duration of cicatrisation and treatment tolerance. this study foresees the inclusion of 22 patients older than 2 years old in 5 centers. when patients are included, they will be randomized and receive the treatment (or placebo) for 4 months.


Eligibility criteria:
inclusion criteria: * known mutation of col7a1 exclusion criteria: * tea drinkers * patient receiving induction treatment,protease inhibitor treatment * liver failure
dynamic changes of ductus arteriosus in < 31 weeks preterm infants: an observational study

Conditions: Preterm; Ductus Arteriosus

Summary: the ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. after birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. the persistent presence of ductus arteriosus leads to significant pressure changes in the systemic and pulmonary circulation, which have adverse effects on extremely/very premature infants. therefore, persistent patent ductus arteriosus (pda) is a systemic disease.

hemodynamic significant pda(hspda) is a risk factor for intraventricular hemorrhage(ivh), bronchopulmonary dysplasia(bpd), necrotizing enterocolitis(nec). a meta-analysis from cochrane shows that compared to conservative treatment, drug therapy for pda within 3 and 7 days after birth does not promote pda closure and reduce the incidence of bpd. therefore, there is currently a tendency not to provide medication intervention. although ductus arteriosus quickly closes itself after birth in normal term infants, however, the dynamic changes detail of ductus arteriosus in preterm infants are unknown.

Eligibility criteria:
inclusion criteria: * less than 32 weeks' gestational age * admission with 1 hours after birth exclusion criteria: * congenital abnormalities * parents' refusal

Keywords: preterm patent ductus arteriosus
brain tumor surgery and postoperative delirium

Conditions: Brain Tumor

Summary: 1. to explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery. 2. to explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain. 3. to explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.


Eligibility criteria:
inclusion criteria: * at least 18 years old and less than 80 years old * receive brain tumor surgery with asa ii\~iii. exclusion criteria: * under the age of 18 or over 80 * consciousness unclear * those who have not signed a consent form * those with high anesthesia risk asa iv or higher

Keywords: brain tumor postoperative delirium
care pathway for sub-acute hip rehabilitation

Conditions: Hip Fractures

Summary: the effectiveness of integrated care pathways for hip fractures in sub-acute rehabilitation settings is not known. the study objective was to assess if a hip fracture integrated care pathway at a sub-acute rehabilitation facility would result in better functional outcomes, shorter length of stay and fewer institutionalisations. a randomised controlled trial on an integrated care pathway was conducted for hip fracture patients in a sub-acute rehabilitation setting. the study supports the use of integrated care pathways in sub-acute rehabilitation settings to reduce length of stay whilst achieving the same functional gains.

all patients admitted to st luke's hospital, a 185-bed hospital in singapore providing multidisciplinary stepdown care, from 8 september 2004 to 14 june 2006 for the purpose of rehabilitation after a new hip fracture were included. patients were excluded if any of the following criteria were present: (i) pre-morbid non-ambulatory status, (ii) nursing home residents, (iii) palliative care patients, and (iv) patients previously enlisted for the trial. administrative staff allocated patients to either icp or usual care according to the last digit of their national registration identity card (nric) numbers, odd numbers to the intervention group and even numbers to the control group. patients were then admitted to 1 of 2 intervention wards or 1 of 3 control wards. patients were enrolled by the principal investigators only after moving into their respective wards because of work flow limitations. those who refused consent or were excluded remained in their assigned wards and received usual care. both intervention and control groups were under the care of multidisciplinary teams but the intervention group had structured assessments and checklists in addition to usual care while the control group had usual care alone.

Eligibility criteria:
inclusion criteria: * patients admitted to st luke's hospital for the purpose of rehabilitation after a new hip fracture. exclusion criteria: * patients were excluded if any of the following criteria were present: (i) pre-morbid non-ambulatory status, (ii) nursing home residents, (iii) palliative care patients, and (iv) patients previously enlisted for the trial.

