Kornimate/medical-research-clean huggingface dataset:
nonpolymer- and polymer-based drug-eluting stents for restenosis (isar-test-1)

Conditions: Coronary Disease

Summary: the purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.

drug-eluting stents represent a major advance in the treatment of restenosis. they have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtained in various patient subsets, these devices are now used in almost 90% of the stent implantation procedures performed in us hospitals. along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data, concern has arisen regarding the safety of these devices. at the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents. a growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery. recently, we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations. using a porcine coronary model of restenosis, we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation. more recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. while the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable, their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated. comparison: polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents

Eligibility criteria:
inclusion criteria: * patients at least 18 years old * stable or unstable angina or a positive stress test * "de novo" coronary artery lesions * written informed consent exclusion criteria: * myocardial infarction within 48 h. before enrollment * target lesion located in left main trunk * contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel
cognitive decline in ad

Conditions: Alzheimer Disease

Summary: there is lack of information on the risk factors of accelerated cognitive decline in older people with alzheimer disease (ad). the extent of neurodegeneration and white matter disease has been reported to be important factors. in addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. the impact of care arrangement and physical activity may also be important. insulin signaling is impaired in alzheimer disease (ad). we therefore propose to perform a cohort study of older people with ad. this will be based on an on-going ad registry which was designed to identify genetic biomarkers for ad. detailed neurocognitive tests and lifestyle information are available. in addition, volumetric mri brain scans were performed in all ad subjects. the hypothesis is that mri brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with ad. the objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in ad.


Eligibility criteria:
inclusion criteria: * sufficient cantonese competency for cognitive test * clinical diagnosis of ad * fast test staging 3-5 exclusion criteria: * subjects who refuse blood taking procedure * no reliable family caregiver informant (person contact at least once a month)
podocyturia as predictive factor for pre-eclampsia

Conditions: Pre-Eclampsia

Summary: pre-eclampsia is an hypertensive disorder appearing during pregnancy, inducing serious maternal, fetal and neonatal mortality and morbidity. podocyn could be identified in the urine, before proteinuria, a key element in the diagnostic of pre-eclampsia. preventive treatment using aspirin could be administrated in early pregnancy. we hypothesized that podocyturia could be an early indicator of preeclampsia. this is a prospective, non-interventional, monocentric study.


Eligibility criteria:
inclusion criteria: * women aged 18 years or more * single pregnancy * first planned prenatal visit before 16 weeks of gestation * planned delivery at hôpital femme mère enfant in lyon, france * patient receiving information and non opposition to participate exclusion criteria: * multiple pregnancy * pregnancy stopped * antecedent of nephropathy * inability to understand information provided * prisoner or under administrative supervision * fetal malformation, chromosomal anomalies * preterm delivery for other reason that any hypertensive disorder of pregnancy or intrauterine growth restriction
hemogram parameter changes with sepsis filter

Conditions: Platelet Abnormality; Renal Failure; Immune System Disorder

Summary: hemodiafiltration is initiated in hemodynamically unstable patients in intensive care units. in some patients, additional devices called cytokine filters or sepsis filters are added to remove inflammatory cytokines. data obtained from hemograms, such as platelet lymphocytosis ratio, are used in the diagnosis or prognosis of many diseases. this study focuses on the change in hemogram rates in patients who received hemofiltration and sepsis filters.


Eligibility criteria:
inclusion criteria: * data of patients who were monitored in the intensive care between january 2020 and december 2022 and who were applied sepsis filters exclusion criteria: * -patients who underwent hemodiafiltration with sepsis filter but could not be followed for 72 hours (death, etc.)
polydeoxyribonucleotide for elbow lateral epicondylitis

Conditions: Lateral Epicondylitis; Extracorporeal Shockwave Therapy; Muscle Strengthening

