Kornimate/medical-research-clean huggingface dataset:
axitinib as second-line treatment for advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this is a phase ii study of axitinib as the second-line on the treatment of advanced hepatocellular carcinoma (hcc). the purpose of this study is a proof-of-concept study to see if axitinib has any anti-tumor effect in hcc. the primary endpoint is disease stabilization that lasts for at least 8 weeks without progression of tumor-related symptoms.

axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways. promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma, thyroid cancer, and melanoma. the potent anti-angiogenic activity of axitinib makes it a promising agent for the treatment of hcc. this is a single-arm, open-label phase ii trial. eligible patients will receive axitinib, starting at 5 mg orally twice daily in the fasting status, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation. dose titration will be done according to the severity of adverse events.

Eligibility criteria:
inclusion criteria: * histologically diagnosed hcc, or clinically diagnosed hcc * inoperable tumor(s) and no applicable curative therapy. not amenable to loco-regional therapy * documented progression with or intolerance to sorafenib treatment as first- line therapy for advanced hcc * at least one measurable tumor, according to recist version 1.1, that has not been treated with any local procedure * ecog performance status 0 or 1 * life expectancy is at least 2 months * child-pugh class a liver function. exclusion criteria: * systemic therapy other than sorafenib as first-line therapy for advanced hcc * history of hcc tumor rupture * presence of brain or leptomeningeal metastases * esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding * history of upper gastrointestinal bleeding within 1 year * major systemic diseases that the investigator considers inappropriate for participation * uncontrollable hypertension * proteinuria * current use or anticipated need for treatment with potent cyp3a4 inhibitor, cyp3a4 or cyp1a2 inducers * requirement of anticoagulant therapy with oral vitamin k antagonists * dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol * other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study

Keywords: hcc
effect of brivaracetam (brv) on nonpsychotic behavioral side effects in subjects treated previously with levetiracetam (lev)

Conditions: Epilepsy

Summary: trial n01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with epilepsy who switched to brv 200 mg/day after discontinuing lev due to such side effects; as well as the efficacy, safety and tolerability of brv. no statistical hypothesis testing will be performed.


Eligibility criteria:
inclusion criteria: * subject with well-characterized epilepsy according to the 1989 international league against epilepsy (ilae) classification * subject with epilepsy who the investigator expects will benefit from levetiracetam (lev) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of lev * subject is currently receiving lev at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day) * subject currently treated with minimum 2 and maximum 3 anti-epileptic drugs (aeds) including lev. vagal nerve stimulation (vns) is allowed and will be counted as a concomitant aed * female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method exclusion criteria: * subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("yes") to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at visit 1 * subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries) * subject has history or presence of status epilepticus during the year preceding visit 1 or during baseline * subject has history or presence of known psychogenic nonepileptic seizures * subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol * subject is pregnant or lactating

Keywords: brivaracetam levetiracetam epilepsy nonpsychotic behavior
study of the effects of farnesoid x receptor (fxr) ligands on the reactivation of latent provirus

Conditions: Hiv

Summary: the farnesoid x receptor (fxr) is a nuclear receptor that controls the transcription of many genes involved in lipid and glucose metabolism. a recent study opens the hypothesis that farnesoid x receptor also participates in deoxyribonucleic acid repair mechanisms and possibly in the fight against cell invasion by foreign genomes. this hypothesis implied that modulation of farnesoid x receptor by ligands could modify human immunodeficiency virus replication. the results of in vitro studies with human immunodeficiency virus-infected cell lines indicate that indeed the modulation of farnesoid x receptor activity by its ligands induces stimulation of virus production rapidly followed by cell death; the overall effect is therefore antiviral. farnesoid x receptor ligands have also shown an effect on the reactivation of proviruses in cellular models of viral latency studies. this last data raises the hope of being able to intervene on the reservoir of human immunodeficiency virus. it is therefore crucial to confirm on quiescent cd4 + t lymphocytes of patients whose viral load is controlled by antiretroviral treatment combining several antiretrovirals the results obtained with the in vitro models. providing proof of concept that farnesoid x receptor agonists can reactivate latent proviruses will open new therapeutic perspectives for attacking the human immunodeficiency virus reservoir with a view to achieving a functional cure for acquired immune deficiency syndrome. the objective of the study is to confirm ex vivo the data obtained in vitro with cellular models and laboratory viral strains. it is therefore necessary to show that farnesoid x receptor agonists can reactivate latent viruses or proviruses present in quiescent cd4 + t circulating lymphocytes prepared from venous blood of hiv-positive patients under cart. human immunodeficiency virus-positive patients will be any patients, irrespective of the viral genotype, who initiated antiretroviral therapy, regardless of the combination of antiretrovirals, away from primary infection, when they already had a complete western blot, indicating an evolution of the infection without treatment and constitution of an already evolved reservoir. patients will have had an undetectable viral load since initiation of treatment with a follow-up of at least one year and will have at least 500 cd4 + t lymphocytes / mm3.


