Kornimate/medical-research-clean huggingface dataset:
endogenous retroviruses in acute myeloid leukemia

Conditions: Leukemia, Myeloid

Summary: allogeneic hematopoietic stem cell transplantation (hsct) is the only curative therapy for numerous malignant hematologic diseases. despite recent advances in the field, relapse rates are still high and the first cause of death. the identification of new relevant therapeutic targets is therefore urgently needed. human endogenous retroviruses (hervs) are accounting for 8% of the human genome. while silenced at the steady state (mainly by methylation mechanisms), hervs reactivations have been described in different conditions such as auto-immune diseases or cancer, leading to an innate and adaptive immune response. several questions are raised in the field of hematology where few data are available, and the exact role of hervs in these diseases is still to define. our team is currently working on the role of hervs in different types of cancer. we developed a bioinformatics approach to identify overexpressed hervs from rnaseq data. we also developed in vitro assays to assess the immunogenicity of different peptides from hervs open reading frames and showed that several epitopes shared among different hervs can induce a specific cd8+ t cell response. more recently, we have analyzed 151 acute myeloid leukemia (aml) rnaseq data from tcga and identified multiple overexpressed hervs in this disease. immunogenicity test are currently ongoing with patient's blood at diagnosis. the main objective of this part of our project is to analyze the establishment of a hervs-specific cd8+ t cell response participating in graft-versus-leukemia effect after hsct for aml patients. secondary objectives are to analyze relations between this response and different clinical factors such as the onset of gvhd or relapse. peripheral blood mononuclear cells (pbmcs) from aml patients will be extracted and frozen at different time point: diagnosis, complete remission (pre-hsct) and after hsct (m3, m6 and m12). this prospective protocol is currently ongoing at the centre hospitalier lyon sud, with around 30 samples already available. after having selected relevant hervs, specific dextramers identified by dna barcode will be synthesized. these dextramers allowing the identification of specific t cell responses directed against up to 1000 epitopes, we will be able to screen specific t cells directed against hervs overexpressed in aml for most common hla. dextramer staining will be performed on pbmcs after thawing. positive cells will be sorted by flow cytometry and dna will be expanded by pcr before performing sequencing, allowing the identification of specific sequences by its unique dna barcode. the analyze of hervs-specific cd8+ t cell responses after hsct will allow us to better define hervs role in the onset of graft-versus-leukemia effect. a specific t cell response without gvhd will define the relevance of such peptides as tumor specific antigens.


Eligibility criteria:
inclusion criteria: * acute myeloid leukemia (all subtypes) * stem cell transplantation indication * non opposition to the study exclusion criteria: - intensive care unit at diagnosis
levothyroxine intervention in pregnant women with tsh （2.5 miu/l-upper limit of reference range） and negative thyroid peroxidase antibody

Conditions: Thyroid Abnormalities; Pregnant Woman; Pregnancy Outcomes

Summary: the goal of this clinical trial is to learn if levothyroxine (l-t4) works to treat pregnant women with tsh 2.5 miu/l-the upper limit of reference range (ulrr) of pregnancy and tpoab-negative. it will also learn about the safety of l-t4. the main quesitons the investigator want to answer are: * will l-t4 reduce miscarriage rates and have an impact on pregnancy complications in pregnant participants? * what medical issues do participants have when taking l-t4 during pregnancy? -investigators will compare l-t4 with placebo (a substance with a similar appearance without medication) to see if l-t4 could reduce miscarriage rates participants should: * take l-t4 or placebo during the whole pregnancy. * visit the hospital once every 6-8 weeks during pregnancy for checkups and tests * keep a diary of their pregncny complications and daily record of l-t4 or placebo intake. * visit the hospital for examination 42 days postpartum for checkups and follow up by phone at 6 and 12 months postpartum.


Eligibility criteria:
inclusion criteria: 1. women of childbearing age（18-45 years old）, natural pregnancy, singleton pregnancy. 2. measure thyroid related indexes within 8 weeks of pregnancy: tsh 2.5miu/l-ulrr, ft4 is normal and tpoab negativity. 3. willing to sign an informed consent form. exclusion criteria: 1. history of recurrent miscarriage (≥3 times). 2. assisted reproduction (artificial insemination, in vitro fertilization and embryo transfer); 3. suffer from diseases that seriously affect pregnancy outcome, including hypertension, diabetes, heart disease, liver and kidney dysfunction, etc. 4. failure of vital organs. 5. except autoimmune thyroid disease，suffer from other autoimmune diseases. 6. thyroid diseases (including hyperthyroidism, thyroid cancer, thyroid amyloidosis and other extensive intrathyroidal diseases, current subacute thyroiditis, iodine-deficiency endemic goiter, thyroidectomy or 131i treatment, previous thyroid ultrasound prompts diffuse thyroid disease, etc.). 7. use of thyroid-related drugs (lithium carbonate, thioureas, sulfonamides, sodium para-amino salicylate, potassium perchlorate, phenylbutazone, sulfate, tyrosine kinase inhibitor, etc.) during screening and affect thyroid functional testing drugs. (including glucocorticoids, metoclopramide, propranolol, amiodarone, sodium valproate, etc.) 8. secondary hypothyroidism or central hypothyroidism. (including pituitary tumors, surgery, radiotherapy, lymphocytic hypophysitis, etc.) 9. l-t4 allergy. 10. unwilling to sign an informed consent. 11. other clinicians judged that they are not suitable to participate in the study.

