Kornimate/medical-research-clean huggingface dataset:
nasal high flow therapy 30 day readmission study

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: the aim of this feasibility study is to provide data for a subsequent randomized controlled trial to investigate if patient outcomes will be improved after an acute copd exacerbation using domiciliary nasal high flow therapy (nhf) compared to standard care. this feasibility study will investigate the following: process, resources, management and scientific aspects of delivering nhf as an adjunct therapy in copd patients.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * male and female * admitted to the respiratory ward(s) of either recruiting hospitals with aecopd as the primary diagnostic reason for admission. exclusion criteria: * given a new home oxygen therapy prescription during the current hospital admission * the investigator believes the participant or their care giver will be unable to safely use the myairvo 2 device following discharge * they have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
travacom post marketing surveillance study

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (iop) medication and when use of travacom is considered appropriate.


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * open-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (iop) agents and when the use of travacom is considered appropriate. * discontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. * mean iop not greater than 36 mmhg in either eye. * read, sign, and date (or legal representative) the informed consent prior to the start of any study-related procedures. * other protocol-defined inclusion criteria may apply. exclusion criteria: * women of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study. * chronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis. * history of clinically significant or progressive retinal disease. * best corrected visual acuity (bcva) score worse than 20/80 snellen. * bronchial asthma or related history that would preclude safe administration of a topical beta-blocker. * severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent. * history of spontaneous or current hypoglycemia or uncontrolled diabetes. * known medical allergy, hypersensitivity, or poor tolerance to any component of travacom deemed clinically significant in the opinion of the principal investigator. * use of any additional topical or system ocular hypotensive medication during the study. * participation in any other investigational study within 30 days prior to screening visit. * other protocol-defined exclusion criteria may apply.

Keywords: oag oht
research study on the immunosuppressive effects of a cell therapy product on pbmc isolated from blood of patients with inflammatory rheumatic diseases

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondylarthritis

Summary: rheumatic diseases regroup a variety of disorders affecting the locomotor system including joints, muscles, connective tissues and soft tissues around the joints and bones. inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic diseases. such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases (ird), include arthritis of various origins such as rheumatoid arthritis (ra), psoriatic arthritis (psa) or spondylarthritis (spa). patients with autoimmune diseases such as ra or spa are in higher risk of fractures compared to the general population. initial pharmacotherapies for ird remain nsaid treatment for pain relief, and anti-resorptive agents (e.g., tnf-alpha blockers) which aim at reducing bone loss and preventing occurrence of new bone erosions. yet current treatments may have strong side effects and are not always effective (e.g., 35-40% of the patients treated with tnf-alpha inhibitors will initially or progressively loose response). therefore there is a need for further treatment modalities in ird, which would focus on both suppressing inflammation and treating bone disorders. current research studies indicate that bone therapeutics' allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to osteo-regenerative and immune-privileged properties). the present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases. in this purpose, in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells (pbmcs) of subjects diagnosed with ra, psa and spa.


Eligibility criteria:
inclusion criteria: * subjects of 18 years of age or older * subjects must belong to one of this group: rheumatoid arthritis (ra) subjects or psoriatic arthritis (psa) subjects or spondylarthritis (spa) subjects exclusion criteria: * subjects diagnosed with other autoimmune/inflammatory diseases other than crohn's disease, psoriasis, uveitis, sjögren's syndrome and auto-immune thyroiditis * subjects with an active cancer and currently receiving a cancer treatment * women with known pregnancy * breastfeeding women * subjects with a known history of hiv and/or hepatitis b and/or hepatitis c infection and/or positive for hbs antigens

Keywords: rheumatoid arthritis psoriatic arthritis spondylarthritis rheumatic diseases inflammation autoimmune diseases osteoimmunology
sublingual versus intranasal administration of dexmedetomidine for sedation of children undergoing dental treatment

Conditions: Anti-anxiety Agents; Moderate Sedation

Summary: the aim of this study is to assess the efficacy of dexmedetomidine drug either used sublingually or intranasally in managing healthy children during dental treatment

each child should fulfill the requirements of having a dental condition which needs treatment in two dental sessions, where each session should not exceed thirty minutes. at the first visit ,either sublingual or intranasal dexmedetomidine will be used, while at the second visit the alternate route will be implemented in a cross-over design. at least one week interval between the two visits will be secured.

