Kornimate/medical-research-clean huggingface dataset:
effectiveness of sensory stimulation for person in a coma or persistent vegetative state after traumatic brain injury

Conditions: Brain Injuries

Summary: appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after traumatic brain injury (tbi). databases were searched and nine articles met inclusion criteria.

background: traumatic brain injury (tbi) accounts for approximately 50,000 deaths in the united states each year. about 17% of survivors have a period of "coma". duration of coma contributes significantly to functional outcomes. objective: to appraise the evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after tbi. data sources and study eligibility criteria: databases searched included medline, psycinfo, cinahl, otseeker, and the cochrane database of systematic reviews. the search was limited to outcomes studies in the hierarchy described by sackett and colleagues (1996), published in english in peer-reviewed journals between 2006 and 2014.

Eligibility criteria:
inclusion criteria: * in coma or persistent vegetative state after traumatic brain injury exclusion criteria: * coma or persistent vegetative state not caused by traumatic brain injury

Keywords: coma persistent vegetative state sensory stimulation
a study in patients with advanced cancers

Conditions: Advanced Cancer; Advanced Solid Tumor; Cancer; Oncology

Summary: a first-in-human study using bio-106 as a single agent and in combination with pembrolizumab in advanced cancers.

this is an open-label, phase 1/2, first-in-human (fih), multiple ascending dose and dose-expansion study of bio-106 administered as monotherapy and in combination with pembrolizumab. phase 1 will define the maximum tolerated dose (mtd) or recommended phase 2 dose (rp2d) of bio-106 that can be advanced to phase 2. phase 2 will define the preliminary efficacy of these regimens in the setting of advanced solid tumors with high unmet medical needs.

Eligibility criteria:
key inclusion criteria: * patients histologically or cytologically documented, locally advanced or metastatic solid tumor. * disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment. * measurable disease as determined by recist v.1.1 or bone only disease. * eastern cooperative oncology group (ecog) performance status of 0 or 1. key exclusion criteria: * history of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody. impaired cardiac function or history of clinically significant cardiac disease * human immunodeficiency virus (hiv) infection, active hepatitis b infection, or hepatitis c infection. * active sars-cov-2 infection. * untreated central nervous system (cns), epidural tumor or metastasis, or brain metastasis. other protocol defined inclusion/exclusion criteria may apply.
metronomic chemotherapy in advanced gastric cancer

Conditions: Metastatic Gastric Cancer; Locally Advanced Gastric Cancer

Summary: phase ii study of weekly metronomic chemotherapy using weekly paclitaxel, oxaliplatin, leucovorin and 5-fu (polf) in patients with advanced gastric cancer

about 80% of patients with advanced gastric cancer are diagnosed at an advanced stage with limited treatment options including systemic chemotherapy with or without radiation. commonly used maximally tolerated dose (mtd) chemotherapy such as dct, ecf, folfox regimens induce responses in the range of 20 to 50% with median survival in the range of 10 to 12 months. metronomic chemotherapy has been found to have more consistent anti-tumor effects through anti-angiogenic and immunomodulating effects. preliminary clinical studies of weekly polf have found very encouraging clinical activities and low overall toxicities in pancreatic cancer and gastric cancer. here we conduct a formal clinical trial to determine the clinical efficacy and side effect profiles of this regimen in patients with advanced gastric cancer.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed gastric cancer ajcc stage iii or iv 2. measurable disease based on ct or endoscopy exam 3. non-surgical candidates or patients who declined surgery 4. non-radiation candidates or patients who declined radiation 5. patients who are able to sign informed consent 6. patients who are 2 weeks out and recovered from surgery 7. patients who have completed radiation to relieve obstructive symptoms 8. patient who previously received oxaliplatin and 5-fu in other mtd regimens 9. adequate marrow function: neutrophil \>1000/ul, hgb \>10g/dl, plt\>50,000 exclusion criteria: 1. allergic to any of the drugs involved 2. concurrent malignancies 3. severe co-morbidities of heart, lungs, kidneys and bone marrow 4. severe psychological disorder 5. severe malnutrition 6. difficult to heal or unhealed wound 7. ecog performance status equal or over 3 8. uncontrolled complications from the malignancy 9. uncontrolled cns metastasis 10. peripheral neuropathy grade 3 or above 11. pregnancy or breast feeding

Keywords: gastric cancer gastroesophageal cancer metastatic advanced
fapi pet for response evaluation and prognosis prediction in liver and biliary cancer patients treated with pd-1 combination therapy

