Kornimate/medical-research-clean huggingface dataset:
biomarkers and outcome 1 and 10-15 years after severe traumatic brain injury

Conditions: Brain Injury Traumatic Severe (Diagnosis); Biomarkers

Summary: after written consent from next-of-kin patients with severe traumatic brain injury was included from the neurointensive care unit (nicu) at sahlgrenska university hospital, gothenburg. blood and csf samples were collected during the initial 3 weeks after trauma. 1 year after trauma patients were assessed according to glasgow outcome scale (gos), nihss and barthels. 10-15 years after trauma a repeated evaluation according to gos was performed by telephone. different biomarkers such as neurofilament light, glial fibrillary acidic protein and tau among others, was analyzed from serum and csf samples. further patients were explored apolipoprotein-e genetype (apoe). the investigators hypothesize that higher biomarkers concentrations and positive test for this gene relate to worse outcome 1-year and 10-15 years after trauma. further that these biomarkers and genetic marker further have prognostic value on outcome 1-year and 10-15 years after trauma. finally, the investigators want to explore the concentrations dynamics of these biomarkers in serum and csf in the acute phase after trauma.

patients with a severe traumatic brain injury (stbi) were included after written consent from next-to kin. the injury was considered as severe if having a glasgow coma scale of 8 or less. within 48h of trauma patients were included from the neurointensive care unit at sahlgrenska university hospital, gothenburg during 2000-2004. patients were intubated and had a ventricular catheter. all patients were treated in accordance with the lund concept. samples from ventricular cerebrospinal fluid (csf) and blood was collected, during the first 3 weeks, then prepared for storage and later analyzed. samples were stored in -70 degrees celsius until analyzed. 1 year after trauma patients were assessed according to glasgow outcome scale (gos), nihss and barthels index. 10-15 years after trauma an evaluation of gos by phone was repeated. biomarkers such as neurofilament light, glial fibrillary acidic protein, tau among others is analyzed in serum and csf. further, patients apoe genotype was explored. the investigators hypothesizes that higher concentrations of these biomarkers both in serum and csf relate to worse 1-year and 10-15 year outcome after a severe traumatic brain injury. further, patients that have the gene apoe4 is predisposed to worse 1 year and 10-15 year outcome after a stbi. the investigators further want to explore the dynamics of these biomarkers in serum and csf in the acute phase after trauma and if these biomarkers gave any prognostic value to on outcome (mortality and functional) 1-year and 10-15 years after trauma.

Eligibility criteria:
inclusion criteria: * reaction level scale \>3, corresponding to a glasgow coma scale \<9 * a therapeutic indication for intracranial pressure monitoring * need for ventilator treatment exclusion criteria: * not residing in sweden
parental anxiety and its relationship with pediatric patients' post-operative responses

Conditions: Post-operative Delirium; Children; Anxiety

Summary: post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. we currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. however, references indicate that parental anxiety can increase the post-operative delirium. heart rate variability was used to measure the anxiety status of parents. we think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using stat-trait anxiety inventory questionnaire.

outcome measures 1. post-operative emergence delirium, observed with an average duration up to 24 hours 2. sedatives used in recovery unit

Eligibility criteria:
inclusion criteria: * american society anesthesia (asa) risks classification i or ii exclusion criteria: * parents who have cognitive problems * parents who have difficulty finishing questionnaire

Keywords: anesthesia
mycoplasma species and the genitourinary system

Conditions: Sexually Transmitted Diseases, Bacterial

Summary: the purpose of this study is to determine if the presence of mycoplasma hominis bacteria is associated with bacterial vaginosis (bv), non-gonococcal urethritis (ngu) or vaginitis in patients attending sexual health clinic. patients were participants of the myco well d-one study. ethics for this follow-on pathway-to-portfolio study (iras:253889) is now approved by nres and hcrw. the important primary aim of this study is to determine if mycoplasma hominis (m.hominis) is associated with bv, ngu and vaginitis in the genitourinary system of patients or if they are bacterial commensals. this is important proof of concept work. the secondary aim for this research is to determine if there are clinical and social parameters that are associated with mycoplasma infection. preliminary analysis of 100 patients yielded pilot data suggesting m.hominis is strongly associated with bv, ngu and vaginitis. we aim to consolidate these findings by expansion to 1000 patients from our completed mycowell d-one study.

the clinical study site is the department of sexual health, dewi sant hospital, cwm taf university health board. this study will retrospectively examine the clinical notes of consented participants (iras project id:253889) in the myco well d-one study (iras project id:230693). notes will be identified by the sexual health clinic number. the clinic proforma records the following parameters: 1. gender the patient identifies with 2. age of the patient when the myco well d-one study sample collected 3. symptoms and signs that were recorded in the patient notes e.g. bv/ngu 4. previous sexually transmitted infections diagnosed 5. drug history 6. treatments the patient received 7. sexual history e.g. type of sexual activity on completion, he parameters associated with positive m.hominis result; bacteria load quantification/antimicrobial resistance) and statistical analysis will be examined as below. i statistical analysis this will be performed on anonymised data. the primary outcome measure of this study is to determine if m.hominis is associated with bv, ngu and vaginitis in the genitourinary system of patients or if it is a bacterial commensal. the secondary outcome for this research is to determine if there are clinical and social parameters that are associated with m.hominis infection.

