Kornimate/medical-research-clean huggingface dataset:
motivational interviewing to support ldl-c therapeutic goals and lipid-lowering therapy compliance in patients with acute coronary syndromes: a prospective randomized clinical study

Conditions: Acute Coronary Syndrome

Summary: this study will investigate the impact of motivational interviewing in achieving low-density lipoprotein cholesterol therapeutic targets in patients with acute coronary syndromes.

to determine whether a strategy of enhanced information about the risks of high plasma low-density lipoprotein cholesterol (ldl-c) and the importance of lipid-lowering medication together with close follow-up and motivational interviewing is superior than usual care in achieving ldl-c therapeutic targets, as set by current practice guidelines (ldl-c \ 50% reduction from baseline ldl-c) in patients with acute coronary syndromes.

Eligibility criteria:
inclusion criteria: * subject hospitalized for acute coronary syndrome (stemi, ntemi or unstable angina) * subject currently on lipid-lowering therapy or prescribed lipid-lowering therapy at hospital discharge (statins and/or other agents) * subject who is 18 years or older * subject or legally authorized representative who is willing and capable of providing informed consent, participating in all associated study activities exclusion criteria: * subject unable to communicate via telephone for study interviewing * subject with contraindication to statin therapy * subject with any medical disorder that would interfere with completion or evaluation of clinical study results

Keywords: motivational interviewing ldl-c ldl target medication adherence
treating nightmares in posttraumatic stress disorder with dronabinol

Conditions: Posttraumatic Stress Disorder

Summary: this randomized controlled exploratory phase ii trial will test the hypothesis that oral dronabinol improves nightmares (primary outcome) and other ptsd symptoms (secondary outcomes) to a greater extent than placebo over a ten week intervention phase in a parallel group design.


Eligibility criteria:
inclusion criteria: 1. diagnosis of posttraumatic stress disorder (ptsd) according to dsm 5 with a 20 item caps-5 total score ≥ 26 2. at least two nightmares a week, an intensity score ≥ 2, with a caps-iv b2 (frequency and intensity for the last week) score ≥ 5 3. men and women between 18 and 65 years of age 4. written informed consent 5. the patient has the capacity to give consent (he/she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention) 6. the patient is not breastfeeding 7. women of child-bearing potential must have a negative urine or serum pregnancy test 8. all participants must use highly effective contraception 9. the patient received stable pharmacological medication for at least 4 weeks prior to study entry (any changes in medication dose or frequency of therapy must be answered with no) exclusion criteria: 1. lifetime cannabis use disorder 2. current substance/alcohol use disorder (≤ 3 months); 3. acute suicidality; 4. psychotic disorder; 5. bipolar disorder; 6. current anorexia nervosa; 7. current major depressive episodes and a madrs score \> 29; 8. dementia; 9. trauma-focused psychotherapy four weeks before the trial 10. initiation of sleep medication 4 weeks prior screening or initiation of alpha adrenergic agents 4 weeks prior to screening 11. acute or unstable medical illness. 12. epilepsy 13. relevant heart diseases 14. known hiv- and/or active hepatitis-b- or hepatitis-c-infection 15. current or past malignant illness 16. the patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons 17. patients, who may be dependent on the sponsor, the investigator or the trial sites, have to be excluded from the trial 18. the patient is legally detained in an official institution 19. the patient does have a known allergy or contraindication against dronabinol 20. the patient does have clinically significant abnormalities in 12-lead ecg 21. the patient does have clinically significant laboratory abnormalities 22. the patient did participate in other interventional trials during the 3 months before and at the time of this trial

Keywords: nightmares posttraumatic stress disorder dronabinol
perspectives of parents about their infants' sleep

Conditions: Insomnia

Summary: behavioral insomnia of childhood (bic) is a common problem in early infancy. the whole family is affected by the problem, but research usually relies only on maternal perception and report. this mixed-method study aimed to explore maternal and paternal perspectives about their child's sleep and sleep problems in early childhood. secondly, infants' sleep will be measured objectively with actigraphy. parental mental health, marital relationship and sleep will be evaluated in order to explore the effects on the perception of their infant's sleep.

