Kornimate/medical-research-clean huggingface dataset:
biomarkers of trained immunity following mmr vaccination

Conditions: Covid19

Summary: this is a substudy of nct04333732. the goal of this sub-study is to identify and characterize biomarkers of trained immunity by measuring, in vitro, immune responses to heterologous products, especially viral associated products, in the mmr vaccinated compared placebo groups. all participants are randomly assigned to mmr or placebo injection at baseline, followed by sars-cov-2 specific vaccination. blood is drawn around 60 to 90 days after the last sars-cov-2 specific vaccine injection.

a sub-study of the crown coronation trial (covid-19 research outcomes worldwide network for coronavirus prevention; nct04333732). the goal of this sub-study is to identify and characterize biomarkers of trained immunity by measuring, in vitro, immune responses to heterologous products, especially virally associated products, in those exposed to mmr vaccine injection compared to those exposed to 0.9% sodium chloride ('normal saline') placebo injection. a secondary objective is comparison of sars-cov-2 neutralization assays between mmr and placebo comparison groups around 60 to 90 days after the last sars-cov-2 specific vaccine injection. all participants are randomly assigned to mmr or placebo injection at baseline, followed by sars-cov-2 specific vaccination. blood is drawn around 60 to 90 days after the last sars-cov-2 specific vaccine injection. peripheral blood mononuclear cells (pmbc) will be isolated from samples and stimulated with heterologous products (for example; roswell park memorial institute medium \[rpmi; negative control\], mmr \[the vaccine itself as specific stimulus\], severe acute respiratory syndrome coronavirus-2 \[sars-cov-2; heat inactivated\], influenza virus \[heat inactivated\], toll-like receptor 3 ligand \[tlr3 ligand; poly i:c\], toll-like receptor 7/8 ligand \[tlr7/8 ligand; r848\], toll-like receptor 4 ligand \[tlr4 ligand; lipopolysaccharide (lps)\]). supernatants will be assayed by multiplex luminex protein assay at 24 hr (for example; type i interferons \[ifn\], interleukin \[il\]-1β , il-6, tumor necrosis factor \[tnf\]-α) and after 5 days (for example; ifn-γ, il-17, il-22, il-10). this process of testing stimulus-response will be conducted on both the baseline and day 30 samples, collected from both the mmr and placebo groups. neutralization assay will be conducted on all samples using wild-type sars-cov-2. measles igg titres will be measured on all samples. measles igg titres will be used for sensitivity analysis.

Eligibility criteria:
inclusion/ exclusion criteria: prospective participant must already be enrolled into the crown coronation trial at the sub-study location. refer to nct04333732 for list of inclusion / exclusion criteria for the study population.

Keywords: covid 19 trained immunity infectious diseases
ultrasound-guided ilioinguinal-iliohypogastric block for inguinal hernia repair

Conditions: Inguinal Hernia

Summary: aim: to investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.


Eligibility criteria:
inclusion criteria: * age above 18 years * unilateral primary inguinal repair * open surgery a.m. lichtenstein * informed consent exclusion criteria: * age below 18 years * secondary surgery * laparoscopic surgery * lack of communicative skills
a study of pf-08046049/sgn-bb228 in advanced melanoma and other solid tumors

Conditions: Cutaneous Melanoma; Non-small Cell Lung Cancer; Colorectal Neoplasms; Pancreatic Neoplasms; Mesothelioma

Summary: this study will test the safety of a drug called pf-08046049/sgn-bb228 in participants with melanoma and other solid tumors that are hard to treat or have spread through the body. it will also study the side effects of this drug. a side effect is anything a drug does to the body besides treating the disease. this study will have 3 parts. parts a and b of the study will find out how much pf-08046049/sgn-bb228 should be given to participants. part c will use the information from parts a and b to see if pf-08046049/sgn-bb228 is safe and if it works to treat solid tumor cancers.


