Kornimate/medical-research-clean huggingface dataset:
power of liquid biopsy tracking in immunotherapy treated stage iv melanoma

Conditions: Metastatic Melanoma

Summary: the advent of immune ici has remarkably improved survival in advanced melanoma patients in the last decade. long term responders following 2 years of treatment with immunotherapy go on to surveillance with frequent radiological imaging every 3-6 months up to 5-10 years. this not only exposes patients with a relatively low risk of recurrence to significant amounts of ionising radiation, but also increases the burden and cost on already stretched radiology departments. therefore, this study aims to assess the feasibility and patient experience of using ctdna with minimally invasive liquid biopsy assays as a biomarker for detecting disease relapse or progression at the point of radiological progression. data from this pilot study will help to design a future validation study for establishing optimal liquid biopsy for surveillance in advanced melanoma patients.

this prospective study will measure ctdna in a simple plasma sample and using a dried blood spot assay, collected at the time of radiological disease progression. we will investigate the use of tumour informed and tumour naïve approaches, assessing targeted sequencing, copy number variations using whole genome low depth sequencing, fragmentomics and methylation as potential methods to improve molecular recurrence detection. we will also collect urine samples to investigate the use of cfdna to detect relapse in the brain, which has been noted to be more challenging to detect using ctdna in the blood than other sites of relapse. in addition, we will investigate the use of novel immunophenotyping technology through a collaboration with meliohealth (imu) in the same setting. the imu platform combines high resolution cellular analysis and machine learning to enable high-content, high-throughput and real-time cellular immunophenotyping from less than 2ml of whole blood. we hypothesize that disease relapse following immunotherapy may detectably trigger a patient's immune system memory, which may be particularly important for those patients who do not shed ctdna.

Eligibility criteria:
inclusion criteria: * histologically proven melanoma * unresectable stage iii or stage iv disease, with confirmed radiological disease progression within 1 month of recruitment * patient has received at least 1 cycle of immunotherapy with checkpoint inhibitors for melanoma * undergoing standard of care active treatment with regular interval imaging or routine imaging surveillance following treatment completion/cessation * age over 16 * not previously diagnosed with hiv, hepatitis b or c (does not need testing) exclusion criteria: * not on routine surveillance with interval imaging per standard of care * unable to provide informed consent due to psychological, medical or cognitive conditions. * unable to comply with schedule of study samples to be collected. concurrent active malignancies needing treatment

Keywords: ctdna testing advanced melanoma immune checkpoint inhibitors (ici)
immunotherapy with ex vivo expanded haploidentical natural killer cells for children/young adults with aml

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical nk cells for children/young adults with primary high risk or refractory aml and relapsed aml.

immunotherapy with nk cells may improve the treatment results in aml. for better efficiency high cell doses or several infusions of nk cells are required. for this purpose, donor nk cells are expanded in the presence of feeder k562-mbil21-41bbl cell line. for patients with high-risk primary aml a cycle of immunotherapy includes chemotherapy (hd-ara-c+ida) followed by three doses of nk cells infusion. for patients with refractory/relapsed aml a cycle of immunotherapy includes chemotherapy (flag - fludarabine, cytarabine, g-csf) followed by three doses of nk cells infusion. a 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.

Eligibility criteria:
inclusion criteria: patients: * primary high risk aml * primary refractory aml * relapsed aml * karnofsky or lansky performance scale greater or equal to 70 * written informed consent donors: * haploidentical family donor * donor suitable for cell donation and apheresis according to standard criteria * written informed consent exclusion criteria: patients: * uncontrolled infection * severe hepatic dysfunction: sgot or scpt \>=5x upper limit of normal for age * positive serology for human immunodeficiency virus (hiv) donors: * pregnancy * positive serology for hiv, hepatitis b or c

Keywords: natural killer cells, immunotherapy
combined spinal/epidural (cse) saline duration/spread

Conditions: Labor Pain

Summary: an attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (cse) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. subjects are in the study from the time their cse is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.


