Kornimate/medical-research-clean huggingface dataset:
study of the pharmacokinetics and safety of carfilzomib in patients with advanced malignancies and hepatic impairment

Conditions: Solid Tumors; Hematologic Malignancies; Hepatic Impairment

Summary: the purpose of this study is to compare the safety and efficacy of carfilzomib, including measuring the amount of the study drug in the blood at certain times following dosing. this study is being done in people with varying degrees of liver function to see if they respond differently to the study drug.


Eligibility criteria:
key inclusion criteria: 1. relapsed or progressive advanced malignancies (solid tumors or hematologic malignancies) 2. at least ≥ 2 prior treatment regimens for the underlying malignancy 3. confirmed advanced solid tumor or hematologic malignancy 4. measurable or evaluable disease 5. clinical diagnosis of chronic hepatic impairment that is stable with no acute worsening of liver failure within one month prior to enrollment. hepatic impairment will be assessed as per national cancer institute organ dysfunction working group criteria (nci-odwg) schema and will fall into one of the following three categories: * cohort 2 (mild): bilirubin \> 1-1.5 × upper limit of the normal range (uln) or aspartate aminotransferase (ast) \> uln, but bilirubin ≤ uln * cohort 3 (moderate): ≥ 1.6-3 × uln; any ast * cohort 4 (severe): bilirubin \> 3 × uln; any ast exception to inclusion criterion #5 for subjects with normal hepatic function: all subjects enrolled with normal hepatic function (n=10) must meet all inclusion criteria as outlined with the exception of inclusion criterion #5, which should be substituted with the following criterion to be enrolled into the study: - cohort 1 (normal hepatic function): bilirubin ≤ uln; ast ≤ uln 6. eastern cooperative oncology group (ecog) performance status 0-2 7. left ventricular ejection fraction (lvef) ≥ 40% 8. adequate renal function (calculated creatinine clearance ≥ 30 ml/min) 9. active congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment key exclusion criteria: 1. subjects with symptomatic brain metastasis or central nervous system (cns) disease 2. significant neurotoxicity (grade 2 with pain or higher) at the time of enrolment 3. known human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv) infection (exception: subjects with chronic or cleared hbv and hcv infection and stable liver function tests \[bilirubin, ast\] will be allowed)
automated system for monitoring urine output in intensive care patients

Conditions: Acute Kidney Injury in the ICU

Summary: acute kidney injury is common among icu-admitted patients, and is associated with increased morbidity and mortality. early recognition is essential to prevent complications. in this study we aim to examine whether strict monitoring of urine output may reduce the incidence of acute kidney injury, allow for less positive fluid balance and reduce the clinical symptoms of fluid overload in icu patients. currently we monitor urine output using a urinometer, with manual recording. from june 2022 we will begin routine use of an automated urine monitoring system in the icu and test its effect on the parameters listed above. we will conduct a before-after retrospective intervention. the group of patients in whom the automated system will be used, from june 2022 to january 2024, will be the study group. the patients admitted to the icu in the period between january 2021 and june 2022 will be the control group. we will include patients aged 18-100, who were admitted to the general intensive care unit in meir medical center from january 2021 to january 2024, and had admission time longer than 48 hours. patients without a urinary catheter will not be included. the study will be conducted in the format of observational data collection from hospital files and computerized systems (metavision system and chameleon system). we estimate that we will include about 900 patients in the study group and about 900 in the control group. all demographic and inpatient data will be statistically examined by a qualified statistician depending on the type of data.


Eligibility criteria:
inclusion criteria: patients aged 18-100, who were admitted to the general intensive care unit in meir medical center from january 2021 to january 2024, and had admission times longer than 48 hours. - exclusion criteria: patients without a urinary catheter, patients with admission times less than 48 hours. -
ultrasound assessment of atherosclerotic plaque burden and cardiovascular risk: a 10-year prospective study

Conditions: Cardiovascular Diseases; Fatty Liver; Atherosclerosis of Femoral Artery; Carotid Artery Plaque; Stroke; Ischemic Cardiovascular Disease; Atheroscleroses

Summary: the p-sonar study is a large, observational, prospective cohort study. the overall aim of the study is to investigate whether plaque burden estimation by 2d ultrasound of the carotid and femoral arteries may enhance cardiovascular risk prediction beyond norrisk-2

design: the p-sonar study is a prospective cohort study of all men and women aged 45-74 years attending a health check at one of 10 ultrasound clinics in norway. time schedule: study inclusion and baseline examinations took place in the period april 2022- march 20025. current status: ultrasound follow-up examinations take place from january 2025 - december 2029.

