Kornimate/medical-research-clean huggingface dataset:
evaluation of electrocardiographic guidance in accurate peripherally inserted central catheter placement in children.

Conditions: Venous Insufficiency

Summary: this study will enroll up to 192 children less than 18 years of age, who will receive electrocardiographic guidance for placement of a picc in addition to radiography done as standard care. the investigators will determine the location of the picc tip from both ecg and radiograph, and then measure the degree of correlation between the two methods.

the placement of peripherally inserted central catheters (piccs) is an important component of medical care for a variety of patients. current practice requires radiographic confirmation of catheter tip placement prior to use of the line for administration of medications. often the final catheter tip position may be uncertain based on radiographic imaging. other times, the catheter is malpositioned and requires adjustment and repeat radiographic imaging. in adult patients, a system of confirmation that is based on electrocardiographic activity has been implemented and is fda approved. this study will enroll up to 192 children less than 18 years of age who will receive electrocardiographic guidance for placement of a picc, in addition to radiography done as standard care. the investigators will determine the location of the picc tip from both ecg and radiograph, and then measure the degree of correlation between the two methods.

Eligibility criteria:
inclusion criteria: * age from birth to 17 years in need of a picc as part of the medical treatment plan * suitable for an upper extremity picc placement * hemodynamically stable, including patients stable on vasopressors exclusion criteria: * hemodynamic instability * cardiac abnormality which leads to abnormal p-wave on ecg * arrhythmia at baseline, documented duirng the current hospital admission * presence of pacemaker or pacing wires which are currently actively pacing * patients who have undergone reconstructive cardiac surgery and/or have anatomic variance that would affect the location of the sinoatrial node in relation to the superior vena cava * premature neonate (\<37 weeks estimated gestational age) * placement of picc in lower extremity

Keywords: peripherally inserted central catheter (picc) electrocardiographic guidance reposition
the different design of orthokeratology

Conditions: Myopia

Summary: in this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 d. they were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.


Eligibility criteria:
inclusion criteria: * the age is greater than 8 years and less than 18 years * the myopia was within -4.00d (including -4.00d), and the astigmatism was within 1.50d (including 1.50d) in both eyes. * be able to complete 12 months of follow-up * they were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians exclusion criteria: * one eye met the inclusion criteria * patients with systemic diseases causing immunocompromised or affecting orthokeratology * there are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc * abnormal cornea * previous corneal surgery or corneal trauma history * active keratitis (e.g., corneal infection) * patients with best corrected distance visual acuity of less than 5.0 * patients with corneal flat curvature lower than 39.00d, or higher than 48.00d * patients with refractive instability * patients with overt strabismus * the corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses * patients with dry eye are not suitable for orthokeratology * patients with corneal endothelial cell density less than 2000 cells /mm2 * patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days
pharmacokinetics and acute effects of multiple dose of nicotine: electronic cigarette and cigarette

Conditions: Nicotine Use Disorder

Summary: the purposes of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.

electronic cigarettes (e-cigarettes) are battery-operated devices that deliver nicotine via inhaled vapour or "vaping". at present, e-cigarettes are becoming increasingly popular among smokers worldwide. however, knowledge about e-cigarette nicotine pharmacology remains limited. the aims of this study are 1) to determine the pharmacokinetics of nicotine after multiple dose administration by electronic cigarette and 2) to compare the acute effects of multiple dose of nicotine administrated by electronic cigarette compared with those obteined by cigarette.

Eligibility criteria:
inclusion criteria: * understanding and accepting the study procedures and signing the informed consent. * male adults volunteers (18-45 years old). * clinical history and physical examination demonstrating no organic or psychiatric disorders. * the ecg and general blood and urine laboratory tests performed before the study should be within normal ranges. minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. these changes and their non-relevance will be justified in writing specifically. * present use of nicotine without serious adverse reactions. * smokers ≥ 3 cigarettes/day. exclusion criteria: * having suffered any cardiovascular and/or respiratory disease in the three months prior to the study start. * history of drug dependence (except for nicotine dependence). * daily consumption \>4 standard units of ethanol. * regular use of any drug in the month prior to the study sessions. the treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session. * having suffered any organic disease or major surgery in the three months prior to the study start. * blood donation 12 weeks before or participation in other clinical trials with drugs in the previous 12 weeks. * history or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs. * subjects unable to understand the nature, consequences of the study and the procedures requested to be followed. * use of any drug or substance inhibitor of cytochrome p-450-1a6 (cyp1a6) (p.e. raloxifene, coumarins, etc)

