Kornimate/medical-research-clean huggingface dataset:
hemodynamically important patent ductus arteriosus in newborns under 32 weeks

Conditions: Patent Ductus Arteriosus After Premature Birth

Summary: to define the characteristics of hemodynamically significant pda by echocardiography, to investigate the systemic effects of the ductus with cerebral and renal doppler flow studies, and to determine the oxygen consumption in the cerebral tissue with nirs in newborns below 32 weeks of age with pda.


Eligibility criteria:
inclusion criteria: * born at less than 32 weeks newborns exclusion criteria: * congenital heart disease * syndromic and/or major congenital anomaly

Keywords: cardiology newborn diseases congenital heart defects patent ductus arteriosus
a pharmacokinetics study of daptomycin in critically ill patients and effects of daptomycin on kidney

Conditions: Outcome, Fatal; Infection

Summary: daptomycin ，is the ﬁrst approved member of a new class of antimicrobials, the cyclic lipopeptides, and presents selective action against gram-positive bacteria, including methicillin- and vancomycin-resistant strains，disrupting the transfer of amino acids in the cell membrane, thus hindering the biosynthesis of bacterial cell cell wall peptide polysaccharide, changing the properties of cytoplasm membrane, can destroy bacterial cell membrane function in many ways, and quickly kill gram-positive bacteria. because of its unique chemical structure and sterilization mechanism, bacteria rarely develop resistance to daptomycin. daptomycin can be reversibility combined with human plasma protein (mainly serum albumin) and metabolized mainly through the kidneys. there is still a lot of controversy about the application of daptomycin in patients with severe illness. although studies suggest that daptomycin has less damage to kidney function than vancomycin, the effect of daptomycin on kidney function in severely ill patients is not yet clear, and more clinical studies are needed to explore their relationship. in addition, it is not clear whether the physiological pathology of specific populations such as sepsis/infectious shock, acute kidney injury, (aki), hypoproteinemia, and renal replacement treatment affects the pharmacokinetics/pharmacodynamics of daptomycin. by exploring the application of daptomycin in patients with severe illness, this study explores the effects of special pathological physiological states such as sepsis/infectious shock and hypoproteinemia on daptomycin pk/pd, as well as the effects of different hemoglobin concentrations of daptomycin on the outcome of kidney function.


Eligibility criteria:
inclusion criteria: 1. patients with severe bloodstream infections eligible for daptomycin indications 2. treatment in the icu 3. patients aged 18 to 65 exclusion criteria: 1. pregnant and lactating women 2. the patient or his agent refused to participate in the trial 3. incomplete clinical medical information 4. patient participates in another clinical trial at the same time 5. previous history of myopathy or current cpk increase more than 2 times than normal 6. patients need to use warfarin anticoagulation 7. patients use tobramycin for anti-infection 8. patients use drugs such as cyclosporine and fibrates that can cause adverse reactions to muscle disease 9. patients with gram-negative bacterial infections caused by abdominal and respiratory infections 10. patients with heart failure, respiratory failure, glasgow coma index (gcs) ≤ 8 points, liver function child pugh score c that are not related to the infection

Keywords: daptomycin pharmacokinetics pharmacodynamics critical ill patients outcome
efficacy and safety of zolpidem-mr administered over a long term period as needed for insomnia (zolong)

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the primary objective of the study is to evaluate the hypnotic efficacy of zolpidem-mr 12.5 mg in comparison with placebo, when administered over a long-term period, on an "as needed" basis, in patients with chronic primary insomnia. secondary objectives of the study are to evaluate the drug taking behavior over a long-term period and the clinical safety and tolerability of zolpidem-mr 12.5 mg in comparison to placebo administered over a long-term period, on an as needed basis.


Eligibility criteria:
inclusion criteria: * patients with chronic primary insomnia the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: primary insomnia chronic insomnia
study comparing two populations of patients treated with anti vegf for diabetic macular edema, one being followed at the hospital and the other one being followed at home using a software allowing self-assessment of visual acuity

Conditions: Diabetic Macular Edema

Summary: verify the reliability of va measured every week at home, by the patient using a tc, compared to the reliability of va also measured by the patient using a tc but every 2 month at the hospital, during standard dme follow-up visits


Eligibility criteria:
inclusion criteria: will be included in the study, patients with all of the following criteria: * aged ≥ 25 years old (the minimum age is set at 25 years old in order to include patient with controlled diabetes); * diagnosed with dme; * followed and treated by anti-vegf ivt in the ophthalmology debarment at hopital saint joseph marseille; * having a va score ≥ 20/100; * able to understand the study and to use a tc; * having an internet access at home; * having given free and informed written consent; * being affiliated with or benefiting from a social security scheme. exclusion criteria: will not be included in the study, patients with one of the following criteria: * treated for another pathology that dme; * already participating to another research study; * pregnant or breastfeeding woman; * subject to a measure for the protection of justice.
is levocetirizine less sedating than cetirizine?

