Kornimate/medical-research-clean huggingface dataset:
intravenous iron in combination with standard of care immunotherapy in melanoma

Conditions: Anemia, Iron Deficiency; Melanoma

Summary: anemia is a common complication among cancer patients and is negatively associated with overall prognosis and therapeutic outcomes. the purpose of this study is to see if giving a dose of iron prior to any standard of care chemotherapy treatment will affect the cells that are believed to make treating melanoma harder, making melanoma more responsive to the standard of care immunotherapy.

this is a pilot single arm, non-randomized study involving adult patients with melanoma receiving standard of care treatment with hemoglobin levels less than 13 g/dl, ferritin levels below 100 ng/ml, and transferrin saturations of less than 30%. cancer-associated anemia remains an underestimated and inadequately treated chronic condition that adversely affects the quality of life and overall prognosis in cancer patients. the correction of anemia in cancer patients would be a clinically applicable strategy to prevent and/or mitigate the expansion of tumor promoting erythroid progenitor cells (epcs). iron is an essential functional component of erythrocyte hemoglobin and is a crucial regulator of erythropoiesis. strategies to therapeutically target the immunosuppressive machinery have emerged as a promising approach for cancer treatment. by promoting epcs differentiation/maturation in anemic melanoma patients, immunosuppression could be mitigated and the therapeutic activity of immune checkpoint inhibitors enhanced. a dose of intravenous iron will be given one week prior to standard of care chemotherapy and antibodies cd71 and cd235a will be used to detect epcs in circulation and tumor microenvironment.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old adults at the time of informed consent 2. ability to provide written informed consent and hipaa authorization 3. biopsy confirmed melanoma 4. eligible for standard of care treatment 5. plan to undergo immunotherapy in neoadjuvant or metastatic setting 6. ecog performance status 0-2 7. anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30% exclusion criteria: 1. history of anaphylactic reaction to intravenous iron or any proposed standard of care treatments 2. diagnosis of hemoglobinopathies 3. therapeutic iron supplementation in the past 3 months (oral iron as part of mvi allowed) 4. diagnosis of hemochromatosis 5. symptomatic brain metastases that require local treatment (brain metastasis which will be treated with systemic immunotherapy or treated metastasis with without need for steroids for symptomatic management are eligible). 6. pregnant or lactating female adults 7. active infections which in research teams' opinion increases risk for toxicities 8. any condition that in the opinion of pi may interfere with patient being able to complete the required procedures.

Keywords: erythroid progenitor cells iron anemia melanoma
effect of using a lower limb robotic device for patients with chronic stroke

Conditions: Gait, Hemiplegic; Quality of Life; Vascular Stiffness; Stroke

Summary: this study will investigate if a lower limb robotic device can be used in a community setting to increase the amount of physical activity that individuals undertake following stroke and consequently improve biomechanical, physiological and health outcomes, in patients with stroke.

recent advances in technology have helped to develop robotic devices to aid gait training in order to develop more normal movement patterns, strengthen the quadriceps and improve quality of gait. lower limb robotic devices have been shown to increase functional mobility, walking speed, step length, balance and endurance within a clinical setting. the purpose of this study is to see if a lower limb robotic device leg can be used in a community setting to improve biomechanical (gait, balance, lower-limb strength), physiological (vascular health) and performance outcomes (aerobic fitness, strength) in patients with chronic stroke

Eligibility criteria:
inclusion criteria: * patients with diagnosis of stroke within 3-60 months * community patients that are medically stable and currently receiving therapeutic input from hobbs rehabilitation * individuals who are able to stand and step with an aid or assistance * cognitively aware of task demands * height: 5ft 2-6ft 3 (158-192 cm) * weight: \<25 stone (\< 159kg) exclusion criteria: * unresolved deep vein thrombosis * unstable cardiovascular conditions * open wounds * active drug resistant infection * recent fractures of involved limb * peripheral arterial disease * incontinence * severe osteoporosis * non weight bearing

Keywords: lower-limb robotic device gait balance pressure chronic stroke blood pressure blood velocity aerobic fitness strength
potential role of sirtuins as epigenetic biomarkers of the patient with atherosclerosis or calcific aortic stenosis

Conditions: Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes

Summary: the project aims to shed light on the role of sirtuins, enzymes belonging to the third class of histone deacetylases (class iii) involved in epigenetic modifications (deacetylation), focusing mainly on sirtuin 6 (sirt6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human vsmc cells.


