Kornimate/medical-research-clean huggingface dataset:
intranasal ketamine for procedural sedation in pediatric laceration repair

Conditions: Laceration

Summary: the purpose of this study is to compare how well three different doses of ketamine, given as a spray into the nose, help to sedate children and help them tolerate repairs of cuts on their faces.

procedural sedation is frequently used to facilitate distressing and painful procedures in the pediatric emergency department. however, administering an intramuscular medication or placing an intravenous line to give intravenous medications can be as distressing as the procedure itself. oral medications generally take longer to work and are subject to first-pass metabolism. another alternative is to give the medication by the intranasal route, which only requires a spray into the nose. ketamine is a good sedative drug with favorable qualities, and is often used intramuscularly or intravenously. it has been used intranasally as a pre-induction by anesthetics, sedation for ct scans, and brief dental procedures, but its use has not yet been demonstrated in the setting of the pediatric emergency department for procedural sedation. we will be comparing three different doses of ketamine, applied intranasally using a mucosal atomization device, and determining if there are any differences in efficacy of sedation, time to onset of sedation, duration of sedation, caregiver and physician satisfaction, and number of adverse events. we will also use this opportunity to determine ketamine bioavailability when given intranasally using the mucosal atomization device.

Eligibility criteria:
inclusion criteria: * children between 1 to 7 years old * simple facial laceration, defined as: linear; requiring two or more sutures; no greater than 5.0 centimeters; does not cross the lid margin of the eye; does not require a plastics/face surgery consult; occured within the last 24 hours. * physician feels that intravenous sedation is required to perform the laceration repair exclusion criteria: * closed head injury, any alteration in level of consciousness, clinical suspicion of intracranial injury or increased intracranial pressure * any conditions that qualify patient as american society of anesthesiologists' (asa) iii or iv * known diagnoses of hyperthyroidism or porphyria * glaucoma or penetrating eye injury * hypertension * any contraindication, including drug allergy, to study medications * severe trauma with other injuries requiring operative intervention * abnormal neurological exam in a previously normal child

Keywords: prospective randomized double blinded sedation ketamine intranasal
a trial investigating the within-subject variability of nn1250 in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of nn1250 (insulin degludec) in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female aged 18-65 years (both inclusive) * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.0-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
evaluation of the relationship between neck pain and ergonomic factors in office workers

Conditions: Disability Physical; Neck Pain; Ergonomic Factors

Summary: the current study aimed to explore the associations between disability levels and occupational risk factors in computer-using office workers with neck pain.

this is a cross-sectional study. all participants will provide informed consent before participating in the study. the study will be conducted in accordance with the helsinki declaration criteria. data will be collected using questionnaires, which include information on demographic, clinical, and occupational ergonomic conditions. patients will be divided into 2 groups as mild-moderate and severe disabled according to their neck disability index values and will be analyzed statistically.

Eligibility criteria:
inclusion criteria: * aged between 18 and 55, * working on computer, * having neck pain at least three months. exclusion criteria: * reporting pregnancy, * having a history of accidents, * trauma or surgery in the neck region, * congenital anomaly of the spine, * rheumatologic disease, * osteoporosis, * spondylosis, * spondylolisthesis, * infection of the spine * cervical disc herniation, * tumor.

Keywords: neck pain office workers ergonomic factors
evaluation of the arthritis foundation tai chi program

Conditions: Arthritis

Summary: the primary goal of this study is to assess the effectiveness and feasibility of the arthritis foundation (af) tai chi program for people with arthritis. arthritis, the most prevalent chronic condition in the us and a leading cause of disability, is characterized by chronic pain and progressive impairment of joints and soft tissues. promoting physical activity is a key public health strategy to addressing arthritis management, but more scientific data regarding effectiveness and feasibility are need to support the promotion of the af tai chi program as an exercise intervention for people with arthritis.


