Kornimate/medical-research-clean huggingface dataset:
davos alzheimer's collaborative healthcare system preparedness to increase cognitive assessment rates for older adults

Conditions: Subjective Cognitive Decline; Alzheimer Dementia

Summary: in this study the investigators explore a pragmatic strategy to increase cognitive screening rates in the community. the investigators will compare the monetary value of different combinations of scd questionnaires, digital cognitive tests, and blood alzheimer's disease (ad) biomarkers to identify the best approach for primary care settings.

the investigators aim to perform a cluster-randomized study, exploring the effectiveness, efficiency, and acceptability of a pragmatic strategy to increase cognitive screening rates in the community. participants will be older adults attending social and cultural centers in the greater munich area. the investigators will compare the monetary value of different combinations of scd questionnaires, digital cognitive tests, and blood ad biomarkers to identify the best approach for primary care settings. as secondary aims, qualitative interviews will be conducted with general practitioners (gps) and their patients to explore the acceptability of the proposed new screening strategy; furthermore, the diagnostic utility of an artificial intelligence-based automated analysis of speech will be assessed. the initiative will not only generate novel insights into the optimal approach for large-scale cognitive screening in the general population, but also contribute to an urgently required cultural change in germany, resulting in a sustainable solution for effective and efficient early recognition and prevention of dementia.

Eligibility criteria:
inclusion criteria: * age 65 years or older exclusion criteria: * younger than 65 years

Keywords: subjective cognitive decline mild cognitive impairment community setting digital cognitive tests blood biomarker
igar-breast teleop trial

Conditions: Breast Cancer

Summary: the aim of this study is to answer the question: can the igar-breast safely and effectively perform teleoperative breast biopsies? this is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. in addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.

in this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring mri-guided biopsy for diagnosis or staging will be screened consecutively. patients who meet the inclusion criteria will be approached for consent to participate in the study. upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the igar-breast system, while the radiologist operates the system from a remote site. all consenting participants will be followed up for the assessment of the secondary outcome measure. a total of 5-10 participants will be consented for the pilot investigation. each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.

Eligibility criteria:
inclusion criteria: * female subjects aged ≥ 18 years who require mri-guided breast biopsy for diagnosis and/or staging subjects are able to tolerate procedures for the mri exclusion criteria: * subjects who refuse or are unable to give free and informed consent subjects requiring more than one breast biopsy subjects with breast implants or other foreign bodies subjects for whom investigator determines igar-breast enabled mri-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) subjects who are pregnant or who plan to become pregnant during the course of the study

Keywords: diagnostic, imaging, mri
myocardial involvement in carriers of duchenne muscular dystrophy: an mri-study

Conditions: Carrier of Duchenne Muscular Dystrophy

Summary: carriers of duchenne muscular dystrophy (dmd) often have no severe symptoms of the scelet muscles, but they may develop a poor heart function due to the involvement of the heart muscle. ultrasound of the heart is recommended, but it can detect a cardiac affection only after the heart has already become weaker. cardiac magnetic resonance tomography can detect myocardial fibrosis already at preserved heart function and may facilitate early therapy. in our study, diagnosed carriers of dmd will undergo examinations of the heart by blood tests, ekg, heart ultrasound and magnetic resonance at enrollment and after one year in order to assess the extent of cardiac affection and its association with the clinical development.


Eligibility criteria:
inclusion criteria: genetic and/or histological identification as a carrier of dmd age above 18 years able and willing to conform to the requirements of the study provided written informed consent exclusion of pregnancy in women of childbearing potential exclusion criteria: claustrophobia excessive obesity to an extent where cmr cannot be performed chronic renal failure with a gfr \<30 ml/min/1,73m² implanted pacemakers/defibrillators severe arrhythmia inability to cooperate during the cmr known intolerance to gadolinium positive pregnancy test unable or unwilling to conform to the study protocol

Keywords: duchenne muscular dystrophy carrier cardiac mri myocardial fibrosis female
veteran's perceptions of ketamine-assisted psychotherapy for depression and end-of-life

Conditions: Depression

Summary: the goal of this exploratory, mixed-method design study is to gather qualitative and quantitative data obtained through interviews and questionnaires with veterans who are currently enrolled at the va for healthcare. the main question this study aims to answer is: how do veterans aged 65+ who are enrolled for care at the va understand ketamine assisted psychotherapy for depression and for end-of-life distress? using a story-completion approach, participants will be provided with a brief story starter involving a fictitious character and scenario and asking them to complete the story. few contextual details will be offered about the character. in responding to ambiguous cues, participants are thought to project their conscious and subconscious perceptions about the phenomenon in question onto the story, a useful method for exploring stigmatized topics. the purpose of this exercise is to ascertain the participants attitudes and perceptions regarding ketamine assisted psychotherapy.

