Kornimate/medical-research-clean huggingface dataset:
virtual reality vs. standard-of-care for comfort during dental procedures in children

Conditions: Dental Procedures

Summary: children sometimes need dental procedures which can be painful and associated with child pain and anxiety. in addition to pain medication, distraction may help children cope with the pain. this may include interacting with books, tv, toys or videogames. virtual reality (vr) is an immersive experience using sight, sound, and position sense. using vr may enhance distraction during the painful procedure and may reduce attention to pain. this study will randomize children (4 - 16 years old) to receive virtual reality or standard of care in addition to local anesthetics during dental procedures. pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. outcome measures will be compared between the two groups.


Eligibility criteria:
inclusion criteria: 1. children age 4 to \< 17 years 2. arriving to the ubc dentistry clinic and need dental assessment/procedures 3. parents will sign a consent form and children will sign an assent form exclusion criteria: 1. children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication) 2. facial features prohibiting wearing the vr goggles 3. children needing sedation that includes inhalation via a mask (n2o) or iv/im sedation

Keywords: virtual reality pain anxiety
epidural versus continuous wound ropivacaine infusion analgesia

Conditions: Postoperative Analgesia

Summary: study hypothesis: the analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques.

the analgesic requirements and pain scores postoperatively differ between the epidural and continuous wound infusion techniques, in patients undergoing myomectomy or hysterectomy.

Eligibility criteria:
inclusion criteria: patients asa i-ii scheduled for abdominal hysterectomy or myomectomy - exclusion criteria: age older than 60 and younger than 25 years, body weight exceeding the 30% of the ideal, consumption of analgesics, sedatives, anxiolytics, antidepressants, calcium channel blockers, cns disease or insulin dependent diabetes -

Keywords: epidural analgesia continuous wound infusion ropivacaine total abdominal hysterectomy
efficacy, safety and tolerability of dnk333 (25 mg bid) in women with diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)

Summary: the purpose of this study is to evaluate the efficacy of dnk333 compared to placebo for relieving symptoms of ibs-d in female patients.


Eligibility criteria:
inclusion criteria: * women of 18 - 65 years of age with ibs-d as defined by the rome ii criteria. * the rome ii criteria is a system used for diagnosing functional gastrointestinal disorders such as irritable bowel syndrome. it involves completing of a questionnaire about gastrointestinal symptoms. * patients who are 50 years of age and older must have had a colonoscopy or a flexible sigmoidoscopy plus a double-contrast barium enema within the past 5 years, which demonstrated no clinically significant findings. * clinically significant findings may include but are not limited to malignant tumors, multiple (≥3) or advanced adenomas, inflammatory bowel disease, diverticulitis, ischaemic colitis, lymphocytic colitis, or collagenous colitis. * patients must report ≥ 3 days with ibs-related abdominal pain/discomfort plus at least 3 days of 2 or more of the following events during the baseline period: * ≥ 3 bowel movements/day * bowel urgency * loose or watery stool exclusion criteria: * patients who answer "yes" to either or both of the two weekly satisfaction questions during the baseline period. the questions are: (1) over the past week did you have satisfactory relief of your ibs-related abdominal pain/discomfort? (2) over the last week did you have satisfactory relief of your overall ibs-d symptoms? * patients with hard or lumpy stools for more than one day during the baseline period. * lactose intolerant patients relieved on a lactose free diet. * use of antidepressants (tricyclic, ssri etc), opioid analgesic drugs or drugs specifically affecting bowel motility during the course of the trial. * women of child-bearing potential who do not use an acceptable methods of contraception. * pregnant or nursing (lactating) women. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: ibs diarrhea gastrointestinal functional disorder ibs-d
comparison of reverse remodeling and pvi versus cfae and/or linear lesions and pvi for persistent af

Conditions: Persistent Atrial Fibrillation

Summary: the hypothesis of this study is that by facilitating reverse atrial remodeling with maintenance of sinus rhythm in the weeks preceding ablation makes it feasible to perform a simple pulmonary vein isolation (pvi) with results equivalent or superior to more complex atrial ablation for patients with persistent af.

