Kornimate/medical-research-clean huggingface dataset:
comparison of the analgesic effect between intrathecal morphine and iv-fentanyl patient controlled analgesia (itm-ivpca) and epidural pca (pcea) in patients undergoing gastrectomy -randomized allocation study-

Conditions: Gastric Cancer

Summary: the present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (itm-pca) compared to patient controlled epidural analgesia using fentanyl and repivacaine (pcea) in patients undergoing gastrectomy. the investigators hypothesized that itm-pca would show comparable analgesic effect to pcea in gastrectomy.


Eligibility criteria:
inclusion criteria: * i or ii of preoperative physical status classification by the american society of anesthesiologists. * more than 20 years old. * undergoing gastrectomy due to gastric cancer. exclusion criteria: * contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly. * prior history of abdominal surgery or spine surgery.

Keywords: patients with undergoing gastrectomy
cardio-ttranssform nuclear imaging study

Conditions: Amyloidosis; Transthyretin Amyloid Cardiomyopathy

Summary: the investigators will evaluate the change in myocardial uptake of 99m-technetium pyrophosphate (tc-99m pyp) tracer on serial planar and spect imaging in patients enrolled in the cardio-ttransform clinical trial (nct04136171).

this is a multicenter trial of 80 subjects enrolled in the cardio-ttransform randomized clinical trial (nct04136171) who will undergo baseline and follow up tc-99m pyp to assess for the change in myocardial uptake of the tracer.

Eligibility criteria:
inclusion criteria: * patients who were screened and eligible to be enrolled or have been already enrolled in the cardio-ttransform randomized clinical trial (nct04136171) and have a baseline 99m-technetium pyrophosphate planar and spect imaging done within 12 months prior to screening for cardio-ttransform. * patients have to meet the inclusion and exclusion criteria of cardio-ttransform trial to be enrolled. * patient willing to consent for the study and undergo the study procedures. exclusion criteria: * none

Keywords: pyrophosphate scintigraphy bone scintigraphy eplontersen tafamidis
congenital uterine anomalies: identifying cancer associations and genetic and environmental factors to improve clinical care

Conditions: Congenital Uterine Anomaly

Summary: the purpose of this research study is to learn more about the health outcomes associated with congenital uterine anomalies (cuas), and the possible environmental and genetic causes of the condition. the researchers plan to investigate whether any cancer associations (with breast, renal, ovarian, vaginal and uterine cancers) exist in females with cuas. the investigator will also investigate any environmental and genetic factors that may be responsible for causing cuas.

aim 1: to identify female subjects diagnosed with a congenital uterine anomaly (cua) receiving care at yale new haven health. aim 2: identify (i) the prevalence of renal, breast, ovarian, uterine and vaginal cancers associated with cuas, and (ii) the association of environmental factors, via a survey obtained by phone, email or interview. aim 3: conduct genetic evaluation of the index subjects, parents, sister(s) (as feasible), and female offspring to identify potential causes and patterns of inheritance using whole exome sequencing (wes) and microarray. following informed consent, blood will be collected for genetic evaluation. dna will be extracted from edta-blood and analyzed using an integrated approach of microarray for copy number variations (cnv), and whole exome sequencing (wes) for single nucleotide variation (snv). undertaking review of the medical records will identify the cohort of patients we wish to survey to then ascertain further information regarding their cua diagnosis and other related details. the information to be elicited from the survey are outlined in the attached survey questions. key associations we seek to investigate include (1) the type and prevalence of renal, breast, ovarian, uterine and vaginal cancers among patients with mullerian anomaly, and (2) identifying potential in-utero exposure to particular environmental agents in patients with cuas. review of the medical records will enable us to undertake this first key step of establishing a cohort of subjects with ma and an initial data set related to their specific health information. we anticipate further investigations may build upon this initial data set, both with the cohort established, and more broadly with collaborators and additional national and international cohorts of patients with ma.

Eligibility criteria:
inclusion criteria: * females * age: 13 or older * encounters limited to: yale new haven hospital, bridgeport hospital, greenwich hospital and lawrence+ memorial hospital. * diagnosis of any variation of cua exclusion criteria: * who will decline to participate in a study upon contact * non-english speaking except spanish speaking * unable to participate in consent or assent process due to mental disability

Keywords: cancer associations environmental factors
hemp oil + user experience study

Conditions: General Wellbeing; Gastrointestinal Health; Physical Discomfort; Sleep; Mood

Summary: presented as an online survey, this study seeks to better understand how thorne customers are using and experiencing the new hemp oil + product and how they feel it compares in the marketplace. hemp oil + is a combination product with a proprietary blend of hemp, clove, black pepper, hops, and rosemary extracts. people who have independently elected to purchase and use hemp oil + before the study starts will be invited to voluntarily participate. if they meet study requirements and give consent they will answer questions online about their experience with hemp oil +. questions address general demographics and wellness, general impressions of the product, how it compares to other products, and any effect it has had on their gastrointestinal health, physical discomfort, sleep, and mood. the survey is expected to take 15-30 min of participant time. data will be analyzed to determine whether the customer experience with hemp oil + is as favorable as it seems from anecdotal reports. analysis will also be conducted to find patterns that can inform future studies, marketing, and customer education efforts.