veterans will be informed of the study by their va providers (behavioral health clinic, primary care, etc). veterans who are interested will have their contact information passed on to the study investigators. once screened and enrolled in the study veterans will complete a brief demographics form, and three brief symptom screening questionnaires: patient health questionnaire 9, ten item personality inventory, and the death anxiety questionnaire. participants then engage in the recorded interview during which they are provided with a brief story starter, as described above. in the story, a fictitious veteran with a diagnosis of depression is offered an opportunity to engage in ketamine assisted psychotherapy (kap). the veteran then receives a cancer diagnosis and is again offered a chance to consider kap. participants are asked to share what questions, concerns, hopes, and expectations may be present for the fictitious veteran in the story. interviews will then be transcribed and the pi and the collaborators will read all transcriptions and generate recurring themes that can be reliably coded. the investigators will then code the transcripts for the presence of themes. data analytic plans include calculating the prevalence of each theme and examining their correlates with measures of severity of symptoms as well as any demographic variables. it is hoped that this data can inform educational and other roll-out efforts within the va system around kap.

Eligibility criteria:
inclusion criteria: * veterans enrolled in va care. * age 65 or older. * fluent in written and spoken english. exclusion criteria: * cognitively impaired to the extent that patient cannot comprehend the survey.
assessment of recombinant hat-rdt specificity

Conditions: Human African Trypanosomiasis

Summary: human african trypanosomiasis hat, or sleeping sickness, is a tropical disease caused mainly by the parasite trypanosoma brucei gambiense (ghat). after a severe epidemic in the 1990s, the world health organization (who) now targets elimination of transmission of ghat by the year 2030, which heavily relies on its diagnosis and treatment. traditional screening tests (like catt or rapid diagnostic tests (rdts)) are based on the detection of antibodies against the parasite using native antigens, which are costly and dangerous to produce. new serological tests, using recombinant antigens, have been developed, but little is known about their field performance. the primary objective of this study is to assess the specificity of the newly-developed recombinant rdts, since it will become very relevant as we move forward towards a screen\&treat strategy. we will also compare the diagnostic accuracy and overall performance of ielisa and molecular testing.

this prospective study will follow two different mobile units as they go on their routine screening of the ghat endemic population. study participants will be enrolled during the routine screening, and after providing informed consent, they will be asked for a 4.5 ml venous blood sample. the three rdts (hat sero-k-set, rhat sero-k-set, bioline hat 2.0) and catt will be performed on site, while part of the sample will be mixed with dna/rna shield for molecular analysis and the rest will be left to decant, to collect plasma for ielisa and tl. confirmatory tests will be performed in the field on any seropositive individual. should any case be confirmed, treatment will be offered, free of charge, following pnltha guidelines. the obtained data will allow for a very precise estimation of the specificity of the newly developed recombinant rdts. this study does not aim to determine the sensitivity of these tests since, due to the very low prevalence, the chance of having sufficient seropositive samples and/or finding a true case are very slim. the diagnostic performance of ielisa and novel molecular tests will also be determined.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent (and assent for minors 12-17years old) * be enrolled in routine hat screening activities dony by the mobile unit (pnltha mobile unit routine active screening teams that visit villages at risk for hat). people living in the village are targeted for screening. * participants must be at least 12 years old exclusion criteria: * chilrden younger than 12 years old * previously treated for hat * refusal to provide informed consent

Keywords: rapid diagnostic test serologic and molecular diagnosis of hat neglected tropical disease
empagliflozin in patients with cirrhosis and ascites

Conditions: Cirrhosis; Liver Failure

Summary: a proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. we will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.


