Kornimate/medical-research-clean huggingface dataset:
the relationship of multifidus and gastrocnemius muscle thickness with postural stability in patients with stroke

Conditions: Stroke; Postural; Defect; Hemiplegia

Summary: this study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with stroke.

multifidus and gastrocnemius muscle thickness will be measured using ultrasound imaging. postural stability will be assessed using the berg balance scale, a clinical balance test that assesses an individual's ability to maintain balance during various functional tasks. the berg balance scale includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. the berg balance scale is a widely used clinical balance test that has good reliability and validity in stroke patients. data will be analyzed using appropriate statistical methods, including correlation and regression analysis, to investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Eligibility criteria:
inclusion criteria: * patients diagnosed with stroke: patients who have a confirmed diagnosis of stroke based on medical history, clinical examination, and diagnostic imaging. * time since stroke onset: the trial may include patients who are at least 6 months post-stroke onset. * ability to understand instructions: patients who are able to understand and follow instructions provided for the study procedures. * ability to provide informed consent: patients who are able to provide informed consent or have a legal representative who can provide informed consent on their behalf. exclusion criteria: * cognitive impairment: patients who have significant cognitive impairment that may affect their ability to follow instructions or participate in the study procedures. * severe motor deficits: patients with severe motor deficits that may limit their ability to perform the study procedures. * other medical conditions: patients with other medical conditions or comorbidities that may affect muscle thickness or postural stability, such as parkinson's disease, multiple sclerosis, or severe osteoarthritis. * inability to tolerate testing: patients who are unable to tolerate the testing procedures, such as the berg balance scale or ultrasound imaging. * implanted devices: patients with implanted devices, such as pacemakers, that may be affected by the ultrasound imaging. * not giving consent.
a study of edp-938 in healthy subjects

Conditions: RSV Infection

Summary: this randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of edp-938 in healthy adult subjects

the first phase assesses single ascending doses for edp-938 (active drug or placebo) in healthy subjects. a "fasted" and "fed" two-part cohort will also assess food effect. the second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects. each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive edp-938 or placebo. the cohort assessing food effect will enroll 10 subjects randomized to receive edp-938 or placebo.

Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive. exclusion criteria: * clinically relevant evidence or history of illness or disease. * pregnant or nursing females. * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * a positive urine drug screen at screening or day -1. * current tobacco smokers or use of tobacco within 3 months prior to screening. * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * history of regular alcohol consumption. * participation in a clinical trial within 30 days prior to the first dose of study drug.

Keywords: first-in-human single ascending dose multiple ascending dose
observational study to assess the efficacy and tolerability of eptadone®, in heroin addicted patients in a mmt

Conditions: Heroin Addiction

Summary: the efficacy and tolerability of eptadone® in the context of a maintenance program will be evaluated in an observational prospective, multicenter study, in heroin addicted patients.

515 patients have been selected among all patients addicted to heroin according icd-10, in maintenance treatment with eptadone, observed in the involved sites. the investigators have used the treatment schemes with eptadone conform to the registered use. the enrollment has been competitive. patients met incl/excl and that have signed the informed consent have been observed for 1 year. follow up visits have been performed according to routine procedures, for patients related to the centres at 3/6/12 months post v1. during the visits patients have been assessed by validated and used as clinical practice questionaries. safety and tolerability have been assessed through the collection of adverse reactions and of laboratory tests.

Eligibility criteria:
inclusion criteria: * both sexes * over 18 years of age * patients with a diagnosis of heroin addiction, according to icd-10 (international classification of diseases-10) * patients who receive a "maintenance treatment" with eptadone® since at least one month * accession to the observational study by informed consent exclusion criteria: * inability to follow the observation and to understand study procedure and follow them * diagnosis of: * decompensated psychotic disorders, * epileptic attacks, not related with drug abuse, * severe-acute or severe-chronic somatic diseases (like aids, tubercolosis, acute hepatitis, sepsis ecc), whereas chronical hcv is not an exclusion criteria.