Eligibility criteria:
inclusion criteria: * age greater than 12 years of age * asa status 1 or 2 * cervical dilation \< 6cm exclusion criteria: * asa assigned 3 or 4 * advanced labor (\> 6cm cervical dilated) * distorted epidural anatomy

Keywords: labor pain treatment duration analgesia analgesic duration with normal saline injection. analgesic duration without normal saline injection
prolactin and fgf21 in gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus in Pregnancy; Hyperprolactinemia Pregnancy

Summary: prolactin (prl) and prl receptor (prlr) signaling has been validated to play an important role in the modulation of glucolipid metabolism. however, the role of serum prl levels in gestational diabetes mellitus (gdm) remains unclear. the investigators aimed to explore the possible influence of serum prl within or without normal range on the development of gdm.


Eligibility criteria:
inclusion criteria: * aged 18 to 45 years * completed a 75-g oral glucose tolerance test (ogtt) * females with pregnancy exclusion criteria: * severe liver and renal dysfunction, preexisting heart disease, malignancy, or endocrine diseases such as pituitary adenoma and hypogonadism * mental illness * genetic disease * current or previous treatment that might affect prl and insulin secretion * diabetes before pregnancy * loss to follow-up, or withdrawal from the study * unable to understand and comply with the study protocol.

Keywords: gestational diabetes mellitus prolactin insulin resistance fibroblast growth factor 21
aa linkage for alcohol abusing women leaving jail

Conditions: Alcohol Use; AA Attendance; Sexual Risk Behavior

Summary: the primary aims of this study are to test the hypotheses that among alcohol abusing and dependent jailed women returning to the community, adding an alcoholic anonymous (aa) linkage intervention will result in less alcohol use at follow-up, increased aa attendance once released, and decreased hiv/sti sexual risk behavior. additionally, this study seeks to test the hypotheses that increased aa attendance will mediate the effect of the aa linkage intervention on alcohol use and that percent days abstinent will mediate the effect of the intervention on hiv/sti sexual risk-taking outcomes.


Eligibility criteria:
inclusion criteria: to be eligible for the study participants must: 1. be 18 years or older 2. live in ri or ma within 20 miles of providence and plan to remain in the area for the next 6 months 3. meet dsm-iv criteria for alcohol abuse or dependence in the last six months 4. do not expect to attend residential alcohol or drug treatment upon release 5. report sti/hiv sexual risk defined as unprotected heterosexual sex at least three times in the three months prior to incarceration 6. speak english. 7. be currently held at the rhode island adult correctional institutions jail facility women will be excluded from participation if they: 1. cannot provide the name of at least two locator persons who will know where they can be found.

Keywords: alcohol use sti incarcerated women aa
quitadvisormd: a point-of-care tool for brief smoking cessation interventions

Conditions: Smoking; Tobacco Use Disorder

Summary: quitadvisormd: a point-of-care tool for brief smoking cessation interventions under a phase ii sbir grant supported by nih/nida, we are developing quitadvisormd: a point-of-care, patient-centered resource for counseling patients who smoke or use tobacco products. it is based on the principles of motivational interviewing, a non-confrontational and very effective method for intervening and treating these patients; the 5 a's of behavioral interventions; and the transtheoretical model of change. through a point and click interface, the tool uses a series of interview questions designed to motivate patients to stop smoking by first assessing their stage of change and then offering effective stage-based interventions and interview techniques. the tool also offers stage-tailored patient information, a clinician educational reference, and the ability to communicate support information patients via email and/or text message.


Eligibility criteria:
inclusion criteria: * any physician providing care for members of southern health through primary care and have access to a point-of-care computing device (smartphone, desktop pc, etc) during patient visits. exclusion criteria: * lack of appropriate computing device
self-management using smartphone application for chronic disease care in real situation (smart-asthma): adult

Conditions: BRONCHIAL ASTHMA

Summary: bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. it can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. in addition, it make large amount of socioeconomic loss as about 3.7 billion us dollars.


