Kornimate/medical-research-clean huggingface dataset:
tongue strength in amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a neurodegenerative disease with a poor prognosis that occurs in adults 64 years on average. its prevalence is 4 to 6/100 000 inhabitants. swallowing disorders occur during evolution and involve the prognosis of patients in the short term by the association of dysphagia with severe malnutrition, and aspiration. the issue of phoniatric monitoring is to detect early onset of the swallowing disorders to develop strategies for respiratory protection, food adapted to disturbances, and speech therapy. the objective of this study is to compare the tongue force in patients with amyotrophic lateral sclerosis at the time of diagnosis and at the onset of swallowing disorders compared to healthy subjects, with the dynamic palatography device developed in the laboratoire parole et langage (umr 7309, cnrs-université aix-marseille, aix-en-provence), which allows the measurement of the strength and duration of the pression of the tongue on the palate.


Eligibility criteria:
inclusion criteria: * adults and legally responsible/ valid medical insurance * patients : als diagnostic already announced * healthy subjects : eat-10 score\<2 exclusion criteria: * non pregnant and non baby feeding * presence of risk factor or suspicion of creutzfeld jacob disease * allergy/intolerance to the glueing paste * antecedent of pathology of the aerodigestive tract * other neurologic disease * morphologic anomaly of the aerodigestive tract * excessive gag reflex
burosumab in children and adolescents with x-linked hypophosphatemia

Conditions: Rare Diseases; X-linked Hypophosphatemia

Summary: in this prospective longitudinal cohort study we studied the efficacy and safety of burosumab in real-clinical practice for \ 13-years old children affected with x-linked hypophosphatemia. 57 children with xlh were switched from conventional treatment to burosumab. after 12 months we assessed the efficacy and safety of treatment with burosumab on the whole cohort and separately on the cohort of \>13-years old adolescents.


Eligibility criteria:
inclusion criteria: * insufficient response or refractory to conventional therapy; * complications of conventional therapy: hypercalciuria and/or nephrocalcinosis, and/or persistent secondary hyperparathyroidism; * need for rapid restoration of phosphate metabolism, e.g., late diagnosis (aged \>8 years) and/or preparation for planned orthopaedic surgery.

Keywords: x-linked hypophosphataemia fibroblast growth factor 23 burosumab hyperparathyroidism
prevalence study of gastrointestinal risk factors in patients with osteoarthritis (oa), rheumatoid arthritis (ra) and ankylosing spondylitis (as).

Conditions: Osteoarthritis (OA); Rheumatoid Arthritis (RA); Ankylosing Spondylitis (AS)

Summary: rational is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with nsaid therapy for oa, ra or as during for at least 2 weeks before study visit (at least one dose).

prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.

Eligibility criteria:
inclusion criteria: * provision of subject informed consent. * female and/or male, aged \> 21 years. * patients diagnosis with ra (acr 1987 or acr/eular 2010 criteria), oa (acr 1986, 1990 and 1991 criteria) or as (new york 1984 criteria or essg 2002 criteria) (documented in the medical record). * patients receiving at least one dose of nsaids. exclusion criteria: * participation in any interventional study involving investigational drugs. * patient refuses to fill in the study questionnaires. * pregnant or breastfeeding women. * patients with active neoplastic disease in the last 5 years, except basal-cell carcinoma.

Keywords: osteoarthritis (oa) rheumatoid arthritis (ra) ankylosing spondylitis (as) gastrointestinal risk factors nsaids
de novo resistance to epidermal growth factor receptor-tyrosine kinase inhibitors

Conditions: NSCLC

Summary: this study is based on the following hypothesis "de novo resistance to egfr-tki in egfr mutation positive patients is related with mutations in egfr downstream genes". investigators will prospectively collect genomic dna and clinical data regarding treatment outcomes to egfr-tki in nsclc patients with activating egfr mutations. investigators will sequence candidate mutations of egfr downstream genes and analyze c-met gene amplification and protein expression in pten, hgf, and igfr. to identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. investigators will attempt to identify biomarkers that are able to predict de novo resistance to egfr-tki in egfr mutated nsclc.

investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable nsclc, planning to treat with egfr-tki, patients with activating egfr mutations, and available tissue sample for dna extraction.