Eligibility criteria:
inclusion criteria: persons attending a health check during the study period. - exclusion criteria: * if they do not consent to participate

Keywords: ultrasound carotid arteries femoral arteries cardiovascular disseases plaque burden subclinical atherosclerosis norrisk2 ischemic stroke ischemic heart disease atherosclerotic cardiovascular disease
internet-based coaching for young adults with neuropsychiatric disorders

Conditions: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Tourette's Disorder

Summary: purpose: to develop a model for internet-based support and coaching to young adults with neuropsychiatric disorders (npd). to improve the individual's psychosocial functioning and his/her understanding of how he/she is functioning. npd comprise problems with social interaction, attention, impulse control and hyperactivity. the most common npd diagnoses are adhd (attention deficit hyperactivity disorder), autism spectrum condition (asc) and tourette's disorder (td). in this study the investigators use internet-based treatment for young adults with npd. method: support/coaching by using communication over the internet (chat and e-mail) with individuals with npd. twice every week during 8 weeks, young adults with npd are offered support and coaching over the internet by psychologist/educational therapist with great experience from npd. the individuals are assessed before and after treatment pertaining to quality of life, sense of coherence, self-esteem, depressive and anxiety symptoms, and parents' evaluation of the young adult's situation.

aims: to develop an internet-based support and coaching model for young people with autism spectrum disorder (asd) and/or attention-deficit/hyperactivity disorder (adhd), and to validate the model. method: a user centred design was applied to develop a model for internet-based support and coaching, where individuals received eight-week support via internet (chat). the model was validated by ten individuals, 15 to 26 years of age, with asd and/or adhd. self-report questionnaires (sense of coherence (soc), the rosenberg self esteem scale, the manchester short assessment of quality of life (mansa), montgomery åsberg depression rating scale (madrs), and the hospital anxiety and depression scale (had)) were distributed before and after intervention. a structured interview regarding the quality of the model, the patient perspective of care and rehabilitation process (pocr), was used after the intervention. results: the validation showed significant improvement of soc, self-esteem and subjective quality of life at follow-up and the majority perceived high fulfilment/importance on the pocr. conclusions: the model can be an important complement to other interventions for young people with asd and/or adhd.

Eligibility criteria:
inclusion criteria: * the individuals had to fulfill a diagnosis of adhd, tourette's disorder and/or an asd (autistic disorder, asperger's disorder or pervasive developmental disorder not otherwise specified (pdd nos), according to the dsm-iv (apa, 1994). * the inclusion age was between 15 and 26 years. exclusion criteria: * mental retardation, * current psychosis, * current major depression, * current alcohol and/or substance abuse/dependence, * severe dyslexia and/or severe psychosocial problems (e.g. criminality)

Keywords: adhd autism spectrum condition tourette's disorder internet-based chat coach
onyx evaluation in the endovascular treatment of intracranial dural arteriovenous fistulae

Conditions: Arteriovenous Fistula

Summary: the objective of this study is to evaluate the safety and performance post last embolization with onyx


Eligibility criteria:
inclusion criteria: * the patient has an intracranial davf which could be treated by onyx embolization, whether or not associated to other embolization products. * the patient is at least 18 years of age. exclusion criteria: * the patient needs to be treated for the davf with another treatment option (for example by surgery) than embolization within a period of less than 6 months (to be counted as from the first treatment) * the patient participates to another clinical study during the treatment period for his/her davf, evaluating another medical devices, procedure or medication. * the patient refuses to give consent to the collection and processing of data required for centralized monitoring. * a condition which could jeopardize follow-up of the patient.

Keywords: davf arteriovenous fistula onyx
evaluation of the clinical, neuropsychological and psychosocial situation of patient with eating disorders.