Eligibility criteria:
inclusion criteria: * all parts: participants must have disease that is relapsed, refractory, or intolerant to standard of care. participants must have histologically or cytologically confirmed metastatic malignancy. * participants must have one of the following tumor types: * parts a and b: participants must have metastatic or unresectable cutaneous melanoma. * part c: participants must have one of the following tumor types: * cutaneous melanoma * non-small cell lung cancer (nsclc) * colorectal cancer (crc) * pancreatic cancer * mesothelioma * a pre-treatment biopsy or submission of archival tissue is required * for participants with cutaneous melanoma * must have been previously treated with an anti-programmed death-1 (anti-pd-1) or anti-programmed death ligand-1 (anti-pd-l1) agent given alone or with other therapies. * participants with a targetable braf mutation must have been treated with, been intolerant of, or been deemed ineligible to receive treatment with braf/mek targeted therapy prior to study entry. * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * measurable disease per recist v1.1 at baseline exclusion criteria: * history of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. exceptions are malignancies with a negligible risk of metastasis or death. * active central nervous system metastases or leptomeningeal disease. participants with previously treated brain metastases may participate provided they are: * clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, * they have no new or enlarging brain metastases, * and are off of corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. * prior therapies cannot include any drugs targeting cd228 or 4-1bb * immunotherapy, biologics, and/or other approved or investigational antitumor treatment that is not completed 4 weeks prior to first dose of study drug, or within 2 weeks prior to the first dose of study drug if the underlying disease has progressed on treatment * melanoma subtypes including acral, uveal, and mucosal are excluded

Keywords: nsclc colorectal cancer crc pancreatic cancer
the effectiveness of saw palmetto and sanmiaoshan on benign prostatic hyperplasia in chinese patients

Conditions: Prostatic Hyperplasia; Adrenergic Alpha-Antagonists

Summary: the purpose of this study is to assess the effect of saw palmetto and sanmiaoshan, on top of alpha blocker, on urinary flow rate and bph symptoms in patients with bph.


Eligibility criteria:
inclusion criteria: * age between 50 and 80 years old * clinically diagnosed to have bph: * suffered from lower urinary tract symptoms with ipss\>=8 * detectable prostatic enlargement determined by dre * urinary flow between 5 and 15ml/second in a total void volume \>=150ml * serum psa level less than 4ng/ml or in between 4-10 ng/ml with percent free psa \>25% or\>=4 with cancer excluded by biopsy exclusion criteria: * acute retention of urine * congestive heart failure, unstable angina, arrhythmia, myocardial infraction * prostatic surgery * prostatic malignancy * gastrointestinal disease * renal impairment with serum creatinine \>140 umol/l * hepatic disorder

Keywords: benign prostatic hyperplasia (bph) currently on alpha blocker
plant-based dietary intervention for treatment of acne

Conditions: Acne

Summary: the purpose of this study is to determine if a low-fat, vegan diet affects the number of acne lesions, acne severity, and acne extent.

acne is the most common skin disorder in the united states. although many cases are transient, the condition is often chronic, causing self-consciousness and social stigmatization over the short term and physical scars and damaged self-esteem over the long term. patients and clinicians have frequently attributed acnegenesis to diet; studies of varying quality have been published on the topic since the 1830s. recently, well-designed, controlled, prospective studies suggest an acnegenic effect of specific dietary factors, including high-glycemic-index foods and dairy products. limited evidence also suggests an acnegenic effect of foods containing saturated fats. more well-designed, randomized, controlled trials are needed to further establish dietary effects on acne. based on epidemiologic observations and results of prior clinical trials, we are conducting a pilot study to determine if a low-fat, low-glycemic-index vegan diet affects the number of acne lesions and acne severity.

