Kornimate/medical-research-clean huggingface dataset:
the pre-op energy trial

Conditions: Cardiac Valve Disease; Coronary Artery Disease; Organ Failure, Multiple

Summary: the pre-op energy trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.

pre-op energy is a single centre, unblinded, parallel group, randomised controlled trial of a pre-operative high energy diet, versus a control group receiving standard care. the trial will test a number of specific hypotheses: 1. a pre-surgery high energy diet will protect against post-cardiac surgery organ failure by altering the pre-surgery cardiometabolic state, a process referred to as 'metabolic preconditioning'. 2. the effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction. 3. the trial intervention will not result in long-term adverse changes in cardiometabolic status. 4. metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis. 5. metabolic preconditioning will confer protection against post-cardiac surgery myocardial injury by increasing the expression of genes that promote myocardial mitochondrial homeostasis via effects on chromatin histone deacetylation. 6. metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.

Eligibility criteria:
inclusion criteria: all of the following: * adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (cabg, valve, or cabg and valve) with cardiopulmonary bypass. * bmi\<30 * able, in the opinion of the investigator, and willing to give informed consent. * do not have diagnosed coeliac disease * able to understand english exclusion criteria: any of the following: * urgent, emergency or salvage procedure * patients with end stage renal failure defined as an estimated glomerular filtration rate (egfr) \<15 ml/min/1.73 m2 calculated from the modification of diet in renal disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation. * patients with persistent or chronic atrial fibrillation. * patients with severe liver dysfunction; hepatitis, cirrhosis, jaundice. * women who are pregnant or who may become pregnant in the intraoperative period. * patients who are participating in another interventional clinical trial. * unable, in the opinion of the investigator, or unwilling to give informed consent. * have diagnosed coeliac disease * unable to understand english exclusion criteria for optional mri research procedure: * permanent pacemaker or icd * brain aneurysm clip * implanted neural stimulator * cochlear implant (specific implant must be checked that it is mr safe) * ocular foreign body (e.g. metal shavings) unless removed * other implanted medical devices: (e.g. swan ganz catheter) * insulin pump * retained metal shrapnel or bullet * claustrophobia
serum and urine ghrelin in adult epileptic patients

Conditions: Epilepsy

Summary: several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. there is a potential relation between its level and antiepileptic drugs (aed) response.

several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. there is a potential relation between its level and antiepileptic drugs (aed) response. objective: to evaluate ghrelin effect in adult epileptic patients and in response to aed. methods: this case control study included 40 adult epileptic patients and 40 healthy controls. participants were subjected to history taking of seizure semiology, full general and neurological examination, electroencephalography and cranial ct or mri. fasting serum acylated ghrelin (ag) and unacylated ghrelin (uag) and urine ag levels were estimated to all participants by enzyme - linked immunosorbent assay (eliza).

Eligibility criteria:
inclusion criteria: * all participants were included if their age more than or equal to 18 years. body mass index \< 30 kg/m2, total cholesterol \< 200mg/dl, serum triglycerides \< 200 mg/dl and random blood glucose level \< 126 mg/dl. exclusion criteria: * participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders). * females with irregular menstrual cycle or on estrogen therapy (7). * participants with organic cerebral lesion that was detected on cranial computed tomography (ct) or cranial magnetic resonance imaging (mri).

Keywords: epilepsy serum ghrelin urine ghrelin
an extension study for t-1101 (tosylate) to treat advanced refractory solid tumors

Conditions: Advanced Refractory Solid Tumors

Summary: t-1101 is a novel anti-cancer agent being developed by taivex therapeutics corporation, and is being studied in a phase i dose escalation trial, protocol tai-001. that trial's primary aim is to study the safety and tolerability of t-1101 (tosylate) in subjects with advanced refractory solid tumors, and provides for a maximum of 2 cycles of treatment. at the end of 2 cycles of treatment, it is likely that some patients will be continuing to receive clinical benefit from t-1101 (tosylate). the intention of this program is to enable these patients to continue to receive t-1101 (tosylate) at the discretion of the principal investigators and taivex therapeutics corporation.


