Kornimate/medical-research-clean huggingface dataset:
candonilimab plus bevacizumab for patients with advanced hcc who progressed on a+t

Conditions: Hepatocellular Carcinoma

Summary: to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

atezolizumab plus bevacizumab is the first-line treatent for patients with advanced hepatocellular carcinoma. however, the second-line treatment is absent for patients who progressed on atezolizumab plus bevacizumab. candonilimab is a humanized bisspecific monoclonal antibody against pd-1/ctla-4 igg1. candonilimab plus lenvatinib showed strong anti-tumor effect, with objective response of 44%. this single-arm, prospective, phase 2 trial is to explore the efficacy and safety of candonilimab plus bevacizumab for patients with advanced hepatocellular carcinoma who progressed on atezolizumab plus bevacizumab.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * eastern cooperative oncology group performance status of 0 to 2 * patients have received atezolizumab plus bevacizumab and the tumor have progressed. patients have not received other treatmets except for the atezolizumab plus bevacizumab. * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma candonilimab plus bevacizumab atezolizumab plus bevacizumab
transesophageal echocardiography to identify patients with low risk of stroke in atrial fibrillation - tiara pilot study

Conditions: Atrial Fibrillation; Stroke

Summary: in this multi centre pilot study we will perform tee in patients with af who are eligible for vka treatment. tte will be used as pre-screening: if tte shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. tee will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. three hundred patients who do not have these features on tte will be randomly assigned to treatment with aspirin or vka. follow-up will be 1 year.

background atrial fibrillation (af) is an independent risk factor for stroke. therapy with vitamin k antagonists (vka) and aspirin reduces the risk of thromboembolism (te) dramatically. risk stratification is nowadays based on clinical characteristics. however, many high risk af patients may actually be at low risk, identified by trans-oesophageal echocardiography (tee). hypothesis a comprehensive strategy of tee based aspirin treatment in af patients eligible for vka therapy is safe and feasible. objectives 1. to show that tee based aspirin treatment is safe when compared with vka therapy. 2. to test the feasibility of tee as a tool to detect all four echocardiographic features of high stroke risk. methods in this multi centre pilot study we will perform tee in patients with af who are eligible for vka treatment. tte will be used as pre-screening: if tte shows left atrial abnormalities or aortic plaque, patients will be excluded from randomisation. tee will be performed in all other patients to detect or exclude complex aorta plaques or signs of left atrial stasis. three hundred patients who do not have these features on tte will be randomly assigned to treatment with aspirin or vka. follow-up will be 1 year. expected results application of a new echo-guided antithrombotic strategy as proposed herein is feasible and may help to reduce bleeding whilst stroke prevention is maintained. if the lower limit of the 95% confidence interval of the yearly incidence of the primary endpoint on aspirin remains below 4.4% then a large multi centre randomised controlled trial will be performed.

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation or atrial flutter, paroxysmal or permanent * conventional indication for vka treatment * signed informed consent exclusion criteria: * planned electro cardioversion * very high risk of te (previous ischemic stroke or systemic te, symptoms of heart failure or left ventricular dysfunction, mitral valve stenosis, hypertrophic cardiomyopathy) * indication for vka treatment other than atrial fibrillation (e.g. mechanic valve prosthesis) * atrial fibrillation secondary to reversible diseases (e.g. thyrotoxicosis) * contraindication for treatment with vka, aspirin, or clopidogrel

Keywords: echocardiography
real-life clinical experience with ialuadapter study

Conditions: Interstitial Cystitis, Chronic; Overactive Bladder Syndrome; Recurrent Urinary Tract Infection

Summary: a retrospective study from a single center was performed. quantitative and qualitative data was obtained on the use of the syringe adapter (ialuadapter®) in 61 patients with ic/bps (n=48), ruti (n=6) and mixed /other diagnoses (including oab; n= 7) who were receiving intravesical therapy. the evaluation period was 6 months during 2018-2019. reasons for trying the syringe adapter, reasons for continuing with it and occurrence of utis before and during the evaluation period were recorded. in addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

introduction intravesical treatment is currently dependent on catheterization which can cause urethral discomfort and risk of urinary tract infections in selected patient groups such as interstitial cystitis / bladder pain syndrome (ic/bps), overactive bladder syndrome (oab) and recurrent urinary tract infections (ruti). this study describes real-life clinical experience of a minimally invasive syringe adapter (ialudapter®) for catheter-free instillation of intravesical treatment. methods a retrospective study from a single center was performed. quantitative and qualitative data was obtained on the use of the syringe adapter (ialuadapter®) in 61 patients with ic/bps (n=48), ruti (n=6) and mixed /other diagnoses (including oab; n= 7) who were receiving intravesical therapy. the evaluation period was 6 months during 2018-2019. reasons for trying the syringe adapter, reasons for continuing with it and occurrence of utis before and during the evaluation period were recorded. in addition, 3 year follow-up data were obtained to assess long-term usage of the syringe adapter.

