Kornimate/medical-research-clean huggingface dataset:
safety, pharmacokinetics and antitumor activity of bgb-b167 alone and in combination with tislelizumab in participants with solid tumors in chinese participants

Conditions: Solid Tumors

Summary: this study will evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary antitumor activity of bgb-b167 monotherapy and in combination with tislelizumab (bgb-a317) in participants with select advanced solid tumors in chinese participants


Eligibility criteria:
inclusion criteria: * participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator * eastern cooperative oncology group (ecog) performance status ≤ 1 * adequate organ function as indicated by laboratory values during screening or ≤ 7 days before the first dose of study drug(s) * women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study * nonsterile men must be willing to use highly effective method of birth control for the duration of the study exclusion criteria: * active leptomeningeal disease or uncontrolled, untreated brain metastasis * active autoimmune diseases or history of autoimmune diseases that may relapse * any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent * history of severe hypersensitivity reactions to other monoclonal antibody products or their excipients * untreated chronic hepatitis b or chronic hepatitis b virus (hbv) carriers * known history of hiv infection.
intravitreal anti-vascular endothelial growth factor administration and its influence on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration

Conditions: Vitreomacular Interface

Summary: purpose: to assess the influence of intravitreal anti-vascular endothelial growth factor (anti-vegf) administration on vitreomacular interface- and retinal morphology in eyes with neovascular age-related macular degeneration (amd) and to identify morphological markers potentially influencing disease prognosis. methods: 43 patients (51 eyes) with treatment naïve neovascular amd subsequently treated with bevacizumab 1.25mg (in 0.05ml of solution) were monitored until month 12 of follow-up. following a loading dose of 3 monthly intravitreal anti-vegf injections, patients were treated as-needed \[pro re nata (prn)\]. functional and morphological changes were assessed using spectral domain optical coherence tomography (sd-oct).

this retrospective study included 43 treatment-naive patients (51 eyes) with neovascular amd over the course of 12 months. patients were treated with a loading dose of 3 initial monthly anti-vegf injections (bevacizumab 1.25mg in 0.05ml of solution-avastin®) and were followed monthly until year 1. re-treatment was performed if needed (pro re nata-prn) as previously reported.

Eligibility criteria:
inclusion criteria: - diagnosis of treatment-naive neovascular amd exclusion criteria: * any treatment with other anti-vegf agents than bevacizumab in the follow-up period * any other diseases leading to macular edema * prior vitrectomy * uveitis * retinal or corneal laser surgery * high myopia (\>6dpt) * preceding eye trauma
bradycare: advanced bradycardia device feature utilization and clinical outcomes

Conditions: Pacemaker

Summary: pacemaker technology is constantly evolving. in the past 10 years, numerous advancements have been made in pacemaker therapy, diagnostics and connectivity. these advancements include automated capture, automated sensing, patient alert functions, algorithms minimizing ventricular pacing, automatic mode switching in response to atrial tachyarrhythmia, rate responsive pacing, advanced diagnostic features, remote monitoring and radiofrequency (rf) technology. however, little information is available on how these new features are being utilized by physicians in the real world and how these features impact patient outcomes. this observational study will gather data on the patients' presenting clinical status, indication for device implantation, utilization of advanced device features, device therapy choices, clinical management and outcomes in a general pacemaker population. the primary aim of the study is to evaluate the usage of advanced features and diagnostics in patients with st. jude medical pacemakers. the secondary aim of the study is to learn more about the progressive clinical outcomes in the general pacemaker patient population. the tertiary aim of the study is to evaluate the correlation between the usage of advanced features in pacemaker patients and the patient's clinical outcomes.

evaluation of device features and diagnostics * programmed parameters: advanced pacemaker features (autocapture, auto sensitivity control (asc), ventricular intrinsic preference (vip®), patient notifier, rf telemetry, and newer advanced features) * device and lead measurements * number of at/af, vt/vf, pmt and ams episodes evaluation of clinical parameters * indication for device implantation * cardiac and arrhythmia history * cardiac drug utilization * cardiac events: incidence and onset of symptomatic atrial fibrillation (af), onset of heart failure (hf), incidence and onset of angina, occurrence of myocardial infarction (mi), occurrence of transient ischemic attack (tia)/ischemic stroke, and occurrence of hemorrhagic stroke * modified specific activity scale (sas) * intrinsic qrs duration * left ventricular ejection fraction (lvef) * adverse events * all-cause, cardiovascular and heart failure hospitalizations * all-cause, cardiovascular and heart failure mortality

