Kornimate/medical-research-clean huggingface dataset:
what is the efficiency when comparing active sentry at low iop vs ozil at high iop?

Conditions: Cataract

Summary: the objective is to assess the efficiency of the active sentry handpiece at low intraocular pressure (iop) compared with the ozil at high iop.

this study is a single site, single-masked, randomized, prospective, contralateral eye study of the efficiency of the active sentry handpiece at low iop compared with the ozil at high iop.

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * be eligible to undergo sequential bilateral uncomplicated cataract surgery. * undergo uneventful cataract surgery. * gender: males and females. * both eyes must have same grade of cataract. * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * patient under 50 years of age. * unable to complete sequential bilateral cataract surgery in both eyes by the same surgeon (js). * patient cataract surgery complicated by posterior capsular tear. * any disease state deemed by pi that increases risk of complicated cataract surgery (ie pseudoexfoliation syndrome, zonular dehiscence, history of eye trauma, ra, prior refractive surgery, etc). the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
vitalthings guardian contactless monitoring

Conditions: Respiratory Depression; Respiratory Failure; Deterioration, Clinical

Summary: this is a confirmatory study without any intervention. it is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. there are no similar devices to vitalthings guardian m10 / m10 mobile on the market, consequently one or more different types of devices must be used as comparators.

the purpose of the clinician investigation is to validate a claim made for the investigational device performance. the objective is to confirm that the device performs at +/- 1.2 respirations per minute (rpm) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. the study will be conducted with patients admitted to the emergency ward after the initial treatment and examination.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the emergency ward (ew) exclusion criteria: * under age (below 18 years) and subjects not able to provide informed consent themselves. subjects dismissed from the ew rooms within 30 minutes from first registration are removed from the study.

Keywords: respiratory rate patient monitoring ultra wideband radar contactless monitoring medical device regulation
rebecca study (radiotherapy for breast cancer and cardiotoxicity)

Conditions: Toxicity Due to Radiotherapy; Breast Cancer; Lesion; Cardiac

Summary: the purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.

rebecca study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the institut regaud claudius-toulouse (icr) and followed for 2 years after radiotherapy. in summary, women aged between 40 and 70 years, surgically treated at icr for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.

Eligibility criteria:
inclusion criteria: * women treated surgically for left or right breast cancer and for who adjuvant treatment is radiotherapy with irradiation of the breast or chest wall irradiation and possibly lymph node chains, * age between 40 and 70 years * adjuvant radiotherapy is helical tomotherapy performed at institut claudius regaud(toulouse, france) exclusion criteria: * indication of adjuvant chemotherapy * clinically or radiologically detectable metastasis * personal history of coronary artery or myocardial disease * personal history of breast cancer or other cancer requiring radiotherapy to the chest * contraindications to injection of iodinated contrast ( for ct ) : pregnancy , renal failure, allergy. * pregnancy, lactation * before radiotherapy, lvef \<50% * before radiotherapy, longitudinal strain \> - 16 % * before radiotherapy,longitudinal strain rate \<1% / s * before radiotherapy, segmental wall motion abnormality * coronary ct before radiotherapy showing that a therapeutic treatment is required

Keywords: tomotherapy breast cancer heart subclinical cardiac lesions myocardial lesions coronary lesions circulating biomarkers ionizing radiation heart absorbed doses
determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the doac edoxaban

Conditions: Drug-drug Interaction

Summary: enzalutamide is one of the oncolytic drugs that showed efficacy and safety in most of the features of prostate cancer. approximately 17% of the patients treated with enzalutamide need pain control. nearly all opioids are metabolized through one of the cyp enzymes induced by enzalutamide, making optimal pain management difficult. for pain control, while using enzalutamide, morphine is being advised since morphine is mainly glucuronidated by ugt2b7 and to a lesser extent ugt1a1. enzalutamide is in vitro an inducer of ugt1a1 and may inhibit ugt2b7 which could alter morphine concentrations, though the clinical relevance of this interaction is unknown. in patients with cancer, direct oral anticoagulants (doacs) are frequently used since vitamin-k antagonists were reported less effective than doacs in preventing thromboembolic events. however, doacs are all metabolized through cyp3a4 or p-gp. due to interaction potential with doacs, patients treated with enzalutamide are switched to low molecular weight heparin (lmwhs) administered subcutaneously which is considered safe but less patient friendly. for patients comfort doacs are preferred over the use of lmwhs. since rivaroxaban and apixaban are both major substrates for cyp3a4, combination with enzalutamide is prohibited. dabigatran is a doac which is only metabolized by p-gp and edoxaban is a minor substrate for cyp3a4. therefore, both might be safe to combine with enzalutamide. however, in patients with an active malignancy edoxaban is preferred according to national guidelines. still, it is unknown if enzalutamide has a significant effect on the edoxaban exposure. the purpose of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics.


