Kornimate/medical-research-clean huggingface dataset:
comparison of ketorolac tromethamine versus naproxen for moderate to severe back pain treatment

Conditions: Back Pain

Summary: the purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.

* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. * experiment duration: 04 days. * 03 visits (days 0, 2 and 4). * efficacy will be evaluated for back pain relief based on visual analog scale. * adverse events evaluation.

Eligibility criteria:
inclusion criteria: * consent of the patient or legal guardian. * men or women aged between 18 and 65. * diagnosis of acute low back pain with moderate to severe pain (visual analog scale greater than 4 cm) exclusion criteria: * fracture confirmed by x-ray * diagnosis of infection, fever, * pregnancy, lactation; * diagnosis of fibromyalgia; * hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other nonsteroidal anti-inflammatory
biomarker testing and treatment patterns among patients with pik3ca mutation in advanced breast cancer

Conditions: Breast Cancer

Summary: this was a retrospective observational study of patients with advanced breast cancer (bc). this non-interventional study was conducted using discrete structured data and medical record abstraction, if needed, from patients treated at texas oncology, the designated research organization and a community oncology practice. the first date of a new diagnosis of advanced bc (de novo or progressed to advanced bc) defined the study index date. to allow for an adequate potential duration of follow-up (retrospectively observed) after the index date over which pik3ca testing and treatment patterns was observed, a minimum follow-up opportunity of 6 months after the diagnosis of advanced bc at the time of data pull and/or abstraction was required.


Eligibility criteria:
inclusion criteria: * patients who met the following criteria were eligible for abstraction: * newly diagnosed advanced bc between 01 january 2015, and 30 june 2020 * evaluated for a pik3ca mutation and identified pik3ca gene status * no evidence of active other malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of advanced bc * at least 18 years of age at the time of first diagnosis of bc * patients may be alive or deceased at the time of abstraction * not ever enrolled in the following interventional clinical trials evaluating pi3k inhibitors: * solar-1 trial (nct0243731) evaluating alpelisib (byl719) * belle-2 or belle-3 trial (nct01610284, nct01633060) evaluating buparlisib (bkm120) * sandpiper trial (nct02340221) evaluating taselisib (gdc-0032) exclusion criteria: none

Keywords: breast cancer, pik3ca, alpelisib, non-interventional study, hr+
focused cardiac ultrasound

Conditions: Ventricular Dysfunction; Pericardial Effusion; Valvular Disease; Septal Defect

Summary: to compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.


Eligibility criteria:
inclusion criteria: * patients presenting to pediatric cardiology clinic at holtz children's hospital requiring comprehensive or limited transthoracic echocardiogram. * willing and able to provide informed consent or assent. * in clinically stable condition as assessed by the principal investigator.. * with adequate echocardiographic windows. exclusion criteria: * patients with poor echocardiographic windows. * patients who refuse informed consent. * pregnant women. * prisoners. * patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
trial to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of bi135585 xx administered as tablet and as solution in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to investigate the safety, tolerability, pharmacokinetics incl. dose proportionality, and pharmacodynamics of bi 135585 xx (part 1), as well as the relative bioavailability of two different immediate release tablet formulations versus oral solution (part 2)


Eligibility criteria:
inclusion criteria: - healthy male volunteers
effects of a workplace prevention program for problematic gambling

Conditions: Gambling

Summary: the purpose of this study is to determine the effects of a workplace prevention program targeting problematic gambling.

there is a considerable knowledge-gap regarding the efficacy of problem gambling prevention in workplace settings. at the same time, this knowledge is widely requested upon both by researchers and government agencies. the evaluation of prevention programs is important both in a public health perspective and for the organizations investing in preventive interventions for problem gambling at the workspaces and the current study aims to contribute with knowledge regarding the potential effects of such an intervention. the purpose of this study is to determine the effects of a workplace prevention program regarding problematic gambling, on a variety of outcomes. the authors hypothesize that the program will lead to differences in: * a change in gambling habits among coworkers and managers * that fewer workers and managers will report problem gambling * that the managers who participate in the intervention will report being more confident in handling gambling and problem gambling at the workplace * that the managers who participate in the intervention will report a higher inclination to engage in a conversation with an employee when suspicion or worry about problem gambling arises * that the number of actions to help employees with problem gambling or other types of harmful use will raise among organizations who participate in the intervention. * an increase in the employees' knowledge about what kind of support regarding gambling or addiction is available from the workplace and where to find it.

