Kornimate/medical-research-clean huggingface dataset:
dietary salt in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: in this study investigators propose to address the following hypotheses: 1) reduction in dietary sodium will decrease inflammation in patients with rheumatoid arthritis (ra). 2) reduction in dietary sodium will decrease blood pressure in patients with ra. 3) reduction in dietary sodium will decrease tissue sodium in patients with ra.

the study is a random-order, 2 period crossover study with washout. participants will be randomly assigned to be on the high-sodium diet (200mmol/24hours x 8weeks) or low-sodium diet (50mmol/24hours x 8 weeks ) with crossover separated by 4-week washout period. investigators will allow a 7-day window on the diet (i.e., to facilitate scheduling the diet can be between 7-9 weeks), and investigators will allow a 1-week window for the washout (i.e., washout can be 3-5 weeks). investigators will measure changes in inflammation (as measured by das28 (using tender and swollen joint count, disease activity and sedimentation rate)), blood pressure measured over a 24 hour period, and tissue sodium (using magnetic resonance imaging (mri)). if a relatively simple dietary modification has a clinically important effect on inflammation and blood pressure regulation in vivo in patients with ra, this will have far-reaching implications for the treatment of ra and prevention of cardiovascular disease in this population.

Eligibility criteria:
inclusion criteria: 1. male and female patients older than 18 years who are willing to participate. 2. satisfy the acr criteria for the diagnosis of ra. 3. have stable disease activity as evidenced by no clinically meaningful change in immunomodulating or corticosteroid therapy in the past 1 month. 4. have moderate disease activity as reflected by a minimum of 3 swollen and tender joints. exclusion criteria: 1. pregnancy 2. receiving dialysis 3. organ or bone marrow transplant 4. taking diuretics, uncontrolled hypertension (\>160/100 mmhg), or cardiac failure requiring treatment. 5. severe edema (as judged by the investigator) 6. diabetes mellitus treated with an insulin pump 7. major surgery within the previous 3 months 8. severe co-morbid conditions such as active cancer likely to compromise study participation 9. unwillingness, or other inability, to cooperate 10. contraindication to mri 11. presence of a condition that could make 24-hour blood pressure monitoring difficult: atrial fibrillation, inability to operate machine, receiving anticoagulants, presence of a condition that in the opinion of the investigator may be exacerbated by blood pressure cuff inflation (e.g., lymphedema).
advanced oxidation protein product and monocyte chemoattractant protein-1 in periodontal disease

Conditions: Inflammation; Periodontal Disease

Summary: this study investigates the levels of advanced oxidation protein product and monocyte chemoattractant protein-1 in gingival crevicular fluid in periodontal disease and health. 25 participants with chronic periodontitis, 25 participants with gingivitis and 25 periodontally healthy subjects are included into this study. in each participant, four sites are identified for gingival crevicular fluid samples.

oxidative stress is the disequilibrium between the formation of free radicals and antioxidant defense mechanisms via damaging cellular macromolecules (dna, protein, lipid, etc..) which are susceptible to oxidative damage. advanced oxidation protein product is identified as a new marker of protein oxidation. monocyte chemoattractant protein-1 is a major chemoattractant for lymphocytes, monocytes and macrophages.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic periodontitis and gingivitis exclusion criteria: * systemic illnesses * any medications known to affect the periodontium * pregnancy and lactation

Keywords: advanced oxidation protein products gingival crevicular fluid monocyte chemoattractant protein-1 periodontal disease
multiomics study of fibrosis factors after liver transplantation and exploration of fibrosis methylation biomarkers

Conditions: Liver Fibrosis

Summary: this is a retrospective observational study in liver transplantation recipients with or without allograft liver fibrosis. based on the gm-seq and tcr-seq data, a novel diagnostic model including dna-methylation and tcr-seq biomarkers will be established.

this is a retrospective study on 60 patients who had previously received liver transplantation in our hospital. the patients will be stratified according to age, including 20 children and 20 adults with allograft liver fibrosis after liver transplantation, while 10 children and 10 adults with fibrosis, respectively. 1. the differential analysis of dna-methylation will be performed between the allograft liver fibrosis cohort and the control cohort based on the gm-seq sequencing data. and the fibrosis-specific dna-methylation cpg sites or regions in liver and peripheral blood will be explored in the liver transplantation recipients. 2. the abundance and diversity of tcr between the allograft liver fibrosis cohort and the control cohort will be analyzed. and the fibrosis-specific tcr sequence of allograft liver fibrosis will be screened based on tcr-seq sequencing and tngs. 3. the characteristics of dna-methylation and tcr-seq biomarkers in allograft liver fibrosis population will be defined. and the similarities and differences of the characteristics between children and adults will be explored. 4. based on the gm-seq and tcr-seq data, a novel diagnostic model including dna-methylation and tcr-seq biomarkers will be established.

