Kornimate/medical-research-clean huggingface dataset:
multi-omic approach to cancer diagnosis: the italian network of excellence for advanced diagnosis (innova)

Conditions: Neoplasms

Summary: the innova project aims to create an advanced multidisciplinary diagnostic platform to support the italian healthcare system and translational research. in this context, wp7, coordinated by the pascale institute and the focus of this study protocol, is responsible for developing a national platform for the multi-omic profiling of cancer patients eligible for precision medicine treatments, with the goal of supporting clinical decision-making.

the study is multicentric, observational, non-interventional, and both prospective and retrospective.

Eligibility criteria:
inclusion criteria: * consent to participate in the study * age \>18 years * performance status (ps) 0-1 * availability of biological samples for multi-omic profiling * availability of radiological images for radiomic assessments * patients with metastatic disease, i.e., stage iv (except for melanoma, where stage ii/iii patients eligible for adjuvant therapy may also be considered) * patients eligible for targeted therapy and/or immunotherapy * patients with aggressive neoplasms, including melanoma, non-small cell lung carcinoma (nsclc), colon carcinoma (braf-mutated, msi), triple-negative breast cancer, ovarian cancer, and cholangiocarcinoma. exclusion criteria: * previous line of immunotherapy or targeted therapy * previous radiotherapy at the sites of the most recent diagnostic biopsy * most recent diagnostic biopsy performed \>24 months before enrollment * absence of measurable lesions * presence of active or untreated brain metastases or leptomeningeal carcinomatosis
a study in people with depression to test the effects of bi 1358894 on parts of the brain that are involved in emotions

Conditions: Depressive Disorder, Major

Summary: to assess the effect of a single dose of bi 1358894 compared to placebo on bold responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fmri in in unmedicated patients with depression.


Eligibility criteria:
inclusion criteria: * patients having a diagnosis of a mdd according to diagnostic and statistical manual of mental disorders-v (dsm-v) (single episode or recurrent) with a madrs total score between ≥ 7 and \< 26 at screening. * male or female aged 18 to 45 years, inclusive at screening. * male or female patients. women of childbearing potential (wocbp) and men able to father a child must be ready and able to use highly effective methods of birth control. * patients must be, in the opinion of the investigator, capable of and eligible for completing the fmri and tasks. * patients must be right-handed. * patients must have acceptable weight as defined by bmi (weight \[kg\]/height \[m\]²) range of 18 to 30 kg/m², inclusive at visit 1. * patients must be a non-smoker or light smoker (≤ 5 cigarettes per day). * patients must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. * further inclusion criteria apply exclusion criteria: * meeting any diagnostic criteria for a major psychiatric disorder (other than mdd), as determined by dsm-v at screening. * has received a prescribed medication (including antidepressants) within 28 days prior to visit 1 (apart from the contraceptive pill) or having received over the counter medication (including pain killers) within 10 days prior to screening. participants who have taken prescription medication may still be entered into the study, if, in the opinion of the investigator, the medication received will not interfere with the study procedures or compromise safety. * patients where it is foreseen (per investigator judgement) that a delay of initiation of standard of care therapy for the depressive disorder to 14 days after day 1 of visit 2 is medically not justifiable. * a history of alcohol or substance dependence or abuse within the last 12 months from visit 1. * has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 or 5 for ideation on the c-ssrs, or a history of suicidal behavior within the past year, as validated by the c-ssrs at screening or treatment visit. * has a history of, or presents (in the opinion of the investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, seizures, space occupying lesions, multiple sclerosis, parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation). * a planned medical treatment within the study period that might interfere with the study procedures. * further exclusion criteria apply
submucosal saline injection followed by endoscopic ultrasound