Eligibility criteria:
inclusion criteria: * human immunodeficiency virus infected patients * t cd4 \> 500/mm3. viral load undetectable for more than a year under stable treatment. no history of virological failure. * under first line cart treatment * indetectable viral load exclusion criteria: * acute or chronic anemias.- * acute infections, fever * vaccination in the two months preceding inclusion.
multimodal brain monitoring as a prognostic tool for intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: to verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. secondary goals: to describe multimodal neuromonitoring parameters variation in the first seven days of ich and identify any trends.


Eligibility criteria:
inclusion criteria: * spontaneous intracerebral hemorrhage * icu admission in the first 24hours * need for intraparenchymal neuromonitoring * over 18 years old exclusion criteria: * tumour, trauma or known vascular lesion * pregnancy
prevalence of chronic abdominal pain in migraneurs

Conditions: Migraine; IBD

Summary: to collect data on the prevalence of chronic abdominal pain in migraneurs in germany


Eligibility criteria:
inclusion criteria: * chronic abdominal pain * migraine exclusion criteria: * not able to sign written informed consent
the dante trial. a randomized study on lung cancer screening with low-dose spiral computed tomography

Conditions: Lung Cancer

Summary: high survival rates have been reported for screen-detected stage i lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. dante is a prospective randomized controlled trial exploring the effects of screening with ldct on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. the prevalence of a set of biomarkers in sputum and blood samples is also being determined.


Eligibility criteria:
inclusion criteria: * male sex * age 60-74 years * smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years) exclusion criteria: * severe cardiopathy * advanced bpco with chronic hypoxaemia (rest sato2 \< 94%) * chronic severe renal insufficiency * hypertension not controlled with drugs * type 2 diabetes or other severe systemic disease * severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient). * severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker * dementia, psychosis, severe depression or maniac-depressive syndrome * actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, n0, recovered from more than 10 years or other tumors recovered from more than 10 years * transplantation less than 5 years or with rejection episodes in the last 2 years * unable subjects

Keywords: lung neoplasms early diagnosis screening spiral computed tomography randomized controlled trial
bone health of people with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: people with cystic fibrosis (cf) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. this study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography \[p-qct\] and bone sonometer). we will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with cf.

a total of 100 subjects with cf and pancreatic insufficiency (8-25 y, half female) will be recruited from the children's hospital of philadelphia (chop) and the delaware valley region. all subjects will have baseline measurements obtained at the nutrition and growth lab at chop. a subset of subjects will return for 12-month follow-up measurements. we will evaluate the influences on bone health, including: gender, stage of pubertal development, body weight and height, food intake (especially calcium and vitamin d), use of steroid medications by mouth, iv administration or inhalation, physical activity and lung health. we will also follow the changes in bone health and growth over 12 months, and see what factors are associated with good and poor bone development. in addition, the information from this study will be very important to planning the future trials of medication and other interventions to treat and, hopefully, to prevent poor bone health in people with cf.

Eligibility criteria:
inclusion: * diagnosis of cystic fibrosis with pancreatic insufficiency * fev-1 ? 40% predicted
sitagliptin therapy to improve outcomes after islet autotransplant

Conditions: Pancreatitis; Diabetes

Summary: the purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.

at the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or glp-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). glp-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells. the primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.