Eligibility criteria:
inclusion criteria: * patients with prostate cancer who will start treatment with enzalutamide within label * patients who are on treatment with opioids and/or therapeutic anticoagulation, that are treated with or willing and able to switch to morphine (2 dd extended release equivalent dose) and/or edoxaban (30mg or 60mg od, according to the label) * age at least 18 years * patients who are able and willing to give written informed consent prior to screening * patients from whom it is possible to collect blood samples * life expectancy of \> 3 months * stable renal function and renal clearance \> 50ml/min exclusion criteria: * patients who are co-treated with drugs that could interfere with the metabolism of enzalutamide, edoxaban and/or morphine
into-hlh: a disease registry for patients with hemophagocytic lymphohistiocytosis (hlh)

Conditions: Hemophagocytic Lymphohistiocytoses

Summary: the purpose of this observational study is to collect data on the natural history of disease of patients with hemophagocytic lymphohistiocytosis (hlh) including diagnosis, treatments, responses, and outcomes.

hemophagocytic lymphohistiocytosis (hlh) is a complex, hyperinflammatory syndrome resulting from the interplay of genetic predisposition and various environmental factors. despite available treatment options for hlh, approximately 30% of patients do not respond to therapy. moreover, the standard therapy is constrained by its toxicities, and safer treatments are pursued. there is an unmet need for a deeper understanding of the natural history, clinical/etiologic diversity, complications, and treatment outcomes of patients with hlh, specifically from north america. the proposed study, a collaboration between cincinnati children's hospital medical center (cchmc), texas children's hospital, and sobi inc. aims to establish a robust registry that will enable investigators to better define the natural history of hlh.

Eligibility criteria:
inclusion criteria: * patients with clinically suspected or confirmed hlh, including those meeting the hlh-2004 diagnostic criteria (primary or secondary forms, including malignancy) and other forms of hlh (macrophage activation syndrome \[mas\], cytokine release syndrome \[crs\], etc.) * signed and dated informed consent and assent (adolescents) exclusion criteria: * none
the effects of aggressive patient management on cancer therapy management

Conditions: Cancer

Summary: a study to see if coordinated aggressive patient management will improve patient treatment outcomes and is cost effective.

this is an observational study of the effects of aggressive patient management. the records of 50 patients treated under the aggressive management plan will be matched with the records of 50 previous patients and attempts made to assess the improvement, if any, found. statistical analysis will compare the outcomes of the study group and the matched control group for initial completion of planned therapy as per prescription, weight loss during therapy, intercurrent illness, and intercurrent hospitalizations. long term analysis will compare the study group's outcomes (compared to expected outcomes) compared to the matched control group.

Eligibility criteria:
inclusion criteria: * live 45 minutes from treatment facility * family income less than 200% federal poverty guideline exclusion criteria: * none

Keywords: outcomes cancer radiotherapy socio-economic
evaluation of atrial fibrillation occurrence in sick sinus and complete atrioventricular block patients after pacemaker implantation (af-pacemaker study)

Conditions: Post Pacemaker Implantation Patients

Summary: this study is prospective cohort study which was performed in multicenter (general hospital) in korea. inclusion criteria is patients post pacemaker implantation. the purpose is to investigate the occurrence of device detected subclinical atrial fibrillation (atrial high rate episode) in patients post pacemaker implantation and assess long term clinical results.


Eligibility criteria:
inclusion criteria: * age: 18-80 years * patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised korean indication guideline on cardiac pacemaker implantation * estimated percentage of atrial pacing \>40% under sinus rhythm (lr≥60bpm, close hysteresis and rest rate) * estimated percentage of ventricular pacing \>40% under sinus rhythm (lr≥40bpm, ddd pacing, close hysteresis and rest rate) * patients who are willing to sign the informed consent. * patients who are willing to receive the implantation and post-operative follow-up. exclusion criteria: * persistent or permanent af * severe hepatic and renal insufficiency (ast or alt ≥ three times of normal upper limit; scr \> 3.5 mg/dl or ccr \< 30ml/min) * thyroid gland dysfunction * pregnancy * malignant tumor * severe organic heart disease (such as moderate to severe mitral regurgitation, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease) * life expectancy \< 12 months * patients unable or unwilling to cooperate in the study procedures.

