Kornimate/medical-research-clean huggingface dataset:
impact of low muscle mass in hnc treated with immunotherapy

Conditions: Head and Neck Small Cell Carcinoma; Sarcopenia

Summary: the purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (scchn) treated with immune checkpoint inhibitors (ici)

body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. however, there are currently no data on impact of body composition and the oncological outcomes in scchn patients treated with immune checkpoint inhibitors (ici) due to recurrence or metastasic disease.

Eligibility criteria:
inclusion criteria: * patients diagnosed with recurrence or metastatic scchn treated with antipdl1, antipd1 or antictla-4 drugs, alone or in combination within our institution. * patients who have previously signed informed consent. * patients with measurable tumor lesions. exclusion criteria: * patients with non-measurable lesions. * patients who do not sign the informed consent. * patients not treated with immunotherapy. * patients in a double-blind trial in whom the assigned branch is not known.

Keywords: head and neck cancer immune checkpoint inhibitors muscle mass sarcopenia
multiple b-value diffusion-weighted imaging(dwi) in evaluation of breast lesions

Conditions: Breast Neoplasms; DWI

Summary: breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. this study is going to evaluate multi-b value diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameter. at the same time, pathological specimens of patients will be collected. the relationship between magnetic resonance(mr) parameters and pathology biomarkers will be evaluated. hope multi-b value diffusion weighted imaging can improve diagnosis for breast lesion and provide the basis for clinical treatment. the fundamental of pathology on mr signal change will be further expounded.

breast cancer is the most commonly diagnosed cancer in women and its definite diagnose is still challenge for radiologist. this study is going to evaluate multi-b values diffusion weighted imaging in discrimination of breast benign and malignant lesions and explore the diagnostic effect of the combination of multi-parameters. at the same time, pathological specimens of patients will be collected. the relationship between mr parameters and pathology biomarkers will be evaluated. by pre-contrast and post-contrast multi-b values diffusion weighted imaging series, patient's apparent diffusion coefficient(adc),tissue diffusivity (d), pseudo-diffusion coefficient (d\*), perfusion fraction (f), distributed diffusion coefficient(ddc) and alpha will be evaluated. parameters of benign , malignant breast lesions and ipsilateral or contralateral normal breast parenchyma as a control group will be measured. receiver operating characteristic (roc) curve analysis is used to test the ability of different parameters in differentiating malignant from begin lesions. after surgical operation, specimen of lesion will be collected(not every patient's specimen will be collected. the investigators should be approved by patient themselves). the biomarkers of specimen will be detected by pathological and molecular-biological methods.then analyze the relation between parameters of the mr imaging and pathological/molecular-biological biomarkers.

Eligibility criteria:
inclusion criteria: * female patient with breast lesion (breast imaging reporting and data system 2,3,4,5) * operation is take in tang-du hospital exclusion criteria: * postoperative patient * suffer radiotherapy,chemotherapy and endocrine treatment * serious image artifacts * lesion with diameter less than 3mm * scan during menstrual period * other magnetic resonance imaging contraindications

Keywords: breast magnetic resonance imaging diffusion-weighted imaging multiple b-value diffusion weighted imaging
xpress eustachian tube dilation study

Conditions: Eustachian Tube Dysfunction

Summary: study to assess the safety and efficacy of the xpress device for transnasal eustachian tube dilation.

prospective, multicenter, randomized controlled trial comparing balloon dilation of the eustachian tube to continued medical management for treatment of persistent eustachian tube dysfunction.

Eligibility criteria:
inclusion criteria: * ≥18 years old * have been diagnosed with symptoms of chronic eustachian tube dysfunction for no less than 12 months prior to enrollment * have an overall etdq-7 score ≥3.0 * have record of failed medical management for eustachian tube dysfunction exclusion criteria: * require concomitant procedures at the time of the study enrollment or procedure * have patulous eustachian tube * have ear tubes in place or perforation of the tympanic membrane * have evidence of internal carotid artery dehiscence * be pregnant at the time of enrollment * be currently participating in other drug or device studies
testicular sperm aspiration (tesa) vs. microfluidic sperm separation (mss)

Conditions: Infertility, Male; Azoospermia; Reproductive Disorder

Summary: normal embryonic development relies on the correct transmission of genetic information, and sperm dna plays a crucial part in this process. causes of poor sperm dna integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. an increase in dna fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate. the best way for sperm selection and processing in assisted reproductive technologies (art) should be noninvasive and cost-effective. it should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. this method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ros), and low dfi