Summary: the goal of this clinical trial is to investigate the synergistic effect of polydeoxyribonucleotide (pdrn) on extensor muscle strengthening exercise (emse) combined with extracorporeal shockwave therapy (eswt) for treating lateral epicondylitis (le) of the elbow in adults aged 18 to 65 years. the main questions it aims to answer are: does the addition of pdrn improve pain reduction as measured by the visual analog scale (vas)? does the addition of pdrn enhance functional outcomes such as the mayo elbow performance score (meps) and hand grip strength index (hgsi)? researchers will compare two groups to see if pdrn provides additional benefits: group 1: emse + eswt + saline injection group 2: emse + eswt + pdrn injection participants will: perform extensor muscle strengthening exercises receive extracorporeal shockwave therapy receive either a saline injection or a pdrn injection at the first outpatient department visit attend follow-up visits at 6 and 12 weeks for assessments


Eligibility criteria:
inclusion criteria: adults aged 18 to 65 years diagnosed with chronic lateral epicondylitis (le) of the elbow willing to perform extensor muscle strengthening exercises able to attend follow-up visits at 6 and 12 weeks exclusion criteria: history of elbow surgery significant trauma to the elbow current use of corticosteroids for le current use of other treatments for le pregnant or breastfeeding women participation in another clinical trial within the last 30 days

Keywords: polydeoxyribonucleotide
gemcitabine/platinum containing regimens as preoperative chemotherapy for patients with non small cell lung cancer

Conditions: Carcinoma, Non Small Cell Lung

Summary: to study the efficacy and tolerability of gemcitabine/platinum chemotherapy in non small cell lung cancer


Eligibility criteria:
inclusion criteria: * histologically of cytologically confirmed non small cell lung cancer * no prior chemotherapy or radiation * no prior malignancy exclusion criteria: * pregnant or breastfeeding * serious concomitant systemic disorder
impact of an educational personalized clinical support device preventive and a referent nurse in surgery for obesity

Conditions: Dumping Syndrome

Summary: the postprandial dumping syndrome is a frequent consequence of roux-en-y gastric bypass due to the rapid emptying of the stomach remnant in to the intestinal lumen. dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. this syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. we hypothesize that a personalized approach based on dietary and nutritional recommendations conducted by a nurse would likely to decrease the frequency of dumping syndrome and improve the postoperative quality of life of patients in the early postoperative period.

the roux-en-y gastric bypass is considered the gold standard of weight loss surgery and is the most commonly performed bariatric procedure worldwide.the postprandial dumping syndrome is a frequent consequence of gastrojejunal anastomosis due to the rapid emptying of the stomach remnant in to the intestinal lumen. dumping-related symptoms occur very early after eating (within 30 minutes), are not associated with concurrent hypoglycemia, and are most prominent in the early postoperative period. the symptoms of dumping syndrome include nausea, abdominal cramps, diarrhea, dizzy spells, weakness and cold sweats either with or after eating.this syndrome very debilitating for the patient can be improved by dietary and nutritional recommendations. we hypothesize that an individualized approach based on dietary and nutritional recommendations and monitoring of patients conducted by a nurse in the first three months after surgery would likely to decrease these problems and improve the postoperative quality of life of patients.

Eligibility criteria:
inclusion criteria: * body mass index ≥40 kg / m2 or ≥35 kg / m2 in the presence of comorbidities related to obesity * indication to roux-en-y gastric bypass exclusion criteria: * contraindication to roux-en-y gastric bypass * refusal to sign the consent form * patient not affiliated to a social security system * pregnancy

Keywords: roux-en-y gastric bypass
prevalence of stuttering in children with adhd at sohag university hospital

Conditions: ADHD Children With Stuttering

Summary: the majority of the latest research suggests that stuttering is associated with significantly elevated levels of trait and social anxiety. the prevalence of children who stutter and have attention deficit/ hyperactivity disorder (adhd) ranges from 4 to 26%. about 10-20% of children who stutter might show adhd. gender ( male) is the dominant risk factor for stuttering, as also applies to other neurodevelopmental disorders. examples include attention deficit hyperactive disorder (adhd), conduct disorder, tics and the gilles de la tourette syndrome (gts). these neurodevelopmental disorders are the second -most prominent set of comorbidities with stuttering. attention-deficit hyperactivity disorder (adhd) and stuttering share many characteristics in addition to temperament . a complex interplay of neural differences, with genetic and environmental components, has been reported as a possible cause of both disorders. in addition, both may appear more frequently in boys than in girls . furthermore, it is emphasized that childhood stuttering can be accompanied by aspects of adhd . likewise, children exhibiting signs of adhd more frequently display speech disfluencies than their peers. it is suggested that children with stuttering and those without stuttering will display different profiles in terms of temperament, certain aspects of adhd, and some types of anxiety. in addition, it is to be expected that there will be some correlations between these variables in children who stutter. however, it is not possible to draw definite conclusions about this issue that could be generalized to all children who stutter. furthermore, there are very few studies that deal with combinations of these variables .