Conditions: Esophageal Cancer

Summary: endoscopic ultrasound (eus) is unsatisfactory in distinguishing between t1a and t1b stage esophageal squamous cell carcinoma (escc). consequently, the national comprehensive cancer network guidelines recommend endoscopic resection (er) as a diagnostic tool for substaging t1 stage escc. however, as an invasive approach, diagnostic er is not an optimal approach especially for t1b cases as most of them might not be fully cured by er. it is necessary to develop reliable and less invasive methods to distinguish between t1a and t1b stage escc. in our previous unicentral trial, we found that submucosal saline injection (ssi) significantly improved the diagnostic accuracy of eus in differentiating between t1a and t1b stage escc. it can be used as an alternative to diagnostic er for preoperative substaging t1 stage escc cases in remote regions where few endoscopists are able to perform diagnostic er. the use of eus and ssi would help t1b stage patients avoid invasive diagnostic er. therefore, we aim to conduct a multi-center clinical trail to examine whether ssi can improve traditional eus accuracy in distinguishing between t1a and t1b stage escc.


Eligibility criteria:
inclusion criteria: * age 18-75 years old, no gender limited; * patients with esophageal squamous cell carcinoma who be confirmed by ordinary endoscopy and pathologic biopsy; * patients who agree to accept endoscopic resection or surgical excision of the lesion in esophagus; * patients with normal cardio-pulmonary function and normal coagulative function,are predicted to be tolerated anesthesia and surgery; * patients who understand test purpose, volunteer to join these study and sign the consent inform. exclusion criteria: * patients with stages of t2, t3, or t4 displayed by eus; * patients who can't tolerate endoscopy and surgical treatment for various reasons; * patients who have distant metastasis, or multiple source of malignant tumors; * patients with blood coagulative disorder; * patients don't accept the endoscopic examination or surgical treatment; * patients with poor compliancy.

Keywords: submucosal saline injection endoscopic ultrasound early esophageal cancer staging
multicenter dispensing study of biofinity toric made-to-order lenses in extended power ranges

Conditions: Myopia; Astigmatism

Summary: the study hypothesis is that the biofinity toric xr lenses will perform as well as or better than the participants' habitual contact lenses.

the study hypothesis is that the biofinity toric xr lenses will perform as well as or better than the participants' habitual contact lenses. further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Eligibility criteria:
inclusion criteria: * has had an oculo-visual examination in the last two years * is at least 18 years of age and has full legal capacity to volunteer * has read and understood the information consent letter * is willing and able to follow instructions and maintain the appointment schedule * is correctable to a visual acuity of 20/50 or better (in at least one eye) * currently wears soft toric contact lenses in both eyes * subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye: * -20.00d to -10.50d spherical powers and cylinder powers from - 0.75 to -2.25 * +8.50d to +20.00d spherical powers and cylinder powers from - 0.75 to -2.25 * -20.00d to -6.50d spherical powers and cylinder powers from -2.75 to -5.75 * -6.00d to +6.00d spherical powers and cylinder powers from -2.75 to -5.75 * +6.50d to +20.00d spherical powers and cylinder powers from-2.75 to -5.75 * has clear corneas and no active ocular disease * demonstrates an acceptable fit with the study lenses exclusion criteria: * has never worn contact lenses before; * has any systemic disease affecting ocular health; * is using any systemic or topical medications that will affect ocular health; * has any ocular pathology or abnormality that would affect the wearing of contact lenses; * has undergone corneal refractive surgery; * is participating in any other type of eye related clinical or research study.
the effect of covid-19 pandemic on adolescent and young adult cancer patients and survivors

Conditions: COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: the study investigates how the covid-19 pandemic has impacted the psychological, financial, physical, and social well-being of adolescent and young adult (aya) cancer patients and survivors. aya cancer survivors have inferior long-term survival compared to the general population, and the negative impact of the global covid-19 pandemic may be even higher in this vulnerable group. the information gained from this study may provide an opportunity to determine the self-reported covid-19 specific psychological distress in aya cancer survivors, and may lead to the development of a targeted intervention to improve physical and psychosocial health for aya cancer patients and survivors.

