Kornimate/medical-research-clean huggingface dataset:
effect of dexmedetomidine on nol-index guided remifentanil analgesia

Conditions: Nociceptive Pain; Anesthesia; Opioid Use; Perioperative/Postoperative Complications

Summary: background: analgesia remains to this day a challenge for anesthesiologists. dexmedetomidine, a potent central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. the classic analgesic strategy focuses on opioid administration guided by estimated time of elimination and hemodynamic response (increase in blood pressure and heart rate). this technique is not sensitive and forces the anesthesiologist to be one step behind nociception, the patient's unconscious response to pain. pmd-200 (medasense, israel) displays the nociceptive level (nol)-index as marker of nociception. the nol-index ranges from 0 (no nociception) to 100 (intense nociception) and the recommended analgesic range during surgery is from 10 to 25 (medasense recommendations). the goal of this study is to compare two analgesia strategies guided by the nol index (range 10-25) using either remifentanil tci (target controlled infusion) alone or remifentanil tci associated with a continuous dexmedetomidine infusion. methods: a total of 100 patients will be included and informed consent will be acquired. this bi-center study will take place at erasme university hospital (primary center) and saint-pierre university hospital. patients will be randomized into either two groups: remifentanil and placebo versus remifentanil and dexmedetomidine. both groups will be monitored using the pmd-200 that will guide the analgesic therapy strategy. investigators and patients will be blinded to dexmedetomidine and placebo administration. the primary outcome will be intraoperative remifentanil consumption. secondary outcomes will include postoperative opioid administration, opioid associated complications, hemodynamics, and hospital length of stay.


Eligibility criteria:
inclusion criteria: - american society of anesthesiologists (asa) grades 1-2 undergoing scheduled stomatological, cervical, and thyroid surgery anticipated to last at least two hours exclusion criteria: * asa score \>2 * preoperative organ dysfunction * patients with non-regular cardiac rhythm * implanted pacemakers * emergent surgery * pregnancy or lactation * allergy or intolerance to any of the study drugs * participation in another interventional study * patient refusal
using the hopes program in transition care

Conditions: Serious Mental Illness; Psychosocial Rehabilitation

Summary: this pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (smi), the helping older people experience success (hopes) program, to help nursing home residents with smi gain the skills needed to successfully live in the community.

this pilot study will collect information about the the potential to use an evidence-based skills training program designed for older people with serious mental illness (smi), the helping older people experience success (hopes) program, to help nursing home residents with smi gain the skills needed to successfully live in the community. although hopes was originally designed to help older people with smi maintain their residence in the community, the curriculum holds promise for helping nursing home residents with smi to learn how to return to life in the community. positive findings would be used to develop a grant application for a larger study of hopes in nursing home residents with smi. to evaluate the feasibility and acceptability of hopes in nursing home settings, the investigators will enroll up to 12 residents of the glencliff home in glencliff, new hampshire. participants will be individuals interested in discharge from glencliff and are willing to attend multiple weekly skills training classes and several assessment sessions. study participation will last until 6 months after discharge from glencliff.

Eligibility criteria:
inclusion criteria: * primary dsm-iv axis i diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder as defined in participants' chart * an expressed willingness to be discharged from glencliff home to the community. * voluntary informed consent for participation in the study by the participant or by the participant's legally designated guardian exclusion criteria: * terminal physical illness or significant medical instability * inability to speak or and understand english * primary or co-morbid diagnosis of dementia

Keywords: serious mental illness psychosocial rehabilitation
cdi-988 safety study in healthy participants

Conditions: Healthy Volunteers

Summary: the goal of this clinical trial is to learn about the safety and pharmacokinetics (pk, the amount of drug in the blood) of a new drug called cdi-988 in healthy volunteers. the main questions it aims to answer are: * are there any side effects of the drug? * what is the amount of drug that reaches the bloodstream? participants will be assigned by chance to take either cdi-988 or placebo by mouth and have physical exams, electrocardiograms (ecgs), vital signs, and blood tests to look for any side effects.

cdi-988 is a severe acute respiratory syndrome coronavirus-2 (sars-cov-2) 3-chymotrypsin-like (3cl) protease inhibitor for oral administration. this study is being conducted in 2 parts to examine the safety, tolerability, and pk of cdi-988 in healthy participants. part 1 will entail escalating single doses in sequential cohorts and part 2 will enroll escalating multiple-dose cohorts. participants will be monitored for adverse events, vital signs, laboratory values, and electrocardiograms (ecgs).

