Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of bevacizumab in high-risk corneal transplant survival

Conditions: Corneal Neovascularization; Corneal Graft Failure

Summary: the leading risk factor for corneal transplant rejection is abnormal blood vessel growth of the host bed. vascular endothelial growth factor (vegf) is thought to be a mediator of this corneal neovascularization (nv), therefore we would like to test the safety and efficacy of local vegf blockade in the promotion of graft survival in high risk corneal transplants.

the purpose of this study is to test the effectiveness of a drug, bevacizumab (avastin), in preventing blood vessels that often occur after a corneal transplantation which are considered at "high-risk" for rejection. in many cases these blood vessels lead to the graft rejection and eventual failure of the corneal transplant. it is hoped that this treatment will increase the chances of corneal graft survival. the medication used in this study is called bevacizumab or avastin (genentech, inc). it works by inhibiting the action of a molecule called vascular endothelial growth factor (vegf). vegf is a substance molecule that binds to certain cells to stimulate new blood vessel formation. when vegf is bound to the drug, it cannot stimulate the formation and growth of new blood vessels. growth of blood vessels into the cornea is a complication which can worsen the prognosis of your corneal transplant and put the transplant at a higher risk for rejection.

Eligibility criteria:
inclusion criteria: * age \> 18 years * patient or legally authorized representative willing and able to provide written informed consent * willing and able to comply with study assessments for the full duration of the study * high-risk characteristics for penetrating keratoplasty: either presence of 1.) corneal nv in one or more quadrants (≥ 3 clock hours nv ≥ 2mm from the limbus) or 2.) extension of corneal nv to graft-host junction in a previous failed graft * in generally good stable overall health exclusion criteria: * history of stevens-johnson syndrome or ocular pemphigoid * ocular or periocular malignancy * non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively * uncontrolled glaucoma * currently on dialysis * has received treatment with anti-vegf agents (intraocular or systemic) within 45 days of study entry * concurrent use of systemic anti-vegf agents * change in topical corticosteroid regimen within 14 days of transplantation * use of systemic immunosuppressive for indication other than corneal graft rejection * pregnancy (positive pregnancy test) or lactating * pre-menopausal women not using adequate contraception (reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method) * uncontrolled hypertension defined as systolic blood pressure (bp) ≥150 or diastolic bp ≥90 mmhg * history of thromboembolic event within 12 months prior to study entry * participation in another simultaneous medical investigation or trial

Keywords: high-risk corneal transplantation penetrating keratoplasty neovascularization corneal blood vessels avastin bevacizumab corneal graft
evaluation of fructans supplementation on parameters of metabolic syndrome

Conditions: Obesity

Summary: obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation. in our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. these effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. moreover, studies have shown that fructans intake promotes satiety (cani et al, diabetes 2007) and or decreases fat mass (abrams et al, journal of pediatrics 2007) in healthy human. an intervention study in obese patients is thus needed to study the effects of fructans in the target population.


Eligibility criteria:
inclusion criteria: * bmi\>30 kg/m2 exclusion criteria: * acute or chronic evoluting disease * alcohol consumption \> 30 units/week * more than 30 minutes of sports 3 times/week * usual consumption of pre/probiotics or fibers supplement * recent consumption of antibiotics * slimming diet or unusual diet * pregnant women * anti-diabetics drugs ou slimming drugs * previous bariatric surgery * severe oesophagus reflux

Keywords: fructans supplementation
the emerging role of resolvins in the prevention of chronic pain after thoracic surgery

Conditions: Patients Scheduled for Thoracic Surgery/Esophagectomy Will be Enrolled; Persistent Post Surgical Pain

Summary: the aim of the study is to investigate whether pre-operative dysregulated systemic lipid mediator pathways are associated with increased risk for the development of persistent post surgical pain. in addition we will investigate whether treatment with an over the counter dietary supplement containing a fractionated marine lipid derivative from anchovy and sardine oil prevents the development of chronic pain after surgery.


