Kornimate/medical-research-clean huggingface dataset:
fungal fiber for gut health

Conditions: Mild Gastrointestinal Symptoms in Healthy Adults; Low-grade Chronic Inflammation; Stress; Gut Health; Gut Permeability; Gut Microbiome; Immune Response; Activity of Daily Living; Nutrition, Healthy

Summary: this study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.


Eligibility criteria:
inclusion criteria: 1. provision of a signed and dated informed consent form 2. declared willingness to comply with all study procedures and availability during the study. 3. female, \>37 years, ≤48 years 4. healthy volunteers who have experienced at least one of the following gastrointestinal symptoms in the last week: abdominal pain, full stomach, bloating, accidental leakage of intestinal gas, loud belching, bowel movements more frequent than usual, discomfort when eating, with a giqli score \<121 5. fiber intake \<20g/day according to r24 6. 18.5 ≤ bmi ≤ 29.9 7. volunteers permanently living in the buenos aires metropolitan area for at least 6 months prior to the intervention. 8. ability to take oral capsules and willingness to comply with intervention regimen of the study. 9. agreement to comply with lifestyle considerations during the study. exclusion criteria: 1. history of chronic immune, metabolic or gastrointestinal diseases. 2. history of gastrointestinal surgery. 3. acute illness within one week prior to screening. 4. treatment with oral or systemic antibiotics within 3 months prior to screening. 5. hospitalization within 3 months prior to screening. 6. consumption of laxatives or antidiarrheals, antispasmodic agents, antacids, anti-inflammatories within three days prior to screening. 7. current intake of fiber or prebiotics as a supplement, or probiotics as a supplement. 8. vegan, vegetarian or on a special diet. 9. pregnancy or breastfeeding. 10. menopause (absence of menstruation for 12 consecutive months) or postmenopause. 11. known allergic reactions to components of the study interventions: inulin, beta-glucan, mushrooms, magnesium stearate, microcrystalline cellulose, hydroxypropylmethylcellulose. 12. treatment with another investigational drug or other intervention in the last 6 months. 13. receives pharmacological intervention for the treatment of a disease 14. any disorder that, in the opinion of the investigator, could jeopardize safety of the participant.

Keywords: gut microbiome gut health healthy women perimenopause pre menopause middle aged women fiber gut brain axis low grade chronic inflammation prebiotic
edible plant exosome ability to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer

Conditions: Head and Neck Cancer; Oral Mucositis

Summary: this study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

the purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these patients.

Eligibility criteria:
inclusion criteria: * patients must have definitive diagnosis of head and neck cancer. * concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer. * patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines. * absence of life limiting medical conditions * ability to understand and willingness to sign a written informed consent document. * ecog performance status 0, 1, or 2 (karnofsky \> 60%). * patients must have adequate bone marrow function. anc \> 1000/microl and platelet count \>100,000/microl * age \>20 years exclusion criteria: * known familial head and neck cancer syndrome * pregnancy * known hiv * patients receiving immunosuppressive drugs * inflammatory bowel disease * active second malignancy in the last 5 years * patients receiving any other investigational agent(s) * patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer

Keywords: plant exosomes grape exosomes grape extract oral mucositis head and neck cancer immune response
an open label placebo study to assess the inhalation profile obtained by acoustic monitoring in copd patients using the nexthaler dpi

Conditions: COPD

Summary: phase iia, single center, open-label, single-arm study, to evaluate the inspiration profile through the nexthaler device in adult copd patients with varying degrees of airflow limitation

