Kornimate/medical-research-clean huggingface dataset:
clinical performance of hydrogel vs. silicone hydrogel contact lenses

Conditions: Myopia

Summary: the aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses

this is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). it is anticipated that this study will involve 2 visits, for each lens pair, as follows: visits: v1 (lens dispensing), v2 (1 hour post lens settling). each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.

Eligibility criteria:
inclusion criteria: * is between 18 and 40 years of age (inclusive) * has had a self-reported visual exam in the last two years * is an adapted soft cl (contact lens) wearer * has a cl spherical prescription between - 1.00 and - 10.00 (inclusive) * has a spectacle cylinder up to 0.75d (diopter) in each eye. * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye. * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses. * has clear corneas and no active ocular disease * has read, understood and signed the information consent letter * patient contact lens refraction should fit within the available parameters of the study lenses * is willing to comply with the wear schedule * is willing to comply with the visit schedule exclusion criteria: * has never worn contact lenses before. * currently wears rigid gas permeable contact lenses. * has a history of not achieving comfortable cl wear (5 days per week; \> 8 hours/day) * has a cl prescription outside the range of - 1.00 to -10.00d * has a spectacle cylinder ≥1.00d of cylinder in either eye. * has contact lens best corrected distance vision worse than 20/25 (0.10 logmar) in either eye. * presence of clinically significant (grade 2-4) anterior segment abnormalities. * presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (past or present) * seborrheic eczema, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea. * has presbyopia or has dependence on spectacles for near work over the contact lenses. * has undergone corneal refractive surgery. * is participating in any other type of eye related clinical or research study.
a clinical evaluation of propel® contour sinus implant

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: the objective of this study is to evaluate the efficacy of propel contour placement following an in-office frontal sinus balloon dilation (sbd) in patients with chronic rhinosinusitis (crs)

a post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers. after successful in-office bilateral balloon dilation of the frontal sinus ostium (fso) using the vensure™ nav balloon device and fiagon cube navigation system, patients will be randomized to receive one propel contour sinus implant on one side while the contralateral side serves as the control.

Eligibility criteria:
inclusion criteria: 1. patient is 18 years of age or older. 2. patient is willing and able to comply with protocol requirements. 3. patient has confirmed diagnosis of crs per international consensus statement on allergy and rhinology, rhinosinusitis 2021 (icar:rs) guidelines. 4. bilateral disease in the frontal sinuses (lund-mackay ct score of ≥1 on each side) on ct scan within 90 days prior to the baseline. 5. a successfully completed in-office bilateral balloon dilation of the fso with no complication on either side that, in the opinion of the clinical investigator is amenable for propel contour sinus implant placement in both fso exclusion criteria: 1. patient has structural obstruction that precludes endoscopic visualization of one or both fsos prior to implant placement. 2. expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus (grade \> 2) unless reduced 30 days prior to the baseline procedure 3. oral-steroid dependent condition such as chronic obstructive pulmonary disease (copd) or other conditions. 4. known history of allergy or intolerance to corticosteroids or mometasone furoate. 5. patients with a known hypersensitivity to lactide, glycolide or caprolactone copolymers. 6. patients with electronic devices in direct connection to the brain or the nervous system such as implantable neurostimulators (e.g. deep brain stimulation), programmable cerebrospinal fluid (csf) shunts. 7. patients with monopolar pacemakers (older designs, with lower resistance to interference) or icd's (implantable cardioverter defibrillator). 8. patients with implantable, body worn devices such as insulin pumps. 9. evidence of purulence coming from paranasal sinuses or ostiomeatal complex. 10. clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis (e.g. bone erosion on prior ct scan, necrotic sinus tissue). 11. active viral illness (e.g., flu, shingles). 12. use of parenteral or injected steroids (e.g. kenalog) 30 days prior to the baseline procedure. 13. use of oral steroids, budesonide or other sinus steroid irrigations/rinses or drops, nebulized steroids administered nasally 14 days prior to baseline procedure.

