Kornimate/medical-research-clean huggingface dataset:
local anesthesia and pain perception during an amniocentesis

Conditions: Pregnancy

Summary: this study is been designed to answer the question of whether local anesthesia (1% lidocaine) decreases the perception of pain associated with amniocentesis in a randomized double blind placebo controlled manner. our objective is to determine the effect of local anesthesia on the maternal pain perception from an amniocentesis.

women meeting criteria for project and agreeing to treatment will be randomized into either the 1% lidocaine or placebo(normal saline) group. the initial injection of either 1% lidocaine or placebo (normal saline) will be administered 2 minutes prior to the amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine or placebo (normal saline) to the depth of the peritoneum. all procedures will be performed by either the maternal-fetal medicine (mfm) or the reproductive geneticist utilizing continuous ultrasound guidance under sterile conditions. each woman will be asked to rate their pain perception immediately after the procedure on two pain scales.

Eligibility criteria:
inclusion criteria: * singleton pregnancies * signed consent to participate in the trial * women between the ages of 18 and 45 years * gestational ages 15 - 24 weeks exclusion criteria: * multiple gestation * refusal to participate in the trial * known hypersensitivity to lidocaine * amniocentesis during this pregnancy * amnioinfusion/amnioreduction where the procedure is likely to be prolonged

Keywords: amniocentesis genetic amniocentesis fetal lung maturity pain control pregnancy high risk pregnancy
a real-world assessment in implementation of the mash patient care pathway in chinese population using the meinian health check-up database

Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)

Summary: the primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk chinese population based on the european association for the study of the liver (easl) 2024 care pathway


Eligibility criteria:
inclusion criteria: for all and study population: 1. male or female, age above or equal to 18 years on health-check-up visit day 2. no missing value on sex for easl at risk population 1. must be part of study population. 2. people with t2d or \[obesity＋above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes for easl not at-risk population 1. must be part of study population. for easl-safe 1. must be part of easl at risk population for aga at risk population 1. must be part of study population. 2. people with 2 or more metabolic risk factors (easl-masld criteria) or t2d or steatosis on any imaging modality or with elevated aminotransferases for csh mafld population 1. must be part of study population. 2. liver steatosis on abdominal ultrasound 3. with at least one component of metabolic syndrome (mets \[csh\]) exclusion criteria: 1. individuals originating from centers with fewer than 100 participants 2. missing value of liver stiffness measurement (lsm) 3. had an interquartile range/median ratio above or equal to 30% of the measurement of lsm 4. missing value on either aspartate aminotransferase (ast) or alanine aminotransferase (alt) or platelet count (plt) 5. missing value on fpg, tg, hdlc or bp (to define the presence of metabolic risk factors) 6. missing value on abdominal ultrasound for easl not at-risk population 1. people with t2d or \[obesity＋above or equal to 1 cardiometabolic risk factor(s)\] or elevated liver enzymes for easl-safe/nfs 1. missing value on globulin
a phase 3 study of tezacaftor (vx-661) in combination with ivacaftor (vx-770) in subjects aged 12 years and older with cystic fibrosis (cf), who have one f508del-cftr mutation and a second mutation that has been demonstrated to be clinically responsive to ivacaftor

Conditions: Cystic Fibrosis

Summary: this is a phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with cf who are heterozygous for the f508del-cftr mutation and a second cftr allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.


