Kornimate/medical-research-clean huggingface dataset:
removing surrogates' uncertainty to reduce fear and anxiety after cardiac events

Conditions: Cardiac Arrest

Summary: the goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. the investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.

this study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the new york presbyterian hospital system. participants must be english- or spanish-speaking and have a device with internet access. participants will be randomized 2:1 to receive the informational intervention program or usual care (control). intervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. all participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. all participants will also wear a geneactiv sleep monitor to track their sleep for one week following hospital discharge.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * surrogate of a living newyork presbyterian hospital cardiac arrest patient * english- or spanish-speaking * has a working smartphone, tablet, laptop, or other device with internet access exclusion criteria: * any medical and/or psychiatric impairment precluding them from complying with the protocol * non-english and non-spanish speaking * lack of internet/device access * surrogate of an adult ca patient who passed away * cannot be reached for initial contact (3 unsuccessful attempts made in icu) * moved to the in-patient floor before initial contact can be established

Keywords: cardiac arrest uncertainty cardiac anxiety acute stress disorder posttraumatic stress disorder sleep caregiver family surrogate information self care
clinical evaluation of orion lamina cover in patients undergoing lumbar laminectomy with instrumented fusion

Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Spondylolisthesis; Spinal Stenosis; Scoliosis; Spinal Fracture

Summary: laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. it removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then utilizes a spinal fixation system to stabilize the structure to relieve lower limb pain, paralysis, and other symptoms. however, the spinal cord that lacks lamina coverage after surgery is often compressed by scar tissue formation and hematoma, leading to postoperative back and lower limb pain. therefore, this trial is divided into two groups, comparing the use of the cross connector of the orion spinal system - the spinal lamina cover and the general spinal fixation system (without lamina cover). for participants undergoing laminectomy with internal fixation and osseofusion, after utilizing the spinal lamina cover of the orion spinal system, whether the nerve compression caused by postoperative scar tissue formation and hematoma can be effectively reduced, and the pain in the back and lower limbs can be improved.


Eligibility criteria:
inclusion criteria: * gender and age: females and males are at least 20 years old * who with degenerative lumbar spondylolisthesis in one or two consecutive segments from lumbar vertebra l1 to sacral vertebra s1, and have objective evidence of back pain and numbness radiating to the lower limbs. * clinical symptoms of degenerative lumbar spondylolisthesis, accompanied by objective symptoms of neurological deficit; spinal stenosis, neurogenic claudication or bilateral radiating pain. * have received at least 3 months of non-surgical treatment without effectiveness. * radiographic examination was consistent with clinical symptoms of degenerative spondylolisthesis or spinal stenosis. * after diagnosis who needs laminectomy with internal fixation and osseofusion * able and willing to sign the consent form and answer the questionnaire. exclusion criteria: * already had lumbar surgery at the same lumbar vertebra * physically health not well * probably pregnant * who suffering from malignant tumors or infections * below 20 years old * unable and unwilling to answer the questionnaire and return to the hospital for treatment * unable to undergo mri examination due to any reason, such as having a cardiac rhythm regulator, ferromagnetic implants, or claustrophobia.
a study of subcutaneous mircera for the maintenance treatment of participants with chronic renal anemia

Conditions: Anemia

Summary: this single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (mircera), a continuous erythropoietin receptor activator (c.e.r.a.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (esa) or on dialysis. eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). the anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.


Eligibility criteria:
inclusion criteria: * adult participants, \>=18 years of age; * chronic renal anemia; * no esa therapy during previous 3 months. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring hospitalization in previous 6 months; * significant acute or chronic bleeding.
treatment with spinal cord stimulation: effect on sensory parameters

Conditions: Chronic Pain

Summary: the primary purpose is to study the effect of spinal cord stimulation (scs) on sensory parameters, using quantitative sensory testing (qst). patients with established scs treatment will be examined with qst. subjects will be randomized to have their scs device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same qst protocol. after the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period. the investigators expect to demonstrate that scs treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.


