Kornimate/medical-research-clean huggingface dataset:
analgesia in children using caudal epidural ropivacaine

Conditions: Inguinal Hernia; Circumcision

Summary: caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. it has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (tobias et al 1994). furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (conroy et al 1993, tobias et al 1995, tobias 1996). this proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. we hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements


Eligibility criteria:
inclusion criteria: 1. age 2 months to 2 years 2. weight 25kg or less 3. asa class 1, 2, 3 4. elective inguinal herniorrhaphy or orchiopexy exclusion criteria: 1. contraindications to caudal epidural analgesia 2. parent's refusal 3. skeletal or spinal cord anomaly 4. coagulopathy 5. infection at the insertion site 6. ongoing bacteremia 7. allergy to ropivacaine

Keywords: caudal epidural analgesia elective circumcision elective inguinal herniorrhaphy
a pilot study to assess microrna biomarkers in early and later stage multiple sclerosis

Conditions: Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Clinically Isolated Syndrome

Summary: this study will look at the blood and cerebrospinal fluid of consented participants who either have early stage multiple sclerosis (clinically isolated syndrome) or who have later stage (secondary progressive multiple sclerosis), or participants who do not have any neurological or autoimmune illness. biomarkers and microrna will be assessed for group differences.

multiple sclerosis is a chronic autoimmune disorder of the central nervous system. while there are current immunomodulatory therapies that have been shown to be efficacious in the early stages of ms, these therapies are less potent in the later phases of ms. we can look at magnetic resonance imaging with gadolinium to measure active disease but it does not detect axonal degeneration. therefore, there is a need to identify other biomarkers that may be used to diagnose ms and predict disease progression. biomarkers found in the cerebrospinal fluid (csf) are in closer proximity to the inflammatory lesion sites and are more sensitive. this pilot study seeks to characterize differences in microrna profiles and cell products in the early and later stages of ms, with the hope that that microrna profiles could then be correlated to clinical and csf inflammation indexes. csf will be obtained from 45 participants.

Eligibility criteria:
inclusion criteria: * able to understand and agree to informed consent; * male or female patients 18-68 years of age * no disease modifying therapy 60 days prior to baseline * edss score of less than or equal to 3.0 if a cis patient; or less than or equal to 7.5 if spms patient * labs within normal range no greater than 2 times the uln or at the discretion of the pi * weight 46 kilograms to 127 kilograms inclusive * no active systemic infection * not currently pregnant or breast feeding * no history of corticosteroid treatment or relapse within 60 days prior to baseline. exclusion criteria: * not able to understand informed consent * if any of the inclusion criteria is not met * hiv infection, or current active hepatitis b or c infection, positive hcvab or hbsag or hbcab * positive pregnancy test * patient withdraws consent * coumadin use within 60 days prior to baseline

Keywords: multiple sclerosis secondary progressive multiple sclerosis clinically isolated syndrome
gastric and intestinal satiation in obese and normal weight healthy people

Conditions: Endocrine System Diseases

Summary: the purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. these facts demonstrate the need for an improved understanding of the pathogenesis of obesity. the gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. to achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (glp-1), peptide tyrosine tyrosine (pyy) and ghrelin levels between normal and obese healthy volunteers. time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13c-octanoic acid breath test; and plasma glp-1, pyy and ghrelin levels will be measured after a standardized nutrient drink.

Eligibility criteria:
inclusion criteria: * healthy subjects * age 18-45 exclusion criteria: * smoking * substance abuse * regular intake of medication * medical or psychiatric illness * gastrointestinal disorders or food allergies

Keywords: glucagon-like peptide-1 peptide tyrosine tyrosine ghrelin stomach small intestine gastric emptying
a bioequivalence study comparing a fixed dose combination formulation, rin 150 and individual reference drugs in healthy volunteers

Conditions: Healthy Volunteers

Summary: this is a bioequivalence study to evaluate the bioequivalence of rin 150 against individual reference drugs in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive hepatitis b surface antigen or hiv serology results; * pregnant or nursing female; * history or active tuberculosis; * participated in investigational drug studies within 3 months; * used prescription or nonprescription drugs within 7 days or 5 half-lives.

