Kornimate/medical-research-clean huggingface dataset:
long-term effect of moderate and vigorous exercise on incident diabetes in obese subjects

Conditions: Type 2 Diabetes; Obesity, Abdominal

Summary: our previous randomized controlled trial has recruited 220 subjects with central obesity and allocated the subjects to the non-exercise control, moderate exercise and vigorous exercise groups. the purpose of our previous study was to investigate the effect of moderate and vigorous exercise on improvement of fatty liver. those subjects will be followed up for incident diabetes at 2 year and 10 year since randomization. the subjects will be invited to participate in on-site visit at 2 and 10 year. questionaire forms will be collected and fasting plasma glucose level and hba1c were measured. the history of diabetes and anti-diabetic medication will be recorded. the incident diabetes will be evaluated.

our previous randomized controlled trial has recruited 220 subject with central obesity and nafld. those subjects were allocated into non-exercise control, moderate exercise and vigorous exercise groups, who received lifestyle education alone, moderate intensity exercise and vigorous intensity exercise, respectively. the exercise intervention lasted one year. those three group subjects will be followed up and evaluated for incident diabetes at 2 year and 10 year since randomization. all the subjects will be invited to participate in on-site visit at 2 and 10 year. questionaire forms will be collected and fasting plasma glucose level and hba1c were measured. the history of diabetes and anti-diabetic medication will be recorded. the incident diabetes will be evaluated.

Eligibility criteria:
inclusion criteria 1. subjects with nafld determined by 1h mrs (intrahepatic triglyceride content ≥5%); 2. 40-65 years old; 3. waist circumference \>90cm for men and \>85cm for women exclusion criteria 1. consumed more than an average of 140 grams of ethanol (10 alcoholic drinks) per week in men and 70 grams of ethanol (five drinks) in women during the past six months; 2. a history of acute or chronic viral hepatitis, drug-induced liver diseases, and autoimmune hepatitis; 3. myocardial infarction in the past six months; 4. biliary obstructive diseases; 5. uncontrolled hypertension (i.e. systolic bp\>180 mmhg, and/or diastolic dbp \>100 mmhg); 6. chronic kidney disease (serum creatinine ≥1.5 mg/dl in men and ≥1.3 mg/dl in women); 7. heart failure (new york heart association iii or iv); 8. currently participating in weight loss programs; 9. currently pregnant or planning to be pregnant; 10. having any medical condition that would affect metabolism (i.e. diabetes, known hyperthyroidism or hypothyroidism); 11. having a medical condition that would limit exercise participation and taking medication that would affect metabolism or weight loss (i.e. thyroid medication and glucocorticoids) or would alter the heart rate response during exercise (i.e. β-blockers); 12. unable to participate in the follow-up examination.

Keywords: type 2 diabetes obesity
treatment of peri-implantitis lesions by using biomaterial

Conditions: Peri-implantitis

Summary: the primary objective of the study is to proof the successful use of geistlich bio-oss® and geistlich bio-gide® (already registered medical devices) in bony peri-implant defects due to peri-implantitis disease.

patient who will considered eligible at the screening visit will undergo surgical treatment procedure within 2 weeks. at the day of the surgery the patients will be randomized into the 2 treatment groups. the subjects will be then prescribed postoperative antibiotics (azitromax 500 mg day one and 250 mg day 2-4). post-operative pain will be controlled with ibuprofen (400mg x 3) for two days to all subjects. subjects will rinse twice daily with chlorhexidine mouth rinse and use modified oral hygiene procedures during the first 5 weeks of healing. subjects will receive professional prophylaxis as required. subjects will be instructed on appropriate oral hygiene throughout the study and will be given appropriate oral hygiene instructions. instructions on post-operative care will be repeated at each visit. in particular the following points have to be covered during the first month after surgery: chlorhexidine rinses, avoidance of brushing, usage of interdental cleaning devices, avoidance of chewing on or trauma to the treated area. in addition subjects will be instructed not to smoke more than 10 cigarettes per day during the entire study period and not to consume alcohol during antibiotic therapy. sutures will be removed after 14 days. photos will be taken during the whole study to document the healing process. further follow up visits will be scheduled 6 weeks and 3,6,9,12 months post-surgery.

