Kornimate/medical-research-clean huggingface dataset:
alfacalcidol supplementation on levator ani muscle strength of menopausal pelvic organ prolapse patients

Conditions: Pelvic Organ Prolapse

Summary: this is a study performed to evaluate the role of vitamin d supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

forty eight pop women were divided into experimental and control groups in this quasi-experimental study. the experimental group was given 0.5 mcg alfacalcidol orally for three months. we measured levator ani muscle strength, serum 25-hydroxy-vitamin d3 levels, and serum vitamin d receptor (vdr) levels at zero months and three months preoperative. enzyme-linked immunosorbent assay (elisa) assessed vdr and myoblast determination protein 1 (myod) protein expressions in levator ani muscle surgical biopsies.

Eligibility criteria:
inclusion criteria: * patients with pelvic organ prolapse stages iii and iv who underwent surgery at menopausal age * normal bmi * initial serum vitamin d levels \<30 ng/ml exclusion criteria: * comorbidities (chronic cough, conspitation) * vitamin d metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat * history of vitamin d supplementation within the last month

Keywords: alfacalcidol myod expression pelvic organ prolapse vitamin d receptorr levator ani muscle strength
a clinical trial of prax-562 in subjects with developmental and epileptic encephalopathies (dee)

Conditions: SCN2A Encephalopathy; SCN8A Encephalopathy

Summary: this is a phase 2, double-blind, randomized clinical trial to explore the safety, tolerability, efficacy, and pharmacokinetics of prax-562 in pediatric participants who have seizures associated with early-onset scn2a-dee and scn8a-dee.


Eligibility criteria:
inclusion criteria: * has a documented rare missense variant in scn2a with onset of seizures occurring in the first three months of life or has a documented de novo (not observed in either parent) missense variant in scn8a with onset of seizures occurring in the first six months of life. * has a seizure frequency as follows: * at least 8 countable motor seizures in the 4 weeks immediately prior to screening as reported by the parent/legal guardian or in the opinion of the investigator and * at least 8 countable motor seizures during the 28 day baseline observation period (during which seizure frequency is recorded in a daily seizure diary). * additional inclusion criteria apply and will be assessed by the study team. exclusion criteria: * has any clinically significant or known pathogenic or likely pathogenic genetic variant other than in scn2a and scn8a or a genetic variant that may explain or contribute to the participant's epilepsy and/or developmental disorder. * has a documented, functionally characterized loss-of-function (lof) missense variant or a presumed lof variant (nonsense or frameshift variant) based on genetic testing and/or clinical evidence that prior exposure to a sodium channel blocker (scb) medication worsened seizures. * has 2 or more episodes of convulsive status epilepticus requiring hospitalization and intubation in the 6 months prior to screening. * additional exclusion criteria apply and will be assessed by the study team.

Keywords: pediatric epilepsy nav1.2 voltage-gated sodium channel scn2a variant scn8a variant developmental and epileptic encephalopathy
follow-up of coronary artery bypass graft patency by multislice computed tomography

Conditions: Coronary Artery Disease

Summary: coronary artery disease is a major cause of morbidity and mortality across the world and coronary artery bypass surgery (cabg) is the most common surgical procedure for treatment. patients with recurrent ischemic symptoms after cabg are most likely to have occluded or significantly stenosis in grafts or native coronary arteries. therefore, there is a need to evaluate the patency of these vessel conduits after cabg. until now, selective coronary angiography is the traditional gold standard for the assessment of both native coronary arteries and bypass grafts. but it is an invasive procedure that requires x-ray exposure, hospitalization, and includes a risk for complication. however, there is an alternative noninvasive method, multislice computed tomography (msct), with high specificity and excellent sensitivity for the detection of the coronary artery disease. it is even cheaper and takes shorter time to perform. accordingly, the purpose of this study is to use msct to evaluate the patency and the quality of all grafts and native coronary arteries after cabg for more than two years. in addition, we will elucidate the relationship of these data and cabg procedures to review our experience.


