Kornimate/medical-research-clean huggingface dataset:
mad study of nx210c

Conditions: Healthy Elderly

Summary: this study will investigate the safety and tolerability of multiple intravenous infusions of nx210c with two ascending doses as well as nx210c pharmacokinetics (pk), and pharmacodynamics (pd) effects in healthy elderly subjects.

the prevalence of neurocognitive disorders (ncd), including neurodegenerative diseases (ndds) such as alzheimer's disease (ad) is increasing. ndds are most common and prevalent in elderly people worldwide and cause progressive neuronal dysfunction, toxicities, and death. these diseases lead to an irreversible weakening of all brain functions, including cognitive impairment. there is not one single cause of cognitive impairment but rather several factors that can contribute to trigger or accelerate cognitive decline. preclinical in vitro and in vivo data have shown that nx210c exhibits important properties, which may be suitable for the treatment of neurological disorders in humans. (i.e., neuroprotection, neuro-regeneration, synaptic transmission, positive effects on cognition, anti-neuroinflammatory action). the first in human single ascending dose study has been completed. in that study, nx210 was administered and well tolerated. the current project is a multiple ascending dose (mad) study and designed to investigate the safety, tolerability, pk and pharmacodynamics (pd) effects of multiple intravenous infusions of nx210c in two dose levels in healthy elderly subjects.

Eligibility criteria:
inclusion criteria: * healthy adult male or female participants, as determined by the investigator, based upon a medical evaluation including medical history, physical examination, neurological examination, mmse, mri, lab tests and ecg. * aged ≥ 55 years, inclusive at screening, and with a maximum weight of 110 kg. * body mass index (bmi) between 18 and 32 kg/m2, inclusive at screening. exclusion criteria: * evidence of any history, or any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator * history of any known neurologic disease, cognitive impairment, or diagnosed decline in cognitive function abnormal related to the age, or history of seizure, (significant) head trauma, loss of consciousness, or significant neuroimaging findings, including but not limited to any previously known or discovered abnormalities on screening brain mri that evoke neurological diagnosis indicative of clinically significant abnormality
bioavailability of four oral prototype extended release formulations with bi 11634 in healthy male volunteers

Conditions: Healthy

Summary: to compare the oral bioavailability and rate of absorption of four prototype extended-release (er) formulations with bi 11634 (single doses) to immediate-release (ir) tablets in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy caucasian males according to the following criteria, based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate), 12-lead ecg, clinical laboratory tests * age ≥21 and ≤45 years * haemoglobin within the normal ranges. * body mass index (bmi) ≥18.5 and bmi ≤29.9 kg/m2 * signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (gcp) and the local legislation exclusion criteria: * relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * relevant surgery of gastrointestinal tract * history of any bleeding disorder or acute blood coagulation defect, for the subject itself or any person of his family as far as known * history of gastric ulcera and cholecystectomy * occult blood in faeces * relevant diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * history of relevant orthostatic hypotension, fainting spells or blackouts * relevant chronic or acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial * use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial * use of acetylsalicylic acid or any other non-steroidal anti-inflammatory drugs (nsaid) within 2 weeks of study start until the end of study * participation in another trial with an investigational drug within two months prior to administration or during the trial * alcohol abuse (more than 40 g/day) * drug abuse * blood donation (more than 100 ml within four weeks prior to administration or during the trial) * excessive physical activities (within one week prior to administration or during the trial) * any laboratory value outside the reference range that is of clinical relevance * inability to understand and comply with protocol requirements, instructions and protocol stated restrictions, the nature, scope and possible consequences of the study * subjects with a history within the past six weeks of closed-head or torso trauma or deceleration injury such as an automobile accident or fall from a significant height
intraoperative normal saline administration and acute kidney injury in patients undergoing liver transplantation

Conditions: End Stage Liver DIsease; Liver Transplant; Complications; Liver Cirrhosis

Summary: the investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. the investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

liver transplantation requires a long operation time and is often associated with a significant amount of surgical bleeding. it is common for the anesthesiologist to infuse large amounts of fluid or blood products due to bleeding, hemodynamic instability, or ascites drainage. therefore, in the anesthesia for liver transplantation, optimal management of fluid administration is necessary and the choice of the type of crystalloid may affect the prognosis or the incidence of postoperative complications of patients. the investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. the investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