Eligibility criteria:
inclusion criteria: 1. male or female gender 2. mild, moderate, or severe acne, as indicated by an evaluator global severity score (egss) score of 2, 3, or 4 3. presence of at least 10 inflammatory or 20 non-inflammatory lesions on the face 4. presence of acne for at least 3 months (by volunteer's history) 5. age at least 18 years 6. ability and willingness to participate in all components of the study 7. willingness to be assigned randomly to a low-fat, vegan diet or a control group 8. intention to remain in the washington dc area for the 16-week study period. exclusion criteria: 1. change in use or dosage of hormone-based contraceptives in the last 3 months or anticipated change during the study period. 2. use of depot medoxyprogesterone contraception 3. use of oral retinoids in the last 6 months 4. use of high doses of vitamin a in the last 3 weeks (≥ 10,000 iu) 5. use of oral antibiotics or topical antibacterial or retinoid agents in the last 1 month 6. presence of more than two nodules or cysts on the face or more than two nodules or cysts on the back and chest. 7. use of medications known to cause or exacerbate acne including lithium, oral or injected steroids, or medications containing iodides or bromides 8. history of alcohol abuse or dependency followed by any current use 9. current or unresolved past drug or alcohol abuse 10. facial hair that would interfere with making acne assessments 11. pregnancy or breastfeeding (currently or in the past 3 months), or intent to become pregnant in the next 4 months 12. history of severe mental illness within the past 3 years 13. unstable medical status 14. current dietary pattern that is low-fat and vegan 15. anticipated difficulty attending or participating in group sessions 16. inordinate fear of blood draws 17. diabetes treated with insulin or any other medications.
association between clinical signs and mri findings of the lumbar facet joints

Conditions: Low Back Pain; Facet Joint Pain

Summary: the purpose of this study is to determine 1. the prevalence of lumbar facet joint pain detected by manual segmental provocation tests 2. the prevalence of mri findings of the lumbar facet joints (hypertrophy, effusion, edema) 3. the association of lumbar facet joint pain and mri findings on a segmental level in subjects with current low back pain and in a control group.


Eligibility criteria:
inclusion criteria for both study groups: * age \> 18 * written informed consent * ability to perform required examinations inclusion criterion for current low back pain-group: - more than (\>=) 30 days of low back pain in the last three months inclusion criterion for control group: - less than 30 days of low back pain in the last three months exclusion criteria for both study groups: * acute radicular low back pain in the last three months * claustrophobia * spondylodesis of the lumbar spine * any metallic implants which are not mri-compatible

Keywords: low back pain facet joint pain
the fast-track centre for hip and knee replacement database

Conditions: Hip; Knee; Fast-track Surgery; Enhanced Recovery After Surgery; Perioperative Medicine; Ambulatory Surgical Procedures; Perioperative/Postoperative Complications; Patient Satisfaction

Summary: this is a prospective study-registry on preoperative patient characteristics and postoperative complications in patients having fast-track hip and knee replacement surgery in 8 danish dedicated arthroplasty departments from all five health regions in denmark. the registry consists of detailed patient and physician reported preoperative characteristics and including prescribed medication and lab results. follow-up is based on electronical medical records by dedicated nurses with physician backup and includes clavien-dindo and comprehensive complication index scoring. all patients having day-surgery also completes a patient reported questionaire on health-care utilization and return to work by day 30. finally, a machine-learning algorithm for identification of "high-risk" patients based on he preoperative data is included.

the study registry is intended for further detailed research on postoperative morbidity, feasibility and safety of day surgery and functional outcomes after fast-track hip and knee replacement in 8 dedicated danish arthroplasty wards across all five health care regions in denmark. the work is a continuation of the lundbeck foundation centre database on hip and knee replacement also registered in clinicaltrials but ceased enrolling in august 2017. the aim of the registry is to provide standardized and comprehensive information on preoperative patient characteristics and postoperative complications, patient reported outcome measures and health-care utilization in fast-track hip and knee replacement within a socialized health-care system. each department have dedicated research personel assuring registration and follow-up supervised by a datamanager, and with database-support from the danish health region of southern denmark. all departments have similar established fast-track protocols as standard of care, but with focus on dividing patients into day-surgery, main fast-track group and high-risk cohorts. preoperative data includes information on prescribed medication, clinical frailty score using cfs v.1, evaluation of pain catastrophizing scale as well as laboratory testing of hemoglobin, kidney function, hb1ac in diabetics and c-reactive protein level. on the basis of the collected preoperative data a machine-learning algorithm for identifying the "high-risk" patients is being refined and with planned induction in the database.

