Kornimate/medical-research-clean huggingface dataset:
product performance report: evaluate long-term reliability & performance of medtronic marketed cardiac therapy products

Conditions: Arrhythmia; Bradycardia; Heart Failure; Sinus Tachycardia

Summary: the main purpose of the product performance report (formerly referred to as system longevity study) is to evaluate long-term performance of medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

all medtronic market-released leads and all market-released ipg, icd and crt devices are eligible to be included in this study.

Eligibility criteria:
subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. inclusion criteria: • subject or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information as required by an institution's irb/mec/reb and one of the following must also apply: * subject is indicated for implant or within 30 days post-implant of at least one medtronic market-released product used for a pacing, sensing or defibrillation application * subjects who participated in a qualifying study (ide) of a medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data exclusion criteria: * subjects who are, or will be inaccessible for follow-up * subjects with exclusion criteria required by local law (emea only) * subjects receiving an implant of a medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant * subjects implanted with a medtronic device whose predetermined enrollment limit for that specific product has been exceeded

Keywords: cardiac pacing implantable cardioverter defibrillator pacemaker sinus bradycardia
standardized dysphagia diet in clinical evaluation of swallowing function

Conditions: Dysphagia, Swallowing Function, Diet Modification, Dysphagia Diet, Diet Standardization

Summary: diet modification has been a vital component in the management of dysphagia. the lingual manipulation of bolus, pharyngeal propulsion, and initiation of swallowing reflex are all affected by the texture of bolus. however, there is a limited literature and consensus regarding how to apply different food consistency in the swallowing function evaluation of dysphagic patients. recently, international dysphagia diet standardization initiative (iddsi) has provided a universal standard of food consistency. the present study aims to evaluate the accuracy of clinical swallowing evaluation using iddsi standardized food in dysphagic patients, in an attempt to establish protocols of clinical evaluation and diet selection in dysphagic patients.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older with a swallowing disorder on the functional oral intake scale (fois) of 1-6. exclusion criteria: * unconscious, unable to communicate via gestures or words and cooperate with commands. * acutely infected or requiring respirator use. * the oropharyngeal structure is abnormal and cannot be examined by endoscopy. * presence of tracheostomy tube
long-term safety extension study of actimmune® (interferon γ-1b) in children and young adults with friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: the purpose of this long term extension study is to evaluate the long-term safety of actimmune® (interferon-γ 1b) in participants with friedreich's ataxia (fa).

this is a multi-center, open-label, long-term safety extension study of actimmune® in the treatment of fa in children and young adults. participants who complete 26 weeks of treatment and the week 28 follow-up visit in hznp-act-302 (nct02593773) will be eligible to enter this long-term safety extension protocol. the day 1 visit of this study (hznp-act-303) occurs on the same day as the week 28 follow-up visit for hznp-act-302 (nct02593773). participants will be required to return for clinic visits at least every 6 months. the treatment duration is open-ended, and treatment will continue until actimmune® is commercially available for the treatment of fa in the united states or until the sponsor decides not to continue development for the treatment of fa.

Eligibility criteria:
inclusion criteria: * written informed consent and child assent, if applicable. * completed 26 weeks of treatment and the week 28 follow-up visit in study hznp-act-302 (nct02593773). * if female, the subject is not pregnant or lactating or intending to become pregnant during the study, or within 30 days after the last dose of study drug. female subjects of child-bearing potential must have a negative urine pregnancy test result at week 26 of study hznp-act-302 (nct02593773) and agree to use a reliable method of contraception throughout the study and for 30 days after the last dose of study drug. exclusion criteria: * if in the opinion of the investigator, patients have a concomitant disease or condition that could interfere with the conduct of the study or potentially put the subject at unacceptable risk, the subject will be excluded from the study.

Keywords: actimmune interferon y-1b
the apple study: two apples a day, keep the doctor away?

