Kornimate/medical-research-clean huggingface dataset:
retrospective analysis of the effect of in-hospital initiation of pcsk9i on clinical outcomes in chinese acs patients

Conditions: Acute Coronary Syndrome

Summary: the objective of this study is to investigate the effectiveness of in-hospital initiation of alirocumab combined with statin ± ezetimibe on major cardiovascular events (mace) in chinese acs patients. the main question it aims to answer is: whether early initiation pcks9i in hospital could reduce recent cardiovascular event risk in chinese acs patients in real-world setting. data from cca database-chest pain center were screened for all acs patients from 01-jan 2021 to 31-dec 2023. patients diagnosed with stemi, nstemi or ua at admission were identified at the first step. then, for intervention group, patients who received alirocumab 75mg combined with statin ± ezetimibe during the acs hospitalization (including the discharge date) will be included; for control group, patients who received statin ± ezetimibe during the acs hospitalization will be included. all enrolled patients were required to have at least one documented follow-up visit.


Eligibility criteria:
inclusion criteria: * patients diagnosed with acute coronary syndrome (acs) upon hospital admission. * patients aged 18 years or older. * patients who received alirocumab 75 mg in combination with statin therapy ± ezetimibe as the intervention group, and those treated exclusively with statin therapy ± ezetimibe as the control group, either during hospitalization or at discharge. * patients with at least one follow-up record. exclusion criteria: * patients who received evolocumab treatment at any time. * patients who received inclisiran treatment at any time.
effect of local application of simvastatin versus bone powder on implant bone changes

Conditions: Dental Caries Extending to Pulp; Dental Implant Failed

Summary: this study is conducted a- to investigate that prf loaded with osteopromotive pharmacological drug can be a great aid in implant rehabilitation, and whether it could be a replacement for the other high price bone graft materials or not. this will be done through: 1. measuring bone changes around the implant by cone beam 2. measuring change in bone density around the implants b- evaluate the effect of statins on osteoblasts activity and expression of various osteogenic products in vitro.

twenty four patients requiring rehabilitation by immediate implantation in an extraction socket were recruited for this study. the patients were divided into three groups (n=8), for the first group; immediately after extraction, prf alone was added into the extraction socket prior to implant insertion. for the second group, prf + 1.2mg statin powder are inserted into the extraction site before implant insertion. for the third group; prf + bone powder are inserted into the extraction site before implant insertion. a conebeam ct was used to evaluate the effect on bone changes and bone density around implant sites, for every patient in all implant groups immediately after the surgery and at follow-up time. in vitro experiment: isolation of human adipose mesenchymal stem cells (had-mscs), characterization and osteogenic differentiation will be done. the cells were divided into two groups one control group and the other statin group. osteogenic markers were measured in both groups and statistical analysis performed

Eligibility criteria:
inclusion criteria: * badly broken down tooth requiring extraction * medically free * any other procedures or surgeries were performed 6 months earlier exclusion criteria: * patients with systemic diseases affecting bone quality or resorption * temporomandibular joint dysfunction * severe attrition or parafunctional habits * patients undergoing radiotherapy or chemotherapy * heavy smokers * vulnerable groups like psychologically unstable patients.
glycaemic control of monthly laps-exendin versus placebo in subjects of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the optimal dose or doses of hm11260c, when administered once a month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * ages eligible for study : 18 years to 74 years * genders eligible for study : male and female * diagnosed with t2dm * taking a stable dose of metformin monotherapy * hba1c levels of between ≥ 7.0% and ≤ 10.0% * females of childbearing potential who are not pregnant and agree to use a reliable method of birth control * written informed consent must be obtained exclusion criteria: * pregnant or nursing (lactating) women * diagnosis of type 1 diabetes mellitus * uncontrolled diabetes defined as a fpg level of \> 240 mg/dl at screening * a significant change in body weight in the 3 months before screening * any history of gi intolerance * personal or family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc * known history of acute or chronic pancreatitis * a history of alcohol or drug abuse or drug addiction
ak-r215 pharmacokinetic study phase i

Conditions: Healthy

Summary: an open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the pharmacokinetics characteristics of ak-r215

an open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the safety and pharmacokinetics characteristics after administration of fixed dose combination or loose combination of ak-r215 in healthy adult male or menopausal female volunteers