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.

levocetirizine, the r-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. we plan to examine whether patients who did not tolerate cetirizine due to sedation are able to tolerate levocetirizine. this study will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine, cetirizine, and placebo in regards to sedation and allergy symptom scores. each patient will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as their own control.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients with perennial allergic rhinitis sensitized (positive rast within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either: * dust mite * cat (if they own an indoor cat) * dog (if they own an indoor dog) * will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold * history of reported sedation/somnolence when taking cetirizine * patient must have taken cetirizine for at least 1 week prior to discontinuing it * patients must have either tolerated levocetirizine in the past or have never tried levocetirizine. exclusion criteria: * chronic urticaria requiring ongoing antihistamine or steroid treatment * atopic dermatitis requiring ongoing antihistamine or steroid treatment * uri or sinus infection during the 2 weeks preceding the beginning of the study * vasomotor (non-allergic) or irritant rhinitis * afrin use * elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency * patients who have not tolerated levocetirizine in the past due to sedation. * taking other prescription or over the counter antihistamines and unwilling to stop them during the study * the presence of a sleep disorder such as sleep apnea or narcolepsy * the use of as needed sleeping aid medication * the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively

Keywords: allergic rhinitis
simplified insulin protocol using lantus in elderly

Conditions: Diabetes

Summary: the purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.

as patients with diabetes age, adverse social and medical problems may arise. because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. this may lead to errors in treatment and poor glucose control. simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. in a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. in this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and a1c (measure of average glucose control over 3 months). the investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.

Eligibility criteria:
inclusion criteria: * age 70 years or older * diagnosis of diabetes mellitus type ii * at least 2 (short-acting or mixed) insulin injections per day * at least 1 episode of hypoglycemia (glucose value \<70) on screening cgm exclusion criteria: * patients with the following illnesses in the past 12 months myocardial infarction angina coronary artery bypass grafting percutaneous transluminal coronary angiography cerebrovascular event (stroke, tia) * active liver disease (history of cirrhosis or lft \> 3 times normal) * on dialysis or with severe renal dysfunction (creatinine clearance \<20 ml/min) * malignancy that limits life span to less than 18 months * patients seen in the geriatric clinic who already have simplified regimen as proposed in the study

Keywords: simplification glargine elderly
randomised clinical trial comparing drug-coated balloon to plain balloon for all peripheral avf stenosis

Conditions: Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Dialysis Access Malfunction

Summary: to compare the access circuit primary patency after ranger drug-coated balloon angioplasty of arteriovenous fistula (avf) stenosis with that after conventional balloon angioplasty

this is a blinded randomized controlled trial recruiting 94 patients with avf stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (ranger) or conventional balloon. all peripheral avf stenoses will be treated with the allocated balloon type. the primary outcome measure is 6-month access circuit patency.

Eligibility criteria:
inclusion criteria: 1. failing avf with at least 1 avf stenosis presenting with any clinical, physiological or haemodynamic abnormalities. both de novo and recurrent stenosis are accepted. 2. avf has been used successfully for at least 1 month (non-mature avf are not allowed). 3. less than 30% residual stenosis after angioplasty. 4. ≥ 21 years old 5. informed and valid consent given. exclusion criteria: 1. thrombosed avfs 2. haemodynamically significant central vein stenosis 3. target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm) 4. contraindication to antiplatelet therapy 5. coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion. 6. allergy / contraindication to paclitaxel. 7. acute infection over proposed puncture site. 8. women who are breastfeeding, pregnant \* or planning on becoming pregnant during study. 9. participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol. 10. currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

Keywords: drug-coated balloon access circuit patency
umbilical cord milking in non-vigorous infants developmental followup (minvifu)

Conditions: Neurodevelopmental Abnormality

Summary: a sub-study to evaluate longer-term developmental outcomes in non-vigorous term and near-term newborns who receive umbilical cord milking in comparison to those who undergo early cord clamping at delivery.

this sub-study investigates the potential difference in neurodevelopmental outcomes during early childhood between newborns who undergo umbilical cord milking and those who experience early cord clamping at birth. the developmental progress of participants is evaluated using the ages and stages questionnaire-3 which measures five developmental areas: communication, problem-solving, fine motor skills, gross motor skills, and personal-social behavior. additionally, the modified checklist for autism in toddlers is employed as a secondary assessment. the recruitment of participants is conducted through the primary study umbilical cord milking in nonvigorous infants trial (nct03631940) with the method of umbilical cord management for each newborn being dictated by the randomized treatment allocation of the primary study.

Eligibility criteria:
inclusion criteria: * enrolled in the primary trial nct:03631940 and parental written consent to participate in developmental follow-up through 2 years of age was obtained. * enrolled in the primary trial nct:03631940 and did not survive to 2 years. exclusion criteria: - enrolled in the primary trial nct:03631940 but parent/guardian declined consent to developmental follow-up participation.

Keywords: neurodevelopmental outcomes disability umbilical cord milking early cord clamping non-vigorous infants term infants near-term infants developmental screening early childhood
a open-label study to assess the long-term safety of difamilast ointment 1% in mild to moderate atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate ad. the study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.


