Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of genoss® ses in patients with acute coronary syndrome (genoss acs)

Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention

Summary: the objective of this study is to evaluate the efficacy and safety of the genoss ses in patients with acute coronary syndrome (acs) in real-world pratice.

the genoss ses is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the genoss ses in acute coronary syndrome (acs) patients undergoing percutaneous coronary intervention. the genoss ses study is a prospective, single-arm, observational study for evaluation of clinical outcomes after genoss ses implantation in acs patients undergoing percutaneous coronary intervention from 10 sites in south korea. the primary endpoint was a device-oriented composite endpoint (doce), defined as a composite of cardiac death, target vessel-related myocardial infarction (mi), and clinically indicated target lesion revascularization (tlr) at 10 months.

Eligibility criteria:
\ 1. patients of 19 and over 2. patients with acute coronary syndrome treated with genoss ses 3. participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants. \ 1. patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents - however, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. patients with known anaphylaxis are excluded 2. patients who are pregnant or planning to become pregnant 3. patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration. 4. patients with a life expectancy of less than 1 year 5. patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment. 6. patients who have already received treatment with another des (drug eluting stent), bvs (bioresorbable vascular scaffolds), or bms (bare metal stent) at the time of registration. 7. patients currently participating in a randomized controlled trial involving medical devices.

Keywords: acs
assessment of infection control, practice efficiency, and health economics of sheathed versus standard cystoscopy

Conditions: Bacteriuria

Summary: the purpose of this research study is to compare the effectiveness and efficiency of using a sterile sheath (endosheath®) during cystoscopy versus a standard scope.

the increasing costs in health care and enhanced infection control requirements necessitate the efficient and reliable use of frequently used techniques like cystoscopy. the health economics of cystoscopy are dependent on maintaining low levels of post-cystoscopy sequelae like urinary tract infection (uti) and its potential precursors, significant asymptomatic bacteriuria and leukocytosis. another key component of the economics and efficiency of cystoscopy is the time and cost related to the reprocessing of these devices in preparation for re-use. the use of disposable endoscope sheaths may limit the need for high level disinfection (hld) between procedures and reduce reprocessing time and potentially prolong the cystoscope lifespan. the rationale for this study is to determine if a sheathed cystoscopy system would provide the desired cost and efficiency advantages compared to procedures done with non-sheathed cystoscopes. this is a prospective, randomized, parallel group, single center clinical trial to assess the clinical outcomes, practice efficiency and health economics of the use of sheathed cystoscopes (endosheath® system) compared to using standard (non-sheathed) cystoscopes. the study will evaluate the infection control (via the change in bacteriuria), clinical practice efficiency and costs of the endosheath technology with cst 5000 scope compared to standard cystoscopy with olympus visera elite otv-s190 digital flexible scope. there will be 30 subjects in the control group undergoing cystoscopy with the standard scope at the clinic, the olympus visera elite, and 30 subjects in the study group undergoing cystoscopy with the endosheath system. the study is designed as a prospective, randomized controlled trial. there will be no active blinding of clinicians or subjects; however, it is anticipated that most subjects will be unaware of differences in the cystoscopy equipment that will be utilized in their routine procedures.

Eligibility criteria:
inclusion criteria: * males and females, at least 18 years of age or older * patients undergoing de novo or follow up diagnostic or therapeutic cystoscopy procedures in a urology clinic setting * antibiotic-free for at least 7 days prior to cystoscopy procedure * patients willing to return to the clinic at approximately two weeks (10 -14 days) post-procedure for a urine test exclusion criteria: * patients with significant lower urinary tract obstruction, gross hematuria * patients having an acute pelvic inflammatory disease or symptomatic uti * patients with urethral strictures * patients with chronic pain conditions * patients unwilling to return to the clinic at approximately two weeks (10 -14 days) for a urine test

Keywords: cystoscopy endosheath infection control bacteriuria
optimizing outpatient anesthesia (osprey-outpatient surgery pain relief enhancement)

Conditions: Opioid Use; Pain, Postoperative

Summary: the overall goal of this research is to improve perioperative pain treatment, decrease post-operative opioid consumption, diminish opioid related side effects, and reduce postop opioid prescribing (and hence opportunity for diversion, abuse, addiction, and fatal overdose).

this protocol will test the innovative, paradigm-shifting hypothesis that anesthesia for outpatient surgery with long-duration opioids (methadone), compared with conventional short-duration opioids, achieves better analgesia, with similar or diminished side effects, may reduce development of chronic postsurgical pain, improves recovery, and importantly, decreases postoperative opioid consumption and could hence diminish take-home opioid prescribing and shrink the population reservoir of unused opioids available for diversion and misuse. two cohorts will be studied, but analyzed separately. 1) short-stay, anticipated next-day discharge surgery (compare short-duration vs long-duration opioid), 2) same-day discharge surgery (compare short-duration vs long-duration opioid).