Eligibility criteria:
inclusion criteria: * bw is above 50kg and bmi is between 18.5 and 30.0 * subject who agreed and signed on informed consent form prior to the study participation exclusion criteria: * presence or history of clinically significant disease * treatment history of any drug which might affect ip within 10days * history of other study drugs within 12weeks
endogenous glp-1 secretion on islet function in people with and without type 2 diabetes

Conditions: Healthy; Type 2 Diabetes

Summary: glp-1 is a hormone made by the body that promotes the production of insulin in response to glp-1 is produced within the islets expressing prohormone convertase 1/3eating. however, there is increasing evidence that this hormone might help support the body's ability to produce insulin when diabetes develops. the purpose of this study is to determine the effect of endogenous glp-1 secretion on insulin secretion in people with and without type 2 diabetes.

accumulating evidence suggests that in rodents and humans glp-1 is synthesized within islets and may act locally in a paracrine fashion. indeed, mice with genetic loss of intra-islet glp-1 exhibit decreased insulin secretion and impaired response to metabolic stressors. 'pancreatic' glp-1 may contribute to the effects of dpp-4 inhibitors in rodents and humans. antagonism of glp1r with exendin-9,39 during fasting impairs the islet cell response to an i.v. glucose challenge. islet glp-1 content is increased in t2dm and in islets from non-diabetic humans exposed to hyperglycemia and free fatty acids. these observations imply that paracrine glp-1 secretion supports islet function in the presence of glucolipotoxicity. in this experiment we will examine the role of endogenous glp-1 secretion in people with and without t2dm and during β-cell stress induced by ffa elevation.

Eligibility criteria:
inclusion criteria - non-diabetic subjects: * weight-stable, non-diabetic subjects exclusion criteria - non-diabetic subjects: * age \ 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). * hba1c ≥ 6.5% * use of glucose-lowering agents. * for female subjects: positive pregnancy test at the time of enrollment or study * history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * active systemic illness or malignancy. * symptomatic macrovascular or microvascular disease. inclusion criteria - diabetic subjects: * weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy exclusion criteria - diabetic subjects: * age \ 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose). * use of any glucose-lowering agent other than metformin. * 2 or more fasting glucose values \> 250mg/dl on medication or after medication withdrawal. * unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study. * for female subjects: positive pregnancy test at the time of enrollment or study * history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * active systemic illness or malignancy. * symptomatic macrovascular or microvascular disease.
learning by repetitive viewing of peer modeling patient education videos by adults with down syndrome

Conditions: Down Syndrome; Trisomy 21

Summary: the learning of appropriate hand washing technique through repetitive watching of a video depicting an adult with ds washing his hands will be studied.

this study is a next step in evaluating the use of videos depicting a person with ds demonstrating hand washing. the initial study demonstrated improvement in hand washing technique with a verbal explanation of hand washing technique using an illinois department of public health handout and viewing one of the handwashing videos one time. the study demonstrated a statistical significant difference between learning by viewing the handout and a video of an adult with ds washing his hands vs just viewing the handout.viewing a handout likely due to small sample size, the study did not demonstrate statistical significance between watching the video of a person with ds washing his hands vs watching the other videos but the trend for the best improvement in handwashing technique was for the group viewing another person with ds demonstrating the handwashing. the hypothesis of this study is that repeated viewing of a video and practicing hand washing will lead to even greater improvement in hand washing technique.

Eligibility criteria:
inclusion criteria individuals with: * ds aged 18 and older * the ability to use a checklist or to be taught how to use a checklist * the ability to use a tablet or to be taught how to use a tablet * access to an internet connection exclusion criteria individuals who: * are not yet adults * are unwilling to consent and/or assent * are unable or unwilling to return the adsc for the 1 month and 2 months follow up visits * sensitivity to soap
combination of hyperthermia and concurrent chemoradiotherapy (ccrt) in treatment failure solid tumors

Conditions: Solid Tumors

Summary: the primary goals of hyperthermia combined with chemotherapy/radiotherapy on treatment failure solid tumors are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.