Eligibility criteria:
inclusion criteria: * healthy males or non-pregnant, non-lactating females * body weight of at least 45 kg. * body mass index ≥18.0 and ≤32.0 kg/m2 * good state of mental and physical health * negative severe acute respiratory syndrome coronavirus 2 (sars-cov-2) test exclusion criteria: * received an investigational drug within 30 days * received a coronavirus disease 2019 (covid-19) vaccine within 7 days * drug or alcohol abuse in the past 12 months * clinically significant abnormal biochemistry, hematology, coagulation, urinalysis test results * clinically significant abnormal ecg or vital signs

Keywords: coronavirus sars-cov-2
bimatoprost ocular insert compared to topical timolol solution in patients with glaucoma or ocular hypertension

Conditions: Primary Open-Angle Glaucoma; Ocular Hypertension

Summary: the objective of this phase 2 study is to evaluate whether the bimatoprost ocular insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.


Eligibility criteria:
key inclusion criteria: * written informed consent * primary open-angle glaucoma or ocular hypertension in both eyes * best-corrected distance vision of 20/80 or better * stable visual field * corneal thickness between 490-620 micrometers key exclusion criteria: * cup-to-disc ratio greater than 0.8 * significant risk of angle closure due to pupil dilation, defined as a shaffer classification of less than grade 2 based on gonioscopy * laser surgery for glaucoma/ocular hypertension on one or both eyes within the last 12 months * past history of corneal refractive surgery * past history of any incisional surgery for glaucoma at any time * corneal abnormalities that would interfere with tonometry readings * current participation in an investigational drug or device study or participation in such a study within 30 days of screening * inability to accurately evaluate the retina

Keywords: glaucoma primary open-angle glaucoma ocular hypertension
assess gsk biologicals' mmr vaccine (priorix) when given to healthy children at the age of 12 to 18 months in singapore.

Conditions: Rubella; Mumps; Measles

Summary: to evaluate the safety and immunogenicity of gsk biologicals' live attenuated mmr vaccine (priorix) in a local population in singapore. the vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).


Eligibility criteria:
inclusion criteria: * a male or female infant between 12 and 18 months of age at the time of the vaccination * written informed consent obtained from the parents or guardians of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine * previous vaccination against mumps and/or rubella * history of, or intercurrent, measles, mumps, and/or rubella disease * known exposure to measles, mumps or rubella within 30 days prior to the start of the study * any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.

Keywords: mumps singapore rubella measles
effects of pregabalin (lyrica) on sleep maintenance in subjects with fibromyalgia

Conditions: Fibromyalgia; Sleep Disorders

Summary: the purpose of the study is to demonstrate the effect of lyrica on wake after sleep onset in subjects with fibromyalgia with sleep maintenance disturbance (on polysomnogram)


Eligibility criteria:
inclusion criteria: * subjects must meet diagnostic criteria for fibromyalgia; * subjects must report difficulty in maintaining sleep at least 3 times per week and meet research diagnostic criteria (rdc) for insomnia disorder, corroborated by subject diary, and meet psg inclusion criteria at visit 3. exclusion criteria: * history of active sleep disorder other than research diagnostic criteria(rdc) insomnia criteria or any sleep or circadian rhythm disturbance; * use of medications known to affect sleep wake function by visit 2; * involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping * psg finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of psg.

Keywords: fibromyalgia sleep maintenance disturbance pregabalin
comparison of radial and ulnar artery intervention in patients with st elevated myocardial infarction

Conditions: ST Elevated Myocardial Infarction

Summary: in the literature, there are no studies comparing these two pathways in st elevation myocardial infarction (stemi). in this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

the transulnar approach is known as an alternative procedure for transradial coronary angiography due to its safety and applicability. for cardiologists, experienced in trans-ulnar access, this access zone is comfortable to use. because less spasm is developing. in addition, no significant difference was found between the transradial and transulnar routes in terms of other complications.in the literature, there are no studies comparing these two pathways in st elevation myocardial infarction (stemi). in this patient group, it will be investigated whether transulnar intervention causes similar or less complications than transradial intervention, and whether it provides superiority or similarity in terms of outcomes.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * admitted for primary percutaneous intervention * either of these two routes has not been used in the last week * a sufficient pulse at both routes exclusion criteria: * cardiogenic shock * stent thrombosis * the use of either of these two arteries in the last 1 week * either of these arteries can not be pulsed or very weak pulsed

Keywords: complication primary percutaneus coronary intervention radial artery ulnar artery
anal precancerous lesions in high-risk patients.

