Kornimate/medical-research-clean huggingface dataset:
anti-pd-1 antibody plus deb-tace for bclc stage a/b hcc

Conditions: Hepatocellular Carcinoma

Summary: this study aimed to evaluate the efficacy and the safety of the anti-programmed-death-1 antibody (anti-pd-1) sintilimab injection in combination with transarterial chemoembolization with drug-eluting beads(tace-deb) in patients with bclc stage a/b hepatocellular carcinoma beyond the milan criteria.

patients with hepatocellular carcinoma (hcc) of bclc stage a/b exceeding the milan criteria have a low resection rate and high postoperative recurrence rate, therefore, optimizing therapy for these patients is an important unmet need. this study aimed to investigate the efficacy and safety of preoperative deb-tace plus sintilimab for the treatment of patients with bclc stage a/b hcc exceeding the milan criteria.

Eligibility criteria:
inclusion criteria 1. age between 18 years and 75 years; 2. ecog ps 0/1; 3. patients with histologically- or clinically-confirmed hcc (based on the american association for the study of liver diseases criteria) that was either bclc stage a and exceeded the milan criteria, or bclc stage b 4. have not received any anti-tumor systemic treatment in the past 5. no contraindications for the treatment of deb-tace and pd-1 inhibitors; 6. liver function: child-pugh score class a 7. the expected survival of the patient is more than 3 months 8. the following conditions must be met: platelets ≥ 75 × 10\^9/l white blood cell count (wbc) ≥ 3.0 × 10\^9/l hemoglobin ≥ 90 g/l aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5 × upper limit of normal (uln); total bilirubin (tbil) ≤ 1.5 × uln blood creatinine ≤ 1.5 × uln pt prolonged ≤ 3 s 9. adequate bone marrow, cardiac, and renal function 10. patients must agree to accept postoperative follow-up required by the design of this study; 11. patients must have the ability to understand and voluntarily sign the informed consent, and must sign an informed consent before starting any specific procedure for the study. exclusion criteria 1. history of other malignancies； 2. in combined with severe heart, lung, kidney or other important organ dysfunction, or combined with serious infection or other serious associated diseases, that cannot tolerate treatment (\> ctcae version 5.0 adverse events of grade 2)； 3. with uncontrolled hepatitis b (hbv-dna\>2000 iu/ml and elevated alt). 4. spontaneous rupture and bleeding of hcc 5. hepatic tumor burden \>50% total liver volume 6. complete occlusion of the portal vein 7. evidence of a bleeding diathesis or coagulopathy, active infections, and autoimmune disease 8. recurrent disease after surgery within the last 5 years 9. history of organ transplantation or plan to have liver transplantation; 10. pregnant women, nursing mothers. 11. patients have other factors that may interfere with patient enrollment and assessment results. 12. refuse follow-up as required by this study protocol and refuse to sign informed consent.

Keywords: hepatocellular carcinoma transarterial chemoembolization immunotherapy
rectal reconstruction in treating patients who are undergoing surgery for rectal cancer

Conditions: Colorectal Cancer

Summary: rationale: rectal reconstruction after surgery to treat rectal cancer may help patients keep some of their bowel function. it is not yet known which method of rectal reconstruction is most effective after surgery. purpose: this randomized phase iii trial is studying three different methods of rectal reconstruction to compare how well they work in treating patients who are undergoing surgery for rectal cancer.

this is a randomized, multicenter study. patients are stratified according to participating center, gender, distance of the distal tumor margin from the dentate line (\> 5 cm vs ≤ 5 cm), age (\< 70 vs ≥ 70), neoadjuvant chemoradiotherapy (yes vs no), and distant metastasis (m0 vs m1). patients are randomized to 1 of 3 treatment arms.

Eligibility criteria:
* histologically proven rectal adenocarcinoma or rectal adenoma with/without neoadjuvant radiochemotherapy * total mesorectal excision needed * age ≥ 18 years * clinically normal function of the sphincter muscles (no history of frequent fecal incontinence for liquid or solid stools) * any t, any n, any m or adenoma * an r0-resection is expected (liver metastases planned to be simultaneously * written informed consent, signed and dated by the patient and the investigator * completed baseline quality of life questionnaire exclusion criteria: * rectal tumor other than adenocarcinoma or adenoma * previous rectal cancer surgery, other than local excision within the last 2 months * histologically proven chronic inflammatory bowel disease * contraindications to any of the 3 surgical techniques * bmi \> 35 * patients with psychiatric, addictive or any disorder that would prohibit the understanding and giving of informed consent, completing the ql questionnaires and/or following the structured interview * inability to read and understand any of the languages available on the ql questionnaires,and spoken during the interview (german, french, italian)

