Kornimate/medical-research-clean huggingface dataset:
hydration dynamics and influence of beverage composition

Conditions: Hydration; Fluid Retention; Dehydration

Summary: the study examines interactions between fluid availability in the gut and fluid retention in the body. the relative rate of fluid uptake, the expansion of the plasma volume, and percent of fluid retained by the body will be measured in response to ingestion of beverages of different composition. healthy, euhydrated adults will be studied. the results will help establish formulations of beverages that sustain if not promote acute euhydration.

using a randomized order for beverage treatments at three separate trials, subjects will ingest 1 liter of one of three beverages in 10 minutes: water, a beverage with 2.5% glucose with 45 mmol sodium/l, or a beverage with 1.7% glucose with 60 mmol sodium/l. before and repeatedly for 2 h after ingestion of the beverage, blood samples will be drawn for assessments of d2o, hb, hct, osmolality, sodium, and glucose. the rate of appearance of d2o will be evaluated using the area under the curve, the slope of the appearance, and half time to plateau. comparisons will be made between beverages for indices of the rate of appearance of d2o, the change in pv over time, and cumulative urine excreted. the cumulative urine produced will be used to calculate a modified bhi for the two glucose-electrolyte beverages and water for comparison with 1.0 (expected for no beverage effect). we hypothesize faster absorption (d2o appearance rate), and better overall hydration (expanded pv and higher modified bhi) will occur for beverages containing glucose and sodium compared to water. further, we hypothesize that of the electrolyte beverages, the beverage with higher sodium content will promote greater overall hydration (less urine excreted) than the beverage with lower sodium.

Eligibility criteria:
inclusion criteria: * have a bmi of 18.5 to 29.9 kg/m2. * be normotensive (\<120/80 mm hg). * must be able to speak and read english. * be physically active or a regular exerciser but be able to abstain from exercise for 48 h prior to each study trial. * fast for at least 8 hours prior to and through the study trial. * be able to abstain from alcohol for 48 h prior to each study. * be able to abstain from caffeine for 24 h prior to each study. * if female, must have regular menstrual cycles, that are \> 27 days and \< 35 days in length. exclusion criteria: * under 18 y of age or over 45 y of age. * have a bmi \ 30. * being pregnant. * lactating. * tobacco user. * have hypotension or hypertension. * have any type of kidney disease or dysfunction. * have diabetes. * have any type of cardiovascular disease. * have been diagnosed with galactosemia. * females with irregular menstrual cycles. * females with polycystic ovary disease.

Keywords: hydration deuterium oxide plasma osmolality sodium urine production fluid absorption euhydration
gut microbiome and p-inulin in ckd - targut ckd study

Conditions: Chronic Kidney Diseases

Summary: the purpose of this phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. the nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.

the overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in ckd patients. in order to design a future clinical trial the following parameters from ckd subjects are needed: 1. intra-patient variability in the composition and function of the gut microbiome 2. inter-patient variability in the composition and function of the gut microbiome 3. impact of p-inulin on the composition and function of the gut microbiome 4. tolerability of p-inulin administration 5. feasibility of collecting stool samples in this patient population

Eligibility criteria:
inclusion criteria: 1. subjects with egfr 15.0 to 50.0 ml/min/1.73 m2 as estimated by the ckd-epi equation 2. albuminuria greater than 300 mg/g creatinine (by spot urine test) if egfr is ≥45 ml/min/1.73 m2 3. age ≥ 18 years 4. for women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. see section 4.2.1 for definition of childbearing potential and acceptable methods of birth control 5. ability to provide informed consent exclusion criteria: 1. use of pre- or pro-biotics during the past 2 months 2. consumption of probiotic yogurt during the past 2 weeks 3. use of antibiotics within the past 3 months if the patient received a single course of antibiotic. if the patient received more than one course of antibiotic treatment, we will wait for 6 months prior to inclusion. 4. presence of hiv infection, chronic wound infection and osteomyelitis 5. presence of or treatment for periodontal infection 6. inflammatory bowel disease, chronic diarrhea, current c. difficile infection 7. cirrhosis or chronic active hepatitis 8. treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \>10 mg in the last 3 months 9. treatment with proton pump inhibitors within the last one month 10. anticipated initiation of dialysis or kidney transplant within 9 months 11. acute on chronic kidney disease 12. expected survival \< 9 months do not disclose or use except as authorized by the pilot clinical trials in ckd consortium. 13. pregnancy, anticipated pregnancy, or breastfeeding 14. incarceration 15. participation in another intervention study 16. severe anemia defined as hemoglobin \<9.0 g/dl any time during the last 3 months 17. patients in whom frequent blood sampling may be difficult

