Kornimate/medical-research-clean huggingface dataset:
influence of prostate cancer radiation on aging

Conditions: Prostate Cancer; Aging Disorder; Radiotherapy; Complications; Inflammation

Summary: previous studies have reported that cancer survivors develop age-related chronic conditions like frailty, sarcopenia, cardiac dysfunction, and cognitive impairment earlier and/or at a greater burden than similarly aged individuals never diagnosed with cancer or exposed to cancer therapies. however, the knowledge about aging-associated consequences of cancer treatment and the processes that underlie differential responses to therapy is very limited. in 2018, a think tank established by the national cancer institute has defined various research needs to expand the evidence base for aging-related consequences of cancer treatment, such as studies to examine aging-related processes that include regularly performed assessments capturing factors associated with physical function or studies to elucidate pathways that lead to the emergence of aging phenotypes and to understand the relationships between biomarkers of aging and functional outcomes in cancer survivors. in addition, study inclusion of older adults with comorbidities and higher levels of frailty has been proposed to achieve an improved understanding of functional outcomes at any age. hypotheses / objectives we hypothesize that prostate cancer radiotherapy accelerates aging-related processes, furthermore, aging-related biomarkers may predict functional outcomes and represent early indicators of aging phenotypes. primary objectives of the proposed study are the determination of the aging-related consequences of radiotherapy in prostate cancer patients and the evaluation of the relationship between biomarkers of aging and age-related clinical conditions.

systematic evaluations of functional and cognitive status, comorbidities, health status, mobility, nutritional status, psychological status, and social circumstances as well as measurements of cellular senescence and chronic inflammation will be performed in a cohort of prostate cancer patients at baseline (before radiotherapy), at the end of radiotherapy and at follow-up intervals thereafter. the evaluation of aging-related biomarkers will include determination of markers of cellular senescence and markers of systemic inflammation. the correlation between genetic variants modulating telomere length and the risk of developing age-related phenotypes will also be analyzed.

Eligibility criteria:
inclusion criteria: * prostate cancer * candidate to definitive radiation treatment * local or locally advanced disease * aged ≥ 65 years * informed consent exclusion criteria: * unable to give written informed consent * metastatic disease

Keywords: telomere length aging radiotherapy
multi-omics study on the pathogenesis of malignant transformation of adenomyosis

Conditions: Adenomyosis; Endometrial Cancer; Ectopic Endometrial Tissue; Eutopic Endometrium; Genomics; Transcriptomics

Summary: this study is to explore the driving genes and the molecular mechanism of malignant transformation of adenomyosis. this study acquired the formalin fixed paraffin-embedded (ffpe) tissue of patients pathologically conformed endometrial carcinoma arising in adenomyosis (ec-aia) treated at peking union medical college hospital from july 15, 2017 to july 15, 2019. the formalin fixed paraffin-embedded tissues from patients pathologically diagnosed with adenomyosis during this time period were also included as control specimens. the eutopic endometrium, normal adenomyosis tissue, and ec-aia tissue were harvested from the ffpe tissue from patients with ec-aia. the normal eutopic endometrium and normal adenomyosis tissue were obtained by laser microdissection. the driving genes and potential molecular mechanism of ec-aia will be found by the technology of whole exome sequencing and transcriptomics (rna-sequencing).


Eligibility criteria:
inclusion criteria: * pathological confirmed diagnosis with atypical hyperplasia and malignant transformation of adenomyosis glandular epithelium (including endometrioid, serous and clear cell carcinoma), with or without concurrent endometrial carcinoma * signed an approved informed consents exclusion criteria: * not meeting all the inclusion criteria. * the formalin fixed paraffin-embedded (ffpe) tissue was not acquired at the required time period. * the patients enrolled had accompanied some other kinds of carcinoma (such as ovarian cancer, cervical cancer, primary peritoneal cancer). * patients had cancer history of certain organ (such as colorectal cancer, gastric cancer, etc.)
risankizumab versus secukinumab for participants with moderate to severe plaque psoriasis

Conditions: Psoriasis

Summary: the main objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months before the baseline visit * subject has stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis * subject must be a candidate for systemic therapy as assessed by the investigator; * subject must be an acceptable candidate to receive secukinumab according to the local label for this compound. exclusion criteria: * history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis; or active skin disease other than psoriasis that could interfere with the assessment of psoriasis; * chronic infections including hiv, viral hepatitis (hepatitis b, hepatitis c), and/ or active tuberculosis. subjects with a positive quantiferon®-tb/purified protein derivative (ppd) test result may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. if presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines. * active systemic infection during the last 2 weeks prior to baseline visit (exception: common cold) * history of any documented active or suspected malignancy or history of any malignancy within the last 5 years except for successfully treated non-melanoma skin cancer (nmsc) or localized carcinoma in situ of the cervix * previous exposure to risankizumab * previous exposure to secukinumab

