Kornimate/medical-research-clean huggingface dataset:
silver graft all comers registry

Conditions: Aneurysm; Graft Failure; Graft Infection

Summary: this web based e-registry will be international, multi-center and prospective. silver graft e-registry to assess the long term clinical benefit of silver graft in an unselected patient population

to assess the long term clinical benefit of silver graft in an unselected patient population with peripheral artery occlusive disease (paod) fulfilling one of the the following criteria: 1. any suitable patient in need of an infrarenal vascular reconstruction with fontaine class iib or indicated vascular reconstruction aneurysm repair. or 2. any suitable patient with an increased risk for early graft failure except those mentioned under (3). these may include * diabetics * fontaine class\> iib * patients of advanced age (≥75 y) * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l) * patients with copd or documented coronary artery disease (prior pci, prior cabg, documented myocardial ischemia) * patients with major amputation * immunosuppressed patients * patients with autoimmune disease, malignancy or 3. any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction.

Eligibility criteria:
inclusion criteria: 1. any suitable patient in need of an infrarenal vascular reconstruction with fontaine class iib or indicated vascular reconstruction aneurysm repair. 2. any suitable patient with an increased risk for early graft failure except those mentioned under (3). these may include * diabetics * fontaine class\> iib * patients of advanced age (≥75 y) * patients with renal insufficiency (creatinine ≥ 1.50 mg/dl or ≥130 µmol/l) * patients with copd or documented coronary artery disease (prior pci, prior cabg, documented myocardial ischemia) * patients with major amputation * immunosuppressed patients * patients with autoimmune disease, malignancy 3. any suitable patient with graft infection or present infection in the anatomical position of indicated vascular reconstruction. exclusion criteria: * any patient with common contraindications for vascular surgery may not be included in this registry. * any patient with an estimated life expectancy less than the first follow-up period, i.e. 12 months is excluded from data entry. * any patient with a known and documented allergy to silver or silver ions.
everolimus-eluting bioresorbable scaffolds versus everolimus-eluting metallic stents for diffuse long coronary artery disease

Conditions: Percutaneous Transluminal Coronary Angioplasty

Summary: the purpose of this study is to determine whether absorb bioresorbable vascular scaffold is non-inferior to xience everolimus-eluting cobalt-chromium stent with respect to target-lesion failure (tlf) at 1 year.


Eligibility criteria:
inclusion criteria: * age 18 and more * diffuse long native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 40 mm requiring at least 2 overlapped stents with a reference-vessel diameter of 2.5 to 3.75 mm on visual assessment * patients with silent ischemia, stable or unstable angina pectoris, and acute myocardial infarction including nstemi or stemi * the patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site exclusion criteria: * subject has known hypersensitivity or contraindication to device material and its ingredients (everolimus, poly(l-lactide), poly(dl-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated * subject has known allergic reaction, hypersensitivity, or contraindication to aspirin; to clopidogrel and prasugrel and ticagrelor; or to heparin and therefore cannot be adequately treated with study medication * an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 12 m after the procedure * stemi requiring primary percutaneous coronary intervention * cardiogenic shock * restenotic lesions * left main * extreme angulation (≥90°) or excessive tortuosity (≥two 45° angles) proximal to or within the target lesion * heavy calcification proximal to or within the target lesion * compromised left ventricular dysfunction (lvef \<30%) * at the time of screening, the subject has a malignancy that is not in remission * terminal illness with life expectancy \<1 year * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period * patient's pregnant or breast-feeding or child-bearing potential

Keywords: bioresorbable vascular scaffold coronary artery disease
prospective follow-up of patients with glycogen storage disease type iii

Conditions: Neuromuscular Disorders

Summary: the aim of this study is to improve knowledge of natural history and methods of monitoring the evolution of glycogen storage disease type iii regarding the muscle and to study the prospective approach of large series of patients, and using the same protocol for the follow up of the children and adults.


Eligibility criteria:
inclusion criteria: * patients with a debranching enzyme deficiency confirmed by enzymatic analysis (debranching enzyme deficiency). * written consent * age: at least 10 years * affiliated with a social security system exclusion criteria: * pregnant and lactating women

Keywords: neuromuscular disorders gsd iii glycogen storage disease
preventive ablation of ventricular tachycardia in patients with myocardial infarction

Conditions: Ventricular Tachycardia

Summary: the berlin vt study is designed to evaluate the impact of prophylactic ventricular tachycardia (vt) ablation on all-cause mortality and unplanned hospital admission for congestive heart failure or symptomatic ventricular tachycardia/ventricular fibrillation (vf) when compared to vt ablation after the third appropriate implantable cardioverter-defibrillator (icd) shock.


