Kornimate/medical-research-clean huggingface dataset:
interactive guided ultrasound examinations done by non-experts of ultrasound imaging

Conditions: Cardiac Disease; Heart Failure; Cardiac Ischemia

Summary: this prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.

the primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (ce-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views. the secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.

Eligibility criteria:
inclusion criteria: * all volunteers must have the ability to provide informed consent. * all volunteers should be affiliated to the french social security. * all volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care. exclusion criteria: * subjects with congenital heart diseases (except bicuspid aortic valve) * pregnant women * adults lacking decisional capacity * adults placed under a legal protection regime (guardianship, curatorship, judicial protection) * adults not affiliated to the french social security * adults in emergent or critical condition * adults with active pain in the intended scanning region * adults with active skin disease or lesions in the intended scanning region * adults with allergy/sensitivity to ultrasound gel

Keywords: echocardiography training follow-up
cytosorb® in patients with acute on chronic liver failure

Conditions: Acute on Chronic Liver Failure; Alcoholic Hepatitis

Summary: the objective of this study is to assess the safety and performance of the cytosorb® therapy in patients with acute on chronic liver failure (aclf) grade ≥ 2 due to a severe alcohol induced hepatitis (maddrey df \> 32) and a severe inflammatory response.


Eligibility criteria:
inclusion criteria: 1. age≥18 2. signed informed consent form (icf) 3. total bilirubin ≥ 8 mg/dl 4. acute alcoholic hepatitis diagnosed by etoh consumption within 6 weeks of onset of symptoms, exclusion of other causes for jaundice and liver biopsy or at least 2 out of the following symptoms: * hepatomegaly * ast \> alt * elevated wbc * ascites 5. maddrey df \> 32 6. systemic inflammation as defined by 2 fulfilled criteria out of: * leucocytosis * body temperature \> 38°c * tachycardia \> 90 bpm * tachypnoeia \> 20 breaths/min 7. aclf grade ≥2 8. creatinine \>2 mg/dl and increase \>1.5 mg/dl despite standard of care exclusion criteria: 1. platelets \< 40,000/mm3 2. inr \> 3.5 3. meld score \> 35 4. ast \> 500 iu/l 5. bilirubin reduction \> 20% in prior 72 hours (early responders to conventional standard of care (soc)) 6. uncontrolled infection, bleeding or hemodynamic instability 7. small liver size (diagnosed by imaging, ultrasound/ct) 8. chronic dialysis 9. contraindications for cytosorb® according to instructions for use 10. aclf grade \<2
a study to evaluate sage-217 in participants with moderate to severe major depressive disorder

Conditions: Major Depression

Summary: this is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of sage-217 in 102 participants diagnosed with moderate to severe major depressive disorder.

part a of the study is an open-label design with dosing of sage-217 for 14 days. part b of the study is a randomized, double-blind, parallel-group, placebo-controlled design. eligible participants were randomized to sage-217 or placebo for 14 days. this study was previously posted by sage therapeutics. in november 2023, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * participant has a diagnosis of major depressive disorder that has been present for at least a 4-week period as diagnosed by structured clinical interview for dsm-iv axis i disorders (scid-i) exclusion criteria: * participant has a history of suicide attempt * participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time * participant has active psychosis * participant has a medical history of seizures * participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder

Keywords: depression
airway microbiome changes after artificial airway exchange in critically-ill pediatric patients.

