Kornimate/medical-research-clean huggingface dataset:
midazolam and ketamine effect administered through the nose for sedation of children for dental treatment

Conditions: Child Behavior; Dental Caries

Summary: randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.

about 10% of children may have behavioral problems during dental treatment, but the evidence for sedative protocols that benefit the care in pediatric dentistry are still weak. this randomized, masked, controlled, parallel design study aims to evaluate the efficacy, safety and cost-effectiveness of intranasal sedation with ketamine / midazolam in healthy children aged 2 to 6 years old. children will be selected among those with dental decay that do not allow dental treatment to be performed, and need at least two restorations under local anesthesia and rubber dam isolation. it is estimated a preliminarily a sample of 84 children equally divided into three groups: a) ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.2 mg / kg, maximum 5 mg) intranasally; b) ketamine (4.0 mg / kg up to 100 mg) + midazolam (0.5 mg / kg, maximum 20 mg) orally; c) midazolam (1.0 mg / kg, maximum 20 mg) orally. the hypothesis is that ketamine / midazolam combination, administered intranasally, it constitutes an effective sedative regime, safe and cost-effective for use in pediatric dentistry in the public service. the primary endpoint is the behavior of the child. secondary endpoints are: sedative administration acceptance, procedure memory and salivary cortisol levels within each intervention group. additionally, we will evaluate: the occurrence of pain and associated changes in facial expressions with potentially painful stimuli in children sedated for dental care; caregivers and paediatric dentists' stress and perception about sedation; adverse events that occur during and after administration of sedatives; cost-effectiveness of the sedative protocols. the experimental design is planned to minimize systematic and random errors and to contribute to higher level of evidence in future systematic reviews. the outcomes of this study have potential impact on public and private health practice, and may support institutional guidelines dealing with this theme.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists i (healthy) or ii (mild and controlled systemic disease such as persistent asthma) * small risk of airway obstruction (mallampati less than 2 or tonsillar hypertrophy occupying less than 50% of the oropharynx) * no medical history of neurological or cognitive changes * absence of facial deformities * term birth * no use of drugs that may impair cognitive functions * at least two teeth with cavities without pulp involvement, requiring dental restoration under local anesthesia and rubber dam exclusion criteria: * positive or definitely positive behavior (frankl et al, 1962) in a dental treatment session conducted by the research team

Keywords: dental caries moderate sedation
vein histology in arteriovenous fistulas and its effect on fistula surgery success

Conditions: Renal Replacement Therapy; Arteriovenous Fistula

Summary: patients whose kidneys have failed need to receive dialysis treatment, most commonly with a dialysis machine. in order to be connected to the machine an operation is often performed to join an artery to a vein in the arm. this forms what is known as an arteriovenous fistula. the fistula causes an increase in the flow of blood through the vein and the vein reacts to this by becoming bigger and thicker, making it easier to connect the patient to the machine. the success rate for the operation is relatively low and only approximately 65 from every 100 operations is still working after a year. it is thought that one factor that may cause problems with the fistula is the ability of the vein to stretch in response to increased blood flow. previous research has shown that veins in kidney failure patients look different to those of people whose kidneys are working when viewed under a microscope. the investigators aim to study the structure of the vein that is used in making fistulas with a microscope and also to test it in an engineering laboratory to see how much it will stretch. the investigators hope that gaining information about the structure of the vein and its ability to stretch will help determine what it is about the vein that affects how well it works as part of a fistula. this information may help surgeons select the best possible vein in a given patient to give the best chance of a working fistula in the future.


Eligibility criteria:
inclusion criteria: 1. patients referred to vascular consultants for av fistula formation for haemodialysis access. 2. ability to give informed written consent 3. aged over 18 at time of referral exclusion criteria: 1. veins identified on preoperative ultrasound scanning to be of a calibre too small to allow sufficient material to be obtained for biomechanical testing (\<3mm diameter). 2. inability to give informed written consent 3. aged under 18 at time of referral 4. inability to attend follow-up appointments

Keywords: histology compliance dialysis arteriovenous access fistula vein
integrating deep learning ct-scan model, biological and clinical variables to predict severity of asthma in children