atrial fibrillation (af) is the most common cardiac disorder currently affecting 2.3 million u.s. adults with an expected increase in incidence to 5.6 million by the year 2050. randomized clinical trials have shown that ablation was superior to antiarrhythmic drug (aad) in maintaining sinus rhythm among patients with symptomatic predominantly paroxysmal af. however the results for catheter ablation of persistent af is much lower and more variable, ranging between 20-80%. moreover there is no agreed-upon standard ablation approach. prior studies suggest that pulmonary vein isolation (pvi) alone has an unacceptably low success rate so most laboratories supplement this approach with additional lesion sets. these include complex atrial fractionated electrograms ("café"), autonomic denervation, and linear left atrial ablation at the roof and mitral isthmus, in an empirical manner or stepwise approach. however, these strategies are time consuming and prone to proarrhythmia, namely post-ablation atrial tachycardias which can occur with an incidence ranging from \< 5 to 50%. the lower efficacy of pvi alone in persistent af has been attributed to adverse electrical, molecular, and structural remodeling of the atria. collectively, atrial remodeling decreases conduction velocity and the effective refractory period, and results in a shortened atrial wavelength, which increases the number and stability of reentrant wavelets. this can cause persistence of af independent of a focal discharge. standard pvi addresses the "focal discharge" or trigger from the pvs that initiates af but not necessarily the underlying atrial substrate. based on these concepts, we hypothesized that successful atrial reverse remodeling by temporary aad therapy would facilitate the performance of pvi alone in patients with persistent af. the utilization of reverse remodeling to enhance the efficiency, efficacy and safety of ablation of af has not been tested in a randomized clinical trial.

Eligibility criteria:
inclusion criteria: * symptomatic persistent af * failure of class i antiarrhythmic drug or amiodarone to control af exclusion criteria: * previous proarrhythmia to class iii aad including excessive qt prolongation or torsade-de-pointes * previous af ablation procedure * congestive heart failure (nyha iii-iv functional class) * left ventricle ejection fraction less than 35% * left atrial diameter \>55 mm * unwillingness to participate

Keywords: atrial fibrillation persistent af catheter ablation duration of 7 days to one year with symptoms and failure of at least one antiarrhythmic drug
detection and clinical significance of circulating cancer cells in patient undergoing radical cystectomy

Conditions: Bladder Cancer; Circulating Tumor Cells

Summary: very few factors may be identified as prognostic for patients with bladder cancer undergoing radical cystectomy. recently, detection of circulating tumor cells has shown to be very promising in anticipating both the likelyhood of distant metastases and survival in patients with breast cancer, melanoma, prostate cancer and other malignancies. in the present study we both tested the detection rate of circulating tumor cells using a pcr based methodology in the peripheral blood of patients undergoing radical cystectomy, and we further correlated our results with their clinical outcome.


Eligibility criteria:
inclusion criteria: * prior trans urethral resection of the bladder (tur) * histological confirmation of a transitional cell carcinoma (tcc) of the bladder * ecog performance status ≤ 2 * wbc count ≥4,000/μl; platelet count ≥150,000/μl; creatinine ≤1.8 mg/dl; ast, alt, and alkaline phosphatase ≤2x the upper limit of normal, normal total bilirubin * recent (within 6 weeks of cystectomy) total body ct imaging study excluding distant metastases as well as upper urinary tract tcc exclusion criteria: * neo-adjuvant chemotherapy (either planned or already performed) * patients receiving investigational medications * subjects not suitable for a radical cystectomy * patients not willing to participate

Keywords: bladder cancer circulating cancer cells
a study of alzheimer's disease using magnetoencephalography (meg) and the synchronous neural interaction™ test

Conditions: Alzheimer's Disease

Summary: this follow-up study is designed to obtain longitudinal clinical and meg scan data to gain information on alzheimer's disease (ad) progression, the stability of healthy control (hc) meg scan data, to enrich the orasi database of ad and hc subjects, and is intended to extend the capabilities of the synchronous neural interaction® (sni) test, which is under development by the sponsor, orasi medical. the current study is intended to extend the database of ad and hc meg scans and will include patients who previously enrolled and completed orasi protocol adg 08-01. this study will include meg scans on up to approximately 50 ad subjects and 70 hc subjects. additionally, ad subjects will complete 3 standard functional tests while hc subjects will complete 2 standard functional tests. apoe genotyping also will be determined for all subjects. the results generated in this study will be used to improve the accuracy of the sni test for diagnosing and tracking the progression of ad.


