Kornimate/medical-research-clean huggingface dataset:
study of nivolumab and relatlimab in advanced mismatch repair deficient cancers resistant to prior pd-(l)1 inhibitor

Conditions: Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy; MSI-H Tumors

Summary: the purpose of this study is to evaluate the safety and clinical activity of nivolumab and relatlimab in patients with microsatellite instability high (msi-h) solid tumors refractory to prior pd-(l)1 therapy.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * eastern cooperative oncology group (ecog) performance status 0 or 1 * have metastatic or locally advanced mismatch repair deficient/msi-h disease. * patients must have received prior pd-1/pd-l1 inhibitor therapy * patients with the presence of at least one measurable lesion. * life expectancy of greater than 3 months. * patients must have adequate organ and marrow function defined by study - specified laboratory tests. * documented left ventricular ejection fraction (lvef) ≥ 50% - 6 month prior to drug administration. * must use acceptable form of birth control while on study. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * known history or evidence of brain metastases. * require any antineoplastic therapy. * history of prior treatment with anti-lag3. * had chemotherapy, radiation, or steroids within 14 days prior to study treatment. * had any investigational cytotoxic drug within 4 weeks prior to study treatment. * have received any investigational drugs, a live vaccine, any allergen hyposensitization therapy, growth factors or major surgery within 28 days prior to study treatment. * major surgery * hypersensitivity reaction to any monoclonal antibody. * has an active known or suspected autoimmune disease. * has a diagnosis of immunodeficiency. * prior tissue or organ allograft or allogeneic bone marrow transplantation. * requires daily supplemental oxygen * history of interstitial lung disease. * significant heart disease * history of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * infection with hiv or hepatitis b or c at screening. * has an active infection. * unable to have blood drawn. * patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * prior life-threatening toxicity to anti-pd-1, anti-pd-l1, anti-pd-l2,or anti-ctla4 * woman who are pregnant or breastfeeding.

Keywords: relatlimab nivolumab immunotherapy anti - pd-1 anti - lag-3 antibodies msi mmr deficient microsatellite instability
spectroscopy in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: new diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat. purpose: this clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or pap testing.

objectives: * to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using fluorescence and reflectance spectroscopy. * to measure the reflection and fluorescence spectra in vivo of sites in the human cervix. * to further refine fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions. * evaluate and validate the wavelength selections for the spectroscopy device derived from in vitro measurements. * determine the sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia. outline: this is a multicenter study. patients are stratified according to menopausal status and current treatment (premenopausal not on oral contraceptive pills \[ocp\] vs premenopausal on ocp vs postmenopausal not on hormone replacement therapy \[hrt\] vs postmenopausal on hrt). * diagnostic study: as part of routine colposcopic evaluation, patients undergo placement of the probe on 1 to 4 sites in the cervix for 2-5 minutes. up to two colposcopically abnormal sites and two normal sites are biopsied. blood is drawn for hormone levels. fluorescence excitation and emission matrix (eem) data and reflectance spectroscopic information is acquired from patients with an abnormal papanicolaou smear. * screening study: fluorescence eem and reflectance spectroscopic information is acquired from patients with a history of normal papanicolaou smears. projected accrual: a total of 800 patients with abnormal papanicolaou smears and 1000 subjects with normal papanicolaou smears are accrued for this study.

Eligibility criteria:
disease characteristics: * referred to the colposcopy clinic at vancouver general hospital, the md anderson cancer center, or the university of texas at austin * abnormal or normal papanicolaou smear * hormone receptor status not specified patient characteristics: * pre or post-menopausal * not pregnant prior concurrent therapy: * not specified

Keywords: cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
soothing and re-epithelizing activity of new cosmetic formulations in comparison to placebo and untreated control area

Conditions: Sensitive Skin

Summary: open clinical study to evaluate the soothing and re-epithelizing activity of a single application of two cometic formulations ("p926 - lichtena dermad crema viso" and "p927 - lichtena dermad crema corpo") on experimentally induced erythema by repeated tape stripping on the forearm (volar surface) of 20 healthy volunteers. study products activity was assessed in comparison to placebo ("p926p - lichtena dermad crema viso - placebo") and versus untreated control area.


