Kornimate/medical-research-clean huggingface dataset:
study of apalutamide with carotuximab in metastatic, castration-resistant prostate cancer

Conditions: Castration-resistant Prostate Cancer

Summary: this is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (arsi) therapy. this study will begin with a safety assessment in the first 10 subjects (part 1: safety lead-in). if the combination is deemed safe, the trial will proceed to the phase ii stage. the purpose of this study is to compare progression free survival (pfs) between patients receiving apalutamide and apalutamide + carotuximab using response evaluation criteria in solid tumors (recist 1.1) and prostate cancer working group 3. the secondary objectives are to describe adverse events related to the intervention, overall response rate (orr), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the orr, radiographic pfs, and biochemical pfs in the overall population.


Eligibility criteria:
inclusion criteria: * history of castration-resistant prostate cancer with rising psa (prostate-specific antigen) on a contemporary arsi (androgen receptor (ar) signaling inhibitor: abiraterone, enzalutamide, darolutamide). bicalutamide, nilutamide, and flutamide will not be considered as contemporary arsis * patient must have had 1 and can have up to 2 prior ar targeted therapy with the exception of apalutamide. * patients must decline or be ineligible for taxane therapy in the opinion of the treating physician. * all patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab) exclusion criteria: * non-psa producing prostate cancers such as small cell prostate cancers or those prostate cancers which exhibit radiographic progression without psa rise * prior use of apalutamide * other prior malignancy requiring active anticancer therapy * prior exposure to carotuximab or any cd105 targeted antibody * active bleeding or pathologic medical conditions that carries a high bleeding risk * a known diagnosis of osler-weber-rendu syndrome

Keywords: prostate cancer castration-resistant crpc
tdcs effect on cognitive functions from patients with alzheimer's disease or progressive primary aphasia

Conditions: Alzheimer's Disease; Progressive Primary Aphasia; Early or Mild State

Summary: the purpose of this study is to evaluate the effect of 10 sessions of anodal transcranial direct current stimulation (tdcs - 1 ma) applied to left cortex dorsolateral prefrontal (cdlpf) of alzheimer's or primary progressive aphasia (ppa) patients compared to the application of a placebo tdcs (sham procedure) on cognitive functions, which are evaluated at short term (1 week post-treatment) and mild term (3 weeks post-treatment). after unblinding, patients who received placebo treatment could be received active tdcs.


Eligibility criteria:
inclusion criteria: * national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association (nincds-adrada) criteria (alzheimer's patient) or gordo-tempini criteria (ppa's patient) * cdr score ≤ 2 * treatment by iache ≥ 3 months * madrs score \< 18 * w/o severe progressive somatic pathology (especially tumor diseases) exclusion criteria: * last neuropsychological assessment \< 6 months * presence of a specific contraindication for tdcs (e.g. personal history of epilepsy, metallic head implant, cardiac pacemaker)
the efficacy of transcutaneous pulsed radiofrequency acupuncture for knee osteoarthritis

Conditions: Osteoarthritis (OA) of the Knee

Summary: efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

with the aging population, knee osteoarthritis (koa) has become a major issue affecting functional living and causing socioeconomic burdens. its etiology includes biomechanical abnormalities, genetics, hormones, and environmental factors. koa causes pain, stiffness, and muscle weakness, affecting daily activities and quality of life. previous studies have shown that traditional acupuncture or electroacupuncture can improve pain and function in knee osteoarthritis. in recent years, pulsed radiofrequency therapy has gradually been applied for pain control in koa. however, both treatments are invasive, and patients may fear and avoid needle insertion, which also has a higher risk of complications. this study aims to combine the strengths of both treatments by using transcutaneous pulsed radiofrequency(tcprf) at acupuncture points. this non-invasive treatment approach aims to achieve effective pain control, allowing patients to participate more actively in rehabilitation therapy.