Eligibility criteria:
inclusion criteria: * patients with ic/bps, recurrent utis and/or oab * receiving intravesical instillations with a conventional single-use catheter before the syringe adapter evaluation period which took place between september 2018 and the end of february 2019 (6m). exclusion criteria: * patients with a high post-void residue of \>100ml or with an indwelling catheter were excluded from the analyses. * patients who cannot sign informed consent.

Keywords: ialudapter intravesical therapy gag therapy intravesical treatment ic/bps recurrent urine tract infection catheterization
cardiovascular risk evaluation in clinical practice in metabolic syndrome patients

Conditions: Metabolic Syndrome

Summary: metabolic syndrome is commonly defined as a set of risk factors and abnormalities that markedly increase the risk of cardiovascular events. its relevance has been confirmed by a recent population-based survey of subjects aged 40-79 years indicating that the prevalence of metabolic syndrome in italy is 34.1% if diagnosed using who criteria and 17.8% if diagnosed using the ncep-atpiii criteria. on the basis of the above considerations, the aim of this study is to promote the use of the score algorithm for estimating cardiovascular risk, and to evaluate its evolution in patients with metabolic syndrome after the implementation of a multifactorial preventive strategy, with particular reference to the correction of lifestyle, hypertension and dyslipidemia.


Eligibility criteria:
inclusion criteria: * patients of both genders aged 40-65 years. * a diagnosis of metabolic syndrome formulated on the basis of the criteria proposed by the ncep - adult panel iii: i.e. the presence of at least three of the following conditions: 1. waist circumference \>102 cm in men and \>88 cm in women 2. triglyceridemia 150 mg/dl 3. hdl cholesterol \<40 mg/dl in men and \<50 mg/dl in women 4. sitting arterial pressure 130/85 mmhg 5. fasting glycemia 110 mg/dl * a risk of cardiovascular death of \>5% at the current age of the patient or \>5% if projected to an age of 60 years, as calculated by means of the score algorithm using the table based on the total/hdl cholesterol ratio relating to low-risk populations and appropriate for italy. * written informed consent. exclusion criteria: * women who have not been in menopause for at least one year or are not surgically sterile, and do not use an effective contraceptive method, such as spermicidal barrier methods or intrauterine devices. the use of oral contraceptives is not allowed. * known or suspected hypersensitivity to valsartan and/or fluvastatin, or other contraindications to their use; * a positive history of ischemic heart disease, peripheral artery disease or cerebral vasculopathy; * patients with an sbp of 180 mmhg and/or dbp of 110 mmhg. * patients with severe medical conditions which, in the judgement of the investigator, contraindicate trial participation or significantly limit life expectancy; * treatment with drugs able to modify the lipid profile (ongoing or in the three months preceding trial entry); * patients unable to follow the planned protocol procedures or sign the informed consent form.

Keywords: metabolic syndrome, cardiovascular risk reduction
ct imaging for guiding pa-tace for hcc

Conditions: Carcinoma, Hepatocellular

Summary: postoperative adjuvant transarterial chemoembolization (pa-tace) may improve survival outcomes in a subset of patients with resected hepatocellular carcinoma (hcc), reliable biomarkers for the criterion for the selection of candidates are lacking. the present study aimed to evaluate whether ct imaging can provide more value for predicting benefit from pa-tace.


Eligibility criteria:
inclusion criteria: * ct scans acquired no more than one month before surgery * confirmation of hcc diagnosis by pathological examination * curative surgical resection exclusion criteria: * prior antitumor treatment * macrovascular thrombosis or metastasis * perioperative mortality * unqualified image artifacts * tumor rupture * mvi status not reported

Keywords: carcinoma, hepatocellular
rotator cuff tendinopathy conservative treatment with collagen, prp or both

Conditions: Rotator Cuff Tendinosis; Rotator Cuff Tears

Summary: the aim of the trial is comparison of the effectiveness of three methods of conservative treatment in partial thickness rotator cuff injury (ptrci): collagen with prp injections, prp injections alone and collagen injections alone.