Keywords: tsh tpoab pregnant women levothyroxine outcome
genetic risk factors and acquired oncogenic mutations of melanoma

Conditions: Melanoma

Summary: though it is generally accepted that exposure to sunlight is a major causative factor for skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as in non-melanoma skin cancer. therefore, a dual pathway has been proposed, distinguishing melanoma that develops on skin that is chronically exposed to sunlight from those that occur on skin that is normally protected. the risk for each type of melanoma is believed to be determined in part by genetic factors. to define these markers reproducibly, the investigators plan to establish a large cohort with comprehensive information regarding sun sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes, total number of nevi, and other types of skin tumors in a central european population. the investigators will obtain blood from all participants for dna as well as serum analyses. based on the finding that genetic variants of the melanocortin-1 receptor (mc1r) gene, associated with red hair and fair skin, have been shown to be associated with increased risk for melanoma, particularly those harboring braf mutations, the investigators will now focus on the study of recently discovered genetic variants associated with pigmentation. furthermore, the investigators will study the relation of these variants with oncogenic mutations of melanoma in braf, ras and c-kit. the study of other genetic variants will follow, once a sufficiently large cohort has been established to reveal an independent genetic risk factor in a multivariate analysis including potential covariates as mentioned above. the identification of genetic risk factors for melanoma will not only help identify individuals with increased risk but also improve our understanding of the molecular background of the development of melanoma.


Eligibility criteria:
inclusion criteria: * patients with or without melanoma exclusion criteria: * hiv and hepatitis c positive individuals.
implantable long-acting pre-exposure prophylaxis for msm

Conditions: HIV Prevention

Summary: the long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable prep (la-prep) products in the future and identify the training needs of physicians. this project specifically focuses on men who have sex with men (msm) seen in primary care settings in texas. the main objective of this project is to examine perspectives of msm and physicians in texas regarding la-prep, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices.

the long-term goal of this project is to better understand factors at the patient and physician level that can be addressed to impact uptake of long-acting, implantable prep (la-prep) products and identify the training needs of physicians. this project is based on the hypothesis that specific barriers to uptake of la-prep may exist that must be addressed to support widespread implementation in primary care settings in the future. primary care settings are the ideal setting for new prep medications that employ innovative strategies for use, including implantable formulations, particularly among men who have sex with men (msm). primary care settings have demonstrated acceptability for other implantable medications, and similar strategies may be helpful for uptake of prep. however, new training and strategies will be needed for physicians to use this type of product with their patients should it become available. at this time, little is known about physician willingness to do the procedures required to insert the implant and what training will be needed. in particular, it is important to assess what training may be needed to effectively engage in health conversations with msm patients. thus, the main objective of this project is as follows: to examine perspectives of msm (n=50) and physicians (n=20) in texas regarding la-prep, including attitudes and barriers to use and implementation by interviewing patients and physicians from the same clinical practices.

Eligibility criteria:
inclusion criteria: * patients must meet the following criteria: 1. be a patient of one of the practices where physicians have agreed to participate or have been seen for a primary care visit in the past 12 months in the dallas austin, or san antonio metro areas; 2. be aged 18-45; 3. be assigned male sex at birth and report having one or more male sexual partners in the past year; and 4. be hiv negative. * physicians who are interested in participating must be a practicing primary care physician in the dallas, san antonio, or austin metropolitan area and be willing to allow recruitment of patient participants from their practice. exclusion criteria: * those individuals who speak a language other than english or spanish will be excluded as well as those who present with a cognitive or other impairment that would prevent them for consenting to participate in the study.

