Kornimate/medical-research-clean huggingface dataset:
mri evaluation of the breast areolar margin and paryenchyma

Conditions: Breast Cancer

Summary: the purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. all patients will have markers placed on both breasts and will undergo an mri. mri results will be examined to identify the pattern of breast gland attachment to the overlying skin. this will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.


Eligibility criteria:
inclusion criteria: * have one of the following indications for mri study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from mri. * no prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants. * capable of fitting into the mri machine. * permission to contact and consent the patient to participate from the investigator(s) * provide written informed consent and authorization for use/disclosure of phi exclusion criteria: * have a contraindication to mri study. * prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants \[patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration\] * inability to fit into the mri machine. * psychological factors that may interfere with successful completion of the study * refusal to provide written informed consent and/or authorization for use/disclosure of phi

Keywords: breast cancer
non-interventional long term follow-up study of participants previously enrolled in the restore study

Conditions: Retinitis Pigmentosa; Retinitis; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Retinal Dystrophies; Retinal Degeneration

Summary: this study will be conducted following good clinical practice (gcp) and international conference on harmonization (ich) guidelines. eligible subjects will be consented to return for scheduled study visits for this study following their completion in study ntxmco-002 (restore). they will not receive a second treatment with mco-010 (or a repeated sham injection) in this study

this study is designed to follow subjects with retinitis pigmentosa (rp) previously enrolled in study ntxmco-002 (restore, nct04945772). in that study, 18 of 27 enrolled subjects received mco-010, an ambient light-activated, multi-characteristic opsin (mco) transgene in an adeno-associated virus serotype 2 (aav2) vector via intravitreal injection (ivt) and 9 of 27 received a sham injection. those who received the sham injection will not be continued in the long-term, follow-up study for drug safety. mco-010 has the potential to restore vision irrespective of the underlying gene mutation, and because it is directed at bipolar retinal cells, intact photoreceptors are not required. further details on mco-010 and the underlying disease under investigation are included in the protocol for restore and are not repeated herein. the current study is a non-interventional long-term safety follow-up of the subjects who completed restore, in accordance with fda guidance on recipients of human gene therapy products.

Eligibility criteria:
inclusion criteria: * previously enrolled in study ntxmco-002 (restore) * able to comprehend and give informed consent. * able to comply with testing and all protocol tests. * agree to participate for the full 3-year duration of follow-up to the best of their ability and barring any unforeseen circumstances. exclusion criteria: * not applicable. subjects will be included in this study and will be consented after completion of all assessments at their final restore study visit

Keywords: gene therapy aav vectors low vision intravitreal injections optogenetics multi-characteristic opsin multi-luminance y mobility test multi-luminance shape discrimination test visual acuity
multi-dose-escalation safety and pharmacokinetic study of sar3419 as single agent in relapsed/refractory b-cell non hodgkin's lymphoma

Conditions: Lymphoma; Non-Hodgkin

Summary: the primary objective is to determine the maximum tolerated dose of sar3419 and to characterize the dose limiting toxicity(ies). secondary objectives are to determine the anti-lymphoma activity, the global safety and the pk profile.


Eligibility criteria:
inclusion criteria: * histologically confirmed cd19-positive non-hodgkin's b-cell lymphoma, relapsed or refractory after standard treatments, with no curative option with conventional therapy * ecog performance status 0 to 2 exclusion criteria: * burkitt's lymphoma, lymphoblastic lymphoma, chronic lymphocytic leukemia (small lymphocytic lymphoma may be included) * chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study * previous radioimmunotherapy within 12 weeks * known intolerance to infused protein products or maytansinoids * poor kidney, liver and bone marrow functions * any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * pregnant or breast-feeding women * patient with reproductive potential without effective birth control methods the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
pupilometric evaluation of patients under procedural sedation with propofol

Conditions: Orthopedic Disorder

Summary: procedural sedation involves the administration of sedative medications that allow patients to tolerate painful procedures. procedural sedation has been formally recommended by experts from the french society of emergency medicine (sfmu) since 2010 and procedural sedation using propofol in emergency departments has been recommended by the american college of emergency physicians in 2018. propofol monotherapy is now widely used in emergency medicine (em) in france as part of procedural sedation for performing painful procedures, however propofol has no analgesic properties per se . pupilometry makes it possible to study the depth of analgesia by evaluating the body's nociceptive response via the ans by studying the pupil diameter. this technique would allow the evaluation of the analgesia level in patients sedated by propofol during the realization of painful procedures. variations in pupil diameter during painful procedures under procedural sedation in an emergency department will be assesed in this study. secondly, patients satisfaction following the procedure will also be evaluated by the use of the french version of the "isas-f", the iowa satisfaction with anesthesia scale.