sleep is essential for healthy growth and development of children. behavioral insomnia of childhood is reported as a common sleep problem of early childhood with a prevalence of 26-68% according to the definition and study population. behavioral insomnia of childhood not only affects children's health but also has impacts on parental mental health and family functioning. most studies on early childhood sleep problems rely on maternal report. however, both parents are affected by children's sleep problem. it is therefore essential for pediatric healthcare professional to understand both mothers' and fathers' perception and interpretation of their children's sleep and sleep problems in the context of family and culture to suggest culturally appropriate intervention according to the family's needs. this study is designed to thematically analyze maternal and paternal perspectives of their child's sleep and sleep problems in early childhood. parents of children aged 6-36 months with and without sleep problems will be invited to participate into the study. both parents of 10-15 children applying for sleep problems to sleep outpatient clinic and both parents of 10-15 children followed up in well child clinic without sleep problems will be included from october 2021 to june 2022. semi-structured individual in depth interviews will be conducted with both mothers and fathers but in different sessions separately to explore parental views and perception of their child's sleep and sleep problems. the interviews are expected to last between 30-45 minutes and will be audio-recorded and transcribed for thematic analysis. through these interviews the investigators will learn what kind of differences are present between the parents' perspectives of infants with and without sleep problems. sleep of all children will be evaluated by turkish version of the expanded brief infant sleep questionnaire, actigraphy and sleep diary. sociodemographic information will be collected. parents in patient and control group will be assessed for the confounding factors by patient health questionnaire-9, generalized anxiety scale-7 test, relationship satisfaction scale, marital life satisfaction scale and pittsburgh sleep quality index.

Eligibility criteria:
inclusion criteria: * parents and their 6-36 months old children exclusion criteria: * divorced or separated couples * infants less than 37 weeks of gestational age * children with diagnosed developmental problems

Keywords: sleep insomnia children actigraphy marital relationship
effectiveness of high-dose zinc therapy and albendazole in the treatment of environmental enteropathy

Conditions: Enteropathy

Summary: the purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural malawian children at high risk for environmental enteropathy.


Eligibility criteria:
inclusion criteria: * 1-3 years of age * lives in study villages exclusion criteria: * unable to drink 100 ml of sugar water * demonstrating evidence of severe acute malnutrition, whz \< or = -3, presence of bi-pedal pitting edema * apparent need for acute medical treatment for an illness or injury * parent refusal to participate and return for 7-week follow-up
determination of left ventricular ejection fraction using cardiac angioscintigraphy

Conditions: Angioscintigraphy; Tomoscintigraphy

Summary: the purpose is to determine whether measurements of left ventricular ejection fraction (lvef) obtained with angiographies recorded by conventional anger camera or d-spect camera are equivalent. secondary purposes are: * to evaluate the influence of cardiac activity recorded by d-spect camera on equivalences defined in primary purpose * to evaluate the influence of the indication for the examination with a distinct analysis of a group having the examination for a known or suspected cardiomyopathy (lvef often abnormally low) and a group having the examination for a chemotherapy supervision with heart initially considered healthy (lvef often normal).

cardiac angioscintigraphy is an examination for a simple, precise and reproducible measurement of left ventricular ejection fraction (lvef). it needs injection of 99mtc labeled albumin or red cells and unfortunately injected activities must be relatively considerable (≈ 900 mbq) for image recording times shorter than 10 minutes. this examination is thus quite irradiant (10 msv) but this inconvenient could be eliminated with new semiconductor cameras. these new cameras allow a better image quality than conventional anger cameras (better spatial resolution and energy) and their detection sensitivity is almost 10 times higher. however, these new cameras can record only 3d images whereas with conventional cameras angioscintigraphy is usually performed in bidimensional way with a possible higher precision and reproducibility of lvef measurement. in this study, patients needing the routine examination for lvef measurements will undergo the conventional examination followed by examination with semiconductor camera (without supplementary injection). if lvef measurement with semiconductor camera will be as precise and reproducible as with conventional camera, angioscintigraphy could be performed with these new cameras with a lower body irradiation of patients.

Eligibility criteria:
inclusion criteria: * patients present in nuclear medicine department for measurement of lvef by cardiac angioscintigraphy for known or suspected cardiomyopathy or for a chemotherapy supervision with heart initially considered healthy * without guardianship, signed informed consent * not in life-and-death emergency and with a stable clinical state * affiliated to social security * preliminary medical examination exclusion criteria: * patients having rhythm disorders (atrial or ventricular extrasystoles in more than 20% cardiac cycles, atrial fibrillation) * incapable to stay in strict decubitus position during image recording times * pregnant or breastfeeding women

Keywords: cardiomyopathy chemotherapy left ventricular ejection fraction
which place for high flow oxygen in icu ?

