Kornimate/medical-research-clean huggingface dataset:
study comparing bivalirudin versus heparin in neonatal and pediatric ecmo

Conditions: Extracorporeal Membrane Oxygenation Complication; Pediatric ALL; Anticoagulants

Summary: the investigators will prospectively enroll 30 neonatal and pediatric ecmo patients at a single pediatric level 1 trauma center. the patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. there will be 15 patients in each arm for a total of 30 patients. primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.

the investigators will prospectively enroll 30 neonatal and pediatric ecmo patients at a single pediatric level 1 trauma center. the patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. there will be 15 patients in each arm for a total of 30 patients. the investigators hypothesize that neonatal and pediatric ecmo patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. the investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ecmo.

Eligibility criteria:
inclusion criteria: * age 1 day to less than 18 years * cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit * receiving venovenous or venoarterial ecmo exclusion criteria: * patients with known or suspected heparin induced thrombocytopenia prior to consent * patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values * patients with plan to decannulate from ecmo within 48 hours * known or suspected pregnant women * previous enrollment in this study * primary language spoken that is not english or spanish
feasibility of a minimally invasive diagnostic algorithm in suspected crohn's disease

Conditions: Crohn's Disease

Summary: the goal of this clinical trial is to learn whether a camera pill examination of the whole bowel can be used to diagnose crohn's disease instead of colonoscopy and a small bowel examination (either mri or camera pill) in patients aged 18-40 years suspected of having crohn's disease. the main question it aims to answer is: how many patients examined with a camera pill examination of the whole bowel will have a complete examination of the whole bowel and have a diagnosis made without need for any more examinations? researchers will compare with patients examined with colonoscopy and a small bowel examination. participants will: * be examined with either a camera pill examination of the whole bowel, or a colonoscopy and a small bowel examination * have their electronic medical records checked to see if a diagnosis has been made * have an interview every three months if diagnosed with an inflammatory bowel disease or after a year if no disease was found


Eligibility criteria:
inclusion criteria: * clinical suspicion of cd\* * age 18-40 years * signed informed consent \*a clinical suspicion of cd is based on the following definition: * diarrhea and/or abdominal pain for more than 1 month (or repeated episodes of diarrhea and/or abdominal pain) and either * fecal calprotectin ≥ 200 mg/kg or * fecal calprotectin ≥ 50 mg/kg plus one or more of the following findings: * c-reactive protein (crp) \> 5 mg/l * thrombocytosis (\> 400 x 109/l) * anemia (hemoglobin \ 0.5 mmol/l compared to the usual level) * prolonged fever (\> 37.5 ◦c for more than 2 weeks) * weight loss (≥ 3 kg or ≥ 5% compared to the normal body weight) * perianal abscess / fistula * family history of inflammatory bowel disease. exclusion criteria: * previous intestinal resection * positive serologic markers for celiac disease * positive stool polymerase chain reaction for pathogenic bacteria * positive stool polymerase chain reaction for intestinal parasites * suspected or established acute bowel obstruction (ileus) * intake of nsaids or acetylsalicylic acid ≤ 4 weeks before inclusion, except low-dose, prophylactic acetylsalicylic acid (≤ 150 mg per day) * intake of opioid or opioid-like medications ≤ 1 week before inclusion * pregnancy or lactation * inability to comply with protocol requirements, e.g. for reasons including alcohol or recreational drug abuse * known gastrointestinal disorder other than functional gastrointestinal disorders * renal failure defined by a plasma-creatinine above the normal reference range

Keywords: capsule endoscopy panenteric capsule endoscopy crohn&amp;#39;s disease inflammatory bowel disease
expectant moms managing attention-deficit/ hyperactivity disorder

Conditions: ADHD; Perinatal; Behavioral Intervention

Summary: the goal of this study is to test a behavioral program for pregnant individuals with adhd. this behavioral program focuses on skills for managing adhd and related symptoms in pregnancy and postpartum. this pilot effectiveness-implementation trial aims to (1) preliminarily evaluate the momma behavioral intervention compared to treatment as usual (tau) on clinical outcomes and (2) evaluate implementation outcomes, including feasibility and acceptability of clinic screening within existing ob workflows; assessment and intervention protocols; provider training/fidelity to manual; and all other study protocols from the perspective of real-world providers and participants.

treating pregnant individuals with adhd may improve parent and child wellbeing, parent-child interactions, and psychosocial familial factors to enhance family resilience and reduce prevalence/severity of child mental health disorders. the current study will test the momma (moms managing adhd) intervention and implement it via a randomized controlled trial (n= 60 pregnant women with adhd; 30 receiving the behavioral intervention and 30 receiving tau), delivered by women's health behavioral therapists. investigators will examine treatment acceptability, feasibility, and appropriateness, as well as implementation factors (fidelity, adherence, facilitators/barriers). in addition, quantitative data will be used to assess parent and child clinical outcomes, including maternal adhd symptom severity and impairment (primary), parent-child attachment, and infant temperament/behavior. finally, changes in target mechanisms (executive function and emotion regulation) and whether changes in the target are associated with change in clinical outcomes will be explored.

