Kornimate/medical-research-clean huggingface dataset:
technological contributions to behavior guidance techniques

Conditions: Behavior; Child; Dental Anxiety; Mobile Applications; Pain

Summary: this study aims to evaluate the effects of three different behavior guidance methods on children's dental anxiety and pain perception.

this study will include 63 children aged 6-8 years who will require pulpotomy followed by a class ii composite restoration and will be divided into three groups: tell-show-do (tsd; group 1), tsd with video modeling (group 2), and tsd with a mobile phone application (group 3). systolic blood pressure (sbp), diastolic blood pressure (dbp), heart rate (hr), and hemoglobin oxygen saturation (spo2) of the participants will be recorded before the procedure, after local anesthesia, after pulpotomy, and at the end of the procedure. faces version of the modified child dental anxiety scale (mcdas f), wong-baker faces pain rating scale (wbfprs), and face, legs, activity, cry, consolability (flacc) pain scales will be applied.

Eligibility criteria:
inclusion criteria: * the patients had no previous dental treatment, * were between ages 6 and 8 years, accepted treatment accompanied by parents, * scored 3 (positive) or 4 (definitely positive) on the frankl behavior scale, * had no systemic disease, * did not need emergency dental treatment, one of the upper molars required pulpotomy followed by a class ii composite restoration, * had no mental or physical disabilities, * understood the commands, and whose parents agreed to participate in the study * signed the consent form. exclusion criteria: * patients who did not meet the inclusion criteria included those who needed other asymptomatic root canal treatment other than pulpotomy indication, * needed restorative treatment due to a history of dental trauma, those who did not want to be included voluntarily, * who cried during the procedure or left the treatment unfinished, * who were determined to be negative (2) or definitely negative (1) according to the frankl behavior assessment scale.
irinotecan liposome in combination with 5-fu/lv versus 5-fu/lv in second-line therapy for gemcitabine-refractory pancreatic cancer

Conditions: Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer After Treatment Failure With Gemcitabine-based Therapy

Summary: to evaluate efficacy and safety of irinotecan hydrochloride liposome in combination with 5-fu/lv as second-line treatment for locally advanced or metastatic pancreatic cancer after treatment failure with gemcitabine-based therapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed pancreatic cancer; 2. unresectable locally advanced or metastatic disease ; 3. documented disease progression after first-line treatment gemcitabine based therapy 4. ecog: 0-1; 5. adequate organ and bone marrow function; 6. sign an informed consent. exclusion criteria: 1. active cns metastasis; 2. uncontrolled tumor-related pain; 3. clinically significant gi disorders; 4. significant cardiovascular disease; 5. active infection or uncontrolled fever; 6. pregnant or breast feeding patients; 7. allergic to a drug ingredient or component; 8. the investigators determined that other conditions were inappropriate for participation in this clinical trial.
on-q catheter caregiver education

Conditions: Anterior Cruciate Ligament Injury; Pain; Catheter (Other); Satisfaction, Personal

Summary: the present study aims to compare caregiver satisfaction and efficacy between two modes of patient education materials (pems): media based and print based. the caregivers of patient's who undergo acl (anterior cruciate ligament) reconstruction surgery and receive an on-q catheter pain block receive both a hand-out (print based pem) and watch a short video (media-based pem) describing how to care for their child's on-q catheter at home. upon enrollment into the study, caregivers are randomly assigned to either first view the hand-out or the video, then complete a 10 questions standardized assessment of information that was presented in the pems. caregivers are called the next day to assess caregiver satisfaction with the pems, which mode of pem was more helpful to them, and how comfortable they felt managing their child's pain pump at home.

the present study aims to compare the efficacy and caregiver satisfaction between two modes of patient education materials (pems): media based and print based. the pems are designed to education caregivers on how to manage their child's on-q catheter pain block at home. after caregivers have enrolled in the study and have been randomized to an education group, study interventions take place in the private family waiting room. immediately after viewing their assigned pem, the caregiver completes a 10 question standardized assessment, formatted as a multiple-choice quiz, of their understanding and knowledge of the information conveyed in both modes of pem. the following day, caregivers are contacted by phone call to answer a number of questions to assess their satisfaction with the pems they received, the mode of pem they preferred, and how comfortable they felt managing their child's pain pump at home. all information is stored in a secure database (redcap).