Eligibility criteria:
inclusion criteria: * has personally used at least one bottle (30 gelcaps) of hemp oil + * provides consent to participate in the study exclusion criteria: * cannot access or use the electronic survey for any reason * was pregnant or nursing when taking hemp oil + * is a thorne employee not willing to participate without compensation
pre-op sildosine and ureteral dilation during f-urs

Conditions: FURS; Ureteral Dilatation; Sildosine

Summary: we proposed that silodosin administration preoperatively may facilitate ureteral access sheath (uas) placement prior to flexible ureteroscopy (f-urs) and decrease the incidence of ureteric injury in some difficult cases.

urolithiasis is a common urological disorder in the world and has a significant effect on the global health system. the goal of treatment is to achieve the highest stone-free rate (sfr) with the least invasive. per¬cutaneous nephrolithotomy and flexible ureterorenoscopy (f-urs) are the two main minimally invasive procedures for the treatment of upper urinary tract stones. the challenging step in flexible ureterorenoscopy (f-urs) is ureteroscopic access sheath (uas) placement, which facilitates fast and safe access to the ureter and collecting system; improves visibility; reduces the risk of infection by reducing intrarenal pressure. however, in some cases, the acute ureteric injury may occur during ureteroscopic access sheath (uas) placement.

Eligibility criteria:
inclusion criteria: * upper ureteric stone or stone kidney (with stone burden equal to or less than 20mm). * 2. non stented. * age (above 18 years old). exclusion criteria: * acute or chronic renal insufficiency. * uncorrected coagulopathy. * previous open (lumber or ureteric) surgery. * active urinary tract infection unless treated.
the efficacy of sinofresh nasal and sinus care nasal spray in eliminating mrsa from the nasal cavity

Conditions: MRSA Infection

Summary: this is a study to assess the ability of sinofresh nasal \& sinus care, an fda approved over-the-counter nasal spray, to eliminate the bacteria in your nose.


Eligibility criteria:
inclusion criteria: * 18 years or older * the volunteer is able to adhere to the study requirements and study visits. * agrees to abstain from use of other nasal sprays for length of study. * diagnosis of an mrsa carrier by pcr testing exclusion criteria: * history of chronic nose bleeds. * history of intranasal steroids in the last 2 months * nasal obstruction severe enough to prohibit effective delivery of a nasal spray * epistaxis * significant excoriation in the opinion of the investigator. * known hypersensitivity to any ingredients

Keywords: mrsa sinofresh nasal spray
the effects and mechanisms of mindfulness based cognitive therapy (mbct) on depressive symptoms and depression relapse

Conditions: Major Depressive Disorder; Recurrent

Summary: this research proposal is intended to elucidate the efficacy and mechanisms underlying mindfulness based cognitive therapy (mbct) in a population in remission from recurrent major depressive disorder (mdd). the first objective of the study is to replicate previous studies' findings of mbct's effects on decreasing depressive symptoms and depression relapse rates. however, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of mbct to an active control condition (acc). the use of a well-designed acc will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to mbct lead to its salutary effects (aim 1). previous mbct studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of mbct. further, few studies have examined the mechanisms underlying effects of mbct on depressive symptoms and relapse. theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of mbct. therefore, the investigators propose to assess each of these potential mechanisms of mbct using self-report, autonomic physiological, and reaction time tasks (aim 2). collectively, these aims are expected to strengthen the evidence base for mbct while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.


