Kornimate/medical-research-clean huggingface dataset:
mesenchymal stem cells in osteonecrosis of the femoral head

Conditions: Avascular Necrosis of Femur Head

Summary: the present study evaluates the effect of xcel-mt-osteo-alpha in osteonecrosis of the femoral head in comparison to the standard treatment of isolated core decompression. xcel-mt-osteo-alpha is a tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue. the working hypothesis proposes that the tissue engineering is a valid and useful technique to achieve bone regeneration, avoiding the progression to collapse of the femoral head.

prospective, open-label with blinded assessor, randomized, parallel, single-dose phase i-ii clinical trial in which 24 patients affected with osteonecrosis of the femoral head arco grade i or ii will enter the trial with the primary objective of assessing the feasibility and safety of "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in osteonecrosis of the femoral head. secondary objectives are to assess the efficacy of the implantation by imaging (magnetic resonance imaging) and clinical questionnaires (pain by visual analogue scale, quality of life by sf-36 and womac index). patients will be randomized to one of the two treatment arms (core decompression and the tissue engineering product composed by "ex-vivo" expanded autologous mesenchymal stem cells fixed in allogenic bone tissue or the standard treatment of isolated core decompression). thereafter, patients will be followed for 12 months.

Eligibility criteria:
inclusion criteria: * 18 to 50 years of age (male and female) * osteonecrosis of the hip arco grade i or ii * abscence of systemic or local infection * laboratory tests with no relevant abnormal findings that contraindicate the surgery. * informed consent form signed * the patient is able to understand the nature of the study exclusion criteria: * osteonecrosis of the hip secondary to femoral neck fracture * patients with no closed cartilage * surgical implants in the femoral head * septic arthritis * patients with severe renal insufficiency * patients expecting or with liver transplantation * positive serology for hiv-1 or hiv-2, hepatitis b (hbsag), hepatitis c (anti-hcv-ab) or syphilis. * pregnant woman or intended to become pregnant, or breath feeding * neoplasia within the previous 5 years, or without remission * immunosuppressive states * the patient is legally dependent * participation in another clinical trial or treated with an investigational medicinal product the previous 30 days * cardiac pacemaker, allergy to contrast or any other condition that contraindicates the mri with contrast agents * other pathologic conditions or circumstances that difficult participation in the study according to medical criteria * the patient does not accept to be followed-up for a period thar could exceed the clinical trial length

Keywords: avascular necrosis of femur head osteonecrosis of the hip osteonecrosis of the femoral head mesenchymal stem cells bone marrow tissue engineering bone diseases musculoskeletal diseases
liver, pancreas and thyroid function in burn patients

Conditions: Burns; Liver Fibroses; Pancreas Disease; Thyroid Diseases

Summary: the purpose of this study is to determine the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. the evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (cap, correlated with hepatic steatosis) via transient elastography (fibroscan©, echosens sa, paris, france). the thyroid and the pancreas will be assessed via ultrasound (ge medical systems, waukesha, usa) and standard blood parameters, respectively.

in this prospective study, the extent to which severe burn injuries affect the morphology and function of liver, pancreas and thyroid. the evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (cap, correlated with hepatic steatosis) via transient elastography (fibroscan©, echosens sa, paris, france). the thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively. the patient will be enrolled during the first days on their admission to the intensive care burn unit, if they meet the inclusion criteria and no exclusion criteria are met. the first assessment of liver, pancreas and thyroid function will be performed within the first 48 hours of admission. the same measurements maybe be repeated approximately weekly until discharge, respectively. furthermore at any follow-up visit up to 15 years post-burn if the patient consents to further participate in the study.

Eligibility criteria:
inclusion criteria: patients with partial thickness burns. only patients who sign an irb-approved consent (≥18 years old) or assent and have their legal guardian consenting to their participation (6 months - 17 years old) will be included. * patient age \> 6 months * total body surface area (tbsa) burned ≥ 30 % * flame, electrical, scald or chemical injury, contact burn * toxic epidermal necrolysis (tens) exclusion criteria: * patient \< 6 months * tbsa burned \< 30 %
high dose intravenous n-acetylcysteine versus iloprost for early, rapidly progressive diffuse systemic sclerosis

