Kornimate/medical-research-clean huggingface dataset:
role of glp-1 in hyperinsulinemic hypoglycemia post-bariatric surgery

Conditions: Hypoglycemia

Summary: the purpose of this study is to evaluate the role of glp-1 in causing extreme postprandial glucose reductions after bariatric surgery in a subset of patients who have severe symptomatic hypoglycemia.

the physiologic mechanisms mediating the glucose-lowering effect of roux-en-y gastric bypass (rygb) or post-vertical sleeve gastrectomy (vsg) are unknown. the reduction in glucose excursions prior to weight loss has lead to postulates that the incretin hormone, glp-1, may play an important role. the purpose of this study is to evaluate the role of glp-1 in causing extreme postprandial glucose reductions in a subset of post-bariatric patients through the pharmacologic blockade of the glp-1 receptor in post-rygb or post-vsg patients with severe symptomatic hypoglycemia.

Eligibility criteria:
inclusion criteria: * men and women ages 18-65 * bmi 25-40 with a clinical diagnosis of severe symptomatic hypoglycemia after bariatric surgery exclusion criteria: * acute medical illness, such as acute bacterial or viral syndrome, febrile illness, acute abdominal symptoms, orthopedic injury within one week * history of cardiac failure, renal insufficiency (estimated crcl\ 160 or dbp\>100) * pregnancy * use of medications that affect glucose metabolism * fasting glucose \>150 or hba1c\>7.5 on metformin * women of childbearing potential (will have a pregnancy test, in addition use of abstinence for at least one month prior to study or use two types of contraceptives, hormonal implant or depo provera) * active, uncontrolled psychiatric disease * participating in other studies or have received investigational medications within the past month or 5 half-lives of the drug, whichever is longer.

Keywords: hyperinsulinemic post-bariatric surgery
tranexamic acid in total knee replacement

Conditions: Osteo Arthritis Knee

Summary: multiple intravenous tranexamic acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

a total of 180 patients undergoing tka for knee osteoarthritis were stratified in three equal groups. all surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. group a (60 patients) received 1g of iv txa, group b (60 patients) received an additional dose of iv txa and group c (60 patients) received three doses of iv txa. the measured outcomes were the hemoglobin (hb) decrease, the transfusion rate, the functional, quality of life (qol) and pain assessment based on their corresponding scoring system.

Eligibility criteria:
inclusion criteria: 1. varus deformity less than 10o 2. lack of extension not more than 10o 3. flexion of at least 90o. exclusion criteria: 1. uncontrolled medical diseases/comorbidities 2. allergy and/or hypersensitivity to txa 3. a known history of thromboembolic disease, cardiovascular disease 4. coronary or vascular stent placed within the past 12 months 5. cerebral vascular disease (a history of stroke) 6. subarachnoid hemorrhage 7. preoperative coagulopathy (a platelet \[plt\] count \<150,000/mm3 or an international normalized ratio greater than 1.5 8. preoperative renal or hepatic dysfunction 9. retinal vein or artery occlusion 10. patients with anemia (\<12 g/dl for female, \<13 g/dl for male)

Keywords: total knee arthroplasty tranexamic acid without tourniquet blood loss function multiple doses
study to determine if olmesartan medoxomil has the potential to benefit the cardiovascular system in terms of arterial protection

Conditions: Metabolic Syndrome; Hypertension

Summary: this study will analyse the dose-dependent effect of olmesartan medoxomil on the change in arterial stiffness in subjects with hypertension and metabolic syndrome