Eligibility criteria:
inclusion criteria: * patient has a current indication for a single-chamber (sr) or dual-chamber (dr) pacemaker or crt-p device. * patient is implanted with an sjm accent™ sr/dr, accent™ sr/dr rf, anthem™ crt-p, anthem™ crt-p rf, or newer sjm pacemaker device. * patient is geographically stable and willing to comply with the required follow-up schedule. * patient is not pregnant or planning to become pregnant. * patient is \>18 years of age. exclusion criteria: * patient's life expectancy is less than 12 months.

Keywords: pacemaker advanced features clinical outcomes
a study of the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and mfolfirinox versus mfolfirinox alone in participants with resected pdac

Conditions: Adenocarcinoma, Pancreatic Ductal

Summary: the purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-fu), irinotecan, and oxaliplatin (mfolfirinox) versus mfolfirinox alone in participants with resected pancreatic ductal adenocarcinoma (pdac) who have not received prior systemic anti-cancer treatment for pdac and have no evidence of disease after surgery.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of pdac * pancreatic cancer tumor, lymph node, metastasis (tnm) pathological staging values of t1-t3, n0-n2, and m0 per the american joint committee on cancer (ajcc) cancer staging manual * macroscopically complete (r0 or r1) resection of pdac * unequivocal absence of disease after surgery as assessed by the investigator within 28 days prior to randomization * ca19-9 level measured within 14 days prior to initiation of study treatment * interval of between 6 and 12 weeks since resection of pdac * full recovery from surgery and ability to receive atezolizumab, autogene cevumeran, and mfolfirinox in the investigator's judgment * adequate hematologic and end-organ function * female participants of childbearing potential must be willing to avoid pregnancy during the treatment period and for 28 days after the final dose of autogene cevumeran, for 9 months after the last dose of chemotherapy, and for 5 months after the final dose of atezolizumab. they must refrain from donating eggs for 9 months after the last dose of chemotherapy. * male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use specified contraceptive methods during the treatment period and for 28 days after the final dose of autogene cevumeran and for 6 months after the last dose of chemotherapy. men must refrain from donating sperm during this same period. exclusion criteria: * prior adjuvant, neoadjuvant, or induction treatment for pancreatic cancer * plan for further adjuvant anti-cancer therapy for pdac (e.g., radiotherapy and/or chemotherapy), not mandated per protocol, to be initiated after completion of mfolfirinox treatment * absence of spleen; distal pancreatectomy with splenectomy is exclusionary * preexisting grade \>/=2 neuropathy * known complete dihydropyrimidine dehydrogenase (dpd) deficiency including homozygous or compound heterozygous mutations of dpyd genetic locus associated with dpd deficiency * disorders of the colon or rectum, or postoperative complication leading to grade \>/=2 diarrhea * pregnancy or breastfeeding * active or history of autoimmune disease or immune deficiency * treatment with brivudine, sorivudine, or their chemically-related analogues, which are inhibitors of dpd, within 4 weeks prior to initiation of study treatment * current or planned treatment with strong inhibitors or inducers of cytochrome p450 3a4 (cyp3a4) and/or uridine diphosphate glucoronosyltransferase 1a1 (ugt1a1).
development of dermatology-related quality of life assessment in patients treated with epidermal growth factor receptor (egfr) inhibitors

Conditions: Skin Toxicities

Summary: epidermal growth factor receptor inhibitors (egfri) are associated with skin toxicities. clinical experience suggests that skin toxicities interfere with health related quality of life (hrql) and may interfere with treatment adherence. no systematic investigations of egfri-associated dermatologic toxicities and impact on hrql have been reported. no patient-reported outcome measures exist to capture the unique concerns of oncology patients who experience egfri-associated dermatologic toxicities. the purpose of this study is to develop a patient-reported outcomes measure to assess dermatologic-related symptoms burden and health-related quality of life among patients receiving an egfri, and to develop a grading system for egfri-associated dermatologic toxicities.


