Kornimate/medical-research-clean huggingface dataset:
use of bart coupled with eeg in the early diagnosis of behavioral disorders in parkinson's disease

Conditions: Parkinson Disease

Summary: the balloon analogue risk task \[bart\] is an experimental task modelizing risky behaviors. in parkinson disease, the correlation between bart and modifications of cerebral activity in ventral striatum has been shown. bart thus seems to be particularly adapted for modelization of hyperdopaminergic behavioral disorders \[typer\] into parkinsonian patients. previously, a version of the bart performed with eeg has been specifically developped by the centre d'investigation clinique of besançon university hospital, in collaboration with the clinical and integrative neurosciences laboratory. preliminary data suggest that the analysis of evoked potentials including feedback-related negativity \[frn\], p300 wave, and reward positivity \[rewp\], could help assessing the motivational and attentional attributes of decision making and the delayed treatment of any reward. the hypothesis of the study that the eeg version of the bart could help predicting the risk to develop typer into parkinsonian patients treated by dopaminergic in routine care.


Eligibility criteria:
inclusion criteria: * probable diagnosis of parkinson's disease according to the movement disorder society criteria * parkinson disease appeared ≤ 60 years old * disease evolving since ≥ 5 years * daily dose for du dopaminergic treatment ≥ 200mg/day dopa equivalent * patients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of: 1. hypodopaminergic behavioral syndrome \[typo\] including apathy, anxiety, depression and/or 2. motor syndrome insufficiently controlled by dopaminergic treatment (akinesia, rigidity, tremor) exclusion criteria: * cognitive disorders (montreal cognitive assessment \[moca\] \< 25/30) * parkinson disease psychosis * hyperdopaminergic behavioral disorders \[typer\] defined by a score ≥ 2 at at least 1 item of hyperdopaminergic behavioral spectrum of parkinson disease * contraindications for dopaminergic agonists * patient treated with deep brain stimulation * serious psychiatric comorbidity (major depressive episode according to diagnostic and statistical manual of mental disorders \[dsm\] v criteria, suicidal patient, other active psychosis, etc.) * unstabilized psychotropic treatment * pregnant or breastfeeding women
trial of otelixizumab for adults with newly diagnosed type 1 diabetes mellitus (autoimmune): defend-1

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. insulin secretion will be assessed using mixed meal-stimulated c-peptide. subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). these study agents will be administered as an addition to insulin, diet, and other physician determined standard of care treatments. defend-1 is now closed to enrollment. defend-2 will begin early in 2010. it is very similar to defend-1 and will again require subjects with new onset type 1 diabetes. please check back here for more details. in the meantime, established and new onset type 1 diabetes patients in north america are welcome to consider the ttedd study: http://www.clinicaltrials.gov/ct2/show/nct00451321?term=ttedd\&rank=1

the following visits are required: * screening visits: 2 to 3 appointments will be conducted to determine eligibility. at 2 of these visits participants will drink a liquid meal and have blood tests done over the post-meal period. * dosing visits: 8 outpatient visits on consecutive days, each lasting about 4-6 hours. * follow-up visits: weekly for the first month, then every 2 weeks for 3 months, followed by monthly visits through 1 year. there will be 3 visits in the second year. * the total duration of the study is 2 years. * glucose test strips, glucose monitors and pdas to record insulin will be provided to all study subjects for the duration fo the study. frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects.

Eligibility criteria:
inclusion criteria: * ages 12-45 * diagnosis of diabetes mellitus, consistent with ada criteria * no more than 90 days between diagnosis and administration of study compounds * requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds. * stimulated c-peptide level greater than 0.20 nmol/l and less than or equal to 3.50 nmol/l * positive for one or more of the autoantibodies typically associated with t1dm: antibody to glutamic acid decarboxylase (anti-gad); antibody to protein tyrosine phosphatase-like protein (anti-ia-2); zinc transporter autoantibodies (znt8); insulin autoantibodies (iaa). a subject who is positive for insulin autoantibodies (iaa) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total. exclusion criteria: * other, significant medical conditions based on the study doctor's evaluation

Keywords: type 1 diabetes new onset type 1 diabetes t1dm type l diabetes juvenile diabetes
uterine scratching in intra-uterine insemination

Conditions: Infertility; Unexplained Infertility

Summary: this study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.

infertility is defined as the absence of conception after a year of unprotected intercourse. in 10 to 30 % of patients, the cause of the infertility is unknown. an emerging practice in unexplained infertility has been to cause a uterine trauma prior to treatment. this is done by doing a small endometrial scratch with a pipelle. this intervention has been study in ivf and has been shown beneficial. theoretically, the uterine scratching could increase the immune response and the vascularization of the endometrium which could help in embryo implantation. however, there is very few data concerning scratching in intrauterine insemination. the studies are mostly small studies and the results are often contradictory. in this randomized controlled trial, the investigators will evaluate the effect of uterine scratching during the follicular phase of an insemination cycle on the pregnancy rate of a large cohort of unexplained infertile couples.