Keywords: microbiome, p-inulin
assessment of the ankle systolic pressure index in patients over 70 years of age with jaundice ulcer

Conditions: Arteriopathy

Summary: arteriopathy of the lower limbs (all) is defined by a decreased ankle perfusion pressure with a systolic pressure index (spi) \<0.9, and constitutes the most advanced situation in terms of cardiovascular prognosis with in 20 % of cases of lesions associated with the heart and / or coronary heart. the severity of all is linked to the risk of a cardiovascular event, hence the need for a hemodynamic evaluation which is mainly based on the measurement of spi.

however, the presence of mediacalcosis, making the arteries incompressible, limits the interpretation of ips. however, all affects 50% of diabetic patients after 20 years of disease with predominant involvement in the infra-popliteal gland consisting mainly of mediacalcosis, but often respecting the arteries of the foot. the recommendations of the french-speaking association for the study of diabetes and metabolic diseases in 1997 and of the american diabetes association in 2001, recommended the spi and the realization of ultrasound for the diagnosis of all. some authors have shown that spi can be falsely normal with 4.3 times more false negative ankle spi in diabetics compared to the general population. this is why this measurement of the spi is coupled with the measurement of the pressure of the big toe (pgt) or even the transcutaneous measurement of the oxygen pressure (tcpo2) as recommended by the american heart association (aha) and the american college of cardiology (acc) in 2005, in case of uninterpretable ips. the subjects at risk of mediacalcosis are: diabetics, renal insufficiency and the very elderly. a recent thesis work confirmed that the spi alone was not reliable as a screening tool in diabetic patients, with good sensitivity of the measurement of pgt. what about a population over the age of 70, without diabetes and without kidney failure?

Eligibility criteria:
inclusion criteria: * man or woman aged\> 70 hospitalized in the vascular medicine department of the paris saint-joseph hospital group * french-speaking patient exclusion criteria: * patient with treated or untreated diabetes * renal failure (gfr ckd-epi or mdrd \<60ml / min) * atcd revascularization or amputation * patient under guardianship or curatorship * patient deprived of liberty * patient objecting to participation in the study * patient under legal protection.
treatment of sleep related breathing disorders in patients with pulmonary hypertension

Conditions: Pulmonary Hypertension; Breathing-Related Sleep Disorder

Summary: the purpose of this study is to study the differential short-term effect of nocturnal oxygen, acetazolamide tablets and nocturnal non-invasive positive pressure ventilation on symptoms, exercise capacity and nocturnal breathing disturbances in subjects with pulmonary hypertension and sleep related breathing disorders * trial with medicinal product


Eligibility criteria:
inclusion criteria: * percapillary pulmonary hypertension diagnosed by right heart catheterisation -- stable therapy and clinical condition for at least 4 weeks * sleep disordered breathing with apnea/hypopnea index \> 10 events/h and/or median nocturnal oxygen saturation \<90% exclusion criteria: * pregnancy * severe daytime hypoxemia (pao2 \< 7.2 kpa) * patients with predominantly obstructive sleep apnea.

Keywords: breathing-related sleep disorder pulmonary hypertension
serum concentration of lgg in patient with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the aim of this study is to investigate the changes in glycopeptides of serum immunoglobulin g in patients with acute myocardial infarction and the relationships between its change and prognosis.

immunoglobin g (igg), a highly abundant glycoprotein in serum, is known to participate in blood immune responses.it has been an increasing interest in the analysis of the abnormal glycosylation of human lgg in healthy and disease states, such as autoimmune diseases and cancer.however, there is few relevant studies about the changes in glycopeptides of serum immunoglobulin g in patients with acute myocardial infarction. this study was performed for the frst timeto assess the quantitative changes of serum igg glycosylation in patients with acute myocardial infarction and the relationships between its change and prognosis.

