Kornimate/medical-research-clean huggingface dataset:
comparative effectiveness of intubating devices in the morbidly obese

Conditions: Obesity

Summary: this prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used. the four different devices are as follows: mcgrath video laryngoscope, glidescope video laryngoscope, video-mac video laryngoscope, and macintosh size 4 direct laryngoscope.

hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (weight loss surgery). the three types of video laryngoscopy devices include; the verethon glidescope, lma mcgrath and karl-storz video-mac.

Eligibility criteria:
inclusion criteria: * patients with a documented body mass index (bmi) of \>35. * patients scheduled to undergo inpatient surgery procedures under general anesthesia. * willingness and ability to sign an informed consent document * 18 - 80 years of age * american society of anesthesiologists (asa) class ii- iii adults of either sex. exclusion criteria: * patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation * patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery * emergency surgeries * pregnancy * the inability to tolerate 0.2mg of glycopyrrolate based on tachycardia. * any other conditions or use of any medication which may interfere with the conduct of the study.

Keywords: direct laryngoscopy video-mac glidescope mcgrath laryngoscopy bariatrics glottic view airway intubating devices tracheal intubation
probe configuration and time-temperature dose ranging for understanding of skin lesion effects

Conditions: Histological Response of Tissue to Cold

Summary: this study is designed to characterize the biological response of the epidermis, dermis and subcutaneous tissue to treatment with the myoscience cryo-touch iii system.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 70 years old * subject is willing and able to give written informed consent. * subject is committed to undergo an abdominoplasty procedure independent of this study. * subject is willing and able to comply with study instructions and commit to all visits for the duration of the study. * subject is in good general health and free of any disease state or physical condition that might impair evaluation or which in the investigator's opinion, expose the subject to an unacceptable risk by study participation. exclusion criteria: * subject is currently enrolled in an investigational drug or a device study that specifically targets the abdominal area. * subject currently smokes. * subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. * subject has used oral or inhaled steroids in the last 14 days and/or has been a chronic user of inhaled or oral steroids in the past such that the investigator feels subject may have compromised wound healing. * subject has used topical steroids in the abdominal area within the last 30 days. * subject is on any systemic immunosuppressive therapy. * subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of the target treatment sites: liposuction, cryolipolysis, or high-intensity focused ultrasound. * history of abdominal hernia. * subject has any of the following conditions: * allergy or intolerance to lidocaine, * other local skin condition (e.g., skin infection) at target treatment site, * any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation. * chronic medical condition or use of medication that in the investigator's opinion would affect study participation or wound healing (such as diabetes, hepatitis, hiv, etc.). * subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
outcomes following tourniquet and non-tourniquet assisted total knee arthroplasty

Conditions: Osteoarthritis

Summary: the overall goal of this study is to determine the effects of intraoperative tourniquet use during total knee arthroplasty (tka), compared to tka without the use of a tourniquet (notqt), for strength and functional recovery following simultaneous bilateral tka. during the procedure, each patient will receive tourniquet-assisted tka (tqt) on one lower extremity while the contralateral lower extremity undergoes tka without the use of a tourniquet (notqt), except for briefly during component cementation. tourniquets are commonly used in tka to improve visualization of the surgical field and limit blood loss. however, studies suggest that tourniquet use may be associated with higher rates of medical complications and poor functional outcomes, including increased swelling, decreased muscle strength and altered neuromuscular activity. we will measure strength, voluntary muscle activation, and other functional outcomes for each lower extremity at 4 time points (preop; inpatient (24-72 hrs after surgery); 3 weeks; and 3 months following tka). we hypothesize that lower extremities in the notqt group will demonstrate improved strength and performance when compared to lower extremities in the tqt group.


Eligibility criteria:
inclusion criteria: * undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis exclusion criteria: * no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance

Keywords: total knee arthroplasty
the effect of proton pump inhibitors on calcium and bone metabolism

Conditions: Calcium Metabolism Disorders

Summary: this prospective, single-blind, matched controlled study aims to evaluate the effect of proton pump inhibitors on biochemical markers of calcium and bone metabolism in an effort to establish additional biological plausibility for the apparent association between proton pump inhibitors (ppis) and osteoporosis-related fractures. young males (age 18-45 years), who are either healthy volunteers, or who complain of daily or frequent heartburn but are otherwise healthy, will be recruited and enrolled in the study. patients with heartburn will be assigned to the intervention group and will be assigned to take a ppi for three months. healthy volunteers will be matched by age to patients in the intervention group and will act as the control group. 70 patients will be enrolled in total. blood studies for all subjects will be taken at 0, 1 and 3 months to test for various biochemical markers of calcium and bone metabolism, which act as surrogate markers of calcium absorption and bone remodeling. levels of biochemical markers in the two groups will be compared using two-way analysis of variance (anova). changes in biochemical parameters within a group will be assessed using repeated measures anova.