Keywords: plaque psoriasis
x-linked biological response to hiv sensing: the anrs ep 53 study

Conditions: Hiv Infection

Summary: short title : x-linked biological response to hiv sensing: the anrs ep 53 study. main outcome : to demonstrate that hiv-infected women carry the tlr7 c.32a\>t snp at a higher frequency than uninfected women, arguing in favor of a role of impaired production of ifn-alpha by pdcs in the risk of becoming infected by hiv-1. secondary outcome : to directly demonstrate at a single cell level that the tlr7 c.32a\>t snp is responsible for a reduce production of ifn-alpha by pdcs after activation of tlr7 by hiv-1 rna. short abstract (public dissemination) : male and female display some differences in how their immune system responds to pathogens. this could be related to hormonal or genetic factors located on the x chromosome. this project aims at characterizing x-linked factors that can influence the innate immune response to hiv-1.

plasmacytoid dendritic cells (pdcs) are key actors of innate immunity that produce high levels of interferon (ifn)-alpha after activation of their toll-like receptors (tlr) by pathogens. a difference between men and women has recently been shown in the level of ifn-alpha produced by pdcs after tlr activation. the production of ifn-alpha in response to tlr7 activation is higher in the presence of estrogens. this could be responsible for gender differences in the level of plasma hiv-1 rna, that is lower in female as compared to male by about 50%, and for the sex-based differences in the susceptibility to hiv infection. besides the role of estrogens, x-linked genetic factors could also be involved in the sex-dependent differences in the tlr7-mediated responses of pdcs. tlr7 gene is located on the x chromosome. a single nucleotide polymorphism (snp) of the tlr7 gene, c.32a\>t, have been associated with accelerated disease progression in male hiv patients, and was found over represented in female hiv as well as hcv patients, suggesting that the t allele is associated with a gender-dependent increase of susceptibility to rna virus infections. a peripheral blood sample will be collected from hiv-infected women and healthy control to measure tlr-7 snp frequency by pcr. ifn-alpha production from pdcs after hiv-1 rna sensing by tlr7 will also be assessed.

Eligibility criteria:
inclusion criteria: 1. caucasian female 2. hiv-1 infection (elisa and western-blot tests) 3. hiv-infection through the sexual route before 50 years-old 4. continuous antiretroviral therapy for more than 6 months 5. plasma hiv-1 rna \<50 copies/ml in the last 6 months 6. age \>18-year old 7. health insurance 8. informed consent exclusion criteria: 1. hiv-infection through vertical or parenteral routes 2. chronic infectious disease, notably hcv infection (hepatitis c virus) 3. acute infectious disease 4. auto-immune disease 5. absence of social security (health insurance) 6. pregnant or breastfeeding woman 7. incapable adult
safety,tolerability, and pharmacokinetic of kpcxm18 for injection

Conditions: Healthy

Summary: to assess the safety,tolerability, and pharmacokinetic of kpcxm18 for injection in healthy subjects

to explore the safety, tolerance and pharmacokinetic of kpcxm18 for injection in healthy subjects by intravenous administration of different doses in single and multiple administration safety, tolerance and pharmacokinetic tests, and to obtain the safe dose range of the test drugs, thus providing dose design basis for phase ii clinical trials.

Eligibility criteria:
inclusion criteria: 1. bmi between 19 and 26 kg/m2；male body weight not less than 50.0kg,female body weight not less than 45.0kg ； 2. general physical examination and physical and chemical examination are qualified. 3. volunteers can communicate well with the investigator, understand and comply with the relevant requirements of the study, understand and sign the informed consent； exclusion criteria: 1. any condition that might interfere with the procedures or tests in this study; 2. drinking（more than 14 units of alcohol per week） in 6 months ; 3. smoking (more than 10 cigarettes per day or equal amount of tobacco) within 3 months (90 days) ; 4. have special requirements on diet, or cannot follow a unified diet ; 5. used a clinical trial drug within 3 months prior to administration ; 6. positive blood pregnancy test of female subjects ; 7. subjects may not be able to complete the study for other reasons or the investigator considers that they should not be included .

