Kornimate/medical-research-clean huggingface dataset:
remote orthophonic follow-up on patients with chronic swallowing disorders

Conditions: Deglutition

Summary: the study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "max educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.

the patients included in the study will benefit from a monthly video follow-up via the web tool "max educ" during the first 6 months of their discharge from the rehabilitation center. they will be contacted each month during 5 months by the cril speech therapist for an interview (20 to 30 minutes). the interview will take place in 2 stages; at first, a discussion phase, during which the speech therapist will take simple news of the patient. the second phase, more formal, will be the opportunity to collect the data necessary for the validation of the secondary endpoints. to do this, the speech therapist will use the deglutition handicap index (dhi) and an interview grid. the interview will be conducted using an interview sheet previously written by the project team. the following elements will be discussed: the perceived swallowing handicap (dhi), the instructions related to diet and their daily application, ongoing rehabilitation follow-ups, notable events as well as his psycho-emotional experience in relation to said disorders. after signing the consent and verifying the eligibility criteria, all patients will be assessed upon discharge from the rehabilitation center by means of video swallowing fluoroscopy, allowing the deglutition score to be established. eortc quality of life questionnaire (qlq) qlq-30 and its annex h \& n35 and the dhi will also be completed at the inclusion visit at t0. they will then be monitored monthly by video from month 1 to month 5. during the end of research visit at 6 months, all the patients included will be reviewed in follow-up consultation with a doctor and a speech therapist within the intensive rehabilitation center for laryngectomees (which corresponds to the standard follow-up) and evaluated by video swallowing fluoroscopy. eortc qlq-30, eortc qlq-h \& n35 quality of life questionnaires and the dhi will also have to be completed.

Eligibility criteria:
inclusion criteria: * patient aged 18 or over and treated for cancer of the upper aero-digestive tract: * patient having spent a stay at the intensive rehabilitation center for laryngectomees * patient with a medical diagnosis of swallowing disorders at risk of inhalation * patient having the possibility of accessing a device allowing the use of the software by video (smartphone, tablet and / or computer) * informed consent signed by the patient. * patient affiliated to a social security scheme or equivalent exclusion criteria: * progressive neurological disease leading to cognitive disorders * patient with guardianship, curators or legal protection * inability to give consent * patient participating in another research including an exclusion period still in progress * patient with speech therapy whose frequency is greater than 1 weekly session

Keywords: remote video follow-up speech therapy aerodigestive cancer
study for patients previously treated in avapritinib clinical trials

Conditions: Gastrointestinal Stromal Tumors

Summary: this is an open-label extension study to provide long term safety data for gist patients who are deriving clinical benefit from avapritinib upon the completion of avapritinib clinical trials.


Eligibility criteria:
inclusion criteria: 1. patient has histologically confirmed metastatic or unresectable gist as established by entry in a previous avapritinib clinical trial and has been receiving treatment with avapritinib on one of these trials. 2. patient continues to receive clinical benefit from avapritinib treatment, as assessed by the investigator. 3. patient or legal guardian, if permitted by local regulatory authorities, provides informed consent. exclusion criteria: 1. patient requires therapy with a concomitant medication that is a strong inhibitor or strong inducer of cytochrome p450 (cyp) 3a4 2. patient has a history of intracranial bleeding either prior to or during avapritinib treatment 3. patients who have poor organ function, defined as adverse events of nci ctcae version 5.0 grade 3 or higher at the time of enrollment must delay start of treatment until symptoms return to grade 2 or baseline, or the start of treatment has been approved by the sponsor. 4. patients who have ongoing cognitive or mood effects adverse events of nci ctcae version 5.0 higher than grade 1 must delay start of treatment until symptoms return to grade 1 or baseline. 5. women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of enrollment and for at least 30 days after the last dose of avapritinib. men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of first dose and for at least 90 days after the last dose of avapritinib. 6. women who are pregnant. 7. women who are breast feeding.
verification of alternative do-it-yourself equipment respirators for the covid-19 personal protective equipment (ppe)

Conditions: COVID

Summary: the covid-19 pandemic health crisis forces health institutions to lower their standards of protection as supplies of personal protective equipment decrease despite the safety of front-line workers worldwide . this shortage specifically affects high-quality protective masks, such as those called ffp2. as alternatives, we offer a reusable mask based on a ventilation mask combined with a breathing filter for anesthesia breathing circuits. the purpose of the study is to assess the sealing potential of this mask in the field and possibly prove a non-inferior sealing compared to standard masks type ffp2.