Eligibility criteria:
inclusion criteria: 1. pathologically proven unresectable nsclc 2. 20 years of age or older 3. planned treatment with iressa® 4. patients with activating egfr mutation (del 19, l858r) 5. available detailed smoking history 6. available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory) 7. available blood sample 8. at least one lesion that is measurable according to the recist 1.1 criteria by ct or mri 9. written informed consent exclusion criteria: 1. more than 3rd line treatment 2. previously treated with other egfr-tki 3. life expectancy of less than 12 weeks 4. pregnant or lactating female 5. any unresolved toxicity greater than ctc grade 2 (version 4.0) from previous anti cancer treatment. 6. unsuitable patient in this treatment as determined by doctor.

Keywords: de novo resistance iressa egfr mutation lung cancer
study assessing efficacy of plasmatherapy in septic shock-induced coagulopathy: feasibility study

Conditions: Septic Shock; Coagulopathy; Disseminated Intravascular Coagulation

Summary: no randomized controlled trial (rct) has investigated the effect of prophylactic fresh frozen plasma (ffp) transfusion in septic or critically ill patients with coagulation abnormalities. the last surviving sepsis campaign therefore suggests with a very low quality of evidence "against the use of fresh frozen plasma during septic shock to correct clotting abnormalities in the absence of bleeding or planned invasive procedures". however, expert opinion highlights that ffp should be transfused "when there is a documented deficiency of coagulation factors (increased prothrombin time, international normalized ratio - inr, or partial thromboplastin time) and the presence of active bleeding or before surgical or invasive procedures". disseminated intravascular coagulation (dic) is responsible for such a severe deficiency of coagulation factors. supplementing the intense deficit of coagulation factors with plasma containing non-activated coagulation factors is therefore a rational therapy in dic patients. octaplaslg® is a donor plasma product, with unique features compared to standard fresh frozen plasma: standardized concentrations of natural pro-/anti-coagulation factors; a standardized volume; pathogen free. octaplaslg® should reduce the "inflammatory hit" on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma.

the present rct is an open-label faisability study. octaplaslg® or a placebo (0.9% nacl) will be allocated to patients with a septic shock-induced coagulopathy defined by decreased platelets (\ 30% decrease within 24 hours) and an inr\>1.40, and started within the 6 hours following coagulopathy diagnosis.

Eligibility criteria:
inclusion criteria: * patient with: * a septic shock defined by sepsis-3 criteria (singer, jama 2016) * and a coagulopathy assessed by decreased platelets (\ 30% decrease within 24 hours) and an inr\>1.40 (vincent, crit care med 2013) without other etiology * randomization within a timeframe of 6 hours after coagulopathy diagnosis * age strictly over 18 years old * subject affiliated to a social health insurance * free and informed consent dated and signed. exclusion criteria: * contraindication to octaplaslg® * contraindication to preventive anticoagulation by heparin * any disorder with a requirement for full anticoagulation on the day of randomization * pt prolongation or thrombocytopenia that is not due to sepsis * history of congenital bleeding disorder predisposing to hemorrhage * medical condition associated with a hypercoagulable state * patient moribund on the day of randomization * do not resuscitate limitation at inclusion in the study * law protection: guardianship or curatorship * pregnancy/breastfeeding

Keywords: septic shock coagulopathy disseminated intravascular coagulation - plasmatherapy
crispr-edited allogeneic anti-cd19 car-t cell therapy for relapsed/refractory b cell non-hodgkin lymphoma (antler)

Conditions: Lymphoma, Non-Hodgkin; Relapsed Non Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma; Non Hodgkin Lymphoma; Lymphoma; B Cell Lymphoma; B Cell Non-Hodgkin's Lymphoma

Summary: cb010a is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of cb-010 in adults with relapsed/refractory b cell non-hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

this clinical trial is a first-in-human, phase 1, multicenter, open-label evaluation of safety and emerging efficacy of cb-010 in adults with relapsed/refractory b cell non-hodgkin lymphoma. the study is conducted in two parts: part a is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. part b is the expansion portion where patients will receive cb-010 at the dose determined in part a.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 at the time of enrollment * documented diagnosis of relapsed or refractory non-hodgkin lymphoma after prior standard of care * eastern cooperative oncology group performance status 0 or 1 * adequate hematologic, renal, liver, cardiac and pulmonary organ function exclusion criteria: * prior therapy with an anti-cd19 targeting agent * active or chronic graft versus host disease requiring therapy * prior allogeneic stem cell transplantation * central nervous system (cns) lymphoma, prior cns malignancy * prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with cns involvement. * primary immunodeficiency * current or expected need for systemic corticosteroid therapy * current thyroid disorder. hypothyroidism controlled with stable hormone replacement is permitted * other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence * unwillingness to follow extended safety monitoring
oasys vs. extreme h20 xtra 59

