Kornimate/medical-research-clean huggingface dataset:
gastrectomy, eating behaviour and glp-1

Conditions: Gastric Cancer; Dumping Syndrome

Summary: patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer are known to have a significantly reduced quality of life. to date, there is very little information on the physiological causes of this. the investigators suspect that overproduction of a hormone (chemical) called glucagon like peptide-1 (glp-1) released by the lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar symptoms seen in this group. to investigate this, the investigators will study the response of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while receiving an infusion of a specific blocker of glp-1 or placebo. the investigators will examine the levels of sugar and associated hormones in the blood, food consumption and food reward behaviour using standard tools. participants will be invited to attend the clinical research facility at addenbrooke's hospital for a screening visit, and two whole day study visits. the study has been designed to assess the role of overproduction of glp-1 by completely blocking its actions, rather than assess the use of the blocking compound as a medication, and is therefore regarded as a physiological study, not a clinical trial. the goal of this study is to demonstrate the magnitude of effect of glp-1 on blood sugar and appetite derangement in patients who have had a gastrectomy. this will guide future work on the development of novel treatment paradigms for the post-gastrectomy patient group.


Eligibility criteria:
inclusion criteria: * • at least 3 months post completion of treatment for gastric cancer, or prophylactic gastrectomy * aged at least 18 years * able to tolerate an oral glucose tolerance test * able to understand and retain all information regarding the study and give informed consent. * willing to receive an infusion of human albumin solution exclusion criteria: * • have a diagnosis of diabetes * have a history of untreated anaemia in the last 3 months * be aged under 18 years * have active gastric cancer * be pregnant or attempting to conceive

Keywords: dumping syndrome gastrectomy glp-1 insulin
social isolation and loneliness in older people

Conditions: Very Late Onset Schizophrenia

Summary: although psychotic disorders such as schizophrenia usually present in late adolescence or early adulthood, research suggests that a substantial subset of people are diagnosed for the first time after the age of 60. this condition is referred to as 'very late-onset schizophrenia-like psychosis' (vloslp). people with vloslp are thought to experience high levels of social isolation, yet there has been little research systematically examining this. additionally, little is known about how lonely people with vloslp feel, or how this group relate to and perceive other people. this study aims to examine levels of social isolation and loneliness in patients with vloslp. the investigators also aim to explore aspects of social cognition in relation to vloslp. a case-control study design will be used to examine the relationship between vloslp, loneliness, social isolation and social cognition. the case group will be people diagnosed with a non-organic psychotic disorder after age 60. the comparison group will be those aged 60 and above in contact with mental health services for a mental health difficulty, except from a psychotic disorder or dementia.


Eligibility criteria:
cases inclusion criteria: * aged 60 and above. * diagnosed with a psychotic disorder after age 60. exclusion criteria: * diagnosed with a psychotic disorder before age 60. * dementia diagnosis. * mild cognitive impairment diagnosis. * clear organic cause for psychosis. * does not speak english to the degree needed to engage with study materials. * mental health problems too severe to fully engage with the study. * other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness. controls inclusion criteria: * aged 60 and above. * diagnosed with any mental health disorder except from a psychotic disorder, dementia, or severe depression. exclusion criteria: * diagnosed psychotic disorder, drug-induced psychosis or organic psychosis. * dementia diagnosis. * mental health problems too severe to fully engage with the study. * does not speak english to the degree needed to engage with study materials. * other medical or psychosocial factor that could limit ability to fully engage with study materials, such as severe intellectual disability or imminently life-limiting illness.
study to evaluate the effect of a known and marketed product, itraconazole (mycosis treatment) on lu af11167 entering the body and subsequently elimination. the study is a drug-drug interaction study in healthy volunteers.

Conditions: Healthy

Summary: the purpose of this study is to evaluate the increase in exposure of lu af11167 following a single oral dose of lu af11167 with and without administration of multiple oral doses of itraconazole (a strong cyp3a4/5 inhibitor) in healthy subjects with inferred metabolic status as cyp2c19 extensive metabolisers


Eligibility criteria:
inclusion criteria: * subjects be 18 years of age and 55 years of age and with a bmi \>18.5 kg/m2 and \<30.0 kg/m2 at the screening visit. women must not be pregnant or lactating. other pre-defined inclusion and exclusion criteria may apply.