Eligibility criteria:
inclusion criteria: * volunteers of both sexes * tewl value on tested skin areas immediately after tape stripping \>15g/m2-h * volunteers in a good general state of health in the investigator opinion * volunteers not taking drugs or undergoing surgical procedure * volunteers who are giving a written informed consent. exclusion criteria: * pregnancy (only for female subjects) * lactation (only for female subjects) * tewl value on tested skin areas immediately after tape stripping \<15g/m2-h * change in the normal habits in the last month * participation in a similar study during the previous month * known allergy to one or several ingredients of the products on trial. * dermatitis * presence of cutaneous disease on the tested area, as lesions, scars, malformations * clinical and significant skin condition on the test area. * diabetes * endocrine disease * hepatic disorder * renal disorder * cardiac disorder * pulmonary disease * cancer * neurological or psychological disease * inflammatory/immunosuppressive disease * drug allergy. * anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago); * using of drugs able to influence the test results in the investigator opinion.
the optimization of procedural pain control in intensive care unit (icu) patients

Conditions: Critical Illness

Summary: the purpose of this study is to determine the influence of morphine 2,5 mg or morphine 7,5 mg iv during a painful and unavoidable intervention in critically ill patients.

in 2006, in the intensive care unit (icu) of the st. antonius hospital an analgesia improvement program has been implemented. this program consisted of training of icu nurses and intensivists using a hospital based standardized pain protocol, and systematic pain measurements in rest, rated by the patient himself whenever possible or otherwise by the attending nurse. this program has resulted in a reduction of severe pain levels (nrs≥4) in icu patients in rest from 41% to 22%. in order to further reduce this percentage, a pain titration protocol is introduced in 2007. as no attention has yet been paid to intervention-related pain levels in these patients, in this prospective study pain control will be studied using different analgesic dosages of morphine iv (2,5 mg vs 7,5 mg) around unavoidable painful interventions within a pain titration protocol for pain control in rest.

Eligibility criteria:
inclusion criteria: * patients admitted to the icu of the st. antonius hospital, between 18-85 years old en weighing between 45-140 kg. exclusion criteria: * pregnancy/ breastfeeding * language barrier * known morphine iv allergy * comatose patients (cooled) * patients who are suspected to be brain-dead * unintubated patients on the verge of intubation due to respiratory insufficiency

Keywords: pain intensive care unit morphine pkpd numerical rating scale critically ill patients
a study to evaluate the safety, tolerability, pharmacokinetics (pk), and antitumor activity of alk201 in participants with advanced solid tumors

Conditions: Advanced Cancer; Advanced Solid Tumors

Summary: this is a first-in-human (fih), open-label, multicenter dose escalation and expansion study of alk201. the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), and antitumor activity of alk201 as a monotherapy in adult participants with advanced solid tumors. the study will also identify recommended dose(s) for subsequent clinical studies of alk201.


Eligibility criteria:
inclusion criteria: * men and women ≥18 and ≤75 years old on the day of signing the icf * at least 1 measurable lesion per recist v1.1 * expected survival ≥3 months * eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 * adequate organ function * female participants of childbearing potential or male participants whose partner is a female of childbearing potential agree to use medically effective contraceptive methods from the date of signing the icf until at least 6 months after the last dose of the ip, and during this period, male participants are not allowed to donate sperms exclusion criteria: * active or pre-existing autoimmune diseases that may relapse * pleural effusion, pericardial effusion, or intraperitoneal effusion accompanied with clinical symptoms, clinically poorly controlled, or requiring repeated drainage * allergies to any component of alk201 or other monoclonal antibodies * primary central nervous system malignancies, or active metastases to central nervous system and/or metastases to meninges * combined with ≥ grade 2 stomatitis and/or nose bleeding at screening * vaccinated with live vaccines within 4 weeks prior to the first dose note: other protocol defined inclusion/exclusion criteria may apply

