Kornimate/medical-research-clean huggingface dataset:
evaluating whole foods supplementation on cognition

Conditions: Sub-optimal Cognitive Function; Sub-optimal Immune Function

Summary: a six-month study which investigated the effect of ginkgo synergy® and choline or opc synergy® and catalyn® on cognitive and immune function markers and quality of life among healthy older adults with no history of significant cognitive deficits


Eligibility criteria:
inclusion criteria: * 60 years of age and older * english speaking * not living in a skilled or intermediate care level nursing facility * no use of dietary supplements for cognitive functioning two weeks before enrolling in the study and during the length of the trial * a mini-mental state exam (mmse) score ≥ 23 exclusion criteria: * a cognitive deficit greater than that indicated according to the mmse score * a clinical diagnosis of ad and/or related disorders * a psychiatric diagnosis of schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, and alcohol or substance abuse/dependence * bleeding disorders * aphasia or sensory, motor, and/or visual disturbances that would have interfered with psychometric tests * gastrointestinal disorders causing impaired absorption of the study supplements * insulin-dependent diabetes * major conditions such as cardiovascular, pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure * hematologic or oncologic disorders treated with chemotherapy in the previous two years * active chemotherapy or radiation treatment for cancer * current cigarette smoking * more than three major medical or psychiatric hospitalizations in the past year * diagnosis of a terminal illness * a t score \> 70 on the global severity index of the brief symptoms inventory (bsi) * a score ≥ 29 on the beck depression inventory-ii (bdi) (15) * prescription and otc sympathomimetic amines and antihistamines within 2 days of an assessment visit * cognition enhancing drugs consumption such as donepezil, rivastigmine, galantamine, and tacrine * coumadin, tricyclic antidepressants, antipsychotics, and anticonvulsants * cognition-enhancing supplements, herbs, or antioxidants that could not be stopped during the trial * participating in a concurrent trial for drugs, supplements, or treatment that affects behavior or cognitive function

Keywords: cognitive functioning immune function cytokines growth factors quality of life dietary supplementation ginkgo biloba improvement of cognitive function
effects of a strength physical exercise program in colorectal cancer patients undergoing chemotherapy treatment

Conditions: Oncology; Chemotherapy-induced Peripheral Neuropathy

Summary: chemotherapy is a crucial treatment in the fight against colon cancer, but unfortunately, its impact is not limited to cancer cells alone. chemotherapy drugs, designed to attack fast-growing cells, also affect healthy tissues, leading to various side effects. one of the most common adverse effects is peripheral neuropathy, a condition that affects the peripheral nerves and can manifest as tingling sensations, numbness, pain or weakness in the extremities. chemotherapy-induced peripheral neuropathy can be especially challenging for colon cancer patients, as it further aggravates quality of life during an already difficult period. nerves responsible for motor and sensory function are compromised, affecting the patient's ability to perform daily activities and weakening their physical endurance. this phenomenon adds to the emotional and physical burden of fighting cancer. however, there are tools that can positively influence these adverse effects, such as physical exercise. although it may seem contradictory, regular physical exercise has been shown to have beneficial effects on peripheral neuropathy. physical exercise can improve blood circulation and promote regeneration of damaged peripheral nerves. in addition, exercise helps to alleviate the pain and discomfort associated with neuropathy, thereby strengthening patients' functional capacity. it is essential to emphasize that any exercise plan must be tailored to the individual capabilities of each patient, and medical supervision is essential. therefore, the combination of chemotherapy and carefully planned physical exercise offers a comprehensive strategy to address both the disease and its side effects, providing colon cancer patients with a better quality of life during their journey to recovery.


Eligibility criteria:
inclusion criteria: * people diagnosed with colorectal cancer and who are receiving chemotherapy treatment. * sedentary people who have not performed physical activity in the last 8 weeks. * ability to understand the evaluation tests and the performance of the exercises. * presence of xxx symptoms (if we focus on neuropathy, it should be inclusion criteria). * voluntary participation in the study. exclusion criteria: - present contraindication/s for physical exercise (musculoskeletal diseases, severe cardiovascular disease, bone metastases,...).