Eligibility criteria:
inclusion criteria: 1. meets full dsm-5 criteria for adhd 2. is between 14- and 22-weeks of gestation 3. 18 years of age or older 4. english speaking exclusion criteria: 1. substance use disorders requiring dual diagnosis treatment 2. intellectual disability 3. bipolar disorder, psychosis, and major depressive disorder with suicidal ideation 4. the following high complexity medical conditions during pregnancy: maternal cancer, multiples, placenta accreta, and/or fetus known to have a severe congenital condition

Keywords: adhd pregnancy perinatal mental health behavioral intervention parenting emotion regulation executive functioning
assessment of pharmacokinetics of single dose odanacatib (mk-0822) in participants with moderate hepatic insufficiency (mk-0822-070)

Conditions: Hepatic Insufficiency

Summary: this open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of mk-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to determine to what degree hepatic dysfunction may impact therapeutic blood levels of mk-0822. the primary hypothesis is that plasma auc0-∞ of odanacatib in participants with moderate hepatic insufficiency is similar to that in matched healthy participants following a single 50 mg oral dose.


Eligibility criteria:
inclusion criteria: * not currently pregnant, nursing or planning to be pregnant through-out the course of the study; agree to use specified contraception per protocol requirement * body mass index (bmi) of ≤ 39 kg/m\^2 (not obese) * judged to be in good health (for healthy participant population) * non-smoker for the past 6-months; social smokers (smoke less than 10 cigarettes within the past 3 months; or per discretion of the study investigator, quit smoking within the past 3 months. * diagnosed with chronic (more than 6 months), stable (no acute episodes of illness within the previous 2 months) hepatic insufficiency (liver dysfunction) with features of cirrhosis due to any cause (for the moderate hepatic insufficiency participant population) * possess the ability to understand the study, grant voluntary informed consent and willingly comply with all study requirements exclusion criteria: * does not meet the age requirement, is mentally or legally incapacitated, has or is expected to have significant emotional problems, or a history of a clinically significant psychiatric disorder * has been diagnosed with a disease or medical condition which may pose a risk to the participant or may confound the study results * compromised renal (kidney) function, significant organ system disease(s) or cancer(s) * unable to refrain from or anticipates the use of any new medication, including prescription and non-prescription drugs or herbal remedies * meets the requirements of the study in regard to current medication profile including: prescribed medications, caffeine, alcohol, over-the-counter drugs, herbals and nutritional products; with expected non-use of recreational (illicit) drugs associated with misuse, abuse and/or addiction * had surgery, donated 1 unit of blood or received another investigational study medication within 4 weeks prior to the study's first dose of investigational product * history of multiple and/or severe allergies, or has had a life-threatening reaction or inability to tolerate prescription or non-prescription drugs or food
spread of dermatophytes among families

Conditions: Onychomycosis; Tinea Pedis

Summary: the objective is to demonstrate person-to-person spread of dermatophytes of the skin and nails among family members, as measured by fungal culture and dna typing of the dermatophytes isolated.

enrolled families consist of at least two members over the age of 14. once the index person is examined and a dermatophyte is isolated from either toenail or foot scale, other family members are examined and cultured. all dermatophyte isolates obtained from each family unit are compared using dna typing and restriction length polymorphism (rflp) to determine whether family members share the same organism or were infected by an outside source.

Eligibility criteria:
inclusion criteria: positive dermatophyte culture - exclusion criteria: * use of antifungal agents, either oral or topical

Keywords: dermatophytes
the quality of life in individuals with parkinson's disease

Conditions: Parkinson Disease; Tremor; Functionality

Summary: this study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with parkinson's disease. the differences between parkinson's disease quality of life questionnaire, nine-hole peg test, grip and pinch strength values in the individuals with and without tremor in the study were investigated.

evaluating the relationship between quality of life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with parkinson's disease. this study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with parkinson's disease. fifty-two individuals with parkinson's disease participated in the study. quality of life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated. the relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with parkinson's disease. the results of individuals with and without tremor were compared.

