Kornimate/medical-research-clean huggingface dataset:
impaired peripheral endothelial function and in-stent restenosis

Conditions: Coronary Artery Disease

Summary: the investigators assessed the hypothesis that whether rh-pat index (rhi) as a marker of endothelial dysfunction could predict occurrence of isr after percutaneous coronary intervention (pci).

this is a prospective observational study of all consecutive patients with coronary artery disease (cad) treated with pci at kumamoto university hospital between january 2010 and september 2012. inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant cad.

Eligibility criteria:
inclusion criteria: * inclusion criteria consisted of patients who were symptomatic for myocardial ischemia and who were undergoing stent implantation for significant cad. exclusion criteria: * exclusion criteria were balloon angioplasty only without stent deployment, death during hospitalization, and patients who had comorbidities affected rh-pat results such as hemodialysis, advanced cancer, after surgery of breast cancer, dementia, collagen disease, and not performing rh-pat with uncertain reason.
assessment of awake surgery with electrocorticographic recordings in the management of gliomas and correlation with imaging data (ecog)

Conditions: Electrocorticography; Karnofski Index; Glioma

Summary: this study proposes to analyze data from intraoperative ecog recordings acquired during wakefulness interventions in order to identify the connection networks involved in cognitive functions. this study also proposes to correlate the ecog data with the imaging data and to analyze the disturbances of the electrophysiological signals induced by the cortical and subcortical brain lesions: this will make it possible to establish a more detailed mapping of the tumor areas and to compare disturbances recorded to those recorded in healthy areas. thus, this approach should make it possible to improve the quality of excision of glial lesions located in eloquent areas, while reducing the risk of neurological sequelae and thus improve the survival and quality of life of patients.


Eligibility criteria:
inclusion criteria: * man or woman over 18 years-old * subject with a non-recurrent glial lesion requiring surgery in vigilant condition; * brain lesion located in the functional zone; * major not protected within the meaning of the law; * subject affiliated to a health insurance scheme; * no medical contraindication to performing an mri (pacemaker); * no medical contraindication to surgery and anesthesia; * karnofski index\> 70; * subject having signed an informed consent. exclusion criteria: * minor subject, pregnant or breastfeeding woman; * major subject subject under measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision; * subject hospitalized without consent; * subject treated with antipsychotics (neuroleptic or lithium); * subject who has already been treated for his glial lesion by surgery and / or radiotherapy; * subject refusing to sign an informed consent. * subject wishing to discontinue participation in the study before completion; * subject for which the surgical intervention and / or the ecog recording could not be carried out after admission to the operating room (whatever the reason).
brolucizumab treatment experience study of patients with namd in uk routine clinical practice

Conditions: Neovascular Age-related Macular Degeneration

Summary: besra is a national, multi-center, prospective, observational study to assess the effectiveness of brolucizumab intravitreal injections in patients with namd treated in the uk.

data will be collected in a standardized manner from hospital medical records (paper and electronic) at participating centers for up to 60 months post- initiation of brolucizumab. in addition to the collection of data from medical records, retinal oct images collected during the first two years of treatment will be transferred to a central reading center for independent grading and interpretation, in order to support the validity of anatomical measurements relevant to the primary and secondary study objectives. patients will be treated with brolucizumab according to routine clinical practice, independent of the study setting. key study design definitions: * index date: the date of the first brolucizumab injection. * index eye: the first eye to be injected with brolucizumab (analyses will be conducted for the index eye only, unless otherwise stated). * post-index period: time between index date and the earliest of treatment discontinuation, date of death or the date of the last recorded visit within the 60 months post-index (2-month window). * study period: the period between 01 september 2020 and 01 march 2027, to allow 6 months pre-index period and up to 60 months (±2 months window) follow-up for each enrolled patient.

