Kornimate/medical-research-clean huggingface dataset:
dose escalation study of interleukin-7 (il-7) and bitherapy in asiatic hcv patients resistant to bitherapy

Conditions: Hepatitis C

Summary: this study is designed to evaluate the safety of biological active dose of a new experimental drug, il-7, in combination with standard bi-therapy in asiatic patients with hepatitis c chronic infection identified as non responders to the standard bi-therapy alone.

this is a phase i/iia inter-patient dose-escalation study assessing weekly doses of interleukin-7 (cyt107) in asiatic adult patients infected by virus of genotype 1 of hepatitis c and resistant to standard treatment with peg-interferon and ribavirin (bi-therapy). the dose escalation is aimed at establishing the safety of a biologically active doses of cyt107 added to the combination therapy of pegylated interferon-alpha and ribavirin. at each dose level, study patients will receive one subcutaneous administration of cyt107 per week for a total of 4. groups of 3 to 6 patients will be entered at each dose level of cyt107. three dose levels are planned. eligible patients initially receive bi-therapy for 6-10 weeks. thereafter, cyt107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after cyt107 treatment discontinuation. the patients are then followed on a regular basis until reaching 48 weeks after the cyt107 treatment. the duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy. participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 weeks. during the visits the following may be done: * medical history, physical examination, blood tests * electrocardiograms (ecg) * chest x-ray * liver/spleen imaging * urine tests

Eligibility criteria:
main inclusion criteria: * hcv genotype 1 infected patients * absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin * metavir ≤ f3 assessed by biopsy in the last 12 months main exclusion criteria: * active infection by hbv * infection by hiv-1 and /or hiv-2 * apart from hcv infection, presence of active infection requiring a specific treatment or a hospitalization * other liver disease * body mass index (bmi) \> 30kg/m2 * relapse after previous response to pegylated ifn alpha and ribavirin therapy * previous bi-therapy with pegylated ifn alpha and ribavirin not well tolerated (in particular treatment discontinuation) * any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma * history of clinical autoimmune disease or active auto-immune disease * history of severe asthma, presently on chronic medications * significant cardiac or pulmonary disease * inability to give informed consent

Keywords: interleukin-7 immune-based therapies hepatitis c chronic hepatitis resistance to peg-interferon and ribavirin bitherapy immune specific responses to hcv taiwan phase 1/2a viral disease liver disease
prospective observation of fibrosis in the lung clinical endpoints study

Conditions: Idiopathic Pulmonary Fibrosis; Idiopathic Non-specific Interstitial Pneumonitis

Summary: idiopathic pulmonary fibrosis (ipf) is a progressive scarring condition of the lungs the cause of which is unknown.there are currently no effective treatments for ipf and the condition tends to cause progressive disability and death with an average survival of 3.5 years from diagnosis. the condition is responsible for the deaths of 4000 people per year in the uk. at present the definite diagnosis of ipf rests on the identification of a specific pattern of fibrosis when a section of fibrotic lung tissue is examined under a microscope. unfortunately, the process of obtaining a lung biopsy requires an operation and is not with out risk. the investigators hope to identify specific markers in the blood and lungs of patients with ipf that will enable the condition to be diagnosed without biopsy. furthermore, the investigators hope to identify indicators(biomarkers) that will predict which patients have more aggressive and progressive disease and also to identify biomarkers that might be useful in identifying a response to treatment and might therefore be used in future clinical trials in ipf. as well as looking at markers in the blood and lungs the investigators also plan to assess the use of daily home lung function measurement and a computerised technique for analyzing lung sounds to see if these are investigations that are able to predict the development of worsening lung fibrosis.


Eligibility criteria:
inclusion criteria: * individuals over the age of 18 with a diagnosis of definite or probable ipf or definite or probable fibrotic nsip as defined by the ats/ers consensus classification exclusion criteria: * patients with co-existent conditions known to be associated with the development of fibrotic lung disease will be excluded. * this includes * connective tissue disease * suspected drug-induced lung disease * asbestosis or other asbestos related disease (pleural plaques, mesothelioma, asbestos pleural effusions) * granulomatous disease including sarcoidosis. * patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms. * non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody etc. will not be used to exclude individuals from the study. * patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study. * patients involved in clinical trials assessing novel ipf therapies will be excluded from enrolment in this study.