primary objective: i. to determine the self-reported coronavirus disease 2019 (covid-19) specific psychological distress in adolescent and young adult (aya) cancer survivors diagnosed between the ages of 15 to 39 and are currently between the ages of 18 to 39. secondary objectives: i. to determine the covid-19 specific health care utilization, health behavior, financial and social disruptions, and health-related quality of life (hrqol). ii. to determine associations between patient demographic and treatment-related variables with covid-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and hrqol. iii. to determine associations between resilience factors (i.e., social support, perceived benefits under times of stress, and the ability to manage stress) with self-reported covid-19 specific psychological distress, healthcare utilization, health behavior, financial and social disruptions, and hrqol. iv. to determine the changes in covid-19 specific psychosocial distress, healthcare utilization, health behavior, financial, and social disruptions. outline: patients and survivors complete a survey online over 20-30 minutes at baseline about covid-19 specific psychological distress, health care utilization, health behavior, social and financial disruptions, hrqol, their social support, perceived benefits under times of stress, and the ability to manage stress. patients and survivors may be contacted again at 6 months and 1 year for covid-19 research.

Eligibility criteria:
inclusion criteria: * patient cohort inclusion: * initial cancer diagnosis between the ages of 15 to 39 * received any cancer treatment at md anderson cancer center with data available in the md anderson cancer center tumor registry * for questionnaire provision: confirmed alive at time of contact exclusion criteria: * patient cohort exclusion: * inability to complete questionnaires in english * seen at md anderson for a second opinion or non-treatment related visit
pco2 gab marker of tissue adequacy of cardiac output in shock state

Conditions: Shock

Summary: 1. to assess validity of of central and pulmonary veno - arterial co2 gradient to predict fluid responsiveness and to guide fluid management and determine the cut off point to continue or stop resuscitation. 2. comparison between pco2 gab and left ventricular outflow tract velocity time integral to determine whether to continue or stop resuscitation and whether pco2 gab is a surrogate of cardiac output or not.

assessing the adequacy of oxygen delivery with oxygen requirements is one of the key-goal of hemodynamic resuscitation. clinical examination, lactate and central or mixed venous oxygen saturation (svo2 an scvo2 respectively) all have their limitations (gavelli et al., 2019). the veno- arterial difference in co2 tension (delta co2 or pco2 gap) is not indicator of anaerobic metabolism since it is influenced by the oxygen consumption. by contrast, it reliably indicates whether blood flow to remove is sufficient to carry co2 from prepheral tissues to the lung in view of its clearance: it, thus, reflects the adequacy of cardiac output with the metabolic condition (valley et al., 2013). the gap is a marker of adequacy of venous blood flow to remove co2 produced rather than a marker of tissue hypoxia (vallet et al., 2013). the gab can be calculated from simultaneous sampling of central venous blood from a central vein catheter and arterial blood. determining the delta pco2 during resuscitation of septic shock patients might be useful when deciding when to continue resuscitation despite a central venous oxygen saturation\>70% associated with elevated blood lactate levels. because a high blood lactate level is not a discriminatory factor in determining the source of that stress, an increased delta pco2 (\>6 mmhg) could be used to identify patients who still remain inadequately resuscitated. fluid responsiveness in shocked patients is conventionally defined as an increase of at least 10% to 15% in stroke volume in response to a fluid challenge. assessment of response to a fluid challenge can be guided with echocardiography. it is achieved by measuring left ventricular outflow tract velocity time integral (lvot vi) immediately before and after fluid challenge (miller et al; 2016).

Eligibility criteria:
inclusion criteria: * all critical ill-patients with acute physiological assessment and chronic health evaluation ii score (apache ii score)≥25 with central line insertion, in the critical care uint of internal medicine department of assuit university hospital in the period between january 2023 to january 2024. exclusion criteria: 1. pateints with poor echocardiographic window. 2. pateints with apache ii score \< 25.

