Kornimate/medical-research-clean huggingface dataset:
a research study to treat patients with advanced hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (hcc).

in addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative time to progression (ttp), time to symptomatic progression (ttsp), response rate (rr) and overall survival between the 2 study populations. the possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints. the safety and tolerability will be assessed in the adverse event section. doxorubicin pharmacokinetics in hcc patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity).

Eligibility criteria:
inclusion criteria: * patients who have a life expectancy of at least 12 weeks * patients with advanced hcc (unresectable, and/or metastatic) which has been histologically or cytologically documented * patients must have at least one tumor lesion that meets both of the following criteria: * can be accurately measured in at least one dimension according to response evaluation criteria in solid tumors (recist) * has not been previously treated with local therapy * patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. local therapy must be completed at least 4 weeks prior to the baseline scan * patients who have an eastern cooperative oncology group (ecog) performance status of 0, 1 or 2 exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from hcc, except cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (ta, tis \& t1). any cancer curatively treated \> 3 years prior to entry is permitted * history of cardiac disease * serious myocardial dysfunction * active, clinically serious infections * known history of human immunodeficiency virus (hiv) infection * known central nervous system (cns) tumors including metastatic brain disease * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Keywords: cancer liver cancer hepatocellular carcinoma hcc
novel biomarker assay for biomarker assay for hcc detection

Conditions: Hepato-cellular Carcinoma

Summary: the primary purpose of this study is to assess the performance feasibility of genetron's novel hcc liquid biopsy biomarkers assay for early detection. piedmont transplant institute will provide a longitudinally collected blood sample from all hcc cases (mixture of early and advanced stage hcc) and cirrhosis control to genetron health after obtaining informed consent.

hcc is a leading cause of cancer-related deaths in the us. early detection is crucial to improve the outcome of hcc. hcc surveillance is recommended for early detection of hcc in patients with cirrhosis. however, current hcc surveillance tests, such as liver ultrasound and afp have relatively low accuracy for the detection of early-stage hcc. genetron health recently published on novel liquid biopsy biomarker for detection of hcc in china. the biomarker showed excellent performance for the detection of hcc among the at-risk population, most of whom had hbv infection. it is crucial to validate the performance of this novel biomarker in an independent population of patients with different etiology of liver disease outside of china. as this novel biomarker is useful in the detection of small hcc, it may also serve as an excellent biomarker for assessment of treatment response and monitoring of recurrence. the primary purpose of this study is to assess the performance feasibility of genetron's novel hcc liquid biopsy biomarkers assay for early detection. piedmont transplant institute will provide a longitudinally collected blood sample from all hcc cases (mixture of early and advanced stage hcc) and cirrhosis control to genetron health after obtaining informed consent. genetron health will analyze the blood sample and provide data to the pi, for internal review purposes. should the initial pilot study be successful, the parties will have a discussion to expand the number of cases and control samples and consider conducting a multicenter prospective study.

Eligibility criteria:
inclusion criteria: * patients diagnosed with hcc (based on histology or radiology according to aasld guideline) or liver cirrhosis (based on the clinical history of hepatic encephalopathy, thrombocytopenia, radiologic features of the nodular liver, features of portal hypertension such as ascites, splenomegaly, or mr elastogram or fibroscan showing result consistent with cirrhosis) * willing and able to provide informed consent to participate in this study exclusion criteria: * unable to provide blood samples * age less than 18 years of age * patient who have active cancers (excluding hcc) in the past five years, except for nonmelanoma skin cancer

Keywords: hcc screening
the efficacy and treatment adherence with an integrated program on hba1c scores in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: it is hypothesized for this study that the coupling of the millon behavioral medicine diagnostic, biopsychosocial evaluation, motivational interviewing, relapse prevention, and ongoing support can produce improved outcomes with diabetics who have previously been unsuccessful with the traditional care. this study examined the relationship between patients' hba1c levels and patients' involvement in the asmart program, a multifaceted program involving psychological intervention. the study was conducted through the kosciusko health department and funded by k21 health foundation.

the study involved 182 type 2 diabetes patients with an hba1c score above 7, reflecting poor control of diabetes. the experimental group consisted of 124 patients who joined the asmart program, while the control group consisted of 60 patients who continued to receive traditional care. statistical analysis involved comparing pretest \& posttest hba1c levels for the experimental group and the control group.

Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with an hba1c score over 7 exclusion criteria: * no type 1 patients * no children under the age of 18

Keywords: psychological intervention stages of change motivational interviewing coping skills hba1c psychological testing integrated care behavioral health
toler-ent study: a study to investigate the tolerance of the high energy, high protein formula sondalis® hp 2 kcal

Conditions: Malnutrition

Summary: a multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated home enteral nutrition (hen). the study aims to analyse the evolution of tolerance and quality of life of hen patients after switching from a high protein high energy (hphe) polymeric enteral nutrition (en) formula with or without fibre to sondalis® hp 2kcal, with or without fibre. eligible patients will give their written consent to participate before being included into the study.


Eligibility criteria:
inclusion criteria: * men or women aged ≥18 years, * being under en with polymeric hphe product with or without fibre (=hphe), * stable caloric prescription during hen for at least one month, * patient with at least a score of 2 on at least 1 item of tolerance questionnaire, * investigators' judgement to change to hphe concentrated, * hen is planned for ≥ 8 weeks, * life expectancy ≥ 3 months. * patient or his/her primary caregiver was required to be able to understand the study and to be fully free to participate in it, * patient having signed an informed consent, * patient registered with a social security scheme, * patient willing to adhere to study procedures, exclusion criteria: * pregnancy or breastfeeding, * being either under pn or ons, * acute intestinal disease such as gastric ulcer, gastritis, gastroparesis, * patient under prokinetic agents during the study phase, * patient receiving antibiotic, chemotherapy in the 7 days prior to inclusion, * patient receiving radiation treatment except head and neck location, * patient expected to receive chemotherapy or radiation treatment during the study except head and neck location , * severe infectious disease and/or fever \> 38,5°c, * emergent hospitalization within last month, * known allergy or intolerance to any of the sondalis® hp 2kcal with or without fibre ingredients, * previous treatment with hphe concentrated at home (2kcal), * current participation in another intervention study or participation in a previous study for which exclusion period applies. * non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian
a study of duloxetine (ly248686) in the treatment of japanese children and adolescents with depressive disorder

Conditions: Depressive Disorder

Summary: the purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in japanese children and adolescents with depressive disorder.


Eligibility criteria:
* a) participants extended from b058(1701a3631) study. * b) new participants. inclusion criteria * a) participants who have completed 7 weeks of dosing in the b058(1701a3631) study and give signed informed consent to continue duloxetine administration in this study. * b) participants diagnosed with major depressive disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) with the mini international neuropsychiatric interview for children and adolescents (mini-kid) ver.7.0.2. * b) participants whose incipient age of depression was ≥7 years old. exclusion criteria: * a, b) have a current or previous diagnosis (dsm-5) of the following as judged by the investigator: * neurodevelopmental disorders * schizophrenia spectrum and other psychotic disorders * bipolar and related disorders * trauma and stressor-related disorders * disruptive · impulse control · and conduct disorders * a, b) have a current diagnosis (dsm-5) of the following as judged by the investigator: * obsessive-compulsive and related disorders * anorexia nervosa, bulimia nervosa, binge-eating disorder * sleep-wake disorders * neurocognitive disorders * disruptive mood dysregulation disorder * a, b) have personality disorders, in the judgment of the investigator.
trial of proton versus carbon ion radiation therapy in patients with low and inter-mediate grade chondrosarcoma of the skull base

Conditions: Chondrosarcoma

Summary: the study is a prospective randomised clinical phase iii trial. proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. however, high-let beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. the aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed.

the study is a prospective randomised clinical phase iii trial. the trial will be carried out at heidelberger ionenstrahl-therapie (hit) centre as monocentric trial. proton therapy is the gold standard in the treatment of low and intermediate grad chondrosarcomas of the skull base. however, high-let beams such as carbon ions theoretically offer biologic advantages by enhanced biologic effectiveness in slow-growing tumors. up until now it was impossible to compare two different particle therapies, i.e. proton and carbon ion therapy directly with each other. the aim of this study is to find out, whether the biological advantages of carbon ion therapy mentioned above can also be clinically confirmed. patients with skull base chondrosarcomas will be randomised to either proton or carbon ion radiation therapy. as a standard, patients will undergo non-invasive, rigid immobilization and target volume definition will be carried out based on ct and mri data. the biologically isoeffective target dose to the ptv in carbon ion treatment will be 60 gy e ± 5% and 70 gy e ± 5% (standard dose) in proton therapy respectively. the 5 year local-progression free survival (lpfs) rate will be analysed as primary end point. overall survival, progression free and metastasis free survival, patterns of recurrence, local control rate and morbidity are the secondary end points. plan quality is also a matter of interest.