Keywords: critical pathway, length of stay, recovery of function, subacute care
self-myofascial release in hemophilic ankle arthropathy

Conditions: Hemophilia

Summary: introduction: hemophilic ankle arthropathy is manifested by degenerative functional alterations (deficit of muscle strength, mobility and proprioception) (intra-articular alterations) and chronic pain. myofascial release techniques are used to treat soft tissue adhesions, relieve pain and reduce tissue sensitivity. design. a randomized clinical trial. aimed: to evaluate the safety and effectiveness of a protocol by self-myofascial release with foam roller applied in patients with hemophilic ankle arthropathy. patients: 70 patients with ankle arthropathy will be recruited for inclusion in the study. patients will be recruited in 5 centers, from different regions of spain. intervention: each session will last approximately 15 minutes, with five physiotherapy sessions per week for a period of 3 months. patients will be evaluated at baseline, after the intervention, and after a follow-up period of 3 months. the treatment program includes 11 exercises that must be administered bilaterally. a mobile application will be developed where each patient will be able to observe the exercises to be carried out. measuring instruments and study variables: digital goniometer (ankle range of motion); visual analog scale and pressure algometer (joint pain); haemophilia joint health score (joint status); dynamometer assess (muscle strength); 6-minute walking test (functionality of lower limbs); mobile device (activity record); finger-floor test (muscle flexibility). at the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment. expected results: to demonstrate the safety of this physiotherapy technique in patients with hemophilia. likewise, an improvement in ankle pain, functionality and joint motion is expected.


Eligibility criteria:
inclusion criteria: * being over 18 years old * patients with a medical diagnosis of hemophilia a or b. * patients with a severe phenotype of hemophilia (\<1% fviii/fix). * patients with a medical diagnosis of hemophilic ankle arthropathy and more than 3 points on the hemophilia joint health score. * nno scheduled orthopedic surgeries during the study phase. * signing the informed consent document. exclusion criteria: * patients with ankle hemarthrosis in the month before the beginning of the study. * patients unable to walk even with technical aids. * patients with hemophilic elbow arthropathy that prevented the performance of the exercises. * patients failing to complete at least 80% of the sessions scheduled in the intervention

Keywords: hemophilic arthropathy ankle self-myofascial release safety joint pain functionality
the precious study: predicting crohn's & colitis outcomes in the united states

Conditions: Crohn Disease; Ulcerative Colitis; IBD; Inflammatory Bowel Diseases

Summary: a multi-center observational study based at referral centers and community hospitals within the us. patients' blood will be collected at enrollment for testing with predictsure ibd™, which will occur at a later date. patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. clinicians and patients will be blinded to the biomarker results.

this is a multi-center, observational study of newly diagnosed ibd (cd or uc) patients. the study aims to assess whether a prognostic biomarker can stratify ibd patients in the us.

Eligibility criteria:
inclusion criteria: * active uc or cd with typical symptoms in conjunction with at least one objective measure of disease activity: elevated crp, calprotectin, endoscopic evidence. * not currently receiving systemic therapy\* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose. * due to be managed using a "step-up" or "accelerated step-up" approach (so will not receive biologics as first line therapy). * aged 16-80 years old. note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve. exclusion criteria: * the presence of any of the following will preclude patient inclusion: * patients with fistulating peri-anal crohn's disease or active perianal sepsis. * obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy. * patients who are scheduled to start on "top-down" therapy or receive biologics as a first line therapy

Keywords: crohn's disease ulcerative colitis ibd inflammatory bowel disease precious
multi-site near infrared spectroscopy (nirs) monitoring of children during tilt table testing

Conditions: Syncope

Summary: purpose of the study this study will explore the use of multi-site nirs monitoring during tilt table testing, combining somatic and cerebral saturations data with hemodynamic data to establish the non-invasive assessment of global cardiac output distribution trends. hypothesis / specific aims study aims: to evaluate the utility of multi-site nirs monitoring in the cardiovascular hemodynamic assessment of children and adolescents during tilt table testing by establishing a non-invasive method to predict cardiac output maldistribution with the use of two-site nirs monitoring in children and adolescents with syncope.


Eligibility criteria:
inclusion criteria: * between the ages of 7 and 21 years * referred to the exercise stress lab due to syncope exclusion criteria: * under 7 or over 21 years of age * referred to the exercise stress lab for anything other than syncope

Keywords: infrared spectroscopy syncope tilt table testing
probiotics and the gut brain axis- do probiotics interact with the vagal nerve?

Conditions: Depressive Disorder, Major

Summary: the purpose of this study is to investigate the effects of a multispecies probiotic on the function of the vagal nerve in patients with major depression and healthy participants in a single-center, randomized, placebo-controlled trial.

after being informed about the study and potential risks, all participants giving written informed consent will be screened for eligibility for study entry and will be randomized in a double-blind manner to receive either a multistrain probiotic or a placebo for 3 months. at entry, 1 week after inclusion, 4 weeks after inclusion and 3 months (end of study) vagal activity will be measured using a 24hr electrocardiogram.