Eligibility criteria:
inclusion criteria: * scheduled to undergo esophagectomy at bwh * 18-80 years old exclusion criteria: * pre-existing chronic pain * current opioid use * current treatment with corticosteroids * evidence of active infection * chronic liver disease * end-stage renal disease (ckd-5) * chronic inflammatory disorders * recent major surgery or illness within 30 days * use of immunosuppressive medication * history of organ transplant * pregnancy or plans to become pregnant * lactating * allergies to fish or fish oil
internet-based cbt for children with anxiety disorders: implementation in clinical settings

Conditions: Anxiety Disorders

Summary: the primary objective of this study is to test the effectiveness of internet-delivered and therapist-guided internet-based cognitive behavior therapy (icbt) for children with anxiety disorders (including social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder and specific phobia) in a randomized trial where participants will be allocated to either icbt or to a supportive control condition. non-responders (defined as those participants who still uphold their primary anxiety disorder after the icbt treatment) will be offered traditional (face-to-face) cbt. follow-ups are conducted at 3 and 12 months after treatment completion.


Eligibility criteria:
inclusion criteria: * a primary diagnosis of any of the following anxiety disorders, as defined by dsm-v (social anxiety disorder, separation anxiety disorder, generalized anxiety disorder, panic disorder or specific phobia) * age between 8 and 12 years * ability to read and write swedish * daily access to the internet * a parent that is able to co-participate in the treatment * participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment exclusion criteria: * diagnosed with autism spectrum disorder, psychosis, bipolar disorder or severe eating disorder * present risk of suicide * ongoing substance dependence * completed cbt for any anxiety disorder within the last 6 months (defined as at least 5 sessions of cbt including in vivo exposure sessions)

Keywords: cognitive behavior therapy child randomized controlled trial internet
study of weekly radiotherapy for bladder cancer

Conditions: Bladder Cancer

Summary: background localised muscle invasive bladder cancer (mibc) is life-threatening and can cause significant symptoms. around 50% of patients with mibc who are referred for radiotherapy are unfit for standard radical treatment (surgery or daily radiotherapy with chemotherapy), but would have a normal life expectancy if their cancer were adequately controlled. retrospective studies suggest that radiotherapy which is given weekly using fewer fractions and higher doses (hypofractionated), may be an alternative where daily radiotherapy is not an option. radiotherapy treatment is planned based on information from a ct scan which shows the position and shape of the bladder. this plan needs to take into account the fact that the bladder's shape and position can change, depending on how full it is and because of where it is in relation to the bowel. a safety margin is therefore added around the bladder on the planned treatment, to reduce the risk of missing any of the bladder with the radiotherapy. it is now possible to take scans of the bladder's position before each treatment and adjust the position of the treatment plan accordingly to ensure the bladder is fully covered by it. in this study we are also looking at whether it is possible to design a series of treatment plans with different size safety margins and then choose one that fits best for each particular day. this is called 'adaptive radiotherapy'. this technique may enable accurate treatment delivery using smaller safety margins and this might help to reduce side effects. aims in patients with mibc not suitable for cystectomy or daily radiotherapy we aim to assess: 1. whether treatment using adaptive planning can be successfully delivered at multiple sites across the uk and results in acceptable levels of toxicity 2. the local tumour control rate achieved by hypofractionated weekly radiotherapy 3. the requirement to treat with adaptive planning. how results will be used results will provide robust evidence for use of hypofractionated radiotherapy and assess whether this is a plausible and worthwhile treatment in this patient population. the randomised element of the trial will support the implementation of image-guided adaptive radiotherapy for bladder cancer in the uk. hybrid will provide evidence on the benefits or otherwise of this methodology and inform the development of further trials in this and other patient groups.


Eligibility criteria:
inclusion criteria: * written informed consent * age ≥18 years * histologically confirmed invasive bladder carcinoma (t2-t4a n0 m0; any histological sub-type) * unsuitable for radical cystectomy or daily fractionated radiotherapy for any reason (including performance status, co-morbidity, patient refusal) * expected survival \>6 months * who performance status 0-3 * willing to undergo post treatment cystoscopy exclusion criteria: * nodal or metastatic disease * concurrent malignancy * previous pelvic radiotherapy * urinary catheter in-situ * any other contra-indication to radiotherapy (e.g. inflammatory bowel disease) * unable to attend for post treatment follow up
the effects of vitamin k2 supplementation on the progression of coronary artery calcification

