Kornimate/medical-research-clean huggingface dataset:
biomarkers for clinical classification and outcomes of immune checkpoint inhibitor-related-related myocarditis in lung cancer

Conditions: Lung Cancer; Myocarditis Due to Drug

Summary: this study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ici)-related myocarditis in patients with lung cancer.a total of 50 patients with ici-related myocarditis will be enrolled, including 25 with severe/critical myocarditis and 25 with subclinical/mild myocarditis. blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. changes in biomarkers after treatment will also be assessed. clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. this model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.


Eligibility criteria:
inclusion criteria: * pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy; * clinically diagnosed with immune checkpoint inhibitor-related myocarditis; * aged 18 years or older; * voluntarily signed informed consent after being fully informed. exclusion criteria: * pregnancy or breastfeeding; * presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia); * concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases; * inability to complete the required examinations and follow-ups specified in the study.

Keywords: lung cancer myocarditis immune checkpoint inhibitors
the effectiveness and safety of intravesical docetaxel instillation for prevent bladder recurrence

Conditions: Urothelial Carcinoma

Summary: the investigators evaluated the efficacy of a single early intravesical instillation of doxetaxel in the prevention of bladder recurrence after nephroureterectomy or distal ureterectomy for upper urinary tract urothelial carcinoma (uut-uc).

approximately 20% to 50% of patients with upper urinary tract urothelial carcinoma (uut-uc) experience bladder recurrence after nephroureterectomy. although many agents have been administered for the prevention of bladder recurrence, the standard prophylactic treatment has yet to be established. a meta-analysis found that a single instillation of chemotherapy immediately after transurethral resection of bladder tumor (turbt) significantly decreased the risk of recurrence in patients with bladder cancer. indeed, a single early instillation of docetaxel was found to reduce the post-turbt bladder recurrence rate among patients with bladder cancer. in this prospective, randomized study, the investigators evaluated the efficacy of a single, early, intravesical instillation of docetaxel in the prevention of bladder recurrence after nephroureterectomy for uut-uc.

Eligibility criteria:
inclusion criteria: * upper urinary tract urothelial cell carcinoma * hb\>10g/dl, anc \>1500mm3, platelet \> 100k * total bilirubin : 1.5 times lower than the normal upper limit * ast/alt: 1.8 times lower than the normal upper limit * alkaline phosphatase: 1.8 times lower than the normal upper limit exclusion criteria: * concomitant bladder tumor * patients diagnosed with bladder cancer within the last 3 years * previous history of hypersensitivity to docetaxel * neurogenic bladder * patients who received chemotherapy for cancer within the last 6 months * patients with active disease not fit for this study * anc \<1500mm3 * pregnant or lactating women * patients with severe hepatic dysfunction * patients with severe renal impairment * patients with hypersensitivity to mannitol, paraplatin, platinum compounds * patients with complications of infection * patients suspected of having infectious fever

Keywords: intravesical chemotherapy docetaxel radical nephroureterectomy
the effect on overall mortality of a national policy of limiting measles vaccination to children below 12 months of age

Conditions: Mortality; Vaccines

Summary: the national expanded programme on immunization (epi) in guinea-bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the epi program. this has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (mv). studies from the bandim health project (bhp) have shown that mv has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. hence, mv seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality. to test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national epi policy (national policy) or receive mv regardless of age and whether some doses of mv may be lost (mv-for-all policy). the investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive mv compared with children randomised to follow the national policy and not receive mv.


Eligibility criteria:
inclusion criteria: * age 9-35 months, not yet received routine measles vaccination, resident in study area exclusion criteria: * to ill to be vaccinated (according to local practice)

Keywords: mortality vaccines
prospective pilot study identifying clinically relevant biological targets for medical therapy

Conditions: Craniopharyngioma, Child

Summary: new data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (cpa) may not be as effective as it could be.

current treatment regimens for pediatric cpa are limited to surgery and radiation therapy. this pilot study seeks to identify biologically rational therapeutics for the medical treatment of adamantinomatous cpa by confirming the overexpression of specific molecules.

Eligibility criteria:
inclusion criteria: 1. patients between 0-21 years of age. 2. patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling. exclusion criteria: 1. patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma 2. patients in whom tissue specimen is not obtained/available 3. patients over 21 years of age. 4. patients who choose not to participate

Keywords: pilot study biological targets ctnnb1 tumor
minimal clinically significant difference (mcid) of multidimensional dyspnea profile (mdp) in copd patients undergoing respiratory rehabilitation

Conditions: COPD

Summary: this study is designed to determine the individual threshold of minimal clinical change (mcid) for each component of the multidimensional dyspnea profile (mdp) questionnaire in copd patients undergoing pulmonary rehabilitation.