Keywords: exercise physiotherapy
a real-world study of the efficacy and safety of icis as first-line therapy for advanced malignancies

Conditions: Malignant Tumor; Immunotherapy; Artificial Intelligence

Summary: in this study, we collected the data of immunohistochemistry, gene detection, image, os, pfs, orr, and so on. secondly, the database of immunotherapy for malignant tumor was established, and the predictive model was constructed to verify and establish the rationality and validity of the biomarkers and predictive system of immunotherapy


Eligibility criteria:
inclusion criteria: 1. informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent. 2. the advanced malignant tumors (solid tumors of the non-small-cell lung carcinoma, stomach, breast, urinary system, etc.) were diagnosed by histopathology. 3. the stage iv according to the eighth edition of iaslc. 4. ps 0-2, the expected survival \> 3 months. 5. the age of 18-75 years. 6. no contraindication to treatment with immune checkpoint inhibitors. exclusion criteria: 1. the patients' compliance was poor, which violated the rules of the trial; 2. the patients with severe dysfunction of vital organs (heart, liver and kidney) ; 3. the patients with other malignant tumors; 4. the researchers considered that the patients should not participate in other conditions of the trial.
covid-19 tests: nasopharyngeal swab vs saliva collected with salivette® cortisol for viral rna sampling for rt-qpcr

Conditions: Covid-19

Summary: the main objective of the tests is to establish saliva collection with salivette® cortisol.


Eligibility criteria:
inclusion criteria: 1. informed consent form signed and dated before any samples have been taken. 2. suspected or confirmed sars-cov-2 infection by pcr within the past five days. 3. male and/or female patients aged 18 years and over.
rivaroxaban pharmacokinetics/pharmacodynamics (pk/pd) study in pediatric subjects

Conditions: Venous Thrombosis; Pediatrics

Summary: the first study with rivaroxaban in pediatric subjects is a phase i study, where the pharmacokinetic/pharmacodynamic (pk/pd) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. this study is a single dose study with multiple pk/pd measurements in pediatric subjects at the end of their venous thromboembolism (vte) treatment.


Eligibility criteria:
inclusion criteria: * pediatric subjects \> 6 months and \< 18 years of age at the time of administration of study drug. * patients who have completed treatment of vte, but are considered to have risk for recurrence of vte exclusion criteria: * any major or clinically relevant bleeding during prior vte treatment * abnormal coagulation tests within 7 days prior to study drug administration * severe renal impairment * planned invasive procedures prior to or after 24 hours of study drug administration

Keywords: venous thrombosis pediatrics
the effect of gluten in patients with irritable bowel syndrome and healthy volunteers

Conditions: Irritable Bowel Syndrome

Summary: patients with irritable bowel syndrome (ibs) often link their symptoms to foods. interest in dietary management recently increased, including the use of a gluten-free diet. to investigate relation of gluten-free diet (gfd) and ibs, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (\>18) and patients with ibs according to rome iv criteria. the aim is to assess gluten-free versus gluten-containing diet in ibs patients and healthy volunteers.

the study is a randomized, double-blind, placebo-controlled, cross-over trial. the aim is to assess the effects of gluten-free diet (gfd) compared to gluten-containing diet (gcd) in ibs patients and healthy volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. the primary hypothesis is that gfd decreases gastrointestinal symptoms compared to gcd and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. the secondary hypothesis is that gfd positively influences psychological factors and quality of life. ibs patients (rome iv) and healthy volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. they start with gfd or gcd and cross over to the other intervention (both for 14 days). in between there is a wash-out period of at least 14 days. the subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). the subjects will follow a strict gfd during the gfd and gcd periods. the subjects will eat and drink as before the study during the washout period. primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including ibs severity scoring system (ibs-sss) and gastrointestinal symtom rating scale-ibs (gsrs-ibs). a 50-point reduction in ibs-sss indicates clinical response. bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the lactulose-nutrient challenge test. secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including csi, hads, hsps, ibsqol, phq-15 and vsi.

Eligibility criteria:
inclusion criteria: * adult patients with ibs according to rome iv criteria exclusion criteria: * allergy or documented intolerance to food, * severe cardiovascular, hepatic, neurological or psychiatric disease * serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (ibd), * diabetes * bowel dysfunction related to previous surgery * pregnant or lactating women * usage of antibiotics within 4 weeks before inclusion * strict avoidance of foods

Keywords: gluten-free diet gluten-containing diet microbiota metabolomics healthy volunteers
atrial fibrillation in young patients: a prospective multicentre registry

Conditions: Atrial Fibrillation; Lone Atrial Fibrillation

Summary: atrial fibrillation is a rare cardiac arrhythmia in young (i.e. \<= 35-year-old) patients. etiological factors, current management and mid- to long-term outcomes remain unknown.

atrial fibrillation in young patients (young-af) is a prospective, observational, multicentric registry, including every consecutive patients aged \< 35-year-old with a diagnosis of atrial fibrillation. the registry will assess demographical, physical activity, toxicologic and genetic factors, as well as current management regarding anticoagulation, anti-arrhythmic drugs and catheter ablation. as an observational registry, patient will be managed with the guidelines-directed standard-of-care.

