Kornimate/medical-research-clean huggingface dataset:
methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in nail psoriasis

Conditions: Nail Psoriasis

Summary: the primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy.

nail psoriasis is one of the risk factors for psoriatic arthritis (psa), especially with distal interphalangeal joints affected. nail changes in psoriasis have been observed in 10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent structures, including dip joints and digital extensor tendons. enthesopathies are among the characteristic features of psoriatic arthritis. in everyday practice, assessment of psoriatic changes in nails is based mainly on clinical indices, such as nail psoriasis severity index (napsi) and modified napsi (mnapsi), while imaging examinations, such as ultrasonography are performed much less frequently. the findings of this study may assess the reasonableness of systemic treatment of nail psoriasis in patients without arthritis as enthesopathy prevention as well as the usability of us nail examinations in ps and psa patients in assessment of morphological changes and a response to treatment. a us examination of nails and distal interphalangeal joint extensor tendons are conducted in all of the patients twice at an interval of six months. the examination is conducted by a rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. an assessment of the nails, extensor tendons and dip joints is made by placing the head on the dorsal side. in order to avoid pressure on surface tissues, an appropriate amount of gel without gel pads was used. the intensified blood flow, made visible by the pd technique, is confirmed by pulsed wave doppler spectrum. the nail thickness is measured as the maximum distance between the dorsal and ventral nail plates. the nail bed thickness is measured as the distance between the ventral plate and the bone margin of the distal phalanx. the nail matrix thickness is measured at the proximal end of the nail bed. the study was approved by the bioethics committee of the warmia and mazury chamber of physicians the study are conducted according to the good clinical practice guidelines. each participant signs an informed consent and be coded with unique id. results of analyses will be saved by indexing with id code only, personal data with individual ids will be saved in additional file. all hard copy will be archived in secure room with coded electronic key.

Eligibility criteria:
inclusion criteria: * patients with psoriatic changes in nails treated at the rheumatological clinic in olsztyn and the clinic of dermatology, sexually transmitted diseases and clinical immunology of the university of warmia and mazury in olsztyn, in whom a us examination revealed dip joint extensor tendon enthesopathy exclusion criteria: * patients diagnosed with osteoarthritis of hands, those who work hard physically and those with changes in nails other than caused by psoriasis

Keywords: distal interphalangeal joint extensor tendon enthesopathy nail psoriasis
oral omega-3 fatty acids in the treatment of dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the investigators hypothesize that oral omega-3-acid ethyl esters (lovaza, glaxosmithkline, research triangle park, nc) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up time) when compared to administration of placebo.


Eligibility criteria:
inclusion criteria: * age \> 18 years * typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking) * schirmer test \< 8 mm/5 minutes * fluorescein tear break-up time \< 8 seconds * no current use of dry eye treatment (except artificial lubrication) * signature on consent form exclusion criteria: * infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye * eyelid or eyelash abnormalities * alteration of the nasolacrimal apparatus * treatment with drugs affecting tearing * concomitant ocular therapies * topical ophthalmic steroids taken during the 4 weeks before the study * pregnant/breast-feeding women * history of liver disease * history of fish and/or shellfish allergy or hypersensitivity * history of corn allergy or hypersensitivity * treatment with systemic anticoagulation therapy * patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)

Keywords: dry eye syndrome recent diagnosis of dry eye syndrome
study evaluating etanercept in patients with rheumatoid arthritis who completed trial 0881a1-301-eu in spain

Conditions: Rheumatoid Arthritis; Inflammation

Summary: the purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881a1-301-eu


Eligibility criteria:
inclusion criteria: * to have completed 0881a1-301-eu study in spain * clinical diagnosis by acr revised criteria of rheumatoid arthritis. exclusion criteria: * hypersensibility to etanercept or any of its components * significant concurrent medical disease

Keywords: rheumatoid arthritis
observational study of sinus rhythm mapping in pulmonary vein isolation naive patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) initially starts in a paroxysmal form, which is mainly based on the presence of triggers. progression of af is accompanied by structural and electrical remodelling which can typically be described as a progressive change in electrophysiological properties of the myocardium caused by cardiovascular comorbidities and af itself. this results in complex electrical conduction disorders, which is defined as electropathology. the aim of our study is to evaluate whether an artificial intelligence (ai)-enabled ecg algorithm (on an ecg in sinus rhythm) can predict electropathology in patients with af who undergo a first pvi.


Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent. * first pvi-procedure * age is 18 years or higher. * 12-lead ecg available in sr during the last 14 days. exclusion criteria: * mitral insufficiency of grade 3 or 4. * participating in another study that may interfere with participation in this study

Keywords: artificial intelligence deep neural network electrocardiogram pulmonary vein isolation
validation of coregistered ct-pet imaging in determining tumor volume and atelectasis in patients with operable non-small-cell lung cancer and tumor associated atelectasis

Conditions: Carcinoma, Non Small Cell Lung

Summary: ct-pet image fusion has the potential to differentiate 'tumor' from 'atelectasis' much better than the ct-scan in patients with non-small cell lung cancer who also have atelectasis. this however has never been validated on a histological level. in this study patients with non small cell lung cancer and atelectasis who are eligible for surgery undergo a ct-scan and a pet-scan prior to surgery. the resection specimen will be compared to the preoperative imaging.


Eligibility criteria:
inclusion criteria: -patients with non small cell lung cancer and atelectasis, who are eligible for surgery. exclusion criteria: * age \< 18 years * pregnancy
the efficacy of the bladder epicheck for detection of recurrent urothelial cell carcinoma

Conditions: Bladder Cancer

Summary: clinical trial to determine the efficacy (sensitivity and specificity) of the bladder epicheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of bladder cancer.

the bladder epicheck test is an in vitro diagnostic device for the detection of dna methylation patterns in urine that are associated with bladder cancer. it is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer this is a, multicenter, prospective, blinded study to evaluate the efficacy (sensitivity and specificity) of a novel methylation test for the detection of recurrent urothelial cell carcinoma in patients with a history of bladder cancer undergoing surveillance.

Eligibility criteria:
inclusion criteria: * any male or female patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance at 3 month intervals. * has had all urothelial cell carcinoma tumor resected within the past 12 months * has a plan for cystoscopic surveillance (adjuvant intravesical therapy allowed) * able to provide legally effective informed consent * able to produce 45ml of urine exclusion criteria: * planning to undergo radical cystectomy or chemotherapy-radiation for urothelial cell carcinoma
vebreltinib plus plb1004 in egfr-mutated, advanced nsclc with met amplification or met overexpression following egfr-tki

Conditions: Non-Small-Cell Lung Cancer

Summary: efficacy and safety evaluation of vebreltinib plus plb1004 in egfr tki relapsed met amplified or met expression in nsclc

open label, multicenter phase ib/ii clinical study to evaluate the safety, efficacy, and pharmacokinetics of vebreltinib in combination with plb1004 in patients with locally advanced or metastatic non-small cell lung cancer with met overexpression or met amplification following egfr-tki treatment failure.

Eligibility criteria:
inclusion criteria: 1. ability to understand and willingness to sign a written informed consent document. 2. aged at least 18 years old. 3. histologically or cytologically confirmed locally advanced or metastatic nsclc (stage iiib\~iv). 4. egfr mutations, including exon 19 deletion and exon 21 l858r. 5. c-met overexpression and/or c-met amplification confirmed after treatment with egfr-tki. 6. at least one measurable lesion as defined by recist v1.1. 7. ecog performance status 0 to 1. exclusion criteria: 1. previous treatment with met inhibitors or hgf-targeted therapy. 2. there are mutations of alk or ros1. 3. have symptomatic and neurologically unstable central nervous system (cns) metastases or cns disease that requires increased steroid doses for control. 4. pregnant or nursing women.

Keywords: non-small-cell lung cancer egfr nsclc lung cancer met amplified met expression
pressure ulcer multi-disciplinary teams via telemedicine (pumtt): a trial in long term care

Conditions: Pressure Ulcers; Multi-disciplinary Wound Care Teams; Remote Support; Digital Wound Photography

Summary: the purpose of this study is to evaluate the effectiveness of 'enhanced' multi-disciplinary wound care teams (mdts) vs. 'usual' care teams in long term care (ltc) facilities in ontario for the treatment of pressure ulcers. ltc facilities with more than 100 beds that are within a 100 km distance from st. mikes and have a problem with pressure ulcers will be asked to participate. a total of 10 ltc facilities will be randomly selected (i.e. selected by chance) from those that agree to participate. the 'enhanced' mdt will be an advance practice nurse(apn) with expertise in wound care who has direct access to the wound care team at st. mikes. this apn will develop treatment plans in consultation with facility staff, providing targeted pressure ulcer treatment education on an ongoing, case by case basis. care is supported by telemedicine with the use of digital photography and online communication between members of the care team. this study is a stepped wedge randomized trial, meaning ltc facilities are assigned to a start date for this study totally by chance. changes in healing rates, wound related pain, cost, number of new pressure ulcers, and number of wounds healed will be measured before, and after the apn is introduced to facilities. in order to gain more insight into how people felt about this model of care, interviews will be held with individuals and groups of staff at 5 randomly selected facilities before, during, and after the study has been completed.