Eligibility criteria:
inclusion criteria: * age from 45 to 85 year-old with knee pain for more than six months * fulfill the combined clinical and radiographic criteria of knee oa established by the american college of rheumatology with a kellgren and lawrence score of 2 or greater * pain score above 3 (range 0-10 on the visual analog scale; higher scores indicate greater pain * could participate in 4 weeks of treatment and 3 months of follow-up exclusion criteria: * knee oa combined with any infection, inflammation, autoimmune disease, or fracture * history or underlying disease that would affect posture and balance, such as malignancy, dizziness, vertigo, or stroke * ever underwent any type of knee operation or internal fixation * pregnant or planning to become pregnant * receiving other treatment for knee oa in previous 3 months * history of epilepsy, electronic devices implanted in the body * active infection at the stimulator contact site * lack of informed consent * any other reason thought likely to result in inability to complete the trial

Keywords: knee osteoarthritis transcutaneous pulsed radiofrequency acupuncture acupoints
kidney and intestinal markers for early detection of organ injury after endovascular aortic repair

Conditions: Ischemia; Fatty Acid-Binding Proteins; Mesenteric Vascular Disease; Acute Kidney Injury

Summary: this study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (evar) for aortic aneurysm or dissection. in this context, patients will be monitored for renal biomarkers (timp-2, igfbp7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-fabp)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (ceus). the ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.


Eligibility criteria:
inclusion criteria: * existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon * aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries * central line is present to perform repeated blood collections * written informed consent is obtained. exclusion criteria: * pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (inr) \>2 or creatinine \>2 mg/dl or renal-replacement therapy in the pre-operative course.) * known allergy to ultrasound contrast media (exclusion for the ceus but not for marker evaluation) * anemia with hemoglobin concentration \< 7g/dl * patients \< 18 years of age * patients not able to give written informed consent

Keywords: evar endovascular aortic repair acute kidney failure mesenteric ischemia
evaluation of covid 19 anxiety in endometriosis patients

Conditions: Endometriosis; Covid19

Summary: it is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period.


Eligibility criteria:
inclusion criteria: * endometriosis patients * no psychiatric illness * no antidepressant use exclusion criteria: * women who had not endometriosis * no extra health conditions * women younger than 18 and older than 45
biospecimen collection in assessing the effect of trametinib with or without uprosertib on biomarkers in patients with persistent or recurrent endometrial cancer enrolled on trial gog02290

Conditions: Recurrent Endometrial Carcinoma

Summary: this trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial gog02290 with endometrial cancer that is persistent or has come back. biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.

primary objectives: i. to explore the impact of trametinib alone or in combination with uprosertib (gsk2141795) on raf-mek-erk and pi3k pathway signaling. secondary objectives: i. to examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with gsk2141795. ii. to examine levels of circulating tumor cells in blood samples before and after treatment and correlate with tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with gsk2141795. iii. to examine the braf/craf dimer or raf/ksr/mek1 dimers in paraffin sections from these patients before treatment by proximity ligation assay (pla) assays. iv. to quantify exosomes from these patients before and after treatment by enzyme-linked immunosorbent assay (elisa) assay with cd63 antibody and explore braf/craf dimer or raf/ksr/mek1 dimers in exosomes from these patients before and after treatment by pla assays. outline: patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. patients also undergo collection of tumor biopsy at screening and day 28.

Eligibility criteria:
inclusion criteria: * patients must be enrolled on gog0229o * patients must have tissue available for molecular analysis. this can be tissue obtained at time of current recurrence or archival tissue from primary diagnosis or recurrence * patients must have disease lesions that are amenable to pre- and post- treatment biopsy * patients must have signed an approved informed consent and authorization permitting release of personal health information exclusion criteria: * patients unwilling to undergo a biopsy
the crt-kir study (cardiac resynchronization therapy [crt] in the early phase after heart surgery)

Conditions: Bundle-Branch Block

Summary: in patients with broad qrs complexes on electrocardiogram (ecg), the delayed electrical activation of the left heart chamber will cause abnormal contraction.this has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= crt treatment). in this study the researchers will investigate the effect of acute crt treatment in the early phase after open heart surgery.

patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle. we hypothesize that patients may benefit from short term (= 72 hours) crt (cardiac resynchronization therapy) in the early phase after open heart surgery. patients: reduced lv function and bundle branch block. study type: randomisation to crt versus standard postoperative treatment study variables: cardiac output, echocardiographic measures, p-bnp and hours with inotropic therapy.

