Kornimate/medical-research-clean huggingface dataset:
long-term impact of nmdar encephalitis

Conditions: Autoimmune Encephalitis

Summary: nmda receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 1.5 people per million per year. patients with anti-nmdar encephalitis experience an acute phase of the disease characterized by psychosis, memory loss, seizures, autonomic nervous system instability, or coma. since the discovery of this disease 14 years ago by prof. dalmau, the clinical presentation of the acute phase has been well characterized, while the psychosocial impact of the disease remains largely unexplored. currently, there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase. given the scarcity of information concerning the post-acute phase, it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease. this is especially important as the patients are young, with a median age of 21 years, and may face lasting limitations potentially detrimental to their success in professional, educational, or social environments.

this study will help improve the management of patients with anti-nmdar encephalitis : * by providing the first assessment of long-term cognitive, psychological and social consequences * by characterizing the patient's journey through the disease * by developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase as well as improving patient care in the long term through the drafting of specific medical recommendations.

Eligibility criteria:
inclusion criteria: * patients with nmdar encephalitis * age ≥ 18 years old * patient affiliated to a social security system * no opposition from the patient exclusion criteria: * patients whithout nmdar encephalitis * age \&lt; 18 years old * patient under guardianship or curatorship * patient with neurological disorders pre-existing encephalitis

Keywords: nmdar encephalitis psychosocial impact
continuous glucose monitoring by subcutaneous measurement compared to frequent point of care measurement by accu chek in critically ill patients

Conditions: Hyperglycaemia; Hypoglycaemia

Summary: the purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the freestyle navigator® (abbott, diabetes care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.

most patients admitted to the icu are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. the use of a continuous glucose monitoring in critically ill patients could have the following advantages: * better insight in the alterations of the blood glucose levels * early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels. * fewer blood samples * decreased workload for the nursing staff in this study, patients will be randomized in: 1. the freestyle group or 2. the accuchek group. patients in both groups will receive a freestyle navigator device, which will stay on the patient up to 5 days, or until discharge from the icu. the medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. in the freestyle group extra glucose level measurements will be made in response to alarms from the device. in both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (bga). when a control measurement by bga results in a glucose level of \ 25 mmol/l, the value will be transmitted to the patient data management system (pdms) and gives an alarm. otherwise, the value will be blinded in the pdms. freestyle navigator data will be downloaded from the device. blood glucose values obtained in the course of usual care will be compared with time-matched freestyle navigator values to assess device accuracy.

Eligibility criteria:
inclusion criteria: * icu-patients \> 18 years * expected length of stay on the icu \> 24 hours * indication for glucose regulation with insulin (according to the current glucose treatment protocol) * availability of the freestyle navigator exclusion criteria: * participation in another trial subject to the wmo * lack of informed consent * contraindication for the use of the accu chek (for example peritoneal dialysis, ht \ 0,65; paracetamol intoxication) * contraindication for placement of the subcutaneous glucose sensor * participation in this trial during previous icu admittance

Keywords: hyperglycemia hypoglycemia insulin critical illness intensive insulin therapy continuous glucose monitoring cgm interstitial fluid glucose intensive care unit blood glucose
quality of life in cardiac pediatric patients attending assuit univeristy hospital

Conditions: Quality of Life

Summary: quality of life(qol) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2)

quality of life(qol) is defined as the individual perception related with their state in life in terms of the cultural structure and system of values in which they live. their objectives, expectations, standards and concerns, whereas health related quality of life is defined as the patient subjective perception of the impact of their disease or its treatment.(1) cardiac disease is the most common congenital defect in children, with an incidence of eight in every 1000 live births. multiple factors have improved and prolonged the lives of children and adolescents with congenital heart disease over the last few decades(2) diagnosis of a life-threatening illness during a child's formative years can have far-reaching effects that ripple through the family and across a lifetime. infants with complex chd experience a range of uncommon and painful events, such as separation from their mother at birth, urgent transfer to specialized intensive care, frequent invasive medical procedures, feeding difficultiesand withdrawal from narcotic pain relief. these earlylife experiences can have profound consequences for the developing child, shaping brain development, the body's immune system and responses to stress.(5) from a neurodevelopmental perspective, children with chd experience greater difficulties compared with their healthy peers. the risk and severity of neurodevelopmental impairment increases with greater chd complexity, the presence of a genetic disorder or syndrome, and greater psychological stress. during infancy, the most pronounced difficulties occur in motor functioning. by early childhood, studies show that children with complex chd have an increased risk of neurodevelopmental impairment, in fine and gross motor skills, and language, attention, executive functioning, emotion regulation and behaviour.(7)