the ongoing 2020 covid-19 pandemic challenges healthcare providers (hcp) worldwide with a rapid consumption and shortage of personal protection equipment (ppe), especially high-level filtration respirator masks. respirators used by hcps are mainly single use face filtering pieces with at least level p2 protection for single shift use following european en 149 standards defining protection level against hazardous particles. in response to the risk of shortage we propose a novel reusable do-it-yourself (diy) respirator assembled with already widely available components in hospital stocks: a standard breathing filter plugged in an anaesthesia facial mask held in place with a hook ring strapped to a silicone head harness. as reports of a modified full-face snorkelling (mfs) mask used for non-invasive ventilation in infected patients emerged in italy, we reckon that it could also be used as ppe with a modified valve and breathing filter.

Eligibility criteria:
inclusion criteria: * adult volunteers working in a first line healthcare service with basic knowledge of donning ppe including respirators * 5 females and 5 males exclusion criteria: * smoking or unhealthy participants with respiratory affections to avoid breathing difficulties during testing * any known allergy towards medical silicone or any other material of each component and ingredients used for disinfection of the test area and material between participants

Keywords: covid protection equipment 3d printable valve fit test
a long-term treatment with b-vec for dystrophic epidermolysis bullosa

Conditions: Dystrophic Epidermolysis Bullosa; DEB - Dystrophic Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa; Dominant Dystrophic Epidermolysis Bullosa

Summary: this is a 112-week (approximately two-year) open-label extension study of beremagene geperpavec (b-vec), for participants aged 2 months and older, who have been diagnosed with dystrophic epidermolysis bullosa (deb). participants will be dosed weekly with the topical b-vec therapy. the primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. the study is for those who participated in phase 3 study, as well as, new participants who were unable to participate in the phase 3 study, who meet all enrollment criteria.


Eligibility criteria:
inclusion criteria: * willing and able to give consent/assent * clinical diagnosis of epidermolysis bullosa * confirmation of diagnosis (either ddeb or rdeb) by genetic testing including col7a1. * age: 2 months of age and older at the time of informed consent/assent * women of childbearing age must be willing to use reliable birth control method throughout the treatment duration and for 3 months following the last treatment application exclusion criteria: * diseases or conditions that could interfere with the assessment of safety of the study treatment and compliance of the participant with study visits/procedures, as determined by the investigator * pregnant or nursing women * active infection in the area that will undergo administration, that the investigator believes will negatively impact the ip application * known allergy to any of the constituents of the product * concurrent skin transplant or mesh skin grafting; if the participant is currently having transplantation or grafting surgeries they must wait until the transplant has begun to heal and the graft has absorbed prior to initiating b-vec therapy * participation in an interventional gene therapy clinical trial within the past three (3) months (not including b-vec administration)

Keywords: deb krystal biotech
the association between non-vitamin k antagonist oral anticoagulant therapy and acute stroke severity and post stroke short-term and long-term outcomes.

Conditions: Therapeutic Drug Monitoring

Summary: non-vitamin k antagonist oral anticoagulant (noac) is the first line therapy to prevent thromboembolism in atrial fibrillation (af) patients. previous investigation showed that preceding noac therapy was associated with lower severity of ischemic stroke, but with higher in-hospital mortality in intracerebral hemorrhage (ich), as compared with antithrombotic agent non-users. measurement of noac level upon acute stroke aids the critical decision of acute management. real-world data regarding the relationship between the noac adherence, the appropriateness of noac regimen, or noac level in acute stroke and the stroke severity or short-term outcome is lacking. further, optimal selection for long-term stroke prevention among patients with acute stroke during noac therapy remains unclear. specific purpose: to analyze the association between noac adherence or noac level upon acute stroke and stroke severity or stroke outcomes, and analyze the impact of starting or withholding antithrombotic therapy after acute stroke on long-term stroke outcomes. specific aim (year 1): to investigate the relationship between noac adherence or appropriateness of noac dose and acute stroke severity or in-hospital mortality based on national health insurance research database (nhird). another important goal is to prospectively establish a cohort of af users who developed acute stroke during noac therapy in national taiwan university hospital (ntuh) (target: around 100 patients annually), measure the noac level upon hospital arrival, record stroke severity, 90-days functional outcomes, post-stroke antithrombotic agents and repeat stable noac level in patients who restart noac treatment. specific aim (year 2): to investigate the relationship between post-stroke antithrombotic therapy, especially changing or retaining preceding noac and long-term stroke outcomes based on nhird. we will also keep enrolling the prospective cohort and follow the 1-year stroke outcome. specific aim (year 3): to complete the process of study enrollment (total: 300 patients) and conduct statistical analysis. the main goal is to finish the aim 1 and 2 based on nhird. in addition, to provide data of emergent noac level and stroke severity or short-term outcome, and post-stroke antithrombotic therapy and long-term outcomes based on the prospectively enrolled cohort.


