Kornimate/medical-research-clean huggingface dataset:
electrical impedance tomography monitoring and invasive mechanical ventilation during pronation in acute respiratory distress syndrome.

Conditions: ARDS, Human

Summary: acute respiratory distress syndrome is an acute form of lung injury. the most commonly used classification criteria for this syndrome are berlin's criteria. the actual literature underlines the advantages of prone position in mild or severe forms of ards in association with invasive mechanical ventilation. the hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.


Eligibility criteria:
inclusion criteria: * mild or severe ards according to berlin's criteria * recruitment maximum 72 hours from the diagnosis of ards exclusion criteria: * other non-ards respiratory system pathologies * hemodynamic instability (mean arterial pressure \< 60 mmhg) * pneumothorax * endocranial hypertension * skin lesions or burns * presence of pacemaker or implantable defibrillator * pregnancy
a pilot cohort study of surgical and non-surgical management of rotator cuff tears

Conditions: Full Thickness Rotator Cuff Tear

Summary: this project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

this project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. the evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair exclusion criteria: * less than 18 years old, * non-operative rotator cuff tears, * calcific tendonitis, fracture, adhesive capsulitis, * severe osteoarthritis of the shoulder, * no prior shoulder surgery
clinical investigation to assess the efficacy and the safety of visuxl® gel administered in patients affected by moderate ded

Conditions: Dry Eye Syndromes

Summary: this is a post-market, european multicenter study. this is a randomized, cross-over, double blind study with competitive enrolment, aimed to enroll a total of 90 patients with a diagnosis of moderate dry eye disease (ded).

the purpose of the study is to evaluate the non-inferiority of the new treatment versus the comparator. patients, after signing the informed consent, will enter into a 1-week screening phase during which the baseline tests will be conducted. baseline (v0), day 30 ± 1 week (v1), day 38 ± 2 days (v2), day 68 ±1 week (v3) of treatment. between v1 and v2 one week of wash out should be performed. of note, all ophthalmologic evaluations listed in the flow-chart will be performed on both eyes of the patient.

Eligibility criteria:
inclusion criteria: * patient informed consent form (icf) signed. * males and females aged ≥18 years at the time of the signature of icf. * patients with moderate dry eye disease (ded) according to ideel questionnaire (score ≥51 and ≤64) and diagnosed at least 3 months before enrolment. * no use of other tear substitutes in the 5 days prior to enrolment, except for refresh solutions. * tbut value \<6 sec. * willing to follow all study procedures, including attending all site visits, tests and examinations. * women must agree to be using two forms of effective contraception, be post-menopausal from at least 12 months prior to trial entry, or surgically sterile. exclusion criteria: * patients with a mild or severe dry eye disease (ded) according to ideel questionnaire (score ≤50 and ≥65, respectively). * use of ophthalmologic products in the 14 days prior to enrolment, except for refresh solutions and stable glaucoma treatment. * no previous history or presence of any disease involving cornea or conjunctiva. * sjӧgren syndrome. * history or active cicatricial conjunctivitis. * history of ocular surface burns. * use of contact lenses. * corneal refractive surgery 1 year post-operative. * any ocular surgery in the previous 3 months preceding the study. * unstable glaucoma (treatment changes in the last year). * any macular or retinal disease that could impact visual acuity. * best corrected visual acuity (bcva) below 20/40. * blepharitis treatment started less than 3 months before enrolment. * neurological, neurodegenerative or cerebrovascular conditions. * any clinically significant history of serious digestive tract, liver, kidney, cardiovascular, cancer or hematological disease. * unstable treatment with systemic medications, such as diuretics, antihistamines, antidepressants, psychotropics, cholesterol lowering agents and beta-blockers. * known hypersensitivity to one of the administered products. * known drug and/or alcohol abuse. * mental incapacity that precludes adequate understanding or cooperation. * participation in another investigational study or blood donation within 1 month prior to icf signature.
evaluation of safety, tolerance and effects on the intestinal flora of a new fermented milk for preterm infants

