Kornimate/medical-research-clean huggingface dataset:
clinical observation of drug retention enema in preventing acute radiation-induced rectal injury

Conditions: Radiation Injuries; Rectal Diseases

Summary: the main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.

the study was a prospective, multicenter, real-world study with eligible patient data as of may 1, 2024. the prospective study was a continuous, multicenter study.

Eligibility criteria:
inclusion criteria: * there are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines; * ecog score 0-1; * normal mind, clear consciousness; * high compliance; * able to cooperate with the interviewer exclusion criteria: * poor compliance, unwilling to participate or unable to cooperate with the interviewer; * patients with other intestinal diseases (such as crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases; * serious heart, brain, liver, kidney disease; * long-term immune dysfunction; * pregnant or lactating women; * patients who terminate treatment for various reasons.
a mixed-method pilot investigation of paradoxical intention for insomnia.

Conditions: Insomnia; Comorbidities and Coexisting Conditions

Summary: the investigators aim to test the preliminary efficacy as well as the acceptability and feasibility of paradoxical intention, which is a psychotherapeutic technique, for improving insomnia symptoms in adults. previous research has tested this technique for insomnia and found overall positive results. however, during the last decades very few studies have examined paradoxical intention. therefore the investigators wish to conduct a pilot study examining the effects in a modern context.

in the 1970s, ascher and efran developed paradoxical intention (pi), instructing sleep onset insomnia patients to stay awake instead of trying to sleep. the american academy of sleep medicine confirmed pi's effectiveness. however, between 2006-2018, pi use in clinical practice declined. the study will investigate pi's acceptability, mechanisms, and predictors for effectiveness. it involves a pilot trial with 40 insomnia patients in sweden, recruited through advertisements and screened through web questionnaires, phone interviews, and sleep diaries. criteria are based on insomnia research standards and diagnostic and statistical manual fifth edition (dsm-5), including insomnia with common comorbidities. participants will undergo baseline assessments, then receive four weekly online pi modules, including educational texts, behavioral experiments, and homework. weekly therapist meetings via phone or video will support and troubleshoot issues. post-treatment, 10-15 participants will be randomly selected for qualitative interviews to evaluate their experiences with pi, focusing on sleep patterns, text volume, therapist support, and homework's impact on sleep quality and treatment adherence. interviews will be audio-recorded and analyzed thematically.

Eligibility criteria:
inclusion criteria: * undergoing three screening phases: a web-based questionnaire, a telephone interview with a structured assessment, and a 7-day sleep diary completion. * screening resulting in diagnosis of insomnia, including co-morbid insomnia. * participant should fulfill the following dsm-5 criteria. (1)difficulty in sleep initiation, maintenance, or early morning awakening. (2)frequency and duration of at least three nights per week and has been present for at least three months.(3) problems persist despite candidates having had adequate opportunity and circumstances for sleep. (4) the sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning. * age above 18 and swedish resident and language proficient. exclusion criteria: * severe depressive episode with suicidal intentions or actions * current or past diagnosis of psychotic or bipolar disorders * current substance use disorder * recent changes in psychopharmacotherapy (within the last three months) or use of "as-needed" hypnotic medications during the trial.

Keywords: insomnia disorder mechanisms mixed-methods paradoxical intention sleep performance anxiety
the performances of spectral domain optical coherence tomography (oct) for distinguishing glaucomatous eyes

Conditions: Glaucoma Patient; Glaucoma Suspect Patient; Normal Population; RNFL Thickness by Location; Macular Thickness by Location

Summary: the purpose of this study is to evaluate performances of each parameters of spectral domain (cirrus) optical coherence tomography for distinguishing between normal eyes, glaucoma suspect and glaucomatous eyes

aim to determine which parameter of cirrus oct is best sensitivity and specificity for glaucoma detection

Eligibility criteria:
inclusion criteria: * bcva at least 20/60 * refractive error +/- 5 d or astig +/- 3 d * enrolled in 3 population group (glaucoma, glaucoma suspect or normal) exclusion criteria: * va less than 20/60 * marked rf error * previous ocular trauma or surgery * unreliable visual field * poor signal cirrus oct (less than 7) * other causes of optic nerve or macular disease other than glaucoma

Keywords: oct spectral domain cirrus glaucoma glaucoma suspect normal population
trastuzumab combined with chemotherapy or endocrine therapy to treat metastatic luminal b2 breast cancer

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare progression-free survival (pfs) of patients with metastatic luminal b2 breast cancer subtype randomised to treatment with trastuzumab combined with chemotherapy or endocrine therapy.