the aim of the research is to determine the minimal clinically significant difference (mcid) in mdp scores in copd patients after a respiratory rehabilitation course using the anchoring method : * the a1 score will be compared with the borg affective dyspnea (borga) scale. * the sensory score will be compared with the borg sensory dyspnea scale (borgs). * the 5 sensory items will be compared with the borg sensory dyspnea scale. * the emotional score will be compared with the borg emotional dyspnea scale. * the 5 emotional items will be compared with the borg affective dyspnea scale. the various questionnaires will be administered to patients at inclusion, after a constant work-rate cycling exercise test, and at isotime during the same cycling exercise test at the end of the pulmonary rehabilitation course. the sensitivity study will be conducted using the visual analog dyspnea scale instead of the borg score. finally, we will also determine the mcid using the distribution method. the mcid score will be correlated with various quality of life and physical performance scores.

Eligibility criteria:
inclusion criteria: * gold b or d copd patient * moderate to severe obstructive ventilatory disorder (fev1\<80%) * admitted for a pulmonary rehabilitation * having given free, informed and written consent exclusion criteria: * lack of french language skills, preventing completion of questionnaires * cognitive impairment preventing completion of questionnaires * patient under guardianship * patient not affiliated to the social security system * chronic ethylism

Keywords: breathlessness mcid copd mdp pulmonary rehabilitation
a first human dose trial investigating safety, tolerability and pharmacokinetics for single doses and multiple doses of nnc0165-1562 in overweight to obese but otherwise healthy subjects

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america. the aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of nnc0165-1562 in overweight to obese but otherwise healthy subjects.


Eligibility criteria:
inclusion criteria: * part i (sd): * male, aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 25.0 and 34.9 kg/m\^2 (both inclusive). overweight should be due to excess of adipose tissue, as judged by the investigator * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator * part ii (md): * male or female, aged 18-55 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 27.0 and 39.9 kg/m\^2 (both inclusive). overweight should be due to excess of adipose tissue, as judged by the investigator * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * any clinically significant weight change (at least 5% self-reported change during the previous 3 months), dieting attempts (e.g. participation in an organised weight reduction programme within the last 3 months), prior obesity surgery, or medications affecting body weight within 3 months prior to screening * male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (pearl index 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product * female subjects who are of child bearing potential (pre-menopausal and not surgically sterilised) and are sexually active with male partner(s) who are not surgically sterilised (vasectomy) and are not using highly effective contraceptive methods (pearl index 1%,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide) combined with a highly effective method of contraception for their male partner(s) (e.g. condom with spermicide), and/or are pregnant, breast-feeding or intend to become pregnant) (applicable to part ii (md) only)
cervix image sharing protocol (cisp)

Conditions: Cervical Cancer; Cervical Abnormalities

Summary: the clinical epidemiology unit in the clinical genetics branch of the division of cancer epidemiology, nci has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. therefore, to support development of algorithms for cervical image recognition software, nci seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on hpv and cervical cancer screening with interested and qualified image analysis researchers. to accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following nci studies: costa rican natural history study of hpv and cervical neoplasia , ascus lsil triage study-- alts , succeed and costa rica vaccine trial .

the clinical epidemiology unit in the clinical genetics branch of the division of cancer epidemiology, nci has a strong interest in fostering cervical cancer prevention solutions for all kinds of settings, including lowresource ones that rely on development of robust, low-cost screening and triage tools. therefore, to support development of algorithms for cervical image recognition software, nci seeks to share digital cervical images and accompanying clinical data from our large epidemiological studies on hpv and cervical cancer screening with interested and qualified image analysis researchers. to accommodate the many researchers that are interested, we have created this standard protocol to describe a unified process for sharing deidentified cervical images and accompanying de-identified clinical data from the following nci studies: costa rican natural history study of hpv and cervical neoplasia , ascus lsil triage study-- alts , succeed and costa rica vaccine trial .

Eligibility criteria:
* this protocol will include de-identified images and clinical data from nci studies.

Keywords: cervix hpv imaging costa rica
vinorelbine/carboplatin versus gemcitabine/carboplatin in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings. for each randomisation arm, 100 patients will be included. the trial was performed as a 2-stage phase ii study according to the optimal design by simon with overall response rate as the primary objective. study design: arm a: vinorelbine 25 mg/m2 d1,8; carboplatin auc=6 d1 q 3 weeks; arm b: gemcitabine 1000 mg/m2 d1,8; carboplatin auc=6 d1 q 3 weeks;