Eligibility criteria:
inclusion criteria: * male and female outpatients * age greater than or equal to 18 years and less than or equal to 75 years * hypertension and metabolic syndrome defined, according to the atp iii/idf 2005 and esh/esc 2007 definitions, as bp greater than or equal to 130/85 mmhg and \<150/95 mmhg (i.e. untreated high normal bp or "low range" mild hypertension) and at least 2 of the following traits at: * abdominal obesity (waist circumference \>102 cm for men and \>88 cm for women) * triglyceride level greater than or equal to 150 mg/dl * high density lipoprotein (hdl) \<40 mg/dl for men and \<50 mg/dl for women * fasting blood glucose greater than or equal to 110 mg/dl and \<126 mg/dl (i.e. no type 2 diabetes) * no anti-hypertensive treatment or treatment with only one anti-hypertensive medication within the last 3 months. note: treatment with angiotensin ii receptor blockers (arb)or angiotensin-converting enzyme inhibitors (ace) is not allowed within the last 6 months. exclusion criteria: * pregnant or lactating female (prerequisite for female subjects of childbearing potential: adequate contraception) * type 1 and type 2 diabetes * "high range" mild hypertension (i.e. systolic blood pressure \[sbp\]: 150 - \<160 mmhg and /or diastolic blood pressure \[dbp\]: 95 - \<100 mmhg) * moderate (sbp: 160 - 179 mmhg and dbp: 100 - 109 mmhg), severe (sbp: greater than or equal to 180 mmhg and/or greater than or equal to 110 mmhg), or resistant (hypertension resistant to treatment)hypertension * secondary hypertension of any aetiology, such as renal disease, pheochromocytoma, or cushing's syndrome

Keywords: arterial stiffness vascular protection
to evaluate the safety of duloxetine in patients with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the patients are being followed in this study to determine the safety of taking the medication duloxetine for a long period of time. the patients participating in this study suffer from stress urinary incontinence.


Eligibility criteria:
inclusion criteria: successfully completed the protocol for study f1j-mc-sbav. - exclusion criteria: treatment with a drug, not including study medication, that has not received regulatory approval at the time of study entry. use of excluded medications within 14 days prior to study entry or at any time during the study. -
the use of virtual reality to reduce anxiety and pain in perioperative settings

Conditions: Perioperative Pain; Perioperative Anxiety

Summary: we will investigate whether the use of virtual reality (vr) preoperatively and intraoperatively can help treat pain and anxiety, as measured by patient feedback, vital signs trends, and the amounts of anesthetics, pain medications and anxiolytics used during surgical procedures. the vr intervention will be studied during short hand surgeries normally performed using local anesthesia and sedation.

virtual reality (vr) is a powerful and inexpensive technology that has been effectively used in healthcare settings to treat anxiety and pain, with minimal side effects. in the last two decades, opioid abuse and deaths related to opioids have increased, and opioid naive patients are at increased risk of opioid abuse when opioids are used during their surgical procedures. in addition, anesthetics, anxiolytics and analgesics, namely opioids, have a myriad of side effects that worsen patient experience, and lead to complications and increased costs. there are limited studies on the use of vr in the perioperative setting. our study is a randomized controlled trial to investigate the use of vr to treat anxiety and pain in perioperative settings. we will recruit 56 patients, 28 in the control group and 28 in the vr group, undergoing short (\<2 hrs) hand or upper extremity surgeries under local anesthesia and monitored anesthesia care (mac). the control group will receive standard anesthetic management and the vr group will be exposed to vr in the preoperative setting and during the surgical procedure, using the clinically validated appliedvr software. the data collected will included satisfaction questionnaires and pain scores for anxiety/pain pre- and post- procedure, vital signs trends to assess sympathetic response during surgery, and amount of anesthetics used. we hypothesize that the vr group will show decreased anxiety and pain, increased satisfaction, and decreased use of anesthetics during the procedure.

Eligibility criteria:
inclusion criteria: 1. 18 years old or older and less or equal to 75 years old. 2. asa physical status i-ii. 3. english speaking. 4. undergoing elective surgery with local anesthetic with sedation. 5. surgical time less than 2 hours. exclusion criteria: 1. asa physical status iii or above. 2. allergy to fentanyl, midazolam or propofol. 3. history of seizure, migraines. 4. chronic pain syndrome. 5. use of high dose opioids or long acting opioids. 6. severe anxiety, on daily anxiolytics. 7. psychiatric comorbidities that preclude the use of vr. 8. physical disabilities that preclude the use of vr technology in a comfortable manner. 9. patient refusal.

