Kornimate/medical-research-clean huggingface dataset:
ortopod cz pilot study

Conditions: Postoperative Delirium (POD); Perioperative Neurocognitive Disorders

Summary: ortopod pilot study is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium. respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia.

ortopod pilot study is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium. respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia. preoperatively, they will be examined using the alba and pobav tests, which serve for rapid and indicative assessment of cognitive functions. furthermore, the functional capacity of patients will be assessed using the clinical frailty scale, and depression will be evaluated using the geriatric depression scale (questionnaire). after the procedure, during hospitalization in the icu/pacu, screening for postoperative delirium will be conducted using the cam-icu tool. the aim of the pilot study is to verify the methodology and obtain baseline data on the incidence of cognitive dysfunction, depression, and frailty preoperatively, as well as the incidence of postoperative delirium in this group of patients before submitting a grant to azv čr. the main research question will be whether preoperative cognitive decline (according to the alba and pobav tests) is associated with the occurrence of postoperative delirium. the second research question will be what percentage of patients with preoperative cognitive deficit (according to the alba and pobav tests) undergo elective total hip arthroplasty. secondary outcomes will include whether there are differences in the alba and pobav test results before and after surgery (cognitive decline after anesthesia and surgery), whether higher clinical frailty scale scores are associated with the occurrence of postoperative delirium, and whether the results on the geriatric depression scale change preoperatively and postoperatively.

Eligibility criteria:
inclusion criteria: * age over 65 years (inclusive) * type of procedure: elective hip replacement (tep) under general or regional anesthesia * asa classification i-iii * absence of sensory impairment (blindness, deafness, deaf-blindness) exclusion criteria: * glasgow coma scale of 14 or less * limited legal capacity * known psychiatric illness with the use of psychiatric medications * effect of premedication, psychiatric, and analgesic sedative drugs (at the time of cognitive function testing) * active oncological disease * chronic use of strong opioids * re-operation

Keywords: postoperative delirium cam- icu alba pobav amnesia light and brief assessment, screening cognitive assessment risk factors seniors
wide field oct + ai for positive margin rates in breast conservation surgery.

Conditions: Breast Cancer

Summary: this is a multi-center, randomized, two-arm study designed to measure the effectiveness of the selene system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.


Eligibility criteria:
inclusion criteria: * female * age 18 years or older * patients undergoing elective breast conservation surgery for the treatment of stage 0-iii invasive ductal and/or ductal carcinoma in situ * may include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * male * metastatic cancer (stage iv) * lobular carcinoma as primary diagnosis * previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation) * subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen * subjects with bilateral disease (diagnosed cancer in both breasts) * participating in any other investigational margin assessment study which can influence collection of valid data under this study * use of cryo-assisted localization * currently lactating * current pregnancy * subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging
individualized treatment of patients with advanced nsclc: potential application for circulating tumor cells (ctc) molecular and phenotypical profiling

Conditions: Advanced Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine the percentage of ctc-positive patients and total ctc numbers in patients with advanced non small cell lung cancer .

the primary aim of the project is to determine the percentage of ctc-positive patients and total ctc numbers in advanced nsclc at baseline, before starting treatment. to valuate ctc count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and ctc count depending on the type and schedule of treatment. furthermore, purified ctc will be obtained by automated platform and dna sequencing will be performed to assess sensitizing mutations in advanced nsclc patients. the egfr mutations or eml4-alk fusion gene detected in ctc will be compared with those reported for the tumor specimen using standard sequencing. in parallel, the ctc count assay will be integrated with mab targeting egfr or eml4-alk fusion gene, to test whether assaying the quote of egfr-positive and alk-positive ctc provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total ctc counts. moreover, it was reported that nsclc cells with egfr mutations manifest activation of the pi3k (phosphatidylinositol 3-kinase)-akt and mek-erk (extracellular signal-regulated kinase) signaling pathways under the control of egfr, and exposure of such cells to egfr-tkis blocks signaling by both pathways and induces apoptosis 13. to evaluate whether live vs. apoptotic ctc changes under treatment may be used as predictor of tumor response, m30-positive ctc will be quantified as previously 8. data obtained with the ctc assay will be correlated with common prognostic factors.

