Kornimate/medical-research-clean huggingface dataset:
a phase iii clinical study of napabucasin (gb201) plus folfiri in adult patients with metastatic colorectal cancer

Conditions: Previously Treated Metastatic Colorectal Cancer

Summary: this is a randomized, open-label, multi-center, phase iii study of napabucasin plus bi-weekly folfiri (arm 1) vs. napabucasin (arm 2) for adult patients with metastatic crc who have failed standard chemotherapy regimens. for patients who have failed bevacizumab with irinotecan-based chemotherapies (treatment failure is defined as radiologic progression of disease during or within 3 months following the last dose), bevacizumab maybe administered in combination with folfiri to patients randomized to arm 1.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the colon or rectum that is metastatic (stage iv) * progression during or within 3 months following the last administration of standard chemotherapy based regimens containing a fluoropyrimidine, irinotecan and oxaliplatin. patients treated with oxaliplatin or irinotecan in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy * patients who are candidates for and have access to anti-vegf therapy (i.e. bevacizumab and regorafenib) and anti-egfr therapy (i.e. cetuximab and panitumumab) and/or tas-102 must have received appropriate therapy. * patients with measurable or non measurable disease * eastern cooperative oncology group (ecog) performance status of \</= 1 * adequate bone marrow, liver and renal function exclusion criteria: * anti-cancer chemotherapy, biologic therapy or any other systemic therapy if administered prior to the first planned dose of study medication within period of time equivalent to the usual cycle length of the regimen. an exception is made for oral fluoropyrimidines (e.g. capecitabine, s-1), where a minimum of 10 days since last dose must be observed prior to the first planned dose of protocol treatment. * major surgery within 4 weeks prior to randomization. * any known brain or leptomeningeal metastases are excluded, even if treated. * known hypersensitivity to 5-fu/lv or patients who as a result of toxicity had to reduce or stop 5-fu infusion at the dose of 900 mg/m\^2/day (total 1800 mg/m\^2/day). * known hypersensitivity to irinotecan or patients who as a result of toxicity had to reduce or stop irinotecan infusion at the dose of 120 mg/m\^2. * known history of human immunodeficiency virus (hiv) infection. known chronic hepatitis b or c active infection. * known microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr). * known dihydropyrimidine dehydrogenase (dpd) deficiency. * patients with qtc interval \> 470 millisecond. * uncontrolled intercurrent illness

Keywords: crc
enzalutamide before surgery in treating patients with kidney cancer

Conditions: Clear Cell Renal Cell Carcinoma; Stage I Renal Cell Cancer

Summary: this pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. androgens are a type of hormone produced by the body that may cause kidney tumors to grow. anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.

primary objectives: i. to investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccrcc). outline: patients receive enzalutamide orally (po) daily for 90 days in the absence of disease progression or unacceptable toxicity. patients then undergo partial or radical nephrectomy. after completion of study treatment, patients are followed up every 3 months.

Eligibility criteria:
inclusion criteria: * clinical t1n0m0 (=\< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography \[ct\] or magnetic resonance imaging \[mri\]) * biopsy proven ccrcc * tumor with androgen receptor (ar) expressed \>= 4580 copies/ug ribonucleic acid (rna) * can provide informed consent * adequate hepatic function (\>= 1.5 x upper limit of normal \[uln\]; patient's with gilbert's disease are not excluded) * adequate renal function (estimated glomerular filtration rate \[gfr\] \> 40ml/min) * no evidence of metastatic disease on baseline imaging (chest x-ray \[cxr\] or chest ct, abdominal ct or mri) * eastern cooperative oncology group (ecog) performance status =\< 2 exclusion criteria: * prior use of androgen deprivation including enzalutamide * pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment * men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age * known hypersensitivity to enzalutamide * history of unprovoked deep vein thrombosis/pulmonary embolism (dvt/pe) in past twelve (12) months * inability to stop anticoagulants/antiplatelet therapy peri-operatively * history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma) * history of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment * any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening * known or suspected brain metastasis or active leptomeningeal disease * current use of exogenous testosterone * retroperitoneal/hilar adenopathy concerning for locally advanced disease * metastatic rcc
study to increase colorectal screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine whether inreach and outreach strategies will be superior to usual care, and combination of both will be superior to either strategy alone.