Conditions: Hepatocellular Carcinoma; Bile Duct Cancer

Summary: the purpose of this study is to explore the ability of positron emission tomography (pet) with \[68ga\]fapi to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-pd-1 antibodies-based combination therapy.

hepatocellular carcinoma (hcc) and bile tract cancers (btc) are major health issue worldwide, particularly in eastern asia. anti-pd-1 antibodies-based combination therapy has shown considerable efficacy in advanced hcc and btc. however, an objective response is only achieved in a portion of patients. thus, there is an urgent need for better patient selection before immunotherapy as well as accurate evaluation of treatment response. pet is a noninvasive imaging technique which might be an effective tool for evaluating anti-pd-1 antibody-based combination treatment in liver and biliary cancer. 68ga-fapi has been developed as a novel agent targeting fibroblast activation protein (fap) that is overexpressed in cancer-associated fibroblasts in liver and biliary cancer. prior studies have shown that fap-expressing caf suppresses anti-tumor immunity while suppressing fap can overcome stromal barriers to immuno-oncological responses. meanwhile, 68ga-fapi pet showed a high detection rate in primary and metastatic lesions in liver and biliary cancer. the aim of this study is to evaluate the ability of positron emission tomography (pet) with \[68ga\]fapi to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-pd-1 antibodies-based combination therapy. our hypothesis is that baseline \[68ga\]fapi pet parameters can predict response and clinical benefit of anti-pd-1 antibodies-based combination therapy and overall survival; that effects of anti-pd-1 antibodies-based combination therapy in liver and biliary cancer can be detected and quantified by \[68ga\]fapi pet after treatment in correlation with other radiological findings and clinical endpoints; that such effects are more prominent with \[68ga\]fapi pet than with the traditional \[18f\]fdg pet.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic and/or unresectable hcc or btc * child pugh a or b liver function status * an ecog performance status score of 0-2 exclusion criteria: * intolerance to anti-pd-1-based combination therapy * active or prior autoimmune disease * concurrent use of immunosuppressive medicaments
sarilumab covid-19

Conditions: Corona Virus Infection

Summary: primary objective: to evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical coronavirus disease 2019 (covid-19). secondary objectives: * evaluate the 28-day survival rate. * evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity. * evaluate changes in the national early warning score 2. * evaluate the duration of predefined symptoms and signs (if applicable). * evaluate the duration of supplemental oxygen dependency (if applicable). * evaluate the incidence of new mechanical ventilation use during the study. * evaluate the duration of new mechanical ventilation use during the study. * evaluate the proportion of participants requiring rescue medication during the 28-day period. * evaluate need for admission into intensive care unit. * evaluate duration of hospitalization (days). * the secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of: * serious adverse events. * major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia. * grade greater than or equal to (\>=) 2 infusion related reactions. * grade \>=2 hypersensitivity reactions. * increase in alanine transaminase (alt) \>=3x upper limit of normal (uln) (for participants with normal baseline) or greater than 3x uln and at least 2-fold increase from baseline value (for participants with abnormal baseline). * major or opportunistic bacterial or fungal infections.

an individual participant would complete the study approximately 60 days from screening to follow-up on day 60 ±7 days.

Eligibility criteria:
inclusion criteria : participants must be \>=18 years of age. participants must be hospitalized for less than or equal to 7 days with evidence of pneumonia and have one of the following disease categories: severe disease or critical disease. laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection. exclusion criteria: unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours. participants with multi organ dysfunction or requiring extracorporeal life support or renal replacement therapy were excluded. presence of neutropenia less than 2000/cubic millimeter (mmˆ3), aspartate transaminase or alt greater than 5x uln, platelets less than 50,000/mmˆ3. prior immunosuppressive therapies. use of systemic chronic corticosteroids for non-covid-19 related condition. known or suspected history of tuberculosis. suspected or known active systemic bacterial or fungal infections. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
the efficacy of distal pharyngeal airway for oxygenation during tee

Conditions: Airway Obstruction

Summary: the purpose of this study is to investigate the effect of using the mcmurray enhanced airway (mea) which is a flexible extended-length distal pharyngeal airway on improving oxygen delivery compared to standard nasal cannula.