Keywords: frontal sinus balloon dilation
levosimendan versus placebo before tricuspid valve surgery in patients with right ventricular dysfunction

Conditions: Patients Referred for an Isolated or a Combined Surgical Correction of Functional Moderate to Severe Tricuspid

Summary: a prospective, multicenter, randomized (two arms, parallel groups); double-blind, placebo-controlled in order to assess the ability of preoperative levosimendan to prevent post-operative low cardiac output in high-risk patients referred to cardiac surgery for correcting functional tricuspid regurgitation. the primary end point is a composite element that includes peri-operative mortality and low cardiac output syndrome at day-90: 1) catecholamine infusion persisting beyond 48 hours after cardiac surgery, 2) the need for circulatory mechanical assist devices in the postoperative period, 3) or the need for renal replacement therapy at any time during intensive care unit stay. if a patient had at least 1 of these criteria, he or she was considered as meeting the primary end point.the secondary end points were 1) each component of the primary end point, and 2) the study drug safety defined as refractory hypotension.

patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid are randomized in 2 arms, the levosimendan group or to the placebo group. in the experimental group, levosimendan is administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. the infusion will begin 24h to 48h before anesthetic induction. in the comparator group, placebo (isotonic sodium) administered as a continuous infusion over a 24-hour period at the rate of 0.2μg/kg/min, with no bolus administration. the infusion will begin \<48h before anesthetic induction

Eligibility criteria:
inclusion criteria: * patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation \[effective regurgitant orifice (ero)\>20mm², or systolic hepatic vein flow blunting or reversal\] * written signed informed consent * affiliation to the french health care system (sécurité sociale) exclusion criteria: * age \< 18 years * severe organic renal dysfunction defined by creatinine clearance \<30ml/min * recent endocarditis (\<3 months) * recent myocardial infarction (\<3 months) * tricuspid valve perforation or prolapse * cardiogenic shock requiring dobutamine support or cardiac assistance * severe liver injury (child c) * left ventricular obstruction * allergy to levosimedan * current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable * pregnant or breastfeeding women * females of childbearing potential without effective method of birth control * patient on ame (state medical aid) unless exemption from affiliation * hypotension with sbp\<90mmhg * severe tachycardia * history of torsade de pointe
paracetamol compared with ketorolac for post-operative analgetic

Conditions: Pain, Postoperative

Summary: post-operative analgetic modalities vary between center to center, especially in indonesia. considerations include potency/effectivity of the analgetics to achieve adequate pain control as soon as possible, reducing the total opioid dose intake and overall reducing potential opioid adverse effects. nsaid have been known to have more adverse effects than acetaminophen (paracetamol) but offers a higher potency for analgetic effects. here the investigators compare whether paracetamol is adequate as a post-operative analgetics and confers fewer overall adverse effects when compared with ketorolac (nsaid)

objective: the purpose of this study was to compare the efficacy of ketorolac versus paracetamol as an adjunct to nalbuphine in the management of post-operative pain following elective cardiac surgery. study design: randomized (single-blind) control trial. sampling technique: computer generated, randomized selection of patients with 50% probability of assignment into either group. place and study duration: (single center) picu and neurosurgery hcu at the cipto mangunkusumo national referral center hospital, jakarat, indonesia, over a period of 6 months, from march to august 2022. methods: eighty-five patients (46 in paracetamol group and 39 in ketorolac group) were randomly assigned to receive either paracetamol (treatment) or ketorolac (control), along with the usual pre and intraoperative sedative/analgetics, and opioid as indicated over the first 48 hours postoperatively. the treatment group received injection paracetamol 15mg/kg six hourly, whereas control group received injection ketorolac 0.5mg/kg eight hourly. primary outcome: the rflacc (pain score) was evaluated at 0, 8, 12, 24 and 48 hours post-operation and a score of 4 or less was taken as a cut-off for adequate pain control. secondary outcomes: the total dose of opioid administered to each patient and adverse effects

Eligibility criteria:
inclusion criteria: * postoperative patients admitted to neurosurgery hcu or picu * parents/guardian signed informed consent forms exclusion criteria: * history of allergy to paracetamol and ketorolac * administration of opioid 24 hours before surgery * liver dysfunction * renal failure

Keywords: acetaminophen ketorolac postoperative pain pediatric nsaid paracetamol opioid morphine
functional change with mms

Conditions: Muscle Weakness

Summary: evaluate the safety and efficacy of magnetic muscle stimulation (mms) of abdominal muscle.