Keywords: first-in-human
duration of antibiotic therapy in critically ill patients: c-reactive protein-guided therapy versus best practice

Conditions: Infection Systemic

Summary: the judicious use of antibiotics is one of the main measures to limit the emergence of multidrug-resistant pathogen related to excessive antimicrobial use. a recent study demonstrated that c-reactive protein (crp) was as useful as procalcitonin (pct) in reducing the time of antibiotic therapy in adult septic patients treated in the icu setting. therefore, the present study proposes to compare the time of use of antimicrobials, costs of hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided by serum levels of crp and a group of therapy based on the best practices of antibiotic therapy (best practice).

all adult patients (aged\> 17 years), hospitalized at the icu (total of 50 beds) of the hospital das clínicas - ufmg, with an assumed or proven infection, will be considered for inclusion. patients who meet the inclusion and exclusion criteria will be allocated randomly into one of the following groups: 1) pcr group: antibiotic therapy will be discontinued according to serum crp levels; 2) "best practice" group, length of antibiotic therapy based on the most recent guidelines in the medical literature, according to the focus and / or causative micro-organism. pcr assays shall be performed daily on serum obtained from blood collected for routine intensive care examinations up to 2 days after antibiotic withdrawal. in the pcr group, antibiotic suspension will be encouraged when levels of this marker are \ 100mg / l), with a limit of seven days, if there is clinical improvement. primary outcomes will be duration of antibiotic therapy and antibiotic-free live days corrected for 1000 days of hospitalization. secondary outcomes will be costs, clinical cure rate, therapeutic failure, 28-day mortality, 90-day mortality, in-hospital mortality, length of hospital stay, nosocomial infection rate, recurrence of infection, and isolation of multidrug-resistant bacteria

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * signed informed consent * assumed or proven infection * patient admitted to the unit participating in the study exclusion criteria: * patients with severe immunosuppression, such as severe neutropenia (\<500 neut/mm3), transplantation of solid organs or cells hematopoietic, hiv infection with cd4+ \< 200/mm3 * patients with multiple trauma, burns or surgery grid size in the last 5 days (except surgery for focus control) * use of antibiotics supposedly or proven to be effective against the infectious process in for more than 48 hours. * patients undergoing palliative care. * patients with death expectancy for the next 24 hours. * patients with bacteremia caused by staphylococcus aureus or candida spp * patients with infections that are known to require prolonged antibiotic therapy

Keywords: intensive care sepsis biomarkers c-reactive protein antimicrobial systemic infection
bioinformation therapy for intestinal cancer

Conditions: Advanced Intestinal Cancer

Summary: the aim of this study is the synergistic effect of cancer ablation and life information rehabilitation therapy on unresectable intestinal cancer.

by enrolling patients with unresectable intestinal cancer adapted to enrolled criteria, this study will document for the first time the synergistic effect of cancer ablation and life information rehabilitation therapy. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies * body tumor 1-6, with at least one tumor length \> 2 cm * kps ≥ 70, lifespan ：3 - 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: cancer ablation life information rehabilitation therapy
epidemiological study on invasive bacterial diseases

Conditions: Invasive Bacterial Diseases (IBD)

Summary: streptococcus pneumoniae (pneumococcus), neisseria meningitidis (meningococcus), and haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (mbis) that result in severe clinical pictures also characterized by a high frequency of serious complications. surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.the present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

pathogen identification by culture methods has been shown to be unsatisfactory, as antibiotic therapy carried out in patients before hospitalization prevents bacterial culture development and subsequent typing in many cases. in addition, technical problems due to sample collection, storage and transport reduce germ viability leading to false negatives in pathogen identification by culture methods. in contrast, molecular diagnosis allows germ identification on biological samples even in the absence of germ viability, thus enabling more accurate diagnosis. surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiological trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.in 2006, the aou meyer immunology laboratory received a grant from the national center for disease prevention and control (ncdc) to develop a molecular diagnostic method for surveillance of invasive infections with neisseria meningitidis (meningococcal,) streptococcus pneumoniae (pneumococcus) and haemophilus influenzae (hemophilus) that would allow identification of the germ on biological samples even in the absence of germ viability, with a view to improving surveillance, prevention and treatment strategies. the project involved performing molecular diagnostic tests on samples from patients referred to hospitals in the tuscany region and outside the region. the present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

