Kornimate/medical-research-clean huggingface dataset:
perception of baby's painful cry in fmri

Conditions: Magnetic Resonance Imaging; Neuronal Activity

Summary: crying is the primary signaling strategy available to the human newborn for eliciting parental care. yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. using modern tools of sound processing and functional magnetic resonance imaging (fmri) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. for that, adults will be tested inside a fmri magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. the cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). to test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). the hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. this process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. the experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.


Eligibility criteria:
inclusion criteria: * man or woman aged between 18 and 50 * contact-less with children * right-handed * giving their written informed consent * subject who agreed to communicate mri results to their attending physician * french social security affiliation exclusion criteria: * any contraindications to pass an fmri test * pregnant woman

Keywords: baby cries pain brain responses neuroimaging fmri
stimulation of sensation and improvement in swallowing using oral capsaicin

Conditions: Dysphagia; Gastroesophageal Reflux

Summary: this is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. the purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function.

swallowing problems are encountered frequently in primary practice and in the hospital setting. the list of possible causes is large, ranging from strokes and neurological disease through to complications of cancer treatment, acid reflux, and surgery. many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to inability to manipulate food and fluids in the correct manner. this can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life. treatment is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid entering the airway. a novel approach is to try to improve sensation within the pharynx so that patients can feel substances present and then manipulate them in a more appropriate and safe manner. in this regard capsaicin, a nutritional supplement derived from peppers, has shown a stimulatory effect on sensory nerves and an ability to improve the swallowing reflex (ebihara et al., 2005). although studies have shown that capsaicin can improve the swallowing reflex, data regarding improvement in swallowing function is lacking. using a small dose of capsaicin administered as a lozenge, we hope to stimulate sensation within the pharynx enough to improve physical swallowing measures on a contrast swallow study. this method of application is comfortable, easy and directed to the site of action.

Eligibility criteria:
inclusion criteria: * patients older than 18 years of age * patients with the following condition: dysphagia, globus, gastroesophageal reflux, neurological disease affecting swallowing or any other condition requiring dynamic swallow study * patients willing to provide written informed consent for their participation in the study exclusion criteria: * patients unable to complete a full dynamic swallow study protocol * patients enrolled in another investigational clinical trial that interferes with any testing or testing results * patients who are pregnant * patients with known sensitivities or allergies to capsaicin or peppers, or nightshades (tomato, bell pepper, eggplant) or latex * patients who are prisoners * patients who are unable to keep a capsaicin lozenge in their mouth safely for 5 minutes

Keywords: dysphagia globus gastroesophageal reflux
endobronchial ultrasound-guided transbronchial needle aspiration using a 22 vs 25-gauge needle

Conditions: Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma; Lung Cancer

Summary: the goal of this clinical research study is to compare the effectiveness of a smaller, 25-gauge needle when used in an endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) instead of a standard 22-gauge needle. the safety of the needles will also be studied.

as a part of participant's standard-of-care, participant will have a bronchoscopy of lesions on participant's lung nodules and/or lymph nodes before the ebus-tbna. participant will sign a separate consent for the bronchoscopy. if participant agrees to take part in this study, before participant's bronchoscopy, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. this is done because no one knows if one study group is better, the same, or worse than the other group. * if participant is in group 1, participant will have the ebus-tbna performed by first using a 25-gauge needle, followed by a 22-gauge needle. * if participant is in group 2, participant will have the ebus-tbna performed by first using a 22-gauge needle, followed by a 25-gauge needle. to perform an ebus-tbna, a needle is inserted into the affected area using ultrasound imaging to collect tissue from the lungs and lymph nodes. the doctor will use the imaging to guide the needle into the area. length of study: participation on the study will be over after the bronchoscopy and ebus-tbna. this is an investigational study. the 22-gauge and 25-gauge needles are fda approved for use in ebus-tbnas. the comparison of the 2 needles for this procedure is investigational. the study doctor can explain how the needles are designed to work. up to 120 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. indication for ebus-guided needle biopsy based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes. exclusion criteria: 1. patients who are pregnant or lactating 2. inability to give informed consent 3. patients in which only one lymph node station is expected to be sampled by the performing clinician.

Keywords: malignant neoplasm of respiratory and intrathoracic organ carcinoma lung cancer ultrasound-guided transbronchial needle aspiration ebus-tbna 25-gauge needle 22-gauge needle
changing eating behaviors of healthy adults through hypnosis

Conditions: Overweight; Obesity

Summary: there is a lot of research on weight loss. in spite of the research on the subject, obesity is a growing disease all through the world. the results of recent reviews and meta-analyzes show that psychological interventions had small effect on weight loss. the investigators propose a different approach to changing eating behaviors with relevance to weight management and hypothesize that participants in the active interventions will significantly improve their eating behaviors than the ones in the control group. the results will improve the psychological interventions for weight loss.

this is a randomized clinical trial consisting of four groups. according to the concept of free will, the decision of action is taken before being acknowledged and is made following the reconstruction of previous experiences. it can be inhibited immediately (max 100ms) after awareness. the investigators want to intervene based on this model using hypnotic suggestions to change eating behaviors. participants were found through social media announcements. three groups receive one session of hypnosis with induction and different suggestions and the control group receives only induction. the eating behavior is measured through computer tasks in which participants have the option to choose pictures of food. the task is performed before, during and after hypnosis and the measurements of eating behavior are taken at all three times.