Keywords: stroke
to demonstrate the relative bioavailability study of ondansetron hcl 24 mg tablets under fasting conditions

Conditions: Nausea; Vomiting

Summary: to demonstrate the relative bioavailability study of ondansetron hcl 24 mg tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: antiemetic
reproductive outcome of em treated by gnrh-a associated with laparoscopy

Conditions: Infertility Associated With Endometriosis

Summary: this study is a multicenter, randomized-control-trial. this study select 1184 infertile patients associated with endometriosis diagnosed by laparoscopy surgery. patients are going to be divided into two groups according to 1:1 ratio randomly assigned to receive gnrh-a. cumulative pregnancy rate, end of treatment to natural pregnancy time, accept the assisted reproductive treatment rate, miscarriage rate, live birth rate will be recorded.


Eligibility criteria:
inclusion criteria: * infertile patients * endometriosis i-ii phase：according to revised american society for reproductive medicine classification of endometriosis: 1996 * bmi:19-28 kg/㎡ * ovarian reserve function is normal（m2-5：bilateral antral follicles≥6 fsh：5-12u/ml） exclusion criteria: * male factor causes infertility * hydrosalpinx or salpingemphraxis * uterine malformation * uterine cavity lesion * contra-indications for gnrh-a * not willing to participate

Keywords: gnrh-a endometriosis efficiency
characterization of explanted hernia meshes from human subjects: a multi-center, prospective study

Conditions: Pathological Conditions, Signs and Symptoms; Hernia

Summary: this study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. we will have evidence that our current options are not only inadequate but can lead to complications. one of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data.

this study will collect a large amount of hernia mesh explants and study the changes that occur in the materials in vivo to use the information to help design new mesh made from novel materials. we will have evidence that our current options are not only inadequate but can lead to complications. one of our main goals is to convince our colleagues to change their surgical practice by publishing and educating them with this data. the objectives of this study are to establish the largest collection of explanted mesh materials in the country; demonstrate by common testing utilized by materials engineers, that in vivo exposure of mesh to the oxidants produced by phagocytosis may lead to chain scission, production of free radicals, and overall degradation of the material both physically and chemically; test mesh materials for a decrease in compliance, which would account for a tendency of mesh to stiffen while in the body reducing abdominal mobility and leading to chronic pain; characterize the histologic reaction of tissues to mesh; and utilize de-identified patient demographics to identify possible clinical characteristics which affect mesh degradation.

Eligibility criteria:
inclusion criteria: * adults (persons 18 and older) * previous placement of hernia mesh material * current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure exclusion criteria: * no retained mesh prosthetic * non surgical candidate

Keywords: hernia mesh implanted mesh material explanted mesh material
effect of hemodialysis on the pk of jtz-951 in subjects with end-stage renal disease

Conditions: Anemia in Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (pk) of jtz-951 and to evaluate the safety of 2 doses of jtz-951 in subjects with end-stage renal disease (esrd) receiving hemodialysis


Eligibility criteria:
inclusion criteria: * subjects who have esrd and have been receiving maintenance hemodialysis for at least 12 weeks prior to the screening visit * body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the screening visit exclusion criteria: * acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission * uncontrolled hypertension at the screening visit or day -1

Keywords: end-stage renal disease hemodialysis pharmacokinetics
prospective feasibility study of endobronchial ultrasound transbronchial cryobiopsy (ebus-tbcb 1.1 mm probe) among patients with mediastinal lymphadenopathies

Conditions: Endobronchial Mass

Summary: mediastinal lymph nodes enlargement with short axis diameter \>15 mm is conventionally defined as a mediastinal lymphadenopathy. the causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age * mediastinal and/or hilar lymphadenopathies \> 20 mm on an injected chest ct scan * suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis * hypermetabolism of mediastinal and/or hilar lymphadenopathies on pet scan (suv max \> 3) * no contraindication for general anesthesia * french-speaking patient * -signed informed consent exclusion criteria: * patient not covered by the french social security system * patient with legal protection * pregnant or breastfeeding patient (if applicable) * patient under guardianship or curatorship * patient deprived of liberty

Keywords: patients with mediastinal lymphadenopathies.
testing mestinon and exercise in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this trial was to test the combined and independent effects of 6 months of exercise and mestinon in people with fibromyalgia. specifically, we wanted to determine if mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms improved by the end of the trial.

earlier, we demonstrated that people with fibromyalgia fail to make adequate growth hormone when they exercise intensively. we also demonstrated that a single dose of mestinon helped people make normal levels of growth hormone when they exercised in our laboratory. we wanted to know if 6 months of exercise with concurrent mestinon therapy would make growth hormone (and related markers) normal and improve fibromyalgia symptoms.