colorectal cancer (crc) screening saves lives, but screening rates are low among underserved populations, particularly latinos. the screening rate in the predominantly latino population served by san ysidro health center (syhc, a federally qualified health center (fqhc)), is just 31%, similar to that reported for latinos nationally, but lower than the overall national average of 65%. previous research has demonstrated that inreach interventions at point of medical care such as patient navigation after screening referral, and outreach outside of usual medical care (such as with mailed invitations) can increase screening rates among underserved populations. however, since these have undergone limited evaluation among low income predominantly spanish-speaking latinos, it is unclear which approach is best, and whether implementing both approaches would be synergistic for optimizing screening rates. we hypothesize that two culturally and linguistically tailored interventions: a) an inreach strategy (ir, consisting of community health worker-delivered in clinic education regarding crc screening and other components), and b) an outreach strategy (os, consisting of mailed invitations to complete screening with an enclosed fecal immunochemical test (fit) and telephone reminders) can substantially increase screening, and further, that the two interventions together will be substantially better than either alone. to test these hypotheses, we propose a randomized trial comparing usual care, ir, os, and ir+os for crc screening.

Eligibility criteria:
inclusion criteria: * individuals age 50 to 75 years, * one or more syhc visits in the last year, * not uptodate with crc screening exclusion criteria: * individuals with personal history of crc or colorectal polyps

Keywords: early detection
feasibility of enhanced dialysis education (edu) intervention for chronic kidney disease (ckd) patients

Conditions: Chronic Kidney Diseases

Summary: the investigators are studying the feasibility, acceptability, and outcomes of an intervention called enhanced dialysis education (edu) intervention. ckd-edu is a palliative care-based dialysis decision-making intervention that involves educating patients and caregivers about dialysis and engaging them in shared decision-making. half of the enrolled patients will receive ckd-edu and the other half will receive usual care.


Eligibility criteria:
inclusion criteria: 1. age ≥75 years old 2. presence of advanced ckd stage 4 or 5 (i.e. e gfr ≤ 25 ml/min) 3. patient's nephrologist is enrolled in the study and has seen that nephrologist at least once 4. speaks english 5. have not attended a dialysis education class or met with the dialysis education coordinator. 6. have not made a dialysis decision exclusion criteria: 1. patient has already been seen by a palliative care clinician or is enrolled in hospice 2. is already on dialysis 3. hospitalized at the time of recruitment
virtual reality application on pain intensity and anxiety level in endoscopy patients

Conditions: Anxiety

Summary: with the virtual reality application in patients with bronchoscopy, it is aimed to reduce the fear, stress and tension arising from the possibility of the development of pain and complications in the patients. the research will be carried out in the form of pretest-posttest application with 30 experimental and 30 control groups. the researcher aims to minimize the fear and stress in the patient by applying the virtual reality application to the patient in the experimental group 10 minutes before the procedure and 5-10 minutes during the procedure.

this study includes the examination of the effect of applying virtual reality interventions, which are used for the treatment of anxiety problems, to patients who will undergo bronchoscopy. for this purpose, first of all, a relaxation intervention will be designed in a virtual reality environment. the virtual reality environment will be organized on the basis of relaxation exercise. in this direction, first of all, an image will be created by taking 3d modeling service and the text of the relaxation exercise prepared in the presence of a professional sound artist will be transferred to the image with sound.

Eligibility criteria:
inclusion criteria: * be18 years and over * ability to communicate adequately * absence of psychiatric problems * those who are determined by the physician that they do not have a physical disability in exercising * volunteering to participate in the research * individuals who have the ability to use technological tools exclusion criteria: those who have communication problems • those with psychiatric problems

Keywords: virtual reality anxiety pain endoscopy patients
buspirone in parkinson's disease

Conditions: Parkinson Disease; Anxiety

Summary: anxiety is highly prevalent in parkinson's disease and negatively impacts quality of life yet it frequently remains untreated and there have been no clinical trials dedicated to evaluating the pharmacological treatment of anxiety in parkinson's disease. buspirone is effective for the treatment of generalized anxiety disorder in the general and elderly population. it is not known if it is effective for the treatment of anxiety in parkinson's disease. this is a single-center, placebo-controlled, double-blind design with participants randomized with a 4:1 allocation ratio to flexible dosage buspirone (maximum dosage 30 mg twice daily) or placebo for 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd by uk parkinson's disease society brain bank clinical diagnostic criteria * significant anxiety as determined by the self-rated parkinson anxiety scale (score ≥ 14) * able to provide written informed consent * at least 18 years of age exclusion criteria: * diagnosis of atypical or secondary parkinsonism * concomitant treatment with an mao inhibitor within the 14 days prior to screening visit * significant renal or hepatic impairment * significant cognitive impairment defined as moca score \< 23 * on-going depression with suicidal or homicidal ideation and concern for patient safety based on clinical determination by the investigator * allergy or intolerance to study drug, matching placebo, or their formulations * history of prior exposure to study drug * lactating or pregnant woman * concomitant treatment with a disallowed medication (detailed in section 6.2) * active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements * concomitant treatment with an anxiolytic or antidepressant will be allowed however potential participants who had dosage changes in the 30 days prior to the screening visit will be excluded * use of an investigational drug within 30 days prior to screening visit * any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation * dysphagia defined as a score of ≥ 2 on mds-updrs item 2.3 chewing and swallowing
mri-based active surveillance to avoid the risks of serial biopsies in men with low-risk prostate ca

