Kornimate/medical-research-clean huggingface dataset:
cohort imea 070 -lenacapavir compassional

Conditions: HIV Infections

Summary: immunovirological follow-up and safety of hiv-infected patients receiving lenacapavir under compassionate access in france between 01/01/2021 and 12/31/2023

retrospective descriptive cohort of patients who received lenacapavir under compassionate access in france with 50 patients in 25 sites in france

Eligibility criteria:
inclusion criteria: * patients who received compassionate access to len between 01/01/2021 and 20/12/202 exclusion criteria: * absence of visits with virological assessment subsequent to inclusion visit * participant opposition to use of follow-up data

Keywords: lenacapavir under compassionate access france cohort
detection of circulating tumor cells in peripheral blood from healthy volunteers and patients with cancer

Conditions: Circulating Tumor Cells (CTCs)

Summary: to address the challenges of isolating and analyzing rare cells, this study aims to validate technical diagnostic instrumentation, tests, protocols and analysis to correlate the number of circulating tumor cells present in whole blood for predicting cancer prognosis and treatment efficacy. investigators propose to enroll and follow cohorts of cancer patients. blood samples will be collected from these patients at regular intervals as determined by their doctors. the patient's disease progression will be monitored over the lifetime of this study. the specific aims are to isolate, enumerate and analyze the number of circulating tumor cells (ctcs) in patient blood using chip-based sorting, filtration and imaging techniques. investigators will also use this study to optimize diagnostic instrumentation, test protocols and downstream ctc analysis. investigators may also correlate the results of these tests with the prognosis of the patients as well as any clinical evidence (e.g. from radiological imaging scans). while investigators focus on prognosis in this study, these correlated tests potentially may also be valuable in future studies for early diagnosis and monitoring of cancer.


Eligibility criteria:
inclusion criteria: for inclusion in the first stage of the study, subjects must fulfill all of the following criteria: 1. provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. 2. patients diagnosed with stage 4 breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts. for inclusion in the second stage of the study, subjects must fulfill all of the following criteria: 1. provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study. 2. patients diagnosed with breast cancer or other types of cancer or chosen to be part of one of the negative control population cohorts. exclusion criteria: the following is regarded as a criterion for exclusion from the study and applicable to both 2 stages : 1. subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the study.
a combined multidomain intervention to prevent cognitive decline associated with cardiovascular risk factors.

Conditions: Aging; Cardiovascular Risk Factor

Summary: the actioncardiorisk trial is designed to investigate the effect of aerobic and progressive resistance training exercises combined with cognitive training, on neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.

the proportion of older adults is on the rise in canada, with the fastest growth recorded among those seventy years of age or older. the prevalence of cardiovascular risk factors (cvrf) such as diabetes, hypertension, and high cholesterol increases drastically with age. individuals with cvrf often show impaired cognition, such as attention and memory deficits. in healthy older adults, exercise training and cognitive stimulation can help enhance cognitive performances. more precisely, combined intervention, including physical and cognitive training, has shown beneficial effects on cognition in older adults without cognitive impairment and with mild cognitive impairment. however, the effect of such programs on cognition in individuals with cvrf is not well documented. this project compares the effect of a physical exercise program, including aerobic and resistance training, alone or combined with cognitive training on cognitive performances and brain imaging outcomes in individuals with cvrf and healthy controls.

Eligibility criteria:
inclusion criteria: * adult aged 60 and older, * normal or corrected vision and normal hearing for their age range, * no cognitive impairment (mini-mental state examination - mmse ≥ 25), * inactive (\< 150 min of physical activity per week). exclusion criteria: * mmse ≤ 24 or diagnosis of dementia, * uncontrolled psychological / psychiatric condition within the past 6 months, * neurological disease, * severe exercise intolerance, * respiratory disease (e.g., asthma, copd), * excessive alcohol consumption (\> 15 drinks/week), * documented cerebral, peripheral or coronary atherosclerotic disease, * chronic systolic or diastolic heart failure, * symptomatic aortic stenosis, * atrial fibrillation, * automatic implantable defibrillator or permanent pacemaker, * malignant exertional arrhythmias, * non-cardiopulmonary limitation to exercise (e.g., arthritis).

Keywords: aging cardiovascular risk factor cognition combined intervention cognitive training physical exercise brain functions biomarkers
study the effect of blood transfusion on oxidant-antioxidant status in term and near-term neonates

Conditions: Blood Transfusion Complication; Oxidative Stress

Summary: primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.

oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (tac) and malondialdehyde (mda), as well as antioxidant minerals, in 65 term and near-term neonates.

