Kornimate/medical-research-clean huggingface dataset:
neoadjuvant vs adjuvant in locally advanced recurrent npc

Conditions: Recurrent Nasopharyngeal Carcinoma

Summary: a multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

eligible patients are randomized into the control group and the experimental group. patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.after endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy. patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. in total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. resectable disease staging rt2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rt3 (excluding the lesions confined to the basal wall of sphenoid sinus), rt4, according to ajcc 8th edition; 3. cervical lymph node metastasis can be controlled locally; 4. aged 18 to 75 years; 5. informed consent forms signed to participate in the trial; 6. without distant metastasis; 7. ≥6months from the accomplishment of radical radiation to recurrence 8. previously only 1 course of radiotherapy; 9. sufficient organ function; 10. ecog score 0-2 and can tolerate surgery,chemotherapy and immunotherapy. exclusion criteria: 1. participate in other interventional clinical trials; 2. uncontrolled illnesses that interfere with the therapy; 3. suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.); 4. any contradiction to surgery; 5. with serious autoimmune disease; 6. the patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration; 7. severe allergic reactions to other monoclonal antibodies; 8. history of radioactive particle planting; 9. vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period; 10. female patients who are at pregnancy or lactation; 11. other situations that the researchers believe not suitable for enrollment
t1d, metabolic syndrome and insulin resistance

Conditions: Type 1 Diabetes; Metabolic Syndrome; Insulin Resistance

Summary: patients with type 1 diabetes (t1d) and metabolic syndrome (ms) require high doses of insulin to achieve a glycemic control, due to insulin resistance (ir). the investigators identified the presence of metabolic syndrome and insulin resistance in patients with t1d in a population of southeast mexico. the sampled population was recruited from the diabetes clinic of the regional hospital of high specialty "dr. gustavo a. rovirosa pérez"; from august 2021 to february 2022, graduated physicians interviewed patients previously diagnosed with t1d. this study included patients older than 18 years and at least six months after being diagnosed with t1d. the interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. a diabetologist evaluated and diagnosed all patients based on the world health organization (who) criteria. fasting glucose, total cholesterol, hdl cholesterol, ldl cholesterol, and triacylglycerols were determined in blood serum using a clinical chemistry system from random access diagnostics. the reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.


Eligibility criteria:
inclusion criteria: * at least six months after being diagnosed with t1d exclusion criteria: * did not attend regular consultations * did not agree to participate or to give a blood sample
using the prevent-teach-reinforce model to reduce problem behaviors in children with autism spectrum disorders

Conditions: Child Development Disorders, Pervasive

Summary: children with autism spectrum disorders often engage in problem behaviors such as self-injury, destruction, aggression, and stereotypy. prior research has clearly shown that these problem behaviors may interfere with learning, daily functioning, and social participation. as such, engaging in problem behaviors has a negative impact on the health and quality of life of children with autism spectrum disorders and their families. one promising solution to reduce problem behaviors in this population is the prevent-teach-reinforce (ptr) model, which relies on the evidence-based practices of positive behavior support. although the use of ptr has been gaining considerably support in schools, the model has never been evaluated as part of a rigorous large-scale study using parents as interventionists. thus, the purpose of the project is to conduct an assessment of the effectiveness of a home-based version of the ptr model in reducing problem behaviors in children with autism spectrum disorders and in improving families' quality of life. our hypotheses are that implementing the ptr will (a) produce larger reductions in problem behaviors than participating in an individual parent training session, (b) increase engagement in prosocial behaviors, (c) decrease parental stress, and (c) improve the quality of life of the family. the results of the study will allow an examination of whether ptr is an effective and acceptable model to reduce problem behaviors at home in this population. given that problem behaviors incur high societal costs when they persist into adolescence and adulthood, the study may potentially lead to large cost reductions in the treatment of difficulties associated with autism spectrum disorders. by reducing engagement in problem behaviors, the implementation of the model may also promote and facilitate the social participation as well as improve the quality of life and health of children with autism spectrum disorders and their families.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism spectrum disorder * must exhibit problem behavior exclusion criteria: * already receiving services to reduce problem behaviors at home