Eligibility criteria:
inclusion criteria * subject (healthy volunteer) has read and signed the study written informed consent form. * male or female ≥ 22 years and ≤65 years of age. * subject has not had weight change exceeding 5% of body weight in the preceding month. * subject agrees to maintain body weight within 5% during the study by not making any changes in diet or exercise routine during the course of the study. * subject has a bmi ≤ 30 as determined at screening. * subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods. * subject agrees to refrain from any new abdominal muscle training exercises of the treatment area during the course of the study. exclusion criteria * subject has had a recent surgical procedure(s) in the area of intended treatment and muscle contractions may disrupt the healing process. * subject needs to administer or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * subject has had an intrauterine contraceptive device inserted or removed within the past month. * subject has a bleeding disorder or hemorrhagic condition * subject is taking or has taken diet pills or supplements within the past month. * subject has an active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system. * subject has metal or electronic implants in or adjacent to the treatment area * subject has an abdominal hernia. * subject has pulmonary insufficiency. * subject has a cardiac disorder. * subject has a malignant tumor. * subject has been diagnosed with a seizure disorder such as epilepsy. * subject currently has a fever. * subject is diagnosed with grave's disease. * subject has a growth plate in the treatment area * subject is pregnant or intending to become pregnant during the study period (in the next 9 months). * subject is lactating or has been lactating in the past 6 months. * subject is unable or unwilling to comply with the study requirements. * subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
dynamic 4dct to examine wrist carpal mechanics

Conditions: Osteoarthritis

Summary: osteoarthritis can develop after an injury like a broken bone. problems with how the bones line up can lead to abnormal loading which will destroy the cartilage that covers and protects the bones. once this happens, patients experience substantial pain and disability. researchers and doctors use planar x-rays to evaluate joints; but these are not always precise and are limited to two dimensions. three-dimensional (3d) computed tomography (ct) can be used to look at the joints of the wrist in three dimensions, but is limited to static frames. symptoms arising from joint instability often occur when the wrist is moving and when it is performing a functional task (opening a jar). four dimensional computed tomography (4dct) can detect dynamics changes in the small structures of the wrist with high temporal and spatial resolution. this novel imaging techniques provides a movie of bones in the wrist, in 3d, while in the scanner. in this proposal, the investigator's will use 4dct and look at how joint alignment of the distal radius effects the joints in the wrist, and investigate how it relates to patient's function, description of pain and the presence of osteoarthritis 10 years following fracture. this imaging will drive safer clinical research and practice and will develop tools that predict the risk of developing arthritis that will help doctors determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and disability.

a series of 60 participants (30 male: 30 female) with current distal radius fractures will be recruited. clinical eligibility will include a unilateral drf treated with closed reduction and casting. these measures will be assessed at baseline (\<6 weeks following injury), 3- 6 months and 12 months following fracture. a second series of 80 participants (40 male: 40 female) who suffered a drf ≥10 years previously will be recruited and tested. exclusion criteria for these two cohorts will include presence of neurological disorders, rheumatoid arthritis or co-morbid health conditions that preclude completion of study measures. twenty additional healthy participants will be recruited.

Eligibility criteria:
inclusion criteria: * fluent in english, capacity to provide consent, * over the age of 18 years old, with no previous injury to either hand or wrist exclusion criteria: * pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid health conditions that preclude completion of study measures

Keywords: 3d ultrasound monitoring
home-hit and type 1 diabetes

Conditions: Type1diabetes

Summary: this study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based high-intensity interval training (home-hit) intervention in people with type 1 diabetes.

this study aimed to use a multi-disciplinary approach to evaluate a home-based high-intensity interval training (home-hit) intervention in people with type 1 diabetes. eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; bmi 27.1±1.2 kg·m-2; v ̇o2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of home-hit. the effect of home-hit on v ̇o2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. adherence and ability to meet target heart rate (hr) thresholds (compliance) were monitored using a hr monitor and mobile phone application. change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. a qualitative online survey was completed post-training. this is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. home-hit resulted in high adherence alongside increased v ̇o2peak and decreased insulin dose. because home-hit is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.

