Kornimate/medical-research-clean huggingface dataset:
early identification of mental disorders: application of a multi-modal & domains system

Conditions: Mental Disorder

Summary: this study aims to build a multi-modal collection template and establish a multi-modal database of seven mental disorders including depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders by collecting voice information, facial micro-expression, eye tracking, eeg physiology data respectively. this study will contribute to the multi-modal diagnosis of major mental disorders such as depression in the future and realize clinical application.


Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria of icd-11 or dsm-5 for depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders, and do not limit subtypes and current disease state; 2. age 15-60; 3. han nationality; 4. gender is not limited; 5. have enough audition level to complete the necessary inspection of the research; 6. understand the research content and sign the informed consent form. if the patient is unable to sign the informed consent form in person due to low education level or other reasons, he or she can be entrusted to sign it by his relatives or his guardian. exclusion criteria: 1. mental retardation that significantly affects the patient's current mental state; 2. patients who have serious physical diseases, and it is difficult to complete the necessary examination, including the history of brain trauma or cerebrovascular disease, severe liver cirrhosis, acute and chronic real failure, severe diabetes, aplastic anemia, moderate and severe malnutrition, other serious physical diseases such as nervous system, heart, liver, kidney, endocrine system and blood system, or diseases that may interfere with the test evaluation (abnormal indexes are more than 2 times higher than normal).
thigh muscle mass and muscle wasting in patients in the emergency department

Conditions: Sepsis; Cardiac Arrest; Acute Respiratory Failure; Patients Who Visit Emergency Department; Shock; Trauma

Summary: the goal of this observational study is to evaluate whether thigh muscle mass and muscle wasting are associated with mortality in patients who visit the emergency department. the main questions it aims to answer are: * is thigh muscle mass associated with mortality in patient who visit the emergency department? * does muscle wasting exist during staying in the emergency department? * is muscle wasting associated with mortality in patient who visit the emergency department? participants will be evaluated for serial thigh muscle mass using point-of-care ultrasound at the emergency department.


Eligibility criteria:
inclusion criteria: * patients who visit the emergency department of korea university ansan hospital during study period * patients with age within the limits * patients who are willing to be participate the study with informed consent * patients who undergo point-of-care ultrasound to evaluate thigh muscle mass exclusion criteria: * patients with age out of limits * patients who have deformities on lower leg * patients who is unable to maintain appropriate position to undergo point-of-care ultrasound * patients who decline to participate the study * patients who have 'do-not-resuscitate' order or are not willing to be resuscitated * patients of whom point-of-care ultrasound on thigh muscle mass was not performed
colesevelam for the treatment of bile acid malabsorption in patients with crohn's disease

Conditions: Crohns Disease; Bile Acid Malabsorption

Summary: the purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with cd in clinical remission with symptoms of bam and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.


Eligibility criteria:
inclusion criteria: * signed informed consent after adequate explanation of the patient information. * male and female patients with cd and 18 to 65 years of age in clinical remission with a crohns disease activity index (cdai) score of 150 or less, with symptoms of functional bam or symptoms of bam after small bowel resection with a frequency of at least 3 to maximal 15 liquid or soft stools per day. * stable medical treatment of cd for a minimal period of 3 months preceding the screening visit, consisting of * either continuous oral treatment of aminosalicylate, prednisolone (a maximum 10 mg/day), azathioprine, 6-mercaptopurine, or methotrexate * or supporting periodic treatment\* with tnf-alpha ak (infliximab, adalimumab, certolizumab) (for patients on tnf-alpha, dosing with tnf-alpha should coincide with baseline visit) * blood serum crp value of less or equal then 1 mg/dl (10 mg/l). * bam assessed with a blood test on a 7α-hydroxy-4-cholesten-3-on excretion of equal or more than 50 ng/ml exclusion criteria: * allergy or hypersensitivity to any of the components of cholestagel or placebo as identified from the medical history * participation at another clinical trial within a period of 4 weeks before the screening visit * presence of any addiction, alcohol abuse or specific disease that would not allow the patient to understand the essence and requirements and potential consequences of the participation to the clinical trial * signs suggestive of the patient being unable to follow the visit schedule as required (for example for professional obligations) * treatment with cyclosporine, or tacrolimus, 3 month or less before screening * oral treatment with antibiotics 3 weeks or less before screening * topical treatment with steroid- or mesalazine-containing applications 3 weeks or less before screening * treatment with bile acid bile acid binding agent (e.g. cholestayramine)6 weeks or less before screening * infectious diseases (hiv, hep b, hep c, tuberculosis, listeriosis, positive clostridium-difficile-toxin- proof in faeces) * current presence of intra-abdominal abscess or fistula * cholestatic liver disease, bowel or biliary obstruction * dysphagia or swallowing disorders * known malignancy or history of malignancy * having undergone intestinal surgery within 6 months from screening * status after intestinal surgery with more then 100cm of resected bowel. * short bowel syndrome * planned -gastrostomy, ileostomy or colostomy. * pregnancy and lactation