as this is an exploratory study, a total of 70 to 80 completed patients, ensuring the following distribution in terms of copd stage as per gold 2013 (updated) spirometric classification of disease severity, are deemed to be sufficient for assessing the inhalation profile through the nexthaler®: * 10 to 20 copd gold stage i patients * 20 patients in each of the copd gold stage ii to iv. assuming a screening failure/drop-out rate of 10%, a maximum of 89 patients will be screened in order to reach the required number of completed patients. all the analyses will be performed separately for the first and the second inhalation. results stratified by disease severity and overall will be presented.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from the patient and/or the legal representatives 2. inpatients and outpatients of both sexes, aged ≥ 40 years 3. documented clinical diagnosis (within the past 6 months) of copd with varying degrees of airflow limitation based on spirometric classification of disease severity according to gold 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). current smokers and ex-smokers are eligible 4. a cooperative attitude and ability to use dpis and to be trained in the proper use of the nexthaler® as confirmed by the activation of the training device bam exclusion criteria: 1. pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable) 2. diagnosis of asthma 3. diagnosis of restrictive lung disease 4. allergy to any component of the placebo treatment 5. inability to comply with study procedures or treatment 6. significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.

Keywords: copd placebo inhalatory profile
a study to assess the safety, tolerability and pharmacokinetics of tcmcb07 in single and multiple ascending doses in health subjects

Conditions: Cachexia

Summary: this study will test an experimental drug named tcmcb07 for the treatment of cancer cachexia. cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. cachexia occurs in many cancers, usually at the advanced stages of disease.


Eligibility criteria:
inclusion criteria: * healthy males and females (woncbp), aged 18 to 55 years inclusive, at time of signing informed consent. * body mass index 18.0 to 30.0 kg/m2 as measured at screening or, if outside this range, considered not clinically significant by the investigator. * weight ≥ 50 kg at screening exclusion criteria: * serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol. * evidence of current severe acute respiratory syndrome coronavirus 2 infection. * clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator. * subjects who have received any ip in a clinical research study within 5 half-lives or within 30 days prior to first dose. however, in no event shall the time between last receipt of ip and first dose be less than 30 days.
ultrasound characteristics of the salivary glands in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Sjogren's Syndrome; Sicca, Asthenia, Polyalgia Syndrome (SAPS)

Summary: the prevalence of sjogren's syndrome (ss) in rheumatoid arthritis (ra) patients varies from 3.5 to 31%. between 30% and 90% of patients with (ra) have dry eye and/or mouth syndrome. to date, no studies have assessed whether ra patients have echostructural changes in their salivary glands suggestive of ss and the factors associated with these changes.the aim of this study is to investigate if there are changes in the echostructure of the salivary glands of ra patients, especially in patients with dry syndrome.

the echopr study is an exploratory pathophysiology, cross-sectional, case-control study. the aim is to study the echo-structure of the salivary glands of patients with ra ( group of 70 patients), in comparison to patients with ss (suspected of strong alteration of the echo-structure)(group of 70 patients) and patients with sicca, asthenia, polyalgia syndrome (saps)(group of 70 patients). after a standard consultation with the rheumatologist, patients in each group will have an salivary gland ultrasound to assess the homogeneity of the echostructure of the parotid and submandibular salivary glands. a salivary flow measurement for 15 minutes and a schirmer test to determine tear secretion for 5 minutes are also performed. all of these tests are performed during a single visit, so the total study time for the patient is one hour. patient recruitment is expected to last 1 year.

Eligibility criteria:
inclusion criteria: patient, male or female, over 18 years of age, followed in the rheumatology department of the clermont-ferrand university hospital, capable of giving informed consent to participate in the research. * for ra subjects: diagnosis of rheumatoid arthritis meeting the acr/eular 2010 classification criteria. * for ss subjects: diagnosis of primary sjögren's syndrome meeting the acr/eular 2016 criteria. * for saps subjects: patients with dry syndrome not meeting the criteria for ss exclusion criteria: * not covered by social security * minors or adults under the protection of the law or under the protection of justice. * pregnant or breastfeeding women * refusal to participate * interference with results or classification bias: secondary causes of dry syndrome: previous radiotherapy of the face and neck, aids, hepatitis c, sarcoidosis, amyloidosis, hyper-igg4 syndrome
effects of nut consumption on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study aimed to investigate the effects of nut consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in korean adults with metabolic syndrome.

a randomized, controlled, parallel, dietary intervention study was designed. subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the nut group, which were supplemented with 30 g of mixed nuts including walnuts, peanuts, and pine nuts for 6 weeks; or allocated to the control group. metabolic markers were evaluated at baseline and at the end of the study.

