Kornimate/medical-research-clean huggingface dataset:
shame propensity in borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: borderline personality disorder (bpd) is a common psychiatric disorder occurring in 2 to 6% of the population. 70% of patients with bpd do at least one suicide attempt (sa) in their lives. it makes bpd the most related to sa condition. negative interpersonal events are among the main stressor inducing a sa. patients with bpd are characterized by emotional dysregulation, impulsivity (repeated parasuicidal and suicidal behaviors), and instability in interpersonal relationships. the feeling of shame related to this psychiatric disorder could be one of the causes of the high sa rate. in this study, patients with bpd will be follow-up during 5 years. the main objective is to study the propensity to feel shame as a predictor of sa. this include: * study of shame propensity as a predictive factor of suicidal behavior - identify homogeneous subgroups of patients with bpd based on sa, and overall functioning. * identify biological markers predicting sa * identify predictive and protective treatments (pharmacological and psychotherapeutic) for sa

this is a 5 years follow-up prospective study recruiting 688 patients. schedule of the study : inclusion period : 3 years duration of follow-up of each patient : 5 years estimated duration of the study : 8.5 years as part of the research, patients will be summoned annually for 5 years. the first visit (at baseline) is included in the usual care the follow-up visits are specifics to the research during the visits patients will complete self questionary and clinical interview. the organization of visits is as follows: * an inclusion visit lasting around 2 hours (clinical evaluation and then self-questionnaires) * a visit to 1 year, 2 years, 3 years, 4 years and 5 years (+/- 1 month) lasting approximately 1 hour 30 (clinical evaluation and passing of self-questionnaires) genetic samples will be taken during the initial visit as well as during the visit to 5 years. they consist of: * a genetic collection consisting of a dna library (3 ethylene diamine triacetic acid (edta) tubes of 6ml - 18 ml). * an off-genetics collection consisting of serum and plasma samples, (1 6 ml edta tube, 1 4 ml heparinized tube, 2 dry tubes of 5 ml each and 2 citrated tubes of 2.7 ml each - 25 , 4 ml).

Eligibility criteria:
inclusion criteria: * to be over 18 * clinical diagnosis of bpd using the scid ii (structured clinical interview for dsm-iv-text reviewed axis ii personality disorders) * having signed the informed consent * able to understand the nature, the purpose and the methodology of the study * able to understand and perform the clinical evaluations exclusion criteria: * deprived of liberty (by judicial or administrative decision) * protected by law (guardianship) * exclusion period in relation to another protocol * not affiliated to a social security scheme

Keywords: psychiatry suicidal behavior borderline personality disorder follow-up study
minimal invasive treatment of inguinal hernia in neonates

Conditions: Inguinal Hernia; Surgery

Summary: in this study, preoperative physical examination findings, peroperative findings and data, and postoperative follow-up results of newborns who underwent inguinal hernia repair with pirs ("percutaneous internal ring suturing") method will be evaluated retrospectively.

congenital inguinal hernia is one of the most common surgical pathologies of childhood. its treatment includes high ligation of the patent processus vaginalis by open or laparoscopic method. there are many described minimally invasive/laparoscopic repair techniques of inguinal hernias in children. one of them is "percutaneous internal ring suturing" or "percutaneous inner ring suturing". there are many studies on the pirs method in children. two of these studies are prospective clinical studies published previously by the investigators of this study: in the first, the pirs method was shown to be a safe and effective method for minimally invasive repair of inguinal hernia in children, and in the second, the use of subparalytic laryngeal masks in anesthesia of patients who underwent pirs was shown to be sufficient for airway protection and anesthesia management in children undergoing laparoscopy. although there are many studies on the repair of inguinal hernia in children with pirs or other minimally invasive methods in the last decade, there are very limited studies on the use of these methods in newborns, a special group of childhood patients. in the literature, there is no study examining only newborn patients. in this context, the study will be a first in the literature.

Eligibility criteria:
inclusion criteria: 1. having undergone pirs surgery at the study institute between october 1, 2015 and january 1, 2023 2. age between 0-28 days exclusion criteria: 1. age \> 28 days 2. having had surgery with open surgery 3. having another surgical procedure performed in the same session
new classification of stomach using probe-based confocal laser endomicroscopy

Conditions: Gastric Cancer; Intestinal Metaplasia; Atrophic Gastritis; Inflammation

Summary: the aim of the present study was to propose a new pcle classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pcle classification system in the stomach.

probe-based confocal laser endomicroscopy (pcle; cellvizio, mauna kea technologies, paris, france) is a newly developed endoscopic device which allows the application of laser microscopy with any conventional endoscope and mosaic imaging. previous studies have demonstrated its application in various gi diseases, including barrett's esophagus, colonic adenoma, ulcerative colitis, and etc. however, limited data are provided on exploring the application of pcle in the stomach. therefore, the aim of the present study was to propose a new pcle classification of gastric pit patterns and vessel architecture, and to assess the accuracy and interobserver agreement of this new pcle classification system in the stomach.