Conditions: Scleroderma, Diffuse

Summary: * systemic sclerosis (scleroderma; ssc) is a rare, disfiguring systemic disorder characterized by fibrosis of the skin and visceral organs that alters every aspect of an individual life * although some features of scleroderma phenotype are well established and represent the hallmarks of the disease, the primary cause is not fully delineated, though both endothelial cell damage, immunological abnormalities and excessive extracellular matrix production are well-documented * recently, excessive oxidative stress has been implicated in the pathogenesis of scleroderma * n-acetylcysteine (nac) exhibits direct and indirect antioxidant properties. its free thiol group is capable of interacting with the electrophilic groups of ros. this interaction with ros leads to intermediate formation of nac thiol, with nac disulphide as a major end product. the net result is a decrease of the concentrations of oh-, h2o2, and hocl. in addition, nac exerts an indirect antioxidant effect related to its role as a glutathione (gsh) precursor. it serves as a central factor in protecting against internal toxic agents. * in view of these considerations we expect that nac can confer substantial benefit in patients with scleroderma reducing skin fibrosis in view of its antioxidant properties, and we have decided to conduct a double blind, multicenter trial to establish whether nac could ameliorate skin fibrosis in scleroderma patients


Eligibility criteria:
inclusion criteria: * clinical diagnosis of early diffuse scleroderma * ability to give an informed consent * use of an acceptable method of birth control (if women in childbearing age). pregnancy will be ruled out before study beginning. exclusion criteria: * connective tissue diseases or other autoimmune diseases other than ssc; * history of intolerance to the study drugs; * severe cardiac failure (nyha \>=3 or left ventricular ejection fraction \<40%), recent (\<6 months) history of myocardial infarction; symptomatic ischemic myocardial disease, ventricular tachyarrhythmia, atrial fibrillation; * resting pao2 \<60mm/hg * creatinine clearance below 90ml/h * severe hepatic failure * bronchial asthma h. hemorrhagic diathesis i. pregnancy or lactation

Keywords: scleroderma, systemic scleroderma, diffuse
validation of accurate commissural alignment during transcatheter aortic valve implantation

Conditions: Severe Aortic Valve Stenosis

Summary: background: transcatheter aortic valve replacement (tavr) has become the preferred therapy for aortic stenosis. given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis degeneration that could require tavr-in-tavr for its treatment progressively increases. during standard tavi procedures the native and the prosthesis commissures are randomly aligned with misalignment in up to 70% of the cases. this might hinder coronary re-access in 18% of the cases, increase the risk of coronary obstruction during future tavr-in-tavr procedures, and has been associated to greater residual gradients. methods: although several techniques have been developed to increase the degree of commissural alignment, all are imperfect or imply manipulation of the system within the patient, potentially increasing the risk of complications. the research team developed a software based on computed tomography analysis that allows planification of accurate commissural alignment by inserting the delivery system in a patient-specific degree of rotation. aim: the proponent team aimed to prospectively validate this methodology comparing a cohort of patients harboring tavr with acurate commissural alignment (aca) vs. a control cohort with non-aca standard technique, in order to determine benefits in terms of coronary re-access and clinical events (coronary events, valve degeneration, and tavr-in-tavr).


Eligibility criteria:
inclusion criteria: * patients diagnosed with severe aortic stenosis admitted to tavr by heart team * pre-procedure ct-scan for planning available. * signed informed consent. exclusion criteria: * allergic to contrast * severe renal failure (gfr \< 30 ml/min) * indication for chronic anticoagulation * horizontal aorta and/or severe aortic tortuosity

Keywords: transcatheter aortic valve replacement (tavr)
use of blood biomarkers and biomarker index to aid in the diagnosis of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: this multicenter prospective trial will evaluate the association between obstructive sleep apnea (osa) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of osa.


Eligibility criteria:
inclusion criteria: * written informed consent * male * 18-70 years old * presentation with symptoms suggestive of obstructive sleep apnea * diagnostic sleep study * blood draw exclusion criteria: * prior (within past year) or current therapy for sleep apnea * use of opioid pain medication, steroids or allopurinol (within past 30 days) * use of chronic anti-inflammatory drugs (within past 7 days) * active cancer under current treatment or monitoring
diagnostic and prognostic biomarkers in parkinson disease

Conditions: Parkinson Disease; Multiple System Atrophy; Progressive Supranuclear Palsy

Summary: the overall goal of probe is to evaluate the feasibility and potential utility of three markers (alpha-synuclein, transcriptomic profiles and olfactory function) to determine the risk or prognosis of pd.

probe will test three biomarkers in pd subjects and controls to determine their feasibility and potential utility as markers of risk and prognosis for pd. this is a case control study, in which pd subjects will be compared to neurologically healthy controls and disease controls (msa and psp). the blood biomarker samples will be drawn once to evaluate blood alpha-synuclein levels as well as collection of lymphocyte mass for array analysis. olfaction will be measured using the upsit for all subjects. the upsit will be conducted as part of postcept for pd subjects and will only be repeated in this study for pd subjects in not done within 6 months. control subjects may also choose to submit a blood specimen for processing and storage at the coriell institute for medical research, a research resource supported by the ninds human genetics resource center. follow-up of the pd population over a 3-year period will allow us to evaluate the prognosis for important motor aspects of pd that will occur frequently in this cohort. these complications of pd include motor complications, postural instability, and non-motor impairment such as cognitive decline. healthy and disease control subjects may give permission at the baseline visit to be contacted and followed in the previously established psg found study using mail and telephone contact to assess clinical status. participation in the found study provides another mechanism to maintain contact with subjects and collect supplemental data beyond that collected at the probe baseline visit.