Keywords: idiopathic pulmonary fibrosis interstitial lung disease prognosis biomarkers mortality acute exacerbations
standardizing the management of patients with coronary microvascular dysfunction

Conditions: Coronary Artery Disease; Microvascular Angina; Microvascular Ischemia of Myocardium

Summary: the samcro is an all comers, prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes (probe). the diagnosis of angina in non obstructive coronary artery disease (anoca) will be confirmed with coronary artery angiography and with the invasive assessment of coronary microvascular dysfunction (cmd) and coronary vasomotion. at least 120 anoca patients with invasively confirmed cmd will be randomized to i) multi-domain lifestyle intervention (experimental arm) vs. ii) standard of care (control arm). all patients will undergo follow-up visits at 6, 12, 24, 36, 48 and 60 months. the study endpoints will be the improvement of angina status and quality of life as assessed by validated questionnaires at one year. all participants in the multi-domain lifestyle group will receive five different kinds of intervention: i) dietary counselling, ii) strict management of cardiovascular (cv) and metabolic risk factors, iii) tailoring of medical therapy on the basis of the invasive assessment of cmd and coronary vasomotion, iv) exercise training and v) psychological intervention. patients randomized to the control group will be managed according to current guidelines. the angina status will be assessed by the seattle angina questionnaire (saq). quality of life will be assessed using the euroqol (eq5d-5l). anxiety and depression will be assessed using the beck depression inventory (bdi).

the aim of the samcro trial is to determine whether a multidomain lifestyle intervention improves angina status and quality of life in anoca patients as compared to current standard of care. patients will be randomized to: experimental arm: multi-domain lifestile intervention patients will receive five different kinds of intervention: i) strict management of cv and metabolic risk factors, ii) tailoring of medical therapy on the basis of the invasive assessment of cmd and coronary vasomotion, iii) dietary counselling, iv) exercise training v) psychological counselling control arm: standard of care patients randomized to the control group will be managed according to current guidelines

Eligibility criteria:
inclusion criteria: * patient admitted to hospital for chronic coronary syndrome (ccs) with indication for coronary artery angiography * absence of obstructive coronary artery disease at invasive coronary artery angiography * coronary microvascular dysfunction as identified by invasive coronary physiology exclusion criteria: * planned coronary revascularization * co-morbidity reducing life expectancy to less than 1 year * any factor precluding 1-year follow-up * prior coronary artery bypass graft (cabg) surgery * presence of a chronic total occlusion (cto)

Keywords: angina in non obstructive coronary artery disease
study to evaluate the safety and efficacy of asc41 in overweight and obese subjects

Conditions: Overweight and Obesity; NAFLD; Hyperlipidemia

Summary: the primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of asc41, a thr beta agonist tables in overweight and obese subjects who have elevated ldl-c .


Eligibility criteria:
key inclusion criteria: * 23kg/m2 ≤ bmi \<40kg/m2. key exclusion criteria: * a history of thyroid disease. * a positive hbsag, hcv ab and/or hiv ab.

Keywords: overweight and obesity nafld hyperlipidemia ldl-c nash
functional intermuscular reduction of spasticity

Conditions: Multiple Sclerosis

Summary: investigators will use muscular dry needling in the calf of one lower extremity, followed by treadmill training with functional electrical stimulation.

this study will be the first to combine a novel two-pronged approach to the management of spasticity (tightness of the muscle) in the calf muscles. first, investigators will decrease spasticity in an innovative way through dry needling. second, investigators will follow this spasticity reduction technique using external electrical stimulation applied to the calf, while the participant walks on a harnessed treadmill (for safety). the investigators believe modulating tone in the calf with dry needling will allow for improved strength with electrical stimulation, while simultaneously improving the efficiency of the muscles during walking. the investigators hypothesize that decreasing spasticity will result in enhanced gait efficiency, and lower fatigue, all while allowing the participant to meet their personal mobility goals.10 the investigators are proposing an innovative study design. assessing changes in muscle spasticity using electromyography and the modified ashworth scale before and after each portion of our two-pronged intervention will enable them to understand the immediate effects of dry needling, as well as the combined effects of function electrical stimulation with with treadmill training. following the intervention assessments with pre-post functional tests will allow us to determine long term changes. this proposal offers a unique approach to management of spasticity in people with multiple sclerosis (ms), with the advantage of being minimally invasive and inexpensive. results of this pilot study will inform the potential use in ms, and will allow for a larger study examining optimal intervention parameters for future use.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ms based on mri 2. ability walk 25 feet 3. spasticity of one lower extremity exclusion criteria: 1. blood clot within the last 6 months 2. bleeding disorder 3. active cancer 4. botox in the lower extremities within 6 months
exosome effect on prevention of hairloss

Conditions: Hair Loss; Alopecia

Summary: many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. there are devastating physical and psychological consequences as a result. exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. the latest generation of natural products for treating hair loss is exosomes.

exosomes contain a variety of growth factors that are derived from stem cells. as they are so small, they can be hidden in the bloodstream and carry different types of proteins. the wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. the only fda-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type ii and iii isoforms). however, these drugs have not been very perfect. both have been associated with limited efficacy, duration of effect, and several significant side effects. regenerative medicine using cell products is looking for a way to heal faster and less cost. present research focus on exosome efficacy on hairloss.