Eligibility criteria:
inclusion criteria: * first episode of atrial fibrillation * less than 35-year-old * diagnostic by 12-lead ecg or continuous monitoring (minimal duration 30 seconds) * french social security number exclusion criteria: * transvenous cardiac implantable electronic device (insertable cardiac monitors are not an exclusion criteria)

Keywords: atrial fibrillation lone atrial fibrillation
lipiodol deposition using endhole vs. pressure-modulated delivery

Conditions: Hepatocellular Carcinoma; Neuroendocrine Tumors

Summary: the goal of this clinical trial is to compare ct scan of the coverage of tumors treated with tace using end hole catheters to those treated with the trinav catheter that alters tissue pressure. both catheters are fda approved for delivery of tace. • is there a difference in ct appearance with delivery in the type of catheter used during the tace procedure? participants will be asked to undergo a tace procedure, a ct scan and review of their medical record to compare end hole and trinav catheters during tace procedures.

hepatocellular (hcc) and neuroendocrine (net) liver metastases undergoing lipiodol transarterial chemoembolization (tace) will be randomized to endhole vs. pressure-modulated catheter delivery. lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.

Eligibility criteria:
inclusion criteria: * male or female, aged \>18 years. * plan to undergo lipiodol tace for hcc or net liver metastases * bilobar disease or distribution for which staged therapy (more than one tace) for distinct target tumors is planned * liver tumor burden does not exceed 50% of the liver volume * patent main portal vein * life expectancy of greater than 6 months * ecog performance status 0-2 * adequate liver function as measured by: total bilirubin ≤ 2.0mg/dl, alt, ast ≤5 times uln, albumin ≥2.5g/dl * adequate marrow and renal function as defined as: * platelets \>75,000/mcl (may be corrected by transfusion) * serum creatinine \< 2.0 mg/dl * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last tace treatment, as recommended for tace treatments not conducted within the trial. * for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last tace treatment. * provision of signed and dated informed consent form and ability to consent for oneself. * stated willingness to comply with all study procedures and availability for the study duration. exclusion criteria: * absolute contraindication to contrast-enhanced mri * absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication * pregnancy or lactation * choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: tace catheter
a study to assess efficacy with respect to clinical improvement in disease activity and safety of tocilizumab in patients wtih active rheumatoid arthritis.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will assess the effectiveness of tocilizumab in combination with traditional dmards with regard to the clinical improvement in disease activity (achievement of ldas) after 24 weeks' treatment in patients with active rheumatoid arthritis (ra) who have had an inadequate response to current traditional dmard and/or anti-tnf therapy. patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing dmards at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. the anticipated time on study treatment is 6 to 12 months, and the target sample size is \<500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * rheumatoid arthritis of \>=6 months duration diagnosed according to the revised 1987 acr criteria; * das28 of \>3.2; * at screening either esr \>=28 mm/h or crp \>=1 mg/dl; * having received permitted dmards, 1 or more; current dmard therapy must have been at a stable dose for at least 8 weeks prior to baseline. exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening; * functional class iv as identified by the acr classification of functional status in ra; * rheumatoid autoimmune disease other than ra; * prior history of or current inflammatory joint disease other than ra.
metformin use to improve pregnancy outcome in women with type 1 diabetes.

