Kornimate/medical-research-clean huggingface dataset:
effect of mof on exercise blood pressure

Conditions: Healthy

Summary: the purpose of this study is to establish an effect of monomeric and oligomeric flavanols supplementation on exercise blood pressure and vascular function in healthy volunteers.

exaggerated exercise blood pressure (bp) response in healthy subjects is recognized as a risk factor of hypertension and cardiovascular events. pathogenetically exaggerated bp response is attributed to compromised vascular(endothelial) functions as well as oxidative stress and inflammation. monomeric and oligomeric flavanols (mof) are dietary components with well-characterized beneficial effects on the redox homeostasis, endothelial function and microvascular health. the objectives of the study will be to evaluate the effects of mof in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy prehypertensive volunteers. in addition, the study will aim to assess the impact of mof supplementation on the exercise-induced renin-angiotensin-aldosterone system (raas) activation and extracellular matrix remodelling. after being informed about the study and potential risks all volunteers signing informed consent form will undergo screening to determine eligibility for the study. eligible subjects will be randomized in the double-blind manner to monomeric and oligomeric flavanols /placebo or placebo/monomeric and oligomeric flavanols sequence (cross-over design) in a 1:1 ratio. monomeric and oligomeric flavanols are derived from grape seeds extract and will be administered in a dose 200 mg per day.

Eligibility criteria:
inclusion criteria: 1. healthy men and women with normal to high-normal resting bp (sbp 120 - 139 mm hg and dbp 80 - 89 mm hg). 2. age 35 - 65 years 3. bmi 20 - 32 kg/m\^2 4. hypertensive response to maximal exercise test defined as sbp ≥ 200 mm hg (men) and ≥ 180 mm hg (women). exclusion criteria: 1. active engagement in the weight loss programs, also including slimming diets. 2. active smoking or abstinence from smoking for less than one year. 3. use of medications that reduce bp and/or can potentially influence other study outcomes (ace-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc). 4. intake of polyphenol-containing supplements for two month before and during the whole course of the study. 5. history of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study. 6. intense sporting (\>10 h/week) and/or participation in the competition at the professional level. 7. pregnancy or breastfeeding. 8. participation in a clinical trial within 4 weeks prior to inclusion into this study. 9. vaccination against covid-19 within two months before the screening/randomization visit or expected vaccination against covid-19 during the study

Keywords: vascular function monomeric and oligomeric flavanols grape seeds extract exercise blood pressure inflammation
effect of weight and/or obesity on ethambutol drug concentrations

Conditions: Obesity; Tuberculosis

Summary: this study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. our hypothesis is that volunteers with a body mass index (bmi) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a bmi \> 40 kg/m2 will have even greater clearance than those who are leaner.


Eligibility criteria:
inclusion criteria: * male and female volunteers, age 18 years of age or older, of all racial and ethnic origins. english and/or spanish speaking volunteers are eligible to participate. * we are recruiting 6 normal weight (bmi \ 40 kg/m2) for this study. half of each group will be male, the other half will be female. exclusion criteria: * creatinine clearance \< 70 ml/min as estimated by the cockcroft-gault equation. * pregnant or nursing or unwilling to use a reliable contraception method during the study period. the effects of ethambutol on pregnancy are unknown. in addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ethambutol, so that the pregnancy and post-partum state would be a confounding variable. * abnormal liver function tests: transaminases \>10 time the upper limit of normal, alkaline phosphatase \> 5 time the upper limit of normal, total bilirubin \>5 time the upper limit of normal. * history of allergy to ethambutol. * ethambutol is contraindicated for any reason. * suspected or documented mycobacterial infection. * history of gout.

Keywords: obesity pharmacokinetics pharmacodynamics dose individualization tuberculosis
adoptive cell therapy of autologous til and pd1-til cells for patients with glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: at present, the investigators want to evaluate safety and efficacy of cell therapy based on tumor-infiltrating t lymphocyte (til）in glioblastoma. here, we also constructed a transgenic modified til cells, stablely express a high-level full-length pd1 antibody (pd1-til cells), which can transduce signals to activate t cells and result in tumor killing. in this study, we design two group patients treated with til cells and pd1-til cells respectively to determine the safety and efficacy of autologous tils or genetically modified tils in patients with glioblastoma.


