Kornimate/medical-research-clean huggingface dataset:
bempeg with pembrolizumab vs pembrolizumab alone in patients with metastatic or recurrent hnscc (propel-36)

Conditions: Metastatic Head and Neck Cancer; Recurrent Head and Neck Cancer

Summary: this is a multicenter, randomized, open-label, phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (bempeg; nktr-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic hnscc with positive pd-l1 expression (cps ≥ 1).


Eligibility criteria:
inclusion criteria: * provide written, informed consent to participate in the study and follow the study procedures. * male or female patients, age 18 years or older at the time of signing the informed consent form (icf). * have histologically or cytologically-confirmed recurrent or metastatic hnscc that is considered incurable by local therapies. * no prior systemic therapy for recurrent or metastatic disease. * the eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. * patients may not have a primary tumor site of nasopharynx (any histology) and/or unknown primary. * have measurable disease based on recist 1.1 as determined by the local site investigator. * eastern cooperative oncology group (ecog) performance status of 0 or 1. measure description: grade - ecog performance status 0 - fully active, able to carry on all pre-disease performance without restriction 1 - restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work 2- ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours • the tumor must have positive pd-l1 expression (i.e., cps ≥1) exclusion criteria: * has disease that is suitable for local therapy administered with curative intent. * has progressive disease within 6 months of completion of curatively intended systemic treatment for locoregionally advanced hnscc. * has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to initiation of study drug * has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) as determined by the investigator. * has a known additional malignancy that is progressing or has required active treatment within 5 years prior to the first dose of study drug * has an active autoimmune disease that has required systemic treatment in the past 2 years * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy * use of an investigational agent or an investigational device within 28 days before the first dose of study drug. * prior treatment with an anti pd-1, anti pd-l1, anti-pd-l2, or anti ctla-4 antibody, agents that target il-2 pathway, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: head and neck cancer head and neck squamous-cell carcinoma hnscc bempeg bempegaldesleukin nktr-214 keytruda pembrolizumab propel-36
the effect of human adipose tissue-derived mscs in romberg's disease

Conditions: Progressive Hemifacial Atrophy; Romberg's Disease

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of adipose tissue derived mesenchymal stem cells (mscs) in patient with progressive hemifacial atrophy.

adipose derived mesenchymal stem cells (admscs) represent an attractive and ethical cell source for stem cell therapy. with the recent demonstration of msc homing properties, intramuscular aplications of mscs to cell-damaged diseases have increased. in a human clinical trial, five patients who had suffered a progressive hemifacial atrophy( romberg's disease) were intramuscular administered autologous hadmscs (1×10e7 cells/500ul) with autologous microlipoinjection one time.

Eligibility criteria:
inclusion criteria: * subjects who understand and sign the consent form for this study. * age :18-75, males and females. * patients with symptom of hemifacial atrophy but not progress disease. exclusion criteria: * patients with currently progressive hemifacial atrophy. * women who are pregnant or breast feeding or planning to become pregnant during the study. * subjects who don't understand purpose and method for this study. * patients with psychical disorder or drug and alcohol addiction. * participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study. * serious pre-existing medical conditions like cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, cancer and diabetes mellitus. * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
the chronology of lifitegrast effect on anterior surface rehabilitation (clear) study

Conditions: Dry Eye

Summary: in patients with dry eye, defined as corneal staining and a reduced tear breakup time, lifitegrast will improve higher order aberrations, ocular scatter index, corneal staining, and tbut as soon as 1 week after initiating treatment.

this is a multicenter, prospective, open label, self-controlled, single group study of the efficacy of lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. all patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days