Keywords: nicotine electronic cigarette cigarette
clemastine in cardiovascular surgery

Conditions: Efficacy and Safety

Summary: in this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine h1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

in this study, a prospective, randomized, double-blind pilot trial designed to evaluate the effect of histamine h1 receptor antagonist clemastine on perioperative anaphylaxis in cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on reducing heparin and protamine associated anaphylaxis.

Eligibility criteria:
inclusion criteria: * 18-75 years old * receiving selective cardiovascular surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease * written informed consent obtained. exclusion criteria: * previous history of cardiac surgery * allergy to clemastine, antihistamines with similar chemical structure or any excipient (sorbitol, sodium citrate, propylene glycol, ethanol) * myasthenia gravis * porphyria patients * bronchial asthma * usage of monoamine oxidase (mao) inhibitors * pregnant or lactating women * mentally or legally disabled patients

Keywords: cardiovascular surgery histamine h1 receptor antagonist anaphylaxis
rrt for ptsd symptoms in survivors of sexual violence

Conditions: PTSD; Rape Sexual Assault

Summary: study to provide evidence of efficacy for rapid resolution therapy in symptoms of ptsd, anxiety, and depression in survivors of sexual violence.

the investigators will recruit 24 participants to complete pre-test measures, participate in a 3 hour therapy session of rapid resolution therapy (rrt), and then re-test one week post treatment and 6 months follow up. if participants do not report a "good result" following the 3 hour session, the investigators will offer a 1.5 hour follow up session participants will receive free therapy for their participation, but will not be paid. participants will be men and women over the age of 18 who do not have a diagnosis of psychosis and are not actively suicidal and have experienced a single rape at least 3 months before enrolling in the study. sessions will be audio recorded and transcribed for construct validity (of rrt). identifying in formation will be removed by the study coordinator before transcripts are coded for validity. this study proposes to use the same methods as rothbaum et al (2005) published in journal of traumatic stress that compares prolonged exposure to eye movement and desensitization and reprocessing (emdr) for ptsd rape victims. the investigators will compare our results to theirs. both of their treatments were 8 sessions, and this study's treatment is one. they also include data for a control group.

Eligibility criteria:
inclusion criteria: * 18-70 years old * self report experiencing a rape any time before 3 months prior to treatment * on pcl-c (positive for ptsd) * score 3-5 on at least one item 1-5 * score 3-5 on at least 3 items 6-12 * score 3-5 on at least 2 items 13-17 exclusion criteria: * history of schizophrenia or psychosis current * suicidal risk * in an ongoing threatening situation (i.e. domestic violence) * participants who are pregnant or become pregnant during the study (if someone becomes pregnant during the study, we will complete treatment if she desires, but will not include data)

Keywords: ptsd psychotherapy rape
cephea early feasibility study

Conditions: Mitral Regurgitation

Summary: the objective of this study is to evaluate the preliminary safety and effectiveness of the cephea mitral valve system for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.


Eligibility criteria:
key inclusion criteria: * mitral valve disease resulting in mitral regurgitation (mr ≥ grade iii) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per american society of echocardiography criteria. * lvef ≥ 30% * in the judgement of the site heart team, transcatheter therapy is deemed more appropriate than open heart surgery. key exclusion criteria: * prior surgical or interventional treatment that interferes with the cephea valve delivery or function. * need for emergent or urgent surgery.
study of buprenorphine hcl buccal film in the treatment of dental pain

Conditions: Dental Pain

Summary: the purpose of this study is to assess the activity of buprenorphine hydrochloride (hcl) buccal film in the treatment of dental pain.