Eligibility criteria:
inclusion criteria: * unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above. * at least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years. * antral follicular count over 5. * normal or mild male factor. * normal uterine cavity. * an iui prescription. exclusion criteria: * polycystic ovary syndrome with irregular menstrual cycles over 45 days * severe endometriosis * iui with donor sperm * patient with invasive intra-uterine procedure in the last 3 months. * contraindication to endometrial biopsy.

Keywords: intra-uterine insemination endometrial injury scratching
study of bxcl501 in agitation associated with delirium in icu patients

Conditions: Agitation; Delirium

Summary: this study is designed to determine and evaluate the optimal bxcl501 starting dose (startd) that will safely and effectively reduce agitation associated with delirium in icu patients. this is an ascending adaptive dose study evaluating the safety and efficacy of four potential starting doses of bxcl501 (120 μg, 180 μg, 240 μg, and 300 μg) in reducing agitation levels in adult icu patients with delirium. for subjects 65 years of age and older, the potential doses will be reduced 50% in line with the precedex (reference drug) label. the purpose of this clinical trial is to identify an optimally safe and effective bxcl501

this is a phase 2, randomized, double-blind, placebo-controlled, ascending starting dose finding study assessing safety, efficacy, tolerability and pk of bxcl501 in four starting dose cohort groups to reduce agitation levels associated with delirium in patients within the icu setting. evaluation of four bxcl501 starting doses compared to placebo will be conducted according to the following ascending doses: cohort 1 (120 μg or placebo); cohort 2 (180 μg or placebo); cohort 3 (240 μg or placebo); cohort 4 (300 μg or placebo). for subjects 65 years of age and older, the starting doses in each cohort will be reduced 50% in line with the precedex (reference drug) label. safety, efficacy, and tolerability will be assessed throughout the treatment period at various timepoints. subjects will receive the first starting dose (bxcl501 or placebo) when baseline rass score is ≥ +1. repeat doses may be administered in increments of 120 μg every 3 to 6 hours post first dose (startd) only if the rass score remains ≥ +1. for subjects 65 years and older, repeat doses may start in increments of 60 μg every 3 to 6 hours post first dose only if rass is still ≥+1.

Eligibility criteria:
inclusion criteria: inclusion criteria for enrollment (informed consent): 1. icu admitted male and female patients, ≥ 18 years, covid 19 (+) and (-) 2. subject or legally appointed representative (lar) able to read, understand and provide informed consent, or to provide assent inclusion criteria for randomization: 3. positive cam-icu 4. rass score ≥ +1 5. subject judged to be likely capable of self-administration exclusion criteria: 1. clinically significant ecg changes, brady- and tachyarrhythmias, qtc prolongation 2. hepatic dysfunction 3. pregnancy 4. known allergy to dexmedetomidine or haloperidol.
reducing cesarean delivery rate in obese patients using the peanut ball

Conditions: Obesity; Cesarean Section

Summary: this study aims to determine if using the peanut ball during labor reduces the cesarean delivery rate when compared to normal intrapartum management (no peanut ball) in the obese patient population.

currently at geisinger medical center danville, use of the peanut ball is at the discretion of attending or resident physicians, or obstetric nurses on the labor and delivery team for the day. despite the common use of this labor adjuvant tool, a well-designed prospective study is necessary to investigate if the peanut ball provides any benefit during the labor process for the obese gravida. if this simple tool is shown to reduce the rate of cesarean delivery, then hospital protocols could be changed to ensure its use during labor. this has the potential to decrease the rate of cesarean delivery in the most vulnerable patient population. the investigators propose a randomized controlled trial (rct) to determine if using the peanut ball during labor provides a reduction in the cesarean delivery rate in the obese patient population. the investigators will compare cesarean delivery rates in patients using the peanut ball to patients receiving routine intrapartum management without the use of the peanut ball. singleton pregnancies complicated by obesity, defined by pre-pregnancy bmi \> 30kg/m2, will be included. study participants will be randomized to one of the two study arms. the peanut ball arm (also referred to as study arm 1) will be managed according to the parameters specified for use of the peanut ball. the participants in the control arm (also referred to as study arm 2) will be managed according to the standard intrapartum management as defined by geisinger's labor \& delivery protocol and per the ob providers. the objective of the study is to determine if use of the peanut ball during labor reduces the cesarean delivery rate in the obese patient population. secondary outcomes of interest include rate of cervical dilation, rate of operative deliveries, fetal position (occiput anterior vs. occiput posterior) at complete dilation (10 cm), and patient satisfaction.