Eligibility criteria:
inclusion criteria: subjects able to read the documents and have medical coverage subjects have a "hair loss grade" as below criteria: 1. basp grade: basic type (m2 to m3, or c2 to c3, or u1 to u3) or specific type (v1 to v3, or f1 to f3) 2. for female: ludwig grade: ⅰ to ⅱ 3. for male: norwood-hamilton grade: iii to iv 4. hair density by phototrichogram: 60 to 190 hair/cm2 5. telogen hair ≥ 5% subject agreeing not to apply any topical treatment subject agreeing to use a neutral shampoo exclusion criteria: 1. sick subject in situation of emergency. 2. subjects who have hereditary history of hairloss 3. pregnant females 4. subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening) 5. subjects who have a medical treatment for alopecia or having stopped it from than 3 months

Keywords: exosome
a study of lumasiran in infants and young children with primary hyperoxaluria type 1

Conditions: Primary Hyperoxaluria; Primary Hyperoxaluria Type 1 (PH1)

Summary: the purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (pk), and pharmacodynamics (pd) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (ph1).


Eligibility criteria:
inclusion criteria: * has genetic confirmation of primary hyperoxaluria type 1 (ph1) * meets urinary oxalate excretion requirements * if taking vitamin b6 (pyridoxine), must have been on stable regimen for at least 90 days exclusion criteria: * if \<12 months old at screening, has an abnormally high serum creatinine * if ≥12 months old at screening, has an estimated glomerular filtration rate (gfr) of ≤45 ml/min/1.73m\^2 * clinical evidence of systemic oxalosis * history of kidney or liver transplant

Keywords: ph1 primary hyperoxaluria hyperoxaluria rnai therapeutic sirna agt
vascular cardiotoxicity of ponatinib

Conditions: Cardiotoxicity

Summary: pre-clinical studies suggest that the third generation tyrosine kinase inhibitor ponatinib can result in microvascular angiopathy and acceleration of atherosclerosis. this study is intended to examine for myocardial microvascular angiopathy and changes in carotid plaque in patients receiving ponatinib as part of their clinical care.

in this study, we will perform serial echocardiography for ventricular function, myocardial contrast echocardiography for microvascular perfusion assessment, blood analysis for myocardial injury, and carotid us for plaque or imt progression in subjects receiving ponatinib. this series of tests is intended to provide information on the presence of clinically-evident or subclinical microvascular angiopathy and plaque acceleration.

Eligibility criteria:
inclusion criteria: * diagnosis of cml or all * prescribed ponatinib exclusion criteria: * pregnancy or lactation * major medical illness involving the heart or vasculature (cad, pad, dcm). * hemodynamically unstable * allergy to ultrasound contrast agents.
intranasal steroid as medical therapy for sleep-disordered breathing in children

Conditions: Sleep Disorder; Breathing-Related; Snoring; Obstructive Sleep Apnea of Child; Sleep Disorders in Children; Tonsillar Hypertrophy; Adenoidal Disorder

Summary: mist+ is studying a nasal spray to see if it will reduce the need for surgery for snoring. children aged 3-12 are invited to take part. snoring affects up to 10% of children and can cause sleeping problems and concentration or behavioural issues in the daytime. currently the most common treatment for snoring is surgery to remove the tonsils and/or adenoids, however many children wait a long time to see a specialist. this research is trying to find if nasal sprays can help children with snoring, and whether this can reduce the need for surgery.

mist+ is a multi centre, double-blind, placebo controlled trial. children 3-12 years of age, who do not respond to a run-in phase of 6 weeks of normal saline intranasal spray to treat sleep disordered breathing, will be randomised 1:1 to a treatment phase of either intranasal corticosteroid (investigational product) or normal saline (placebo). participants will receive treatment for 6 weeks and receive follow up at at 12 weeks, 6, and 12 months.