Keywords: delta pco2 gap echocardiography left ventricle outflow tract velocity
assessment of coronary artery lesion using optical coherence tomography versus intravascular ultrasound for bioresorbable vascular scaffold implantation

Conditions: Coronary Artery Disease

Summary: the primary objective is to determine whether ivus- (vs. oct-) guided bvs implantation is non-inferior to achieve a large in-scaffold minimal lumen area (primary endpoint) measured by oct at 1-year follow-up.


Eligibility criteria:
inclusion criteria: * age 20 years or older * patients who have at least one epicardial coronary artery lesion with an evidence of inducible ischemia * willing and able to provide informed written consent * eligible for pci exclusion criteria: * patients presenting with stemi within 2 weeks * bypass graft lesion * lesion with left main disease * expected length of scaffold \> 40 mm * bifurcation lesion requiring side branch stenting * small vessels \< 2.75 mm * stented lesion * suspected coronary spasm even after sufficient nitrate injected * cases in which the ivus or oct imaging catheter failed to cross the lesion * poor quality ivus or oct images * contraindication to dual anti-platelet therapy * chronic total occlusion * angiographically large-sized vessel (\>3.5mm of reference lumen diameter) * life expectancy shorter than 2 years * pregnancy

Keywords: oct ivus bvs
evidence based algorithm for proximal humerus fractures

Conditions: Proximal Humeral Fracture

Summary: proximal humerus fractures are particularly frequent injuries and represent 6% of all fractures with an overall incidence of 63/100.000 in human. the goal is to assess our institutional evidence based algorithm for treatment of proximal humeral fractures. objective(s): 1. test the algorithm in terms of clinical applicability and clinical outcome 2. compare general outcome and general complication/revision rate to the literature. inclusion / exclusion criteria: inclusion: all patients with an acute proximal humeral fracture (not older than 48 hours) admitted to our institution later than 1.1.2014. exclusion: multilevel and pathological fractures are excluded. terminally ill patients and those not being able, or willing to sing the informed consent. project centre(s): single-centre. statistical considerations: standard descriptive statistics will be performed using r-statistics program. considering the population of 160 patients, we will be able to detect differences in proportions as low as 0.15 with power 82% and alpha = 0.05. other methodological considerations: terms applicability of a treatment protocol and adhesion to protocol are not well defined for decision making in orthopaedic surgery.


Eligibility criteria:
inclusion criteria: * acute traumatic proximal humeral fracture * signed informed consent exclusion criteria: * fracture older than 48 hours at admission * multilevel fractures of the humerus * pathological fractures * terminally ill patients.
prevalence of a localized or diffuse pruritus in a population with one or several, primitive or secondary, brain tumor(s)

Conditions: Pruritus; Brain Tumor

Summary: the association between the presence of pruritus, especially centrofacial, and the presence of a brain tumor is a widespread notion in the medical community but based on a single publication by andreev et al. in the british journal of dermatology published in 1975. no other study has studied this association with a rigorous methodology. the aim of this study is to evaluate the prevalence of pruritus in patients with one or more primary or secondary brain tumor(s), benign(s) or malignant(s).

* monocentric prospective observational study * on the inclusion period * patients who are seen in radiotherapy consultation and / or department of neurosurgery * complying with the inclusion criteria, not falling within the exclusion criteria * re-reading of cerebral mri (cmri) with precision on the location(s) of the brain tumor(s) according to a predefined anatomic descriptive diagram * complete the questionnaire by a dermatologist (characteristics of pruritus, brain lesion(s), characteristics of the population)

Eligibility criteria:
inclusion criteria: * age \> 18 years * diagnosis of benign or malignant brain tumor, primary or secondary. * accepted non-opposition * realization of a cerebral mri (cmri) exclusion criteria: * age \< 18 years * absence of cerebral imaging of the cmri type * absence of non opposition * realization of a treatment modifying the brain structure (radiotherapy / surgery)
evaluation of effects of silymarin on cisplatin induced nephrotoxicity in upper gastrointestinal adenocarcinoma