Eligibility criteria:
inclusion criteria: * atrial fibrillation * under dabigatran, rivaroxaban, apixaban or edoxaban therapy. * developing ischemic stroke, transient ischemic attack or intracranial hemorrhage during noac therapy. exclusion criteria: * refuse to provide blood sample for non-vitamin k antagonist oral anticoagulant (noac) concentration measurement. * refuse to provide informed consent.
focal hdr brachytherapy boost to stereotactic radiotherapy

Conditions: Prostate Cancer

Summary: to determine if fbt+srt is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (mid) in urinary irritation/obstructive qol

in this phase iir trial investigators primarily seek to determine if fbt boost (15gy) to sbrt (35gy/5) can be shown to be superior to standard care (whole-gland bt boost 15gy to rt 37.5gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (mid) in urinary irritation/obstructive qol as measured by epro (epic-26) at 12 and 24 months post completion of therapy.

Eligibility criteria:
inclusion criteria: * histological diagnosis of prostate cancer planned for curative-intent hdr brachytherapy boost to external beam radiotherapy to the prostate gland. * ecog 0-1 * charlson comorbidity index ≤ 4 * imaging visible disease encompassing \< 50% of the prostate gland and consistent with biopsy findings. exclusion - none
safety and efficacy of endobronchial valve for bronchoscopic lung volume reduction surgery: a prospective pilot study

Conditions: Emphysema; Chronic Obstructive Pulmonary Disease

Summary: the goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . the main questions it aims to answer are: does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? what surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves? participants will: undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves. receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.


Eligibility criteria:
inclusion criteria: * 1. patients with chronic obstructive pulmonary disease based on gold diagnostic criteria; * 2. age range from 40 to 85 years old (including 40 and 85 years old); * 3. bmi ≤ 35kg/m2; * 4. 15% ≤ fev1% pred ≤ 45%; * 5. tlc\>100% pred, rv\>140% pred, and dlco/red% ≥ 20%; * 6. 100m ≤ 6wmd ≤ 500m after rehabilitation training; * 7. quit smoking for more than 4 months; * 8. the evaluation result of pulmonary bypass ventilation function is negative; * 9. participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative. exclusion criteria: * 1. being pregnant or breastfeeding; * 2. paco2\>50mmhg and/or pao2\<45mmhg; * 3. obvious bronchiectasis or other infectious lung diseases; * 4. hospitalization due to pulmonary infection or acute exacerbation of copd within the past 12 months prior to baseline assessment twice or more times; * 5. coagulation dysfunction, platelet count\<60e+09/l; * 6. myocardial infarction or congestive heart failure within the past 24 weeks; * 7. previous lobectomy, lvrs or lung transplantation; * 8. anticoagulant therapy that cannot be stopped before surgery; * 9. uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure\>45mmhg) or lungs diagnosed within the past 12 weeks arterial hypertension; * 10. left ventricular ejection fraction (lvef) within the past 12 weeks is less than 45%; * 11. pulmonary nodules that require intervention; * 12. patients participating in other clinical trials; * 13. individuals with other contraindications to bronchial operations; * 14. other circumstances that the researcher deems unsuitable for participation in this clinical trial.
allergen immunotherapy in allergic patients

Conditions: Allergic Rhinitis

Summary: our aim was to evaluate the effectiveness of subcutaneous allergen immunotherapy with the symptom scores (rss), visual analog scale (vas) and medication scores (ms) and the impact on quality of life with rhinoconjunctivitis quality of life questionnaire (rqlq) in allergic rhinitis patients sensitized to different allergens. also the development of new sensitizations and asthma during the immunotherapy were determined.

allergic rhinitis patients sensitized to at least one common aero-allergen who completed a three or five year period of allergen immunotherapy in our outpatient clinic between 2002-2013 were enrolled in the study and patients with allergic rhinitis who received only medical treatment were chosen as the control group. patients were separated in two groups according to sensitization patterns including pollens or house dust mites. all patients were evaluated before immunotherapy, in the first and the fifth years of treatment and two years after the treatment.