Eligibility criteria:
inclusion criteria: * patients underwent cabg and performed msct after the surgeries exclusion criteria: * nil

Keywords: multislice computed tomography coronary artery bypass grafting patients underwent surgeries
effect of plavix on no (nitrogen monoxide) production of the endothelial function

Conditions: Peripheral Arterial Disease

Summary: to determine whether in the laser doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. laser doppler /ld/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ach/ /endothelium dependent/ and sodium nitroprusside /nsp/ /endothelium independent/ on the microcirculation of the skin


Eligibility criteria:
inclusion criteria: * proven, peripheral arterial disease, fontain ii-iii stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment * doppler index \< 0,8 exclusion criteria: * hypersensitivity to the active ingredient or one of the components of the drug * active pathological bleeding, e.g. gastric ulcer, intracranial bleeding * pregnancy, breast-feeding * severe, known hepatic insufficiency * severe, known renal insufficiency the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: fontain ii-iii stage
clinical study to evaluate cryoballoon™ full and swipe ablation systems for ablation of human esophageal epithelium

Conditions: Esophageal Cancer

Summary: this study will evaluate the c2 cryoballoon™ full and swipe ablation systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study

the primary outcomes for the study are the safety and treatment effect of the c2 cryoballoon™ ablation system. an esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

Eligibility criteria:
inclusion criteria: * minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation * older than 18 years of age * requires a clinically necessary esophagectomy for esophageal cancer or other indications. exclusion criteria: * patient has esophageal narrowing limiting access to the intended sites of ablation
comparison between neuro 1 and neuro 2 cochlear implant speech processors

Conditions: Sensorineural Hearing Loss; Cochlear Hearing Loss

Summary: the present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the neuro 2.

nowadays, cochlear implants (ci) are successfully used to rehabilitate severe to profound sensorineural hearing loss. oticon medical recently developed a new cochlear implant system, including a new implantable internal part (neuro zti) and a new speech processor (neuro 1). this new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. a second version of this speech processor has very recently been developed, called the neuro 2. the neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. however, the neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries...). some improvements available on the neuro 2 may be particularly interesting for children. the aim of the present study is twofold: 1. compare the satisfaction of adult and pediatric users for the speech processor neuro 1 with their satisfaction for the neuro 2, and 2. show that audiological outcomes are at least as good for the neuro 2 than for the neuro 1. the participants come at the hospital for three visits. the neuro 1 is evaluated during the first visit (v1). evaluation of the neuro 2 takes place during the second (v2, 15 days after v1) and the third (v3, 3 months after v2).

Eligibility criteria:
inclusion criteria: * informed consent * native french speaker or fluent french speaker * patient already fitted with one or two speech processor neuro 1 for at least 5 months exclusion criteria: * vulnerable patients, at the exception of children (pregnant women, persons under guardianship) * no social security affiliation * non-compliant patient

Keywords: cochlear implant
large language models to improve the quality of care of cardiology patients

Conditions: Hypertrophic Cardiomyopathy (HCM); Cardiomyopathy; Genetic Disease; Cardiology

Summary: this study evaluates the impact of large language models (llms) versus traditional decision support tools on clinical decision-making in cardiology. general cardiologists will be randomized to manage real patient cases from a cardiovascular genetic cardiomyopathy clinic, with or without ai assistance. each case will be assessed by two cardiologists, and their responses will be graded by blinded subspecialty experts using a standardized evaluation rubric.

large language models have been shown to improve physician performance in simulated settings. large language models have demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultation. however, it remains uncertain whether large language models improve clinical reasoning of clinicians using real world cases. clinicians dedicate years of training to develop expertise, with clinical knowledge a key component. clinicians have different areas of expertise, from generalists spanning diseases of all organ systems and patients of all ages, to subspecialists dedicated to often a handful of diseases effecting a specific organ. both skill sets are vital to a well-functioning medical system, as generalists generally care for patients and refer to specialists when dedicated, specialty knowledge is required. there is a paucity of specialists, and thus the quality of triaging and referral to specialists is of upmost importance. we hypothesis that large language models may be able help generalists management complex patients, and improve their triage to specialists and subspecialists. the scarcity of subspecialist medical expertise, particularly in rare, complex and life-threatening diseases, poses a significant challenge for healthcare delivery. this issue is particularly acute in cardiology where timely, accurate management determines outcomes. in this study, we will recruit general cardiologists as participants who will be randomized to answer clinical management cases with or without access to a large language model. each case is a real patient case of a patient referred to a subspeciality cardiovascular genetic cardiomyopathy clinic. each case will be performed by two general cardiologists (one with access to a large language model and one without access). each case has multiple components, and the participants will be asked to answer questions related to the management. answers will be graded by independent, blinded subspeciality cardiologists with expertise and training in genetic cardiomyopathies. an evaluation rubric was developed by 10 expert discussants.