Conditions: Diabetic Pregnancy; Insulin Resistance; Type1diabetes

Summary: the study investigates whether additional metformin medication in combination with regular insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1 during pregnancy.

insulin resistance during pregnancy of diabetes mellitus type 1 patients (dm1) increases the need for insulin and makes it more difficult to maintain normoglycemia. fetal exposure to hyperglycemia induces macrosomia which increases fetal and neonatal morbidity and mortality. further more obesity and excess weight gain during pregnancy enhances insulin resistance and it's an independent risk factor for fetal macrosomia. metformin is a medical treatment for type 2 diabetes (dm2) where consequential pathophysiology includes insulin resistance. it reduces hepatic glucose production and enhances the use of glucose in muscles relieving insulin resistance. metformin has also found to inhibit weight gain effectively. metformin has approved to be safe and effective in patients with gestational diabetes (gdm). it has found to reduce weight gain and improve postprandial blood glucose levels during pregnancy and reduce neonatal birth trauma in gdm. however, there are no previous studies about the use of metformin in pregnant women with dm1. two hundred women with dm1 will be randomized to get placebo or metformin in addition to regular insulin treatment. the sample size has been estimated to demonstrate the difference of 15 % in the need to increase insulin dosages during the pregnancy between the study groups.

Eligibility criteria:
inclusion criteria: * a pregnancy of a woman with type 1 diabetes. exclusion criteria: * multiple pregnancy, significant underlying disease (hearth disease, kidney transplant, ibd (inflammatory bowel disease ), sle (systemic lupus erythematosus ), diseases with use of high dosage corticosteroids (severe asthma or rheumatic disease), severe complications of diabetes (nephropathy, neuropathy, gastroparesis or severe retinopathy), substance abuse, smoking, bmi \<18, strong early pregnancy nausea (=hyperemesis)

Keywords: insulin need diabetic pregnancy insulin resistance metformin
dedica (dose of heparin during coronary angioplasty) trial

Conditions: Stable Angina; Angina, Unstable; Non-ST Elevation (NSTEMI) Myocardial Infarction

Summary: international guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. however, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents. thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 ui/kg) versus low-dose (50 ui/kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.

* patients undergoing coronary angioplasty will be randomised to standard vs. low-dose heparin. the study will include "all-comers" (patients with either stable angina or acute coronary syndromes); only patients with st-elevation myocardial infarction will be excluded. * an act (activated clotting time) will be performed after the initial bolus of heparin: for the standard dose group the target act will be \> 300 sec. (as recommended by guidelines) while for the low-dose the target act will be \> 180 sec. aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.

Eligibility criteria:
inclusion criteria: * stable angina, unstable angina or non-st elevation myocardial infarction undergoing coronary angioplasty. * mandatory pretreatment with aspirin and clopidogrel exclusion criteria: * st elevation myocardial infarction * coronary interventions with rotational atherectomy * coronary interventions on chronic total occlusions (cto)

Keywords: angioplasty heparin trial
recruitment assessed by electrical impedance tomography

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Summary: the recruit study is a multinational, multicenter physiological observational study conducted by the plug working group. it is a single-day study (1.5-2 hours) associated with specific lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung recruitment in mechanically ventilated patients with ards by electrical impedance tomography (eit).

despite higher positive end-expiratory pressure (peep) being associated with multiple physiologic benefits, randomized clinical trials comparing higher vs. lower peep levels failed to show improved survival of ards patients. higher peep should fully exploit its benefits only when implemented in patients with higher potential for alveolar recruitment (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with airway closure. retrospective analysis of randomised clinical trials with peep suggests that when high peep is used in responders (oxygenation), survival may be better. conversely, in the absence of significant recruitment, higher peep should be avoided and lower peep might be recommended. titration of peep provided by the mechanical ventilator in patients with severe lung injury should thus be based on bedside information on lung recruitability. however, no valid method exists to define the best peep to optimize recruitment and minimize lung overdistention. recruitability varies and is often not assessed. electrical impedance tomography (eit) is a non-invasive bedside imaging technique for measuring the potential for lung recruitment in ards patients. by performing lung (de)recruitment maneuvers and in-depth analyses, we will define lung recruitability indices and develop methods for real-time and personalized peep selection. this study will prove the feasibility of minimizing risks associated with inadequate mechanical ventilation by eit.

Eligibility criteria:
inclusion criteria: * intubated moderate and severe ards according to the berlin definition (pao2/fio2 ratio \<= 200 mmhg) * under continuous sedation with or without paralysis exclusion criteria: * age \<18 years * bronchopleural fistula * pure copd exacerbation * contraindication to eit monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode belt placement) * hemodynamic instability (systolic bp \< 75 mmhg or map \< 60 mmhg despite vasopressors and/or heart rate \< 55 bpm) * attending physician deems the transient application of high airway pressures to be unsafe

Keywords: mechanical ventilation lung recruitment ards electrical impedance tomography