Keywords: colesevelam ibd bile acid malabsorption crohns disease
study of intravitreal regn2176-3 in participants with neovascular ("wet") age-related macular degeneration (amd)

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the primary objective of the study was to explore the effect of regn2176-3 on the early treatment diabetic retinopathy scale (etdrs) best-corrected visual acuity (bcva) in participants with neovascular age-related macular degeneration (amd), compared to intravitreal aflibercept injection (iai) monotherapy. the secondary objectives of the study were the following: * to explore the effect of 2 dose levels of ivt regn2176-3 on anatomical changes of cnv in participants with namd compared to iai monotherapy (at week 12) * to evaluate if short-term treatment with regn2176-3 followed by iai monotherapy offered the same or additional benefit compared to continuous treatment with regn2176-3. also to determine if there was benefit in initiating iai treatment prior to regn2176-3 compared to continuous treatment with iai. * to assess the safety and tolerability of ivt regn2176-3 in participants with namd


Eligibility criteria:
key inclusion criteria: 1. men or women ≥50 years of age 2. active subfoveal cnv secondary to amd as evidenced by fa in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea 3. bcva etdrs letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit 4. provide signed informed consent key exclusion criteria: 1. any prior treatment with anti-vegf treatment in the study eye 2. any prior treatment (ie, systemic or ocular treatment) with pdgf or pdgfr inhibitors 3. dense fibrotic scar or atrophy in the study eye involving the center of the fovea 4. presence of retinal pigment epithelial tears or rips involving the macula in the study eye 5. prior vitrectomy in the study eye 6. any history of macular hole of stage 2 and above in the study eye 7. any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery 8. history of corneal transplant in the study eye 9. evidence of diabetic retinopathy or diabetic macular edema in either eye 10. positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit
fatigue and symptom burden in low-risk cancer patients undergoing treatment for febrile neutropenia

Conditions: Fatigue; Febrile Neutropenia; Solid Neoplasm

Summary: this trial studies how fatigue and symptom burden in low-risk cancer patients undergoing treatment for febrile neutropenia. cancer and numerous cancer treatments are associated with various symptoms including anemia, fever, and neutropenia, which may also be associated with fatigue. treating low-risk cancer patients for febrile neutropenia may reduce levels of fatigue.

primary objectives i. to determine whether fatigue improves as patients are treated for febrile neutropenia (day #1, day #2 and day #6). secondary objectives i. to identify clinical factors associated in cancer patients with low risk for outpatient treatment of febrile neutropenia on either outpatient febrile neutropenia treatment pathway presenting with moderate to severe fatigue. ii. to describe demographic information in cancer patients with low risk for outpatient treatment of febrile neutropenia and fatigue while enrolled in either of two outpatient febrile neutropenia treatment pathways. outline: patients complete a questionnaire on days 1, 2, and 6 regarding fatigue, sleep disturbance, depression, and other symptoms.

Eligibility criteria:
inclusion criteria: * cancer patients with solid tumors at low risk for outpatient treatment of febrile neutropenia evaluated in the ec and enrolled in outpatient febrile neutropenia pathways (pathway 1 or 2). low risk is defined as hemodynamically stable solid tumor patients that do not have pneumonia or are on steroids. febrile neutropenia is marked by a temperature greater than or equal to 38.3 degrees celsius and an absolute neutrophil count (anc) less than or equal to 1000 within 24 hours. * patients must be able to speak, read and write in english. * patients must be able to complete the required survey tools independently. * patients must report a moderate to severe fatigue level to question # 3 of the brief fatigue inventory (bfi) (4 or greater on a 0-10 scale) on ec admission day. * pregnant women if they meet eligibility criteria of the febrile neutropenia (nf) pathway and are able to take the oral/intravenous (iv) antibiotic prescribed by the pathway. exclusion criteria: * patients will be excluded from the study if they are not on the neutropenic pathway at the time of study entry.
effects of an act-based psychological treatment in relatives of people with intellectual disabilities

Conditions: Parent-Child Relations; Parental Stress

Summary: investigation of the efficacy of acceptance and commitment therapy (act) for the psychological treatment of parental stress in relatives of people with intellectual disabilities

after being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry. patients who meet eligibility requirements will receive psychological intervention consisting in 3-session group act-based treatment. the participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up. the clinical trial will include a control group.

