Kornimate/medical-research-clean huggingface dataset:
the effect of dietary intervation on endothelial glycocalyx in covid-19 patients.

Conditions: COVID-19; Endothelial Dysfunction

Summary: the food supplement endocalyx is considered to support the endothelial glycocalyx integrity by supplying sulfated polysaccharides, anti-oxidant enzymes and additional substrates for glycocalyx synthesis. the investigators will study the effect of endocalyx on endothelial, vascular and left ventricular myocardial function in patients with covid-19 infection.

sixty patients who have been hospitalized due to covid-19 infection will be randomized to receive food supplement endocalyx (4 capsules per day) (n=30) or placebo (n=30) for 4 consecutive months.

Eligibility criteria:
inclusion criteria: * caucasian patients * hospitalization for covid-19 infection * diagnosis of covid-19 proven by pcr exclusion criteria: * pregnancy and breastfeeding * foreseen inability to attend scheduled visits * history of acute coronary syndrome. coronary artery disease will be excluded by a clinical history, examination and electrocardiogram. * moderate or severe valve disease * primary cardiomyopathies * chronic obstructive pulmonary disease * asthma * chronic kidney disease (estimated glomerular filtration rate \[egfr\] ≤60 ml/min/1.73 m2) * liver failure * malignancies

Keywords: covid-19 arterial stiffness endothelial glycocalyx coronary microcirculation left ventricular myocardial deformation
acute health effects of passive vape among copd patients

Conditions: Electronic Cigarette Use; Second Hand Smoke; Lung Function

Summary: the use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible. the aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease copd in a randomized controlled double-blinded cross-over study.

introduction: the use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible. aim: to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease (copd). design: in a randomised double-blinded cross-over study non-smoking copd patients were exposed for four hours at two different exposure conditions separated by 14 days; a) clean filtered air and b) passive vaping under controlled environmental conditions. measurements: tsi p-trak ultrafine particle counter was used for particle counts. health effects, including lung function (fev1/fvc) and fraction of exhaled nitric oxide (feno) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure. analysis: mixed methods approach taking both time and exposure into account.

Eligibility criteria:
inclusion criteria: * never smoker or ex-smokers ≥ 6 months * aged 18+ * a known diagnosis of copd (fev1/fvc \< lower limit of normal, app. 70%) * mrc ≥ 2 or cat score ≥ 10 exclusion criteria: * exposure to smoking more than 30 min./day * treatment with inhaled or oral corticosteroids * known hypersensitivity to constituents in e-cigarettes * any other disease that could influence the study parameters * conditions that prevent safe access to the climate chambers (such as claustrophobia) * perennial rhinitis * deformed nasal airways * not being able to change from long-acting medication to short-acting medication

Keywords: electronic cigarettes secondhand vape health effects lung function biomarkers chronic obstructive pulmonary disease
acupuncture to prevent postoperative bowel paralysis (paralytic ileus)

Conditions: Ileus; Neoplasms

Summary: the purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.


Eligibility criteria:
inclusion criteria: * previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure * hospital admission must be same day as surgery exclusion criteria: * incapacitating disease * concurrent herbal or laxative use * use of heparin or coumadin * upper or lower extremity deformities * chronic constipation prior to cancer diagnosis * history of cerebrovascular accident or spinal cord injury * chronic pain that has been treated with any form of major opioid or weak opioids (=/\> 30mg/24 hours) * pacemaker or metal implants * concurrent alternative medicine/herbal use

Keywords: colostomy ileostomy
mulberry leaf extract and blood glucose control in diabetics

Conditions: Diabetes Mellitus Type 2

Summary: mulberry leaf teas or extracts are used as a natural remedy for diabetes in some countries. animal studies have shown some effect of mulberry leaf extract on blood glucose. the purpose of this trial is to assess the effect of mulberry leaf extract on type 2 diabetics, by measuring blood glucose two hours after eating a meal and taking a capsule containing either mulberry leaf extract or a placebo.