Eligibility criteria:
inclusion criteria: * adult patients * patient admitted at vital emergency room, * patient with an orthopedic trauma, * patient under procedural sedation with propofol. exclusion criteria: * patient's refusal of pupilometry measurement. * pre-existing pupil abnormalities. * history of pathologies with dysautonomic impairment (advanced diabetes, systemic amyloidosis, multiple sclerosis, uncontrolled hypertension, ...). * recent administration of metoclopramide, droperidol, clonidine, dexmedetomidine * nitrous oxide prior to procedural sedation
a study evaluating the efficacy of sar 1118 (0.1%, 1.0%, 5.0%) ophthalmic solution in subjects with dry eye conducted in a controlled adverse environment (cae)

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of sar 1118 ophthalmic solution compared to placebo in the treatment of dry eye.


Eligibility criteria:
inclusion criteria: * signed informed consent form and hipaa document * willing and able to comply with all study procedures * be at least 18 years of age * patient-reported history of dry eye in both eyes * demonstrate a positive response when exposed to the controlled adverse environment model * a negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period exclusion criteria: * any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy * unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period * any blood donation or significant loss of blood within 56 days of visit 1 * any history of immunodeficiency disorder, positive hiv, hepatitis b, c, or evidence of acute active hepatitis a (anti-hav igm), or organ or bone marrow transplant. * use of any topical ophthalmic preparations (including tear substitutes) 72 hrs prior to screening assessments and through the entire study period * any significant illness that could interfere with study parameters * history of laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery within 12 months prior to visit 1, and/or any other ocular surgical procedure within 12 months prior to visit 1; or any scheduled ocular surgical procedure during the study period. * known history of alcohol and/or drug abuse

Keywords: dry eye ophthalmic delivery
microtransplantation with decitabine and cytarabine improves patient outcomes in myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to investigate whether infusion of g-csf mobilized hla-mismatched peripheral blood stem cells (g-pbsc) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (mds) patients.


Eligibility criteria:
inclusion criteria: * patients 10 to 90 years old with primary or treatment-related mds or chronic myelomonocytic leukemia; * international prognostic scoring system(ipss) intermediate-1,intermediate-2,or high risk; * bone marrow blasts \> 11% or \<= 10% and poor cytogenetics; * lack of an hla-identical donor; * eastern cooperative oncology group (ecog) performance status 0-2; * adequate cardiac and hepatorenal functions. exclusion criteria: * have an hla-identical donor

Keywords: decitabine microtransplantation myelodysplastic syndromes chemotherapy
nonalcoholic fatty liver disease and atherosclerotic risk in children

Conditions: Overweight and Obesity; Non-alcoholic Fatty Liver Disease

Summary: nonalcoholic fatty liver disease is a serious health condition in overweight children which can lead to heart disease. this project will examine the links between liver health and cardiovascular risk factors in overweight and obese children, and will test the effect of a long-term after-school exercise program. provision of comprehensive evidence for the benefits of exercise on children's health may reduce barriers to vigorous physical activity programs during a childhood obesity epidemic.

this is an ancillary study adding cardiometabolic outcome measures to an ongoing nih-funded randomized trial of exercise in overweight children ("smart study," r01 hl087923, p.i. davis, nct02227095). this presents the opportunity to obtain detailed measures of liver and vascular health to provide information about the effects of exercise on these conditions.

Eligibility criteria:
inclusion criteria: * 8-11 years of age * overweight or obese (bmi-for-age \>= 85th percentile) * able to participate in exercise testing and intervention * participating in the smart study exclusion criteria: * medical condition or medications that would interfere with measurements * participation in weight control or formal exercise program outside physical education that meets more than 1 day/week * t-score \> 75 on the brief behavior regulation scale to avoid program disruption * unable to complete magnetic resonance imaging.

