Kornimate/medical-research-clean huggingface dataset:
transarterial radioembolisation in comparison to transarterial chemoembolisation in uveal melanoma liver metastasis

Conditions: Uveal Melanoma

Summary: characterisation of effect of sirt and dsm-tace as local treatment options for liver metastases in patients with advanced uveal melanoma with respect to progression-free survival and exploratory comparison of secondary endpoints regarding application, activity, adverse effects and impact on quality of life in a randomized study design.

this is a randomized phase ii trial to evaluate the effect of transarterial radioembolisation with yttrium-90 microspheres (sirt) and transarterial chemoembolisation with cisplatin (dsm-tace) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival and multiple secondary endpoints. patients in study arm a will receive transarterial radioembolisation one time only. patients in study arm b will receive transarterial chemoembolisation every 4 to 6 weeks until complete tumor devascularisation is observed or disease progression or intolerable toxicity occur. at the time of local tumor progression patients will be offered the other treatment respectively (either sirt or dsm-tace) as part of the study.

Eligibility criteria:
inclusion criteria (main): * ecog performance status of 0, 1 or 2 * histologically or cytologically confirmed liver metastases of uveal melanoma * at least one measurable lesion according to recist criteria v1.1 determined mri (if contraindications against mri exist ct with contrast media can is allowed) * metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation) * prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved * surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved exclusion criteria (main): * surgically treatable liver metastases * previous intraarterial hepatic treatment (e.g. radioembolisation, chemoembolisation, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion) * previous treatment with external liver radiation * major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein * liver cirrhosis child-pugh c * progressive liver failure * renale failure, bone marrow insufficiency, coagulopathy * uncontrolled or severe medical conditions which could impair the ability to participate in the trial such as unstable cardiac disease or uncontrolled infection * other malignancy and/or metastases in need of treatment * current treatment with any anti-cancer therapy

Keywords: uveal melanoma liver metastasis chemoembolisation radioembolisation
effectiveness, safety & nurse management study of mabthera sc in patients with non-hodgkin's lymphoma: real-life setting

Conditions: Non-Hodgkin's Lymphoma

Summary: this prospective, open-label, multicenter, observational study will investigate the effectiveness and safety of mabthera sc (rituximab, subcutaneous) induction therapy in patients with non-hodgkin's lymphoma, following a first initial treatment of mabthera iv (rituximab, intraveneous). induction treatment period in the study is estimated to be 8 months.


Eligibility criteria:
inclusion criteria: 1. indication according to the summary of product characteristics (spc) for mabthera sc formulation: * as treatment of previously untreated patients with stage iii-iv follicular lymphoma in combination with chemotherapy * as treatment of patients with cd20 positive diffuse large b cell non-hodgkin's lymphoma in combination with chemotherapy 2. at least 4 treatment cycles with mabthera is planned 3. patients \>/= 18 years at inclusion 4. patients written informed consent 5. treatment decision to prescribe mabthera sc has been taken by the physician prior to recruitment into the study exclusion criteria: 1. contraindications according to spc for mabthera sc formulation: * hypersensitivity for the active substance or murine antibodies, hyaluronidase or any other excipients * active and severe infections * patients with severe immunsuppression 2. patient included in clinical trials with experimental pharmaceuticals 3. pregnancy
prediction of nodat after renal transplantation

Conditions: Renal Transplantation

Summary: a statistical analysis of the predictive value of ogtt and fpg testing executed as part of standard clinical practice after renal transplantation for the diagosis of new-onset diabetes mellitus after transplantation.

all patients transplanted in our department receive a formal oral glucose tolerance test (and thus also fasting plasma glucose concentration) in the first week after renal transplantation. this testing for dm or impaired glucose tolerance (igt) is part of our standard clinical protocol and data are collected prospectively in all these patients in an electronic patient medical file. the development of diabetes mellitus in all transplant patients is documented, including dm therapy.

Eligibility criteria:
inclusion criteria: * primary or secondary single kidney transplantation * age older than 18 years exclusion criteria: * pre-existing dm or documented impaired glucose metabolism * combined organ transplantation

Keywords: nodat ogtt fpg renal transplanation risk factors predictive value
addressing modifiable breast cancer risk factors with project conect

Conditions: Weight Loss; Breast Cancer Risk Factors

Summary: the objective of this protocol is to adapt and pilot test an existing lifestyle modification intervention for weight loss for women with overweight or obesity who have had a recent false positive mammography screen. the purpose of this pilot trial is to establish feasibility of connect online to engage change tool (conect) to promote weight loss through increased physical activity and diet change.


