Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, tolerability and effectiveness of mt-0814 for the treatment of age-related macular degeneration

Conditions: Age-related Macular Degeneration

Summary: age-related macular degeneration (amd) is the leading cause of blindness among adults in north america. the current standard of care for patients with exudative ("wet") amd is anti-vascular endothelial growth factor (anti-vegf) therapy which must be administered by an injection into the eye every 4-8 weeks. mt-0814 is being developed for the treatment of patients with exudative amd, and could offer an alternative, safer and less burdensome therapy.


Eligibility criteria:
inclusion criteria: * must agree to sign informed consent form, and to comply with protocol requirements, including study visits. * must have clear optic media in the study eye that is capable of producing high-quality fundus images. exclusion criteria: * has active cnv due to causes other than amd in the study eye. * has retinal vascular disease or retinal degeneration other than amd in the study eye. * has had intraocular surgery, cataract surgery or lasik surgery on the study eye within 90 days prior to the study. * has had yttrium aluminum garnet (yag) laser capsulotomy on the study eye within 30 days prior to the study. * has active inflammation, infection, or other severe ocular disease in either eye. * has aphakia in the study eye. * has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either eye. * is a contact lens wearer and is unable to discontinue their use in both eyes for the duration of the study. * has a serious allergy to, or experienced a prior significant adverse reaction to fluorescein angiography (fa) or indocyanine green angiography (icga). * has participated in any other clinical trial and/or has taken any investigational drug or product within 90 days prior to the study. other protocol-defined inclusion/exclusion criteria could apply.

Keywords: exudative wet amd age-related macular degeneration age related macular degeneration
multi-strain probiotics for adhd

Conditions: Attention Deficit and Hyperactivity Disorders

Summary: probiotics are widely used as supplement for various neurodevelopmental disorders. the mechanism of their therapeutic potential lies in the "gut-brain axis", a two-way communication pathway through the neuroendocrine system. in the past, there have been many experiments to study the possible efficacy of probiotics in patients with adhd. although some studies have shown that probiotics can improve adhd symptoms, most studies have used behavioral rating scales to evaluate. as a result, it is susceptible to informant bias. standardized attentional tests and quantitative electroencephalogram (qeeg) can provide more objective data and detect possible changes in brain networks. such changes may precede behavioral phenotypes. therefore, the purpose of this study is mainly to detect the therapeutic effect of multiple strains of probiotics in patients with attention deficit hyperactivity disorder by using standardized attention tests and quantified brain waves (qeeg).


Eligibility criteria:
inclusion criteria: a patient is eligible for the study if all of the followings apply: 1. 8-11 children diagnosed with adhd by board certified pediatric psychiatrist according to dsm-5 (assessment tool using snap criteria, at least 6/9 symptoms of inattention and/or hyperactivity/impulsivity (≧2/3 on each severity scale) on parents' and teachers' observation) 2. on stable psychotropic mediations (i.e. no change in dose of methylphenidate or antipsychotics) for past 8 weeks exclusion criteria: any patient meeting any of the exclusion criteria will be excluded from study participation: 1. patients with major mental or neurological diseases such as intellectual disability, autism group disorders, schizophrenia, severe depression, bipolar disorder, epilepsy, brain injury, etc. 2. those who have serious gastrointestinal diseases, physiological diseases or genetic diseases. 3. have used antibiotics or edible probiotic-related products (including drops, tablets, capsules, bacterial powder) in the past month. 4. participated in other clinical research in the past month. 5. vegetarians or those currently undergoing special diet therapy. 6. evaluation by the pediatric psychiatrist not suitable for entering the test

Keywords: adhd probiotics quantitative electroencephalogram
neonatal sars-cov-2 anti-spike protein receptor-binding domain antibodies at delivery

Conditions: COVID-19

Summary: to assess the association between neonatal sars-cov-2 antibody level at delivery and infant covid-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.