Eligibility criteria:
inclusion criteria: * allergic rhinitis/asthma exclusion criteria: * pregnancy, * malignity, * autoimmunity

Keywords: immunotherapy, house dust mites, pollens, allergic rhinitis
choroidal blood flow in acute and chronic central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: patients with central serous chorioretinopathy (csc) will be monitored with laser speckle flow graphy (lsfg), swept source optical coherence tomography (ss-oct) and ss-oct angiography (ss-octa). the aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute csc and chronic csc.

acute csc - the proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity. chronic csc - the proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with pdt. the research of such changes will increase the understanding of the treatment response. this knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.

Eligibility criteria:
inclusion criteria:- * able to sign informed consent * possible to obtain fundus imaging * acute csc ˂4 months of duration in one eye, defined as: 1. subfoveal presence of srf on oct 2. present attack is 1st -3rd attack of csc b) patient history and examination consistent with acute csc c) characteristic appearance of acute csc on fundus autofluorescence (faf) and oct * chronic csc ≥4 months of duration in one eye, defined as: 1. subfoveal presence of srf on oct 2. subjective visual loss/symptoms 3. characteristic appearance of chronic csc on faf, fluorescein angiography (fa), and indocyanin angiography (icga) and oct 4. patient history and examination consistent with chronic csc exclusion criteria: * history of retinal disease other than csc (e.g. retinal detachment) * contraindications for fa, icga or pdt (only for chronic csc)
afatinib treatment for patients with egfr mutation positive nsclc who are age 70 or older

Conditions: Carcinoma, Non-Small-Cell Lung; ErbB Receptors

Summary: continuous treatment until progression or occurence of intolerable adverse event (ae) or end of trial. the end of trial is one year after the last patient has entered the study.


Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed nsclc stage iv cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. staging is based on american joint committee on cancer (ajcc) staging for nsclc 7th edition (r12-4710) * evidence of common egfr mutation (del 19 and/or l858r) * age \>= 70 years * eastern cooperative oncology group (ecog) performance status 0-1 (r01-0787) * further inclusion criteria apply. exclusion criteria: * prior participation in an afatinib clinical study, even if not assigned to afatinib treatment * prior systemic therapy for metastatic or recurrent nsclc. * concurrent investigational therapy or investigational therapy within 4 weeks of start of afatinib therapy * radiotherapy within 4 weeks prior to start of study treatment, except as follows: * palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or * single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling. * major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study * systemic chemotherapy, biological therapy, immunotherapy or investigational agents within 5 half-life of the drug or within four weeks prior to the start of afatinib treatment (if the half-life of the drug is unknown). * men, capable of fathering a child, who are unwilling to use adequate contraception prior to study entry, for the duration of study participation, and for at least 28 days after treatment has ended. * further exclusion criteria apply.
dha supplementation for lactating mothers

Conditions: Docosohexaenoic Acid Supplementation of Mothers to

Summary: the purpose of this research study is to find out whether preterm infants are receiving enough of the essential and long chain fatty acids important for brain development and immune function. our current intravenous (iv) fats do not contain the long chain fatty acids and different milk sources have different compositions. we would like to evaluate lactating mothers dietary intake and breastmilk level of fatty acid status by doing an analysis of their blood and breastmilk samples after they have been supplemented with a currently used fatty acid supplement (dha- martek biosciences, now known as dutch state mines (dsm) nutritional lipid) the dha supplement is available over the counter. the information learned from this research study may benefit other mothers and babies in the future. the information could help make sure premature babies are receiving the right nutrients they need for appropriate growth and development.

we designed a prospective, randomized trial to test the hypotheses that dha supplementation to human milk providers will increase dha concentration in milk and infant blood levels; and that infants receiving milk from dha-supplemented providers will be receiving a more appropriate enteral intake to better mimic intrauterine accretion. in addition, we hypothesize that pro-inflammatory cytokines will be reduced in the mothers and infants receiving the higher dha diet.

Eligibility criteria:
inclusion criteria: •lactating mothers at cincinnati university hospital with infants born at \< 29 weeks gestation. exclusion criteria: * the presence of congenital anomalies (trisomy 13, 18, 21, urethral, gastrointestinal and cardiac defects) that affect the standard course of care. * mother's \<18 and * mothers with known allergy to algeal source * mothers with history of bleeding disorders or taking any other medication that may increase the risk of bleeding * infants with bleeding disorders or receiving any other medication that may increase the risk of bleeding

Keywords: dha preterm infant inflammation growth developement