Kornimate/medical-research-clean huggingface dataset:
safe & easy environment at home for patients presenting a frail syndrome

Conditions: Cognitive Deterioration

Summary: all over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability. building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous information and communication technologies (ict) solutions which are not always easy to use in everyday life. the safee (safe easy environment) project aim is to improve the safety, autonomy and quality of life of older people at risk. the safee project develop non pharmacological therapeutic through diferent ict (stimulation aromatherapy automatic fragrance, training interface based on kinect sensor...) . the goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

the non pharmacological therapeutic will be install at patient's home : * aromatherapy, * music therapy, * cognitive training in multimedia application offering cognitive games. also smart phone will be given to the patient : * to help him move with a geolocation application, * to remind him of his daily needs (shopping lists, people to call, etc ...) with an alert apllication.

Eligibility criteria:
inclusion criteria: * male or female age ≥ 60 years with memory complaint * score at the mini mental test (mmse) ≥ 26. * score at the clinical dementia rating scale (cdr) ≤ 0.5. exclusion criteria: * sensory defect (visual or olfactory) preventing the patient to perfectly meet therapeutic solutions. * prescription new psychotropic medication (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week preceding the assessment. * subject epileptic. * subject vulnerable
the development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency (the detection study)

Conditions: Pancreatic Exocrine Insufficiency

Summary: detection. the development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.

pancreatic exocrine insufficiency (pei) is prevalent and progressive among patients with pancreatic cancer, treatment with pancreatic enzyme replacement therapy (pert) has been proven to reduce gastrointestinal symptoms, improve quality of life and survival and is therefore recommended in nice guidelines. despite this, most patients with pei do not receive pert. one cause for under treatment is lack of a well-tolerated and accurate diagnostic test that can provide quick results. the current, most widely used test, the faecal elastase stool test, has low accuracy, particularly after surgery, and results take several days. furthermore, the test cannot help with dosing of pert. metabolomics can be used to quantify metabolites in blood. these metabolites are directly influenced by normal digestion and absorption of food, for example blood lipid levels are very different in the fed and fasted states. this program of work will give a standard meal to healthy controls and patients with pei and screen their blood before and after a test meal. differences in the metabolic profile will be used to develop a 'fingerprint' of pei based upon one metabolite or a combination of metabolites. the ultimate goal is to develop a simple blood test that can be used outside of specialist centres that is acceptable to patients, can accurately diagnose pei and can guide treatment with pert. this body of work aims to investigate the metabolome of patients with pei (of different causes), pei will be defined in the different cohorts by a multimodel approach with the 13c mtgt as primary reference test and fe-1 and pei-q used as supporting tests. a test meal will be given to fasted participants alongside baseline blood samples and breath samples. patients will then have blood and breath taken hourly for 6 hours. blood samples will be spun and frozen for batch metabolomic analysis.

Eligibility criteria:
inclusion criteria: (for main pancreatic cancer cohort) * pdac * pei (as defined by breath test) * tolerating oral diet inclusion criteria: (for cf cohort) * cf * pei (as defined by breath test) * tolerating oral diet inclusion criteria: (for cp cohort) * cp * pei (as defined by breath test) * tolerating oral diet exclusion criteria (all arms): * no other gi conditions * for each arm no evidence of the other arm conditions * for health controls, no history of cp, cf or pancreatic cancer * no gi surgery (except pancreatic resection in the pancreatic cancer cohort) * unable to consent * unable to travel to uhb for testing * prognosis \< 2months * performance status 2+

Keywords: exocrine insufficiency pancreatic cancer metabolomics metabolites chronic pancreatitis cystic fibrosis
twin pregnancy cohort

Conditions: Pregnant With Complication; Twin Pregnancy With Antenatal Problem

Summary: the investigators know that multiple factors are involved in the risk of obstetric complications. the twin pregnancy model appears to be an interesting model for a bio-statistical analysis of data collected in the context of a complete pregnancy, in particular because it can reveal differences for a common exposure. the aim of the study is to constitute a prospective cohort of twin pregnancies. the collection of data on the health of mothers, pregnancies, childbirth, and the health of twins at birth should make it possible to reveal results with sufficient statistical power for a prospective study.