Keywords: methadone heroin addiction methadone maintenance treatment adequate dosage of methadone
prevalence of carotid artery stenosis and abdominal aortic aneurysms in brussels: a population-based screening study.

Conditions: Carotid Artery Stenosis; Abdominal Aortic Aneurysm; Epidemiology

Summary: both abdominal aortic aneurysm (aaa) and carotid artery stenosis (cas) are frequent clinical entities, with major morbidity and mortality. this project obtains robust data on the prevalence of aaa and cas in the brussels capital region. using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the brussels capital region, starting at the age of 60. with these data we can have a far better view on the belgian situation of these two main vascular clinical entities. the data can provide insights on if, and how, belgian public health policy can be improved concerning aaa and cas.

a population-based screening study to determine the prevalence of carotid artery stenosis (cas) and abdominal aortic aneurysms (aaa) in the brussels capital region. the study population is the 60+ inhabitants of the brussels capital region; recruitment of 4680 subjects. using duplex ultrasound, a low invasive examination, information is obtained on the abdominal aortic diameter and the degree of stenosis of the carotid bifurcation. the objective is to determine not only the prevalence of, but also the risk factors associated with cas and aaa among 60+ brussels inhabitants. to collect these data, a questionnaire is made including demographic features, associated risk factors, but also previous treatment for aaa or cas and the current medication of the subject. examination is done by one-time duplex ultrasound to perform a diameter measurement of the abdominal aorta and determine the degree of stenosis of the carotid arteries. data collection will be done in an electronic case report form, and statistical analysis will be done by a multi-variable logistic regression model.

Eligibility criteria:
inclusion criteria: 1. candidate is at least 60 years old. 2. candidate lives in brussels capital region at the time of study participation. 3. candidate must sign and date the informed consent form prior to study participation. exclusion criteria: 1. candidate is suspected of being unable to comply with the study protocol.

Keywords: carotid artery stenosis abdominal aortic aneurysm epidemiology stenosis population screening
mechanical ventilation in the emergency department: a prospective cross-sectional study

Conditions: Respiratory Failure; Mechanical Ventilation; Acute Lung Injury

Summary: despite its life-saving potential, the mechanical ventilator has great potential to do harm. despite years of research, the mortality in acute lung injury (ali) remains very high. treatment options after ali onset are very limited, therefore prevention may be the best option. unfortunately, the emergency department has not been studied with respect to mechanical ventilation practices, and its contribution to ali is unknown. the investigators hypothesize that mechanical ventilation is frequently used in the ed and for a variety of reasons, and that ed mechanical ventilation has an effect on long term outcomes.


Eligibility criteria:
inclusion criteria: * ventilation either via an endotracheal tube or tracheostomy exclusion criteria: * non-invasive positive pressure ventilation; * death in the immediate post-intubation phase of care; * chronic ventilator-dependence, either at home or extended care facility.

Keywords: respiratory failure mechanical ventilation acute lung injury
effect of cuff pressure of endotracheal tube on post

Conditions: Laparoscopic Surgery; Tracheal Intubation Morbidity; Sore-throat

Summary: the main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.

for patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. the incidence of postoperative sore throat was evaluated via direct questioning in all patients. this study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.

Eligibility criteria:
inclusion criteria: - patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia exclusion criteria: * patients who already had sore throat and hoarseness before surgery * patients who were expected to have anticipated difficult airway * surgery duration \< 1 hour

Keywords: laparoscopic surgery endotracheal intubation cuff pressure sore throat hoarseness
a study evaluating ft-sw in unilateral breast cancer-related lymphedema patients

Conditions: Breast Cancer Related Lymphedema

Summary: the objective of the study is to demonstrate equivalency in treatment effect, as determined by objective measurements, between the modified therapy cycle software and the fda-cleared flexitouch therapy cycle software.


