Kornimate/medical-research-clean huggingface dataset:
a two-part, 12-week study of etoricoxib as a treatment for rheumatoid arthritis (ra) (mk-0663-107)

Conditions: Arthritis, Rheumatoid

Summary: this is a 2-part (6 weeks duration for each part), randomized, double-blind, placebo-controlled study in participants with rheumatoid arthritis. the hypothesis is that etoricoxib (60 mg and 90 mg) administration will demonstrate superior efficacy compared to placebo after 6 weeks of treatment, as measured by the greater mean improvement from baseline in the disease activity score c-reactive protein (das-28 crp), and by the greater mean improvement in patient global assessment of pain (pgap) from baseline over 6 weeks of treatment. additionally, the added benefit of increasing the dose of etoricoxib from 60 mg to 90 mg will be assessed in the second part of the study.


Eligibility criteria:
inclusion criteria: * is male or female ≥ 18 years of age in general good health (other than ra) * has an american college of rheumatology rheumatoid clinical response criteria (acr) functional class i, ii, or iii * has a diagnosis of ra at least 6 months ago and was at least 16 years of age when diagnosed * has a history of positive therapeutic benefit with nonsteroidal anti-inflammatory drugs (nsaids) and is taking an nsaid on a regular basis and at a therapeutic dose level and is not anticipated to undergo a change during the study exclusion criteria: * has a concurrent medical/arthritic disease that could confound or interfere with evaluation of efficacy * has a history of gastric or biliary surgery (including gastric bypass surgery) or small intestine surgery that causes clinical malabsorption * has an active peptic (gastric or duodenal) ulcer or history of inflammatory bowel disease * has a confirmed medical diagnosis of ischemic heart disease, cerebrovascular disease, or peripheral artery occlusive disease * class ii-iv congestive heart failure * has uncontrolled hypertension (systolic \>160 mm hg or diastolic \> 90 mm hg) at visit 1 or visit 2 * has a clinical diagnosis of hepatic insufficiency defined as child-pugh score ≥5 * has estimated glomerular filtration rate ≤30 ml/min * has a history of neoplastic disease within 5 years (exceptions: basal cell carcinoma or carcinoma in situ of the cervix) * is allergic to etoricoxib; history of a significant clinical or laboratory adverse experience associated with etoricoxib; hypersensitivity to aspirin or nsaids; or allergy to acetaminophen/paracetamol * has a personal or family history of an inherited or acquired bleeding disorder * requires oral corticosteroid therapy in excess of the equivalent of 10 mg daily of prednisone and/or have not been on a stable dose for at least 4 weeks prior to visit 1 and/or whose dose is not expected to remain stable during the study * treated with b-cell depleting therapies within the past 6 months or anticipate this treatment during this trial * is a recreational or illicit drug use, or history within 5 years of drug or alcohol abuse/dependence; * is morbidly obese (defined as body mass index ≥40 kg/m\^2) * is pregnant or breast feeding
impact of positive end-expiratory pressure on hepatic venous flow

Conditions: Valvular Heart Disease

Summary: the purpose of this study is to determine the difference in the impact of moderate positive end-expiratory pressure (peep) on hepatic venous flow doppler in patients undergoing cardiac surgery: conventional versus protective ventilation strategy the possible changes in forward and backward flows (doppler profiles) of hepatic venous flow at different degrees of peep in conventional and protective ventilation strategies are analyzed by using intraoperative transesophageal echocardiography (tee) in patients undergoing cardiac surgery .

following data would be determined after 5 min-exposure volume controlled ventilation employing tidal volume of 10 ml/kg and 6 ml/kg with low peep (with 2 mmhg) and moderate peep (7 mmhg) during remifentanil-based anesthesia (1.0 mcg/kg/min) for cardiac surgery (n=12) 1. sum of forward hepatic venous flow 2. sum of backward hepatic venous flow 3. peak velocity of diastolic hepatic venous flow 4. lung compliance 5. peak airway pressure 6. mean airway pressure 7. other pressure derived hemodynamic parameters:heart rate; systolic, diastolic, and mean blood pressures; systolic, diastolic, and mean pulmonary artery pressures; central venous pressure (cvp), pulmonary capillary

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery * patients provide written informed consents exclusion criteria: * re-do or tri-do surgery * patients with active infection * patients with endocrine disease * patients ischemic heart disease * patients with tricuspid valve regurgitation greater than mild degree
tobacco use and covid-19 incidence in the finnish general population

Conditions: SARS-CoV-2 Infection; Covid19

Summary: this is an observational study of participants in three general population health surveys (finsote 2018, 2019, 2020) who are followed up until the incidence of sars-cov-2 infection or end of follow-up. the primary objective is to examine the association between tobacco use and the risk of sars-cov-2 infection in a general population sample in finland.