Eligibility criteria:
inclusion criteria: * consecutive patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2004 and 2018 exclusion criteria: * patients with baseline renal dysfunction of hepatorenal syndrome or chronic kidney disease * missing preoperative serum creatinine value * missing other baseline or outcome variables * patients who received retransplantation
uremic toxins in the intensive care units (icu): patients with lactate acidosis

Conditions: Acute Renal Failure

Summary: study of the kinetics of uremic toxins in the icu patients with acute renal failure, in order to optimize the dialysis dose: patients with lactate acidosis. the sampling of blood and dialysate will be done during dialysis with different durations (4, 6 and 8 h)


Eligibility criteria:
inclusion criteria: * includes icu patients with lactate acidosis with acute renal failure exclusion criteria:

Keywords: icu patients lactate acidosis
psychometric validation of a french-language version of the perma-profiler: tools for assessing multidimensional subjective well-being

Conditions: Psychiatric Disorder

Summary: the main objective of this study is to carry out the psychometric validation of the perma-profiler in a population representative of the general french population and in comparison with the reference questionnaire the perma-profiler.


Eligibility criteria:
inclusion criteria: * adult (≥18 years). * person able to read and understand french * person willing to participate in this study exclusion criteria: * the person does not understand the french language * person has a history of traumatic brain injury * the person refuses to participate in the study
study of temzolomide and gleevec in advanced melanoma

Conditions: Melanoma; Advanced Melanoma

Summary: this study has been designed to evaluate the side effects of gleevec when given in combination with temzolomide; and to learn more about how these drugs work in the body and whether this combination is useful in treating patients with melanoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * prior chemotherapy, immunotherapy, radiation therapy (phase i portion only), cytokine, biologic, or vaccine therapy is permitted, however no prior treatment with temozolomide * measurable disease * performance status \<= 2 * life expectancy greater than 3 months exclusion criteria: * no prior treatment with temozolomide or imatinib mesylate * organ allografts * prior radiotherapy, or prior intratumor injection therapy, to areas of measurable disease that are used as target indicator lesions, unless progression has occurred at that site or measurable disease has developed outside the treatment area * pregnancy or lactation * history of second cancer * known hypersensitivity to temozolomide or imatinib * use of any experimental therapy within 3 weeks prior to baseline evaluations done prior to enrollment

Keywords: temzolomide gleevec melanoma advanced melanoma phase ii
guided meditation during radiation therapy for brain tumors

Conditions: Brain Neoplasms

Summary: the goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (rt) in patients with brain tumors. the main question it aims to answer is: • what is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each rt session. researchers will compare this intervention to standard of care (no intervention) during rt.


Eligibility criteria:
inclusion criteria: * participant aged ≥ 18 years. * radiologically confirmed tumor of the brain. note: participants may have tumor resected after diagnosis. * eligible to undergo radiation treatment for brain tumor for 25-33 treatments. * willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment. * karnofsky performance score ≥ 60 or ecog performance score ≤ 2. * moca mini score ≥ 11 * able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. exclusion criteria: * active suicidal ideation or active psychotic state in the opinion of the investigator. * an unstable illness that, in the opinion of the investigator, would interfere with study treatment. * prior radiation therapy to the brain. * inability to understand and/or speak the english language.
thyroid autotransplantation in quadriceps femoris muscle

Conditions: Thyroid

Summary: providing an almost natural ectopic thyroid in patients undergoing total thyroidectomy, remains a challenging subject that can benefits patients with a non-pharmacological substitute for their normal gland. this study seeks to prove that thyroid autotransplantation is possible and reliable.

total thyroidectomy, rather thyroidectomy, is currently widely accepted as the modality of choice for treatment of benign thyroid disorders that require surgical excision. the goal of post-thyroidectomy management is to reach a "safe physiological status" of thyroid hormonal profile. although exogenous levothyroxine replacement has long been safely used as a replacement after total thyroidectomy, it is not considered optimal, as it is bounded by patient's compliance with the treatment and follow-up schedule, effect of mal-absorption, and the inability to compensate for daily physiological alterations. the concept of endocrinal tissue auto-transplantation has been largely investigated in the case of parathyroid gland, and to a lesser extent for pancreatic islets. although both the experimental studies of thyroid autotransplantation and the early case reports of lingual thyroid autotransplantations have shown encouraging results, a very limited number of clinical studies investigated thyroid autotransplantation in adult patients with benign thyroid disorders. moreover, the discrepancy in the patients' characteristics and thyroid autotransplantation technique in these studies hinders the standardization of thyroid autotransplantation for clinical practice. hypothetically, thyroid autotransplantation offers and attractive alternative for subtotal thyroidectomy, as it enables the preservation of native responsive thyroid tissue in an accessible location, and, thus, evades the risk of possible regrowth in the neck region. the present preliminary clinical study is conducted to investigate the feasibility and outcome of thyroid autotransplantation after total thyroidectomy for patients with benign thyroid disorders (other than thyroiditis).