Keywords: pre exposure prophylaxis hiv msm primary care
trial comparing transversus abdominis plane block versus epidural anesthesia for pain management in colorectal surgery

Conditions: Colon Cancer; Rectal Cancer; Colonic Diverticulosis

Summary: the primary outcome for this study is the numeric pain score (nps) for elective patients undergoing elective colorectal surgery that have been randomized to transversus abdominis plane block or epidural anesthesia for the management of perioperative pain in elective colorectal surgery.

adequate peri-operative analgesia is a vital component of post-operative management for patients undergoing colon and rectal surgery, affecting hospital length of stay, quality of life, and patient outcomes. there are many options for the peri-operative management of pain after elective colorectal surgery. this is a randomized clinical trial comparing the transversus abdominis plane block using exparel® to epidural anesthesia for the enhanced recovery pathway perioperative management of pain for elective colorectal surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing elective open and minimally invasive (laparoscopic and robotic) colon and rectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectum; * surgical procedure either through standard open or minimal invasive approach (laparoscopic or robotic); * patients \> 18 years of age; * able to provide informed written consent * patients capable of completing questionnaires at the time of consent exclusion criteria: * documented allergic reaction to morphine, hydromorphone, lidocaine, bupivicaine and/or fentanyl; * contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated inr, anticoagulation, patient refusal, etc) or tap block (patient refusal); * urgent or emergent surgery precluding epidural catheter placement or tap block; * systemic infection contraindicating epidural catheter placement or tap block; * unwillingness to participate in follow up assessments; * prisoners * pregnant women

Keywords: continuous epidural analgesia transversus abdominis plane block
strategies to reduce addiction stigma among health professionals

Conditions: Opioid Use Disorder; Substance Use Disorders; Stigma, Social

Summary: the aim of this study was to evaluate the effects of exposure to stigma reduction message frames communicated by visual campaigns and narrative vignettes among a national sample of health professionals.

this randomized experiment evaluated the impact of exposure to message frames communicating the importance of non-stigmatizing language regarding addiction and the effectiveness of medication treatment for opioid use disorder delivered through a visual campaign alone or through a visual campaign in addition to a narrative vignette from the perspective of one of three messengers (a person with opioid use disorder, a clinician, or a health system leader) on attitudes toward people with opioid use disorder and medications for treating opioid use disorder among a national sample of health professionals.

Eligibility criteria:
inclusion criteria: * employed as health professional in the united states, including clinicians (e.g., physicians, nurses, physician assistants, pharmacists, and optometrists), technicians and technologists (e.g., laboratory technologist or technician, emergency medical technician, paramedic, licensed practical or licensed vocational nurse, medical records or health information technician, etc.), health aids and assistants (e.g., nursing aide, home health aide, medical assistant, pharmacy aide, phlebotomist, etc.) * participant in existing web-based survey panel (ipsos's knowledgenetworks panel and partner opt-in panel) exclusion criteria: * not employed in health profession * not able to complete experiment and survey in english
changes in ciprofol dosage in insomnia patients undergoing digestive endoscopy

Conditions: Insomnia; Digestive Endoscopy

Summary: to compare the dosage requirement of ciprofol during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

the investigators aim to investigate whether ciprofol dosage requirement is increased in patients with insomnia undergoing digestive endoscopy compared with normal sleep patterns.

Eligibility criteria:
inclusion criteria: * patients with insomnia: 1. age of 18 - 64 years; 2. asa physical status of i - ii; 3. bmi of 15 - 30; 4. scheduled for digestive endoscopy under intravenous anesthesia; 5. positive screening results according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for insomnia disorder; 6. 8-item sleep condition indicator (sci; score 0-4; range 0-32, higher score means better sleep) scored 16 or less; * patients with normal sleep: 1. age of 18 - 64 years; 2. asa physical status of i - ii; 3. bmi of 15 - 30; 4. scheduled for digestive endoscopy under intravenous anesthesia; 5. no history or evidence of insomnia. exclusion criteria: 1. associated with any neurological disease; 2. daily alcohol consumption; 3. any contraindication to intravenous anesthetic drug, such as hypotension or shock; 4. history of allergy to any drug used in the study; 5. pregnancy or breastfeeding; 6. patients with sleep apnea syndrome; 7. acute upper respiratory infection; 8. patients with psychological diseases who report suicidal thoughts; 9. patients who need to work or take care of children/elderly people frequently at night.

Keywords: insomnia digestive endoscopy ciprofol
efficacy and safety of telitacicept in early sle

Conditions: Lupus Erythematosus, Systemic

Summary: the purpose of this study is to evaluate the safety and efficacy of telitacicept in adult patients with early stage of sle .

this is a phase 4, multicentre, randomised, double-blind, open-labeled study to evaluate the efficacy and safety of telitacicept in adult subjects with active early stage of sle (disease duration less than 2 years).