Eligibility criteria:
program inclusion criteria: * to be eligible to participate in the workplace program, the participant must be currently employed as manager in one of the organizations that will participate in the study exclusion criteria: -

Keywords: gambling prevention workplace policy
the effectiveness of a mechanical manual therapy device in the treatment of neck pain

Conditions: Neck Pain

Summary: this study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. we are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.


Eligibility criteria:
inclusion criteria: * currently experiencing neck pain which does not extend below the elbow * pain at least 4/10 over the past 24 hours * appropriate for conservative management of neck pain * english speaking exclusion criteria: * surgery to the neck within the past 6 months * systemic problem know to affect sensation * other chronic pain condition other than neck pain * neck pain as the result of trauma such as whiplash * neck pain as the result of a fracture

Keywords: neck pain manual therapy exercise
drug use investigation for cell-culture derived influenza a (h1n1) emulsion ha vaccine

Conditions: Swine-Origin Influenza A H1N1 Virus

Summary: this is to evaluate safety of cell-derived a/h1n1 influenza ha vaccine in healthy japanese subjects.


Eligibility criteria:
inclusion criteria: 1. healthy japanese exclusion criteria: 1. the person has received any other company's new influenza vaccine (swine-derived a/h1n1) before vaccination with this product. 2. the person has participated in any clinical study of this product or any other company's new influenza vaccine (swine-derived a/h1n1) and received the investigational vaccine. the person is regarded as a subject in one of the following items 3) to 6) who is not appropriate to receive preventive vaccination as described in the current package insert. 3. the person shows obvious fever. 4. the person obviously suffers from serious acute disease. 5. the person has obviously shown anaphylaxis due to an ingredient of this vaccine. 6. the person is otherwise in an inappropriate state to receive preventive vaccination.

Keywords: influenza a h1n1 subtype vaccine adjuvant cell culture
efficacy and safety of vegf trap eye in diabetic macular edema (dme) with central involvement

Conditions: Macular Edema

Summary: to determine the efficacy of intravitreally (ivt) administered vegf trap-eye on the best-corrected visual acuity (bcva) assessed by the early treatment diabetic retinopathy study (etdrs) chart in subjects with diabetic macular edema (dme) with central involvement.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years with type 1 or 2 diabetes mellitus * subjects with diabetic macular edema (dme) secondary to diabetes mellitus involving the center of the macula in the study eye * decrease in vision determined to be primarily the result of dme in the study eye * best-corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score of 73 to 24 (20/40 to 20/320) in the study eye exclusion criteria: * laser photocoagulation (panretinal or macular) in the study eye within 90 days of day 1 * more than 2 previous macular laser treatments in the study eye * previous use of intraocular or periocular corticosteroids in the study eye within 120 days of day 1 * previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of day 1 * active proliferative diabetic retinopathy (pdr) in the study eye * uncontrolled diabetes mellitus, as defined by hba1c \>12% * only 1 functional eye even if that eye is otherwise eligible for the study

Keywords: diabetic macular edema dme vegf trap-eye best-corrected visual acuity (bcva)
an induction study of mirikizumab in participants with moderately to severely active ulcerative colitis (lucent 1)

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the safety and efficacy of mirikizumab in participants with moderately to severely active ulcerative colitis (uc) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for uc.


Eligibility criteria:
inclusion criteria: * diagnosis of uc for at least 3 months prior to baseline. * confirmed diagnosis of moderately or severely active uc, as assessed by the modified mayo score (mms). * demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for uc. * if female, must meet the contraception requirements. exclusion criteria: * participants with a current diagnosis of crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis). * participants with a previous colectomy. * participants with current evidence of toxic megacolon. * prior exposure to anti-il12p40 antibodies (e.g. ustekinumab) or anti-il-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Keywords: interleukin-23 (il-23) antibody il-23p19
acarbose, postprandial hypotension and type 2 diabetes

Conditions: Type 2 Diabetes; Postprandial Hypotension

Summary: postprandial hypotension carries a risk of significant morbidity and morbidity including syncope, falls, dizziness, fatigue, stroke and myocardial infarction. current therapy consists of dietary manipulation (smaller meals) caffeine and octreotide injections all of which are suboptimal and poorly studied. the study hypothesis is that administration of acarbose will decrease the drop in blood pressure and increase in heart rate in response to food in people with type 2 diabetes. acarbose suppresses postprandial glycemia be slowing digestion in the small intestine and delaying gastric emptying. this is a placebo-controlled cross over study involving 2 - 4 hour meal tests. during the meal tests heart rate, blood pressure, cerebral artery velocity will be measured. during one meal test subjects will receive acarbose 50 mg po and during the other will receive placebo. order of treatment assignment will be done in randomized fashion. a total of approximately 200 cc of blood will be drawn during each meal test.