Conditions: AIN3; AIN2; HSIL, High Grade Squamous Intraepithelial Lesions

Summary: hiv-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, crohn´s disease and lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. there is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

procedures in all patients: 1. digital anorectal evaluation 2. colonoscopy with retroflection and visualization of the anal squamocolumnar junction 3. after identification of this area 5% acetic acid will be applied. 4. visualization under nbi/bli. 5. biopsies of all the suspected lesions of anal high-grade squamous lesions (hsil).

Eligibility criteria:
inclusion criteria: 1. hiv-positive patients 2. solid transplanted recipients 3. crohn's disease patients under immunosuppression: steroids, thiopurines, biologics 4. patients with lupus under immunosuppression 5. women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva. exclusion criteria: 1. previous anal/perianal cancer history 2. previous known history of anal/perianal intraepithelial neoplasia 3. pelvic radiation
orelabrutinib in combination with r-chop for cd5-positive dlbcl patients（rocket trial）

Conditions: Diffuse Large B Cell Lymphoma (DLBCL)

Summary: this is a prospective, single-arm, multicenter, phase ii clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the r-chop (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in cd5-positive diffuse large b-cell lymphoma (dlbcl) patients.

the purpose of this phase ii clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with r-chop for untreated cd5-positive dlbcl patients. the induction phase consisted of 6 cycles of orelabrutinib in combination with r-chop (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. after 8 cycles of induction therapy, if the response is assessed as complete remission (cr), maintenance therapy with orelabrutinib will be conducted. the primary endpoint is the 2-year event-free survival (efs) rate.

Eligibility criteria:
key inclusion criteria: 1. subjects fully understand and voluntarily participate in this study and sign informed consent. 2. aged ≥18 years, both male and female. 3. pathologically confirmed cd5-positive dlbcl 4. there must be at least one measurable or evaluable lesion that meets the evaluation criteria for lugano 2014 lymphoma. 5. eastern cooperative oncology group(ecog) performance status score of 0-2. 6. expected survival ≥3 months. 7. sufficient bone marrow, liver, and kidney function. key exclusion criteria: 1. dlbcl combined with other types of lymphoma. transformed dlbcl. 2. dlbcl with central nervous system invasion. 3. the patients had previously received btk inhibitors. 4. the patients have contraindications to any drug in the combined treatment. 5. patients with the infection of human immunodeficiency virus (hiv) and/or acquired immunodeficiency syndrome. 6. inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug. 7. pregnant and lactating women, and subjects of childbearing age who do not want to use contraception. 8. mentally ill persons or persons unable to obtain informed consent. 9. the investigators think that the patient is not suitable for the study.

Keywords: dlbcl orelabrutinib cd5-positive r-chop
topical lidocaine patch in low back pain

Conditions: Acute and Chronic Non-radicular LBP

Summary: patients with acute or chronic lower back pain (lbp) participated in a phase iv clinical trial to assess the effectiveness of lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic lbp.


Eligibility criteria:
inclusion criteria: * non-radicular lbp pain for ≤12 months (non-radicular defined as lbp that does not radiate below the mid-buttock and with no sensory symptoms in the leg) * had lbp as the primary source of pain. patients may have had mild to moderate spinal stenosis and no radicular symptoms * had an average daily pain intensity score of \>4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (question 5 of bpi) within 24 hours prior to the screening visit. * had a normal neurological examination, including: * motor strength * sensory testing (light touch, pinprick, and vibration) * deep tendon reflexes patients were eligible for participation in the long-term chronic (\>12 months) group of the study if they also: * had lbp for greater than one year. patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy exclusion criteria: * had a history of greater than one back surgery or one back surgery within 3 months of study entry * had severe spinal stenosis and radicular symptoms * had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of lbp relief * had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry * had received trigger point injections within 2 weeks prior to study entry * had received botox injections within 3 months prior to study entry * were taking a lidocaine-containing product that could not be discontinued while receiving lidoderm * were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide) patients were excluded from participation in the long-term chronic (\>12 months) group if they also: * had an undefined spinal diagnosis * had a history of lumbar spine surgery within 6 months prior to study entry
salivary extracellular vesicle associated lncrnas in heart failure (seal-hf)