Eligibility criteria:
inclusion criteria: * sexually active participants aged 18 to 100 years * participants can give informed consent in writing. exclusion criteria: * patients who have been sexually assault. * participants who cannot give informed consent in writing.
prevention of intraoperative bleeding and postoperative swelling in orthognathic surgery through the use of tranexamic acid

Conditions: Intraoperative Bleeding; Postoperative Edema

Summary: purpose of the study: * to evaluate the effect of tranexamic acid (txa) of intraoperative blood loss in patients subjected to bi-maxillary orthognathic surgery * to evaluate the potential effect of txa on fibrin structure * to evaluate the potential effect of txa of binding of plasminogen to fibrin * to evaluate the potential effect of txa on postoperative edema formation. hypothesis: h0: intraoperative bleeding cannot be significantly reduced by preoperative administration of tranexamic acid h0,1: postoperative edema cannot be significantly reduced by preoperative administration of tranexamic acid

the study population consists of patients referred to simultaneous mandibular and maxillary osteotomy at the department of oral and maxillofacial surgery, hospital of south west denmark in 2014. hundred patients (50 men and 50 women) will be enrolled in the study. reportedly, the mean intraoperative blood loss in the placebo group is expected to be 436 ml with a standard deviation of 208 ml. the difference in blood loss between the txa-group and the placebo group to be detected is 100 ml. the dropout frequency is estimated to 10%. to fulfil these assumptions a minimum of 40 patients should be included in each group to reach a power of 0.8 and an alpha of 0.05. in order to accommodate an even gender distribution a block randomization is performed resulting in the randomization of 100 patients. the patients will be randomized to receive blindly either 10 ml tranexamic acid (100 mg/ml) (pfizer, ballerup, denmark) or 10 ml saline (9mg/ml) preoperatively. intraoperative blood loss will be determined by deducting the total volume of irrigation fluids from the volume of the contents of the surgical suction device. postoperative edema formation will be determined by 3d surface scanning and volumetric analysis will be carried out in the "landmarker" software.

Eligibility criteria:
inclusion criteria: * patients must be 18 years or older * patients must be eligible for elective bi-maxillary orthognathic surgery * no severe reduction of kidney function * no known medical conditions * signed informed consent exclusion criteria: * hypersensitivity to tranexamic acid * a medical history of acute venous thrombosis and/or arterial thrombosis * the presence of fibrinolytic conditions as a result of disseminated intravascular coagulation, with the exception of a predominant activation of the fibrinolytic system with acute severe bleeding. * severe kidney deficiency * cramps in the medical history * intake of omega-3 fatty acids, gingko biloba, ginger and garlic supplements within 3 months of surgery. * pregnancy (female participants will be tested on the day of surgery)
non-invasive diagnosis of cold urticaria

Conditions: Urticaria Cold

Summary: the investigators subjected 63 patients (39 with typical cold urticaria and 24 with atypical cold urticaria ) and 15 healthy controls to temptest® cold stimulation tests and critical temperature threshold assessments. blood microcirculation photoplethysmography measurements were performed 5 min before and 10 min after the ice cube on the volar forearm.


Eligibility criteria:
inclusion criteria: * cold urticaria exclusion criteria: -
a study to evaluate the safety and efficacy of jnj-64565111 in non-diabetic severely obese participants

Conditions: Obesity

Summary: the purpose of this study is to assess the effects of jnj-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to (\>=) 35 to less than or equal to (\<=) 50 kilogram per square meter (kg/m\^2) at the screening visit * stable weight (that is, change of \<= 5 percent \[%\] within 12 weeks before screening based on medical history) * women must be either: (a) postmenopausal, or (b) permanently sterilized or otherwise be incapable of pregnancy, or (c) heterosexually active and practicing a highly effective method of birth control, or (d) not heterosexually active * woman of childbearing potential have a negative pregnancy test at screening * willing and able to adhere to specific the prohibitions and restrictions exclusion criteria: * history of obesity with a known secondary cause (for example, cushing's disease/syndrome) * history of type 1 diabetes mellitus, type 2 diabetes mellitus (t2dm), diabetic ketoacidosis (dka), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * has a hemoglobin a1c (hba1c) of \>= 6.5% or fasting plasma glucose (fpg) \>= 126 milligrams per deciliter (mg/dl) (\>= 7.0 millimoles per liter \[mmol/l\]) at screening * screening calcitonin of \>= 50 picograms per milliliter (pg/ml) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (men 2), regardless of time prior to screening * history of glucagonoma
cabbage leaf wraps in osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