Eligibility criteria:
inclusion criteria * age 18-65 years undergoing general anesthesia and moderately painful ambulatory surgery with anticipated postop stay of \< 24 hours * signed, written, informed consent exclusion criteria * history of liver or kidney disease. * females who are pregnant or nursing. * chronic opioid use (e.g. preoperative daily use of methadone, fentanyl transdermal patches, or ≥ 3 oxycodone pills)
barriers to physical activity in patients with cognitive, neuromotor or sensory impairments during aging

Conditions: Disability or Chronic Disease Leading to Disablement

Summary: people with disabilities are less physically active than the general population. their barriers to physical activity are multiple and include intrapersonal, organizational, societal and interpersonal reasons. nevertheless, at present, the evolution of their barriers to physical activity and the short- and long-term impact of medical and medico-social treatments to limit them are unknown. the aim of this study is to describe barriers to physical activity, or disability-related underperformance factors in competitive sports, in patients with cognitive, neuromotor or sensory impairments during aging.

this is an ambispective, monocentric, cohort study of subjects with cognitive, neuromotor or sensory impairments followed in a physical medicine and rehabilitation department. all consecutive eligible outpatient subjects consulting to the parasport health unit of the physical medicine and rehabilitation department of our university hospital will be included. clinical activities related to the parasport health unit and performed outside the hospital will also be included. data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.

Eligibility criteria:
inclusion criteria: * patients \>= 6 years old ; * consulting to the parasport health unit of the physical medicine and rehabilitation department of our university hospital ; * having a neuromotor, cognitive or sensory impairment ; * no opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it, or from each of the holders of parental authority if a minor ; * affiliation to a social security scheme. exclusion criteria: * under court protection.

Keywords: physical activities barriers disability
comparison of post-operation cardiopulmonary capacity of patients underwent conventional and robot-assisted coronary artery bypass graft and valve replacement surgery

Conditions: Coronary Bypass Graft Stenosis; Valvular Heart Disease

Summary: robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. however, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.

the study is a prospective cohort study. the experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. the control group will include 20 patients for each conventional procedure. once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. the recruitment and allocation will only be done after the patient has decided which type of surgery to receive. however, in case of change of surgery type, the patient will be excluded from the trial. cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. primary outcomes include the change of maximal oxygen consumption (vo2), anaerobic threshold and the result of six minute walking test before and after surgery. secondary outcomes include the change vital capacity (fvc), resting heart rate, oxygen pulse (o2 pulse), wound pain visual analog scale (vas) and duke activity status index (dasi) before and after surgery. the hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery

Eligibility criteria:
inclusion criteria: * patient who undergo surgery for coronary artery bypass graft or valvular replacement. exclusion criteria: * pregnant * patients who receive more than one type of surgery * severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks. * cannot perform the cardiopulmonary exercise testing * other contraindications for cardiopulmonary exercise testing

Keywords: cardiorespiratory fitness robotic assisted surgery cardiopulmonary exercise testing
evaluate inflammation caused by gingivitis in adults

Conditions: Gingivitis

Summary: the purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice


Eligibility criteria:
inclusion criteria: * subjects must be adult males or females 18 to 60 years old * subjects must be able and willing to follow study procedures and instructions * subjects must have generalized, moderate plaque-associated gingivitis as determined by the investigator or designee during the screening examination * subjects must present with at least 20 teeth in the functional dentition, excluding third molars * each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing exclusion criteria: * subjects who have chronically used (two weeks or more) total (triclosan/copolymer) dentifrice within 6 months prior to enrollment * subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity * subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening * subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis * subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment * subjects with orthodontic appliances or removable partial dentures * subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. all other medications for chronic medical conditions should be initiated at least three months prior to enrollment * subjects who currently smoke or who report using tobacco products within one year of screening. * subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment * subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis * female subjects who report being pregnant * subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination. * subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or tuberculosis * subjects diagnosed with human immunodeficiency virus (hiv) or subjects that are immunocompromised as determined by the investigator * medical condition which precludes not eating/drinking for approximately 8 hours.
exisulind in preventing polyps in patients with familial adenomatous polyposis

Conditions: Colorectal Cancer; Small Intestine Cancer

Summary: rationale: exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis. purpose: randomized phase ii/iii trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.

objectives: * determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis. * determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug. outline: this is a randomized, double-blind, placebo-controlled study. patients are randomized to one of two treatment arms. * arm i: patients receive oral exisulind 4 times daily. * arm ii: patients receive oral placebo 4 times daily. treatment continues for 1 year. projected accrual: a total of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * one of the following diagnosis: * diagnosis of familial adenomatous polyposis * prior total or subtotal colectomy * attenuated adenomatous polyposis coli * may have colon intact * 10-40 duodenal polyps from second portion to 10 cm distal to papilla of vater patient characteristics: age: * 18 to 80 performance status: * not specified life expectancy: * not specified hematopoietic: * hemoglobin at least 10 g/dl * platelet count at least 100,000/mm\^3 * no active hematologic disease hepatic: * ast and alt less than 1.5 times upper limit of normal (uln) * alkaline phosphatase less than 1.5 times uln * no active hepatic disease renal: * creatinine less than 1.5 mg/dl * no active renal disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no active peptic ulcer disease * no serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival * no prisoners or institutionalized patients * no known allergy to sulindac or related compounds * no active internal malignancy within the past 5 years * no alcohol or drug abuse within the past 5 years prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics other: * no prior non-steroidal anti-inflammatory drugs (nsaids) or salicylates more than 10 days a month for the past 3 months * no concurrent nsaids (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine) * aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)

