Kornimate/medical-research-clean huggingface dataset:
prophylactic intra-coronary adenosine to prevent post coronary artery stenting myonecrosis

Conditions: Coronary Artery Stenosis; Coronary Artery Disease

Summary: myocardial damage occurs in up to 40% of cases when sensitive biomarkers are measured after coronary artery stenting. such events have been associated with poor outcomes both at 30 days and long term. the cause of such damage is multi-factorial and includes distal propagation of atheromatous and thrombotic debris and the subsequent infiltration of the microcirculation with inflammatory cells. individually or together these events can occlude the micro-circulation and lead impaired blood flow to heart muscle. the vasodilator adenosine is commonly used in cases of impaired flow in an endeavor to improve flow rate and limit myocardial damage. unfortunately the efficacy of this therapy is limited. more recently, there have been clinical studies looking at the administration of adenosine before any potential damage by ballooning or stenting, in an effort to avoid poor distal flow post procedure and thus limit any myocardial damage. although small numbers of subjects have been included in these trials, there have been encouraging preliminary data. the aim of this study is to assess whether the use of intra-coronary adenosine given directly into the target coronary artery prior to stenting can reduce the incidence of myonecrosis (heart muscle damage)over placebo. we also aim to assess whether this translates to better outcomes at 30 day follow up.

prior clinical studies looking at the administration of adenosine before coronary artery stenting have looked at small numbers of subjects and did not mandate previous statin therapy or high dose loading of clopidogrel before stenting, both of which can also help lower the rate of peri-procedural myonecrosis. our aim is to assess the above mentioned therapy in patients on optimal treatment with statins, dual antiplatelet agents and standard of care anti-coagulants.

Eligibility criteria:
inclusion criteria: * patients undergoing percutaneous coronary balloon angioplasty and stenting * ages 18 years and older * timi iii flow on the initial angiography * native coronary artery lesions exclusion criteria: * patients unable to give consent * adenosine allergy * severe asthma with bronchial reactivity * cardiogenic or circulatory shock * acute or chronic total coronary artery occlusions * patients requiring rotablator therapy * in stent restenosis * second or third degree av block without a permanent pacemaker * st-elevation mi * elevated baseline ck/ ck-mb or troponin levels (pre-existing non-stemi) * current pregnancy * patients not already on statin therapy or intolerant of statins

Keywords: coronary artery disease coronary artery stenting peri-procedural myonecrosis adenosine
effect of intensive ldl-cholesterol targeting for elderly patients with cardiovascular disease: i-old trial

Conditions: Cardiovascular Disease

Summary: although there have been studies regarding intensive lowering of low-density lipoprotein (ldl)-cholesterol with high intensity statins in patients with cardiovascular disease, elderly patients were either excluded or accounted only a small portion of study subjects. therefore, this study sought to compare the clinical outcomes according to the ldl-cholesterol therapy targeting (intensive targeting \[ldl-cholesterol \<55mg/dl\] vs. conventional therapy \[moderate intensity statin therapy\]) in elderly patients with ≥75 years and documented cardiovascular disease.


Eligibility criteria:
inclusion criteria: 1. age ≥75 years 2. documented cardiovascular disease (at least 1 of the following) a. previous acute coronary syndrome (mi or unstable angina) b. or stable angina with imaging studies of coronary artery disease or functional studies of myocardial ischemia c. or coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft) d. or peripheral artery disease. exclusion criteria: 1. mi or stroke within 1 year 2. ldl-cholesterol level less than 55 mg/dl without statin therapy 3. active liver disease or persistent unexplained serum ast/alt elevation more than 2 times the upper limit of normal range 4. allergy or hypersensitivity to any statin 5. life expectancy less than 1 years 6. inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
the effect of ldl557 on improving degenerative arthritis in the elderly

Conditions: Arthritis; Joint Pain

Summary: this project is to conduct a clinical trial of synbio tech inc.'s ldl557 capsule for joint protection. to understand the improvement of joint discomfort and inflammation after supplementation, we hope to provide an updated choice for modern people's joint protection.


