Kornimate/medical-research-clean huggingface dataset:
evaluation of serum- and oct biomarkers in patients with dme treated with anti-vegf or dexamethasone implant

Conditions: Diabetic Macular Edema; Visual Impairment; Diabetes Mellitus; Hyperglycaemia (Diabetic); Oxidative Stress; Vascular Endothelial Growth Factor; VEGF

Summary: this study aims to investigate the association between serum biomarkers and clinical response to anti-vegf or dexamethasone implant by assessing oct-biomarkers in patients with diabetic macular edema, dme, and to compare these with a group of naive patients (those not previously treated for dme).

this prospective, observational, controlled, non-randomized, monocenter study will include patients with dme at the sahlgrenska university hospital in gothenburg, sweden undergoing treatment with either anti-vegf or dexamethasone implant, or those being previously untreated. patients will be segregated into three primary cohorts: 1. patients currently treated with anti-vegf, 2. patients currently treated with dexamethasone implants, and 3. patients not previously treated for dme (naive patients). patients blood will be analyzed for serum biomarkers known to correlate with dme: vegf, il-6, il-8, mcp-1, ang-2, plgf, tnf-a, and icam-1. blood will be drawn at study entry/baseline for all three groups, and for group 3. naive patients, blood will also be drawn after 4 weeks of treatment. oct scans will be performed at study entry/baseline and after 4 weeks of treatment for qualitative and quantitative assessment of the retina and choroid and scans will be analyzed for the following markers: dril, drol, hrf, and subretinal fluid (srf). based on the response to treatment, investigators plan to further divide patients into two subcategories: responders vs non-responders. the investigators intent is to scrutinize any correlation between circulating serum biomarkers and imaging biomarkers.

Eligibility criteria:
inclusion criteria: * type i or type ii dm. * dme involving the center of the fovea with cft more than 280 microns and the presence of intraretinal cysts. exclusion criteria: * prior history of any other macular disease. * previous treatment with dexamethasone implants in the last six months for those in the anti-vegf group. * previous treatment with anti-vegf in the last two months for those in the dexamethasone implant group. * prior vitreoretinal surgery. * previous laser treatment of the macula. * previous panretinal photocoagulation. * ocular surgery in the previous 3 months.

Keywords: optical coherence tomography
glutamatergic amino acids and oxytocin levels in the plasma of patients in first psychotic episode (fpe)- before and after neuroleptic treatment

Conditions: Schizophrenia; Schizophreniform; Schizoaffective Disorder; Brief Psychotic Episode

Summary: the goal of our research is to check the levels of d-serine, glycine, and other glutamatergic amino acids, in patients with first psychotic episode (fpe). these patients are in the early stage of the disease, treated with neuroleptics for short periods of time, and are usually hospitalized for the first time. the hypothesis of the research is that we will find low levels of glycine and d-serine in these patients. following an anti-psychotic treatment we will expect these levels to return to the norm, and that this correction will be accompanied by a reduction of positive and negative symptoms. in addition, we will check the d-serine and glycine levels in the plasma of first degree relatives of the patients and a group of healthy subjects. the results of this study might support the hypothesis that the glutamatergic system in involved in the pathology of schizophrenia from it's early stages. in addition, we will check the levels of oxytocin and estrogen in the plasma of patients in fpe. our hypothesis is that we will find low levels of estrogen and high levels of oxytocin in this group of patients. the results of the study might support the hypothesis that estrogen and oxytocin are involved in the pathology of schizophrenia from it's early stages.


Eligibility criteria:
inclusion criteria: * subjects between 18-60 years * clinical diagnosis of schizophrenia, schizophreniphorm disorder, schizoaffective disorder, brief esychotic episode exclusion criteria: * two years or more of positive symptoms * neuroleptic treatment for more then twe weeks in the prior month, or for more then six weeks at any time. * drug induced psychotic episode

Keywords: first-psychotic-episode (fpe) glutamatergic system glycine d-serine oxytocin estrogen
randomized assessment of tcms for vt storm

Conditions: Ventricular Tachycardia

Summary: three-arm randomized clinical trial comparing two strategies of tcms to sham stimulation in patients with vt storm. the hypothesis of the study is that tcms will reduce the burden of vt in the 24 hours after randomization compared to sham stimulation and that tcms with theta burst stimulation (tbs) will be more effective at reducing vt burden than low frequency tcms.


