Kornimate/medical-research-clean huggingface dataset:
inspiratory muscle training in burned adults

Conditions: Burn Injuries

Summary: the study outlines burn injury impact, emphasizes need for long-term rehabilitation. study assesses inspiratory muscle training efficacy in improving respiratory strength, lung function, and exercise capacity in adult burn patients.

the study aimed to evaluate the effectiveness of adding inspiratory muscle training to pulmonary rehabilitation in adult burn patients. fifty-two participants were randomly assigned to either inspiratory muscle training plus pulmonary rehabilitation or pulmonary rehabilitation alone for 8 weeks. inspiratory muscle training consisted of using a powerbreathe device for inspiratory muscle strengthening.

Eligibility criteria:
inclusion criteria: * burn-injured adults aged 20-49. * admitted to the clinic after acute treatment. * recovering from burns affecting at least 20% total body surface area. * partial or full-thickness burns. exclusion criteria: * smokers. * had open or unhealed wounds. * had any known neurological deficit. * neuromuscular diseases. * musculoskeletal deformities. * pulmonary diseases. * severe cardiac problems. * inability to participate in regular exercise.
fast-release orodispersible tramadol tablet (tradonal odis®) as analgesia for hysterosalpingography

Conditions: Infertility; Pain

Summary: this study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet. tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. it has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. the orodispersible tramadol tablet is a new galenic form and is available on the belgian market for the last three years. pregastric absorption leads to a quicker onset of action. so far, evidence shows that pain during and immediately after the hysterosalpingography (hsg) procedure is only significantly reduced by iv opioid analgesia. this study evaluates the analgetic potential of an orodispersible opioid tablet. this tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. its abuse potential is very low and its respiratory depressant effect is negligible.

four arm prospective randomized double blinded trial patients that need a hsg as part of their diagnostic work-up and are eligible for randomization are counseled about possible participation. after signing the informed consent patients will be randomized in one of the following four groups: group 1: fast-release orodispersible tramadol tablet + metal cannula group 2: placebo + metal cannula group 3: fast-release orodispersible tramadol tablet + balloon catheter group 4: placebo + balloon catheter tablets are administered 30 min before the procedure primary endpoint: * vas at the six different assessment points secondary endpoint * adverse effects and complications such as: nausea, vomiting, constipation, drowsiness, respiratory depression, hypotension, allergic reaction and infection

Eligibility criteria:
inclusion criteria: * \> 18 and \< 45 years * written informed consent exclusion criteria: * contra-indication to tramadol, morphine or to other opioids * concomitant use of mao inhibitors or use less than 2 weeks prior to procedure * use of any other cns-acting drug * contra-indication to radio-contrast medium (allergy) * patient already taking analgetics * history of cervical stenosis * presence of pelvic inflammatory disease or any other condition causing pelvic pain * clinical and/or laboratory evidence of any major disease * pregnant or lactating

Keywords: hsg analgesia tramadol metal cannula balloon catheter
biodistribution and kinetics of 18f-arag in non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study is to assess the biodistribution and kinetics of a novel t-cell imaging agent in non-small cell lung cancer patients undergoing immunotherapy with and without adjuvant radiation therapy. this study is assessing the change in kinetics that occurs in this patient population to better understand the distribution of this compound in patient disease circumstances.

the overall goal of this project is to evaluate the ability of \[18f\]-arag, a novel t-cell activation imaging biomarker, to measure t-cell activation before and after treatment with programmed death (pd) pd-1/pd-l1 inhibition and with pd-1/pd-l1 inhibition plus radiation therapy in nsclc patients. early preclinical and clinical studies have shown promise for immunotherapy treatments for several malignancies \[1\]. immunotherapy is expected to grow in importance; however, it presents difficult challenges for response assessment. for instance, successfully treated tumors may actually increase in size after therapy due to inflammation and only later shrink \[2\]. recist criteria \[3\] designed to detect early effects of cytotoxic agents by size reduction, or the more recently proposed immune-related response criteria (irrc) \[4\] do not allow an early assessment of immunotherapeutic response since both depend on tumor size change. furthermore, fdg pet is confounded by inflammatory effects causing hypermetabolism \[5\] \[6\]. thus, it is imperative to develop new imaging and analysis protocols to evaluate immune-checkpoint blockade approaches. a method that evaluates t cell activation would permit an assessment of a basic first step in the process of assessing immunotherapy efficacy. there are two main goals associated with this project. we propose to 1) assess the \[18f\]-arag biodistribution and kinetics, in non-small cell lung cancer (nsclc) tumor(s) and tumor draining lymph nodes on \[18f\]-arag pet/ct imaging before and after 1 course of immunotherapy and 1 course of immunotherapy plus radiation 2) correlate (potential) change in \[18f\]-arag uptake within the tumor(s) or tumor draining lymph nodes with clinical and pathologic response in patients treated with immunotherapy.

