Kornimate/medical-research-clean huggingface dataset:
eeg biomarkers for predicting response to antidepressant therapy

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the potential early eeg predictors of an individual's response to treatment with antidepressant medications. objectives: * prospectively confirm accuracy of current eeg biomarker algorithm * determine preferred clinical intervention for subjects with negative indicator * identify predictors of worsening suicide ideation

according to recent clinical studies sponsored by the nih, fewer than half of subjects diagnosed with a major depressive episode respond to the first trial of an antidepressant medication. while the majority of subjects eventually respond to treatment with an antidepressant, failure with the first line medication puts subjects at increased risk for never receiving adequate treatment of their depression. several lines of reasoning support the rationale for further investigating eeg as a means of predicting response and resistance to antidepressants. prior studies suggest that changes in neuronal activity in the anterior cingulate and prefrontal regions are related to depression and that changes in brain response to treatment may also produce alterations that can be detected by recoding frontal eeg activity. in this protocol, we proposed to identify possible neurophysiologic indicators of treatment outcome in depression, particularly indicators of brain response that appear early (within 7 days) during treatment with antidepressants. we will test whether quantitative eeg (qeeg) biomarkers can be reliably associated with response or non-response to treatment with antidepressant medications, using both monotherapy and combination drug treatments. comparison(s): selecting the best treatment for subjects with resistance to an initial antidepressant poses a considerable challenge for clinicians. the most widely prescribed antidepressants usually require 4-6 weeks of therapeutic dosing before a marked clinical improvement in symptoms is observed. therefore, determining the optimal regimen can take several weeks or months for subjects who are resistant to the first line antidepressant. a tool for predicting eventual clinical response to antidepressants could help inform and accelerate the process of identifying the most efficacious treatment option for a given subject.

Eligibility criteria:
inclusion criteria: * subject has diagnosis of major depressive disorder exclusion criteria: * subject is suffering from cognitive, bipolar, or psychotic disorder * subject has had a course of ect within the past six months * subject has any known contraindication for use of any of the study drugs * subject has a known drug dependency or substance abuse within the past six mon ths * subject is currently pregnant or not using a medically acceptable means of birth control

Keywords: major depressive disorder, depressive disorder, unipolar depression, antidepressants, electroencephalography
postmenopausal evaluation and risk-reduction with lasofoxifene (pearl)

Conditions: Osteoporosis

Summary: the purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.


Eligibility criteria:
inclusion criteria: postmenopausal at least 5 years; screening bone mineral density more than or equal to 2.5 s.d.s below the mean for young adults at the lumbar spine or femoral neck. exclusion criteria: metabolic bone disease other than osteoporosis; taking approved medications for osteoporosis; have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 s.d.s below the mean for young adults at the lumbar spine or femoral neck.
the 2015 pelotas (brazil) birth cohort study

Conditions: Mother-Child Relations; Preterm Birth; Infant Development; Breast Feeding; Physical Activity; Pregnancy Related; Medicine, Narrative

Summary: this is the fourth birth cohort to be carried out in the city of pelotas (brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.

the pelotas 2015 birth cohort is the fourth birth cohort being established in pelotas since 1982. data is being collected with a focus on maintaining fidelity to the tools and instruments used in the previous cohorts with minimal adaptations when necessary. all children born in pelotas during 2015 were included in the cohort, and the cohort has been followed four times, at birth, 3, 12 and 24 months (ongoing). in addition, an antenatal study identified and interviewed 73.8% of the mothers that subsequently delivered children that are now part of the cohort. the 4275 children included in the cohort are part of extensive assessments that include information on antenatal health and care, pregnancy health, gestational age, physical activity, sleep, health behaviours, socio-demographic characteristics, perinatal conditions, child anthropometry, delivery information, child mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development, access to health services, medicine use by both mother and child and genetic material. the cohort also nests 2 randomized clinical trials and a series of sub-studies. the data is starting to be analyzed and, among other findings, confirm the already alarming trends in surgical deliveries, amounting to 65.2% of all deliveries in 2015.