Keywords: pain anxiety intraoperative care
double randomized and placebo controlled trail of tianqi pingchan granule to prevent levodopa-induced dyskinesia

Conditions: Levodopa-Induced Dyskinesia

Summary: a randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of tianqi pingzhan granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of tianqi pingzhan granule in the prevention of levodopa induced dyskinesia.

the aim of this clinical trail is to evaluate the effect of tianqi pingzhan granule in the prevention of levodopa induced dyskinesia in adults. all patients included in the study should meet the inclusion criteria. half of participants will receive tianqi pingzhan granule, while the other half will receive a placebo of tianqi pingzhan granule. all participants will be assigned to either the active group or the control group randomly. during the clinical trail both doctors and patients are double-blind except serious adverse events occurred.

Eligibility criteria:
inclusion criteria: patients with pd aged 30-85，have at least the following two conditions: 1. dosage of levodopa ≥ 400mg/d; 2. grade of h\&y≥3; 3. risk score of dyskinesia\>4; exclusion criteria: 1. pd patients with dyskinesia; 2. taking other chinese medicines against parkinson's disease; 3. pregnant and lactating women; 4. impaired cognitive function (according to pre-entry mmse score): secondary education level: mmse \<24 points; primary education level \<20 points; illiterate \<17 points; 5. accompanied by a history of mental illness; 6. impaired liver and kidney function; 7. accompanied by severe other systemic diseases; 8. previous traditional chinese medicine preparations or serious adverse reactions 9. before the enrollment, the ekg showed obvious abnormalities and required clinical intervention. 10. pd related brain surgery 11. patients who are participating in other clinical studies or has participated other clinical studies within 30 days before 12. patients unable to cooperate with the survey
study to assess the distribution, metabolism and excretion of [14c]azd6765 after a single-dose intravenous administration

Conditions: Major Depressive Disorder

Summary: this is a study to assess the distribution, metabolism and excretion of \[14c\]azd6765 after a single-dose intravenous administration.


Eligibility criteria:
inclusion criteria: * subjects must have a normal creatinine clearance of ≥60 ml/min * subjects who self-identify their race as asian exclusion criteria: * history of any clinically significant medical, neurologic or psychiatric disease as judged by the investigator * history of symptomatic orthostatic hypotension (ie, postural syncope) * subjects who have received any radiolabelled study drug within 12 months of the screening visit. * subjects who are monitored for radioactivity as part of their occupation * subjects who have been exposed to radiation levels above background, (eg, throughx-ray examinations) of \>5msv in the last year, \>10 msv over the last 5 years or a cumulative total of \>1msv per year of life.

Keywords: major depression disorder
beta-carotene and alpha-tocopherol chemoprevention of second primary malignancies in head and neck cancer patients

Conditions: Neoplasms

Summary: epidemiologic studies suggest that low dietary intakes and low plasma concentrations of antioxidant vitamins and minerals are associated with increased risks of cancer, especially for epidermoid tumors. patients with stage i or ii head and neck cancer have a good prognosis, with a 5-year relative survival of 60% to 90%, depending of the tumor site. however, the benefit of treatment is often compromised by the occurrence of second primary cancers, which develop in 20% of patients during the first 5 years after diagnosis. we conducted a randomized chemoprevention trial among patients with head and neck cancer treated by radiation therapy to determine whether supplementation combining two antioxidants, alpha-tocopherol and beta-carotene, could reduce the incidence of second primary cancers in this patient population (primary objective of the trial). this study was conducted with funds from the ncic (#008176,004738,013211) and was completed. in this cohort of head and neck cancer patients, we evaluated whether nine potential prognostic serum markers measured at the time of diagnosis were related to recurrence, occurence of second primary cancers and survival. this study was conducted with funds from the ncic (#018100) and was completed. presently, we evaluate genetic polymorphisms(gwas) associated with prognosis (ncic grant #019502). we also assess the relationship between vitamin d (dietary intake, serum level, and genetic polymorphisms of key vitamin d-related genes) and head and neck long-term outcomes (nci grant #1r03ca141615-01).


Eligibility criteria:
inclusion criteria: * histologically documented stage i or ii head and neck cancer exclusion criteria: * karnofsky performance score of less than 60 * multiple primary head and neck cancer * history of cancer * severe cardiovascular disease * inadequate renal, hepatic or hematologic function * anticoagulant therapy * pregnancy * average daily supplement intake of beta-carotene or vitamin e in the preceding year greater than 6.0 mg and 50 iu, respectively.