background: rotator cuff injury (rci) occupy third place in the population among the musculoskeletal system pathologies (16%) after low back pain (25%) and knee pain (19%). partial thickness rci (ptrci) is the sum of degenerative, overload and microtrauma processes and their incidence increases significantly with age (up to 30% over 60). one of the factors contributing to the injury is a negative collagen balance and slowed tendon metabolism in proportion to its blood supply disorders. conservative treatment of ptrci of degenerative origin is the first choice management, but there are no clear guidelines. external supply of collagen and prp could potentially counteract these processes. aim: comparison of the effectiveness of three treatment concepts: collagen with prp, prp alone, collagen alone in the treatment of ptrci. design: randomized prospective trial without blinding setting: open study for outpatients, single center study population: local population methods: three groups of patients (each group 30 patients) with ptrci confirmed by ultrasound (n=90). the assessment of the supraspinatus tendon (ssp) in standard position of internal rotation of the upper limb for ultrasound examination, assessment of the thickness of the rc in cross-section (mm). each group treated by three ultrasound guided injections into the shoulder bursa every consecutive week: group a - collagen (3 amp collagen md shoulder) together with prp (2ml); group b - collagen alone (3 amp collagen md shoulder); group c - prp alone. all patients were allowed to continue rehabilitation protocol. primary control tools: nrs, quickdash, eq-5d-5l in control points: ia (initial assessment), 6, 12 and 24 weeks after last injection. secondary control tools: percentage of patients where the rc continuity were preserved and percentage of patients who had ultrasonographic signs of rc regeneration (crossection width increase, improvement of echogenicity) during the observation period between w0 and 24 weeks.

Eligibility criteria:
inclusion criteria: * clinical signs and symptoms of rotator cuff pathology * an adult person consenting to injections * partial thickness rotator cuff injury confirmed by ultrasound examination without coexisting severe pathologies (systemic inflammatory disease, malignancy, severe stage oa) * no traumatic event * no injections or any other local treatment in previous 1 month exclusion criteria: * full thickness rotator cuff injury * acute, traumatic injuries requiring surgical treatment * coexisting injuries of the shoulder joint requiring other intervention * severe pathologies of the shoulder of another origin (systemic inflammatory disease, malignancy, severe stage oa) * no consent
the rate and predictors of vaginal bleeding among women with placenta previa

Conditions: Placenta Previa; Vaginal Bleeding; Antepartum Hemorrhage

Summary: placenta previa is usually diagnosed when the placenta implanted in the lower uterine segment, thus partially or totally overlying the internal os . it occurs with an incidence of 0.3-0.5%. it is associated mainly with prior caesarean delivery . the condition is frequently complicated by invasion of placental villi beyond the decidua basalis causing placenta accreta . placenta previa is a major cause of massive haemorrhage during pregnancy and after delivery . the antepartum bleeding from placenta previa- can be life-threatening, thus, the prediction of this bleeding is of great importance . it is important to distinguish between women at high and low risk for antepartum haemorrhage with placenta previa especially at late pregnancy . however, the potential risk factors for antepartum haemorrhage in women with placenta previa have not been thoroughly examined.


Eligibility criteria:
inclusion criteria: * pregnant women ≥ 28 weeks. * diagnosed to have placenta previa by ultrasound exclusion criteria: * women with complicated pregnancies (e.g. preeclampsia, diabetes mellitus and cardiac, renal, antiphospholipid syndrome). * women with premature rupture of membrane. * women who will refuse to participate.
post marketing surveillance study on emselex after launch in germany

Conditions: Overactive Bladder

Summary: - data are obtained of emselex in routine treatment of overactive bladder. the general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.


Eligibility criteria:
inclusion criteria: * patients who are treated with emselex for overactive bladder exclusion criteria: * exclusion criteria are the contraindications as specified in the german product information

Keywords: overactive bladder
safety and efficacy of virtual reality mindfulness in patients with psychosis

Conditions: Schizophrenia Spectrum Disorders; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorders; Psychotic Disorder Not Otherwise Specified

Summary: this study is to evaluate the safety and efficacy of virtual reality mindfulness in patients with psychosis.

this study is randomized, single-blind and parallel group trial to evaluate the safety and the efficacy of virtual reality mindfulness in patients with psychosis once a week over 8 weeks treatment period. both groups can experience the screen coming out of the head-mounted display for 30 minutes in a comfortable sitting position.