Eligibility criteria:
inclusion criteria: 1. diagnosis of namd 2. ≥50 years of age at index date 3. receipt of at least one injection of brolucizumab during the eligibility period 4. able and willing to provide signed informed consent exclusion criteria: 1. received treatment for retinal vein occlusion, diabetic macular edema (dme) and/or myopic choroidal neovascularization (mcnv), and/or has received a new diagnosis of diabetes-related macular degeneration in the index eye within 6 months prior to the index date 2. receipt of anti-vegf treatment other than brolucizumab in the index eye at index date 3. any active intraocular or periocular infection or active intraocular inflammation in the index eye at index date 4. has been on anti-vegf treatment for longer than 3 years (before index date) 5. has a contraindication and is not eligible for treatment with brolucizumab according to the beovu® (brolucizumab) summary of product characteristics (smpc) ("beovu 120 mg/ml solution for injection in pre-filled syringe - summary of product characteristics (smpc)" 2020) 6. any medical or psychological condition in the treating physician's opinion which may prevent the patient from participating in the study 7. participating in a parallel interventional clinical study 8. participating in a parallel non-interventional study (nis) generating primary data for an anti- vegf drug.

Keywords: brolucizumab intravitreal injections namd uk
effects of time-restricted eating supported by mobile technology in patients with non-alcoholic fatty liver disease: randomized controlled trial

Conditions: Non-Alcoholic Fatty Liver Disease; Time Restricted Feeding; Mobile Technology

Summary: in non-alcoholic fatty liver disease (nafld), it is established that calorie restriction is the most essential dietary modification. the time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with nafld. therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with nafld.


Eligibility criteria:
inclusion criteria: * aged ≥ 19 years who are willing and able to complete all procedures * hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 db/m)) exclusion criteria: * body mass index (bmi) \<23 * other causes of chronic liver disease (hbv, hcv), autoimmune diseases or chronic cholestatic liver disease * medications which cause liver disease or secondary hepatic steatosis (tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks) * significant alcohol intake (\>210g/week for men, \>140g/week for women) * severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmhg) * psychiatric illnesses which limit ability to exercise safely * diagnosed with diabetes on medication or insulin * participation in a weight-loss program within 12 weeks * mri contraindications
ostéopontin as a marker of stenosis - osmosis

Conditions: Stenosis

Summary: our hypothesis is that a plasma protein named osteopontin (opn) could serve as a biological predictive marker of acute avf dysfunction. in several scientific studies, plasma opn was correlated with coronary stent restenosis, and with cardiovascular outcome in patients with diabetes and renal insufficiency. this protein is secreted by several cellular types, like distal tubule epithelial cells, macrophages, but also fibroblasts and cardiac and vascular endothelial cells, in response to several specific stimuli. it acts like a cytokine, inducing immunological mechanisms as well as tissue remodeling. the main objective of this study is to show that the amount of plasma opn is higher in patients presenting with an avf stenosis, compared with patients with a functioning avf. osmosis is a monocentric pilot study that will include patients into two groups during 12 months (no specific follow-up). the control group will include patients that have been dialyzed on an avf, in the dialysis center of nice university hospital, for at least 3 months without any incident. the experimental group will include hemodialysis patients hospitalized in the department of vascular surgery for acute avf dysfunction, needing endovascular or open surgical revision for venous stenosis. blood will be withdrawn right before dialysis or surgical procedure. plasma opn will me measured by elisa. their clinical data would be collected from medical file at the same time. after the procedure, patients will be followed-up according to usual protocols. to show a significant difference of 100ng/ml plasma opn between the two groups, with a power of 90% and alpha risk of 0.05, we plan to include 76 patients


Eligibility criteria:
inclusion criteria: * patients under a social security scheme * written informed consent obtain * 18 years old or older * end-stage renal failure disease with 3 months dialysis minimum on a native arteriovenous fistula non-inclusion criteria: * subject under juridicial protection * pregnant or lactating women * subject already enrolled in a clinical trial involving a drug or an implantable medical device exclusion criteria: * withdrawal of consent * investigator or sponsor decision
short-term effects of an sglt2 inhibitor on divalent ions in autosomal dominant polycystic kidney disease

Conditions: Autosomal Dominant Polycystic Kidney Disease

Summary: this study aims to better understand electrolyte handling in patients with autosomal dominant polycystic kidney disease treated with the sglt2 inhibitor empagliflozin. patients will be randomized into two groups and take empagliflozin or a placebo for 2 weeks with a wash-out period of 2 weeks. the primary outcome is tubular handling of the divalent ions calcium, phosphate and magnesium. secondary outcomes include diuresis, safety and tolerability.

this investigator-initiated randomised, single-blind, placebo-controlled cross-over study aims to better understand tubular electrolyte handling of divalent ions in patients with autosomal dominant polycystic kidney disease treated with the sglt2 inhibitor empagliflozin. after randomization, at week 0, participants collect 24-hour urine sample and a patient visit to assess vitals and blood tests takes place. after this visit, period 1 starts with a 2-week treatment of either empagliflozin 10mg or placebo. at week 2, the second 24-hour-urine sample and 2. patient visit and blood test take place. after this visit, wash-out period for 2 weeks starts where no study drug will be administered at week 4, the period 2, the crossover-period starts for an additional 2 weeks. at week 6; a final and third 24-hour urine sample, clinical visit and blood test takes place. at week 3 \& 7, a phone consultation will assess safety.