Eligibility criteria:
inclusion criteria: * informed consenct * confirmed diagnosis of depression according to icd-10 or dsm-v * age between 18 and 65 years exclusion criteria: * suicidality * no informed consent or no ability to provide consent * cardiovascular disease * pregnancy, breastfeeding * alcohol or drug dependency * other severe psychiatric or organic conditions (epilepsy, brain tumor, recent surgery) * malignant diseases * dementia (mmst\<20) * severe autoimmune-disorder or immunosuppression (systemic lupus, hiv, multiple sclerosis) * antibiotic therapy in the last month * misuse of laxative * acute infections * diarrhoea * gastrointestinal surgeries (except appendectomy) * no probiotic intake in the last 6 months * no regular intake of other supplements, probiotics or antibiotics during the study

Keywords: depression vagal function multispecies probiotic heart rate variability
the value of circulating tumor cells in patient with nsclc in postoperative recurrence monitoring

Conditions: Non-small-cell Lung Carcinoma

Summary: the purpose of this study is to assess the value of circulating tumor cells (ctc)for non-small cell lung cancer in the postoperative recurrence monitoring by comparing the ctcs, ct and tumor markers at different time points.the time of ctc and carcinoembryonic antigen(cea) detection is baseline, 2\~7 days, 3 months, 6 months, 12 months, 24 months, 36 months after the surgery. and the time of ct detection is 6 months, 12 months, 24 months, 36 months after the surgery.


Eligibility criteria:
inclusion criteria: * age 18-80 years old * patients with histologically documented (stage ⅰ/ⅱ/ⅲa ) non-small cell lung cancer. * patients will undergo surgery. * patients with preoperative ctcs ≥8.5 units / 3 ml * informed consent must be obtained from all patients prior to beginning therapy. patients should have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with histologically documented not (stage ⅰ/ⅱ/ⅲa ) non-small cell lung cancer. * after the operation review, patients' result of ctc, ct and tumor markers is incomplete at the same point. * the blood sample isn't collected in predetermined time. * the blood samples appear hemolysis. * the blood sample isn't enough.

Keywords: non-small-cell lung carcinoma circulating tumor cells
ischemia in hemodialysed patients: ivabradine versus carvedilol

Conditions: Coronary Heart Disease; Angina; Hemodialysis

Summary: in hemodialysed patients, coronary heart disease is the leading cause of mortality and morbidity. most of the commonly used drug for ischemia are used in this patients, but few prospective data are available. among anti-ischemic drugs betablocker provided evidence of beneficial effects on outcome and, in dialysis patients, carvedilol was successfully used also in heart failure. ivabradine is the latest anti-ischemic drug that provided evidence of benefit in general population, but no study is available in dialysis patients. aim of the present study is to compare in a randomized, double-blind, parallel group trial the effects of ivabradine compared with carvedilol on event-free survival at 18 months in a hemodialysed population of patients with established coronary heart disease.


Eligibility criteria:
inclusion criteria: * documented cad evidenced by either coronary angiography (\>50% diameter stenosis of a major coronary artery) or a previously documented myocardial infarction * transient ischemia evidenced by abnormalities during an exercise ecg (standard bruce protocol), myocardial perfusion scintigraphy, or stress regional wall motion study done within 6 months of study entry exclusion criteria: * unstable angina pectoris * myocardial infarction or coronary revascularization within 3 months of study entry * an ecg abnormality interfering with exercise st-segment interpretation (eg, st-segment depression \>0.5 mm, qrs duration \>0.1 second, r-wave amplitude \<8 mm,preexcitation,or atrial fibrillation) * inability to undergo exercise testing * uncontrolled hypertension * other serious condition (medical, psychiatric, cognitive, or social) * symptoms of sufficient severity (canadian class ii or higher) to require antianginal medications other than nitrates * heart failure * greater than first-degree atrio-ventricular block, asthma, or other contraindications to betablocker therapy