Eligibility criteria:
inclusion criteria: * all children with adhd exclusion criteria: * 1-children ageed below 6 years old. 2- children with adhd with other behavioral and neurological disorders.
effects of nopal fractions on postprandial glucose regulation and appetite variables in healthy humans

Conditions: Glucose Tolerance; Appetite Sensations

Summary: postprandial effects of nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial


Eligibility criteria:
inclusion criteria: * healthy * non-smokers * diet accordance with the nordic nutrition recommendations * bmi: 18.5-25 kg/m2 exclusion criteria: * metabolic disorders * food allergies * no probiotics or other food /supplement which may interfere with the study

Keywords: healthy subjects diabetes prevention obesity prevention
home use of cupping massage in chronic neck pain

Conditions: Neck Pain

Summary: the purpose of this randomized controlled study is to determine the effectiveness of cupping massage as home use for patients with chronic nonspecific neck pain compared to relaxation exercise.

see above

Eligibility criteria:
inclusion criteria: * mean neck pain intensity 45mm * neck pain for at least 3 months * age 18-75 * partner or friend for the application of the massage exclusion criteria: * specific neck pain due to trauma, neurological disorder, prolapse, operation, cancer * severe deformity of the spine * skin disease, allergy on the neck area * hemophilia, anticoagulation, antiplatelet disorder * severe psychiatric disorder * severe comorbidity * regular intake of opiates and corticosteroids \>10mg prednisolon * pregnancy * participation in other clinical trials
sedation efficacy and safety of remazolam besylate in ventilated surgical critically ill patients

Conditions: Effect of Drug; Adverse Drug Event; Mechanical Ventilation Complication; Critical Illness; Surgery; Sedation

Summary: a multi-center, prospective, randomized, double-blind, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ventilated patients after surgery compared to dexmedetomidine.


Eligibility criteria:
inclusion criteria: * 18-64 years old * must accept no-cardiac elective surgery * must under general anaesthesia * can be combined regional tissue anesthesia * must admitted to icu with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours * light or moderate sedation must needed exclusion criteria: * intracranial surgery or severe neurological or spinal cord disease * schizophrenia, epilepsy, and parkinson's disease * coma, severe dementia, or language barrier before surgery * cardiac dysfunction or arrhythmia * severe liver dysfunction(child-pugh c class) * severe kidney dysfunction * use of dexmedetomidine or remifentanil besylate 24 hours before or during surgery * pregnancy or lactation * any investigational drug useage 30 days before surgery * refuse to participant.
study of rsd1235-sr for the prevention of atrial fibrillation/atrial flutter recurrence

Conditions: Atrial Fibrillation

Summary: this study is designed to evaluate the safety, tolerability and preliminary efficacy of vernakalant (oral) in subjects with sustained atrial fibrillation of greater than 72 hours and less than 6 months duration


Eligibility criteria:
inclusion criteria (partial list): * subjects must have sustained, symptomatic atrial fibrillation for greater than 72 hours and less than 6 months duration * subjects must have adequate anticoagulant therapy exclusion criteria (partial list): * subjects may not have class iii or class iv congestive heart failure * subjects may not have uncorrected electrolyte imbalance

Keywords: afib af
cocoa extract for migraine trial

Conditions: Migraine

Summary: the goal of this clinical trial is to assess the feasibility of recruitment and adherence to a high-dose cocoa extract supplement in individuals diagnosed with episodic migraine. the main questions it aims to answer are: * will we be able to enroll 114 participants during the recruitment period? * will participants take study pills daily during the pill-taking period? researchers will compare two doses of cocoa extract to placebo to determine the acceptability of higher doses of cocoa extract supplementation in this patient population. participants will be asked to: * provide two urine samples * complete daily questionnaires * take four study pills a day for 12 weeks