Eligibility criteria:
inclusion criteria: * patients with atherosclerosis or calcific aortic stenosis with and without diabetes older than 18 years of either sex; * patients without atherosclerosis undergoing surgical procedure for endocarditis; * patients who will have signed informed consent exclusion criteria: * patients for whom biological material cannot be recovered for study purposes; * patients who refuse to participate in the study
serum profile of inflammatory factors, immune and angiogenic in temporal lobe epilepsy

Conditions: Epilepsy

Summary: epilepsy affects 0.7% of the general population and 15-20% of patients develop drug resistance. the temporal lobe epilepsy (tle) is the most common symptomatic focal epilepsies with a particularly high rate of drug (about 20 to 30%). in this type of epilepsy, where feasible, surgical removal of the home is the best therapeutic outcome. mechanisms of epileptogenesis and drug resistance are still mysterious. of recent clinical and experimental studies have shown that dysfunction of the blood-brain barrier (bbb) contributes to epileptogenesis and drug resistance. it is now recognized that cytokines exacerbate the excitability and permeability of the bbb, which was recently confirmed by studies showing that treatment of inflammation reduces epileptogenesis. moreover, we have described an association between pathological angiogenesis and bbb permeability in the tissue of patients with excision of drug-resistant tle. with experimental models, it was revealed an activation of the vegf-vegfr2 by seizures leading to rapid degradation of the bbb. the investigators hypothesis is that the identification of factors involved in bbb permeability may designate potential targets for drug-resistant partial epilepsy.


Eligibility criteria:
inclusion criteria: * patient with temporal lobe epilepsy (tle) * patient with epilepsy for at least two years. arm 1: patient with drug-resistant tle proved potentially a candidate for surgery. arm 2: patient with tle seizure-free for 12 months or more exclusion criteria: * patient with a scalable general pathology may lead to increased inflammatory markers: neoplasia, chronic inflammatory diseases etc. ... * patient with neurological history other than epilepsy with evolutionary potential or likely to interfere with the inflammatory markers
risk stratifying copd exacerbations

Conditions: COPD Exacerbation

Summary: to identify clinical characteristics on presentation which predict differential outcomes in patients with exacerbation of copd.

exacerbations of copd (ecopd) are heterogenous but are often considered as a single clinical entity. clinical characteristics on presentation may predict outcome of patients with ecopd. decaf score was previously proposed to predict in-hospital mortality but has not been validated in asian subjects. rome classification was recently proposed to better risk stratify ecopd according to symptoms, physiological parameters and laboratory findings on admission, but no prospective validation study is available so far. this study aims to identify clinical characteristics on presentation to predict outcome of patients with ecopd.

Eligibility criteria:
inclusion criteria: * background history of copd, defined by the gold 2023 guidelines * presented with exacerbation of copd, defined by the gold 2023 guidelines * age \>= 18 years old * informed consent available exclusion criteria: * age \< 18 years old * no informed consent
check it! positive psychology intervention to improve adherence in adolescents with t1d

Conditions: Type 1 Diabetes Mellitus

Summary: problems with diabetes management in adolescents with type 1 diabetes are common - occurring at rates as high as 93% - and have serious health consequences, including poor blood sugar control and risk for later complications. therefore, the investigators proposed to test a positive psychology intervention for adolescents with type 1 diabetes aimed at increasing motivation for diabetes management; specifically, to increase the frequency of blood glucose monitoring. this intervention will boost positive mood in adolescents (age 13-17) through tailored exercises in gratitude, self-affirmation, small gifts, and parent affirmation as a way to improve motivation for diabetes management. in addition, this study will explore the use of technology, by comparing telephone-administered vs. automated text-messaging versions of the intervention, to determine which mode of delivery is more appealing, convenient, and beneficial for adolescents in managing their diabetes. participants and parents will complete questionnaires on mood and diabetes management during a routine clinic visits at baseline, 3 months, and 6 months. clinical measures of diabetes management will be collected from participants' electronic medical records.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes for at least 6 months * hba1c between 8-12% * speak and read english * caregiver living with child exclusion criteria: * other uncontrolled health conditions
timing of iron supplementation in very low birth weight infants