Eligibility criteria:
inclusion criteria: * caregivers of patients undergoing acl repair/reconstruction. these caregivers are registered in the children's hospital of colorado medical record. exclusion criteria: * illiterate or blind individuals

Keywords: anterior cruciate ligament on-q catheter nerve block acl reconstruction patient education materials
precision cancer therapy in rare cancers

Conditions: Rare Malignant Neoplasm

Summary: some rare cancers are hard-to-treat and patients have a poor prognosis. it is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. however in many cases these drugs are not approved for the rare cancers. in this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

all patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on dna / rna level. patients will be treated based on the molecular characteristics of the tumor cells.

Eligibility criteria:
inclusion criteria: * ecog 0-2, * identified biomarker, * reasonable biochemistry exclusion criteria: * ecog 3-5 * serious other diseases
piloting an internet-based therapy for insomnia in a population of veterans with substance use disorders

Conditions: Chronic Insomnia

Summary: the purposes of this study is to examine the feasibility of implementing an internet-based treatment for insomnia among veterans with substance use disorders, some with co-morbid serious mental illness, and to develop potential methods to support and encourage veterans while they self-administer this treatment. our hypotheses are that the implementation of an internet-based therapy will be feasible and that a method of support can be devised, and tested in the future.


Eligibility criteria:
inclusion criteria: * inability to sleep within 30 minutes of going to bed or awakening during the night for 30 minutes for greater than or equal to 3 days per week * above criteria occurring every week for greater than or equal to 3 months * at least one symptom of daytime impairment: (reduced motivation, sleepiness, fatigue, lack of concentration, performance at home, work, social life, relationships impaired) * able to provide valid consent * willing to participate in an internet-based cognitive behavioral therapy for insomnia * english speaking exclusion criteria: * self-reported or provider diagnosed sleep apnea or related nighttime respiratory problem, restless legs syndrome or related nighttime movement disorder * acute psychiatric decompensation requiring inpatient admission or emergency department services within the last month (suicidality, homicidally, mania, psychotic decompensation) * current treatment or treatment within the last month for opiate addiction with methadone maintenance or buprenorphine. * has a conservator e. shift work interfering with the establishment of regular sleep patterns f. previous or ongoing cognitive behavioral therapy for insomnia
modified dosage for moderate acute malnutrition (modam-mam)

Conditions: Moderate Acute Malnutrition

Summary: protocols for the community-based management of acute malnutrition (cmam) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. the overarching goal of this research project is to simultaneously test two novel simplified approaches in cmam with potential to improve program coverage. the simplified approach includes two parallel clinical trials for sam and mam treatment. two fixed-dose regimes of rutf will be tested against the current fixed-dose regimen of rusf for children with mam.


Eligibility criteria:
inclusion criteria: 1. age 6-59 months 2. reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year 3. uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility 4. pass appetite test conducted at the time of enrollment 5. consent for randomization into the study given by mother, father, and/or other primary caregiver 6. mid-upper arm circumference of 115-124 mm without nutritional edema 7. weight-for-height z-score (whz) between -2 and -3 exclusion criteria: 1. complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. this includes, but is not limited to: a. hypothermia b. high fever c. signs of hypoglycemia d. lethargy or altered mental status e. moderate to severe dehydration f. shock g. other medical complications requiring hospitalization or higher-level medical evaluation 2. treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months 3. known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
automated ai-based system for early diagnosis of diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: in this pivotal trial, we aim to perform a prospective study to find the efficacy of ipredict, an artificial intelligence (ai) based software tool on early diagnosis of diabetic retinopathy (dr)in the primary care, optometrist and other diabetes-screening clinics. dr is one of the leading causes of blindness in the united states and other developed countries. every individual with diabetes is at risk of dr. it does not show any symptom until the disease is progressed to advanced stages. if the disease is caught at an early stage, it can be prevented, managed or treated effectively. currently, screening for dr is done by the ophthalmologists, which is limited to areas with limited availability. this is also time-consuming and expensive. all of these can be complemented by automated screening and set up the screening in the primary care clinics.

