Kornimate/medical-research-clean huggingface dataset:
tenosynovial giant cell tumors (tgct) observational platform project

Conditions: Giant Cell Tumors

Summary: tgct is a rare disease that is difficult to manage, surgical resection is the primary treatment currently available. to date no disease registry exists and there is little data available detailing the management of patients with diffuse tgct (d-tgct), the burden of d-tgct for patients (including pain, joint stiffness, swelling, reduced mobility and quality of life) or the economic impact of d-tgct. this study aims to collect data by an observational disease registry involving no intervention to the patient or changes to investigators treatment decisions.

gct is a rare, benign, but potentially locally aggressive and recurrent disease. treatment pattern and treatment initiation, continuation or changes are solely at the discretion of the physician and the patient. there will be no attempt to influence the prescribing patterns of any individual treating physician. all medication will be prescribed in the usual standard of care and will not be provided by the study sponsor. participation in the study will in no way influence payment or reimbursement for any treatment received by patients during the study. it is the responsibility of the investigator and his study staff to enter all relevant patient data required for this registry in the electronic case report form (ecrf) and in the patients' medical records. approximately 15 sites from up to 6 european countries (france, germany, italy, the netherlands, spain and united kingdom) and 4 sites from the us are planned to participate. the sites will be specialized sites that treat d-tgct regularly.

Eligibility criteria:
inclusion criteria: * written informed consent for participation in the study (icf) * patients with d-tgct (diagnosed histologically) confirmed naïve or recurrent case exclusion criteria: * as this is a non interventional study, no explicit exclusion criteria have been defined

Keywords: tenosynovial giant cell tumors disease registry routine clinical practice real world evidence
feeding progression in preterm infants

Conditions: Infant, Premature, Diseases; Feeding Behavior; Feeding Patterns

Summary: preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. the feeding progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. the study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.

preterm infants are at high risk for feeding issues. feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. the transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. currently, there is limited evidence to guide this transition. there are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. however, there is currently no evidence to guide providers in their choice of oral feeding schedule. the primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. the secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. the study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. this study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.

Eligibility criteria:
inclusion criteria: * gestational age between 23 0/7-33 0/7 weeks * eligible for oral (po) feeding as determined by the attending neonatologist exclusion criteria: * infants with major congenital malformations * infants with chromosomal defects * diagnosis of neonatal abstinence syndrome or opiate withdrawal * grade 3 or 4 intraventricular hemorrhage

Keywords: oral feeding premature infants neonatal intensive care unit
the effect of an individually adapted lumbosacral orthosis on plantar pressure and balance

Conditions: Orthosis; Low Back Pain, Postural

Summary: the aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain.

the aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain, comfort, plantar pressure, static and dynamic balance in individuals with low back pain. thirty male and female volunteers between the ages of 18-65 who came to istanbul medipol university prosthesis orthotics center and experienced low back pain were included in the study. the study will be designed as crossover. the study consists of three methods and a single group, which are orthosis-free, worn by a person with low back pain, and adapted by a prosthetist orthotist. following both orthosis insertion methods, pain severity will be measured with visual analogue scale (vas) and comfort level was measured with orthosis comfort score. they will be asked to wait for 30 minutes with orthosis, and then the pain severity and comfort level were measured again. y balance test (ybt) and functional reach test (frt) will be used for dynamic balance. plantar pressure and static balance will be analyzed with pedobarography device. static pressure and stabilometric data will be found.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * one or more recurrent low back pain during the last 12 months,-at least 6 points on the oswestry disability index, * negative straight leg raising test result, * not having any lower extremity injuries in the last 6 months, * no history of recent trauma or infection exclusion criteria: * neurological symptoms due to nerve root compression * one-sided leg pain more severe than lower back pain, pain in feet and toes shooting pain, numbness in the same area, paresthesia, * disease that causes neurological sequelae (stroke, traumatic brain injury, parkinson's, those who have had it (such as multiple sclerosis), * presence of malignancy,

Keywords: low back pain lumbosacral orthosis orthosis adjustment postural control plantar pressure balance
correlation of ffr and ifr with cardiac pet perfusion in patients with severe aortic valve stenosis