Eligibility criteria:
inclusion criteria: * admitted for delivery * pre-pregnancy bmi \> 30kg/m2 * planned vaginal delivery at geisinger medical center (gmc) * gestational age \> 37 weeks 0 days * singleton pregnancy * cephalic presentation * english speaking exclusion criteria: * pre-pregnancy bmi \< 30kg/m2 * contraindication to vaginal delivery * planned cesarean delivery (i.e., an elective primary or repeat cesarean delivery) * gestational age \< 37 weeks 0 days * multifetal gestation * intrauterine fetal demise * non-english speaking * greater than 9cm at the time of randomization

Keywords: peanut ball
study of sgb-3908 in healthy subjects and mildly hypertensive subjects

Conditions: Hypertension,Essential

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (pk), and pharmacodynamic (pd) effects of sgb-3908 in healthy subjects and mildly hypertensive subjects. the study will be a single ascending dose (sad) phase.


Eligibility criteria:
inclusion criteria: * has body mass index (bmi) ≥18 and ≤30 kg/m\^2 and has bodyweight ≥ 50 kg; * has systolic blood pressure (sbp) ≥100 mmhg and ≤150 mmhg and diastolic blood pressure (dbp) ≥65 mmhg and ≤95 mmhg at screening; exclusion criteria: * has mental illness, liver and kidney disease, gastrointestinal disease, nervous system disease, or other related systemic diseases that affect the trial; * has a history of hospitalization or other clinically significant diseases within 1 month before screening, major surgery within 6 months before screening, or other unstable conditions judged by the investigator; * has a history of orthostatic hypotension or syncope; * patients with clinically significant abnormalities confirmed by physical examination, 12-lead electrocardiogram, laboratory tests, etc., or those who meet any of the following conditions during screening need to be excluded: 1. alanine aminotransferase (alt), aspartate aminotransferase (ast), total bilirubin higher than 1.5× upper limit of normal (uln) 2. serum creatinine (cr) higher than uln 3. serum potassium higher than 5 mmol/l 4. qt/qtc interval prolongation during screening (qtcf\>450 ms)

Keywords: healthy mildly hypertensive
imaging the neuroimmune system in ptsd

Conditions: Post Traumatic Stress Disorder

Summary: in this study, individuals with and without post-traumatic stress disorder (ptsd) will undergo one positron emission tomography (pet) scan using the radiotracer \[11c\]pbr28, which binds to the 18kda translocator protein (tspo). a subset of individuals who complete the first pet \[11c\]pbr28 scan will be invited to complete an inflammatory challenge and second pet \[11c\]pbr28 scan. approximately 3 hours prior to the second \[11c\]pbr28 pet scan, lipopolysaccharide (lps; endotoxin) will be administered to evoke a robust neuroimmune response. subjects will also undergo behavioral and cognitive testing. vital signs, subjective response, and peripheral biomarker levels will be assayed periodically throughout the experimental session. specific aims: 1) determine if individuals with ptsd exhibit neuroimmune system disruption relative to well-matched comparators at baseline. 2) determine if individuals with ptsd exhibit a disrupted neuroimmune response after a classical immune stimulus relative to well-matched comparators. 3) determine if lps differentially alters cognitive function, subjective response, or physiological markers in individuals with ptsd compared to well-matched comparators. hypothesis: individuals with ptsd will exhibit a suppressed neuroimmune system at baseline and an attenuated neuroimmune response following lps challenge, relative to matched trauma controls.