Conditions: Tracheostomy; Endotracheal Tube; Ventilator Associated Pneumonia; Tracheitis; Microbial Colonization; Pediatric Infectious Disease; Pediatrics

Summary: artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (picu, nicu respectively) are lifesaving for patients in respiratory failure, among other conditions. these devices are not without a risk of infection - ventilator-associated infections (vais), namely ventilator associated pneumonia (vap) and ventilator-associated tracheitis (vat), are common. treatment of suspected vai accounts for nearly half of all pediatric intensive care unit (picu) antibiotic use. vai can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. when patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. there however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. this research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. this study will involve the prospective collection of tracheal aspirates from patients with artificial airways. we will screen and enroll all patients admitted to a the nicu or picu at cohen children's medical center (ccmc) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. tracheal aspirates are routinely obtained in the nicu and picu from suctioning of an artificial airway and is a minimal risk activity. these samples will be brought to the feinstein institutes for medical research for 16 s ribosomal dna (16srdna) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. tracheal aspirate sets will be analyzed against each other. additionally, clinical and epidemiological data from the electronic medical record will be obtained. antibiotic exposure will be accounted for via previously published means.


Eligibility criteria:
inclusion criteria: * all patients with tracheostomies in the pediatric or neonatal intensive care unit * patients with endotracheal tubes undergoing artificial airway exchange in the pediatric or neonatal intensive care unit exclusion criteria: * none
fmri connectivity in fracture hip patients

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Summary: the long-term goal of this study is to evaluate cognitive function preoperatively and develop techniques of intervention in the perioperative period which would optimize brain function and functional recovery following surgery.

in this protocol, subjects who are anticipated to be operated for hip fracture will be studied after surgery. brief cognitive exam will be done followed by fmri of connectivity and diffusion tensor imaging (dti). connectivity (neuronal changes) and dti (anisotropy and mean diffusivity) data will be compared with age matched controls and correlated with subjective measures of cognition.

Eligibility criteria:
inclusion criteria: * patients 65 years and older * patients who have fracture hip and are anticipated to have surgery exclusion criteria: * patients who have contraindications for mri like pacemaker, automatic implanted cardiac defibrillator (aicd), implanted infusion pumps etc. * patients who are claustrophobic * patients with severe cognitive impairment (who may not be able to cooperate during the cognitive exam and fmri)
buckets vs. braces prospective study

Conditions: Elbow Pain; Shoulder Pain

Summary: the purpose of this research study is to determine if there is a difference in shoulder or elbow pain between youth athletes who throw regularly without a brace, those who use a brace, and those who limit their throw count by placing the ball in a bucket during a 12-week study.


Eligibility criteria:
inclusion criteria: * males or females aged 8- 12 years old * participation and attendance on at least 80% of practices league team * only participating on one baseball team for the next 12 weeks exclusion criteria: * patients \ 12 years of age * elbow pain at the start of the season * history of an elbow or shoulder injury, past surgeries * participants currently under the care of a physician for an elbow or shoulder issue * participants taking outside private coaching

Keywords: buckets vs. braces
a clinical study of mk-6552 and modafinil in healthy men (mk-6552-005)

Conditions: Healthy; Narcolepsy

Summary: the goal of this study is to learn what happens to mk-6552 in a person's body over time. researchers will compare what happens to levels of mk-6552 in people's blood when it is taken with and without modafinil. researchers also want to learn about the safety of mk-6552 taken with and without modafinil and if people tolerate it.


Eligibility criteria:
inclusion criteria the main inclusion criteria include but are not limited to the following: * is in good health based on medical history and physical examination * has a body mass index ≥18 and ≤32 kg/m\^2, inclusive exclusion criteria the main exclusion criteria include but are not limited to the following: * has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * has a history of cancer
zoledronic acid versus alendronate for prevention of bone loss after organ transplantation

Conditions: Heart Transplantation; Liver Transplantation; Bone Resorption

Summary: the purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. zoledronic acid is given as a single intravenous infusion. alendronate is given as a weekly pill. both are expected to be very effective, but it is not known which one will work best.