Eligibility criteria:
inclusion criteria: 1. female 2. 40-65 years of age, 3. received a negative mammography screening result in the previous four weeks 4. moderately sedentary lifestyle (less than 120 minutes/week moderate intensity activity), 5. answer "no" to all questions on the physical activity readiness questionnaire (par-q). 6. bmi 25-40 kg/m2 7. has access to a computer or mobile device with wireless internet 8. able to speak and read english (language requirements are necessary because we cannot accommodate additional languages in prototype development phase.) exclusion criteria: 1. previous history or current diagnosis of breast cancer 2. pregnancy or lactation 3. involvement in a weight loss program 4. major co-morbidities (e.g.,diabetes, hypertension, etc.) 5. history of disordered eating 6. currently taking medication that may impact weight (e.g., synthroid, metformin)

Keywords: physical activity diet nutrition breast cancer prevention mammography screening
artificial intelligence (ai) - assisted visual impairment screening model: community-based implementation and evaluation of performance, feasibility and costs.

Conditions: Visual Impairment

Summary: the goal of this observational study is to evaluate the performance, operational efficiency, acceptability, feasibility, and cost-effectiveness of an ai-assisted screening model for visual impairment in a community setting. the main questions it aims to answer are: * can the ai-assisted screening model improve screening and referral accuracy compared to the current traditional screening approach? * does the ai-assisted model enhance operational efficiency and reduce healthcare costs in a community setting? researchers will compare the ai-assisted model with the current traditional screening approach to assess its impact on screening accuracy, operational efficiency, and cost-effectiveness. participants will: * undergo vision screening using either the ai-assisted model or the traditional model. * provide feedback on the acceptability of the screening approach. * contribute to evaluating the feasibility and costs associated with each screening method.


Eligibility criteria:
inclusion criteria: * individuals aged 50 years old and above. exclusion criteria: * individuals aged below 50 years old.

Keywords: visual impairment community screening randomized controlled trial (rct) artificial intelligence (ai)
pelvic floor rehabilitation for gynecological cancer patients

Conditions: Malignant Female Reproductive System Neoplasm

Summary: as cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance. pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (pfd) can severely affect a patient's life. pfd negatively affects health-related quality of life (hrqol). evaluation of pfd provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making. the pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them. several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking. research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.

patients with cervical or colorectal cancer who underwent surgery or radiotherapy are recruited for the study. * pfm strength is measured using a perineometer (biocon-200,mcubetechnologycompany,seoul,korea). vaginal pressure is measured using a vaginal silicon pressure sensor (cmh2o; sensitivity0.06kpa,sensitivity 5mv, threshold1.5v). * the motor evoked potentials (meps) from the pelvic floor are obtained by sacral and transcranial magnetic stimulation using a magstim 200 stimulator (magstim co., whitland, wales, uk). patients are instructed to lie in the left lateral decubitus position,intra-anal sponge electrode (dantec,skovlund, denmark)was lubricated and gently inserted into the anal canal. * monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding to the primary motor center in the precentral gyrus using a double-cone coil(9902-00,magstim). a figure-eight coil(9762-00,magstim)was used to stimulate the dorsolateral area of the sacrum corresponding to the exit of the sacral cortical facilitation * we measured the latency, amplitude, and excitability threshold(et) of meps detected in pelvic floor muscles with and without facilitation. the excitability threshold at rest(ret) is defined as the lowest intensity that produced mep responses of 100μv for optimal facilitation, we measure the latency of the meps with minimal contraction (10% of mvc) with ret intensity and amplitude with a moderate contraction * patient-reported hrqol quality of life general and condition-specific aspects of hrqol were assessed using the eortc qlq-c30 questionnaires.