Summary: this randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee, kellgren lawrence stadium 2-3 * at least 50% of days with complaints * initial pain intensity 45mm on a 100mm visual analoge scale exclusion criteria: * medication with corticoids or immunsupressing drugs * secondary arthritis/arthrosis * operation to the knee within 12 months prior * injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid) * severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.) * participation in other studies * pregnancy, breastfeeding
video stylet vs. flexible bronchoscopy for c-spine

Conditions: Intubation;Difficult; Intubation Complication

Summary: comparison of cervical spine movement during intubation with the c-mac video stylet to flexible bronchoscopy

elective surgical patients who require intubation will be randomised to one of 2 groups: 1. c-mac video stylet 2. flexible bronchoscopy during intubation, fluoroscopy will be recorded for later analysis to determine the amount of cervical spine movement during the intubation process. the intubation will also be timed to determine the duration of the intubation process.

Eligibility criteria:
inclusion criteria: * elective surgery requiring oral intubation * undergoing elective non-cardiac surgery * american society of anesthesiologists physical status 1-3 * age 18-80 years exclusion criteria: * gastro-esophageal reflux disease * body mass index \> 35 kg/m2 * possibility of pregnancy * previous neck surgery * unstable c-spine * known or predicted difficult airway.

Keywords: cervical spine injury
effectiveness of the nephrocheck™ after tavi

Conditions: Transcatheter Aortic Valve Implantation; Acute Kidney Injury; Postoperative Acute Renal Failure

Summary: postoperative acute renal failure is a frequent complication after a transcatheter aortic valve implantation (tavi). the current practice cannot predict acute kidney injuries (aki) early enough to prevent an organic dysfunction triggering, consequently, cortical tubular necrosis. several recent studies in cardiac surgery have shown that sonographic criteria, the renal resistive index (irr), and a urinary biomarker, the nephrocheck™, could predict aki promptly. these markers, sonographic and biologic, have both the advantage to be non-invasive and easy to perform. each marker seems to have sensitivity and specificity to predict aki promptly after cardiac surgery. therefore, the irr and the nephrocheck™ test could become essential tests to guide clinicians in determining rapidly whether a patient will develop aki after a tavi procedure. however, so far, no study has tested the nephrocheck™ in patients undergoing tavi. therefore, the aim of this prospective observational study will be first to determine the effectiveness of the nephrocheck™ to predict aki at an early stage after a tavi procedure. the secondary outcome will be to compare the nephrocheck™ with the rri in predicting at an earlier stage than the traditional method an aki.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo a tavi exclusion criteria: * chronic dialysis patients with anuria

Keywords: transcatheter aortic valve implantation acute kidney injury early acute kidney injury detection nephrocheck™ renal resistive index
the registration on the use of feilike heji in minors

Conditions: Bronchial Asthma

Summary: feilike heji is produced by guizhou jianxing pharmaceutical co. ltd. for the treatment of phlegm heat caused by lung cough phlegm yellow, bronchial asthma, bronchitis, see the syndrome of proprietary chinese medicine (approval number: z20025136) approved by the state and the drug from radix scutellariae, radix peucedani, radix stemonae, red gentian root of deal, phoenix tree, spreading hedyotis herb, red tube 7 flavour, with qingrejiedu, antitussive expectorant effect. in order to fully understand the safety of feilike heji in clinical practice and fulfill the responsibility of production enterprises for patients, the production enterprises initiated this study to further evaluate the safety and understanding of the function characteristics of feilike heji in a wide range of people, so as to guide the clinical rational drug use.


Eligibility criteria:
inclusion criteria: * all minor patients (age \<18 years old) who use feilike mixture at the specified monitoring time and in the monitoring center (department) . * voluntarily participate in this study and meet ethical requirements. exclusion criteria: * not applicable.
evaluation of the efficacy of hippotherapy for children with developmental disorders

Conditions: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder

Summary: hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. the purpose of the current research is to evaluate the efficacy of hippotherapy for children with developmental disabilities. the hypothesis is that children with developmental disabilities who are treated with hippotherapy will show better outcomes than children with the same problems who are not treated with hippotherapy.

hippotherapy is every program of horseback riding meant to treat people with physiological, mental, social, cognitive or behavioral problems. most studies that tested hippotherapy were uncontrolled and focused on motor problems, such as cerebral palsy. today, hippotherapy is used for various developmental problems such as attention deficit / hyperactivity disorder (adhd) and autism spectrum disorder (asd), without clear information about its efficacy for these populations. the purpose of the current research is to evaluate the efficacy of 6 months of hippotherapy for children with developmental disabilities. the hypothesis is that children with developmental disabilities who are treated with hippotherapy for 6 months will show better outcomes than children with the same problems who are not treated with hippotherapy. assessment: * brief questionnaire * stony brook questionnaire all questionnaires will be applied at the beginning of the study and after 6 months.