Conditions: Asthma in Children

Summary: artificial intelligence (ai) offers substantial opportunities for healthcare, supporting better diagnosis, treatment, prevention and personalized care. analysis of health images is one of the most promising fields for applying ai in healthcare, contributing to better prediction, diagnosis and treatment of diseases. deep learning (dl) is currently one of the most powerful machine learning techniques. dl algorithms are able to learn from raw (or with little pre-processing) input data and build by themselves sophisticated abstract feature representations (useful patterns) that enable very accurate task decision making. recently, dl has shown promising results in assisting lung disease analysis using computed tomography (ct) images. current severe asthma guidelines recommend high-resolution and multidetector ct as a tool for disease evaluation. ct scans contain prognostic information, as the presence of bronchial wall thickening, air trapping, bronchial luminal narrowing, and bronchiectasis are associated with longer disease duration and disease severity in adults. only a small number of studies have reported chest ct findings in children with severe asthma, and their relationship to clinical and pathobiological parameters yielded inconsistent results. thus, to which extent ct scans add prognostic information beyond what can be inferred from clinical and biological data is still unresolved in children. the project is expected to build an dl-severity score to prognoses severe evolution for children with asthma, using a dl model to capture ct scan prognosis information.

the aims of this project are: * to build a large database of clinical, biological and radiological data collected from pediatric patients with severe asthma; * to design and train a forecaster model based on dl techniques to predict asthma severity in children; * to estimate transition probabilities between asthma severity levels using a multi-state markov model taking into account qualitative and quantitative information obtained from ct imaging. our evaluation of dl-severity and existing clinical scores in childhood asthma is expected to reveal that emerging methodologies assisted by dl techniques can provide accurate severity predictions, when compared with existing clinical scores. such an accurate prediction model would allow pediatricians to identify features that are the most indicative of severity and progression of asthma and would be employed to formulate intervention strategies and early medical attention for children.

Eligibility criteria:
inclusion criteria: * age 6-17 years * confirmed diagnosis of severe asthma according to ers/ats guidelines exclusion criteria: * other diseases that may mimic asthma according to ers/ats guidelines (i.e., cystic fibrosis, primary ciliary dyskinesia, tracheobronchomalacia, etc)

Keywords: asthma children severe asthma artificial intelligence deep learning computed tomography
evaluate the safety and tolerability of incb019602 when administered with metformin in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: determine the effect of treatment with incb019602 administered as an add-on to stable dose metformin therapy in type 2 diabetic subjects on safety and glycemic control.


Eligibility criteria:
inclusion criteria: * established diagnosis of t2d * currently taking metformin monotherapy at a stable dose level * fpg between 150 and 270 mg/dl exclusion criteria: * history or clinical manifestations of renal impairment * hyperglycemia \> 270 mg/dl * receiving thiazolidenediones, exenatide or sulfonylureas within 90 days prior to screening * prior use of acipimox which is known under the name olbetam within 90 days prior to screening. * diagnosed major depression within the last 2 years requiring hospitalization * history of chronic insulin therapy for glycemic control
muscle strength and inflammatory response in patients with inclusion body myositis

Conditions: Inclusion Body Myositis

Summary: comparison of a group of 20 ibm patients with 20 controls matched on age, gender and weight.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * written consent exclusion criteria: * current infection * cancer within 1 year * immune deficiency
study of daily pentoxifylline as a rescue treatment in duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: the purpose of this study is to see if male children with duchenne muscular dystrophy (dmd) have changes in strength when given the drug pentoxifylline as a rescue treatment. a total of 64 subjects are expected to participate through all other centers of the cooperative international neuromuscular research group (cinrg) worldwide. the primary purpose of this study is to see whether the addition of pentoxifylline to a steroid regimen is effective in treating deteriorating muscle strength by comparing the muscle strength of ptx treated subjects and placebo treated subjects.

dmd is the most common and devastating type of muscular dystrophy (incidence 1 in 3500 live born males worldwide). dmd is characterized by a complete loss of dystrophin, leading to progressive muscle weakness and wasting. no cure is currently available despite our present understanding of the disorder and the discovery and characterization of the causative gene and its protein product dystrophin in 1987. corticosteroids (prednisone, deflazacort) may delay disease progression and until now it is the only treatment that proved to be beneficial for patients with dmd. other alternative supplements like creatine and glutamine also delay diseased progression.

Eligibility criteria:
inclusion criteria: * male * age 7 years to 100 years * ability to ambulate for 10 meters. assistive devices are allowed. * diagnosis of dmd confirmed by at least one the following: * on stable dose of prednisone, prednisolone or deflazacort for at least 12 months prior to screening. * participants who are on stable dose of any combination of the following compounds (creatine, glutamine, coenzyme q10, vitamin e, c or d, juven, arginine, calcium) must have taken these medications for at least 2 months prior to screening. subjects are not required to take these medications to participate in the study. * all other herbs, supplements or green tea (other than those noted above) have been discontinued 3 months prior to screening. * ability to provide reproducible qmt bicep score with no more than 15% variation between scores during screening. * normal blood clotting ability evidenced by a platelet function assessment (pfa). exclusion criteria: * currently enrolled in another treatment clinical trial. * history of significant concomitant illness or significant impairment of renal or hepatic function. * history of impairment of blood clotting ability (as evidenced by increased pt/ptt or pfa over the upper limit of normal (uln)). * recent cerebral or retinal hemorrhage. * history of bleeding diathesis or gastric ulcer.