Eligibility criteria:
inclusion criteria: * men with high dna fragmentation (\>20%) undergoing tesa-icsi or zymot-icsi exclusion criteria: * spouse with advanced maternal age (\> 40 years) * egg donation cycle
healthcare support for remote hiv patients

Conditions: HIV Infections

Summary: adherence to antiretroviral therapy (art) is crucial for treatment success in hiv+ patients. this study proposes the use of a smartphone application, specifically developed for this project, to monitor art adherence and assess quality of life among hiv+ patients. the aim is to optimize long-term disease management through the early identification of comorbidities and clinical complications

since the first cases were reported more than 35 years ago, 78 million people have been infected with hiv and 35 million have died from aids-related illnesses. currently, the availability of tarv regimens associated with good tolerability and high levels of efficacy make it necessary to turn attention toward new standards of efficacy indicative of patients' mental and physical well-being. indeed, health-related quality of life (hrqol) is becoming increasingly preponderant as a therapeutic outcome. despite tarv-related viroimmunologic success, people living with hiv (plwh) continue to have lower hrqol than the general population. indeed, much evidence confirms the impact on quality of life not only of therapeutic treatments but also of social and relationship issues and comorbidities. improving hrqol is now, therefore, a primary goal for the care and support of plwh. evaluations of new treatments and interventions to improve care, therefore, require the measurement, in addition to clinical endpoints, of hrqol using valid and reliable instruments. therefore, the importance of pros (patient reported outcomes), which represent the description of the patient's own reported state of health, without any interpretation by clinicians or health care personnel, emerges in this area. in this way, the patient is directly involved in his or her own process of care. adherence to tarv is essential for successful treatment and improved quality of life. unfortunately, non-adherence to treatment is a common problem among hiv-infected patients. the covid-19 emergence has significantly revolutionized the health care system leading to the implementation of new modes of care, including the use of technological tools to ensure remote medical care. the present study, targeting hiv-infected patients undergoing virological suppression, aims to use a smartphone application to facilitate continuity of care remotely, promoting adherence to therapy and thus the effectiveness of tarv, assessing the patient's quality of life and identifying possible comorbidities or other critical clinical

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hiv-infected patients * hiv plasma rna values \< 50 copies/ml * patients referred to the hiv outpatient clinic at the sc infectious diseases of the azienda alexandria hospital * patients on a stable antiretroviral regimen for at least 6 months * patients who have the ability to download the application under study * patients who have signed the informed consent exclusion criteria: * newly diagnosed patients

Keywords: hiv/aids mobile application digital health
safety and preliminary efficacy of jk500 cell injection in relapsed/refractory pediatric acute myeloid leukemia

Conditions: Acute Myeloid Leukemia, Childhood; Relapsed Leukemia; Refractory Leukemia

Summary: this study is a prospective, single-center, single-arm exploratory clinical study, aiming to complete the preliminary clinical observation of 12 children with relapsed/refractory acute myeloid leukemia treated with jk500 cell injection to evaluate the safety of clinical infusion and the initial efficacy of jk500 cell injection in the treatment of children with relapsed/refractory acute myeloid leukemia.

the main components of jk500 cell injection are regenerative natural killer (nk) cells derived from human embryonic stem cells and 0.9% sodium chloride solution.

Eligibility criteria:
inclusion criteria: 1. age ≤18, male or female; 2. patients diagnosed as acute myeloid leukemia (aml) according to the revised world health organization (who) criteria in 2016; 3. patients who failed to achieve cr after two standard-dose induction therapy or had recurrence within six months after cr; 4. the subject or the guardian of the subject must fully understand the purpose, nature, method and possible adverse reactions of the test, agree the subject as the subject, and sign the informed consent. exclusion criteria: 1. acute promyelocytic leukemia, chronic myelocytic leukemia, acute mixed-cell leukemia or known central nervous system leukemia; 2. aml associated with congenital syndromes such as down syndrome, fanconi's anemia, bloom's syndrome, koch's syndrome, or congenital aplastic anemia; 3. the subjects have active virus infection, and during the screening period, the serum virology test is performed, and the human immunodeficiency virus (hiv) antibody is positive, hepatitis b surface antigen or e antigen is positive, hepatitis c antibody is positive, or treponema pallidum antibody is positive; 4. presence of active systemic infection; participated in a drug trial within the past 4 weeks; 5. patients who suffered from a clinically significant disease within 28 days before receiving the study product or underwent a major surgical operation within 28 days before receiving the study product, or are expected to need major surgery during the trial; 6. children with liver and kidney dysfunction, including: 1. serum creatinine \>2× upper limit of normal reference value; 2. serum total bilirubin \> 2× upper limit of normal reference value; 3. aspartate aminotransferase (ast) and alanine aminotransferase (alt) \> 2× upper limit of normal reference values 7. children who have used live attenuated vaccine 4 weeks before administration or plan to use live attenuated vaccine within 6 months after administration; 8. have any other conditions that may cause the subject to be unable to complete the study or present a significant risk to the subject in the opinion of the investigator.
clinical effect of the association of noninvasive ventilation and high flow nasal oxygen therapy in resuscitation of patients with acute lung injury (florali study)