Eligibility criteria:
inclusion criteria: * female 18 years of age or older * diagnosis of unilateral breast cancer-related lymphedema * stage i or early stage ii lymphedema without severe fibrosis at the time of enrollment * ≥ 5% volume difference between affected and unaffected arm as verified via perometry * willing and able to give informed consent * willing and able to comply with the study protocol requirements and all study-related visit requirements exclusion criteria: * in-home use of pcd within previous 3 months * therapist or self-administered manual lymph drainage (mld) within previous 1 week * mastectomy or lymph node removal on side without lymphedema * bilateral lymphedema * heart failure (acute pulmonary edema, decompensated acute heart failure) * acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism) * active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the arms or trunk * active cancer (cancer that is currently under treatment, but not yet in remission) * poorly controlled kidney disease (glomerular filtration rate \< 30 mls per minute), hypoproteinemia, pulmonary hypertension, hypothyroidism, cyclic edema, or munchausen syndrome * bmi \>50 * any circumstance where increased lymphatic or venous return is undesirable * currently pregnant or trying to become pregnant * allergy to iodine
oxytocin and uterotonic agent use for cesarean delivery

Conditions: Uterine Atony; Hypotension

Summary: the central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery the investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will: 1. reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. secondary outcomes to be evaluated will be: 1. reduce the side effects associated with uterotonic drug use 2. reduce the time to establishment and maintenance of adequate uterine tone

the current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. a stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. this algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents. more specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 iu; 2) oxytocin should not be administered as a rapid iv bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i or ii health status * age between 18 and 50 yrs * singleton pregnancies in vertex position * elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision exclusion criteria: * conditions that predispose to uterine atony and postpartum hemorrhage

Keywords: uterine atony hypotension cesarean delivery hemorrhage phenylephrine ephedrine
painful breastfeeding and osteopathic treatment on the mother-newborn dyad

Conditions: Painful Breastfeeding

Summary: pain during lactation is the first reason to stop breastfeeding. when usual known aids are ineffective, osteopathic treatment is a possible way to decrease the pain and improve the quality and the duration of lactation. the aim of this study is to compare usual known aids alone and usual known aids added to osteopathic treatment of the baby and the mother. the primary outcome is the lactation rate (exclusive or partial) at 1 month after birth

breastfeeding is recognized to be essential for childhood health and public health. the first reason to stop breastfeeding before the second month after birth is pain during lactation. the second reason to stop breastfeeding is back-to-work, generally two months after birth. few years ago, osteopathic treatment has been introduced at maternity hospital of bordeaux when usual known aids are ineffective. the osteopathic treatment is completely integrated in the maternity hospital of bordeaux but no strong evaluation is available in literature. a pilot evaluation on 27 patients showed a good effectiveness of osteopathic treatment on breastfeeding at 1 months ½ after birth (85% of patients) breast pain decreased or disappeared after the osteopathic treatment. another evaluation showed a small rate of lactation (15% of patients) in a non treated group at 1 month ½. in the present study, osteopathic treatment will be added to usual known aids for 40 mother-newborn dyads when pain during lactation is greater than 7 (0 to 10 scale). the experimental group will be compared with 40 "non treated" mother-newborn dyads (only usual known aids in routine care). among other, breastfeeding and pain during lactation will be evaluated at the maternity hospital discharge and will be repeated at 1 month after birth.

Eligibility criteria:
inclusion criteria: * mother 18 yrs and older who chose to breast-feed (exclusive or not) * singleton newborn after 37 weeks of gestation, weighing at least 2500 g at birth, after 36 hours of life * pain during lactation greater than 7 (scale 0 to 10) in one or both breasts * usual known aids ineffective to reduce pain during lactation * mother speaking and understanding french * mother affiliated or beneficiary to a health system * signed informed consent. exclusion criteria: * medical contraindication to osteopathic treatment (non stabilized infection, acute neurological pathology, tumor or cancer process, maternal psychiatric disorders) * severe congenitale malformation, especially not allowing normal lactation * patient under legal protection * persons deprived of their liberty by judicial or administrative decision

Keywords: osteopathic manipulative treatment pain breastfeeding
ultrasound- guided continuous serratus anterior plane block versus ultrasound- guided continuous thoracic paravertebral block in multiple traumatic rib fractures.