Eligibility criteria:
inclusion criteria: * premature neonates ≤36 weeks in need for blood transfusion. exclusion criteria: * critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies) * extremely low birth weight neonates(\<1000gm birth weight ) * recipient of blood transfusion before enrollment in the study. * neonates planned for exchange transfusion .
incidence of mri sacro-iliac (si) joint anomalies in women with spondyloarthritis (spa)

Conditions: Spondylarthritis

Summary: retrospective study comparing the incidence of inflammatory and structural lesions seen on mri of the sacro-iliac (si) joints in a population of women affected by spondyloarthritis (spa) and control women population (misia study nct02956824). a previous study (misia) demonstrate spa may be misdiagnosed on mri in postpartum women due to increased stress on the joint following pregnancy and childbirth, as mri of the si joints may show lesions that could mimics spa. the primary objective of this study is to compare the incidence and pattern of mri inflammatory and structural lesions of the si joints between spa and control women, and determine differentiation criteria in spa women.


Eligibility criteria:
inclusion criteria: * women aged 18 to 50 years old * spa diagnosed * pelvis mri performed exclusion criteria: - pelvis mri unavailable

Keywords: diagnostic imaging magnetic resonance imaging sacroiliac joint anomalies
a retrospective study on extranodal dlbcl

Conditions: Lymphoma; Extranodal Lymphoma; Diffuse Large B Cell Lymphoma

Summary: the aim of this study is to prospectively collect clinical information of patients with extranodal dlbcl, assess the effectiveness of treatment for extranodal dlbcl in the real world, and explore the optimal treatment strategies in real-world populations.

dlbcl is a highly common aggressive non-hodgkin's lymphoma. for specific extranodal sites of dlbcl, traditional chemotherapy protocols often cannot provide satisfactory results for patients. the aim of this study is to prospectively collect clinical information of patients with extranodal dlbcl, including the distribution of involved sites (such as central nervous system, testes, skin, breast, gastrointestinal tract, etc.), prognosis of diffuse large b-cell lymphoma with involvement of different extranodal sites, genetic mutation characteristics, correlation with molecular subtypes, impact of different treatment regimens on efficacy, assess the effectiveness of treatment for extranodal dlbcl in the real world, and explore the optimal treatment strategies in real-world populations.

Eligibility criteria:
inclusion criteria: * 1. ≥ 18 years (including 18 years). * 2. pathologically diagnosed with diffuse large b-cell lymphoma according to the 2016 who classification, including non-specific types and various special subtypes. * 3. newly diagnosed dlbcl with involvement of extranodal organs. * 4. patients who have received clinical treatment for lymphoma. * 5.patients with measurable lesions, including at least one effective efficacy assessment. exclusion criteria: * 1. patients receiving supportive care only. * 2. patients who cannot obtain effective efficacy assessment data.

Keywords: lymphoma extranodal
treatment of knee arthrosis with platelet-derived growth factors vs. hyaluronic acid.

Conditions: Knee Osteoarthrosis

Summary: primary aim of this trial was to assess efficacy three intraarticular injections of platelet lysate when compared to hyaluronic acid. additional objectives were to compare the treatment groups in terms of a number of functional scales and of number of adverse events.

intra-articular injections of hyaluronic acid are effective in improving symptoms and slow disease progression, but are not able to revert the damage mechanism and trigger cartilage healing. growth factors included in prp could stimulate cartilage repair, normalize synovial fluid viscoelasticity, induce a correction in tissue damage, improve articular function, control pain and ameliorate quality of life. primary aim of this trial was to assess, among patients with grade ii/iii osteoarthrosis of the knee, efficacy (as determined by improvement at mri 6 months after the first injection) of three intraarticular injections of platelet lysate when compared to hyaluronic acid. additional objectives were to compare the treatment groups in terms of a number of functional scales (womac, lysholm, tegner knee, scale, aks, lequesne, vas) and of number of adverse events.

Eligibility criteria:
inclusion criteria: * grade ii/iii oa of the knee demonstrated at mri17,18, according to shahriaree classification system - modified * no previous oa treatment with local hyaluronic acid or steroid injections * ife expectancy \>1 year * no ongoing pregnancy * ability to understand and complete clinical and functional scales lysholm, womac, aks, vas * written consent.