Conditions: Microbial Colonization; Enzyme Overdose

Summary: the goal of this clinical trial is to learn about the gut microbiome in healthy postmenopausal women aged 50-64. the main questions it aims to answer are: * investigate whether the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria could be decreased by ingestion of 2 apples a day for a period of 6 weeks * examine changes in gut microbiota composition, diversity, and functional capacity * examine feasibility of eating 2 apples a day for a period of 6 weeks participants will eat 2 apples a day for a period of 6 weeks. six weeks includes the period from the start of the study and gathering of baseline characteristics/questionnaires till the finish.

it is know that estrogen levels decrease after menopause. there are many different factors affecting these levels though; the gut microbiome has been identified as one of these. not only the composition of the gut microbiota plays a role here, but also its activity is of special interest. the gut microbiota for instance produces the bacterial enzyme β-glucuronidase which has been shown to de-conjugate biliary excreted estrogens, leading to reactivation and reabsorption of estrogens into the bloodstream. it might be expected that this reabsorption results in elevated blood estrogen levels. elevated levels of estrogen have been linked to not only development but also recurrence of breast cancer. apples are known for their pectin which has prebiotic properties and a potential decreasing effect on β-glucuronidase activity. in vitro studies and animal studies have already shown the β-glucuronidase decreasing impact of pectin. in humans this was never examined before. this study aims to investigate whether it is possible to lower the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria by a simple dietary intervention. this dietary intervention consists of the ingestion of two whole apples a day, one in the morning and one in the evening, during the period of 6 weeks. thereby this study aims to examine the feasibility of this intervention. it is hypothesized that 1. this is a feasible intervention 2. this results in a decrease in the activity of the bacterial enzyme β-glucuronidase and the abundance of β-glucuronidase-producing bacteria. which would be in line with the findings of in vitro and animal studies and 3. an increase in microbial diversity

Eligibility criteria:
inclusion criteria: * age 50-64 * postmenopausal women * recent negative breast cancer screening (\< 6 months) exclusion criteria: * the regular consumption of one ore more apples a day * previous gastrointestinal surgery (excl. appendix surgery) * any type of cancer in history, except for basal cell carcinoma (bcc) * inflammatory bowel disease * mammography older than 6 months * antibiotic use within three months before fecal sampling * physically or mentally incapable or incompetent to sign informed consent * known apple allergy or complaints matching with apple allergy * less good dental state
prospective survey of body mass index in people with spinal cord injury.

Conditions: Spinal Cord Injuries

Summary: this study is a prospective national survey of body mass index, and includes all patients with a new spinal cord injury hospitalized at clinic for spinal cord injuries, rigshospitalet and spinal cord injury center of western denmark during a period of 9 months. informed consent is retrieved from all participants.

the current study is a sub- study in a ph.d project containing 4 sub- studies. the protocol for the current study includes all four sub- studies, and each of the other three sub- studies will be registered ongoing individually. the current study is a prospective national survey of body mass index (bmi), and includes all patients with a new spinal cord injury hospitalized at clinic for spinal cord injuries, rigshospitalet (csci) and spinal cord injury center of western denmark during a period of 9 months whereby 100 patients are expected to participate. data are collected at admission and discharge. at csci bmi is collected every 6 weeks and all outcome measures will also be collected at follow up 6 months after discharge. a vo2peak test at discharge is performed as well, and in some participants accelerometry is performed in order to describe the amount and intensity of physical activity. test- retest reliability of the vo2peak test and accelerometry is investigated as well. patients with a new spinal cord injury within the last 12 months, who are admitted for rehabilitation several months after the time of injury are also included in the prospective survey. therefore the data for bmi at the time of injury is collected for all patients at admission to primary rehabilitation from both the patient journal and also by asking the patient about weight and height at the time of injury

Eligibility criteria:
inclusion criteria: * all newly injured patients with spinal cord injury (within the last 12 months)admitted at clinic for spinal cord injuries, rigshospitalet and spinal cord injury centre of western denmark, are included regardless of age, neurological level of lesion and completeness of the injury if informed consent is retrieved. exclusion criteria: * insufficient skills in danish language * reduced mental function that prevents reading and answering the questionnaires

Keywords: body mass index
effectiveness and dissemination of computer-based cognitive behavioral therapy and online stress management program for adolescents

Conditions: Depression

Summary: the aim of this study is to investigate the effectiveness of a computer-based cognitive behavioral therapy (ccbt) and online stress management program for adolescents, and identify the characteristics of depressed adolescents that participate in the programs.