Eligibility criteria:
inclusion criteria: * this study is open to all adult subjects with histological confirmation of nsclc enrolled in the parent protocol. * age 21 years of age or greater * ecog performance status of 0, 1, 2 or 3 at the time of enrollment. * patient with life expectancy ≥ 24 weeks from the time of screening to the study * ability to give informed consent exclusion criteria: * patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed). * severe impaired renal function with estimated glomerular filtration rate \<30 ml/min/1.73 m2 and/or on dialysis. * pregnancy * breast feeding an infant * unable to tolerate the expected radiation therapy prescription
femoral rotation and patellar positioning after tka

Conditions: Knee Osteoarthritis; Joint Pain; Joint Instability; Patella Disorder; Knee Pain Chronic; Prosthetic Complication

Summary: analysis of patellar positioning in the trochlear groove after tka with and without the use of dynamic tensioner.

it appears that by precisely adjusting femoral component rotation and its relation to soft tissues in the area we can achieve better function of the patellofemoral joint and thus reduce the occurrence of anterior knee pain. achieving proper femoral component rotation is challenging, as the bony landmarks are difficult to identify. this goal may be accomplished by using a dynamic tensioner - a device that intraoperatively measures joint gap stiffness in extension and 90 degrees flexion. this is especially important in knees with high grade arthritis and limb malalignment, where ligaments' and tendons' efficiency is affected.the aim of this study was to analyze patella positioning in the trochlear groove on ct scans of patients undergoing tkr with use of a dynamic tensioner and compare it to the ones undergoing standard measured-resection technique. secondary outcome was to assess the frequency of anterior knee pain, range of motion and patient-reported outcome 3 and 12 months after the surgery.

Eligibility criteria:
inclusion criteria: * age over 60 * bmi \< 40 * ablity to walk for 10meters * leg length discrepancy \<5mm * knee flexion \> 90 degrees * hip extension \< 0 degrees * hip flexion \> 90 degrees * iii / iv level of osteoarthritis in kellgren - lawrence scale exclusion criteria: * varus/valgus/ fixed flexion deformity \> 15 degrees * revision tka * prior uka
effectiveness of yangxue qingnao granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction

Conditions: Stroke, Acute Ischemic

Summary: evaluate the effectiveness of yangxue qingnao granules in preventing post thrombolytic hemorrhage transformation in patients with acute cerebral infarction, and explore its possible mechanism


Eligibility criteria:
inclusion criteria: * age ≥ 50 years old, regardless of gender * after the onset of this disease, the national institutes of research stroke scale score was 2 ≤ nihss ≤ 20 points * patients who have developed symptoms within 4.5 hours and can receive rt pa intravenous thrombolysis treatment * according to the 2019 diagnosis points for major cerebrovascular diseases in china, patients with ischemic stroke were diagnosed as having a good recovery from the first or last onset (mrs score ≤ 1 point before this onset) * obtain the patient or their legal representative to voluntarily sign an informed consent form approved by the ethics committee. exclusion criteria: * intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; if it is only oozing blood, the researcher can determine whether it is suitable for enrollment * severe consciousness disorder: nihss scored\>1 point in the 1a consciousness level item * after controlling the patient's blood pressure, the systolic blood pressure remains ≥ 180mmhg or the diastolic blood pressure remains ≥ 100mmhg * blood glucose\<2.8mmol/l (random blood glucose measurement device can be used) * patients with severe mental disorders and dementia * diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, cirrhosis, etc; or alt or ast\>2.0 x uln * diagnosed with severe active kidney disease and renal insufficiency; or serum creatinine\>1.5 × uln * concurrent malignant tumors or ongoing anti-tumor treatment; for subjects diagnosed with malignant tumors after enrollment, the decision to continue participating in the study can be based on the researcher's judgment and the subject's willingness * suffering from severe systemic diseases, with an estimated survival time of\<90 days * history of major surgery within 4 weeks prior to enrollment * participated in other clinical studies within the first 30 days of randomization, or is currently participating in other clinical studies * the researcher believes that it is not suitable to participate in this clinical study * patients who are allergic to any ingredient in the study drug
cardiotoxicity and risk factors in patients with colorectal cancer receiving fluoropyrimidine

Conditions: Colorectal Cancer

Summary: observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-fu or capecitabine, with or without other chemotherapy combinations.

all patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy. patients will be evaluated with 12-lead ecg and blood sample for tni and nt pro-bnp before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle. all patients developing cardiovascular events will be submitted to blood sample for tni, nt-probnp, hstni and cardiac examination.