Eligibility criteria:
parkinson disease inclusion criteria: * subject is participating in postcept and meets uk brain bank criteria for pd * willing and able to provide informed consent healthy control inclusion criteria: * spouse or non blood relative of the pd subject * no known current diagnosis or history of a neurological disease * mmse score \>27 * age \>45 * willing and able to provide informed consent parkinsonism/disease control inclusion criteria (msa and psp) * a diagnosis of probable msa based on consensus criteria or probable psp based on ninds-psp criteria * willing and able to provide informed consent exclusion criteria for all groups: * current use (within 7 days prior to baseline visit) of anticoagulants (e.g., warfarin or heparin) * known bleeding disorder (acquired or inherited) * known blood disorder (e.g. leukemia) or a history of anemia with a documented hematocrit \<30 * known pregnancy * history of nasal trauma, sinusitis, or other nasal pathology that would interfere with smell testing

Keywords: parkinson disease multiple system atrophy msa progressive supranuclear palsy psp observational biomarker
improving neurocognitive deficits and function in schizophrenia with transcranial magnetic stimulation

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the purpose of this study is to determine whether repetitive transcranial magnetic stimulation (rtms) is effective in remediating cognitive deficits while also improving functionality in veterans with schizophrenia.

high-frequency, repetitive transcranial magnetic stimulation (rtms) to the dorsolateral prefrontal cortex (dlpfc), the dysfunctional brain region most implicated in cognitive deficits in schizophrenia, has recently been shown to improve cognition in non-veteran samples with schizophrenia. the investigators' goal is to confirm the efficacy of this treatment modality to remediate cognitive deficits and improve functionality in veterans with schizophrenia, as well as to gain a better understanding of the neural mechanisms responsible for cognitive deficits and their remediation. the investigators propose conducting a small-scale study to generate pilot data supporting the feasibility of conducting rtms with veterans and the effectiveness of rtms in this population. in addition, the investigators will conduct neurophysiologic experiments to test whether certain neural maker of abnormal brain function improves with rtms.

Eligibility criteria:
inclusion criteria: * scid (structured clinical interview for dsm disorders) confirmed diagnosis of schizophrenia or schizoaffective disorder * stable medication regimen (no change in dose or agents within the 2 weeks prior to study entry and throughout the duration of the study) * stable social environment and housing to enable regular attendance at clinic visits * ability to undergo cognitive testing, eeg scans and rtms * iq (intelligence quotient) \> 80 (wasi full scale score) * in general good medical health * is in treatment with a psychiatrist and/or primary care physician within the vha (veteran's health administration) system exclusion criteria: * pregnant or lactating female * history of prior adverse reaction to tms * on medications known to significantly lower seizure threshold, e.g.: * clozapine * chlorpromazine * clomipramine * history of seizures or conditions known to substantially increase risk for seizures * implants or medical devices incompatible with tms * acute or unstable chronic illness that would affect participation or compliance with study procedures, e.g.: * unstable angina * substance abuse/dependence (not including caffeine or nicotine) within one-month period prior to study entry or during study participation * unstable psychiatric symptoms that precludes consistent participation in the study, e.g.: * active current suicidal intent or plan * severe psychosis * history of loss of consciousness greater than 15 minutes due to head injury. * participation in another concurrent clinical trial * patients with prior exposure to rtms * have a mass lesion, cerebral infarct or other active central nervous system disease, or history of traumatic brain injury

Keywords: schizophrenia transcranial magnetic stimulation electroencephalography
the prognostic value of limited transthoracic echocardiogram (ltte) during trauma resuscitation

Conditions: Patients Who Are in Shock and Intubated in the Trauma Bay (TB)