Conditions: Acute Lung Injury; Acute Respiratory Failure

Summary: the aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation : 1. conventional oxygen therapy (o2 conventional) 2. high flow nasal oxygen therapy (o2-hfn) 3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (o2-hfn/nppv).


Eligibility criteria:
inclusion criteria: * hypoxemic and no hypercapnic acute respiratory failure : * severe dyspnea at rest with a respiratory rate \>25 breaths/min * pao2/fio2 \<300 * paco2 \<45 mmhg, exclusion criteria: * age \<18 years * nppv contraindications * past history of respiratory chronic disease (copd, cystic fibrosis...) * cardiac pulmonary edema * pre-defined intubation * other than respiratory organ failure : systolic pressure \<90 mmhg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( glasgow score ≤ 12) * profound aplasia (white cells count \<1000/mm 3)

Keywords: ali
gender-based differences in heart failure hospitalizations among patients with heart failure treated with spironolactone

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Summary: aldosterone antagonists or mineralocorticoid receptor antagonists (mras) are used as therapeutic agents for the management of hf with reduced ejection fraction (hfref). gender-related differences have been described in the regulation of the renin-angiotensin-aldosterone system (raas), which is at the core of the pathophysiology of hf. regarding gender-related differences in the use of mras, less is known about the effects of androgens on the raas, even though studies have suggested that androgens may increase the raas pathway. there are conflicting results because many clinical trials were not specifically designed to investigate gender differences.

the rales trial investigated the effect of spironolactone on symptomatic hf patients without any difference in treatment benefits between both genders. however, only 30 % of the patients enrolled were females. another trial investigated the gender-based differences in the treatment of hfpef patients with spironolactone. the results showed no significant sex differences in clinical endpoints, but a substantial reduction in all-cause mortality was associated with spironolactone use in females but not in males. the utilization of hf pharmacotherapy has been controversial, given recent discoveries presented by the paragon-hf trial.

Eligibility criteria:
inclusion criteria: * all adult (≥ 18 years) ambulatory patients of both sexes with a diagnosis of hfref (lvef≤ 40%) and nyha class ii-iv under optimized medical therapy who are presented to the outpatient clinic and started spironolactone at the time of enrollment. exclusion criteria: * pregnancy or breastfeeding * serum creatinine \> 2.5 mg/dl (221 µmol/l) in males and \> 2 mg/dl (177 µmol/l) in women (or estimated glomerular filtration rate (egfr) ≤ 30 ml/minute/1.73 m2) * hyperkalemia (serum potassium level \> 5 meq/l) * renal transplantation * concomitant administration of potent cyp3a inhibitors * concomitant administration of potassium supplements or potassium-sparing diuretics * disorders of the adrenal glands (such as addison disease). * patients who used mra in the last 2 weeks before enrollment.

Keywords: heart failure gender spironolactone
a 36-month analysis of the clinical performance of individualized cad/cam-produced dental implants: a cohort study

Conditions: Tooth Loss; Dental Implant

Summary: the goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized cad/cam pre-fabricated root-analog dental implants over a 36-month period. the main questions it aims to answer are: 1. are these novel implants safe, effective, and clinically viable for 36 months? 2. do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. the study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.


Eligibility criteria:
inclusion criteria: * received a personalized dental implant using the identical dental implant system during the previous interventional phase; * completed the 12-month follow-up period after implant placement in the previous interventional phase; * available for follow-up evaluations during the 36 months of the observational study. exclusion criteria: * occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase; * development of uncontrolled medical conditions during the follow-up period; * inability to attend scheduled follow-up visits; * refusal to participate in the observational study.
evaluating the long-term effects of microfocused ultrasound on facial tightening using quantitative instruments

Conditions: Facial Aging

Summary: a non-randomized, evaluator-blinded study was conducted to observe the changes in the face before and after facial rejuvenation using microfocused ultrasound. the efficacy of microfocused ultrasound in facial rejuvenation was evaluated using standardized photographs in conjunction with a dermatological testing system and to explore the effects of microfocused ultrasound on the function of the skin.

