Kornimate/medical-research-clean huggingface dataset:
cognitive, psychological and electrophysiological attributes to suicide among depressed patients

Conditions: Suicide; Major Depressive Disorder; Quantitative EEG (qEEG)

Summary: this study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.

objectives: 1. to investigate the ability of qeeg to suspect suicidal potential in patients diagnosed with major depression. 2. to test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients. 3. to give an objective and more reliable method than traditional questionnaires to assess the seriousness of suicidal ideations in patients suffering from depression who usually don't reveal their actual intentions.

Eligibility criteria:
inclusion criteria: * age between 16 and 65 years * both males and females will be enrolled * patients present with the clinical picture of major depression according to dsm 5 criteria. exclusion criteria: * psychotic features associating depressive episode * bipolar depression * the condition is due to another medical condition * the condition is substance or medication-induced * intellectual disability * comorbid epilepsy

Keywords: suicide major depression quantitative eeg (qeeg)
the effect of the educatıon and counselıng of prostatectomy patıents

Conditions: Prostate Cancer; Surgery; Nursing Caries

Summary: the research was planned as a randomized controlled experimental study. this study is planned to be conducted in the urology clinic of a university hospital located in the south of turkey. the population of the research will be the patients admitted to the urology clinic for prostatectomy. the sample of the study will consist of patients who meet the criteria for participation in the study and volunteer to participate in the study. evaluation of the research data will be done with the spss package program.


Eligibility criteria:
inclusion criteria: * being 18 years or older, * being literate, * being able to understand and speak turkish and not have a hearing impairment, * agreeing to participate in the research. exclusion criteria: * development of any complications during the surgical intervention, * having any psychiatric disorder that will reduce the ability to comprehend and understand, * having other concomitant cancer, * having metastases.
pro osteon bone void filler study

Conditions: Osteoarthritis; Revision Arthroplasty

Summary: this study was designed to observe the outcomes of pro osteon according to its cleared indications for use.

the purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of pro osteon® as a bone void filler. fda has cleared this device via premarket notifications 510(k) k063346, k980817, and k990131. there will be no experimental or investigational devices used.

Eligibility criteria:
inclusion criteria: inclusion criteria will be the same as the stated indications stated in the summary of the fda approved 510(k) k063346, k980817, and k990131 application. these indications are stated below: * pro osteon® 500r resorbable bone graft substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. * pro osteon® 500r is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e, the extremities, spine and pelvis). these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. pro osteon® 500r can be combined with autogenous blood, and/or sterile fluids (saline or ringer's solution). the product provides a bone void filler that resorbs and is replaced with bone during the healing process. * surgical techniques and patient care are to be standard for the surgeon participating in the protocol and should be maintained the same throughout the course of the data-collection. * all patients must sign an irb-approved informed consent to be enrolled into the study. exclusion criteria: exclusion criteria will be the same as the stated contraindications stated in the summary of the fda approved 510(k) k063346, k980817, and k990131 application. these contraindications are stated below: * pro osteon® 500r resorbable bone graft substitute is contraindicated for fractures of the growth plate * for segmental defects * for indications which may be subjected to excessive impact or stresses * when there is significant vascular impairment proximal to the graft site * when there are metabolic or systemic bone disorders that affect bone or wound healing * in infected sites * when stabilization of the defect is not possible. * the use of pro osteon® 500r is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible.

Keywords: total knee arthroplasty revision tibial void bone filler
individualized neuromodulation for the core clinical features of drug addiction

Conditions: Amphetamine Use Disorders

Summary: using specific eeg biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop tacs based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop tacs methods.

the current study delineates a robust correlation between prefrontal cortex eeg signals and the psychological craving associated with methamphetamine usage. dependents exhibit heightened β oscillation energy in the mpfc region and diminished γ oscillation energy across the dlpfc-mpfc region. previously, through the implementation of rtms interventions on the left dlpfc, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the mpfc region. this indicates that both β and γ oscillation energies are instrumental in representing the involvement of mpfc and dlpfc during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when ma dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. therefore, the investigators intend to employ the non-invasive transcranial alternating current stimulation (tacs) technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Eligibility criteria:
inclusion criteria: * individuals aged between 18 and 45 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations. * meet the diagnostic criteria set forth by the dsm-v concerning the severity of amphetamine-type substance addiction. * a history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week. * consent to actively cooperate in the completion of subsequent follow-up assessments. exclusion criteria: * severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an iq score less than 70. * a diagnosis of schizophrenia or other severe mental illnesses as per the dsm-5 criteria. * abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years. * severe organic diseases that might compromise study participation. * contraindications to tacs, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.

Keywords: individualized therapy closed-loop amphetamine-type stimulants tacs
efficacy and safety study of rimegepant for the preventative treatment of migraine in pediatric subjects

Conditions: Migraine

Summary: the purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.