Eligibility criteria:
inclusion criteria: * using smartphone * alleged bronchial asthma over 3months \& positive of bronchodilator response test or bronchial provocation test exclusion criteria: * copd * active pulmonary tuberculosis * acute exacerbation within 4weeks * severe psychological disorder * severe systemic disease; severe lc, esrd ... * malignancy

Keywords: asthma smartphone application
gapcare fall prevention pilot survey

Conditions: Fall

Summary: gapcare (geriatric acute \& post-acute care coordination program for fall prevention) is an early stage investigation that surveys older adults who present to the emergency department for any illness to determine the feasibility of an emergency department (ed)-based multidisciplinary intervention for preventing recurrent falls in older adults. in this observational study, older adults will be approached during routine clinical care in the ed and asked about prior falls, prior experiences having falls treated in the inpatient and outpatient setting, and the investigators will solicit feedback on potential improvement to care in the ed setting for falls.


Eligibility criteria:
study inclusion criteria for gapcare * adult 65 years-old or older * able to communicate in english * no cognitive impairment (≥4 on sis) exclusion criteria • unable to give informed consent due to intoxication or altered mental status

Keywords: geriatric
repeated treatments of qlt091001 in subjects with leber congenital amaurosis or retinitis pigmentosa (extension of study ret ird 01)

Conditions: LCA (Leber Congenital Amaurosis); RP (Retinitis Pigmentosa)

Summary: the purpose of this study is: * to evaluate the safety of up to 3 additional courses of oral qlt091001 administered once daily for 7 days in subjects treated previously with a single 7-day course of qlt091001 in study ret ird 01 * to evaluate whether up to 3 additional courses of oral qlt091001 administered once daily for 7 days can maintain or improve visual function.


Eligibility criteria:
inclusion criteria: * subjects with lca or rp due to rpe65 or lrat deficiency who received a 7-day treatment course of qlt091001 and completed the day 30 visit in study ret ird 01 * subjects who meet any one of the following criteria at least 1 month after start of the 7-day treatment course in study ret ird 01: * no increase in gvf (in at least 1 eye): follow-up gvf increased ≤20% from baseline or * decrease in gvf (in at least 1 eye): follow-up gvf decreased below the highest previous response by ˃20% or * considered a reasonable candidate for retreatment, based on the investigator's discretion, in consultation with the independent dsmb and the sponsor, based on regression or lack of response in other parameters of visual function (e.g., subjective reports of changes in color vision or adaptation to low light) but who do not meet other (gvf) criteria for study entry exclusion criteria: * subjects with any clinically important abnormal physical finding at screening. * subjects who have taken any prescription or investigational oral retinoid medication (e.g., accutane,® soriatane®) within 6 months of day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure. * subjects with liver failure, uncontrolled thyroid disease, hypersensitivity to retinoids, or hypervitaminosis a * subjects who have taken any supplements containing ≥10,000 iu vitamin a within 60 days of screening
stoma tube decompression and postoperative ileus after major colorectal surgery

Conditions: Ileus; Bowel Obstruction

Summary: postoperative ileus is common after colorectal surgery, occurring in up to 20% of patients. stomas are frequently created in conjunction with major colorectal surgery. obstruction at the level of the stoma is a common cause of bowel obstruction or ileus. this is often manifested by decrease or delay in stoma output and is often attributed to edema at the level of the stoma. thus, a temporary tube (red robinson catheter) is placed into the stoma at bedside, which often relieves the obstruction until the edema at the level of the stoma resolves and stoma function occurs around the temporary tube. at this time, the tube is removed and the stoma continues to function normally. the purpose of this study is to evaluate whether a stoma tube (red-robinson catheter) placed at the time of stoma creation would reduce the incidence of postoperative ileus in patients undergoing major colorectal surgery with creation of a stoma.