Keywords: chemoprevention trial antioxidant alpha-tocopherol beta-carotene second primary cancer head and neck cancer adverse effect of radiation therapy quality of life mortality cancer free survival cancer recurrence
a study to observe the safety of vyloy (zolbetuximab) in people in south korea with gastric or gastroesophageal junction cancer.

Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer; Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer; Metastatic Gastric Adenocarcinoma or Cancer; Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary: this study is for people in south korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (gej) cancer. their cancer is locally advanced, unresectable, or metastatic. locally advanced means the cancer has spread to tissue close by. unresectable means the cancer cannot be removed by surgery. metastatic means the cancer has spread to other parts of the body. in south korea, vyloy is approved for the treatment of gastric cancer or gej cancer. the people in this study will receive vyloy as part of their usual treatment for their cancer. in standard clinical practice vyloy is given to people slowly through a tube into a vein. the main aim of the study is to collect information in a real-world setting about the safety of vyloy in people with gastric cancer or gej cancer in clinics in south korea. this study will also help researchers learn how long people's gastric cancer or gej cancer stays stable. this study is about collecting information only. this is known as an observational study. the individual's doctor decides on treatment, not the sponsor (astellas). the study will last about 1 year (54 weeks).


Eligibility criteria:
inclusion criteria: * patients who receive treatment with vyloy injection, according to the approved local label. exclusion criteria: * patients with any contraindication for vyloy injection, according to the approved local label. * patients who are registered or scheduled to be registered in any clinical trials involving investigational drug administration.

Keywords: locally advanced unresectable gastroesophageal junction (gej) adenocarcinoma cancer locally advanced unresectable gastric adenocarcinoma cancer metastatic gastric adenocarcinoma cancer metastatic gastroesophageal junction (gej) adenocarcinoma claudin 18.2 human epidermal growth factor receptor 2 (her2) negative zolbetuximab pharmcovigilence
discrimination of dili and aih by artificial intelligence

Conditions: Drug-induced Liver Injury; Autoimmune Hepatitis

Summary: a retrospective, multi-center, non-interventional cohort study has been going to explore whether artificial intelligence can discriminate drug-induced liver injury and autoimmune hepatitis. a machine learning-based tool will be developed and validated to help clinicians to differentiate between drug-induced liver injury and autoimmune hepatitis

research objectives: 1. to develop a machine learning-based model from retrospective data. 2. to validate the machine learning-based model from internal dataset and external datasets nationwide. 3. to setup a website or application based on the above model to discriminate drug-induced liver injury and autoimmune hepatitis.

Eligibility criteria:
inclusion criteria: * drug-induced liver injury 1. rucam ≥6 and met one of the following biochemical conditions: a.) alt≥5 uln, b.) or alp ≥2 uln, iii) or alt≥3 uln and tbil≥2 uln. 2. rucam was between 3-5, the medical records were further reviewed by the three authors to determine the eligibility. * autoimmune hepatitis 1. the revised international autoimmune hepatitis group (iaihg) diagnostic score≥6 points. 2. liver biopsy available, which is compatible with typical features of aih. 3. if liver biopsy was unavailable, patients who achieved biochemical resolution after sustained immunosuppressive therapy. exclusion criteria: * drug-induced liver injury 1. hepatotropic viral infection: hepatitis a, b, c, d and e. 2. non-hepatotropic viral infection: cytomegalovirus (cmv) and epstein-barr virus (ebv), etc. 3. hypoxic ischemic hepatitis and congestive liver disease. 4. alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years. 5. biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. autoimmune hepatitis. 7. parasitic infection. 8. sepsis. 9. previous liver transplantation or bone marrow transplantation. 10. pregnancy or lactation. 11. genetic and metabolic liver diseases. * autoimmune hepatitis 1. hepatotropic viral infection: hepatitis a, b, c, d and e. 2. non-hepatotropic viral infection: cytomegalovirus (cmv) and epstein-barr virus (ebv), etc. 3. hypoxic ischemic hepatitis and congestive liver disease. 4. alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years. 5. biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. drug-induced liver injury. 7. parasitic infection. 8. sepsis. 9. previous liver transplantation or bone marrow transplantation. 10. pregnancy or lactation. 11. genetic and metabolic liver diseases.