Keywords: adenocarcinoma of the rectum stage 0 rectal cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent rectal cancer
reducing suicide risk in adolescents and young adults via a psychobehavioral intervention to regularize daily rhythms

Conditions: Bipolar Disorder; Major Depressive Disorder; Mood Disorders; Suicide; Suicidal Ideation

Summary: the purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. the investigators aim to achieve this with this study of brain emotion circuitry self-monitoring and regulation therapy for daily rhythms (be-smart-dr), that provides self-directed strategies to regularize sleep and other drs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.

this is a randomized control trial (rct) with subjects randomized 2:1 (using block randomization) to be-smart-dr or a psychoeducational control comparator condition (cc). participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (mri) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (ema). subjects will participate in 12 weekly sessions and 6-month in person follow-up. objectives 1. show pre-post be-smart-dr suicidal ideation and propensity (si/p) decreases associated with dr regularity and quality increases 2. show pre-post be-smart-dr improvements in the functioning of a brain system that subserves emotional and other behavioral control (i.e., a hypothalamus-amygdala-ventral prefrontal cortex (vpfc), (hav), system)

Eligibility criteria:
inclusion criteria: * with diagnostic and statistical manual 5 (dsm5) bipolar disorder (bd) i, ii or otherwise specified (os) or major depressive disorder (mdd) * have a history of 1 or more suicide attempts and/or a score of at least 3 on the ssi exclusion criteria: * significant medical or neurologic illness (especially if related to cerebral tissue) * mri contraindication, * pregnancy by urine test * current moderate or severe alcohol/other substance use disorders except caffeine/nicotine * positive urine screen for benzodiazepines, cocaine, amphetamines, phencyclidine, opiates, oxycodone; not cannabis as its use is common in this population and it can remain positive for a month * current evidence-based individual psychotherapy (e.g. cognitive behavioral therapy, dialectical behavioral therapy,) or treatment directly targeting brain regions of interest e.g. transcranial magnetic stimulation or electro-convulsive therapy, * current psychosis * inability to provide informed consent, including iq\ 25, or too symptomatic by pi's judgment * active suicidal plan or intent or columbia suicide severity rating scale (c-ssrs) stage "4" risk (some intent to carry out the plan; as indicated by multisite study assessing suicide risk in randomized clinical trials or if revealed on any rating scale or in judgment of any study clinician. * homicidal ideation
empathy in post-traumatic stress disorder in comparaison to a control population

Conditions: Mental Disorder; Post-traumatic Stress Disorder; Empathy

Summary: it has been shown in the literature that the symptoms of post-traumatic stress disorder influence the quality of life of patients, in particular through the cognitive alterations they can cause. social cognition is also itself impacted. it refers to the perception, interpretation and processing of information relating to the social environment and relationships. it is affected by the symptomatology of ptsd both in terms of the response to emotional stimuli, the perception of self and others, and the quality of intimate relationships. these elements lead to reflection on the origin of these alterations, in particular the impact of ptsd on the patient's empathy capacity, defined as the recognition and understanding of the feelings and emotions of another individual. this parameter is also little studied in the literature, only a study dating from 2010 finds a correlation between ptsd and empathy. it is in this context that the realization of a new study studying the capacity for empathy of patients with ptsd in comparison with a control group with a larger and more representative population was envisaged. the primary outcome of this study is to analyze the post-traumatic stress disorder's repercussions on empathy by passing the interpersonal reactivity index (iri) on patients in comparison with a control group. the first hypothesis is a lower total score but a higher personal distress sub-score in the ptsd population. the secondary outcomes are to describe the cofactors that can influence empathy in association or not with post-traumatic stress disorder: sociodemographic data (age, sex, education level...), traumatic event type determined through the "inventory of traumatogenic events", human intervention, duration and severity of the disorder (evaluated by the impact of events scale) ... the number of subjects required was calculated at 19 patients and 19 controls.


Eligibility criteria:
any patient or controls who score positively off the diagnostic criteria for comorbidities such as major depressive episode, generalized anxiety disorder, psychotic disorder and autism spectrum disorder are not included. these criteria will be assessed through the mini diagnostic interview and the autism spectrum quotient.
wear experience with daily toric contact lenses over a long day

Conditions: Contact Lens; Astigmatism of Both Eyes

Summary: this study is evaluating the wear experience of a daily toric contact lens after 10, 12, 14, and 16 hours of lens wear.