Eligibility criteria:
inclusion criteria: 1. subject has at least a 6 month history of migraine (with or without aura) and including the following: 1. 14 or less headache days per month during the 3 month period prior to the screening visit 2. 6 or more migraine days during the observation period 3. 14 or less headache days during the observation period 4. pediatric migraine disability assessment scale (pedmidas) disability score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the baseline (randomization) visit 5. ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches 6. migraine attacks, on average, lasting 4 - 72 hours if untreated 7. subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the screening phase, and the dose is not expected to change during the course of the study. 2) male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent. 3)subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the screening visit. exclusion criteria: 1. subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine 2. the subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to screening visit. 3. the subject has a history or diagnosis of complications of migraine 4. the subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study. 5. the subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the screening visit. subjects with a lifetime history of psychosis and/or mania are excluded. 6. history of suicidal behavior or the subject is at risk of self-harm or harm to others. 7. history of major psychiatric disorder. 8. the subject has a current diagnosis or history of substance abuse 9. the subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Keywords: migraine migraine prevention phonophobia photophobia nausea pediatric migraine adolescent migraine
effect of power wheelchairs on the development and function of young children with severe physical disabilities

Conditions: Cerebral Palsy; Child, Preschool

Summary: self-produced locomotion often is limited in children with cerebral palsy and other conditions that cause severe motor impairments. as a result, these children may be at risk for secondary impairments in spatial cognition, communication, social development, and other domains influenced by independent mobility. to compensate, power mobility has increasingly been advocated for young children with severe motor impairments. the study hypotheses were: 1. children with severe disabilities that prevent independent locomotion who learn to use power mobility devices when they are 14- to 30-months-of-age will have greater communication, social, and cognitive development over a 12-month period, and will demonstrate more competent coping skills than children with the same characteristics who do not use power mobility. 2. parents of children who use power mobility will view it as a positive influence on their children's lives, and will perceive their children's development to be more mature than the parents of children who do not use power mobility will perceive their children's development.

more extensive description is not desired.

Eligibility criteria:
inclusion criteria: * age 14 to 30 months * motor impairment that prevents functional independent mobility * vision and hearing adequate to use a power mobility device safely. * cognitive abilities assessed to be at least equivalent to a 12-month level or alertness and interest in the environment that suggests a trial of power mobility is warranted.

Keywords: cerebral palsy wheelchair disabled children
study of single-ascending doses of ds-6016a in healthy japanese subjects

Conditions: Fibrodysplasia Ossificans Progressiva

Summary: this study will assess the safety, tolerability, and pharmacokinetics of ds-6016a after subcutaneous injection in healthy japanese participants.


Eligibility criteria:
inclusion criteria: * japanese healthy male subjects. * age ≥20 and ≤45 years upon providing informed consent. * body mass index (bmi) ≥18.5 and \<25.0 kg/m\^2 at screening. exclusion criteria: * have a history of hypersensitivity to any drugs or substances, or being idiosyncratic (eg, having penicillin allergy) * have alcohol or drug dependence, etc.

Keywords: fibrodysplasia ossificans progressiva bone morphogenetic protein activin receptor-like kinase-2
helicobacter pylori eradication and irritable bowel syndrome: a prospective study

Conditions: Irritable Bowel Syndrome

Summary: h. pylori is frequently observed in patients with irritable bowel syndrome(ibs). however, the effect of h. pylori eradication on ibs is not clear.

patients with ibs symptoms using rome iv criteria will be included. testing for h. pylori will be done. patients with h. pylori will receive triple therapy and followed after two weeks for eradication and assessment of ibs symptoms.

Eligibility criteria:
inclusion criteria: * patients newly diagnosed with ibs and h.pylori exclusion criteria: * patients received previous treatment of h.pylori * patients receiving treatment for ibs.
intravenous acetaminophen as adjuvant therapy for pain control in geriatric hip fracture patients

Conditions: Pain; Hip Fracture

Summary: this research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of iv acetaminophen (ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. iv acetaminophen has received fda approval. iv acetaminophen does not have the liver toxicity as oral acetaminophen. no oral acetaminophen will be administered. all patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. subjects may receive the normal dvt prophylactic treatments post-op.

approximately 46 subjects will be enrolled at lgh. subjects will be randomized 1:1 to receive either iv acetaminophen 1000 mg q6 hours (fda recommended dose) or iv placebo. while receiving the study drug/placebo the subject's blood pressure, heart rate, respiratory rate, \& pain intensity will be monitored. additional pain meds will be given if needed. study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided. participation in the study will end at time of discharge from the hospital. researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.