Eligibility criteria:
inclusion criteria: * women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection exclusion criteria: * infectious diseases of the urinary tract and vagina

Keywords: pelvic floor dysfunction neuromodulation rehabilitation
cardiotoxicity in the elderly

Conditions: Cardiotoxicity; Elderly; Cardiac Magnetic Resonance

Summary: cartier (cardiotoxicity in the elderly) is a prospective cohort study of newly diagnosed elderly cancer patients equal or greater than 65 years of age conduced in one tertiary center (hospital universitario de salamanca at spain. the study is academically funded in its integrity by the instituto de salud carlos iii (spanish ministry of science, innovation and universities). the investigators of the study are the only responsible for the study design, data collection, and data interpretation. all study participants provide written informed consent. all enrolled patients will undergo serial surveys, 6-minutes walking test (6mwt), electrocardiogram, echocardiogram, blood samples, cmr, physical examinations and multidisciplinary clinical evaluations; before each chemotherapy cycle and at 3, 6, 9 and 12 months, 3 years and 5 years after finalization of chemotherapy, except for mri that will be performed before 1st, 3rd, 5th cycles and at 3, 6, 9,12 months, 3 years and 5 years after chemotherapy ending

surveys completion and examinations will be obtained at the same day: within 72 hours before each cycle of treatment or at 3, 6, 9, 12 months, 3 years and 5 years' follow-up after ending the whole antitumoral course of treatment. a fully dedicated research nurse will play a vital role in ensuring that the study run smoothly and that all participants will be safe and fully informed. questionnaires completion and quality of life assessment will initially be performed followed by the 6mwt. participants blood pressure measurement, electrocardiogram and echocardiogram will be then taken \>30 minutes after finishing the walking test. blood sample extraction will be performed after echocardiography to finalize with cardiac magnetic resonance. a complete medical history, physical examination and evaluation of these examinations for each participant will be performed by a cardiologist at the cardio-oncology unit, where prevention and treatment protocols for cardiotoxicity will be applied and discussed in a multidisciplinary way with referral oncologists and hematologists before every cycle of treatment and after course of antitumoral ending follow-up.

Eligibility criteria:
inclusion criteria: * newly diagnosed cancer initiating antisudoral treatment * capability to sign the informed consent * capability to realize 6 minutes walking test exclusion criteria: * previous chemotherapy * contraindications to undergo cardiac magnetic resonance (cmr) * enrollment in onco-hematologist current clinical-trials * clinical situation making difficult the realization of the proposed examinations or the course of chemotherapy.
efficacy of local overpressure treatment for meniere's disease

Conditions: Meniere's Disease

Summary: the purpose of this study to date, is that no causal therapy for meniere's disease has been discovered. local overpressure treatment for meniere's disease is a new treatment form that has been shown in animal and human experiments to reduce the endolymphatic hydrops, a condition that is generally believed to be the pathologic hallmark of meniere's disease. this study analyzes the efficacy of local overpressure treatment by measuring subjective vertigo severity and objective audiovestibular function parameters.

randomized double-blind controlled trial. patients with unilateral meniere's disease that suffer from recurring vertigo attacks are allocated to either a verum or a placebo device and are treated for 4 months. before during and after the treatment period, subjective and objective audiovestibular function parameters are measured.

Eligibility criteria:
inclusion criteria: * unilateral definite meniere's disease according to the aao-hns criteria exclusion criteria: * previous destructive treatment (gentamicin, saccotomy, vestibular neurectomy

Keywords: meniere vertigo overpressure treatment caloric irrigation hearing levels vertigo severity functional disability scale
evaluation of hpv oncotect ™ for the etiological diagnosis of hpv-induced oropharyngeal cancers

Conditions: Oropharyngeal Cancer

Summary: to determine the sensitivity of hpv oncotecttm to diagnose oropharyngeal cancers induced by oncogenic hpv


Eligibility criteria:
inclusion criteria: 1. untreated oropharynx epidermoid carcinoma 2. patient ≥ 18 years old 3. patient affiliated to a social security scheme or beneficiary of such a scheme 4. information to the patient or his legal representative and signature of informed consent exclusion criteria: 1. non-oropharyngeal epidermoid carcinoma 2. oropharyngeal epidermoid carcinoma previously treated
safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients

Conditions: Chronic Myeloid Leukemia

Summary: this study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase


Eligibility criteria:
inclusion criteria: -patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry exclusion criteria: * treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including hsct) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide * uncontrolled congestive heart failure or hypertension * myocardial infarction or unstable angina pectoris within past 12 months * known t315i mutations * qtcf \>450 msec * significant arrhythmias other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic myeloid leukemia, cml, nilotinib, myelogenous, philadelphia chromosome
prospective study of sinonasal and skull-base tumours management

Conditions: Nasal Neoplasm; Nasal Neoplasm Benign; Skull Base Neoplasms; Skull Base Osteomyelitis; Sinonasal Disorder; Sinus Disease

Summary: this observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. the main questions it aims to answer are: * what is the caseload of patients with the included pathology in our centre * what are the results of management of these cases * what are the epidemiological characteristics of included patients * what is the quality of life of included patients.

sinonasal tumours and tumours that involve the adjacent skull base are rare entities. however, their management necessitates a special knowledge of ent areas and specifics of sinonasal anatomy and skull base. due to the heterogeneity of pathological diagnoses of sinonasal and skull-base tumours, one of the main aims of this study is to provide epidemiological characteristics in our geographical area. furthermore, to compare with other tertiary referral centres, we will analyse management results, which could improve the management of these diseases. since the sinonasal area and skull base house several important neuroanatomical structures and senses, we aim to provide an analysis of the patient-reported quality of life.

Eligibility criteria:
inclusion criteria: * sinonasal and/or skull-base cancer * sinonasal disease expanding through the skull-base * the patient's written informed consent exclusion criteria: * lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement
surgical stress after laparoscopic compared to open liver resection

Conditions: Insulin Resistance

Summary: the purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.


Eligibility criteria:
inclusion criteria: * asa 1-2 * left hemihepatectomy(liver resection) * left lateral sectionectomy(liver resection) exclusion criteria: * patients with diabetes mellitus * drug abuse * bmi \>24 or \<18

Keywords: laparoscopic liver resection cytokine release
elderly falls prevention with slife program in primary care

Conditions: Accidental Falls; Frailty; Elderly; Activities, Motor

Summary: this study aims to guide older people living in the community on appropriate strategies within a fall prevention program. this program is aimed at training in daily activities carried out through group workshops (guided by a physiotherapist) and at preventing risk situations at home.

two-arm, non-blind, non-inferiority experimental design. multicenter, randomized trial. the study tries to assess whether a group intervention following the principles of the slife program is more effective than an usual health advice reducing the incidence of falls.

Eligibility criteria:
inclusion criteria: * people older than 65 years of age * living at home * speak and read spanish exclusion criteria: * heart failure (nyha class iii and iv) * recent stroke (\<6 months) * parkinson's disease * in active cancer treatment (last 6 months) * gold class iii and iv chronic obstructive pulmonary disease * unstable lower extremity fracture * amputated lower extremity * treatment less than 6 months of depression * uncontrolled resting blood pressure of a systolic \> 160 or diastolic \> 100 or more * unavailability for intervention, planned travel or relocation more than 2 months within the first 6 months of the study * moderate to severe cognitive impairment (mini mental cognitive assessment \<23) * current participation in another interventional clinical trial
a study to investigate the effects of food and morning versus evening on single and multiple doses of ono-5334 in healthy post menopausal women

Conditions: Healthy Post Menopausal Women

Summary: the study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ono-5334 in healthy post menopausal women.

this study consists of 2 parts. part 1; the study will investigate the effects of morning versus evening dosing on the pharmacodynamics of multiple doses of 150 mg of ono-5334 in healthy post menopausal women. the study design will be single-blind and 16 subjects will be enrolled. part 2; the study will investigate the effects of food on the pharmacokinetics of a single dose of 150mg of ono-5334 in healthy post menopausal women. 12 subjects will be enrolled.

Eligibility criteria:
inclusion criteria: * healthy caucasian women aged between 55 to 75 years inclusive * subjects weighing at least 50 kg with mass index between 19 to 30 kg/m2 inclusive * subjects who have been amenorrhoeic for at least 5 years. * subjects who are confirmed at screening visit to have oestradiol and follicle stimulating hormone (fsh) levels consistent with menopause exclusion criteria: * subjects who have a clinically relevant history or presence of any clinically significant disease or disorder * subjects who have a clinically relevant history of insomnia or sleep disorders