Eligibility criteria:
inclusion criteria: * must be current soft toric contact lens wearers with longs days of lens wear within the parameters of precision1® lenses available. * distance visual acuity of 20/25 or better with current lenses. * recent eye exam in the last year. * good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi). * ability to give informed consent. * must have a working smart phone or device and be willing to receive and respond to texts and/or emails. * willing to spend time for the study, which includes three in-person study visits (with a possible fourth visit if needed), wearing contact lenses on days between study visits, and responding to communications on a smart phone or other electronic device on five weekdays between visits 2 and 3. exclusion criteria: * current ocular inflammation or infection as assessed by the study investigator. * currently pregnant, lactating, or planning to become pregnant during the course of the study.

Keywords: toric contact lens daily contact lens
effects of left ventricular pacing optimilization on cardiac perfusion, contractile force, and clinical performance in patients with ventricular dysfunction and heart failure

Conditions: Left Ventricular Dysfunction; Heart Failure

Summary: to compare a surgical approach of lv lead placement for biv pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.


Eligibility criteria:
inclusion criteria: * heart failure nyha iii or iv * qrs duration \>120msec or, when paced \> 200msec on 12-lead ecg * lbbb on ecg * lv ejection fraction 35% or less * lv dyssynchony on echocardiography exclusion criteria: * severe (drug refractory) heart failure with short (\<6 months) life expectancy. * permanent or persistent atrial fibrillation * other indications for cardiac surgery within 6 months * life expectancy less than one year due to other conditions * major contra-indication for general anaesthesia * participation in another study * pregnancy or the desire to become pregnant during the follow up of the study.

Keywords: cardiac resynchronisation therapy epicardial lead coronary sinus
mri gadopiclenol enhanced imaging of cns tumors

Conditions: Image

Summary: the purpose of this pilot study is to compare a standard of care mri scan to a non-standard of care mr imaging with portable (0.064 tesla) mri following the administration of non-soc contrast called gadopiclenol on 10 subjects with known brain tumors. participants will be randomized to receive either standard mri or portable mri first following contrast injection

this study compares a routine mri scan with a new portable mri scanner known as the "hyperfine" using a contrast dye called gadopiclenol, the contrast is fda approved. if participants choose to participate in this study, they will receive two mri scans on the same day. one on the traditional standard of care mri scanner and the other on the new portable hyperfine mri. the hyperfine mri scanner is not fda approved due to being a very low risk medical device. however, the device is compliant with all of the fda requirements regarding design control regulations and risk analysis. participants will only receive one contrast injection that will be used for both scans. the selection of which scan is given first will be randomly selected (50/50 chance). participation in this study will last two days. the first day participants will receive both mri scans and the second day participants will receive a phone call from the research staff to check on them.

Eligibility criteria:
inclusion criteria * female or male adult patient (18 years and older). * patient presenting, at the time of inclusion, with known or highly suspected focal areas of disrupted blood brain barrier (bbb) due to primary or secondary tumor/s. this lesion must have been detected on a previous imaging procedure (computerized tomography (ct) or mri). * patient scheduled for a routine cns contrast-enhanced mri examination for clinical reasons. * patient able and willing to participate in the study. * patient with health insurance. exclusion criteria * patient presenting with acute or chronic grade iii (at least) renal insufficiency, defined as an estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m² based on egfr assessment on the day of each mri. * pregnant or breast-feeding female patient (a female patient of childbearing potential must be using a medically approved contraception method until the last study visit). * patient with any contraindication to mri examinations including active implants, passive implants which are mri incompatible, and metallic foreign bodies. * patient with known contra-indication(s) to the use or with known sensitivity to any gbca. * patient having received any contrast agent (mri or ct) within 3 days prior to study gadopiclenol administration

Keywords: mri radiology
genetic architecture of plasma t-pa and pai-1

Conditions: Cardiovascular Diseases; Heart Diseases; Thrombosis; Atherosclerosis

Summary: to determine the effects of six genes on thrombotic risk factors known to be associated with the development of heart disease.

