Kornimate/medical-research-clean huggingface dataset:
hepatic and cardiac metabolic flexibility in obese with nafld.

Conditions: NAFLD - Nonalcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) covers a spectrum from reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (nash) and cirrhosis. new evidence indicates that nafld is associated with development of heart failure, abnormal ventricular glucose and fatty acid (fa) utilisation and cardiosteatosis. the mechanisms behind cardiac involvement and the progression from nafld to nash are poorly understood but must include altered cardiac and intrahepatic lipid handling. in collaboration with renowned research groups from oxford, mayo clinic and copenhagen investigators plan comprehensive kinetic studies of heart and liver fa uptake and oxidation, ventricular function and substrate utilisation, and hepatic triglyceride (tg) secretion in order to assess mechanisms governing cardiac and hepatic lipid and glucose trafficking in subjects with nafld and nash and the relationship with heart function. in addition, the investigators will assess skeletal muscle and adipose tissue enzyme activities, gene expression and protein concentrations in these subjects to define mechanisms involved in the cross-talk between heart, liver, muscle and adipose tissues. investigators will address these questions using innovative tracer techniques (11cpalmitate, 11c acetate, 18fdg glucose pet tracers and tg tracers) in combination with hepatic vein catherisation to study cardiac and liver substrate trafficking, as well as nmr spectroscopy, echocardiography, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. effects of acute exercise will be assessed. the overarching goals are to define abnormalities and differences between nafld and nash in hepatic lipid (fa and tg) metabolism and to assess the effect of exercise on both hepatic, cardiac and adipose and skeletal muscle lipid and substrate utilisation.


Eligibility criteria:
inclusion criteria: * 10 obese subject men/women with nafld (mr spectroskopi, fibro scanner) (bmi \> 30). * 10 obese subject men/women without nafld (mr spectroskopi, fibro scanner) (bmi \> 30). * age between 40-70 years * written consent before the start of the study exclusion criteria: * known current disease * fixed medical drug consumption, statins and antihypertensive drugs (non-beta blocker). however, pause 3 weeks before the examination date * blood donation within the last 3 months prior to the study * participation in experiments involving radioactive isotopes within the last 6 months * alcohol abuse (over 21 items per week for men and 14 for women) * smoking * weight over 130 kg * cancer patients * large intake of medication
vegf gene transfer for critical limb ischemia

Conditions: Critical Limb Ischemia; Ischemia; Leg Ulcer

Summary: the purpose of this gene therapy study is to evaluate the safety and efficacy of intramuscular gene transfer using vascular endothelial growth factor (vegf) or placebo in patients with moderate to high-risk critical limb ischemia (a condition in which there is poor blood circulation in the leg). this trial will assess whether vegf improves rest pain and/or heals ulcers in the legs of patients with peripheral artery disease (blockages in leg arteries.) vegf is dna, or genetic material that will be injected into the leg muscles on three separate occasions, each 2 weeks apart. once the dna is in the leg, it directs the cells of the artery wall to increase its production of vegf, which has been shown to cause new blood vessels to grow. this experimental therapy is designed to grow new blood vessels around blockages in the leg arteries. the total length of participation in this study is approximately 1 year and will require approximately 8 clinic visits within that year. following enrollment in the study, testing may be done for cancer screening, blood work, physical exams, vascular testing and eye exams. there is no charge for any testing or office visits required by the study. this study has been approved by the food and drug administration (fda).


Eligibility criteria:
inclusion criteria: * be at least 21 years old * have critical limb ischemia * have severe blockages in at least one artery in the affected leg as demonstrated by an angiogram * have nonhealing leg ulcers and/ or have severe rest pain secondary to a severely decreased blood flow * agree to participate in follow-up. exclusion criteria: * have any evidence of malignant neoplasms (other than non-melanoma skin cancer or in situ carcinoma) within the last 5 years * be pregnant or lactating * have a history of alcohol or drug abuse within 3 months of screening * have advanced (rutherford category 6) critical limb ischemia, characterized by extensive tissue loss or gangrene * have osteomyelitis * have undergone successful aortic or lower extremity surgery, angioplasty, or lumbar sympathectomy within the 2 months preceding screening * be a suitable candidate for surgical or endovascular revascularization in the limb in which treatment is proposed * subjects in whom arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder

Keywords: nonhealing leg ulcers ischemic rest pain
mobile messaging for improved nutrition

Conditions: Diet, Healthy; Anemia

Summary: this project will examine the impact of an infant and young child feeding (iycf) voice messaging intervention delivered to mothers and fathers in senegal on the consumption of a minimum acceptable diet and anemia prevalence in their children.

this is a cluster-randomized control trial (crct) conducted with 488 mother, father, and child triads in 104 villages in three regions in senegal: thies, diourbel and fatick. mothers and fathers in the experimental group will receive 16 voice and text messages over the course of 16 weeks. one voice and 1 text message with the same content will be sent per week over the 16 week period. we will include eight scripted messages which have previously been piloted. we will also include eight unscripted messages from positive deviants from communities similar to our study population that were included in our pilot study. a text message with the same content as the voice message will be sent to each triad mother and father to increase the reach of the intervention. we will conduct baseline and endline assessments of infant and young child feeding practices in both the experimental and control groups. primary outcomes will include the prevalence of anemia and minimum acceptable diet in children. minimum acceptable diet is an indicator of dietary diversity and a proxy for nutrient adequacy. secondary outcomes include the frequency of consuming key foods targeted in the intervention over the previous 7 days and infant and young child feeding indicators of complementary feeding of the child. in addition, infant and young child feeding knowledge, beliefs, and norms (of mothers and fathers in triads) and intentions (of mothers in triads) will be included as secondary outcomes.

Eligibility criteria:
inclusion criteria: * residing in thies, diourbel or fatick regions of senegal * household is member of village farming group * mothers and fathers (or caregivers) that have a child 6-19 months at baseline * mothers and fathers (or caregivers) that are 18 years or older * mothers and fathers (or caregivers) have the ability and mental capacity to consent to their participation * mother/father (or male/female caregivers) have access to mobile phone * child between 6-19 months at baseline exclusion criteria: -does not meet study inclusion criteria

Keywords: senegal infant and young child feeding
immunogenicity and safety of pentaxim™ in an indian population

Conditions: Diphtheria; Tetanus; Polio; Pertussis; Haemophilus Infections

Summary: the present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of aventis pasteur's dtacp-ipv// prp\~t combined vaccine (pentavac™ or pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. safety: this study will describe the safety after each dose of the primary series of the study's combined vaccine (pentaxim™).


Eligibility criteria:
inclusion criteria: * aged 42 to 56 days inclusive on the day of inclusion * born at full term pregnancy (\> 37 weeks) with a birth weight ≥ 2.5 kg * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past. * any vaccination preceding the trial vaccination (except bcg and hepatitis b) * history of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis b or haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or haemophilus influenza type b infection with the trial vaccine or another vaccine. * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of/current seizures * febrile illness (rectal temperature ≥ 38.0°c or axillary temperature ≥ 37.4°c) or acute illness on the day of inclusion.

Keywords: diphteria tetanus polio acellular pertussis hib haemophilus influenzae type b
mental stress on balance

Conditions: Mental Stress

Summary: objectives: this study aimed to examine the impact of mental stress on balance systems in healthy adults. study population \& sample size: participants were delimited to 178 students that enter oral and practical exams at different levels in faculty of physical therapy, kafrel-sheikh university. balance was measured using mini-sitcib test before and after the exam. another 40 subject that have no exam were recruited to work as control group study design : it is a controlled trial. methods : after obtaining the consent form, and demographics. the mobile application was opened, and a new experiment was created. abdominal support was modified so it contains a pocket in its centre so the mobile can fit onto it. participants were asked to conduct a mini-sitcib test before and after the exam in experimental group and before and after 30 min in control group. the data was extracted and stored anonymously on the hard drive as csv files.