this is a non-inferiority study to examine trastuzumab combined with chemotherapy or endocrine therapy in patients with metastatic luminal b2 breast cancer subtype. the main purposes of this study are to test the safety and clinical benefit of trastuzumab combined with chemotherapy or endocrine therapy in treating luminal b2 breast cancer (hormone receptor positive and human epidermal growth factor receptor (her2) positive or amplification). this multicentre, randomized study is designed to recruit up to 392 subjects to identify 196 research subjects for each study treatment.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. patients with an eastern cooperative oncology group (ecog) score of 0 or 1. 3. histologically confirmed metastatic or local recurrence of breast cancer. 4. er positive and/or progesterone receptor (pr) positive, her-2+ defined as immuno-histochemistry3+ staining or fish+. 5. prior adjuvant trastuzumab therapy is permitted, but disease-free interval (dfi) must be more than 12 months. 6. patients must have measurable or evaluable disease. 7. adequate bone marrow reserve with neutrophils \> 1000 and platelets \> 100,000. 8. adequate renal function with serum creatinine \< 2.0. 9. adequate hepatic reserve with serum bilirubin \< 2.0, alanine transaminase(alt) \< 3 times the upper limit of normal, and alkaline phosphatase \< 5 times the upper limit of normal. 10. adequate cardiac reserve with at least 45% of left ventricular ejection fraction (lvef) by echocardiogram. 11. able to give informed consent. 12. life expectancy of at least 12 weeks. exclusion criteria: 1. pregnant or breast feeding. 2. ecog score ≧2 3. dfi \<12 months. 4. lvef \< 45% by echocardiogram. 5. uncontrolled medical problems. 6. evidence of active acute or chronic infection. 7. hepatic, renal, or bone marrow dysfunction as detailed above. 8. concurrent malignancy or history of other malignancy within the last five years except as noted above. 9. known severe hypersensitivity to trastuzumab. 10. patients were unable or unwilling to comply with program requirements.

Keywords: luminal b2 subtype first line treatment
a study of the efficacy and safety of adalimumab in pediatric subjects with enthesitis related arthritis

Conditions: Enthesitis Related Arthritis (ERA)

Summary: the purpose of this study is to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with enthesitis related arthritis (era).


Eligibility criteria:
inclusion criteria: * diagnosis of enthesitis related arthritis (era) as defined by international league of associations for rheumatology (ilar); * disease activity defined as at least 3 active joints and evidence of enthesitis in at least one location; * inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug and at least one disease modifying anti-rheumatic drug, either sulfasalazine or methotrexate. exclusion criteria: * any ilar juvenile idiopathic arthritis (jia) subtype other than era; * psoriasis or a history of psoriasis in the patient or first-degree relative; * presence of immunoglobulin m (igm) rheumatoid factor; * presence of systemic jia; * history of inflammatory bowel disease; * previous biologic therapy including anti-tumor necrosis factor (anti-tnf) therapy with a potential impact on pediatric era; * infection(s) requiring treatment with iv anti-infectives within 30 days prior to baseline or oral anti-infectives within 14 days prior to baseline.

Keywords: inflammatory back pain ankylosing spondylitis sacroiliitis juvenile idiopathic arthritis enthesitis arthritis
gut microbiome in fecal samples from patients with metastatic cancer undergoing chemotherapy or immunotherapy

Conditions: Metastatic Carcinoma; Stage IV Colorectal Cancer; Stage IVA Colorectal Cancer; Stage IVB Colorectal Cancer

Summary: this research trial studies the gut microbiome in fecal samples from patients with cancer that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy. studying samples of feces from patients with metastatic cancer in the laboratory may help doctors learn if the make-up of the gut microbiome has a positive or negative influence to a patient's response to chemotherapy or immunotherapy.

primary objectives: i. to quantitatively determine the composition of the microflora and their gene and protein expression levels in patients with metastatic colorectal cancer being treated with fluorouracil (5-fu) based chemotherapy, or anti-pd1 immunotherapy. secondary objectives: i. compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with response to chemotherapy or immunotherapy. ii. compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with toxicities and side effects resulting with chemotherapy or immunotherapy. outline: patients undergo collection of fecal specimens at baseline, prior to start of each course of chemotherapy or immunotherapy, at the end of weeks 2, 4, 6, and 8, at the end of course 3 and courses thereafter of chemotherapy or immunotherapy, and at the time of disease progression or going off-treatment. fecal specimens are analyzed via 16s ribosomal ribonucleic acid (rna) gene sequencing, meta-transcriptomics analysis, and meta-proteomics analysis.