Eligibility criteria:
inclusion criteria: * over 18 years of age * high level of understanding of spanish * having children diagnosed with intellectual disability exclusion criteria: * current psychological and/or psychiatric treatment,

Keywords: stress acceptance and commitment therapy health parent-child relations
safety and efficacy of the hydrophobic intraocular lens asqelio monofocal with biaspheric design

Conditions: Cataract; Pseudophakia

Summary: the goal of this observational study is to learn about the asqelio monofocal intraocular lens (iol) model qlio130c in patients undergoing cataract surgery. the aim of the study is to evaluate the lens implementation safety and efficacy after at least 24 months.

this is a retro-prospective, post-marketing observational study of a ce-marked medical device. the efficacy and safety of the asqelio monofocal intraocular lens (iol) model qlio130c from ast products, inc, billerica, usa, will be studied in patients implanted according to standard clinical practice. twelve-month follow-up data will be collected from the medical records of the patients included in the study, and after 24 months they will be scheduled for a review.

Eligibility criteria:
inclusion criteria: * subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with asqelio monofocal model qlio130c. * subjects for whom postoperative emmetropia (±0.5 d spherical equivalent) was planned. exclusion criteria: * any pathology that reduces the potential visual acuity (va) with its best correction beyond 0.30 logmar. * previous corneal surgery. * rubella or surgery due to traumatic cataract. * ocular trauma or refractive surgery. * any other ocular or systemic condition that, in the opinion of the investigator, should exclude the subject from the study
onset and offset of ticagrelor in esrd

Conditions: Chronic Kidney Disease

Summary: patients with severe chronic kidney disease or end stage renal disease (esrd) on hemodialysis (hd) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. not enough study has been conducted about the antiplatelet effects of ticagrelor in these cardiovascular high risk patients. we hypothesized ticagrelor would achieve more and faster antiplatelet effects compared with clopidogrel in esrd patients on hd.

chronic kidney disease (ckd) is a strong risk factor for cardiovascular morbidity and mortality, and confers an increasing risk of stent thrombosis even when dual antiplatelet therapy (clopidogrel and aspirin) is administered. recently, we demonstrated that patients with severe ckd or end stage renal disease (esrd) on hemodialysis (hd) exhibited higher platelet reactivity to clopidogrel than did those with normal renal function. one of good option to overcome high platelet reactivity in esrd patients would be ticagrelor which has been already shown improved clinical outcomes. but little is known the antiplatelet effects of ticagrelor in esrd patients on hd. the present study was designed to determine the antiplatelet effect as well as the onset and offset action of ticagrelor compared with clopidogrel in patients with esrd undergoing maintenance hd.

Eligibility criteria:
inclusion criteria: * esrd patients undergoing regular (≥ 6 months) maintenance hd * ongoing (≥ 2 months) treatment with clopidogrel * p2y12 reaction units (prus) were more than 235 exclusion criteria: * known allergies to aspirin, clopidogrel, or ticagrelor * concomitant use of other antithrombotic drugs (oral anticoagulants, dipyridamole) * thrombocytopenia (platelet count \<100,000/mm3) * hematocrit \<25% * uncontrolled hyperglycemia (hemoglobin a1c \>10%) * liver disease (bilirubin level \>2 mg/dl) * symptomatic severe pulmonary disease * active bleeding or bleeding diathesis * gastrointestinal bleeding within the last 6 months * hemodynamic instability * acute coronary or cerebrovascular event within the last 3 months * pregnancy * any malignancy * concomitant use of a cytochrome p450 inhibitor or nonsteroidal anti-inflammatory drug * recent treatment (\<30 days) with a glycoprotein iib/iiia antagonist

Keywords: platelet ticagrelor clopidogrel end stage renal disease hemodialysis
a study to evaluate safety, drug levels and effectiveness of cc-92480 (bms-986348) in combination with other treatments in participants with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to assess the safety, tolerability and preliminary effectiveness of cc-92480 (bms-986348) in novel therapeutic combinations for the treatment of relapsed or refractory multiple myeloma (rrmm).