Eligibility criteria:
inclusion criteria: * central or inferior corneal fluorescein staining defined by the oxford scale * reduced tear break up time (tbut) ≤ 10 seconds. * able to comprehend and sign a statement of informed consent. * willing and able to complete all required postoperative visits. exclusion criteria: * ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure performed in the study eye within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study. * clinically significant ocular trauma. * active ocular herpes simplex or herpes zoster infection * ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) that is active, at the discretion of the investigator. * ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye), at the discretion of the investigator. * active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings, in the opinion of the investigator. * moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis that would interfere with study findings, in the opinion of the investigator. * severe (grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) * eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that would interfere with study findings, in the opinion of the investigator. * ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity). * patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
spatially transcriptomics reveals molecular signatures in crps

Conditions: Complex Regional Pain Syndromes

Summary: this observational study aims to understand phenotype-specific molecular signatures in patients with complex regional pain syndrome (crps).

participants who meet the diagnostic criteria for crps, aged 19\~80 years, and agree to participate in this study will undergo a 4mm-sized skin punch biopsy in the involved limb, as well as the contralateral side (internal control). spatial transcriptomics will be used to identify immune cell signatures and differentially regulated genes (degs) in the epidermis, vasculature, sweat gland, and nerve plexus of the involved ipsilateral (vs contralateral) side of the patient's skin.

Eligibility criteria:
inclusion criteria: * meets the budapest diagnostic criteria * consents to participation in this study * aged between 19 and 80 years old * symptoms and/or signs of sensory, vasomotor, and sudomotor changes exclusion criteria: * who do not agree to participate in this study * who has contraindications for skin punch biopsy (e.g. thrombocytopenia, taking anticoagulant drugs)
non-inferiority study of erector spinae plane block compared to thoracic epidural in pain management of rib fractures

Conditions: Rib Fractures

Summary: the purpose of this study is to compare 2 pain control treatments for people with 3 or more rib fractures.

2.1 primary objective * compare efficacy of espb to tea for mrf analgesia. 2.2 secondary objective * compare systemic opioid and non-opioid medication use in patients with espb and tea. 2.3 tertiary/exploratory/correlative objectives * determine improvement in respiratory function in espb versus tea before and after analgesia placement. * compare complications that occur in patients who receive espb versus tea. * compare dermatome levels relative to catheter placement that achieve analgesia for tea and espb. * compare differences in deep vein thrombosis (dvt) prophylaxis and incidence between espb and tea. * differences in length of stay (los) for tea versus espb. * differences in risk of delirium between tea and espb. * differences in oxygen and ventilatory support between tea and espb. * patient satisfaction of pain management.

Eligibility criteria:
inclusion criteria: * 18 years or older * radiological evidence of 3 or more rib fractures * within 48 hours of admission to hospital with rib fractures * can actively participate by answering questions during tea or espb placement * moderate-severe (4-10 out of 10) pain at the time of enrollment exclusion criteria: * greater than 48 hrs since admission to the hospital with rib fractures * patient refusal * prisoner * infection at the site of tea or espb insertion * allergy to local anesthetics * depth from skin to catheter placement target 6 or more centimeters * greater than 7 consecutive ribs involved on each side * other regional or epidural block already received * unable to follow commands/altered mental status * dementia * sepsis (temperature \> 38 degrees celsius \& positive blood cultures) * elevated intracranial pressure (icp \> 12 mm hg) * coagulopathy (inr \> 1.4) or recent therapeutic anticoagulant use (varies with which medication the patient is on) * preexisting central nervous system disorders, such as multiple sclerosis * thrombocytopenia (platelets \<70,000) * spine fracture or previous back surgery * preload dependent states (aortic stenosis, hypertrophic obstructive cardiomyopathy) * aortic transection * hemodynamic instability (patients with maps \<60 and/or patients requiring pressor support) * tattoo at sight of catheter placement
comparing efficacy of bone marrow aspirate concentrate (bmac) combined with allograft in treatment of calcaneus fractures

Conditions: Fractures, Bone

Summary: the purpose of this study is to evaluate the efficacy of bmac when used in conjunction with viable allograft bone for treating displaced intra-articular calcaneal fractures, in terms of rate of allograft incorporation into the host tissue, bone healing, and functional outcome.