Eligibility criteria:
inclusion criteria: * pregnant women * delivery of a twin pregnancy * gestational age \>25 weeks * age \>18 years exclusion criteria: * singleton pregnancy * miscarriage

Keywords: pregnant women environment adverse outcome age >18 years gestational age >25 weeks delivery of a twin pregnancy
effects of a novel neurofeedback protocol on adhd subcomponents

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: mounting evidence suggests that closed-loop brain-training, commonly known as neurofeedback (nfb), may represent a new therapeutic opportunity for patients with attentional deficit/hyperactivity disorder (adhd), which manifests as difficulties with attention and inhibitory control. in this context, the investigators have focused on an attention-enhancing form of nfb based on the eeg alpha rhythm, known to influence sensory detection and attention. in light of recent evidence showing that both attention and impulsivity can be modified with a single-session of alpha-nfb, the objective is to determine whether these effects stabilize in the long-term, after multiple, daily sessions of training at home. a short- (single-session) and a long-term (multi-session) experimental design will be used to collect eeg, behavioral, and clinical data pre-to-post nfb. the single-blind study will recruit 48 adult adhd participants randomly assigned to either neurofeedback or control groups. each participant will undergo individual at home sessions of 45-minute video-replay of popular television (tv) series while recording their 1-channel eeg (30 sessions, 5 sessions/week, 6 weeks total). in the neurofeedback group, self-regulation of alpha rhythm will be reflected in the dynamically varying opacity of the video-replay window, i.e. the window would turn lighter/darker and reveal/obscure video content during episodes of low/high alpha amplitude, respectively. in the control group, the recording will be passive without real-time eeg neurofeedback (i.e. constant brightness and volume). before and after at home training, each participant will have two visits in the lab: (1) complete clinical and neuropsychological evaluation and (2) eeg session including resting state and task-related eeg before and after a short nfb intervention (30 minutes). for the control group participants, the latter will be replaced by a sham intervention utilizing non-contingent feedback. given that stronger alpha rhythmicity is associated with increases in inhibitory/excitatory balance, it is expected that alpha-nfb (i) will homeostatically normalize alpha rhythm power and (ii) the degree of normalization will be a dimensional predictor of individual improvement in behavioral and clinical measures of executive function, impulsivity and inattention. these results should lay the foundation for building neurocognitive treatments, by harnessing neuroplasticity mechanisms intrinsic to the brain.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of adhd * currently stabilized (euthymic) * general good health * normal or corrected-to normal visual acuity exclusion criteria: * mood disorders * ptsd * borderline personality disorder * substance use disorder * structural brain abnormalities * cerebrovascular disease * epilepsy * stroke * head trauma * cardiovascular disease * renal failure * hepatic dysfunction * impaired visual acuity

Keywords: electroencephalography alpha rhythm attention impulsive behavior neurofeedback
maintenance chemotherapy for metastatic colorectal carcinoma and biological marker

Conditions: Metastatic Colorectal Cancer

Summary: colorectal cancer patients with metastases (mcrc) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. about 40% of patients present with metastatic (stage iv) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.therefore, our study is designed to investigate that colorectal cancer patients with metastases (mcrc) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

Eligibility criteria:
inclusion criteria: - age between 18 and 75 years eastern cooperative oncology group performance status (ecog ps) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease life expectancy of at least 3 months intact organ function, including complete blood counts (cbc) showing normal values or any toxicity limited to grade 1 and blood chemistry (sma) showing liver and renal functions \< 1.5 upper normal limit (unl). patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy signed informed consent exclusion criteria: - known hypersensitivity to capecitabine concurrent any other cancer (except bcc or squamous cell carcinoma of skin). inability to adhere to monthly visits to the oncology unit for evaluation. presence of brain metastases. previous radiotherapy to the only site of measurable disease. evidence of severe or uncontrolled systemic disease no previous chemotherapy for metastatic disease positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
study to evaluate real-world pharmacoeconomics of crizotinib in nsclc patients