Eligibility criteria:
inclusion criteria: * heterozygous for f508del-cftr mutation and a second cftr allele with a gating defect that is clinically demonstrated to be ivacaftor responsive * fev1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening * stable cf disease as judged by the investigator. exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at screening and week -4 visits). * sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
patient satisfaction of glazed ips empress cad versus glazed celtra duo ceramic laminate veneers

Conditions: Tooth Discoloration; Tooth Fractures

Summary: the most frequent reason for failure of laminate veneers made of glass ceramics (feldspathic, leucite based and lithium silicate based ceramics) was fracture of the ceramic, therefore, ceramic materials that have higher fracture resistance, especially for patients suffering from abnormal occlusion, are needed.

ips empress cad is a leucite glass-ceramic of the sio2-al2-o3-k2o material systems with leucite crystal ranging from 5 to 10 µm in size. the leucite crystals increase the material strength and interferes with crack propagation, while the fracture energy is absorbed by the crystalline phase. the resistance and flexural strength (160 mpa) is improved by the difference in the coefficient of thermal expansion between the glass phase and the crystalline phase and the cooling process following sintering phase. celtra duo: is a new generation of glass ceramic material. with the aid of a new manufacturing process, the glass ceramic is infiltrated with 10% zirconia by weight, producing zirconia reinforced lithium silicate ceramic (zls). the material is characterized by a unique homogenous structure with fine grains that provides excellent material quality and consistency, high strength properties and long term performance. in addition, the material offers satisfying processing characteristics which can be milled and polished easily. after milling the restorations are shaded correctly shaded, with no need for crystallization step 10. the milled restorations have a flexural strength of 210 mpa. after stain and glaze firing the restoration will exhibit a flexural strength up to 370 mpa.

Eligibility criteria:
inclusion criteria: * all subjects are required to be 1. from 18-50 years old, be able to read and sign the informed consent document. 2. physically and psychologically able to tolerate conventional restorative procedures 3. have no active periodontal or pulpal diseases, have teeth with good restorations 4. patients with teeth problems indicated for laminate veneer: 1. discoloration 2. fracture not involving more than 50% enamel loss 3. mild malposition 4. diastema 5. enamel fluorosis 6. stained or defective restorations 5. willing to return for follow-up examinations and evaluation exclusion criteria: * 1. patients in the growth stage with partially erupted teeth 2. patient with fractured teeth of more than 50% enamel loss 3. patients with poor oral hygiene and motivation 4. pregnant women's 5. patient with post and core endodontically treated teeth 6. psychiatric problems or unrealistic expectations 7. lack of opposite occluding dentition in the area intended for restoration 8. patients involved in contact sports 9. teeth with deep discoloration
time window for ischemic stroke first mobilization effectiveness

Conditions: Brain Ischemia; Stroke Rehabilitation

Summary: early mobilization was thought to be effective in patients with acute ischemic stroke. as the essential component of stroke unit care, early mobilization has already been part of routine clinical practice. however, it is uncertain that which and when medical service focusing on functional recovery should be delivered after the emergency interventions for stroke. besides, the optimal time window, for delivering early mobilization after acute ischemic stroke, has not been verified with strong evidence.

the time trial is a pragmatic, investigator-initiated, multi-center, randomized, 3-arm parallel group, clinical trial. this trial will be conducted in 57 general hospitals in mainland china affiliated with the china stroke databank center and will enroll 6033 eligible patients with acute ischemic stroke. participants will be randomly allocated to either (1) the very early mobilization group in whichmobilization is initiated within 24 hours from stroke onset, (2) the early mobilization group in which mobilization begins between 24 and 72 hours poststroke, or (3) the late mobilization group in which mobilization is started after 72 hours poststroke. the mobilization protocol is otherwise standardized and identical for each comparison group. mobilization is titrated by baseline mobility level and progress of patients throughout the intervention period. the primary outcome is death or disability assessed with the modified rankin scale at 3 months poststroke. secondary outcomes include impairment score of the national institutes of health stroke scale, dependence in activities of daily living as measured using the modified barthel index, cognitive ability assessed with the mini-mental state examination, incidence of adverse events, hospital length of stay, and total medical costs. study design: an investigator-initiated prospective multicenter randomized 3-arm clinical trial sample size: 1500 cases