Eligibility criteria:
inclusion criteria: * adolescents that scored above the threshold for mild depression (phq, ces-d) exclusion criteria: * adolescents with severe depression/neuropsychiatric conditions
a study to assess the impact of lebrikizumab on health-related well-being and control of skin manifestations in participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis; Eczema

Summary: the main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe ad in real-world clinical practice settings across europe, as measured using validated 5-item world health organization well-being index (who-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall qol among adult participants.


Eligibility criteria:
inclusion criteria: * adult (greater than or equal to \[\>=\] 18 years) male or female participants with diagnosis of moderate-to-severe atopic dermatitis. * adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe atopic dermatitis. * willingness and ability to participate in the study; participants must give their written consent to participate. exclusion criteria: * hypersensitivity to the active substances or to any of the excipients of lebrikizumab (ebglyss®). * participants with pre-existing helminth infections. these participants should be treated for helminth infection before starting lebrikizumab therapy. * concomitant use of live and live attenuated vaccines. * pregnant women, except when the potential benefit justifies the potential risk. * participants included in a clinical trial at baseline or at any time during the planned study period. * participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study. * participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
monitoring after cardiac arrest: electroencephalogram and cerebral oximetry in predicting outcome

Conditions: Cardiac Arrest; EEG With Periodic Abnormalities; Hypoxic-Ischemic Encephalopathy

Summary: because of its high incidence, it is essential to determine the neurological prognosis after cardiac arrest. however, there is not much information to guide post-cardiac arrest care. also, dynamic monitoring of the state of the brain can help provide information about the patient's prognosis other than previously described serum biomarkers. therefore, the researchers will monitor postcardiac arrest patients in the intensive care unit for 48 hours by electroencephalogram and cerebral oximetry and collect blood samples for serum biomarkers: neuron-specific enolase (nse), human neurogranin (nrgn) and human trigger receptor expressed on myeloid cells (trem-2), which are associated with neuronal damage. and investigate the relation of these data to mortality.

after cardiac resuscitation and intubation, the patient will be followed up with electroencephalogram-based monitoring and cerebral oximetry in the icu for 48 hours. as standard, post-cpr patients will be sedated with midazolam (0.02- 0.1 mg/kg/s) and remifentanil (0.25- 0.5 mcq/kg/min) for 24 hours. brain function measurements will be recorded under sedation for the first 24 hours and without sedation for the second 24 hours. the values recorded were suppression ratio, suppression time, patient state index, oxyhemoglobin and deoxyhemoglobin, and regional oxygen saturation. after 24 hours, a 2 ml blood sample will be taken for biomarkers (nse, nrgn, trem-2). patient survival will be followed up for seven days and 28 days. the demographic data of the patients (age, gender, body mass index, asa scores, comorbidities, history of previous operations), blood pressure, heart rate and spo2, cpr duration, the reason for arrest(4h/4t), and inotropic-vasopressor support before and after arrest will be recorded; gcs, apache-2, and sofa scores will be recorded when the patient is first admitted to the intensive care unit and at the time of cardiac arrest.

Eligibility criteria:
inclusion criteria: * experienced cardiac arrest * permanent spontaneous circulation is maintained for at least 48 hours after cpr * immediate intensive care follow-up after cardiac resuscitation exclusion criteria: * • patients under 18 years of age * presence of previously known neurological disease (cerebral palsy, neurodegenerative disease, encephalitis, etc.) * immunosuppressive patients due to previously known hematological malignancy or solid tumor * patients with a history of head trauma * patients with cardiac arrest within 48 hours after spontaneous circulation is established * patients sedated for more than 24 hours

Keywords: post-cardiac arrest electroencephalogram cerebral oxymetry biomarkers brain injury
comparison of outcome of lactose free formula milk with yogurt in children with acute diarrhea

Conditions: Acute Diarrhea

Summary: this study was aimed to look at the effect of lactose free formula milk in comparison with home-made plain yogurt in children with acute watery diarrhea.

a randomized controlled trial using non probability consecutive sampling was carried out on 60 children (30 in each group) in department of paediatrics unit i, services hospital lahore. an informed written consent was taken from parents of the children. ethical issues considered and maintained throughout the study. then all children were randomly divided in two groups by using lottery method. in group 1; children were given yogurt while in group 2, children were given lactose free formula milk. in both groups, feed was given 5-8 times per day. patients were followed-up till resolution of symptoms and discharge from hospital.