Eligibility criteria:
inclusion criteria: * age 65 year and older * type 2 diabetes exclusion criteria: * less than 65 years of age

Keywords: type 2 diabetes, postprandial hypotension, acarbose
effects of botanical microglia modulators in gulf war illness

Conditions: Gulf War Illness

Summary: the overall objective of this protocol is to test if gulf war illness (gwi) involves chronic inflammation that cannot be measured with typical techniques. the investigators will be observing the effects of nine different botanical compounds (supplements) that are known to suppress inflammation. if one of those supplements helps the symptoms of gwi, it will give the investigators information about what is wrong in people with gwi.

there is still a poor understanding of the pain, fatigue, and other symptoms that affect approximately 250,000 veterans. the precise mechanism of gulf war illness (gwi) is not understood, and there is no targeted treatment for the condition. a current model for gwi points to the central nervous system, immune cells, called microglia that may be hyperactive in patients with gwi. discovering effective treatments for this disorder is a top priority of gwi research. given the investigator's preliminary data, it is suspected that gwi is a form of low-level neuroinflammation that involves hypersensitivity of receptors on microglia. in order to help test that hypothesis, the investigators will be administering supplements that have been shown in vitro or animal in vivo to suppress microglia function in a way that is anti-inflammatory and neuroprotective. if any of these agents suppress symptoms in gwi, it will give the investigators important information about the disease that may allow for creation of better diagnostic tools and treatments in future research studies. observing the effects of the selected nine anti-inflammatory botanical compounds, in this clinical study, is a strong compliment to the ongoing mechanistic gwi research.

Eligibility criteria:
inclusion criteria: 1. male 2. age 39-65, inclusive 3. veterans who meet the kansas inclusion criteria for gwi 4. present in persian gulf between 1990 and august 1991 5. patient completes daily report during 2 week baseline period (at least 80% completion rate) 6. able to receive a venous blood draw exclusion criteria: 1. positive rheumatoid factor at screening 2. positive anti-nuclear antibody at screening 3. c-reactive protein\> 3mg/l at screening 4. erythrocyte sedimentation rate\> 40mm/hr at screening 5. auto-immune disorder 6. diagnosed rheumatologic condition 7. major ptsd symptoms 8. hypotension (under 90/60 mm hg) or history of cardiovascular disease 9. antihypertensive, anticoagulant medication, nitroglycerine, lithium medication use 10. diabetes with hemoglobin a1c \>9% 11. history of anaphylaxis to study botanical compounds 12. current daily use of opioid medication 13. hospital anxiety and depression scale, depression subscale score of 16 or higher at baseline 14. current litigation of worker's compensation claim 15. blood or clotting disorder 16. acute infection (body temperature over 100 degrees f) 17. current daily use of confounding-anti-inflammatory medication as part of regular medication regimen 18. individuals that are not able to read \& understand english

Keywords: gulf war syndrome chronic multisymptom illnesses medically unexplained illnesses
evaluation of the additional efficacy, and safety of olmesartan medoxomil 20mg / hydrochlorothiazide 12.5mg in the treatment of chinese patients with mild to moderate essential hypertension

Conditions: Essential Hypertension

Summary: this study is designed to evaluate the additional efficacy and safety of olmesartan medoxomil/hydrochlorothiazide in the treatment of chinese patients with mild to moderate essential hypertension, who fail to attain the blood pressure goals with olmesartan medoxomil monotherapy


Eligibility criteria:
inclusion criteria: * at visit 3, mean seated diastolic blood pressure (sedbp) ≥ 95 mmhg and \< 110 mmhg, and mean seated systolic blood pressure (sesbp) ≥140 mmhg and \< 180 mmhg * at visit 4, mean sedbp ≥ 90 mmh * no significant disorder in blood, kidney, liver, cardiovascular system or endocrinology system exclusion criteria: * patients with known or suspect secondary hypertension * unstable angina * history of acute myocardial infarct, or ptca or surgical cardiac procedures 3 months before entry into this study * prior or current congestive heart failure (nyha grade iii or iv), hypertrophic obstructive cardiomyopathy, valvular disease or rheumatic heart disease * arrhythmia of clinical significance * bilateral renal artery stenosis, isolated renal artery stenosis, post kidney transplantation * acute glomerular nephritis * gout sufferers, even with the normal serum uric acid at entry * retinal hemorrhage /exudate * type 1 diabetes mellitus * uncontrolled type 2 diabetes mellitus * hypovolemia * patients with autoimmune disease
brain gut axis changes after bariatric surgery and their relationship to weight loss

