Kornimate/medical-research-clean huggingface dataset:
lidocaine infusions for chronic pain in children

Conditions: Pain, Chronic

Summary: this is a study to evaluate the efficacy and safety of lidocaine in the management of chronic pain in children. all participants will receive lidocaine infusion and severity of pain and degree of chronic-pain related disability will be assessed before and up to 4 weeks after infusion. adverse events will be recorded.

reports have shown that intravenous lidocaine infusions have been effective in relieving chronic pain that has been resistant to other therapies, with minimal side effects. the investigators would like to determine whether severity of pain and degree of chronic-pain related disability could be reduced with lidocaine infusion in children and to understand whether the dose of lidocaine correlates with blood levels in the same manner as it does in adults. the investigators will recruit 24 patients aged 8-18 with chronic pain that has not been relieved by standard therapies. each patient will receive a lidocaine infusion over 2 hours. blood will be drawn for lidocaine concentration before the beginning of the infusion, immediately after and 0.5, 2 and 4 hours after. severity of pain and degree of disability will be recorded using a questionnaire measuring pain scores, sleep disruption, social disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks and then 4 weeks after. this study will help the investigators better understand the effectiveness and safety of intravenous lidocaine for chronic pain in children.

Eligibility criteria:
inclusion criteria: 1. diagnosed with a chronic pain condition (\> 3 months) other conventional medical therapies (anticonvulsants, tricyclics etc), have not been effective. 2. american society of anesthesiologists class 1 or 2 3. age 8-18 years 4. ability to understand and use the numeric rating scale to rate their pain and to understand and answer other questionnaires 5. negative pregnancy test in participants of child-bearing potential (females 12 years of age and older, or menarchal if under 12) exclusion criteria: 1. history of seizures 2. known liver or renal disease 3. patient taking strong cyp1a2 inducers or inhibitors (fluvoxamine, phenytoin, cimetidine, amiodarone) or beta blockers (propranolol, metoprolol, nadolol) 4. allergy or sensitivity to lidocaine or other local anesthetic 5. cardiac conduction anomalies (eg. heart block, wolff-parkinson-white) 6. serum electrolytes (potassium, sodium, magnesium or calcium) outside of reference ranges 7. pregnancy withdrawal criteria 1. patient or parent/guardian request 2. refusal to have intravenous access and serum levels drawn 3. inability to complete pain scores on the questionnaires (paper or electronic) at the first infusion and weekly for 2 weeks and at one month following infusion 4. baseline free carnitine concentration \< 26 micromoles/l or total carnitine \< 32 micromoles/l (reference values from sickkids department of pediatric laboratory medicine "guide to laboratory services")

Keywords: anesthetics, local lidocaine pediatrics children adolescents
mobile phone-based smoking cessation program

Conditions: Substance Use Disorder (SUD)

Summary: in this online, randomized controlled trial (rct), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. participants will receive a 12-week intervention with follow-up at week 26. the primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. the main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. about 2000 smokers with willingness to make a quit attempt within a month from october 2022 to april 2023 or until the recruitment process is complete will be recruited. the final 26-week follow-up will be completed in november 2023. the trial results will be available by the end of 2023 .


Eligibility criteria:
inclusion criteria: * in this rct, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with cvds diagnosis or risk. exclusion criteria: * patients unwilling to quit smoking

Keywords: smoke cessation cardiovascular diseases
study of kn026 in combination with palbociclib and fulvestrant in patients with advanced breast cancer

Conditions: HER2-positive Metastatic Breast Cancer

Summary: this is an open-label, multicenter, dose-escalation and parallel-group expansion phase ii clinical trial to evaluate the efficacy, safety and tolerability of kn026 in combination with palbociclib and fulvestrant in women or male with her2-positive metastatic breast cancer .the subjects will receive 20 mg/kg iv q2w+ palbociclib 100/125 mg/day orally+/-fulvestrant 500 mg im until progressive disease, unacceptable toxicity or death.

kn026 is an anti-her2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of her2, leading to a dual her2 signal blockade.