Conditions: Hypoxemia

Summary: patients with respiratory failure often need oxygen and/or ventilatory support. patients who need only oxygen support, usually received low flow oxygen (\< 15 liters / min), as well as in respiratory weaning. now new devices can be used. they provide high flow oxygen with different benefits. this high flow devices provide exact fraction of inspired oxygen (fio2), allows a positive end expiratory pressure and supplies a wash out flow. the hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. in addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.

the investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (emg) of sterno-mastoid..

Eligibility criteria:
inclusion criteria: patients with respiratory failure. * spontaneously breathing patient requiring administration at least 40% oxygen, or, * patient under mechanical ventilation, during respiratory weaning. exclusion criteria: * facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients. * neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.

Keywords: hypoxemia high flow oxygen therapy respiratory failure
validation study of a patch-based psg system

Conditions: Sleep Disorder

Summary: this study is a study that qualifies as "other clinical investigation" under art. 82 mdr and §47 abs. 3 mpdg with a ce-marked device that aims to demonstrate that the physiological signals from the onera sts system are substantially equivalent to physiological systems recorded by traditional psg systems. furthermore, the study aims to identify the proportion of users who can successfully perform an overnight onera sts study in an unsupervised home setting. the onera sts will be used within its approved indication, and the study participants will not be subjected to additional invasive or burdensome procedures.


Eligibility criteria:
inclusion criteria: * 18 years and older * either referral for a suspected sleep disorder requiring a sleep diagnostic study, or, * an already diagnosed sleep disorder requiring a planned follow-up psg. exclusion criteria: * inability to provide informed consent * history of allergic reactions to adhesives or hydrogels or a family history of adhesive skin allergies * severe skin condition at sites of patch administration such as wounds, burns or on any damaged skin * has an implanted cardiac stimulator or diaphragmatic pacer * has an anatomical abnormality that, in the opinion of the principal investigator, makes the subject ineligible for inclusion * will be exposed to high-frequency surgical equipment, near strong magnetic fields or with devices such as mris, external cardiac stimulators during their use of the onera device
study comparing a pantoprazole formulation to the currently marketed tablet for gerd and erosive esophagitis

Conditions: Gastroesophageal Reflux; Esophagitis

Summary: the purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.


Eligibility criteria:
inclusion criteria: * gerd and a history of erosive esophagitis documented by endoscopy * h. pylori negative exclusion criteria: * gastrointestinal conditions such as esophageal stricture, esophageal varices, previous vagotomy * achlorhydria

Keywords: gastroesophageal reflux disease (gerd)
efficacy and safety of alss treatment for icis-lf in patients with hcc

Conditions: Immune-Mediated Hepatitis; Liver Failure; Hepatocellular Carcinoma

Summary: this study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.

immune checkpoint inhibitors (icis) are commonly used for advanced stage of hepatocellular carcinoma (hcc) in recent years. the incident rate of grade 4 immune checkpoint inhibitors-induced immune mediated hepatitis reaches 14.5%. since these patients usually develop into liver failure, it is urgent to find out a more suitable therapy. artificial liver support system (alss) treatment has been proved to effectively control both immune mediated hepatitis and liver failure, it may be a new therapy for immune checkpoint inhibitors-induced liver failure (icis-lf) in patients with hcc. therefore, this study aims to investigate the efficacy and safety of alss treatment, including the classic mode of plasma exchange (pe) and new combination mode of double plasma molecular adsorption system (dpmas) with sequential low-dose plasma exchange (lpe), for icis-lf in patients with hcc. sixty patients with hcc and icis-lf will be enrolled in this study. the participants are randomly divided into trial group (dpmas+lpe, and comprehensive internal medical treatment) and control group (pe and comprehensive internal medical treatment). symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 65 years old; 2. clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus dna \> 0.5 year); 3. clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. the last treatment of immune checkpoint inhibitors is less than three months from inclusion; 4. the level of hepatitis b virus dna \< 2000 iu/ml； 5. serum aspartate aminotransferase/alanine aminotransferase \> 20 times upper limit of normal；serum total bilirubin\>10 times upper limit of normal； 6. prothrombin time international ratio \> 1.5; 7. platelets \> 50\*10 e9/l; 8. without intrahepatic bile duct dilation due to tumor progression. exclusion criteria: 1. other active liver diseases; 2. other malignancy; 3. pregnancy or lactation; 4. human immunodeficiency virus infection or congenital immune deficiency diseases; 5. severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation; 6. active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease; 7. patients received artificial liver support system treatment in one week before inclusion; 8. patients can not follow-up; 9. investigator considering inappropriate
pethidine versus nitrous oxide for pain relief during labor