Keywords: bioequivalence rin 150 healthy volunteers
dynamic f-dopa pet for differential diagnosis between recurrence and radionecrosis of brain metastasis

Conditions: Brain Metastases; Radiation Necrosis

Summary: contrast-enhanced magnetic resonance imaging is the most widely used examination for detecting the presence of brain metastasis. functional sequences such as perfusion weighted imaging makes it possible to differentiate tumor recurrence from cerebral radionecrosis. however, this imaging technique may exhibit limitations, especially for brain lesions consisting of a mixture of necrotic tissue and tumor progression or depending on the location of the lesion in the brain. the use of 18f-dopa pet is another option available to oncologists. many studies on gliomas showed the superiority of this imaging technique over contrast-enhanced mri. however, this imaging solution has been very poorly studied for brain metastases. the new pet technology equiped with silicon detectors makes it possible to obtain greater sensitivities than those of previous generations. it also make possible to obtain images in very short acquisition times. after injection, the hardware allows to obtain the perfusion kinetics of the lesion thanks to a very short temporal sampling (i.e. three seconds). the main objective of this pilot study is to evaluate the association between early activity measurements (\< 4 minutes post-injection) of 18f-fdopa in pet and the differential diagnosis between radionecrosis and recurrence of cerebral metastases treated by radiotherapy.


Eligibility criteria:
inclusion criteria: * patient referred for cerebral 18f-fdopa pet examination prescribed as part of his usual medical care for brain metastasis * age ≥ 18 years old * affiliation to a social security program * ability of the subject to understand and express opposition exclusion criteria: * age under 18 * person under guardianship or curators * pregnant woman

Keywords: silicon pet/ct 18f-dopa short time examination brain metastases radiation necrosis
primary dysmenorrhea and osteopathic treatment

Conditions: Pelvic Pain; Pelvic Pain Syndrome; Sexual Dysfunction

Summary: this study is adressed to women with primary dysmenorrhea, it´s a gynecological disorder that is defined as colicky pain associated with menstruation and is located in the lower abdomen and in the lumbo-pelvic area. it appears between the first 8-72 hours and four days of the menstrual cycle and affects almost 85% of women, 30% of them severely. this study aims to demonstrate that osteopathic manual therapy is an effective therapeutic option in patients with primary dysmenorrhea. another objective is to verify that osteopathic manual treatment provides an improvement in the intensity of pain, quality of life and a reduction in the consumption of medicines in these patients.

it will be a prospective study, a double-blind randomized controlled clinical trial. the sample group will include 60 patients, between 18 and 30 years old divided into two experimental groups. the experimental group (n = 30) will be treated following an osteopathic treatment, through a bilateral global pelvic manupulation (gpm) and a specific internal technique for mobility of the cervix, and the control group (n = 30) will only carry out a bilateral gpm. a measurement will be made before the first treatment, another after each session, and the last one two weeks after the last intervention (anthropometric measurements, quality of life questionnaire, sexual health, osteopathic tests, pressure point with algometer, pain and medicines consumption). the established outcome measures are: pain intensity according to the visual analog scale (vas), depression points measured with an algometer, a health-related quality of life questionnaire, questionnaire sexual health and sexual dysfunctions, and the measurement of drug consumption.

Eligibility criteria:
inclusion criteria: * crampy pain in the lower abdomen or lumbo-pelvic area between 8 hours and 4 days after menstrual bleeding. * clinical evolution of at least three menstrual cycles with said pathology. * moderate menstrual pain or severe intensity, minimum 5 vas scale. * regular menstrual cycle, between 21 and 35 days. * accept informed consent. exclusion criteria: * being receiving any other physiotherapeutic or pharmacological treatment for primary dysmenorrhea during the 3 weeks prior to the beginning of the intervention. * suffering from cardiovascular diseases, prolapse, amenorrhea, hemophilia, tumor or infectious processes, use of iuds, consumption of oral contraceptives or suffering from any injury that affects the sensory-motor function.