Eligibility criteria:
inclusion criteria: * ltc facility must be located within the toronto central or central lhin geographic boundaries. * ltc facility must be \<100 km from the st. michael's hospital wound care team. * ltc facility must be entering data into mds. * ltc facility administrator must consent to participate. * ltc facility must report a pu prevalence rate \>5.5% in the 4th quarter 2009 mds. \[this is the average pressure ulcer prevalence rate for ontario ltc facilities as reported by the canadian institute of health information (cihi) in the 4th quarter 2009.\] * individual with pu (or substitute decision maker (sdm)) must provide informed consent. exclusion criteria: * ltc facility \<100 beds. * ltc facility \>100 km from the st. michael's hospital wound care team * ltc facility reporting a pu prevalence rate \< 5.5% in the 4th quarter 2009 mds.
qidong hepatitis b intervention study

Conditions: Hepatitis B; Liver Neoplasms; Liver Diseases

Summary: during 1983-1990 in the jiangsu province of china, 80,000 infants were randomised by area of birth between control, standard hepatitis b vaccination (at 0, 1 and 6 months of age) and standard vaccination plus a booster dose at about 2 to 3 years of age. the aim is to prevent establishment of chronic hbv infection in early childhood, hence to prevent the morbidity of chronic hepatitis b in young adolescents and the incidence/mortality several decades later from liver cancer and other hbv related chronic liver diseases. long-term follow-up through central registries will determine the impact of vaccination on liver cancer incidence and mortality.


Eligibility criteria:
inclusion criteria: all infants born in qidong between september 1983 and november 1990 exclusion criteria: -

Keywords: hepatitis b hepatocellular carcinoma prevention vaccination
anderson-fabry disease in chronic kidney disease patients not on renal replacement therapy

Conditions: Focus of Study: Prevalence of Fabry Disease in CKD Population

Summary: anderson-fabry disease is a rare x-linked lysosomal storage disorder due to the deficiency of alfa-galactosidase a (agal). the subsequent accumulation of glycosphingolipids may lead to to cardiac, renal, and central nervous system impairment as well as premature death. recently published studies suggest that the true incidence of the disease may be underestimated in certain risk groups, e.g. in patients with chronic kidney disease (ckd). therefore, the investigators initiated a multicenter case-finding study in austria by screening patients with chronic kidney disease not yet on renal replacement therapy. molecular isoforms of globotriaosylceramide (gb3), characterized by different chain lengths of their n-acyl residues, will be determined in a urine sample. characteristic parameters, including the ratio of c24/c18 isoforms will be used for identifying patients liable to have the disease. a positive result will be confirmed by biochemical and genetic testing. a sample size of 5.000 chronic kidney disease patients is envisaged allowing for detection of 1 to 25 patients with anderson-fabry disease.


Eligibility criteria:
inclusion criteria: * chronic kidney disease kdoqi stage 1-5 * informed consent exclusion criteria: * patients already on renal replacement therapy * not willing to participate

Keywords: anderson fabry disease chronic kidney disease prevalence
sarcopenia in axial and peripheral spondyloarthropathies

Conditions: Spondylarthropathy; Sarcopenia

Summary: spondylarthropathies (spa) are among the most common chronic inflammatory rheumatisms in adults, responsible for a muscular loss or sarcopenia which can be very disabling, not much documented in the literature, and not yet studied in france. in addition, sarcopenia is associated with decreased physical activity and increased risk of falls and fractures. a better characterization of the determinants of this muscular loss will allow to better detect and take care of it. the aim is to conduct the first french study on the prevalence and severity of sarcopenia in patients with spondyloarthropathies and to study the variables that may be associated with it. finally, we propose to evaluate obesity related to sarcopenia in these patients and compare them to cases matched for age and sex (from ofely / strambo cohorts, lyon, france). this is a prospective interventional and monocentric study with minimal risks and constraints: patients will be included for one day for an evaluation of their sarcopenia by measuring their muscle strength, physical performance and body composition and recording of their socio-demographic and disease characteristics.