Keywords: lu af11167 interaction
effect of energy- and protein-rich foods on physiological functions and quality of life in undernourished patients

Conditions: Malnutrition

Summary: the purpose of this study is to determine whether individualised nutritional therapy comprised of appetising, energy- and protein-rich foods can have a positive effect on physiological function and quality of life of undernourished patients as compared to usual nutrition care.

undernutrition and insufficent dietary intake in hospitalised patients is a widespread problem. it is associated with increased morbidity and mortality, worsened physiological function and quality of life and increased expenses for the health care system. food quality has been shown to be positively associated with dietary intake in patients. however, there has lacked knowledge on how food quality can be optimised to promote intake. a project was therefore initiated, which aimed at establishing a framework for developing appetising, energy- and protein-rich foods for patients at nutritional risk. this project included qualitative and quantitative investigation of nutritional risk patients' meal experiences and preferences (se citations below). these results have served as a basis for optimsing energy- and protein-rich foods as part of an indivudalised nutritional therapy aimed at improving dietary intake in nutritional risk patients.

Eligibility criteria:
inclusion criteria: * nutritional risk as per nutrition risk screening 2002 (nrs-2002) * hospital admited at rigshospitalets (various medical departments) * expect length of stay \>= 5 days * informed consent to participate exclusion criteria: * dementia or other psychiatric condition resulting in an inability to give informed consent and to understand study materials. * inability to fairly perform the functional measurements (i.e., handgrip strength, reaction time) due to a hand, wrist, arm, shoulder injury or condition. * enteral or parenteral nutrition as primary nutritional therapy. * previous participation in the study.

Keywords: malnutrition nutritional risk intake food sensory nutritional therapy energy protein handgrip strength reaction time quality of life
effect of the synbiotic probinul-neutro® on gastrointestinal symptoms and plasma p-cresol level in chronic renal failure

Conditions: Chronic Kidney Disease

Summary: the interest on gastrointestinal (gi) dysfunction in ckd has been growing in the last years. it is now accepted that gi dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. another mechanism by which gi dysfunction contributes to systemic symptoms in ckd is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. epidemiological evidence has strongly linked one of these compounds, p-cresol, to cardiovascular risk and mortality in ckd. in the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and gi symptoms and in ckd patients not on dialysis yet.

in patients with chronic kidney disease (ckd), alterations in gut microbioma are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that has been associated to ckd progression and cardiovascular mortality. this double blind randomized placebo controlled pilot study evaluates whether probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in non-dialyzed ckd patients. thirty patients on iii-iv ckd stages were randomized to receive either probinul neutro® or placebo for four weeks. total plasma p-cresol concentrations was assessed at baseline, and 15 and 30 days after treatment start. at the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were quantified by subjective assessment questionnaires.

Eligibility criteria:
inclusion criteria: * age \>18 years * egfr between 20 and 60 ml/min (stage 3-4 ckd, according to the k/doqi ckd classification) exclusion criteria: * severe infections * diabetes * malignancy * history of food intolerance * autoimmune disorders * severe malnutrition * clinical conditions requiring artificial feeding * kidney transplant

Keywords: chronic kidney disease p-cresol synbiotic
irrisept vs traditional antibiotic irrigation for virgin penile prosthesis placement

Conditions: Erectile Dysfunction; Penile Prosthesis; Complications, Infection or Inflammation

Summary: the purpose of this study is to assess whether intraoperative irrigation with irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

to conduct a prospective, randomized, controlled trial of all virgin penile prosthesis implantations with the goal of assessing irrisept's candidacy as an alternative to traditional antibiotic irrigation (rifampin, gentamicin for all patients, with the addition of amphotericin b if patient has a history of diabetics) during penile prosthesis surgery. the investigators believe that irrisept provides adequate antibacterial and antifungal coverage to serve as an alternative to traditional antibiotic therapy. additionally, the investigators believe a cost analysis would support the use of irrisept in the event that non-inferiority is demonstrated.

Eligibility criteria:
inclusion criteria: * inclusion criteria include all men undergoing penile prosthesis (any manufacturer) implantation (inpatient or outpatient) exclusion criteria: * exclusion criteria include men who are having revision implant surgeries, men who may require intraoperative complex reconstruction including graft for peyronie's disease, and transgender males

Keywords: inflatable penile prosthesis irrisept
phacotrabeculotomy versus cci+phaco in patients with borderline control of intraocular pressure

Conditions: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma

Summary: the purpose of the study is to determine whether combined cataract and glaucoma surgery (phacotrabeculotomy)is more effective in lowering intraocular pressure than cataract surgery alone in patients with borderline control of intraocular pressure.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary open angle or pseudoexfoliative glaucoma and cataract exclusion criteria: * other glaucoma than poag or pex-glaucoma * medically uncontrolled glaucoma: iop \> 24 mmhg with two topical medications iop \> 21 mmhg with three topical medications * iop \< 18 mmhg with two topical medications iop \< 16 mmhg with three topical medications * previous ocular surgery * other ocular pathologies affecting visual acuity * disorders of immune system