Eligibility criteria:
inclusion criteria: * minimum age 18 * able to understand participant information and cooperate at the neurological examination * uncomplicated treatment with spinal cord stimulation for at least 3 months * pain in only one extremity * treatment effect in only one extremity exclusion criteria: -

Keywords: chronic pain electric stimulation therapy neurologic examination
umbilical cord milking versus immediate cord clamping in full term neonates (≥ 37 weeks) requiring resuscitation

Conditions: Hypoxic-Ischemic Encephalopathy; Perinatal Asphyxia

Summary: the objective of the study is to compare the incidence of hypoxic ischemic encephalopathy (all stages) among singleton term neonates (≥ 37 weeks) requiring resuscitation who will undergo umbilical cord milking as compared to immediate cord clamping.

enrolled participants will be randomly allocated to one of two study groups: 1) umbilical cord clamping, 2) immediate cord clamping umbilical cord clamping group: in the babies requiring resuscitation during vaginal delivery, the delivering obstetrician will place the infant on the mother's abdomen and about 20 cm of umbilical cord would be milked towards the infant with intact umbilical cord. the cord milking will be done four times by the obstetrical provider or by a second team member at the rate of 20 cm/2 sec. this procedure can be done in 15-20 seconds. length of 20 cm can be estimated by the length of a sponge holding forceps which is approximately 25 cm. the umbilical cord will then clamped 2 -3 cm from the umbilical stump. immediate cord clamping: this will occur by clamping the umbilical cord as soon as possible (average 30 seconds). further resuscitation will be done in accordance with nrp 2015 guidelines. stop watch will be used to calculate the duration after which the cord is clamped and cut, time to first breath, and time required to achieve hr \> 100/min

Eligibility criteria:
inclusion criteria: vaginally born, singleton term gestation (≥ 37 and \& \< 42 weeks), requiring resuscitation at birth exclusion criteria: * major congenital anomaly (antenatally diagnosed or visible at birth) * rh negative pregnancy * hydrops * abruptio placneta/ placenta previa * fetus with absent and reversal of end diastolic flow * cord avulsion * refusal of consent
a study comparing multiple doses of vi-0521 with placebo and their single-agent constituents for treatment of obesity in adults

Conditions: Obesity

Summary: the objective of this study is to evaluate the safety and efficacy of various doses of vi-0521 compared to both placebo, and the single-agent components that comprise each combination dose. this study will provide confirmatory data to demonstrate that doses of vi-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.


Eligibility criteria:
inclusion criteria: * 70 years of age or less with body mass index (bmi) between 30 and 45 kg/m2 * informed consent * females of child-bearing potential must be using adequate contraception exclusion criteria: * stroke/myocardial infarction (mi)/unstable cardiovascular disease within 6 months * clinically significant renal, hepatic or psychiatric disease * unstable thyroid disease or replacement therapy * nephrolithiasis * obesity of known genetic or endocrine origin * participation in a formal weight loss program or lifestyle intervention * glaucoma or elevated intraocular pressure * pregnancy or breastfeeding * drug or alcohol abuse * smoking cessation within previous 3 months or plans to quit smoking during study * eating disorders within past year * cholelithiasis within past 6 months * type 2 diabetes * previous bariatric surgery * bipolar disorder or psychosis * steroid hormone therapy not stable for 3 months * systolic blood pressure \> 160 mmhg, diastolic blood pressure \> 100 mmhg
retrospective evaluation of photo-oxidized decellularized bovine pericardium in cardiac repair or reconstruction surgery

Conditions: Congenital Heart Disease; Cardiac Anomaly

Summary: the objective of this postmarket, retrospective, single center study is to evaluate the clinical outcomes of patients who have received photofix® decellularized bovine pericardium (photofix) as a patch within a cardiac surgical repair or reconstruction procedure. photofix is prepared from bovine pericardium, which is stabilized using a dye-mediated photo-oxidation process and sterilized using aseptic processing techniques.

this study will include a review of approximately 300 charts spanning the implant period of january 1, 2018 through june 30, 2019. those that meet the inclusion and exclusion criteria will undergo full review and data extraction to be captured in the electronic database. given the retrospective nature of the study design, a waiver of consent will be requested from the institutional review board (irb). potential subjects this study are pediatrics or adults who underwent cardiac repair surgery that necessitated the use of a patch. targeted cardiac procedures include intracardiac repair (including annulus and septal repair), great vessel repair (including superior vena cava, inferior vena cava, pulmonary arteries, pulmonary veins, and ascending aorta), and suture line buttressing and pericardial closure. follow-up data will be abstracted from the subject's medical record. study specific testing, including imaging and laboratory testing, will not be required.