Eligibility criteria:
inclusion criteria: * age \> or = 18 years old * patients willing to participate and provide an informed consent * patients scheduled to undergo an elective tee procedure. exclusion criteria: * patients with history of uncontrolled gastroesophageal reflux disease * patients with anatomical airway obstruction * have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements
functional and proprioceptive status in patients with hemophilic ankle arthropathy

Conditions: Haemophilia

Summary: introduction: hemophilic ankle arthropathy is manifested by functional degenerative alterations (muscle strength deficit, mobility and proprioception), intra-articular and chronic pain. design: case-control study. objective: to observe the differences between patients with hemophilic ankle arthropathy and their healthy peers, regarding dorsiflexion, dorsiflexion strength, biomechanical analysis of gait and balance, and functionality. patients: 10 patients with hemophilic ankle arthropathy and 12 healthy subjects without ankle joint damage. measurement instruments and study variables: dorsiflexion (range of motion), dorsiflexion strength (dynamometry), biomechanical analysis of gait and balance (rs scan® model platform), and functionality (2 minute walk test). expected results: analyze the main differences and their relationship based on the clinical and independent variables of patients with hemophilia, compared to their healthy peers.


Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a and b. * over 18 years. * with medical diagnosis of ankle arthropathy. * with clinical evaluation by hemophilia joint health score. * in prophylactic treatment or on demand with fviii / fix concentrates for coagulation. * no previous hemarthrosis of the ankles in the 3 months prior to evaluation. exclusion criteria: * patients with inhibitors (antibodies against fviii or fix). * patients with neurological or cognitive disorders that prevent the understanding of questionnaires and physical tests. * failure to sign the informed consent document

Keywords: hemophilic arthropathy ankle joint pain functionality range of motion proprioception
the effect of novel high-intensity interval training on physical fitness in older adults

Conditions: High-intensity Interval Training

Summary: high-intensity interval training (hit) has been demonstrated to be an effective strategy to improve markers of health and fitness across a wide range of healthy and clinical populations. currently however, there is only limited evidence which has examined the effectiveness of hit in older adults (\>50 years). hit is an appealing strategy in this group as it has the potential to impact both cardiorespiratory and muscular fitness, which both play an important role in maintaining functional fitness and quality of life in a time-efficient manner. developing an understanding of novel strategies for delivering this type of exercise training may ultimately provide a viable alternative to traditional modes of exercise training for a broader range of participants. as such, the purpose of this study is to evaluate the effects of a novel, high-intensity interval training exercise protocol to improve physical fitness in adults aged over 50 years. this research also aims to evaluate if this type of training intervention is feasible in this population, through analysis of adherence and intervention fidelity.


Eligibility criteria:
inclusion criteria: 1. must be aged 50-85 years 2. must be able to provide informed consent to participate 3. must be free from all exclusion criteria exclusion criteria: 1. symptoms of or known presence of heart disease of major atherosclerotic cardiovascular disease 2. early family history of sudden cardiac death 3. condition or injury or co-morbidity affecting the ability to undertake exercise 4. diabetes mellitus 5. pregnancy or likelihood of pregnancy

Keywords: high-intensity interval training functional fitness quality of life older adults
longitudinal imaging biomarkers of disease progression in dlb

Conditions: Lewy Body Disease

Summary: the researchers are trying to determine the paths of change in imaging biomarkers of dementia with lewy bodies (dlb) and their associations with rate of cognitive and functional decline.

the proposed project will enroll 90 subjects with probable dlb, 60 from mayo clinic rochester (mcr) and 30 from mayo clinic jacksonville (mcj). additionally, 45 controls will be enrolled, 30 from mcr and 15 from mcj. we will obtain up to six assessments in each subject over the 5 years of the study, baseline, six month and annually thereafter. we will follow these cohorts with clinical and biospecimen data collection annually and once at six months, and csf collection annually within the guidelines of the parkinson's disease biomarker's program (pdbp). clinical neuroimaging will be performed annually and include: a) dopamine transporter imaging with ioflupane (123i) spect (datscan) as the biomarker of lbd-related loss of dopaminergic activity, b) structural mri ad- signature atrophy as the biomarker of ad-related neurodegeneration, c) β-amyloid (aβ) deposition on pet as the biomarker of aβ pathology. in patients from the mcr site, we will investigate av-1451 pet. since the specificity of av-1451 pet is not established for tau deposition in dlb, we will investigate this biomarker in a subset of dlb patients to determine the pattern of av-1451 uptake compared to clinically normal controls, and its association with atrophy, aβ load and clinical disease progression in dlb.

