Kornimate/medical-research-clean huggingface dataset:
safety, pharmacokinetics and pharmacodynamics after single and multiple dosing of azd5423 in japanese healthy male subjects

Conditions: Healthy

Summary: the purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post acth stimulation, dehydroepiandrosterone sulphate (dheas), osteocalcin and 24 hours urine cortisol) of azd5423 following administration of single and multiple ascending doses in healthy male japanese subjects.


Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture * male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after the last dose of investigational product * have a body mass index (bmi) between 18 and 27 kg/m2 and weight at least 50 kg and no more than 80 kg * be able to inhale from the i-nebⓡ according to given instruction exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product * any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigators * any positive results on screening for serum hepatitis b surface antigen, hepatitis c antibody, human immunodeficiency virus (hiv) and syphilis

Keywords: safety tolerability pharmacokinetics pharmacodynamics azd5423 japanese
patient important gastrointestinal bleeding in the icu

Conditions: Gastro Intestinal Bleeding; Patient Engagement; Family Members

Summary: this study will engage patients and families to create a definition of what matters most to them about upper gastrointestinal (gi) bleeding. this information will help to define the outcome of "patient-important gi bleeding" which is a secondary endpoint for the ongoing international randomized trial revise (nct03374800), comparing acid suppression versus no acid suppression in the intensive care unit (icu). other outcomes in revise are clinically important upper gi bleeding, mortality, pneumonia and clostridioides difficile infection. guided by patient and family input, a series of open-ended questions will elicit patient and family views about what matters most about this complication in interviews and focus groups. the investigators will develop the definition of "patient-important gi bleeding" by analyzing interview and focus group transcripts of critically ill survivors and family members of critically ill patients who may or may not have had gi bleeding, and who were not enrolled in the revise trial. patient and family perspectives (anticipated to be different from what clinicians consider to be clinically important gi bleeding), will be used to refine a new trial outcome for research on gi bleeding in the intensive care unit (icu). also, study results will help clinicians understand how to better support patients and families; to explain testing and treatment options when gi bleeding occurs in practice in the icu.

this is a parallel mixed-methods multi-center study. design: this is a parallel mixed-methods multi-center study in which the qualitative data are dominant and patient and family involvement is paramount. data collection will be quantitative and qualitative interviews and focus groups. the objective is to elicit views from patients and families regarding the features of a gi bleed that are important to patients. the investigators will recruit 6-10 patients and 6-10 family members for individual interviews, along with 6-10 focus groups consisting of 3-4 patients and family members.

Eligibility criteria:
patient inclusion criteria: * was admitted to an icu, whether or not a gi bleed developed in the icu * \> 18 years of age family member inclusion criteria: * family members of icu patients whose loved one was in the icu for at least 72 hours, whether or not their family member developed a gi bleed * \> 18 years of age patient/family member exclusion criteria: * prohibitive communication challenges (e.g., serious psychological or psychiatric illness in the patient and/or family, inability of patient and/or family to communicate reasonably well in english or other languages for which an interpreter exists - professional staff or otherwise); * patient or family declines. * family member whose loved one died in icu
evaluation of the pan-microbiome and host immune response in cf

Conditions: Cystic Fibrosis (CF)

Summary: investigators will examine temporal and regional dynamic changes in the microbiome of cystic fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses. while chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (cf), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. this is a multi center, longitudinal cohort of adult cystic fibrosis subjects recruit4ed from nyu and columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in cystic fibrosis (cf). there will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.