Keywords: duchenne genetic muscular dystrophy dmd
psychoeducation for uveal melanoma

Conditions: Uveal Melanoma

Summary: this clinical trial evaluates a video-based psychoeducational intervention for patients with uveal melanoma. uveal melanoma (um) is a rare intraocular cancer. um patients face an uncertain course of survivorship in terms of their visual acuity, treatment-related side effects, and risk for eventual metastasis of the cancer. learning about patients' thoughts and reactions to informational resources may better support patients during ocular melanoma survivorship.

primary objective: i. to assess the efficacy of the psychoeducation intervention (compared to the control condition) in modifying illness perceptions of disease control, chronicity, and coherence (i.e., to become less threatening) over the course of the follow-up period. secondary objective: i. to assess the efficacy of the psychoeducation intervention (compared to the control condition) in reducing the degree of participant's depressive and anxiety symptoms over the course of the follow-up period. outline: participants are randomized to 1 of 2 arms. arm i: participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. arm ii: patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.

Eligibility criteria:
inclusion criteria: * adults (age 18 years and older at visit 1) * history of uveal melanoma as documented in their university of california, los angeles (ucla) medical record * receipt of uveal melanoma treatment and/or ongoing follow-up care at the ucla jules stein eye institute, as documented in their ucla medical record * ability to read, write, and converse in english * access to the internet via a computer or cell phone * access to a personal email address * written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study exclusion criteria: -
a non-interventional pilot study to explore the role of gut flora in alzheimer's disease

Conditions: Alzheimer Disease; Alzheimer Disease 1; Alzheimer Disease 2; Alzheimer Disease 3; Alzheimer Disease 4; Alzheimer Disease 5; Alzheimer Disease 6; Alzheimer Disease 7; Alzheimer Disease 8; Alzheimer Disease 9, Late-Onset; Alzheimer Disease 10; Alzheimer Disease 11; Alzheimer Disease 12; Alzheimer Disease 13; Alzheimer Disease 14; Alzheimer Disease 15; Alzheimer Disease 16; Alzheimer Disease 17; Alzheimer Disease 18; Alzheimer Disease 19; Alzheimer Disease, Early Onset; Alzheimer Disease, Late Onset; Alzheimer Disease Focal

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding alzheimer's disease.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding alzheimer's disease.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients age 18 and older 3. diagnosis of alzheimer's disease or dementia by a physician 4. mini mental status exam score less than 26 exclusion criteria: 1. refusal to sign informed consent form 2. treatment with antibiotics within 2 weeks prior to screening 3. treatment with probiotics within 2 weeks prior to screening 4. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 5. postoperative stoma, ostomy, or ileoanal pouch 6. participation in any experimental drug protocol within the past 12 weeks 7. treatment with total parenteral nutrition 8. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 9. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Keywords: microbiome
plasma tmao (trimethylamine n-oxide) as a predictive marker in coronary disease patients

Conditions: Coronary Disease

Summary: the primary aim of the current research project is to determine whether the tmao concentration in the blood can serve as a prognostic indicator of myocardial infarction. the hypothesis is that in patients with recent myocardial infarction, tmao concentration in blood is higher than in patients undergoing scheduled coronarography.

to the study will be included volunteers - patients with stable angina (sa), who were scheduled for conventional coronary angiography, and patients with acute coronary syndrome (acs) who were admitted to the hospital with chest pain and undergoing coronography surgery. blood samples will be taken from volunteers once - before the coronography surgery by qualified medical personnel.

Eligibility criteria:
inclusion criteria: * diagnosed stable angina (sa) or acute coronary syndrome (acs) and planned coronography exclusion criteria: * unconscious patient

Keywords: trimethylamine-n-oxide
periodontal management in hypertensive patients (periotension trial i)

Conditions: Periodontal Diseases; Gingivitis; Hypertension

Summary: treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.