Eligibility criteria:
inclusion criteria: 1. recurrent patients with histologically confirmed brain glioblastoma multiforme. 2. patients with maximum safe resection of the tumor (≥95%) confirmed with contrast mr or ct within 72 hours after surgery. 3. age from 18 to 70 years. 4. karnofsky performance score ≥ 60. 5. adequate organ function within 14 days of study registration including the following: adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (anc) ≥ 1.0×10\^9/l, platelets ≥100×10\^9/l; hemoglobin ≥ 9 g/dl. hepatic: bilirubin ≤1.3 mg/dl or 0-22 mmol/l, aspartate transaminase (ast) and alanine transaminase (alt) \ 60 ml/min/1.73 m2. electrocardiogram: normal. 6. written informed consent must be obtained from all patients. exclusion criteria: 1. pregnant or breast-feeding patients. pregnancy testing will be performed on all menstruating females within 14 days of study enrollment. patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. 2. patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, aids, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol. 3. patients with any conditions that could potentially alter immune function (e.g., aids, multiple sclerosis, diabetes, renal failure). patients currently received any other investigational agents. -

Keywords: glioma til pd1-til immunotherapy
urinary t cell biomarker for prediction in lupus nephritis

Conditions: Lupus Nephritis

Summary: urinary t-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. the investigators hypothesize that the amount of cd4+ effector/memory t-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (ln) after 6 months of therapy. in a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). treatment will be performed to the discretion of the treating clinician. after 6 months of treatment response will be determined as either complete response or partial response.


Eligibility criteria:
inclusion criteria: * biopsy proven lupus nephritis * in absence of a biopsy a sledai of at least 10 \& at least two renal elements of the renal sledai (rsledai) * informed consent * diagnosis of sle according to the american college of rheumatology (acr) criteria exclusion criteria: * biopsy-proven non-sle related disease * urinary tract infection * active menstrual bleeding * kidney transplantation during observation time

Keywords: lupus nephritis systemic lupus erythematodes urinary biomarker outcome prediction urinary effector memory t lymphocytes glomerulonephritis non-invasive biomarker flow cytometry treatment outcome cd4-positive t-lymphocytes/immunology
the safety&efficacy of repetitive transcranial magnetic stimulation for post-stroke upper extremity function improvement

Conditions: Stroke

Summary: a randomized, controlled, subject and rater-blind, exploratory clinical trial to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation for improvement of upper extremity function after stroke.

some studies related to rtms for the recovery of motor function (upper and lower extremity functions) after stroke are being conducted, and the clear mechanism has not been elucidated. it is known that function is restored through various neurophysiological changes. however, there are not many studies on rtms in the chronic stroke period, 3 months after the onset of stroke recovery, which is slow, and among them, there is no established standard for which part of the brain should be stimulated for treatment. recently, techniques for finding brain regions that are activated when performing a specific action through an imaging technique called fmri (functional magnetic resonance imaging) are being used in various fields. based on the idea in this regard, recent studies have been conducted that the effect of rtms treatment is better than the existing method when fmri is used to identify the brain regions involved in the movement of the upper and lower extremities. the purpose of this study is to evaluate the safety and efficacy on upper extremity function after stroke using fmri and rtms.

Eligibility criteria:
inclusion criteria: * adults over 20 years of age * patients 3 months or more after stroke onset * patients with nihss score of 1 or more to 20 or less * after hearing and fully understanding the detailed explanation of this clinical trial, the subject or legal representative voluntarily decides to participate and agrees in writing to abide by the precautions exclusion criteria: patients who fall under one or more of the following conditions are not eligible to participate in the study. * patients with systemic infectious disease at the time of participation in the clinical trial * in the case of a person with impaired consent (mmse less than 10 points), if not accompanied by a guardian * those with severe medical conditions such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc., who are in poor general condition * other cases where the researcher determines that participation in this clinical trial is not appropriate * those who are contraindicated in repetitive transcranial magnetic stimulation a. when metal materials (deep brain stimulation electrode, brain aneurysm clip, cardiac pacemaker, etc.) are in the body b. uncontrolled epilepsy (epilepsy), patients with psychiatric disorders * pregnant, lactating women and patients with potential for pregnancy * patients with contraindications for imaging tests * those who have undergone cerebral surgery due to past or current related medical history

Keywords: stroke functional magnetic resonance imaging repetitive transcranial magnetic stimulation rehabilitation
quality of life of older patients who are undergoing treatment for cancer and of their family caregivers

Conditions: Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: studying quality-of-life in patients having cancer treatment and in their caregivers may help identify the intermediate- and long-term effects of treatment on patients with cancer and on their caregivers. purpose: this clinical trial is studying quality of life of older patients who are undergoing treatment for cancer and of their family caregivers.