Eligibility criteria:
inclusion criteria: * undergoing anti-egfr cancer therapy * over 18 years old exclusion criteria: * unable to complete the questionnaire * unable to follow instructions or give consent

Keywords: egfri hrql quality of life development of a standardized hrql instrument for anti-egfr therapy induced
evaluation of the h1-coil deep tms in the treatment of negative symptoms and cognitive deficit in schizophrenia

Conditions: Schizophrenia

Summary: the study evaluates the feasibility of using a 4 week stimulation protocol with the deep tms h-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients


Eligibility criteria:
inclusion criteria: * dsm iv diagnosis of schizophrenia * panns negative \> 21 exclusion criteria: * risk factors for convulsions * panns positive \> 24
a study to evaluate the effects of a prebiotic and probiotic supplement to provide relief from symptoms associated with bacterial vaginosis and yeast infections.

Conditions: Bacterial Vaginosis; Yeast Infection

Summary: this virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. the study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.


Eligibility criteria:
inclusion criteria: * women * age 25+ * self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor. * suffers from digestive issues, including bloating, gas, or other digestive discomfort. * generally healthy - do not live with any uncontrolled chronic diseases. * willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study. * if taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration. exclusion criteria: * any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * planning to undergo any procedure related to their vaginal health. * started any new medications or supplements that target vaginal health in the past 3 months. * anyone with known severe allergic reactions that require the use of an epi-pen, or any known allergies to any of the product ingredients * women who are pregnant, breastfeeding, or attempting to conceive * unwilling to follow the study protocol * anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.
a randomized controlled trial of the treatment of mallet fractures

Conditions: Mallet Fracture

Summary: intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as mallet fractures. treatment of mallet fractures remains controversial. although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. there are many different operative techniques, all with specific disadvantages. the investigators hypothesis is that operative treatment of mallet fractures with one meniscus arrow® has a better outcome than conservative treatment with a mallet splint.


Eligibility criteria:
inclusion criteria: * avulsion fracture involving more than 30% of articular surface exclusion criteria: * (sub)luxation of the distal phalanx * patients with a mallet fracture developed 3 weeks or more prior to presentation * patients with a mallet fracture with failure of conservative treatment
five-year outcomes of rapid-deployment aortic valve replacement with the edwards intuity tm valve

Conditions: Severe Aortic Valve Disease

Summary: objectives: this report presents 5-year outcomes of the rapid-deployment edwards intuity tm valve in a single-center prospective study. methods: all consecutive patients who underwent an aortic valve replacement with an edwards intuity tm bioprosthesis at la timone hospital, marseille, france, were prospectively included between july 2012 and june 2015 and were followed for 5 years. the primary outcome was overall mortality at 5 years.


Eligibility criteria:
inclusion criteria: * consecutive patients implanted by the intuity tm bioprosthesis * for severe aortic valve stenosis or severe aortic regurgitation * including reoperation and combined surgery * between july 2012 and june 2015 exclusion criteria: * absence of patient's authorization for anonymous publication of their clinical data for research purposes

Keywords: severe aortic stenosis severe aortic regurgitation
comparing between co2 phenylephrine and phenylephrine only treatment in patients with progressing cerebral infarction

Conditions: Acute Ischemic Stroke

Summary: progressing stroke is associated poor functional outcome and neurological deficit. currently, no treatment for progressing stroke is recommended on the guideline. carbogen is a mixture of 5% co2 with 95% o2. carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia. co2 dilate cerebral arteriole and concentration of co2 is correlated with cerebral blood flow. increased cerebral blood flow following dilation of cerebral arteriole by co2 might halt and revert progressing stroke. induced hypertension is alternative treatment of progressing stroke. increasing blood pressure also induce cerebral blood flow. phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart. several studies reported that the effectiveness of phenylephrine on progressing stroke. therefore, this study will compare the effectiveness of carbogen + phenyleprhine versus phenlyephrine in progressing stroke patients.