Eligibility criteria:
inclusion criteria: * extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone * males or non-pregnant females, aged 18 to 45 years * good general health and capable of providing informed consent exclusion criteria: * history of substance abuse or dependence * positive urine toxicology screen or alcohol breath test * history of hypersensitivity to or allergy to any study drug * donation of blood within prior 30 days * use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours
safety and preliminary efficacy of l-arginine in severe falciparum malaria

Conditions: Severe Falciparum Malaria

Summary: background: mortality from severe malaria remains \~15% despite the use of the most rapidly parasiticidal antimalarial therapy, artesunate. adjunctive treatments may improve outcome. our overall goal is to determine if adjunctive treatment with l-arginine is safe and improves outcomes in severe malaria. in studies to date, we have shown that l-arginine is safe in moderately severe malaria, increases nitric oxide production and improves endothelial function. we now propose to extend these studies to patients with severe malaria. aims: to determine the safety, preliminary efficacy, pharmacokinetics and pharmacodynamics of l-arginine infusion in severe malaria. hypothesis: l-arginine will improve endothelial function, lactate clearance time and tissue oxygen delivery compared to saline with no clinically significant adverse effects. methods: based on previous pharmacokinetic modeling and simulations, we propose a phase 2a randomised controlled trial of l-arginine vs saline in severe malaria, each given over 8 hours. if safety is demonstrated this will be followed by a phase 2b open-label study of 24-hour infusion of l-arginine in severe malaria with safety and preliminary efficacy compared with the 8 hour infusions given in phase 2a. the primary outcomes will be the improvement in endothelial function and lactate clearance in patients given l-arginine infusion compared with those who received saline. among the secondary outcomes will be safety and the effect of l-arginine vs saline on tissue oxygen delivery (nirs). data from both phase 2a and 2b will be used to generate a pharmacokinetic/ pharmacodynamic model.

see brief summary

Eligibility criteria:
inclusion criteria: 1. age 18-60 years 2. informed consent obtained 3. time of commencement of artesunate ≤18 hrs before infusion of l-arginine 4. any level of p. falciparum parasitemia, and one or more of the following criteria: i. acute renal failure (creatinine \>265umol/l) ii. hyperbilirubinemia (total bilirubin \>50 umol/l) with either renal impairment (creatinine \>130umol/l) or parasitemia of \>100,000 parasites/ul iii. blackwater fever iv. hyperparasitemia (\>10% parasitised red cells) v. cerebral malaria (glasgow coma score \ 32) exclusion criteria: 1. pregnancy or lactation 2. diabetes 3. serious pre-existing disease (cardiac, hepatic, kidney) 4. systolic blood pressure \<90 mmhg after fluid resuscitation 5. initial istat test showing any of the following values: i. k+ \> 5.5 meq/l ii. cl- \> 110 meq/l iii. hco3- \< 15 meq/l 6. known allergy to l-arginine 7. evidence of concurrent bacterial infection 8. concurrent therapy with any of the following medications: iv. spironolactone, v. oral nitrates, vi. phosphodiesterase inhibitor (eg sildenafil \[viagra\]) vii. alpha-blocking antihypertensive agents (eg prazosin) viii. l-arginine

Keywords: severe falciparum malaria
an open-label extension trial to investigate possible drug-drug interactions between stiripentol or valproate and cannabidiol in patients with epilepsy

Conditions: Epilepsy

Summary: this trial consists of 2 parts: a double-blinded phase and an open-label extension phase. the open-label extension phase only will be described in this record. all participants will receive the same dose of gwp42003-p. however, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.


Eligibility criteria:
note: participants who enroll in france or sweden must be aged 18-55 years. key inclusion criteria: * participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition. key exclusion criteria: * participant has clinically significant unstable medical conditions other than epilepsy. * participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope). * participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the c-ssrs in the last month. * participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial. * participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including sativex®) within the 3 months prior to trial entry. * participant has any known or suspected history of any drug abuse or addiction. * participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including sativex) for the duration for the trial. * participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal product (imp), e.g., sesame oil.