Eligibility criteria:
inclusion criteria: * must be willing and able to provide fecal samples according to protocol schedule * cohort a * diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated * scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (folfox) or folinic acid-fluorouracil-irinotecan (folfiri) based chemotherapy for the advanced disease * must have radiologic evidence of disease * cohort b * diagnosis of metastatic cancer * scheduled to begin pembrolizumab or another anti-pd-1 or anti-pd-l1 antibody as single agent therapy for the treatment of the advanced disease * must have physical or radiologic evidence of disease exclusion criteria: * patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study * patients are not enrolled or a research protocol for treatment
vitamin k status and markers of vascular function in patients with and without postural hypotension

Conditions: Orthostatic Hypotension

Summary: postural hypotension is common in older people, leading to falls, decline in function, and dependence. available treatments have limited efficacy and tolerability; novel approaches to treatment are therefore needed. decreased vascular health, stiffening of the arteries and consequent decreased vascular reactivity are thought to contribute to postural hypotension and are therefore therapeutic targets. recent trial evidence has suggested that vitamin k may exert beneficial effects on vascular health particularly in respect to inhibiting calcification. calcification increases vascular stiffness, decreases compliance and thus decreases the ability of blood vessels to autoregulate blood pressure and flow - which could contribute to postural drops in blood pressure. worsened vascular health could also impact adversely on baroceptor function, which is needed for blood pressure autoregulation and which is disrupted in patients with orthostatic hypotension. vitamin k intake is below recommended daily intake in 60% of adults in the uk. in animals, vitamin k supplementation may be able to reverse calcification of arteries, and in humans vitamin k has been shown to arrest decline in carotid artery elasticity compared to placebo. high levels of circulating vitamin k were also associated with lower levels of crp in the framingham cohort, suggesting a possible role in the suppression of chronic inflammation that is known to accompany vascular disease. the recent ecko study suggested that vitamin k may reduce falls and fractures; an intriguing question that follows on from this is whether this could be due to beneficial effects on vascular health and postural hypotension, leading to less dizziness and reduced falls. this cross-sectional comparative study aims to find whether there is a difference in the vitamin k status of patients with postural hypotension compared to those without postural hypotension and whether differences in vitamin k status are associated with other markers of vascular function in patients with and without postural hypotension. this could potentially lead to new treatments for the condition for which there is currently little of proven benefit.


Eligibility criteria:
inclusion criteria: * 65 years or older * for postural hypotension group: \>20mmhg systolic bp drop or \>10mmhg diastolic bp drop on standing, and syncopal symptoms on standing. * for control group: no fall in bp or \<20mmhg systolic bp drop and \<10mmhg diastolic bp drop on standing, and no syncopal symptoms on standing. no previous diagnosis of orthostatic hypotension. exclusion criteria: * on warfarin * unable to consent * unable to stand unaided

Keywords: orthostatic hypotension vitamin k
intratumoural administration of coxsackievirus a21 for the control of malignant melanoma (pxs-x02)

Conditions: Malignant Melanoma

Summary: the purpose of this study is to determine the safety of an injection of coxsackievirus a21 into a melanoma tumour, and also to see if there is a tumour response.

coxsackievirus a21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. this study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Eligibility criteria:
inclusion criteria: * stage iv melanoma (ajcc classification) * minimum of 2 sc metastases * failure or refusal of standard chemotherapy * ecog score of 0 or 1 * other exclusion criteria: * metastatic cns disease * ocular or mucosal melanoma * immunodeficiency * splenectomy * other
general;general practitioners and embolism prevention in nvaf patients treated with rivaroxaban:real-life evidence

Conditions: Atrial Fibrillation

Summary: in atrial fibrillation patients,anticoagulant therapy with warfarin has an excellent stroke preventive. meantime,warfarin may also increase the risk of hemorrhagic events. considering this,warfarin is a drug which puts a great burden on patients and medical providers. with the population aging, the number of non-valvular atrial fibrillation patients is increasing, and a necessity that not only specialist but also general practitioners. anticoagulant therapy with warfarin is not easy for general practitioners and is not commonly used among general practioners. in such circumstances, rivaroxaban,a new oral direct factor xa inhibitor,has become available. rivaroxaban is administrated once a day and exert an anti- coagulant effect soon after administration. it hardly reacts with foods or other drugs and therefore does not require regular monitoring. general study is to investigate the effectiveness of stroke and systemic embolism in non-valvular atrial fibrillation patients when it is prescribed by general practioners in real life settings.