Eligibility criteria:
inclusion criteria: 1. histologically confirmed metastatic breast cancer; 2. all patients were required to give written informed consent; 3. to have received a previous treatment with anthracyclines and taxanes; 4. previous radiotherapy is allowed, whenever the radiated area is not the only disease location; 5. at least 4 weeks since the last previous antineoplastic treatment; 6. patients must have recovered from all previous toxicities; 7. karnofsky performance status \>= 70%; 8. adequate hematological, renal, cardiac and hepatic function; 9. life expectancy of at least 12 weeks; 10. patients able to comply and to receive an adequate follow-up; exclusion criteria: 1. only bone metastases; 2. active infection; 3. previous treatment with one of the study drugs; 4. application of other cytotoxic chemotherapy; 5. insufficient renal function (creatinine clearance \< 60ml/min); 6. clinically unstable brain metastasis; 7. pregnancy or lactation; 8. other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin); 9. abnormal liver function (bilirubin \> 2.0-fold upper normal limit (unl); alanine aminotransferase and aspartate aminotransferase \>2.5-fold unl). in patients with hepatic metastasis, a value of alanine aminotransferase and aspartate aminotransferase of up to 5-fold unl is permitted; 10. males; 11. second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma;

Keywords: mbc, vinorelbine, carboplatin, gemcitabine, pfs
multiple firings in double-stapled colorectal anastomosis

Conditions: Rectal Cancer

Summary: multiple linear stapler firings during double stapling technique (dst) is associated with anastomotic leakage (al) after laparoscopic low anterior resection (lar). we aim to investigate the risk factors and then to develop a deep learning model to predict the usage of ≥3 linear stapler cartridges during dst anastomosis.


Eligibility criteria:
inclusion criteria: * 1) carcinoma of rectum confirmed by histopathological evaluation; * 2) tumor located in the mid-low rectum (less than 10cm from the anal verge); * 3) performance of dst anastomosis; * 4) pelvic mri obtained within 14 days before surgery. exclusion criteria: * 1) other anastomotic techniques (e.g., trans-anal rectal excision); * 2) hartmann's operation or other procedures without anastomosis; * 3) the number of linear stapler cartridges was not traceable in the operative report.
personalized objects can improve the diagnosis of emcs from mcs

Conditions: Patients in Minimally Conscious State

Summary: in this study，researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (mcs).

the coma recovery scale-revised (crs-r) is an important tool for the assessment of behaviors in doc.clinical practice has shown that self-referential stimuli, such as the patient's own name and face, are more effective to elicit the patient's response than that of non-self-referential stimuli. the item "functional object use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.the rest assessments were performed following the standard protocol of crs-r. the differences between functional use of the two types of objects was analyzed by chi-square test. researchers expected to see some of the patients in mcs are re-diagnosed as emcs with the using of personalized objects.

Eligibility criteria:
inclusion criteria: * patients in minimally conscious state; * patients with stable condition; * each patient has athletic ability to some extent. exclusion criteria: * premorbid neurology antecedent; * patients in coma or vegetative state; * patients \< 1 months after the acute brain injury.
water intake associated with aerobic exercise in coronary

Conditions: Coronary Artery Disease

Summary: the need to restore water losses resulting from physical activity has become established and diffused into international consensus for healthy individuals or high-performance athletes. however, the influence of fluid replacement when administered during and after exercise on cardiorespiratory parameters, cardiac autonomic modulation, and subjective perceptions of effort and pain of individuals with autonomic alterations known as the coronary arteries remain poorly understood. in this sense, this study intends to investigate the influence of hydration on cardiac autonomic modulation, cardiorespiratory parameters, subjective perception of exertion and pain of coronary arteries submitted to aerobic exercise in the model of a cardiovascular rehabilitation session. a total of 31 individuals will be recruited in this study and will perform four standardized cardiovascular rehabilitation sessions. only in the second and the fourth session will the volunteers be instructed to ingest a quantity of water predetermined by the evaluator, based on the loss of body mass measured in the first and the third sessions. the outcomes (autonomic modulation, cardiorespiratory variables and perceptions) will be evaluated before, during and after exercise. the results of this study will enable professionals working with this population to implement awareness strategies on the importance of fluid intake in cardiovascular rehabilitation programs.


Eligibility criteria:
inclusion criteria: * men with coronary heart disease ischemia, over 45 years * at least three months of cardiovascular rehabilitation exclusion criteria: * smokers, alcoholics * uncontrolled metabolic disease (eg, uncontrolled diabetes and thyroid diseases) * abnormal hemodynamic responses during exercise such as disproportionate increase / fall of heart rate and / or blood pressure to low / high levels of load * myocardial ischemia and / or severe ventricular arrhythmias during the exercise test

Keywords: autonomic nervous system fluid therapy heart rate exercise
objective measure of recovery after outpatient surgery

Conditions: Hernia, Inguinal; Convalescence

Summary: this is a study using wearable monitoring devices, patient activity and sleep patterns to monitor pre and post operative following outpatient inguinal hernia surgery to determine when these parameters return to baseline.


Eligibility criteria:
inclusion criteria: * patients presenting for outpatient inguinal hernia repair without significant medical comorbidities * patients who consent to participating and willing to wear device for designated time period per protocol exclusion criteria: * history of chronic opioid use * inability to speak english * inability to give informed consent

Keywords: recovery of function