Eligibility criteria:
inclusion criteria: * cf diagnosis * able to produce sputum * no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days * fev1 ≥ 30% of predicted. exclusion criteria: * initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhdnase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment * introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment * use of new investigational therapy within 4 weeks * current smoker; use of oral corticosteroids * initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks. * liver enzymes \> 3 times the upper limit * pregnancy additional exclusion criteria for bronchoscopy subgroup (aims 2 and 3): * fev1 \< 50% of predicted. * significant cardiovascular disease defined as abnormal ekg, known or suspected coronary artery disease or congestive heart failure. * significant renal disease (creatinine clearance \< 30%). * severe malnutrition (bmi \<18kg/m2)

Keywords: cystic fibrosis (cf)
gut microbiome in orthopaedics

Conditions: Total Knee Arthroplasty; Inflammation; Gastrointestinal Health

Summary: patients having knee replacement surgery regularly experience joint pain and compromised bone quality leading to implant loosening and periprosthetic fractures. the role of the gut microbiome, which is the collection of bacteria and other microbes within the human gastrointestinal tract, is just beginning to be recognized, including its potential effects on pain, infection, and loosening after total joint replacement. antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, but they also harm gut microbiota and reduce their potentially beneficial effects. probiotics may have a role to play in enhancing bone quality and decreasing synovial inflammation after joint replacement surgery, and this study will explore the potential relationship of probiotic use with implant migration, bone density, and patient outcomes. this study is a randomized, controlled, double-blinded trial comparing probiotic use with placebo in post-menopausal women undergoing primary total knee replacement. the main questions it aims to answer are: * to compare implant migration between groups from baseline to six weeks post-surgery * to compare bone density and joint inflammation between groups from baseline to six weeks post-surgery * to compare gut microbiome composition and patient-reported outcome measures between groups from baseline to six weeks post-surgery

participants will take a daily probiotic (de111®) or placebo once daily starting 3 weeks prior to surgery until six weeks after surgery. the following will be completed at baseline and 6 weeks: * bloodwork * fecal sample collection * mrsa swab * patient-reported outcome measures * ct imaging scan in addition, the following will be done: * intraoperative fluid and tissue collection * positron emission tomography-magnetic resonance imaging (pet-mri) scan at 6 weeks post-surgery researchers will compare the probiotic and placebo groups for any significant differences in implant stability, bone quality, inflammation, gut microbiome composition, and pain.

Eligibility criteria:
inclusion criteria: * signed informed consent obtained prior to any study-related activities * postmenopausal female patients of london health sciences centre (lhsc) aged 55-75 years * scheduled to undergo primary total knee replacement for osteoarthritis exclusion criteria: * unable to understand and respond to the provided questionnaires * male sex * inflammatory arthritis * periprosthetic infection * prior surgery with hardware insertion in the target knee * metabolic syndrome * inflammatory bowel disease * body mass index \<18.5 kg/m2 * immune-compromised condition (e.g. aids, lymphoma, patients undergoing long-term corticosteroid treatment) * any contraindications for pet-mri * allergy to cephalosporin antibiotics
rheumatologic adverse events and cancer immunotherapy

Conditions: Oncology; Autoimmunity; Arthritis; Adverse Drug Event

Summary: in this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. in this form, we try to determine if he presents rheumatologic complications of his immunotherapy. if the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs. the number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist. the aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.


Eligibility criteria:
inclusion criteria: * patient with cancer needed to be treated by immunotherapy exclusion criteria: * patient already treated by immunotherapy
arm training in standing after stroke

Conditions: Stroke

Summary: this study will examine the feasibility of providing task-oriented arm training in standing or during walking in individuals with movement deficits due to stroke. participants will received 24 sessions of arm training in standing over an 8-week period that focus on arm and hand function.

residual motor deficits are common after stroke and often have a negative impact on the performance of functional activities and overall quality of life. a frequently reported contribution to these functional limitations is an inability to incorporate the weaker arm and hand into daily activities. while rehabilitation interventions can improve arm functional capacity, these improvements often do not translate into increased real-world arm use which is often reduced after stroke. the performance of skilled arm and hand movements in standing requires precise coordination between upper extremity movement and balance control. many everyday functional tasks that require the arm are performed in standing (e.g. opening a door or meal preparation at the kitchen counter), however, training of arm function in rehabilitation is often done in sitting. an important rehabilitation approach may be to create a training environment that resembles the way the arm is used in everyday life (i.e. standing). this study will examine the feasibility of providing task-oriented, functional arm training in standing and during walking in individuals with motor deficits due to stroke.

