Kornimate/medical-research-clean huggingface dataset:
the association between microplastics and macrogenomics and metabolomics in gastric cancer

Conditions: Gastric Cancers

Summary: the aim of this study was to identify and quantify microplastics in blood, stool, and tumor surgical specimens from gastric cancer patients by analyzing the nature, type, and abundance of microplastics using laser direct infrared (ldir) spectroscopy, scanning electron microscopy (sem), and pyrolysis-gas chromatography-mass spectrometry (py-gc/ms). meanwhile, combining macro-genomic and metabolomic techniques to explore the association between microplastics and host microbiota and metabolic profiles, and to reveal the potential effects of microplastics on gastric cancer incidence and development will provide new insights into the relationship between microplastic contamination and gastric cancer, as well as an important scientific basis for future public health strategies and cancer prevention and control measures.

this this study is planned to collect blood, cancer and paracancer tissues, and stool samples from 20 patients with gastric cancer, 2 gastric cancer tissues (at least 1cm\^3 each), 2 gastric paracancer tissues (at least 1cm\^3 each), 2 venous bloods (5ml each), and 1 stool (at least 10g each) from each patient. samples will be collected from december 2024 through november 2025, with an expected total of 140 samples. sample collection, transportation, and storage are described in iv.2. \& 3. samples will be analyzed for the type, nature, and abundance of microplastics by laser direct infrared spectroscopy (ldir), scanning electron microscopy (sem), and pyrolysis-gas chromatography-mass spectrometry (py-gc/ms), which is expected to detect microplastics such as polyamides, polyethylene terephthalate (pet), and polyvinyl chloride (pvc). at the same time, blood and tissue samples will be metabolomically assayed using nnr-ivd technology and macro-genomic sequencing will be performed to explore potential associations between microplastics and microbiota and metabolic pathways in gastric cancer patients. by analyzing the distribution characteristics of microplastics in gastric cancer patients and their relationship with microbial communities and metabolic pathways, this study will reveal the impact of microplastics on the tumor microenvironment and further understand their role in gastric cancer development and progression.

Eligibility criteria:
inclusion criteria: * age ≥18 years old; * diagnosed with gastric cancer by pathology before surgery and not receiving chemotherapy, radiotherapy or immunotherapy; * no history of other gastrointestinal diseases; * complete clinical data and basic information; * willing to participate in this study and sign an informed consent form. exclusion criteria: * patients receiving neoadjuvant radiotherapy or chemotherapy; * patients with other malignant tumors other than gastric cancer; * patients with incomplete or unclear pathological data; * individuals who are not willing to participate in the study.

Keywords: gastric cancer microplastics macrogenomic metabolomics microenvironment
a study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of mk-5823 in overweight or obese participants who are healthy or have type 2 diabetes mellitus (mk-5823-002)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of mk-5823 in overweight/obese participants who are healthy and overweight/obese participants with type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * male or female of non-childbearing potential * a body mass index between 27 and 35 kg/m\^2 and weighs at least 50 kg * judged to be in good health and for the t2dm panels, good health other than the diagnosis of t2dm * for t2dm panels only: has a diagnosis of t2dm and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin * a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months exclusion criteria: * history of stroke, chronic seizures or major neurological disorder * history of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases. * history of clinically significant endocrine abnormalities or diseases (including type i or type ii, or steroid-induced diabetes for healthy participant panel; and excluding t2dm for the t2dm panels) * irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain. * history of neoplastic disease * history of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness * requires treatment with systemic or ocular corticosteroids * for t2dm panels, a history of hypoglycemic unawareness * for t2dm panels, active treatment with any anti-hyperglycemic drug other than metformin * for t2dm panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. avandia or actos) within 12 weeks of study participation * unable to refrain from using any medication beginning 2 weeks before study participation * consumes excessive amounts of alcohol (\>3 per day) * consumes more than 6 caffeinated beverages per day * had major surgery or donated or lost more than 1 unit of blood * participated in another investigational study within 4 weeks of study participation * history of significant multiple and/or severe allergies or anaphylactic reaction * hypersensitivity to glucagon or insulin * uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation * woman of child-bearing potential or is a nursing mother * for t2dm panels, age \>50 years
metabolic syndrome and inflammatory markers

Conditions: Metabolic Syndrome

Summary: the metabolic syndrome has been recognized as a proinflammatory state. it has been shown that many different diets such as mediterranean diet, dash diet, foods with low glycemic index and low saturated fat diet, independent of weight loss, may be effective in improving the metabolic syndrome. our objective was to evaluate the effect of ramadan fasting on high-sensitive c-reactive protein (hs-crp) and fibrinogen levels in metabolic syndrome.