Keywords: cannabidiol gwp42003-p epidiolex stiripentol valproate
examining the neural effects of a behavioral intervention for physical activity in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis \[ms\] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the united states. this disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. there is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with ms. nevertheless, this population is strikingly sedentary and physically inactive. this highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. to that end, this project is a phase-ii randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function in persons with ms.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * relapse free in the last 30 days * being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months * ambulate without assistance * low risk for contraindications for mri exclusion criteria: * moderate or high risk for undertaking strenuous or maximal exercise

Keywords: physical activity
10% carbohydrate drink for preventing post-operative nausea and vomiting (ponv) after spinal morphine

Conditions: Nausea and Vomiting, Postoperative

Summary: ponv after intrathecal morphine, occurs up to 30-40 percent. the patients having tkr normally are female, obese and non-smoker which are risk factors for ponv. recently, a multimodal approach, combining several means to minimize ponv, has found wide acceptance as a standard of care. in our hospital, most of the patients are supposed to fast after midnight the oral rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not this method can reduce the incidence of ponv after low dose (0.2 mg) intrathecal morphine is not investigated yet. the aim of this study is to investigate the effect of preoperative oral rehydration therapy on the incidence of ponv.

we enroll patients who are undergoing tkr under spinal anesthesia with 0.5% heavy bupivacaine 10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25% bupivacaine 20 ml. the enrolled patients will fast after midnight and in the morning they are allowed to drink 10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10% carbohydrate drink is drunk between evening and midnight and extra water if needed in the study group. in the control group, the patients are allowed to drink until midnight. total of water consumption between 18.00-24.00 will be recorded in both groups. in the morning, the study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. the premedications should not include sedation or gi mobility drugs. before starting anesthesia, the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh their feeling from 0-10. the surgery and pain therapy will be tha same in both groups and the ponv (incidence, severity and rescue therapy) at recovery room and 24 hours postoperative period will be recorded.

Eligibility criteria:
inclusion criteria: * patients are under going unilateral tkr, with asa i-iii who scheduled started in the morning list (before noon) exclusion criteria: * diabetes * history of motion sickness * chronic kidney disease (ckd, creatinine \> 2 mg/dl) * hiatus hernia or gastro esophageal reflux * patients receiving drugs that might affect gi motility such as opioids

Keywords: postoperative nausea and vomiting (ponv) spinal morphine total knee replacement (tkr) blood sugar carbohydrate drink
effects of intraoperative continuous airway pressure (cpap) on the inflammatory response to one-lung ventilation

Conditions: Lung Cancer

Summary: this is a randomized placebo-controlled trial studying the effects of intraoperative continuous airway pressure (cpap) on the inflammatory response of the lung with cancer undergoing lobectomy.

pulmonary lobectomy induces an inflammatory response of this lung caused by intraoperative atelectasis and re-expansion. this inflammatory response can be attenuated with treatment, also decreasing postoperative pulmonary complications (ppc). thus, avoiding complete atelectasis with partial insufflation of the lung during surgery could be useful to decrease inflammatory response and ppc.

Eligibility criteria:
inclusion criteria: * adults (18-80 aged) with american society of anesthesiologists physical status i-iii, scheduled to undergo elective thoracic surgery with lung resection performed through thoracotomy, and requiring olv (one lung ventilation)during surgery. exclusion criteria: * ongoing treatment with any dose of systemic or topical steroids, acute pulmonary or extrapulmonary infections (elevated c-reactive protein \[crp\]), history of recurrent pneumothoraces, previous thoracic surgery.

Keywords: lung cancer cpap ppc lobectomy one-lung ventilation
simulation for the retention of skills in the management of obstetric hemorrhages

Conditions: Postpartum Hemorrhage; Simulation Training; Healthcare Providers

Summary: the aim of this study is to evaluate the retention of knowledge and skills after theory+simulation training versus theoretical training alone in postpartum haemorrhage immediately, 3 months and 6 months after training in south kivu, in the east of the democratic republic of congo.


Eligibility criteria:
inclusion criteria: * work in one of the selected maternity units * have two years' experience * be either a gynaecologist, obstetrician, general practitioner, midwife, nurse, anaesthetist or laboratory technician. exclusion criteria: -

Keywords: osce