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle according to the 1997 american college of rheumatology (acr) classification criteria or 2019 eular/acr classification criteria * 18-65 years of age * body weight 45-90kg * antinuclear antibody titers ≥1:80, and/ or anti-double-stranded dna antibodies * sledai-2k score ≥8 scores * disease duration less than 2 years (defined as the duration between the first appearance of any symptom/sign attributed to sle and baseline) * a stantard therapy for at least 30d for patients who are not treatment-naive * negative pregnancy test for child-bearing women at screening and baseline * provide written informed consent exclusion criteria: * known to be allergic to prednisone acetate, meprednisone, hydroxychloroquine, and immunosuppressants including mycophenolate mofetil, cyclophosphamide,et al * active serious neuropsychiatric systemic lupus erythematosus or other severe situations of sle who need pulse steroid treatment * severe lupus nephritis: 24hup more than 6g, serum creatinine \> 221umol/l * history of severe active central nervous system (cns) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or cns vasculitis) requiring intervention within 60 days of baseline (day 1) * abnormal liver function (alt or ast is 2 times higher than normal) * baseline igg below the lower limit of the normal range * pregnancy or breastfeeding women * have a history of malignant tumors * have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis) * chronic infections, such as hepatitis b virus or hepatitis b and c and hiv * cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure \> 160mmhg or diastolic pressure \> 100mmhg) or diabetics * active hemorrhage or peptic ulcer * with other concommitant autoimmune disease; * receipt of b-cell-targeted therapy (including belimumab) within 1 year before randomization * receipt of ivig within 28 days before randomization * receipt of tnf inhibitor, il-1r inhibitor or plasma exchange therapy within 90 days before randomization * participated in other drugs clinical trials within 4 weeks. * receipt of live vaccine within 4 weeks before randomization * receipt of covid-19 vaccine within 4 weeks before randomization * subjects who in the opinion of the investigator are not suitable to participate

Keywords: lupus erythematosus, systemic telitacicept
study to assess safety/tolerability/efficacy of gefitinib versus docetaxel in locally advanced or metastatic non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a randomized, open- label, parallel group, phase iv, multicentre study. the total number of patients expected to be recruited is 40. these randomized patients will have a histologically or cytologically confirmed adenocarcinoma histology of locally advanced or metastatic nsclc. patients will be recruited by investigational sites that have expertise in treating patients with non-small cell lung cancer. the study will compare gefitinib monotherapy 250 mg/day orally with docetaxel 60 mg/m2 intravenously over 1 hour every 3 weeks with a primary endpoint of safety and tolerability. the target population will be patients who have received one prior platinum-based chemotherapy and are now considered suitable candidates for further chemotherapy with docetaxel. at study entry, patients will be randomized on a 1:1 basis stratified with respect to performance status (0-1 vs. 2). patients may continue to receive treatment with either gefitinib or docetaxel until disease progression, unacceptable toxicity or the occurrence of any of the other specific criteria. an independent committee will be appointed to perform a blinded review of all patient scans. any assessments/visits after screening should be performed within a window of plus or minus 3 working days of the scheduled visit date. if selected screening evaluations are done within 7 days of day 1, cycle 1 of treatment, and are acceptable for study entry, they do not have to be repeated on day 1 unless the investigator believes that they are likely to have significantly changed. any patient who discontinues from study treatment without radiological evidence of disease progression (except for withdrawal of consent by patient) should continue to have objective tumor assessments every 6 weeks in order to collect information on progression of disease


Eligibility criteria:
inclusion criteria: * locally advanced (stage iiib) or metastatic (stage iv) nsclc, not amenable to curative surgery or radiotherapy * treatment with one prior chemotherapy regimen, which must have been platinum based\* \*patients must have demonstrated radiological or clinical progression since completion of previous chemotherapy regimen. * adequate hepatic function, defined as both a bilirubin \ 5xulrr, 1.5xulrr \ ulrr, 1xulrr \ 2.5xulrr, ast or alt \ 5xulrr for more information please refer to taxotere® (docetaxel) prescribing information exclusion criteria: * prior therapy with gefitinib or other egfr tk inhibitors (her-1 receptor inhibitors/small molecule or monoclonal antibody therapy) * prior docetaxel treatment for nsclc * patients with pre-existing peripheral neuropathy ³ grade 2 (nci ctcae criteria) * past medical history of interstitial lung disease, drug induced interstitial disease, radiation pneumonitis that required steroid treatment or any evidence of clinically active interstitial lung disease

Keywords: non-small cell lung cancer locally advanced or metastatic nscl cancer
post-marketing surveillance of ventilat® in long-term therapy in chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: study to obtain further information on the tolerability and efficacy of ventilat® metered dose inhaler in long-term treatment of chronic obstructive pulmonary disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * patients of both genders older than 40 years, who suffer from chronic obstructive pulmonary disease * only patients who have not been treated with ventilat® within the last year are to be considered for inclusion exclusion criteria: * contraindications listed in the instructions for use/summary of product characteristics for ventilat® metered dose inhaler