Eligibility criteria:
inclusion criteria: * self-reported doctor diagnosed arthritis * age 18 years or older * able to move independently without assistance exclusion criteria: * pregnancy * non-english speaking * cognitive impairment * serious medical conditions: history of mi, stroke, prescribed beta-blockers, surgery in past 6 months, uncontrolled hypertension, chest pain, diabetes mellitus * severe impairment of physical functioning * participation in tai chi exercise in last 3 months

Keywords: arthritis tai chi
impact of bact/alert® virtuo®, biofire® blood culture identification 2-bcid2 and reveal® (biomérieux) on the optimization of antibiotic therapy for gram-negative bacteremia in the icu

Conditions: Bacteremia

Summary: bacteremia is a frequent infection in intensive care units. it is associated with a high mortality rate and the rapid implementation of appropriate antibiotic therapy is strongly correlated to patient clinical outcomes. innovative technologies have emerged to shorten the turnaround time of blood culture samples by obtaining susceptibility testing of the incriminated pathogen at an early stage, and therefore to rapidly adjust the antibiotic therapy of patients with gram-negative bacilli bacteremia. the study investigators hypothesize that the implementation of the innovative bact/alert® virtuo®, biofire® bcid2 and reveal® solutions for the analysis of blood culture samples will increase the proportion of patients with gram-negative bacilli bacteremia who receive appropriate and optimized antibiotic therapy 24 hours after blood culture collection.


Eligibility criteria:
inclusion criteria: * the patient must be a member or beneficiary of a health insurance plan * patient admitted to the icu with at least one positive blood culture for gram-negative bacteremia for the 'after' section of the study only: * patient must have given their free and informed consent or included by emergency procedure * patient signed the consent form or included by emergency procedure exclusion criteria: * the subject is participating in this study, or is in a period of exclusion determined by a previous study * consent refusal * patient with a polymicrobial blood culture * patient with a second episode of bacteremia * moribund patient
intranasal ketamine as a sedative for venipuncture

Conditions: Respiratory Tract Disease; Acute Pain; Diseases of the Digestive System

Summary: randomized clinical trial, controlled, double-blind, parallel two-arm.

randomized, double-blind, placebo controlled study conducted at the clinical hospital of porto alegre between november / 15 and august / 16. this study was approved by the ethics committee of the institution. participated children requiring venipuncture randomized in the intervention group who received the ketamine in 4 mg/kg and placebo saline group. the groups were compared: puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.

Eligibility criteria:
inclusion criteria: * children hospitalized in the pediatric inpatient units, with the presence of legal guardian; * aged 3 months to 12 years; * requiring venipuncture independent research. exclusion criteria: * severe neurological sequelae; * patients who need immediate venipuncture at risk; * presence of active nosebleeds; * patients using drugs sedative and analgesic continuos; * children who have experienced clinical change with ketamine.

Keywords: ketamine intranasal administration pediatric nursing
the effects of epidural fentanyl on vaginal delivery

Conditions: Cervical Dilatation; Bishop Score; Duration of Delivery

Summary: the study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.


Eligibility criteria:
inclusion criteria: * american society of anaesthesiologists physical status i or ii * nulliparous * normal singleton uncomplicated pregnancies of more than 38 weeks * cephalic presentation of the fetus * anticipated vaginal delivery * active stage of labour * cervical dilatation between 3-5 cm * regular uterine contractions * normal cardiotocographic recordings. exclusion criteria: * medical problems during pregnancy * bmi≥40 kg m-2 * opioid allergy * prior administration of opioids or other analgesics
hati salama (secure voucher)

Conditions: Malaria

Summary: the use of long-lasting insecticide treated nets (llins) is shown to reduce malaria prevalence. the tanzania net voucher scheme has been an active component of bed net distribution to pregnant women in tanzania since 2004. the transition from paper vouchers to electronic vouchers in this program has increased efficiency and the ability to track and distribute nets since 2007. although the program has been successful, to date, electronic voucher redemption varies widely across the country and it has not been clearly established as to what barriers exist for women who receive electronic vouchers in the program. this cluster-randomized trial was designed to examine perceived barriers to electronic voucher redemption among pregnant women and to evaluate if educational and personalized text messages around electronic voucher redemption and bed net usage will increase electronic voucher redemption when directed at pregnant women who receive electronic vouchers in the currently existing program.