Eligibility criteria:
inclusion criteria: 1. patients with advanced malignancy who are receiving t-1101 (tosylate) in a previous taivex therapeutics corp. sponsored study that has reached its endpoint, and who are, in the opinion of the investigator and/or sponsor, expected to continue to have an overall positive benefit/risk from continuing treatment. 2. women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation, including the 30 days period after last study drug dosing. 3. women of childbearing potential who have a negative pregnancy test within 7 days of the first dose of t-1101 (tosylate) in this long term extension trial. 4. patients who have completed the end of study assessments in their originating study. every effort should be made to conduct the end of study visit such that the patient does not have any interruption in t-1101 (tosylate) dosing. 5. signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment. 6. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. exclusion criteria: 1. any medical condition that, in the opinion of the investigator and/or sponsor, could jeopardize the safety of the patient. 2. hypertension that cannot be controlled by medications (\>150/100 mmhg despite optimal medical therapy). 3. progressive or untreated metastatic brain or meningeal tumors. 4. pregnancy or breastfeeding. male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. female patients must be surgically sterile or be postmenopausal, or must agree to the use of highly effective contraception during the period of therapy. highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, intra-uterine devices (iuds), sexual abstinence, or a vasectomized partner. 5. substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
resonance breathing intervention opioid use disorder

Conditions: Substance-Related Disorders

Summary: this study aims to assess the feasibility of an intervention for the management of craving, stress, anxiety, and depression among people who use opioids via a resonance breathing smartphone app.

most evidence-based treatments for substance use disorders (sud) require face-to-face interactions with individuals who comprise a recovery support network. however, in the moment relapse occurs, people in recovery are often not in the presence of these trusted individuals. this project aims to address this issue by providing people in recovery with an application (app) that can be added to phones and other mobile devices to help them manage cravings, anxiety, and stress triggers at the specific moments they feel compelled to use. the connection between an individuals mind and body works in both directions. psychological distress can cause psychosomatic symptoms in the body (e.g., stress is related to multiple chronic health conditions), but individuals can also use their bodies to affect psychology aspects (e.g., exercise can improve mood by releasing endorphins). a similar scientific theory is the foundation of controlled breathing interventions for anxiety, stress, and drug cravings. psychological distress can disrupt the balance of our autonomic nervous system (which is responsible for our fight or flight response to threat), but breathing exercises can restore balance and decrease stress. the goal of this study is to test the feasibility, utility, and efficacy of an app that delivers controlled breathing exercises.

Eligibility criteria:
inclusion criteria: to be eligible, participants need to be the legal age of majority (18 years of age or older), have the ability to read and speak in english, and have a history of alcohol or illicit drug use. exclusion criteria: individuals with no access to a smartphone phone with a data plan, inability to provide consent and having suicidal thoughts or psychotic episodes.

Keywords: opioid use disorder resonance breathing substance use disorder heart rate variability drug craving
gene-environment interactions in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will create alzheimer 's disease risk profiles for defined combinations of genotypes and environmental exposures. this study will carry out a molecular epidemiologic study to identify genetic and environmental risks factors using state of the art techniques. the following will be done during the course of this study 1) recruit both alzheimer's patients and cognitively normal aged veterans. 2) evaluate gene interaction in alzheimer's disease. 3) evaluate gene-environment interactions on the risk of alzheimer's disease. these procedures should initially address the question as to whether certain genes either independently or synergistically modify the risk of alzheimer's disease. this study will also determine whether certain environmental factors (smoking, alcohol consumption etc.) can modify the risk of ad and whether this effect is dependent on certain genetic backgrounds. this study will provide information that will be useful in designing therapies, develop risk factor profiles to be further tested in future studies, designating patients for specific therapies based on genetic factors and providing data and genetic material for future studies. this study will also provide a cohort of older and well characterized cognitively normal veterans for prospective genetic epidemiological studies on aging.


Eligibility criteria:
the grecc located at this hospital represents the leading edge of clinical care focusing on the needs of the aging veteran. we will recruit all 100 patients currently hospitalized at the dementia unit. we will also recruit from the outpatient memory clinic. we will enroll 400 ad patients total. since, cases and controls will be ascertained from the same population, we also expect the socioeconomic status of individuals in these two groups to be the same. in the past year 9600 patients were treated on an outpatient basis. they were almost entirely white and male (\>90%). the age demographics are 23% between 60-69, 23% between 70-79 and 5 % 80 or greater. the outpatients are seen for a wide variety of conditions. we plan to enroll 100 patients a year for 4 years (400 total). they will be seen once and have the same neuropsychological exams as the ad patients. control subjects will be enrolled if their mini-mental score is greater than 24.