Eligibility criteria:
inclusion criteria: * ≥3 episodes of sustained vt or appropriate icd therapies within 24 hours despite the use of at least one antiarrhythmic drug exclusion criteria: * plan for catheter ablation of vt in the next 24 hours * pregnancy * contraindication to tcms (i.e. implantable ventricular assist device, metal implanted in the head or neck \[except the mouth\], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)
invasive prenatal testing decisions in pregnancy after infertility

Conditions: Pregnancy

Summary: this study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test (ipt) procedure, such as amniocentesis or chorionic villus sampling. women who become pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. when choosing whether or not to have ipt they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precarious. women who are pregnant with their first child after a period of infertility and have made a decision regarding whether or not to undergo ipt may be eligible for this study. participants complete an online password-protected questionnaire that measures infertility and decision-making variables and explores women's perceptions of the impact of infertility on their ipt decision-making process. the questionnaire covers the following areas: * subject's demographic information, such as age, marital status, number of children, education, race, ethnicity * subject's infertility history * subject's thoughts and feelings about infertility * subject's thoughts and concerns about other people's (e.g., husband, doctor, other infertile women) opinions about ipt * subject's decision about whether or not to have ipt and her feelings regarding the decision * the effect of subject's infertility history on her decision to have or not have ipt

women who are pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. when choosing whether or not to have invasive prenatal testing they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precious. the proposed study aims to explore the invasive prenatal testing decision-making experiences of women who are pregnant after infertility. a cross-sectional design will be used to investigate relationships between the infertility experience and decisional conflict associated with deciding whether or not to have invasive prenatal testing. women who are pregnant after infertility will be recruited from online support groups and websites for pregnancy after infertility. participants will be asked to complete a questionnaire that measures infertility and decision-making variables and elicits their perceptions of the impact of infertility on their ipt decision-making experience. the main outcome measure is decisional conflict.

Eligibility criteria:
* inclusion criteria: women. self-reported history of infertility. currently pregnant. first pregnancy after period of infertility. have been offered ipt during current pregnancy for risk of aneuploidy due to maternal age greater than 35 years, abnormal first or second trimester screening or an ultrasound anomaly. have made decision about ipt. ability to read and write english. exclusion criteria: men, children.

Keywords: amniocentesis chorionic villus sampling fertility genetic counseling decisional conflict prenatal testing questionnaire
perceptions, representations and experiences of septic isolation of hospitalized patients for covid-19 infection

Conditions: COVID19

Summary: the aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for covid-19 infection. this analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. it would also provide patient-specific responses to their expectations, as to their families.

sars-cov2 is a new virus responsible for the covid-19 pandemic. for the first time, it was observed in wuhan, china in december 2019. for this previously unknown contagious disease, which can cause severe respiratory infections, isolation precautions in hospitals and public places are one of the cornerstones for fighting this pandemic. hospital isolation precautions have been present since the 19th century as a means to control the spread of infections. septic isolation includes contact isolation, droplets and air. isolation precautions must be prescribed by a physician. to our knowledge, there are few studies about the impact of septic isolation on hospitalized patients at both the psychological level and the relationship with doctors. this study could enable a better understanding and communication between the medical profession and patients in septic isolation during hospitalization. it could also provide patient-specific responses to their expectations.

Eligibility criteria:
inclusion criteria: * major patients * living in metropolitan france during the sars-cov2 pandemic * being or having been hospitalized in isolation contact and droplet for a covid-19 infection (proven or suspected) * being in the process of leaving hospital * ready for no opposition for participation in the protocol exclusion criteria: * patients under guardianship or curatorship * patients unable to give free and informed consent; * patients under safeguarding justice * hospitalized patients on oxygen therapy with speech dyspnea

Keywords: septic isolation, perception, questionnaire
a randomized trial to evaluate ampyra for gait impairment in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the effect of ampyra on a number of symptoms in parkinson's disease. ampyra is a medication approved by fda for gait dysfunction in multiple sclerosis. there are multiple studies to suggest that persons with multiple sclerosis benefit from this medication and have major improvements in gait after taking this medication. however, this medication was never studied in parkinson's disease. this study aims to learn about possible benefits of ampyra in parkinson's disease (pd).

subjects with parkinson's disease will be randomly assigned to two groups. one group will receive ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while the second group will first receive placebo and then ampyra.