Eligibility criteria:
inclusion criteria: * patient scheduled for open heart surgery (coronary artery bypass graft \[cabg\] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and lv ejection fraction \ 9.12 s) exclusion criteria: * severe right heart failure * permanent atrial fibrillation * congenital heart disease * serious non-cardiac disease

Keywords: cardiac resynchronization heart failure open heart surgery surgery
study dynamic haptic robotic trainer (dhrt) and dhrt+ for cvc insertion training for surgical residents

Conditions: Central Line Complication; Central Line Infection

Summary: human participants will include medical residents and patients. each year the entering 1st year medical residents at hershey medical center and cedars-sinai medical center will be taught to perform these procedures using the dhrt or the dhrt+ devices. the resident's performance will be measured and evaluated by these devices during the training. the technique of the training does not differ from what is currently taught at either of these institutions. in addition the residents will be required to pass the same skills assessment currently required at their institution. upon successfully passing the skills assessment the residents will perform cvc interventions on under supervision. during this supervision the attending will fill out a short survey about the residents performance. after the procedure the investigators will examine patient files to determine any changes in central line related complications and infection rates due to new clinical educational practices.


Eligibility criteria:
inclusion criteria: * patient undergoing central venous catheterization exclusion criteria: * patient that is not undergoing central venous catheterization
hysteroscopic tissue removal system versus bipolar resectoscopy for polypectomy: long-term results

Conditions: Endometrial Polyp

Summary: in this study, a comparison is made between two types of polyp resection methods (hysteroscopic tissue removal and bipolar resectoscopy). more specifically, the effects of the resection on symptoms such as abnormal uterine bleeding, and on the recurrence of polyps. the aim of the study is to find a superior method in terms of symptom relieve and polyp recurrence so this method can be used in gynaecological practice.

* rationale: several techniques for hysteroscopic removal of intrauterine polyps exist today. up until the first decade of this century, larger polyps were usually removed via bipolar resectoscopy. later, the hysteroscopic tissue removal system (morcellation) was introduced in which the abnormal tissue is mechanically removed, which is then immediately aspirated. previous studies comparing bipolar resection and morcellation show that this is an effective, fast, and safe method without major complications. however, the long-term results are still largely unknown. * research question/goal: to investigate the long-term results of the effectiveness of hysteroscopic removal of intrauterine polyps. bipolar resection and morcellation are compared here. * study design: this is a prospective cohort study. the patients previously participated in a randomized study (2011-2014) and will now be contacted again for the completion of a one-time questionnaire. the study has an observational design. * study population: women with a history of endometrial polyp that was previously removed via hysteroscopic morcellation in a previous study. * primary and secondary endpoints: the primary endpoint is the risk of recurrence of abnormal uterine bleeding at post-surgery follow-up. secondary endpoints include recurrence of other symptoms, time to recurrence, symptom relief, onset of new symptoms, onset of new polyp, satisfaction with regards to symptoms, satisfaction with regards to the treatment in general, need for additional treatments for blood loss and occurrence of pregnancy (in subfertility group).

Eligibility criteria:
inclusion criteria: * participation in earlier study exclusion criteria: * n/a
safety and tolerability of inhaled treprostinil in adult ph due to copd

Conditions: Pulmonary Hypertension; Chronic Obstructive Pulmonary Disease

Summary: this is a multicenter, single-arm trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (ph) associated with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: 1. diagnosis of who group 3 ph associated with copd 2. subjects are required to have a right heart catheterization (rhc) within one year prior to the first dose of study drug with the following parameters: 1. pulmonary vascular resistance (pvr) ≥ 4 wood units (wu) and 2. a left ventricular end diastolic pressure (lvedp) or pulmonary capillary wedge pressure (pcwp) of ≤ 12 mmhg if pvr ≥ 4 wu to \< 6.25 wu or ≤ 15 mmhg if pvr ≥ 6.25 wu and 3. a mean pulmonary arterial pressure (mpap) of ≥ 30 mmhg 3. clinical diagnosis of copd will be made using accepted global initiative for chronic obstructive lung disease (gold) diagnostic criteria, including baseline spirometry with the following documented parameters: 1. fev1 \< 65% predicted, and 2. fev1/ fvc \< 70 4. baseline 6mwd ≥ 100 meters exclusion criteria: 1. the subject has a diagnosis of pulmonary arterial hypertension (pah) or ph for reasons other than copd as outlined in inclusion criterion 3. this would include, but is not limited to, the concomitant presence of thromboembolic disease (acute or chronic), untreated or inadequately treated obstructive sleep apnea, connective tissue disease (including but not limited to systemic sclerosis/scleroderma, or systemic lupus erythematosus), sarcoidosis, interstitial lung disease,human immunodeficiency virus-1 infection, and other conditions under who group 1, 2, 4, and 5 classifications. 2. the subject has received any food and drug administration (fda)-approved medication for the treatment of pah (ie, prostacyclin, prostacyclin receptor agonist, endothelin receptor antagonist \[era\], phosphodiesterase type 5 inhibitor \[pde5-i\],or soluble guanylate cyclase \[sgc\] stimulator) within 60 days of the first dose of study drug, except for acute vasoreactivity testing. 3. the subject has evidence of clinically significant left-sided heart disease as defined by the following criteria per the most recent assessment: 1. left ventricular end diastolic pressure (lvedp) or pulmonary capillary wedge pressure (pcwp) \>15 mmhg (or \>12 mmhg if pulmonary vascular resistance \[pvr\] ≥4 to \<6.25 wu) 2. left ventricular ejection fraction \<40% as assessed by either angiography or echocardiography.