the goal of this study is to conduct a phase ii clinical trial evaluating the safety and efficacy of combination of low temperature (40-43℃ range) hyperthermia and concurrent chemoradiotherapy (ccrt) in treatment failure solid tumors. there are 3 reasons of conducting this clinical trial. firstly, it has been demonstrated that hyperthermia can enhance the efficacy of chemotherapy, radiotherapy or chemoradiotherapy in various cancers, with acceptable safety profiles. secondly, the salvage outcomes for treatment failure solid tumors were frustrated. thermal enhancement ratio (ter) was observed when using hyperthermia combining radiotherapy or chemotherapy. this strategy should be investigated in its efficacy in treating those failing from previous standard treatment and maybe several times of salvage therapy. thirdly, biologically reciprocal complementation between hyperthermia, chemotherapy and radiotherapy was observed. the reason may be complicated, including theories involving hypoxia, immunomodulation and reperfusion ... etc. if the immunity microenvironment could be improved by addition of hyperthermia, an unexpected survival benefit as compared with the literature may be potentially demonstrated from this study.

Eligibility criteria:
inclusion criteria: 1. age of 20-85 years, with ecog performance 0-2. 2. treatment failure solid tumor(s), with histologically or clinically confirmed recurrence or progression after primary treatment of either single modality of surgery, chemotherapy or radiotherapy or any combinations. 3. complete surgical excision is not feasible as salvage treatment for the recurrent or progressive tumor(s), or the patient does not agree to receive the surgical procedure. 4. salvage radiotherapy is possible, and a total dose of 50gy/22fx is considered tolerable. 5. measurable lesions by image examinations or endoscopy within 2 months. 6. the distribution of the lesions of interest does not exceed 20cm range. 7. the patient can tolerate implementation of cisplatin and taxotere weekly therapy, with respect to hematopoietic status, renal function, liver function, allergy and other potential adverse effects. exclusion criteria: 1. re-irradiation of 50gy/22fx is considered not tolerable. 2. future tumor response to treatment in this study is not possibly evaluated using image examinations or endoscopy. 3. the patient is participating in other clinical trials. 4. future regular clinical follow-up is not possible. 5. the patient has large-area metallic implants within hyperthermia field (not including metallic hemoclips with small area and few numbers). 6. the patient has pacemakers.

Keywords: treatment failure
using patients' social contact to improve out-patient endoscopy among blacks

Conditions: Compliance; Colon Cancer

Summary: non-attendance to out-patient endoscopic procedures is high among underserved blacks. the overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist. improved adherence and better quality of procedures are postulated with involvement of social contacts.

the overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks. these are three sub-projects: project 1: involves recruiting 400 patients referred for colonoscopy by their primary care physicians project 2: involves recruiting 400 patients scheduled for colonoscopy by their endoscopist project 3: involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists

Eligibility criteria:
inclusion criteria: * patients referred for out-patient colonoscopy by primary care physicians * patients scheduled for out-patient screening colonoscopy * patients scheduled for out-patient upper endoscopy exclusion criteria: * patients who were referred for colorectal cancer (crc) screening as in-patients * patients with personal history of familial adenomatous polyposis syndrome (fap) * patients with family history of hereditary non-polyposis colorectal cancer syndrome (hnpcc) * patients with inflammatory bowel disease * patients with crohn's disease * patients with ulcerative colitis * patients with personal history of crc * patients who have had colonic resection

Keywords: colonoscopy upper endoscopy adherence disparities
intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in open rhinoplasty

Conditions: Intraoperative; Ketamine; Magnesium Sulfate; Postoperative Analgesia; Rhinoplasty

Summary: the study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.

postoperative pain remains one of the most crucial factors affecting patient satisfaction. these symptoms can be distressing for the patient and it may lead to negative psychological implications. ketamine is a non-competitive n-methyl d-aspartate (nmda) receptor antagonist that works by blocking the nmda receptors in the central and peripheral nervous systems. magnesium sulfate is also an antagonist for nmda receptor that has been evaluated in several studies and showed that mg sulfate decreased consumption of postoperative opioids. ketamine and magnesium sulfate have different sites of action on nmda receptors, so their combination may produce a synergistic effect on nmda receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years. * both sexes. * american society of anesthesiologists (asa) physical status i - ii. * scheduled for rhinoplasty under general anesthesia. exclusion criteria: * receiving analgesic or any medications since 48 hours before the surgery. * drug addiction. * cardiovascular disease. * respiratory disease, renal, liver, metabolic and neurological disease. * pregnancy or breast feeding. * asthma.
psychologically informed education intervention for adolescents with atraumatic lower-extremity injuries

Conditions: Leg Injury

Summary: this is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. a set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). after participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through redcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.