Eligibility criteria:
inclusion criteria: * males with metabolic syndrome exclusion criteria: * conditions with insulin resistance including; * type 2 diabetes mellitus, * infections, * stresses, * uremia, * acromegaly, * glucocorticoid excess, * hypertension , * cirrhosis and * any addiction or drug therapy and conditions witch cause changes in hs-crp and fibrinogen levels including infection, trauma, infarction, inflammatory arthritis, various neoplasm and liver diseases.

Keywords: metabolic syndrome,ramadan,fasting,inflammatory markers, iran
gut microbiome and p-inulin in hemodialysis

Conditions: End-Stage Renal Disease; Gut Microbiome Dysbiosis

Summary: the microbiome trial is a non-randomized, open-label, sequential, multi-center study of p-inulin for patients with hemodialysis-dependent end-stage renal disease.

this primary objective of this exploratory study is to characterize the safety and tolerability of p-inulin (prebiotin®, provided by jgi medical) in altering the composition and function of the human gut microbiome, thereby reducing the generation of gut-derived uremic toxins, improving gut barrier function and attenuating systemic inflammation in patients treated with maintenance hemodialysis. the study also aims to assess the feasibility of conducting a full-scale trial of p-inulin. the primary efficacy parameters of the trial will be intra- and inter-participant variability in gut metabolites and bacterial composition. secondary parameters of interest include tolerability and safety of p-inulin, willingness of hemodialysis patients to enroll in a study requiring repeated collection of stool samples, and participant adherence to agent treatment and specimen collection schedules.

Eligibility criteria:
inclusion criteria: * maintenance hemodialysis therapy for end-stage renal disease * at least 18 years of age * at least 90 days since hemodialysis initiation * self-reported average stool frequency of at least 1 every other day * for women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of p-inulin. * ability to provide consent exclusion criteria: * use of prebiotics or probiotics during the past 8 weeks * consumption of probiotic yogurt during the past 2 weeks * use of antibiotics within the past 8 weeks * presence of hiv infection, chronic wound infection, osteomyelitis, or current hemodialysis * inflammatory bowel disease, chronic diarrhea, current c. difficile infection * cirrhosis or chronic active hepatitis * anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months * expected survival less than 9 months * pregnancy, anticipated pregnancy, or breastfeeding * incarceration * participation in another intervention study * severe anemia defined as hemoglobin \<9.0 g/dl within the past 4 weeks as documented in the dialysis unit patient record

Keywords: hemodialysis p-inulin gut microbiome
effectiveness of acupuncture for phonotraumatic injuries

Conditions: Phonotraumatic Injuries

Summary: the purpose of this study is to investigate the efficacy of acupuncture for the treatment of phonotraumatic lesions of the vocal folds, using the international classification of functioning disability and health (world health organization, 2001) as the conceptual framework to guide the selection of outcome measures.

the experimental hypothesis for this study is that needling at the designated treatment acupoints will bring about greater improvement in structural and functional impairment in the vocal folds and its sequelae, as compared to placebo treatment. however, it is further hypothesized that treatment benefits from acupuncture will be outweighed by continued phonotrauma following termination of treatment, and thus will not be maintained at long-term follow-up. further, it is expected that voice-related quality-of-life improvements may be equal for genuine acupuncture as compared to placebo. finally, it is hypothesized that the acupuncture protocol should have comparable effects for male and female subjects.