Eligibility criteria:
inclusion criteria: * children of age 4-24 months presenting with acute diarrhea * both gender exclusion criteria: * children on antibiotic therapy within 48 hours prior to presentation * malnourished children (-2sd as per who criteria) * children with severe dehydration requiring iv fluids * children \< 4 months of age (as weaning not started yet)

Keywords: lactose free formula milk yogurt
the effect of arrhythmia surgery on quality of life in patients with atrial fibrillation undergoing cardiac surgery

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is connected with an increased morbidity and mortality. in addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. af is frequently associated with valvular and coronary disease. in the af patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. for symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. for more effective symptom control "add-on" arrhythmia surgery is being advocated. however, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life. the hypothesis being studied is that add-on arrhythmia surgery in patients with af undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with af.

multicentre prospective parallel randomised controlled trial. in total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. this assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. patients completed quality of life questionnaires, comprising the rand 36-item health survey 1.0 (sf-36), multidimensional fatigue inventory-20 (mfi-20) and euroqol (eq-5d and vas) at baseline and 3, 6 and 12 months following operation.

Eligibility criteria:
inclusion criteria: * patients undergo valvular surgery and/ or coronary surgery, * all patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation. * patients have given written informed consent. exclusion criteria: * patients who do not speak dutch or can not read dutch. * patients with a sick sinus syndrome. * patients with contraindications for oral anticoagulant agents. * incompetent to act for oneself

Keywords: atrial fibrillation health related quality of life add-on surgery ablation randomised controlled trial sf-36 euroqol mfi-20
intra-surgical evaluation of cats tonometer prism and abbott medical optics versus alcon phacoemulsification machines

Conditions: Cataract Surgery

Summary: this study will measure the dynamic real-time intraocular pressure (iop) in the anterior chamber during standard phacoemulsification surgery. what is known: * fluidics control is determined to be one of the primary drivers of physician decision making in choosing phacoemulsification equipment. * active pressure system fluidic control has a perceived and possibly real (based upon recent literature) improvement in intra-cameral iop stability and reduced pressure fluctuations. * improved fluidics can allow for reduced dynamic iop fluctuations, in-the-bag positioned phaco tip, and intra-cameral fluid flow all of which will likely improve corneal health post-operatively.


Eligibility criteria:
inclusion criteria: * • age 18 or greater * bilateral cataracts for which phacoemulsification extraction and posterior iol implantation has been planned for both eyes * subjects able to give informed consent * nuclear sclerotic cataract graded 2+ or 3+ * naturally dilated pupil size (in dim light) \> 4.0 mm (with no dilation medications) for both eyes * preoperative corneal astigmatism of 2.5 d or less * ages between 55 and 80 * availability, willingness, and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * • uncontrolled systemic disease that in the opinion of the investigator would put the subject's heath at risk * intraoperative complications * subjects with only one functional eye * those with one eye having poor or eccentric fixation * mild or severe cataracts, predominantly posterior subcapsular cataracts * high corneal astigmatism (i.e. those eyes displaying an oval contact image) * those with corneal scarring or who have had corneal surgery including corneal laser surgery * microphthalmos * buphthalmos * severe dry eyes * blepharospasm * nystagmus * keratoconus * any other corneal or conjunctival pathology or infection. * central corneal thickness greater than 0,600 mm or less than 0,500 mm (2 standard deviations about the human mean) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus, immunocompromised, etc.) * uncontrolled systemic or ocular disease * history of ocular trauma or prior ocular surgery * fuchs dystrophy * subjects who may be expected to require retinal laser treatment or other surgical intervention, including lri's * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 4.0 mm under mesopic/scotopic conditions) * contact lens usage within 6 months for pmma contacts lenses, 1 month for gas permeable lenses or 1 week for extended-wear and daily-wear soft contact lens