Eligibility criteria:
inclusion criteria 1. age between 12 and 17 years 2. atraumatic lower extremity pain for \>4 weeks exclusion criteria 1. suspicion or evidence of complete tendon or ligamentous tear. 2. current fracture in the lower extremity. 3. prior history of surgery in the lower extremity. 4. neurologic or developmental disorder, which alters lower extremity function. 5. numbness and tingling in any lumbar dermatome. 6. red flags present for non-musculoskeletal involvement (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing).

Keywords: adolescent atraumatic education patellofemoral tendinopathy apophysitis overuse
a study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody vyd222 in healthy adult participants

Conditions: COVID-19

Summary: a study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody vyd222 in healthy adult participants.

this is a phase i, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of vyd222, a monoclonal antibody targeting sars-cov-2, in healthy adult volunteers. the primary objective is to evaluate the safety and tolerability of multiple dose levels of vyd222 after a single administration in healthy participants. the secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of vyd222 after administration in healthy participants.

Eligibility criteria:
inclusion criteria: * has a body mass index 18.5 to 32.0 kg/m2, inclusive. * negative for current sars-cov-2 infection by rapid antigen test on day -1. * is seropositive to n and/or s sars-cov-2 antigens at screening. * for participants assigned female sex at birth: is not of childbearing potential or is of childbearing potential and practicing highly effective contraception. * is able and willing to provide written informed consent. * note: other protocol defined inclusion/exclusion criteria apply exclusion criteria: * intends to receive a covid-19 vaccine/booster within 3 months of day 1. * is pregnant, breastfeeding, or seeking pregnancy while on study. * has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured. * has had any symptoms of acute respiratory illness (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing. * has evidence of active infection with hiv, hbv, or hcv. * has donated more than 500 ml of blood within 60 days before the scheduled dose of study drug. * had major surgery within 30 days prior to study drug dosing or planned surgeries within 12 months after planned study drug dosing. * received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to screening or planned administration of any investigational drug or biologic during the study period. * received immunoglobulin or blood products within 6 months prior to screening. * previously received a mab within 6 months or 5 half-lives (whichever is longer) prior to screening. * note: other protocol defined inclusion/exclusion criteria apply
registration trial of the drug-coated balloon for the symptomatic cerebral atherosclerotic stenosis

Conditions: Cerebral Atherosclerotic Stenosis

Summary: the purpose of the trail is to determine whether dcb is superior to conventional balloon in treating cerebral atherosclerotic stenosis


Eligibility criteria:
incsion criteria: * age 18 to 80 years old at informed consent signing. * symptomatic atherosclerotic stenosis of cerebrovascular arteries with ≥70% stenosis. * medication ineffective. * modified rankin scale(mrs) score≤2. * the subject or guardian is able to understand the purpose of the study, is willing to participate and has given written informed consent. exclusion criteria: * history of acute ischemic stroke within 2 weeks; * stenosis due to non-atherosclerotic lesions such as arterial dissection, moya-moya disease and vasculitic disease; * target vessels complete occlusion or with thrombus in target vessels; * target vessel with severe calcification or distortion that making interventional device is difficult to place; * history of stenting in the target artery; * target vessel restenosis following stenting or balloon angioplasty; * combined with other lesion with ≥70% stenosis in target vessel. * residual stenosis ≥50% or vessel dissection with obvious blood flow restriction occurs after predilation. * combined with intracranial tumour, arteriovenous malformation or aneurysm of the target vessel. * history of intracranial hemorrhage within 90days. * presence of severe systemic diseases that cannot tolerate surgery, such as severe liver and kidney dysfunction; * contraindication to the use of anticoagulants and antiplatelet agents, such as sllergy to anticoagulants and antiplatelet agents, active bleeding or coagulation disorders; * allergic to contrast agents or rapamycin; * pregnant or lactating women; * participating or intending to participate in any other drug/device clinical trials; * life expectancy \<1 year; * any other conditions that the investigator deems the patient unsuitable for enrollment.