Conditions: Aortic Valve Stenosis; Coronary Artery Disease

Summary: aortic valve stenosis (as) affects 2-7% of persons \> 65 years, symptoms include: angina and dyspnea, dizziness and syncope. coincidence of coronary artery disease (cad), also presenting with angina and dyspnea, in patients with as between 40 - 65% . angina in as caused by significant reduction of coronary flow reserve (cfr). cfr is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). ffr (fractional flow reserve) use in patients with as potentially invalid due to dysfunctional cfr leading to potential undertreatment of cad in these patients.cfr disturbance in as mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. current studies are investigating the validity of ffr and ifr in as patients. recent data demonstrate very good correlation between ffr and ifr derived values to pet myocardial perfusion imaging values in patients with no evidence of as. our study aims to investigate the diagnostic performance of ffr and ifr in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate ffr- and ifr derived values with those extracted from pet-perfusion imaging.


Eligibility criteria:
inclusion criteria: * patients with severe aortic stenosis eligible for transcatheter aortic stenosis * left ventricular ejection fraction \> 55% * no intolerance of adenosin * no history of bradycardia, atrioventricular blockade * intermediate coronary stenosis with ffr\> 0.8 * age \>65 exclusion criteria: * intolerance of adenosin * left ventricular ejection fraction \< 55%

Keywords: aortic valve stenosis pet-ct coronary artery disease ffr
compass study: an online cognitive-behavioural therapy (cbt) program treating anxiety and low mood in long-term conditions during the covid-19 pandemic

Conditions: Treatment of Illness-related Distress in Physical LTCs

Summary: this study is a single-centre, interventional randomised controlled trial. participants will be individually randomised to receive either compass online cbt + "usual care" (standard ltc charity support), or usual care only. randomisation will be stratified by recruiting charity site to ensure a balance of participants with different ltcs across the intervention and control arm. randomisation will occur using a 1:1 allocation ratio managed by recap software. participants randomised to compass will receive access to the online program. it consists of 11 online modules which target challenges associated with living with ltc(s) and includes, amongst other things, psycho-education, patient examples, interactive tasks and goal setting. participants are linked to a therapist; 'guide', who will provide 6 x 30 minute support sessions delivered fortnightly in the format preferred by the client (phone and/or in-site message). participants allocated to the usual care control arm will receive the usual care that is available to them via their charity. all charities include a helpline which can be accessed via telephone or email. the helplines at all charities offer one-off emotional and/or informational support provided by people trained in active listening and/or counselling skills. additional support avenues that can be accessed may include online support groups, local community support groups and informational resources.


Eligibility criteria:
inclusion criteria: * aged 18 or over * have responded to sign posting advise from the ltc charity or responded to an advert placed on a ltc charity website expressing their interest in taking part in the study. * speak english to a sufficiently high standard to allow them to interact with digital cbt programs. * live in the uk and can provide contact details of their registered general practitioner * have an email address to allow them to register with a digital cbt program and have a basic understanding of the internet. * scores ≥3 on the shortened patient health questionnaire (phq-4) self-report measure of depression and anxiety in relation to their ltc and/or the covid-19 pandemic. exclusion criteria: * evidence of alcohol and/or drug dependency, cognitive impairment, severe mental health disorders, including bipolar disorder or psychosis * acute suicidal risk requiring a level of support that cannot be provided by therapists who are supporting patients remotely in their use of digital health interventions. * receiving active psychological treatment. active psychological treatment is defined as receiving treatment from a psychologist/counselor/therapist or engaging with other online psychological treatment interventions.
cmr-derived quantitative perfusion for prediction of ffr

Conditions: Chronic Coronary Syndrome

Summary: patients will undergo quantitative perfusion assessment in cardiovascular magnetic resonance imaging (dual bolus or dual sequence approach) as well as invasive coronary angiography for assessment of fractional flow reserve (ffr) including assessment of coronary flow reserve (cfr) and microcirculatory resistance (imr).