Eligibility criteria:
inclusion criteria: * non-valvular atrial fibrillation patient who are prescribed rivaroxaban by general practitioners exclusion criteria: * patients are contraindicated for rivaroxaban * patients judged as inappropriate for this study by investigators
just breathe, breathing life into innovative therapies for ards- cohort a: vilobelimab

Conditions: Acute Respiratory Distress Syndrome (ARDS); ARDS; ARDS (Acute Respiratory Distress Syndrome); Acute Respiratory Distress Syndrome

Summary: this is a phase 2 multicenter, randomized, double-blinded, placebo-controlled study that will evaluate the safety and efficacy of host-directed therapeutics in hospitalized adults diagnosed with acute respiratory distress syndrome (ards) utilizing a platform trial design. cohort a: participants will be randomized to receive either a placebo or vilobelimab. this record describes the default procedures and analyses for cohort a. please see nct06703073 for information on the bp-ards-p2-001 master protocol.

this is a master protocol for a phase 2 platform clinical trial to evaluate host-directed therapeutic candidates (i.e., investigational product, ip) for the treatment of hospitalized participants diagnosed with ards. the safety and efficacy of each ip will be studied within its own cohort (ip versus placebo). all patients will continue to receive standard treatments for ards as per the investigator. an individual participant will complete the study in approximately 90 days. the study will include a screening period (\<24 hours from providing informed consent to treatment), in-hospital treatment period with ip/placebo starting on day 1 through discharge from the hospital, and a follow-up period after discharge from the hospital through the end of study (day 90 + 2 weeks). outcome data will be assembled for each patient over time (such as ventilatory status, oxygenation, and survival). functional status using the who ordinal scale and karnofsky scale will be collected. resource utilization will be calculated (length of stay in a critical care setting, days intubated, and survival). all participants will undergo a series of physical exams, laboratory assessments/biomarker collections, ecg, chest x-ray or ct scan, and questionnaires through day 90. exploratory biomarkers will be evaluated over time to facilitate clinical learning. this record only includes information relevant to the vilobelimab cohort.

Eligibility criteria:
inclusion criteria: the following inclusion criteria are in addition to the exclusion criteria specified in the master protocol nct06703073. * ards severity of moderate or severe based on pao2/fio2 or spo2/fio2 assessment at the time of randomization exclusion criteria: * no additional exclusion criteria beyond the exclusion criteria specified in the master protocol nct06703073.

Keywords: barda just breathe ards acute respiratory distress syndrome acute respiratory failure
peer comparison feedback on opioid prescribing

Conditions: Opioid Use

Summary: we aim to determine if descriptive normative feedback of peer prescribing reduces opioid analgesic prescribing by emergency medicine providers

state-based prescription drug monitoring programs (pdmps) are being implemented to reduce prescription drug abuse and diversion. on august 24, 2016, pennsylvania initiated its mandated pdmp. in prior research, we found that ed providers reduced opioid prescribing by 17% immediately after pdmp went live. still, there is variability between providers in the frequency of opioid prescribing even after pdmp initiation. changing clinician prescribing behavior is difficult, but recent research has shown that using peer comparisons can assist behavior change (meeker d et al., jama, 2016). in this study, we will randomize a convenience sample of ed providers to receive either their opioid prescribing history data with peer comparative data or without peer comparative data. we will examine the effect on immediate perceived norms as well as impact on opioid prescribing in the subsequent 3 months. results could inform behavioral feedback to alter clinician prescribing behaviors

Eligibility criteria:
inclusion criteria: * emergency medicine provider * writes 10 or more opioid prescriptions per month (on average) exclusion criteria: * none
post-authorisation safety study of samsca (tolvaptan) used in routine medical practice

Conditions: SIADH; Non-SIADH Hyponatremia; Non-Hyponatremia

Summary: a drug utilisation survey is performed to monitor and document the drug utilisation patterns of samsca in routine medical practice. a post-authorisation safety study is performed to collect information on the safety of samsca when used in a real-life setting.

drug utilisation survey the drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the smpc, patient age and patient gender distributions on a prescription level. in addition, the indication for use will be further categorised as * siadh * non-siadh hyponatraemia * non-hyponatraemia post-authorisation safety study sodium levels at baseline and rate of sodium correction under therapy will be analysed. safety findings will be described. the number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below: * renal safety * aquaresis-related adverse effects * serum sodium correction rate * glucose homeostasis * cardiovascular safety and hemodynamics * respiratory system * drug metabolism and drug interactions * drug exposure during pregnancy * paediatric safety subgroup analyses will be performed for all safety findings by indication subgroups (siadh and other indications), subgroups according to siadh-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.

Eligibility criteria:
inclusion criteria: * patients who are treated with samsca exclusion criteria: * patients who have not signed the data consent form

Keywords: sodium siadh hyponatremia vasopressin salt water