Eligibility criteria:
inclusion criteria: * idiopathic pd with stage hoehn and yahr stage\>2-3 and with gait freezing or postural instability. * on stable dosage dopamine agonist/levodopa, and expected to remain on the same dosage of treatment for the duration of study * age less than 80, onset of disease at age more than 45. * able to give consent exclusion criteria: * past medical history of seizures, * history of renal insufficiency, * history of cardiac arrhythmia, * severe arthritis, * women of childbearing potential, * cognitive impairment * age more than 80. * pd patients stage 4 h\&y * pd patient with recent introduction of dopamine agonist or imao b * pd patients participating in other studies

Keywords: parkinson's gait dysfunction ampyra 4-aminopyridine
thrombin generation values and percutaneous coronary intervention results.

Conditions: Coagulation Disorder; Ischemic Heart Disease; Artery Coronary Stenosis

Summary: cardiovascular diseases are the most common cause of death in the western world. myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus. past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients. in the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.

the aim of our study is to investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients. in total 340 patients are planned for inclusion in this trial. after signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (cat). in addition information about the course and results of cardiac catheterization will be collected.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome: st segment elevation myocardial infraction, unstable angina, non st elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome . * planned percutaneous coronary intervention. * ability to give informed consent. exclusion criteria: * acute coronary syndrome in the last 6 month prior to current event. * thrombophilia * pregnancy * liver failure or cirrhosis * anticoagulant current use * active cancer

Keywords: thrombin generation calibrated automated thrombogram ischemic heart disease percutaneous coronary intervention
ct quantitative assessment of interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: interstitial lung disease (ild) refers to a broad category of heterogeneous lung diseases with different etiologies and features characterized by inflammation and fibrosis of the lung parenchyma and manifested as exertional dyspnea, interstitial patterns on high resolution computed tomography (hrct), and abnormal pulmonary function tests (pfts) the aim of this study is to investigate is there any correlation between changes seen in the lung parenchyma by hrct and the pulmonary functions of the patients.

this study will utilize a cross-sectional prospective study design in a single institution to investigate the correlation between ct chest findings including lung densitometry and pulmonary function test results in patients with ild. the study population will consist of consecutive patients diagnosed with ild recruited from the pulmonary clinic or inpatient service. high resolution ct chest and pulmonary function tests are routine diagnostic tests used for diagnosis of interstitial lung disease . both tests are non invasive for the patient and will be acquired for all patients and then their results will be correlated.

Eligibility criteria:
inclusion criteria: * diagnosis of ild (based on clinical, radiological, and pulmonary function criteria +/- histopathological criteria). * availability of ct chest dicom images and pulmonary function test results (within a 2-weeks period from each other). exclusion criteria: * pregnancy * pulmonary edema. * primary pulmonary hypertension; * chronic obstructive pulmonary disease * congestive heart failure
trial comparing mini-arc precise pro and the trans vaginal obturator tape for stress urinary incontinence

Conditions: Stress Urinary Incontinence; Urethral Sling Surgery

Summary: randomized comparison of two surgeries for the treatment of female stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * women with stress urinary incontinence with a positive cough test * patient request surgery for treatment exclusion criteria: * prodominantely overactive bladder * previous failed procedure * mucp \<20 cm h2o * presence of vaginal prolapse \> stage 1 * voiding dysfunction (pvr\>100 ml)
telehealth rapid intervention for externalizing behaviors in asd

Conditions: Autism Spectrum Disorder; Disruptive Behavior; Externalizing Behavior; Parent-Child Interaction Therapy; Telehealth

Summary: the purpose of this research study is to evaluate a time-limited version of parent child interaction therapy (pcit) delivered via telehealth for young children with autism spectrum disorder (asd) and disruptive behavior problems. families will be randomly assigned to receive 10 sessions of tele-pcit or treatment as usual. families will complete a baseline assessment, a post-treatment assessment, and a 3-month follow-up.


Eligibility criteria:
inclusion criteria: 1. be between 2:0 -6:11 years old 2. have elevated levels of disruptive behavior problems as defined by the eyberg child behavior inventory 3. have a diagnosis of asd based on a positive autism diagnostic observation schedule (ados-2), a semi-structured parent interview, record review, and an asd dsm-5 criteria checklist. 4. have a receptive language age equivalent of at least 24 months as defined by the peabody picture vocabulary test 5. are of low ses background defined by having primary medicaid exclusion criteria: 1. presence of severe self-injurious behavior 2. children who are receiving psychotropic medication and are not stable on their current medication regimen. children receiving psychotropic medications who are on a stable regimen for one month will not be excluded.
implementation of a tool on alimentary empowerment in new-born baby