Conditions: CHF; ADHF; Control

Summary: the purpose of this study is to determine the relationship between the levels of ribonucleic acid (rna) circulating molecules, including ones in extracellular vesicles from different organs in the blood and in the saliva of patients with acute decompensated heart failure (adhf) and chronic heart failure (chf) to see if a new, non-invasive diagnostic test can be developed for heart failure exacerbation.

the primary objective of this study is to investigate the expression of extracellular vesicle rnas (evrnas) during admission for and decongestion of adhf patients and determine their diagnostic and prognostic potential. the main hypothesis is that these evrnas are dynamically regulated in response to volume status changes. thus, the aim is to delineate: i) the utility of salivary evrna expression in discriminating adhf from compensated chronic heart failure states in adhf patients, chronic heart failure patients and controls (n=30 each); and ii) assess changes in expression in adhf patients during decongestion. plasma and salivary evrna levels will be correlated to determine accuracy of salivary extracellular vesicles (evs) to reflect changes in plasma. this is a multi-cohort study that will make use of clinical saliva and plasma samples of 90 subjects across three groups. the first group will consist of 30 patients admitted to the hospital for adhf (clinical samples will be collected during acute decompensation and after diuresis of adhf patients). the second group will consist of 30 patients with chronic heart failure who are seen in the outpatient clinic. the control group will also include 30 supraventricular tachycardia (svt) patients recruited through the electrophysiology lab (ep). for each group, blood plasma and saliva samples will be obtained.

Eligibility criteria:
inclusion criteria chf: * at least 18 years of age * stable disease defined as chf of any type, new york heart association (nyha) functional class ii/iii/iv, n-terminal pro-b-type natriuretic peptide (nt-probnp) ≥600 pg/ml if left ventricular ejection fraction (lvef) ≤30%; ≥1000 pg/ml if lvef 31-35%; ≥2500 pg/ml if ef \>35% inclusion criteria adhf: * at least 18 years of age * clinical signs and/or symptoms (including exertional or rest dyspnea, orthopnea or paroxysmal nocturnal dyspnea (pnd)) and n-terminal pro-bnp level \> 1000 pg/ml or bnp \> 400 pg/ml, or clinical evidence of congestion: x-ray evidence of pulmonary edema or pleural effusions, elevated jugular venous pulse (jvp), lower extremity edema, or rales on pulmonary examination, right heart catheterization evidence of elevated filling pressures (right atrium (ra) pressure \> 10 mmhg; pulmonary capillary wedge pressure (pcwp) \> 18 mmhg) and clinical response to intravenous (iv) diuretic therapy (as judged by a physician) inclusion criteria control: * at least 18 years of age * diagnosis of svt with planned svt ablation in the ep lab exclusion criteria: * active pregnancy or lactation * cardiac amyloidosis * active malignancies
study of the effect of calorie supplementation on growth in young children on adhd medication

Conditions: ADHD

Summary: the purpose of this study is to see if supplementing calories with pediasure is effective in maintaining height, weight, and bmi percentiles for young children during 2 years of treatment with adhd medication.

this is a pilot study evaluating the effect of caloric supplementation on maintenance of growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old children with adhd. the study will assess the efficacy of caloric supplementation in maintaining baseline percentiles for height, weight, and body mass index (bmi). patients will be randomly assigned to receive either pediasure for caloric supplementation, or no supplementation. secondary aims include assessing the tolerability and efficacy of long-term, open-label atomoxetine treatment in 5 and 6 year old children with adhd, and obtaining adequate pilot data regarding the safety, efficacy, and potential effects of atomoxetine on growth parameters in order to submit a multisite r01 to more adequately assess atomoxetine treatment and its effects in young children with adhd.

Eligibility criteria:
inclusion criteria: * children who participated in the 8 week dbpc trial of atomoxetine (1k23mh066127) who wish to participate in a long-term, open label trial of atomoxetine. * parents and patients must be able to attend regular study visits. visits will be scheduled every 30 days for the first 6 months and then every 60 days for the next 18 months. * children who are on alternate medications due to inefficacy or intolerability of atomoxetine may still participate. exclusion criteria: * parents who are unwilling to provide informed consent.

Keywords: adhd growth atomoxetine pediasure