Conditions: Eating Disorders

Summary: eating disorders (ed) are serious mental illnesses with an excess mortality and many affects in the quality of life of patients and thier relatives. management of ed is very difficult : the prognosis remains relatively poor both in terms of remission rate and quality of life. in this context, the contribution of new strategies for pathophysiological exploration and the development of therapeutic options are crucial. in this project the investigators aim to constitute un cohort of patients from a day unit specialized in the management of ed. a prospective follow-up will be offered to patients to assess their clinical and psycho-social evolution. the overall objective is to identify which factors are prognostic of clinical improvement of the ed. we also want to better characterize patients that will migrate from diagnosis to another.

the investigators propose to assess, with a cohort of patients with ed the prognostic value of cognitive abnormalities associated with ed (cognitive flexibility and central coherence) they will recruit 370 patients suffering from a current ed (anorexia, bulimia, binge eating disorder, eating disorder not otherwise specified). each patient will be reassessed every year for 3 years.

Eligibility criteria:
inclusion criteria: * respond to dsm 4 criteria for ed * age 15 to 65 years * signing an informed consent. * affiliated to a social security scheme or being the beneficiary of such a scheme. exclusion criteria: * manifest inability of the subject to understand / perform clinical and neuropsychological evaluations and tasks * major protected by law (guardianship) * privation of liberty by judicial or administrative decision * pregnant or lactating women

Keywords: eating disoders neuropsychology pronostic
kinesio taping in stroke patient

Conditions: Stroke; Cardiovascular Diseases; Physical Disability

Summary: despite being nearly independent in daily life, chronic high-functioning stroke survivors still experienced mild impairments in skilled hand function. kinesio taping (kt) has been used to help stroke patients improve their balance and ambulation. few studies explored the effects of kt on fine motor function in stroke patients. the purpose of this study was to investigate the hand function performance of high-functioning stroke survivors after kt. participants were divided into two groups: kt group and control group. last two days, the kt group received kt intervention. after the taping was removed, baseline and post-test evaluation were conducted. outcome measures included muscle strength, range of motion (rom), spasticity, fine motor function, and self-reported upper limb disability. the results revealed that the kt group had less spasticity, increasing rom trend, and improved fine motor function and disability. kt improved spasticity, active movement, and muscle flexibility, resulting in more skilled and delicate hand function in chronic high-functioning stroke survivors.


Eligibility criteria:
inclusion criteria: * (1) stroke with unilateral hemiparesis, (2) onset duration \> 6 months, (3) brunnstrom stage in the proximal and distal parts of the upper extremity \> stage iii, and (4) adequate cognitive ability to understand and cooperate with the experiment procedure. exclusion criteria: * participants with skin problem (such as allergies, open wound), a history of upper extremity musculoskeletal diseases (such as fractures, tendon ruptures), or other peripheral neurological or systemic diseases were excluded.

Keywords: kinesio tape high-functioning stroke hand function stroke
randomized trial for pharmacogenomics-based proton pump inhibitor therapy in children

Conditions: Gastroesophageal Reflux

Summary: proton pump inhibitors are administered to children as off-label use in japan. the purpose of this study is to evaluate the effects of cyp2c19 genotypes on pharmacokinetic /pharmacodynamic profiles of ppi in children. the results will provide the beneficial information for the individualized medicine of ppi in children.


Eligibility criteria:
inclusion criteria: * patients with gastroesophageal reflux * the patient's parent or guardian gives written informed consent including pharmacogenomic analysis * the patient is willing and able to give assent to participate. exclusion criteria: * serious hepatic disease, pulmonary disease, renal disease and blood disorder * inadequate clinical conditions

Keywords: gastroesophageal reflux children lansoprazole cytochrome p450 2c19 (cyp2c19) pharmacogenomics genetic polymorphisms individualized medicine pharmacokinetics/dynamics
combination chemotherapy before surgery in treating patients with mesothelioma of the lung

Conditions: Malignant Mesothelioma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. purpose: phase ii trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung.