Eligibility criteria:
inclusion criteria: * age 18 years or older * presence of peri-implantitis * a peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph. * clinically a probing depth ≥ 5 mm combined with bleeding and/or pus should be present at the site. * during surgical exploration an intraosseous component of at least 3 mm at the deepest point must be present. * the defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). only 3 and 4 wall intraosseous defects will be included. * implants included in the study must have been in function for more than 12 months. * ability to fully understand the nature of the proposed surgery and ability to sign an ethics committee-approved informed consent form exclusion criteria: * subjects with diabetes mellitus (hba1c \> 7.0) * subjects taking prednisone or other anti-inflammatory prescription drug * subjects taking medications known to have effects on gingival growth * if the same patient has more than one defect meeting the inclusion criteria, only one such defect will be included in the study * general contraindications for dental and/or surgical treatments * smokers (\> 10 cigarettes per day). * pregnant or lactating women * allergy to collagen * inability to consent for participation in the study and/or to accept the proposed
efficacity study with the protégé everflex stent in popliteal lesions

Conditions: Peripheral Arterial Disease

Summary: this study will assess the results up to 12 months with the protégé everflex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.


Eligibility criteria:
inclusion criteria: general inclusion criteria * de novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement * patient presenting a score from 2 to 5 following rutherford classification * patient is willing to comply with specified follow-up evaluations at the specified times * patient is \>18 years old * patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study * prior to enrollment, the guidewire has crossed target lesion * patient is eligible for treatment with the self-expanding nitinol everflex (ev3) stent angiographic inclusion criteria * the target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation * the target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type a or b lesions according the tasc ii guidelines * target vessel diameter visually estimated is \>3.5mm and \<7.5 mm * there is angiographic evidence of at least one-vessel-runoff to the foot exclusion criteria: * presence of another stent in the target vessel that was placed during a previous procedure * presence of an aortic thrombosis or significant common femoral ipsilateral stenosis * previous by-pass surgery in the same limb * patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated * patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site * perforation at the angioplasty site evidenced by extravasation of contrast medium * patients with known hypersensitivity to nickel-titanium * patients with uncorrected bleeding disorders * aneurysm located at the level of the sfa and/or popliteal artery * female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding * life expectancy of less than twelve months * ipsilateral iliac treatment before the target lesion procedure with a residual stenosis \> 30% or ipsilateral iliac treatment conducted after the target lesion procedure * use of thrombectomy, artherectomy or laser devices during procedure * any patient considered to be hemodynamically unstable at onset of procedure * patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

Keywords: symptomatic popliteal artery stenosis or occlusion
delirium related to proton pump inhibitors use

Conditions: Proton Pump Inhibitor Adverse Reaction; Delirium; Hyponatremia

Summary: delirium is a frequent and severe condition, especially in old adults. its occurrence is due to a drug in 30% of cases. in 2009, the french national health authority (haute autorité de santé) mentioned proton pump inhibitors (ppis) among the drugs causing delirium. most reports of delirium associated with ppi use in the literature are due to severe hyponatremia due to syndrome of inappropriate antidiuretic hormone secretion. however, a few case reports have described the occurrence of delirium ppi without hyponatremia related to ppi use. in 2016, a prospective observational study including 675 old adults found an association between ppi use and the occurrence of delirium. evidence linking delirium and ppi use is thus scarce. by using data from the pharmacovigilance database of the world health organization (who), the investigators aim to describe the characteristics of delirium reports in which ppi were suspected to be involved, and to evaluate the association between ppi use and delirium, and the impact of hyponatremia in this association by performing a disproportionality analysis.