Eligibility criteria:
inclusion criteria: * live births * mothers living in urban area of the city * delivered during 2015 exclusion criteria: * stillbirths below 500g * mothers living outside pelotas

Keywords: cohort studies infant development pregnancy brazil observational studies epidemiology maternal health
sensory motor training on foot weight distribution in patients with foot burn

Conditions: Burn; Postural Stability

Summary: the purpose of the current study is to investigate the effect sensory motor training on foot weight distribution and postural stability in patients with foot burn.

pain, contractures, scars, altered sensations, muscle weakness, and postural balance impairment are potential complications of foot burn that negatively influence a person\&#39;s ability to function normally and correlate with gait abnormalities like reduced step height and length, along with slower gait speed. these gait disturbances pose significant challenges for burn patients, affecting their mobility and overall quality of life. so, this study aims to understanding how sensory motor training can improve balance, gait, and overall functional mobility is essential for guiding the development of evidence-based rehabilitation protocols tailored to the unique needs of this population.

Eligibility criteria:
inclusion criteria: * patients will suffer from foot \&#34;planter surface\&#34; second degree thermal burn (partial thickness). * patients who have undergone skin grafting and those who have not undergone skin grafting are both eligible for inclusion in the study. * patients will begin the training program after complete wound healing. * patients will be given their informed consent. exclusion criteria: * patients who had an open wound at or near treatment site. * patients who had chemical or electrical burn. * patients with specific conditions such as musculoskeletal impairments impacting independent walking (e.g., strokes, severe arthritis). * uncontrolled cardiovascular or pulmonary diseases. * patients with neurological, psychiatric illness, severe behavior or cognitive disorders. * metabolic or vascular disease with a neurological component such as diabetes. * patients with hearing problems, individuals with otitis media, and patients experiencing nystagmus and visual problems. * malignant conditions. * uncooperative patients.

Keywords: sensory motor training foot weight distribution postural stability foot burn
efficacy, safety, tolerability and pharmacokinetics of kaf156 in adult patients with acute, uncomplicated plasmodium falciparum or vivax malaria mono-infection

Conditions: Malaria

Summary: this study will assess efficacy, safety , tolerability and pk in uncomplicated adult malaria patients with p. vivax or p. falciparum infection after 3 day dosing with kaf156 at 400 mg/day (part 1) and single dosing with kaf156 at 800mg (part 2)


Eligibility criteria:
inclusion criteria: -male and female patients aged 20 to 60 years;presence of mono-infection of p. falciparum or p. vivax; weight between 40 kg to 90 kg. exclusion criteria: * patients with signs and symptoms of severe/complicated malaria * infection with more than one parasite species * women of child-bearing potential; pregnant or nursing women * those who have taken any anti-malarial treatment in the preceding 14 days or other investigational drugs within 30 days or 5 half-lives

Keywords: acute malaria, kaf156
study of acceptability and tolerance of an orofacial myofunctional rehabilitation pacifier in infants

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the development of the medical device tested was inspired by palatal plates used to treat myofunctional disorders in young patients with down syndrome. this protocol is intended to evaluate the acceptability and tolerance of this pacifier in infants aged 1 to 6 months during 4 test. if acceptability and tolerance are satisfactory, an effectiveness study will be carried out to determine whether this medical device could prove useful in preventing the occurrence of obstructive sleep apnea syndrome (osas) in very young children, via orofacial myofunctional rehabilitation


Eligibility criteria:
inclusion criteria: * infant aged 4 weeks to 6 months coming to the pediatric sleep department to perform a polysomnography or polygraphy with video, during hospitalization of at least 24 hours, * affiliate or beneficiary of a social security scheme, * with informed consent of the 2 legal representatives. exclusion criteria: * known allergy to silicone.

Keywords: obstructive sleep apnea syndrome pacifier
botulinum toxin and mesotherapy on enhancement of facial scarring

Conditions: Facial Scars

Summary: most of the body's tissues can undergo wound repair following a disruption of tissue integrity. upon healing, these wounds result in scar formation. the scars widen when the overlying musculature pulls apart suture lines. botulinum toxin a (bta) is known to prevent fibroblast proliferation and it also induces temporary muscle paralysis. also, mesotherapy is the non-invasive transdermal injection which can aid the skin to increase collagen and elastin production. thus, both techniques are eligible for enhancement of facial scars.


Eligibility criteria:
inclusion criteria: * patient suffering from vertical or oblique forehead lacerations caused by trauma. * recent and fresh wounds. * atrophic scar (linear scar). exclusion criteria: * infected wound. * patient on chemotherapy treatment and history of malignancy. * patients suffering from burns on the forehead or complicated lacerations. * allergy to drugs used in this study
retrospective chart review to evaluate safety and tolerability of advate among previously untreated patients in china with moderate to severe hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this post-marketing safety study is to evaluate the safety, immunogenicity, and effectiveness of advate in previously untreated patients (pups) in china with moderate to severe hemophilia a.


