Kornimate/medical-research-clean huggingface dataset:
behavioural intervention for dysphagia in acute stroke

Conditions: Dysphagia

Summary: swallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. this study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".

stroke compromises swallowing function, causing dysphagia, in one quarter to one half of all patients. dysphagia is associated with an increased risk of aspiration pneumonia, dehydration and malnutrition. despite the development and implementation of several strategies of managing dysphagia after stroke, few have been evaluated by means of randomised controlled trials. comparisons: this study aims to compare stroke patients with dysphagia assigned to receive usual swallowing care, prescribed by the attending physician; standardised low intensity intervention comprising swallowing compensation strategies and diet prescription; or standardised high intensity intervention and dietary prescription .

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke within the previous 7 days * clinical diagnosis of swallowing difficulty exclusion criteria: * no previous history of swallowing treatment * no previous history of surgery of the head or neck

Keywords: swallowing disorder stroke standardized swallowing therapy randomized controlled trial
study of new implantable loop recorder

Conditions: Tachyarrhythmias; Syncope

Summary: the goal of this ide clinical study is to evaluate the quality of the cardiac signal recordings obtained by the st. jude medical (sjm) confirm implantable cardiac monitor (device).


Eligibility criteria:
inclusion criteria: * patients who have clinical syndromes or situations at increased risk of cardiac arrhythmias * patients who experience transient symptoms that may suggest a cardiac arrhythmia * patients who have been previously diagnosed with atrial fibrillation * patients who are suspected to have atrial fibrillation (af) but af has not been documented * patients who have provided written informed consent to participate in the study. exclusion criteria: * patients who are under the age of 18 years * patients who have a life expectancy less than 1 year * patients who are unable to comply with the follow-up schedule * patients who are currently implanted with a pacemaker or defibrillator * patients who the physician deems inappropriate for the study

Keywords: implantable cardiac monitor arrhythmias atrial fibrillation
parent therapist partnership to provide early, intensive exercise in perinatal stroke

Conditions: Perinatal Stroke

Summary: a prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.

a mixed-methods randomized controlled trial at 3 healthcare centres: edmonton, calgary and ottawa. the period of participation for each child is 12 months. the immediate group will have 3 months of intervention and 9 months follow-up. the delay group will be followed for 6 months (waitlist-control period), then given the opportunity to receive the same intervention and followed for 3 months after the intervention. the intervention will be delivered by clinicians in the rehabilitation centres in partnership with the child's parents. therapists will provide training 2 days a week and will coach the parents to provide the training at home for 2 days a week. the intervention is elevate (engaging the lower extremity via active therapy early) and consists of child-initiated, intensive leg activities for one hour a day, four days a week for 12 weeks.

Eligibility criteria:
inclusion criteria: * children ages 8 months to 3 years * medical history and physical exam consistent with perinatal stroke * hemiparesis in the upper and/or lower extremity * parental agreement to adhere to the training and testing schedule exclusion criteria: * bilateral motor impairment * epileptic seizures that could interfere with training * cognitive, behavioural or developmental impairments that preclude participation in the protocol * botulinum toxin a injections or surgery in the lower extremities within the previous six months * concurrent casting during the intervention phase (including constraint-induced movement therapy with casting) * diagnosis associated with neurological/developmental regression * parent unable to communicate (verbal and written) in english or french

Keywords: walking intensive exercise rehabilitation cerebral palsy early intervention
study of intravitreal (ivt) regn910-3 and ivt regn910 in patients with either neovascular ("wet") age related macular degeneration (amd) or diabetic macular edema (dme)

Conditions: Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema

Summary: the primary objective of the study is to investigate the safety and tolerability of intravitreal (ivt) regn910-3 and ivt regn910 in patients with neovascular age-related macular degeneration (amd), and separately in patients with diabetic macular edema (dme).