Eligibility criteria:
inclusion criteria: * pregnant women capable of providing informed consent

Keywords: mhealth text message
orexin antagonism for suicide risk: a proof-of-concept clinical trial

Conditions: Suicide Risk; Major Depressive Disorder (MDD)

Summary: the goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with major depressive disorder and elevated suicide risk. the main question it aims to answer is: is suvorexant safe, feasible, and tolerable for participants? participants will: * take surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks) * visit the medical center at the beginning of the study (week 1), after taking suvorexant for two weeks (week 3) and following the full suvorexant dose (week 5) for in-person assessments. * fill out self-report assessments (remotely) at week 2 (after one week of suvorexant) and week 4 (after three weeks of surovexant)


Eligibility criteria:
inclusion criteria: * veteran * at least 18 years of age (up to 70 years) * primary diagnosis of major depressive disorder as determined by the study psychiatrist and confirmed by the mini-international neuropsychiatric interview (mini) * lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the columbia-suicide severity rating scale (c-ssrs) exclusion criteria: * clinically significant medical or neurological condition * current use of strong cyp3a live enzymes or moderate cyp3a inhibitors or strong cyp3a inducers * current use of digoxin * currently pregnant, not using contraception, nursing, or trying to become pregnant * active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder * severe traumatic brain injury * imminent suicidal or homicidal risk * free of unstable medical conditions or any contraindication to suvorexant (per fda prescribing label) as determined by patient interview and review of available medical records.

Keywords: suicide risk proof-of-concept clinical trial suvorexant orexin antagonist
derivation and validation of the extended care (ex-care) model ii

Conditions: Postoperative Complications

Summary: the goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in brazil. the main question it aims to answer is: •is the extended care (ex-care) ii model a good tool to assess the risk of death among patients operated in brazilian hospitals within 30 days after surgery? information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death). the sample will be divided in two groups. the first, called derivation sample, will be used for the development of the ex-care ii model. the second, called validation sample, will evaluate the performance of this new model.

from four predictors collected preoperatively ( american society of anesthesiology physical status (asa-ps) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the ex-care ii model. discrimination and calibration measures will be used to determine the accuracy of the model. in addition, each predictor will have their odds ratio calculated for the study outcome. once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.

Eligibility criteria:
inclusion criteria: * patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study exclusion criteria: * diagnostic procedures, with sedation only or with local anesthesia * patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation * in the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement

Keywords: risk assessement validation study postoperative mortality
neural correlates of acute pain dynamics

Conditions: Pain

Summary: this work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * pregnant * history of chronic pain * history of neurological diagnosis * history of psychiatric diagnosis

Keywords: mesolimbic system dopamine circuits psychophysics
the combination of immunotherapy and neoadjuvant chemoradiotherapy in msi-h locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: the study evaluates the addition of immunotherapy of pd-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (msi-h) locally advanced rectal cancer (larc). a total of 50 msi-h larc patients will receive 2 cycles of pd-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of pd-1 antibody, finally received the total mesorectal excision (tme) and 6 cycles of adjuvant chemotherapy of xelox. the tumor response grade, adverse effects and long-term prognosis will be analyzed.


Eligibility criteria:
inclusion criteria: 1. pathological confirmed adenocarcinoma 2. clinical stage t3-4 and/or n+ 3. the distance from anal verge less than 12 cm 4. without distance metastases 5. age 18-70 years old, female and male 6. kps \>=70 7. ugt1a1\*28 6/6 or 6/7 8. the msi status is msi-h or d-mmr 9. without previous anti-cancer therapy or immunotherapy 10. with good compliance 11. signed the inform consent exclusion criteria: 1. pregnancy or breast-feeding women 2. history of other malignancies within 5 years 3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 4. immunodeficiency disease or long-term using of immunosuppressive agents 5. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln 6. dpd deficiency 7. ugt1a1\*28 7/7 8. the msi status is mss or p-mmr 9. allergic to any component of the therapy
impact of laparoscopic gastric bypass surgery and weight reduction on lower esophageal sphincter (les)