Eligibility criteria:
inclusion criteria: * have fibromyalgia exclusion criteria: * subjects will be excluded if they have a history of rheumatic disease or other disorder that may compromise ability to safely complete study protocol, be pregnant, nursing, or currently involved in unresolved litigation.

Keywords: fibromyalgia exercise mestinon
wound powder for pressure ulcers at end-of-life

Conditions: Pressure Ulcer; Wounds

Summary: this study will test a special powder for ulcers caused by a variety of conditions such as pressure that sometimes happen when a person is at the end of life. the powder will be applied to these ulcers to see if it helps with pain, odor and drainage (leakage). people who are being cared for by hospice or palliative care organizations will be invited to be in the study. the study will also find out if the powder is easy to use by caregivers as well as improving the comfort and quality of life of the person who has the ulcer.

aim 1. in a comparative 2-group design, we will evaluate and compare the feasibility of the intervention through assessment in both settings (home-based and inpatient) on: 1. adherence to rgn107 protocol by licensed care providers and/or family or other caregivers providing wound care; measures include implementation of procedures, frequency of dressing changes. 2. reach, enrollment, disenrollment, acceptability, satisfaction; measures include difficulties with recruitment and enrollment, side effects such as burning, peri-wound skin irritation. 3. usability issues such as powder ability to stick to wound and ease of use of applying powder. aim 2. estimate variability of outcome measurements and effect sizes and investigate the presence of a preliminary "signal" of clinical efficacy in two groups of hospice/home health/residential individuals receiving rgn107 in: 1. physical wound symptoms outcomes, specifically pain, odor and exudate. 2. quality of life of individuals receiving and caregivers using rgn107.

Eligibility criteria:
inclusion criteria: * aged 21 years or older * patient prognosis \> 1 month and \< 6 months * pressure wounds * pain or odor or exudate score \> 2 on vas * wound caregiver able to perform required protocol activities exclusion criteria: * known allergies to turmeric, mint, sandalwood * using negative pressure wound therapy * currently using topical creams or ointments applied to wound bed (powder will not adhere to these products) * wound with eschar covering (powder will not stick)

Keywords: wound palliative care hospice pressure ulcers
art therapy pain management adolescents pediatric ed

Conditions: Pain

Summary: this project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. we want to find out how well art therapy is able to decrease the pain they are experiencing. art therapy will involve making art and working with an art therapist to find new ways of expressing thoughts and feelings through art making. in adolescents presenting to the emergency department with a painful condition, our aims are as follows: aim #1: to determine the degree that art therapy intervention reduces pain and anxiety. aim #2: to determine the degree that art therapy reduces pain and anxiety 1 hour after the intervention. aim #3: to explore the qualitative experience of patients undergoing art therapy intervention.

pain is one of the most common reasons for patients to visit the emergency department (ed), and can be treated using both complementary and pharmacological strategies. however, children are often undertreated for pain which results in not only short term problems, but long term consequences such as trauma and stress-induced disorders; health care avoidance as adults; increased pain sensitivity; and decreased response to future analgesia. there have been variable efforts made to improve the ed management of pain in children, but adolescents are frequently overlooked. a review of the literature revealed that art therapy for pain management in adolescents is understudied. the majority of studies describe the effects of art therapy on the emotional well-being in surgical and oncology populations in adults and children. the studies that did evaluate the effectiveness of art therapy for pain management in children focused primarily on surgical and medical oncology populations with children aged 2-14 years. of these studies, none evaluated adolescents in the ed, which is a high volume and high stress environment that confers a distinct experience for patients compared to other medical settings. evaluation of art therapy interventions using quantitative self-report measures with strong validity in children and further delineation of the patient experience related to art therapy is necessary. advanced evaluation of aforementioned interventions would expand the evidence base needed to describe effectiveness of these interventions and support greater implementation and dissemination. these are the gaps in knowledge that the investigators aim to fill with the proposed study.

Eligibility criteria:
inclusion criteria: * 12 to 18 years of age, inclusive * painful condition with self-reported pain score of \>3/10 exclusion criteria: * critical illness as per attending physician * any neurological or developmental condition that precludes engagement in art therapy or ability to use a self-reported measure of pain * chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia) * medical condition necessitating multiple painful procedures (e.g. malignancy, organ transplant) * does not speak english

Keywords: art therapy pain management pediatrics emergency medicine