mental health is a critical but often overlooked aspect of overall health. research has shown that mental stress can have detrimental effects on physical health, including balance impairments, in healthy adults. balance is a crucial physiological function that impacts daily activities and quality of life. imbalance due to mental stress can increase the risk of falls, injuries, and other health issues, particularly in the aging population. objectives: this study aimed to examine the impact of mental stress on balance systems in healthy adults. study population \& sample size: participants were delimited to 178 students that enter oral and practical exams at different levels in faculty of physical therapy, kafrel-sheikh university. balance was measured using mini-sitcib test before and after the exam. another 40 subject that have no exam were recruited to work as control group study design : it is a controlled trial. methods : after obtaining the consent form, and demographics. the mobile application was opened, and a new experiment was created. abdominal support was modified so it contains a pocket in its centre so the mobile can fit onto it. participants were asked to conduct a mini-sitcib test before and after the exam in experimental group and before and after 30 min in control group. the data was extracted and stored anonymously on the hard drive as csv files.

Eligibility criteria:
inclusion criteria: * bmi between 20 and 30 * free of any diseases exclusion criteria: * any trauma within last 2 weeks
usability, adherence and diagnostic performance of pointcheck in pediatric population

Conditions: Hematologic Malignancy

Summary: single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.


Eligibility criteria:
inclusion criteria 1. study subjects, or their parent/legal guardian for subjects \<18 years, must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. subjects between the ages of 7 and 17.9 years must provide assent. 2. male or female aged 7 years to 65 years. 3. adults (\> 18 years) diagnosed diagnosed with hodgkin/non-hodgkin lymphoma or breast cancer. 4. children and adolescents (7 - 18 years) with liquid or solid tumors. 5. scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia (table 1) 30. 6. able (in the investigator's opinion) and willing to comply with all study requirements. exclusion criteria 1. participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator. 2. participants with a history of vasculitis, raynaud syndrome, scleroderma, mixed connective tissue disease, or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold. 3. participants with circulating tumor cells in previous or current lab determinations. 4. adult (\>18 years) participants with leukemia of all types and pediatric (7-18 years) participants with leukemia that are either not in remission or in the minimal residual disease category. 5. participants with any condition producing significant tremor (e.g., essential tremor, parkinson´s disease, dystonic tremor). 6. unstable participants (pediatric or adults) or adult participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmhg). 7. any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. 8. other unspecified reasons that, in the opinion of the investigator or sponsor, make the subject unsuitable for enrolment.
decellularized femoral artery allograft (nexeon avx) prospective registry

Conditions: End-Stage Renal Disease

Summary: post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (nexeon avx decellularized femoral artery,

the clinical objective of this prospective, observational, post market registry study, cr-21-005, is to assess the safety and efficacy of a decellularized human femoral artery allograft (nexeon avx decellularized femoral artery, lifenet health, virginia beach, va) in the creation of vascular access for hemodialysis in patients with esrd.

Eligibility criteria:
inclusion criteria: 1. be male or female, ≥18 years of age at the time of graft placement 2. have a diagnosis of esrd or renal dysfunction requiring hemodialysis 3. subject requires dialysis access to start or maintain dialysis treatment and placement of an av access graft is a viable access option. 4. have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (icf) approved by an institutional review board (irb), and to agree to abide by the study restrictions and return to the site for the required assessments 5. have provided written authorization for use and disclosure of protected health information exclusion criteria: 1. be participating in a study of another investigational drug or device 2. have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (lincomycin, polymyxin b, ciprofloxacin, meropenum, gentamicin, or vancomycin) and processing reagents (n-lauroyl sarcosine, denarase and glycerol/glycerin) 3. have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment 4. have a history or evidence of severe peripheral vascular disease in the upper extremities 5. have the inability or be unable or unwilling to follow the study visit schedule 6. have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
feasibility of the multiple sclerosis performance test in participants with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective is to evaluate the feasibility of the multiple sclerosis performance test (mspt) in a clinical care setting when used by participants with multiple sclerosis (ms).