Eligibility criteria:
inclusion criteria: * frankl behavior rating score 2. * asa i physical status. * dental intervention under local anesthesia not requiring more than 30 minutes. * no previous dental experience. * parent/guardian written consent. exclusion criteria: * dental treatment indicated requiring general anesthesia. * mouth breathers. * patients with acute upper respiratory illness. * medically compromised patients. * cognitively impaired patients.
evolution of the rate and causes of death in geriatric ssr

Conditions: Death

Summary: in view of the ageing population and the increasing fragility of geriatric patients, it seems interesting to carry out a retrospective epidemiological observational study, on the evolution of the mortality rate and the causes of death in services of suite care and geriatric rehabilitation, in order to apprehend at best the supports, in particular palliative


Eligibility criteria:
inclusion criteria: * major patients (≥ 18 years) * all patients who died during their stay in geriatric ssr between 01/01/2013 and 31/12/2017 * patients who have not expressed their living refusal to reuse their medical data for research purposes exclusion criteria: - refusal on the part of patients of their living to reuse their medical data for research purposes

Keywords: evolution of the rate causes of death in geriatric ssr
radiotherapy - anastrazole concomitant : evaluation of the side effects

Conditions: Breast Cancer

Summary: this study is a description of the radiation effects on the healthy tissues in patients receiving anastrozole, sequential or in association with radiotherapy.


Eligibility criteria:
inclusion criteria: * post-menopausal woman without superior age limit * no metastatic breast cancer, stade i-ii, estrogen receptor positive or progesterone receptor positive, treated by conservative surgery or total mastectomy and requiring additive treatment by radiotherapy and hormonotherapy * the patients including in another clinical trial can be include in this observatory

Keywords: breast cancer radiotherapy hormonotherapy
gabapentin for insomnia symptoms and nighttime vasomotor symptoms (vms) in peri- and postmenopausal women

Conditions: Menopause; Hot Flashes; Vasomotor Disturbance

Summary: the broad goal of this study is to obtain pilot data to determine the tolerability and preliminary efficacy of the non-hormonal agent gabapentin for insomnia symptoms and nighttime vasomotor symptoms (vms) when open-label gabapentin is administered at low dose and only at night in peri- and postmenopausal women. we hypothesize that the majority of participants will be able to increase and tolerate treatment, and insomnia symptoms and the frequency of nighttime vms will improve on low-dose gabapentin dosed at bedtime.

thirty-two peri- and postmenopausal women at the boston sites (mgh and bwh) were enrolled into this open-label pilot study. the study was a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks. the intervention study followed a 3-week screening period to establish a stable baseline for insomnia symptoms and vms and to determine the safety of administering gabapentin in study participants. tolerability and treatment response (insomnia symptoms, nighttime vms) were assessed systematically at each study visit. the dose titration schedule was followed in all participants unless there are dose-limiting toxicities.

Eligibility criteria:
inclusion criteria: 1. females aged 40-65 years 2. postmenopausal or perimenopausal 3. having bothersome hot flashes 4. having some bothersome hot flashes during the night 5. insomnia or problems sleeping 6. in general, good health 7. signed informed consent exclusion criteria: 1. recent use of hormone therapy or hormonal contraceptives (with the exception of the mirena iud) 2. recent use of any prescribed therapy that is taken specifically for hot flashes 3. recent use of any over-the-counter or herbal therapies that are taken specifically for hot flashes 4. recent use of any prescribed medications with known hot flash efficacy 5. known hypersensitivity or contraindications (reasons not to take) to gabapentin 6. not using a medically approved method of birth control, if sexually active and not 12 or more months since last menstrual period 7. recent drug or alcohol abuse 8. lifetime diagnosis of psychosis or bipolar disorder 9. suicide attempt in the past 3 years or any current suicidal ideation 10. current major depression (assessed during screening) 11. pregnancy, intending pregnancy, or breast feeding 12. history of: 1. renal insufficiency or a kidney disorder 2. sleep disorder diagnosis of sleep apnea, restless legs syndrome, periodic limb movement disorder, or narcolepsy 13. any unstable medical condition 14. working a night/rotating shift 15. abnormal screening blood tests 16. current participation in another drug trial or intervention study 17. inability or unwillingness to complete the study procedures
cannabis and opioid use disorder

Conditions: Opioid Use Disorder

Summary: this study plans to enroll participants with opioid use disorder who are not currently seeking treatment to assess the effects of cannabis on opioid withdrawal and other related outcomes.


