Kornimate/medical-research-clean huggingface dataset:
enteric immune-nutrition formula (anom®) for patients receiving major upper gastrointestinal surgery

Conditions: Chronic Upper Gastrointestinal Hemorrhage

Summary: perioperative usage of immunonutrition (anom®) can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. (anom®)immunonutrition product name

background: perioperative usage of immunonutrition can attenuate the pro-inflammatory cytokines and reduce postoperative infectious complications and length of hospital stay after major upper gastrointestinal surgery. the aim of this study was to elucidate the effect of immunomodulating diets, anom®, on surgical outcome in elective major upper gastrointestinal tract operations. material and methods: design: prospective, randomized, controlled trial. participants: seventy upper gastrointestinal tract cancer patients planned to undergo major upper gastrointestinal surgery in eesophagus、stomach、pancreas or duodenum, interventions: patients will be divided randomly into two groups to receive anom® or standard diet. before surgery, 800ml anom® or standard diet (sen) will be given for 5 days by mouth. after operation, 5% distill water (d5w) combined with anom® or standard diet since the 2nd post-operation day (pod2) until day 14 (pod14) or until discharged day by enteric route using nasogastric tube(ng) tube or jejunostomy. postoperative parenteral nutrition will be given to maintain adequate nutrition. clinical assessment: the preoperative and postoperative immunological parameters, infection complications, and hospital stay will be compared.

Eligibility criteria:
inclusion criteria: 1. age ranged from 18 to 80 years old 2. patients with upper gastrointestinal diseases, and was planning to receive elective major upper gastrointestinal tract surgery, such as subtotal gastrectomy, proximal gastrectomy, total gastrectomy, esophagectomy, pancreatectomy, pancreaticoduodenectomy, duodenectomy, etc. 3. patient is able to understand the requirements of the study and signs the informed consent form. exclusion criteria: 1. patient with severe malnutrition condition, albumin \< 2.6mg/ml 2. patient with severe pulmonary, cardiovascular, renal or hepatic disease 3. patient with immunosuppressive therapy or immunological disease recently 4. patient with on-going infection with any condition 5. patient with emergency operation 6. patient with widespread metastatic disease before surgery 7. patient with bowel obstruction disease 8. investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)

Keywords: immunomodulating diet postoperative infection
role of toxins in lung infections caused by pseudomonas aeruginosa

Conditions: Pseudomonas Infection; Cystic Fibrosis

Summary: some bacteria that cause disease can produce toxic substances that may worsen the disease. pseudomonas aeruginosa is a bacteria that can produce a variety of toxins and is of special interest for patients with cystic fibrosis and repeated long term lung infections. the goal of this study is to determine whether specific toxins produced by pseudomonas aeruginosa may be important in the disease process of chronic lung infections of patients with cystic fibrosis. this study will attempt to measure bacterial production of toxins in blood and sputum and immune system response to toxins in the blood....

the goal of this study is to determine whether virulence determinants that use the type iii-secretory pathway may be important in the pathogenesis of chronic pseudomonas aeruginosa lung infections in patients with cystic fibrosis (cf). the studies will quantify bacterial effector proteins in serum and sputum and the immune response to specific products as reflected by antibodies in serum. candidate effector proteins include: (1) exotoxin a, a non-type iii-dependent adp-ribosyltransferase and cytotoxin that does not use the type iii secretory pathway, (2) exos, a type iii pathway-dependent extracellular adp-ribosyltransferase with cytotoxic activity, (3) exou, another type iii-dependent cytotoxin, that is responsible for epithelial injury in acute lung infections, and (4) pcrv, a homolog to the v antigen of yersinia.

Eligibility criteria:
* inclusion criteria: patients with cystic fibrosis with a defined mutation in the cystic fibrosis transmembrane regulator (cftr) (e.g., any of the known variants of the cftr gene, such as the delta f508 allele). patients will have been tested or will be tested for the cftr gene under another protocol. research volunteers that are age-and race-matched as control subjects. exclusion criteria: patients who are less than 9 years of age. research volunteers less than 18 years of age. patients or research volunteers who test positive for human immunodeficiency virus (hiv) or a positive serum test for hepatitis b and/or c virus. patients or research volunteers who test positive for tuberculosis. research volunteers with pulmonary disease or infection.