Eligibility criteria:
inclusion criteria: * age: 5-17 years. * a diagnosis of adhd or asd. exclusion criteria: * none.

Keywords: adhd asd
delving into participation trends of scleroderma clinical trials

Conditions: Scleroderma

Summary: typically, specific demographic subsets tend to exhibit greater engagement in medical research. nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics. the study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with scleroderma * patient has self-identified as planning to enroll in an observational clinical trial * patient is a minimum of 18 years or older exclusion criteria: * patient is pregnant * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: scleroderma
a study of bruton's tyrosine kinase (btk) inhibitor ibrutinib in participants with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma

Conditions: Lymphocytic Leukemia

Summary: the purpose of this study is to evaluate the safety of ibrutinib in japanese participants with treatment-naive chronic lymphocytic leukemia ( cll) or small lymphocytic lymphoma (sll).

this is a phase 1, open-label and multicenter study. the study consists of a screening phase (28 days prior to the first administration of the study drug), treatment phase (time when the first dose of ibrutinib is administered until disease progression, the investigator no longer considers the treatment to be tolerable, or the participant meets any one of the discontinuation criteria) and follow-up phase (end of the last dose of study drug until 30 days after the last dose of study drug or the start of subsequent anti-cll/sll therapy, whichever comes first). participants will be instructed to take 3 capsules of ibrutinib (at a dose of 420 mg) orally once daily starting at cycle 1, day 1. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * diagnosis of lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) that meets published diagnostic criteria * for cll participants: measurable nodal disease by computed tomography (ct), defined as at least 1 lymph node greater than (\>) 1.5 centimeter (cm) at the longest diameter at a site that has not been previously irradiated. adequate hepatic function, defined as serum aspartate transaminase (ast) and alanine; for sll participants: at least 1 measurable site of disease according to the revised response criteria for malignant lymphoma * eastern cooperative oncology group (ecog) performance status of 0-1 * adequate hepatic function, defined as serum aspartate transaminase (ast) and alanine transaminase (alt) \<2.5 × upper limit of normal (uln), and total bilirubin less than or equal to (\<=) 1.5 × uln (unless due to gilbert's syndrome) * a woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hcg\]) or urine pregnancy test at screening exclusion criteria: * known involvement of the central nervous system by lymphoma or leukemia * history or current evidence of richter's transformation or prolymphocytic leukemia * uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura * any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat cll/sll * received any immunotherapy, live vaccine, or investigational drug within 4 weeks prior to the first dose of the study drug

Keywords: lymphocytic leukemia ibrutinib pci-32765 jnj-54179060
l-arginine in treatment of intrauterine growth restriction

Conditions: Intrauterine Growth Restriction Asymmetrical

Summary: intrauterine growth restriction is an important problem in neonatal care. intrauterine growth restriction (iugr) is defined as a fetal weight below the 10th percentile for gestational age. one of the main causes of iugr is placental insufficiency. nitric oxide(no) increases placental blood flow. so,it might be useful to improve iugr pregnancy outcome .

the study population includes pregnant women attending antenatal care clinic of ain shams university maternity hospital who first time diagnosed of iugr at our antenatal care outpatient clinic either referred for this cause after confirm diagnosis of iugr and distributing patient into two groups patient in first group will receive oral l-arginine 3000mg/day till delivery and acetylesalicylic acid 75mg once daily. patients in second group will receive acetylesalicylic acid 75mg once daily. then follow up of both group by: 1. daily fetal movement counting 2. day after day ctg 3. doppler twice weekly 4. pelvic u/s weekly for: a) head circumference, abdominal circumference, femur length b) fetal weight c) liquor amount: amniotic fluid index or meanvertical pocket decision of delivery will be determined when: a) fetal distress (non stress ctg) b) mother starts labour c) reversed umbilical artery doppler.

Eligibility criteria:
inclusion criteria: * all pregnant women diagnosed with iugr from 28 weeks * singleton pregnancy * no maternal systemic disease * no congenital fetal malformation * estimated fetal weight below 10th percentile exclusion criteria: * all pregnant woman diagnosed with iugr before 28 weeks * multiple pregnancy * maternal systemic disease * congenital fetal malformation