Eligibility criteria:
key inclusion criteria: * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations * diagnosis of ms, including clinically isolated syndrome * ability to understand the audio and visual instructions for the test modules * visual function, based on the investigator's clinical judgement that does not preclude an ability to interact with the multiple sclerosis performance test (mspt). key exclusion criteria: * unable or unwilling to provide informed consent * participants younger than 18 years of age, unless their parent or legal guardian provides the required signed and dated informed consent and authorization to use confidential health information and the participant provides assent in accordance with national and local subject privacy regulations note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: clinically isolated syndrome
microbiology of severe acute tonsillitis, peritonsillar cellulitis, and infectious mononucleosis

Conditions: Acute Tonsillitis; Peritonsillar Cellulitis; Infectious Mononucleosis

Summary: prospective, observational study of the microbiology of patients referred to a tertiary care center with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis.

patients referred to tertiary care centers with acute throat infections are most often treated with antibiotics. however, very little is know concerning the prevalent pathogens in patients with acute throat infections without abscess formation. evidence suggests that fusobacterium necrophorum plays an important role in complications of acute tonsillitis (e.g. peritonsillar abscess), but also uncomplicated acute tonsillitis. this study aims to explore the throat microbiology of patients with severe acute tonsillitis, peritonsillar cellulitis, or infectious mononucleosis with a special attention to a possible role of fusobacterium necrophorum.

Eligibility criteria:
inclusion criteria: 1. patients referred to our tertiary care center with acute tonsillitis with or without signs of peritonsillar cellulitis and with or without infectious mononucleosis. 2. center score 3 or 4. exclusion criteria: 1. abscess formation. 2. previous tonsillectomy.

Keywords: fusobacterium necrophorum acute tonsillitis peritonsillar cellulitis infectious mononucleosis microbiology antibody development
effect of intranasal anti-ige antibodies on ige production

Conditions: Allergy

Summary: in this study, participants will receive either intranasal anti-ige-antibodies (n=5) or intranasal allergen (n=5) or intranasal placebo (n=5). blood samples will be obtained before nasal administration of study drugs and 3, 5 and 8 weeks thereafter. in the serum samples, specific and total ige levels will be assessed.

the intranasal challenge study will be performed over 8 weeks outside of the birch pollen season (november to january) as a randomized, double blind and placebo-controlled study. during a screening visit, 15 individuals will be recruited according to eligibility criteria. they will be randomized into 3 groups (i.n. administration of anti-ige antibodies, bet v 1 or placebo). intranasal administration will take place on three consecutive days and serum samples will be taken 3, 5, and 8 weeks (+/- 4 days) after the treatment for analysis of total and specific ige levels

Eligibility criteria:
inclusion criteria: birch pollen allergy exclusion criteria: history of anaphylaxis autoimmune diseases treatment with corticosteroids, antihistamines, immunosuppressant drugs, beta-blockers significant medical conditions pregnancy or lactation
comparing risk of heat illness based on peak core temps during preseason football camp across 3 different age levels

Conditions: Exertional Heat Illness; Hydration Status

Summary: to collect field data in professional, collegiate, and high school football players to determine how they respond physiologically to the rigors of preseason training environment. investigators will compare core temperature, hydration status, practice guidelines regarding rest and hydration, and baseline knowledge of heat illness and hydration among the three levels. the hypothesis is higher peak temperatures will be observed in the younger less experienced football players.

observations will occur over a 4-5 day period at the start of pre-season training camp. researchers will meet with the high school volunteers and their parents to discuss the study and obtain informed consent prior to participating. participants will swallow the hqinc cortemp pill at least three hours (or late the night before) before practice. temperature readings will be scanned every 15-30 minutes throughout practice. pre and post practice weights will be recorded as well as urine specific gravity to help assess hydration status. participants will also fill out a short 1 page questionnaire regarding their prior heat acclimatization, sleep habits, and baseline knowledge of hydration and heat illness. protocol will be the same at all three age/competition levels.

Eligibility criteria:
inclusion criteria: * football player on one of the teams from the pre-selected teams. male. exclusion criteria: based on being able to swallow hqinc cortemp pill 1. any athlete weighing less than eighty (80) pounds. 2. any athlete with any known or suspected diseases of the gastrointestinal tract. 3. any athlete with impairment of the gag reflex. 4. any athlete with previous gastrointestinal surgery. 5. any athlete with history of problems with their esophagus. 6. any athlete who might undergo an mri scan before the temperature sensor has been eliminated from the body. 7. any athlete with problems moving food through their gastrointestinal tract. 8. any athlete having a cardiac pacemaker or other implanted electro medical device.

Keywords: exertional heat illness hydration status preseason football heat stroke