Eligibility criteria:
inclusion criteria: * male or female subject \>= 18 years; * histologically or cytologically confirmed, metastatic or locally advanced unresectable her2-positive; * adequate organ function assessed within 7 days prior to first trial treatment * ecog score 0 or 1; * left ventricular ejection fraction (lvef) ≥ 50% at baseline; * life expectancy \>3 months exclusion criteria: * untreated active cns metastasis or leptomeningeal metastasis; * uncontrolled tumor-related pain; * has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment; * major surgery for any reason within 28 days; * curative radiation within 3 months of the first dose of trial treatment; * history of uncontrolled intercurrent illness; * other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance

Keywords: kn026 palbociclib her2-positive mbc
phase ii study of tin mesoporphyrin vs phototherapy for hyperbilirubinemia in premature newborns

Conditions: Hyperbilirubinemia

Summary: objectives: i. compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in greece. ii. evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.

protocol outline: patients are randomly assigned to a clinical group within 96 hours of birth. patients are stratified by gestational age, clinical status, and age at treatment. one group receives tin mesoporphyrin. patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold. the second group receives phototherapy with special blue fluorescent lamps for at least 24 hours. patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * premature infants of gestational age 210 to 251 days * no blood group isoimmunization (direct coombs' positive), e.g., rhesus or abo * no glucose-6-phosphate dehydrogenase deficiency --prior/concurrent therapy-- * no maternal phenobarbital in last month of pregnancy --patient characteristics-- renal: no congenital renal abnormality cardiovascular: no congenital heart abnormality pulmonary: no asphyxia requiring assisted ventilation at delivery other: no other major congenital abnormality, i.e.: * central nervous system * chromosomal * gastrointestinal no evident or suspected congenital infection, i.e.: * cytomegalovirus * herpes * rubella * syphilis

Keywords: hematologic disorders hyperbilirubinemia rare disease
is it possible to screen for type 2 diabetes at day 2 in gestational diabetes mellitus patients postpartum?

Conditions: Gestational Diabetes Mellitus; Type 2 Diabetes

Summary: within 6 months of delivery, women who had gestational diabetes mellitus should be screened for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in a 75-g oral glucose tolerance test. however, not all women are screened. the objective of this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum versus 8 weeks post-partum. the investigators want to measure the specificity, sensitivity, false and true predictive values of the screening test at 48 hours post-partum compared to the gold-standard.


Eligibility criteria:
inclusion criteria: * dx of gestational diabetes treated with insulin * to be in post-partum * delivery of a baby of at least 37 weeks of gestation * have signed the consent form exclusion criteria: * history of glucose intolerance of diabetes before the pregnancy * obstetrical pathology during pregnancy

Keywords: type 2 diabetes post-partum screening
long-term safety and effectiveness of mdma-assisted therapy for ptsd

Conditions: PTSD

Summary: the goal of this long-term follow-up study is to measure how long effects of mdma-assisted therapy last in participants with ptsd who were treated in a prior phase 3 clinical trial of mdma-assisted therapy. the main question it aims to answer is: does mdma-assisted therapy result in lasting reductions in ptsd symptoms? participants who have received at least one dose of mdma-assisted therapy will take a ptsd assessment at least six months after their last mdma-assisted therapy session in the main study.

this non-interventional study will serve as the long-term follow-up (ltfu) protocol for mdma-assisted therapy clinical trials and will measure persistence of effectiveness using the caps-5 as a measure of ptsd symptom severity. the primary objective of this study is to evaluate the long-term effectiveness of mdma-assisted therapy for treatment of ptsd as measured by the change in caps-5 total severity score (actual or imputed) from the main study baseline and study termination to ltfu ir assessments (visit 1). additionally, this study will gather data to support health economics and cost effectiveness analyses of this treatment. participants who have received at least one dose of investigational medicinal product (imp) in the main study will be eligible to participate in this study.

Eligibility criteria:
inclusion criteria: 1. enrolled in a maps-sponsored study of mdma-assisted therapy for the treatment of ptsd 2. have received investigational medicinal product (imp) in at least one experimental session in the main study 3. agree to be contacted by study team at least six months after the last experimental session in the main study to schedule and participate in ltfu visits exclusion criteria: 1. are not able to give adequate informed consent 2. have any current problem which, in the opinion of the investigator or medical monitor, might interfere with participation
safety and efficacy of iv diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass

Conditions: Myocardial Stunning

Summary: this study aims to confirm the safety and efficacy of diazoxide as an additive to hyperkalemic cardioplegia in patients undergoing cardiac surgery with cardiopulmonary bypass. the investigators hypothesize that diazoxide combined with hyperkalemic cardioplegia provides superior myocardial protection and reduced myocardial stunning compared with standard cardioplegia alone. the investigators will randomize 30 patients in a 2:1 fashion to treatment vs control. safety will be assessed by comparing mean arterial blood pressure measurements, glucose levels and incidence of adverse events between the two groups. efficacy will be assessed by comparing right and left ventricular function in pre-operative vs post-operative transesophageal echocardiograms, need for mechanical circulatory support, ease of separation from bypass and vasoactive inotrope score (vis) between the two groups. the information gained could pave the way for the use of katp (potassium-atp) channel openers to prevent stunning, improve patient outcomes, and reduce health care costs related to myocardial stunning that requires inotropic and mechanical support following cardiac surgery.

this is a randomized blinded phase i clinical trial. thirty patients total will be randomized on a 2:1 basis to treatment (iv diazoxide added to cardioplegia) vs control (cardioplegia alone). diazoxide will be added to the first dose of cardioplegia only. subsequent doses of cardioplegia will not contain additives.