Eligibility criteria:
inclusion criteria: 1. living donor liver transplantation of left outer lobe or left half liver for biliary atresia in children (≤18 years old), or orthotopic liver transplantation for hepatitis b cirrhosis in adults (\> 18 years old), regardless of gender; 2. oral tacrolimus immunosuppressive therapy; 3. received liver transplantation in our hospital for the first time and did not receive liver transplantation again; 4. patients need to be admitted to hospital for programmed liver biopsy or receive liver biopsy due to abnormal liver function; 5. complete clinical data and samples (including liver puncture biopsy specimens, plasma, and pbmc of the same period); 6. the subjects or their guardians voluntarily join the study, sign the informed consent, comply well, and cooperate with follow-up. exclusion criteria: 1. combined multi-organ transplantation; 2. pregnancy or lactation; 3. severe systemic infection; 4. contraindications of liver biopsy with multiple organ failure or coagulation dysfunction; 5. previous history of allergy to narcotic or sedative drugs; 6. in the stage of acute rejection hormone shock therapy; 7. incomplete clinical data and samples; 8. situations considered unsuitable for inclusion by other researchers.

Keywords: liver fibrosis liver transplantation biomarkers dna methylation
minimally invasive biomarker for asthma disease severity

Conditions: Asthma; Healthy

Summary: can a clinical test be developed that could help manage asthma symptoms?

project goals: develop a point-of-service assay to assess eosinophilic airway inflammation proposal specific aims: 1. to establish the infrastructure and test the feasibility of sputum collection in a clinical setting as a minimally invasive patient sampling process for biomarker testing 2. to transform the laboratory-based eosinophil peroxidase (epx) elisa detection assay into a clinic-friendly assessment that does not require sophisticated laboratory equipment

Eligibility criteria:
asthma subjects: inclusion * provider diagnosed asthma * feno\>50 ppb * fev1 \> 1.0 liter exclusion * copd by history * bronchiectasis by history * pregnant participants normal subjects: inclusion - age matched to asthma subjects exclusion * any eosinophil disorder by history * asthma by history * rhinitis or sinusitis by history

Keywords: healthy volunteers asthma sputum eosinophils
hemoglobin transfusion threshold in traumatic brain injury optimization: the hemotion trial

Conditions: Traumatic Brain Injury; Transfusion

Summary: most trauma deaths are related to traumatic brain injury (tbi). although the management of patients has improved, mortality remains unacceptably high, and half of survivors of moderate and severe tbi are left with major functional impairment. current management guidelines are based on limited evidence and practice is highly variable. most acutely ill patients with tbi will develop anemia, which may decrease oxygen delivery to a fragile brain. while clinical practice is moving towards transfusing at low hemoglobin (hb) levels, experts have expressed concerns regarding restrictive strategies, which may adversely affect clinical outcomes in tbi. our primary objective is to evaluate the effect of red blood cell (rbc) transfusion thresholds on neurological functional outcome. we hypothesize that a liberal transfusion strategy improves outcomes compared to a restrictive strategy.


Eligibility criteria:
inclusion criteria: * acute moderate to severe blunt tbi * glasgow coma score \[gcs\] ≤ 12 * hb level ≤ 100 g/l exclusion criteria: * patient has received transfusion after icu admission * contraindications or known objection to transfusions * glasgow coma scale (gcs) of 3 with dilated fixed pupils. * patient is brain dead * active life-threatening bleeding with hemorrhagic shock or requiring urgent surgical procedure * a decision to withold or withdraw life-sustaining therapies was made * no fixed address

Keywords: traumatic brain injury (tbi) red blood cells (rbc) transfusion intensive care unit (icu) transfusion threshold anemia oxygen delivery neurocritical care critical care neurology and trauma
acute changes in intraocular cytokines after intravitreal bevacizumab