Conditions: Nutritional Status

Summary: to examine if early iron supplementation (starting oral iron at 14 days of life) would improve the nutritional iron status(measured by serum ferritin) of very low birth weight infants at postnatal age of 60 days, when compared to the standard regime of starting iron at 2 months of life.

smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low body iron stores. despite having low iron stores, very low birth weight (vlbw) infants are not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks. such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis becomes active (by 8 weeks of life). depletion of iron stores is the first step in the continuum of changes that occur in iron deficiency. iron deficiency induces biochemical defects (such as impaired synthesis of dna and collagen) even before any features of microcytic, hypochromic anemia become evident. the rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency; poor school-age performance has been reported among children who had low iron stores in their neonatal period. early iron supplementation i.e. starting iron once the infant reaches full enteral feeds could potentially improve the iron stores and prevent its depletion. surprisingly, few studies are available till date to support (or refute!) this view. the current study was designed to test the hypothesis whether early iron supplementation would increase the nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to the existing regime of starting iron at the age 2 months.

Eligibility criteria:
inclusion criteria: * infants who have reached at least 100 ml/kg/day of oral feeds by day 14 of life exclusion criteria: * major congenital anomalies * rh hemolytic disease * twin-to-twin transfusion syndrome * refusal to give consent

Keywords: iron supplementation timing serum ferritin very low birth weight infants
adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer

Conditions: Biliary Tract Cancer; Extrahepatic Cholangiocarcinoma; Gallbladder Cancer

Summary: the study is a multicenter phase ii randomized controlled trial. the purpose is to investigate the efficacy and safety of adjuvant immunotherapy combined with chemoradiation for patients with high-risk resectable extrahepatic cholangiocarcinoma and gallbladder cancer.

the trial will recruit 92 patients, and they will be randomized (1:1) into two groups (chemoradiation+immunotherapy group, observation group) after operation. patients in chemoradiation+immunotherapy group will receive camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. after 1 or 2 courses of camrelizumab, patients went on to receive capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week) concurrent with radiotherapy (45 gy to regional lymph nodes and 54 to 59.4 gy to preoperative tumor bed). patients in observation group will not receive any anti-cancer therapy.

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years; 2. primary resectable extrahepatic cholangiocarcinoma and gallbladder cancer proved by pathology which underwent radical surgery; 3. pathology indicates r0 with t2-4 or n1; or r1; 4. ecog ps 0-1; 5. adequate hematologic, hepatic and renal function: anc ≥ 1.5x10\^9/l, hb ≥ 80g/l, plt ≥ 100 x10\^9/l, albumin ≥ 28g/l, total bilirubin \< 1.5×uln, alt and ast \< 2.5×uln, crea\<1.5×uln; 6. at least 6 months of life expectancy. exclusion criteria: 1. pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial; 2. received previous anti-cancer therapies; 3. with purulent, infected or delayed healed wounds; 4. have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months; 5. have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis; 6. have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment; 7. uncontrollable hypertension, systolic pressure\>140mmhg or diastolic pressure\>90mmhg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy; 8. symptomatic congestive heart failure (nyha class ii-iv). symptomatic or badly-controlled arrhythmia. congenital long qt syndrome or modified qtc\>500ms upon screening; 9. have active autoimmune diseases that require systemic treatment within 2 years before enrolment; 10. active tuberculosis, having antituberculosis therapy at present or within 1 year; 11. have a known history of prior invasive malignancies within 5 years before enrolment; 12. have other uncontrollable comorbidities; 13. infection of hiv, known syphilis requiring treatment; 14. allergic to chemotherapeutics.
osteopathic manual therapy (omt) and brain structure and function in primary headache patients: a pilot study

Conditions: Primary Headaches (includes Migraines, Tension, Cluster Headaches)

Summary: chronic headaches are associated with changes in brain structure and function that may be associated with increased suffering and disability. understanding how osteopathic manipulative therapy (omt) affects these changes would reveal new insight into how the brain processes pain and returns to normal function. also, demonstrating these changes would provide evidence regarding how omt causes a reduction in pain and disability, supporting the recommendation for omt as a primary treatment option for headaches.