Eligibility criteria:
inclusion criteria: * - infants of both sex. * age :from 2 years to 18 years. * attending assuit university children hospital including nicu, pediatric cardiology department, outpatient clinics. * patients diagnosed with congenital heart disease (cyanotic, acyanotic, cardiomyopathy, rheumatic heart). exclusion criteria: * - patients suspected to have congenital heart but excluded on echo diagnosis. patient with any associated lesions (patients have any congenital anomalies with congenital heart like down syndrome)
molecular prognosis of lymphomas of the central nervous system (alyce-molecular)

Conditions: Central Nervous System Lymphoma

Summary: central nervous system lymphoma (pcnsl) is a diffuse large b cell lymphoma (dlbcl) entity with a particularly poor prognosis (median survival less than 3 years). they are still poorly characterized biologically, largely because of their rarity (300 cases / year in france) and the difficulty for obtaining a material of sufficient quality and quantity. it is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of myd88 or tbl1xr1 for example). a collection of 74 pcnsls has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort alyce). informed consent was gathered for all patients. comparative genomic hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). the objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in dlbcls and pcnsls, and the molecular determination of the original cell by the (rt-mlpa) reverse transcriptase-multiplex ligation-dependent probe amplification technique. the integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in pcnsl.


Eligibility criteria:
inclusion criteria: * adults * with a lymphoma of the central nervous system * patients having signed the consent for the conservation of their samples within the cohort exclusion criteria: * \<18 old years * other diagnosis than lymphoma of the central nervous system * no consent form signed
health-related quality of life in patients with bladder cancer

Conditions: Bladder Cancer

Summary: rationale: gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably. purpose: this clinical trial is studying health-related quality of life in patients with bladder cancer.

objectives: * to identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer. * to collect and examine data on health-related quality of life (hrqol) and symptom management. * to analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis). outline: patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). patients complete a series of questionnaires including the lepore social constraint measure; reach social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; impact of events scale; brief symptom index-18 and global severity index; eortc qlq-c30 (general health-related quality of life); and eortc qlc-bls24 (disease-specific health-related quality of life).

Eligibility criteria:
disease characteristics: * diagnosis of non-invasive bladder cancer within the past 4 years patient characteristics: * not pregnant * able to read, speak, and understand english prior concurrent therapy: * not specified

Keywords: stage 0 bladder cancer
safety, pharmacokinetics and pharmacodynamics study of inhaled qbw276 in patients with cystic fibrosis

Conditions: Pulmonary Cystic Fibrosis

Summary: this is a study of multiple doses of inhaled qbw276 in patients with cystic fibrosis on top of standard of care. the study was divided into 3 cohorts. cohorts 1 and 2 are designed to be a randomized, double-blind, placebo-controlled, parallel arm, multiple dose study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of inhaled qbw276 over 1 week (cohort 1) or 2 weeks (cohort 2) in patients with cystic fibrosis regardless of their genotype. the study was terminated after cohort 2 due to the resource issues.