Eligibility criteria:
inclusion criteria: 1. patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on aasld guidelines)10 and who do not require large volume paracenteses 2. egfr \>= 30ml/min/1.73 m2 3. \>=18 years old exclusion criteria: 1. hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis) 2. direct bilirubin \>=3 mg/dl 3. systolic blood pressure \< 100 mmhg 4. active malignancy including hepatocellular carcinoma undergoing treatment 5. history of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections 6. use of sglt-2 inhibitors in the last 10 days, or previous use with intolerance 7. type 1 diabetes 8. history of frequent hypoglycemic episodes 9. use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with sglt2 inhibitor. 10. hepatic hydrothorax requiring thoracentesis in the prior 8 weeks 11. hepatic encephalopathy grade ii or greater at the time of enrollment 12. patients who have had tips placed 13. previous liver transplant 14. participation in another trial with an investigational drug within the 30 days prior to informed consent 15. pregnancy or breastfeeding 16. inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease) 17. change in diuretic dose in the prior 2 weeks 18. patients with hospitalization for alcoholic hepatitis in the past 6 months 19. significant worsening of creatinine (more than 50% increase) in the past 4 weeks 20. meld-na \> or equal to 20 21. hemoglobin \<8
efficacy and safety of interwoven self-expandable nitinol stent for femropopliteal arterial occlusive diseases

Conditions: Femoropopliteal Occlusive Disease

Summary: interwoven self-expandable stent is a recent endovascular method to treat complex femoropopliteal lesions trying to reach a reasonable patency and durability like in surgical bypass.

stenting of the femoro-popliteal segment is indicated in case of elastic recoil, flow-limiting dissection, insufficient per- cutaneous transluminal angioplasty (pta) or long lesion length. however, in-stent restenosis (isr) or fracture after endovascular treatment remains a serious concern, especially for lesions of a long segment or near the knee joint. besides the current availability of covered or drug-coated stents, there is the self-expandable bare-metal nitinol stent which rapidly evolved during the last decade from closed-cell to open-cell and, more recently, to interwoven stents. interwoven nitinol stent design of fully connected structures facilitates a continuous but a traumatic synergy between the stent and vessel wall and hence enables axial compliance. investigators here conduct a prospective study to evaluate the efficacy and safety of self- expandable nitinol stent especially interwoven supera stent (iw; supera veritas®; abbott vascular, santa clara, ca, usa) in femoropopliteal complex occlusive lesions.

Eligibility criteria:
inclusion criteria: * patients with critical limb ischemia(grade 4,5\&6 rutherford classification) and patients with disabling claudications which interferes with routine activities (grade 3 rutherford classification). * patients with chronic total occlusion(cto) of femoropopliteal segment which is equal or beyond 10 centimeters length. * patients with recoil after transluminal angioplasty or occlusion in previously deployed stent. * if the lesion extends to popliteal artey against knee flexion. exclusion criteria: * pediatric patients. * patients with isolated infra-popliteal occlusion. * patients with popliteal blind segment with bad runoff. * patients with acute thrombotic occlusions. * patients with previous bypass surgery in affected limb. * patients with aneurysmal lesion in the affected limb.
incorporation of patient reported outcomes data in the care of us veterans with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the overall goal of this proposal is to address barriers to the use of patient reported outcome (pro) data in the dept. of veterans affairs (va) health care system.

this is a randomized, controlled, single-blinded study that compares outcome data in patients for whom pro data either is or is not made available to the treating physician. the question addressed by this proposal is whether patient reported outcome (pro) data change patient's outcomes. the hypothesis is that the availability of these data in the form of the patient-completed multidimensional health assessment questionnaire/routine assessment of patient index data (mdhaq/rapid3) questionnaire will change patient-centric outcomes such as patient reported well-being, patient satisfaction and medication compliance.

Eligibility criteria:
inclusion criteria: * us veteran * within north florida/south georgia (nf/sg) veterans integrated service network exclusion criteria: * outside of service network * non-veteran

Keywords: rheumatoid arthritis veterans
sarcopenic obesity: estimation of prevalence and identification of clinical and biological determinants in a cohort of adult obese patients and longitudinal follow-up

Conditions: Obesity and Overweight

Summary: context: obesity, defined as excessive body fat, can lead to disability and loss of autonomy. if there is concomitant quantitative and qualitative muscle loss, sarcopenic obesity (so) is suspected in this context. although this clinical entity was defined several years ago, it is only very recently that precise assessment criteria have been established for screening and diagnosing this pathology (donini et al. 2022). defined by the espen/easo consensus, so has various consequences for health, particularly in terms of mobility and worsening of co-morbidities. it is therefore necessary to screen for so, to determine its prevalence in the general population and to identify the determining factors in the loss of muscle mass during obesity. most studies on the prevalence of sarcopenic obesity focus on the elderly population, bearing in mind that the prevalence of this syndrome in the elderly will increase rapidly as a result of the shift in the incidence of obesity from adults to this population in the coming decades. the aim of this project is to determine the prevalence and determining or predisposing factors for sarcopenic obesity in a population of obese people in a broad age range (18-70 years). longitudinal follow-up of this cohort is planned in order to assess multifactorial changes (body composition, muscle function and physical performance) at 5 and 10 years after their inclusion in the obesar-2 study. in addition, patients who have undergone bariatric surgery will also be followed in the shorter term to analyse the phenotypic changes induced by rapid weight loss on muscle loss.