Eligibility criteria:
inclusion criteria: * subject has undergone a cardiac procedure which falls within the indications for use and required the use of photofix decellularized bovine pericardium exclusion criteria: * subject required valve leaflet repair using photofix

Keywords: bovine pericardium patch cardiac repair cardiac reconstruction
effects of an amino acid-based hgh secretagogue on triiodythyronine

Conditions: Growth Hormone Treatment; Aging

Summary: in a recent randomized, double-blind, cross-over clinical trial, serum growth hormone (hgh) increased 682% above baseline 120 minutes after oral administration of an amino acid-based dietary supplement (serovital), p=0.01 vs placebo. in contrast to the mechanism of hgh stimulation by ghrelin, the investigators hypothesize that the supplement suppresses somatostatin, a know inhibitor of both hgh and tsh. to test this hypothesis, the investigators measured triiodothyronine (t3) after administration of the amino acid-base supplement.

two molecular targets that regulate the synthesis and secretion of human growth hormone (hgh) include 1) ghrelin, an endogenous ligand secreted by the stomach that also has appetite-stimulation properties distinct from its hgh-stimulating effects, and 2) somatostatin, a family of 14 and 28 amino acid peptides that act as a potent noncompetitive inhibitor of the release of hgh. the investigators recently reported that oral administration of a 2.9g/dose of serovital, a blend of l-lysine hcl, l-arginine hcl, oxo-proline, n-acetyl-l-cysteine, l-glutamine, and schizonepeta (aerial parts) powder, leads to a significant 682% mean increase in endogenous hgh levels in male and female subjects in a period of 120 minutes following acute consumption. in the work presented here, the investigators seek to characterize the mechanistic target associated with this measured increase in endogenous hgh by serovital, which the investigators hypothesize to be somatostatin. the investigators test this hypothesis by assaying thyroid function, a secondary inhibition target of somatostatin. the investigators further compare our findings to ghrelin-based hgh secretagogues.

Eligibility criteria:
inclusion criteria: * 12 healthy males and 4 healthy females * between 18 and 70 years exclusion criteria: * pregnant or nursing * taking any chronic medication including birth control pills.

Keywords: somatostatin thyroid hormone growth hormone
niv versus hfo versus standard therapy immediately after weaning from mechanical ventilation in ards patients

Conditions: Mechanical Ventilation Complication; Weaning Failure; Acute Respiratory Distress Syndrome; High-flow Oxygenation

Summary: the weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ards. the aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

hfno (high-flow nasal oxygenation and niv (non invasive ventilation) are to be randomly compared in the ards postextubation period.

Eligibility criteria:
inclusion criteria: ards exclusion criteria: severe icu-aquired weakness severe copd
comparison of idegasp (inclusive three explorative formulations) with insulin degludec and insulin aspart separately injected in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this trial is to compare insulin degludec and insulin aspart (idegasp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (novomix® 30) in subjects with type 1 diabetes mellitus. each subject will be randomised to four out of nine possible treatment arms. idegasp 40, idegasp 45, idegasp 55 and ideg high concentration were explorative formulations, not similar to the proposed commercial formulation.


Eligibility criteria:
inclusion criteria: * glycosylated haemoglobin a1c (hba1c) below or equal to 10.0 % based on central laboratory results * diagnosed with type 1 diabetes and treated with insulin for above or equal to 12 months * body mass index (bmi) between 18.0 and 27.0 kg/m\^2 (both inclusive) exclusion criteria: * a subject with a history of significant multiple drug allergies or with a known or suspected allergy to the trial product or any medicine chemically related to the trialproduct, as judged by the investigator * a subject who is known to have hepatitis or who is carrier of the hepatitis b surface antibodies, or has a positive result to the test for hiv antigen (hbsag) or hepatitis c antibodies * a subject who has participated in any other trials involving investigational products within the 3 months preceding the start of dosing
functional imaging reserve in neurohiv

Conditions: HIV

Summary: the purpose of this research study is to look at the brain's efficiency and ability to make up for deficits in the front of the brain to see if people living with hiv (plwh) are still able to perform well on various cognitive tasks even though there are other underlying processes at work, like inflammation, that affect the brain in a negative way. results of this study may provide insight into the pathophysiology of disease and may reveal arenas for future possible interventions in plwh who have impaired neuropsychological performance.

this proposal systematically characterizes brain efficiency and recruitment in virologically suppressed persons living with hiv (plwh) and demographically similar hiv uninfected (hiv-) controls. this proposal collects advanced functional neuroimaging that provide critical information about cerebral blood flow (cbf) and brain connectivity (functional connectivity strength; fcs); quantitative measures of immune dysfunction in the blood and cerebrospinal fluid (csf) (immune activation and immune exhaustion); and neuropsychological performance testing. this overall goal of this proposal is to delineate the interplay between dysfunction in frontal networks and recruitment of compensatory networks that underlie the neuropsychiatric symptoms seen in plwh.

