Kornimate/medical-research-clean huggingface dataset:
mtf image modifications

Conditions: Modulation Transfer Function; Visual Acuity; Contrast Sensitivity

Summary: human visual acuity and contrast sensitivity are highly dependent on various different parameters. each should be optimized for perfect visual performance. however, in real life our eyes lack such parameters, which might lead to unsatisfying results even after spectacle correction or contact lenses. a promising approach would be to design intra ocular lenses (iol), which are implanted into the eye for example in the course of cataract extraction and are able to compensate for the human eyes' aberrations. for example cutoff frequency, edge-sharpness or specific contrast for selected structure sizes would need to be considered. since, an aberration free optical system is almost impossible and since the impact of each single parameter is not yet known, iol design parameters would have to be chosen very carefully. furthermore, image quality of iols still is tested ex vivo by ray tracing for example, but this does not guarantee perfect function after implantation, as our visual system has complex image precessing units form the retina to the brain. the present study picks one of these parameters and seeks to assess its impact on visual quality in-vivo. by subjectively grading different images with objective changes to image quality by variations of the modulation transfer function (mtf), the potential influence and thus on our subjective visual impression shall be assessed.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 35 years, nonsmokers * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, emmetropia or ≤ 1 diopter exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug (except oral contraceptives) * symptoms of a clinically relevant illness in the 3 weeks before the first study day
efficacy, safety, and immunogenicity of avt02 with moderate-to-severe chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: safety and efficacy study of avt02 (alvotech biosimilar to adalimumab), in patients with moderate to severe plaque psoriasis.

a multicenter, double-blind, randomized, parallel-group, active control study to compare the efficacy, safety, and immunogenicity of avt02 versus humira® in patients with moderate-to-severe chronic plaque psoriasis (alvopad ps). this study will be conducted at about 40 study centers in central and eastern european countries. a contract research organization, will oversee operational aspects of this study on behalf of alvotech swiss ag (alvotech), the sponsor of the study.

Eligibility criteria:
inclusion criteria: * patient with moderate-to-severe chronic plaque psoriasis who has involved body surface area (bsa) ≥ 10% (palm method), ≥ 12 on the pasi, and static physicians global assessments (spga) ≥ 3 (moderate) at screening and at bl. * patient has had stable psoriatic disease for at least 2 months (ie, without significant changes as defined by the investigator or designee). * patient is a candidate for systemic therapy and the patient has a previous failure, inadequate response, intolerance, or contraindication to at least 1 systemic antipsoriatic therapy including, but not limited to, methotrexate, cyclosporine, psoralen plus ultraviolet light a (puva), and ultraviolet light b (uvb). exclusion criteria: * patient has prior use of 2 or more biologics for treatment of pso. * patient diagnosed with erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, medication-induced psoriasis, other skin conditions (eg, eczema), or other systemic autoimmune disorder inflammatory disease at the time of the screening visit that would interfere with evaluations of the effect of the study drug on psoriasis. * patient has prior use of any of the following medications within specified time periods or will require use during the study: 1. topical medications within 2 weeks of bl (week 1). 2. puva phototherapy and/or uvb phototherapy within 4 weeks prior to the bl visit. 3. nonbiologic psoriasis systemic therapies (eg, cyclosporine, methotrexate, and acitretin) within 4 weeks prior to the bl visit. 4. any prior or concomitant or biosimilar adalimumab therapy, either approved or investigational. 5. any systemic steroid in the 4 weeks prior to bl. note: only key inclusion/exclusion criteria mentioned here. patients will be screened and randomized per the list in the protocol
gleam: noninvasive glucose measurement using impedance tomography

Conditions: Diabetes Mellitus

Summary: the gleam study aims at assessing the potential of electrical impedance tomography (eit) for noninvasive glucose measurement.

within the gleam study, paired samples of eit and blood glucose measurements will be collected in individuals with type 1 diabetes during standardized euglycemia, hypoglycemia and hyperglycemia. these samples will be used to assess the potential of eit for noninvasive glucose measurement and/or dysglycemia detection.