Keywords: arterial stiffness
effect of esmolol on perioperative stress reaction

Conditions: Esmolol; Stress Reaction; Airway Obstruction; Catecholamine; Overproduction

Summary: the goal of this clinical trial is to observe the effect of low dose continuous infusion of esmolol on perioperative stress response in patients undergoing airway intervention .

airway intervention is known to activate stress response and release catecholamines resulting in severe hemodynamic instability. various techniques which are recommended to prevent the stress response include increasing the depth of anesthesia, improving surgical procedures and the use of various pharmacological agents. esmolol blocks the action of the endogenous catecholamines, we plan low dose esmolol infusion decrease stress response and hemodynamic fluctuation during airway intervention. 46 patients scheduled airway intervention under general anesthesia were randomly divided into esmolol group and control group. esmolol 50μg/kg/min or saline 50μg/kg/min were iv administered before operation beginning. if hr（heart rate）is greater than 90 beats/min, esmolol or saline 50μg/kg/min is added each time, with interval more than 5 min and the peak value is 200 μg/kg/min. if the heart rate is lower than 60 times/minute, stop medication. plasma level of norepinephrine, epinephrine, and cortisol before induction of anesthesia and 30 minutes after beginning of operation were determined by high-performance liquid chromatography. perioperative hemodynamics changes, extubation time, incidence of severe sinus bradycardia and bronchospasm were recorded.

Eligibility criteria:
inclusion criteria 1. american society of anesthesiologists (asa) physical status i to iii.; 2. body mass index (bmi): 20-30 kg/m2; 3. elective airway intervention under general anesthesia with jet ventilation，duration of operation less than 2hs; 4. sign informed consent for clinical trial exclusion criteria 1. the patient and his or her family refused to participate in the study; 2. severe respiratory or/cardiovascular or/ neurological disease, or/ hepatic or/renal dysfunction 3. those who are allergic to the drugs used in this study; 4. psychiatric history or with unstable mental state; 5. patients with atrioventricular block 6. patients with history of asthma 7. patients now treated with β-adrenergic receptor blockers 8. patients participating in other clinical trial

Keywords: continuous infusion
great saphenous vein electrocoagulation

Conditions: Venous Disease; Varicose Veins

Summary: introduction: lower extremity chronic venous insufficiency is a prevalent disease that adversely affects an individual's quality of life. varicose vein endovenous radiofrequency treatment have a lower risk of iatrogenic injuries and offer faster return to work activities, when compared with open surgical techniques. endovenous electrocoagulation can selectively and safely cause great saphenous vein (gsv) wall necrosis but its clinical results has never been studied before. objective: the objective of this study is to compare great saphenous vein electrocoagulation and radio frequency (rf) endovascular varicose vein treatment clinical results and quality of life improvement in a prospective double blind randomized controlled clinical trial. methods: consecutive patients with varicose veins and primary gsv reflux will be randomized to electrocoagulation or radiofrequency endovenous treatment. the primary outcome measure will be gsv occlusion rate at 3 and 6 months after treatment verified by duplex scanning (ds). secondary outcome measures will be pain visual analogue scale (vas), bruising, neuropathy and vein thrombosis frequency in the immediate postoperative period (1 week); and clinical etiology anatomy and pathophysiology (ceap) classification ,venous clinical severity scale (vcss), and aberdeen varicose vein questionnaire (avvq), obtained preoperatively, at 3 and 6 months postoperatively. for statistical analysis, we will use the student's t test, the mann-whitney test and pearson's correlation, considering positive statistical significance when level of p \<0.05.

all patients included in the study will be preoperatively examined to evaluate the severity of venous disease, using the ceap classification, vcss and avvq. they will undergo venous ds with the aim of investigating gsv insufficiency, its caliber and depth and presence of previous thrombophlebitis. patients will be randomized on the day of surgery with an electronic table of random numbers: group 1:electrocoagulation treatment. group 2: radiofrequency treatment. patients and outcomes assessor will be blinded to the group of endovenous treatment.

Eligibility criteria:
inclusion criteria: * symptomatic varicose veins of the lower limbs and partial or total failure (venous reflux) of the gsv exclusion criteria: * previous varicose vein surgery with removal of the gsv * pregnant women * patients in use of anticoagulants * known thrombophilia * presence of saphenous vein tortuosity and/or depth less then 7 mm from the skin * gsv diameter \ 12 mm * previous deep vein thrombosis * peripheral arterial disease.