Eligibility criteria:
inclusion criteria: * current opioid use disorder exclusion criteria: * current medical conditions that require medical management
an evaluation of the talk test for exercise prescription for home-based cardiac rehabilitation

Conditions: Coronary Artery Disease

Summary: the objectives of this pilot rct are to examine if the talk test is an effective and safe tool as compared with cpet for exercise prescription in patients who have undergone cabg or pci and enrolled in a home-based cr program with virtual exercise training monitoring.

the talk test has been shown to be a valid, practical and inexpensive tool for guiding exercise training in patients with cad. the general premise of the talk test is that exercising at or above the ventilatory threshold or lactate threshold does not allow comfortable, conversational speech and thus serves as a means of estimating the cut point between moderate and vigorous intensity exercise. the talk test can be used to produce exercise intensities (64 to 95% hr peak i.e. moderate-to-vigorous intensity exercise) within accepted canadian association of cardiovascular prevention and rehabilitation (cacpr) guidelines for exercise training, to avoid exertional ischemia, and has been shown to be consistent across various modes of exercise (i.e. walking, jogging, cycling, elliptical trainer and stair stepper). there is a critical need to evaluate the effectiveness and safety of using the talk test as the principal method of exercise prescription in patients with cad who have undergone cabg or pci when compared to standard care cpet. such a trial has wide-scale appeal for cr programs across canada and beyond. it will directly and positively impact patient care by reducing the need for in-person interactions for cpet, of paramount importance during covid-19 outbreaks, between patients and cr staff, thus reducing covid-19 infection risk and concerns of contracting the virus.

Eligibility criteria:
inclusion criteria: * recently underwent pci or cabg (at least 4 weeks but less than 12 weeks post-event or procedure); * able to perform a cpet; * at least 40 years of age; * access to mychart; and, * access to email and the internet * access to a cellphone with broadband internet (4g, lte, 5g). exclusion criteria: * currently participating in a virtual or on-site cr program; * ventricular ejection fraction ≤45%; * unstable angina or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy; * unable to return for 12-week follow-up visits.

Keywords: coronary artery disease talk test cardiopulmonary exercise test cardiac rehabilitation
impact of a balance reeducation protocol on pain, function and postural control of low back pain patients

Conditions: Low Back Pain

Summary: the purpose of this study is to compare the effects of a balance reeducation protocol and an evidenced based protocol on pain, function and postural control of low back pain patients.

both groups will perform general exercises for back pain (stretch and strength of paraspinal and abdominal muscles, plus exercises to enhance lumbar and pelvic flexibility but the balance or experimental group will perform in addition five minutes of exercises that challenge postural stability in the sitting position. the evolution of the two groups concerning pain level, function and postural control will be compared.

Eligibility criteria:
inclusion criteria: * must have low back pain longer than three months and age between 40 and 69 years old exclusion criteria: * balance or neuromuscular disorders, spine surgery, diabetes.

Keywords: low back pain balance reeducation pain function
functional mri (fmri) in cgrp induced migraine

Conditions: Migraine Without Aura

Summary: in patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (cgrp). the patients will then be stimulated with noxious heat via a thermode placed at the forehead. at the same time the blood-oxygenation-level-dependent (bold) response will be measured via functional magnetic resonance imaging (fmri), to estimate the central-nervous pain response. the regions of interest (roi) will be thalamic region and medulla oblongata. then the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the bold response at the rio's previously defined. a 3-tesla mri scanner will be used in this trail. this study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach.


Eligibility criteria:
inclusion criteria: * patients know with migraine without aura. * no less then 1 migraine attach pr month and no more then 6 attaches per month. * weight 50-100 kg. * women must be using secure birthcontrol. exclusion criteria: * tension type headache more then 1 day/month. * all other prim. og sec. headache types then migraine without aura. * daily use of medication other then birthcontrol pills. * pregnant and lactation women. * headache on the trail day or 5 days previous to the trail day. * contraindications to mri-scans. * hypertension or hypotension. * known heart or lung condition. * mental illness or substance abuse. * other considerable conditions judged by the including doctor.