Keywords: autism spectrum disorder problem behavior
high flow nasal oxygenation versus non-invasive ventilation for patients with blunt chest trauma

Conditions: Chest Trauma

Summary: chest trauma remains an issue for health services for both severe and apparently mild trauma management. severe chest trauma is associated with high mortality and is liable for 25% of mortality in multiple traumas. moreover, mild trauma is also associated with significant morbidity, especially in patients with preexisting conditions. thus, whatever the severity, a fast-acting strategy must be organized. in order to improve the prognosis of patients with severe chest trauma, early and continuous application of non-invasive mechanical ventilation (niv) can indeed reduce the need for intubation and shorten intensive care unit length-of-stay. among different mechanisms, the early use of positive end-expiratory pressure after chest trauma, when feasible, seems mandatory to optimize oxygenation and improve clinical outcomes. indeed, interventions aimed at preventing ards after chest trauma carry the greatest potential to reduce the substantial morbidity, mortality, and resource utilization associated with this syndrome.

in the past years, high-flow nasal cannula oxygen (hfnc) has gained an important popularity among intensivest to manage patients with acute respiratory failure, filling a gap in the ventilatory support escalation between facemask oxygen and non-invasive or invasive mechanical ventilation. interestingly, the use of hfnc was widely and rapidly adopted in icus.a unique feature of hfnc is its ability to comfortably deliver high flows of warmed humidified gas, 20-70 l min, with a fio2 range of 0.21-1.0. physiological responses to hfnc therapy include increases in airway pressure, end-expiratory lung volume (eelv), and oxygenation which are probably optimal with higher flows (60-70 l/min), while the effects on dead-space washout work of breathing, and respiratory rate may be obtained with intermediate flows (20-45 l/min). many studies have found that high flow nasal oxygen is much better tolerated by patients compared to non-invasive ventilation, which may improve compliance. nevertheless, there is no clear consensus on the treatment outcomes (such as intubation rate, escalated respiratory support rate, and mortality) of high flow nasal oxygenation versus non-invasive ventilation for patients with traumatic chest injuries.

Eligibility criteria:
inclusion criteria: * rib fractures, pulmonary contusion, and admission within 24 h of injury * hypoxemia (spo2 90 % while breathing 10 l/min oxygen in the er), or hypercapnia (paco2 45 mm hg) on study entry * respiratory rate 25/ min despite an optimized intravenous analgesia * no indication of mechanical ventilation at the time of admission to the intensive care unit exclusion criteria: * patients \< 18 years old * patient already admitted to icu on mechanical ventilation * requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause * facial fractures or base of skull fractures * who did not receive a chest computed tomography (ct) scan * glasgow coma scale ≤ 12
behavioral contract adherence intervention

Conditions: Renal Transplantation

Summary: there is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (rtrs) to improve immunosuppressant therapy (ist) adherence and clinical outcomes. the objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve rtrs' ist adherence rates (contracts are written, signed agreements between the rtr and healthcare provider in which the rtr agrees to be adherent to ist according to mutually agreed upon criteria); and (2) measuring the effects of ist adherence on rtrs' health-related quality of life (hqol) and healthcare utilizations and costs. the primary hypothesis was that at one year post trial enrollment, rtrs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater hqol and lower healthcare utilizations and costs. once it is better understood how to implement effective ist adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve hqol, and reduce healthcare utilizations and costs. therefore, we pursued the following specific aims: (1) determine the effectiveness of an ist adherence contract-based intervention on ist adherence; (2) determine the relationship between ist adherence, the intervention, and rtrs' hqol; and (3) determine the influence of ist adherence and the intervention on rtrs' healthcare utilizations/costs. to achieve the specific aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, hqol, and healthcare utilizations/costs were collected over a 12-month period for each rtr study participant and analyzed. this project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult rtrs by providing data regarding an adherence intervention and the impact of ist adherence and the behavioral contract intervention on rtrs' health and economic outcomes and hqol. collectively, this new knowledge will provide critical steps toward optimizing rtrs' graft maintenance, productivity, and hqol, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.