Conditions: Coronary Artery Disease

Summary: both coronary artery calcification (cac)and its annual progression are a strong predictors of cardiovascular events. the development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. an important inhibitor of calcification is matrix gla protein (mgp): a protein present in the vascular wall where it is synthesized by vascular smooth muscle cells (vsmc). mgp requires vitamin k-mediated carboxylation to function properly. deficiency of vitamin k has been demonstrated to cause arterial calcification and a diet containing large amounts of vitamin k2 was associated with lower cac and cardiovascular risk. in animal studies, active supplementation of vitamin k2 caused regression of existing arterial calcification. therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of vitamin k2 (menaquinone-7) to patients with established cac will lead to a decreased progression-rate of cac after 24 months of follow-up in comparison to placebo.


Eligibility criteria:
inclusion criteria: * age 18 years or older * baseline coronary computed tomographic angiography (ccta) of sufficient quality * baseline agatston calciumscore 100 - 400 exclusion criteria: * baseline-scan of insufficient quality * heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol) * chronic or paroxysmal atrial fibrillation * presence or scheduled coronary revascularization procedure * history of myocardial infarction or stroke. * presence of diabetes mellitus. * known kidney disease or a glomerular filtration rate (gfr)mdrd \< 60 ml/min/1.73m2 * malignant disease (exception: treated basal-cell or squamous cell carcinoma). * use of vitamin k antagonists. * a life-expectancy \< 2 years * pregnancy or wish to become pregnant in the near future.

Keywords: coronary artery calcification vitamin k trial treatment
investigational air-activated adhesive-backed heat patch (3-cell)

Conditions: Healthy

Summary: this is an open-label study. a total of approximately 60 subjects will be randomly assigned to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe or a heat patch (30 subjects) alone. the study will consist of 2 visits.


Eligibility criteria:
inclusion criteria: * subjects who complete an appropriately administered informed consent process that includes signing the consent form. * subjects 18-75 years old of either sex. * are of any skin type or race, providing the skin pigmentation will allow discernment of erythema; * subjects who are in good general health. * subjects who are willing and able to have the test products applied as directed, and comply with study instructions. * participants must be willing to restrict their activity for the 8 hour patch wear time. * all participants agree to wear a t-shirt provided by the site for the entire 8 hour patch wear time. exclusion criteria: * subjects who have a history of sensitivity to any of the test products or adhesion material. * subjects who are pregnant. * subject with excessive hair at the application sites, scar tissue, tattoo, or coloration that would interfere with placement of test product or skin assessment. * subjects with diabetes, rheumatoid arthritis, poor circulation or have any clinically significant chronic illness. * subjects with active dermatitis (including sunburn) in the treatment area, or other visible dermatological disease which, in the investigator's opinion, might interfere with the response to the test products or interfere with the skin assessments associated with the test products. * have history of significant dermatologic cancers (eg, melanoma, squamous cell carcinoma). * subjects who have used topical dermatological products in the application area within 24 hours prior to the test product application. * subject using a concomitant medication that, in the investigator's opinion, could interfere with the interpretation of study results. examples of such drugs include non-steroidal anti-inflammatory drugs (nsaids, e.g., aspirin), topical or systemic corticosteroids, and cold/cough products containing antihistamines and/or either phentolamine, pseudoephedrine or phenylpropanolamine. * subjects who have received an investigational medication or device within 30 days prior to enrolment into this study. * subjects who are currently participating in an investigational study. * subject who are known to be noncompliant or are unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Keywords: temperature profile air activated 3-cell patch adhesion
contrast enhanced spectral mammography vs. mri for breast cancer screening