Conditions: Dry Eye

Summary: to compare the performance of oasys to extreme h20 xtra 59 in dry eye contact lens pts who receive restasis in 1 eye and vehicle (endura) in the other eye.


Eligibility criteria:
inclusion criteria: * male or female at least 19 years of age * contact lens wearers * patients with mild to moderate symptoms of dry eye exclusion criteria: * male or female younger than 19 years of age
development and evaluation of a cbt-based transdiagnostic transcultural web app for mental health problems

Conditions: Depression; Anxiety

Summary: this study aims to (1) develop a cbt-based transcultural, transdiagnostic interactive web app and (2) assess the feasibility, acceptability, and preliminary efficacy of this intervention.

three-quarters of the global burden of mental disorders, including depression and anxiety, lies in low and middle-income countries (lmics) (who, 2017). however, the treatment gap for common mental disorders in lmics is significant, with an estimated 90% of people in these settings unable to access appropriate mental health care (vos et al., 2015). despite the strong evidence supporting effectiveness in several disorders, cognitive behaviour therapy (cbt) remains underutilized internationally due to the limited availability of comprehensive training programmes and qualified cbt-trained staff. (myhr \& payne, 2006). however, self-help and gsh can be delivered online and have been found to be effective and feasible for individuals with depression and anxiety (andrews et al., 2018). furthermore, leveraging the unprecedented increase in cell phone users and internet technologies, as well as the decline in prices of handheld mobile devices, may overcome barriers to care and address the substantial mental health treatment gap in these settings (lambert \& littlefield, 2009; lewis et al., 2012; un foundation-vodafone foundation partnership, 2020; who, 2011). we, therefore, propose the development and evaluation of a cbt-based transcultural, transdiagnostic interactive web app to address symptoms of depression, anxiety and stress.

Eligibility criteria:
inclusion criteria: * individuals aged 18 to 65 years * at least 5 years of education * computer literate * owning a smartphone or a personal computer with a reliable internet connection * score of 8 or higher on hospital anxiety and depression scale-depression or anxiety scales as measured by their primary care clinician. exclusion criteria: * substance use disorder according to dsm-5 criteria * significant cognitive impairment (for example, profound learning disability or dementia) * active psychosis as determined by their primary care clinician

Keywords: cbt web application depression anxiety self-help manual
utilization of hiv drug resistance testing in treatment experienced patients (utilize study)

Conditions: HIV Infections

Summary: the primary objective of this trial was to assess the presence of susceptibility to tipranavir and other arvs of the hiv-1 isolates in treatment experienced patients. the secondary objective was to examine clinicians' use of hiv drug resistance testing in treatment experienced patients currently failing a pi based haart regimen.


Eligibility criteria:
inclusion criteria patients that meet the following inclusion criteria will be eligible for participation in this study: 1. signed patient informed consent prior to study participation. 2. hiv-1 infected male or female ?18 years of age. 3. have confirmed (2 consecutive) hiv rna ?1000 copies/ml (one of the results must be within 3 months of enrollment into the study). 4. current haart regimen contains a protease inhibitor for ?3 months. 5. physicians considering a change in the patient?s haart regimen. f.) history of treatment with 2 or more protease inhibitors (including the current pi). low dose ritonavir (i.e.\< 400 mg. bid) is not counted as one of the pis. exclusion criteria a patient with any of the following criteria will be excluded from participation in the study: 1. arv medication naive. 2. active opportunistic infection. c.) known or suspected non-adherence to current haart regimen as assessed by the investigator.
esophageal multisegmented fcsems for malignant strictures

Conditions: Oesophageal Cancer; Esophageal Stent Stenosis

Summary: objective: to assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (sems) for the palliation of patients with malignant dysphagia. study design: prospective observational nonrandomized clinical study. study population: a total of 30 patients with malignant dysphagia will be included. sample size calculation does not apply for this type of study. intervention: all patients will be treated with the esophageal multisegmented fully covered sems. primary end points: * safety: complications and adverse events during follow-up with special attention to stent migration rates; * efficacy: technical success of stent placement. secondary end points: * recurrent dysphagia including its cause; * functional outcome: ogilvie dysphagia score and who performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up); * tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up); * pain related to esophageal stent.