Conditions: Obesity

Summary: the purpose with this study is to investigate whether gastric bypass surgery and the following weight reduction impact the tone in esophageal sphincters and the esophageal function. in a previous study our group used high resolution solid-state manometry to investigate the pressure in the esophagus and esophageal sphincters in obese patients going through laparoscopic bariatric surgery. these studies showed that the barrier pressure between the stomach and esophagus is significantly lower in obese compared to lean patients. in this study the investigators will examine these patients once more, now after weight reduction to see whether the barrier pressure is back to normal compared to lean patients.

the prevalence of obesity has increased dramatically in recent decades. the gastrointestinal changes associated with obesity have clinical significance for the anesthesiologist in the perioperative period. the upper and lower esophageal sphincters (ues and les) play a central role in preventing regurgitation and aspiration. the barrier pressure, defined as the difference between the les pressure and the intragastric pressure is known to be lower in obese patients compared to lean patients. this might result in a higher risk of regurgitation and aspiration of stomach contents in during induction of anesthesia. some studies are made on patients before and after bariatric surgery but results are sparse. in this study the investigators will examine 30 patients before and after bariatric surgery. our group have performed the measurements on patients before surgery and presented the results in another article. those patients will be asked to take part of another measurement now 12-18 months after surgery. 30 patients will be consecutively asked and enrolled in this study. measurements will be performed using high-resolution-solid state manometry.

Eligibility criteria:
inclusion criteria: * 18-60 year, * bmi prior to surgery \> 35, * asa-classification 1-3 exclusion criteria: * patient refusal
predictors of the response to adalimumab in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. all those features lead to great disability. because it represents a major problem of the public health care system, ra has been selected as one of the main objectives of the government for the next five years. ra patients who do not respond to dmards require a treatment by tnf-a blocking agents. however, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the g4 region. the purpose of the present research project is to determine potential predictive factors of the response to a new tnf-a blocker ie adalimumab. to address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cdna arrays from blood mononuclear cells, and use of different imaging tools. the criteria of judgement will be the clinical, structural and bone responses to those new agents. this study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period. at the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this tnf-a blocker. indeed, they will be prescribed only for the patients who are likely to respond to those drugs. thus, this study should allow to elaborate theranostic algorithms. such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.


Eligibility criteria:
inclusion criteria: * acr classification criteria of ra * das 28 \> 5.1 * inadequately controlled by at least one dmard * biologics naïve exclusion criteria: * exclusion criteria of adalimumab and methotrexate (regulation authorities)

Keywords: biologics
evaluation of a carbon nanotube enabled solid-state head ct

Conditions: Head Trauma

Summary: purpose: the purpose of this study is to evaluate stationary head ct (s-hct) as a diagnostic tool in patients with known head trauma. participants: participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head ct in the past 24 hours or who will undergo a ct scan of the head. procedures (methods): this investigation will be a single arm, prospective clinical trial. participants will have one single visit, which will include the s-hct scan. no follow-up is required. all images will be de-identified before inclusion within a reader study. the investigators will perform a reader study with physician readers comparing the acquired imaging s-hct images and conventional head ct.

this investigation will be a single arm, prospective clinical trial evaluating stationary head ct (s-hct) as a diagnostic tool in patients with known head trauma. the investigators hypothesize that a stationary head ct (s-hct) system based on the carbon nanotube linear array x-ray source can provide diagnostic quality head ct images. patients included in the study will be 50 people who have had either a head trauma or a brain bleed and have undergone a head ct in the past 24 hours or who will undergo a ct scan of the head.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * medically stable patient with head trauma or known intracranial hemorrhage (subdural or intraparenchymal) or skull fractures * patient has undergone conventional head ct imaging at unc hospitals within the past 24 hours or will undergo a ct scan of the head * willing and able to provide written informed consent exclusion criteria: * unable to provide consent * any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-hcg results, obtained within 24 hours prior to the research scan, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses) * breastfeeding