in this pivotal trial, we aim to invite diabetic patients to participate in the trial by having non-dilated photos of their eyes taken by an fda-approved drs plus camera at their own doctor's office which will test the feasibility of our proposed automated ai based dr diagnosis software solution,. the color fundus photos will be captured and then be transmitted securely and analyzed by ihealthscreen's hipaa compliant server at amazon cloud. the deep learning module will analyze the image for finding the disease severity. the automated report will be generated which will report as referable dr or more than mild (mtm) dr detected i.e., moderate dr, severe dr - proliferative or non-proliferative dr or non-referable dr or mtm dr not detected, i.e., mild dr or no dr. the same images will be evaluated by 3 ophthalmologists and will be adjudicated if any disagreement between the gradings. the automatic and expert evaluation will be compared to compute the sensitivity, specificity and auc.

Eligibility criteria:
inclusion criteria: * age of subjects: patients ≥ 18 years of age. * gender of subjects: both males and females will be invited to participate. * subjects with diabetes (a1c level 6.5 or higher) or fasting plasma glucose (blood sugar level) 126 mg/dl (≥7.0 mmol/l) * subjects must be willing and are able to comply with clinic visit, understand the study-related procedures/provisions, and provide signed informed consent. * asymptomatic patients with dr. exclusion criteria: * subject has retinal degenerations and retinal vascular diseases such as age-related macular degeneration or having undergone prior retinal surgery. * history of ocular injections, * subject has persistent visual impairment in any eye; * history of macular edema or retinal vascular (vein or artery) occlusion; * laser treatment of the retina, or intraocular surgery other than cataract surgery without complications; * subject is currently enrolled in an interventional study of an investigational device or drug; * subject has ungradable clinical reference standard photographs (i.e., not gradable quality image). if the patient image is not gradable automatically, we will suggest the patient to refer the ophthalmologist.
sgi-110 in combination with an allogeneic colon cancer cell vaccine (gvax) and cyclophosphamide (cy) in metastatic colorectal cancer (mcrc)

Conditions: Metastatic Colorectal Cancer

Summary: this study will be looking at whether cy/gvax in combination with sgi-110 is effective (recruits cd45ro+ t cells to the tumor which may be a marker of anti-tumor activity) and safe in patients with metastatic colon or rectum cancers.


Eligibility criteria:
inclusion criteria: 1. documented cancer of the colon or rectum who have received and are stable on first or second-line therapy regimens for metastatic colorectal cancer 2. eastern cooperative oncology group (ecog) performance status of 0 to 1 3. adequate organ function as defined by study-specified laboratory tests 4. must use acceptable form of birth control through the study and for 28 days after final dose of study drug 5. signed informed consent form 6. willing and able to comply with study procedures exclusion criteria: 1. currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions 2. systemically active steroid use 3. another investigational product within 28 days prior to receiving study drug 4. major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug 5. chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to receiving study drug 6. pregnant or lactating 7. unwilling or unable to comply with study procedures

Keywords: colorectal neoplasms intestinal neoplasms gastrointestinal neoplasms digestive system neoplasms neoplasms by site neoplasms digestive system diseases gastrointestinal diseases colonic diseases intestinal diseases rectal diseases
core stabilization exercises on shoulder impingement syndrome

Conditions: Subacromial Impingement Syndrome

Summary: the objective of this retrospective study was to look into the effects of core stabilization exercises applied in conjunction with classic physiotherapy program on pain, muscle strength, disability, and posture in sis.


Eligibility criteria:
inclusion criteria: * patients between the ages of 35 and 60 who were diagnosed by a physical therapy and rehabilitation doctor with at least ten years of experience, whose sis was confirmed by mri, and who had shoulder complaints for at least three months, patients with positive signs, a positive hawkins-kennedy test, significant loss of active and passive shoulder movements or painful range of motion (rom), and patients whose treatment and evaluation methods were appropriate for the study design were enrolled in the study exclusion criteria: * patients who had upper extremity surgery, patients with a history of shoulder trauma and corticosteroid application to the shoulder region in the previous year, a history of shoulder dislocation, infection, tumor, adhesive capsulitis, reflex sympathetic dystrophy, congenital anomaly, rheumatic disease, and chronic severe systemic disease, as well as professional athletes and patients whose evaluations were missing in the previous month were excluded
a trial of infant flow biphasic nasal continuous airway pressure (ncpap) versus infant flow ncpap for the facilitation of extubation in infants </= 1250 grams