tobacco use, as a leading risk factor of death and disability due to respiratory diseases, was expected to increase the risk of sars-cov-2 infection and covid-19 deaths. earlier epidemiological studies, however, showed that smokers were underrepresented among patients hospitalized due to covid-19. the most recent meta-analysis has confirmed these early findings, showing that current smokers had lower risk of sars-cov-2 infection than never smokers (relative risk 0.71, 95% credible interval 0.61; 0.82). a majority of these studies are based on samples of hospitalized patients, tested population or specific population groups, which might not represent the general population. in addition, data on tobacco use has been primarily collected from electronic health records or retrospectively and therefore prone to misclassification and information bias. a message of a protective effect of tobacco use could undermine public health efforts to curb its use and reduce the perception of harm in the general population. studies with general population samples and prospective data collection are thus urgently needed. the aim of the study is to examine the association between tobacco use and the risk of sars-cov-2 infection. we will explore several forms of tobacco use (smoking, moist smokeless tobacco and e-cigarettes) and investigate whether introducing a potential collider bias by adjusting for mediating risk factors (alcohol use, physical activity and obesity) could have explained earlier results. we will use data from a prospective cohort study of nationally representative health surveys in finland linked to sars-cov-2 incidence data, which is less subject to collider and recall bias than previous case-control studies.

Eligibility criteria:
inclusion criteria: * permanent residents of finland * registered in the population register at the moment of sampling * aged 20 and over * participated in the finsote surveys in 2018, 2019 or 2020 exclusion criteria: * temporary residents in finland or tourists * age less than 20 years old * did not participate in finsote surveys in 2018, 2019 and 2020

Keywords: tobacco use sars-cov-2 covid-19 epidemiology cohort studies incidence
studying the presence of cfrd complications with thoughtful recruitment (spectrum)

Conditions: Cystic Fibrosis (CF); Cystic Fibrosis-related Diabetes; Diabetes; Retinopathy; Neuropathy; Nephropathy; Blood Pressure; Cardiovascular Risk; Microvascular

Summary: this multicenter cross-sectional study will include a diverse population of adolescents and adults with cf. the overall aim is to describe prevalence of diabetes microvascular complications and macrovascular surrogates in people with established cfrd.


Eligibility criteria:
inclusion criteria: * written informed consent (and assent when applicable) obtained from participant or participant's legally authorized representative * for adults: must be able to consent on one own's behalf (i.e., cannot lack cognitive capacity to consent due to the required patient-reported outcomes) * be willing and able to adhere to the study protocol requirements * age ≥ 12 years at time of enrollment * cf diagnosis based on two cf causing mutations and/or positive sweat test according to cff diagnostic criteria * cfrd diagnosis ≥ 5 years at time of enrollment exclusion criteria: * history of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject * history of transplant * pregnancy reported by participant at time of consent or at any point during active study participation pulse wave velocity exclusion criteria: * erratic, accelerated or mechanically controlled irregular heart rhythms including arrhythmias * carotid or aortic valve stenosis * peripheral artery disease or leg artery disease * generalized constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying raynaud's phenomena or intense cold. * possible exclusions based on investigator medical provider assessment (additional precautions may be followed to allow inclusion): * pressure reading should not be conducted on a limb where there is intravenous access, arterio-venous shunt, or where circulation is compromised. * pressure reading should not be conducted on the side of the body that a mastectomy was done.

Keywords: cystic fibrosis cfrd cystic fibrosis-related diabetes observational physical activity tracker continuous glucose monitoring cgm diabetes blood pressure cardiovascular risk microvascular diabetes complications social determinants of health
a pilot study of a dendritic cell vaccine in hiv-1 infected subjects

Conditions: HIV-1 Infection; HIV Infections

Summary: the purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to hiv.

this is a randomized trial to evaluate whether mrna-transfected dendritic cell vaccination is safe and immunogenic in hiv-infected participants who are on antiretroviral therapy.