Keywords: glaucoma cataract surgery intraocular pressure phacoemulsification trabeculotomy
safety and effects of giving a new hiv vaccine (genevax-hiv) to hiv-negative volunteers

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to see if it is safe to give genevax-hiv, a new hiv vaccine, to hiv-negative volunteers. this study will also look at how this vaccine affects the immune system of these volunteers.

in this open-label study, volunteers are given an intramuscular injection of genevax-hiv vaccine using the biojector 2000. safety measures and immune response are assessed accordingly.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are 18 - 60 years old. * are hiv-negative and in good health. * are able to understand how infections such as hiv are spread. * agree to use effective methods of birth control during the study. exclusion criteria you will not be eligible for this study if you: * have hepatitis b or c. * have any condition that may prevent you from completing the study. * are allergic to bupivacaine, vaccines, or certain local anesthetics. * have taken certain medications or have received certain therapies that may affect your immune system. * have an immune system disorder or have received therapy for an immune system disorder. * have been exposed to hiv within 6 months prior to study entry. * have received an experimental hiv vaccine or any other experimental treatment within 30 days prior to study entry. * have received blood transfusions within 6 months prior to study entry. * abuse alcohol or drugs or have an uncontrolled psychiatric disorder. * are pregnant or breast-feeding.

Keywords: injections, intramuscular hiv antibodies immunity, cellular aids vaccines hiv seronegativity dose-response relationship, immunologic vaccines, dna
flax muffins and cholesterol lowering

Conditions: Above Optimal Plasma LDL Concentrations

Summary: this clinical trial is being conducted to study the ldl (bad) cholesterol lowering abilities of flax. the purpose of this study is to find the lowest dose of flax that can lower ldl-cholesterol.


Eligibility criteria:
inclusion criteria: * male and non-pregnant/non-lactating female * body mass index 18.5-40.0 kg/m2 * fasting plasma ldl cholesterol 2.6-5.0 mmol/l * regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily) * willing to comply with protocol requirements * willing to provide informed consent exclusion criteria: * medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications * fasting plasma triglycerides ≥ 4.0 mmol/l * medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/l or use of insulin or oral medication to control blood sugar * medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks * medical history of inflammatory disease (ie. systemic lupus erythematosis, rheumatoid arthritis, psoriasis) * medical history of liver disease or liver dysfunction (defined as plasma ast or alt ≥ 1.5 times the upper limit of normal (uln)) * medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the uln) * active treatment for any type of cancer within 1 year prior to study start * major surgery within the last 3 months * other medical, psychiatric, or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol * unstable body weight (defined as \> 5% change in 3 months) or actively participating in a weight loss program * tobacco and/or nicotine replacement use, current or within the last 3 months * taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents * any food allergy, aversion or unwillingness to eat wheat or flax * daily consumption of flax containing products in the past month * regular intake of \> 2 alcoholic drinks per day. standard drink (13.6 g alcohol)= beer (5% alcohol) 360 ml (12 fl.oz); spirits (40% alcohol) 45 ml (1.5 fl.oz); wine (12% alcohol) 150 ml (5 fl.oz) * participation in another clinical trial, current or in the past 4 weeks

Keywords: flax muffin cholesterol lignan ala
cardiac mri-guided deferiprone therapy for acute myocardial infarction patients

Conditions: Acute Myocardial Infarction Type 1

Summary: the objective of this randomized, controlled pilot study is to determine the efficacy of deferiprone to reduce the amount of free iron inside the hemorrhagic zone of myocardial infarction among hemorrhagic myocardial infarction patients.


Eligibility criteria:
inclusion criteria 1. age ≥ 18 years 2. index anterior wall stemi 3. emergency coronary angiogram with primary pci exclusion criteria 1. prior history of mi / pci / coronary artery bypass graft (cabg) within previous 1 year 2. patients with previous history of left ventricular ejection fraction (lvef) \< 40% 3. use of investigational drugs or devices 30 days prior to randomization 4. known allergy or contra-indication to gadolinium/contrast agents 5. egfr \< 30 ml/kg/min 6. any contraindication against cardiac mri (such as metal implants) 7. women who are pregnant or breastfeeding. women of reproductive potential must have a negative pregnancy test prior to randomization 8. body weight \> 140 kg (or 309 lbs.) 9. absolute neutrophil count - anc \< 1.5 k/cumm 10. history of chronic liver disease 11. elevated hepatic enzymes (both alt and ast) \> 2 times of upper normal limit 12. patients with iron storage disease (hemochromatosis, thalassemia) or who are already treated with iron chelators 13. any clinically significant abnormality identified prior to randomization that in the judgment of the sponsor-investigator or delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone. 14. life expectancy of less than 1 year due to non-cardiac pathology