Eligibility criteria:
inclusion criteria: * pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus mbi exclusion criteria: * other type of bacterial infections.
diabetes health enhancement program to improve health of people with diabetes

Conditions: Diabetes

Summary: management of chronic diseases, such as diabetes, relies upon the health care providers and the patients self-care. self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies, but have not typically included individuals on medicaid. our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels, improve health status and improve self-care practices.

design, setting and population: a phase 3, one year prospective trial, randomized to intervention or control (usual care) with medicaid or dual-medicare beneficiaries, with diabetes, aged 40-85 years old residing in south king county, washington. intervention: a targeted, multi-component, self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals. main outcome measures: glycemic control (hba1c), physical and mental health, self-care practices. recruitment status: completed: participants are no longer being recruited; data analysis is complete.

Eligibility criteria:
inclusion criteria: * insured under medicaid (ssi) or dual enrolled under medicaid and medicare for at least one year * diagnosed type 1 or type 2 diabetes for at least 1 year (\>1 inpatient or \>2 outpatients visits with icd-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications) * aged 40-85 years * geographically close to the southeast senior center in south king county, washington, and have a primary care provider (not hmo). exclusion criteria: * serious kidney disease (serum creatinine \>2.5 or end-stage renal disease) * other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation) * pregnancy * inability to given informed consent.

Keywords: diabetes behavioral change chronic care model stage of change medicaid dual eligible ethnic self-care
generating health evidence from dietary supplementation with a micro-vegetable blend

Conditions: Inflammation

Summary: micro-vegetables (mv) are seedlings of larger vegetables. they can be grown quickly and are a concentrated source of micronutrients. mv are thought to have broad health benefits, including many inflammatory conditions. these include metabolic, cardiovascular, and cognitive diseases. this could have important implications for the health of an ageing uk population. less than a third of british adults consume 5 portions of fruit and vegetables per day; this is the level that reduces risk of morbidity and mortality. vegetables, including mv may - at least in part - exert their health effects by changing the level and type of bacteria in the mouth and gut. despite their promise, the mv scientific literature is not yet extensive enough to support definitive health claims. it requires the addition of high-quality studies that are relevant to humans. this study will firstly investigate the anti-inflammatory effects on skeletal muscle and adipose tissue in older adults, using a proteomics approach. second, this study will assess concentrations of circulating inflammatory markers in the sera collected from participants at baseline and at the conclusion of a 6-week period. further, this study will describe the effects of six weeks mv consumption on cognition, and the oral and gut microbiome. as the bioactive compounds in the mv are owed to the potential beneficial effects for human health, these will be characterised in sera collected from participants.


Eligibility criteria:
inclusion criteria: * aged 60 years and above * body mass index \> 25kg/m2 * able to give written informed consent to participate in the study exclusion criteria: * not meeting any inclusion criteria * have had an adverse reaction to a local anaesthetic in the past * hepatitis b, hepatitis c or hiv positive * have a bleeding disorder or are regularly taking a medication that will impair their blood's capacity to clot (e.g., aspirin, clopidogrel, warfarin, heparin) * have had a severe adverse reaction to plasters * have a gastrointestinal disorder that may impair the absorption of the supplement from the gastrointestinal tract * have an autoimmune condition * have a diagnosed neurocognitive disorder * have a skin condition that is likely to increase the risk of infection at the biopsy site * frequent use of medication or recreational drugs likely to affect our results * recent infection or vaccination * known allergy to any vegetables * participated in a nutrition supplementation study in the last month