Eligibility criteria:
inclusion criteria: * - patients 18-75 years old with adpkd, defined according to international diagnostic and classification criteria14, treated at cantonal hospital graubünden (ksgr) and the university hospital zürich (usz) independent of baseline treatment with the vasopressin receptor antagonist tolvaptan * informed consent as documented by signature exclusion criteria: * - renal replacement therapy or kidney allograft recipient * chronic kidney disease ckd kdigo stage g4 (egfr under 30ml/min/1.73m2) * patients younger 18 years of age * diabetes mellitus type 1 * recurrent urinary tract infections (uti) defined as more than 3 infections requiring antibiotic treatment or over 1 requiring hospitalization/year. * patients with uncontrolled hypertension (defined as ambulatory systolic bp over 180mmhg), liver cirrhosis (child pugh b and c) * patients not able or not willing to stop the following medications during the study period of participation in the trial: * thiazide diuretics * carbonic anhydrase inhibitors * sodium bicarbonate * 1, 25 (oh) vitamin d (calcitriol) * bisphosphonate, denosumab, teriparatide * pregnant or lactating women * known allergy to study drug * inability to understand and follow the protocol

Keywords: phosphate calcium magnesium empagliflozin adpkd
retr(osteomyelitis)

Conditions: Osteomyelitis

Summary: this is a retrospective study describing the management of osteomyelitis in a referece center, with success and failures.

chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with the risk of fracture and amputation. it is caused by the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess. chronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery. despite the progress made in both antibiotics and surgical treatment, the probability of failure of this treatment (infectious recurrence) is of the order of 20%, and has unfortunately remained stable for more than 20 years. an innovative treatment, cerament-g (bonesupport ab laboratory, sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin (ce marking), fills the "dead space" which is formed during surgery, prevents this cavity filled with blood from becoming infected, and promotes the regeneration of the bone within this space, limiting the risk of fracture in the medium and long term. it also locally delivers very high doses of gentamicin for several weeks.

Eligibility criteria:
inclusion criteria: * patients who presented with osteomyelitis between 2017 and 2021 exclusion criteria: * patients who objected to participating in the study

Keywords: hematogenous bone substitute
evaluation of the quality of life of patients with opioid-induced constipation under treatment with naloxegol

Conditions: Opioid-induced Constipation

Summary: opioid-induced constipation (oic) is a common feature in patients treated with strong opioids. such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. peripherally-acting, mu-opioid receptor antagonists (pamoras), such as naloxegol, have proven to be effective against oic in patients with inadequate response to laxatives without reducing opioid analgesic effect. however, evidence regarding efficacy and safety on patients with cancer is still scarce. the objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing quality of life outcomes, and to obtain data on its safety in the long term in patients with cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of cancer * treatment with opioids * oic symptoms * inadequate response to laxatives * karnofsky equal or above 50 * ambulatory * must be able to complete questionnaire forms exclusion criteria: at the start of the study: * hypersensitivity to naloxegol or vehicle * suspicion or high risk of gastrointestinal block * high risk of gi perforation * severe liver failure * pregnancy or breastfeeding * use of potent cyp3a4 inhibitors * cognitive impairment

Keywords: naloxegol, pamora
a phase i, open-label, multicenter, dose-escalating study to evaluate the safety and tolerability of kh658 gene therapy in participants with neovascular age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: van-2401 is phase i clinical trial to assess the safety and tolerability of kh658 in subjects with neovascular amd. kh658 is gene therapy designed to deliver a protein which targets and blocks vegf via an adeno-associated viral vector. the standard of care for patients with neovascular amd are anti-vegf treaments, which have demonstrated improvement in vision and reduction in fluid. a one time placement of a product which inhibits vegf has the potential to reduce the patient burden of regular ocular injections.