Keywords: knee arthrosis platelet-derived growth factors
impact of air quality on exacerbations of copd in the somme

Conditions: Acute Exacerbation Copd

Summary: all copd patients with a diagnosis of acute exacerbation in emergency room in university hospital of amiens-picardie between 01/01/2017 and 31/12/2017. the investigator will collect for each patient the home address and the work address. the duration of 1 year was chosen to take into account seasonal variations. in parallel, a daily report of the rate of ozone, particles (pm2.5 and pm10), dioxide nitrogen but also odours and pollens will be done by atmo picardie.


Eligibility criteria:
inclusion criteria: * all copd patients with a diagnosis of acute exacerbation of copd in the emergency room. the definition of copd and acute exacerbation are the official definition of the société de pneumologie en langue française. exclusion criteria: * no exclusion criteria

Keywords: pollution ozone copd particles
evaluating a peer-facilitated skills-based intervention for caregivers of concurrent disordered youth

Conditions: Caregiver Burden

Summary: families of adolescents struggling with comorbid mental illness and addiction problems typically experience considerable emotional, financial and social burdens. concurrent disorders (cds) within families contribute to added stress and interpersonal conflict, as well as disrupt normal routines such as social and occupational activities. despite the difficulties associated with being a family member of youth with cd, current mental health and addictions practices neglect to address this population. the overall purpose of this project is to assess the feasibility and clinical effectiveness of a dialectical behaviour therapy skills (dbt) based training group for families of youth with cds. the following main hypothesis will be examined: family members of youth with concurrent disorders who participate in a 12-week skills group led by therapists and/or peer facilitators will show reduced caregiver burden and parenting stress from pre to post treatment.

this study is designed to assess whether a 12-week skills based intervention is feasible and effective in addressing issues experienced by families of youth with concurrent mental health and addiction problems. eligible subjects will be invited to participate in the following intervention: the intervention is based on a dbt skills training model for families, the family connections© model. this model was originally developed for families of individuals with borderline personality disorder (bpd) and later adapted for this study for cd.the family connections model is a 12-week (90-minute once-weekly sessions) skills training group designed to be led by therapists and/or peer support facilitators. the family groups in this study will be facilitated by two family members with experience being part of a family group and training and they will work with or without a professional therapist. groups will consist of a maximum of 16 family members. family members will receive a manual which describes the skills to be covered. the skills-training will be delivered in two cities in collaboration with two organizations: camh, toronto and the children's centre thunder bay. participants will be recruited through advertisements posted on flyers and relevant websites. the family intervention will evaluate change over time and use a mixed between/within subject, pre/post and follow-up design. assessments will occur at baseline, mid-skills training (4 weeks), after 12-week skills training (post intervention), and at 12-week post intervention follow-up.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, * literacy in english, * are family members of an adolescent scoring in the clinical range on at least one subscale of the child behavior checklist (cbcl) exclusion criteria: * has adolescent children participating in the sister youth intervention protocol #069-2011.

Keywords: concurrent disorders mental health addictions caregiver burden
study of a diabetes prevention patient activation clinical decision support tool

Conditions: PreDiabetes; Lifestyle, Healthy; Activation, Patient

Summary: the investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. the investigators objective is to design and pilot test a prediabetes clinical decision support (cds) tool in the electronic health record (ehr) that will assess the patient's activation level based on responses to a questionnaire. based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to prediabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, dpp) to support patient activation.

patient activation, which incorporates elements of self-efficacy and readiness to change, is particularly important in managing conditions like pre-diabetes, where the mainstay of treatment is behavioral lifestyle change and self-management. unfortunately, primary care physicians (pcps) often do not have adequate training on how to promote patient activation. traditionally, patient decision aids are used in shared decision-making to help elicit patient preferences and guide treatment options. however, the guides primarily focus on reviewing treatment options rather than increasing patient activation, which is key to successful and efficient behavioral counseling. the patient activation measure (pam) is a widely used and validated patient-reported outcome measure for assessing patient activation. studies have demonstrated that using pam to tailor care to a patient's activation level decreased health service utilization while improving clinical outcomes like blood pressure and self-management behaviors. the investigators overarching goal is to increase the percentage of patients engaging in diabetes prevention activities to reduce the incidence of diabetes. the investigators objective is to design and pilot test a pre-diabetes clinical decision support (cds) tool in the electronic health record (ehr) that will assess the patient's activation level based on responses to a questionnaire. based on the patient's assessed level of activation, the tool will generate several communication recommendations to guide clinicians in conversations related to pre-diabetes/lifestyle change and tailor recommendations about available resources (e.g., care manager, health coach, dpp) to support patient activation.