Eligibility criteria:
inclusion criteria: * men and women, 18 to 80 years old * hospitalized or attending the rheumatology department for spondyloarthopathy. exclusion criteria: * no signed consent * immobilization for a period of more than 15 days during the last 3 months * pregnant or breastfeeding woman * not affiliated to the national healthcare insurance * difficulty in understanding french * psychiatric disorder

Keywords: spondylarthropathy sarcopenia lean mass fat mass
the multi-media social skills project for adults

Conditions: Autism Spectrum Disorders

Summary: this study is investigating the development of a social skills training program for adults with asperger's syndrome or high-functioning autism, ages 18 to 35 years. the principal investigator for this study is dr. michael murray, the director of the autism studies division at the penn state hershey medical center. the purpose of this study is to adapt a social skills training program to address and enhance the social skills of adults with asperger's syndrome and high-functioning autism.

during group study visits, a group of six young adults with asperger's syndrome or high-functioning autism will meet weekly for about 90 minutes. the purpose of the group sessions is to work on everyday social skills such as initiating and maintaining conversations, establishing friendships, and dealing with situations such as job interviews and dating. a generalization session will be held every week after the group therapy session with same-age peers who have been screened to participate in the study. the purpose of including peers in the class is to give young adults with asperger's syndrome and high-functioning autism a chance to practice the social skills learned in the group study visit with a peer group. study participants will be paired with a typically developing peer for an outing in the community to a nearby restaurant or shop or an in-class exercise such as a mock job interview.

Eligibility criteria:
inclusion criteria: * between 18 and 35 years of age * must be a pennsylvania resident * a primary diagnosis of asperger's syndrome or high-functioning autism, as confirmed by the srs-2 * a verbal iq of 85 or above on the kaufman brief intelligence test, second edition * english as primary language spoken * ability to fluently speak in full sentences exclusion criteria: * a significant language delay * difficulty with aggression directed at peers * a primary thought disorder * a secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment * a current high school student at start of intervention * low social motivation demonstrated through formalized assessment and/or by responses given to screening interview

Keywords: social skills asperger's high-functioning autism young adults
novel outreach methods to increase enrollment to early phase clinical trials

Conditions: Cancer; Malignancy; Malignant Neoplasm

Summary: this trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically african americans) to early phase cancer clinical treatment trials. both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).


Eligibility criteria:
inclusion criteria for patient subjects: * aged 18 years or older * self-described african american race (patients who self-describe as "more than one race" will be included) * scheduled for new or consult oncology appointment at the study site * scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit. * for prostate cancer patients: 2 or more increasing prostate specific antigen (psa) values i the 6 months prior to visit * other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site inclusion criteria for provider subjects: * oncology provider at study site scheduled to see patients meeting criteria above exclusion criteria for patient subjects: * estimated glomerular filtration rate (gfr) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions * bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution * initiated new anti-cancer therapy within last 2 months * evaluated for possible enrollment/randomization in the last 2 months * prior enrollment/randomization on this recruitment trial
a study to test the effect of survodutide (bi 456906) on cardiovascular safety in people with overweight or obesity (synchronize™ - cvot)

Conditions: Obesity

Summary: this study is open to adults who are at least 18 years old and have a body mass index (bmi)bof 27 kg/m2 or more. people can take part if they have cardiovascular or chronic kidney disease. people who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. participants must have previously tried to lose weight by changing their diet. the purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (bi 456906) are less or more likely to develop serious cardiovascular problems. it also aims to find out whether health parameters like blood pressure improve. overweight and obesity are linked to cardiovascular disease. survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. placebo looks like survodutide but does not contain any medicine. every participant has a 2 in 3 chance of getting survodutide. participants inject survodutide or placebo under the skin once a week. all participants also receive counselling on diet and physical activity. participants are in the study for up to 2 years and 3 months. during this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. during these visits, the doctors check participants' cardiovascular and overall health. the results are compared between survodutide and placebo groups. the study staff also takes note of any unwanted effects.


Eligibility criteria:
inclusion criteria: 1. male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is \>18 years. 2. body mass index (bmi) ≥27 kg/m2 at screening with established cardiovascular disease (cvd) and/or at least 2 weight-related complications or risk factors for cvd or bmi ≥30 kg/m2 at screening with established cvd or chronic kidney disease (ckd), and/or at least 2 weight-related complications or risk factors for cvd. further inclusion criteria apply. exclusion criteria: 1. previous treatment with glucagon-like peptide-1 receptor (glp-1r) agonists within 3 months before screening. 2. type 1 diabetes. 3. less than 3 months between the last dose of glp-1r agonists and glp-1r agonist/insulin/glucose-dependent insulinotropic polypeptide (gip) combinations and screening. 4. known clinically significant gastric emptying abnormality (e.g., severe diabetic gastroparesis or gastric outlet obstruction). further exclusion criteria apply.