Eligibility criteria:
inclusion criteria: * definite diagnosis of idiopathic parkinson disease * age between 40 and 80 years * being literate * having a grade between 1-4 from the modified hoehn and yahr scale * having a score lower than 11 in hospital anxiety and depression scale exclusion criteria: * who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity * using antidepressants * having vision loss * deep brain stimulation

Keywords: quality of life upper limb functionality tremor electromyography parkinson's disease
effect on the quality of life of a therapeutic education program in patients with marfan syndrome

Conditions: Marfan Syndrome

Summary: this is a before-after, observational, prospective, multicenter cohort study. the study will consist of 2 phases: an initial observational phase of a minimum of 3 months before the therapeutic education program (tep) intervention, then a phase of evolution analysis of at least 3 months.

during the first observational phase, the quality of life assessment will be carried out 3 months apart without intervention. the data obtained during this first phase will make it possible to characterize the functional impact in patients, to verify the reproducibility of our evaluations, and to evaluate the spontaneous evolution of the parameters over a period of 3 months. during the second phase of evolution analysis, the quality of life will be assessed at 3 month intervals (m9, m12) after the therapeutic education program (m6). the comparison between the evolution during the two phases, before and after the tep will allow us to assess the benefits of the tep.

Eligibility criteria:
inclusion criteria: * patient aged between 7 and 25 years old with marfan syndrome or related according to ghent criteria * for minors, no oral opposition from the holders of parental authority and consent of the minor. * for adults, no oral opposition collected * patient affiliated to a social security scheme or equivalent exclusion criteria: * inability of the patient to understand the content of the tep sessions or the questionnaire about quality of life (non-french speaking, severe intellectual disability) * patient who has already participated in a tep session for his pathology. * protected adult: patient under legal guardianship or curator protection
ultrasound vs. predetermined distance techniques for paravertebral nerve block in patients having breast surgery

Conditions: Mastectomy; Breast Neoplasms

Summary: the purpose of this study is to compare ultrasound and predetermined distance techniques for finding the paravertebral space to inject the local anesthetic (numbing medicine) when you are given anesthesia for surgery. the paravertebral space is located on either side of the spinal cord and contains the nerves that provide sensation to the chest wall. the predetermined distance technique is a series of measurements taken to determine the location of the paravertebral space where the local anesthetic is injected. the ultrasound technique uses direct visualization of the local anesthetic being placed in the paravertebral space. this type of anesthesia has many benefits including decreasing your pain after breast surgery.


Eligibility criteria:
inclusion criteria: * females age 25 - 85 * asa physical status i-iii * scheduled for primary mastectomy * ability to give informed consent exclusion criteria: * allergy to: local anesthetics fentanyl hydromorphone propofol midazolam * patient refusal * infection at the injection site * peripheral neuropathy * bilateral breast surgery * prior thoracic surgery on surgical side * severe spinal deformity * coagulopathy

Keywords: mastectomy breast cancer breast surgery
validation of biva for nutritional assessment in cirrhotic patients

Conditions: Liver Cirrhosis; Malnutrition

Summary: despite the importance of nutritional status in patient's outcome, there is no gold standard for nutritional assessment. traditional techniques used in healthy subjects to assess nutritional status cannot be used in cirrhotic patients due especially to ascites and peripheral edema, and altered rates of biochemical markers due to liver failure. bioelectrical impedance vector analysis has emerged as a useful method to assess body composition and nutritional status especially in patients at the extremes of body weight (fluid overload, excess of adipose tissue, etc.). with previous results from our research group, biva showed to be useful for evaluating cirrhotic patients. the aim of this study is to validate our previous results and validate biva for nutritional assessment in patients with liver cirrhosis


Eligibility criteria:
inclusion criteria: diagnose of liver cirrhosis by two or more of the following criteria: * albumin \< 3.4 g/dl * inr ≥ 1.3 * total bilirubin ≥ 2 mg/dl * portal hypertension (esophageal varices, splenomegaly, ascites, etc.) * liver biopsy * ambulatory patients exclusion criteria: * personal history of surgery in the last four weeks * thyroid disorders without replacement therapy * pregnancy * active alcoholism with alcohol ingest in the previous 6 months. * acute or chronic renal failure * hepatic or renal transplant

Keywords: bioelectrical impedance vector analysis nutritional assessment nutritional status mortality complications
serum parameter prior and after eus-guided fine needle aspiration of the pancreas

Conditions: Pancreatitis

Summary: endoscopic ultrasonography (eus ) -guided fine needle aspiration (eus -fna ) of focal pancreatic lesions is an essential diagnostic procedure with high therapeutic effect in clinical routine. the aim of this study is to determine the levels of serum lipase, serum amylase and the tumor marker ca 19-9 prior and after eus-fna. in animal experiments on dogs, an increase of all three parameters was observed after surgery on the pancreas. for humans, these clinically important data are not yet available . it is assumed that the probability of pancreatitis with increased activity of lipase and amylase will rise with the number of puncture procedures as well as the size of the puncture needle. in addition, the post-interventional assessment of the tumor marker ca 19-9 could result in a false positive assumption of malignant neoplastic pancreatic lesion.