Eligibility criteria:
inclusion criteria: * ppi use * delirium mentioned in the safety report

Keywords: proton pump inhibitor delirium drug safety hyponatremia
immune response in celiac disease on in-vitro gluten challenge

Conditions: Celiac Disease

Summary: the main purpose of this study is to see how cells taken from the lining of the intestine behave in the laboratory with exposure to gluten and other substances that act on the immune system. the cells lining the intestine of a person with celiac disease should be different than a person without celiac disease. the study doctors would like to see how the cells react after coming in contact with gluten and if substances that act on the immune system can prevent gluten related inflammation. examples of these substances include steroids. the cells should produce chemicals of their own in response to the gluten. these other chemicals will be measured and the results compared between those with: * celiac disease that does not respond to a gluten-free diet (refractory celiac disease) * celiac disease which is controlled by a gluten-free diet * uncontrolled celiac disease (either newly diagnosed with celiac disease or not on a gluten-free diet * gluten-sensitivity * disorders other than celiac disease.

the primary purpose of this study is to determine the effect of in-vitro introduction of gluten on inflammatory response primarily interferon-γ and other cytokines, such as il-15, il-18 and il-21, in cultures obtained from small intestinal mucosal biopsy samples of subjects who underwent upper endoscopy. secondary goals include comparing the inflammatory response to immunosuppressants and cytokines after exposing the cultures obtained from small intestinal mucosal biopsies taken from rcd i subjects with intestinal mucosal biopsies taken from subjects with ced controlled on a gluten-free diet (gfd), uncontrolled ced, gluten sensitivity and non-celiac controls.

Eligibility criteria:
inclusion criteria: * 18-75 years of age * undergoing a clinically indicated upper endoscopy exclusion criteria: * anticoagulation or antiplatelet therapy * known active non-celiac intestinal inflammatory disorder

Keywords: celiac disease refractory celiac disease gluten sensitivity
enhancing digitally delivered diabetes education with real-time cgm

Conditions: Diabetes Type 2

Summary: the current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. results on the effectiveness of this intervention will be compared for non-insulin using patients.

the current research study seeks to investigate the impact of incorporating continuous glucose monitoring (cgm) into the evidence-based text messaging diabetes education program, dulce digital, focusing on individuals with type 2 diabetes (t2d) who are not on insulin therapy. this innovative approach stems from the rationale that real-time continuous glucose monitoring (cgm) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. in standard care, individuals with t2d, particularly those not on insulin, may not routinely have access to cgm devices. the cgm device, an integral part of recommended diabetes therapy, is fda approved for use in all people with diabetes. however, reimbursement for cgm devices varies by health plans, and currently, centers for medicare \& medicaid services (cms) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a cgm device during diabetes self-management education for individuals with non-insulin-using t2d. this study aims to determine if adding a cgm device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * are not currently using a cgm * are not using insulin therapies * speak english, spanish or arabic * have a1c between 7.5% and 12.0% in last 90 days * have a cellphone that can receive/send text messages and counts steps exclusion criteria: * are using insulin therapies * are pregnant * are currently using a cgm * are currently participating in another diabetes-related study

Keywords: diabetes cgm diabetes education
efficacy and safety study of buprenorphine hcl buccal film in subjects with low back pain

Conditions: Pain; Low Back Pain

Summary: the purpose of this study is to determine whether buprenorphine hydrochloride (hcl) buccal film is effective and safe in the treatment of chronic low back pain (clbp).

this is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. during the double-blind treatment period, this study will evaluate the effectiveness of buprenorphine hcl buccal film versus placebo buccal film in treating clbp in subjects. buprenorphine hcl buccal film is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. buprenorphine is a synthetic opioid that is classified as a partial µ-receptor agonist and a schedule iii controlled substance in the united states.

Eligibility criteria:
inclusion criteria: * male or non-pregnant and non-nursing female aged 18 or older * history of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point numerical rating scale\] reported at the open-label titration period day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs \[nsaids\], and muscle relaxants) of approximately 12 to 24 hours * currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer * stable health, as determined by the investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures * female subjects of childbearing potential must be using a recognized effective method of birth control * written informed consent obtained at screening, prior to any procedure being performed exclusion criteria: * reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis * surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening * hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia * corrected qt (qtc) interval of \>450 milliseconds on the 12-lead electrocardiogram (ecg) * history of long qt syndrome, or an immediate family member with this condition * diagnosis of moderate to severe hepatic impairment. * history of severe emesis with opioids * clinically significant sleep apnea

Keywords: buccal soluble film enriched enrollment randomized withdrawal
clinical trial of orthokeratology lens (mcok-01)

Conditions: Myopia

Summary: a prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens

the test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. the number of enrolled subjects is 390, and clinical observation is performed for 12 months.