Eligibility criteria:
inclusion criteria: * age 18-80 years old, males or females; * patients with nsclc confirmed by histopathology or cytology; * life expectancy \> 6 months; * patients are voluntary to participate and sign the informed contents exclusion criteria: * any condition which might hamper compliance to the schedule of assessments

Keywords: circulating tumour cells in advanced non small cell lung cancer
butcoins - metabolic effects of resistent starch and arabinoxylans in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: background life style related disease is an increasing problem all over the world. the metabolic syndrome (mets) is a condition characterized by abdominal obesity, high blood lipids, high blood pressure and slightly elevated blood sugar. subjects with mets have high risk of developing type 2 diabetes and cardiovascular disease. dietary fibers have been shown to have positive effects on the components of mets. the investigators have special interest in the combination of two types of fiber (resistant (rs) starch and arabinoxylans (ax)) . hypotheses increase of rs and ax in the dietary composition has a positive effects on components of mets i.e. decreases blood lipids, improves blood sugar, blood pressure and markers of inflammation. the subjects undergo two dietary interventions of 4 weeks duration each: a "healthy carbohydrate diet" with a high content of rs and ax is compared to a "western style diet" with a low content of rs and ax.

background life style related disease is an increasing problem all over the world. the metabolic syndrome (mets) is a condition characterized by abdominal obesity, dyslipidemia, hypertension and impaired glucose tolerance. subjects with mets have high risk of developing type 2 diabetes and cvd. resistant starch (rs) and arabinoxylans (ax) are dietary fibers that have been shown to have positive effects on the components of mets. the combination of rs and ax has not been tested before . hypotheses increase of rs and ax in the dietary composition has a positive effects on components of mets i.e. decreases postprandial lipaemia, improves glucose tolerance, insulin resistance, blood pressure and markers of inflammation. design: a nonblinded randomized cross over study two dietary interventions of 4 weeks duration each. a healthy carbohydrate diet with a high content of rs and ax is compared to a western style diet with a low content of rs and ax. between the two interventions, there is a wash out period of 4 weeks. the primary outcome is postprandial lipaemia estimated by a high fat meal test of 6 hours duration. the test is performed before and after each intervention. secondary outcomes are: * glucose tolerance and insulin resistance estimated by ogtt * 24 hours blood pressure * mri estimation of liver fat content * postprandial changes in genes of adipose tissue

Eligibility criteria:
inclusion criteria: at least 3 out of the 5 following criterions * central obesity (female \>80 cm, male \>94) * hdl cholesterol (female \< 1,03 mmol/l, male \< 1,29 mmol/l) * blood pressure (\> 130/85) * fasting blood glucose \> 5,6 mmol/l exclusion criteria: * diabetes * gastrointestinal disease * anticoagulation treatment * serious liver, heart or kidney disease * anaemia * corticosteroid treatment * waist circumference above 130 cm * alcohol or drug addiction * pregnancy og lactation

Keywords: dietary fibers resistent starch arabinoxylans postprandial lipaemia insulin sensitivity body composition gene expression metabolic rate blood pressure
improving depression treatment for older minority adults

Conditions: Depression

Summary: the purpose of this study is to improve access to quality depression care for older, low-income, minority adults in public sector health care. the study will examine current depression care in a public sector geriatric clinic that serves mostly spanish-speaking latinos and pilot study assessments and treatments in order to lay the groundwork for a large study of quality improvement for depressed older minorities

depressive disorders affect 5-10% of older primary care patients, although rates may be higher among latinos, especially among immigrants and those less acculturated. late-life depression may be chronic and recurrent and results in significant morbidity and mortality. despite a growing evidence base for the treatment of geriatric depression, only half of depressed older adults receive mental health care; fewer than 10% receive specialty services. treatment rates are even lower for low-income, ethnic minorities who may be more ill and disabled, may lack adequate insurance and have different treatment preferences, and who frequently face barriers to accessing care. recent quality improvement interventions for geriatric depression have targeted primary care, the location where older patients and ethnic minorities are most likely to receive mental health services. a recent multi-site, randomized trial of collaborative care for geriatric depression in primary care offered patients their choice of treatments, including antidepressant medication or 6-8 sessions of a structured psychotherapy. although the intervention had few cultural accommodations, both processes and outcomes of care improved for depressed older minorities. however, because the study only included latinos who were english-speaking and mostly high school graduates, these results may not generalize to a large proportion of ethnic minorities. this study first examines current rates of depression and patterns of depression treatment in a public-sector geriatric clinic that serves mostly spanish-speaking latinos. then depressed patients are identified and their depression treatment preferences and barriers to care are assessed. patients are enrolled in a 6-month patient-centered, evidence-based intervention, and they, family members, and clinic medical providers are interviewed at program end to assess the feasibility, acceptability, and possible effectiveness of the intervention.