Eligibility criteria:
inclusion criteria: * independent indication for pancreatic eus-fna * age ≥ 18 years * patient able to give informed consent exclusion criteria: * contraindications for eus-fna * pregnancy * no informed consent available * known stenosis of esophagus or duodenum * relevant coagulation disorders
the effects of california strawberries on parameters of cardiovascular health

Conditions: Childhood Obesity; Cardiovascular Disease

Summary: the prevalence of childhood obesity has been increasing over the past couple of decades. similar to adults, overweight and obesity in young children and adolescents is associated with an increased number of cardiovascular risk factors including dyslipidemia, hypertension, insulin resistance and type 2 diabetes. epidemiological and clinical studies suggest that foods and ingredients rich in select flavonoids, such as cocoa, red grape products, tea, citrus fruits, and strawberries are protective against the development of cardiovascular disease. strawberries are rich in flavonoids, particularly anthocyanins, flavanols, flavonols, ellagic acid and its glucose ester, ellagitanin. a number of in vitro studies have observed that these isolated compounds, as well as strawberry extracts have the potential to affect outcomes of cardiovascular health, including vascular reactivity, cellular signaling and oxidant defense6,7. we hypothesize that strawberry intake will lead to improvements in select measures of cardiovascular function in overweight and obese adolescent males.


Eligibility criteria:
inclusion criteria: * male subjects, age 14 - 18 years. * bmi for age and gender \>75th percentile (based on cdc growth charts) * subject is willing and able to comply with the study protocols. exclusion criteria: * inability to wear pat probes * inability to remain still and remain quiet during test procedures * bmi for age and gender ≤ 75th percentile (based on cdc growth charts) * the use of medications that affect vascular function * regular use of dietary supplements during the last 6 months * blood pressure for age, gender and height ≥95th percentile * chronic/routine high intensity exercise or current participation in a sports program * self/parent reported use of anticoagulation agents including nsaids * self/parent reported use of oral cortisone or other immunosuppressive agents, * self/parent reported underlying neoplasia or immunological disease * self/parent reported diabetes * food faddists or those taking a non-traditional diet * allergies to fruit * abnormal liver, cbc or chemistry panels (laboratory values outside the reference * range) if determined to be clinically significant by the study physician. * self/parent reported malabsorption (e.g. difficulty digesting or absorbing nutrients from food, potentially leading to bloating, cramping or gas). * asthma (can be worsened by mild to moderate food allergies).

Keywords: strawberry, cardiovascular, obesity, adolescent
bispectral index (bis) for classification of procalcitonin (pct) sepsis grades in critically ill patients with sepsis

Conditions: Sepsis, Severe

Summary: to evaluate the discriminative power of bis monitoring to classify the degree of mental state associated with the pct graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis.

to evaluate the discriminative power of bis monitoring to classify the degree of mental state associated with the pct graded sepsis cascade, and to assess its utility for monitoring the improvement or deterioration of sepsis. the primary endpoint of our study was to use an artefact-free 10-min mean bis value to classify the degree of sepsis. as secondary endpoints, we correlated the mean bis value to various mental state and sepsis parameters; pct, c-reactive protein (crp), glasgow coma scale, and sequential organ failure assessment (sofa) score. in a longitudinal study, patients' pct sepsis grades were reassessed at a later time point and a second artefact-free 10-min mean bis value was recorded to evaluate bis evolution within the same patient.

Eligibility criteria:
inclusion criteria: patients with sepsis * patients with sepsis exclusion criteria: * patients who received drugs that would interfere with bis monitoring
a phase 1/2 study of an investigational drug, aln-cc5, in healthy adult volunteers and patients with pnh

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of aln-cc5 in healthy adult volunteers and subjects with pnh


Eligibility criteria:
inclusion criteria: * adequate complete blood counts, liver and renal function * 12-lead electrocardiogram (ecg) within normal limits * female subjects of child bearing potential agreeing to use a protocol specified method of contraception * male subjects agreeing to use protocol specified methods of contraception * willing to provide written informed consent and willing to comply with study requirements exclusion criteria: * any uncontrolled or serious disease, or any medical or surgical condition, that may interfere with participation in the clinical study and/or put the subject at significant risk * received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study * history of multiple drug allergies or intolerance to subcutaneous injection * parts a and b of the study: used prescription medications within 14 days or 7 half-lives of administration of the first dose of study drug. * history of meningococcal infection

Keywords: pnh rnai therapeutic