Conditions: Obesity; Bariatric Surgery Candidate

Summary: assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors. obese women undergoing weight loss surgery will be recruited to participate in the study. these individuals will undergo a screening visit and 4 study visits. the study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. each study visit will include evaluation of brain function (fmri), anthropometrics, blood and stool samples and eating behaviors questionnaires.

assessing the changes in the brain-gut axis after weight loss surgery and their relationship with weight loss and changes in eating behaviors. obese women undergoing weight loss surgery will be recruited to participate in the study. these subjects will undergo a screening visit and 4 study visits. the study visits will occur before, and at 1-, 6- and 12 months after the weight loss surgery. each study visit will include evaluation of brain function (fmri), anthropometrics, blood samples (gut hormones, cytokines, metabolomics ) and stool samples (16s rna and metabolomics) and eating behaviors questionnaires (yfas, tfeq, food cravings/preferences scales, 3-day food food intake records) primary outcomes: weight loss after surgery and changes in eating behaviors scales (yfas, tfeq) , metabolomics, appetite related hormones and gut microbiome (16s rna) secondary outcomes: changes in brain function (fmri/mrs), diet (3-day food intake records) and inflammatory markers.

Eligibility criteria:
inclusion criteria: * women, age 18-55 years * eligible and approved for undergoing laparoscopic gastric bypass (lrygb) or laparoscopic sleeve gastrectomy (lsg) following the guidelines for clinical application of laparoscopic bariatric surgery by of american gastrointestinal and endoscopic surgeons (sages) * right-handed exclusion criteria: * previous major gastrointestinal surgery including weight loss surgery (partial or complete resection of stomach and/or small bowel, whipple procedure, etc) * use of medications known to affect hunger, satiety, or intestinal motility. * unwillingness or inability to give informed consent * any contraindication to undergo mri * current or past alcohol or drug abuse problem or smoking * pregnancy, lactating or post partum less than 12 months * body weight at enrollment greater than 350 lbs. * current use of insulin and or insulin dependent diabetes * renal insufficiency, retinopathy, or neuropathy. * post menopausal (defined as no menses for 12 consecutive months)
virtual reality for urological procedures

Conditions: Feasibility; Anxiety State; Pain; Satisfaction, Patient

Summary: it is standard practice for most cystoscopies and vasectomies in an office or outpatient setting to be performed under local anesthesia while the patient is awake and conscious. however, given the conscious nature of these procedures, patients may experience anxiety-inducing stressors that they otherwise would not under general anesthesia. stressors such as hearing surgical terminology, technical discussion, and injection of local anesthetic have been previously documented as sources of perioperative anxiety and pain in awake surgeries. the current study will examine the feasibility and pilot outcomes of virtual reality (vr) guided meditation therapy during cystoscopies and vasectomies. feasibility will be examined through: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures (including randomization) and outcome measures, and (3) participant acceptability and suitability of the vr intervention during the procedures. the investigators will also evaluate pilot outcomes of the vr intervention on pain, anxiety, and overall satisfaction with the procedure. results of this study will inform the development of a large-scale randomized clinical trial (rct) to evaluate the efficacy of this intervention. participants will be asked to complete questionnaires before and after their procedure and will be asked for a verbal measure of their pain and anxiety during the procedure.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * can speak and read english * have an indication for a cystoscopy or elected for a vasectomy * are scheduled to undergo their respective procedure under local anesthesia at the men's health clinic between the dates of may-november 2024. exclusion criteria: * those who are not competent to provide informed consent (e.g., due to cognitive impairment) * those who are unable to participate in a vr intervention (e.g., due to visual or auditory impairment)

Keywords: feasibility virtual reality perioperative mental health
study evaluating piperacillin/tazobactam in complicated urinary infections.

Conditions: Urinary Infections

Summary: the primary objective is to study the efficacy of piperacillin/tazobactam in patients with complicated urinary tract infections


Eligibility criteria:
inclusion criteria: * hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with piperacillin-tazobactam. exclusion criteria: * patients known, or thought to be hypersensitivity to beta-lactams * patients with an uncomplicated urinary tract infection

Keywords: urinary infections