Eligibility criteria:
inclusion criteria: * 1 diagnosed with ischemic stroke through anamnesis, clinical symptoms, and radiographic assessment; * 2 aged 18 years or older; * 3 of ischemic stroke within 12 hours before eligibility check; * 4 able to verbally respond to the instructions; * 5 with stable vital signs (systolic blood pressure 120-180 mmhg, heart rate 50-100/min, body temperature \ 92%) * 6mmse score \> 16; * 7participation in the time trial and sign the consent form. exclusion criteria: * 1 diagnosed with hemorrhagic stroke; * 2 nihss score \< 2; * 3 pre-morbid modified ranking scale (mrs) score of 3-5; * 4 refusing randomization; * 5 having severe limb dysfunction or systemic diseases rendering them unable to cooperate in the mobilization intervention; * 6 having severe cognitive and mental dysfunctions; * 7 currently enrolled in another trial or having participated in a clinical trial within 6 months before stroke onset.

Keywords: acute ischemic stroke early rehabilitation early mobilization time window multicenter randomized controlled trial
development of a family-based treatment for adolescent methamphetamine use

Conditions: Behavior and Mental Disorders; Methamphetamine Disorders

Summary: the aims study compares a methamphetamine-specific treatment intervention to a treatment-as-usual functional family therapy (fft) approach for adolescents ages 15 to 19. adolescents are assigned to one of two treatment conditions: (1) 16 weeks of fft designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use; or (2) 16 weeks of a combination of fft and a methamphetamine-specific intervention involving group and individual therapy sessions; families are assessed using questionnaires and interviews, and adolescents participate in neuropsychological testing, before, during, and after treatment to provide information about family functioning, the adolescent's drug use, the adolescent's peers, and other factors that may contribute to treatment success. adolescents also provide urine specimens for drug screening at assessment visits. through a partnership with oregon health and science university (ohsu), adolescents will participate in functional magnetic resonance imaging appointments at the hospital to examine regional brain blood flow during tasks designed to measure impulsivity and risk-taking behaviors. as a treatment development grant, study investigators will study adolescents' acceptance of and response to the newly developed methamphetamine-specific treatment approach.


Eligibility criteria:
inclusion criteria: * 15 to 19 years of age. * have at least one parent or parent figure willing to participate. * meet dsm-iv diagnostic criteria for drug-abuse or dependence, including a specific meth use disorder. * reports meth use on at least 5 of the previous 90 days. * have contact with the parent on at least 40% of the past 90 days. * with their parent be willing to accept randomization to one of the two treatment interventions. * be willing to participate in the imaging task in the fmri pilot study. * have basic english competency. * have sufficient residential stability to permit probable contact at follow-up. exclusion criteria: * evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures. * have a medical or psychological condition that would preclude undergoing the fmri scan. * have a sibling who is participating in the study.

Keywords: methamphetamine abuse
post-op lidocaine patch

Conditions: Pain, Postoperative

Summary: randomized control trial evaluating use of lidocaine vs placebo patch for post-operative cesarean incision pain.

the purpose of this study is to determine if lidocaine patches decrease post-operative pain associated with cesarean births. while the lidoderm lidocaine patch has been fda approved for the treatment of skin pain, it has not been studied in women undergoing cesarean birth who experience postoperative pain. even though this medication has been used in post-operative pain in published studies, the use of this medicine under these circumstances is still considered experimental. a lidocaine patch may provide added benefit for pain control in addition to standard medicines participants would receive after surgery, such as spinal, intravenous, and oral pain medications following cesarean delivery.

Eligibility criteria:
inclusion criteria: * pregnant patients who require a scheduled or non-urgent cesarean birth * patient able to receive neuraxial analgesia * patient able to give verbal and written consent for both cesarean birth and study exclusion criteria: * patients requiring emergent cesarean birth * patients allergic to lidocaine or adhesive * patients who have already received an epidural during this admission or requiring general anesthesia for cesarean birth * patients using chronic oral neuromodulators * patients with cardiac disease or using anti-arrhythmic agents * patients with fibromyalgia or chronic pain syndromes such as rheumatoid arthritis, osteoarthritis, or lupus. * daily narcotic or opiate use for greater than the 2 months prior to enrollment in the study.