Eligibility criteria:
inclusion criteria: * subjects were enrolled if their body mass index (bmi) was ≥23 kg/m2 and they met the criteria for metabolic syndrome. exclusion criteria: * subjects were excluded if they had a nut allergy, peptic disorder, a history of cancer or cardiovascular disease including coronary artery disease, heart valve disease, or stroke, or established chronic diseases such as chronic renal insufficiency or cirrhosis. subjects were also excluded if they:1) were receiving treatment with hypoglycemic agents for diabetes or had hba1c \>7%; 2) were receiving corticosteroid treatment; 3) had started antihypertensive or lipid-lowering agents, or changed their doses within the previous month; 4) had a weight change ≥5 % of body weight during the three months prior to the study; 5) were pregnant; or 6) were regular nut consumers (\>15g/day of nuts at least three times a week).

Keywords: nuts metabolic syndrome lipid profile inflammation oxidative stress endothelial function
psychosocial determinants of continuing or discontinuing infertility treatment: a psychological analysis

Conditions: Infertility

Summary: the current study aims to explore and analyse the decision making process of couples in regards to continuing or discontinuing infertility treatment. a longitudinal, prospective cohort design is used which allows the monitoring of patients over a longer period of time. data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth interviews) to allow for a more specific and in depth experience than can be obtained by using a questionnaire study. innovative aspects of the study include: 1. exploration of determinants of continuing and discontinuing infertility treatment by using a comprehensive psychological theory (both surface and in-depth) 2. exploration of gender differences in the decision making process in continuing or discontinuing treatment 3. longitudinal and prospective arm of the study will allow to gain insight into the 'process' 4. prediction of continuing/discontinuing treatment based on psychological variables.


Eligibility criteria:
inclusion criteria: * first ivf/icsi treatment * sufficient knowledge of dutch to fill out questionnaires * heterosexual couples exclusion criteria: * insufficient knowledge of dutch * having had previous ivf/icsi treatment

Keywords: drop-out predictors of treatment continuation/discontinuation ivf/icsi infertility counseling psychology assisted reproduction counselling
peg-asparaginase associated pancreatitis, hepatotoxicity and hyperlipidemia in children with all

Conditions: Acute Lymphoblastic Leukemia; Pancreatitis

Summary: the purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with peg-asparaginase in children with acute lymphoblastic leukemia.

leukemia is the leading cause of cancer in children in europe and the u.s. with an annual incidence of appoximately 3,5 cases per 100.000 children 0-14,9 years. although the rate of cure has increased significantly, treatment is still unsuccesfull in appoximately 20 % of the patients. there is great variation in the how the individual patient processes the different chemotherapeutic agents. furthermore there is a signifikant difference regarding the severity of sideeffects and toxicities. so far it has not been possible to predict which patients are at speciel risk of developing toxicities. acute pancreatitis is a severe sideffect/toxicity when treating all. patients are at risk of developing pancreatitis, because of the drug asparaginase. the condition can not be prevented and in severe cases, e.g. hemorhaggic pancreatitis the only solution is to discontinue the drug, in spite of the fact that asparaginase is on of the most important drugs when treating leukemia. in the current study we will map the occurence of pancreatitis, hepatotoxicity and hyperlipidemia among approximately 1000 children and adolescents with leukemia. this study is unique because it is the largest study of its kind regarding asparaginase associated pancreatitis. among other things it will involve extensive genetic analysis. we believe that this study will improve the possibilities, not only, for individualized treatmentvi mener at dette studie vil forbedre mulighederne for individ orienteret behandling, but also for other studies like this regarding other toxicities in patients with cancer.

Eligibility criteria:
inclusion criteria: * ir- or sr- type all, and treatment with peg-asparaginase exclusion criteria: * hr all, and changing subgroup from ir or sr to hr

Keywords: acute lymphoblastic leukemia pediatric asparaginase pancreatitis
soft coagulation for the prevention of adenoma recurrence

Conditions: Colonic Adenomas

Summary: recurrence after endoscopic mucosal resection of laterally spreading lesions (lsl) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. we aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the emr mucosal defect margin in reducing adenoma recurrence following colonic emr.