Eligibility criteria:
inclusion criteria: 1. previously untreated patient (pup) in china with moderate to severe hemophilia a. 2. investigator prescribed advate as the predominant therapeutic agent for the management of hemophilia a 3. informed consent form from patient and/or legal representative will need to be signed per local regulation exclusion criteria: 1. presence of an inherited or acquired hemostatic defect other than hemophilia a, and any other clinically significant chronic disease 2. participants who participated in another investigational fviii drug study, or had participated in any clinical study involving an investigational fviii drug during the course of the observation period
a study of escitalopram in the treatment of children and adolescents with generalized anxiety disorder

Conditions: Anxiety Disorders,Generalized Anxiety Disorder

Summary: this is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (gad) and evaluated using standard questionnaires as having at least moderate severity of gad. participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. the purpose of this research is to study the safety and effectiveness of escitalopram in minors with gad.


Eligibility criteria:
inclusion criteria: * subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. the subject will complete an informed assent prior to study participation. * subject meets dsm-5 criteria for a primary diagnosis of gad at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the mini-international neuropsychiatric interview for children and adolescents (mini kid). * male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug. * female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug. * female subjects who are not of childbearing potential do not need to use any methods of contraception. this includes preadolescent and adolescent females who have not reached menarche. - subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol. exclusion criteria: * current diagnosis of mdd, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder. * suspected or previously diagnosed intellectual disability disorder. * one or more first-degree relatives with diagnosed bipolar i disorder. * history of seizure disorder (other than febrile seizures). * history of electroconvulsive therapy at any time during the subject's lifetime. * known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications. * taking any medications that are contraindicated to escitalopram (escitalopram oxalate). * inability to speak, read, or understand english well enough to complete the assessments. * no active suicidal ideation or lifetime history of suicidal behavior as assessed by columbia-suicide severity rating scale (c-ssrs).
a study of rivaroxaban to reduce the risk of major venous and arterial thrombotic events, hospitalization and death in medically ill outpatients with acute, symptomatic coronavirus disease 2019 (covid-19) infection

Conditions: Coronavirus Disease 2019 (COVID-19)

Summary: the purpose of this study is to evaluate whether rivaroxaban reduces the risk of a composite endpoint of major venous and arterial thrombotic events, all-cause hospitalization, and all-cause mortality compared with placebo in outpatients with acute, symptomatic coronavirus disease 2019 (covid-19) infection.


Eligibility criteria:
inclusion criteria: * coronavirus disease 2019 (covid-19) positive diagnosis by locally obtained viral diagnostic test (example, polymerase chain reaction \[pcr\]). this may be nasal swab or saliva test or other available technology to demonstrate current infection * confirm that participant is known to health system, with at least 1 contact in electronic medical records (emr) prior to screening * symptoms attributable to covid-19 (example, fever, cough, loss of taste or smell, muscle aches, shortness of breath, fatigue) * initial treatment plan does not include hospitalization * presence of at least 1 additional risk factor: a) age more than or equal to (\>=) 60 years; b) prior history of vte; c) history of thrombophilia; d) history of coronary artery disease (cad); e) history of peripheral artery disease (pad); f) history of cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal cell carcinoma) h) history of diabetes requiring medication; i) history of heart failure; j) body mass index (bmi) greater than or equal to (\>=) 35 kilogram per meter square (kg/m\^2); k) d-dimer greater than (\>) upper limit of normal for local laboratory (within 2 weeks of the date of the covid-19 test and prior to randomization) exclusion criteria: * increased risk of bleeding such as a) significant bleeding in the last 3 months; b) active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e) prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and undergoing treatment * any illness or condition that in the opinion of the investigator would significantly increase the risk of bleeding (example recent trauma, recent surgery, severe uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis, severe liver disease, known bleeding diathesis) * known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients * positive covid-19 antibody or serology test after 2-week period of acute, symptomatic covid-19 infection * known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein i antibodies) antiphospholipid syndrome
paresthesia in hand and antebrachium following cardiacsurgery: incidence, risk factors and clinical course

Conditions: Paresthesia; Peri-operative Injury; Complication,Postoperative; Upper Limb Nerve Lesion

Summary: to describe the incidence and severity of paresthesia in hand and antebrachium in patients that have undergone cardiacsurgery.

