Kornimate/medical-research-clean huggingface dataset:
korean diet efficacy clinical trial

Conditions: Obesity

Summary: to determine: 1. the acceptability of a korean diet to an australian overweight and obese population 2. which korean recipes are easily prepared 3. the effect of a korean diet on weight, blood pressure, and metabolic complications of obesity in this population.

the primary endpoint (korean diet acceptability) will be assessed by reliability tested questionnaire, dietary compliance, and quantities of food returned over the 12 weeks. analysis of differences in weight loss will be based on all participants with a baseline and a 12-week weight assessment. in order to investigate the impact of missing data, all subjects will be analysed using last weight observation carried forward and baseline weight carried forward. other secondary endpoints will determine the effect of the korean diet on blood pressure, metabolic parameters and chronic metabolic disease control in the australian population.

Eligibility criteria:
inclusion criteria: * residents of metropolitan sydney * aged 18-65 years * bmi 25-45kg/m2 exclusion criteria: * diabetes treated with oral medications or insulin * unstable angina or recent onset of cardiovascular disease * serious hepatic or renal disease * serum transaminases (alt or ast) \> 2.5 times upper limit of normal * serum creatinine \> 1.5 times upper limit of normal or urinary microalbumin \>40 mg/l or egfr \< 60ml/min/1.73m² * alcohol or illicit drug abuse * pregnant, breastfeeding, or planning pregnancy during the study * serious gastrointestinal disease (inflammatory bowel disease, active peptic ulcer, recent helicobacter pylori treatment) * treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. some anti-psychotics, anti-depressants, or corticosteroids * hypothyroidism defined by elevated thyroid stimulating hormone (tsh) and low free thyroxine (ft4), or current hyperthyroidism under treatment * participation in another weight loss clinical trial within past 3 months * individuals who have lost \>10% weight within past 3 months * vegetarian eating practices * inability to cook or lack of facilities for home cooking * inability to read and write english * subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening

Keywords: korean diet
allium extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers

Conditions: Immunity

Summary: to analyze the efficacy of daily consumption of a combination of garlic and onion extracts on the incidence of respiratory infection symptoms in healthy elderly volunteers living in a residence. the duration of symptoms and related medication will also be studied.

it is a controlled, randomized, double-blind, parallel-group nutritional intervention study. 66 healthy elderly volunteers living in a nursing home will be randomly distributed into 2 equal groups: control group and intervention group. for 36 weeks the volunteers will take the product immediately after lunch. during that time they will maintain their lifestyle and nutritional habits. every 4 weeks, the medical team of the residence will review the cases of respiratory diseases of infectious origin of the volunteers.

Eligibility criteria:
inclusion criteria: * live in a nursing home with medical services. * accept being vaccinated for the flu. * freely accepted to participate in the study and sign the informed consent document. * have the consent of the family. exclusion criteria: * having any disease that affects the development and results of the study. * be unable to understand the study and sign voluntarily and freely the informed consent. * have a low expectation of compliance with the study protocol.

Keywords: garlic onion immunity
evaluation of killing activity of expanded natural killer cells from blood in patients with pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: pancreatic cancer, one of the deadliest epithelial malignancies, has a 5-year survival rate of only about 8%. the mortality rate has decreased slightly, but the incidence rate has been steadily increasing, and it is predicted to be the second leading cause of cancer mortality in 2030. early diagnosis of pancreatic cancer and the development of innovative therapies are needed, and various basic and clinical studies based on pancreatic cancer biology are underway. recently, studies on the effect of natural killer (nk) cells on cancer progression and the development of therapeutic agents using them have been actively conducted. nk cells are a component of innate lymphoid cells, accounting for approximately 5-15% of total peripheral blood mononuclear cells (pbmc).

investigators will apply a new method to evaluate the activity of nk cells in pancreatic cancer patients, and to analyze the correlation with the progression of the tumor and the prognosis of the patient. and investigators will analyze the multifactorial factors affecting the activity of nk cells and conducted this study to help establish new diagnostic and therapeutic strategies for pancreatic cancer.