Conditions: Serratus Anterior Plane Block; Thoracic Paravertebral Block; Ultrasound; Multiple Traumatic Rib Fractures; Analgesia

Summary: the aim of this study is to compare the analgesic efficacy of ultrasound guided continuous sap block and ultrasound guided continuous tpvb in patients with multiple traumatic rib fractures.


Eligibility criteria:
inclusion criteria: * patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs). exclusion criteria: * • contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity. * patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness. * patients had indications for mechanical ventilation on admission or during the study period. * patients had indications for immediate surgery for other associated injuries. * patients with hemodynamic instability. * patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.
arterial versus venous graft recruitment by intra-aortic balloon pump

Conditions: Coronary Artery Disease

Summary: the aim of this study is to evaluate the different performance of arterial and venous graft with intra-aortic balloon pump support following coronary artery bypass.


Eligibility criteria:
inclusion criteria: * all patients undergoing coronary artery bypass surgery exclusion criteria: * aortic insufficiency; * diffuse atherosclerosis impeding intra-aortic balloon pump introduction

Keywords: coronary artery bypass graft intra-aortic balloon pump transit-time flowmetry
implantable system for remodulin post-approval study

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of the implantable system for remodulin (isr) post approval study (pas) is to provide evaluation and periodic reporting of the safety and effectiveness of medtronic market-released isr, including the catheter and the pump.

the isr pas is an observational, prospective, non-randomized, multi-center study. it will enroll a minimum of 50 newly implanted patients at up to 10 us sites, observing and reporting catheter-related complications and pump failures through 5 years post implant.

Eligibility criteria:
inclusion criteria: * subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements. * subject is intended to receive an eligible isr product. * subject is at least 22 years of age. exclusion criteria: * subject is pregnant. * subject who is expected to be inaccessible for follow-up. * subject with exclusion criteria required by local law. * subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness).

Keywords: pah pulmonary arterial hypertension pulmonary hypertension remodulin treprostinil delivery for pah implantable pump drug pump intrathecal catheter targeted drug delivery programmable pump
oxytocin and dyadic psychotherapy in the treatment of post partum depression

Conditions: Postpartum Depression

Summary: rationale and hypotheses of the current research: the investigators speculate that mothers suffering from ppd exhibit high levels of depression and low levels of oxt, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. while dyadic psychotherapy has been studied in this context, it is unknown which depressed women will respond to this type of therapy, and whether such a response is mediated by the pro-bonding effect of oxytocin. the aim of this study is three-fold: 1. to study the effect of the administration of a single dose (24iu) of oxytocin on cerebral circuit processing and connectivity of empathy and attachment. 2. to examine whether the clinical response of mothers suffering from postpartum depression to short term dyadic psychotherapy (based on improved mother-child interactions) can be predicted by a unique brain response pattern to oxytocin. 3. to assess the relationship between levels of oxytocin in mother and baby and the effectiveness of psychological dyadic treatment on mothers suffering from postpartum depression.


Eligibility criteria:
inclusion criteria: * women of all ages who are 3 to 8 months post-partum. * women who have completed a minimum of 12 years of education. * women who are willing and able to provide informed consent for their participation and after the study has been explained. infant participation will be allowed after consent has been obtained from mothers. * current dsm-iv-tr diagnosis of ppd disorder as confirmed by scid (administered as part of the study of protocol number ppd1, proposed to the helsinki committee on june 2014). * symptoms: bdi total score \>9, epds total score \>10 * treatment with antidepressants will be allowed provided that patients have been on the medication for at least 4 weeks prior to entry into the pre-treatment assessment phase of the study. exclusion criteria: * unwilling or unable, in the opinion of the investigator, to comply with study instructions. * pregnant women. * clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning). * women with significant risk of committing suicide or harming others in the opinion of the psychiatrist. * women with a current dsm-iv-tr substance or alcohol abuse. however, patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included. * women who suffers from depression due to physical condition. * women who suffers from severe major depression (madras\>30) * women who suffers from chronic depression (over 6 months)

Keywords: postpartum depression diadic psychotherapy oxytocin fmri attachment empathy