Eligibility criteria:
inclusion criteria: both gender healthy adults who want to change their eating behavior exclusion criteria: severe mental illness \<18 years a diagnosed eating disorder

Keywords: overweight obesity weight loss hypnosis eating behavior free will
risk and risk perception of knee osteoarthritis in the us

Conditions: Knee Osteoarthritis

Summary: the investigators have created an interactive knee osteoarthritis (oa) risk calculator that estimates a user's risk of developing symptomatic knee oa as well as the user's risk for undergoing a total knee replacement (tkr) within their lifetime. to test the impact of the calculator, the investigators recruited oa-free subjects from amazon's mechanical turk. participants were randomized to either access general information about oa or use the risk calculator in addition to accessing general oa information. the investigators hypothesized that participants randomized to the risk calculator arm would have more accurate perception of their knee oa risk and would have increased willingness to change risky behavior compared to the general oa information group.


Eligibility criteria:
inclusion criteria: * participants must be between the ages of 25 and 45 * participants must live in the united states * participants must not be diagnosed with osteoarthritis exclusion criteria: * all participants who did not meet the inclusion criteria
hybrid ablation plus medical therapy for persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: this clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the biotronik icm (biomonitor3® or future generation of biotronik icm).

in this study, subjects will be randomized (1:1) to conventional af management vs. biotronik icm-guided af management following ablation for persistent af. subjects will be followed for 15 months including a 3 month blanking period following af ablation. the study subject population will include subjects with persistent atrial fibrillation (sustained af episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent af ablation and icm (biotronik icm) implantation.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * history of persistent atrial fibrillation (sustained af episode lasting more than 7 days, but less than a year) * planned to undergo first af ablation with successful biotronik icm implant before or at time of ablation exclusion criteria: * paroxysmal atrial fibrillation * long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year) * permanent atrial fibrillation * left atrial diameter of 60 mm or greater * patients with chf status prohibiting ep study and ablation, but may be re-considered for enrollment later after effective treatment * patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting ep study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.) * patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment * serious known concomitant disease with a life expectancy of \< 1 year * pregnancy or nursing * unwilling or unable to give informed consent * existing cied such as pacemaker or icd

Keywords: biotronik biomonitor icm af ablation atrial arrhythmia
inactivated convalescent plasma as a therapeutic alternative in patients covid-19

Conditions: Infections, Coronavirus

Summary: convalescent plasma is a way to provide passive immunity to a person exposed to an infectious agent. it has been used as a therapeutic tool for emerging viral infections without specific treatment and with high morbidity and mortality, such as influenza h1n1, h5n1, h7n9, ebola, mers, sars-cov1, and even sars-cov2, with satisfactory results regarding evolution clinic of patients treated and without significant adverse events reported. one of its main advantages of convalescent plasma is to generate a rapid immune response (even faster than a vaccine), against a pathogen that circulates in a specific geographic area, probably common for both donor and recipient.

this study consists of obtaining convalescent plasma by means of apheresis, from recovered donors, who meet the eligibility criteria to donate. then this plasma will be inactivated by riboflavin and uv based photochemical treatment (mirasol technology - terumo bct®), in order to add more transfusion security to the procedure. finally, it will be transfused to covid-19 patients hospitalized in any of the participating clinics. there are currently no reported significant adverse events associated with this therapy. have been published two serial cases reports,more evidence is necessary to standardize the treatment.

Eligibility criteria:
inclusion criteria: * over 18 years old * confirmed laboratory diagnosis for qrt-pcr to sars-cov-2 * meet any of the following medical criteria (defined by who): be currently hospitalized with: pneumonia, severe pneumonia, acute respiratory distress syndrome (moderate or severe), sepsis or septic shock * the patient, or his representative, must sign an informed consent exclusion criteria: * participate in another clinical trial for covid- 19 * history of acute allergic transfusion reactions due to transfusion of blood or other components, especially plasma components (fresh frozen plasma, cryoprecipitate and platelets), * history of allergic reaction due to iga deficiency * allergic reaction to sodium citrate or riboflavin (vitamin b2) * history of immunosuppression

Keywords: covid-19 pathogen inactivation apheresis convalescent plasma
efficacy and safety of three times a day biasp-70 compared to two times a day biasp-30 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. this a clinical trial to study the efficacy and safety of three times a day biasp-70 compared to two times a day biasp-30 in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks * hba1c at least 7.5% and below 10.0% exclusion criteria: * proliferative retinopathy or maculopathy requiring acute treatment * impaired hepatic and/or renal function * cardiac diseases * uncontrolled hypertension * known hypoglycemia unawareness or recurrent major hypoglycemia
assessing cognitive performance among adults with attention disorders working on treadmill

Conditions: Attention Deficit Disorder

Summary: randomized clinical trial in which individuals who have been diagnosed with adhd and are regularly treated with methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions: * while taking methylphenidate and sitting at a desk * while taking methylphenidate and walking on a treadmill workstation * without taking methylphenidate while sitting at a desk * without taking methylphenidate while walking on a treadmill workstation the investigators will compare the cognitive achievements outcomes and evaluate the efficiency of studying in each of these four conditions.

the rationale of this clinical trial is to identify the intervention that best contributes to better cognition results of adults with adhd's: physical activity, drug or a combination of the two? the study will enable to determine which factor will improve cognitive results. the findings of this trial will help determine the best treatment method that can be offer to adults with adhd.