Keywords: atrial high rate episode pacemaker atrial fibrillation stroke
relaxation music for chronic pain

Conditions: IBS - Irritable Bowel Syndrome; IBD - Inflammatory Bowel Disease

Summary: chronic pain is a common complaint in inflammatory bowel disease (ibd). compounding these concerns, opioid analgesics are frequently used to treat severe acute pain. an estimated 30% of chronic pain patients due to ibd report opioid use. those who continue to use opioids can develop opioid misuse, and opioid misuse portends addiction and overdose so there is a need for better, non-addictive treatment options. music interventions effectively reduce pain and pain-related symptomology. meta-analytic results indicate listening to music can reduce acute and chronic pain. music listening also decreases emotional distress from pain as well as the use of pain medication. music interventions have demonstrated these positive effects on pain across a number of settings, including surgical, in-patient, and community settings. importantly, due to the ubiquity of music - especially freely available online music - music interventions are easily accessible and highly scalable.


Eligibility criteria:
inclusion criteria: * 18 or older * living in u.s. * have a pain rating related to ibs, crohn's, or colitis of five or greater in average pain on a 0-10 numeric rating scale in the preceding week * have had pain related to ibs, crohn's, or colitis for at least 3 months and for at least 15 days in the preceding 30 days * gad score (moderate to severe anxiety) exclusion criteria: * are currently using or have used prescription opioids in the past 3 months * have a current cancer diagnosis * in one of our prior music studies * have formal experience with mindfulness
a trial comparing the effect of nn1250 after different routes of injection in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial was conducted in europe. the aim of this clinical trial was to compare the exposure and effect of nn1250 (insulin degludec) after different routes of injection in healthy subjects.


Eligibility criteria:
inclusion criteria: * considered generally healthy upon completion of medical history, physical examination, vital signs and ecg (electrocardiogram), as judged by the investigator * body mass index 18.0-27.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
safer food allergy management for adolescents

Conditions: Food Allergy; Adherence, Medication

Summary: among the 15 million people with food allergies in the u.s., adolescents experience the highest risk of adverse events. yet, there are few evidence-based strategies to improve food allergy management in adolescents. in a cohort multiple randomized controlled trial, this study will include two experiments to test the effectiveness of text message reminders and incentives to encourage epinephrine-carrying.

among the 15 million people with food allergies in the united states, adolescents experience the highest risk of adverse events, including death from anaphylaxis. visits to one pediatric emergency department for anaphylaxis doubled between 2001 and 2006, suggesting a rapidly escalating public health burden. despite this critical concern, there are few evidence-based strategies to improve food allergy management in adolescents, who must sustain three core prevention strategies: diligent avoidance of allergenic foods, consistent carrying of potentially life-saving epinephrine auto-injectors, and prompt administration of epinephrine in the event of anaphylaxis. the objective of this study is to develop and test interventions to encourage safer food allergy management among adolescents. the primary outcome is consistency of epinephrine-carrying, measured using cell phone photographs at randomly-timed check-ins. this study will be among the first to longitudinally track normative food allergy management practices and one of the first to test behavior change strategies. in a cohort multiple randomized controlled trial (n=130), the study will include two experiments to test the effectiveness of text message reminders and incentives, using various incentive designs that have proven effective in prior behavioral economics interventions to encourage weight loss and smoking cessation. aim 1. test the impact of a text-message reminder system on consistency of epinephrine carrying. aim 2. test the impact of modest incentives on consistency of epinephrine carrying. based on promising preliminary data, the central hypothesis is that, compared to controls, adolescents who receive text message reminders plus modest financial incentives will more consistently carry their epinephrine.

Eligibility criteria:
inclusion criteria: * food allergy diagnosis by a physician and recorded in the medical chart * prior prescription of epinephrine auto-injector to treat anaphylaxis * access to a cell phone capable of sending and receiving text messages and photographs (our team will provide cell phones to participants willing to participate, but who do not own a cellphone) * fluent in english * between ages 15-19 at baseline exclusion criteria: * unable to obtain permission (consent) of a parent to participate in the study * will not or cannot give assent * currently participating in another clinical trial with related aims
to determine the effect of forlax® treatment in children with chronic constipation who may also suffer from soiling/ faecal incontinence.

