Kornimate/medical-research-clean huggingface dataset:
burden of illness and treatment assessment of patients with dry eye disease: a cross-sectional survey of real-world patients with dry eye disease in the us

Conditions: Dry Eye Disease

Summary: this study employed secondary database analysis of the adelphi dry eye disease (ded) disease specific programme™ (dsp™), a templatized cross-sectional survey with retrospective data collection that is administered by adelphi to a convenience sample of patients diagnosed with ded, and their consulting physicians in the united states. in addition to the survey data, the ded dsp also included recorded medical history data as reported by physicians (optometrists, ophthalmologists or refractive surgeons).


Eligibility criteria:
inclusion criteria: main sample: * ≥ 18 years of age. * physician-confirmed ded diagnosis (at time of data collection). xiidra® oversample: * ≥ 18 years of age. * physician-confirmed ded diagnosis (at time of data collection). * have a current prescription for xiidra® for their ded (at time of data collection). exclusion criteria: main sample: • involved in a ded clinical trial (at time of data collection). xiidra® oversample: * involved in a ded clinical trial (at time of data collection). * included in the main sample previously.
hormonal and bone turnover marker response to an acute bout of resistance or plyometric exercise

Conditions: Osteoporosis; Osteopenia

Summary: we are interested in determining if there exist a short-term response in the serum markers and hormones that participate in the regulation of bone tissue formation and breakdown to a single, high-intensity exercise session of weight lifting (resistance exercise) or jumping (plyometrics). we are also interested in determining if the bone marker response to exercise is altered by changing the negative energy state caused by the exercise treatment, when subjects are given a moderate calorie meal.

bone tissue responds to impact and strain forces, like high-intensity exercise, by upregulating the bone remolding process, resulting in the deposition of calcium phosphate minerals into the collagen matrix of bone. bone remodeling is a continually active process that involves both activation cells regulating bone formation (osteoblasts) and resorption (osteoclasts). alterations in the balance between formation and resorption are critical for changes in bone density and mineral content to occur, which is regulated by several hormones including vitamin d and growth hormone, the sex hormones estrogen and testosterone, and parathyroid hormone. importantly, it remains unclear how single bouts of physical activity contribute to the overall changes in remodeling and whether those acute alterations can be detected in the hours after exercise. additionally, research studies examining the effects of exercise on bone remodeling often draw blood samples after 24 hours of physical inactivity, potentially diminishing the magnitude of the exercise response. therefore, we plan to evaluate the acute effects of plyometrics and resistance exercise on changes in serum hormones and markers of bone turnover in non-sedentary, healthy males, with or without a moderate calorie supplement.

Eligibility criteria:
inclusion criteria: * male * no symptoms of disease * non-sedentary * age 25-65 exclusion criteria: * medications or supplements that affect bone metabolism or prevent exercise * previous or current medical condition affecting bone health, including osteoporosis. * cardiovascular disease * metallic implants affecting accuracy of bone density scan * current smoker * current participation in high-intensity jumping or resistance exercise in the last 3 months.
arma (antireflux mucosa ablation) in patients with chronic refractory reflux disease

Conditions: Gastro-esophageal Reflux; Reflux, Gastroesophageal

Summary: pilot study of the possible clinical response to anti reflux mucosal ablation in patients with chronic refractory reflux disease

prospective, non-controlled, monocentric pilot study in patients with therapy-refractory reflux symptoms under proton pump inhibitor (ppi) therapy or intolerance of the necessary therapy or rapid recurrence of the symptoms with tapering therapy. the symptoms must have existed for \>6 months. gastroesophageal reflux disease (gerd) must be diagnosed before inclusion in the study. this is the case if either erosive reflux esophagitis according to los angeles classification grades a-d is present or non-erosive reflux disease (nerd) has been confirmed by a 24-hour ph measurement/impedance measurement. the measurement must show either an increased number of reflux events or a prolonged time under reflux. in addition, there must be a high correlation between symptoms and reflux events when reporting symptom events. the gerd-hrql score is queried for the clinical quantification of symptoms. an esophageal motility disorder, especially achalasia or relevant hypomotility must be ruled out in an high resolution esophageal manometry. a relevant gastric emptying disorder is ruled out using a c13 octanoate breath test. patients with a hill iv axial hernia, a paraesophageal hernia, or barrett's esophagus are not included. pregnancy must be ruled out in women of childbearing age. the arma procedure is explained to the patient in detail with the expected benefits and risks in oral and written form. in addition, alternative treatments such as surgical fundoplication are discussed. in the arma procedure, a gastroscopy is performed under sedation with propofol. argon plasma coagulation (apc) is performed in inversion at the gastroesophageal junction in a crescent or horseshoe shape over a width of 1.5 - 2 cm, as described in the original publication. the intended destruction of the uppermost layer of the gastroesophageal junction is intended to induce an inflammatory reaction with subsequent shrinkage of the corresponding tissue section. this leads to a tightening of the gastroesophageal junction with subsequent improved tightness, so that reflux events occur less frequently. patients will be monitored in hospital for 48 hours. the existing drug therapy is continued for 4 weeks and then tapered off. endoscopic and clinical follow-up checks take place after 2 and 6 months using gastroscopy and gerd-hrql score.