Eligibility criteria:
inclusion criteria: * hiv-1 positive * cd4+ t cell count \>200 * undetectable hiv viral load for 6 months prior to screening * on antiretroviral treatment for 12 months prior to screening exclusion criteria: * hepatitis c positive * detectable hiv viral load within 6 months prior to study entry * females who are pregnant or nursing

Keywords: hiv vaccine dendritic cells treatment experienced
besingcardiorehab: cr in belgium versus singapore

Conditions: Ischemic Heart Disease

Summary: background: cardiac rehabilitation is indicated for ischemic heart disease patients; the program content of which is well described in both european and american guidelines. in contrast, literature on cardiac rehabilitation program content and efficacy in the asian population is sparse. methods: besingcardiorehab will be an intercontinental, retrospective cohort study conducted in two cardiac rehabilitation referral centers in belgium and singapore. the first aim is to compare the impact of phase ii center-based cardiac rehabilitation on major adverse cardiac events for ischemic heart disease patients between europe (i.e. belgian) and asia (i.e. singaporean) in the long-term. the second objective is to compare the efficacy of phase ii cardiac rehabilitation on short-term morbidity (assessed with the validated smart risk score) between index european and asian ischemic heart disease patients. the level of compliance of the belgian and singaporean cardiac rehabilitation programs to european guidelines standards will also be evaluated. hypotheses besingcardiorehab will be one of the first studies assessing cardiac rehabilitation in asia. based on the besingcardiorehab study results, phase ii center-based cardiac rehabilitation programs, can/will be adapted in order to improve program content and outcomes.

besingcardiorehab is an intercontinental, multi-center, retrospective cohort study conducted in two cardiac rehabilitation referral centers (heart center hasselt in belgium and national heart center singapore in singapore). patients will be divided in four groups (1:1:1:1) based on i. whether or not they received phase ii cardiac rehabilitation and ii. whether they are from belgium or singapore. the first objective of besingcardiorehab is to compare the impact of phase ii center-based cardiac rehabilitation on major adverse cardiac events for ischemic heart disease patients between europe (i.e. belgian) and asia (i.e. singaporean) in the long-term. the second objective is to compare the efficacy of phase ii cardiac rehabilitation on short-term morbidity (assessed with the validated smart risk score) between index european and asian ischemic heart disease patients. the level of compliance of the belgian and singaporean cardiac rehabilitation programs to european guidelines standards will also be evaluated.

Eligibility criteria:
inclusion criteria: i. patients in the revascularised, stabilized and asymptomatic phase following an acute coronary syndrome (acs) (unstable angina, non st-elevation acs or st-elevation acs) ii. patients initially presenting with stable angina who are revascularised or asymptomatic under optimal medical treatment (not amenable for revascularization). exclusion criteria: i. end-stage chronic kidney disease (stage v, gfr \< 15 ml/min/1.73 m2 and/or dialysis) ii. severe chronic obstructive pulmonary disease (copd) (gold stage iii-iv, tiffeneau index \< 0.70 and fev1 \< 49% of normal) iii. terminal cancer with a prognosis of \< 1 year.
investigating hereditary cardiac disease by reprogramming skin cells to heart muscle

Conditions: Eletrophysiology of iPS-derived Cardiomyocytes

Summary: hereditary cardiac arrhythmias (genetically caused disturbances of heart rhythm) are life threatening conditions affecting otherwise healthy young individuals. due to the inaccessibility of heart tissue, the abnormal electrical current(s) in the heart cells causing the rhythm disturbance can be difficult to study in detail and therefore in many cases remain untreatable. the investigators propose to study heart cell electrical function from such patients by reprogramming skin cells to become stem cells and then differentiating them to heart muscle cells. the hypothesis of the study is that the differentiated cardiac cells will display electrical abnormalities dependent on the mutation causing the disease. these abnormalities can therefore provide a clue as to the nature of the mutation causing the disease or information about its effective management


Eligibility criteria:
inclusion criteria: * clinical features of brugada syndrome (ecg findings) * mutation positive or mutation negative * idiopathic ventricular fibrillation exclusion criteria: * not able to give informed consent * age less than 18 years * clinical diagnosis ambiguous

Keywords: ips cells cardiomyocytes brugada ventricular fibrillation electrophysiology
youth throwers respond to stretching

Conditions: Shoulder Posterior Capsular Contracture

Summary: the purpose of this study is to document the rates of youth baseball player demographics, incidence of arm pain, usage of different pitch types, and degree of internal rotation contracture in the throwing versus the non-throwing shoulder. we followed a subgroup of players for a year to see if a particular stretch would help reduce the internal rotation contracture.

introduction: overhead throwing can cause contracture of the shoulder posterior-inferior glenohumeral ligament which can lead to injuries such as superior labral tears. we show that instruction on stretching can favorably alter progression of posterior contractures. methods: 1261 male baseball players ages 7-15 completed a questionnaire and shoulder examinations. measurements of rotation of both shoulders were made with the subjects in the supine position with the scapula stabilized. glenohumeral internal rotation deficit (gird) was calculated. pitch type and player position, among other variables, were recorded. the prospective cohort was 175 players who were examined twice a year apart. players with excessive gird (exgird) were given stretching instruction, and the control group was those without exgird who were not given instruction. change in gird as a result of this intervention was documented.