Keywords: primary dysmenorrhea spinal manipulation pelvic pain pain threshold sexual dysfunctions osteopathic treatment manual therapy visceral manipulation
feasibility testing a shared decision making intervention for people with kidney failure, their relatives, and the health professionals in kidney services: a pilot randomized controlled trial study protocol

Conditions: Kidney Failure; End of Life

Summary: the aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.

the objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. the intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. we will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. the research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process. the desire trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. randomization will be performed as block randomization with a 1:1 allocation.

Eligibility criteria:
inclusion criteria: * adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. inclusion criteria will be adults ≥75 years of age, with an estimated glomerular filtration rate \<15, and not suited for a kidney transplant. exclusion criteria: * adults who are cognitively unable to participate will be excluded from the research.

Keywords: shared decision making patient decision aid
post marketing surveillance study for onivyde® in south korea

Conditions: Metastatic Pancreatic Cancer

Summary: the purpose of this study is to characterize the safety of onivyde when used under standard clinical practice in south korea; and to describe effectiveness in patients receiving onivyde in combination with 5-fluorouracil (5-fu) and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in south korea.


Eligibility criteria:
inclusion criteria: patients who are prescribed onivyde per investigator's judgment shall be included if: * patient / legally authorized representative/ family member gave written informed consent * patient is indicated for treatment according to onivyde south korea prescribing information * histologically or cytologically confirmed adenocarcinoma of exocrine pancreas * documented metastatic disease * patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy * adequate hepatic, renal and hematological function exclusion criteria: * patients enrolled in servier sponsored onivyde registry or any other servier sponsored onivyde study * patients who have experienced severe hypersensitivity reaction to onivyde or irinotecan hcl * patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation of interstitial lung disease. patients with confirmed diagnosis of interstitial lung disease
genetic predictors of incident cardiovascular disease

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to evaluate how current genetic information about cardiovascular disease susceptibility genes contributes to the prediction of future cardiovascular disease outcomes.

background: during the 1980s and 1990s, genetic research in cardiovascular disease (cvd), as well as other common chronic diseases, has been dominated by single gene linkage and association studies focused on understanding of the genetics of prevalent disease. rarely have there been studies of the longitudinal predictive value of these genetic variations. furthermore, few studies have attempted to address the complex and high-dimensional genetic reality that underlies an individual's risk of disease. a crucial next step in cvd genetic research is the evaluation of the contribution of variations in many genes simultaneously, and their interactions with traditional risk factors, to the longitudinal prediction of cvd in individuals and families. design narrative: the study uses participants from the rochester family heart study (rfhs) which provides one of the richest genetic epidemiological resources for this type of study. the rfhs represents 3941 individuals distributed among 552 three- generation pedigrees ascertained without regard to health status during two phases of collection. phase i was from 1984 - 1988 and phase ii was from 1988 - 1991. these participants have extensive demographic, physiological, genetic, and clinical information measured at baseline. this study builds upon this already established resource by conducting a longitudinal follow-up of the rfhs participants to address two central questions: 1) do measured genetic variations in known susceptibility genes provide additional predictive information about risk of future cvd outcomes beyond the information provided by more traditional risk factors? and 2) do these measured genetic variations explain patterns of disease aggregation in families and can these patterns be used to predict disease in future generations?

Eligibility criteria:
no eligibility criteria
parenteral nutrition light protection and premature outcomes

Conditions: Premature Birth

Summary: investigators propose a prospective study to investigate the effect of full light protection of the pn on cholestasis and other oxidative stress associated diseases in premature infants when they receive pn for more than one week. each infant enrolled in this study will receive full pn light protection including the pn bag, lipids and tubing. demographic characteristics, clinical outcomes (incidence of cholestasis, feeding tolerance, bpd, rop, nec and mortality) and oxidative stress markers (e.g., carboxyhemeglobin) will be evaluated. phase one of this study employed a retrospective chart review methodology to evaluate the effect of no pn light protection vs partial pn light protection (pn solution only while it's the tubing and lipids remained exposed to light). infants from phase one of this study will serve as the controls in the evaluation the effect of full pn light protection on the cholestasis, clinical outcomes and oxidative stress. investigators propose to collect urine and saliva samples in infants who we expect to receive pn for a minimum of 5 days, on days 0, 3, 5 and every 7 days after tpn initiation until 2 weeks after the end of iv nutrition to evaluate oxidative stress.