Eligibility criteria:
inclusion criteria: * patients of the lac+usc medical center geriatric clinic * english- or spanish-speaking * positive for depression on the geriatric depression scale * current major depressive disorder or dysthymia * all adult family members, especially caregivers, and all regular clinic providers eligible for interviews exclusion criteria: * history of bipolar disorder or psychosis * significant cognitive impairment (score less than 24 on the mini-mental status examination, adjusted for age and education) * acute suicidal ideation

Keywords: psychotherapy behavior therapy counseling aging medically underserved population
blood groups as biomarker to optimize odds of response to anti-pd-1 drugs

Conditions: Melanoma; Cancer

Summary: blood is an investigator-initiated, multicenter, prospective biomarker study in patients with advanced melanoma treated with anti-pd-1 monotherapy in the first-line setting. the "studied products" will be administered and managed within routine medical care in belgium. the overall goal is (i) to investigate biomarkers for anti-pd-1 monotherapy and (ii) to gather evidence on real-life use of anti-pd-1 monotherapy in melanoma.


Eligibility criteria:
inclusion criteria: * histologically proven advanced melanoma. * anti-pd-1 monotherapy of advanced (unresectable or metastatic) melanoma (prescribed within its approved indication as per usual practice according to riziv/inami regulations) in the first-line setting. * no prior systemic therapy for advanced melanoma. * have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1. * at least 18 years of age. exclusion criteria: * prior treatment with any drug specifically targeting t-cell co-stimulation or immune checkpoints (e.g., antibodies targeting pd-(l)1 or ctla-4, chimeric antigen receptor t (car-t) cell therapy). * metastasis-directed therapy (surgery or radiotherapy) with definitive intent (local therapy to address symptomatic sites of disease is permitted). * previous systemic treatment for advanced melanoma. * active central nervous system (cns) metastases (previously treated brain metastases are permitted if stable) or carcinomatous meningitis. * diagnosis of any other malignancy within 5 years prior to study inclusion, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low-risk prostate cancer on surveillance without any plans for treatment intervention, or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease and symptoms.

Keywords: immunotherapy anti-pd-1 nivolumab pembrolizumab biomarker
on-line cognitive training for parkinson's disease

Conditions: Parkinson Disease

Summary: application of online cognitive training in patients affected by parkinson's disease and mild cognitive impairment. the treatment consists of a 6-week on-line cognitive training preceded and followed by neurological, neuropsychological and motor assessment.

at the recruitment, participants will undergo a neurological visit, a neuropsychology assessment (2 tests for each considered cognitive domain: memory, attention, visuospatial, executive function, language) and a motor assessment with wearing sensors under supervised conditions. in the treatment arm only, patients will have the neuronation application installed on their personal technology device (smartphone or tablet) and are asked to complete 4 training session three times a week. each session is composed of 5 exercises from one out of 4 cognitive domains: memory, attention, speed and reasoning. the training is tailor made, the complexity of the exercises is adjusted online, based on the patient's performance. participants are re-assessed at the end of the 6-week cognitive training (t1) to find out its effects on cognition and motor ability. the same assessment is administered also after 1 (t2) and 3 (t3) months from the end of the cognitive training to test long-term effects.

Eligibility criteria:
inclusion criteria: * ease of use of at home internet connection * active presence of a caregiver to help with the use of the app * sufficient physical ability to use a technological device * signature of informed consent exclusion criteria: * presence of systemic pathologies potentially responsible for cognitive deficits * presence of pathologies of the central nervous system potentially associated with cognitive deficits * no access to internet connection * cognitive rehabilitation within the previous 6 months * major depression (assessed by beck depression inventory at baseline)
clinical outcomes related to cardiac resynchronization therapy deactivation of super responders

Conditions: Cardiomyopathy

Summary: the purpose of this study is to determine clinical outcomes related to deactivation of cardiac resynchronization therapy device in subjects with super response.