Eligibility criteria:
inclusion criteria: * male * baseball player * ages 8 to 15 exclusion criteria: * female (suspected hormonal/gender influences on capsular elasticity) * prior throwing arm surgery

Keywords: shoulder posterior inferior glenohumeral ligament posterior capsule capsular contracture baseball throwing injury
effective maneuver for post-laparoscopic shoulder pain

Conditions: Gynecologic Diseases

Summary: the aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. however, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. the aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopy for benign gynecologic diseases * patients aged 19-65 years * patients with american society of anesthesiology physical status i-ii * patients obtaining written informed consent exclusion criteria: * patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome * patients with past history of pneumothorax or any pulmonary surgical history * patients with any shoulder surgery histories * patients who required to conversion to open surgery from laparoscopic surgery * patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity * patients with inability to understand or express 10 point visual analogue scale * pregnant women
titration of oxygen levels during mechanical ventilation with electronic alerts

Conditions: Mechanical Ventilation

Summary: fractional oxygen during mechanical ventilation, is a life sustaining therapy in the intensive care unit , used for about a million patients annually. oxygen therapy needs to be tightly balanced as both hypoxia and hyperoxia are harmful. establishing precision in oxygenation has significant implications for improving patient outcomes, resource utilization and reducing iatrogenic harm to a vulnerable population. the investigators propose an approach using a oxygen titration protocol consisting of electronic health records based alerts to guide oxygen adjustment.

the investigators will conduct a prospective randomized, clinical trial in the medical intensive care unit at ohio state university medical center. in the intervention arm, respiratory therapists' will conduct oxygen titration with the help of a novel, high fidelity, electronic health records based, protocol consisting of electronic alerts and decision support tool. oxygen titration in the control arm will be done without alerts and will be per "current standard of care". participants for this study will be identified and recruited from patients admitted to the ohio state university, wexner medical center and james cancer hospital, medical intensive care unit.

Eligibility criteria:
inclusion criteria: • critically ill subjects who require mechanical ventilation for at least 24 hours. exclusion criteria: * subjects without research authorization, * pregnancy, * pneumothorax, * carbon monoxide poisoning, * hyperbaric oxygen therapy * acute st elevation myocardial infarction
steroids in total knee arthroplasty

Conditions: Postoperative Pain; Inflammation; Osteoarthritis

Summary: the purpose of this study is to evaluate if the use of two small doses of intravenous (iv) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. the investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.

adequate pain control after total knee arthroplasty (tka) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. this study is designed to assess whether the use of two small doses of intravenous (iv) steroids around the time of surgery decrease a patient's pain or use of pain medication. secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. the study will compare the effect of two different doses of iv dexamethasone given preoperatively before tka, when compared to placebo.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total joint arthroplasty of the knee * adult patients ages 18-100 years * patients must have smart phone and/or device for app usage exclusion criteria: * current chronic steroid use * patients undergoing revision knee surgery * patients ambulating preoperatively with assistive devices * patients with avascular necrosis of the operative knee * patients with a history of an adverse reaction to glucocorticoid steroids * patients unable to provide informed consent * patients with inflammatory arthritis * prisoners * current smokers * patients \<18 years of age * any patient with a complicated postoperative course that requires transfer to the intensive care unit (icu) or to another facility for further management will be removed from the study. * any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen history of infection of surgical knee. * patients with diabetes. * patients that have an intolerance to toradol. * patients that do not have smart phone and/or device for app usage

Keywords: osteoarthritis postoperative pain total knee arthroplasty orthopaedics inflammation
mlc901 in moderate traumatic brain injury

Conditions: Moderate Traumatic Brain Injury

Summary: this study wants to evaluate whether mlc901 will help improve the condition of adult patients with moderate traumatic brain injury.

this is a double blind placebo controlled randomized trial to determine whether giving mlc901 for 6 months will improve the outcomes in a adult patients with moderate traumatic brain injury.

Eligibility criteria:
inclusion criteria: * age 18-65 years * moderate tbi * presenting at the study site within 7 days of injury * participant or his/her legal representative able to comply with the study protocol and willing to provide written informed consent exclusion criteria: * penetrating hi * co-existing severe or unstable injury * physician's medical judgment that surgical intervention is likely within the next 48 hours * physician's medical judgment that participation is not in the participant's best interest * pre-injury mrs\>2 * pregnancy * inability to take study drug orally or via ngt * participation in another investigational drug study * intake of nootropic drugs which are not standard tbi medications