Eligibility criteria:
inclusion criteria: 1. otolaryngological diagnosis within the preceding 15 days of swelling or thickening of at least one vocal fold, or nodules, fibrous mass, cyst, polyp, or chronic (non-infectious) laryngitis, which by history are traceable to phonotrauma and by history appear stable or worsening; 2. age 20-55 yr exclusion criteria: 1. no prior voice therapy; 2. no medication or therapy that may affect voice during the period of participation; 3. no acupuncture treatment for any condition within the preceding 10 year; 4. no diagnosed or suspected neurological conditions, hearing loss (i.e. hearing threshold of the better ear not exceeding 35db hl at 250 hz, 500 hz, 1000 hz, 4000 hz and 8000 hz), history of asthma, and no upper respiratory infection at the time of recruitment.
local minocycline to reduce future inflammation and bone loss in periodontal maintenance patients

Conditions: Moderate to Advanced Chronic Periodontitis

Summary: the purpose of this study is to determine the effect of local application of minocycline microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed with moderate-severe chronic periodontitis within a periodontal maintenance program.

the over-arching goal of this application is to initiate a program to involve undergraduate dental students and their patients in clinical research to evaluate the efficacy of dental therapy. specifically, the purpose of this study is to determine the effect of local application of minocycline microspheres on the periodontal inflammation and bone loss prevention in patients diagnosed with moderate-severe chronic periodontitis on periodontal maintenance in the undergraduate clinic. few studies evaluating locally-applied minocycline during periodontal maintenance therapy have been reported even though the drug is commonly used in this protocol. a 6-month treatment study by meinberg et al. (2002), demonstrated that in moderate-to-advanced chronic periodontitis patients, scaling and root planing with subgingival minocycline resulted in improved pocket depths and less frequent bone height loss over one year than conventional periodontal maintenance. the prevention of bone loss and inflammation is key to maintaining teeth in function and comfort for the patient's lifetime. patients from the unmc college of dentistry (and eventually creighton university school of dentistry) undergraduate periodontal clinic, who are already enrolled in periodontal maintenance therapy, will be recruited to participate in this study. the selected patients will continue their periodontal maintenance care but will be placed into either the test group (receiving minocycline in a periodontally inflamed pocket along with subgingival mechanical debridement) or the control group (receiving subgingival mechanical debridement alone). radiographs will be taken at baseline and at the study's completion (24 months) to obtain bone loss data, and periodontal measurements and gingival crevicular fluid (gcf) will be used to monitor markers of inflammation and bone resorption. the hypothesis to be tested in this clinical trial is that the use of minocycline at baseline and 6 month intervals in conjunction with subgingival mechanical debridement will reduce interproximal bone height loss and periodontal inflammation more than mechanical debridement alone.

Eligibility criteria:
inclusion criteria: * diagnosis of moderate-severe chronic periodontitis * attending regular periodontal maintenance visits at unmc cod * one quadrant with at least one \> 5 mm interproximal pocket and 3 posterior teeth exclusion criteria: * systemic diseases which impact periodontal inflammation and bone turnover * drugs which significantly impact periodontal inflammation and bone turnover * surgical periodontal therapy within the last year * pregnant or breast-feeding females
nebivolol, lifestyle modification and arterial stiffness

Conditions: Hypertension

Summary: numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. however, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. in contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. in addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.


Eligibility criteria:
inclusion criteria: * stage 1 hypertension * 40-75 years * weight stable (+/-2 kg) * sedentary to recreationally active * willing to be randomized to one of three arms * verbal and written consent * approval by medical director exclusion criteria: * blood pressure outside stated range * diabetes or taking diabetes medications * total cholesterol \>6.2 mmol/l; triglycerides \>4.5 mmol/l * past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease * medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements * known allergy or hypersensitivity to nebivolol or any of its components * inability to perform regular physical activity or participate in other components of lifestyle modification * pregnant or planning to become pregnant
translating sleep health into quality of recovery (tranquil) study

Conditions: Sleep Disorder; Sleep Disturbance

Summary: this is a novel observational study with the overarching aim of evaluating the association between poor sleep health and poor quality of recovery in a surgical setting. it hopes to assess and optimize the perioperative sleep health of patients so significant improvements in their quality of recovery and health outcomes may be achieved.