Keywords: cystic fibrosis effector proteins cytotoxin lung injury genetic screen natural history
observational study in the management of ulcerative colitis with oral 5-asa

Conditions: Ulcerative Colitis

Summary: the objectives of this study are to investigate how oral 5-asa drugs have been used in the condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage), or in the transition from the condition with symptoms such as abdominal pain or diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to study how many patients will be able to maintain the remission stage during the observation period and how many times the patients will experience the active stage (relapse), as well as how symptoms will change during the observation period to discover better treatment plans.

period: 2012-2014 observation time: 0, 26week, 52week matters investigated: 1. pucdai scores(stool frequency, bloody stool, physician's global assessment) 2. medication adherence (vas scale) 3. remission, relapse 4. age, gender, body height, body weight, date of diagnosis, extension of inflammation, classification by clinical course, smoking, alcohol, work, disease complication, duration of remission maintained to enrollment(remission patient)

Eligibility criteria:
inclusion criteria: 1. outpatients 2. adult patients who have been diagnosed with mild to moderate active ulcerative colitis or ulcerative colitis in the remission stage according to the diagnostic criteria for ulcerative colitis (draft revised on february 13, 2010) 3. patients who have been treated with remission induction therapy or remission maintenance therapy with oral 5-asa drugs (pentasa® tablets 250 mg, pentasa® tablets 500 mg, asacol® tablets 400 mg and salazopyrin® tablets 500 mg as well as drugs that have been proved equivalent to these drugs) 4. patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study exclusion criteria: 1. patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on february 13, 2012) 2. patients who have received total / subtotal colectomy 3. patients who have been complicated with malignant tumor 4. patients who are pregnant or possibly pregnant 5. other patients whom investigators and subinvestigators considered inappropriate to participate in this study

Keywords: 5-asa, ulcerative colitis, active, remission, adherence
incobotulinumtoxin a and yoga-like isometric exercise in adolescent idiopathic lumbar scoliosis

Conditions: Scoliosis Idiopathic; Scoliosis; Adolescence; Scoliosis; Lumbar Region

Summary: the study uses a yoga-like isometric posture and botulinum injections to reduce the curves in adolescent idiopathic lumbar scoliosis. three previous studies show that the yoga pose is effective for reversing scoliotic curves; botulinum toxin has been approved by the fda for teenagers. however, no studies using the two of them together have been done until this one.

the randomized control 6-month study employs an isometric yoga-like posture to strengthen the weak side, and one set of botulinum injections to weaken the strong side of adolescent idiopathic lumbar scoliosis between 25 and 60 degrees. it is open to people between 12 and 18 years of age who are willing to do the pose every day for three months. this is a crossover study: after 3 months, every patient who was placebo will be offered the actual proven yoga pose and botulinum toxin injections. two additional free x-rays at 3 weeks and 3 months following the botulinum injection will also be available to each placebo patient. in this way every patient - placebo or not - will receive the full proper treatment within 3 months.

Eligibility criteria:
inclusion criteria: 1. fourteen - 18 years of age, 2. scoliotic curve greater than 25 degrees, less than 45 degrees, 3. stated willingness to do the yoga and yoga-like poses daily, 4. written, signed consent by patient and parent/guardian 5. pre-test cobb films no less than 3 months old read by independent radiologists. * exclusion criteria: 1. neurological, muscular or neuromuscular disease, (e.gs., cerebral palsy, myopathy, stroke), 2. genetic abnormalities that affect limb growth, proportionality or metabolism, (e.gs., mucopolysaccharidoses, marfan's syndrome, refsums disease). 3. pregnancy and other conditions prohibiting x-rays or minute(s)-long exertion (e.gs., congestive heart failure, great weakness, copd). 4. previous exposure to botulinum neurotoxin type a. sexually active female subjects must present a recent negative pregnancy test.

Keywords: adolescent idiopathic scoliosis scoliosis yoga isometric botulinum
identification and analysis of immunomodulatory molecules in patients with hematologic disorders and healthy volunteers

Conditions: Hematologic Diseases; Healthy Volunteers

Summary: this research study goal is to analyze the plasma and the cells that make up part of the immune system. we want to learn how the plasma and cells work. these may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.

this research study goal is to analyze the plasma and the cells that make up part of the immune system. these cells, called white cells or leukocytes, are present in blood. we want to learn how these cells work to prevent infection and how they respond after an infection occurs. we also want to study certain molecules present on the plasma, on or in these cells, and the genetic material that allows these molecules to be made. these molecules may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms. this study may increase our understanding of a variety of diseases including infections such as hiv, allergic diseases such as asthma, joint diseases such as rheumatoid arthritis, certain cancers, and the rejection process that sometimes occurs after transplantation of an organ.