Eligibility criteria:
inclusion criteria: * age ≥18 years * scheduled for total pancreatectomy and iat at um exclusion criteria: * pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl * medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids) * significant renal disease: serum creatinine levels of \>3.0 mg/dl in men and \>2.5 mg/dl in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis. * for female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months. * islet yield \<1,000 ie/kg body weight (exclusion for treatment with drug/placebo)

Keywords: pancreatitis pancreatectomy islet autotransplant sitagliptin diabetes
linking optic nerve mri and the retinal axonal loss after optic neuritis

Conditions: Optic Neuritis

Summary: this study evaluates the length of optic nerve lesion on 3d-dir sequence as an imaging biomarker predictive of retinal axonal loss and visual disability, 12 months after the occurence of a first clinical episode of optic neuritis.

neurologists and neuro-ophthalmologists are in need for reliable and robust imaging biomarkers enabling to predict retinal axonal loss and visual disability after clinical episode of optic neuritis (on). length of optic nerve lesion measured on mri may be one of them. the aim of our study is to measure the association between the extent of inflammatory demyelinating process on optic nerve at the acute of on and the retinal degenerative process following optic nerve injury. the investigators planned to include 50 patients suffering from a recent clinical episode of on. extent of demyelinating inflammatory process will be assessed by the length of optic nerve double inversion recovery (dir) hypersignal at the acute phase of on. the axonal degenerative process following optic nerve demyelinating injury will be assessed by retinal atrophy measured on optical coherence tomography at 12 months after on, by visual disability measured on low vision contrast acuity scale and by microstructural quality analysis of optic nerve measured on diffusion tensor imaging sequence of the optic nerve.

Eligibility criteria:
inclusion criteria: * patient suffering from an acute clinical episode of optic neuritis (on) confirmed by neurophthalmological examination * \< 2 months between start of acute episode of on and inclusion exclusion criteria: * past history of homolateral episode of on * retinal diseases * diabeta mellitus * pregnancy

Keywords: optic neuritis dir visual disability cis multiple sclerosis nmosd
a continuation trial for subjects with systemic lupus erythematosus that have completed protocol lbsl02

Conditions: Systemic Lupus Erythematosus

Summary: this is a continuation study to evaluate the long-term safety and efficacy of lymphostat-b™ in subjects with sle disease, that completed study lbsl02 and benefitted from treatment.

the purpose of this continuation study to evaluate the long-term safety and efficacy of lymphostat-b™ in subjects with systemic lupus erythematosus (sle), that completed study lbsl02 and benefitted from treatment.

Eligibility criteria:
primary inclusion criteria 1. have completed the lbsl02 trial and achieved a satisfactory response. primary exclusion criteria 1. required more than 2 courses of corticosteroids for treatment of severe sle flares in the last 5 months of lbsl02. 2. had an sle flare during the last 30 days of lbsl02 and through the 1st dose in lbsl99. 3. used any of the following prohibited medications during their participation in lbsl02: * other investigational agents. * biologic therapeutic agents: adalimumab (humira™), etanercept (enbrel™), infliximab (remicade™), and rituximab (rituxan™). * intravenous cyclophosphamide. * corticosteroids \>100 mg/day prednisone equivalent for reasons other than severe sle flare.

Keywords: sle lupus
improving diabetes care through effective personalized patient portal interactions

Conditions: Diabetes Mellitus

Summary: patient-facing ehealth technologies, such as online patient portals, connect patients with the healthcare system, help them access their health information, and support self-management of health conditions. this study tested an intervention to improve adoption and use of the my healthevet patient portal for diabetes management.