Keywords: risk factors genes epidemiology apolipoproteins e alzheimer's disease
gnrh agonist plus hormone replacement therapy vs hormone replacement therapy on ivf outcomes

Conditions: Polycystic Ovary Syndrome; Infertility, Female

Summary: the study is conducted at arash women's hospital on all women undergoing the frozen embryo transfer cycle. patients who signed informed consent will be randomly divided into two groups. the first group will receive gnrh agonist plus hormone replacement therapy for endometrial preparation. group 2 will receive hormone replacement therapy. the random allocation and final outcome of the study will be assessed by a person who is unaware of the study process. also, the statistician will be unaware of the study process


Eligibility criteria:
inclusion criteria: the first or second cycle of embryo transfer normal uterine cavity pco diagnosis based on rotterdam criteria and correction (2018) age 20 to 40 years exclusion criteria: infertility with severe male factor endometriosis immunological disease fsh higher than 10 bmi greater than or equal to 30 endometrial thickness on the day of transfer is less than 7 mm history of recurrent miscarriage
ezetimibe/simvastatin in patients with metabolic syndrome (0653a-107)(completed)

Conditions: Hypercholesterolemia; Metabolic Syndrome

Summary: a 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease to study the effects of ezetimibe/simvastatin and atorvastatin on lipids.


Eligibility criteria:
inclusion criteria: * patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at high risk for coronary heart disease (chd) with ldl-c above 70 mg/dl or 100 mg/dl depending on their chd risk category exclusion criteria: * a condition which, in the opinion of the investigator, pose a risk to the patient or interfere with participating in the study * patient is likely to be greater than 20% noncompliant in taking study medications * patients with chronic medical conditions * patients with unstable doses of medications * pregnant or lactating women, women intending to become pregnant * patient is currently receiving prescription therapy with statins or other lipid-altering medications * patient with type 1 or type 2 diabetes mellitus that is poorly controlled, newly diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin)
phase i trial of cea specific aav-dc-ctl treatment in stage iv gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the clinical safety and preliminary efficacy of cea specific cytotoxic t lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with cea gene in the treatment of stage iv gastric cancer patients.

carcinoembryonic antigen (cea) describes a set of highly related glycoproteins involved in cell adhesion.cea is normally produced in gastrointestinal tissue during fetal development, but the production stops before birth. the serum levels are raised in some types of cancer,such as gastric cancer.the expression of cea in these cancers and succedent unfavourable prognosis such as tumor hyperplasia, recurrence make cea become the desirable therapeutic target. cancer immunotherapy is the use of the immune system to treat cancer. immunotherapies fall into three main groups: cellular, antibody and cytokine.cellular therapies involve the removal of immune cells from the blood or from a tumor. immune cells specific for the tumor are activated, cultured and returned to the patient where the immune cells attack the cancer. cytotoxic t cells and dendritic cells can be used in cell-based immunotherapy. this study is for patients that have a stage ⅳ gastric cancer with elevated serum cea concentration. this research study uses special immune system cells called cea-specific cytotoxic t lymphocytes , a new experimental therapy. blood will be collected from the patient and the cea-specific ctls will be made.the cells will be injected by iv into the patient.the investigators will follow the patient from their last infusion,monitor side effects of immunotherapy and learn more about the way the t cells are working in the patient's body.the investigators will use blood samples to see how long the t cells last and to look at the immune response to the patient's response to cancer.

Eligibility criteria:
inclusion criteria: * any patient, at least 18 yrs old regardless of sex, with a diagnosis of stage iv gastric cancer * patients with life expectancy greater than or equal to 6 weeks. * patients with a karnofsky score of greater than or equal to 80. * serum cea ≥ 20ng/ml. * patient provides consent for all required biopsies. exclusion criteria: * patients with severe active infection. * patients receiving systemic corticosteroid within 48 hours of ctl infusion. * patients with hbv,hcv,hiv infection.