Keywords: artificial intelligence differential diagnose
prevention of parastomal hernia by mesh placement

Conditions: Parastomal Hernia

Summary: concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.

subject to inclusion and exclusion criteria, patients will be randomized 1:1 to the control and intervention groups: randomization groups: * group 1 (control): ileal conduit * group 2 (intervention): ileal conduit with concurrent mesh placement. ethicon physiomesh composite mesh will be utilized for this study. this is a composite mesh with a reduced polypropylene content. it is a widely used, commercially available hernia mesh, and its use and placement are simple and well described. the mesh will be placed at the time of radical cystectomy and ileal conduit. a small circle of mesh, the diameter of the ileal conduit, will be excised to allow for fitment around the ileal conduit. the mesh will be placed so that it encompasses the ileal conduit in a non-constricting manner, and will be sutured to the anterior abdominal wall. product will be stored in a secure, sterile manner at the umh operating room sterile supply room, and in accordance with institutional policies. patients from both groups will be followed up in a standard fashion. follow up visits and clinical assessment will be at 6 weeks after surgery, 3 monthly during the first year, then every 6 months for at least 5 years. during each visit, patients will be clinically evaluated for the presence or absence of parastomal hernia, and any routine surveillance radiology imaging will be reviewed. parastomal hernia is clinically defined as an incisional hernia at the site of the ileal conduit stoma. this may be clinically apparent by examining the patient during performance of abdominal straining or valsalva maneuver, or may be evident on radiology imaging.

Eligibility criteria:
inclusion criteria: 1. patients eligible to undergo urinary diversion with ileal conduit. 2. patients with the ability to understand and willingness to sign a written informed consent document. 3. men and women aged 18 to 80 years. exclusion criteria: 1. patients unable or unwilling to consent to the proposed surgery 2. pregnant women 3. patients with prior ileal conduit surgery undergoing revision.

Keywords: hernia mesh ileal conduit
energy costs of spasticity in spinal cord injury: a pilot investigation

Conditions: Basal Energy Expenditure; Spasticity

Summary: the purpose of this study is to determine if there is a relationship between spasticity and relative changes in basal energy expenditure in persons with spinal cord injury.

obesity is at epidemic proportions in the population with spinal cord injury (sci), and is likely the mediator of the metabolic syndrome in this special population. recent literature reviews have suggested that obesity is present in \> 67% of persons with sci. additionally, recent studies have demonstrated the causal relationship between adipose tissue accumulation and vascular inflammation, dyslipidemia, insulin resistance / glucose intolerance, hypertension and thromboemboli. obesity in sci occurs because of acute and ongoing positive energy balance, i.e., greater caloric intake than energy expenditure. total daily energy expenditure (tdee) in sci is reduced primarily because of muscular atrophy and diminished muscular contraction; pharmacological treatment of spasticity possibly reduces energy expenditure (ee) even further, but has not been evaluated to date. tdee is comprised of three components: basal energy expenditure (bee), thermic effect of activity (tea) and thermic effect of food (tef). of the three, bee contributes the greatest amount (65-75% tdee) and is the most sensitive to changes in spasticity. dampening spasticity has been reported to increase weight gain and necessitate reduced caloric intake in a child with spastic quadriplegia. similarly, athetosis in patients with cerebral palsy increased resting metabolic rate (rmr) as compared to control subjects with no athetotic movements. although several studies have reported energy requirements for persons with neurodevelopmental disabilities, and even sci, however, none have attempted to measure the metabolic effect of spasticity.

Eligibility criteria:
inclusion criteria: * c1-t10 sci at least 1 year post injury * spasticity in the legs * veteran exclusion criteria: * recent increase in spasticity * botox within 6 months * phenol within 2 years * prior surgery for spasticity

Keywords: basal energy expenditure spasticity modified ashworth scale penn spasm frequency score