the goal of this small scale study is to test the feasibility of engaging veterans in a supported adoption intervention to promote effective patient portal use in a sample of veterans with uncontrolled type ii diabetes. participants were eligible for recruitment if they were veterans age 18-85 who were actively receiving care at one of the study sites (as determined by having an upcoming scheduled appointment), had uncontrolled glucose (hba1c \>= 8.5%), and had either never used the va patient portal or were inactive registrants who have not used the patient portal in the past 12 months. participants who met these conditions and did not opt out of the study were randomized to one of four arms: 1) encouragement i (brochure + mailed training guide), 2) encouragement ii (brochure + mailed training guide + invitation to group training), 3) encouragement iii (brochure + mailed training guide + invitation to group and one-on-one training), and 4) comparison (standard patient portal enrollment brochure only). all arms received the standard my healthevet patient portal enrollment brochure along with an invitation to participate in the study. those randomized to any of the encouragement arms received a mailed training guide. the my healthevet training guide for veterans living with diabetes was designed in conjunction with veteran co-investigators based on feedback from patients living with diabetes who were my healthevet users. it provided step by step guidance on how to use the features veterans living with diabetes find most helpful with specific examples of use for diabetes self-management. those in encouragement arm ii were also invited to attend one of several group training sessions. those in encouragement iii were invited to schedule a one-on one session to learn how to use the patient portal. those in the comparison condition were asked during their interview if they would like a training guide mailed to them at the end of the trial, and those interested were mailed a training guide.

Eligibility criteria:
inclusion criteria: * veterans * hemoglobin a1c result \>=8.5% at most recent lab test prior to recruitment * non use of the va patient portal, defined by not being registered or registered with no activity in 12 months * currently being seen at one of the sites participating in the study (upcoming appointment scheduled) exclusion criteria: * non-veterans * controlled hemoglobin a1c levels (a1c\<8.5%) at most recent lab test prior to recruitment * recent use of the patient portal

Keywords: diabetes mellitus personal health records patient outcome assessment mental health
psma pet additive value for prostate cancer diagnosis in men with negative/equivocal mri

Conditions: Prostate Cancer

Summary: this clinical trial will evaluate psma pet additive value for significant prostate cancer (spca) diagnosis in men with negative/equivocal mri

this open label, phase iii, multi-centre, randomised trial with a non-inferiority objective will evaluate the additive diagnostic value of psma pet for men with negative/equivocal mri in the diagnosis of significant prostate cancer. patients with a clinical suspicion of prostate cancer with pi-rads 2 or 3 on mri, meeting all the inclusion and none of the exclusion criteria will be randomised into experimental and control arms. patients in the experimental arm would be subjected to pelvic psma pet/ct, wherein the psma negative patients would not undergo biopsy as opposed to psma positive patients who will be subjected to transperineal targeted prostate biopsy. whereas patients in the control arm will only receive standard of care (soc) with no additional imaging (psma pet) and will undergo transperineal template prostate biopsy. the co-primary objectives are to assess (1) the percentage of men with spca in the experimental arm (transperineal targeted biopsy) compared to the control arm (transperineal template biopsy) defined as the presence of a single biopsy core indicating disease gleason score (gs) 3+4(\>10%)=7, grade group (gg) 2, and (2) the percentage of men who avoid transperineal prostate biopsy between both arms. the secondary objectives include determining the percentage of clinically insignificant pca on targeted biopsy (experimental arm) versus transperineal template biopsy (control arm); estimating the difference in complications from transperineal prostate biopsy between both arms; the health economics impact between the experimental and control arms; estimating the mean difference between both arms in change from baseline in health-related quality of life (qol); estimating the mean difference between both arms at each time point in generalised anxiety and cancer worry.

Eligibility criteria:
inclusion criteria: * patients must meet all the following criteria for study entry: 1. males aged ≥ 18 years at the time of consent 2. no previously diagnosed prostate cancer 3. no previous prostate biopsy 4. having undergone mri within 9 months prior to randomisation and meet one of the following criteria: * pi-rads 2 and ≥1 red flag defined as: * psa density \>0.1 * abnormal dre * strong family history (1 first degree relative or ≥2 second degree) * brca mutation * psa \>10 * psa doubling time \<36 months * psa velocity \>0.75/year * pi-rads 3 5. intention for prostate biopsy 6. willing and able to comply with all study requirements exclusion criteria: * patients who meet any of the following criteria will be excluded from study entry: 1. having a psa \>20ng/ml 2. having ≥ ct3 on dre 3. significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol

Keywords: prostate cancer psma pet