Kornimate/medical-research-clean huggingface dataset:
impact of [18f] psma-1007 imaging for primary staging of prostate cancer

Conditions: Prostate Cancer (Adenocarcinoma)

Summary: the introduction of psma diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. as a result, 18f-psma-1007 (radelumin®) was approved in germany and several eu countries, most recently in germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (bcr). this could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of psma-pet diagnostics in the coming years. the investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called real-world-evidence (rwe) study. the planned study will enable us to analyze the diagnostic accuracy of radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (ai) will be made possible.

depending on the study design and definition of the patient population, the detection rate of pelvic lymph nodes in particular using psma imaging is reported to be \>80%. the results of the studies thus demonstrate a superior diagnostic accuracy compared to previous methods as well as a significant influence of psma imaging on the clinical course. radelumin® was approved on the basis of these promising results from numerous retrospective studies and the prospective, randomized approval study. nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. these result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. in the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.

Eligibility criteria:
inclusion criteria: * \> 18 years * planned \[18f\]psma-1007 pet/ct examination in patients with a first diagnosis of prostate cancer * informed consent exclusion criteria: - examinations with limited assessability due to technical errors, such as imaging artifacts.

Keywords: psma psma-pet psma pet/ct primary staging
a study of pf-04554878 in patients with advanced non-hematologic malignancies

Conditions: Cancer

Summary: phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (fak) inhibitor pf-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. screening consists of medical history, physical examination ecog performance status, blood draws, a pregnancy test for female patients of childbearing potential, a fdg-pet and tumor imaging. treatment consists of pf-04554878 pills continued until progression of disease, unacceptable toxicity, or patient request. evaluations for bioactivity are measured by serial fdg-pet and blood tests for biomarkers related to fak and pyk2 activities.


Eligibility criteria:
inclusion criteria: * patients with advanced non-hematologic malignancies. * adequate organ function, including bilirubin less than 1.5 x uln, and ecog (eastern cooperative oncology group) performance status of 0-2. exclusion criteria: * clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent cyp 2c8 inhibitors, and history of clinically significant cardiac or pulmonary disorders

Keywords: focal adhesion kinase; advanced non-hematologic malignancies
genetic information to inform treatment and screening for prostate cancer, gifts study

Conditions: Prostate Carcinoma

Summary: this trial studies the role of inherited (present at birth) mutations in cancer risk genes such as brca2, brca1, atm, chek2, and others in relation to prostate cancer. this study may help researchers understand the frequency and importance of inherited mutations in cancer risk genes in patients with prostate cancer and potentially help identify better ways to treat cancer in patients who have a mutation in one of these genes.

outline: participants complete questionnaire over 20 minutes at baseline, then undergo collection of saliva sample for genetic testing. participants identified to have an inherited mutation in a deoxyribonucleic acid (dna) repair gene undergo genetic counseling. participants whose genetic testing does not indicate an inherited mutation in a dna repair gene receive a letter thanking them for their participation and emphasizing the importance of ongoing communication with their physician and family members about cancer risk. participants will be sent newsletters every year to encourage study engagement and update health questionnaires every two years.

Eligibility criteria:
inclusion criteria: case ascertainment * signed informed consent form providing agreement for germline genetic testing, use and release of health and research information * male aged 35 to 89 years * diagnosis of prostate cancer * resident of washington state * willing to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history * willing and able to provide a saliva sample * united states (u.s.) mailing address inclusion criteria: family recruitment * signed informed consent form providing agreement for germline genetic testing, use and release of health and research information * males aged 35 to 89 years * willingness to complete a questionnaire (online or on paper) to provide basic demographic information, family cancer history, and health history * willingness and ability to provide a saliva sample * u.s. mailing address exclusion criteria: case ascertainment * unable to provide informed consent, e.g. decisional impairment * prior bone marrow transplant * currently under treatment for a hematologic malignancy * study team members exclusion criteria: family recruitment * unable to provide informed consent, e.g. decisional impairment * prior bone marrow transplant * currently under treatment for a hematologic malignancy * study team members
home plate: a trial to improve home food preparation practices among parents of toddlers

Conditions: Obesity

Summary: this study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.

barriers to healthy eating and active living are at the heart of the obesity epidemic. this study focuses on a key factor underlying healthy eating: home food preparation. this study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. the investigators will partner with community-based organizations serving families with children ages 1 to 3 years in west philadelphia aiming specifically to: 1. test the intervention's effect on diet and physical health. hypothesis 1: the intervention group will have improved home food preparation practices and a healthier diet compared to the control group. 2. test the intervention's effect on family health. hypothesis 2: the intervention group will report improved parenting skills and more hopeful patterns of thinking. 3. identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.