Summary: primary caregiver thoracic ultrasound (u/s) is a skill which is growing in utility in critical care. first introduced for volume assessment in nephrology and cardiology, it is now being researched in emergency and critical care. data is still evolving in its use in initial trauma evaluation. inferior vena cava (ivc) diameter correlates with outcome in trauma, but utility of its measurement on u/s in the emergency department still has some controversy. in trauma specifically, small studies suggests benefit to the use of u/s to predict volume status, and most of these data are from one author. it is not known if this can be applied more broadly. the prognostic value of findings on limited transthoracic echocardiogram (ltte, sonosite ultrasound) has been studied in several small studies, and only one small randomized controlled trial has proven benefit to its use. due to inter-rater reliability and the fact that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one group, it is not known if it can be applied to all trauma populations. research question: does ltte (sonosite ultrasound) predict mortality, emergency surgery, intensive care unit (icu) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as well as or better than other methods of organ perfusion? hypotheses: 1. use of ltte is associated with improved outcomes (less organ failure, decreased hospital and icu stays, transfusions, and mortality). 2. ltte predicts mortality, emergency surgery, icu stay, hospital stay, time on ventilator, number of and transfusions better than other methods of organ perfusion (tachycardia, hypotension, lactate, lactate clearance, creatinine, base deficit).


Eligibility criteria:
inclusion criteria: * patients arriving to trauma bay aged 18 or higher * hypotensive (systolic blood pressure (sbp) \< 90 mmhg or mean arterial pressure (map) \< 65, on 2 measurements) * respiratory failure (requiring mechanical ventilation) exclusion criteria: * unable to draw blood before transfusion or fluid challenge * patient arrests within 10 minutes of arrival * pregnant note: if inferior vena cava (ivc) not visible on ultrasound (u/s), pt will go to non-ivc group.

Keywords: trauma echo echocardiogram ultrasound inferior vena cava collapsibility
heterogeneous distribution of health literacy and emotional state on patients with functional dyspepsia.

Conditions: Dyspepsia

Summary: patients with indigestion were often found in gastroenterology clinic, those who about 20 % was caused by organic, while the rest of patients are showed abnormal inspection, and these are so called functional dyspepsia. functional dyspepsia is a chronic and repeated occurrence of digestive disorders, patients often visit hospitals frequently and unable to get fully cured. current symptom diagnoses are based on rome iii criteria as diagnostic criteria. although functional dyspepsia condition should combine with physical and mental treatments, due to the reasons behind the complex, there is still no effective classification could be acted in health education and drug intervention.

health literacy can be defined as "ability for obtaining basic health information and understanding medical services." within 10 years, healthy development and application of knowledge used in medical care and public health fields that have raised more attentions, many european countries set health knowledge as one of the main indicators for health care policy in the future. to promote behavior of self-care health for people, enhance the effective use of medical service , also reduce health care cost and unequally medical information. anxiety and depression are two common reactions when it comes to negative emotional states, which related to a body and caused a vicious cycle of disease. some patients suffer from functional dyspepsia symptoms were diagnosed with anxiety or depression symptoms often ignore body care due to lack of health literacy. the purpose of this study is to investigate the distribution of functional dyspepsia patients with health literacy and emotional status, in order to provide more effective health education mode, thereby reducing the waste of medical resources, and promote patient health.

Eligibility criteria:
inclusion criteria: * patients diagnosed with functional dyspepsia , can self-reading and the self-administered questionnaire. exclusion criteria: * due to physical illness, cognitive ability is limited and other factors can not were completed self-administered questionnaires.

Keywords: disease anxiety depression combine negative emotional states functional dyspepsia
registry in patients with aorto-iliac or iliac aneurysms

Conditions: Vascular Aneurysm

Summary: the pliant ii registry is undertaken to examine the real-world outcome after treatment of consecutive patients with uni- or bilateral aorto-iliac or iliac aneurysms using the e-liac stent graft system.

in this study, patients will be observed who receive one or two e-liac stent graft(s) for aorto-iliac or iliac aneurysms. the e-liac stent graft(s) will be implanted at the discretion of the treating physician. participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the e-liac stent graft system. informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before intervention and before data are being collected. the period of data collection will be 60 months starting from the intervention for each patient. 100% verification of patient informed consent and essential study documents will be performed at each study site. 60% of patient´s source documentation will be randomly monitored.

Eligibility criteria:
inclusion criteria: * age between 18 and 85 years * patient must have an aorto-iliac or iliac aneurysm * patient must have a unilateral or bilateral iliac aneurysm * patient´s anatomy must be suitable for stent graft placement on preoperative angio ct scan * patient must be available for the appropriate follow-up times for the duration of the study * patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to intervention exclusion criteria: * female of child bearing potential * patients with ruptured iliac aneurysms * patients with juxtarenal, pararenal or suprarenal aneurysms * patients pretreated with nellix (endologix) or altura (lombard medical) * patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints * patient with malignancy needing chemotherapy or radiation * patients with life expectancy of less than 3 years * patient minor or under guardianship

Keywords: aorto-iliac iliac aneurysm