Conditions: Preterms With Gestational Age Ranging From 30 to 35 Weeks

Summary: the intestinal flora is a complex ecosystem which is known to play various important functions in the gut. recent data have reported a delay in intestinal colonization in preterm. modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.the aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.

this prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. preterm infants with a gestational age (ga) ranging from 30 to 35 weeks and whose mother chose formula feeding were enrolled during their first three days of life. both parents provided informed written consent. infants were randomly assigned to receive either the fermented preterm formula (fpf) or, as a control, a formula adapted for preterm infants (pf). the pf was formulated to meet the nutritional needs of preterm infants. the fpf was identical, except for a manufacturing process including a fermentation step with two probiotic strains, bifidobacterium breve c50 and streptococcus thermophilus 065, inactivated by heat at the end of the manufacturing process. this process conferred a probiotic/prebiotic activity.for each neonate, background information about the pregnancy and neonatal parameters were collected. anthropometric parameters (weight, height, head circumference); gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal bleeding, nec); drug administration; and intake of formula and mother's milk were recorded twice a week until discharge. stools were collected twice a week from diapers for microbiological analysis and measurement of fecal inflammatory markers. all samples were immediately stored at -80°c.

Eligibility criteria:
inclusion criteria: * preterms with gestational age ranging from 30 to 35 weeks * eutrophic * formula feeding exclusion criteria: * malformation or metabolic disease * newborns whose parents did not provide informed consent * contraindication to enteral feeding

Keywords: premature birth, infant, infant formula, bacterial colonization, bifidobacterium, calprotectin
role of the dentist in the control of the alcoholic habit in patients with potentially malignant oral lesions

Conditions: Oral Potentially Malignant Disorders; Alcohol Drinking

Summary: introduction: alcohol is the most consumed psychoactive substance, its consumption is very prevalent and there is a low perception of the risk it poses in our society. alcohol is a risk factor and a causal factor for multiple pathologies, including cancer and potentially malignant oral lesions (lopm). the dentist can play a relevant role in the evaluation of consumption, as well as provide brief interventions (bi) to assist them in the cessation of the habit. objectives: the main objective is to evaluate the efficacy of the intervention, carried out by dentists, to stop or reduce alcohol consumption in a patient with lopm. material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 1 experimental arm and a control group, carried out in a single-center manner. group 1 incident brief intervention and group 2 no incident intervention (only usual clinical information). 200 patients from the unit of oral medicine, oral surgery and implantology of the university of santiago de compostela will participate in this study, they will make an initial visit, one month, three months, six months and one year. in these visits, evaluations related to alcohol consumption, the evolution of injuries, quality of life and satisfaction with the bi were carried out. predictable results: if ib contributes to the cessation or reduction of alcohol consumption, and improves the clinical evolution of lopm, it could be implemented immediately in our oral medicine unit and could lay the foundations for its implementation in different public centers and private.


Eligibility criteria:
inclusion criteria: 1. patients with a clinical and histopathological diagnosis of oral lichen planus (opl) and/or oral leukoplakia (lo) (in all its clinical forms) as chronic lopms according to the who 2017 classification. 2. patients over 40 years old 3. patients in follow-up, with chronic injuries, without medical and/or surgical treatment for at least 1 month 4. patients with frequent daily alcohol consumption \> 1 standard beverage unit (more than two glasses of wine/beer per day or one glass of liquor/distilled drink per day) exclusion criteria: 1. participants who do not sign the informed consent. 2. patients with a score above 20 in the audit. 3. patients undergoing treatment for problems with alcohol and other drugs. 4. patients with systemic pathology associated with alcohol consumption 5. pregnant patients. 6. patients undergoing active pharmacological treatment for opl. 7. patients who have undergone surgical resection and/or co2 laser treatment for lo in the last month. 8. patients with a history of malignant oral lesions.