Eligibility criteria:
inclusion criteria: * treated hypertension * have at least 20 natural teeth * presence of any form of periodontal diseases according to guidelines * absence of other significant oral infections. exclusion criteria: * secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations) * individual is pregnant or nursing * primary pulmonary hypertension * professional oral hygine within past 6 months * flu, rhinitis, sinusitis etc. within past 4 weeks * use of antibiotics within past 4 weeks * hospitalization for any reason within the past 3 months * allergic disorders; history of chronic infectious disease, * chronic hepatitis b or c infection * chronic obstructive pulmonary disease (copd), tuberculosis * other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or crohn's disease * use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion. * history of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
outcomes of traumatic arterial injuries in upper vs. lower extremities

Conditions: Vascular Trauma

Summary: the purpose of this study is to identify and compare the causes of vascular trauma at the extremities, injury characteristics, types of vascular surgical interventions, and the outcomes of traumatic vascular injuries between the upper and lower extremities.

1. primary patient assessment patients will be clinically assessed on presentation, and resuscitation protocols will be initiated if signs of hypovolemic shock are present according to advanced trauma life support guidelines. 2. history and physical examination are the most important components of the diagnostic protocol the presence of hard signs of arterial injury * absent or diminished pulses * active haemorrhage * large, expanding, or pulsatile hematoma * bruit or thrill * distal ischemia is considered an indication for surgery, and no further specific investigative measures will be taken. soft signs of vascular trauma should be noted as well including * small, stable hematoma * unexplained hypotension * history of haemorrhage that is no longer present * proximity of injury to major vessels 3. investigations including: * the use of a hand-held doppler examination as a diagnostic aid * duplex us and cta for imaging. * lab investigations: complete blood picture, coagulation profile and kidney function tests. options of intervention: all vascular trauma patients will be admitted for operative management and follow up. the specific surgical intervention will be determined by the vascular surgeon according to type, site, and extent of the injury, ranging from ligation of the injured vessel to vascular graft interposition. an injury to a peripheral artery that does not result in complete transection can be repaired depending on luminal diameter with an interrupted or continuous suturing technique. a complete transection of a peripheral artery is first managed with minimal debridement back to healthy intima at both ends then an end-to-end anastomosis or with an interposition graft of autogenous vein or prosthetics arterial graft.

Eligibility criteria:
inclusion criteria: * all peripheral arterial injuries of one or more of the extremities. exclusion criteria: * vascular injuries limited to the venous system only. * vascular injuries limited to thoracic, abdominal, or neck vessels.
efficacy/safety of midurethral sling

Conditions: Stress Urinary Incontinence

Summary: the trans-obturator tape (tot), which exhibits a satisfactory cure rate and a relatively diminished invasiveness, has been increasingly accepted as a surgical treatment of stress urinary incontinence (sui) patients. nevertheless, in contrast to the well-recognized therapeutic benefit of the enhanced resistance to the bladder continence during urine storage, if the voiding function of the bladder adapts to the tot-enhanced outlet resistance has not been adequately investigated. this study retrospectively assayed the voiding efficacy of each voiding cycle, to clarify if the thermodynamic efficacy of the bladder was modified in response to the tot surgery.

the urodynamic study included free uroflowmetry, postvoid residual, filling and voiding cystometry, and a urethral pressure profile. the filling cystometry and urethral pressure profile were performed with 37 degrees c normal saline similar to body temperature at an infusion rate of 80 ml/min. all patients received a pre- and a post-operative urodynamic evaluation, in which pre-operative evaluation was conducted 1-4 weeks before tot procedure, and post-operative evaluation was done at 4-6 weeks follow-up. complete multichannel urodynamic studies including free uroflowmetry, filling and voiding cystometry, and urethral pressure profile was performed in each patient. the urodynamic parameters measured were the maximum flow rate (qmax), voided volume, post-void residual volume (pvr), and detrusor pressure at qmax (pdet. qmax). the filling cystometry and urethral pressure profile were performed with 37 degrees c normal saline at an infusion rate of 80 ml/min. all data were recorded and analyzed using a medical measurement systems (mms ud-200, enschede, the netherlands). all data in this study will be expressed as mean ± sem. after checking the normality and variance of data, two-way anovas were used to assess the difference in values among testing groups and time points; and post hoc student-newman-keuls tests were used to compare the means of groups when there was a significant difference between groups. significance was set at p\<0.05.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stress urinary incontience * have urodynamic investigations before and after operation. exclusion criteria: * exclusion criteria will be a history of (1) cardiovascular, (2) neurological, or (3) other medical (such as diabetes or inflammation) problems as well as (4) patients who received a concomitant surgical procedure.