Eligibility criteria:
inclusion criteria: - diagnosed as stemi. * with left ventricular ejection fraction（lvef）\>=45% * written informed consents are obtained * admitted within 24 hours after chest pain attacked exclusion criteria: * complicated with rheumatic heart disease, coronary arteritis, hypertrophic cardiomyopathy or dilated cardiomyopathy * complicated with malignant tumor,the immune system diseases, blood system diseases, recently (within 2 weeks) taking glucocorticoid drugs, the use of immunosuppressive agents and cerebral infarction * with acute or chronic infection, surgery or trauma in the last month * secondary hypertension, severe liver dysfunction,severe renal insufficiency * with abnormal thyroid function or allergy to iodine agent refusal to sign the informed consent

Keywords: immunoglobulin g
escorting octogenarian for gastric cancer surgery

Conditions: Gastric Cancer

Summary: an objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.

an objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.

Eligibility criteria:
inclusion criteria: - pathologically confirmed gastric cancer patients clinically fit for gastric cancer surgery exclusion criteria: - non gastric cancer patients clinically unfit for gastric cancer surgery

Keywords: gastric cancer postoperative complication octogenarian
a mediation analysis investigating dry needling treatment mechanisms in a chronic low back pain population

Conditions: Chronic Low Back Pain (CLBP)

Summary: low back pain is a common problem that many adults experience at some point in their lives. one treatment being studied is dry needling, a technique where a small needle is inserted into a specific area of muscle to help relieve pain. so far, the research on dry needling for low back pain hasn't been clear, and it's hard to know when and for whom it will work best. this study aims to figure out how dry needling works to help people with chronic low back pain by looking at the underlying factors. by understanding how dry needling helps people, we can develop a more targeted approach to treatment, which could lead to better outcomes for people with chronic low back pain. the goal of this study is to identify the factors that make dry needling effective for people with chronic low back pain, so that this this information can be used to provide more personalized and effective care. eligible participants will attend 5 research sessions lasting approximately 1 hour and complete 2 online surveys. at 3 of those sessions, participants will receive dry needling to their low back. as part of the research, participants will complete questionnaires related to how pain effects their life. participants will also undergo testing for muscle stiffness, low back mobility and strength, and pain sensitivity. to be included in this study participants must: * be 18-65 years of age * have low back pain for at least 3 months


Eligibility criteria:
inclusion criteria: 1. ages 18 - 65, 2. currently experiencing pain in the space between the twelfth rib and the horizontal gluteal fold with or without radiating leg pain b) low back pain symptoms that are chronic, in that symptoms, have persisted for at least 3 months with pain experienced on most or every day in the past 3 months c) not currently receiving treatment for their low back exclusion criteria: 1. non-english speaker 2. presence of a medical condition known to affect sensation 3. history of surgery to the low back 4. history of blood clotting disorders or medical conditions associated with bleeding disorders 5. current use of the medication causing difficulty with clotting (such as blood thinners) 6. contraindication to the application of needles including, but not limited to, diabetes, local infection, epilepsy, fear of needles or metal allergy 7. women who are pregnant or currently attempting to become pregnant 8. diagnosis of active cancer 9. inability to obtain the testing position (laying prone).

Keywords: low back pain chronic low back pain dry needling
magnetic resonance imaging (mri) interpretations for lumbar spinal stenosis (lss)

Conditions: Lumbar Spinal Stenosis

Summary: the objective of this study is to establish a relationship between the degree of radiologically established anatomical stenosis and the severity of self-assessed outcome measures in patients that have undergone and mri.

magnetic resonance imaging(mri) has become the gold standard of evaluation of lumbar spinal stenosis (lss. lss is defined as the narrowing of the spinal canal. thus far, there has been no formal grading system in literature. physicians, particularly radiologists, in their interpretations, currently describe the degree of stenosis at each level as normal, mild, moderate or severe. unfortunately, there is no consensus on criteria of these definitions. treatments and surgical plans are based primarily on this information. consequently, the reliability and accuracy of this information is critical in terms of optimizing outcomes. in this study 50-100 mri studies of patients diagnosed with symptomatic lumbar spinal stenosis will be collected, de-identified, and assigned a study identification number for tracking purposes. three "raters" from upstate and three "rater" from outside the institution, that have experience reviewing mri's will be asked to review the mri's and classify the lss at all lumbar levels as normal, mild, moderate or severe in the central canal, lateral recesses and the neuroforamen. the raters will not have any information about the patients. the mri's will then be given a new identification number, and the patient's self-assessment questionnaires (which are also de-identified and given the study id number) will be given to the raters, for a second review. the raters will have the patients gender, age and outcomes scores from short form 36, visual analog scale, oswestry disability index and zurich claudication questionnaires. the raters will classify the mri, as normal, mild, moderate or severe using the outcomes and information supplied. the data from both ratings will be compiled and compared to assess the reliability of the radiologically established anatomical stenosis when compared with the subjects outcome scores. this study is for current patients in upstate orthopedics office.