Eligibility criteria:
inclusion criteria: * cohorts 1 and 2 = any genotype on any standard of care treatment * cohort 3 = f508del homozygotes on standard of care at that time * fev₁between 40 and 100% * lci2.5 ≥ 8 if fev₁is more than 80% exclusion criteria: * adrenal or electrolyte abnormalities * lung transplant * autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)

Keywords: cystic fibrosis
the brain, neurological features and neuropsychological functioning in adults with phenylketonuria: a pilot study

Conditions: Phenylketonuria

Summary: newborn screening and early treatment prevent the most severe manifestations of phenylketonuria (pku). however, executive functioning deficits, attention deficit disorder, slow processing speed, and visual-motor problems commonly occur. many adults with this disorder also suffer depression and anxiety. using advanced electroencephalogram (eeg) and magnetic resonance imaging (mri) techniques, including novel mr spectroscopy (mrs) we hope to discover why this distinct constellation of deficits occurs in pku. adult subjects with pku will undergo eeg and comprehensive mri evaluations, including a novel method of mr spectroscopy to determine brain phenylalanine levels. in addition, they will receive neurological and neuropsychological examinations and dietary evaluation.


Eligibility criteria:
inclusion criteria: 1. adult with classic pku who has been seen at one of the hospitals collaborating in this study 2. age 18-55 years 3. medical records available that include genotype and blood phenylalanine levels during the first 6 years of life. (we have over 300 patients with pku with genotypes in our clinic, of whom about half are adults.) 4. capable of providing informed consent 5. able to undergo mri procedures without sedating medication 6. does not have metal implants 7. not currently on kuvan, large neutral amino acid therapy or involved in any clinical trials. - exclusion criteria: 1. mild pku or mild hyperphenylalaninemia 2. less than 18 years old or great than 55 years old 3. no medical records available for the first 6 years of life 4. no record of genotype 5. not capable of providing informed consent 6. not able to undergo mri without sedating medication 7. has metal implants 8. currently taking kuvan, large neutral amino acid therapy or involved in any clinical trial -

Keywords: phenylketonuria mri neuropsychological functioning neurological functioning eeg
transcranial magnetic stimulation for binge eating disorder

Conditions: Binge-Eating Disorder

Summary: the primary goal of this study is to elucidate the impact of disorder provocation on the efficacy of tms for the treatment of bed. in order to meet this objective, the investigators propose to evaluate this relationship in using a crossover study. secondary objectives of this study include determining whether tms with or without bed symptom provocation has effects in altering neurophysiology as detected by fmri.

current literature has demonstrated that transcranial magnetic stimulation (tms) targeting the dorsolateral prefrontal cortex (dlpfc) has some efficacy in treating binge eating disorder. the investigators believe that tms may be beneficial in the treatment of binge eating disorder. the purpose of this study is to determine whether tms has efficacy for binge eating disorder and if symptom provocation affects treatment. this study will be conducted as a pilot study in the keck hospital clinics. 32 adult patients with a clinical diagnosis of binge eating disorder will be recruited.

Eligibility criteria:
inclusion criteria: * english speaking (epsi and binge eating disorder scale available only in english) * diagnosed with binge eating disorder as defined by the dsm-5 and in treatment for at least 6 months * stable doses of medications for at least 6 weeks * female subjects of childbearing age must consent to pregnancy tests at the beginning of each treatment session; will be counseled to use barrier methods during the course of this study exclusion criteria: contraindications to receiving tms such as: 1. aneurysm clips or coils 2. stents in the neck or brain 3. deep brain stimulators 4. electrodes to monitor brain activity 5. metallic implants in ears and eyes 6. shrapnel or bullet fragments in or near the head 7. facial tattoos with metallic or magnetic-sensitive ink 8. other metal devices or object implanted in or near the head

Keywords: transcranial magnetic stimulation
sonographic visibility of breast biopsy marker clips up to 4 weeks after placement

Conditions: Breast Cancer

Summary: the purpose of this study is to determine how long collagen based marker clips remain visible by ultrasound after placement in suspicious breast lesions and if collagen based marker clips can be reliably identified in the operating room and serve as effective guidance for surgical removal of high risk or malignant breast lesions.