Eligibility criteria:
inclusion criteria: * karnofsky performance score ≥60% * age \>18 years and \<80 years * informed consent signed by the patient * histological confirmation of low/ intermediate grade chondrosarcoma with infiltration of the skull base. exclusion criteria: * inability to understand the aims of the study, no informed consent * prior rt of skull base region * other malignancies with disease-free interval \< 5 years (excepting pre-cancerous lesions) * participation in another trial * pregnancy * simultaneous cht or immunotherapy.

Keywords: chondrosarcoma radiation carbon ion
video decision support for advance care planning in geriatric patients with frailty

Conditions: Frail Elderly

Summary: as the proportion of the aging population continues to rise, age-related frailty syndrome, characterized by a decline in the function of multiple physiological systems and accompanied by vulnerability to stress, has become a significant issue. it has been associated with higher mortality rates, hospitalization rates, risk of falls, occurrence of fractures, decreased mobility, depression, cognitive decline, dementia, loneliness, and admission to long-term care facilities. advance care planning is a thoughtful and communicative process that helps individuals, while still cognitively capable, to pre-determine and express their preferences for medical care in the event of future incapacity. with the ongoing development in the field of frailty and the rapid aging of the population, the increasing age may be accompanied by severe illnesses, symptom burden, functional dependence, caregiver burden, and extensive medical utilization. the importance of advance care planning is increasingly emphasized, but its implementation and promotion remain challenging. in addition to systematic promotion from a policy perspective, tools to assist patients in decision-making have been proposed. video decision aids can encourage people to engage in advance care planning by sparking conversations about informed consent and helping individuals contemplate the choices they may face. video decision aids can also assist individuals in envisioning future scenarios and reflecting on their decisions. previous randomized controlled trials have explored the benefits of such video tools for specific patient populations, such as cancer patients, heart failure patients, and elderly individuals hospitalized. however, there is a need for innovative approaches to enhance the knowledge, willingness, and actual signing rates of advance care planning for frail elderly individuals. this study aims to develop a video decision aid specifically tailored for the elderly frail population undergoing advance care planning. through a randomized controlled trial, the study aims to validate its actual benefits, expecting to assist the elderly frail population in understanding and expressing their willingness for advance care planning, increasing the actual willingness to sign advance directives, and helping clinical healthcare teams achieve person-centered, high-quality care for this population.


Eligibility criteria:
inclusion criteria: * age \> or = 65 y/o can communicate and sign informed consent diagnosed to be frailty with clinical frailty scale 4-7 exclusion criteria: * impaired visual acuity or hearing that can't watch video had signed advance decision before

Keywords: frailty advance care planning shared decision making
noradrenalin vs terlipressin in hepatorenal syndrome

Conditions: Hepatorenal Syndrome

Summary: the purpose of this study is to determine whether noradrenalin is as effective and safe as terlipressin in the treatment of hepatorenal syndrome

hepatorenal syndrome (hrs) is a major complication of cirrhosis; it is characterized by functional renal failure and poor prognosis. arterial dilation is a key pathogenic event of hrs, leading to reduction of the effective blood volume, homeostatic activation of vasoactive systems and renal vasoconstriction with decrease in renal blood flow. the clinical signs of hrs vary depending on the clinical pattern. hrs type 1 is characterized by a rapidly progressive renal failure; hrs type 2 by a moderate and more stable renal failure. hrs type 1 has a very poor short term prognosis, with a median survival of only about 2 weeks; patients with hrs type 2 have a median survival of about 6 months. the management of hrs still constitutes a major challenge. liver transplantation is the ideal treatment, but it has important inherent drawbacks, such as the organ shortage and the time needed to perform the transplant, that is too long to consent the survival of these patients. the management of hrs has focused on improving renal function, thus extending patients survival and allowing the performance of the liver transplant. in the last years, remarkable results have been obtained using vasoconstrictor drugs. by improving the effective blood volume, vasoconstrictors induce the suppression of homeostatic vasoactive systems and increase renal blood flow and glomerular filtration rate.among vasoconstrictors, terlipressin, a v1 vasopressin agonist, has currently the best efficacy pedigree. however, it is expensive and is not available in many countries, including north america. more recently, it was suggested that alpha-adrenergic drugs such noradrenalin and midodrine may be also effective in hrs. noradrenalin would have the potential advantage of wider availability and of lower cost. the current prospective randomized study was undertaken to assess the efficacy and safety of noradrenalin vs terlipressin in patients with hrs.