Conditions: Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Apnea of Prematurity

Summary: the purpose of this study is to compare two methods of delivering nasal continuous airway pressure (ncpap): biphasic mode and a continuous mode, to see which is better in getting babies off the ventilator and decreasing lung damage.

chronic lung disease (cld) remains a significant problem among low birth weight infants with a reported incidence of up to 26% in infants \< 1500 grams. nasal continuous positive airway pressure (ncpap) has been demonstrated to provide effective non-invasive respiratory support for preterm infants. the use of ncpap is associated with a decreased need for mechanical ventilation and may impact on the incidence of cld. there are two types of ncpap now available, a biphasic mode which allows for cycling at two different levels of positive pressure and a continuous mode which allows only for one level of positive pressure. comparisons: biphasic ncpap will be compared with continuous cpap to see which better facilitates the extubation of preterm infants who weigh \</= 1250 grams at birth. the incidence of cld, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and necrotizing entercolitis will also be compared between the two groups.

Eligibility criteria:
inclusion criteria: * infants \</= 1250 grams who are going to be extubated exclusion criteria: * congenital abnormalities of the upper airway * acquired nasal septum injury * congenital heart disease excluding patent ductus arteriosus

Keywords: continuous positive airway pressure infant,newborn artificial respiration
focused registry to collect clinical data on the matrixwave system

Conditions: Mandibular Fractures

Summary: the goal of this registry is to evaluate the performance of the matrixwave(tm) mmf system in patients suffering from non-condylar and/or condylar fractures. the evaluation will focus on the clinical performance in terms of : * surgical technique * application time * intra- and postoperative complications * short term patient-reported outcomes

following standard of care (routine) procedures, a total number of 50 patients suffering from non-condylar and/or condylar fractures of the mandible requiring mmf for a minimum of two weeks during or subsequent to open reduction internal fixation (orif) will be prospectively enrolled in this registry. data on the classification of the injury (ao cmf fracture classification system) and the time needed for application of the matrixwave(tm) mmf system will be collected. follow-up (fu) visits will be performed between 2 to 6 weeks and at 3 months according to standard of care to evaluate the mandible function impairment, pain and local complications (anticipated procedure-related adverse events) related to the matrixwave(tm) mmf system.

Eligibility criteria:
inclusion criteria: * age 18 years or older at the time of the surgery * diagnosis of a mandibular fracture requiring orif and use of mmf during or subsequent to surgical intervention for a minimum of two weeks * informed consent obtained, i.e.: * ability to understand the content of the patient information/icf * willingness and ability to participate in the clinical investigation according to the registry plan (rp) * signed and dated ec/irb approved written informed consent exclusion criteria: * pre-traumatic non-occlusion due to hypodontia, edentulousness or severe malalignment of dental arches (e.g. complete crossbite) * concomitant maxillary fracture (e.g. le fort) * any not medically managed severe systemic disease * recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * pregnancy or women planning to conceive within the registry period * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry * intra-operative decision of the surgeon to use other mmf systems than the matrixwave mmf system

Keywords: mandibulo-maxillary fixation malocclusion
compatibility of qnox values with hemodynamic changes in tracheal intubation procedures

Conditions: Qnox Values as a Predictor of Pain Response

Summary: the study aimed to analyze the compatibility of qnox values with hemodynamic changes as a predictor of pain response in tracheal intubation procedures

fifty-four patients were given informed consent before enrolling the study. non-invasive blood pressure monitor, electrocardiogram, pulse oxymetry, and conox probe were set on the subjects in the operation room. baseline hemodynamic is noted. general anesthesia induction was done by fentanyl 2.5 mcg/kg and propofol 2 mg/kg. endotracheal tube intubation was facilitated with rocuronium 0.8 mg/kg as muscle relaxant. qnox values right before intubation and after intubation is noted, as well as hemodynamic changes in one minute after intubation

Eligibility criteria:
inclusion criteria: * patient undergoes general anesthesia with tracheal intubation * fasting as required for surgery * physical asa status i - ii * signing informed consent exclusion criteria: * patient with difficult airway management * patient with history of central nervous system abnormalities * patient with history of hypersensitivity to drugs for general anesthesia

Keywords: qnox values, hemodynamic changes, predictor of pain