Conditions: Complications of Diabetes Mellitus

Summary: purpose: to evaluate the acute changes in intraocular cytokines after intravitreal bevacizumab (ivb) in proliferative diabetic retinopathy. design: prospective, open-label, controlled, randomized interventional clinical trial. participants: twenty eyes of 28 consecutive patients who are scheduled for pars plana vitrectomy (ppv) for proliferative diabetic retinopathy were prospectively enrolled. methods: all patients were randomly assigned to receive ivb either at 2 or 7 days before ppv. aqueous humor samples were taken from anterior chamber just before ivb and at the time of surgery. multiplex cytokine array were used to assay various cytokines


Eligibility criteria:
inclusion criteria: * patients with proliferative diabetic retinopathy who were scheduled for ppv for vitreous hemorrhage or tractional retinal detachment (trd) exclusion criteria: * eyes with any pharmacologic intervention on study eye within 6 months * eyes with panretinal photocoagulation on study eye within 3 months * eyes with any pharmacologic intervention on fellow eye within 3 months, * history of ocular diseases other than diabetic retinopathy * history of ppv on study eye * history of systemic thromboembolic events including myocardial infarction and cerebrovascular accidents.
multicenter study to evaluate the safety and efficacy of revanesse® ultra retreatment

Conditions: Nasolabial Fold Correction

Summary: to compare improvement with retreatment for all subjects undergoing correction of nasolabial folds (nlfs) in the initial sym2014-02 study, who were retreated with revanesse ultra at visit 6/week 24 and to determine the safety of repeat injections of revanesse ultra. the retreatment phase was optional.

the subjects completing the initial phase of the sym2014-02 study (nct02987205) who had returned to baseline wrinkle severity rating scale (wsrs) score or as needed for optimal correction if wsrs scores had not returned to baseline, were offered the option for retreatment with revanesse ultra visit 6/week 24 (± 7 days) optional open-label retreatment with revanesse ultra for subjects who had returned to baseline wrinkle severity rating scale (wsrs) score or as needed for optimal correction if wsrs scores had not returned to baseline; end of study for subjects not being retreated visit 7/week 28 (± 7 days) follow-up for retreated subjects visit 8/week 52 (± 7 days) end of study for retreated subjects a telephone contact was performed at week 40 (± 7 days) for retreated subjects to assess adverse events (aes) and concomitant medications. this report presents the results for all subjects who received optional open-label retreatment with revanesse ultra at visit 6/week 24. this study was performed in compliance with good clinical practice (gcp), including the archiving of essential documents. number of subjects (planned and analyzed): seventy-one subjects received retreatment.

Eligibility criteria:
inclusion criteria: subjects from the sym2014-02 initial study who were: * men or women at least 22 years of age with two fully visible bilateral nasolabial folds each with a wsrs score of 3 or 4 (moderate or severe) that may have been corrected with an injectable dermal filler. * subjects were eligible for retreatment when wsrs scores had returned to baseline for either or both nlfs (retreatment group). * if scores had not returned to baseline, subjects were also eligible to be injected for either one or both nlfs as needed to achieve optimal correction (optimal correction group). exclusion criteria: -
aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia undergoing chemotherapy

Conditions: Acute Leukemia; Anorexia; Anxiety; Depression; Dyspnea; Insomnia; Nausea; Pain

Summary: this randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.

primary objectives: i. does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients? secondary objectives: i. does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? ii. do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience? outline: patients are randomized to 1 of 2 groups. group i: patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 pm in the evening until morning during week 1 and placebo intervention using rose water during week 2. group ii: patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in group i during week 2.

Eligibility criteria:
inclusion criteria: * patients who are newly diagnosed with acute leukemia and hospitalized to receive their initial 4 weeks of intensive induction chemotherapy for this disease exclusion criteria: * asthma or other reactive airway disease * sleep apnea * planned less than two week hospitalization * change in pain medications/sleeping medications/anxiety medications/antiemetics during the trial * patients who have not completed their initial steroids * patients who are confused and unable to give informed consent

Keywords: aromatherapy essential oils acute leukemia
organisational culture and nutritional care

Conditions: Nutrition

Summary: the study explores the impact of organisational culture on multidisciplinary teams in the provision of nutritional care for older hospitalised acute in-patients by collaborating with patients and/or their relatives and healthcare practitioners to influence change.