Eligibility criteria:
important inclusion criteria: 1. subjects who are male or female ≥2 years of age at screening (visit 1). 2. subjects who have a diagnosis of ad based on the american academy of dermatology ad diagnostic criteria 3. subjects who have had a diagnosis of ad for at least 3 months prior to screening . 4. subjects who have an iga of mild or moderate ad severity and treatable body surface area (bsa) ≥3%at baseline if not previously enrolled in study medi-mm36-301 or b. iga ≤ 3, with no minimum bsa and completed through week 4/eot visit 6 of the study medi-mm36-301. 5. subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements. important exclusion criteria: 1. subjects who have an ad flare (defined as rapid intensification of ad) within 28 days prior to screening or baseline (except for those previously enrolled in study medi-mm36-301) or history of consistent requirement for high-potency topical corticosteroids to manage ad signs and symptoms. 2. subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected ad 3. subjects with significant systemic or localized infection 4. subjects with minimal/mild depression and suicidal ideation 5. subjects using restricted medications, biologics and alternative therapies, or using investigational drug -
precision medicine for l/gcmn and melanoma 2

Conditions: Melanoma (Skin Cancer); Nevi and Melanomas; Congenital Melanocytic Nevus

Summary: the primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (vocs) for the early identification of metastases. the secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.

this is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. the study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. the results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as pet, mri, etc.) and correlated with standard prognostic biomarkers (cfdna mutations in braf, nras, etc.) obtained using liquid biopsy.

Eligibility criteria:
inclusion criteria: * be over 18 years old * have a histopathological confirmed melanoma diagnosis (stage ii, iii or iv ajcc) exclusion criteria: * not signing the informed consent form * present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles

Keywords: volatilomics breath analyzer skin patch melanoma l/gcmn liquid biopsy cfdna non-invasive diagnostics
colorectal health research champions

Conditions: Cancer of Colon; Cancer of Rectum

Summary: the purpose of the colorectal health research champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.


Eligibility criteria:
inclusion criteria: the individual is \> 30 years of age * they are literate * they are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research. to participate in a chat hosted by the chrc the inclusion criteria is: * adult of any gender * over 30 years of age. exclusion criteria for chat hosted by the chrc: -those \< 30 years of age

Keywords: prevention
evaluation of a school-based training program for suicide prevention

Conditions: Suicide

Summary: this study will determine whether a training program designed to help school staff members identify adolescents at risk for suicide will increase the number of students who are referred to mental health services.

the rate of suicide among adolescents has significantly increased in recent years. psychiatric disorders are often associated with increased suicide risk; therefore, the ability to identify adolescents with signs of depression and other psychiatric conditions is clear. this study will determine the effectiveness of a suicide prevention training program called question, persuade, refer (qpr) in increasing the number of potentially suicidal adolescents who are referred to mental health services. the training is designed to help school staff recognize signs that a student may be suicidal, provide tips on how to question students about any suicidal thoughts they may have, and provide techniques to persuade students to seek suicide prevention help. school staff will be randomly assigned to either receive qpr training for 2 years starting immediately or be placed on a waiting list for later training. the rates of referral to the school district's prevention/intervention centers will be used to assess the effectiveness of qpr training. in addition, the impact of qpr training on school staff members' knowledge and attitudes about intervening with at-risk students will be assessed through surveys at four time points over the 2-year study duration with a randomly selected portion of staff in the 32 participating schools. surveys completed by randomly selected 8th and 10th grade students will also be used to determine whether the intervention is effective in reducing suicidal thoughts or attempts. study hypothesis: more students in schools that have question, persuade, refer (qpr)-trained staff will be referred for a mental health evaluation than in schools without qpr-trained staff.

Eligibility criteria:
inclusion criteria for school staff members: * currently working as a staff member in cobb county school district inclusion criteria for students: * parent or guardian willing to provide informed consent

Keywords: suicide prevention depression adolescent students school teachers
surgeons' mental distress and risks after severe complications following emergency surgery

Conditions: Mental Health

Summary: surgeons experience higher levels of work stress, even under normal circumstances. many can suffer from substantial levels of mental health issues, especially when faced with severe complications. however, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help. patients in need of emergency surgery are usually characterized by critical conditions and high surgical risks. emergency surgeons always do not have enough time to clearly explain the ins and outs of the disease to the family members of the patients, only tell the key issues and risks that need to be paid attention to during the operation. the tone of the explanation maybe direct and blunt, which also could cause the incomprehension and dissatisfaction of the patients and their families. due to the lack of communication, although the patient is in critical condition, the family members always think that the disease should be cured after arriving at the hospital. therefore, once severe complications occur after the operation, the family members often find it difficult to accept the reality. this is also one of the important reasons for medical disputes in emergency surgery. in addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. such pressures may bring great risks of psychological distress. surgeons are also the victims when they encounter severe complications following emergency surgery. their mental distress should not be minimized. until now, little has been known about the effects of surgical complications on surgeons. in the current study, based on a large-scale questionnaire survey in china, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after emergency surgery. the investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.


Eligibility criteria:
inclusion criteria: * emergency surgeons who experienced severe complications after emergency surgery. exclusion criteria: * other conditions that do not meet the inclusion criteria.