Conditions: Neonatal Feeding Disorder

Summary: the alimentation of the premature newborn children is one of main thing concerning of nurses and pediatricians in neonatology. the absence of common tool of evaluation of the children cause a great discrepancy in prescriptions and the practices of the nursing.the aim of this study is to estimate the improvement of the food empowerment of the premature newborn children after the introduction of a help tool at the food progress which allows to fit the prescription of food(supply) to the capacities of the newborn child.

if the importance of feeding premature newborns is a central concern during their management, the absence of an evaluation tool leads to a great disparity in their implementation (particularly marked by at regular times by the care teams), which can eventually lead to oral disorders. the possibility of an assessment of the newborn's skills could allow a homogenization of therapeutic proposals and thus a potentially faster progression of dietary independence of the newborn. this method could also encourage parental involvement in feeding care. the objective of the study is to evaluate the impact of a tool to help food progression on food autonomy.

Eligibility criteria:
inclusion criteria: * born before 37 weeks of pregnancy * hospitalized in ghpsj neonatology * predictable duration of hospitalization of at least 7 days exclusion criteria: * parents not speaking french language * new borm with complication du to his prematurity
neurological outcome of vlbw infants with early hypotension

Conditions: 1. VLBW Infants; 2. Hypotension

Summary: comparison of short and long term neurological outcome of vlbw infants with and without early onset hypotension required intervention. the cohort includes all vlbw infants born in our institution between january 1997 and december 2000.


Eligibility criteria:
inclusion criteria: -vlbw infants born at the sheba medical center between january 1997 and december 2000 exclusion criteria: - none
clinical trial ceftriaxone in subjects with als

Conditions: Amyotrophic Lateral Sclerosis; ALS

Summary: the purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (als).

it is known that nerve cells called motor neurons die in the brains and spinal cords of people with amyotrophic lateral sclerosis (als). however, the cause of this cell death is unknown. researchers think that increased levels of a chemical called "glutamate" may be related to the cell death. for this reason researchers want to study drugs that decrease glutamate levels near nerves. ceftriaxone-a semi-synthetic, third generation cephalosporin antibiotic-may increase the level of a protein that decreases glutamate levels near nerves. studies of ceftriaxone in the laboratory suggest that it may protect motor neurons from injury. ceftriaxone is approved by the u.s. food and drug administration (fda) for treating bacterial infections but not for treating als. also, ceftriaxone has not been given to people over a long period of time, such as months or years. the goals of this study are to evaluate the safety and effectiveness of ceftriaxone as a treatment for als, and to determine the safety and effectiveness of long-term use of the drug in people with als. a total of 600 eligible people with als will be enrolled in this multi-center research study. participants will be randomly assigned to receive treatment with ceftriaxone (2/3 of participants) or placebo (1/3 of participants) for at least 12 months. the study consists of three stages. the first stage, which has completed enrollment, will look at whether ceftriaxone enters the cerebrospinal fluid (the fluid that surrounds the spinal cord, also called csf) in amounts that are high enough to be of possible benefit. the second stage, which has also completed enrollment, will look at the safety and side effects of the study drug when taken daily for at least 20 weeks. the study is currently enrolling subjects for the third stage, which began in spring 2009, and will determine whether the study drug prolongs survival and slows decline in function due to als.

Eligibility criteria:
inclusion criteria: * participants will be people with als, at least 18 years of age. * participants must be medically able to undergo the study procedures and have a caregiver or other individual who will be available to help with daily study medication administration. * participants should live within a reasonable distance of the study site, due to frequent study visits. exclusion criteria: * participants cannot be taking any other experimental medications for als, or have a history of sensitivity to cephalosporin antibiotics (such as ancef, keflex, ceclor, ceftin, lorabid, suprax, or fortaz).

Keywords: amyotrophic lateral sclerosis als ceftriaxone cephalosporin antibiotic motor neurons
efficacy and safety of durvalumab in non-small cell lung cancer with leptomeningeal metastasis

Conditions: Leptomeningeal Metastasis; Durvalumab

Summary: the purpose of this study is to observe the clinical efficacy and safety of durvalumab combined with intrathecal chemotherapy in non-small cell lung cancer with leptomeningeal metastasis


Eligibility criteria:
inclusion criteria: 1. male and female age 18 or more 2. pathologically proven non-small cell lung cancer 3. mri(magnetic resonance imaging,mri) imaging findings or the detection of malignant cells in cerebrospinal fluid 4. patients have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. kps score \<60 2. history of autoimmune diseases 3. with severe hepatic and renal dysfunction 4. has a history of (non-infectious) pneumonitis that required steroids

Keywords: leptomeningeal metastasis durvalumab intrathecal chemotherapy