this prospective observational study was conducted at the rabin medical center, israel. mothers were enrolled from september 2021 to mid-february 2022, prior to transfer to the delivery room, and followed at the maternity and infant ward. the study was approved by the institutional ethics committee (rmc- 0275-21). written informed consent was obtained from the participating mothers. inclusion criteria included maternal recipient of at least one dose of the bnt162b2 mrna covid-19 vaccine or prior microbiologically-confirmed natural covid-19 infection. exclusion criteria included (a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Eligibility criteria:
inclusion criteria: included maternal recipient of at least one dose of the bnt162b2 mrna covid-19 vaccine or prior microbiologically-confirmed natural covid-19 infection exclusion criteria: (a) preterm birth at \<34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.
adrenal exhaustion syndrome in critically ill patients without improvement

Conditions: Survival

Summary: we study the relationship between patient outcomes and sequential changes of serum cortisol level.

elevated corticosteroid level to meet physiologic needs during acute illness is a protective response for stress. this homeostasis is maintained by the hypothalamic-pituitary-adrenal (hpa) axis. however, inadequate response as corticosteroid insufficiency in critically ill patients is reported with increasing frequency, especially in severe sepsis and septic shock. thus, corticosteroids could be beneficial for septic shock or severe acute illness. once considered as normal adrenal function, adrenal insufficiency may developed later with chronic critical illness as adrenal exhaustion syndrome. it is easily overlooked and is possible due to the chronic secretion of systemic cytokines or other hpa axis-suppressive substances. there is still no consensus how often adrenal function testing should be repeated, although a re-evaluation should be considered if clinical symptoms and signs suggest adrenal insufficiency or deteriorating clinical condition.

Eligibility criteria:
inclusion criteria: * age over 18 * icu admission * had two cortisol data exclusion criteria: * first cortisol data abnormal * cortisol data not checked in icu
hemodynamic measurements during cesarean section with spinal anesthesia

Conditions: Healthy

Summary: the purpose of this study is to determine the effect of low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion on blood pressure, cardiac output and systemic vascular resistance.

hypotension during cesarean section with spinal anesthesia is common. we compare low dose versus standard dose spinal anesthesia with and without intravenous phenylephrine-infusion.

Eligibility criteria:
inclusion criteria: * healthy pregnant women for elective cesarean section exclusion criteria * shorter than 160 or taller than 180 cm * pre-pregnant body mass index (bmi) over 32

Keywords: hemodynamic hypotension spinal anesthesia healthy pregnant women for elective cesarean section
fixed versus flexible gonadotropin-releasing hormone (gnrh) antagonist initiation

Conditions: Subfertility

Summary: this is a comparison of pregnancy achievement between two gnrh antagonist protocols which differ in the timing of gnrh antagonist initiation.


Eligibility criteria:
inclusion criteria: * \< 39 years of age * bmi 18.5-29.9 * \<= 3 previous ivf cycles exclusion criteria: * pcos * endometriosis

Keywords: gnrh antagonists
study of alofanib in patients with metastatic gastric cancer

Conditions: Gastric Cancer

Summary: this is a non-randomized multicenter phase 1b clinical trial of the safety and pharmacokinetics, as well as the preliminary efficacy of monotherapy with alofanib, an allosteric fibroblast growth factor receptor 2 inhibitor, in patients with advanced gastric cancer who have exhausted the resource of standard therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed gastric cancer (adenocarcinoma) * progression of the disease (clinical and/or radiological) on previous standard systemic therapy * measurable lesions according to the recist 1.1 criteria * possibility to assess the amplification of fgfr2, fusion of fgfr2 genes, overexpression of fgfr2, phosphorylation of frs2 * ecog ps 0-2 * age \>= 18 years old * adequate function of organs * absence of any psychological, family, social or geographical circumstances that could potentially serve as obstacles to the implementation of the study * patients capable of childbearing should use an effective method of contraception * signed informed consent exclusion criteria: * participation in another clinical study and concomitant treatment with any research drug or any study of antitumor therapy, including radiation, within 28 days before inclusion in this study * presence of metastases in the central nervous system and / or carcinoma of the meninges at the time of inclusion in the study * presence or history of present signs of any condition, therapy or laboratory abnormalities that could limit the interpretation of the results of this study * any malignant tumor within the previous 5 years, with the exception of adequately cured cervical cancer in situ or squamous cell skin cancer, or basal cell skin cancer with limited growth, subject to adequate control over the course of this disease * pregnancy * known positive status for human immunodeficiency virus (hiv) or active hapatitis b and c * surgery within 7 days before the first dose of the study drug * signs of bleeding or hemorrhagic diathesis

Keywords: gastric cancer metastases patients with previous treatment failures fgfr2 abnormalities
a prognostic study for patients with cardiovascular disease in niigata

Conditions: Cardiovascular Diseases; Heart Failure

Summary: the goal of this observational study is to investigate the prognosis of cardiovascular disease in niigata prefecture. specifically, it aims to clarify the current status of medical treatment for cardiovascular disease patients in regional cities in japan, where the population is aging. with patient consent, the study will track long-term medical treatment progress using health insurance claim data recorded in japan's unique social security system.