Eligibility criteria:
inclusion criteria: * board certified or board eligible cardiologist. exclusion criteria: * not currently practicing clinically

Keywords: large language models cardiology
caelyx as primary treatment for patients with breast cancer and a history of heart disease and/or age over 65 years

Conditions: Breast Cancer

Summary: this is a multicenter study of a primary chemotherapy regimen in breast cancer patients at risk of developing cardiotoxicity. the aim of the study is to evaluate the response rate at surgery.

this is a phase ii, uncontrolled, open label, multicenter study of a primary chemotherapy regimen consisting of four cycles of liposomal pegylated doxorubicine 35 mg/m² iv plus cyclophosphamide 600 mg/m² on day 1 every 4 weeks followed by paclitaxel 80 mg/m²/week for 12 weeks before surgery in breast cancer patients at risk of developing anthracycline-induced cardiotoxicity. surgery (tumorectomy, quadrantectomy, or mastectomy plus lymphadenectomy) will be performed 2 to 5 weeks after the last primary chemotherapy infusion. patients with \> 10% of hormone receptor-positive cells will receive appropriate hormone therapy according to menopausal status. patients treated with breast-conserving surgery will receive radiation therapy to the mammary gland. patients with t4 tumors or significant axillary involvement (≥ ypn2) will receive radiation therapy to the breast or chest wall and to the lymph node chains.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer (tumor \> 2 cm). * estrogen receptor-negative or -weakly positive tumors (less than 50% of cells), as evaluated using ihc. * risk factors for developing anthracycline-induced cardiomyopathy. exclusion criteria: * severe heart failure (nyha class iii or iv) . * metastatic disease. * lvef \< 45%. * pregnant or breast-feeding patients.

Keywords: breast cancer anthracyclines cardiopathy
efficacy and safety of lgx818 in patients with advanced or metastatic braf v600 mutant nsclc

Conditions: Non-Small Cell Lung Cancer

Summary: this is an open-label, multi-center, single arm phase ii study to evaluate the efficacy and safety of novel braf (b-raf murine sarcoma viral oncogene homolog b1) inhibitor encorafenib (lgx818) when used as single agent in patients with advanced or metastatic (stage iiib or iv) braf v600 mutant nsclc. patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic nsclc.


Eligibility criteria:
inclusion criteria: * presence of braf v600e mutation in tumor tissue * histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc * at least one measurable lesion as defined by recist v1.1 * patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic nsclc. * eastern cooperative oncology group (ecog)/world health organization (who) performance status 0-2 exclusion criteria: * patients with symptomatic central nervous system (cns) metastases * history of leptomeningeal metastases * prior therapy with a braf inhibitor * patients taking prohibited medication listed in the protocol * presence or history of a malignant disease other than nsclc that has been diagnosed and/or required therapy within the past 3 years. * impaired cardiovascular function or clinically significant cardiovascular diseases * pregnant or lactating women or woman of childbearing potential

Keywords: nsclc, non-small cell lung cancer, braf v600, lgx818
comparison of contrast agents for mri perfusion analysis in brain tumor patients

Conditions: Central Nervous System Neoplasms

Summary: this study will compare the use of two contrast agents to analyze blood flow characteristics of brain tumors.

this study will compare contrast agents, gadobenate dimeglumine and gadobutrol, for mri perfusion analysis in brain tumor patients.

Eligibility criteria:
inclusion criteria: * subjects with brain tumors will be enrolled. these subjects may be newly diagnosed, undergoing treatment or undergoing follow-up. if a subject has undergone surgery or treatment they should have what appears to be residual tumor. exclusion criteria: * renal failure (gfr \<45). subjects will be screened utilizing unmc gadolinium contrast guidelines. * allergic reactions to mri contrast agents. * subjects who do not fit the criteria for the population we are evaluating. * subjects should not participate in this study if they have any of the following conditions: * anxiety attacks * panic disorder * claustrophobia * pregnant, or trying to become pregnant * breast feeding * subjects should not participate in this study if they have certain kinds of metal in their body, for example: a heart pacemaker, defibrillator, neurostimulator, a metal plate, certain otologic implants, certain types of heart valves, metal slivers in eye, brain aneurysm clips or metal slivers and bullet fragments in or near certain structures in their body. our standard mri safety screening will be performed on all subjects. * if a subject has metal in their body that requires an additional x-ray beyond what is needed for the clinical mri examination to safely perform the research mri examination that subject would be excluded.subjects not being able to return for a follow-up examination