Eligibility criteria:
inclusion criteria: * current diagnosis of primary headache (migraine, tension-type, cluster) from a healthcare provider * have experienced at least one headache episode a month for the previous 1 year (or longer) * age of ph onset was less than 50 years, currently taking medication for headaches. exclusion criteria: * presence of headaches due to some other underlying medical condition (secondary headaches) * traumatic brain injury * fibromyalgia, epilepsy * diagnosis of a neurodegenerative disorder * history of brain tumor or cancer * history of cervical radiculopathy (pinched nerve in the neck) * currently undergoing manual therapy type treatment or have a a treatment within 2 weeks of enrollment(chiropractic, omt, massage, pt) * currently pregnant * have had an injection to treat headaches within the previous 3 months from study enrollment * contraindications to mri.

Keywords: migraine headaches osteopathic manipulative treatment brain omt
mindfulness training for first responders

Conditions: Burnout

Summary: the present study evaluates the efficacy of mindfulness-based attention training on measures targeting cognitive abilities and emotional well-being in first responders.


Eligibility criteria:
inclusion criteria: 1. individuals who are between 18 and 75 years of age 2. individuals who are fluent english speakers 3. individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have internet connection 4. individuals who are willing and able to consent to participate in the study 5. participants in all phases of the study must be individuals who are affiliated with the los angeles county fire department peer support group. exclusion criteria: 1. individuals with an active and untreated mental health issue and/or hospitalization for psychological/mental health issues within the past month
the safety and efficacy of snc-109 car-t cells therapy the rgbm

Conditions: Recurrent Glioblastoma Multiforme (GBM)

Summary: a phase i study to evaluate the safety, tolerance and pharmacokinetics of snc109 in patients with rgbm

it is planned to recruit about 50 patients with rgbm subjects. the protocol consists of screening period, lymphocytes apheresis period, operation period, pre-infusion evaluation (-2\~-1 days), infusion (day 0), infusion observation (day 1-post infusion), and follow-up period (last infusion-720 days). the incidence of dose limitation toxicity (dlt) will be observed within 28 days after the first infusion. subjects in this study will receive multiple infusions, starting with 5×104 car+ t cells/dose in the first subject, and the safety review committee (src) will evaluate the subsequent dosing regimen, dose, infusion interval, and number of treatment cycles. subsequent subjects will be evaluated by the src on the basis of available pk and safety data, and the src will determine the dosing regimen, dose, infusion interval and number of treatment cycles based on observed evidences.

Eligibility criteria:
inclusion criteria: * age ≥18，both sexes; * diagnosed with a history of glioblastoma, and the recurrent glioblastoma has confirmed by histological/molecular pathology (including astrocytoma world health organization (who) grade 4); * karnofsky (kps) ≥50; * the estimated survival time is ≥12 weeks; * blood pregnancy tests for women of childbearing age are negative; * the patient himself/herself, and/or his/her legal guardian, agree to participate in the trial and sign the informed consent form. exclusion criteria: * known allergies to study drugs or drugs that may be used in the study; * severe concurrent diseases in the heart, lungs, liver, or other vital organs; * hypertension is poorly controlled or accompanied by hypertensive crisis or hypertensive encephalopathy; * in addition to the glioblastoma, with other severe central nervous system diseases or complications or aggressive malignancies; * long-term use of immunosuppressant drugs, or large doses of steroids; * received live or attenuated vaccine or other surgery had no related to gbm within 4 weeks prior to lymphocytes apheresis; * lymphocytes apheresis or cell infusion combined with infection or unexplained fever.

Keywords: gbm
sterile wound care liquid dressing in treatment of diabetic ulcer in necrosis stable stage: a randomized control trial

Conditions: Diabetic Ulcers; Diabetic Ulcers in Necrosis Stable Stage

Summary: this study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy. participants will be assigned with a 1:1 ratio into intervention group and control group. participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.


Eligibility criteria:
inclusion criteria: 1. severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected. 2. poor glycemic control; fasting blood glucose \>15mmol/l; glycosylated hemoglobin \>12%. 3. active bleeding within the wound that prevents implementation of standard basic treatment protocols. 4. serum albumin \<20g/l; hemoglobin \<60g/l; platelets \<50×10\^9/l 5. advanced malignant tumor patients 6. autoimmune disease activity period 7. history of allergy to aseptic wound care liquid dressing 8. patient unable to cooperate or has mental disorders 9. pregnant and lactating women 10. eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity 11. skin tumors 12. active skin diseases 13. according to the researcher's judgment, patients who clearly have factors affecting wound healing that cannot be removed are not suitable for this study or cannot comply with the requirements of this study

Keywords: diabetic ulcers