Conditions: Chronic Constipation

Summary: the purpose of this study is to determine whether forlax® is more effective than placebo in relieving chronic constipation in children who may also suffer from soiling or faecal incontinence.


Eligibility criteria:
inclusion criteria: * chronic constipation (defined as at least 3 months of less than 2 bowel movements (bms) per week and/or one of the following symptoms : hard stool, painful defecation, encopresis) * constipation previously treated by dietary advice (high fiber diet) for at least two weeks without efficacy exclusion criteria: * organic bowel diseases * suspected gi obstruction * history of gi surgery
cost-effectiveness of web-based follow ups

Conditions: Osteoarthritis in the Knee Joint; Osteoarthritis in the Hip Joint

Summary: complications following total joint arthroplasty are rare, and the majority of follow-up visits are routine. the technology now exists to conduct annual follow-up assessments without having to physically see the patient. this study will investigate the cost-effectiveness of web-based follow-up assessments compared to standard in-clinic follow-ups. we will also assess patient satisfaction, preference, and the validity of the web-based follow up assessments. patients coming up to their 1 year follow-up or greater will be randomized to either the web-based group or the usual care group. web-based patients will complete all questionnaires using an online database system, and have their x-ray taken at their local radiology facility. the surgeon will review radiographs online. if there are any concerns with the x-ray or responses to questionnaires, arrangements will be made for the patient to be seen at the clinic. patients in the usual care group will come into the clinic for their follow-up assessment and have their x-ray taken at university hospital as usual. online assessment could significantly decrease wait times in orthopaedic clinics, as well as increase availability for or time and new consultations. this approach could also potentially reduce patient burden by decreasing travel distances, financial burden and time requirements.


Eligibility criteria:
inclusion criteria: * patients who have had a primary total hip or total knee arthroplasty exclusion criteria: * patients with osteolysis, or previous complications from their joint replacement

Keywords: osteoarthritis arthroplasty web-based electronic follow-up
deprescribing to reduce injurious falls among older adults with dementia

Conditions: Dementia

Summary: stop-falls-d is an educational intervention to inform and activate patients, their care partner(s), and their primary care providers to work together to reduce use of central nervous system (cns) active medications and prevent adverse outcomes (falls and injuries) associated with their use.

the study design is a pragmatic, one-arm pilot trial to test the feasibility and acceptability of implementing a deprescribing intervention with older people with dementia and their care partners in primary care. the intervention consists of patient-facing educational brochures on cns-active medications and decision support for the primary care provider. ethnic/minority groups will be over-sampled to ensure a diverse study sample.

Eligibility criteria:
older adult sample inclusion criteria: * diagnosed dementia (dementia diagnosis code or prescription for dementia medication) * receiving primary care at a kaiser permanente washington integrated group practice outpatient clinic * prescribed at least one cns-active medication on a chronic (3 months or more) basis exclusion criteria: * skilled nursing facility resident * current cancer diagnosis * on hospice or palliative care care partner sample inclusion criteria: * aged 18 years or older * self-identify as a care partner for the older adult with dementia
comparison of neuronaute smart system to a standard electroencephalogram system in hospital

Conditions: Epilepsy

Summary: the proposed study is designed to evaluate the performance of the neuronaute in comparison with the gold standard eeg in patients with a regular appointment at the hospital. the design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed. volunteers will be asked to participate to this study. this study will enroll 35 outpatient subjects aged 18 to 85. informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study. patients will be submitted to the studied device record neuronaute following by the gold standard eeg. a grid with all eeg activity recorded during the trial will be provided for evaluation after completion of the trial.


Eligibility criteria:
inclusion criteria: * patients, with a regular appointment to perform an eeg recording: (i) suspected of epileptic disorders or (ii) epilepsy already diagnosed. * age (\> 18 years), * affiliated to the social security * informed consent. exclusion criteria: * no informed consent * age (\< 18 years) * no affiliation to the social security * unsuitable anthropometric parameters * pregnant women * recent brain surgery * wound or scores on the body and the scalp * ongoing participation in another clinical trial * allergy to any component from md including : silver, polyamide, silicone * sensory disorders making the patient insensitive to pain on the skin * behavioral disorders making the patient excessively agitated or aggressive; * motor or mental disorders preventing the patient from expressing his or her pain; * cardiorespiratory disorders likely to be aggravated by slight compression of the chest; * the susceptibility to tension headaches (the compression exerted by the bonnet may in certain cases trigger a headache)

Keywords: electroencephalography epilepsy eeg