Eligibility criteria:
inclusion criteria: * males aged 18-50 years * healthy (or healthy with heartburn only) exclusion criteria: * female gender * previous allergy to ppi * regular beach seekers (more than once a week) * intestinal disease * recent fracture (within the past six months) * kidney stones * intake of the following medications: * vitamin d or calcium supplements * ppis or h2 receptor antagonists within the past year * one-alpha * anticonvulsants * glucocorticoids

Keywords: calcium bone metabolism proton pump inhibitors rabeprazole esomeprazole lanzoprazole vitamin d bone and bones
rotation or change of biotherapy after tnf blocker treatment failure for axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: axial spondyloarthritis (axspa) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. axspa prevalence is around 0.17% of the french population. tumor necrosis factor (tnf) was the first target defined in axspa. since one third of axspa patients failed to the first tnf blocker, many axspa patients received a second biological disease-modifying antirheumatic drugs (bdmards). until few months, the only choice was to use a second tnf blocker.since 2003, pharmaceutical companies investigated efficacy of tnf blockers already used in rheumatoid arthritis. etanercept is a fusion protein with tnf receptor type ii p75 and igg1 fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. certolizumab is a fusion between a fab fragment targeting tnf and a peg fraction. all demonstrated efficacy versus placebo in a randomized double blinded study in case of failure to the first tnf blockers, rheumatologists will follow the "treat-to-target" principle. this approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. this concept was also suggested for axspa with low levels of evidence and recommendation. so rheumatologist will provide the best treatment in case of failure to the first tnf blockers, which is a daily clinical situation. since few months, rheumatologists have the choice between targeting il-23/17 axis compared to a second tnf blocker.


Eligibility criteria:
inclusion criteria: * active axspa with basdai\>4 or asdas\>3.5, who need change in tnf blocker treatment * aged over 18 years * inadequate response after at least 3 months to the 1st tnf blocker * if non biologic dmard treatment : stable dose for at least on month before inclusion * if oral corticosteroids treatment : stable dose for at least on month before inclusion * if nsaids treatment : stable dose for at least on month before inclusion * ability to complete questionnaires * social security affiliation * informed written consent given exclusion criteria: * any contra-indication to tnf blocker and/or secukinumab * inflammatory bowel diseases * existing pregnancy, lactation, or intended pregnancy within the next 15 months active tuberculosis or other severe infections such as sepsis or opportunistic infections * active infections, including chronic or localised infections. * moderate to severe heart failure (nyha classes iii/iv) * impossibility to give informed consent * impossibility to be followed for 12 months

Keywords: tnf blocker change of biotherapy
vein external support trial

Conditions: Coronary Heart Disease

Summary: prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the vgs fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.


Eligibility criteria:
primary inclusion criteria: 1. patient scheduled for on-pump cabg on clinical grounds 2. vein grafts indicated for right and circumflex coronary arteries and lima indicated for the lad on clinical grounds 3. native circumflex and right coronary arteries have at least one stenosis in each vessel\> 75% primary exclusion criteria: 1. concomitant non-cabg cardiac procedure 2. prior peripheral vascular or cardiac surgery 3. emergency cabg surgery (cardiogenic shock, inotrophic pressure support, iabp)
etiology study of prostatitis

Conditions: Prostatitis

Summary: prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. the objective of this study is to look at the etiology of chronic prostatitis(bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate.

prostatitis is so widespread a disease that affects people from youths to seniors, with approximately a third experiencing a remission of symptoms over a year follow-up. although the etiology of prostatitis is still not clear, it is mainly thought to be due to infection of bacteria or other microorganisms. traditional techniques to identify bacteria (e.g. on agar petri plates) are limited in what they can identify. although hmp (human microbiome project) has turned many mysteries into common sense, little is done on the relationship of bacteria in the prostate for prostatitis. up to now, there is still no research being done on the microbiome (bacterial species) of the prostate. the objective of this study is to look at the etiology of chronic prostatitis (bacteria or non-bacteria prostatitis), mainly focusing on the effect of bacteria in the prostate. modern sequencing methods, such as 16s rrna amplification, cloning and sequencing will be used to evaluate the role of bacteria in prostatitis. the basic idea is to survey the microbes present in expressed prostatic fluid using 16s sequencing to compare healthy men and prostatitis patients in a small cohort to see if there are correlations between microbes found and symptoms.