this study adopts an action research (ar) approach given that sustained change is more likely if it incorporates authentic staff engagement. the key choice made in formulating the research design is to adopt an approach that is collaborative and participatory in a process of action and learning. here, eligible health practitioners involved in any aspect of the patients' food and nutritional care or helping to feed patients during mealtimes would be represented in one central team, engaging as co-researchers in the study. patients and/or relatives will participate in a focus group or interview session. the ar team participants will be involved in the iterative action research cycle, reflecting on current nutritional care practices, collectively evaluate patients' stories and consider ways to improve eating and drinking on the wards. the ar team will meet throughout the course of 12 months. the study will provide insight into the impact of organisational culture ('the way the investigators do things') in the delivery of good nutritional care and elucidate the roles and responsibilities of nurses and other staff groups involved in the provision of nutritional care. this research will provide data on the organisational culture of interdisciplinary teams working at both micro and macro levels while providing insight into the potential for ar to be used in a wider arena within the hospital to improve practice.

Eligibility criteria:
inclusion criteria: * recently discharged patients aged 65 or over * recently discharged patients at the time of data collection * who at the time of admission received oral nutrition and hydration exclusion criteria: * patients aged under 65 * current in-patients * patients who have had no oral nutrition. e.g patients who had percutaneous endoscopic gastrostomy (peg) feeds whilst admitted * patients who are feeling too unwell to participate * patients lacking the mental capacity to give verbal or written consent

Keywords: malnourishment nutritional deficiency undernutrition
evaluation of the quality of care in the emergency department by studying the appropriateness of admissions of patients accessing the emergency department (asst papa giovanni xxiii)

Conditions: Quality of Care; Evaluation; Emergency Departments; Appropriateness

Summary: the aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the emergency department to admit or not to admit patients.

the information normally recorded in the emergency department medical record will be used, as well as the available clinical and administrative databases. for reasons of feasibility, the investigators will also restrict the analysis to patients coming to the emergency department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

Eligibility criteria:
inclusion criteria: * adult patients * presentation in the emergency department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness. exclusion criteria: * voluntary removal of the patient; * sending home with instructions to return for further services
dural puncture epidural versus combined spinal epidural with epidural volume extension in labor analgesia

Conditions: Labor Pain

Summary: labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. in the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta. in the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. pain is transmitted through the t10-l2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. in the second stage, pain from the vagina and perineum is added to uterine pain. this pain is transmitted by the pudendal nerves through the s2-4 nerve roots. in this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.


Eligibility criteria:
inclusion criteria: * asa i and ii parturients * pregnant patients in active labor * active labor with cervical dilation \< 5cm * 37-42 weeks of gestational age * pregnant women between the ages of 18 and 45 exclusion criteria: * patients who do not want to participate voluntarily in the study * pregnant women outside the age range of 18 - 45 * pregnants other than nullipar * patients with allergic reactions to anesthesia and analgesia drugs to be used * severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac) * gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.) * substance abuse history * chronic pain history * psychiatric problems and communication difficulties * bmi\> 35 kg / m2 * failure in neuraxial interventions
child and adolescent anxiety disorders (cams)

Conditions: Anxiety Disorders; Social Phobia; Generalized Anxiety Disorder

Summary: this randomized, controlled trial compared the efficacy of the medication sertraline (zoloft®), cognitive-behavioral therapy, the combination of these treatments, and placebo for youth with anxiety disorders.

anxiety disorders are among the most common conditions affecting children and adolescents. these disorders impair school, social, and family functioning. when left untreated, they also put children at risk for major depression and substance abuse in late adolescence and adulthood. previous studies demonstrated the efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors for the treatment of child anxiety disorders. this study is testing the relative and combined efficacy of cognitive behavioral therapy and selective serotonin reuptake inhibitors as compared to each other and pill placebo. during phase i of this two-phase study, 488 participants were randomly assigned to receive sertraline (zoloft), cognitive behavioral therapy, a combination of these treatments, or a placebo for 12 weeks. phase ii involved a 6-month maintenance period for participants.

Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders (dsm-iv) criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder exclusion criteria: * major neurological disorder or medical illness that would interfere with participation in the study

Keywords: phobic disorders anxiety, separation