Eligibility criteria:
inclusion criteria: * 20 to 80 years old * documented hiv infection for at least 1 year or confirmed hiv - status * plwh must be on stable cart regimen for at least 12 months with undetectable plasma hiv rna (less than 50 copies per ml) * at least 9 years of education * able to provide informed consent * if female, a negative pregnancy test and not breast feeding * able to undergo an mri scan exclusion criteria: * significant neurological disorders (e.g. stroke, head injury with loss of consciousness for more than 5 minutes, developmental learning disability) * active uncontrolled axis i psychiatric disorder according to the dsm 5 * current or history of substance use disorder (including, but not limited to amphetamines, cocaine, alcohol, opiates, and barbiturates) * prescribed blood thinners * allergic to lidocaine or similar anesthetic * history of any bleeding disorder * contraindication to mri scanning (e.g. claustrophobia, pacemaker, etc.) * pregnant or breastfeeding
efficacy and safety of atacicept in systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: this is a multi-center, double-blind, randomized, phase 2b trial to evaluate the efficacy of atacicept in subjects with systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * eligible male and female subjects, aged 18 years or older * must have at least moderately active sle, as defined as sle disease activity index-2000 (sledai-2k) score greater than or equal to \[\>=\] 6 at screening visit * at least 4 of the 11 american college of rheumatology (acr) classification criteria for sle (diagnosed \>= 6 months prior to the screening visit) * be seropositive for anti-nuclear antibodies (ana) and/or anti-double-stranded deoxyribonucleic acid (anti-dsdna) antibodies * other protocol defined inclusion criteria could apply exclusion criteria: * subjects have demyelinating disorder * severe central nervous system sle * use of cyclophosphamide within 3 months of the screening visit * urine protein:creatinine ratio (upcr) \>= 2 milligram per milligram (mg/mg) per day * other protocol defined exclusion criteria could apply

Keywords: atacicept placebo
effectiveness of a preoperative educational video for reducing opioid consumption after hand surgery

Conditions: Opioid Use; Hand Injuries and Disorders; Surgery

Summary: this study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery.

this study seeks to determine if watching a preoperative educational video influences opioid consumption and proper disposal following elective hand surgery. patients undergoing elective hand surgery are randomized to either watch a preoperative educational video or not. patients are asked to record their pain medication usage postoperatively, as well as their daily pain levels and satisfaction with their pain control after surgery.

Eligibility criteria:
inclusion criteria: * undergoing elective hand surgery * surgeon is planning to prescribe opioids for postoperative pain control exclusion criteria: * emergent surgery * surgeon not planning to prescribe opioids for postoperative pain control
targeted next generation sequencing and intellectual disability

Conditions: Intellectual Disability

Summary: the purpose is to determine the benefit of next generation sequencing (ngs) targeted on genes involved in intellectual disability for etiologic diagnosis of intellectual disabilities. in other words, it concerns the number of patients whose etiologic diagnosis will be established with ngs and could not with common techniques. actually, the molecular etiology of intellectual disability is crucial to calculate the risk of recurrence and allows the perinatal diagnosis to these families. secondary purposes are: 1. to determine the place of ngs in the strategy of etiologic diagnosis of intellectual disability, to determine the order of analyses performed for a patient with intellectual disability without clinical signs. 2. to evaluate the number of variants with unknown significance and thus non-usable for genetic counselling without supplementary analysis. 3. to determine the number of samples that can be at most pooled keeping a good efficacy of capture and results with suitable read depth 4. to determine the possibility of detecting copy number variations (cnvs) in genes of interest with ngs 5. to establish genotype/phenotype correlations for each gene for which a mutation has been identified 6. to optimize the software pipelining for a rapid analysis for diagnosis.


Eligibility criteria:
inclusion criteria: * moderate or severe intellectual disability * availability of patient and parent dna * no etiologic diagnosis with standard approaches: negative fragile x, normal pangenomic 180k and 1m array-cgh * informed consent of person having parental authority exclusion criteria: * non availability of parent dna * patient lost to follow-up