Eligibility criteria:
inclusion criteria: * women and men aged ≥18 years * self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the international classification of headache disorders 3rd edition) * individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the american migraine study (ams) migraine screener. the ams migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status. * history of migraine dating for at least one year * self-report of 4 to 14 migraine attacks during the 30 days prior to enrollment in the study * completion of at least 22 headache diary days during the 28 day run-in period o report migraine frequency between 4 to 14 days during the 28 day run-in period * if currently using medications to prevent or treat migraine, no new medication use within the past 3 months * no new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial * be willing to complete all study procedures and be randomized to all interventional groups * be fluent in english * own an iphone or android device and be willing to download mycap to the device exclusion criteria: * self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder * kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol * current alcohol or substance abuse (self-reported) * self-reported clinician diagnosis of medication overuse headache * currently or recently (past 6 months) received botox treatment for migraine * failure to return the baseline urine sample * currently pregnant, nursing, or intending to become pregnant during the study period. * unwilling to forgo use of out-of-study supplements of cocoa extract during the trial * extreme sensitivity to caffeine

Keywords: migraine cocoa extract cocoa flavanol
de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle (choral)

Conditions: Mortality; Oral Health; Dryness, Mouth; Pain, Orofacial

Summary: the objective of the choral study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.

infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (icus). a commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. in this study 6 participating intensive care units (icus) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. the investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (vacs) and oral health status. a concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..

Eligibility criteria:
inclusion criteria: * all patients who receive mechanical ventilation in the participating icus. exclusion criteria: * does not meet inclusion criteria.
safety study of homeo-gh (bone marrow derived clonal mesenchymal stem cell) to treat acute/chronic graft versus host disease (gvhd)

Conditions: Graft-vs-Host Disease

Summary: official title: five-week, multi-center, phase i clinical trial to evaluate safety of homeo-gh after intra venus administration for the treatment of graft versus host disease patients sponsor: homeotherapy co.,ltd study design: single group, open label, 5 week, safety study this study is designed to evaluate the safety of ex-vivo cultured adult human clonal mesenchymal stem cells (cmsc) derived from human bone marrow in subjects experiencing acute or chronic graft-versus-host disease (gvhd). study type: interventional

allogeneic mscs being used in current human clinical trials are nonclonal, i.e., such mscs may have other types of cells in the final stem cell product. some concerns exist about the heterogeneity of these nonclonal mscs that are isolated and expanded by the conventional density-gradient centrifugation method. recently, we developed a new protocol, called the subfractionation culturing method (scm), to generate single-cell-derived clonal msc (cmsc) lines from whole bone marrow aspirate without employing any centrifugation step for mononuclear cells and enzyme treatment process. this method allowed us to rapidly establish single-cell-derived human clonal msc (hcmsc) lines from raw bone marrow aspirates and to establish a library of these hcmsc lines (song et al., 2008). the goal of this study is to evaluate the safety of allogeneic cmscs established by the scm and manufactured in gmp facility. this phase i clinical trial is a multicenter, single dose study of cmsc (1 x 10e6 cmscs/kg recipient's bodyweight). clonal mscs will be infused to acute or chronic gvhd patients via an intravenous injection. every patients will receive the same treatment

Eligibility criteria:
inclusion criteria: * informed consent obtained from patient * patients with ages greater than 18 years * neutrophill count \> 1,000 cells/mm3 * adequated cardiac function with no evidence of cardiac disease * patients who had complete remission after bone marrow transplantation * patients who can sign an informed consent form by him- or her-self or legal representative exclusion criteria: * patients with unstable transplant after bone marrow transplantation * patients with unstable vital sign * patients with positive penicillin skin test * patients who had transplantation to treat solid tumor * patients with bacterial, viral or fungal infection not being controlled by the adequate treatment (more than moderate infection) * patients who, in the investigator's point of view, are not in proper state for the treatment