Eligibility criteria:
inclusion criteria: * patients scheduled for pcle examination * aged between 18 and 80 years old exclusion criteria: * esophageal, gastric or duodenal cancer or other malignancy * history of upper gi tract surgery * coagulopathy or bleeding disorders * allergy to fluorescein sodium * pregnant or breast-feeding (for females) * impaired renal function
quercetin for cardio-skeletal muscle health and estrogen deficiency

Conditions: Menopause Related Conditions

Summary: double blind randomized controlled parallel pilot trial of quercetin vs placebo oral administration in 24 postmenopausal women. the study team will conduct a feasibility pilot in preparation for a larger efficacy trial that will test the protective effects of quercetin against cardiac and skeletal muscle dysfunction and changes in structure induced by estrogen loss and potential mechanistic pathways in post-menopausal women at risk of heart failure with preserved ejection fraction (hfpef).

participants receive either oral quercetin 1000 g/day or placebo for 20 weeks. quercetin levels, biomarkers, ultrasounds (heart and muscle), functional assessments will be measured on enrollment and after the intervention. the study coordinator will contact participants weekly to monitor safety and ensure compliance. all quercetin administration will be supervised by claudia l campos, md, associate professor of internal medicine, medical director internal medicine clinic.

Eligibility criteria:
inclusion criteria: * female, postmenopausal, aged 60 to 74 * stated willingness to comply with all study procedures and availability for the duration of the study * high risk of heart failure with preserved ejection fraction (hfpef) using web-based primary care physician-hf risk tool (khan s, et al.10-year risk equations for incident heart failure in the general population. information used for calculation include: age, gender, race, hypertension treatment (yes or no), fasting glucose value, smoking status, body mass index, systolic bp, diabetes treatment (yes or no), total cholesterol, hdl cholesterol, and electrocardiogram qrs duration. prospective participant's with scores \>= 10% will be included. * electrocardiogram (ekg) on medical record exclusion criteria: * history of congestive heart failure or use of loop diuretics * recent myocardial infarction (mi), stroke, angina, or atrial fibrillation (in the past 6 months), either self-reported and or in the electronic medical record. * uncontrolled diabetes mellitus * uncontrolled hypertension * significant renal insufficiency requiring dialysis or estimated glomerular filtration rate (egfr) \< 15 ml/min * liver disease * psychiatric disease - uncontrolled major psychoses, depressions, dementia, or personality disorder * participants reporting extreme energy intakes \>3500 or \<500 kcal/day * plans to leave area within the study period * refuses informed consent

Keywords: estrogen deficiency post-menopause cardiac diastolic function skeletal muscle function skeletal muscle structure cardiac structure
a study of mabthera added to bendamustine or chlorambucil in patients with chronic lymphocytic leukemia (mable)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this randomized, open-label, parallel group study will assess the effect on response rate and the safety of mabthera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. patients will be randomized to receive six 4-week cycles of either a) mabthera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or b)mabthera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). patients in group b can receive up to 6 further cycles of chlorambucil as monotherapy. anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * chronic lymphocytic leukemia * active cll with progressive binet stage b or c * ineligible for treatment with fludarabine * for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed * eocg performance status \>/=2 exclusion criteria: * patients who have relapsed within \<12 months of first dose of prior rituximab or chlorambucil first-line therapy * previous or planned stem cell transplantation * radioimmunotherapy within 6 months prior to starting study treatment * transformation to aggressive b-cell malignancy * any other concurrent anti-cancer therapy, or glucocorticoid \>/=20mg daily prednisolone or equivalent
peabody developmental motor scale-2 in 0 - 24 months in turkey

Conditions: Motor Development; Infant, Premature, Diseases

Summary: this study is the determination of the turkish version of the peabody developmental motor scale-2 and its turkish validity reliability in infants age between 0 - 24 months and to spread its use for evaluation in early rehabilitation in our country.