Eligibility criteria:
inclusion criteria: * must be able to give blood * must be able to give informed consent * signed, written informed consent exclusion criteria: * individuals with a history severe anemia, inadequate venous access, severe blood or coagulation disorders. * pregnant women are excluded because it is a unique immunotolerant state and will alter the profile of immunomodulatory molecules.

Keywords: hematologic diseases genomics cytokines chemokines receptors
semaglutide as an adjunct to dieting in the treatment of type 2 diabetes

Conditions: Type2 Diabetes

Summary: the pharmacological approaches in the treatment of type 2 diabetes (t2dm) have advanced radically during the last decades. however, focus on long-term management of body weight, which is an essential part of treatment success, is often lacking. excluding surgery, there are only a few effective treatment methods for obesity. management of obesity is also greatly challenged by weight regain, which is common after a successful lifestyle intervention. weight regain typically results in the deterioration of glucose homeostasis in t2dm. however, understanding the pathomechanisms of weight regain and subsequent worsening of glucose homeostasis is still insufficient. therefore, t2dm treatment programs that target long-term weight management have been scarce. this study aims to fill the gaps in the current knowledge by advancing the development of treatment programs for t2dm that simultaneously head for improved glucose metabolism and improved long-term body weight control.

in this randomized, double-blind, parallel, placebo-controlled trial we compare the effects of semaglutide 1.34 mg/ml vs. normal dieting by randomizing the patients with both t2dm and overweight/obesity (bmi ≥27) (n=50, aged ≥18 to \< 65 years) to two groups: both groups participate in a similar lifestyle treatment to induce weight loss, but one group gets an add-on of semaglutide 1.34mg/ml while the other is treated with placebo. additionally, a reference group of healthy normal weight non-diabetic individuals (bmi ≤ 25 kg/m2, n=25, aged ≥18 to \< 65 years) are included as controls at the initiation of the study.

Eligibility criteria:
inclusion criteria: * age ≥18 years and \<65 years * bmi: ≥27 kg/m2 * t2dm (hba1c ≥ 6.0% if on anti-diabetic medication or hba1c≥6.5% if non- medicated) * participant is willing and able to give informed consent for participation in the study exclusion criteria: * contraindication to trial drugs * use of insulin or glp-1ras (during the past 3 months) * use of anti-obesity drugs (during the past 3 months) * weight change of \>5% during the past 3 months * bariatric surgery or planned bariatric surgery during the trial * history of pancreatitis * impaired renal function (gfr\<30 ml/min/1.73m2) * impaired hepatic function (alat\>2 x upper limit normal) * clinically significant active cardiovascular disease * clinically significant abnormality in the ecg * cancer (except basal or squamous cell skin cancers) * major psychiatric disease (such as severe depression, bipolar disorder, schizophrenia) * substance abuse * learning disability * females of childbearing potential not using adequate contraceptive methods * pregnancy * lactation * any other condition that in the opinion of the investigator could interfere with the conduction of the study or interpretation of the study results

Keywords: weight loss dieting
effectiveness, complications, and mortality of tle in patients.

Conditions: Transvenous Lead Extraction

Summary: the number of devices for cardiac pacing and defibrillation has increased in recent years. however, although they have improved in terms of quality and extended lifespan after implantation, they are not free from complications. the achilles' heel of cardiac implantable electronic devices (cieds) is the risk of infections and lead failure, which, when untreated, can be the cause of poor outcomes and a high mortality rate. abandoned leads predict serious adverse events, such as lead infections, death, electrical interference, or potential problems during future tle procedures. therefore, it is crucial to extract them, presuming the decision is warranted based on a patient's individual risk. tle is a standard treatment for device-related complications, and while tle procedures are relatively rare in comparison to the number of cieds that are implanted, the need for tle has grown in recent years due to the aging population, an increasing number of upgrades of pacing systems, and a related rise in infection rates. according to the european lead extraction controlled registry (electra), the most frequent indication for tle is cied infection, with the majority of them being local infections. the second most common reason for tle is lead dysfunction, which is observed in 38.1% of cases. in such cases, the treatment must be fast and effective. tle is the first-line treatment for those patients and prevents further serious or even lethal complications. however, the goal of tleis often to remove leads and also maintain access in the occluded vein by moving the sheath over the lead to the lead myocardial interface. tle technology has recently shown substantial progress in improving the safety and effectiveness of the procedure. as a rule, single traction is the primary method of treatment, followed by more aggressive techniques such as locking stylet, mechanical sheaths, powered extraction sheaths, and femoral snares. data obtained in previous studies. indicated that identifying predictors of such undesirable adverse events appeared essential for optimizing the procedural technique. another vital element to address were patients deemed at high risk of stricter follow-up and stronger secondary prevention strategies; notably, infected tle patients have unique characteristics. the analysis of independent predictor outcomes could, thus, allow clinicians to better identify high-risk tle patients. in light of this, the current registry aimed to investigate the composite short-term outcomes for infected and non-infected patients in real-world populations.