Eligibility criteria:
inclusion criteria: * written, informed consent * type 1 diabetes mellitus as defined by who for at least 6 months * aged 18 - 60 years * hba1c ≤ 9.0 % * insulin treatment with good knowledge of insulin self-management * use of a continuous (cgm) or flash glucose monitoring system (fgm) * native language german or swiss german exclusion criteria: * incapacity to give informed consent * contraindications to insulin aspart (novorapid®) * known allergies to adhesives of the eit device (e.g., gel electrodes) * pregnancy, breast-feeding or lack of safe contraception * active heart, lung, liver, gastrointestinal, renal or psychiatric disease * patients with implantable electronic devices (e.g., pacemaker or implantable cardioverter defibrillator (icd)) or thoracic metal implants * epilepsy or history of seizure * active drug or alcohol abuse * chronic neurological or ear-nose-and-throat (ent) disease influencing voice or history of voice disorder * thoracic or back deformities * body mass index (bmi) \>35.0 kg/m2 * open wounds, burns, or rashes on the upper thorax * active smoking * medication known to interfere with voice or to induce listlessness (e.g., opioids, benzodiazepines, etc.)
prospective evaluation to characterize the real-world performance of the embovac aspiration catheter

Conditions: Acute Ischemic Stroke

Summary: a post-market study evaluating the embovac aspiration catheter in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

the perfect study is a prospective, multi-center, single arm, post-market clinical follow-up study. the objective of this post-market clinical follow-up study is to assess the performance of the embovac aspiration catheter in the treatment of acute ischemic stroke in a real-world clinical setting. the study will also report on clot characteristics and clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. subject ≥ 18 years old. 2. subject experiencing acute ischemic stroke with angiographic confirmation of large vessel occlusion of the distal intracranial internal carotid artery, middle cerebral artery or anterior cerebral artery 3. a clinical decision has been made to use the embovac™ aspiration catheter prior to enrollment in the research 4. embovac™ aspiration catheter is attempted to be used for the first 3 clot removal passes for the target intracranial occlusion 5. pre-stroke mrs ≤ 1 6. nihss ≤ 30 7. informed consent has been provided by the subject or the subject's legally authorized representative. exclusion criteria 1. potential study candidate has already undergone standard of care assessments or treatment that deviate from the clinical research protocol requirements 2. all patients with severe hypertension on presentation. all patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy 3. known cerebral vasculitis. 4. known cancer with life expectancy less than 12 months. 5. stenosis, or any occlusion, in a vessel proximal to the target occlusion that requires treatment or prevents access to the site of occlusion. 6. computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage on presentation. 7. baseline computed tomography (ct) or mri showing mass effect or intracranial tumor (except small meningioma). 8. evidence of dissection in the extra or intracranial cerebral arteries. 9. occlusions in multiple vessels. 10. confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication). 11. currently participating in an investigational clinical trial that may confound study endpoints.

Keywords: acute ischemic stroke perfect embovac
randomized trial in knee osteoarthritis using low intensity ultrasound - evaluating feasibility (relief)

Conditions: Knee Osteoarthritis

Summary: the purpose of this pilot study is to determine the feasibility of conducting a high quality clinical trial to investigate the effects of low intensity, pulsed ultrasound on knee osteoarthritis pain and physical function.


Eligibility criteria:
inclusion criteria: * over 40 years of age; * have medial tibiofemoral compartment knee oa; * have mild to moderate medial compartment radiographic oa severity (determined by the attending surgeon and/or advanced practice physiotherapist on the basis of a standing x-ray or mri scan depending upon which is available at initial consult); * have stable ('not getting worse or better overall despite short-term fluctuations during the past three months') pain having an average intensity ≥ 3 and ≤ 8 on an 11-point verbal numeric rating scale, vnrs) in one knee which is aggravated by activity and eased with rest; * limited pain from other lower extremity joints; and * no change in first line pain medication in the past 2 months and willingness to forego alterations in pain medication for the duration of the study unless deemed medically necessary. exclusion criteria: * history of traumatic oa or previous surgical intervention in the knee or knee effusion; * intra-articular injection of the knee in the previous 6 months; * received ultrasound treatment for knee oa within the past 6 months; * body weight changed ≥ 5% in the past 2 months; * level of physical function insufficient to perform the required assessments or administer the intervention (e.g. intermittent claudication, severe peripheral neuropathy, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, chronic pain, arthritis in joints other than the study knee, bone fracture in the past 3 months); * conditions listed as precautions or unknown safety risks for using the exogen express ultrasound device (pregnant or nursing women, individuals with thrombophlebitis, vascular insufficiency, abnormal skin sensitivity, sensory paralysis, open wound at the medial joint line of the knee, taking steroids/anti-coagulants, prescription non-steroidal anti-inflammatory, calcium channel blocker or applying the exogen express in close proximity to someone wearing a cardiac pacemaker); * unable to read, write and/or understand english; * other illness or reasons judged by the participant, clinicians or researchers to make participation inadvisable (e.g. plans to move or travel, cognitive deficit resulting in difficulty comprehending and complying with instructions, caregiving demands/lack of social support for participation); * unwillingness to sign informed consent; or * participation in a competing study.