the study group will consist of patients with intra-articular calcaneal fractures admitted to our academic level i trauma center that underwent open reduction internal fixation. inclusion criteria will be patients with a closed displaced intra-articular fracture sanders type iii without any evidence of neurovascular injury. patients will be randomly divided into three groups according to the plan of management: autograft alone, viable allograft combined with bmac, or viable allograft alone. radiographic imaging and three-dimensional standing computed tomography will be used to assess the articular surface, bohler's angle, the crucial angle of gissane, and the height, width and length of the calcaneus. the american orthopedic foot and ankle society (aofas) ankle-hind-foot scoring system and visual analog scale (vas) will be used to post-operative evaluation of the patients.

Eligibility criteria:
inclusion criteria: * closed displaced intra-articular fracture without any evidence of nerve or blood vessel injury, the fractures belonged to sanders type iii according to sanders classification and amenable to open reduction internal fixation * life expectancy of at least 1 year * patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen * adequate soft tissue coverage at the fracture site through primary closure. * unilateral or bilateral calcaneal fractures. exclusion criteria: * pregnant or breastfeeding women or planning on becoming pregnant during the investigational period * patient is currently participating in an investigational drug or other device study or previously enrolled in this study. * uncontrolled diabetes mellitus (hemoglobin a1c levels \> 10%) * a current endocrine or metabolic disorder known to affect osteogenesis * currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy. * inadequate neurovascular status in the involved limb that may jeopardize healing. * patients who have a preexisting calcaneus deformity that cannot accommodate a reduction or a previous history of osteomyelitis in the index limb. * other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.

Keywords: calcaneus fracture bone graft bone marrow aspirate stem cells
acute effects of herbal dietary supplements on aerobic performance

Conditions: Diet, Healthy

Summary: positive effects of herbal supplements such as red berries, ginseng, ashwagandha on athletic performance have been reported. the aim of this study was to evaluate the acute effects of a herbal dietary supplement prepared from a mixture of red berries, ginseng and ashwagandha on aerobic performance of recreational athletes.

in the beginning of the study anthropometric measurements (weight (kg), height (cm), bmi, waist circumference (cm), body fat percentage, lean body mass, skeletal muscle mass) will be taken from the participants who accepted to participate in the study. during the study, participants will be restricted from consuming alcohol, caffeine, red fruit, ginseng and ashwagandha. first, yoyo intermittent recovery level 1 performance test (the yo-yo test is a maximal aerobic endurance fitness test, involving running between markers placed 20 meters apart, at increasing speeds, until exhaustion) will be done to all participants in this step, participants will not drink anything. then there will be a 2-week break. at the end of the 3-week break, the participants will be divided into two groups by block randomization method and one group will receive a herbal nutritional supplement mixture (100 ml 30 minutes before training). the other group will drink a placebo prepared with the same texture and consistency as our main mixture, containing an equal amount of carbohydrates (100 ml 30 minutes before training). then the same performance test will be repeated. at the end of the test also 1 and 2 minutes after end of the test, the participants' heart rate measurement will be taken with a finger-type pulse oximeter and recorded . at the end of the test, perceived exertion levels will be questioned using the borg scale.

Eligibility criteria:
inclusion criteria: * being a student in the exercise and sports sciences department * not using any supplement * not being in a period that will affect sleep patterns (midterm/finals week, holiday, etc.) * doing regular exercise exclusion criteria: * having a known food allergy * using any supplement * being a professional athlete * drinking alcohol regularly

Keywords: athlete performance nutritional supplement recovery
assessment of corneal biomechanical properties using corvis st following lasik, prk, and cxl

Conditions: Myopia; Keratoconus; Refractive Surgery

Summary: to evaluate corneal biomechanical changes using the corvis st in patients who have under-gone lasik, prk, and corneal cross-linking (cxl).