Eligibility criteria:
inclusion criteria: - 1. males and females ages 50 to 85 (inclusive) with a study eye which meets the following criteria: a. previously received ivt treatment of anti-vegf for neovascular amd, with documented response to anti-vegf therapy during the first 2 weeks of screening b. active macular cnv lesion secondary to amd evidenced by sd-oct c. have a etdrs bcva letter score of 63 to 25 in the study eye at screening for the first subject in each cohort (sentinel subject), followed by etdrs bcva letter score of 73 to 25 for the rest of the subjects each cohort; d. are willing and able to sign the study written informed consent form (icf). exclusion criteria: - 1. have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular amd except ivt anti-vegf 2. retinal pigment epithelial tears or rips at screening 3. any history or presence of vitreous hemorrhage; 4. have any condition preventing visual acuity improvement; 5. have any other cause of cnv; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, epiretinal membrane or vitreo-macular traction; full thickness macular hole; 6. history of intraocular or periocular surgery in the prior 3 months; 7. prior trabeculectomy or other filtration surgery (slt or migs are permitted); 8. corneal transplant; 9. any use of long-acting intraocular steroids, including implants, within six months prior; 10. uncontrolled glaucoma; 11. intraocular implant 12. participated as a subject in any interventional clinical trial within 1 month prior; 13. have received any gene or cell therapy product at any time in the past (either eye or systemically); 14. have active intraocular inflammation in either eye at screening or a history of uveitis in either eye 15.have active ocular or periocular infection in either eye; 16. have presence or history of scleromalacia in either eye;

Keywords: age-related macular degeneration
integrated neuromuscular inhibition versus instrument assisted soft tissue mobilization in chronic back pain

Conditions: Chronic Non Specific Low Back Pain

Summary: this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain


Eligibility criteria:
inclusion criteria: * 1. the patient's age ranged from 18 to 30 years.(geogre et al, 2021) 2. patients with low back pain for more than 3 months (pain felt between t12 and the gluteal fold). 3. patient with chronic low back pain 4. normal body mass index from 18 -25kg/m2. exclusion criteria: * the subjects will be excluded if they have any of the followings: 1. lumbar discogenic lesions or any inflammatory arthritis, tumors, infection involving the lumbar spine. 2. patients with decreased range of motion secondary to congenital anomalies, muscular contracture, or bony block. 3. previous lumbar or hip surgery or trauma. 4. any hip structural abnormality such as malformations, impingements and degeneration. 5. patients with cognitive impairments that would limit their participation

Keywords: chronic non specific low back pain integrated nouromuscular inhibition technique instrument assisted soft tissue mobilization technique
supplementary food on prevention of moderate malnutrition in children

Conditions: Moderate Acute Malnutrition (MAM)

Summary: the study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (mam) in preschool mildly malnourished children. children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. the study will last 12 months


Eligibility criteria:
inclusion criteria: * (2-5 years old), who are from low socioeconomic classes (e and d classes) * reside in rural areas, and with whz- between \> -3 and ≤ -2, and * informed consent given by the subject's mother or caregiver exclusion criteria: * severe acute malnutrition (haz, waz and whz-scores ≤-3) based on the 2006 world health organization (who) reference values (24) * vitamin a deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter) * (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours). * current consumption of other supplementary foods. * peanut or other ingredient allergy based on prior report. if some direct family member is allergic to peanuts, child would not be enrolled.
pilot study to examine the post-dose changes in exhaled nitric oxide (eno) following treatment with fluticasone propionate (fp)/salmeterol (sal) combination product advair

Conditions: Asthma

Summary: to examine the post-dose changes in exhaled nitric oxide (eno) following treatment with inhaled advair in subjects with chronic but stable asthma as defined in global initiative for asthma (gina) guidelines.


Eligibility criteria:
inclusion criteria: * must be able to speak, read, and understand english * exhaled nitrous oxide levels must be greater than or equal to 60 ppb at screening and greater than or equal to 55 ppb at visits 2, 9, and 16 * must have history of at least 6 months of chronic, but stable asthma * except for the presence of asthma, subjects must be in general good health exclusion criteria: * past or present history of experiencing allergic reaction to medications used in this study * subjects must not be receiving ongoing regular treatment with inhaled corticosteroids * subjects must not have ragweed allergy * subjects must have no recent history of respiratory infections for at least 1 month prior to screening and until the end of the study