Eligibility criteria:
inclusion criteria: * clinical indication for vasodilatator cmr or invasive coronar angiography * capability to give informed consent exclusion criteria: * general: non-compliance, \<18 years of age, pregnancy * contraindications for cmr (non-cmr compatible device, chronic kidney disease (egfr \<30ml/min), allergies (medications)
exercise training on health and medical costs of metabolic syndrome individuals.

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine if an exercise training intervention together with conventional medical treatment can decrease the annual healthcare cost in patients with metabolic syndrome.

it is proposed a multicentral clinical trial with cluster randomization among research nodes located in towns of castilla-la mancha and toledo neighborhoods (spain). the aim is to compare the annual healthcare cost of patients receiving conventional medical treatment against patients receiving the same intervention plus exercise training for 16 weeks. exercise training will be based on high-intensity interval training conducted on stationary bikes, and strength training using weight-bearing exercises. each research node will be composed of the clinical center and the sports facilities available in the town/neighborhood. research nodes will be randomized into two experimental interventions: i.) conventional medical treatment, and ii.) conventional medical treatment + exercise training. after verbal and written information about the study and related potential risks, all patients fulfilling inclusion criteria will be included after giving written informed consent. at baseline, and after 12 and 24 months, annual healthcare costs will be obtained from the volunteers' clinical records. in addition, at baseline, and after 4, 12, and 24 months, metabolic syndrome components prevalence, metabolic syndrome z-score, body composition, and cardiorespiratory fitness will be tested.

Eligibility criteria:
inclusion criteria: * fulfilling criteria for metabolic syndrome diagnosis. exclusion criteria: * at baseline, engagement to an exercise training program for the last 6 months.

Keywords: metabolic syndrome exercise training healthcare cost high-intensity interval training strength training
study comparing the safety and efficacy of bol-303259-x to latanoprost in subjects with glaucoma or ocular hypertension

Conditions: Intraocular Pressure

Summary: the objective of this clinical investigation is to determine the most effective drug concentration(s) of bol-303259-x in the reduction of iop in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.


Eligibility criteria:
inclusion criteria: * subjects must have a diagnosis of open angle glaucoma (oag) or ocular hypertension (oh) in one or both eyes. * iop requirements at visit 3, a mean/median iop ≥ 26 mmhg at a minimum of 1 time point, ≥ 24 mmhg at a minimum of 1 time point, and ≥ 22 mmhg at 1 time point in the same eye, and mean/median iop ≤ 32 mmhg in both eyes at all 3 measurement time points. * subjects with best-corrected visual acuity (bcva), using early treatment of diabetic retinopathy study (etdrs) protocol, of +0.7 logmar units (snellen equivalent \~20/100) or better in either eye. exclusion criteria: * subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs. * subjects with known contraindications to nitric oxide (no) treatment. * subjects whose central corneal thickness was greater than 600um in either eye. * subjects with any condition that prevented reliable applanation tonometry in either eye. * subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye. * subjects with previous or active corneal disease. * subjects with a history of severe dry eye. * subjects with monophthalmia. * subjects with optic disc hemorrhage. * subjects with a history of central retinal vein and artery occlusion. * subjects with a history of macular edema. * subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from visit 1 (screening). * subjects who had incisional ocular surgery or severe trauma within the previous 6 months from visit 1 (screening). * subjects with very narrow angles (3 quadrants with less than grade 2 according to shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye. * subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye. * subjects who were expected to require treatment with ocular or systemic corticosteroids. * subjects who were in need of any other topical or systemic treatment of oag or oht. * subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect iop during the study period.
shr-1210 in combination with gemox in patients with advanced btc

Conditions: Biliary Tract Cancer; Cholangiocarcinoma

Summary: this is a single-arm, open-label and exploratory clinical study of pd-1 monoclonal antibody shr-1210 combined with gemox regimen (gemcitabine combined oxaliplatin) in the treatment of advanced biliary malignancies. in oder to observe and evaluate the efficacy and safety of pd-1 antibody shr-1210 combined with gemox in the treatment of patients with advanced biliary malignant tumor (btc),subjects with pathological confirmed biliary cancer, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma will be enrolled. 28 days as a treatment cycle, shr-1210 3mg/kg and gemcitabine 800 mg/m2 will be administered iv q2w (d1 and d15 of a treatment cycle),and oxaliplatin 85mg/m2 will be administered iv q2w (d2 and d16 of a treatment cycle). pd-1 antibody combined chemotherapy will be used up to 6 cycles.shr-1210 3mg/kg iv q2w will be administered beyond 6 cycles chemotherapy until disease progression or un-tolerable toxicity.