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: this is a phase iv multicenter trial to evaluate the pharmacoeconomic (pe) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced alk-positive non-small cell lung cancer (nsclc) patients. nsclc represent 80% of all new cases of lung cancer. one molecular subtype of nsclc is the alk-positive subtype. the anaplastic lymphoma kinase (alk) is a transmembrane receptor tyrosine kinase. activation of alk occurs through the formation of gene fusions and in nsclc, the gene fusion partner for alk is primarily eml4. the resulting fusion protein is capable of activating the alk kinase domain, leading to cell growth. the estimated prevalence for alk rearrangements in nsclc is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for egfr and kras. crizotinib is a potent inhibitor of alk and is approved for the treatment of advanced alk+ nsclc patients. this is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. the pharmacoeconomic impact of using genetic information in early treatment decisions in nsclc has not been determined. the study will enable real-life heath economics and outcome research (heor). approximately 90 patients will be recruited. patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed locally advanced or metastatic nsclc * presence of the alk-fusion oncogene (alk+) as determined using a validated testing platform * planned first or second-line treatment with crizotinib * signed and dated irb-approved informed consent document * ability to read and understand english or french * 18 years of age or older
a phase 3, vehicle-controlled efficacy and safety study of idp-123 lotion in the treatment of acne vulgaris (301)

Conditions: Acne Vulgaris

Summary: this is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of idp-123 lotion in comparison with idp-123 vehicle lotion.

this is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, efficacy, and tolerability of idp-123 lotion and idp-123 vehicle lotion. to be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne.

Eligibility criteria:
inclusion criteria: 1. male or female at least 9 years of age and older; 2. written and verbal informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. subject must have a score of 3 (moderate) or 4 (severe) on the evaluator's global severity assessment at the baseline visit; 4. subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; 5. subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; 6. subjects with two or fewer nodules exclusion criteria: 1. use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema; 3. any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. subjects with a facial beard or mustache that could interfere with the study assessments; 5. subjects with more than two (2) facial nodules; 6. evidence or history of cosmetic-related acne
pharyngeal carriage rates and genetic typing of group a streptococcus and streptococcus pneumonia among israeli military basic trainees

Conditions: Carriage; Group A Streptococcus; Streptococcus Pneumonia

Summary: the study is aimed at assessing pharyngeal and nasopharyngeal streptococcus pneumonia carriage and pharyngeal group a streptococcus carriage among field units new recruits.


Eligibility criteria:
inclusion criteria: * israeli military basic trainee exclusion criteria: * none
carotid artery plaque vulnerability assessment using ultrafast ultrasound techniques

Conditions: Carotid Artery Plaque

Summary: objective: to explore the association between spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, at maximum stenosis, and post-stenosis) and carotid plaque vulnerability defined by histology staining. secondary, to assess the association between ultrasound elastography and carotid plaque vulnerability defined by histology staining. furthermore, to assess the association between blood flow-derived parameters, including wall shear stress (wss), vector complexity and vorticity, and plaque vulnerability. to evaluate the hemodynamic consequences of a cea. last, to explore whether the presence of circulating biomarkers is related to the degree of plaque vulnerability (as reflected by histology and/or ultrasound). study design: a multicentre, prospective, observational, cohort study in a total of 70 patients. study population: patients with a carotid artery stenosis ≥50% according to clinically performed imaging (i.e. duplex, computed tomography angiography (cta), or magnetic resonance angiography (mra)) that are scheduled for a cea. intervention (observational): a carotid ultrasound with flow and elastography (strain and shear wave) measurements will be performed maximally 2 weeks prior to the cea. in the first 20 included patients in the radboudumc, a 10 ml blood sample will be collected during surgery via the arterial line that is applied for regular care. the plaque excised during cea will be histologically examined to assess the plaque composition, and therefore plaque vulnerability. ultrasound-based flow imaging will be repeated six weeks after the cea to assess the hemodynamic consequences of the cea procedure. besides, clinical parameters will be subtracted from electronic health record or, if missing, anamnestically collected from the patient. main study parameters/endpoints: association between 2d spatio-temporal blood flow velocities (peak systole and end-diastole at prior-stenosis, maximum stenosis and post-stenosis), measured by ultrafast ultrasound measurements, and plaque vulnerability (stable versus unstable), defined by histology staining.