Eligibility criteria:
inclusion criteria: * the patient who is admitted to the pancreatic surgery department for the treatment of pancreas tumor * patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up. * life expectancy of at least 6 months based on discretion of treating * adequate hematologic function defined by the following laboratory parameters: hemoglobin \> 100, platelet count \> 100 and absolute granulocyte count \> 1.5. exclusion criteria: * patients who received preoperative chemotherapy or radiotherapy. * previous or concurrent malignancies. * any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, serous infection.
effect of acupressure on the "yin-tang" and "shen-men" points on pre and postoperative anxiety in elective caesarean section: a prospective, single-blind, randomised, controlled trial

Conditions: Cesarean Section; Pregnancy; Preoperative Anxiety

Summary: preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta.

preoperative anxiety occurs commonly in elective caesarean section and is associated with increased perioperative morbidity. some groups have used non-pharmacological techniques such as acupressure for its treatment since drugs cross the placenta. the aim of this study is to examine the efficacy of acupressure with co-stimulation of the "yin-tang" and "shen-men" points on the reduction in pre- and postoperative anxiety in elective caesarean section. a single-blind, randomised, controlled, single-centre study will be conducted in asa i or ii patients undergoing elective caesarean section under perispinal anaesthesia. patients will be randomised into two groups: the acu+ group (co-stimulation of the "yin-tang" and "shen-men" points) and the acu- group (stimulation of two sham points). anxiety will be assessed using the state-trait anxiety inventory (stai) score and by measuring skin conductance (electrodermal activity \[eda\]) during three periods: period 1 (at inclusion, in the patient's hospital room on the morning of the procedure), period 2 (before arrival in the operating theatre) and period 3 (in the postoperative recovery room). true or sham acupressure will be applied using adhesive beads positioned between periods 1 and 2 and left in place until the end of period 3.

Eligibility criteria:
inclusion criteria: * informed consent obtained * adult patients * asa class i or ii * scheduled caesarean section at chru tours maternity * under perispinal anaesthesia (spinal anaesthesia or spinal and epidural anaesthesia combined) exclusion criteria: * higher or equal to asa class iii * heart rhythm disorder * treated with a psychotropic drug (anxiolytic, sedative, antidepressant, antipsychotic, mood stabilizer) * psychiatric history * drug or alcohol abuse * local contraindications to acupuncture (local signs of infection or inflammation, scars) * scheduled to caesarean section under general anaesthesia. patients will be excluded in the event of transition to general anaesthesia or cancellation of the procedure.

Keywords: acupressure stai (state trait anxiety inventory) eda (electrodermal activity)
perioperative epidural versus intravenous local anesthetic infusion in open upper abdominal surgery

Conditions: Acute Pain

Summary: the study evaluates the efficacy of intravenous lidocaine as an analgesic modality in patients undergoing open upper abdominal surgery; when compared with thoracic epidural analgesia. half of participants will receive intravenous lidocaine infusion, while the other half will receive thoracic epidural bupivacaine infusion.

postoperative pain is one of the commonest problems encountered by anaesthesiologists, especially after open abdominal surgeries, in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes. despite the fact that epidural blocks provide superior analgesia; it is not often an ideal option as it frequently causes hypotension that may require excessive intravenous fluid administration, which is particularly deleterious after bowel surgery. other complications include epidural hematoma and higher failure rate. furthermore epidural analgesia may be contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients refusing the technique. other modalities to control postoperative pain are used e.g. intravenous analgesics and continuous wound infiltration, but none of which was proven to be as effective as epidural block. whether perioperative lidocaine infusion is as effective as epidural block in reducing post-operative pain, is this study's concern. some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well as acute postoperative pain with encouraging results. lidocaine infusion was found to reduce postoperative pain, opioid consumption and the length of hospital stay. although risks of neurological and cardiac toxicity exist, these were not substantiated in the trials. lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well as anti-inflammatory properties. it also accelerates the return of post-operative gastrointestinal function, which is of particular importance after major abdominal surgery. opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases their incidence.

Eligibility criteria:
inclusion criteria: * patients undergoing open upper abdominal surgery exclusion criteria: * bleeding diathesis * history of allergy to local anesthetics * pregnancy/ lactation * cardiovascular disease * respiratory disease
a medical device to treat wide-neck brain aneurysms

Conditions: Ruptured Cerebral Aneurysm

Summary: the study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.

patients with ruptured brain aneurysms will be treated with the nautilus, then will be followed up for one year.