Keywords: treprostinil ph copd 6 minute walk test
a study of real-world treatment of adults with urothelial cancer in south korea and saudi arabia

Conditions: Metastatic Urothelial Cancer

Summary: cancer in the bladder lining (urothelial cancer) can be treated in many ways. one way is to directly attack cancer cells. enfortumab vedotin is a treatment that can do this. another way is to help the body's immune system find and attack cancer cells. avelumab is a treatment that can do this. both treatments were recently approved in some countries. doctors have standard clinical practice guidelines to help them treat people with cancer. this study is about collecting information on how adults with urothelial cancer are treated in standard clinical practice. the people in this study will have locally advanced or metastatic urothelial cancer. locally advanced means the cancer has spread to tissue close by. metastatic means the cancer has spread to other parts of the body. the goal of this study is to learn how people with urothelial cancer receive medical care in clinics in south korea and saudi arabia. the main goals are to learn more about the people receiving treatments, and the treatments they receive. this study is about collecting information only. the individual's doctor decides on treatment, not the study sponsor (astellas). information will be collected from the people's medical records. this will include 12 months before treatment starts, and during treatment. also, doctors will answer questions in interviews and surveys about how they care for people with urothelial cancer.


Eligibility criteria:
inclusion criteria: physician sample: * medical oncologist or urologist (medical oncologists only in saudi arabia. a minimum of 15 medical oncologists in south korea, increased where possible, with the remaining sample consisting of urologists) * personally responsible for treatment and management of la/muc patients * at least 50 percent of time spent in management of patients * see a minimum of 4 la/muc patients per month * accept all survey rules and requirements patient sample: * confirmed/physician assessed diagnosis of la/muc * patient is not currently enrolled in a clinical trial exclusion criteria: * patients currently enrolled in a clinical trial * patients participating in, or who have previously participated, in a clinical trial

Keywords: bladder cancer la/muc
contrast-enhanced mr imaging as a breast cancer screening in women at intermediate risk

Conditions: Breast Cancer

Summary: a multicenter randomized controlled trial to evaluate the performance of mri, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer. two surveillance programs will be compared. women will be randomly assigned with a 1:1 ratio to: 1. yearly two-view mammography (mx) and breast ultrasonography (us) or 2. yearly mri.

women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in italy are based on mammography every two years starting at age 50.women will be randomly assigned to yearly two-view mammography (mx) and breast ultrasonography (us) or to yearly mri.

Eligibility criteria:
inclusion criteria: * women aged 40-59 years with * cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). the lifetime cumulative risk of breast cancer will be computed using the ibis breast cancer risk evaluation tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. the evaluation of the composition of the mammary gland will be performed using the bi-rads classification. women with mammography in class 4 (i.e., \>75% of glandular component) will be eligible for randomization. * written informed consent exclusion criteria: * signs or symptoms of breast cancer at enrolment; * previous diagnosis of ductal carcinoma in situ or invasive breast cancer; * brca or p53 mutation carrier status; * general contraindications to mri (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent; * contraindications to any intravenous administration of contrast agent; * ongoing or planned pregnancy (for the duration of the study); * hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years * presence of breast implants; * previous diagnosis of cancer at any site; * life-threatening diseases; * mental disability precluding informed consent to participate

Keywords: breast cancer intermediate risk