Eligibility criteria:
inclusion criteria: * renal transplant recipient * at least 21 years of age * receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus * be at least one year post-transplant * obtain immunosuppressant therapy from avella specialty pharmacy for at least one year prior to study enrollment and during the study period exclusion criteria: * pregnant * prisoner * institutionalized * unable to give informed consent

Keywords: immunosuppressant therapy adherence quality of life economic outcomes
detection of prostate cancer with non-invasive method based on dna methylation of circulated tumor dna, pbmc

Conditions: Prostate Cancer; Prostate Adenocarcinoma; Prostate Cancer Metastatic

Summary: prostate cancer is a leading cause of mortality and morbidity. the purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in pbmc, t-cells and circulated tumor dna in prostate cancer patients.


Eligibility criteria:
inclusion criteria: * informed consent: the patient must sign the appropriate approved informed consent documents in the presence of the designated staff exclusion criteria: * pregnant women * minors (subjects less than 18 years of age) * prisoners * patients having other than one cancer * subjects unable to consent for themselves * symptomatic of acute prostatitis
study assessing an algorithm-based strategy of eculizumab discontinuation in children and adults with ahus

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: atypical hemolytic syndrome (ahus) is a severe renal disease affecting children and adults. it is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. the discovery of complement alternative pathway as a major risk factor for ahus has led to the design of a disease-specific treatment, the anti-c5 monoclonal antibody, eculizumab. complement inhibition using eculizumab has clearly improved the renal outcome of ahus patients with a dramatic decrease in the risk of end-stage renal disease. however, the optimal duration of eculizumab therapy is still debated. the present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with ahus.

a visit (physical examination; blood pressure measurement) will be performed every month for 3 months, and every 3 months for 21 months. blood (serum creatinine, platelet count, hemoglobin, ldh, haptoglobin) and urine (proteinuria/creatininuria ratio and microscopic hematuria) tests will be performed every 2 weeks from inclusion to m6 and subsequently every month starting m7 urine dipstick (for albuminuria and microscopic hematuria) will be performed by the patients at home at least twice a week. markers of complement activation and biomarkers of endothelial cells activation and immune cells activation will be assessed at baseline, m1, m3, m6, m9, m12, m18 and m24.

Eligibility criteria:
inclusion criteria: 1. children and adults under eculizumab treatment for ahus (initial episode or relapse) defined by at least two of the following: thrombocytopenia (platelet count \ upper limit of normal, undetectable haptoglobin, presence of schizocytes on blood smear), acute kidney injury (serum creatinine and/or proteinuria/creatininuria \> upper limit of normal for age or an increase \> 15% compared to baseline levels ) 2. patients not requiring dialysis. 3. adults: hus remission and normal or stabilized renal function under eculizumab treatment since at least 6 months (3 months in patients with mcp mutations) 4. children: age \> 3 years at eculizumab withdrawal; hus remission and normal renal function under eculizumab treatment since at least 3 months in children with isolated mcp mutation, at least 6 months in children with complement mutation other than mcp. exclusion criteria: 1. patients on dialysis. 2. women treated with eculizumab starting or planning a pregnancy. pregnancy including the post-partum period is high-risk periods for the occurrence of ahus. 3. patients who did not give informed consent. 4. patients under protection of a judicial authority patients can be enrolled in the study within ten weeks after eculizumab stop.

Keywords: atypical hemolytic uremic syndrome (ahus) eculizumab discontinuation
tvns for depression

Conditions: Depressive Disorder

Summary: this is a phase ii, randomized, sham controlled, clinical trial. this clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous vagus nerve stimulation (tvns) treatment protocol for patients with moderate / severe depressive episode.