Eligibility criteria:
inclusion criteria: * chronic prostatitis (bacteria or non-bacterial prostatitis) with pelvic pain and luts (low urinary tract symptom); diagnosed mainly by nih-cpsi score. we use nih-cpsi score 15 as a base line for identifying prostatitis patients:those scored more than 15 will be grouped as prostatitis patients. exclusion criteria: * inadequate follow-up data * other types of prostatits patients * patients who in the opinion of the investigators would not be suitable for study * uti patients (within 6 months before enrolment) * antibiotics (within 6 months before enrolment) * urinary tract surgery (within 6 months before enrolment)

Keywords: prostatitis pelvic pain urinary symptoms sexual dysfunction
in silico study assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease

Conditions: Atherosclerotic Cardiovascular Disease

Summary: study ckjx839b1fr01 in an in silico trial to predict the efficacy of inclisiran therapy on major adverse cardiovascular events (mace) and cardiovascular (cv) death in virtual patients with atherosclerotic cardiovascular disease (ascvd) and elevated ldl-c.

purpose of this study is to predict the size of efficacy of inclisiran 300 mg s.c., administered on day 1, month 3 (day 90), and every 6 months thereafter in addition to currently available lipid lowering therapies (llts) on a 3-point-major adverse cardiovascular events (3p-mace) defined as a composite of cv death, non-fatal myocardial infarction (mi) or non-fatal ischemic stroke, and on cv death, in a secondary prevention cohort of ascvd virtual patients with a ldl-c ≥ 70 mg/dl. this will be compared to 1) placebo in adjunct to high-intensity statin therapy with or without ezetimibe, 2) ezetimibe in adjunct to high-intensity statin therapy, 3) evolocumab in adjunct to high-intensity statin therapy and ezetimibe.

Eligibility criteria:
inclusion criteria : 1. patients with atherosclerotic cv disease, defined as any of the following i. previous mi ii. previous ischemic stroke iii. previous symptomatic peripheral arterial disease (pad) as evidenced by either intermittent claudication with abi \<0.85, prior peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease 2. fasting ldl-c ≥ 70 mg/dl 3. under stable (≥ 4 weeks) well-tolerated high-intensity statin with or without ezetimibe. exclusion criteria : patients with acute coronary syndrome, ischemic stroke, peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \<4 weeks prior to the first study visit

Keywords: atherosclerotic cardiovascular disease hypercholesterolemia dyslipidemia high cholesterol hyperlipidemia inclisiran sirna kjx839 myocardial infarction ischemic stroke peripheral arterial disease in silico model in silico simulation pcsk9 inhibitors arteriosclerosis atherosclerosis arterial occlusive diseases vascular diseases cardiovascular diseases
using social incentives and gamification for weight loss promotion

Conditions: Weight Loss; Obesity; Physical Activity

Summary: this is a 36-week, three-arm randomized, controlled trial using a team-based model to compare two weight loss programs to control. each intervention will use insights from behavioral economics to leverage social incentives and gamification.

obesity is a leading risk factor for morbidity and mortality affecting more than one in three adults in the united states. modifiable health behaviors contribute to this growing epidemic. insights from behavioral economics have shown promise for motivating behavior change through the use of financial incentives. however, social incentives or those influences that impact individuals to adjust their inherent behaviors based on social ties and connections have not been well examined. social incentives are a more patient-centered approach that leverages and enhances the existing connections and influences on the individual. since one individual's behavior change is connected to many others within their network, social incentives have the potential to be a scalable intervention that impacts the community. gamification, or the use of game design in non-game situations, is often used in the real world, but its effectiveness is unknown. in this study, investigators will conduct a 36-week, three-arm, randomized, controlled trial using a team-based model to compare two weight loss programs to control. each intervention will use insights from behavioral economics to leverage social incentives and gamification.