Eligibility criteria:
inclusion criteria: * pathology confirmed biliary malignancy, including intrahepatic bile duct carcinoma, extrahepatic bile duct carcinoma, and gallbladder carcinoma. * age:18-75 years, male or female. * the estimated survival period is more than 3 months. * ecog 0-1. * there is at least one measurable lesion, according to the recist 1.1 standard. * patients has not been treated by oxaliplatin, gemcitabine and pd-1 / pd-l1 antibody. * patients who have been treated tegafur or capecitabine as adjuvant chemotherapy or first-line treatment may be selected. exclusion criteria: * there were concurrent malignant tumors, except for the cured skin basal cell carcinoma and cervical carcinoma in situ. * other drug clinical trials have been taken in four weeks. * patients with a history of central nervous system metastasis or central nervous system metastasis are known before the screening. * patients with a history of unstable angina. * the urine routine indicated that the urine protein was greater than ++ and confirmed the 24-hour urine protein quantification \>1.0 g. * have used immune-targeted therapy drugs. * the patient had received a liver transplant. * having a history of chronic autoimmune diseases such as systemic lupus erythematosus. * having a history of immunodeficiency, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;

Keywords: btc pd-1 antibody
renal biomarkers to predict recovery following venoarterial extracorporeal membrane oxygenation

Conditions: Acute Kidney Injury

Summary: the investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of venoarterial extracorporeal membrane oxygenation (va-ecmo). tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring va-ecmo. in these patients, traditional markers of kidney function (urine output and serum creatinine level) do not accurately represent renal function.


Eligibility criteria:
inclusion criteria: * age more than 18 years * refractory or advanced cardiogenic shock prior to institution of va-ecmo exclusion criteria: * history of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (gfr) less than 60 ml per min * cognitive impairment * pregnant women * patient or surrogate is not fluent in english * long-term immunosuppression
effects of melatonin on reperfusion injury

Conditions: Reperfusion Injury, Myocardial

Summary: acute myocardial infarction is a major cause of mortality and morbidity. primary percutaneous coronary intervention (ppci) is currently the most effective treatment strategy in acute myocardial infarction. however, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. several studies have shown that melatonin protects against ischemia/reperfusion injury (iri). in our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. the investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with st segment elevation myocardial infarction undergoing ppci.


Eligibility criteria:
inclusion criteria: st segment elevation myocardial infarction undergoing primary percutaneous poronary intervention exclusion criteria: * unconscious at presentation * had cardiogenic shock * had a history of myocardial infarction * stent thrombosis * renal insufficiency * had previously undergone coronary artery bypass surgery

Keywords: melatonin reperfusion injury myocardial infarction
systemic anti-tumor activity and safety of the combination of sbrt and concurrent pd-1 blockade in metastatic rcc.

Conditions: Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC

Summary: prior research has indicated that stereotactic body radiotherapy (sbrt) can effectively trigger systemic anti-tumor immune response. the goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy and concurrent anti-pd-1 antibody treatment in patients of metastatic clear renal cell carcinoma. the primary objective was to assess the objective response rate (orr) in non-irradiated lesions, and incidence of adverse events (aes).


Eligibility criteria:
inclusion criteria: * age≥18 years at the time of signing informed consent; * histologically confirmed, advanced renal cell carcinoma of stage iv (ajcc 8); * previously received sbrt and concurrent pd-1 blockade treatment； * evidence of measurable metastatic kidney cancer according to recist 1.1 criteria. exclusion criteria: * patients who cannot be adequately followed up; * has a known additional malignancy that is progressing or requires active treatment.

Keywords: stereotactic body radiotherapy, abscopal effects pd-1 blockade