Eligibility criteria:
inclusion criteria: each participant must meet all of the following criteria to be enrolled in this trial: * is between the ages of 3 and 12 years inclusive at the time of randomisation * has symptoms of sleep disordered breathing (sdb) as determined by a brouillette score ≥ -1 on telehealth/phone screening * has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. exclusion criteria: participants meeting any of the following criteria will be excluded from the study: * has a bmi over the 97th centile for age and gender * has a history of tonsillectomy and/or adenoidectomy * has a prior diagnosis of craniofacial, neuromuscular, syndromic or defined genetic disorders * has a history of haemorrhagic diathesis or recurrent (daily) or severe epistaxis * has a history of nasal surgery or trauma which has not fully healed * has active tonsillitis or nasal infection (must be resolved prior to randomisation) * is assessed to have stertor (snoring) while awake at rest * has a known hypersensitivity to the study drug or its formulation * has used oral, intravenous, or intranasal steroids in the past 6 weeks. (inhaled steroids for asthma will be allowed concomitantly during the study) * daily use of antihistamine or decongestant nasal sprays * is known to require systemic steroids prior to the completion of the study treatment phase * has had treatment with any other investigational drug within 6 months prior to randomisation * is unable to provide consent without the aid of an interpreter. * in the opinion of the investigator may be unable to follow the protocol
analysis of postoperative ocular surface changes and intervention effect after ppv in mgd dry eye patients

Conditions: Meibomian Gland Dysfunction of Unspecified Eye, Unspecified Eyelid

Summary: aim: to observe ocular surface changes after phacovitrectomy in patients with mild to moderate meibomian gland dysfunction (mgd)-type dry eye and track clinical treatment response using a keratograph 5m and a lipiview interferometer. methods: forty cases were randomized into control group a and treatment group b; the latter received meibomian gland treatment 3 days before phacovitrectomy and sodium hyaluronate before and after surgery. the average non-invasive tear film break-up time (nitbutav), first non-invasive tear film break-up time (nitbutf), non-invasive measured tear meniscus height (ntmh), meibomian gland loss (mgl), lipid layer thickness (llt) and partial blink rate (pbr) were measured preoperatively and 1 week, 1 month and 3 months postoperatively.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of dry eye * clinical diagnosis for mgd exclusion criteria: * eye trauma or eye surgery within the prior 6 months * use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months * other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy * intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision * long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber * postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment * the need for a second operation during the study follow-up eye trauma or eye surgery within the prior 6 months * use of drugs that affect tear secretion and the stability of the tear film (including anti-glaucoma drugs, cortisol drugs, etc.) within the prior 6 months * other diseases that affect the function of the eye surface, such as meibomian gland cysts, blepharitis, eyelid valgus, incomplete closure, chronic tear cystitis, corneal disease, glaucoma, or optic neuropathy * intraoperative suture fixation or closure of a corneal, conjunctival, or scleral incision * long-term postoperative intraocular hypertension that could not be controlled easily with oral drugs and required puncture and drainage through the anterior chamber * postoperative corneal epithelial defects lasting more than 1 week or necessitating the use of contact lenses for treatment * the need for a second operation during the study follow-up

Keywords: meibomian gland dysfunction dry eye non-invasive ocular surface analyser pars plana vitrectomy ,meibomian gland massage
adenovirus and fungal load in pediatric stem cell transplant patients

Conditions: Adenovirus; Other Mycoses

Summary: this study is designed to determine the rate at which stem cell transplant patients can develop infection caused by a group of viruses, known as adenovirus, and common fungi. stem cells are unspecialized cells, capable of producing more stem cells or other specialized cells, and are used to replace damaged or diseased cells. the study will be conducted in children (2-17years old) being transplanted with stem cells from a donor. patients undergoing stem cell transplantation are more likely to develop infections as their immune systems are weakened. blood, stool, urine and throat swab samples will be collected (for at least 100 days on a weekly basis) to detect infection(s) caused by adenovirus or fungus. subjects will participate for up to 1 year following the transplant procedure.

this study is a multi-center observational study to determine the usefulness of real time pcr in the detection of adenovirus and fungal infections in patients following hsct. quantitative viral load monitoring will be evaluated to establish correlation with clinical symptoms and to measure the effectiveness of the therapeutic interventions. samples will be collected prior to hsct and on a scheduled weekly basis for 100 days post-hsct and after that when patients show signs of infection. patients' signs and symptoms and outcomes will be recorded for correlation with viral load. in addition, viral cultures will be performed on the same schedule as pcr assay using 3 samples (throat swab, stool, and urine). the study will be conducted at approximately 6 centers in the united states.

Eligibility criteria:
inclusion criteria: 1. pediatric patients greater than or equal to 2 years of age. 2. allogeneic hsct. 3. willing and able to give signed informed consent, or have a legally authorized representative who is willing to give consent. informed assent will be required for children \<18 years of age. 4. reliable and willing to make themselves available for the duration of the study. exclusion criteria: 1. autologous transplant patients are not eligible for the study. 2. patients previously enrolled in the study may not reenroll in the event of a subsequent hsct. 3. pediatric patients less than 2 years of age are not eligible for the study.

Keywords: adenovirus, fungal, diagnostics, children