Eligibility criteria:
inclusion criteria: * age: 18-70 * sex: men and women * clinical nutrition patient receiving a metabolic assessment to optimise clinical and paraclinical management * patient meeting obesity criteria defined by bmi \> 30 kg/m². * patient of legal age who has given free, informed and signed consent * patient covered by social security non-inclusion criteria : * patients with cancer or severe chronic disease (renal failure, respiratory failure, liver failure) * patients with neuromuscular disease * patient with total walking disability * patients who are minors * patient refusing to take part in the study * pregnant or breast-feeding women * under guardianship, curatorship, deprived of liberty or under court protection * patient who has taken part in the obesar study
skamo-1: characterization of the upper layers of skin

Conditions: Diabetes

Summary: diabetes is a frequent disease characterized by chronic hyperglycemia, and its prevalence is increasing worldwide. historically, patients with diabetes were required to monitor capillary blood glucose concentration up to several times a day through fingertip sampling. recently marketed devices now allow measurements of interstitial fluid blood glucose continuously, thus limiting pain associated with sampling. however, they are still invasive and have to be changed every 14 days. therefore, to optimize continuous glycemia monitoring while avoiding pain, discomfort, and the risk of infection, non-invasive methods are needed. among the different strategies being developed, optical wearable sensors with specific signal processing are a promising option. the sensors detecting this optical signal will be included in a device. yet, wearing a device may slightly modify several properties of the skin, such as its humidity and thermal regulation, and subsequently have an impact on the measured optical signal. therefore, it is important to better understand how a device affects these characteristics to include these parameters in the future device algorithms.


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years and ≤ 60 years * signed informed consent * person who is affiliated to a social security scheme or who is beneficiary of such a scheme exclusion criteria: * body mass index (bmi) \> 30 kg/m2 * any acute or chronic disease with vascular impact * any cutaneous disease on sites implicated in the study (dorsum of the forearm) * allergy to one of the material used in the sham device and during the procedure of the study * the persons mentioned in articles l1121-5 to l1121-8 of the public health code may not be included in this research * subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
pocket-size cardiovascular ultrasound in stroke

Conditions: Ischemic Attack, Transient; Transient Ischemic Attack; Stroke; Cerebrovascular Accident; Cerebrovascular Apoplexy; Apoplexy

Summary: among patients admitted with cerebral ischemia (stroke and transitory ischemic attack (tia)) it is important to reveal the underlying cause of the disease. in special it is important to reveal if carotid artery stenosis is present as such a finding will directly influence on treatment and follow-up. for the diagnosis of carotid artery stenosis due to atherosclerosis ultrasound examinations is the cornerstone, but computer tomography and magnetic resonance imaging may be better in some cases. development of high quality pocket-sized ultrasound scanners has allowed for semi quantitatively bed-side assessment of the carotid arteries and the heart. the investigators aim to study the feasibility and reliability of bed-side assessment of the carotid arteries and the heart by pocket-sized ultrasound scanners and the clinical influence of this examination when performed by experienced users. the investigators hypothesize that a significant proportion of this patient population can be clarified bed-side with no need of further imaging procedures for the assessment of the carotid arteries and the heart.

population: approximately 100 patients admitted to the department of medicine, levanger hospital with history and findings suspicious of stroke/transitory ischemic attack (tia). informed consent mandatory. no exclusion criteria. hypotheses: the carotid arteries and the heart can be assessed bed-side by pocket-size ultrasound scanners with high feasibility and reliability. bed-side assessment of the carotid arteries and the heart by pocket-size ultrasound scanners may reduce the need for more advanced (higher cost) imaging procedures. methods: pocket-size imaging device from ge ultrasound, commercial available. approved for clinical use. high-end echocardiography and carotid doppler ultrasound by high-end equipment (ge vivid 9) and computer tomography and magnetic resonance imaging at the department of radiology, levanger hospital.

Eligibility criteria:
inclusion criteria: * admitted to the department of medicine with history and findings suspicious of (transient) cerebrovascular ischemia and willing and able to give their informed written consent exclusion criteria: * none

Keywords: hand-held ultrasound diagnosis cardiovascular carotid artery stenosis