Conditions: Labor Pain

Summary: systematic opioids and inhaled nitrous oxide (n2o ) are common methods for pain relief during labor. the aim of the current study is to evaluate the efficacy of systemic pethidine compared to n2o given for pain relieve in term, multiparous women in labor.

pain relief during labor and delivery is an essential part of good obstetrical care. labor pain and its relief have implications on the course of labor, maternal and fetal outcomes and the satisfaction with childbirth overall. many women would like to have a choice in pain relief during labor but also would like to avoid invasive methods of pain management in labor (as epidural). both, inhaled analgesia and parenteral opioids are common pharmacological interventions aim to relieve the pain of labor.nitrous oxide in a 50/50 mix with oxygen is the most common concentration used for labor pain management. it is self-administered via facemask, intermittently, and has rapid onset and offset effect. main side effects, including nausea, vomiting, dizziness and drowsiness. pethidine is one of the most frequently used opiate agonists. it can be given intravenous or intramuscularly. its analgesic effect starts within 10-20 minutes and lasts 2-4 hours. reported maternal side effects include nausea, vomiting and dysphoria. pethidine may lead to changes in fetal heart rate tracing during labor, respiratory depression, impaired sucking reflex and restlessness. given the fact that these two routine interventions are given in different ways and have different side effects profile, the investigators aim in this randomized controlled trial to compare the analgesic effect of these two methods and their maternal and perinatal secondary effects in multiparous laboring women.

Eligibility criteria:
inclusion criteria: 1. multiparity (para 2 or more). 2. term pregnancy: 37-42 weeks of gestation. 3. singleton pregnancy. 4. vertex presentation. 5. in labor: at least 2 contraction in ten minutes and cervical dilatation of 2 centimeters or more. exclusion criteria: 1. women who desire epidural as a first line analgesia during labor. 2. women receiving pethidine during the last 24 hours (prior to entering labor room). 3. contra-indication for vaginal delivery. 4. contra-indication or allergic reaction to either pethidine or nitrous oxide. 5. history of drug abuse. 6. previous cesarean delivery.

Keywords: labor analgesia nitrous oxide meperidine multiparous visual analogue scale
efficacy and biomarker development for lung cancer treated with immune checkpoint inhibitors

Conditions: Lung Cancer

Summary: the purpose of the study is to find some biomarkers to predict the the adverse events of immune checkpoint inhibitors monotherapy or plus platinum based chemotherapy in lung cancer.

the purpose of the study is to find some biomarkers to predict the the adverse events of immune checkpoint inhibitors monotherapy or plus platinum based chemotherapy in lung cancer. step 1: all the lung cancer patients treated with immune checkpoint inhibitors monotherapy or plus platinum based chemotherapy were enrolled in this study. step 2: all the adverse events were evaluated by principal investigator. step 3: all the blood and ffpe samples were collected for further anaysis. step 4: correlation between adverse events and gene profile was analysis. step 4: predict model was construted with ai.

Eligibility criteria:
inclusion criteria: 1. understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. age ≥ 18 years. 3. histologically or cytologically confirmed lung cancer. 4. treated with immune checkpoint inhibitors with or without chemotherapy. 6. predicted survival ≥ 12 weeks. 7. adequate bone marrow hematopoiesis and organ function 8. presence of measurable lesions according to recist 1.1. exclusion criteria: any conditions can not match for the inclusion criteria, includign do not have the data to perform adverse events evalutation.
the effect of water intake on glucose regulation

Conditions: Glucose Metabolism Disorders; Dehydration (Physiology); Water Deprivation

Summary: there is a growing body of evidence suggesting low water intake and elevated levels of the hormone vasopressin exacerbate glucose regulation. this project will examine the physiological mechanism by which low water intake impairs glucose homeostasis. in the current proposal we aim to: 1) quantify the degree of glucose impairment as a response to elevated vasopressin due to low water intake and 2) identify the physiological mechanism by which elevated vasopressin, as a response to low water intake, impairs glucose regulation


Eligibility criteria:
inclusion criteria: bmi 27.5-35 exclusion criteria: * bmi \ 35 * high physical activity * diabetes * impaired liver or kidney function * cardiovascular disease * weight change of more than 3 kg in the past month * pregnancy * previous surgery on digestive tract (except appendectomy) * fluid balance will be exclusionary such as * serotonin re-uptake inhibitors.

Keywords: water vasopressin