Eligibility criteria:
inclusion criteria: * typical reflux symptoms more than 2x per week during ppi therapy more than 6 month * proof of gastro-esophageal reflux in ph metry oder ph/impedance measurement exclusion criteria: * age \< 18 y * primary motility disorder of the esophagus * hiatal hernia \> 3 cm * hill classification \> iii * pregnancy * coagulation disorder * mandatory intake of oral anticoagulation drugs

Keywords: reflux disease endoscopic therapy
variation between hospitals in short-term mortality after acute coronary syndromes: a caliber study

Conditions: Acute Coronary Syndrome

Summary: we seek to investigate whether hospitals in england and wales vary in their rate of mortality following admission for heart attack or unstable angina, the extent of such variation, whether discharge diagnosis affects the extent of variation, and whether such variation has changed over time. furthermore, we will investigate what individual- or hospital-level factors explain variation in mortality between hospitals.

several studies have looked at between-hospital variation in mortality following myocardial infarction but have lacked patient-level data. those with individual-level data have been limited by: * use of in-hospital mortality as an outcome measure, which can be affected by length of stay, * restriction to patients aged 65 and over, or otherwise selected patients, and * patient-level explanatory factors lacking clinical detail, particularly medications given in hospital. minap patient-level data allow the investigation of hospital variation in mortality (in-hospital and 30-day) in a group of unselected patients, taking into account clinical details such as medication use in hospital, as well as features of the hospitals providing care. the proposed study will establish the extent of variation between hospitals in england and wales, whether this varies by acs diagnosis, whether the variation has reduced over time and finally which patient-level or hospital-level factors explain any variation found. a statistical analytic protocol for this study, dated 15.4.2010, is available on request. this study is part of the caliber (cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the nihr and wellcome trust. the central theme of the caliber research is linkage of the myocardial ischaemia national audit project (minap) with primary care (gprd) and other resources. the overarching aim of caliber is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. caliber has received both ethics approval (ref 09/h0810/16) and ecc approval (ref ecc 2-06(b)/2009 caliber dataset).

Eligibility criteria:
inclusion criteria: * admitted between january 2003 to june 2009 (or latest date data available) exclusion criteria: * admitted to hospital with fewer than 25 admissions in given year

Keywords: hospital variation 30 day mortality in hospital mortality acute coronary syndrome myocardial infarction unstable angina hospital performance trends
a phase iia study to assess the tolerability, safety, and efficacy of azd4017 for raised intra-ocular pressure

Conditions: Raised Intraocular Pressure

Summary: the purpose of this study is to evaluate the efficacy of systemically administered azd4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (iop).


Eligibility criteria:
inclusion criteria: * must have a diagnosis of intra-ocular hypertension (raised iop), or primary open-angle glaucoma (poag), with iop \>20 mmhg and ≤36 mmhg in the study eye, and is currently prescribed a stable dose of a single anti-glaucoma medication that began at least 30 days prior to the screening visit; or * must have a diagnosis of intra-ocular hypertension (raised iop), defined as an iop ≥22 mmhg and ≤36 mmhg in the study eye while not on anti-glaucoma medication * male patients must be willing to use barrier contraception with spermicide, ie, condoms, from the day of first dosing until 3 months after dosing with ip * placebo treatment for duration of the study must not be considered detrimental to the patient exclusion criteria: * have uncontrolled intra-ocular hypertension (\>36 mmhg) * have experienced a significant visual field loss or showed evidence of progressive visual field loss within the last year (as defined by \>1 db/yr average loss or vision threatening new defect) * have had severe eye trauma at any time

Keywords: raised intraocular pressure
evaluating patient reported outcomes in radiation therapy, the pro-rt study

Conditions: Breast Carcinoma; Head and Neck Carcinoma; Lung Carcinoma; Malignant Solid Neoplasm

Summary: this study explores the use of the hugo platform to involve study participants in their healthcare and treatments. the hugo platform may allow researchers to collect better and more accurate real-time health data, from other clinics/hospitals, pharmacies and other electronic devices. the purpose of this research is to see if the use of the hugo platform is consistent, accurate, cost effective, and time efficient, as it collects and transmits important real-time health information from other clinics/hospitals, pharmacies, and other electronic devices.

primary objectives: i. evaluate the data aggregation from a patient centered platform over a follow up period for completeness and quality, including externally linked electronic health record (ehr) information, toxicity completion, and the patient reported outcomes (pro) response rates for study patients, compared with historical pre-coronavirus disease (covid) cohort of registry patients. ii. to explore biometric information obtained from wearables as it pertains to the toxicity of treatment for patients using a wearable device. iii. to estimate app-based survey completion rates using hugo-based survey incentive completion (gift cards). iv. to explore the cost data available on the platform. outline: patients complete surveys via the hugo platform at baseline (before treatment), after treatment, and at 3 and 6 months after treatment. patients' medical records and fitbit information are also collected into the hugo platform.