many breast cancers and other breast lesions are discovered as a palpable abnormality by patients or their providers during a breast exam. diagnostic imaging and biopsy of these lesions may reveal high-risk or malignant findings. these palpable lesions can be removed in the operating room by the surgeon using touch as guidance. however, there are many lesions discovered by screening examinations that surgeons cannot palpate. when this occurs, a radiologist will percutaneously place a wire or wires at the site of the breast lesion using sonographic or mammographic guidance. the surgeon then uses the wires as a guide for complete and successful resection of the lesion. new marker devices have been developed that are sonographically visible. they consist of the standard mammographically visible metallic clip surrounded by a sonographically visible collagen plug. it is hypothesized that radiologists and surgeons can effectively localize the clip with intra-operative ultrasound and then resect the lesion. if so, the pre-operative wire localization procedure could be eliminated. this could improve the patient experience while saving time and money by reducing the number of invasive procedures from 3 (biopsy, wire-localization and operation) to 2 (biopsy and operation).

Eligibility criteria:
inclusion criteria: * patients with suspicious breast lesions that have undergone biopsy and marker clip placement within 28 days (4 weeks) of pre-operative consultation visit. * patients or their legal representative must be able to provide written informed consent. * patients must be over 18 years old. exclusion criteria: * under the age of 18 years * unable to give written informed consent * patients will be excluded if the clip was placed more than 4 weeks prior to their pre-operative appointment or wire-localization.

Keywords: breast cancer ultrasound high risk marker clip
a study of endostar combined with chemotherapy for treatment of osteosarcoma

Conditions: Osteosarcoma

Summary: purpose: this study will assess the safety and efficacy of endostar combined with chemotherapy in osteosarcoma patients.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed osteosarcoma, who have no evidence of metastasis * at least one measurable lesion * life expectancy \> 3 months * ecog performance status 0-2 * adequate hematologic, cardiac, renal, and hepatic function * patients with prior chemotherapy should have at least 4 weeks clearance period before entering this study exclusion criteria: * evidence of metastasis * serious infection * evidence of bleeding diathesis * significant cardiovascular disease * pregnant or lactating woman * allergic to e.coli preparation

Keywords: osteosarcoma endostar chemotherapy
study of tng260 and an anti-pd antibody in stk11 mutated solid tumors

Conditions: Non Small Cell Lung Cancer; Solid Tumors, Adult; Lung Cancer; Lung Adenocarcinoma

Summary: the goal of this interventional clinical trial is to learn about tng260, a corest inhibitor, in combination with pembrolizumab in patients with advanced solid tumors with a known stk11 mutation. the main question\[s\] it aims to answer are: * the recommended dose for phase 2 * to evaluate the safety and tolerability of the combination therapy * to determine the pharmacokinetics of tng260 * to evaluate the initial antineoplastic activity participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

this is a first-in-human phase 1/2, open-label, multicenter, dose-escalation and expansion study designed to determine the maximum tolerated dose and recommended phase 2 dose(s) and evaluate the safety and tolerability, pharmacokinetics, and antineoplastic activity of escalating oral doses of tng260 when administered with a standard dose of pembrolizumab in participants with locally advanced or metastatic stk11 mutated solid tumors.

Eligibility criteria:
inclusion criteria: * is ≥18 years of age at the time of signature of the main study icf. * has ecog performance status of 0 or 1. * has measurable disease based on recist v1.1. * all participants must have documented stk11 mutation in a solid tumor, which is identified through a validated analytical method * has confirmed histologic or cytologic diagnosis of a locally advanced or metastatic solid tumor. * adequate organ function/reserve per local labs * adequate liver function per local labs * adequate renal function per local labs * negative serum pregnancy test result at screening * written informed consent must be obtained according to local guidelines exclusion criteria: * known allergies, hypersensitivity, or intolerance to tng260, pd-1 antibody or its excipients * uncontrolled intercurrent illness that will limit compliance with the study requirements * active infection requiring systemic therapy * currently participating in or has planned participation in a study of another investigational agent or device * impairment of gi function or disease that may significantly alter the absorption of oral tng260 * active prior or concurrent malignancy. * central nervous system metastases associated with progressive neurological symptoms * current active liver disease from any cause * clinically relevant cardiovascular disease * a female patient who is pregnant or lactating

Keywords: stk11 kras wild type lkb1