Eligibility criteria:
inclusion criteria: 1. subject is ≥18 years old 2. subject who presents with an angiographically confirmed, wide neck intracranial saccular, acutely ruptured aneurysm. wide neck is defined as 4-7mm. 3. aneurysm dome ≥5 mm. 4. subject is neurologically stable with a hunt \& hess score of i, ii, or iii. 5. in the opinion of the treating physician, placement of the nautilus is technically feasible and clinically reasonable. 6. the subject or authorized representative is able to provide informed consent and has signed the irb-approved informed consent form. 7. subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule. exclusion criteria: 1. subject with any neurological deficit occurred within the last 180 days; defined as previous non-aneurysmal subarachnoid hemorrhage or any other non-aneurysmal intracranial hemorrhage, stroke, transient ischemic attacks (tia), concussion, head trauma, cranial surgery, radiation therapy to the head. 2. premorbid mrs score ≥3. 3. subject has another aneurysm which, in the investigator's opinion, will require treatment within the follow-up period (1 year). 4. women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test. 5. subject with other serious comorbidities that carry a high risk of neurologic events such as: * significant acute or chronic cardiovascular disease such as myocardial infarction within the past 180 days * uncorrectable coagulation abnormality * uncontrolled diabetes mellitus with target organ injury * organ failure of kidney, liver, heart or lungs * arteriovenous malformation or arteriovenous fistula, moyamoya disease, or any other vasoconstriction * premorbid intracranial tumor or hematoma 6. severe or unstable conditions or diseases (e.g., non-significant neurological deficit, cancer, hematologic or coronary disease) or chronic conditions that in the opinion of the investigator may increase the risk associated with study participation for study device administration or may interfere with the interpretation of study results. 7. extreme vessel stenosis or tortuosity or other vascular anomalies that would prevent delivery of the device to the target. 8. comorbidities that may preclude obtaining follow-up dsa. 9. known allergy to nickel and/or heparin that cannot be medically treated. 10. subject is currently participating in another interventional clinical study. 11. subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)
a prospective study of eus guided celiac block

Conditions: Chronic Pancreatitis; Pancreatic Cancer

Summary: the purpose of this prospective study is to measure the clinical effectiveness of eus-guided cb in subjects, 50 who have chronic pancreatitis and 50 who have pancreatic cancer, that are already undergoing celiac block for clinical reasons.


Eligibility criteria:
inclusion criteria: * patients with chronic abdominal pain from documented chronic pancreatitis or pancreatic cancer or other visceral malignancy that are undergoing eus-guided cb (for purposes other than this study) will be eligible to participate in this study. * patients with chronic pancreatitis and pancreatic cancer must have documented disease by ct, ercp, or eus. * no evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol. * patient must provide signed written informed consent exclusion criteria: * patients that have had a previous celiac plexus block are eligible for this study
fascia iliaca block for post-operative pain control after total hip arthroplasty

Conditions: Osteoarthritis of the Hip

Summary: this study evaluates post-operative pain management and narcotic consumption in patients receiving a fascia iliaca block with local anesthetic versus patients receiving fascia iliaca block with saline for total hip arthroplasty.

although many improvements have been made in implant technology and surgical approaches for total hip arthroplasty, management of post-operative pain remains a major clinical issue. inadequate pain control can lead to numerous unwanted side effects and limited physical function, especially in a older population. most surgeons have adopted a multi-modality pain management approach using a variety of pharmaceuticals, including nerve block with local anesthetic. in the literature, there are a number of technical variations described for the fascia iliaca nerve block. at the christ hospital, cincinnati, ohio, anesthesiologists use a more proximal approach to the fasica iliaca block enabling a significantly easier cephalad spread of the local anesthetic into the pelvis targeting all three nerves; the femoral, lateral femoral cutaneous, and the obturator. this prospective, double-blinded, randomized, single-center study is designed to test the primary hypothesis that fascia iliaca block with a local anesthestic decreases narcotic consumption and provides improved pain control compared to placebo in the first 24 hours after surgery in patients undergoing total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * anterior approach total hip arthroplasty (tha) for unilateral osteoarthritis * english-speaking * age 18 to 75 years * american society of anesthesiologists (asa) physical status 1 to 3 * bmi \< 40 kg/m2 * minimum weight of 50 kg. * no contraindications to study procedures exclusion criteria: * hip revision surgery * allergy to local anesthetics * allergy to oxycontin * allergy to pregabalin * allergy to fentanyl * allergy to midazolam * allergy to hydromorphone * bmi \> 40 kg/m2 * chronic pre-operative opioid use
loteprednol etabonate ophthalmic ointment vs. vehicle in the treatment of inflammation following cataract surgery