patients will participate in a double blind randomized cross over trial for 6 weeks. four 2 weeks, half of the type 2 diabetic patients will receive mulberry leaf capsules three times per day with meals (made from mulberry zuccarin tablets - new nordic, 400 mg of mulberry leaf extract per tablet) and half will receive placebo capsules. following a one week wash out period, the treatments administered to each group will be reversed for the next 2 weeks, and data will continue to be gathered for a final wash out week. patients will keep a diary of food, exercise, and fasting glucose each morning as well as at least one 2 hour pc glucose each day. weight, hemoglobin a1c, liver function tests, and renal function tests will be done at baseline and at the end of the 6 weeks. as well, blood pressure will be monitored when the 2 weekly batches of medication are distributed, and at the end of the 6 weeks.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * baseline hemoglobin a1c greater than or equal to 7.5 or fasting glucose greater than 7 (si units) exclusion criteria: * on insulin * history of hepatic or renal disease * pregnant or nursing women

Keywords: diabetes mellitus type 2 mulberry leaf extract post prandial blood glucose
open label extension of 2 mg/kg pegunigalsidase alfa (prx-102) every 4 weeks in adult fabry disease patients

Conditions: Fabry Disease

Summary: the objective of cli-06657aa1-03 (formerly pb-102-f51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult fabry patients who have successfully completed pb-102-f50.

this is an open-label study to assess the long-term safety and efficacy of pegunigalsidase alfa treatment of 2.0 mg/kg administered intravenously every 4 weeks. the duration of treatment will be until pegunigalsidase alfa is commercially available to the patient, or at the discretion of the sponsor.

Eligibility criteria:
inclusion criteria: 1. completion of study pb-102-f50. 2. the patient signs informed consent. 3. female patients and male patients whose co-partners are of child-bearing potential agree to use a medically accepted, effective contraception method. these include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) supplemented with a barrier method (preferably male condom), intrauterine device (iud), intrauterine hormone-releasing system (ius), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. contraception should be used for 2 weeks after treatment termination. exclusion criteria: presence of any medical, emotional, behavioral, or psychological condition that, in the judgment of the investigator, would interfere with patient compliance with the requirements of the study.

Keywords: glomerular filtration rate proteinuria prx-102 pegunigalsidase alfa fabry disease
oxycodone hydrochloride injection in the postoperative pain relieving treatment

Conditions: Other Acute Postoperative Pain

Summary: to determine the efficacy and safety of oxycodone i.v. patient-controlled analgesia (pca) in the pain relieving treatment during 48h postoperative period, by comparing with morphine i.v. pca.


Eligibility criteria:
inclusion criteria: 1. patients of either sex aged 18 to 65 years old, with a standard body weight \[standard body weight = height (cm) - 100\] ±15%. 2. asa i and ii. 3. scheduled on elective open upper abdominal surgery under general anesthesia (liver, gall bladder, spleen, stomach, kidney, colon surgery), of which predicted operation duration is between 2-4h. 4. hospitalized patients on non-emergency condition who have been given appropriate preoperative treatments. 5. patients who are willing to participate in the study and have signed the written informed consent. 6. negative pregnancy test result should be obtained for women of child-bearing age. exclusion criteria: 1. long-term analgesics or psychotropic drugs (including opioids, nsaids, sedatives, antidepressants) taken for the chronic pain, or patients abusing alcohol. 2. body weight is less than or over ±15% of the standard body weight. 3. severe impairment of liver and renal function at preoperative stage (alt, ast, bun, cr). 4. medical history of recovering from abnormal surgery anesthesia. 5. medical history of hypertension (systolic blood pressure ≥180hg, diastolic blood pressure 110hg). 6. esophagus reflux disease. 7. sedatives, anti-emetics, and anti-pruritic drugs were taken 24 hours before operation. 8. have known hypersensitivity to opioids. 9. monoamine oxidase inhibitors and antidepressant drugs were taken within 15 days. 10. patients with shock. 11. patients with copd. 12. patients can not understand the vas or unable to use pca. 13. pregnant or parturient women.
exploratory efficacy study of neurostem® in subjects who control group of neurostem®

Conditions: Alzheimer's Disease

Summary: this study is to evaluate of exploratory efficacy of neurostem® in subjects who control group of neurostem® phase-i/iia clinical trial