Eligibility criteria:
inclusion criteria: * age 18 to 70 years * ability to read and provide informed consent * has an iphone 4 or newer * have self-reported body mass index of 30 or greater and in-person body mass index of 28 or greater exclusion criteria: * conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write english * conditions that would make participation unsafe such as current treatment for drug or alcohol use, myocardial infarction or stroke within the last 6 months, metastatic cancer, pregnant, breastfeeding or plan to become pregnant during study period, previous diagnosis of an eating disorder, or history of unsafe weight loss practices * already enrolled in another weight loss study * any other medical conditions or reasons that they could not complete a 36-week weight loss program
computer-assisted cancer risk behavior counseling

Conditions: Diabetes; Diabetes Mellitus; Hypertension

Summary: to test whether or not giving patients information before their doctor visits changes the care they receive and what type of information is best to give before the doctor visit.

patients are randomized into one of three groups. before a single visit with diabetes care provider, the patient is called to answer interview questions about their health, diabetic care and behavior habits. after a patient visits with their doctor, they are called again to answer question about the visit they just had. if a patient is place into group a or b, based on their answers to the questions they are mailed a printed report before their doctor visit. the report will indicate how things are going the patient's diabetic care and recommended questions to ask his/her health care provided about diabetes. group a feedback report will emphasize the risks from diabetes and the feedback reports for group b will emphasize things to do to protect oneself from problems from having diabetes. participants randomized to group c will only receive printed reports after a doctors visit. no extra visit will be scheduled with the participants doctor, no travel is required, no blood tests are required and ther doctor will not be involved in the study unless the study participant chooses to discuss it with his/her doctor.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * has type 2 (adult-onset) diabetes; * developed diabetes after the age of 21; * has a scheduled doctor visit about diabetes in the next few months

Keywords: doctor-patient relation physician-patient relation diabetes office visits comparative study health behavior randomized controlled trials health promotion health education computer-tailor information
dual time point pet in lymphoma

Conditions: Hodgkin's and Non-Hodgkin's Lymphoma

Summary: this study aims to investigate the value of dual time point pet/ct in lymphoma. since fdg uptake is linked to glucose metabolism, pet imaging is also used to detect suspected sites for infectious and inflammatory disorders. in a clinical setting, it is a challenge to distinguish between fdg uptake in benign and malignant lesions and this gives rise to a considerable quantity of false positive results and decreased positive predictive values. performing fdg-pet imaging sixty minutes after injection is common practice in the staging and surveillance of lymphoma but this procedure may not be optimal, especially not in settings where benign inflammatory lesions are of clinical concern. in an attempt to find an alternative method for this discrimination, dual time point fdg-pet was introduced. this technique has shown itself to be a potentially promising method in fdg-pet imaging for distinguishing between malignant and benign lesions using suv values. the reason for the different fdg uptake patterns between inflammatory and malignant lesions is unclear. several factors may contribute to this phenomenon on a cellular basis. it has been shown that cancer cells exhibit increased numbers of glucose transporter and low level of glucose-6-phosphatase. varying levels between different cancer cell types may explain the different fdg uptake curves. because various cell types exhibit varying rates of fdg uptake we believe that kinetic investigation may prove to be of value in understanding different types of lymphoma and identifying how to perform precise imaging for staging and surveillance.


Eligibility criteria:
inclusion criteria: * age\>18 years * planned for curative treatment exclusion criteria: * previously treatment with chemotherapy or irradiation * primary cns lymphoma * recurrent lymphoma * transformation from indolent lymphoma * presence of diabetes mellitus, hiv, chronic inflammatory disease or infections * pregnancy or lactation
safety & efffficacy of genakumab in patients with frequent flares

Conditions: Acute Gout Arthritis

Summary: the purpose of this study is to evaluate the efficacy and safety of genakumab injection in patients with gouty arthritis (ga).

a multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (nsaids) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.

Eligibility criteria:
inclusion criteria: * male or female, 18 years ≤ age ≤75 years * bmi≤40kg/m2 * meeting acr 2015 preliminary criteria for the classification of acute arthritis of primary gout. * start of acute gout flare within 4 days prior to enrolled * history of ≥ 2 gout flares within the 12 months prior to study start * evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either nsaids and/or colchicines * baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (vas) exclusion criteria: -

Keywords: acute gout arthritis