Eligibility criteria:
key inclusion criteria: 1. for patients with amd: 1. active subfoveal choroidal neovascularization (cnv) secondary to amd, including juxtafoveal lesions that affect the fovea as evidenced by fa or oct in the study eye, as determined by the investigator 2. men or women ≥50 years and older 2. for patients with dme: 1. patients with clinically significant dme with central involvement (≥300 μm in the central subfield on spectral domain oct) 2. men or women ≥18 years and older key exclusion criteria: 1. for patients with neovascular amd: 1. evidence of choroidal neovascularization (cnv) due to any cause other than amd in either eye 2. evidence of diabetic retinopathy (dr) or dme in either eye 2. for patients with dme: evidence of neovascular amd or cnv due to any cause in either eye 3. prior iai in either eye 4. ivt bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an ae with any of these previous treatments that would preclude administration of drug in this study 5. any prior treatment with angiopoietin inhibitors 6. any prior systemic (iv) anti-vegf administration 7. history of vitreoretinal surgery in the study eye 8. pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit 9. previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening (the inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
camostat mesylate for protein-losing enteropathy after fontan operation

Conditions: Fontan Operation; Protein-Losing Enteropathy; Camostat Mesylate

Summary: this study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of camostat mesylate in patients with protein-losing enteropathy after fontan operation.


Eligibility criteria:
inclusion criteria: * history of protein-losing enteropathy after fontan operation * more than 6 months after fontan operation * more than 3 months of protein-losing enteropathy history (ascites, edema, diarrhea, etc) and less than 3.0 mg/dl of serum albumin without evidence of renal or liver disease exclusion criteria: * inability to take oral camostate mesylate * hypersensitivity to camostate mesylate * patients with taking similar medication or prohibited combination drug * patients participating in other clinical trials * patients with diet limitation * patients with genetic disease such as galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption

Keywords: fontan operation protein-losing enteropathy camostat mesylate
efficacy and mechanism of transcranial temporal interference stimulation (ttis) in the treatment of adolescent depression

Conditions: Adolescent; Depression - Major Depressive Disorder

Summary: this trial is a single-center, single-blind, randomized, sham-stimulation controlled clinical trial. the primary objective of the trial is to detect the targeted effect of ttis on the nucleus accumbens of adolescent depression patients using functional magnetic resonance imaging (mri). the secondary objective is to evaluate the potential therapeutic efficacy of tis treatment for adolescent mdd by assessing changes in clinical characteristics of participants, electrophysiological outcomes, and providing feasibility and tolerance estimates for large-scale efficacy trials. thirty adolescent mdd participants aged 13 to 17 will be recruited and randomly assigned to receive 10 tis treatments or sham stimulation treatments (15 participants per group). the trial includes pre-treatment and post-treatment mri brain scans, clinical assessments, and resting-state eeg, fnirs acquisition. follow-ups will be conducted at baseline, after the 10th day of treatment, at the 4th week, and the 8th week. the montgomery-åsberg depression rating scale (madrs), the 17-item hamilton depression rating scale (hamd-17), and the self-rating depression scale (sds) will be used to assess changes in depressive symptoms of the subjects. the hamilton anxiety rating scale (hama) and the self-rating anxiety scale (sas) will be used to assess anxiety symptoms of the subjects. the wechsler adult intelligence scale-revised china (wais-rc) will be used to assess cognitive function of the subjects.


Eligibility criteria:
inclusion criteria: * 1) age 13 - 17 years old; 2)meet the dsm-5 criteria for mdd with a current mde without psychotic features, as confirmed by the mini 3) hamd-17 total score of ≥20 4) no change in treatment regimen in the 4 weeks prior to screening 5) no severe mental disorders or intellectual disabilities; 6)can cooperate actively with the experimental process and subsequent follow-up. exclusion criteria: * 1) serious diseases such as heart, liver, kidney and hematopoietic system disorders; 2) abuse drugs or are addicted to alcohol or suffer from uncontrollable mental illnesses; 3) active suicidal intent, confirmed by the mini module b (suicidality) or hamd-17 item #3 score ≥3; 4) pregnant or lactating; 5) those who have identified definite organic lesions such as infarction foci, softening foci, hemorrhage foci, and space-occupying lesions through plain scan of cranial mri; 6) those with implanted objects in the brain (such as aneurysm clips, shunt devices, stimulators, cochlear implants or electrodes) or any other metal objects in or near the head, and cannot be safely removed; 7) change in medication or psychotherapy treatment regimen before screening 8) could not cooperate with fmri examination or ttis treatment; 9)have received other forms of brain stimulation treatment in the past 3 months.

Keywords: adolescent depression transcranial temporal interference stimulation
larotaxel + cisplatin versus gemcitabine + cisplatin in first line treatment of locally advanced/metastatic urothelial tract or bladder cancer

Conditions: Urinary Bladder Neoplasms

Summary: this is a randomized, open-label, multi-center study comparing the efficacy and safety of xrp9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. the primary objective is to compare overall survival. secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.