Eligibility criteria:
inclusion criteria: 1. history of remote myocardial infarction 2. left ventricular ejection fraction ≥ 30 to ≤ 50 % as estimated by cardiac mri, 3d-echocardiography or via ventriculography within 30 days before enrollment 3. documentation of sustained ventricular tachycardia (vt) by any kind of electrocardiography (ecg) including 12 lead ecg, holter ecg, rhythm strip, event monitoring, event recorder or pacemaker within 30 days before enrollment 4. implantable cardioverter-defibrillator (icd) indication for secondary prevention 5. patients who are planned to be implanted with biotronik icds (single, dual, triple chamber or dx device) 6. patient has provided written informed consent 7. patient accepts activation of home monitoring® exclusion criteria: 1. age \ 80 years 2. known arterial or venous thrombosis 3. class iv new york heart association (nyha) heart failure 4. valvular heart disease or mechanical heart valve precluding access to the left ventricle 5. acute myocardial reinfarction or acute coronary syndrome 6. cardiac surgery involving cardiotomy within the past 2 months 7. patients requiring chronic renal dialysis 8. thrombocytopenia or coagulopathy 9. incessant vt or electrical storm 10. bundle branch reentry tachycardia as the presenting vt 11. pre-existing implantable cardioverter-defibrillator (icd) 12. pregnancy or breast feeding women 13. acute illness or active systemic infection 14. other disease process likely to limit survival to less than 12 months 15. significant medical problem that in the opinion of the principal investigator would preclude enrollment in the study 16. unwillingness to participate or lack of availability for follow-up 17. participation in another interventional clinical investigation during the course of the study, i.e. the participation in a non-interventional clinical investigation is allowed.
diclofenac patch for treatment of mild to moderate ankle sprain

Conditions: Ankle Sprain

Summary: the primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. in this study, the location being studied will be either the left or right ankle. the secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

cerimon pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

Eligibility criteria:
inclusion criteria: * 18 to 75 years of age * has sustained a painful grade 1 or 2 ankle sprain (appendix h) no more than 48 hours prior to study entry * presence of pain of at least 5, with a maximum of 9, on an 11-point numerical rating scale (nrs) exclusion criteria: * grade 3 ankle sprain or bilateral sprain (see appendix h) * previous injury to the same ankle within 3 months prior to current injury * aspirin or short half-life nsaid use within 12 hours, or longer half-life nsaid use within 24 hours prior to study entry (appendix b) * opioid use within 24 hours prior to study entry * topical treatment, other than ice packs, applied to the painful region since time of injury * a history of peptic ulcer disease within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder * a history of, or evidence for, underlying disease in the injured ankle, such as osteoarthritis or gout * clinically significant, poorly controlled pulmonary, gastrointestinal, hepatic, renal, endocrine, or cardiovascular disease * a history of hypersensitivity to diclofenac or diclofenac-containing products * a history of intolerance to acetaminophen (rescue medication in this trial) * a history of skin sensitivity to adhesives (e.g. adhesive tape) * pregnant or breastfeeding women and women of child-bearing potential not using effective means of contraception
the effect of floorball on health and performance in subjects with lifestyle diseases

Conditions: Type2 Diabetes, Cardiovascular Diseases

Summary: to investigate the effect of floorball on health and performance in subjects with either type 2 diabetes or cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * diagnosed with a cardiovascular disease (bp \>140/90mmhg) * physical activity \<2 hours pr. week. * not participating in any regular physical activity the last 2 years exclusion criteria: * age \<18 years * injuries that prevent the subject from playing floorball * type 1 diabetics * alcohol \>14 units pr. week. * pregnancy * participation in other scientific studies * abuse of illegal drugs * other known serious diseases
plasma metabolic biomarkers for gastric cancer diagnosis