Eligibility criteria:
inclusion criteria: * individuals aged 18 or older at the time of enrollment (regardless of gender). * individuals who have been hospitalized in the cardiology department of a participating medical institution. * individuals covered by japan's national health insurance (nhi) or the late-stage elderly medical care system, which provide health coverage for self-employed individuals, retirees, and the elderly. exclusion criteria: * individuals who are unable to obtain consent from themselves or their legally authorized representatives.
impact of extreme heat on myocardial blood flow and flow reserve in young and older adults

Conditions: Aging; Heat Stress; Hyperthermia; Heat Strain

Summary: extreme heat causes a disproportionate number of hospitalizations and deaths in older adults relative to any other age group. importantly, many hospitalizations and deaths are primarily due to cardiovascular events such as myocardial infarction. previous data indicate that older adults have attenuated skin blood flow and sweating responses when exposed to heat, resulting greater increase in core body temperature. despite these observations, relatively little is known about the risk for myocardial ischemia potentially contributing to the aforementioned higher morbidity and mortality in older adults during heat waves. the broad objective of this work is to determine the impact of ambient heat exposure on myocardial blood flow and flow reserve in young and older adults. aim 1 will test the hypothesis that older adults exhibit attenuated myocardial flow reserve compared to young adults during heat stress. aim 2 will determine if the percent of maximal myocardial flow reserve (assess via vasodilator stress) during heat exposure is higher in older adults compared to young adults. the expected outcome from this body of work will improve our understanding of the consequences of aging on cardiovascular responses to ambient heat stress.


Eligibility criteria:
inclusion criteria: * healthy male and female individuals * 18-35 years or 65+ years of age * free of any underlying moderate to serious medical conditions exclusion criteria: * known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia. * taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses. * abnormalities detected on routine screening. * current smokers, as well as individuals who regularly smoked within the past 3 years. * body mass index of greater than 30 kg/m\^2 * pregnant individuals
ethics education to support nurse leaders in healthcare

Conditions: Knowledge, Attitudes, Practice

Summary: using an exploratory study design with an educational intervention, a pre/post evaluation of ethical confidence and competence will be completed for nursing leaders working in either acute care or post-acute care with primary purpose to increase ethical competency and confidence in decision making for nursing leaders in a clinical role.

the purpose of this project is to implement an ethics educational program that has been developed in collaboration with subject matter experts to support patient facing nursing leaders. the intervention is an ethics education pathway, which will be used for approximately 60-80 patient-facing nurse leaders who practice in either acute care or post-acute care over a 6-week period. one pre and two post-assessment questionnaires will be distributed, which include the "ethical competence support questionnaire" © and the "ethical safety questionnaire" ©. permission for the instrument use was obtained from the author.

Eligibility criteria:
inclusion criteria: * employment within an in-patient or outpatient non-profit healthcare setting as a nursing leader. * settings include acute-care units and post-acute care facilities exclusion criteria: * nurses working direct care 100% of their time without any formal leadership responsibilities

Keywords: nursing ethics clinical ethics ethical competence
multiple dose safety, tolerability, pk，pd and food effect study of hec96719 in healthy adult subjects

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: the safety, tolerability, pharmacokinetic, pharmacodynamics and food effect study of hec96719 in healthy subjects


Eligibility criteria:
inclusion criteria: * willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. * female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication. * when signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited. * male body weight ≥50kg, female body weight ≥45kg, and body mass index (bmi) in the range of 18-28 kg/m2 (including the critical value). * no clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest x-ray (posterior and anterior) results. exclusion criteria: * positive for viral hepatitis (including hepatitis b and c), hiv and syphilis. * those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations. * consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. * positive results from urine drug screen test. * donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. * subjects who plan to receive or have had organ transplants. * subjects considered by the investigator to have other factors unsuitable for participation in this study.
feasibility of exosome analysis in cerebrospinal fluid during the diagnostic workup of metastatic meningitis (exo-lcr)

Conditions: Breast Cancer

Summary: the investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. all the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.

the primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (csf) microvesicles (from unsupervised bioinformatics analysis) and csf cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial csf samples (hereafter referred to as initial proteomic profile and initial cytology).