Eligibility criteria:
inclusion criteria: * all patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected * patients with the following surgeons ( david hughes md, gerald rothacker md, frank essis md, james carson md, michael gish md, vincent battista md) exclusion criteria: * documented drug or alcohol addiction or abuse * documented serum sodium levels \> 145 mmol/l * documented serum chloride levels \> 107 mmol/l * impaired liver function defined as an alt or ast \> 3 times the upper limit of normal, child-pugh class c, or patients with documented active liver disease * known allergy or intolerance to acetaminophen * weight ≤ 50 kg * creatinine clearance (crcl) ≤ 30 ml/min as determined by the cockcroft-gault equation * documented dementia * acetaminophen (\> 650 mg) or opioid (\> 7 mg iv morphine equivalence) use within the previous 24 hours * documented chronic opioid use
pharmacokinetics of intramuscular adrenaline in food--allergic teenagers

Conditions: Anaphylaxis

Summary: food allergy affects up to 2% of adults and 8% of children in the united kingdom (uk), and is a major public health issue. it is the commonest cause of life-threatening allergic reactions (anaphylaxis), which can be fatal. adrenaline (epinephrine) auto-injector (aai) devices are the first-line treatment for anaphylaxis, yet in a uk survey, over 80% of 245 teenagers experiencing anaphylaxis did not use their aai. delays in, or lack of adrenaline (epinephrine) administration during anaphylaxis are risk factors for fatal anaphylaxis. in 2010, a coroner's investigation into the death of a food-allergic teenager in the uk raised several questions around aai safety and efficacy, since the teenager died despite administering her auto-injector device. this prompted a review by the medicines and healthcare products regulatory agency (mhra) in 2014 into the clinical and quality considerations of aais. two recommendations which came from the review was that companies 'should be encouraged to develop a 0.5mg \[dose\] aai.' in the uk currently only emerade, one of the three companies selling aais, manufactures a 0.5mg (500mcg) version. emerade also has a longer needle length (23mm) compared to other aais (typically 15mm). the investigators plan to formally assess the pharmacokinetics (pk) and pharmacodynamics (pd) of self-injection with intramuscular adrenaline (epinephrine) in teenagers at risk of anaphylaxis due to food allergy, and have been prescribed aai. 1. the investigators will compare self-injection with 300mcg vs 500mcg in teenagers of body weight \>40kg. in a 40kg person, an adrenaline dose of 300mcg results in an effective under-dosing of 30% by body weight. 2. the investigators will also assess the impact of needle length on injection, by comparing two different devices, both of which deliver 300mcg, but one via a 15mm needle and the other with a 23mm needle.


Eligibility criteria:
inclusion criteria: * age 13 - 18 years inclusive * body mass \>40kg * prescription of aai due to physician diagnosis of immunoglobulin e-mediated food allergy. * written informed consent from parent/guardian together with patient assent, for participants under 16 years of age. for young people age 16+ years, consent will be obtained from the participant themselves. exclusion criteria: * known cardiac comorbidity (including hypertension, structural or electrophysiological diagnoses) or prescribed a medicine to control cardiovascular disease/hypertension. * known endocrine or renal disease * poorly controlled asthma requiring daily rescue treatment with a bronchodilator. * pregnancy * unwilling or unable to comply with study requirements
variations of high sensitivity troponin t in neonates

Conditions: Newborn; Newborn, Transient

Summary: troponin t-us is a cardiac marker for myocardial infarction. its use in neonates is increasing, yet normal values are still to be determined for the latest generation of tests, such as high sensitivity cardiac troponin t test. this study is an observational study designed to determine biological normal values of high sensitivity cardiac troponin t test (troponin t -us) in newborns.

* approximately 400 subjects will be recruited over a planned recruitment period of 2 months. during labour, or pre natal hospitalization, information about the study will be given to every mothers by the midwife or the pediatrician. absence of opposition will be notified in the medical file. * at birth, every child born alive is possibly eligible for this study, if he doesn't meet the exclusion criteria. * after clamping the umbilical cord, the midwife realizes the systematic sample for assessment of ph and lactate. if the mother did not object to the study, the midwife will use 200µl of this very same sample to assess troponin t blood level. this sample goes to the same laboratory to be analyzed. the blood sample for troponin t measurement must be brought to the laboratory within 2 hours, just as ph and lactate must be. the midwife in charge of this patient also fills a form with informations from the patient's medical file. this form is anonymized for the study. * samples will not be stored, remaining swab after analysis will be destructed. * before discharge, all children undergo a medical exam by a pediatrician, whether they are in maternity or in neonate. the pediatrician who examines the child fills a second form that summarizes the noteworthy events of his hospital journey. subjects have the right to withdraw from the study at any time for any reason. if one of the parents wishes to withdraw from the study after the first troponin t measurement is made, we will ask for their permission to use the collected data.

Eligibility criteria:
inclusion criteria: * every newborn, born alive in rené dubos maternity, without regarding the way of birth. * absence of malformative syndromes or genetic abnormalities in prenatal echographies * absence of parental opposition exclusion criteria: * multiple pregnancies * post natal discovery of malformative syndromes or genetic abnormality. all congenital heart diseases will be excluded. * parental opposition at any time of the study

Keywords: neonatology troponin t standards