objectives: * obtain quality of life and psychosocial data from older patients who are undergoing treatment for cancer and from their family caregivers. outline: this is a pilot, cross-sectional study. patients undergo a 45-minute interview in person or by phone to provide demographic data and to complete quality of life questionnaires, including functional assessment of cancer therapy (fact), spiritual tool, quality and satisfaction with treatment (quest), and profile of mood state (poms), at baseline and at 3 and 12 months. caregivers undergo a 20- to 30-minute interview in person or by phone to provide demographic data and complete quality of life questionnaires, including the caregiver reaction assessment (cra), quest, and poms, at baseline and at 3 and 12 months. caregivers complete the quality of death and dying (qodd) questionnaire 2-3 months after the patient's death. projected accrual: not specified

Eligibility criteria:
disease characteristics: * patient: * confirmed diagnosis of any type of cancer * undergoing cancer treatment at ireland cancer center * caregiver: * identified family caregiver of a patient diagnosed with cancer * patient and caregiver may participate regardless of whether the other person agrees to participate or not patient characteristics: performance status * ecog 0-3 (patient) life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * able to speak and comprehend english * cognitively competent to be interviewed (patient) prior concurrent therapy: not specified

Keywords: psychosocial effects of cancer and its treatment unspecified adult solid tumor, protocol specific
early occupational therapy in mechanical ventilated patients with covid-19

Conditions: Covid19; Critical Illness; Impairment, Cognitive; Impairment, Coordination

Summary: this study evaluates the feasibility of an early occupational therapy (ot) protocol in critical adult patients requiring mechanical ventilation with covid-19.

a randomized clinical trial with an experimental-control will be implemented, considering the prospective multicenter group, with parallel groups, in a 1:1 ratio, in 3 chilean hospitals. a control group will has a standard analgesia, sedation, delirium and mobilization (asdm) measures or an intervention group will have early ot plus asdm. the intervention group will receive 20 ot sessions, which considers a predefined protocol of actions according to the patient's condition

Eligibility criteria:
inclusion criteria: * age equal to or greater than 18 years. * need for hospitalization in icu. * at least 12 h of invasive mechanical ventilation * informed consent signed by legal representative and / or patient. * positive covid-19 diagnosis exclusion criteria: * known cognitive impairment before admission with short iqcode (informant questionnaire on cognitive decline in the elderly) scores\> 3.3 were excluded. * previous functional impairment, faq (functional activities questionnaire) defined as \> 6 points. * severe communication disorder and cultural limitation of language (language different from spanish) * patient with limited therapeutic proportionality. * neurocritical patients (moderate-severe traumatic brain injury / stroke of some kind / among others) * spinal injury or unstable fractures that limit mobilization
lactobacillus reuteri for treatment of uncomplicated uti in pregnant women

Conditions: Urinary Tract Infection in Pregnancy

Summary: prevalence of uro-genital infections during pregnancy move between 7% to 12% in developed countries, meanwhile in developing countries this figure moved between 14% and until 55%, such is the case of mexico. meanwhile use of antibiotics for 3 to 7 days had established as a standard of care, the use of non-antibiotic therapy, such as cranberry powder or probiotics for prevention/treatment of this conditions is scarce. randomized controlled trial aimed to evaluate the safety and efficacy of probiotic vs. antibiotics to treat pregnant women with uncomplicated cystitis or asymptomatic bacteriuria

randomized controlled trial, aimed to evaluate the efficacy of lactobacillus reuteri dsm 16666/atcc 55845 \& lactobacillus reuteri dsm 17938 for the treatment of pregnant women with asymptomatic bacteriuria or uncomplicated acute cystitis. as primary outcome we will evaluate the number of cases with clinical (symptoms severity) or bacteriological cure in pregnant women with uncomplicated cystitis or asymptomatic bacteriuria after 7 days treatment with probiotics vs. placebo. as secondary outcome we will evaluate a) rate of recurrence cases in each group; b) time to relapse; c) frequency of pyelonephritis; d) birth weight and head circumference; d) number of cases of preterm babies (less than 36 weeks of gestation); e) frequency of antibiotic as rescue treatment; f) frequency of adverse related events in each arm and g) frequency of preeclampsia. women on active group will receive a combination of at least 5\*10\^8 cfu of lactobacillus reuteri dsm 16666/atcc 55845 \& lactobacillus reuteri dsm 17938, pac-a and zinc. women in control group will receive o amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) ror patients with positive dipstick.