Conditions: Ocular Inflammation

Summary: to evaluate the clinical safety and efficacy of loteprednol etabonate ophthalmic ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery


Eligibility criteria:
inclusion criteria: 1. subjects who are candidate for routine, uncomplicated cataract surgery 2. subjects who, in the investigator's opinion, have potential postoperative pinholed snellen visual acuity (va) of at least 20/200 in the study eye. exclusion criteria: 1. subjects who will require concurrent ocular therapy with nsaids, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., restasis), or with ocular or systemic corticosteroids 2. subjects who have known hypersensitivity or contraindication to the study drug(s) or their components 3. subjects who are monocular or have pinholed snellen va 20/200 or worse in the non-study eye 4. subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit
jumping exercises approach in individuals with chronic ankle instability

Conditions: Joint Instability; Chronic Disease; Sprains

Summary: the aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. it is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.

there is a need for; 1. more homogeneous sub- groups with chronic functional instability of the ankle. 2. studies are needed that older patients (up to 50 years) and also take into account women. 3. in addition, studies should be performed in a clinical environment and also at the same time clinically adapted test can be used as a form measurement. ( hiller et al. , 2011).

Eligibility criteria:
inclusion criteria: * ankle injury more than 6 months ago * chronic instability * functional instability of the ankle * experience with proprioceptive exercises exclusion criteria: * foot surgery * fresh ankle injury * acute foot pain with signs of inflammation * mechanical / anatomical ankle instability * athletes with regularly jumping exercise (eg volleyball, basketball) * taking medications which affect balance and coordination * diseases that affect the balance * serious diseases such as tumors, infections, neuropathies, severe articular degeneration * non-german-speaking patients

Keywords: chronic functional instability ankle
effect of diet composition on liver fat and glucose metabolism

Conditions: Fatty Liver

Summary: this study is designed to determine if the amount of fat and saturated fat in the diet contributes to the development of a condition called fatty liver disease in the absence of changes in weight.

a condition called non-alcoholic steatohepatitis is characterized by fat accumulation in the liver and associated inflammation. this condition is strongly associated with obesity, insulin resistance and type 2 diabetes. diets high in saturated fat result in fatty liver, insulin resistance and liver injury in animal models. dietary composition may contribute not only to hepatic fat accumulation and insulin resistance but may also promote inflammation leading to chronic liver disease in humans. this study will test the hypothesis that a diet high in fat and saturated fat contributes to liver fat accumulation, insulin resistance and inflammation by comparing the effects of a four-week, weight stable high fat/high saturated fat diet (55% calories from fat/25% saturated fat) with a four-week, weight stable low fat/low saturated fat diet (20% fat/8% saturated fat) in overweight and obese subjects.

Eligibility criteria:
inclusion criteria: * age 18-55 years old, men and women, otherwise in good general health, bmi \>27 kg/m2 exclusion criteria: * abnormal glucose tolerance, fasting glucose\>100 mg/dl or diabetes * history of liver condition or alanine aminotransferase (alt) above the upper limit of the normal range * use of medications that cause insulin resistance or fatty liver: niacin, glucocorticoids, estrogens, tamoxifen, amiodarone, accutane, sertraline, atypical antipsychotics, anti-hiv medications * chronic use of anti-inflammatory medications (aspirin, ibuprofen, naprosyn, steroids, etc) * average alcohol intake \>20 grams/day * tobacco use * creatinine \>1.5 mg/dl for men and \>1.4 mg/dl for women * hematocrit \<33% * pregnancy or lactation * significant weight loss within the past 6 months (\>5% body weight) * claustrophobia or any contraindications to being placed in the magnet for the mrs scan such as pacemakers, defibrillators, brain aneurysm clips, etc. * other serious medical conditions or inflammatory conditions such as cancer, inflammatory arthritis, etc. * history of multiple food allergies or intolerances or severe food allergies * history of coronary artery disease, history of or treatment of hyperlipidemia, ldl \>200 mg/dl, fasting triglycerides \>300 mg/dl * weight \>300 pounds

Keywords: fatty liver insulin resistance diet inflammation oxidative stress