Conditions: Gastric Cancer

Summary: the aim of this observational study is to comprehensively analyze the metabolites in plasma samples from gastric cancer patients using advanced mass spectrometry detection technology, in conjunction with both broad-spectrum and targeted metabolomics approaches. the goal is to construct a dedicated plasma metabolite database for gastric cancer patients. simultaneously, we will delve into the exploration and validation of a series of metabolic biomarkers for early gastric cancer diagnosis. the objective is to establish a safer, more convenient, and more sensitive early screening method, thereby providing a reliable scientific foundation and critical evidence for improving the early diagnostic process for individuals at high risk of gastric cancer.

firstly, a wide-targeted metabolomic measurement will be conducted on plasma samples from the discovery cohort to identify potential metabolite candidate markers and construct a gastric cancer patient-specific metabolite database with extensive metabolite information. secondly, a more precise targeted metabolomic measurement will be conducted in the modeling cohort. bioinformatics methods will be used to conduct an in-depth analysis of a wide range of metabolite information to screen out metabolic marker combinations with high gastric cancer-specific diagnostic efficacy. ultimately, an external validation cohort will be introduced to validate these metabolic biomarkers, aiming to ensure reliability and stability across different patient populations.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gastric cancer or benign gastric diseases through gastroscopy and pathological examination. * collection of plasma samples prior to surgical treatment. * availability of complete clinical data. exclusion criteria: * previous reception of anti-tumor treatments (including radiotherapy, chemotherapy, etc.) before blood collection. * coexistence of other systemic tumors. * absence of plasma sample collection before surgical treatment. * incomplete clinical data. * pregnancy status.
predictive models of treatment responses and survival outcomes in patients with osteosarcoma

Conditions: Osteosarcoma

Summary: the aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with osteosarcoma and compared these models with currently available models.

the investigator performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven osteosarcoma. secondly, the investigator aimed to compare the predictive accuracy with currently available noninvasive model.

Eligibility criteria:
inclusion criteria: * receiving no treatment before diagnosis * with written informed consent exclusion criteria: * clinical data missing * without written informed consent
electrodermal patterns of arousal in children

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study was to explore the feasibility of detecting physiological patterns of arousal to sensory inputs in children with and without autism spectrum disorder (asd). accordingly, two questions directed this methodological research investigation: (1) is there a relationship between rest (tonic) and response (phasic) patterns of arousal among typically developing children and children with asd?, and (2) is there a difference in eda response to sensation between typically developing children and children with asd?

this methodological research design is a prospective exploratory test-retest design assessing the relationship between tonic and phasic electrodermal activity (eda) variables. eda during rest and in response to a variety of sensations was measured using skin conductance. descriptive statistics summarized eda dependent variable data using skin conductance response (scr) magnitude, scr amplitude, skin conductance level (scl), non-specific response (nsr) and habituation (hab). the data was used to assess the relationship between tonic and phasic patterns of arousal and compare response patterns between groups using the sensory challenge protocol (scp) in children with asd and typically developing children (td).

Eligibility criteria:
inclusion criteria: boys ages 4 - 11 years old. * able to sit for 30 minutes and follow simple directions. * children with confirmed autism spectrum disorder via school records or parent report. * typically developing children free of medical or neurological conditions. exclusion criteria: * medical or neurological conditions other than autism. * hearing loss or visual impairments. * children taking medications known to affect arousal. * children who are not able to follow simple commands.
efficacy and safety of plecanatide in children 6 to <18 years of age with irritable bowel syndrome with constipation (ibs-c)

Conditions: Irritable Bowel Syndrome With Constipation

Summary: this study of the efficacy and safety of plecanatide in children 6 to \<18 years of age with irritable bowel syndrome with constipation (ibs-c)

the purpose of this study is to evaluate the safety, efficacy and pharmacokinetic (pk) parameters of plecanatide of once daily oral 4 dose levels of plecanatide (0.5, 1.0, 2.0, or 3.0 mg) for 4 weeks as treatment in children 6 to \<18 years of age with ibs-c. the study will include a 28-day screening/baseline period, a 4 week treatment period, and a 2-week post-treatment follow-up period. patients/caregivers will visit the clinic 4 times during the study.