Eligibility criteria:
inclusion criteria: * patient with histologically proven breast cancer; * patient with suspected metastatic leptomeningeal involvement; * age ≥ 18 ans ; * who performance status ≤ 2 ; * affiliation to the national social security system ; * with informed and signed consent exclusion criteria: * history of another cancer than the one for which the patient is referred; * contraindication to lumbar puncture or cerebrospinal mri * pregnant or breastfeeding woman

Keywords: leptomeningeal metastases proteomic profile cerebrospinal fluid cytology analysis
dermacyd silver floral (lactic acid) - photo evaluation

Conditions: Hygiene

Summary: primary objective: to demonstrate the absence of photoirritation and potential photosensitization of the product dermacyd silver floral.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii integral skin test in the region * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion exclusion criteria: * lactation or pregnancy * use of antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection * disease which can cause immunosuppresion, such as diabetes, hiv * concomitant use of photosensitivity drugs * history of sensitivity or photosensitivity withr topic products * cutaneous active disease which can modify the study results * history or activity of photodermatosis * personal or family antecedents of cutaneous neoplasia photo induced * presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis * intense exposure solar in the test region * use of new drugs and/or cosmetics during the study * previous participation in studies using the same product in test * relevant history or confirmation of alcohol or other drugs abuse * intolerance detected or suspected for some component of the sample tested * medecin or sponsor employees or their close family. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of ultrasound-guided corticosteroid injection versus palpation-guided injection for de quervain's disease

Conditions: De Quervain Disease

Summary: the purposes of this study are to compare the effectiveness and side effects of us-guided and palpation-guided corticosteroid injections for de quervain's disease.

de quervain's disease is a common clinical disorder, characterized by pain at radial side of the wrist. it often interferes wrist and thumb movement, and may affect activity of daily life. it is caused by overuse and impaired gliding of the abductor pollicis longus (apl) and extensor policis brevis (epb) tendons at the styloid process of the radius. it is associated with postpartum baby care, or jobs or hobbies that involve repetitive hand and wrist motions. the most effective treatment is corticosteroid injection into the tendon sheath of the conjoined tendons of apl and epb. over the past few years because of advancement of sonography in the musculoskeletal system, ultrasound (us)-guided intra-sheath injection has become popular, and it has been proved to improve the accuracy of placement of needle tip in the tendon sheath, however, studies comparing the effect and side effects of us-guided corticosteroid injection with palpation-guided injection for de quervain's disease have never been reported before. the purposes of this study are to compare the effectiveness and side effects of us-guided and palpation-guided corticosteroid injections for de quervain's disease. the investigators plan to recruit 70 patients with de quervain's disease, half of them will be randomly assigned into us-guided injection group, and the other half into the palpation-guided injection group. each subject will receive one shot of injection and each subject will expect to fill in the evaluation form at baseline, and at 1 week, 3 months, and 6 months after the injection. statistics will be performed after completing the patients' treatment and evaluations.

Eligibility criteria:
inclusion criteria: 1. pain and tenderness at the radial side of the wrist. 2. positive finkelstein sign, or pain on resistive maximal isometric contraction of extension and/or abduction of the affected thumb. 3. pain intensity on a 10-point visual analog scale (vas) for pain to ≧ 3 on active thumb abduction or extension. 4. patient agrees to receive either palpation-guided or us-guided local corticosteroid injection. 5. age ≧ 20 years old. exclusion criteria: 1. presence of an absolute contraindication for corticosteroids or local anesthetics injection. 2. during pregnancy. 3. severe systemic diseases with poor control. 4. prior treatment with corticosteroid injection and/or surgery at the same anatomical location in the last 6 months. 5. being unable to fill-in the follow-up forms.

Keywords: de quervain disease ultrasound-guided injection intra-articular injection