Keywords: cesarean section postoperative pain
effectiveness validation of celbrea® in symptomatic women or with diagnostic doubt of breast pathology (detect-bh)

Conditions: Breast Disease; Benign Breast Disease; Breast Cancer

Summary: this is an observational, prospective, and transversal study, designed to evaluate the effectiveness of celbrea® in women from the local community coming to consult at the breast pathology unit of la paz hospital (madrid, spain), because of discomfort, breast symptoms, or because they have been sent for specialized evaluation because of a diagnostic doubt, providing actualized data on the effectiveness of the device within the context of the real-world scenario. because of its transverse nature, the observation period will be limited to the necessary amount of time to perform the initial consult, additional tests when prescribed by the physician, and the celbrea® test.


Eligibility criteria:
inclusion criteria 1. women ≥ 18 years old coming to consult at the breast pathology unit of la paz hospital (madrid, spain), because of: * discomfort or breast symptoms including, but not limited to, signs or symptoms detected through a self-examination, changes of color or shape in the nipple, nipple discharge, change of appearance or color of breast skin, lumps, etc. * refered for evaluation because of diagnostic doubt. 2. capable of following the instructions necessary for the study. 3. have signed the informed consent form. exclusion criteria: 1. women who are pregnant or lactating at the time of the study. 2. women suffering from one of the following breast pathologies: * personal history of breast cancer, previous or current. * current chemotherapy or radiotherapy for any type of cancer. * history of breast surgery (reductive, reconstructive, mastectomy, lumpectomy, and others). * fever. * swelling or local infections on the breasts. * open wounds in breast skin.

Keywords: breast symptoms diagnostic doubt celbrea breast thermal activity indicator
closed loop ventilation with high tidal volumes and safe transpulmonary pressure in copd (copd-safe)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study evaluates the safety and efficacy of high tidal volumes generated by "adapted support ventilation (asv) mode' in mechanically ventilated severe copd patients. every patient will be ventilated consecutively with asv and volume control (vc) modes at 2 different levels of minute volume in 2 sets. asv mode is expected to be safe measured by adequate inspiratory transpulmonary pressures and expected to be as effective as vc mode with lower intrinsic positive end expiratory pressure (ipeep) levels.

acute exacerbations of chronic obstructive pulmonary disease (copd) may require mechanical ventilation. various mechanical ventilation strategies and modes can be used to manage respiratory insufficiency in such patients. high tidal volumes required for mechanical ventilation of patients with obstructive pathologies is a well-known fact. adapted support ventilation (asv) is an intelligent closed-loop mechanical ventilation mode which automatically adjusts ventilation to lung mechanics. led by measured lung mechanics, asv mode often generates higher than usual tidal volumes during mechanical ventilation of copd patients, particularly if the minute volume (mv) target is high. thus, the effects of high tidal volumes on inspiratory transpulmonary pressure (ptp), and whether ptp stays within safe limits during asv mode is of great interest. patients with acute exacerbation of copd who required mechanical ventilation will be enrolled in the first 24 hours of admission to the intensive care unit. all patients will be deeply sedated. an esophageal balloon catheter will be inserted in order to measure transpulmonary pressure. 100 % minute volume target will be calculated in advance as 100 ml per ideal body weight. patients will be ventilated with two different mv targets in two sets. 'adapted support ventilation' and 'volume control (vc)' modes will be used consecutively within each set. while the target minute volume will be 100 % in the first set, the volume target in the second set will be tuned to decrease patients paco2 below 45 mmhg. the sequence of ventilation mode will be randomized within each set. ventilation periods will be 30 minutes with 15 minutes washout period in between. i̇f ptp increase above 20 cmh20 at any ventilation mode, the tidal volume will be decreased. asv mode is expected to be safe, assessed by adequate inspiratory transpulmonary pressures, and expected to be as effective as vc mode with lower intrinsic positive end expiratory pressure (ipeep) levels.