Keywords: colon cancer rectal cancer small intestine cancer
intracoronary imaging with nirs-ivus to characterize arterial plaques

Conditions: Coronary Artery Disease

Summary: to characterize atherosclerotic coronary artery plaques using advanced intra-coronary imaging with a combined near-infrared spectroscopy and intravascular ultrasound catheter before and after percutaneous intervention

this study is being performed to characterize the composition and morphologic characteristics of atherosclerotic coronary artery plaques with intra-coronary near-infrared spectroscopy and intravascular ultrasound in patients undergoing percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: 1. subject is at \> 18 years of age 2. subject presents to the catheterization laboratory to undergo clinically-indicated, invasive coronary angiography 3. subject is willing and able to provide informed written consent 4. subject is found to have ≥ 1 severe coronary artery stenosis by invasive angiography and percutaneous coronary intervention is planned for definitive treatment or found to have ≥ 1 intermediate coronary artery stenosis and ivus planned for lesion assessment 5. coronary anatomy is deemed suitable for combined nirs-ivus by the interventional cardiologist performing invasive angiography and intervention exclusion criteria: 1. subject is pregnant or suspected to be pregnant 2. subject is unable to provide informed consent 3. subject has coronary artery anatomy deemed by interventionalist as unsuitable for nirs-ivus

Keywords: near infrared spectroscopy; lipid core; vulnerable plaque
parent-based prevention (pbp) for parents with eating disorders

Conditions: Eating Disorders; Eating Behavior

Summary: parents with eating disorders exhibit greater concerns and dilemmas about developing healthy habits in their children. studies indicate that the offspring of parents with eating disorders have more developmental and interpersonal difficulties. consequently, these parents should receive personalized care to enhance their parental capacity and support them in their decision making process. the parent-based prevention of eating disorders (pbp) is a promising intervention that may help improve feeding and eating practices and children outcomes, by engaging both parents in a short-term program. this study aims to empirically evaluate the feasibility and acceptability of pbp over a wait-list control group (i.e., treatment-as-usual) in a randomized case series trial.

a parental history of an eating disorder is linked with greater risk of eating and socio-emotional problems in the offspring, and more stressful parent-child interactions. further, parenting concerns often exacerbate existing eating disorder symptoms in parents. parent-based prevention (pbp-b) is a focused intervention aimed to support parents with eating disorders and their partners in developing healthy eating and lifestyle behaviors in their children. the program also focuses on reducing mealtime conflict and improving couple communication. this study tests the feasibility, acceptability and preliminary outcomes of the parent-based prevention (pbp) program for these parents and their partners. parents with any lifetime eating disorder diagnosis who have at least one child 1-5 years old will be randomized to receive pbp immediately or following a 16-week waitlist period. this study will investigate whether pbp is feasible, acceptable, and associated with improvement in short-term outcomes that predict long term risks of eating and weight disorders (e.g., parental cognition associated with feeding practices and child eating behaviors and socio-emotional symptoms). the study will collect important case series data that will inform the design of larger, adequately powered studies to test ways to reduce the likelihood of eating and weight difficulties in the offspring of parents with eating disorders.

Eligibility criteria:
inclusion criteria: * a biological parent of a child between 1-5 years of age. * a lifetime diagnosis of an eating disorder. exclusion criteria: \* current medical condition necessitating more intensive care to manage symptoms.

Keywords: secondary prevention parent-based prevention
a study to collect blood samples from patients with spinal muscular atrophy for biomarker analysis

Conditions: Muscular Atrophy, Spinal

Summary: in this single center study blood samples for biomarker analysis will be collected from patients with spinal muscular atrophy. up to 21 ml blood will be drawn from eligible patients at a single visit.


Eligibility criteria:
inclusion criteria: * self-identified as 5q-autosomal recessive spinal muscular atrophy (sma) type i, ii or iii as judged by their neurologist upon diagnosis * ability and willingness to provide blood samples * willingness (by the patient or patient's parents or legal guardian) to complete to their best ability a questionnaire which requests specific clinical and genetic information * able to participate and willing to give written informed consent or assent. informed consent will be obtained from the patient, or the patient's parent or legal guardian. exclusion criteria: * any known genetic condition other than spinal muscular atrophy, unless it is not interfering with the purpose of this study based on the sponsor's judgment * participation in a clinical trial (except observational studies) within the previous 14 days * donation of blood or significant blood loss within three months prior to screening * concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of this study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study