Keywords: alcohol abuse substance abuse monitoring program dentistry health promotion clinical trial
study to access safety of durvalumab in indian adult patients with locally advanced nsclc

Conditions: Unresectable Non-small Cell Lung Cancer (NSCLC)

Summary: a prospective, multicenter, phase-iv clinical trial to assess safety of durvalumab in indian adult patients with locally advanced, unresectable non-small cell lung cancer (nsclc)


Eligibility criteria:
inclusion criteria: 1. provision of signed, written and dated informed consent prior to any study specific procedures 2. male or female aged 18 years or older 3. as per local prescribing information and in view of positive benefit-risk assessment, patient prescribed durvalumab treatment as per independent clinical judgment of treating physician for either exclusion criteria: 1. concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study 2. current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced nsclc is allowed. 3. prior exposure to any anti-pd-1 or anti-pd-l1 antibody including durvalumab. 4. for nsclc cohort only: 1. mixed small cell and non-small cell lung cancer histology 2. any unresolved toxicity ctcae \>grade 2 from the prior chemoradiation therapy. 3. patients with ≥grade 2 pneumonitis from prior chemoradiation therapy 5. active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis. note: patients with vitiligo, grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. 6. female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control 7. any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
diagnostic and interventional therapy in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: the study aims to evaluate the course of patients with acute pancreatitis. thereby we analyze different diagnostics and compare ultrasound, mri and ct-scan in detection of necrotic areas and evaluate interventional therapy methods like percutaneous drainage techniques regarding the outcome. laboratory values were assessed as well.

for laboratory values different inflammation markers were measured and compared.

Eligibility criteria:
inclusion criteria: * age \> 18 years * acute pancreatitis * written formal consent exclusion criteria: * pregnancy * missing formal consent * individual contraindications for ct-scan * mri or endoscopic ultrasound

Keywords: acute pancreatitis interventional therapy ct-guided drainage therapy percutaneous necrosectomy comparison of different diagnostic procedures: mri, ct, ultrasound evaluation of interventional therapy including percutaneous drainage techniques und necrosectomies
evaluation of the safety and efficacy of reformulated raltegravir (mk-0518) 1200 mg once daily in combination with truvada™ in human immunodeficiency virus (hiv)-1 infected, treatment-naive participants (mk-0518-292)

Conditions: HIV Infection

Summary: to evaluate the safety and efficacy of reformulated raltegravir (mk-0518) 1200 mg once daily in combination with truvada™ versus raltegravir 400 mg twice daily in combination with truvada™ in hiv-1 infected, treatment-naive participants. the primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with truvada™, as assessed by the proportion of participants achieving hiv-1 ribonucleic acid (rna) \<40 copies/ml at week 48.


Eligibility criteria:
inclusion criteria: * hiv-1 positive * naïve to antiretroviral therapy including investigational antiretroviral agents * not of reproductive potential or, if of reproductive potential agrees to 1) true abstinence, or 2) use of an acceptable method of birth control during the study exclusion criteria: * use of recreational or illicit drugs or has recent history of drug or alcohol abuse or dependence * has been treated for a viral infection other than hiv-1 (such as hepatitis b) with an agent that is active against hiv-1 including but not limited to adefovir, tenofovir, entecavir, emtricitabine, or lamivudine * has documented or known resistance to raltegravir, emtricitabine, and/or tenofovir before the first dose of study drug * has participated in a study with an investigational compound or device within 30 days or anticipates participating in such a study during this study * has used systemic immunosuppressive therapy or immune modulators within 30 days or is anticipated to need them during the study (short courses of corticosteroids are allowed) * requires or is anticipated to require any of the following prohibited medications while in the study: phenobarbital, phenytoin, rifampin, rifabutin, or calcium, magnesium and aluminum containing antacids, such as tums™, maalox™ and milk of magnesia™ * has significant hypersensitivity or other contraindication to any of the components of the study drugs * has current, active diagnosis of acute hepatitis due to any cause * is pregnant, breastfeeding, or expecting to conceive during the study * female participant expecting to donate eggs or male participant expecting to donate sperm during the study * is or has a family member (spouse or children) who is investigational staff or sponsor staff directly involved in this trial
evaluation of a novel technique for the discovery of new, tumor-specific targets for the deployment of innovative immunotherapeutics against cancer.