Eligibility criteria:
inclusion criteria: * must be at least 21 years of age * must be able to undergo or have undergone an mri of the lumbar spine * must be able to read/understand english * must be a current patient in our practice exclusion criteria: * prisoner
itacitinib combined with incb024360 and/or itacitinib combined with incb050465 in advanced solid tumors

Conditions: Solid Tumors

Summary: this is an open-label, phase 1b, platform study in subjects with advanced or metastatic solid tumors. the study will be divided into 3 parts (part 1a, part 1b, and part 2). part 1a will evaluate a jak inhibitor with jak1 selectivity (itacitinib) in combination with an ido1 inhibitor (epacadostat; incb024360; group a) and itacitinib in combination with a pi3k-delta inhibitor (incb050465; group b) to determine the mtd or pad and the recommended part 1b doses for each combination. once the recommended dose has been identified for each treatment group in part 1a, subjects with advanced solid tumors will be enrolled into expansion cohorts based upon prior treatment history with a pd-1 pathway-targeted agent (part 1b). in part 2, additional expansion cohorts will be enrolled to further evaluate lower doses of itacitinib and incb050465 in subjects with select tumor types.


Eligibility criteria:
inclusion criteria: * male or female, age 18 years or older. * willingness to provide written informed consent for the study. * part 1a: subjects with histologically or cytologically confirmed advanced or metastatic solid tumors that have failed prior standard therapy (including subject refusal or intolerance). * part 1b: subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment. * part 1b: must have documented confirmed disease progression on a prior programmed cell death-1 (pd-1) pathway targeted agent or must be pd-1 pathway-targeted treatment naïve. * part 2: subjects with hnscc, nsclc, pancreatic ductal adenocarcinoma, salivary gland cancer, and transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, have been intolerant to treatment, or have refused standard treatment. * willingness to undergo a pre-treatment and on-treatment tumor biopsy to obtain the specimen. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * laboratory parameters not within the protocol-defined range. * receipt of anticancer medications or investigational drugs within a defined interval before the first administration of study drug. * received an immune-suppressive based treatment for any reason within 14 days prior to the first dose of study treatment. * has not recovered from toxic effect of prior therapy to \< grade 1. * active or inactive autoimmune process. * has received a live vaccine within 30 days of planned start of study therapy. * active infection requiring systemic therapy.
pilot study:role of dietary fiber in pcos anovulation

Conditions: PCOS

Summary: the purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (pcos).

we hypothesize that 6 months of fiber supplementation will improve ovulation in women with pcos by improving insulin sensitivity independent of weight loss. in this pilot study, we will determine the feasibility of conducting a larger double-blind, randomized trial in women with pcos to test this hypothesis. we will evaluate 15 women over a 10-month period, starting with a 4-month intervention-free observation period to determine the effect on ovulation of adding up to 22g/day of fiber supplementation to their usual weight-maintenance diets (to achieve 28-36 g fiber/day assuming baseline dietary fiber intake, could feasibly be translated into clinical practice.

Eligibility criteria:
inclusion criteria: * women with pcos between the ages of 18-45 years and with a body mass index of less than or equal to 45 * less than or equal to 8 periods annually * elevated serum free testosterone concentrations * normal thyroid function tests and serum prolactin * exclusion of late-onset adrenal hyperplasia * acceptable health based on interview, medical history,physical examination, and lab tests * ability to comply with the requirements of the study * ability and willingness to provide signed, witnessed informed consent exclusion criteria: * diabetes mellitus * clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease * high blood pressure * current or recent(within 2 months prior to study entry) injection of any drugs known or suspected to affect reproductive function including oral contraceptives,metformin,thiazolidinediones,glucocorticoids, gnrh-agonists, or anti-androgens (spironolactone,flutamide,etc) * documented or suspected history of use of recent (within one year) illicit drug abuse or alcoholism * ingestion of any investigational drugs within 4 weeks prior to study onset * pregnancy or lactation(less than or equal to 6 weeks postpartum)