Eligibility criteria:
inclusion criteria: 1. patients with myopia and myopic astigmatism 2. those who are not willing to wear glasses in daily life 3. fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness 4. those who can visit the institution on scheduled dates 5. those who can receive guidance and tests as required by the investigator 6. those who fully understand and follow the instructions of the lenses for this clinical trial exclusion criteria: \ 1. best corrected vision acuity of less than 0.8 with spectacles 2. subjective refraction test shows spherical power greater than -6.00d，less than -0.50d or astigmatism greater than 1.5d 3. patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses) 4. the medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, retinal detachment, etc.) 5. the medical history of refractive corneal surgery 6. those in need of a strength out of the scope of lens for this clinical trial 7. having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial 8. all corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts. 9. pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding 10. those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days 11. prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days 12. prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses) 13. minor/adult subjects who lack mental capacity 14. other not suitable for this clinical trial at investigator's discretion \ (1) those who are determined to be unable to obtain good centralized positioning even though changing strength (2) pregnancy confirmed (3) those who are difficult in continuing the clinical trial at investigator's discretion
prevention of the hepatic sinusoidal obstruction syndrome by means of anticoagulants

Conditions: Sinusoidal Obstruction Syndrome; Colorectal Liver Metastases

Summary: the purpose of the study is to determine whether anticoagulant use (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) is able to prevent the development of the sinusoidal obstruction syndrome secondary to oxaliplatin-based neoadjuvant chemotherapy in patients suffering from colorectal liver metastases.

surgical resection remains the only curative treatment for patients suffering from colorectal liver metastases, but only 15-25% of patients are initially eligible for resection. the majority of patients suffering from colorectal liver metastases receives chemotherapy prior to liver surgery in order to downsize the colorectal liver metastases. preoperative treatment with oxaliplatin-based chemotherapy is related to sinusoidal injury, the so-called sinusoidal obstruction syndrome. patients with histologically proven sinusoidal injury undergoing liver surgery have a higher risk of post-resectional morbidity. damage to the hepatic sinusoids is a key factor for the development of the sinusoidal obstruction syndrome. anticoagulants (i.e. salicylates, clopidogrel, low-molecular weight heparin, or coumarin derivates) might be able to prevent this damage and, consequently, the development of the sinusoidal obstruction syndrome in patients suffering from colorectal liver metastases treated with neoadjuvant chemotherapy.

Eligibility criteria:
inclusion criteria: * age \> 18 years * colorectal liver metastases that are eligible for resection * operated from january 2008 up until december 2009 at maastricht university medical centre exclusion criteria: * irresectable colorectal liver metastases

Keywords: colorectal liver metastases neoadjuvant chemotherapy oxaliplatin sinusoidal obstruction syndrome anticoagulants
the effect of oral zanthoxylum schinifolium seed oil in individuals with dry eye disease

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of 10-weeks oral consumption of zanthoxylum schinifolium seed oil (zso) in patients with mild dry eye disease.

in this double-blind, randomized and placebo-controlled trial, twenty participants experiencing dry eyes symptoms were recruited, and randomly assigned to consume 4 g/day of either zso or soy bean oil (sbo) as placebo for 10 weeks. all participants completed the study. follow-ups of dry eye symptoms and objective signs, inflammatory and oxidative stress markers, and blood lipid analysis were performed.

Eligibility criteria:
inclusion criteria: * men and women * 20 to 70 years with dry eye disease * low tear break-up time (tbut) (\<10 seconds) or low schirmer score (with application of local anesthetic) (\<10mm for 5 min) or presence of corneal and conjunctival damage at the time of screening. * blood level of triglyceride higher than 150 mg/dl or hdl-cholesterol less than 40 and 50 mg/dl for men and women, respectively. exclusion criteria: * under the anti-inflammatory eye drops for dry eye (topical steroid and topical cyclosporin) * hypolipidemic medication within 3 months of study entry * history of chronic disease * any clinical trial using an investigative medicinal product within 2 months before the first dose of the present study * allergic or hypersensitive to any of the ingredients in the test products. * women who were pregnant or breast feeding * a history of alcoholism or drug abuse or medical or psychological conditions

Keywords: zanthoxylum schinifolium seed oil soy bean oil omega-3 fatty acid dry eye disease