Keywords: ultrasound therapy tibiofemoral joint, medial nonsurgical
study of sequentially applied repetitive transcranial magnetic stimulation in obsessive- compulsive disorders

Conditions: Obsessive-compulsive Disorder

Summary: the purpose of study was to investigate possible therapeutic effects and safety of sequentially combined low-frequency repetitive transcranial magnetic stimulation (rtms) to the right dorsolateral prefrontal cortex (dlpfc) and supplementary motor area (sma) in patients with treatment-resistant obsessive-compulsive disorder (ocd).

obsessive-compulsive disorder (ocd) is a relatively common psychiatric disorder characterized by repetitive, intrusive thoughts and time-consuming behavioral or mental acts. many ocd patients who do not respond to conventional treatments experience severe distress and disruptions in their daily activities. novel approaches including psychopharmacological therapy and surgical techniques for treatment-resistant ocd have been proposed. with recent advances in non-invasive technique for stimulating the cerebral cortex, repetitive transcranial magnetic stimulation (rtms) has been proposed as a potential therapeutic approach for various psychiatric illnesses including ocd. because of contradictory findings and a lack of controlled trials in ocd, rtms cannot be yet recommended as routine therapy for ocd. however, it may have a potential clinical effect as a putative add-on treatment for ocd and an alternative therapy for treatment-resistant ocd. for useful clinical applications, it is very important to develop methods to enhance the efficacy of rtms. there are a number of putative ways to do this, and one of them is sequentially combining two forms of stimulation which are considered to have potential therapeutic effects. more recently, the sequential application of two stimulation regimens (high-frequency left-side rtms and low-frequency right-side rtms to the prefrontal cortex) has been found to have a substantial therapeutic effect in patients with treatment-resistant major depression. therefore, the investigation for a sequentially combining effect of both the right prefrontal and the sma stimulation would be worthwhile in ocd patients.

Eligibility criteria:
inclusion criteria: * ocd patients who had failed adequate trials (a lack of at least a 25% reduction in the yale-brown obsessive-compulsive scale (y-bocs) 15 after at least eight weeks of treatment) of at least two serotonin re-uptake inhibitors (sri) and behavioral therapy. exclusion criteria: * subjects were excluded if: * they presented with a movement disorder other than a tic * any psychotic symptoms * other anxiety disorders * mental retardation * alcohol or other substance abuse within the last six months * a history of psychosurgery, encephalitis or significant head trauma

Keywords: obsessive-compulsive disorder repetitive transcranial magnetic stimulation right dorsolateral prefrontal cortex supplementary motor area (sma)
circulating tumor cells and tumor dna in hcc and net

Conditions: Carcinoma, Hepatocellular; Neuroendocrine Tumors

Summary: background treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies. circulating tumor cells (ctc) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. ctc is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. detection of circulating tumor dna (ctdna) specifically adds specificity to the analysis of the ctc. the investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support. purpose and method in a blood sample from patients with neuro-endocrine tumor (net) and hepatocellular carcinoma (hcc), the investigators will by cell separation, flow cytometry and dna sequencing and digital polymerase chain reaction (pcr): 1. identify and isolate the ctc and investigate these for tumor-specific mutations. 2. quantify ctdna and analyze this for specific mutations, which in the past has been found frequent in net and hcc. 3. compare findings of mutations on ctc and ctdna with mutations in tissue biopsies. the results are compared with the clinical data on disease course, including the effect of treatment and survival. subjects 40 patients with small intestinal/unknown primary net before treatment with somatostatin analogues 30 patients with pancreatic net before treatment with everolimus 30 patients with presumed radically treated hcc 30 patients with hcc in treatment with sorafenib a blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years. perspectives in several cancer types molecular diagnostics have had significant influence in treatment and control strategy. the goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. the study will bring new knowledge to this growing field of research.