Eligibility criteria:
inclusion criteria: * presence of carotid artery stenosis (≥50%) according to conventional clinically performed imaging (duplex/ct(a)/mr(a)) and scheduled for a cea; * possibility to perform carotid ultrasound ≤2 weeks before the cea * ≥18 years old; * able to provide signed or oral informed consent. exclusion criteria: * hampered carotid blood flow imaging during clinically performed duplex/doppler measurements due to near to total carotid occlusion at the side of interest or a calcified plaque; * restenosis after carotid revascularisation at side of interest; * participating in another clinical study, interfering on outcomes;

Keywords: ultrasound shear wave elastography atherosclerotic plaques strain elastography ultrafast ultrasound flow imaging histological plaque characterization
lifestyle change in women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this project aims to compare "diet" and "diet and exercise combination" interventions in obese women with polycystic ovary syndrome. this project will be carried out in the dokuz eylül university research and application hospital gynecology outpatient clinic between june 1, 2022 and june 1, 2024. the purpose of the project will be explained to women who meet the sampling criteria, and their informed consent will be obtained. a prospective and randomized comparison of "diet" and "diet and exercise combination" interventions, which are among the first-line treatment lifestyle changes recommended for pcos, will be done. in the project, 33 women in the first group will receive "diet" intervention for 12 weeks, and 33 women in the second group will receive "diet and exercise combination" intervention. "descriptive characteristics form" will be filled in for both groups, then at the beginning and at the end of the project, routine ultrasonography and laboratory test parameters for pcos diagnosis criteria and menstrual cycle characteristics will be recorded, hirsutism score, alopecia score and acne level will be evaluated, the utian quality of life scale, body appreciation scale, and the short form of the oxford happiness questionnaire will be filled out. body composition analysis will be performed in both groups at the beginning of the project, in the fourth and eighth weeks, and personal dietary recommendations will be given. kitchen scales will be given to both groups to adapt to dietary recommendations and a mobile nutrition application will be used to record their diets. person-specific exercise recommendations will be given to the second group at the beginning of the project, in the fourth and eighth weeks. in addition, women will be informed with a guide to behavioral changes specific to pcos, which will be prepared specific to their group. exercise parameters will be recorded by giving the same mobile application. mobile nutrition application data will be collected via e-mail in the fourth, eighth and twelfth weeks of the project.


Eligibility criteria:
inclusion criteria: * being between 20-41 years old, * diagnosis of polycystic ovary syndrome, * having a secondary education or higher education, * having a body mass index of 30 and above, * volunteering to participate in the research exclusion criteria: * having a psychiatric diagnosis, * using a contraceptive method containing hormones in the last three months, * presence of one or more of the etiologies of hyperprolactinemia, thyroid dysfunction, cushing's syndrome, congenital adrenal hyperplasia and other hyperandrogenemia, * diagnosis of hypertension, type 1 or type 2 diabetes mellitus, * using one or more of the drug types such as antiandrogen, steroid, antidiabetic, ovulation induction agents in the last three months, * impairment of liver, kidney or heart functions, * limited physical exercise