Eligibility criteria:
inclusion criteria: * relapsed or refractory multiple myeloma (mm) and must: 1. have documented disease progression during or after their last myeloma therapy. 2. for part 1 dose finding: be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in mm; for part 2 dose expansion: be refractory to or have relapsed after at least 2 prior lines of therapy that include an immunomodulatory drug (imid), a proteasome inhibitor, an anti-cd38 mab, and a t-cell redirecting therapy (trt, eg, a car-t or t-cell engaging bispecific treatment) unless the participant is not a candidate for trt. * must have measurable disease. * eastern cooperative oncology group performance status (ecog ps) of 0 or 1. * agree to follow the cc-92480 pregnancy prevention plan (ppp). exclusion criteria: * known active or history of central nervous system (cns) involvement of mm * plasma cell leukemia; waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, m-protein, and skin changes (poems) syndrome; or clinically significant light-chain amyloidosis. * impaired cardiac function or clinically significant cardiac disease * previous sars-cov-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to cycle 1 day 1 (c1d1) * for part 1: received prior therapy with cc-92480 * for part 2: received prior therapy with cc-92480, tazemetostat, bms-986158, or trametinib * previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment * received any of the following within 14 days prior to initiating study treatment: 1. plasmapheresis 2. major surgery 3. radiation therapy other than local therapy for myeloma associated bone lesions 4. use of any systemic anti-myeloma drug therapy * used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment * covid-19 vaccine within 14 days prior to c1d1 other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-986348 cc-92480 bms-986158 dexamethasone tazemetostat trametinib
comparative bioavailability of dexketoprofen trometamol oral solution vs tablet formulations

Conditions: Acute Pain

Summary: the purpose of this study is to compare the bioavailability of 25 mg dkp.tris given as an enantyum® oral solution (test formulation) and keral® tablet (reference formulation). in addition, this study intends to evaluate the safety and tolerability of test and reference formulations.

the study was conducted in 1 site and included 26 successfully screened and randomized healthy subjects(12 female and 14 male). the study consisted of: * screening visit (performed within 3 weeks prior to 1st pk study session), for the evaluation of study eligibility. * two pharmacokinetic (pk) study sessions, separated by a minimum of a 7 day washout period, including the administration of one out of 2 study treatments at each study session (namely 25mg dkp.tris given as enantyum® oral solution or keral® tablet) according to the sequence as per randomisation list, and blood sampling for pk assessment on plasma at pre-defined time up to 24 hours post-dose. * end of study visit (7-10 days after last treatment administration).

Eligibility criteria:
inclusion criteria: - healthy male and female subjects between 18 to 50 years old, with a body mass index (bmi) between 18 kg/m2 and 28 kg/m2- exclusion criteria: * history of previous allergy idiosyncrasy / sensitivity to dkp.tris or other nsaids (aspirin, ibuprofen etc). * any condition which might interfere with the absorption, distribution, metabolism or excretion of the drugs. * surgery within previous 6 months, or blood loss \> 400 ml within previous 3 months. * subject with positive human immunodeficiency virus (hiv), hepatitis b surface antigen (hep b) and hepatitis c virus antibody (hep c) results. * history of clinically significant alcohol, medicine or drug abuse.

Keywords: dexketoprofen bioavailability comparative pharmacokinetic
dose ranging study to determine the safety, reactogenicity and immunogenicity of typhoid fever vaccine (ty800) in healthy adult subjects

Conditions: Typhoid Fever

Summary: the purpose of this trial is to examine the safety and immunogenicity of ty800 oral vaccine in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy males or females aged 18 to 55 years, inclusive * capable of understanding and complying with the protocol requirements and be available for the duration of the protocol exclusion criteria: * history of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids * history of typhoid fever infection, vaccination against typhoid fever or participation in a clinical trial using s.typhi organism at any time * history of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. endemic regions are south and east asia, the indian subcontinent, africa and central and south america including mexico * history of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease * allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame. * people who are commercial food handlers, day care workers, or health care workers involved in direct patient care. also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding

Keywords: prevention of typhoid fever in adult travelers