Eligibility criteria:
inclusion criteria: 1. subjects who have been treated with placebo in phase 1/2a clinical trial of neurostem® 2. subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial (in case it is difficult for the participant to sign, the consent of the legal representative) exclusion criteria: 1. history of stroke within 3 months prior to study enrollment 2. severe liver disorder (equivalent to double the normal values of alt and ast) at visit 1 3. severe kidney disorder (serum creatinine ≥1.5mg/dl) at visit 1 4. abnormal laboratory findings at visit 1 * hemoglobin \< 9.5 g/dl for male and \<9.0 g/dl for female * total wbc count \< 3000/mm3 * total bilirubin \>= 3 mg/dl 5. suspected active lung disease based on chest x-ray at visit 1 6. bleeding disorder (abnormal blood coagulation test result (i.e. platelet count of \< 137,000/mm3, pt ≥ 1.5 inr, or aptt ≥ 1.5 x control anti-coagulant or anti-platelet, without anticoagulant or anti-platelet therapy) 7. diagnosis of cancer (of any body system, including brain tumor) 8. contraindicated for any of the tests performed during the clinical trial period (for example, mri, ct, pet) 9. whom the principal investigator considers inappropriate for participation in the study due to any reasons other than those listed above
laparoscopy combined with enhanced recovery pathway

Conditions: Crohn's Disease

Summary: laparoscopy combined with an enhanced recovery pathway versus laparoscopy combined with a traditional recovery pathway after ileocolon resection for crohn's disease.

thirty patients with cd of ileocolon will be randomly assigned to two groups.one group is erp group which include no bowel preparation nor fasting, no abdominal drains, early removal of urinary catheter, early solid dietary intake and mobilization and restrictive fluid management.in the end,we can compare the time to first flatus、time to first flatus 、postoperative length of stay postoperative hospital expense、complication grade readmission within 30 days of discharge between the two groups.

Eligibility criteria:
inclusion criteria: * adult patients (18 years≤aged≤75 years) were included if they had histologically or radiographic proven cd with disease localized to the terminal ileum with or without ascending colon involvement. exclusion criteria: * those patients were excluded：previous bowel resection or strictureplasty, preoperative radiological evidence of large phlegmons/abscesses/enteric fistulas (assessed by magnetic resonance imaging or computed tomography), emergency surgery, and anesthesiological contraindications to laparoscopy.

Keywords: laparoscopy enhanced recovery fast-track
sintilimab or placebo with chemotherapy in esophageal squamous cell carcinoma ( orient-15 )

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this is a randomized, double-blind multi-center, phase iii study comparing the efficacy and safety of sintilimab or placebo in combination with chemotherapy as first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma. after the interim analysis conducted by the idmc, an open-label assignment of experimental arm therapy will continue in regions outside of china, in order to further evaluate the efficacy and safety of sintilimab in combination with chemotherapy in subjects representing the western population with advanced esophageal squamous cell carcinoma


Eligibility criteria:
key inclusion criteria: * histopathologically confirmed unresectable, locally advanced, recurrent or metastatic escc (excluding mixed adenosquamous carcinoma and other histological subtypes) * ecog ps of 0 or 1 * subject must be unsuitable for definitive treatment, such as definitive chemoradiotherapy and/or surgery. for subjects who have received (neo)adjuvant or definitive chemotherapy/radiochemotherapy, time from the completion of last treatment to disease recurrence must be \> 6 months could provide archival or fresh tissues for pd-l1 expression analysis with obtainable results * have at least one measurable lesion as per recist v1.1 key exclusion criteria: * escc with endoscopy-confirmed near-complete obstruction requiring interventional therapy * post stent implantation in the esophagus or trachea with risk of perforation * received systemic treatment for advanced or metastatic escc. * received a cumulative dose of cisplatin ≥ 300 mg/m2 and the last cisplatin dose was within 12 months of randomization or the first dose of study treatment in the open-label phase. * high risk of hemorrhage or perforations due to tumor invasion in adjacent organs (aorta or trachea), or have fistula formation. * hepatic metastasis \> 50% of the total liver volume. * received palliative therapy for a local lesion within 2 weeks prior to the first dose. * received systemic treatment with chinese traditional medicines with anti-cancer indications or immunomodulators (including thymosins, interferons, and interleukins) within 2 weeks prior to the first dose of study treatment. * received systemic immunosuppressants within 2 weeks prior to randomization, excluding local use of glucocorticoids administered by nasal, inhaled, or other routes, and systemic glucocorticoids at physiological doses (no more than 10 mg/day of prednisone or equivalents), or glucocorticoids to prevent allergies to contrast media.

Keywords: escc esophageal cancer esophageal neoplasms esophageal neoplasms malignant esophageal squamous cell carcinoma neoplasms, squamous cell esophageal diseases carcinoma, squamous cell gastrointestinal diseases paclitaxel cisplatin fluorouracil antineoplastic agents anti-pd-1 sintilimab
preoperative evaluation of 3d reconstruction tool for nipple-sparing mastectomy

Conditions: Breast Cancer

Summary: the goal of this clinical study is to explore whether preoperative application of 3d reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.

the 3d reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. compared with electrosurgical knife separation，the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3d tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.

Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of breast cancer * age: 18 to 70 years old * no infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins; * participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction; exclusion criteria: * inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy; * participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 nccn guideline recommendations, where retaining the nac fails to yield negative margins;
capsular repair in fai impingement surgery

Conditions: Hip Injuries

Summary: the investigator's hypothesis is that capsular repair (after cam or mixed femoroacetabular impingement (fai) surgery) requiring moderate capsulotomy, would result in similar patient outcomes in the short, mid and long term, both clinically and radiographically, compared to those without capsular repair. the objective of this clinical trial is to evaluate the clinical efficacy with regards to pain, range of motion and return to work and activities of daily living. secondary objective is to evaluate radiographic characteristics between both groups.


Eligibility criteria:
inclusion criteria: 1. male or female patients aged between 16-51 years of age. 2. healthy patients undergoing hip arthroscopy due to cam or mixed fai 3. no major osteoarthritic (oa) changes according to x-ray and surgery observation (tonnis 0-1) 4. no previous hip surgery 5. no other influential disabilities in lower limbs 6. no chronic use of nsaid, analgesics, steroids or chemotherapy drugs 7. base line activity level (tegner 3 and above) exclusion criteria: 1. patients with concomitant disease that may affect joints 2. patients with major ligamentous laxity 3. patients who have undergone only minor vertical capsulotomy (as in small pincer only lesions) 4. patients with extreme range of motion needs (such as ballet dancers) 5. patients suffering from connective tissue disease 6. patients suffering from bilateral symptomatic fai that are being operated on for their first hip 7. patients with relative or proven dysplastic hip determined by center edge angle and/or extreme version abnormalities as measured on apical ct/mr cuts and pelvic xr 8. patients who needed ilio-psoas release 9. patients whose cartilage hip status was defined as advanced oa during surgery 10. patients who following surgery would be instructed to avoid full weight bearing on the operated hip for more than 4 weeks 11. concomitant use of prp (platelet rich plasma) or hyaluronic acid during the surgical procedure 12. patients with preoperative hip stiffness

Keywords: capsular repair fai hip
a phase 1 dose escalation study of vx-708 in healthy participants

Conditions: Pain

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple ascending doses of vx-708 in healthy participants

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * male and female of non-childbearing potential are eligible * body mass index (bmi) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kg key exclusion criteria: * history of febrile illness or other acute illness within 14 days before the first dose of study drug * history of cardiac dysrhythmias * part a cohorts with midazolam ddi evaluation (cohort a4) only * hypersensitivity to midazolam or benzodiazepines * part a cohorts with csf sampling (cohorts a2 and a3) only * hypersensitivity to local anesthetic for lumbar puncture * history of conditions leading to increased intracranial pressure (e.g., brain tumor, idiopathic intracranial hypertension, venous sinus thrombosis) * part b only * hypersensitivity to itraconazole other protocol defined inclusion/exclusion criteria may apply.
visceral adiposity index and triglyceride/high-density lipoprotein cholesterol ratio in the congenital hypogonadotropic hypogonadism and effect of testosteron treatment

Conditions: Hypogonadism

Summary: the study is designed to answer the following questions: 1. what is the levels of visceral adiposity index and triglycerides/hdl cholesterol ratio in hypogonadism? 2. what is the effect of testosterone replacement on the visceral adiposity index and triglycerides/hdl cholesterol ratio?

this is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2007-2010.

Eligibility criteria:
inclusion criteria: * men * congenital hypogonadism * treatment naive exclusion criteria: * previous history of androgen replacement * hypertension * diabetes mellitus

Keywords: visceral adiposity index triglycerides / hdl cholesterol ratio testosterone
cost-effectiveness of four methods in preventing fissure caries in permanent teeth

Conditions: Dental Caries

Summary: the aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in china. the four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (art) sealant, sodium fluoride varnish, and silver diamine fluoride (sdf) solution. the specific study objectives are: 1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children, 2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in china, and 3. to compare the cost-effectiveness of the above four caries prevention methods.


Eligibility criteria:
inclusion criteria: * school children in good general health * has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries exclusion criteria: * children with major systemic disease or on long-term medication * children not cooperative and refuse dental treatments

Keywords: dental caries