there are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (cp), mental problems and autism spectrum disorder in infancy . in particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of cp .a clinical tool often used in predictions is a neurological examination. various standard variants are available, such as the hammersmith infant neurological examination (hine), alberta infant motor scale (aims). pgms-2 was developed by folio and fewell (2000) to determine the gross and fine motor development levels of children from birth to 71 months. the scale can be used for both children with healthy development and children with special needs. in the development of the peabody developmental motor scale (pgms), which is the original version of pgms-2 used in this study, a developmental structure was adopted instead of sticking to a certain theoretical perspective. pgms is the first nationally standardized assessment tool that gives gross and fine motor scores separately in the united states of america (usa).this study is the determination of the turkish version of the peabody developmental motor scale-2 and its turkish validity reliability in infants age between 0 - 24 months and to spread its use for evaluation in early rehabilitation in our country.

Eligibility criteria:
inclusion criteria: * infants between 0-24 months (adjusted age for premature infants will be calculated),who are followed as neurologically and developmentally at risk infants * infants who are not in neonatal intensive care unit exclusion criteria: * infants with congenital heart problems * infants of families who do not accept the study * infants with musculoskeletal system anomaly * infants connected to respiratory equipment

Keywords: validity peabody developmental motor scale ii (pdms-2) motor development
performance evaluation of an investigational blood glucose monitoring system

Conditions: Diabetes

Summary: the purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the investigational blood glucose monitoring system (bgms) and obtain valid glucose results.


Eligibility criteria:
inclusion criteria: * males and females, 18 years of age and older * type 1 or type 2 diabetes * able to speak, read, and understand english * willing to complete all study procedures exclusion criteria: * pregnancy * hemophilia or any other bleeding disorder * previously participated in a study using the contour plus system * working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors. * working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company. * a condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
memantine as an additive therapy in patients with traumatic brain injury

Conditions: Mild Traumatic Brain Injury; Moderate Traumatic Brain Injury (TBI)

Summary: memantine has shown promise in mitigating secondary brain injury in previous studies. one study demonstrated that early memantine administration in moderate tbi patients resulted in lower serum neuron-specific enolase levels and improved glasgow coma scale scores. however, other trials investigating memantine's impact on long-term cognitive function in tbi patients have yielded mixed results. there is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with tbi.

the current study aims to evaluate the cognitive function, neuroprotective effect, and s-100β serum level effect of memantine in patients with mild to moderate traumatic brain injury (tbi) patients.

Eligibility criteria:
inclusion criteria: 1. patients between 18 and 70 years of age 2. patients mild (gcs 13-15) to moderate (gcs 9-12) tbi were assessed for the study eligibility. exclusion criteria: 1. comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours. 2. acute or chronic renal insufficiency. 3. hepatic diseases. 4. autoimmune diseases. 5. malignancies. 6. pregnancy. 7. patients unable to tolerate enteral feeding. 8. more than 24 hours (h) since traumatic injury

Keywords: traumatic brain injury (tbi) memantine s100β
instrument for glaucoma early detection and monitoring

Conditions: Glaucoma

Summary: to introduce a rapid and objective electrophysiological technique that can assess visual function in the magnocellular pathway, which is thought to be affected in early-stage glaucoma.

the clinical study will evaluate a novel instrument designed to record visual evoked potentials elicited by stimuli determined in prior research (greenstein et al., 1998; badr et al., 2003) to drive select visual pathways that exhibit glaucomatous damage in an efficient and automated manner. the results obtained with this novel device will be compared with results obtained using an existing commercial device. statistical results, sensitivity and specificity, will be generated for the assessment of the accuracy of the test to discriminate glaucoma patients from controls. repeatability of the test will also be analyzed based on the test-retest results. visual evoked potential (vep) is a measure of neural function in the eye and brain. three skin electrodes are placed on the surface of the scalp to record the electrical activity from the brain while the subject is observing a flickering stimulus with isolated-check/dot pattern. the whole procedure is non-invasive and the risks are negligible. isolated-check/dot stimuli of about 10 hz with luminance contrast of 10%, 15%, -10%, and -15% will be used to test each eye. eight samples for each stimulus will be recorded. each experimental run takes 2 seconds. the t-circ statistical method is performed to process the data, and the vep signal to noise ratio (snr) is calculated in order to obtain an optimized condition (stimulus and threshold) to separate glaucoma patients and normal group.