Eligibility criteria:
inclusion criteria: * signed written informed consent * age ≥ 18 years * histologically confirmed adenocarcinoma of colon or rectum (any t, any n, any m) receiving for the first time 5-fu or capecitabine, with or without other chemotherapy combinations exclusion criteria: * prior treatment with fluoropyrimidines * prior or concurrent chest radiotherapy * any prior or concurrent treatment with cardiotoxic drug * any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )

Keywords: cardiotoxicity fluoropyrimidine colorectal cancer
et 743 (yondelis) in men with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the main purpose of this study is to find out what effects (good or bad) trabectedin (et743) has on men with advanced prostate carcinoma.

* treatment with trabectedin will be given once a week for three consecutive weeks with one week of no treatment. this four week period constitutes one cycle. * trabectedin is given as an infusion through a central venous catheter and is administered over 3 hours. * on day 1 of each cycle a history, physical exam and blood tests will be performed and trabectedin will be administered. * on day 8 and day 15 of each cycle blood work will be performed and trabectedin will be administered. * patients will continue to receive trabectedin as long as there is no disease progression or unacceptable side effects. * scans (ct, mri or bone) or x-rays may be done while the patient is on the trial at the discretion of the physician.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * radiographically documented metastatic disease * surgical or chemical castration * prostate specific antigen (psa) \> 5 ng/ml * castration resistant prostate cancer (crpc) * one previous taxane-based chemotherapy regimen * eastern cooperative group (ecog) performance status 0,1 or 2 * neutrophil count \> 1,500/ul * platelet count \> 100,000/ul * serum bilirubin \< 1.0 x upper limit normal (uln) * serum alkaline phosphatase \< 1.5 x uln * asparate aminotransferase/alanine aminotransferase \< 2.5 x uln * albumin \> 2.5 g/dl * serum creatinine \< 1.5 x uln * prior hormonal therapy exclusion criteria: * chemotherapy treatment within 4 weeks of study entry * patient not employing adequate contraception * serious illness or medical conditions, specifically: uncontrolled congestive heart failure or history of myocardial infection or active angina pectoris within 6 months; active infectious process; chronic active liver disease, including chronic hepatitis b, c or cirrhosis * current anti-cancer treatment with any non-fda approved investigational drug

Keywords: advanced prostate cancer prostate cancer trabectedin et 743 yondelis
effect of ozurdex® 0.7 mg on improvement of efficacy of bevacizumab for central retinal vein occlusion

Conditions: Non-Ischemic Central Retinal Vein Occlusion

Summary: this is a study designed to determine if the addition of ozurdex® to bevacizumab (avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

this is a multicenter clinical study designed to determine if the addition of ozurdex® injection to bevacizumab (avastin®) eye injections reduces the need for repeat bevacizumab eye injections in patients with nonischemic central retina vein occlusion.

Eligibility criteria:
inclusion criteria: 1. male or female subjects (aged 18 or older); 2. provide written informed consent and sign/date a health information release; 3. women of childbearing potential must be willing to practice effective contraception for the duration of the study. exclusion criteria: 1. any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; 2. use of systemic steroids within 1 month prior to baseline visit (visit 1) or anticipated use at any time during the study (inhaled and intranasal steroids are allowed); 3. sitting systolic blood pressure equal to or greater than 160 mmhg or diastolic blood pressure equal to or greater than 100 mmhg at the baseline visit (visit 1); 4. use of warfarin, heparin, enoxaparin or similar anticoagulants within 2 weeks prior to baseline visit (visit 1) or anticipated use at any time during the study; 5. known allergy or hypersensitivity to the study medications or their components; 6. previous enrollment in an ozurdex® clinical trial or previous use of an ozurdex® implant.
quantitative requirements of docosahexaenoic acid for neural function in children with phenylketonuria