Keywords: acute myocardial infarction intramyocardial hemorrhage deferiprone
rct study of levosimendan improving prognosis of cardiac arrest

Conditions: Heart Arrest

Summary: this study is intended to use a multicenter, double-blind, superior effect, placebo controlled randomized controlled clinical trial to explore the therapeutic effect of levosimendan (within 6 hours after the recovery of spontaneous circulation) on mortality and multiple organ dysfunction such as heart and brain in patients with cardiac arrest who have recovered from active cardiopulmonary resuscitation but have low cardiac output syndrome and coma, and the impact of 30-day mortality and neurological function after cardiac arrest.


Eligibility criteria:
inclusion criteria: * 1: age\>18 years old 2: after active cardiopulmonary resuscitation, patients with cardiac arrest obtain the recovery of spontaneous circulation (rosc), which is defined as having palpable arterial pulse lasting for more than 20 minutes 3: patients with witnessed cardiac arrest 4: rosc lasts for less than 60 minutes 5: low cardiac output syndrome after rosc (lvef\<40%) 6: still in a coma after rosc, glasgow score\<8 points 7: complete enrollment within 180 minutes after rosc exclusion criteria: * 1: patients receiving extracorporeal cardiopulmonary resuscitation 2: patients with severe neurological deficits prior to cardiac arrest 3: patients with severe renal dysfunction (creatinine clearance rate\<30ml/min) 4: patients with confirmed or suspected pregnancy 5: patients with intracranial hemorrhage 6: patients with end-stage diseases, such as advanced malignant tumors or other severe wasting diseases 7: patients who are unwilling to participate in the study

Keywords: cardiac arrest levosimendan injection prognosis
a study to evaluate the safety and tolerability of tirbanibulin ointment 1% in adult participants with actinic keratosis

Conditions: Keratosis, Actinic

Summary: the purpose of the study is to evaluate the safety, tolerability and treatment effect of tirbanibulin ointment 1% when applied to a field of approximately 100 cm\^2 on the face or balding scalp.


Eligibility criteria:
inclusion criteria: * having a treatment field (tf) on the face or balding scalp (excluding lips, eyelids, and inside nostrils and ears) that measures approximately 100 cm\^2 (eg, mid face) and contains 4 to 12 clinically typical, visible, and discrete actinic keratosis (ak) lesions within the tf * willing to avoid excessive sunlight or ultraviolet (uv) light exposure, including the use of tanning beds, to the face or scalp during the study * ability to understand the purpose and risks of the trial, willingness and ability to comply with the protocol, and provided written informed consent in accordance with institutional and regulatory guidelines exclusion criteria: * presence in the tf of 1. clinically atypical and/or rapidly changing ak lesions in the tf 2. hyperkeratotic or hypertrophic lesions, recalcitrant disease (had cryosurgery on 2 previous occasions) and/or cutaneous horn 3. confluent ak lesions (ie, non-discrete lesions defined as per inclusion criteria) 4. history of invasive squamous cell carcinoma (scc), bowen's disease, basal cell carcinoma (bcc), or other malignant tumors in the tf 5. any other dermatological disease that causes difficulty with examination * previous treatment with tirbanibulin ointment 1%. * anticipated need for inpatient hospitalization or inpatient surgery from day 1 to day 57 * treatment with 5-fluorouracil, imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other treatments for ak within the tf or within 2 cm of the tf, within 8 weeks prior to the screening visit * use of systemic retinoids (eg, isotretinoin, acitretin, bexarotene) within 6 months prior to the screening visit
the effects of mhealth intervention on health empower of overweight and obese women's body weight during pregnancy

Conditions: Overweight and Obese Pregnant Women

Summary: evaluate the health empowerment program with mhealth to promote physical activity for overweight and obese pregnant women.

this two-phase study develops an mhealth application (app) based on social-cognitive theory (sct) and evaluates its effectiveness for overweight and obese women, which can help to prevent excessive gwg by enhancing optimal weight and healthy behavior during pregnancy.

Eligibility criteria:
inclusion criteria: 1. pregnant women--who have had, 8-12 weeks 2. pre-pregnancy body mass index \> 25 kg/m2 exclusion criteria: -