Eligibility criteria:
inclusion criteria: * age: 40 - 75 years old * visual acuity: 20/30 or better exclusion criteria: * eye disease other than glaucoma

Keywords: glaucoma vep detection device diagnosis vision
study of paq™ (a simple patch on insulin delivery device) in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (t2dm) who is currently treated with basal/bolus insulin therapy, to use paq™ (a simple patch on insulin delivery device) to control his/her blood glucose.

this is a single center, open label, feasibility of use and performance evaluation of paq™ (using insulin aspart) in patients with t2dm who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (oads) for glycemic control. the patient's participation in the study is comprised of four phases: screening, baseline evaluation, transition to paq™ use, and paq™ treatment period. the use of these phases will allow an orderly transition to paq™ treatment as well as a reliable construct from which to interpret the final data.

Eligibility criteria:
inclusion criteria: 1. male/female patient's ≥ 30 ≤ 65 years of age. 2. clinical confirmation of t2dm diagnosis by history and medication usage or glucose tolerance test. 3. currently treated with insulin using a basal/bolus regimen with or without concurrent use of oads (metformin and/or glitazone). 4. currently on a stable insulin regimen "as judged by the investigator" (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days. 5. currently uses between 20 to 50 units/day basal insulin. exclusion criteria: 1. uncontrolled hyperglycemia, hba1c \> 9.0% requiring adjustment to his/her insulin regimen. 2. treated with premixed insulin, or neutral protamine hagedorn (nph)/glargine/detemir insulin without use of bolus/meal time insulin. 3. patient has had an episode of severe (assisted) hypoglycemia within the past 30 days. 4. currently treated with sulfonylurea or incretin-based therapy \[glucagon-like peptide-1(glp-1) agonist or dipeptidyl peptidase-4 (dpp-4) inhibitor\]. 5. total daily dose (tdd) of insulin is \>100 units/day. 6. have a meal-time bolus doses that exceeds the capacity of the bolus insulin reservoir at any given meal. 7. have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives. 8. taking or has taken prednisone or cortisone medications in the previous 30 days. 9. pregnant or is planning to become pregnant during the study period. 10. has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the investigator would compromise the patient's safety or successful participation in the study. 11. unable to follow the study clinical investigational plan (cip)
the effect of adt on psma expression in metastatic prostate cancer

Conditions: Prostate Cancer

Summary: thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18f-psma 1007 pet/ct at baseline, 3 weeks after the initiation of gnrh-antagonist, at one year and at the time of castration resistant prostate cancer (crpc). the aim of the study is to classify metastatic lesions into those with psma-flare and those without and determine their potential to progress during the follow-up until crpc.

in metastatic prostate cancer androgen deprivation therapy (adt) has been traditionally used as a first line approach. based on histological studies, animal models and psma-pet imaging, it is known that administration of adt increases prostate specific membrane antigen (psma) expression. preliminary results of our previous prospective clinical trial (clinicaltrials.gov identifier: nct03313726) with nine men demonstrated a heterogenous flare in psma expression 2-3 weeks after adt, more evidently in bone metastases. our hypothesis is that metastatic lesions having psma-flare respond differently to adt and have different outcome than those without psma-flare. therefore, the objective of the study is to demonstrate the psma-flare seen in bone lesions 3 weeks after adt and then determine the potential predictive value of the phenomenon in the progression to castration resistant prostate cancer (crpc). thirty-five men with newly diagnosed, metastatic pc will undergo 18f-psma 1007 pet/ct before and 3 weeks after the initiation of sub-cutaneous injection of gnrh-antagonist (degarelix, firmagon®). a subgroup of 20 patients will receive an additional fdg pet/ct scan before adt to investigate whether lesions with psma flare show a different metabolic behaviour on fdg pet. during the follow-up, 18f-psma 1007 pet/ct will be also performed once a year. finally all patients will repeat 18f-psma 1007 pet/ct at the time of crpc. in addition to imaging, psa is measured, and blood drawn for androgen levels and biomarkers in three months interval.

Eligibility criteria:
inclusion criteria: * age: 40 to 85 years old * language spoken: finnish * diagnosis: histologically confirmed adenocarcinoma of prostate * adequate histological sampling consisting of at least 3 biopsy samples from each lobe * no previous surgical, radiation or endocrine treatment for prostate carcinoma * clinical stage:t1c-t4nanym1 * serum creatinine ≤ 1,5 x uln * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethical committee approved informed consent documents in the presence of the designated staff exclusion criteria: * previous pc treatment * uncontrolled serious infection * prior usage of 5-ari medication in past 12 months

Keywords: prostate specific membrane antigen gnrh antagonist positron emission tomography psma-pet/ct