Eligibility criteria:
inclusion criteria: * acute exacerbation of chronic obstructive lung disease * being intubated for less than 24 hours * not being planned to be extubated in 24 hours * expiratory time constant (rcexp) more than \> 2.0 s exclusion criteria: * restrictive lung pathologies * impaired hemodynamic status * esophageal pathologies * bronchopleural fistula

Keywords: mechanical ventilation adaptive support ventilation transpulmonary pressure intrinsic peep safety
radiation treatment plan evaluation learning tool pilot project

Conditions: Radiation Oncology

Summary: this study involves both the development of a novel learning tool, the radiation treatment plan evaluation learning module, as well as a pilot program to validate this tool as an effective resource to teach treatment plan review and optimization to radiation oncology residents.

this study involves both the development of a novel learning tool, the radiation treatment plan evaluation learning module, as well as a pilot program to validate this tool as an effective resource to teach treatment plan review and optimization to radiation oncology residents. stud procedures include screening for eligibility and completion of surveys and oncology examinations. participation is expected to last about 6-8 weeks. it is expected about 20 radiation oncology resident physicians will participate in the study.

Eligibility criteria:
inclusion criteria: * the pilot program will be open to radiation oncology resident physicians that are in their pgy-2, pgy-3, or pgy-4 year. * all residents must have completed a breast cancer-specific radiation oncology rotation at least 3 months prior to enrollment in the pilot program in order to be eligible. exclusion criteria: -the study will not include any special populations.

Keywords: radiation oncology education
changes in glucose metabolism after roux-en-y gastric bypass

Conditions: Type 2 Diabetes; Obesity

Summary: besides causing weight loss roux-en-y gastric bypass (rygb) has profound effect on glucose metabolism leading to remission of type 2 diabetes early after surgery. however the mechanisms for this improvement remain uncertain. the aim of this study is to investigate the changes in insulin sensitivity and beta-cell function 1 week and 3 months following rygb using oral and intravenous test.

investigators plan to study 24 obese patients already enrolled for roux-en-y gastric bypass surgery (rygb). 8 with type 2 diabetes (dm2), 8 with impaired glucose tolerance (igt) and 8 with normal glucose tolerance (ngt) before, within the first week and 3 month after rygb using a liquid mixed meal test (mmt) and an insulin modified frequently sampled intravenous glucose tolerance test (im-fsigt). furthermore, an oral glucose tolerance test (ogtt) will be performed before and after 3 months. blood will be sampled in fasting and during the tests measuring plasma glucose, insulin and c-peptid (ogtt, mmt and im-fsigt) and glp-1, glucagon, gip and glp-2 (mmt). beta-cell function will be assessed from the mmt (insulinogenic index - igi), ogtt (igi) and the im-fsigt (acute insulin response, air) in order to examine whether changes in beta-cell function after rygb depend on an oral stimulus. insulin sensitivity will be assessed in fasting (homa-ir), during the im-fsigt (minimal model: si) and from mmt/ogtt (matsuda index). insulin clearance/hepatic extraction of insulin will be assessed in fasting and during the intravenous and oral test.

Eligibility criteria:
inclusion criteria: * patients eligible for rygb, age 18-60 years, bmi 35-60 kg/m2 at time of referral to operation, blood pressure \ 700 pmol/l. exclusion criteria: * obesity caused by medical treatment for psychiatric disease. mental retardation. alcohol or drug abuse. severe cardiopulmonary disease. history of peritonitis, ventricular disease, upper gastrointestinal surgery, recurrent oesophagitis or severe complications to general anesthesia. bad compliance. treatment with thyroid hormones or antithyroid treatment. treatment with anorectic medicine later than 3 months prior to surgery. furthermore prior to surgery each patient has to loose 8 % of bodyweight to reduce the risk of operative complications. before each test day all glucose lowering medication will be paused for an appropriate amount of time depending on the type of medicine.