Eligibility criteria:
inclusion criteria: * bmi 18-40 kg/m2; * those with early stage degenerative arthritis symptoms judged by x-ray to be kellgren-lawrence grading scale level 1 or 2, and the physician determines that long-term treatment is not needed or womac score\>2.0 or womac total scale score\>12 or vas score ≦3. exclusion criteria: * smoking * alcoholism * diabetes * breastfeeding women and pregnant women. * those consuming dietary supplements were excluded. * those who use non-steroidal anti-inflammatory analgesics and those who have had joint surgery. * rheumatoid arthritis. * those who have had joint injections within 6 months. * those with cardiovascular and cerebrovascular, rheumatoid or mental diseases. * patients undergoing cancer treatment.
efficacy and safety of 8-weeks of glecaprevir/pibrentasvir in treatment-naïve adults with hcv genotype 1-6 and aspartate aminotransferase to platelet ratio index (apri) ≤1

Conditions: Hepatitis C Virus (HCV)

Summary: a study to evaluate the efficacy and safety of glecaprevir(gle)/pibrentasvir(pib) in treatment-naïve participants with chronic hepatitis c virus (hcv) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (apri) of less than or equal to 1.


Eligibility criteria:
inclusion criteria: * hepatitis c virus (hcv) genotype (gt) 1, 2, 3, 4, 5, or 6 infection. mixed gt and indeterminate gt may be acceptable. * aspartate aminotransferase (ast) to platelet ratio index (apri) score of less than or equal to 1, at time of screening. * does not have current active hepatitis b virus infection defined as: * positive hepatitis b surface antigen (hbsag), or * hepatitis b virus (hbv) deoxyribonucleic acid (dna) \> lower limit of quantification (lloq) in subjects with isolated positive anti-hepatitis b core (hbc) (i.e., negative hbsag and anti-hepatitis b surface\[hbs\]) * platelets ≥ 150,000 cells/mm³ * albumin ≥ lower limit of normal (lln) * positive anti-hcv antibody (ab) and plasma hcv ribonucleic acid (rna) viral load ≥ 1,000 iu/ml at screening and for at least 6 months before screening. * no past history/evidence of cirrhosis. * no history of hepatocellular carcinoma. * hepatitis c virus treatment-naïve (had not received a single dose of any approved or investigational anti-hcv medication). * if female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

Keywords: chronic hepatitis c virus (hcv) hepatitis hcv genotype aspartate aminotransferase platelet aspartate aminotransferase to platelet ratio index (apri) glecaprevir pibrentasvir sustained virologic response 12 weeks post dosing (svr12)
medtronic resolute onyx core (2.25 mm - 4.0 mm) clinical study

Conditions: Coronary Artery Disease

Summary: the purpose of this trial is to assess the safety and efficacy of the resolute onyx zotarolimus-eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.


Eligibility criteria:
inclusion criteria: * must be an acceptable candidate for percutaneous coronary intervention (pci), stenting, and emergent coronary artery bypass graft (cabg) surgery * must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study * must require treatment of either a) a single target lesion amenable to treatment or b) two target lesions located in separate target vessels * target lesion(s) must be de novo lesion(s) in native coronary artery(ies) exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * history of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative * history of a stroke or transient ischemic attack (tia) within the prior 6 months * active peptic ulcer or upper gastrointestinal (gi) bleeding within the prior 6 months * history of bleeding diathesis or coagulopathy or will refuse blood transfusions * concurrent medical condition with a life expectancy of less than 12 months * currently participating in an investigational drug or another device trial that has not completed the primary endpoint * documented left ventricular ejection fraction (lvef) \< 30% at the most recent evaluation
clinical development of mr spectroscopy and imaging in brain cancers

Conditions: Malignant Gliomas; Astrocytomas; Oligodendrogliomas

Summary: the investigators will examine the disease specificity of 2-hydroxyglutarate in non-glioma brain lesions, and the clinical utility of 2-hydroxyglutarate, glycine and citrate in isocitrate dehydrogenase (idh) mutated gliomas and idh wild type gliomas.

2-hydroxyglutarate (2hg) imaging will identify glioma, tumor progression and response to therapy noninvasively at an earlier time point than currently detectable with standard mr imaging. this utility of 2hg can be used for improving the patient care in a more effective manner when the 2hg imaging is incorporated in regular clinical mr scans in brain tumor patients. we aim to translate the 2hg mrs protocol into two clinical mr centers at utsouthwestern medical center: the mary nell and ralph b. rogers magnetic resonance center with philips 1.5tesla and 3tesla scanners and the algur h. meadows diagnostic imaging center with a ge 3tesla scanner. in addition, we will perform magnetic resonance (mr) scans in patients with neurological diseases that can mimic gliomas, including stroke, epilepsy, encephalitis, and brain metastases in order to establish the specificity of 2hg to malignant gliomas.