Eligibility criteria:
inclusion criteria: * healthy women on the second or third trimester of pregnancy with positive urine culture according to the operational definition with or without symptoms * age 18 to 40 years * verbal and written informed consent for participation in the study exclusion criteria: * pathologic pregnancy (different for uti) * no supplementation of probiotics 2 weeks before study start or during the study period. * antibiotic therapy within last 2 weeks before randomization * known allergies towards the ingredients of the experimental product * inability to comprehend the study protocol * systemic diseases * multiple pregnancy
using tissue-based spatial data to understand how obesity-related tumor metabolites fuel prostate cancer progression

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm; Prostatic Neoplasm; Obesity

Summary: evaluate the protein expression of lactate dehydrogenase enzyme (ldha) and mct-1/-4 transporters, involved in lactate synthesis and transport, in prostate carcinoma tissues from severely overweight/obese (bmi \> 27.5) and non-severely overweight/normoweight (bmi \< 27.5) patients affected by prostate carcinoma. ii. characterize the immune infiltrate in the prostate carcinoma of the aforementioned patients. iii. assess the association between intra-tumoral lactate accumulation (using ldha and mct-4 protein expression levels as readouts) and alterations in the tumor immune microenvironment and/or deregulation of relevant oncogenic pathways.


Eligibility criteria:
inclusion criteria: * affected by prostate cancer exclusion criteria: -
study to evaluate the safety of treatment with a"llergovac® himenópteros" in patients sensitized to this venom

Conditions: Allergy to Himenoptera Venom

Summary: it is a safety and tolerability study of allergovac himenopteros in patients sensitized to apis mellifera, polistes dominula or vespula spp. to get this aim all adverse reactions will be recorded through the study. in addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.


Eligibility criteria:
inclusion criteria: * 1. patients over 14 years of age with allergy to bee venom, polistes or vespula. to meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific ige detection in the skin test and / or ige against the himenoptera venom. 2. prescription treatment with hymenoptera venom must be indicated and patients are susceptible to receive allergovac® hymenoptera, according to usual clinical practice. 3. patients who have given their written consent. in the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor. exclusion criteria: 1. patients who have received treatment with allergovac® hymenoptera prior to inclusion in the study. 2. patients under treatment with immunotherapy against aeroallergens. 3. patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study. 4. patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires. 5. patients who are participating in another clinical trial or observational study.
correlation between peripheral venous pressure and central venous pressure in the cardiac intensive care unit

Conditions: Prospective Studies; Heart Failure

Summary: in patients admitted to a coronary care unit, what is the correlation coefficient and limits of agreement for paired measurements of peripheral venous pressure and central venous pressure at multiple time points during the patient's hospitalization?

the treatment of numerous cardiac conditions requires assessment of intravascular volume status, using central venous pressure (cvp) as the gold standard. measurement of cvp requires placement of an invasive venous catheter, with insertion of a venous catheter into a central vein to obtain cvp. catheter placement is invasive, costly and not without complications. ideally, there would exist a peripheral surrogate for cvp that would be 1) minimally invasive to obtain, 2) low cost and 3) strongly correlate with cvp over a wide range of physiological conditions. the peripheral venous system is in continuity with the central venous system and, as such, would be expected to have a pressure that correlates with central venous pressure. numerous previous studies suggest a correlation between peripheral venous pressure (pvp) and central venous pressure. prior studies have demonstrated a reasonable correlation between cvp and pvp in patient populations including decompensated heart failure, cardiac and non-cardiac surgery(1), liver transplant donors(2) and recipients(3), neurosurgical(4) and pediatric patients.(5) in an earlier study published by the authors of this paper, the mean difference between pvp and cvp in patients with acute heart failure syndromes was 0.4 mmhg with a correlation coefficient of 0.947. one limitation of the earlier study was that it established this correlation at only one point in time. in the study presented here, pvp and cvp will be obtained and correlation will be assessed across multiple time points during a given patient's hospitalization. this is a prospective, single center cohort study to investigate the correlation between peripheral venous pressure and central venous pressure.

Eligibility criteria:
inclusion criteria: * we plan to enroll patients who meet the following criteria: patients admitted to an intensive care unit for invasive hemodynamic monitoring. all eligible patients will be those who have already undergone pulmonary artery catheterization via the internal jugular or subclavian veins and upper extremity peripheral iv placement per routine standard of care prior to enrollment. exclusion criteria: * patients will be excluded from this study for the following reasons: age less than 18 years of age, inability to obtain consent, femoral pulmonary artery catheter, or if their attending physician refuses to allow enrollment.

Keywords: catheterization, peripheral/methods humans acute disease aged female male follow-up studies heart failure/physiopathology prospective studies stroke volume/physiology venous pressure/physiology