Eligibility criteria:
inclusion criteria: * patients with histology/cytology confirmed transitional cell carcinoma (tcc) with locally advanced (t4b) or metastatic urothelial tract or bladder cancer * ecog performance status 0 or 1 * no prior palliative chemotherapy exclusion criteria: * (neo)adjuvant chemotherapy if \< 6 months between end of (neo)adjuvant chemotherapy and relapse * less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization * prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose \> 300 mg/m² the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: cancer neoplasms bladder urothelial tract
the effect of nasal cannula during the first 2 hours postoperative in patient undergoing thoracotomy

Conditions: Lung Surgery; Hypoxia; Postoperative

Summary: during early postoperative after lung resection surgery, patients without oxygen supplementation may experience hypoxemia. oxygen supplementation can be given via oxygen mask or cannular. in this study the investigators want to the sudy the effect of oxygen supplementation via oxygen cannular during the first 120 minutes after surgery


Eligibility criteria:
inclusion criteria: * age =/\> 18 years * lobectomy or pneumonectomy or wedge resection * asa 1-3 * preoperative oxygen saturation \< 95 % * receiving epidural analgesia exclusion criteria: - cannot communication

Keywords: thoracotomy oxygen saturation postoperative
fluid investigation colloid vs crystalloid reg. renal hemodynamics and function

Conditions: Renal Impairment

Summary: comparing the effects of crystalloid versus colloid fluid resuscitation in cabg patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.

due to blood loss and sirs postoperative hypovolemia is a usual feature after cabg surgery. substantial controversy persists regarding the best choice of fluid to be used for resuscitation in this setting regarding renal function and oxygen supply-demand matching. in our study we aim to investigate differences in functional renal parameters by dividing patients postoperatively in two groups, substituted either with crystalloid fluid, ringer-acetat, 20 ml/kg or colloid, hes 6% (130/0,4) 10 ml/kg under 20 minutes. central and renal hemodynamics will be measured before (baseline) and after fluid administration by blood sampling and thermodilution in both pulmonary artery catheter and renal vein catheter. measurement endpoints will mainly consist of central hemodynamics, renal blood flow, gfr and renal oxygen extraction rate which we aim to compare between groups.

Eligibility criteria:
inclusion criteria: * elective fast track cabg patients, postoperative exclusion criteria: * hemodynamic instability * preoperative renal impairment * major postoperative bleeding

Keywords: elective cabg renal impairment gfr renal blood flow colloid crystalloid thermodilution technique oxygen supply demand
transpacific tavr registry

Conditions: Heart Valve Diseases; Aortic Valve Insufficiency

Summary: this registry evaluates the long-term outcome of transcatheter aortic valve replacement (tavr) in real-world clinical practice.

this study is connected with asian tavr registry(nct02308150). some subjects from asian tavr registry continue 10 years follow-up on this tp-tavr registry.

Eligibility criteria:
inclusion criteria: * all patients undergoing tavr * informed consent

Keywords: tavr tavi real-world
transcutaneous tibial nerve stimulation for urgency urinary incontinence

Conditions: Urge Incontinence; Overactive Bladder

Summary: this is a single-center, double-blinded, randomized controlled trial evaluating the efficacy of ttns versus a sham intervention. both interventions will be performed by participants in their homes after standardized instruction. the primary outcome is a comparison of the mean change in oab-q scores before and after treatment between the intervention and control groups. changes in the number of urgency incontinence episodes and an estimation of cost effectiveness will additionally be measured. intention to treat analysis will be performed.


Eligibility criteria:
inclusion criteria: * ≥ 6 episodes urgency incontinence on 3-day voiding diary * duration of symptoms ≥ 3 months * off antimuscarinic or 3-adrenoreceptor agonist therapy for 2 weeks * no known neurologic disease * ability to complete home sessions and clinic follow up * ability to complete voiding diaries * internet access and proficiency * english or spanish-speaking exclusion criteria: * pregnant * known or suspected urinary retention * symptomatic urinary tract infection unresolved at the time of randomization * recurrent urinary tract infection (≥ 3/12 months) * bladder pain syndrome * known or suspected advanced (stage iii or iv) pelvic organ prolapse * neurogenic bladder * current or prior bladder malignancy * current or previous use of bladder botox injections, percutaneous tibial nerve stimulation, or sacral neuromodulation * pacemaker or other implantable device * disease affecting lower extremities * bilateral metallic lower limb implant * incarceration