Eligibility criteria:
inclusion criteria: * super response to cardiac resynchronization therapy * near normal left ventricular ejection fraction * \>99% pacing exclusion criteria: * \<99% pacing * atrial fibrillation * ischemic cardiomyopathy

Keywords: heart failure super responder
mhealth intervention to prevent postpartum smoking relapse

Conditions: Tobacco Use Cessation; Pregnancy Related

Summary: this project aims to develop an adapted and enhanced mhealth couple intervention to prevent post-partum smoking relapse.

the main goal of this project is to develop, implement, and disseminate effective and sustainable interventions to prevent and reduce smoking in families over their reproductive life span. so, the purpose of this project is to adapt, enhance, and test the implementation feasibility and efficacy of an evidence-based pregnancy and postnatal smoking relapse pilot mhealth intervention. the scientific relevance of this research project is given by: 1) testing a cultural-adapted version of the icoach mobile application for the prevention of smoking uptake after birth. 2) the cultural adaptation will be obtained based on the existing literature regarding the adaptation of preventive interventions for substance use. 3) the icoach app intervention is enhanced with sms-delivered content addressing the dyadic efficacy for smoking cessation aiming to improve both partners' skills to work together as a team to prevent smoking uptake after birth.

Eligibility criteria:
inclusion criteria: * older than 18 years * gave up smoking 6 months before or during pregnancy * owns a smartphone * has a stable partner/husband * offers the partner's contact data * signs the informed consent * co level (ppm) below 4 exclusion criteria: * younger than 18 years * smoker * does not own a smartphone * does not have a stable partner/husband * refuses to offer the partner's contact data * refuses to sign the informed consent * refuses the co level measurement or the co level (ppm) is above 4

Keywords: mhealth smoking postpartum
development of tumor organoids from undifferentiated primary carcinomas to guide therapeutic decisions

Conditions: Undifferentiated Carcinoma

Summary: the study is based on the constitution of a collection of tumor and blood samples for the development of tumoroid for functional tests to predict clinical response to treatment.


Eligibility criteria:
inclusion criteria: * patient with undifferentiated primary carcinoma (upc) with histological and immunohistochemical evidence, validated in a local and/or national upc multidisciplinary consultation * patient with indication for 1st-line treatment at the time of inclusion. * patient with life expectancy greater than 3 months * patient of legal age * patient affiliated to a social security scheme * signature of informed consent prior to any specific study procedure exclusion criteria: * persons deprived of their liberty or under guardianship (including curatorship) * pregnant or breast-feeding patient

Keywords: tumoroid organoid
using fluorescence angiography to detect occult shock

Conditions: Hypoperfusion

Summary: the purpose of this study is to determine if fluorescence angiography can detect occult shock (hypoperfusion).

hypoperfusion may be multifactorial, due to hemorrhage, shock or other disease processes resulting in either capillary leak into the interstitium or profound vasodilatation. currently, diagnosis of hypoperfusion depends on indirect markers of perfusion such as lactate, blood pressure, creatinine, urine output, and mental status. these are all late signs of hypoperfusion as they are precursors to impending system failure. in this study, the focus will be on one of the most common causes of hypoperfusion in the surgical population; sepsis and septic shock.

Eligibility criteria:
inclusion criteria: * sepsis arm inclusion criteria: * diagnosis of severe sepsis and septic shock. * sepsis is defined as at least two of the following signs and symptoms (sirs) that are both present and new to the patient and suspicion of new infection: * hyperthermia \>38.3°c or hypothermia \<36°c * tachycardia \>90 bpm * tachypnea \>20 bpm * leukocytosis (\>12,000 μl-1) or leukopenia (\ 10% bands. * hyperglycemia (\>120 mg/dl) in the absence of diabetes. * severe sepsis includes sirs and at least one of the following signs of hypoperfusion or organ dysfunction that is new and not explained by other known etiology of organ dysfunction: * hypotension (\<90/60 or map \<65) * lactate \>2 * areas of mottled skin or capillary refill \>3 seconds * creatinine \>2.0 mg/dl * disseminated intravascular coagulation (dic), platelet count \<100,000 * acute renal failure or urine output \<0.5 ml/kg/hr for at least 2 hours * hepatic dysfunction as evidenced by: * bilirubin \>2 or inr \>1.5 * cardiac dysfunction * acute lung injury or ards * control arm inclusion criteria: * do not have diagnosis of sepsis, severe sepsis, or septic shock * are not on vasopressors * are normo-thermic exclusion criteria: * sepsis arm exclusion criteria: * pregnant * iodide allergy * burns * control arm exclusion criteria: * pregnant * iodide allergy * burns * individuals for whom a surrogate decision maker is not available, or is not able to consent to the study.

Keywords: hypoperfusion sepsis