Eligibility criteria:
inclusion criteria: * must comprehend english well * be 18-55 years of age * meet enhanced dsm-iv criteria for remission of mdd, recurrent and have a history of three or more previous episodes of dsm-iv major depression in the absence of a history of mania or hypomania * at least one of those episodes was within the past two years * participant must be in remission and if on antidepressant medication (adm), they must be on a stable dose with no change in type or amount for past 12 weeks or participants must be off adm at t1 for at least the preceding 12 weeks * have, at screening assessment, residual depressive symptoms indicated by a beck depression inventory-ii (bdi-ii;\[72\]) score between 6-19. exclusion criteria: * bipolar disorder * schizophrenia or borderline personality disorder * current suicidal thoughts and/or suicide attempt in last two months * current anxiety disorder if it constitutes the predominant aspect of the clinical presentation and requires primary treatment not offered in the project * substance abuse or dependence within last three months * dementia or subnormal intellectual potential * current obsessive-compulsive disorder * current eating disorder * history of previous mindfulness training or more than eight lifetime sessions of cbt * current use of psychotherapy or counseling

Keywords: mindfulness clinical trial intervention prevention
social cognition and interaction training for autism

Conditions: Autism; Social Behavior

Summary: purpose: to collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. the therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions. participants: cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions. procedures: participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. the post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. the entire study duration is expected to be approximately 17 weeks. these outcome measures will measure the effectiveness of the treatment.


Eligibility criteria:
inclusion criteria: 1. between the ages of 13-69. 2. symptoms of a neurodevelopmental disorder. 3. english as primary language and ability to speak in fluent, full length sentences: treatment will be conducted in a group setting in english. exclusion criteria: 1. inability to speak english fluently.
aerobic exercises for multiple sclerosis

Conditions: Multiple Sclerosis, Primary Progressive

Summary: multiple sclerosis (ms) is a chronic inflammatory demyelinating disease of the central nervous system (cns) .it is the most common neurological disorders affecting young adults.multiple sclerosis is an autoimmune disease that results in progressive neural degeneration. cytokines play an important role in the pathogenesis and treatment of ms.

this research aims to evaluate the effect of aerobic exercises on the immune system anti-inflammatory (il-10) and pro inflammatory (il-17) cytokines and its consequences on the functional status in the multiple sclerosis patients. aerobic exercises are a term to describe planned, structured and repetitive physical activity undertaken over a prolonged period to maintain or improve physical fitness and functional capacity .

Eligibility criteria:
inclusion criteria: age ranged from 25 to 45 years. all the patients were remitting relapsing ms according to (revised mcdonald criteria. duration of ms disease was one to two years before starting of the study. last attack occurred three months ago. all patients were able to ambulate exclusion criteria: patients with other neurological deficits , patient with significant orthopedic abnormalities for both lower limbs, patient with contracture , patient with deformities, pregnant females

Keywords: multiple sclerosis aerobic exercises cytokine il-10 cytokine il-17
safety, and immunogenicity of two influenza vaccines in healthy subjects 3 to 64 years old

Conditions: Influenza

Summary: this protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a novartis conventional influenza vaccine licensed in the eu and many other worldwide countries, according to the us fda draft guidance for industry "clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in march 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a novartis conventional influenza vaccine already licensed in us. the purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.


Eligibility criteria:
inclusion criteria: * healthy subjects 3 to 64 years of age exclusion criteria: * receipt of other investigational products within 3 months or other vacine within 1 month; * allergy to eggs, egg products, or any other vaccine component; * laboratory confirmed influenza disease within 6 months; * have previously received an influenza vaccination (3 to 8 years only);

Keywords: influenza, egg-derived, healthy children, healthy adolescents, healthy adults, safety, immunogenicity, trivalent, inactivated, vaccination
immunomediated non-alcoholic steatohepatitis; prevalence and characterization. instinct study

Conditions: Main Hypothesis is That in the NASH Associated to IMIDs, to Different Phenotypes co Exist

Summary: nafld is a common comordidity in patients with imid, including inflammatory bowel disease and psoriasis. nevertheless, the prevalence of nafld and nash in the imid population is not clear, and the risk factors are not completely understood. interestingly, nash and most of imids share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on tnfa or imbalance in t cell subtypes like th17/treg. this common pathogenesis may explain, at least in a subset of patients, the development of nash in the absence of classic metabolic risk factor. thus, our main hypothesis is that in the nash assciated to imids two different phenotypes co-exist. first, a predominantly inflammatory phenotype, and not associated to the metabolic syndrome ande second, a predominantly metabolic phenptype, strongly associated to he metabolic syndrome. in this way, we believe that in a particular subset of nafld patients, nash could be considered as an imid, as most of the definiting features of imids are present. to demonstrate our hypothesis, we consider a two-stage study. first, we will determine the nafld and nash prevalence in a cohort of well-characterized imid patients and controls. second, we will adress the molecular and immunophenotype characterization in liver biopsies of nash patients with and without the co-existence of imids.