Eligibility criteria:
inclusion criteria: * diagnosis of probable dlb, at least 18 years of age, reliable informant who personally speaks with or sees the participant at least weekly, sufficiently fluent in english, must be willing and able to consent to the protocol and undergo up to 6 visits over 5 years, willing and able to undergo neuropsychological testing and no contraindication to mri imaging. exclusion criteria: * presence of another neurologic disorder which could impact findings, such as multiple sclerosis, brain tumors, etc., unwilling to return for follow-up yearly and undergo neuropsychological testing and mr imaging, if undergoing tau imaging cannot have qt prolongation, do not have a reliable informant.
clinical trial of an mri based patient specific focal knee resurfacing implant

Conditions: Cartilage Damage; Knee Injuries

Summary: the goal of this study is to evaluate the efficacy, safety and performance of the episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).

lesions in the cartilage are common disorders. in the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. the quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (oats) are methods used for treatment of the lesions. some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis. episurf medical has developed a focal knee resurfacing (fkr) implant, the episealer® implant. the implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. the implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (mri). the episealer® device is ce marked. the episealer® implant consists of a peg and a hat. the implant exists in five different diameters (12,14,17, 20 and 25mm), depending on the lesion size. the shape of the hat is circular or oval. the episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. to enhance the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an interlaying biocompatible pure titanium coating. a previous study (s57685) showed that episealer is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing). this device is a good solution when there are no alternative treatments, except prosthesis surgery, available. the goal is to evaluate the efficacy, safety and performance of the episealer® device in a larger sample size and on the long term.

Eligibility criteria:
inclusion criteria: * subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible * minimal age 18 years (preferred age group \>40 years) * suitable for implant, to be determined by analysis of mri imaging. suitability is set by the size and location of the lesion. * informed consent exclusion criteria: * under age (\<18yrs) * active or recent (\<1 yr) septic arthritis of the involved knee * associated symptomatic untreated ligamentary or meniscal pathology in the involved knee * (severe) osteoarthritis in the involved or other compartments of the involved knee * severe osteoporosis * mri not possible (eg. due to pacemaker) * marked valgus- or varus alignment (\>6 degrees)
effect of short-term intensive insulin sequential exenatide therapy in newly diagnosed type 2 diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: the randomized, controlled trial is to investigate and evaluate the effects of short-term continuous subcutaneous insulin infusion (csii) sequential exenatide therapy on β-cell function, long-term glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

the uk prospective diabetes study has shown that β-cell function progressively deteriorates over time in people with type 2 diabetes mellitus, irrespective of lifestyle and existing pharmacological interventions. the progressive nature of type 2 diabetes is one of the major challenges in the treatment of affected patients, and agents that could alter the natural history of this condition would add greatly to current treatment approaches. short-term intensive insulin therapy of newly diagnosed type 2 diabetes will improve beta-cell function and usually leading to a temporary remission time. the effect of glp-1 receptor agonists on beta-cells is stimulation of glucose-dependent insulin release, followed by enhancement of insulin biosynthesis. it is stimulating beta-cell proliferation, induction of islet neogenesis, and inhibition of ß-cell apoptosis. exenatide is synthetic exendin-4, glp-1 receptor agonist. exenatide exerts direct effects on β-cell, which indicates that may contribute to delay disease progression. however, no study has evaluated effect of short-term intensive insulin sequential exenatide therapy model on β-cell function and glycemic remission rate in newly diagnosed type 2 diabetic patients. this current study is thus designed to evaluate effect of short-term intensive insulin sequential exenatide therapy model on β-cell function , glycemic control and glycemic remission rate in newly diagnosed type 2 diabetic patients.

Eligibility criteria:
inclusion criteria: 1. newly-diagnosed type 2 diabetic patients, drug naïve 2. age 30\~70 years 3. fpg 7.0\~16.7mmol/l 4. bmi 20\~35 kg/m2, stable body weight (≤10% variation) for at least 3 months prior to screening 5. female patients of reproductive age should practice a reliable method of birth control throughout the study exclusion criteria: 1. acute or severe chronic diabetic complications 2. recently suffered from mi or cva. 3. severe gastrointestinal disease 4. other severe intercurrent illness 5. serum aminotransferase (alt and ast) level higher than 2 times of the upper normal limits and/or serum creatinie≥133µmol/l (1.5mg/dl) 6. tested positive for glutamic acid decarboxylase antibody 7. use of weight loss drugs, corticosteroids, drugs known to affect gastrointestinal motility, transplantation medications, or any investigational drug 8. history of pancreatitis 9. pregnant or lactation women.