Eligibility criteria:
inclusion criteria: 1. patients between 18 and 69 years 2. patients with a diagnosis of depression according to the scid 3. score greater than or equal to 18 on the hamilton rating scale 17-item version (equivalent to moderate or severe depressive episode) 4. agreement to participate in the study as recommended in the ic. exclusion criteria: 1. patients with psychiatric indication for hospitalization 2. patients with psychiatric comorbidity 3. patients with a diagnosis of personality disorder 4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.
use of automated office blood pressure monitoring

Conditions: Hypertension; Uncontrolled Hypertension; Hypertension, White Coat; Hypertension, Resistant to Conventional Therapy

Summary: blood pressure measurements by three methods office blood pressure measurement (obpm), automated office blood pressure measurement (aobpm), and home blood pressure measurement (hbpm) were collected retrospectively across three visits for patients (n=28) referred to a specialty hypertension (htn) clinic. demographic data were analyzed using summary statistics. the differences between aobpm, hbpm, and obpm were examined using mixed models repeated measures analysis for time and method for each visit.


Eligibility criteria:
inclusion criteria: * 19 years and older * uncontrolled bp * prescribed three or more antihypertensive medications at the time of referral * higher risk for poor cv outcomes than patients with essential htn * obpm systolic bp of greater than 140 mmhg and diastolic bp of greater than or equal to 90 mm hg upon initial clinic assessment. exclusion criteria: * less than 19 years old * had a systolic bp of less than 140 mm hg and diastolic bp of less than 90 mmhg upon initial clinic assessment. * also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled obpm were excluded.
clinical evaluation of etafilcon a contact lenses using a novel molding process

Conditions: Refractive Error Correction

Summary: this study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. subjects will wear bilaterally both test and control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.


Eligibility criteria:
inclusion criteria: -potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. must be at least 18 and not more than 70 years of age (including 70) at the time of screening. 4. the subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear). 5. the subject must have normal eyes (i.e., no ocular medications or infections of any type). 6. the subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 d in each eye. 7. the subject's refractive cylinder must be \< 0.75 d in each eye. 8. the subject must have best corrected visual acuity of 20/25 or better in each eye. exclusion criteria: 1. currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). 2. any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. 3. any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, prk, lasik, etc.). 4. any ocular infection. 5. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 6. monovision or multi-focal contact lens correction. 7. participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. 8. history of binocular vision abnormality or strabismus. 9. any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., hiv, by self-report). 10. suspicion of or recent history of alcohol or substance abuse. 11. history of serious mental illness. 12. history of seizures. 13. employee of investigational clinic (e.g., investigator, coordinator, technician).
teaching children with asthma and who live in a rural setting how to self-manage their asthma

Conditions: Asthma

Summary: to determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.

many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life. the type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity. few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations. the goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers. we hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.

Eligibility criteria:
inclusion criteria: * physician diagnosed asthma, attend elementary school in rural county agreeing to participate exclusion criteria: participation in another asthma study or having other respiratory illness such as cystic fibrosis, bpd -
a clinical study of the effects of environmental pollution on obesity

Conditions: Obesity and Overweight

Summary: this study aims to assess the effects of environmental pollution (including environmental indicators such as pm2.5, pm5, pm10, so2, nox, o3, and greening index) on obese patients and to explore the possible mechanisms by which environmental pollution promotes obesity.

firstly, the effects of environmental pollution on obese patients were investigated by analysing the baseline conditions and obesity levels (including bmi, waist circumference, hip circumference, etc.) and underlying diseases of obese patients in regions with different pollution levels. secondly, the association between environmental pollution levels on blood test characteristics (including renal function, sex hormones, glucose tolerance test, trace elements, liver function and blood routine) of obese patients was investigated to find possible mechanisms.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * obese patients with bmi ≥30; * patients without surgical treatment prior to enrolment; * willingness to participate in the study and sign an informed consent form; * complete clinical data. exclusion criteria: * patients with systemic diseases such as severe cardiorespiratory insufficiency affecting the choice of treatment regimen; * patients assessed by the investigator to be inappropriate for enrolment; * patients with incomplete clinical data.

Keywords: air pollution obesity prevalence overweight environment