Keywords: migraine with out aura
effects of ras on gait in pd patients with dbs

Conditions: Parkinson Disease

Summary: participants will be asked to walk along with the metronome beats (ras) during the participants' stimulation state (on or off) for four minutes for each state. the researcher will collect the gait parameters (cadence, velocity, and stride length) of patients before, during, and after ras in both dbs on and off states. using mds-updrs, participants' gait patterns will be collected before and after ras while both dbs is on and off. electrophysiological activity (local field potentials, lfps) will be collected across all stages (pre, during, and post-ras) of evaluation.

given the evidence that rhythmic auditory stimulation (ras) can modulate beta oscillation and improve gait parameters, the purpose of this study is to examine behavioral and neurophysiological rhythmic entrainment mechanisms. participants who complete the consent and enrollment process will remain for an additional up to 1 hour following the participants' routine clinic visit at the jons hopkins outpatient clinic. the protocol will consist of two parts (dbs on and dbs off). the order of stimulation states will be randomly assigned to the participants. during dbs on, participants will receive the participants' previously optimized stimulation after a 10-minute washout period. the researchers will measure participants' gait parameters (cadence, velocity, and stride length) with a 2-minute walk (a set distance of 10 meters during the 2-minute walk) and gait patterns using relevant items from the mds-updrs-iii rating scale during stimulation on (pre-ras). the participants will then walk to the metronome beats for a total of four minutes (2 minutes for the same beat as baseline cadence and 2 minutes for 10% faster than baseline cadence) (ras), and the gait parameters will be recorded. the order of the tempo will be randomized across the participants. finally, after this 4-minute walk, the same assessment as for pre-ras will be conducted (post-ras). electrophysiological activity (local field potentials, lfps) will be collected across all stages (pre, during, and post-ras) of evaluation. in dbs off, there will be a separate 10-minute washout period if it is taking place after dbs on so that the participant's brain circuits can adjust to not being stimulated. except for the dbs stimulation state, dbs off will follow the same protocol as dbs on above.

Eligibility criteria:
inclusion criteria: * patients diagnosed with parkinson disease (pd) (and) * pd patients who implanted deep brain stimulation (dbs) of the subthalamic nucleus (stn) with percepttm pc exclusion criteria: * inability or unwillingness to follow directions for study procedures

Keywords: parkinson disease deep brain stimulation rhythmic auditory stimulation
thromboelastometry guided dic prevention after cesarean section in pregnant women with placenta previa

Conditions: DIC Syndrome

Summary: evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent dic development during icu stay after cesarean section in women with placenta previa who require a massive blood transfusion.

placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, patients present with bleeding per vagina occurring usually in the second and third trimester. bleeding in placenta previa is associated with maternal morbidity and mortality. transfusion therapy is integral in the acute management of major obstetric hemorrhage. the most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is dic. patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. massive blood transfusions are listed as the main maternal morbidity indicators6.therefore, early detection of these predictors of dic and timely intervention of this life-threatening condition is very important. dic is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: prothrombin time (pt), activated partial thromboplastin time (aptt), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., d-dimer or the soluble fibrin monomer (sfm) 8. none of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of dic, owing to the multifaceted nature of dic9, these reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose dic. thromboelastography (tem) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. tem uses three tests: fibtem to reveal impaired fibrinogen function, intem to reveal coagulation factor deficiency and extem to reveal extrinsic pathway defects

Eligibility criteria:
inclusion criteria: * asa physical status i or ii * age: ≥ 18 years * patients with all types of placenta previa * eligible for general anesthesia * elective cesarean section * singleton term pregnancy * normal coagulation profile: prothrombin time (pt), activated partial thromboplastin time (aptt), the platelet count, fibrinogen level exclusion criteria: * parturient refusal * known coagulopathy * women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases. * eclampsia and preeclampsia * emergency surgeries * foetal abnormalities * drug induced thrombocytopenia as antibiotics