Eligibility criteria:
inclusion criteria: * duration of type 1 diabetes \>6 months, * no significant history of hyper- or hypoglycaemia exclusion criteria: * duration of type 1 diabetes \<6 months, * significant history of hyper- or hypoglycaemia, * pregnancy or planning pregnancy, * uncontrolled hypertension (\>180/100 mmhg), * angina * autonomic neuropathy, * taking any medication that affects heart rate (hr) * major surgery planned within 6 weeks of the study * severe nonproliferative * unstable proliferative retinopathy
performance in walking in osteoarthritis patients

Conditions: Osteoarthritis

Summary: few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. no studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. our study aims to show the effectiveness of an eccentric reinforcement. this is a randomized, interventional trial.

few data exist to date on the effect of eccentric muscle building in knee osteoarthritis. no studies have compared the effect of eccentric versus concentric reinforcement in knee osteoarthritis. our study aims to show the effectiveness of an eccentric reinforcement, the interest of a work supervised by a sports coach to maintain activity over time and to study the effect of this activity at the muscular level. the main objective is to study the effect of an eccentric muscle strengthening program on walking performance in osteoarthritis patients. the secondary objectives are to study: the effect of fatigue on walking, the relationship between fatigue and the level of physical activity, the effect of training on perceived fatigue and the effect of training on the function and at muscular level. this is a randomized, interventional trial. 40 subjects are planned. inclusion criteria include: age 40-85 years, kl 2 and 3. the subjects are divided into two groups to perform either eccentric or concentric work. 2 sessions per week for 6 weeks. at baseline and at the end of the study a clinical evaluation and mri will be carried out for evaluation of the criteria of judgment

Eligibility criteria:
inclusion criteria: * autonomous subjects aged 40 to 85 * subjects meeting acr criteria for gonarthrosis * subjects with a score of kellgren and lawrence at least one knee greater than or equal to 2 * signature of consent form * subjects affiliated to social security exclusion criteria: subject with a kellgren and lawrence stadium at 4 for at least one of his two knees * subjects with symptomatic femoro-patellar arthrosis * subject with a pathology that makes walking testing impossible. * non-autonomous subjects, with a pathology impairing walking * subjects with symptomatic osteoarthritis of the hip and / or with a hip or knee prosthesis * subject incapable of signing consent and unable to understand information leaflet.
the safety and effectiveness of palonosetron hydrochloride capsule was used to cinv

Conditions: Nausea and Vomiting

Summary: to observe and evaluate the safety and effectiveness of palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; the characteristics of the applicable population, clinical medication and clinical benefits of palonosetron hydrochloride capsules were analyzed.

at present, as the mainstream antiemetics of cinv, oral administration is the most commonly used method of drug therapy. clinical studies showed that there was no difference in the efficacy of 5-ht3 receptor antagonist between different administration routes (oral and intravenous). at the same time, because the oral route is the most convenient, oral preparations provide more and more convenient choices for clinicians and patients. to observe and evaluate the safety and effectiveness of palonosetron hydrochloride capsule in preventing acute nausea and vomiting caused by moderate emetic chemotherapy; the characteristics of the applicable population, clinical medication and clinical benefits of palonosetron hydrochloride capsules were analyzed.

Eligibility criteria:
inclusion criteria: * for patients with malignant tumors who can accept chemotherapy, the disease type is not limited. the specific chemotherapy scheme is the chemotherapy scheme with moderate risk of vomiting (for the risk level of vomiting, refer to the 2019 csco anti-tumor treatment related nausea and vomiting prevention and treatment guidelines); * 18-75 years old, kps score ≥ 70, and the expected survival time is more than 3 months; * before treatment, ecg, blood routine test, liver and kidney functions and electrolytes were basically normal; * all patients signed the informed consent form exclusion criteria: * patients with chemotherapy contraindications, patients allergic to 5-ht3ra, pregnant women and lactating women; * people with digestive tract obstruction; patients with serious heart disease, liver and kidney disease and metabolic disorder; patients suffering from epilepsy or using psychotropic and sedative drugs; * used antiemetic drugs or chemicals within 24 hours.those who have vomited before treatment may have brain metastasis, intracranial hypertension, gastrointestinal obstruction, psychological abnormalities, etc.patients with factors causing nausea and vomiting.