patients who have undergone heart or liver transplantation are usually required to remain on medications, such as prednisone and cyclosporine a or tacrolimus, that prevent the body from rejecting the transplanted organ. these medications may cause bone loss which leads to thinning of the bones (osteoporosis) and therefore greatly increase the risk of having broken bones (fractures) after transplantation. several published studies have shown that 14% to 35% of heart transplant patients develop fractures (spine, ribs and hip) during the first year after transplantation. we have previously shown that alendronate (fosamax), a drug approved by the fda for prevention and treatment of postmenopausal osteoporosis and prednisone-induced osteoporosis, prevents bone loss after heart transplantation. we are conducting this study to determine whether a newer drug, zoledronic acid, is as effective as alendronate. this study is a randomized, double-blind, placebo-controlled 2-year study. participants will receive one dose of active zoledronic acid during the first month after heart or liver transplantation and weekly placebo alendronate pills or one dose of placebo zoledronic acid and weekly active alendronate pills for the first year after transplant. over 2 years, participants will provide blood samples on nine occasions. bone density will be performed 4-5 times and spine xrays will be performed twice.

Eligibility criteria:
inclusion criteria: * a man or woman, aged 20 to 70, of any race who has had a heart or liver transplant exclusion criteria: * hyperparathyroidism * paget's disease * hyperthyroidism * cancer * severe kidney disease, * intestinal disease * active peptic ulcer disease * current or past treatment for osteoporosis * pregnancy or lactation * severe oral/dental disease

Keywords: heart transplantation liver transplantation immunosuppression bone density/drug effects alendronate zoledronic acid comparative study humans
kubota glass parameter refinement study

Conditions: Myopia; Myopia, Progressive; Vision Disorders

Summary: length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. the results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. the transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.

Eligibility criteria:
inclusion criteria: * be of legal age or, if under legal age have written consent of their parent or guardian to participate. * sign written informed consent (and the california bill of rights, if applicable). * ages 8-24 (inclusive) and able to understand and assent to participation * have need of optical correction for myopia, from -1.00 to -5.00 diopters (d). * have a refractive astigmatism of less than -1.00 d. * best spectacle corrected visual acuity (bscva) of 20/25 or better. * be willing and able to follow instructions and attend the schedule of follow-up visits. exclusion criteria: * not able or willing to provide informed consent and assent * eye injury or surgery within twelve weeks immediately prior to enrollment * currently enrolled in an ophthalmic clinical trial * pregnant or lactating or expect to become pregnant during the trial * evidence of systemic or ocular abnormality, infection or disease * any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye * habitually uncorrected anisometropia ≥ 2.00 * subjects who have undergone corneal refractive surgery * use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses

Keywords: myopia spectacles
a clinical study to assess the efficacy and safety of da-3002

Conditions: Turner's Syndrome

Summary: a study demonstrates the non-inferiority of da-3002 when compared with genotropin®.


Eligibility criteria:
inclusion criteria: * diagnosed with turner's syndrome through chromosome analysis * the chronological age: 2≤age≤12 * the yearly growth rate should be less than 6cm; the bone age should be equal or less than 12; the height ≤ 10th percentile for the heights of their agemates * before the adolescence, tuner stage i (breast) * normal thyroid function exclusion criteria: * growth hormone was administered for 12 months or longer in the past * treated with estrogen or adrenal androgens for 12 months or longer in the past * malignancy, cns trauma, psychiatric disorder

Keywords: turner's syndrome short stature dwarfism
study about effectiveness of silver-containing textiles for treatment of acute neurodermatitis

Conditions: Neurodermatitis

Summary: the purpose of this study is to investigate whether the treatment of acute neurodermitis with silver-contained textiles is equivalent or more effective to the conservative exogenous treatment with a corticosteroid. secondary aim is to define skin comfortability of the textiles.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute neurodermitis * age: 2-70 years * patients are mobile * patient's information and willingness to participate exclusion criteria: * acute viral infection (herpes zoster, eczema herpeticum) * acute staphylodermas * other skin-diseases affecting outcomes of intervention (e.g. psoriasis) * current uv-treatment * current other immunosuppressive or immunomodulated therapy * current antimicrobial therapy (e.g. antibiotics) * severe general diseases (e.g. melanoma, renal insufficiency, autoimmune diseases) * pregnancy * fertile females without effective contraception
a tailored, optimised, and person-centred programme to promote lifestyle modification in people with metabolic syndrome