Eligibility criteria:
inclusion criteria: * hepatorenal syndrome * age: 18-75 years * informed written consent exclusion criteria: * multinodular hepatocellular carcinoma (more than 3 nodules) * portal vein thrombosis * ongoing bacterial infection * ongoing or recent (less than one week) bleeding * cardio-pulmonary failure * coronary artery disease * peripheral artery disease * arterial hypertension

Keywords: hepatorenal syndrome ascites portal hypertension cirrhosis
long-term follow-up safety after dds implantation with/without cdnf infusions

Conditions: Parkinson Disease; Movement Disorders; Neuro-Degenerative Disease; Nervous System Diseases; Brain Diseases

Summary: this study is a follow up to the hp-cd-cl-2002 clinical study. it evaluates the long-term safety in patients with parkinson's disease after implantation of an investigational drug delivery system (dds) with or without infusions of cdnf. all patients will have at least the port explanted.

a patients participation in the study will last for up to 4 years and will include up to nine visits: * screening (1 visit, same as hp-cd-cl-2003 end-of-study visit) * pre-surgery / explantation surgery / post-surgery (3 visits) * safety (4 visits) * dat-pet (dopamine transporter - positron emission tomography) examination (1 visit) * end-of-study visit (1 visit) study examinations and assessments: * physical examination: pulse rate, blood pressure, temperature, body weight and height, body mass index (bmi), neurological exam * ecg (electrocardiography) and blood and urine tests * pregnancy tests for women of childbearing age * completion of a patient diary to record mobility and time asleep * parkinson's kinetigraph (pkgtm) data logger: a watch-type movement recording device * questionnaires, rating scales and forms: quality of life, mood, memory, impulse control, mental health. * magnetic resonance imaging (mri) * positron emission tomography scans (pet) * skin condition over any remaining implanted subcutaneous portion of the device. * skin healing after port / device removal. for more information: https://treater.eu/clinical-study/

Eligibility criteria:
inclusion criteria: 1. completion of visit 4 (implantation of dds) within main study hp-cd-cl-2002. 2. patients who: * discontinued main study after visit 4 of main study or discontinued extension study. * received 6 doses in main study but didn't participate in extension study. * received 12 doses including extension study. 3. provision of informed consent. exclusion criteria: * none

Keywords: parkinson cdnf drug delivery system intracerebral parkinson disease nervous system disease movement disorders brain diseases neurodegenerative diseases parkinsonian disorders basal ganglia diseases central nervous system diseases dopamine cardiotonic agents sympathomimetrics autonomic agents peripheral nervous system agents physiological effects of drugs dopamine agents neurotransmitter agents molecular mechanisms of pharmacological action protective agents
elimination of protein-bound uremic retention solutes by prometheus artificial hepatic system versus conventional dialysis

Conditions: Renal Failure, Chronic

Summary: comparison of the efficacy of dialysis by conventional dialysis versus prometheus artificial hepatic system

after inclusion, patients will be dialysed with low-flux artificial kidneys. 1 week of dialysis exists of 3 days of dialysis. in week 4, day 2, patients will be treated once with the prometheus artificial hepatic system or with high-flux dialysis. the other days low-flux kidneys will be used. week 5 and 6 are a wash-out period. week 7 is identical to week 4 but the other system than in week 4 is used. blood samples are taken at regular moments in week 3, week 4 (day 2) and week 7 (day 2).

Eligibility criteria:
inclusion criteria: * stable patients * at least 3 months on dialysis * arterio-venous fistula exclusion criteria: * diabetic patients * malignancies * acute illnesses