Eligibility criteria:
inclusion criteria: * age 18 years or older * scheduled for cardiac surgery with cardiopulmonary bypass and cardioplegic arrest * patient scheduled for elective cardiac surgery exclusion criteria: * patient with diabetes mellitus on sulfonylurea medications * scheduled for left ventricular assist device (lvad) or heart transplant * left ventricular ejection fraction \< 30% * pre-operative placement or planned use of mechanical circulatory support during surgery * allergy to thiazide and its derivatives * history of gout * patient is pregnant or breastfeeding
detecting a volume deficit during spontaneous breathing

Conditions: Hypovolemia

Summary: 13 healthy volunteers (4 females) were tilted 45° head-up while breathing through a facemask fitted with an inspiratory and expiratory resistor. a brachial arterial catheter was used to measure blood pressure and thus systolic pressure variation and pulse contour analysis determined stroke volume and thereby cardiac output in order to detect a central volume deficit.

thirteen healthy volunteers (4 women) at an age of 25 years (range 18-36) were recruited through www.forsøgsperson.dk. the volunteers were placed on a tilt table and provided with a facemask with an opening of 30-33 mm. a hook ring was fitted with an inspiratory resistor, an expiratory resistor, a combination of the two resistors, or with no resistance and each resistor provides a 7.5 cmh2o threshold resistance. each resistor was applied for two minutes with variables obtained in the last minute. the table was then tilted 45° head-up to accumulating blood in the legs and therefore a reduction in the central blood volume. conversely, 20° head-down tilt was used to expand the central blood volume. for each volunteer measurements with the four respiratory interventions was randomized, whereas the tilt table position was in fixed order: supine, head-up tilt, and head-down tilt. three-lead ecg recorded heart rate. a 20 g arterial catheter was placed in the brachial artery of the non-dominant arm and connected to a transducer for reading of blood pressure and stroke volume variation (vigileo-flotrac™, version 1.07, edwards lifesciences, nyon, switzerland). also sv and co variation and the arterial pressure curve were recorded for subsequent determination of arterial pressure variations. additionally, a catheter was placed via a brachial vein to the superior caval vein for recording of central venous pressure and svo2. while the subjects were breathing spontaneously, the respiratory rate was measured by capnography and peripheral oxygen saturation by fingerprobe. variation in the arterial pulse pressure (ppv) was 100 x ((ppmax - ppmin) / ((ppmax + ppmin)/2)), where ppmax and ppmin is the maximal and minimal difference between systolic and diastolic pressure during the respiratory cycle, respectively. by the same formula systolic pressure variation (spv) was calculated.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pregnancy * lactating * any regular or acute use of medicine

Keywords: central volume deficit head-up tilt systolic pressure variation
is anesthetic loss of consciousness a top down or bottom up phenomenon. what does the neurologic examination say?.

Conditions: Anesthesia; Functional

Summary: using very slow or fast propofol intravenous injection, monitored using standard american society of anesthesiology (asa) standard and sedline eeg (med tech), the patient was evaluate by a neurologist every 30 sec using the four coma scale.

clinical experimental randomized study, approved by the ethic committee, with informed consent, included asa i- ii adults, without neurological illness and normal physical exam. the patient randomized in two groups, rapid induction (gr) with propofol in target controlled infusion (tci) effect site mode using the phamacokinetic (pk) model from marsh ke0 1,21 min-1 using a calculated target of 5.4 ug/ml (loss of counsciousness ec95) and slow induction (gl) 10 mg/kg/h with calculated effect site concentrations (cecalc) same pk model. the same neurologist, blind to the correspondent group, evaluated all the patients every 30 sec using the coma four scale until loss of counsciousness (loc), defined as a four (e0 no eyes opening response and /or m0 no motor response). at loc the existance of brainstem reflex was evaluated (b no pupil and corneal reflex), respiratory pattern (r apnoea), cecalc and patient state index (psi) sedline™ was recorded during all the examination. after loc in both groups we maintain in gr the initial target (5.3 ug/ml) and the loc cecalc during 10 min without intervention, except respiratory support if it was required. frontal eeg 4 channel and spectrogram from sedline monitor was extracted for each case and posterior analysis. fisher exact test was used to describe primary outcome and difference between b and r for each group. the difference in time to reach loc loc, ce and psi was analysed with t- student.