Eligibility criteria:
inclusion criteria: * age ≥20 years * anterior circulation progressing stroke * neurological worsening either 1 point in nihss score or mrc grade exclusion criteria: * age under 20 years. * patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator. * patients with moyamoya disease. * patients with severe cerebrovascular reactivity (cvr) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator. * patients unable to undergo co2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions). * patients with hypersensitivity to phenylephrine. * patients with persistent bradycardia (heart rate \< 50 bpm). * patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage. * patients with a pre-stroke modified rankin scale (mrs) score ≥ 2, indicating impaired functional independence. * patients ineligible for phenylephrine treatment due to any of the following: myocardial infarction or unstable angina within the past 3 months. cardiac ejection fraction \ 200 mmhg. serum creatinine \> 2 mg/dl. pregnancy. * use of monoamine oxidase (mao) inhibitors. * patients who do not consent to participate in the study.

Keywords: co2 carbogen phenylephrine lacunar infarction progressing stroke
endpoint calibration for a phase 2 study of lisinopril in multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: this study aims to calibrate the multiple sclerosis functional composite (msfc) for home implementation in a phase 2 trial of lisinopril in multiple sclerosis. in this initial stage, participants are required to travel to the study site one day a week for three weeks to complete the msfc. they are also required to complete the msfc at home once weekly for three weeks using remote sensing technology and video conferencing.


Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 18 and 64. 2. documented informed consent 3. documented diagnosis of rrms via 2010 mcdonald criteria 4. normal blood pressure at baseline: 90-140 mmhg systolic and 60-90 mmhg diastolic 5. baseline score of 0-5.5 on kurtzke's expanded disability status scale (edss) 6. availability of a person in the home who is physically able and willing to steady the subject if s/he loses balance during the walk test. exclusion criteria: 1. hypotensive at baseline: \<90 mmhg systolic or \<60 mmhg diastolic 2. hypertensive at baseline: \>140 mmhg systolic or \>90 mmhg diastolic 3. bradycardia at baseline: \< 50 bpm

Keywords: multiple sclerosis telemedicine remote monitoring lisinopril
evaluation of the nv-vpac1 prostate cancer (pca) urine diagnostic test in subjects with biopsy-confirmed prostate cancer, benign prostatic hypertrophy, or bladder/kidney stones.

Conditions: Prostate Cancer; Benign Prostatic Hypertrophy; Bladder Stones; Kidney Stones

Summary: this is a double-blind, study to evaluate the performance of nv-vpac1 pca urine diagnostic test in three distinct populations being treated at the intermountain urology clinic. the first population (positive control) is comprised of men with biopsy-confirmed pca who are scheduled for prostatectomy. the second population (negative control) is comprised of men with benign prostatic hypertrophy (bph) who are scheduled for transurethral resection of the prostate (turp). the third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.


Eligibility criteria:
subjects with prostate cancer inclusion criteria: * males 18-80 years of age * biopsy-confirmed prostate cancer * scheduled within 2 weeks for prostatectomy * signed informed consent exclusion criteria: * presence or history of another cancer diagnosis, with the exception of certain skin cancers * currently treated with finasteride (proscar®, propecia®), dutasteride (avodart®) or anti-androgen therapy (lupron®) * participated in a clinical study with an investigational drug within 2 weeks of the screening visit. subjects with benign prostatic hypertrophy inclusion criteria: * males 18-80 years of age * diagnosis of bph made by clinical symptoms (e.g., enlarged prostate, dribbling urine stream, frequent and urgent urination) * scheduled within 2 weeks for turp * signed informed consent exclusion criteria: * presence or history of any cancer diagnosis, with the exception of certain skin cancers * currently treated with finasteride (proscar®, propecia®) or dutasteride (avodart®) * participated in a clinical study with an investigational drug within 2 weeks of the screening visit. subjects with bladder/kidney stones inclusion criteria: * males or females 18-80 years of age * diagnosed with bladder/kidney stones * scheduled within 2 weeks for cystoscopy * signed informed consent exclusion criteria: * presence or history of any cancer diagnosis, with the exception of certain skin cancers * participated in a clinical study with an investigational drug within 2 weeks of the screening visit.

Keywords: nv-vpac1 prostate cancer urine diagnostic test
surgical treatment of long bone metastases

Conditions: Bone Metastases; Surgery

Summary: to provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

the objectives of this study were to examine clinical outcomes after reconstruction with intramedullary fixation (imn) or endoprosthetic reconstruction (epr) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the musculoskeletal tumor society system (msts); (4) differences in complication rate between patients treated with inm versus epr; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.

Eligibility criteria:
inclusion criteria: * bone metastases of the extremity exclusion criteria: * bone metastases of the spine