Eligibility criteria:
inclusion criteria: * one of the above mentioned diseases * planed surgery, rfa, somatostatin analogue, sorafenib or everolimus treatment * signed informed consent exclusion criteria: * age below 18, concomitant invasive cancer (not skin cancer) and planed emigration of denmark.

Keywords: tumor dna circulating tumor cells biopsy
safety, pharmacokinetics, and pharmacodynamics of mtx-101 in healthy adults and patients

Conditions: Healthy Volunteers; Celiac Disease; Type 1 Diabetes

Summary: first in human study to understand the potential side effects of mtx-101, how long mtx-101 lasts in the human body, and how mtx-101 affects specific human immune cells.

this is a prospective, multi-center, randomized, double-blind, placebo-controlled, single ascending dose (sad) and multiple ascending dose (mad) study to evaluate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of mtx-101 in healthy adults (ha) and participants with celiac disease (ced) and type 1 diabetes (t1d). this study will enroll has only in part a and ced and t1d patients only in part b.

Eligibility criteria:
inclusion criteria: * adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (day 1). * healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the investigator. * body mass index (bmi) ≥ 18 kg/m2 and ≤ 32 kg/m2. * body weight ≥ 45and ≤ 100 kg. * negative coronavirus disease 2019 (covid-19) test within 24 hours prior to each dose. * persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from day 1 through the duration of the study. exclusion criteria: * clinically significant findings in physical examination (pe), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ecg), and safety laboratory parameters at screening in the opinion of the investigator. * renal function calculated by the chronic kidney disease-epidemiology (ckd-epi) equation with estimated glomerular filtration rate (egfr) \&lt; 90 ml/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of screening. * any disease or condition that, in the opinion of the investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems. * receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to day 1. * positive serology for human immunodeficiency virus (hiv) type 1 or 2, hepatitis (hep) b surface antigen, or hep c. * positive test results for drug screen, including alcohol, at the time of screening or on day 1 prior to randomization. * use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing. participants must abstain from nicotine use while inpatient. * history of receiving a live vaccine within 1 month of screening. * history of splenectomy. * history of covid or influenza vaccine within 2 weeks prior to screening. * planning to receive any vaccinations during the study period. * history of recurrent infections of uncertain cause.

Keywords: healthy volunteers celiac type 1 diabetes
relationship between hearing thresholds, handicap and time for treatment-seeking

Conditions: Hearing Impairment

Summary: purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. methods: retrospective study. records of 152 elderly and 48 adults with hearing impairment were analyzed. the iso audiometric thresholds average (500 to 4000hz) and high frequencies average (2000 to 6000hz), the speech recognition thresholds and the total, social and emotional scores from the hearing handicap inventory for the adults (hhia) and elderly (hhie) were compared with the time between the onset of hearing complaints and the first treatment seeking. results: the average time for treatment seeking was 7,6 years. no statistical difference was found between iso and high frequency audiometric average, hhia/e scores and time for treatment seeking between adults and the elderly. weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. there was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. conclusions: the search for treatment seems to be multifactorial. despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.


Eligibility criteria:
inclusion criteria: * older than 18 years old. without experience with hearing aid use. diagnosed with sensorineural hearing loss. audiogram data available exclusion criteria:

Keywords: hearing loss handicap counseling
efficacy and safety of bms-690514 in combination with letrozole to treat metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if bms-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy


Eligibility criteria:
inclusion criteria: * documented invasive breast cancer * greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor * her2+ and her2- (human epidermal growth factor receptor) disease * rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane * ecog performance status = 0 or 1 exclusion criteria: * prior hormonal therapy for metastatic disease * prior hormonal therapy with letrozole for adjuvant disease * symptomatic brain metastases * prior treatment with any tyrosine kinase inhibitor