Eligibility criteria:
inclusion criteria: * age 18+ * english speaking * consented for outcomes registry study (15-000136) * undergoing radiotherapy for cancer treatment with curative intent * willing to and able to give consent and participate in study * willing to complete all surveys * able to access a device (computer, smartphone, or tablet) with web access every day to complete study surveys * willing to connect to a device (i.e., a smartphone, fitbit, or tablet) that can regularly link to hugo for data transfer * willing to share personal information to tremendous to be able to obtain the visa e-cards for time and effort put into this study * willing to use the hugo health data sharing platform * willing to create a mayo clinic patient portal (if not already created) exclusion criteria: * unable to give consent and enroll prior to administration of baseline survey * partial breast radiation therapy (rt) (3 fraction), due to overlap in cadence used for all disease sites * stereotactic body radiation therapy (sbrt) to the lung, due to overlap in cadence used for all disease sites * co-enrollment on another pro related study (soft rule) * coordinator would need to get source data from adam via hugo * response data will only be accessible by select people
myopericarditis after messenger ribonucleic acid (mrna) covid-19 vaccination in children 5-11 years old

Conditions: Myopericarditis; Myocarditis; Vaccination; Complications; COVID-19 Pandemic; SARS-CoV2 Infection

Summary: myopericarditis is a rare complication to messenger ribonucleic acid (mrna) covid-19 vaccines, especially in male adolescents and young adults. the risk in children 5-11 years old is unknown. in denmark, the pfizer-biontech mrna covid-19 vaccination was recommended from december 1, 2021 in individuals aged 5-11 years old. we aim to estimate the incidence of myopericarditis in children 5-11 years old after mrna covid-19 vaccination among vaccinated individuals based on a nationwide prospective population-based cohort study with detailed clinical phenotyping.

aim the project seeks to estimate the incidence of myopericarditis in children 5-11 years old after mrna covid-19 vaccination. hypothesis the incidence of myopericarditis after mrna covid-19 vaccination in children 5-11 years old is significantly lower than the incidence in adolescents. method prospective nationwide population-based cohort study of all individuals aged 5-11 years hospitalized due to myocarditis and pericarditis after covid-19 mrna vaccination in the period december 1, 2021 to february 1, 2022. the setting is a multicenter study including all 18 danish pediatric departments, providing 24 hours emergency service, and in- and out-patient treatment for all danish inhabitants aged ≤ 17 years. as part of a pediatric nationwide covid-19 research set-up, all 18 departments have a principal investigator responsible for prospective real-time data collection of vaccine-associated disease. to calculate the incidence of myopericarditis among danish individuals 5-11 years old, the number of individuals who have been mrna covid-19 vaccinated will be attained from the national covid-19-vaccine database at the statens serum institut.

Eligibility criteria:
inclusion criteria: children 5-11 years old hospitalized due to myocarditis and pericarditis following mrna vaccination exclusion criteria: viral or bacterial cause of myopericarditis, or other known cause of myopericarditis

Keywords: myopericarditis myocarditis vaccination sars-cov2 mrna vaccination children
the effect of a series of systemic cryotherapy treatments on the functional state of patients with multiple sclerosis

Conditions: Multiple Sclerosis (ICD10-G35); Surface Electromyography; Whole-body Cryotherapy

Summary: multiple sclerosis (latin: sclerosis multiplex; ms) is a chronic, inflammatory and degenerative disease of the central nervous system (cns) characterised by a varied course and symptomatology. the chronic nature of the disease and gradual loss of tissue within the cns result in increasing neurological deficits and motor failure over time. due to the characteristics of the symptoms and the chronic course of ms, patients with ms use various forms of physiotherapeutic procedures throughout most of their lives, including especially often whole-body cryotherapy (wbc) treatments. the aim of this study was to assess potential changes in bioelectrical muscle activity during rest and contraction after exposure on 20 series of whole body cryotherapy (wbc) in patients with multiple sclerosis (ms). assessment potential relationships between the semg parameters and functional state in patients with multiple sclerosis pre and post 20 series of wbc. finally, 114 patients with ms participated in the planned procedures of research. the participants were randomly assigned to the two groups, wbc and control. the sample size was 60 in wbc, and 54 in control groups. testing before and after series of wbc consisted of: clinical assessment of fatigue was performed by the fatigue severity scale (fss), gait speed using timed 25 foot walk (t25-fw), hand grip strength (hgs), and surface electromyography (semg) of the dominant hand.