Eligibility criteria:
inclusion criteria: asa 1-2 patients programmed for elective surgery, normal neurologic examination - exclusion criteria: neurologic illness, receiving drugs that affect central nervous system during the last 48 hours -

Keywords: propofol pharmacology anesthesic induction drug titration
efficacy of fluoride varnish containing xylitol coated calcium phosphate versus conventional fluoride varnish in management of hypersensitivity of exposed root surfaces in adult patients

Conditions: Hypersensitivity

Summary: this clinical trial will be conducted to compare the efficacy of fluoride varnish containing xylitol coated calcium and phosphate or potassium nitrate gel versus conventional fluoride varnish in the management of hypersensitivity of non-carious exposed root surfaces in adult patients over a 12 months period.


Eligibility criteria:
inclusion criteria of participants: males or females. age: 20-50 years old. patients having at least one tooth with exposed root surface teeth with hypersensitivity, vas ≥5 patients with good oral hygiene. co-operative patients who show interest to participate in the study exclusion criteria of participants: patients with bad oral hygiene patients with orthodontic appliances, or bridge work that might interfere with evaluation patients who are allergic to any ingredients will be used in the study. carious teeth mobile teeth. (grade 2 or grade 3) teeth with hypersensitivity, vas \<5 patients with physical disabilities pregnant or lactating women other dental defects that causes pain. allergy from any used materials or any allergic reaction during our clinical trial (the trial will be stopped at once and all the needed management against any allergic reaction will be done.)
study of motor representations in healthy subjects and amnestic mci

Conditions: Mild Cognitive Impairment

Summary: walking, brain and functional magnetic resonance imaging study of motor representations in healthy subjects and amnesic mci.

review and compare mapping brain activation in magnetic resonance imaging about healthy subjects according to age (\ 60 years) and mci through the combination of two paradigms: on mechanically simulated by korvit® boots and imagination of the walk.

Eligibility criteria:
inclusion criteria: * obtaining the signature of consent to participation in the study * age above 18 years * lack dementia as nicds-adrda criteria * lack of pre-existing musculoskeletal disorders, regardless of the cause (except mci). * absence of a history of stroke or other cerebrovascular disease with spinal sensorimotor sequelae. * no cons-indication for performing a brain mri. * witennses, population of young (\<40 years) * witnesses ,population of older subjects (\> 60 years) * witnesses lack of mci * mci patients, criteria mci criteria according to dubois exclusion criteria : * refusal of mri. * contraindications to brain mri.

Keywords: mild cognitive impairment magnetic resonance imaging
surgical approach to uterine septum

Conditions: Uterine Septum; Surgical Complication; Septum; Uterus; Treatment Side Effects; Treatment

Summary: the objective of this study is to determine if the use of scissors without electrosurgery is superior to bipolar electrosurgery for resection of uterine septum. the investigators will be comparing procedure-level variables such as operative time, complications, and need for additional procedures.

this study is being done to compare two different surgical techniques that can be used to remove the uterine septum. at northwestern, both procedures are done routinely. surgeon preference and comfort dictates which is offered. both techniques are thought to achieve the same goal of removing the participants septum with a procedure called a hysteroscopy in which the participants are taken to the operating room and a scope with a camera is inserted inside their uterus while it is expanded with sterile water. the difference is the instrument used to remove the septum. one technique uses scissors without electricity or heat followed by removal of the excess tissue with a thin tube using suction. the other technique uses an electrical loop (electrosurgery) to cut and remove the tissue. the investigators will be comparing these two procedures by measuring things such as operative time, cost, and the amount of fluid (saline) the participants body absorbs. as mentioned above, to visualize the inside of the participants uterus, the investigators will expand it by filling it with saline.some of this fluid is absorbed by the walls of the uterus and is routinely measured. this will be one of the measurements used to compare the two surgical techniques. about 4 weeks after the participants procedure they will have a routine follow up visit to determine if there is any septum left. the investigators will do this by doing an in-office hysteroscopy at this appointment. this might be a simple vaginal ultrasound, ultrasound with saline or a follow up hysteroscopy. if there remains some septum, it would be removed during a second hysteroscopy. it is common to need a second or even third procedure to completely remove the septum. the investigators anticipate the two techniques being compared will have similar success rates in removing the uterine septum, although there is some data to suggest that the current standard of care procedure which is using electrosurgery could cause additional adhesive disease and require another procedure to remove the adhesions. currently, there is little data comparing these two techniques and so this study will help us understand if one causes more adhesions or not.

Eligibility criteria:
inclusion criteria * have a confirmed septum (\>1.0 cm) confirmed with 3d imaging and/or mri * 20-44 years old exclusion criteria * known tubal disease * bleeding diastasis * no blood thinners * no concurrent laparoscopy scheduled * patient with confirmed fibroids over \>1 cm figo (international federation of gynecology and obstetrics) type 1