Eligibility criteria:
inclusion criteria: mentees 1. english-speaking 2. able to give informed consent. 3. legal guardian and caregiver of at least one child, age 1-3 years inclusion criteria: children 1. 1-3 year old children of mentee primary caregivers enrolled in the study 2. if a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study. inclusion criteria: peer mentors 1. eligible peer mentors should meet the inclusion criteria set forth above for mentees. (children of peer mentors will not be eligible for this study.) in addition, 2. the study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills. exclusion criteria 1. caregivers and children not meeting the inclusion criteria above. 2. caregivers who are pregnant at the time of enrollment. 3. caregivers or children with a medical condition that significantly affects their diet or eating habits. (the study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.) 4. subjects who, in the opinion of the investigator, may be unable to participate in the study schedules or procedures.

Keywords: obesity nutrition home food preparation home food environment peer mentoring early head start cooking diet
safety of an inactivated enterovirus type 71 vaccine in healthy adults

Conditions: Infection; Viral, Enterovirus

Summary: a blind, randomized and placebo-controlled clinical trial with inactivated enterovirus type 71 vaccines in healthy adults

a total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they will be randomized to receive two different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine in adults

Eligibility criteria:
inclusion criteria: 1. healthy males and females, aged from 18 to 49 years old. health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator 2. provided legal identification for the sake of recruitment. 3. subjects are able to understand and sign informed consents. exclusion criteria: 1. histroy of hand-foot-mouth disease 2. women of lactation, pregnancy or about to be pregnant in 60 days 3. subject that has allergic history of vaccine, or allergic to any ingredient of vaccine 4. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 5. congenital malformations or developmental disorders, genetic defects, or severe malnutrition 6. epilepsy, seizures or convulsions history, or family history of mental illness 7. autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency 8. history of asthma, angioedema, diabetes or malignancy 9. history of thyroidectomy or thyroid disease that required medication within the past 12 months 10. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 11. asplenia, functional asplenia or any condition resulting in the absence or removal the spleen 12. acute illness or acute exacerbation of chronic disease within the past 7 days 13. any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) 14. history of any blood products within 3 months 15. administration of any live attenuated vaccine within 28 days 16. administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days 17. axillary temperature \> 37.0 centigrade before vaccination 18. abnormal laboratory parameters before vaccination 19. any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
covid-19 vaccination in adolescents and children

Conditions: Covid19

Summary: objectives to assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the covid-19 vaccines-bnt162b2, coronavac-chosen by the hong kong government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults. hypothesis to be tested the safety profile and the magnitude and durability of immune responses to the covid-19 vaccines in children are non-inferior to those in adults. design and subjects a single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of covid-19 vaccines by intramuscular injection (and intradermal injection) instruments mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry. interventions bnt162b2 and coronavac, by intramuscular or intradermal route main outcome measures types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory t cell responses for 3 years.


Eligibility criteria:
inclusion criteria: 1. informed consent from the parents or a legally acceptable representative for an underage participant 2. biological parents of students enrolled in the trial or unrelated healthy adults 3. ability to adhere to the follow-up schedules 4. willingness to report reactogenicity daily for 7 days post dose 1, 2 and 3 (and 4) proactively 5. willingness to receive that vaccine available for that particular recruitment period (as student-parent pair, if applicable) 6. good past health, including pre-existing clinically stable disease, such as paediatric or immune disorders 7. prior covid-19 (for covid-19 survivor subgroup) exclusion criteria: 1. reported pregnancy or breastfeeding
pilot study to evaluate the knowledge and understanding on surgery for patients with hysterectomy

Conditions: Gynecologic Cancer; Myoma

Summary: the purpose of this study is to assess the level of knowledge of surgery for women who underwent hysterectomy


Eligibility criteria:
inclusion criteria: * women who underwent hysterectomy at national cancer center, korea * age \> 20 years exclusion criteria: * the patients who refuse to participate or give consent to the procedure
3d printed enlarged carpal models for anatomy training

Conditions: Anatomical Pathological Condition; Educational Problems

Summary: 3d modeling enables medical professionals or students to better understand complex structures. in many studies, 3d printed models have been used in the training, treatment and surgery of medical disciplines such as neuroscience, cardiovascular surgery and otolaryngology. in addition, 3d modeling allows patients' magnetic resonance imaging (mri) and computed tomography (ct) images to be transferred to 3d printers to print these complex structures.