Keywords: varicose veins catheter ablation catheter ablation, electrical catheter ablation, radiofrequency
gideon non-nexavar arm - hcc patients who are treated with any therapy other than nexavar at individual study start

Conditions: Carcinoma, Hepatocellular

Summary: this study is an international prospective, open-label, multi-center, non-interventional study. the protocol will allow enrollment of all patients with diagnosis of hcc in whom a decision to treat with sorafenib has not been made at time of study enrollment. all patients will be followed-up until withdrawal of consent, lost to follow-up, death, or the end of the study. detailed information concerning the past medical/surgical history, performance status, methods of diagnosis and staging, etc. of patients with hcc will be collected, and practice patterns of the physicians involved in the care of patients with hcc under real-life conditions will be evaluated.


Eligibility criteria:
inclusion criteria: * outpatients with histologically/cytologically documented or radiographically diagnosed hcc in whom a decision to treat with sorafenib has not been made at this time. radiographic diagnosis needs typical findings of hcc by radiographic method i.e. on multi-dimensional dynamic ct, ct hepatic arteriography (ctha)/ct arterial portography (ctap) or mri. * patients must have signed an informed consent form * patients must have a life expectancy of at least 8 weeks exclusion criteria: * patients in whom a decision to treat with sorafenib is made at time of study start * patients who have received sorafenib in the past or are currently treated with sorafenib * hospice patients

Keywords: hcc liver cancer cancer of liver cancer, liver hepatic cancer cancer, hepatic carcinoma, hepatocellular
explanation about sleep in post trauma patients

Conditions: Post Traumatic Stress Disorder; Sleep Deprivation

Summary: this study is designed to test the effect of an explanation about the first sleep following trauma exposure, on the development of post traumatic stress disorder (ptsd) in the months following the traumatic event.

this is a single blind, prospective, placebo controlled trial in which trauma victims are randomized to receive an explanation about the first sleep following trauma exposure. to provide a baseline prior the explanation, participants will receive a medical and psychological evaluation. at this point the participants will be given one of two explanations about sleep. the experimental group will receive an encouragement to deprived sleep explanation, and the control group will receive an encouragement to sleep explanation, lorazepam 1mg will be offered to assist sleep. after two weeks the research assistant or study psychiatrist will perform behavioral ratings and complete history details pertaining to ptsd risk factors. participants will be assessed again by the study psychiatrist or research assistants at 1 \& 3 months. further assessments might be done at 6 \& 13 months. eligible subjects will include men and women age 18-70, who have been exposed to an event meeting the dsm-iv "a.1" criterion for trauma exposure, and who provide written, informed consent to participate in the study. potential participants will be recruited from trauma victims who arrived at the chaim sheba medical center emergency room.

Eligibility criteria:
inclusion criteria: 1. persons age 18-70, who have been exposed to an event meeting the dsm-iv "a.1" criterion for trauma exposure. 2. persons who arrived at the chaim sheba medical center emergency room. 3. who provide written, informed consent to participate in the study - exclusion criteria: 1. physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by clinical judgment; 2. traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 3. overt psychopathology, intoxication, or under the influence of substances. 4. evidence or history of schizophrenia, bipolar, other psychotic condition; 5. prior history of ptsd; 6. current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 7. assessed serious suicide risk. -

Keywords: sleep deprivation, ptsd,prevention
does short-term anti-seizure prophylaxis after traumatic brain injury decrease seizure rates?

Conditions: Seizures; Traumatic Brain Injury

Summary: the primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. a secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.

the efficacy of anti-seizure prophylaxis in head injury patients remains controversial. current recommendations for the use of anti-seizure prophylaxis are based upon a single institution study that has not been reproduced with other studies contradicting their conclusions. the proposed study will be a randomized prospective study at loyola university medical center to assess the efficacy of anti-seizure prophylaxis in patients who have suffered traumatic brain injury (tbi). patients with suspected tbi will undergo computed tomographic (ct) scan of the head. following identification of tbi on ct scan, patients will be randomized to one of two study groups. patients will be randomized to receive a seven-day course of anti-seizure prophylaxis with levetiracetam (ucb pharma inc.; keppra) or randomized to a study group that will not receive anti-seizure prophylaxis. patients will be consented prior to entry in the study. patients will be followed for a total of seven days post injury for clinical signs of seizure activity. additionally, patients will be assessed at one month post injury for clinical signs of seizure activity.

Eligibility criteria:
inclusion criteria: * patients who have suffered intracranial injury identified by ct scan exclusion criteria: * age less than 18 * pregnant patients * death in ed * seizure history or use of antiepileptic medication prior to admission * contraindication to study drug * any post-injury seizures prior to randomization

Keywords: seizures traumatic brain injury prophylaxis levetiracetam