Conditions: Metabolic Syndrome; Primary Prevention of Atherosclerotic Cardiovascular Disease

Summary: this is a mixed-methods study comprising a 2-arm randomised controlled trial and a qualitative study. this study aims to evaluate the effects of a lifestyle modification on the control of metabolic syndrome, with assessments measured at baseline, immediately at the end of the active phase of intervention (12 weeks) and 8 weeks thereafter (20 weeks). it will be conducted in multiple community centres in hong kong. individuals fulfilling the following eligibility criteria will be recruited: 1) chinese people with metabolic syndrome defined by the 'harmonising the metabolic syndrome' (hms) criteria by three or more abnormal findings out of five components (i.e., raised blood pressure, raised triglycerides, lowered hdl, raised fasting blood glucose, and central obesity)\[1\]; 2) aged ≥18; 3) community-dwelling; 4) independent in daily living, and 5) possessed a digital device with internet connection. participants will be randomly allocated in a 1:1 ratio to receive the top critical pathway (intervention group) or once-off brief lifestyle advice (control group). evaluation outcomes will be measured at baseline (t0), 12 weeks (t1) and 20 weeks (t2) thereafter. the outcome assessment includes health-promoting lifestyle profile-ii (hplp-ii), reversal of metabolic syndrome, defining characteristics of metabolic syndrome (body mass index, systolic and diastolic blood pressure, triglycerides, high-density lipoprotein, fasting blood glucose and waist circumference) and the 12-item short-form health survey version 2 (sf-12v2). triglycerides, high-density lipoprotein and fasting blood glucose will be measured using a portable point-of-care analyser.


Eligibility criteria:
inclusion criteria: 1. chinese adults with metabolic syndrome defined by the 'harmonising the metabolic syndrome' (hms) criteria by three or more abnormal findings out of five defining characteristics (i.e., raised blood pressure, raised triglycerides, lowered high-density lipoprotein, raised fasting blood glucose, and central obesity) 2. aged ≥18 3. community-dwelling 4. independent in daily living 5. possessed a digital device with an internet connection exclusion criteria: 1. has established atherosclerotic cardiovascular diseases (coronary heart disease, cerebrovascular disease and peripheral arterial disease) 2. has psychiatric diseases 3. cannot read chinese 4. has impaired communication or cognitive function (as indicated by an abbreviated mental test score of ≤6)

Keywords: metabolic syndrome
buprenorphine/naloxone - facilitated rehabilitation for opioid dependent adolescents - 1

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Eligibility criteria:
male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.

Keywords: opioid dependence behavioral intervention
evaluation of hypoglossal nerve stimulation in humans with obstructive sleep apnea

Conditions: Sleep Apnea; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Disorder

Summary: this proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach. minimally invasive off the shelf medical devices will be used and observation of the characteristic physiological responses to stimulation of the hgn, will be assessed.


Eligibility criteria:
inclusion criteria: * subject must be eligible for an osa diagnostic or surgical procedure. * subject suffers with moderate to severe osa based on history and a physical exam. * subject has failed, refused or has not tolerated cpap treatment. * subject is willing and capable of providing informed consent. * subject is willing to have a representative electrode array temporarily placed in the submandibular, sublingual and mylohyoid space. --subject is willing to participate in the designated follow-up visits. * subject must be in good general health. * subject is able to understand and has voluntarily signed and dated the irb or ec approved informed consent form (icf) prior to initiation of any screening or study-specific procedure. * subject must be minimum of 21 years and maximum 80 years of age. * subject's hypoglossal nerve must be able to be visualized using ultrasound exclusion criteria: * subject has body mass index above 38kg/m2. * subject has had surgical resection or radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat. * subject has significant co-morbidities making them unable or inappropriate to participate in this poc study. * subject plans to become pregnant, is currently pregnant or breastfeeding during the study period.