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Multiparametric MRI; Gleason's Score 6

Summary: phase ii non-inferiority randomized trial of annual systematic biopsies versus mpmri and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume gleason's score 6, but no prior mri imaging of the prostate.

this is an unblinded, randomized trial of trus biopsy-based active surveillance versus mpmri-based active surveillance. patients on the trus biopsy-based arm will undergo annual systematic biopsies without any mri staging or guidance. patients on the mpmri- based arm will undergo annual mpmri surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.

Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration. * gleason score ≤ 6 * psa \< 10 ng/ml * completed and documented history and physical addressing all inclusion/exclusion criteria. exclusion criteria: * a diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates. * previous mri imaging of the prostate. * prior history of pelvic radiotherapy. * prior history of prostatectomy. * contraindication to prostate mpmri (renal failure, hip prosthesis, pacemaker, etc). * contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy). * patients on testosterone replacement therapy who are unwilling to discontinue. * medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements. * unable to understand, or unwilling to complete the informed consent process.

Keywords: low risk prostate cancer
safety and efficacy of intravenous thrombolysis in patients with ischemic stroke and direct oral anticoagulants intake

Conditions: Ischemic Stroke

Summary: do-it is an international, multicenter, prospective, two-arm, randomized, open label, blinded endpoint superiority trial determining the safety and efficacy of intravenous thrombolysis (ivt) in participants experiencing an acute ischemic stroke (ais) with recent (within the last 48 hours) intake of direct oral anticoagulant (doac). for this purpose, 906 adult participants experiencing an ais with recent doac intake will be enrolled at several high-volume international stroke centers and randomly assigned in a ratio of 1:1 to one of two treatment arms: (1) ivt and standard of care/best medical treatment or (2) standard of care/best medical treatment. the do-it trial is a definitive test of the hypothesis that ivt is superior to standard of care for achieving better outcome at 90 days in ais participants with recent doac intake.


Eligibility criteria:
inclusion criteria: * informed consent (deferred consent when possible according to national legislation) * ais eligible to receive intravenous alteplase/tenecteplase as per standard of care disabling according to the judgement of the treating physician * doac ingestion within 48 hours prior to enrollment, or patient with an ongoing prescription of doac but exact time point of last intake is unknown. * either * can be randomized within 4 hours 15 minutes and treated within 4 hours 30 minutes of last known well time or * mri showing a pattern of "dwi-flair-mismatch", i.e. acute ischemic lesion visibly on dwi ("positive dwi") but no marked parenchymal hyperintensity visible on flair ("negative flair") indicative of an acute ischemic lesion ≤4.5 hours of age and treatment can be started within 4.5 hours of symptom recognition (e.g., awakening). exclusion criteria: * contra-indications to ivt by the current standard of care of the treating physicians with the exception of recent doac intake as specified above. * intended reversal by specific or unspecific reversal agents * pregnancy or lactating women. to be reasonable sure to exclude women with ongoing pregnancy, women are not considered of childbearing potential if they fulfill the following criteria * age \> 55 years or * age \< 55 years and at least 12 months since last menstrual period or * have had a documented surgical sterilization * patient \< 18 years of age (since the benefit of ivt is unproven in this population) since the benefit of ivt might be smaller in patients in which additional endovascular treatment is planned, the investigators will cap patients with intended mechanical thrombectomy at 20% of the trial population. if this number is reached, the following additional exclusion criterion will be applied: * intended treatment with endovascular reperfusion strategies

Keywords: doac noac (novel oral anticoagulants) anticoagulation r-tpa (tissue-type plasminogen activator) alteplase tenecteplase rivaroxaban apixaban dabigatran edoxaban
single dose, single administration study of technosphere inhalation powder in diabetic subjects with mild or moderate kidney disease compared to diabetic subjects with normal kidney function