surgery and pain may cause sleep disturbances that affect both physical and mental well-being of patients. sleep disturbance can cause an increased risk of confusion after surgery, increased pain needing some or more medication, untoward events (heart and breathing problems), delayed recovery and increased lengths of hospital stay. hospitalization interferes with sleep patterns, causing poor quality sleep due to noise, light, pain, medication administration and nursing checks. the circadian rhythm, which is the "body clock" is a 24-hour cycle that tells our bodies when to sleep and rise. this in turn helps in regulating many physiological processes in the body. sleep disruption affects the body clock, thereby changing hormone levels that may be responsible for poor wound healing. this study aims to evaluate sleep problems before disruption post-operatively and also evaluate the relation between poor sleep health and quality of recovery utilizing sleep health measurements such as sleep quality, sleep timing, and sleep efficiency. objectives of the study: 1. to examine the associations between specific pre-operative sleep-health parameters, predicting poor sleep health, and patient-centered outcomes such as pain control, delirium, sleep-related quality of life, and quality of recovery scores in the peri-operative period. 2. to estimate the association between presence of intrinsic sleep disorders and patient centric outcomes such as pain control, delirium, sleep-related quality of life and quality of recovery scores in the post-operative period. 3. to validate a set of subjective and objective measures of various sleep health domains in the post-operative period.

Eligibility criteria:
inclusion criteria: 1. adult patients (\>18 years). 2. asa physical status i - iv. 3. undergoing elective primary or revision lower limb joint replacement surgeries (such as total or partial hip or knee replacement). exclusion criteria: 1. patients undergoing emergency surgeries; cardiac, trauma, organ transplantation or organ retrieval, obstetric or intracranial neurosurgeries. 2. pregnant or lactating patients. 3. inability to wear study-related monitoring devices per instruction or provide informed consent limiting adherence to protocol.

Keywords: sleep
equol supplementation on blood pressure and vascular function

Conditions: Hypertension

Summary: we propose to perform a 24-week randomized, double-blind a placebo-controlled trial among 207 non-equol producing postmenopausal women with prehypertension to examine the effectiveness of equol (10mg and 20mg/d) on 24h ambulatory blood pressure, vascular function and other cardiovascular risks (lipid profile, glycemic control and inflammatory biomarkers) and explore the optimal dosage of equol.

inclusion criteria 1. hong kong chinese women aged 45-65 y with 2\~8 years menopausal; 2. mean sbp above 130 mmhg or dbp above 80 mmhg or both based on an average of 6 bp readings on two different occasions measured by sphygmomanometer. 3. equol non-producer is defined as 24-hour urinary log10 s-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). exclusion criteria 1. subjects on anti-hypertensive medication or with average sbp≥160 or dbp≥100 or both; 2. use of medications known to affect bp within past 6 months; 3. medical history or presence of certain chronic diseases that could affect bp or limit the individual's ability to participate in the study; 4. present or history of certain cancers; 5. regular smoker or alcohol consumption more than 30 g/day; 6. known soy allergy.

Eligibility criteria:
inclusion criteria: 1. hong kong chinese women aged 45-65 y with 2\~8 years menopausal; 2. mean sbp above 130 mmhg or dbp above 80 mmhg or both based on an average of 6 bp readings on two different occasions measured by sphygmomanometer. 3. equol non-producer is defined as 24-hour urinary log10 s-equol:daidzein ratio less than -1.75 after daidzein challenge (60mg daidzein daily for 7 consecutive days). 4. written informed consent will be obtained from all the participants prior to enrolment. exclusion criteria: 1. subjects on anti-hypertensive medication or with average sbp≥160 or dbp≥100 or both; 2. use of medications known to affect bp within past 6 months (hormone therapy, hypoglycemic or weight reduction agents); 3. medical history or presence of certain chronic diseases (stroke, cardiac infarction, severe liver and renal disease etc.) that could affect bp or limit the individual's ability to participate in the study; 4. present or history of breast cancer, endometrial cancer, ovarian cancer, thyroid disorder, abnormal uterine bleeding after menopause; 5. regular smoker or alcohol consumption more than 30 g/day; 6. known soy allergy.