Eligibility criteria:
inclusion criteria a patient will be eligible for study participation if he or she meets all of the following criteria: 1. male or female child aged 6 to \< 18; 2. meets rome iv criteria for child/adolescent ibs-c 3. patient's parent/guardian/lar is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per irb guidance; 4. patient and patient's parent/guardian/lar demonstrates an understanding, ability, and willingness to fully comply with study procedures exclusion criteria a patient will be excluded from the study if he or she meets any of the following criteria: 1. the patient has a mental age \<4 years in the investigator's opinion; 2. the patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation; 3. the patient is pregnant or lactating; 4. the patient's mobility or normal exercise tolerance is compromised in the investigator's opinion; 5. the patient has been screened for or participated in another synergy study in the past; 6. the patient has a sibling that is currently participating or has participated in another synergy study.
the effect of combined spinal epidural anaesthesia on qtc interval undergoing cesarean section

Conditions: Analgesia

Summary: cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section. the most important side effects of spinal anaesthesia are problems such as hypotension, bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary retention. combined spinal-epidural (bsi) anaesthesia is the application of spinal and epidural anaesthesia together. high-dose local anaesthetics can cause significant hypotension when the epidural block is administered alone. the administration of spinal anaesthesia alone causes changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood pressure. sympathetic blockade leads to arterial vasodilation, and arterial resistance may decrease by 5-20% during spinal anaesthesia. due to the increased risk of maternal complications in obese pregnant, fetal morbidity and mortality have increased. in addition, supine hypotension syndrome is a common problem in obese pregnant women. the aim of this study is to compare the change in qtc interval in obese and non-obese term pregnancies planned for elective cesarean section with combined spinal epidural anaesthesia. thus, it is aimed to develop new protocols that will minimize cardiac pathologies during and after surgery in obese pregnant women.


Eligibility criteria:
inclusion criteria: * participants with bmi≥30 and bmi values between 18.5 and 24.9. exclusion criteria: * allergic to the drugs used in the study, * who do not accept regional anesthesia, * body mass index did not meet the inclusion criteria in the study, * under 150 cm in height, * who received treatment other than perinatal iron and vitamin drugs, * smoking or drinking alcohol, * with a known fetal anomaly, * with placental disorders such as placenta previa, * with multiple pregnancy * have renal or liver disease, * diagnosed with hypertension or preeclampsia, * uncooperative and previously treated or currently receiving treatment for a psychiatric disorder * mothers who do not want to participate in the study will not be included in the study.
microbial sampling of carious dentin

Conditions: Caries,Dental

Summary: the school of dentistry is seeking to determine whether viable microorganisms remain within tooth structure after conventional, mechanical removal of areas of tooth decay, prior to placement or replacement of tooth restorations (fillings). the long-term goal of the work is to decrease the failure rate, and therefore increase the longevity, of tooth restorations (fillings) in human patients and populations.

it is proposed that with informed consent, and in a sterile operating environment (controlled, micron level-filtered environmental air flow, in addition to conventional instrument sterilization) dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. the limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice. this last step, removal of tissue guided by estimated hardness, is as described above the universally accepted standard. following removal, the exposed dentin surface will be examined visually with an 15x operating microscope to detect any areas of discolored dentin. any such areas will be micro-sampled using ultra slow-speed, 0.2 mm diameter rotary cutting instruments and removal of resultant dentin flakes with sterile fibers. each prepared cavity will then be restored using conventional tooth filling materials and techniques. immediately after removal each dentin flake will be weighed, placed into bacterial transport medium, then sonicated. the transport medium will be divided in two, and separate samples added to bacterial growth medium under anaerobic and aerobic growth conditions. any viable microorganisms detected will be identified both by conventional plating techniques using visual identification, and by a commercial laboratory using rna analysis.

Eligibility criteria:
inclusion criteria: * aged 18-99, male or female, no significant systemic illness exclusion criteria: * diabetic, hypertensive, pregnant
compliance of diabetic patients treated with metformin

Conditions: Type 2 Diabetes Mellitus

Summary: metformin is the 1st line treatment in all subjects with type 2 diabetes without a contraindication to its use. the compliance with the use of metformin is not optimal mainly owing to relatively frequent gastrointestinal side effects. however, hard data about the real compliance are currently not available. in this trial we aim at assessing the compliance with metformin intake using a combination of serum metformin measurement and a specific questionnaire. we will further evaluate the impact of different pharmacological forms of metformin (standard vs. xr - extended release) on its compliance and try to identify common characteristics associated with reduced compliance.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus on metformin therapy for at least 3 months exclusion criteria: -