objectives: * determine the proportion of patients with potentially resectable mesothelioma of the pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine. * determine the response rate and overall survival of patients treated with this regimen. * determine the tolerability of this regimen in these patients. * determine the number of postoperative hospitalization days and occurrence and duration of surgical complications in patients treated with this regimen. * determine the quality of life of patients treated with this regimen. * compare the proportion of patients who report psychological distress at 3 months after surgery vs at study registration. outline: patients receive cisplatin iv on day 1 and gemcitabine iv on days 1, 8, and 15. treatment repeats every 28 days for 3 courses. within 6 weeks after completion of chemotherapy, patients undergo restaging by ct scan followed by surgical resection. quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery, and then at 3 and 6 months. patients are followed every 3 months for 1 year and then every 6 months thereafter. projected accrual: a total of 61 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically and clinically confirmed pleural mesothelioma * stages t1-3, n0-2, m0 by ct scan of the chest * mediastinoscopy required for staging of mediastinal lymph nodes * considered completely resectable patient characteristics: age: * over 18 performance status: * who 0-2 life expectancy: * not specified hematopoietic: * not specified hepatic: * no severe liver disease renal: * creatinine no greater than 1.7 mg/dl cardiac: * adequate cardiac function * no cardiac disease that would preclude forced hydration or surgery pulmonary: * predicted postoperative fev_1 greater than 1 by spirometry other: * no contraindication to surgery * no other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer * no uncontrolled infection * no uncontrolled diabetes * no neurologic or psychiatric disorders that would preclude study compliance * no other serious illnesses that would preclude study participation * no other circumstances that would preclude study participation prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * no prior pleurectomy or lung resection except for diagnostic purposes

Keywords: stage ia malignant mesothelioma stage ib malignant mesothelioma stage ii malignant mesothelioma stage iii malignant mesothelioma
bcma-targeted lcar-bcdr cells in patients with relapsed/refractory multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: this is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, pk, and anti-tumor efficacy of lcar-bcdr cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.


Eligibility criteria:
inclusion criteria: 1. the subject voluntarily participates in the clinical study; fully understand and be informed of the study and sign the informed consent (informed consent form, icf); willing to follow and able to complete all test procedures; informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease; 2. subjects ≥ 18 years of age. 3. documented initial diagnosis of mm according to imwg diagnostic criteria. 4. presence of measurable disease at screening. 5. received a pi and an imid (except thalidomide). 6. received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (pd) was documented by imwg criteria as the best response to the regimen. also, subjects refractory or intolerant to any pi and any imid in their previous treatment afterwards are eligible. 7. expected survival ≥ 3 months. 8. clinical laboratory values meet screening visit criteria 9. fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -hcg\]) at screening time and before initial treatment with cyclophosphamide and fludarabine; exclusion criteria: 1. no response to prior bcma-targeted car-t therapy (except in subjects who relapsed after cr to prior car-t treatment). 2. prior treatment with any antibody targeting bcma. 3. diagnosed or pretreated for an invasive malignancy other than multiple myeloma. 4. prior anti-tumor treatment (before pretreatment) with insufficient washout period. 5. known active, or prior history of central nervous system (cns) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma. 6. positive of any hepatitis b surface antigen (hbsag), hepatitis b virus deoxyribonucleic acid (hbv dna), hepatitis c antibody (hcv-ab), hepatitis c virus ribonucleic acid (hcv rna), human immunodeficiency virus antibody (hiv-ab) at the time of screening. 7. serious underlying medical conditions 8. male subjects who have a birth plan during the study period or within 1 year after the study treatment. 9. female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment. 10. the investigator considered that the subjects were not suitable for any conditions of participation in the study.
retarded phosphatidylcholine in steroid-dependent chronic active ulcerative colitis

Conditions: Ulcerative Colitis; Phosphatidylcholine

Summary: the purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis. the hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. the background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (uc) compared to healthy controls and patients with crohn´s disease. the content was measured in non-inflamed areas of the colon in uc. thus, we evaluate whether a substitution of colonic pc is an effective method for steroid dependent uc. see: gut. 2005 jul;54(7):966-71. stremmel et al.

design: prospective, randomized, placebo-controlled, double-blinded study. population: 60 patients with chronic active ulcerative colitis and steroid dependency inclusion: chronic active ulcerative colitis, clinical index 5 or more, endoscopic index 5 or more, steroid dependent course since at least 4 months. main criteria: complete steroid reduction

Eligibility criteria:
inclusion criteria: * signed letter of content * diagnosis of ulcerative colitis (clinical, endoscopic and histologic evidence) * chronic active and steroid dependent course over at least 4 months (cai \> 4, eai \> 4) exclusion criteria: * infectious colitis * toxic megacolon * ulcerative proctitis or less than 20cm inflamed

Keywords: retarded phosphatidylcholine chronic active steroid