Eligibility criteria:
inclusion criteria: * adult male or female with simple nodular goitre. * patients who are fit for surgery. exclusion criteria: * children (male or female) * patients with malignant or recurrent goitre * patients who are unfit for surgery
lymphatic morphology of fontan patients

Conditions: Lymphatic Abnormality; Plastic Bronchitis; Protein-Losing Enteropathies; Univentricular Heart; Congenital Heart Disease

Summary: the fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. however, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (ple) and peripheral edema. the hypothesis is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity. the morphology will be described using t2-weighted non-contrast mri.

the fontan procedure has revolutionized the treatment of patients born with a congenital univentricular heart defect. however, over time, it is associated with severe lymphatic complications such as plastic bronchitis, protein-losing enteropathy (ple) and peripheral edema. it has been proposed that these complications arise due to a elevated central venous pressure of the changed circulation. the hypothesis of the study is that patients with a univentricular circulation have a changed morphology which may be associated with both the degree of lymphatic complications and their physical capacity. the morphology will be described using t2-weighted non-contrast mri. the main lymphatic vessel, the thoracic duct, will be rendered and measured using 3d software, and the lymphatic changes characterized by dr. yoav dori (chop, pennsylvania, usa), using a newly published grading system. the above will be correlated with the amount of complications experienced by the patients, and their physical capacity measured by both ipaq questionaire and cpx test. the study population consists of patients with a fontan circulation operated at incor heart institute, são paulo, brasil and hospital das clínicas, ribeirão preto, brasil. exclusion criteria were mental illness, genetic syndromes and age \<18 years. the patient group will be compared with age, gender and weight matched healthy controls.

Eligibility criteria:
inclusion criteria: - fontan circulation exclusion criteria: * age \<18 years * mental illness * genetic syndromes
study to assess the efficacy of cognitex

Conditions: Elderly; Memory Impairment

Summary: a single-center, open label study to assess the efficacy of cognitex in elderly subjects with memory impairment


Eligibility criteria:
inclusion criteria: 1. ability to give written informed consent. 2. age: 90≥ years ≥60. 3. gender: male and female. 4. memory test performance within or below the mean established for adults in the computerized cognitive tool, with a maximum of four neuropsychological subtests scored 1.5 sd above the mean. 5. language: subjects must be able to read, write and speak hebrew. 6. ability to perform tests and interviews. exclusion criteria: 1. evidence of delirium, confusion, or other disturbances of consciousness. 2. evidence of dementia. 3. any neurological disorder that could produce cognitive deterioration. such disorders include parkinson's disease, stroke, intracranial hemorrhage, local brain lesions including tumors and normal pressure hydrocephalus. 4. history of any infective or inflammatory brain disease including those of viral, fungal, or syphilitic etiologies. 5. head injury immediately preceding cognitive deterioration. 6. evidence of depression as determined by a the geriatric depression scale (short version) score of 5 or more. 7. current diagnosis or history of alcoholism or drug dependence. 8. any medical disorder that could produce cognitive deterioration including renal, respiratory, cardiac, and hepatic disease, diabetes mellitus, endocrine, metabolic or hematological disturbances unless well controlled, and malignancy not in remission for more than two years 9. use of anti-clotting or antiplatelet medications or supplements for less than two years. 10. history of clotting or platelet disorder unless well controlled. 11. use of any supplement that may significantly affect cognitive functioning during the month prior to study initiation. 12. use of any experimental medication within 1 month prior to screening or as concomitant medications. 13. history of hypersensitivity or allergy to soy or fish.