Keywords: dendritic cells cytotoxic t-lymphocytes adeno-associated virus
morphine versus ketorolac in renal colic

Conditions: Renal Colic

Summary: the study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in renal colic.

the study will take place in the emergency department of the clinical emergency hospital bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in renal colic. the patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. a scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. after 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : chlorhydrate drotaverine 40 mg, xilocaine 100 mg, both diluted in 100 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of renal colic * grade 5 pain on a 1-10 visual pain scale exclusion criteria: * contraindications of ketorolac or opioids * pregnancy * allergies to ketorolac or opioids * refusal of participation

Keywords: ketorolac pain relieve morphine
study to characterize the pharmacokinetics of a single dose of sc abatacept 125 mg using the bd autoinjector or the prefilled syringe

Conditions: Rheumatoid Arthritis

Summary: the primary purpose of the protocol is to describe the pharmacokinetics of a single dose of abatacept 125 mg in rheumatoid arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

sc=subcutaneous

Eligibility criteria:
key inclusion criteria: * subjects ≥18 years of age * diagnosis of rheumatoid arthritis confirmed by participant's physician * disease activity under control key exclusion criteria: * change in disease-modifying antirheumatic drug (dmard) therapy within 3 months of enrollment * exposure to investigational drug within 4 weeks or 5 half lives whichever is longer * current or prior use of rituximab ≤6 months * current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic dmards, tofacitinib, cyclophosphamide, mycophenolate mofetil \& d-penicillamine
comparison of intraspinal nerve root stimulation with dorsal column stimulation

Conditions: Back Pain

Summary: this study will systematically evaluate the programming parameters of the precision spinal cord stimulation device to optimally relieve pain while minimizing any uncomfortable side effects.

this study will investigate the efficacy of subthreshold intraspinal nerve root stimulation (inrs) in treating back pain. the efficacy of this strategy will be tested against dorsal column stimulation (dcs), the commonly-accepted technique for spinal cord stimulation. dcs will be tested at subthreshold and suprathreshold (perceptible) amplitudes. a substudy will involve patients who prefer suprathreshold dcs over inrs and subthreshold dcs. its purpose is to systematically assess the pain relief afforded by a number of programs with different pulse widths. the overall purpose of this study is to investigate methods of making pain relief via electrical stimulation more comfortable by either using subthreshold amplitudes or by adjusting the pulse width of perceptible stimulation to a more pleasing range.

Eligibility criteria:
inclusion criteria: * have chronic low back pain following spine surgery (failed back surgery syndrome. * be an appropriate candidate for spinal cord stimulation (scs) and for the surgical procedures required for scs. * have experienced significant though short-lived pain relief with local anesthetic injection. * be 18 years of age or older. * be willing and able to comply with all study related procedures and visits. * be capable of reading and understanding patient information materials and giving written informed consent. exclusion criteria: * have any significant medical condition that is likely to interfere with study procedures. * have any evidence of neurologic instability. * have any other chronic pain condition. * have a condition currently requiring or likely to require the use of mri or diathermy. * have an active implantable device. * are pregnant or planning to become pregnant in the next year. * are a current substance abuser (including alcohol and illicit drugs). * have a significant psychiatric disorder. * have participated in any drug or device trial in the last 4 weeks or plan to participate in any other trial during the duration of this study.

Keywords: failed back surgery syndrome back pain chronic pain spinal cord stimulation
efficacy of art to interrupt hiv transmission networks

Conditions: HIV

Summary: the investigators are conducting a study to learn more about the spread of hiv infection within different geographic regions and populations in san diego county, with the goal of demonstrating that early use of hiv treatment can reduce the number of new infections in our community. at the study visits, participants will be examined by the study staff and asked to donate some blood. participants will also be asked several questions about themselves, their background, behaviors, health, and the general geographic area in which they live. by collecting information about antiretroviral treatment choices that are made by study participants, the investigators will be better able to measure how effectively hiv treatment can interrupt (i.e., block) the spread of hiv. all of the information gathered at the study visits will be de-identified and analyzed. study staff will use the information to better understand in which groups of people, and in what areas of san diego, hiv is spreading most quickly. this information will be used to determine how well antiretroviral therapy (hiv treatment) by certain individuals can control the spread of hiv within the population.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years of age 2. newly diagnosed hiv infection 3. art naïve (≤7 days art, previous use of pep or prep are not exclusions) 4. subject must be able to provide written consent 5. subject must agree to study specific specimen collections and visit schedule. 6. subjects with newly diagnosed hiv infection who were identified on or after may 1, 2014 will be eligible for enrollment as long as they are co-enrolled to either aeh020 (project 08-0278) or aeh030 (project 140093) and did meet the above study inclusion criteria (items at the time of enrollment to protocols aeh020 or aeh030). exclusion criteria: 1. any factor or factors that in the opinion of the local investigator that could prevent compliance with study requirements. 2. contraindication to phlebotomy or specimen collection.