Eligibility criteria:
inclusion criteria: * referred for removal of a colonic polyp \>= 20mm in size * able to give informed consent to involvement in trial exclusion criteria: * younger than 18 years of age * highly dependant on medical care * women who are pregnant or may be pregnant. * taken clopidogrel within 7 days * taken warfarin within 5 days * had full therapeutic dose unfractionated heparin within 6 hours * had full therapeutic dose low molecular weight heparin (lmwh) within 12 hours * known clotting disorder * previous attempt at emr of the polyp referred for resection * polyp located at the ileo-caecal valve, appendiceal orifice * fully circumferential polyp * incomplete snare resection of the polyp

Keywords: snare tip soft coagulation endoscopic mucosal resection adenoma recurrence adenoma colonoscopy
exenatide for stress hyperglycemia

Conditions: Stress Hyperglycemia

Summary: stress hyperglycemia is a common phenomenon in cardiac surgery that concerns diabetic and non diabetic patients. it has been shown that perioperative hyperglycemia is an independent risk factor of postoperative mortality and morbidity. the leuven et al.'s study suggested that strict glycemic perioperative control using an intensive insulin therapy could reduce mortality and morbidity in surgical intensive care's patients. this study included a majority of cardiac surgery patients. others studies have suggested that the beneficial effect of insulin-based tight perioperative glycemic control might be hampered by iatrogenic hypoglycemia. moreover, insulin therapy failed to obtain perioperative glycemic stability in most patients. exenatide (byetta ®) is an incretin mimetic, characterized by an anti-hyperglycemic effect that depends on the blood glucose level. we hypothesize that continuous intravenous infusion of exenatide could improve perioperative glycemic control and stability and could reduce the risk of iatrogenic hypoglycemia compared to a conventional insulin therapy during the perioperative period of cardiac surgery.

the phase ii of the study will assess the safety and the efficacy of a continuous intravenous infusion of exenatide for the management of post operative stress hyperglycemia after planned coronary artery graft bypass (cabg) surgery. a nested cohort study will concern the 24 first patients included in the study (12 patients/group) to assess the impact of a continuous intravenous infusion of exenatide on post operative glycemic variability after planned cabg surgery. the aim of the phase iii of the study will compare the efficacy of a continuous intravenous infusion of exenatide to the gold standard treatment, i.e the intravenous infusion of short-acting insulin, for the management of post operative stress hyperglycemia after planned cabg surgery.

Eligibility criteria:
inclusion criteria: * age over 18. * patient consent. * non insulin requiring type 2 diabetic patients. * non diabetic patients. * planned coronary artery bypass graft (cabg) surgery. * asa (american society of anesthesiologists) score 1, 2, or 3. exclusion criteria: * pregnancy and breast feeding. * pancreatectomy. * acute pancreatitis. * chronic pancreatitis. * type 1 diabetic patients. * insulin requiring type 2 patients. * hba1c\>8% * ketoacidosis. * hyperosmolar coma. * preoperative blood glucose level above 300 mg/dl \[21\]. * insulin or exenatide contraindication. * history of renal transplantation or currently receiving renal dialysis or creatinine clearance below 60 ml/min. * emergency surgery. * planned non cabg cardiac surgery.

Keywords: stress hyperglycemia perioperative glycemic control cardiac surgery coronary artery bypass surgery
an extension study of the efficacy and safety of fingolimod (fty720) in patients with relapsing multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study was an extension study of nct00537082. this study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (fty720) to relapsing multiple sclerosis.

a decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. the study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 feb 2010. the efficacy data for months 0-6 in this study report is from the core study nct00537082.

Eligibility criteria:
inclusion criteria: * patients who completed 6 months of treatment with the study drug and the month 6 visit in the core study nct00537082. * females of childbearing potential who have a negative pregnancy test in the core study nct00537082. exclusion criteria: * patients who permanently discontinued study drug treatment prior to the month 6 visit in the core study nct00537082. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: fty720 multiple sclerosis ms