Eligibility criteria:
inclusion criteria * preterm infants \<32 weeks of gestation, who receive tpn for a minimum of 5 days * infants with gastrointestinal surgical problems (e.g., ileal atresia, gastroschisis), expected to receive tpn for a minimum of 5 days exclusion criteria * infants who receive tpn for \<5 days * infants who developed cholestasis due to non-tpn-related causes
use of expressive writing in irritable bowel syndrome (ibs)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to test whether disease-related expressive writing is effective in the treatment of irritable bowel syndrome (ibs).

expressive writing involves writing about traumatic, stressful or emotional events. expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, and pain. given its simplicity, and obvious advantages in terms of cost efficiency, expressive writing appears to have great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. this modality has not been studied in irritable bowel syndrome (ibs), a common gastrointestinal condition, which is lacking well-defined etiology or treatments and is best understood in a biopsychosocial context.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of irritable bowel syndrome exclusion criteria: * non-english speakers
pivotal study of sat-001 in treatment of pediatric patient with myopia

Conditions: Myopia

Summary: the objective of this clinical investigation is to evaluate the efficacy and safety of sat-001 designed as software as medical device (samd) for slowing myopia progression and treatment in pediatric myopia patients.

myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in asian countries including korea. this study is a confirmatory clinical trial designed to evaluate the efficacy and safety of sat-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.

Eligibility criteria:
inclusion criteria: 1. children aged 5 to less than 9 2. meet the following refractive criteria by cycloplegic refraction 1. spherical equivalent refractive error (ser): -0.75 to less than -6.00 d in each eye 2. astigmatism of 1.50 d or less in each eye 3. anisometropia of 2.00 d or less 3. best corrected visual acuity of 0.2 logmar or better in each eye at the screening visit 4. able to successfully accomplish sat-001, the investigational device (able to follow the written and verbal instruction) 5. subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding) exclusion criteria: 1. history of atropine use within 3 days prior to baseline (visit 2) (prior treatment of myopia control with low dose atropine within 1 month prior to baseline) 2. current or prior use of multifocal lenses (e.g. progressive addition lenses), orthokeratology (ortho-k, e.g. dream lens), or rigid gas permeable (rgp) within 1month prior to baseline(visit 2) 3. ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., or presence of malignant tumors in the orbital area 4. history of eye diseases such as manifest strabismus, intermittent strabismus, amblyopia, and nystagmus (excluding strabismus that maintains binocular vision) 5. history of ocular surgery such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (excluding simple double eyelid surgery) 6. down's syndrome or cerebral palsy 7. within 6 months prior to the screening visit (visit 1), has experience of other clinical trial medications or investigational device 8. clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator may consider inappropriate for participation in the clinical trials 9. systemic diseases that could impact both vision and visual field 10. history of growth hormone treatment within 1 month prior to baseline (visit 2) 11. other reasons for participation in the trial at the discretion of the investigator
study of aripiprazole in patients with bipolar i disorder

Conditions: Bipolar Disorder

Summary: the purpose of this research study is to compare the efficacy of aripiprazole with placebo in combination with lithium or valproate monotherapy, in the treatment of bipolar i patients with manic or mixed episodes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of bipolar i disorder, manic or mixed episode exclusion criteria: * first manic or mixed episode * allergic, intolerant, or unresponsive to lithium and valproate or to aripiprazole * participation in a previous clinical trial within the past month or ever participated in a trial with aripiprazole

Keywords: bipolar mania