Keywords: hemodialysis coronary heart disease angina betablocker carvedilol ivabradine
plasma dihydroceramides are associated with hepatic steatosis in type 1 and type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Summary: sphingolipids are associated with metabolic diseases. distribution of plasma sphingolipids in type 1 and type 2 diabetes has never been studied. the objective of the ceradiab study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

sphingolipids represent a major class of lipids that are structural and signaling molecules. major bioactive sphingolipids include ceramide, dihydroceramide, sphingosine, sphingosine-1-phosphate and sphingomyelin. sphingoliplids are involved in development of various chronic metabolic diseases. some ceramides species are implicated in pancreatic β-cell apoptosis and in insulin resistance in muscle, fat and liver. some studies have shown association between inhibition of ceramide synthesis, insulin sensibility and lower hepatic steatosis. the deposition of hepatic lipids, especially triacylglycerol, defines the development of hepatic steatosis. however, sphingolipids appear to play an important role in non-alcoholic fatty liver disease (nafld) and in its progression. changes in plasma shingolipids concentrations may also contribute to the pathogenesis in cardiovascular disease and atherosclerosis. distribution of plasma sphingolipids concentrations in type 1 and type 2 diabetes has poorly been studied. the objective of the ceradiab study is to compare plasma sphingoliplids concentrations in type 1 and type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: * type 1 or 2 diabetes exclusion criteria: * atypical diabetes * family dyslipidemia * nonmetabolic hepatopathy * severe renal failure * corticosteroid or immunosuppressive therapy

Keywords: sphingolipids hepatic steatosis non-alcoholic fatty liver disease macrovascular complications insulin resistance microvasclar complications nafld
electronic monitoring combined with weekly feedback and reminders

Conditions: Asthma

Summary: a total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids (ics) were randomly allocated to receive electronic monitoring combined with instant messaging software -based weekly feeding back adherence and reminders to keep taking the ics (intervention group) and to receive electronic monitoring only (control group). the device-monitored adherence rates and caregiver-reported adherence rates were analyzed.


Eligibility criteria:
inclusion criteria: 1. patients having mild or moderate persistent asthma 2. 6 months-3 years 3. taking regular inhaled steroids, with no change in their medication in the last month. exclusion criteria: participants who had severe persistent asthma or another respiratory disease or did not live in shanghai were excluded.

Keywords: pediatric asthma adherence electronic device
ultrasound findings of thumb muscles in 1st carpometacarpal osteoarthritis

Conditions: Osteoarthrosis; Ultrasound

Summary: carpometacarpal (cmc) joint osteoarthritis is a disorder that is estimated to affect more than one-third of postmenopausal women, leading to decreased muscle strength, reduced joint range of motion, and pain.the pathogenesis of thumb cmc osteoarthritis involves complex interactions between biomechanical forces, genetic predisposition, hormonal changes, repetitive microtrauma, and aging. an important factor in the progression of carpometacarpal osteoarthritis is the loss of joint stability provided by the surrounding muscles (2). the common methods for diagnosing thumb cmc oa is plain radiographs and clinical examinations. however, radiographs are unable to assess the role of surrounding structures, including muscles and ligaments. ultrasound is a cost-effective, radiation-free, and easily applicable imaging method.

in this cross-sectional study, patients with various stages of 1st carpometacarpal (cmc) joint osteoarthritis (oa) were assessed using standard radiographs based on the modified eaton litter classification. postmenopausal women with clinical and/or radiological evidence of 1st cmc oa will be included (group 1). in the healthy control group, subjects will be matched based on age and hand dominance (group 2). demographic information including age, sex, height, weight, body mass index (bmi, kg/m²), dominant hand, and symptom duration (in months) will recorded. pain levels will be assessed using the visual analogue scale (vas).the thickness of the thenar eminence muscles (longitudinal thickness of the first dorsal interosseous muscle (fdi), abductor pollicis brevis (apb), and opponens pollicis (opp)) was measured using musculoskeletal ultrasound. muscle strength in both hands will be evaluated using grip strength measured with a dynamometer . pressure pain threshold (ppt) for painful and non-painful finger joints will be assessed using a hand-held algometer

Eligibility criteria:
inclusion criteria: postmenopausal women with clinical and/or radiological evidence of 1st cmc oa exclusion criteria: * de quervain\&#39;s tenosynovitis, flexor carpi radialis tendon pathology, and carpal tunnel syndrome, as well as those with hand trauma or hand surgery within the past year, had received steroid and local anesthetic injections into the 1st cmc joint within the last 3 months, or had connective tissue disorders, rheumatologic, or autoimmune diseases

Keywords: osteoarthrosis ultrasound thenar muscles
study of human insulin inhalation powder in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the lilly/alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 2 diabetes. patients will be treated for 24 months with a 2-month follow-up period.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * non smoker * normal lung function exclusion criteria: * pulmonary, hepatic, or renal disease * congestive heart failure * active malignancy * systemic glucocorticoid therapy