Conditions: Breast Cancer

Summary: this research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast magnetic resonance imaging (mri) for cancer screening

mammography is the main way to help find breast cancers early so they can be treated. unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. in these women, breast mri is also used to help find breast cancers. contrast enhanced mammography is a new type of mammogram. it uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. this is similar to breast mri. for this study, participants who had both cem and mri evaluating a finding that initiated from a screening exam will be included. radiologists will compare the images to see if the contrast enhanced mammograms and the breast mri find the same number of breast cancers. if the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Eligibility criteria:
inclusion criteria: * cesm and mri exam performed within 3 months of one another. * cesm and breast mri exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and mri) * cesm studies will include at least four low energy and four recombined images (lcc, lmlo, rcc, rmlo). * mri exams will include at least fluid sensitive sequence, multi-phase t1-weighted exclusion criteria: * imaging sets with implants. * imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study mri or cesm. * imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available

Keywords: breast cancer screening breast mri contrast enhanced spectral mammography
ambulatory geriatric evaluation - frailty intervention trial

Conditions: Frail Elderly; Deaths

Summary: the main purpose of this randomised controlled trial is to study if a comprehensive geriatric assessment (cga) and follow up for community-dwelling elderly people can improve outcomes such as health and health-related quality of life among both patients and relatives, feeling of safety among both patients and relatives and reduce costs, compared with usual care.

frail older adults are at increased risk of vulnerability and serious health problems. this leads to increased suffering and higher healthcare utilization. there are major gaps in the knowledge needed to create the most favourable care model for preventing frailty and increasing health-related of life. the purpose of this randomised controlled trial is to study if a comprehensive geriatric assessment and follow up in community-dwelling elderly people can prevent frailty, hospitalisation and adverse effects of frailty, improve health and health-related quality of life, and reduce costs, compared with usual care. in a randomized, controlled trial with 24 months of follow-up, a total of 430 older adults with multimorbidity will be randomized into two groups. the intervention group will receive comprehensive geriatric assessment and follow up and the same standard health care services as the control group. the comprehensive geriatric assessment and follow up will be provides through an outpatient facility that tailors care from a holistic perspective and, based on each patient's individual needs in line with the policy program that sweden's pensioners' organizations have presented in 2010 together with the swedish association of geriatric medicine. the team includes, among other things. a. geriatricians, nurses, physiotherapists, assistance officer, dietician, pharmacist and co-operation with the dental hygienist. the primary outcome is development of frailty and hospitalization. secondary outcomes are adverse effects of frailty, health and health-related quality of life and costs. there is a knowledge gap of how health care can identify persons with frailty and risks for frailty and how to meet their specific care needs. the study aims to fill a clinically important knowledge gap that can guide further development of future care for older people with multi-morbidity and frailty. cga is readily transferable to clinical practice.

Eligibility criteria:
inclusion criteria: * elderly 75 years and above * have been hospitalized three or more times in the last 12 months * have three or more diagnoses in their medical records according to the international classification of diseases (icd-10) * live in their own homes (not nursing home) in the municipality of norrkoeping * accept to participate in the study. exclusion criteria: - fulfilling the inclusion criteria but living in a special accommodation for the elderly

Keywords: quality of life feeling of security costs multiprofessional team geriatric competence
talocrural mobilization with movement in spastic cerebral palsy

Conditions: Spastic Cerebral Palsy (sCP)

Summary: the aim of this randomized controlled trial is to find the effect of mulligan's mobilization with movement of talocrural joint in cerebral palsy patients having spasticity on improving ankle range of motion, improving balance and its effect on gait speed.

cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. it is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. in spastic cp, there is significant weakness that contributes to abnormal posture and movement. this is also accompanied by decreased muscle endurance and loss of selective motor control (smc). spastic diplegia is a very common form of cp, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with cp have in both static and dynamic balance. joint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments. the mulligan mobilization with movement (mwm) is a physical therapy technique that combines joint mobilization techniques with active movement. it aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides. this study will contribute in describing long lasting effects of mobilization with movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing mwm with conventional therapy and those with conventional therapy alone

Eligibility criteria:
inclusion criteria: * both genders * age group 8-18 years * diagnosis of spastic cerebral palsy * cp to follow verbal directions * modified ashworth scale score of '1' or '1+' * function classification system (gmfcs) level i or ii ability to walk * 10 m or more independently exclusion criteria: * visual, hearing disorders * verbal and cognitive disorders (unable to comprehend commands) * recent lower extremity surgery * botulinum toxin injection

Keywords: talocrural joint mobilization with movement spasticity cerebral palsy