Eligibility criteria:
inclusion criteria: consecutive patients who underwent tle between 2016 and 2022 entered the extract registry. exclusion criteria: - no

Keywords: transvenous lead extraction cardiac implantable electronic devices
a study of an investigational drug, aln-aat, in healthy adult subjects and patients with zz type alpha-1 antitrypsin deficiency liver disease

Conditions: Antitrypsin Deficiency Liver Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered aln-aat in healthy adult subjects and patients with zz type alpha-1 antitrypsin deficiency liver disease.


Eligibility criteria:
inclusion criteria: * adequate complete blood counts, liver and renal function. * 12-lead electrocardiogram (ecg) within normal limits * female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization * male subjects agree to use appropriate contraception * willing to provide written informed consent and willing to comply with study requirements * nonsmokers for at least 5 years before screening exclusion criteria: * any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk * received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study * active serious mental illness or psychiatric disorder requiring current pharmacological intervention * history or evidence of alcohol or drug abuse within 12 months before screening. * history of intolerance to sc injection

Keywords: rnai therapeutic aat alpha-1 antitrypsin deficiency
observational study on hypothyroidism in young children following iodine contrast exposure

Conditions: Hypothyroidism

Summary: to investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.


Eligibility criteria:
inclusion criteria: - all children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g. contrast enhanced ct, cardioangiography) exclusion criteria: * congenital hypothyroidism or other forms of preexisting hypothyroidism * preexisting thyroid hormone replacement therapy less than three months of observation before the radiological examination (if greater than three months old) * less than two weeks follow-up available after the contrast exposure.

Keywords: children iodinated contrast agents
lyric4 outcomes evaluation

Conditions: Hearing Loss

Summary: the goal of this clinical investigation is to obtain feedback on lyric4 device updates within a cohort of experienced adult lyric hearing instrument users. the main question it aims to answer is: • do device updates cause a change in lyric patient experience? participants will be asked to complete questionnaires about their past experience with lyric, as well as their experience with lyric during the study period. they will also be asked to undergo aided audiometric testing with lyric devices.


Eligibility criteria:
inclusion criteria: * experience with lyric hearing instruments * willingness to travel to the study site and complete study procedures * adults, age 18 or older * fluency with english (written/spoken) exclusion criteria: * no lyric hearing instrument experience * ear health issues preventing lyric fitting or requiring medical clearance prior to fitting * difficulty reading when corrected for vision loss

Keywords: hearing loss
establishing pressures at the egj during diaphragmatic breathing using high-resolution esophageal manometry

Conditions: Gastroesophageal Reflux; Dysphagia; Esophageal Motility Disorders

Summary: the goal of this study is to determine which position, maneuvers or combination thereof generates the highest pressure at the egj as assessed by high-resolution esophageal manometry and thus greater or more robust contraction of the diaphragm.

this is a prospective, single-center study of adult (age ≥18 years) participants undergoing high-resolution esophageal manometry to assess the optimal method of diaphragmatic breathing. included patients will complete two validated surveys, the brief esophageal dysphagia questionnaire (bedq) and the gastroesophageal reflux disease questionnaire (gerdq). patients will then undergo a standard protocol of supine and upright swallows with high-resolution manometry analyzed according to the chicago classification v4.0. after completion of the standard manometry protocol, participants will then perform a protocol assessing different techniques and positions for diaphragmatic breathing.

Eligibility criteria:
inclusion criteria: * patients undergoing high-resolution esophageal manometry exclusion criteria: * prior esophageal or gastric surgery * chest tube * major concomitant illness * sinus disease precluding manometry placement * history of heavy alcohol or tobacco use * poor comprehension and/or fluency of english language * inability or unwillingness of individual to give written informed consent