Eligibility criteria:
inclusion criteria: * nafld with biopsy proven disease above 18 years * imid patients above 18 years * all participants must give informed written consent exclusion criteria: * patients who had any clinical evidence of malignancy * other secondary cause of chronic liver disease. alternative causes of liver disease included excessive alcohol intake (higher than 20 g/day in women and 30 g/day in men), viral hepatitis, chronic alcohol consumption, autoimmune hepatitis, wilson´s disease, alpha-1-antitripsine deficiency, inborn errors of metabolism or drug induced liver injury
study of safety and efficacy of hdm201 in combination with lee011 in patients with liposarcoma

Conditions: Liposarcoma

Summary: to determine the mtd/rp2d of the hdm201 and lee011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.


Eligibility criteria:
inclusion criteria: * patients with histologically documented, locally advanced or metastatic wd/dd liposarcoma who have received at least one prior systemic therapy * patients with radiologic progression, defined by recist v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment * ecog performance status of 0-1 exclusion criteria: * prior treatment with compounds with the same mode of action * patients with tp53 mutated tumors, if the molecular status is known * symptomatic central nervous system metastases * inadequate organ function * previous and concomitant therapy that precludes enrollment, as defined by protocol other protocol-defined inclusion/exclusion criteria may apply.

Keywords: liposarcoma mdm2 inhibition cdk4 inhibition hdm201 lee011
migraine inducing effects and changes in brain haemodynamics of pgi2

Conditions: Headache; Migraine; Vasodilatation

Summary: we hypothesised that intravenous infusion of pgi2 induced headache or migraine and cranial vasodilatation in migraineurs.


Eligibility criteria:
inclusion criteria: * migraine without aura and healthy apart from that * age 18-55 years * 50-100 kg * secure contraceptives exclusion criteria: * tension type headache more than 3 time a month * other primary headaches * medication prior to the study (closer than 4 times plasma halflife) * migraine or headache 5 days prior to study. * hypertension (systolic bp \>150 mmhg and/or diastolic bp \>100 mmhg). * hypotension (systolic bp \<90 mmhg and/or diastolic bp \<50 mmhg). * heart-vessel disease of any kind incl cerebrovascular disease. * anamnestic or clinical signs of psychiatric disease or abuse. * anamnestic or clinical signs of disease of any kind relevant for participation in the study.

Keywords: headache migraine vasodilatation
placental transfusion effect on hemodynamics of premature newborns

Conditions: Pre-Term

Summary: the objective of this study is to perform ultrasound doppler measurements to evaluate the hemodynamic changes associated with different methods of placental transfusion (intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life.

this study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at alexandria university children's hospital. evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (nicu) at alexandria university children's hospital.

Eligibility criteria:
inclusion criteria: * premature neonates ≤ 32 weeks gestational age regardless birth weight who will be admitted to neonatal intensive care unit in the first day of life. exclusion criteria: * preterm babies \>32 weeks * major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies). * evidence of head trauma causing major intracranial hemorrhage. * monochorionic multiples. * concern for abruptions, placenta previa or retroplacental hematoma. * cord accident, or avulsion at the time of delivery. * refusal to perform the intervention by the obstetrician
cardiac ct angiography in patients with acute ischemic stroke

Conditions: Acute Ischemic Stroke; Coronary Artery Disease

Summary: mortality rates after acute ischemic stroke remain high despite continuously improving treatment. in this context, it is important to note that a relevant portion of acute ischemic stroke patients die from adverse cardiovascular events, such as myocardial infarction, rather than from complications associated with the stroke itself. a possible reason might be that this patient group often suffers from at least moderate asymptomatic coronary artery disease. this study seeks to integrate cardiac computed tomography angiography into the standard-of-care diagnostic protocol of acute ischemic stroke. the aim of this prospective mono-centric trial is to enable accurate diagnosis of therapy-relevant coronary artery disease, other concomitant cardiac findings and cardiac causes of acute ischemic stroke, without delaying stroke therapy. in the long-run, the goal is to investigate whether cardiac computed tomography angiography and the resulting therapeutic measures (interventions or medications added) can improve functional outcome and rate of adverse cardiac complications in patients with acute ischemic stroke compared to a retrospective matched-cohort of patients without cardiac ct imaging.


Eligibility criteria:
inclusion criteria: * patients aged 40 years or above, presenting at the emergency department of the university medical center hamburg-eppendorf with a suspected acute ischemic stroke and a relevant neurological deficit (nihss score \> 4). exclusion criteria: * a causal differential diagnosis for the acute stroke syndrome with absent intracranial vessel occlusion. * no correlation for the patients' symptoms in the cranial cta (no vessel obstruction).

Keywords: computed tomography angiography