Eligibility criteria:
inclusion criteria: * willing to participate * titmus stereopsis score \>40 arc/s exclusion criteria: * previous experience of carpal bones models either in real world or virtual reality * history of upper extremity trauma in past 6 months * total or partial eye sight lost

Keywords: resin segmentation
twins born in guangzhou

Conditions: Twin Diseases; Immune Development; Childhood Obesity; Host and Microbiome; Neurodevelopment

Summary: the 2-big is a twin birth cohort study located in guangzhou, china.its initial aim is to facilitate research on understanding the interplay between genes and environmental factors on disease etiology. data are collected regarding environmental, family and lifestyle exposures on twins from birth to 18 years old. biological samples including blood and tissue samples are also collected from the twins and their parents.

twins share the same intrauterine environment and the early family environment. when conducting research of chronic disease etiology, twins cohort can be a good control of bias from age, gender, genetic and early environment. twin-based designs provide an estimate of the relative contribution of genetic and non-genetic factors to a specific phenotype. twins study has an advantage of calculating heritability of traits. since heritability of traits is various from different populations. it is important to establish database to calculate the heritability of traits associated with chronic major diseases in chinese population. twins cohort is rare in china at present. therefore, extensive information including physical characteristics, mental health, and behaviors is collected from both twins and their parents. longitudinal follow-up and surveillance of common diseases are also to be conducted. the 2-big aims to explore epigenetic markers and genes related to health status, as well as gene-environment interactions on diseases, both in intrauterine and childhood stages, especially in chinese population.

Eligibility criteria:
inclusion criteria: 1. live twins delivered in guangzhou women and children's medical center 2. permanent residents or families intended to remain in guangzhou with their children for no less than 3 years 3. baseline information during pregnancy available

Keywords: twin early development cohort
tes with random noise stimulation applied to children with brain injury

Conditions: Brain Injury; Motor Skills Disorders

Summary: 50 children between 4 and 7 years old with moderate to severe motor impairment, 50% males 50% females will participate in an interventional study in two groups: placebo and experimental group. placebo group will only receive traditional treatment with physiotherapy and the experimental or trns group will receive physiotherapy plus trns brainnoninvasive stimulation.

in this interventional study with double blind assignment to placebo and experimental group, gross motor function measure (gmfm) and neurophysiological are the parameters measured with eeg amplifier before and after 30 sessions. work hypothesis is that the trns group will present better motor functionality after 30 sessions of 30 minutes of duration of electrical brain stimulation administered during physiotherapy exercises 2 days per week than the group that only receives treatment with physiotherapy during 30 minutes 2 days per week without trns.

Eligibility criteria:
inclusion criteria: * patients between 3 and 7 years. * meet criteria for congenital or acquired brain injury . * patients who have been diagnosed at least 1 year before inclusion in the study. exclusion criteria: * acute visual or hearing loss. * other neurological disorders: migraine, epilepsy, tuberous sclerosis * other neurodevelopmental disorders like asd, adhd, pdd, etc ...

Keywords: qeeg erp trns brain injury motor impairment transcranial brain non-invasive stimulation electroencephalogram
bevacizumab plus modified folfox6 regimen as the salvage treatment in metastatic breast cancer (mbc) patients

Conditions: Metastatic Breast Cancer

Summary: the objective of this phase ii study is to evaluate efficacy and safety of avastin plus modified folfox6 regimen in her-2 negative metastatic breast cancer patients. fifty-five patients will be enrolled into this study.

anthracyclines and taxanes are the most frequently used agents for breast cancer,both in adjuvant and in first-line metastatic settings.for the patients who do not respond or relapse early after the administration of a taxane or anthracycline regimen,it is clearly needed to explore new combinations and schedules of drugs.oxaliplatin has shown very promising activity in mbc either in monotherapy or in combination with 5-fluorouracil(5-fu) with or without leucovorin (lv). avastin is a target therapy with proven efficacy in the treatment of mbc. avastin plus folfox regimen showed synergetic effet and been used as the standard trial in metastatic colorectal cancer patients. based on the above reason, we initiate this phase ii study to evaluate efficacy and safety of avastin plus modified folfox6 regimen in her-2 negative metastatic breast cancer patients.

Eligibility criteria:
inclusion criteria: 1. age\>=18years 2. eastern cooperative oncology group (ecog) performance status (ps) \ = 12 weeks; 3. histological-proven, her-2 negative measurable stage iv disease; 4. exposure to anthracyclines, taxanes either in the neoadjuvant/adjuvant or in the metastatic setting and had documented disease progression after the firstline or secondline treatment 5. patients previously treated with radiotherapy were eligible for the study, provided that measurable disease existed outside the radiation field. 6. at least 3 weeks from the prior chemotherapy or radiotherapy. at least 2 weeks from the prior endocrine therapy. exclusion criteria: 1. patients with active infection or other serious underlying medical conditions 2. patients had prior treatment with 5-fu infusion and/or oxaliplatin therapy 3. inadequate bone marrow, liver, renal, medullary, and cardiac functions 4. evidence of spinal cord compression or brain metastasis 5. history of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer 6. pregnant or lactating women 7. serious uncontrolled intercurrent infection 8. history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 9. serious non-bleeding wound, peptic ulcer or bone fracture 10. prior dihypopyrimidine dehydrogenase deficiency 11. hypersensitivity to chinese hamster ovary cell products or other recombinant human or humanlised antibodies

Keywords: metastatic breast cancer, her-2 negative breast cancer avastin, folfox regimen