this observational study aims to evaluate corneal biomechanical changes in patients who have undergone lasik, prk, and corneal cross-linking (cxl) using the corvis st (oculus). a total of 90 patients will be recruited from the clearvision laser center database between january 2025 and december 2025. participants will undergo non-contact biomechanical assessments at multiple postoperative time points to track corneal stability and elasticity over time. data collection \& measurements patient demographics, clinical history, and baseline preoperative data, including corneal thickness (pachymetry) and refractive status, will be collected. the corvis st will be used to measure key biomechanical parameters, such as corneal deformation amplitude (cda), applanation times (a1t \& a2t), radius of curvature at highest concavity (rhc), stiffness parameter (sp-a1), integrated radius (ir), and the corvis biomechanical index (cbi). measurement protocol all measurements will be conducted in a controlled environment with stable room temperature and humidity. patients will be properly aligned, and three consecutive measurements per eye will be taken to ensure repeatability. data will be recorded at specific intervals: lasik \& prk: 1 month, 3 months, 6 months, and 12 months cxl: 1 month, 3 months, 6 months, 12 months, and 24 months potential benefits \& risks the study aims to provide valuable insights into corneal biomechanical stability post-surgery, improving postoperative management and long-term visual outcomes. risks are minimal, with only transient discomfort associated with the non-invasive corvis st measurements. this study will contribute to a better understanding of corneal biomechanics in refractive and therapeutic procedures, potentially guiding future surgical decisions and patient care strategies.

Eligibility criteria:
inclusion criteria: - 1. adults aged 18-60 years. 2. patients who have undergone lasik, prk, or cxl at least 1 month prior to measure-ment. 3. stable refraction for at least 3 months post-procedure. 4. no evidence of active ocular disease or infection. exclusion criteria: * 1. history of other ocular surgeries (excluding lasik, prk, or cxl). 2. presence of keratoconus or other corneal ectatic disorders not treated with cxl. 3. systemic or ocular conditions affecting corneal biomechanical properties (e.g., dia-betes, connective tissue disorders). 4. current or recent use of medications influencing corneal biomechanics.

Keywords: corneal biomechanics prk lasik cxl
stable and independent communication brain-computer interfaces

Conditions: Healthy; Tetraplegia; Locked-in Syndrome

Summary: people with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake. restoring the ability to communicate to people with locked-in syndrome will have a positive effect on their quality of life, will enable them to reintegrate into society and increase their capacity to lead productive and fulfilling lives. this study sims to develop a new assisted communication device based on a brain-computer interface, a system that allows the user to control a computer with his brain activity. the investigators will develop this brain-computer system for long-term stability and independent use by using adaptive decoders. the investigators will test the long-term stability and independence of this system with healthy volunteers, people with tetraplegia and people with locked-in syndrome over time periods of several months.


Eligibility criteria:
inclusion criteria for healthy persons: * older than 18 * fluent in french, english, german or italian * good visual acuity inclusion criteria for people with tetraplegia: * older than 18 * fluent in french, english, german or italian * good visual acuity * diagnosed with spinal cord injury, brainstem stroke, spinal stroke, muscular dystrophy or other non-degenerative motor neuron disorders * limited or no ability to use both hands - less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on both sides inclusion criteria for people with locked-in syndrome: * were fluent in french, english, german or italian before losing the ability to speak * enough visual capability to see large letters from a distance of around 50cm according to caretaker's or guardian's opinion exclusion criteria for healthy persons: * smokers * substance or alcohol abuse * neurological or psychiatric illness * history of cranio-facial surgery * metallic implants that would prohibit the subject from having a mri scan * medications that may retard motor coordination and cognitive ability (such as sedatives) * seizure disorders * treated with anti-epileptic medications exclusion criteria for people with tetraplegia and locked-in syndrome: * disabling neurological illness other than tetraplegia or locked-in syndrome * disabling psychiatric illness * history of cranio-facial surgery