Conditions: Mild Nephropathy; Moderate Nephropathy; Diabetes Mellitus

Summary: 24 diabetics with mild \& moderate renal disease and 12 diabetics without renal disease. one screening, one dosing \& one follow-up visit with technosphereâ® inhalation powder given at visit 2 via medtoneâ® inhaler and pk testing at 26 designated time points

this phase 1, single-dose trial is being conducted to determine if nephropathy affects the way the kidneys eliminate the byproducts of technosphereâ® inhalation powder as compared to kidneys free of disease. this trial will test the safety, tolerability and pharmacokinetics of the study medication. the trial consists of a screening, dosing and a follow-up visit. single dose administration of technosphereâ® inhalation powder occurs at the dosing visit. (v2) with serum and urine pk testing .

Eligibility criteria:
inclusion criteria: * non-smoking males and females, = 18 and = 80 years with a bmi of = 37 kg/m2 * type 1 or type 2 diabetic * subjects with mild or moderate dnp and subjects with normal renal function, based on gfr rate and albuminuria * normal pulmonary function and performance based on pfts exclusion criteria: * no history of copd, asthma, or active respiratory infection; must be able to perform pfts * no dose and/or formulation changes within the preceding 6 weeks for any concomitant medications * no clinically significant major organ/systemic disease * no previous or current chemotherapy or radiation therapy that may result in pulmonary toxicity * no clinically significant abnormalities on screening laboratory evaluation, except abnormal laboratory renal parameters in subjects with dnp

Keywords: nephropathy kidney disease diabetic renal diabetics
stingless bee honey augmentation in major depressive disorders: a randomized clinical trial

Conditions: Major Depressive Disorder (MDD)

Summary: the goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in major depressive disorder (mdd) in adults. it will also learn about the adverse effects of the honey. the main questions it aims to answer are: 1. is there any effect of sbh on depressive symptoms between intervention and control groups in mdd? 2. are there any effects of sbh on bdnf between intervention and control groups in mdd? 3. are there any effects of sbh on oxidative stress between intervention and control groups in mdd? 4. are there any effects of sbh on verbal learning and memory between intervention and control groups in mdd? there is no placebo. participants will: take stingless bee honey or nothing every day for 2 months visit the clinic once every 4 weeks for checkups and tests report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires


Eligibility criteria:
inclusion criteria: * adults with ages 18 to 65 with major depressive disorder scores of beck depression inventory malay version equal or more than 11 exclusion criteria: * women in pregnancy or breast-feeding. patients who with honey allergy or stingless bee honey allergy. currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month. patients with major depressive disorder comorbidity either with generalized anxiety disorder, panic disorder, social anxiety disorder, bipolar disorder, substance-use disorder, suicidal ideation or attempt, dementia, alzheimer disease, diabetic, hypertension, chronic kidney disease
medtronic shock-less study on physician utilization of shock reduction programming

Conditions: Cardiovascular Disease

Summary: the purpose of this clinical trial is to determine whether periodic therapy programming reports illustrating physician usage of shock reduction programming can increase utilization of recommended programming guidelines for defibrillators.

shocks delivered to patients by defibrillators, while life-saving, can create anxiety, pain and decrease quality of life. previous studies have shown that device programming and features can safely reduce the number of shocks patients receive. this study will explore the extent to which physicians use these programming and features. it will determine whether repeat and frequent awareness to how they program their own subjects and the programming trends of all enrolled subjects will change their programming patterns. this will be accomplished by understanding physicians' device programming behaviors and providing reports as a tool to help physicians manage their subjects and provide shock reduction programming recommended by previous publications.

Eligibility criteria:
inclusion criteria: * subject (or subject's legally authorized representative) is willing and able to sign and date the patient consent form (pcf) and authorization for access to and use of health information, if applicable * subject has been implanted with a medtronic market released icd or crt-d device (us/canada - concerto®/virtuoso® or newer model; asiapacific, israel, latin america - entrust™, insync sentry®, or concerto®/virtuoso® or newer model) within the past 30 days * subject has commercially released ra (if applicable), rv, and lv (if applicable) leads exclusion criteria: * subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the medtronic clinical trial leader

Keywords: implantable cardioverter defibrillator (icd) cardiac resynchronization therapy-defibrillator (crt-d) lead integrity alert (lia) therapy programming report (tpr)