Keywords: brain tumor extraaxial metastasis glioma primary brain tumor secondary brain tumor mri perfusion dynamic contrast enhancement cbv cbf ktrans
cbart: the reduction of psychological and physiological stress in women undergoing ivf

Conditions: Psychological Stress; DNA Degradation, Apoptotic; Telomere Shortening; Fertility Disorders

Summary: the study is a randomized controlled trial of a cognitive behavioral interventions and an art-based stress reduction treatment protocol (cb-art) with 100 women, identified with elevated perceived stress, before undergoing ivf treatment; in order to examine its effect on perceived stress, plasma cfd, telomere length and pregnancy rates. cb-art is a 6-session treatment protocol that has been utilized with women coping with stress, depression and pain and is effective in reducing these indicators, developed and evaluated by our research team. the treatment protocol emphasizes processing together with the client's recalled image, symptom or memory (ism) pertaining to a current distressing mental or physical state. cb-art is a multi-method model that integrates cognitive behavioral interventions and art-based stress reduction interventions. the innovation in this method is the transformation of imagined and drawn images and memories rather than solely verbally discussing their contents. the focus is on changing compositional elements that comprise each image and memory, thus providing a therapeutic venue to reframe and transform stress producing, recalled images and memories and reduce symptoms of perceived stress. art making is beneficial for eliciting an emotional response and provides a concrete platform to conduct the cognitive processing that initiate change on the paper and then in the mind. furthermore, the soothing qualities of interacting with art making foster and enhance behavioral relaxation techniques. our study population, women with infertility problems, who are designated to undergo ivf treatment and have been identified to have elevated perceived stress scores on the perceived stress scale (above 15) will be randomized and allocated to receive the cb-art intervention tailored to reduce stress or treatment as usual.


Eligibility criteria:
inclusion criteria: * hebrew speaking nulliparous women * between the ages of 18-35 * without an axis i psychiatric diagnosis exclusion criteria: * women over 35 * do not speak hebrew * have an axis i psychiatric diagnosis that would prevent them from participating in the intervention
accuracy of three /four-dimensional ultrasound in diagnosing placenta accreta spectrum

Conditions: Placenta Accreta Spectrum

Summary: the placenta accreta spectrum (pas) which includes accreta, increta, and percreta represents a significant obstetric challenge. pas complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. antenatal diagnosis of pas allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. this approach has reduced maternal morbidity rates, including less blood loss, fewer transfusion requirements and, intraoperative urologic injuries as well as improve fetal outcome. ultrasound evaluation, with grayscale and color doppler imaging, is the recommended first-line modality for diagnosing pas. grayscale ultrasound features suggestive of placenta accreta include an inability to visualize the normal retroplacental clear zone, irregularity and attenuation of the uterine-bladder interface, retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder wall when using color doppler. magnetic resonance imaging (mri) has been used to predict the depth of placental invasion, but it is expensive and often not immediately available. recently, a new imaging technique utilizing three-dimensional (3d)/four-dimensional (4d) volume rendering ultrasound (vru) was proposed as a promising tool for the preoperative diagnosis of placenta previa accerta spectrum. by using "crystal vue" and "realistic vue" volume rendering mode, it could detect 11 out of 12 cases (91.6%) of pas which was subsequently confirmed during surgery. accordingly, the aim of this study is to examine the diagnostic performance of 3d/four-dimensional (4d) volume rendering ultrasound (vru) for placenta previa accerta spectrum in correlation with the clinical (operative) and pathological findings.


Eligibility criteria:
inclusion criteria: * pregnant women in their third trimester * with a single fetus in the current pregnancy * a previous delivery by at least 1 cesarean section * having an anterior placenta previa or anterior low-lying placenta by ultrasound assessment exclusion criteria: * cases with twin or multiple pregnancies, * cases with a non-previa placenta or posterior low lying or previa placenta, * cases without previous deliveries by cesarean section * cases before the third trimester of pregnancy.