Eligibility criteria:
inclusion criteria: * male or female patients who are 15-59 years (inclusive) of age at time of consent. * patients with current dsm-5 (diagnostic and statistical manual of mental disorders-fifth edition) diagnosis schizophrenia spectrum and other psychotic disorders including bipolar and related disorders or depressive disorder with psychotic symptoms. * patients who can agree to participate in the study in a stable state (clinical global impression score of 5 or less) and cooperate appropriately with questionnaires and tests. * patients with a sofas score in the range of 41 to 80 points. * patients with a panss score of less than 85 points. exclusion criteria: * patients who are currently in poor health due to serious physical illness * patients who are currently pregnant or lactating. * patients who are accompanying intellectual disability with an intelligence quotient (iq) of 70 or lower * patients who have difficulty in agreeing to and participating in research due to severely impaired ability to verify reality * patients with a panss score of 85 or higher or a cgi of 6 or higher * patients with a sofas score of 40 or less or 81 or more * patients who are currently in hospitalized

Keywords: virtual reality mindfulness
multimodal investigation in the diagnosis and treatment of chronic adult hydrocephalus

Conditions: Chronic Adult Hydrocephalus

Summary: idiopathic chronic adult hydrocephalus (icah) is due to expansion of the fluid-filled cavities in the brain. the clinical symptoms are gait disturbance, mental decline and incontinence. treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that icah is a classic, curable cause of dementia. diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (csf) via a lumbar puncture (lp). in practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after csf depletion. in consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression. over recent years, the cognitive profile of patients with icah has become better characterised and reproducible, objective techniques have been developed to assess motor function and csf flow in the brain. the investigators project aims to define the value of these new investigative techniques in the positive diagnosis of icah, in comparison to current decision-making tools.


Eligibility criteria:
inclusion criteria: * adult 65 years or older * hospitalized patients (at the university hospital of tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically * patient undergoing lumbar puncture subtractive * informed consent form signed * affiliated to a medical insurance exclusion criteria: * contraindications to mri * inability to walk or to stand before having lumbar puncture * patient under trusteeship and guardianship, or judicial protection

Keywords: computerised gait analysis ultrasound measurement of cerebral pulsatility mri flow urinary incontinence scale subtractive lumbar puncture
blood levels of local anaesthetic in knee arthroplasty using a continuous infusion device

Conditions: Osteoarthritis, Knee

Summary: the primary goal is to evaluate ropivacaine blood concentrations during and after local anaesthetic (ropivacaine) infiltration - the caledonian technique - for total knee replacement surgery. the investigators plan to measure these levels by testing blood samples taken over a timed period. this will allow us to confirm whether the current regimen of local anaesthetic use is within safe limits.

local anaesthetic (la) toxicity may occur when the blood levels of a drug become particularly high. there is a need to confirm that the technique is safe to use. in addition, journal case reports may only describe serious side-effects of toxicity such as abnormal heart rhythms whilst more subtle clinical signs are rarely reported. the investigators would like to study whether or not toxic levels may be approached in some patients or whether more subtle toxicity symptoms and signs are missed. for example, irregular heartbeat, low blood pressure or confusion/agitation. therefore, the investigators intend to study ropivacaine blood levels in patients receiving a total hip replacement in the golden jubilee national hospital. a series of timed samples will be taken during the perioperative period. the anaesthesia and surgery will be performed as routine and no new treatment will be involved. patient demographics, ropivacaine blood levels and clinical observations following la administration will be collected.

Eligibility criteria:
inclusion criteria: * male or female patients greater than 65 years of age exclusion criteria: * patients with a known sensitivity/allergy to ropivacaine or amide-type local anaesthetics * patients who are not suitable for the caledonian technique * patients who refuse or are unable to give consent * patients undergoing bilateral hip replacements * patients with known heart, liver or kidney failure

Keywords: knee arthroplasty
urinary prostaglandin e metabolite (pge-m), a metabolite of prostaglandin e2 (pge2): a novel biomarker of crohn's disease activity

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether urinary pge-m levels correlate with crohn's disease activity and to compare how well urinary pge-m correlates with other non-invasive biomarkers of disease activity such as c-reactive protein (crp) and fecal calprotectin.

the available clinical measures of crohn's disease activity can be overly influenced by functional symptoms. placebo response rates in clinical trials are high. several non-invasive biomarkers are currently available for assessing inflammatory bowel disease (ibd) disease activity including erythrocyte sedimentation rate, c-reactive protein and fecal calprotectin. although these markers hold some promise, their performance is less than ideal. what is needed is a simple, non-invasive, biologic measure of crohn's disease. cyclooxygenase-2 (cox-2) is involved in prostaglandin e2 (pge2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. we have developed an assay to quantify the major urinary metabolite of pge2, pge-m. pge-m has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls.

Eligibility criteria:
inclusion criteria: * outpatient male or female 18 years or older * confirmed diagnosis of crohn's disease * informed consent obtained * able to give blood, urine and stool samples * willing to undergo a diagnostic colonoscopy as part of routine crohn's disease care exclusion criteria: * unable to give consent * ulcerative colitis * does not meet inclusion criteria * pregnant

Keywords: crohn's disease