Keywords: tibial nerve stimulation transcutaneous electrical nerve stimulation overactive bladder urgency urinary incontinence
a phase i study of tq-b3395 on tolerance and pharmacokinetics

Conditions: Advanced Cancer

Summary: to study the pharmacokinetic characteristics of tq-b3395 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria:
inclusion criteria: * histological documentation of advanced solid tumors,lack of the standard treatment or treatment failure.in expanding stage,enroll the non-small cell lung cancer with egfr+(except exon 20) * 18-70 years,ecog ps:0-1,life expectancy of more than 3 months * main organs function is normal * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * 14 days or more from the last cytotoxic therapy * patients participated in other anticancer drug clinical trials within 4 weeks or patients participating in other clinical trials now * blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmhg，diastolic pressure≥90 mmhg); patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qtc≥470ms) and patients with grade 3 or higher congestive heart failure (nyha classification) * patients with non-healing wounds or fractures * patients with drug abuse history and unable to get rid of or patients with mental disorders * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
prophylactic dli for the prevention of relapse post hsct in patients with high risk myeloid malignancy

Conditions: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute

Summary: the trial will be conducted as a multicentre open label, randomised prospective phase ii clinical trial in patients with high risk myeloid malignancies. the primary objective is to evaluate whether prophylactic donor lymphocyte infusions (dli) delivered as part of a planned schedule improves the disease free survival of patients with myeloid malignancies.


Eligibility criteria:
patient inclusion criteria 1. haematological cancer which can be one of the following 1. acute myeloid leukaemia (aml) if intermediate or high risk in cr1 2. aml if favourable risk in cr2 3. patients with aml or mds with residual cytogenetic or molecular disease pre-hsct 4. cmml 5. myelodysplastic syndrome (mds) defined by an ipss category int-1 or higher with \<5% blasts at the time of randomisation following cyto-reduction if necessary 6. secondary mds or aml; defined as arising from antecedent haematological disease or secondary to prior chemotherapy. 2. patients with sibling or 9/10 or 10/10 hla matched unrelated donor 3. patients receiving alemtuzumab based reduced intensity conditioned hsct 4. age \>/=18 years 5. able to comprehend and give informed consent patient exclusion criteria 1. patients with \>5% blasts at time of hsct 2. patients eligible for myeloablative (bu/cy of cy/tbi) hsct protocols 3. patients with myelofibrosis 4. patients with hypersensitivity to alemtuzumab, melphalan, fludarabine or busulphan 5. ecog performance status \> 2 6. patients who are pregnant or lactating
high-flow oxygen therapy during exercise in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: objectives: 1. to evaluate endurance time during cardiopulmonary exercise test (cpet) performance comparing standard oxygen therapy to high-flow nasal cannula (hfnc) oxygen therapy in subjects with idiopathic pulmonary fibrosis (ipf) with exertional desaturation. 2. to assess oxygenation level (peripheral and muscular) as well as dyspnea and fatigue during exercise in ipf subjects with exertional desaturation using oxygen supplementation with hfnc compared with standard oxygen supplementation. method: multicenter crossover clinical trial. patients with ipf presenting oxygen desaturation during the six-minute walking test (6mwt) (spo2 mean ≤ 85%) will be included consecutively . each subject evaluated will perform initially an incremental cpet to evaluate the patient's maximum exercise capacity. supplemental oxygen will be applied to maintain spo2 \>85% with a venturi mask. maximum exercise capacity and the appropriate final oxygen inspiratory fraction (fio2) needed for the following tests will be determined. posteriorly each patient will perform two constant load cpet (at 75% of the maximum workload achieved with the incremental cpet); one with standard oxygen therapy and the other one with hfnc oxygen therapy. endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded. evaluation measures: endurance time, dyspnea and leg fatigue (borg scale), and oxygen saturation.


Eligibility criteria:
inclusion criteria: * subjects with ipf diagnosis according to the 2018 international consensus guidelines * mean spo2 ≤ 85% during the 6mwt performed under room air conditions exclusion criteria: * fibrotic interstitial lung diseases other than ipf * chronic obstructive pulmonary disease (copd) * inability to perform a complete cpet due to osteo-articular or cognitive limitations * end-stage lung disease * severe pulmonary hypertension

Keywords: exertional desaturation high-flow nasal cannula