Eligibility criteria:
inclusion criteria: * patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients; * requiring treatment for dysphagia (ogilvie score of 2-41); * life expectancy of less than 12 months. exclusion criteria: * stenosis after laryngectomy; * distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter; * esophageal fistula; * tumor length of more than 14 cm; * previous stent placement for the same condition; * inappropriate cultural level and understanding of the study; * coagulopathy; * patients with eosinophilic esophagitis or an esophageal motility disorder; * nickel titanium (nitinol) allergy.
neuroproprioceptive "facilitation, inhibition" and brain plasticity

Conditions: Multiple Sclerosis

Summary: this study investigates whether neuroproprioceptive "facilitation, inhibition" physical therapy induces plastic and adaptive processes of the cns (white matter integrity changes), if they relate to clinical improvement, and whether therapeutic effect differs between different kinds of therapies.

in the multi-arm parallel-group exploratory trial, patients with multiple sclerosis were divided into three groups by an independent study coordinator, and underwent three kinds of neuroproprioceptive "facilitation, inhibition" physical therapy. at baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from dti .

Eligibility criteria:
inclusion criteria: * prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist, * expanded disability status scale score (edss) max. 7.5 exclusion criteria: * other neurological disease or conditions disabling movement

Keywords: multiple sclerosis physical therapy white matter integrity neuroproprioceptive "facilitation, inhibition" functional recovery network reorganization neurohormones dehydroepiandrosterone
healing touch during chemotherapy infusions for women with breast cancer

Conditions: Breast Cancer

Summary: to study if healing touch is effective during chemotherapy treatment for breast cancer

to study the effectiveness of healing touch provided during chemotherapy infusions on the experience of women undergoing treatment for breast cancer. healing touch (ht) is a gentle, non-invasive form of energy-balancing work that promotes relaxation and can help manage the side effects of chemotherapy.

Eligibility criteria:
inclusion criteria:- stage i or ii breast cancer * post-operative * concurrent enrollment on a treatment protocol of 8 weeks of adriamycin + cyclophosphamide given every other week followed by 8 weeks of paclitaxel given every other week * ecog performance status: 0 to 2 * speak and read english exclusion criteria:- previous chemotherapy exposure - concomitant energy-work interventions (ht, reiki, qigong, acupuncture).
falls in stroke patients after hospital discharge: prevalence and risk factors

Conditions: Stroke

Summary: the purposes of this study are: (1) to investigate the incidence and causes of falls of stroke patients residing in taipei city and taipei county after their discharge from the national taiwan university hospital, (2) to investigate the relationship between clinical manifestations of stroke patients before their hospital discharge and their incidence of falls after hospital discharge, and (3) to identify the risk factors for stroke patients who frequently fall after hospital discharge.

falls are one of the most common accidents among stroke patients. stroke patients are more prone to falls than community-dwelling older adults because of their cumulative risk factors of falls such as cognitive impairment and motor dysfunction. recent studies on falls in taiwan have primarily focused on falls of community-dwelling older adults. research focused on falls among stroke patients in taiwan, however, is scarce. studies reported by researchers in other countries have only investigated the incidence and causes of falls of patients staying in medical institutions up to three months post-stroke. therefore, the incidence and immediate causes of falls remain unknown for post-hospital discharge stroke patients during their sub-acute and chronic stages. in addition, whether falls of stroke patients after hospital discharge could be predicted by their clinical manifestations during hospital stay also requires further investigation.

Eligibility criteria:
inclusion criteria: * between 40 and 75 years old * first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke) * ever received rehabilitation therapies at national taiwan university hospital * being willing to take the clinical assessments * residents of taipei city or taipei county exclusion criteria: * having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter * having other neurological diseases(ex. parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke

Keywords: stroke fall fall prediction clinical manifestations frequent faller