Eligibility criteria:
inclusion criteria: 1. men and women, aged 18-55 years 2. subjects with ptsd will have a primary, current diagnosis of ptsd according to dsm-v criteria (i.e., caps-5 ascertained diagnosis) 3. able to read and write english and to provide voluntary, written informed consent exclusion criteria: 1. current medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology including copd, anemia, uncontrolled daily asthma or asthma requiring the use of an inhaler more than 1x/week with an act score below 20. \[we will not exclude individuals taking ssris and tris due to high prevalence of use within the ptsd population and due to evidence suggesting no effect of these drug classes on endotoxin response\]. 2. past or current neurological disorder or disorders affecting the brain including but not limited to multiple sclerosis, history of stroke, brain tumors, traumatic brain injury with loss of consciousness, seizure disorder 3. current or regular use of over-the-counter medication that may affect the immune system 4. women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or iud 5. contraindications to mri such as claustrophobia or metal in their body 6. individuals who are classified as "low binders" for the rs6971 polymorphism (\<10% of the population)

Keywords: neuroimmune system lipopolysaccharide
study of cryospray ablation of low grade or high grade dysplasia within barrett's esophagus

Conditions: Barrett's Esophagus; High Grade Dysplasia; Low Grade Dysplasia

Summary: the purpose of this study is to evaluate the safety and effectiveness of the cryospray ablation system to treat esophageal low grade dysplasia (lgd) or high grade dysplasia (hgd) within barrett's esophagus (be).

the study will consist of an estimated 200 subjects with hgd or lgd within be who are deemed inoperable or refuse standard surgical treatment. a maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

Eligibility criteria:
inclusion criteria: * karnofsky performance status of 50-100% * life expectancy greater than 5 years * hematopoietic, hepatic and renal lab clearance * previous endoscopy with histological confirmation of lgd or hgd within be * for group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery. * for group 2, endoscopic ultrasound (eus) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (t0n0m0 by eus). exclusion criteria: * pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years). * esophageal stricture preventing passage of endoscope or catheter. * active esophagitis * emr performed less than 8 weeks prior to csa treatment. * emr performed on greater than 90% circumference of any area of the esophagus. * any previous esophageal surgery, except fundoplication without complications. * known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. * concurrent enrollment in an investigational drug or device trial that clinically interferes with the lcs dysplasia endpoints. * psychiatric or other illness deemed by the investigator as an inability to comply with this protocol. * medically unfit or other contraindication to tolerate upper endoscopy. * inability to tolerate therapy with a proton pump inhibitor (ppi). * refusal or inability to give consent. * other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free). * concurrent chemotherapy. * prior radiation therapy which involved the esophagus. * prior adenocarcinoma involving the esophagus or stomach. * prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.

Keywords: low grade dysplasia high grade dysplasia barrett's esophagus cryospray ablation ice cryotherapy cryo cryospray
endovascular treatment of wide neck saccular cerebral aneurysms

Conditions: Wide Neck Saccular Cerebral Aneurysms

Summary: intracranial aneurysm (ia) is a cerebrovascular disorder in which the weakness of a cerebral artery wall causes a localized dilation of the blood vessel. intracranial aneurysm can develop and rupture, and about 85% of spontaneous subarachnoid hemorrhage (sah) cases are caused by the rupture of intracerebral aneurysm. two treatments are available globally: microsurgical clipping and endovascular treatment. endovascular treatment of intracerebral aneurysms using detachable platinum coils ( was introduced in 1990 by guido guglielmi, an italian neurosurgeon ) of different shapes and sizes are deposited into the aneurysm through a microcatheter, which reduces the blood flow and induces thrombus formation . wide neck aneurysm defined by neck diameter greater than 4 mm or dome-to-neck ratio less than 2 despite advances in endovascular techniques , the treatment of wide-necked aneurysms remains problematic . endovascular treatment of intracranial aneurysms is associated with lower morbidity and mortality rates and faster recovery compared with traditional microsurgical clipping. in wide-necked intracerebral aneurysms, complete coil embolization is often technically difficult owing to the risks of distal coil migration or coil impingement on the parent vessel . complete coil embolization using a single microcatheter without a supporting device in cases of wide-necked intracerebral aneurysm is technically difficult. total occlusion rates have increased recently as a result of the advancement of supporting devices these may include balloon remodeling, use of three-dimensional (3d) coils (russian doll technique), combined use of stents and coils (stent assisted coiling), flow diverters, use of intrasaccular flow disruption (like web), double catheter technique or combined extra- and intrasaccular devices.


Eligibility criteria:
inclusion criteria: * all patients of spontaneous subarachnoid haemorrhage due to ruptured wide neck saccular cerebral aneurysms * unruptured denovo wide neck saccular cerebral aneurysms exclusion criteria: * other forms of cerebral aneurysms rather than saccular type : fusiform and dissecting aneurysms * complex aneurysms : giant and thrombosed aneyrsms * any spontaneous subarachnoid haemorrhage with world fedriation of neurosurgery societies (wfns) grade 4\&5 * any patient unfit for general anesethia or has serious renal impairment