Eligibility criteria:
inclusion criteria: * subject enrolled and completed orasi protocol adg 08-01 * subject understands the study procedures and agrees to participate in the study by giving written informed consent. in the event the subject lacks the capacity to sign the consent form then the subject's legally authorized representative (lar) may sign on the subject's behalf. see section 5. informed consent for details. * subject is a non-smoker. * subject is judged to be in good health other than ad, if applicable exclusion criteria: * subject has a history or diagnosis of a significant neurological condition other than alzheimer's disease including parkinson's disease, vascular dementia, lewy body dementia, frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, seizures, epilepsy, stroke, adhd, dyslexia, or severe traumatic brain injury. * subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder. * subject has a modified hachinski ischemia scale (his) score greater than 4. * the subject has a recent history (within 2 years) of alcohol or substance abuse/dependence. * subject had an mri within two weeks prior to study visit 2. * subject has metal dental braces, pacemaker or other common medical devices that may interfere with the meg scan. * subject is unable to complete the meg scan procedure. * investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation

Keywords: alzheimer's disease magnetoencephalography meg sni
evaluation of device settings for airway clearance using the monarch airway clearance system

Conditions: Cystic Fibrosis

Summary: the study will be an open label laboratory study with all subjects receiving hfcwo with the monarch® system objective: assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume methodology: subjects will receive hfcwo using the monarch® system at multiple frequency / intensity combinations on a single visit day. frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.

the study will be an open-label, laboratory study. all enrolled subjects will receive hfcwo therapy with the monarch® system. the study will be conducted at one (1) site in the us. the study will evaluate oscillating airflow and oscillating volume induced during therapy with the monarch® system. subjects will also rate the comfort of the therapy. patients with cystic fibrosis (cf) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study. therapy with the monarch® system will be delivered using multiple frequency/intensity combination settings. the order of settings will be randomized for each study subject. during therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (vas).

Eligibility criteria:
inclusion criteria: * documented diagnosis of cf (by sweat test and/or genetics * age \> 15 years * require regular home airway clearance therapy * current user of the monarch® system with a minimum of 4 weeks experience with the device * signed informed consent. if patient is a minor, parents/guardians must give written informed consent and patient must give written assent * patient must be on a stable regimen of cf medication exclusion criteria: * history of pneumothorax within the past 6 months prior to study visit * history of hemoptysis requiring embolization within the past 12 months prior to study visit or hemoptysis of \> 100 ml within a 24-hour period within the past 30 days * history of lobectomy * recent chest surgery or chest trauma * inability to perform the monarch® system therapy as directed * pregnant or lactating female * have a pacemaker or implantable cardioverter defibrillator (icd) * requirement for oral or iv antibiotics that are not part of the subject's usual course of treatment within the past 14 days prior to screening
hiv prevention program for patients receiving care at a sexually transmitted diseases clinic

Conditions: HIV Infections; Sexually Transmitted Diseases

Summary: this study will determine the effectiveness of a two-step hiv prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (stds).

numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. this study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for hiv prevention. at study entry, participants will undergo a physical exam, various std tests, and a rapid hiv test, which can provide test results within several hours. while waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a dvd on safer sex. after receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention. two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. these participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. participants who choose not to participate in the workshop will complete the study after receiving their std and hiv test results. participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for std testing.