Eligibility criteria:
inclusion criteria: * prediabetes * patient at johns hopkins general internal medicine clinic at green spring station * mychart account exclusion criteria: * history of diabetes * non-english speaker * severe intellectual disability or psychiatric comorbidities
safety and tolerability of toleromune grass in grass allergic subjects with rhinoconjunctivitis

Conditions: Allergy

Summary: grass pollen allergens are universally recognised as a major cause of allergic diseases in humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis. worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. toleromune grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy. the purpose of the present study is to evaluate the safety and tolerability of multiple ascending doses of toleromune grass in subjects allergic to grass.

this study is designed as a randomised, double-blind, placebo-controlled study to evaluate the safety and tolerability of escalating multiple doses of toleromune grass in subjects with a documented history of allergic rhinoconjunctivitis on exposure to grass. the efficacy of toleromune hdm will also be explored lpsr, epsr, cpt and levels of grass specific ige. the study will consist of 3 study periods. in period 1, screening will be performed up to a maximum of 6 weeks before randomisation. period 2 (treatment period) will consist of 4 visits (visits 3a-3d) four weeks apart. the first cohort will receive the lowest dose and successive dose groups will increasing doses of toleromune grass, provided the first administration of the previous dose was safe and well tolerated. in period 3, 2 post-treatment challenge visits will take place, the first will be 2 weeks after the last administration in the treatment period and the second will be 17 weeks after the first administration. follow-up will be conducted 3-10 days after the second ptc.

Eligibility criteria:
inclusion criteria: * male or female, aged 18-65 years * minimum 2 year history of rhinoconjunctivitis on exposure to grass * positive skin prick test to whole grass allergen * lpsr to whole grass allergen 8-10 hours after intradermal injection of greater than 35mm diameter response * positive cpt to whole grass allergen with a score ≥4 exclusion criteria: * subjects with a history of asthma * subjects with an fev1 \<80% of predicted * subjects with a rye grass specific ige \>100 ku/l * subjects with an acute phase skin response to whole grass allergen with a mean wheal diameter \> 50 mm * subjects who score \>1 for redness of conjunctiva or who have any watering or itchiness in the eye before administration of the cpt * treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquillisers or psychoactive drugs * history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment)

Keywords: grass allergy immunotherapy rhinoconjunctivitis toleromune grass
humidity in incubators for tiny infants

Conditions: Extremely Premature Infant

Summary: the objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (nicu). the hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. higher (90%) and lower (70%) starting humidity will be compared.


Eligibility criteria:
inclusion criteria: * inborn infant of \<25 weeks' gestation admitted to the nicu exclusion criteria: * infants with known congenital skin conditions * outborn infants * infants with unknown gestational age prior to birth

Keywords: humidification protocol
investigating usability of c-sight in the homes of brain injury survivors

Conditions: Stroke; Brain Injuries; Spatial Neglect; Attention Deficit

Summary: a brain injury can damage the brain, so that it no longer receives information about the space around one side of the world. if this happens, people may not be aware of anything on one side, usually the same side they also lost their movement (the most affected side). this severe condition is called spatial neglect. currently there is no recommended diagnostic test or clinically-proven treatment for the condition. in a recent study, the investigators found a long-lasting reduction in neglect if people practiced picking-up an object with their unaffected hand. this intervention is called spatial inattention grasping home-based therapy (sight). it requires people to lift wooden rods of different lengths. once a person is familiar with the task, they can practice on their own at a time convenient to them in their homes. the investigators have developed the first computerized version of sight (c-sight) as well as a novel diagnostic test for neglect using portable low-cost motion-tracking technology that can be used in the patient's home. in the proposed study, the investigators will investigate how usable and acceptable this technology is in people's homes. stroke survivors (recruited from community settings) will undergo a 7-day self-led training at their homes with c-sight. at the end of the intervention, 1:1 semi-structured interviews will be carried out with both stroke survivors and carers to investigate usability and acceptability of c-sight. moreover, spatial neglect, carer burden and motor function will be assessed pre- and post-completion of c-sight.


Eligibility criteria:
inclusion criteria: * +18 * suffered brain injury * have tv with around 2 meters in front of it to be able to run the therapy * live in the norfolk, suffolk, essex or cambridgeshire (uk) * no other pre-existing neurological disorders (such as dementia) * no language impairment (able to follow 1-stage command) * mental capacity to consent * no known learning disability * no major psychiatric illness * no history of substance abuse

Keywords: telerehabilitation spatial neglect sight computorized therapy stroke innatention self-admnistered therapy usability