Eligibility criteria:
inclusion criteria: 1. able to freely give written informed consent to participate in the study and have signed the informed consent form; 2. males or females, 18\> years of age and older inclusive at the time of study screening; 3. american society of anesthesiologists (asa) class i-iii (appendix iii); 4. due to undergo ileostomy or colostomy creation via laparotomy or laparoscopy; exclusion criteria: 1. mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures; 2. american society of anesthesiologists (asa) class iv or v; 3. children \<18 years

Keywords: stoma ileus postoperative stoma tube
hospital admissions in children aged 3 months to 5 years presenting with fever to the emergency department

Conditions: Fever

Summary: this study primarily aims to describe factors associated with hospitalisation of children aged 3 months to 5 years presenting with fever to an urban paediatric a\&e departments by describing and analysing characteristics both of those patients admitted to hospital and those managed in the community. to complement this, information on the short-term healthcare utilization by families attending the emergency department because of feverish illness will be collected. the study will be carried out in one participating centre in switzerland and the united kingdom, respectively, to enable a head to head comparison of the assessment and admission practices in two european countries. the resulting data will be used as the basis for further research in this area and will provide information on how to optimally structure service provision in acute febrile childhood illness.

a significant number of children 0 to 5 years of age are seen in paediatric accident \& emergency departments (a\&e) with feverish illness. most of these patients could safely be managed in a primary care setting, particularly with guidelines in place on how to optimally assess these children. some patients, however, will require admission, either because of a potentially serious underlying disease or because of other factors, for example parental concern or difficulties in communication because of language barriers. an increase in the number of children attending a\&e departments with feverish illness as well as a rise in the volume of admissions has been noted over time. to enable an appropriate adaptation of acute medical services for children an in depth understanding of the assessment and admission processes is crucial.

Eligibility criteria:
inclusion criteria: * child aged 3months to 5years * temperature above or equal to 38°c measured by any method or reported hot by parents exclusion criteria: * none

Keywords: feverish illness in children
a maajor radiation-based pci study in stemi and nstemi

Conditions: Myocardial Infarction (MI); Radiation Toxicity; Coronary Stenosis; Coronary Thrombosis; Coronary Artery Calcification; Coronary Occlusion; Coronary Syndrome; Coronary Artery Disease

Summary: in france and italy, approximately 240,000 percutaneous coronary angioplasties (pci) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring rotablator rotary atherectomy (arota). the medical literature lacks sufficient data regarding several key aspects of complex angioplasty. these include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

a retrospective database of the hemodynamics department of the centre cardiologique du nord and clinica mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between february 1, 2008, and july 7, 2018, was used to identify complex angioplasties and standard angioplasties. two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. these complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria). the following criteria were employed to delineate complex or very complex angioplasties: * unprotected left coronary common trunk angioplasty (ut-pci) * angioplasty with rotablator rotary atherectomy (arota-pci) * angioplasty of chronic coronary occlusion (cco-pci) * angioplasty of a bifurcation lesion (cbl-pci) the following definitions pertain to the classification of angioplasty procedures: * standard angioplasty: this encompasses angioplasty procedures that do not meet the criteria for complexity. * complex angioplasty: this designation is applied to angioplasty procedures that meet at least one criterion for complexity. * very complex angioplasty: this designation is applied to angioplasty procedures that meet at least two criteria for complexity.

Eligibility criteria:
inclusion criteria: * the patient presents with a stemi or nstemi requiring either a non-complex or complex pci. exclusion criteria: -

Keywords: pci,des, radiation
a first-in-human study of bg-c137, an anti-fgfr2b antibody drug conjugate, in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and preliminary antitumor activity of bg-c137 in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed advanced or metastatic solid tumors. 2. life expectancy of ≥ 3 months. 3. prior standard systemic therapy in the advanced or metastatic setting. dose escalation: participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. safety expansion and dose expansion: participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting. 4. participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of fgfr2b expression levels and other biomarker assessments. 5. ≥ 1 measurable lesion per recist v1.1. 6. eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. adequate organ function as determined per protocol. exclusion criteria: 1. prior exposure to topoisomerase i inhibitor (top1i)-based antibody-drug conjugate (adc) therapies or fgfr2b-targeted adc therapies. 2. active or chronic corneal disorder, history of corneal transplantation, corneal keratitis, keratoconjuntivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. 3. spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \[whichever is shorter\] for chemotherapy, adcs, or investigational therapy) before first dose of study drug(s). 5. toxicities due to prior therapy that have not recovered. 6. any malignancy ≤ 2 years before first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively. 7. history of interstitial lung disease (ild), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: bg-c137 advanced solid tumor first-in-human fgfr2b adc