Eligibility criteria:
inclusion criteria: * diagnosis or symptoms of an std within 3 months prior to study entry or have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an std * able to understand english exclusion criteria: * psychosis or impaired mental status that would prevent participant from providing informed consent * have been tested for hiv within 3 months prior to study entry * hiv infected

Keywords: stds sexual behavior health behavior hiv seronegativity
ulcerative colitis mayo score with artificial intelligence

Conditions: Ulcerative Colitis; Colonoscopy; Deep Learning

Summary: this project will use deep learning to classify colonoscopy images of different severity of ulcerative colitis, so as to assist clinicians in the accurate diagnosis of ulcerative colitis.

in this project, artificial intelligence was used to colonoscopic images of patients with ulcerative colitis with different disease activity levels and classify them according to the evaluation standard mayo score to assist endoscopists in identifying disease activity levels of patients with ulcerative colitis during colonoscopy. it can help clinical endoscopists to accurately identify, and the visualization technology of artificial intelligence category response map can comprehensively display the areas with high importance for deep network classification results, and visualize the experimental lesion sites, thus effectively verifying the reliability and interpretability of deep network. this study can provide strong support for accurate identification of disease activity in clinical ulcerative colitis, effectively reduce the workload of clinicians, and provide a convenient, effective and practical clinical teaching tool.

Eligibility criteria:
inclusion criteria: 1. subjects were 18-72 years old, male and female; 2. clinical diagnosis of ulcerative colitis; 3. the subjects underwent colonoscopy and the colonoscopy report was complete. exclusion criteria: 1. subjects are younger than 18 years old or older than 72 years old; 2. subjects underwent colectomy, ileostomy, colostomy, ileostomy, or other intestinal resection; 3. subjects with ambiguous diagnosis.
a laboratory model for heroin abuse medications - 8

Conditions: Heroin Dependence; Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, laam, naltrexone, naltrexone microcapsules, and methoclocinnamox) on i.v. and smoked heroin self-administration."

abuse of prescription opioid medications has increased dramatically in the u.s. during the past decade, as indicated by a variety of epidemiological sources. however, few studies have systematically examined the relative reinforcing effects of commonly abused opioid medications. the current inpatient study was designed to compare the effects of intravenously delivered fentanyl , oxycodone, morphine, buprenorphine and heroin in morphine-maintained heroin abusers. all of the participants received all of the drugs tested; drugs and doses were administered in non-systematic order.

Eligibility criteria:
inclusion criterion 1. dsm iv criteria for opioid dependence 2. no major mood, psychotic, or anxiety disorder 3. physically healthy 4. able to perform study procedures 5. 21-45 years of age 6. current use of i.v. heroin in amounts/frequencies 7. not seeking treatment for opioid dependence exclusion criterion 1. dsm iv criteria for dependence on drugs other 2. participants requesting treatment 3. participants on parole or probation 4. pregnancy or lactation 5. birth, miscarriage or abortion with 6 months 6. recent history of or current significant violent behavior 7. current major axis i psychopathology, other than heroin dependence ( e.g., mood disorder with functional impairment or suicide risk, schizophrenia), which might interfere with ability to participate in the study 8. hepatitis with sgot or sgpt \> 3 times normal 9. significant suicide risk 10. current or history of chronic pain 11. sensitivity, allergy, or contraindication to opioids

Keywords: heroin, opioid disorders, substance related disorders
developing an in-vitro diagnostic risk-stratification test for oral cancer

Conditions: Oral Squamous Cell Carcinoma

Summary: the purpose of this study is to verify the discriminatory value of previously identified salivary transcriptome and proteome markers for oral squamous cell cancer in an intended use population of patients with oral lesions suspicious for cancer.

saliva samples are collected from patients before clinically driven oral biopsy for lesions suspicious for cancer. specimens are processed by laboratory personnel blinded to the tissue diagnosis. six pre-specified mrna markers (il1b, il8, sat, dusp1, oaz1 and s100p) are measured by polymerase chain reaction. markers are compared in cancer and control by raw ct values as well as by delta ct after adjustment for housekeeping gens. appropriate housekeeping genes are identified in a random subset of cancer and control patients and then verified in the remaining subjects. predictive models are generated by a pre-specified method and robustness evaluated by bootstrap analysis. the model is then further validated in a second cohort. three pre-specified protein markers (il8, il1b, and m2bp) are a secondary endpoint and will also be compared in cancer and control patients.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for biopsy of an oral lesion suspicious for squamous cell cancer exclusion criteria: * patients with known prior oral malignancy in last 2 years or other cancer in last 5 years other than non melanoma skin cancer or with immune deficiency

Keywords: salivary biomarkers