Conditions: Upper GI Cancer; Cisplatin Adverse Reaction

Summary: cisplatin is a potent chemotherapeutic agent that has been widely used to treat many solid tumours. acute renal failure, despite conservative fluid and electrolyte management, frequently reported adverse event and limiting cisplatin use. silymarin, a flavonolignan complex isolated from silybum marianum, has a strong antioxidant, hepatoprotective, anticancer and in animal model nephroprotective properties. neutrophil gelatinase-associated lipocalin (ngal) protein is a promising biomarker to detect acute kidney injury due to cisplatin. milk thistle extract inhibitory effects on epidermal growth factor receptor, vascular endothelial growth factor and insulin-like growth factor-i have shown in the previous in-vitro studies.the aim of present study,a randomized double-blind placebo- controlled clinical trial, to investigate the therapeutic effect of silymarin on cisplatin induced nephrotoxicity and it's impact on chemotherapy. fifty-eight patients with diagnosed upper gastrointestinal tract carcinomas randomized to silymarin (420mg) or placebo plus chemotherapy \[cisplatin 50-60 mg/m2, 5-fluorouracil mg/m2, docetaxel 60-80 mg/m2 every 21 days\] for 63 day after inclusion. serum creatinin, blood urea nitrogen (bun), serum and urine electrolyte will be measured daily during chemotherapy. changes in urine ngal, serum vascular endothelial growth factor (vegf)and caspase activity assessed up to 64 days.

this study will look for possible protective effects silymarin on kidney injury in patients receiving cisplatin.

Eligibility criteria:
inclusion criteria: * age\>18 years * diagnosed * measurable upper gastrointestinal adenocarcinoma * swallow problem * would like to participate in the study * glomerular filtration rate(gfr)\>45ml/min/1.73m2 exclusion criteria: * end stage renal disease * requiring dialysis * post transplantation * receiving contrast media during last 72 hours * chronic use of corticosteroids * chronic use of angiotensin-converting enzyme inhibitor(acei ) * untreated hypo-and hyperthyroidism * ejection fraction\<60% * active urinary tract infection * iver disease ( five fold increase of liver enzyme in asymptomatic or 3 fold increase in symptomatic * use of other nephrotoxic agents such as aminoglycoside, amphotericin * karnofsky performance status \<70

Keywords: cisplatin nephrotoxicity antioxidant urine neutrophil gelatinase-associated lipocalin (ngal)
impact of locoregional treatment of soft tissue sarcoma on status of patients aged 70 years and over

Conditions: Soft Tissue Sarcoma Adult

Summary: in order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

this is a prospective cohort including 100 patients \> 70 year-old treated by surgery for lower-limb soft-tissue sarcoma. data on clinical and geriatric characteristics of the patient as well as functional and quality of life assessment will be collected among patient participation (3 years). primary endpoint is to describe evaluation of the impact of locoregional treatment of soft tissue sarcoma on the functional status.

Eligibility criteria:
inclusion criteria: 1. aged more than 70 years, 2. soft tissue sarcoma histologically proven, 3. sarcoma of the soft tissues of the lower limbs, 4. operable disease (first-line treatment or neo-adjuvant therapy), 5. ecog, performance status ≤ 2, 6. decision of surgery validated in multidisciplinary consultation meeting, 7. reports of the non-opposition documented in the patient file before any procedure specific to the study, 8. affiliation to system of social security (accordance with article l1121-11 of the code of public health). exclusion criteria: 1. metastatic disease from the onset or relapse 2. participation in another study involving a similar geriatric assessment. 3. geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures. 4. persons deprived of liberty or placed under judicial protection

Keywords: soft tissue sarcoma surgery functional impact elderly patient geriatrics