background: abnormalities in the plasminogen activator system have been implicated in the pathogenesis of arterial and cerebral thrombosis. in particular, elevated plasma levels of plasminogen activator inhibitor-1 (pai-1), tissue-type plasminogen activator (t-pa), and t-pa/pai-1 complexes have been found to correlate with increased risk of myocardial infarction (mi) and/or stroke. vascular fibrinolytic balance is, to a large part, determined by the competing effects of t-pa and pai-1, and reflects a complex interplay between genetic and environmental factors. the present collaboration focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (raas) and atherothrombotic events derives from an interaction between the raas and the fibrinolytic system. the study is part of an initiative "thrombosis of the arterial and cerebral vasculature: new molecular genetic concepts for prevention and treatment" which was released in april 1999. the objective of the initiative is to establish collaborative teams of closely interacting investigators with diverse, complementary areas of expertise to elucidate the molecular genetic mechanisms of thrombosis in the arterial and cerebral vasculature. design narrative: the investigators will use two population-based samples of unrelated individuals to address their aims: 1) study subjects in the prevend study in groningen, the netherlands in whom dna and plasma samples and clinical data have already been collected and 2) an estimated 2000 unrelated study subjects from ghana, africa in whom data need to be collected. the collaborative study focuses on the common hypothesis that the association between activation of the renin-angiotensin-aldosterone system (raas) and atherothrombotic events derives from an interaction between the raas and the fibrinolytic system.

Eligibility criteria:
no eligibility criteria
comparison of user experience with wheelsoft wheels intalled on a wheelchair compared with normal wheels.

Conditions: Back Pain; Personal Satisfaction; Fatigue

Summary: two groups of randomised rehabilitation patients will try a softwheels wheelchair and a regular one. one group will start with the softwheelsl and then change to the regular, and the other will start with the regular and then change to the softwheel.

the patients who are received to the rehabilitation ward and are confined to the use of a wheelchair are randomized to two groups. the first are given a wheelchair with wheelsoft wheels and the second group with regular wheels. the wheels of the chair are all covered to look similar to regular wheels (the regular wheels are also covered). all the patients will be taken once a day to a 10 minute trip with the wheelchair. after two days a questionnaire regarding their experience with the chair will be passed. on the third day the groups will change their wheels to the other kind. and again taken to daily trips and a final questionnaire on day four. we will collect additional data from the patients: age, sex, medical record, weight, height, ethnic background, marital status, working status.

Eligibility criteria:
inclusion criteria: * wheelchair bound for at least 4 days exclusion criteria: * not able to answer verbal questions * over 95 kg of weight (wheel limit)
pacific northwest udall center (panuc) clinical core

Conditions: Parkinson Disease; Cognitive Impairment

Summary: this study evaluates cognitive impairment in subjects with parkinson disease (pd) and similar neurological disorder through obtaining longitudinal clinical and neuropsychological data. the long term goal is to have a well-characterized subject population to contribute to our understanding of the natural history, diagnosis and ultimate treatment of cognitive impairment in patients with pd and similar disorders.

the pacific northwest udall center (panuc) clinical core has recruited and characterized a cohort of more than 600 individuals with parkinson's disease (pd) during the initial funding period. data from the panuc clinical core, in collaboration with other udall centers and other academic medical centers, have helped confirm apolipoprotein e (apoe) (1) and glucocerebrosidase (glucosidase, beta, acid or gba) (2)as genes that increase the risk and modify the phenotype (1) of cognitive decline in pd. understanding the mechanisms underlying these gene effects is the focus of this renewal application, and the clinical core will provide well-characterized pd and control subjects of appropriate genotypes for panuc projects. in addition, the majority of the existing cohort will be retained for additional longitudinal clinical and neuropsychological testing follow-up to support ongoing genetic and biomarker studies, with a refined battery of tests and a uniform biannual frequency of visits designed to maximize efficiency. balance and gait testing (already piloted at the portland site) will be added to the test battery for the entire cohort as an innovation that is thought to reflect higher order cns function closely related to cognition. this innovation leverages the expertise of dr. horak, an investigator introduced to the panuc by way of panuc pilot award funding during the last funding period. as in the current cycle, clinical core subjects will be followed in identical fashion at two sites: one at uw directed by dr. hu, and the other at ohsu directed by core leader dr. quinn. project 3 leader dr. horak will oversee balance and gait testing at ohsu and dr. kelly will oversee balance and gait testing at uw.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson disease * over 18 years of age exclusion criteria: - under 18 years of age
liberal transfusion strategy in elderly patients

Conditions: Transfusion-dependent Anemia; Surgery; Anemia

Summary: in this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a rbc unit each time hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single rbc unit each time hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage iii, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.


Eligibility criteria:
inclusion criteria: * patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered * registered patients will be randomised only if they indeed develop severe anaemia (if hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery exclusion criteria: * preoperative hb level ≤ 9 g/dl * chronic kidney disease requiring dialysis * suspected lack of compliance with follow-up procedures * participation in other interventional trials * expected death within 3 months * inability to provide informed consent with absence of a legally authorised representative/ legal guardian * temporary inability to provide informed consent * previous participation in our trial * patients who are prevented from having blood and blood products according to a system of beliefs (e.g. jehovah's witnesses) * preoperative autologous blood donation.