Eligibility criteria:
inclusion criteria: (120 brain tumor patients) * all races and ethnicities * must meet at least one of the 3 following criteria regarding diagnosis: * histological diagnosis of a brain tumor * pre-operative mr imaging suggestive of a brain tumor * radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem) * pretreatment evaluations required for eligibility include a medical history, physical examination, and neurological exam within 30 days prior to study entry. * patient must be able to provide study-specific consent prior to study entry and health insurance portability and accountability act of 1996 (hipaa) authorization. * karnofsky performance status \>70% * life expectancy greater than 3 months. (50 non-tumor neurological disorders) * all races and ethnicities * patients with clinically-proven multiple sclerosis, temporal lobe epilepsy, stroke, or encephalitis. (5 health volunteers) * 18-40 years of age * all races and ethnicities * excellent general health exclusion criteria: * under age 18 * cardiac pacemaker * intracranial clips, metal implants, or external clips within 50 cm from the head * metal in eye * pregnancy * claustrophobia * obesity or any other factors that provide difficulty with supine pose in the magnet * patients who are unable to provide informed consent * patients who are pregnant or nursing * patients with severe kidney dysfunction or uncontrolled cardiac dysfunction * patients who are claustrophobic or have other contraindication to mri, such as implanted pacemaker device, vascular clips, surgical clips, prosthetic valves, pace¬makers, otologic implants * patients with uncontrolled psychiatric manifestations of their brain tumor * patients for 7 tesla scans can have no metal in the body

Keywords: mrs biomarkers
screening of hereditary upper gastrointestinal cancer in china

Conditions: Improve the Screening Criteria of Chinese Hereditary Upper Gastrointestinal Tumors

Summary: through exploring the specific genetic mutations in the upper gastrointestinal tract tumors with a family history and specific clinical pathological types，we establish a complete family and follow-up system，in order to improve the screening criteria of chinese hereditary upper gastrointestinal tumors and carry on primary prevention of disease.


Eligibility criteria:
inclusion criteria: patients with gastric cancer, esophageal adenocarcinoma, or duodenal adenocarcinoma meet one of the following criteria: 1. age≤30; 2. age≤35，gastric cancer with special pathological types; 3. age≤50，≥one first-degree relative of a malignant tumor; 4. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative; 5. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis; 6. msi or dmmr of tissue specimen; patients with esophageal squamous cell carcinomas meet one of the following criteria: 1. ≥ two first-degree／second-degree relatives of a malignant tumor，and ≥one first-degree relative; 2. have ≥two types of malignancies，and age ≤50 at the first time of diagnosis; 3. msi or dmmr of tissue specimen; exclusion criteria: * patients do not meet one of the inclusion criteria;
the effects of strength and balance training on physical function in overweight children

Conditions: Obesity, Childhood

Summary: this intervention study aims to examine the efficacy of a school-based exercise programme to improve strength and balance in overweight and obese 7-11-year-olds in the united kingdom. the main question\[s\] it aims to answer are: * is the school-based exercise programme effective in improving lower limb muscular strength and balance control? * how do increases in strength and balance skills impact physical function, the risk to musculoskeletal health, and physical activity? participants will attend baseline, post-intervention, and follow-up testing that includes assessment of strength, balance, 3d gait, plantar pressure, physical function and physical activity. the intervention group will take part in physical activity sessions in their school for 1 hour twice a week for a total of 8 weeks. researchers will compare the intervention group to a control group that will take part in no-activity sessions and carry out their normal school and seasonal activities.


Eligibility criteria:
inclusion criteria: * overweight or obese exclusion criteria: -
cervical foraminal stenosis and radiculopathy - acdf versus minimal invasive posterior cervical foraminotomy.

Conditions: Radiculopathy

Summary: a prospective randomized clinical trial. cervical spondylotic foraminal stenosis with radiculopahty. comparison results between 2 treatment options: acdf and minimal invasive posterior cervical foraminiotomy. 80 patients to be followed for 2 years. parameters to study: ndi, vas, eq-5d, complications, health economics, recurrens of stenosis, movement of facet joints pre- and postoperatively (foraminotomy group).