Eligibility criteria:
inclusion criteria: * documented diagnosis of ms, * functional status classified according to the expanded disability status scale (edss) to a level lower or equal to 0-3 * no contraindications for wbc treatments found in the medical examination * no other serious chronic diseases identified that may affect the results of the tests carried out * readiness to participate in daily wbc * a written statement of volunteers about not using wbc treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study.
corneal nerves after treatment with cenegermin

Conditions: Neurotrophic Keratitis

Summary: neurotrophic keratopathy (nk) is a condition in which patients have fewer or complete absence of nerves in the cornea, characterized by the reduced or absent corneal sensation. the lack of nerves in the cornea also result in damages of the cornea and in severe situation the loss of the eye. cenegermin (trade name oxervate) is a nerve growth factor eye drops designed to treat nk, and currently, it is the only fda-approved medication for this purpose. even though cenegermin is effective in the majority of patients, there is a lack of understanding of how cenegermin works in the eye. in this study, investigators aim to determine the structural and functional effects of cenegermin on the cornea, using non-invasive technologies including in vivo confocal microscopy on study participants with nk over the course of a year.

cenegermin (oxervatetm) is a recombinant human form of nerve growth factor developed by dompé farmaceutici s.p.a. for patients who are diagnosed with corneal epithelial defects due to moderate to severe stages of nk.

Eligibility criteria:
inclusion criteria 1. patients ≥18 years of age; and 2. persistent corneal epitheliopathy that is refractory to treatments for ≥2 weeks; and 3. evidence of decreased corneal sensitivity, defined as ≤45mm on cochet-bonnet esthesiometer, within the area of the persistent corneal epitheliopathy; and 4. evidence of decreased corneal sensitivity, defined as above, in ≥1 corneal quadrant outside the persistent corneal epithelial defect. exclusion criteria 1. patients with severe neurotrophic keratopathy characterized by corneal stromal ulceration involving over 75% of the total central corneal thickness and impending perforation. 2. patients who have used cenegermin eyedrops, autologous serum eyedrops, plasma-rich plasma eyedrops, or umbilical cord eyedrops for the treatment of neurotrophic keratopathy 8 weeks prior to study recruitment. 3. corneal surgery (including keratoplasty or refractive surgical procedures) within three months before study enrollment. 4. presence of concurrent bacterial or fungal infection.

Keywords: cenegermin neurotrophic keratopathy corneal nerve corneal sensation
validation orthèse pour gonarthrose

Conditions: Gonarthrosis

Summary: a study about the effects of different fastening systems for knee braces on comfort, ease of installation and treatment efficacy both physical and psychological. two different systems will be tested, velcro straps and a cable-fastening system.

there are 2 main types of knee braces for gonarthrosis: soft knee braces and rigid knee braces. soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells. three main types of fastening systems are used on these types of orthoses: velcro systems, hybrid systems and cable fastening systems. therefore, different configurations exist to reduce biomechanical deficits caused by the pathology. each fastening system has its advantages and disadvantages. velcro straps are fast and intuitive to use, altough multiple difficulties are mentionned: adjusment, cleaning, the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps. hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process. cable fastening systems also use quick-release fasteners. the adjusment process is simple and precise with minimal noise with these systems. comfort, efficacy and ease of use are essential qualities of a knee brace. confort is primordial as it is directly linked to treatment adherence by the patients. efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient. ease of use must be optimized as it presents an opportunity to increase treatment adherence. the goal of the fastening system developped in partnership with laboratoires victhom is the increase the ease of use of the knee brace while maintaining comfort and treatment efficacy.

Eligibility criteria:
inclusion criteria: * has worn an odra knee brace multiple hours a day during the last 6 months exclusion criteria: * wounds on the lower body

Keywords: knee brace orthosis treatment efficacy arthrosis comfort ease of use
study to compare two formulations of lamotrigine in healthy subjects

Conditions: Mental Disorders

Summary: this study intends to compare the pharmacokinetic characteristics, safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility criteria:
inclusion criteria: * body weight \>50 kg (males) or \>45 kg (females) and bmi within the range 19 to 30 kg/m2 inclusive. exclusion criteria: * female subjects of childbearing potential will not be eligible to participate if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days. * female subject is pregnant (positive serum human chorionic gonadotrophin (hcg) test at screening and pre-dose to the study) or lactating. * female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (iud). * female subjects using hormonal replacement therapy. * history of regular alcohol consumption * current smokers of 10 or more cigarettes per day

Keywords: tolerability safety pharmacokinetic characteristics