Conditions: Phenylketonuria

Summary: patients with phenylketonuria (pku) have an inborn error in the metabolism of the amino acid phenylalanine (phe) and thus must follow a strictly controlled protein-restricted diet from early infancy. this protein-restricted diet is devoid of natural dietary sources of n-3 long chain polyunsaturated fatty acids (lc-pufa), such as eggs, meat, milk or fish. therefore, blood concentrations of n-3 lc-pufa, especially of docosahexaenoic acid (dha) are reduced in pku children compared to healthy controls. dha availability is considered important for optimal neurological function. previous studies have shown that neural function of pku children is improved by high dose supplementation of fish oil providing dha, as shown by significant improvements of both visual evoked potential latencies and of fine motor skills and coordination, but no dose response relationship has been established so far. this multicentric double-blind randomized trial aims at determining quantitative dha requirements for optimal neural function in pku children. patients with classical pku from several major treatment centers in europe will be randomized to receive between 0 and 8 mg of dha per kg body weight daily for a duration of 6 months. biochemical (fatty acid composition of plasma phospholipids, lipoprotein metabolism and metabolic profiles), and functional testing (visual evoked potentials, fine motor skills, cognitive function and markers of immune function) will be performed at baseline and after 6 months. intake per kg body weight will be related to outcome parameters and thus a possible dose response relationship will be defined. the results from this study are expected to contribute to the improvement of the diet of pku patients, but they also have the potential to help defining quantitative dha needs of healthy children. the primary hypothesis is that supplementation with dha improves visual function in children with pku.


Eligibility criteria:
inclusion criteria: * children with classical pku, who have been diagnosed and treated from the newborn period onwards * classical pku must have been established by a baseline plasma phenylalanine (phe) level \>1200 µmol/l or detection of underlying mutations * children are clinically healthy besides classical pku * good metabolic control (a minimum of 2 phe-values during the last 6 months are needed with average phe values being below 480 µmol/l in the last 6 months) * no n-3 lc-pufa supplementation for at least 6 months before enrolment * written informed consent of parents exists exclusion criteria: * severe neurological symptoms * history of neurological disease * children are unable to take dha-capsules regularly * acute illness, especially infections at the time of clinical examination/testing * children with weight/height over the 97th percentile or below the 3rd percentile * known hypersensitivity to fish oil products

Keywords: phenylketonuria docosahexaenoic acid visually evoked potential choice-reaction time
salivary profiling in infants treated for suspected sepsis: the spitss study

Conditions: Infection; Newborn

Summary: the aim of this study is to develop a faster, safer, and more accurate method for determining if a newborn has an infection. this study involves analyzing saliva for markers of infection and inflammation known as cytokines. we will analyze infant's saliva repeatedly for inflammatory biomarkers (cytokines) within the first 36 hours of their standard of care treatment. we hypothesize that levels of these cytokines will more quickly predict which babies are truly infected and which babies are not compared to the blood tests currently being used.

specific aim 1: develop a predictive model of neonatal infection based upon the expression profile of six salivary inflammatory biomarkers, crp, procalcitonin, tumor necrosis factor-alpha (tnf-α), and interleukins (il) 1β, 6, and 8, within the first 36 hours of treatment. serial saliva samples collected at the initiation of antibiotic therapy and 18-36 hours into treatment from 2,250 neonatal 'rule out sepsis' evaluations will undergo multiplexed quantification of the six salivary inflammatory biomarkers. diagnostic accuracy will be calculated and predictive models will be developed, incorporating clinical, demographic, and biomarker data. specific aim 2: validate the predictive model of neonatal infection developed in aim 1 on an external cohort of newborns. serial saliva samples from an additional, prospective cohort of 1,750 infants undergoing a 'rule out sepsis' evaluation will be collected to test the validity of the predictive model for neonatal infection. specific aim 3: establish normative salivary reference ranges of the inflammatory biomarkers across varying gestational ages and weights, and assess the potential of these biomarkers to predict other neonatal morbidities. salivary samples from the subset of uninfected newborns from aims 1 and 2 will be combined and used to establish the 95% reference intervals of the salivary inflammatory biomarkers at each time point. salivary profiles will be correlated to discharge diagnoses (i.e. bronchopulmonary dysplasia, periventricular leukomalacia) to assess the ability of each biomarker, alone and in combination, to predict neonatal morbidities known or hypothesized to be associated with an inflammatory response.

Eligibility criteria:
inclusion criteria: neonates \< 43 weeks' gestation, currently admitted to the nicu or well-baby nursery. exclusion criteria: neonates suffering from a lethal genetic or chromosomal abnormality or other non-infectious, life-limiting illness, known at the time parents would be approached for consent.