Conditions: Estrogen Receptor Positive Breast Cancer

Summary: the goal of this interventional, prospective research on human bodily material is to discover new, cancer-specific molecular structures (i.e. glycopeptides) within surgically removed, estrogen receptor positive breast cancer tumors. the main goal it aims to achieve is: to discover tumor-specific targets, that allow the use of very potent immunotherapeutic drugs as treatment for solid tumors, such as estrogen receptor positive breast cancer. these new targets are very specific for cancer cells, meaning that virtually no healthy cells should be attacked by the treatment, resulting in less side effects. participants will undergo standard of care treatment, comprising surgical removal of the breast tumor. part of these tissues will be used for this clinical research.


Eligibility criteria:
inclusion criteria: * female * minimally 18 years old * diagnosed with estrogen-receptor positive breast cancer * this must be a primary tumor exclusion criteria: * male * younger than 18 years old * previous history of other tumors
shock us study: fluid responsiveness in sepsis measured by ultrasonography

Conditions: Sepsis

Summary: the study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. the investigators propose a prospective observational research study of patients presenting to one of three yale new haven hospital emergency departments, york street campus, st. raphael's campus, and shoreline medical center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.

after each 1 liter fluid challenge of iv fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.

Eligibility criteria:
inclusion criteria: * all patients age greater than 18 years who meet criteria of sepsis. septic shock will be defined as those patients with severe sepsis and persistent hypotension (\<90mmhg systolic blood pressure) despite a fluid challenge of at least 20cc/kg * patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial us is performed * a number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. these patients will only have one ultrasound performed for each of the desired study measures. exclusion criteria: * patients unable to provide consent such as non-english speaking patients or patient/health care proxy unable to give consent * history of significant trauma * incarcerated patients * failure to complete fluid challenge * pericardial disease or heart transplant. patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (ejection fraction \<40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately
a safety study of mirikizumab (ly3074828)

Conditions: Psoriasis

Summary: the main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. the study will investigate how the body processes the study drug and how the drug affects the body. the study will last about 3 months for each participant.


Eligibility criteria:
inclusion criteria (psoriasis participants): * chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline * plaque psoriasis involving \>2% body surface area (bsa) in affected skin other than the face and scalp at screening and baseline * are willing and able to washout topicals for at least 14 days before baseline on the 2 target lesions inclusion criteria (healthy participants): * are overtly healthy males or females, as determined by medical history and physical examination * are women not of childbearing potential * are between the ages of 18 and 65 years, inclusive, at the time of screening * have a body mass index between 18.5 and 32.0 kilogram per square meter (kg/m2), inclusive, and a minimum body weight of 55 kg * have clinical laboratory test results within normal reference range for the central laboratory, or results with acceptable deviations that are judged to be not clinically significant by the investigator * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * have given written informed consent approved by lilly and the erb governing the site exclusion criteria (psoriasis and healthy participants): * have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy). prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval * within 28 days prior to baseline: have received systemic nonbiologic psoriasis therapy * within 14 days prior to baseline: have received topical psoriasis treatment * have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of data * have had clinically significant symptomatic herpes zoster within 3 months of screening * show evidence of active or latent tuberculosis (tb) * have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study * have significant allergies to humanized monoclonal antibodies or any components of the mirikizumab product formulation or have a history of significant atopy * have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and cervical carcinoma in situ, with no evidence of recurrence within 5 years prior to baseline