Eligibility criteria:
inclusion criteria: * at least 18 years old * had a stroke at least 6 months prior to enrollment * show evidence of continued arm and hand weakness * have some ability to move the arm and hand that is weaker from the stroke * be able to stand with minimal assistance or less without support of the weaker arm for at least 2 minutes * be able to follow two-step commands. exclusion criteria: * acute medical issues that would interfere with participation * another neurologic diagnosis that may impact movement (e.g. parkinson's disease) * severe apraxia or hemispatial neglect * pain that interferes with arm movement or standing

Keywords: rehabilitation upper extremity
stress-mri assessment after right coronary artery cto recanalization

Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease; Coronary Artery Stenosis

Summary: the hypothesis of this study is that stress-mri is a clinically significant method of myocardial perfusion assessment after coronary angioplasty with stenting of right coronary artery (rca) chronic total occlusion (cto) is performed.


Eligibility criteria:
inclusion criteria: * stable angina, ccs fc ii-iv * "right-dominance" coronary circulation according to coronary angiography * absence of other significant atherosclerotic coronary lesions (more than 65%) * high risk of myocardium ischemia according to stress-mri data (perfusion defect in 2 or more segments in the area of interest) * signed, documented informed consent prior to admission to the study exclusion criteria: * acute coronary syndrome * contraindications for adenosine stress test * low and moderate risk of myocardium ischemia according to stress-mri data (perfusion defect in less than 2 segments in the area of interest)

Keywords: coronary stenosis drug-eluting stent coronary angioplasty with stenting ischemic heart disease chronic total occlusion right coronary artery stress-mri
bone structure and strength evaluated by extreme-ct scan before and after treatment of hyper- and hypothyroidism

Conditions: Hyperthyroidism; Hypothyroidism

Summary: the aim to evaluate the bone structure by dexa-scan, extreme ct and bone markers before and one year after treatment for a thyroid functional disorder

the aim to evaluate the bone structure by dexa-scan, extreme ct and bone markers before and one year after treatment for a thyroid functional disorder. women with hyper- og hypothyroidism are included and undergo usual treatment. patients are stratified into 10 different groups.

Eligibility criteria:
inclusion criteria: informed consent, female sex, age 20-85 years, indication for treatment of the thyroid disorder, exclusion criteria: pregnancy, renal insufficiency, known osteoporosis, other disease that may affect bone metabolism, medication which affects bone metabolism, t-score below -3.5, thyroidea ophthalmopathy with indication for steroids,

Keywords: osteoporosis hyperthyroidism hypothyroidism
hearing and cognition in aging adults

Conditions: Presbycusis

Summary: this cohort study is expected to provide valuable insights into the complex interplay between auditory and cognitive functions and how they change over time. the results of this study will have important implications for the prevention, diagnosis, and treatment of age-related hearing and cognitive disorders

the aim of the study is to identify the early perceptual and cognitive alterations related to age-related hearing loss or presbycusis, establish a correlation between the degree of hearing loss and the deterioration of cognitive functions, and examine the effectiveness of hearing loss management in reversing observed cognitive impairments. this project has the potential to shed light on the importance of early detection of hearing impairments in preventing cognitive decline. the data collected from this cohort, rigorously assessed for both auditory and cognitive functions, could serve as the basis for several high-level scientific investigations.

Eligibility criteria:
inclusion criteria: * normal hearing (pure tone audiometry \< or = 20 db) * residency in one of the three neighborhoods : * affiliation with a social security system exclusion criteria: * individuals under guardianship, trusteeship or curators * history of neurological pathologies * taking of psychotropic medication.