Eligibility criteria:
inclusion criteria: \* insured by maccabi health services * diagnosed with adhd by neurologist/psychiatrist/developmental doctor * take methylphenidate as part of the treatment for adhd and have agreed to not take the drug if asked to * understand the language and simple instruction * willing to participate in the study and sign the agreement form exclusion criteria: * suffer from heart disease or chronic respiratory illness * women who are pregnant

Keywords: attention deficit disorder cognitive performance treadmill
endocrine treatment alone for elderly patients with estrogen receptor positive operable breast cancer and low recurrence score

Conditions: Breast Cancer; Cancer of Breast; Breast Neoplasms; Cancer of the Breast

Summary: multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. these trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. a new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (er)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. the investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with er+ breast cancer and low ki67 scores.


Eligibility criteria:
inclusion criteria: * newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as ct1 or t2, n0-1, and m0. * disease must be er+ and her2-. * ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index * measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram. * 70 years of age or older. * ecog performance status ≤ 3 * able to understand and willing to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * prior surgery for this cancer * a history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer. * currently receiving any other investigational agents. * a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study. * uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements. * known hiv-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
study to explore the efficacy and safety of bio89-100 (pegozafermin) in participants with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: this study is designed to assess the efficacy, safety, and tolerability of different doses and dose regimens (once weekly \[qw\] or every 2 weeks \[q2w\]), subcutaneous (sc) dosing of bio89-100 (pegozafermin) compared to placebo in participants with severe hypertriglyceridemia (shtg).


Eligibility criteria:
inclusion criteria: 1. male or female age ≥21 to ≤75 years. 2. screening fasting triglyceride ≥500 milligrams (mg)/deciliters (dl) and ≤2000 mg/dl. 3. willing to maintain current eating and exercise habits from time of signing the informed consent and for the duration of the study. 4. participants could be taking statins and/or prescription fish oil as background therapy or not be taking any background therapy. 5. magnetic resonance imaging - whole liver proton density fat fraction (mri-pdff) of ≥6% for participants screened for the fibrate expansion cohort. exclusion criteria: 1. uncontrolled or newly diagnosed hypertension. 2. body mass index \>45 kilograms (kg)/meters squared (m\^2). 3. receiving niacin, proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitors, or supplements that could lower lipid levels. 4. type 1 diabetes mellitus. 5. diagnosis of type 2 diabetes mellitus \<6 months prior to screening. 6. history of malignancy within 5 years prior to screening. 7. participants with known lipoprotein lipase impairment or deficiency (fredrickson type 1), apolipoprotein c-ii deficiency, or familial dysbetalipoproteinemia (fredrickson type 3). 8. clinically or otherwise documented cardiovascular or cerebrovascular disease. 9. weight change ≥5% in 3 months prior to first screening visit or weight change ≥5% during screening or planning to try to lose weight during conduct of study.

Keywords: hypertriglyceridemia dyslipidemia lipid disorder fgf21
"feasibility and safety of the calcium alginate hydrogel sealant for the treatment of cryptoglandular fistula-in-ano: phase i/iia clinical trial"

Conditions: Anal Fistula

Summary: background: complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. biological sealants have emerged as an effective alternative for maintaining the integrity of the anal sphincter. the investigators aimed to assess the feasibility and safety of calcium alginate hydrogel injections into the tract as treatment for complex cryptoglandular fistulas. methods: a prospective, single-center, case series of this novel technique was conducted in a level 3 hospital, including patients diagnosed with trans-sphincteric perianal fistulas and treated with a calcium alginate hydrogel sealant. a strict follow-up was performed by an independent surgeon at 1, 3, 6, and 12 months. the main outcome measures were feasibility, safety (number of adverse events) and efficacy of the treatment.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥18 years * cryptoglandular paf treated by seton placement for at least 3 months, with a single external fistulous orifice and internal fistulous orifice exclusion criteria: * informed consent form not signed or withdrawn * not possible to adhere to follow-up routine * another investigational drug in the previous 3 months * allergy to alginate * grade iv in american society of anesthesiologists scale * pregnancy * history of radiotherapy in the perineal area * diagnosis or suspicion of intestinal blow disease * immunosuppression, active neoplasia at the time of recruitment or in previous year, or positive for human immunodeficiency virus internal fistulous orifice not located during the procedure * simple anal fistula (submucosa or low intersphincteric perianal fistula, except association with faecal incontinence * anal stenosis that prevents exploration * undrained collections \>2 cm * rectovaginal fistulas * fistulas of non-cryptoglandular origin

Keywords: cryptoglandular anal fistula calcium alginate sealant