primary efficacy endpoints:utilizing the 3d life viz mini system for standardized photo modeling enables the comparison and identification of enhancements in treatment outcomes. this research utilized standardized photo modeling to record the facial and mandibular conditions of patients, capturing images both before and after treatment (immediately post-operation and at 7, 30, 90, 180，270 and 360 days). the detection of improvements in treatment effects was then achieved through pairwise comparisons of the modeled data derived from these photographs;secondary efficacy endpoints: global aesthetic improvement scale, patient satisfaction scores, digital visual analog scale

Eligibility criteria:
inclusion criteria: 1. ages between 25 and 60 years old. 2. clear manifested skin issues such as sagging and wrinkles: merz facial aesthetics score of 2 or above. 3. absence of significant systemic diseases, cardiovascular disorders, impaired liver or kidney function, malignant tumors, etc. 4. willing to participate in this study and sign an informed consent form. exclusion criteria: 1. pregnant or lactating women. 2. individuals with a scar-prone constitution, allergic or abnormally healing skin. 3. treatment areas with damaged skin, acute inflammation, active infection, rosacea, vitiligo in the progressive stage, or severe acne. 4. patients with skin conditions such as urticaria, itching, or other dermatological diseases. 5. those with psychological disorders or drug allergies. 6. individuals harboring unrealistic expectations about treatment outcomes. 7. treatment areas containing metal foreign bodies or fillers deemed unsuitable for treatment by the physician. 8. recent facial laser treatments or injections within the past month, including but not limited to filler treatments such as hyaluronic acid, botulinum toxin, and prp injection therapy. 9. any skin-tightening cosmetic treatments on the face or neck within the last three months. 10. any minimally invasive cosmetic treatments on the face within the last three months. 11. thread embedding treatments on the face within the last year, excluding thread blepharoplasty. 12. patients with severe insomnia or those requiring intense sun exposure within the next three months. 13. patients deemed unsuitable for participation by the investigator. 14. those unable to cooperate with the treatment and complete all required visits.

Keywords: facial aging microfocused ultrasound rejuvenation
comparison of infant pain responses between two different methods of urine collection

Conditions: Pain; Intensive Care, Neonatal

Summary: the purpose of this study is to determine which of the two procedures commonly used to collect urine, percutaneous suprapubic aspiration (spa) and urethral catheterization (uc), is less painful, and the success rates and complication rates associated with both methods.

infants hospitalized in the nicu undergo numerous invasive and painful procedures. exposure to early repeated painful procedures has been correlated with both short-term and long-term negative sequelae, such as altered pain responses and increased sensitivity to pain (taddio 2005). fifty eligible infants in the nicu will be randomized to undergo urine collection by either suprapubic aspiration (spa) or urinary catheterization (uc). outcome measures will include pain, procedure success, and procedure duration. pain will be measured using facial grimacing (the infant's face will be videotaped for the entire procedure), heart rate and oxygen saturation. procedure success will be defined by the collection of about 2ml of urine (falcao, 1999). the procedure duration in seconds for the first attempt will be calculated. infants will be monitored during the procedure for adverse events such as apnea, bradycardia, desaturation, emesis, increased ventilatory support. results will be extremely valuable in aiding health care providers to choose a urine collection technique that minimizes the pain and maximizes the success of the procedure.

Eligibility criteria:
inclusion criteria: * infants in the neonatal intensive care unit (nicu) who require urine samples for microbiological analysis exclusion criteria: * clinical diagnosis of birth asphyxia or seizures * neurological conditions * congenital anomalies associated with the central nervous system, gut, or genitourinary tract * abdominal distension or abdominal infection/cellulitis * colostomy * inguinal hernia * organomegaly * bleeding diatheses (thrombocytopenia or coagulopathy) * receiving analgesics or sedatives

Keywords: diagnostic techniques, urological urinary catheterization aspiration neonates neonatal intensive care unit infant, newborn infant, premature infant, low-birth weight
acute intermittent hypoxia in persons with multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the overall objective of this project is to investigate the effectiveness of acute intermittent hypoxia (aih), to improve muscle strength and activity level in individuals with relapsing-remitting ms.


Eligibility criteria:
inclusion criteria: * have relapsing-remitting ms * volitional ankle plantar flexion strength in at least one leg * are relapse free for 30 days * patient-determined disease steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet) exclusion criteria: * currently taking antispasticity medications, * have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea * pregnant or nursing women (safety for developing fetus or infant is unknown) * cognitive concerns (must be able to consent to study, follow steps)