some patients report tingling and/or numbness in hand and/or antebrachium after cardiac surgery, but potential risc factors and clinical course are not well described, and the incidence or severity is not known. many factors may impact on the development of these complaints: age, bmi, pre-operative neurological deficits, diabetes, type, technique and duration of cardiac surgery, positioning of arms and hands during surgery, placement of the arterial line, time-to-extubation and post-operative positioning during this period. the investigators aim to describe incidence and clinical course of these complaints and possibly identify modifiable risc factors in a retrospective cohort of patients that have undergone fast-track cardiac surgery, as a part of the on-going patient-centered quality improvement. the study included 361 patients. conclusion the incidence of hand paresthesia following cardiac surgery was 10%. this study found an increased occurrence of paresthesia after aortic valve surgery and prolonged aortic cross-clamp duration; these differences were not statistically significant. the impact of arterial line placement and patient positioning as a risk factor remains unclear. the majority of patients with paresthesia were overweight and had pre-existing comorbidity, with 11% reporting preoperative paresthesia. the clinical course of hand paresthesia following cardiac surgery was predominantly transient and not severe.

Eligibility criteria:
inclusion criteria: * adult patients * cardiac surgery in the period from january 2022 to december 2023 * perioperative data entered into the quality database safebrain

Keywords: paresthesia upper limb cardiac surgery peri-operative complication
profile-mi - the fapi fibrosis study

Conditions: Myocardial Infarction; Myocardial Fibrosis

Summary: the investigators here propose to investigate the timing and pattern of myocardial fibrosis activity following acute myocardial infarction using hybrid 68ga-fapi positron emission tomography and cardiovascular magnetic resonance. the investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling. simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will be assessed enabling the exploration of the presence of unstable atheroma.

fibrosis is a fundamental process underlying almost all cardiomyopathic conditions. established fibrosis can be detected by existing imaging techniques including cardiovascular magnetic resonance. however, these techniques are not specific for fibrosis and do not directly measure fibrosis activity or matrix remodelling. this limits the ability to detect early disease and differentiate active from end-stage phenotypes. fibroblast activation protein is a key factor in fibrogenesis that is expressed in the myocardium following myocardial infarction and in thin-capped fibroatheroma. radiolabelled fibroblast activation protein inhibitor (68ga-fapi) measures in vivo fibrosis activity and matrix remodelling, as supported by preliminary pilot studies. the timing and pattern of myocardial fibrosis activity following acute myocardial infarction will be investigated using hybrid 68ga-fapi positron emission tomography. the investigators hypothesise that peak fibrosis activity will occur within 2-4 weeks of acute myocardial infarction and will predict subsequent scar formation and cardiac remodelling. simultaneously, matrix remodelling and fibrosis activity in aortic and coronary atheroma will also be assessed allowing exploration of the presence of unstable atheroma. this project will enhance understanding of fibrosis activity and matrix remodelling in myocardial infarction and unstable atherosclerotic plaque with potential future application to a broad range of cardiovascular diseases.

Eligibility criteria:
inclusion criteria: * specific to cohort; * aged 50 years or older exclusion criteria: * claustrophobia * inability to undergo mri * egfr \<30ml/min/1.73\^m2
a rct comparing lactulose and rifaximin associated with a vegetable diet in the prevention of post-tips overt hepatic encephalopathy

Conditions: Cirrhotic Patients Undergoing TIPS Placement

Summary: this is a randomized controlled trial whose purpose is to evaluate the efficacy of therapy with lactulose and rifaximin associated with a vegetable diet in the prevention of post-tips hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: * consecutive cirrhotic patients undergoing tips exclusion criteria: * age \>75 years; bilirubin levels \>5 mg/dl; creatinine levels \>3 mg/dl; a serious cardiac or pulmonary dysfunction; a child-pugh's score \>11 (except for the patients candidates to early tips); a model end-stage liver disease (meld) score \>18; a diagnosis of hepatic carcinoma; sepsis; spontaneous bacterial peritonitis; renal insufficiency. present he or previous spontaneous/recurrent he, alcohol/psychoactive drugs intake (positive alcoholaemia and/or benzodiazepines or opioid urine metabolites) at the moment of evaluation, unrelated neurological disease including dementia (mini mental state \< 26).
study the role of genetic variation in the determining lipid profile response to dietary change

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine whether plasma lipoproteins and lipid responsiveness to a dietary modification is influenced by cetp gene polymorphism.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * history of any cardiovascular diseases * type 1 diabetes * type 2 diabetes * use of lipid-lowering medications * hypertension * pregnancy * current intake of vitamins and supplements * history of endocrin disorder