Keywords: cognitex subjects
hiv resilience qualitative study hong kong

Conditions: HIV Infections; Elderly Infection

Summary: this qualitative study aims to explore lived experiences of older adults living with hiv in hong kong. twenty older chinese adults of age 50 or above will be recruited from an hiv specialist clinic providing hiv care in the public service. qualitative, semi-structured interview will be conducted to explore risk factors contributing to life stress and adversity, and protective factors associated with resilience. the qualitative data will be delineated to propose a typology of older adults living with hiv as characterized by their unmet needs, barriers and facilitators of resilience-building.

objectives: the intersection of hiv and ageing has important implications for health and psychosocial wellbeing, which are complex in nature. in a setting with growing number of older adults living with hiv in hong kong, as in many other regions in the world, addressing their unmet healthcare needs is paramount. failure to understand and recognise their needs will impede healthy ageing. this study aims to explore lived experiences of older adults living with hiv in regards their complex needs and resilience-building, with the specific objectives of examining associated factors of resilience development at individual-social- and structural level. design: a qualitative study targeting 20 older chinese adults of age 50 or above who are living with hiv who are divided under the following groups: group a: chinese men who have sex with men and group b: chinese heterosexual males and females settings: clinic providing hiv care in the public service methods: participants will be recruited through purposive sampling based on their age (50-64; 65 and above of age), gender and sexual orientation. qualitative, semi-structured interview will be conducted to explore: (1) risk factors contributing to life stress and adversity, and (2) protective factors associated with resilience. interviews will be digitally recorded, transcribed verbatim and managed using "nvivo" software. themes will be developed, constantly compared within and between targeted groups, using grounded theory approach. anticipated outcomes: the qualitative data will be delineated to propose a typology of older adults living with hiv as characterized by their (1) unmet needs, (2) barriers of resilience-building, and (3) facilitators of resilience-building.

Eligibility criteria:
inclusion criteria: * known and confirmed hiv infection * age of 50 or above * normally living in hong kong * permanent residents of hong kong * able to communicate in cantonese exclusion criteria: * active psychiatric disorder * prisoners or under institutionalized care * unable to give consent

Keywords: hiv resilience qualitative research elderly
azithromycin treatment of hospitalized children with asthmatic symptoms

Conditions: Childhood Asthma With Acute Exacerbation

Summary: the purpose of this double-blind, randomized, controlled clinical trial is to investigate the effect of a three-day azithromycin treatment versus placebo treatment in children aged 1-5 years who are hospitalized due to asthma-like symptoms.

the children who are included must be have a known history with one or more previous episodes of asthmatic symptoms and is currently / have received treatment with saba as monotherapy or saba in combination with ics and possibly ltra. the primary purpose during hospitalization is to replicate the results of our previous study, where it was shown that azithromycin treatment significantly shortened the duration of the asthmatic episode. in this study, hospitalized children who provide a more diverse group than the copsac2010 cohort will be included. in addition, the study aims to focus on examining the individual response to treatment. the expectation is that in the future the study will be able to contribute to personal treatment based on the child's respiratory microbiome and / or immunological profile so that only the children who will benefit from the azithromycin treatment will receive it. the expectation is also that the study will contribute to an increased understanding of the influence of bacteria on asthma-like episodes in preschool children, and thus will lead to an evidence-based better treatment of these. the study hypothesis is: ● that antibiotic treatment with azithromycin compared to placebo in the patient group aged 1-5 years, known with previous episode (s) with asthma-like symptoms and is currently / have received treatment with saba as monotherapy, or saba in combination with ics and possibly ltra, will lead to a significant reduction in the symptom burden and duration of the asthmatic episode in days.

Eligibility criteria:
inclusion criteria: * previous episode(s) with asthma-like symptoms and / medical treatment with saba as mono-therapy or saba in combination with ics and possibly ltra. * the parent/guardian(s) agrees to admit the child and is willing to follow the procedure of the trial. * the child is between 12-71 months old. * fluent danish skills with parents / guardians. exclusion criteria: * known allergy to macrolide antibiotics. * known impaired liver function. * known renal impairment. * known with neurological or psychiatric diseases. * known with congenital or documented acquired qt interval. * known for clinically relevant bradycardia, cardiac arrhythmia or severe heart failure. * clinical signs of pneumonia (objective findings, including severe tachypnoea: respiratory rate (rf)\> 50 and / or fever: temperature\> 39 °c and / or c-reactive protein (crp)\> 50).

Keywords: asthma infections wheeze antibiotics