Eligibility criteria:
inclusion criteria: * cervical radiculopathy on 1 or 2 levels correlated on mri and ct arm pain more than 30 (vas). duration more than 3 months. exclusion criteria: * myelopathy. soft disc hernia. previous neck surgery. tumors, infection, wad, trauma, generalized pain syndrome.

Keywords: cervical foraminal stenosis minimal invasive foraminotomy
gabapentin for bipolar & cannabis use disorders

Conditions: Bipolar I Disorder; Bipolar II Disorder; Cannabis Use Disorder; Substance Use Disorders

Summary: the proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain gaba/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (cud) and bipolar disorder (bd), using a medication that has been shown to increase cortical gaba (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional magnetic resonance imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with cud+bd.

bipolar disorder (bd) is the axis i condition most strongly associated with cannabis use disorder (cud); there is a six-fold increase in the prevalence of cud in individuals with bd relative to the general population. individuals with co-occurring cud and bd (cud+bd) have substantially worse clinical outcomes than those with either bd or cud alone. response to mood stabilizing medications appears to be poor, yet little is known about optimal treatment for cud+bd, as there have been no randomized medication trials for cud+bd to date. convergent evidence supports dysregulated brain γ-aminobutyric acid (gaba)/glutamate homeostasis as a candidate target for pharmacological intervention in cud+bd. preclinical and clinical studies have demonstrated that cud and bd are each associated with prefrontal gaba and glutamate disturbances and that impulsivity, a core neurobehavioral feature of both cud and bd and a key research domain criteria (rdoc) construct, is causally related to gabaergic/glutamatergic functioning. gabapentin has been consistently shown in preclinical research to modulate gaba and glutamate transmission. in human proton magnetic resonance spectroscopy (1h-mrs) studies, both acute and chronic gabapentin dosing have been shown to increase brain gaba levels, however, few studies have investigated gabapentin effects on glutamate levels. researchers propose that gabapentin may impact clinical outcomes in cud+bd individuals both directly and indirectly through their impact on impulsivity.

Eligibility criteria:
inclusion criteria: * meets dsm-v criteria for bipolar disorder * meets dsm-v criteria for cannabis use disorder * using at least one mood stabilizing medication exclusion criteria: * serious medical or non-inclusionary psychiatric disease * concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin * history of clinically significant brain injury * presence of non-mri safe material, or clinically significant claustrophobia.
propofol versus ketamine for moderate procedural sedation in the emergency department (ed)

Conditions: Sedation

Summary: this study is a clinical trial of moderate sedation with propofol versus moderate sedation with ketamine for procedural sedation in the emergency department.


Eligibility criteria:
inclusion criteria: * patients who require moderate procedural sedation with propofol in the ed exclusion criteria: * age \> 17 years * pregnant * intoxicated * cannot give informed consent * allergy to ketamine or propofol * patient will require deep procedural sedation * asa physical status score \> 2

Keywords: ketamine propofol procedural sedation moderate procedural sedation in the ed
a study in healthy men to test whether bi 409306, bi 425809 or lamotrigine can reverse the memory problems caused by ketamine

Conditions: Healthy

Summary: the main objective of this trail is to investigate if and to what extent bi 409306, bi 425809 and lamotrigine attenuate ketamine induced cognitive deficits.


Eligibility criteria:
inclusion criteria: 1. healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (bp, pr), 12-lead ecg, and clinical laboratory tests 2. age of 18 to 55 years (inclusive) 3. bmi of 18.5 to 32 kg/m2 (inclusive) 4. signed and dated written informed consent prior to admission to the study, in accordance with gcp and local legislation 5. male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion: * use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration, or barrier method (e.g. diaphragm with spermicide) * sexually abstinent * vasectomised (vasectomy at least 1 year prior to enrolment) * surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) * postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea exclusion criteria: 1. any finding in the medical examination (including ecg) deviating from normal and assessed as clinically relevant by the investigator 2. repeated measurement of systolic blood pressure outside the range of 100 to 140 mmhg, diastolic blood pressure outside the range of 50 to 90 mmhg, or pulse rate outside the range of 50 to 90 bpm 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease assessed as clinically relevant by the investigator 5. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 6. cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair) 7. history of diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders 8. history of relevant orthostatic hypotension, fainting spells, or blackouts further exclusion criteria apply