Keywords: presbycusis aging cognitive decline speech in noise sound localisation hearing loss
effectiveness of a manual therapy protocol in patients with masticatory muscle disorders

Conditions: Temporomandibular Disorder

Summary: comparing the efficiency between manual therapy protocol and effleurage in patients with temporomandibular disorders.

the investigators want to get better insights into the outcome of a manual therapy protocol compare with effleurage. the treatment is meant for people who has masticatory muscle disorders. besides, if the trial can reduce the pain's intensity and the trial can improve range of motion in the dysfunction of temporomandibular joint. the results will be register on the short and long term.

Eligibility criteria:
inclusion criteria: * patients who are between 18 and 60 years old. * patients who have myofascial pain or myofascial pain and restricted oral opening taking into account diagnostic criteria for temporomandibular disorders (dc/tmd). * patients who have pain in their masticatory muscles while they are doing functional activities with their temporomandibular joint for, at least, the last six months. exclusion criteria: * patients who cannot receive manual therapy. * patients who took or have been taking pills in the last two months before they start in the trial like: antidepressants, antiepileptics, muscle relaxants or medications for metabolic diseases; because they affect the musculoskeletal system. * surgery intervention in the temporomandibular joint. * patients who have received physiotherapy sessions in the last six months. * red flags: malignant or inflammatory tumors, infectious diseases that contraindicate manual therapy, cervical surgery, previous history of whiplash, fibromyalgia, trigeminal neuralgia, osteoarthritis or rheumatoid arthritis. * patients who lost their teeth (excluding the third molar) or people using a total or partial dentures.
naltrexone maintenance treatment of alcoholism

Conditions: Alcoholism

Summary: the purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence. * expresses a desire to cut down or stop drinking. exclusion criteria: * currently meets criteria for dependence on substances other than alcohol. * history of opiate dependence or evidence of current opiate use. * significant medical disorders that will increase potential risk or interfere with study participation. * liver function tests more than 3 times normal or elevated bilirubin. * female patients who are pregnant, nursing, or not using a reliable method of birth control. * inability to understand and provide a consent form. * treatment with an investigational drug during the previous month. * prior treatment with naltrexone. * chronic treatment with any narcotic-containing medications during the previous month. * sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists. * current treatment with disulfiram. * more than 6 weeks of abstinence. * meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
patient neuropsychological outcomes after laser ablation

Conditions: Cognitive Change

Summary: patient neuropsychological outcomes after laser ablation

this is a multicenter sub-study that will include comprehensive neuropsychological assessment data collection done at baseline (within 1 year prior to the index litt procedure) and at follow-up (at least 6 months from the index litt procedure). visual field testing will be conducted in a subset of enrolled patients. up to 250 subjects may be enrolled at up to 15 study sites.

Eligibility criteria:
inclusion criteria: 1. patient or legally authorized representative provides written authorization and/or consent. 2. patient is enrolled in the laantern trial and had an epilepsy diagnosis without the presence of a malignant brain tumor. 3. patient is 16 years of age or older. 4. patient has completed a baseline comprehensive neuropsychological assessment with a neuropsychologist. exclusion criteria: 1. patient does not complete the index litt procedure as specified in the laantern registry.

Keywords: quality of life neuropsychological test scores visual field
the use of candy and honey in decreasing salivary gland damage following radioiodine therapy for thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131i (radioiodine) therapy.


Eligibility criteria:
inclusion criteria: * \>18 years old * they had a histological diagnosis of papillary, follicular, medullary or anaplastic thyroid cancer * they had undergone total thyroidectomy * they were able to provide consent exclusion criteria: * patients who had distant metastases, * a history of salivary-gland disorders, * collagen tissue disease * diabetes mellitus, * previous radioiodine therapy or external radiation to the head or neck * allergy to the honey

Keywords: thyroid cancer radioiodine treatment xerostomia sialadenitis