Eligibility criteria:
inclusion criteria: * age \>18 years * non-malignant surgery * danish social security number * elective procedure exclusion criteria: * unwilling to provide informed consent

Keywords: hip replacement knee replacement perioperative medicine enhanced recovery after surgery perioperative/postoperative complications ambulatory surgical procedures
randomized controlled study on optimize neoadjuvant chemoradiotherapy for locally advanced rectal cancer

Conditions: Advanced Rectal Cancer

Summary: although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. induction chemotherapy is one of the most studied strategies. however, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. in our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. this study will focus on how to optimize neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * pathological confirmed rectal cancer * clinical stage t3-4 or t any n1 * no metastasis * distance of tumor is no more than 10cm from anal verge * no previous radiotherapy * age ranged from 18 to 70 * eastern cooperative oncology group score system 0-1 exclusion criteria: * clinical stage t1-2 n0 * distance metastasis * multiple primary tumor * cachexy

Keywords: rectal cancer neoadjuvant chemoradiotherapy optimization
tofacitinib in psoriatic arthritis subjects with inadequate response to tnf inhibitors

Conditions: Psoriatic Arthritis

Summary: to examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one tnf inhibitor either due to lack of efficacy or an adverse event.


Eligibility criteria:
inclusion criteria: * active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints * active plaque psoriasis at screening * inadequate efficacy or lack of toleration to previously administered tnf inhibitor exclusion criteria: * non-plaque forms of psoriasis (with exception of nail psoriasis) * history of autoimmune rheumatic disease other than psa; also prior history of or current, rheumatic inflammatory disease other than psa

Keywords: psoriatic arthritis tofacitinib acr20 haq-di tnf inhibitor failure
rosuvastatin efficacy and safety evaluation in hypercholesterolaemic patients

Conditions: Hypercholesterolaemia

Summary: this is a single-arm, phase iv, open-label, prospective, non interventional study to evaluate the efficacy, tolerability and safety of rosuvastatin administered for 24 weeks in approximately 900 greek subjects with hypercholesterolemia under normal clinical practice.


Eligibility criteria:
inclusion criteria: * patients with hypercholesterolaemia who are already in treatment with rosuvastatin according to the approved spc for no longer than 1 month prior to study entry * patients that are able to read, understand and sign the patient information \& consent form * patients that are willing to comply with all study requirements exclusion criteria: * patients that are likely not to comply with all study requirements * patients that currently participate or have participated in a 3 months period prior to study entry in another clinical trial * female of child bearing potential that do not use a reliable method of contraception. pregnancy or lactation. * patients that meet any of the contraindications described in the approved spc

Keywords: rosuvastatin hypercholesterolaemia
prevention of postoperative atrial fibrillation

Conditions: Postoperative Atrial Fibrillation

Summary: the primary aim of this study is to determine the safest and most effective therapeutic strategy to decrease the incidence of postoperative atrial fibrillation following cardiac surgery in an era with shorter icu and hospital length of stay. a secondary goal is to evaluate the length of hospital stay associated with each treatment strategy.


Eligibility criteria:
inclusion criteria: * age \> or = to 18 years * sinus rhythm * undergoing either coronary artery bypass graft surgery (cabg), valvular heart surgery or a combined procedure exclusion criteria: * received a class-i or class-iii antiarrhythmic agent in the past six months * had second or third degree heart block * had a resting heart rate of less than 50 beats per minute * had a systolic blood pressure less than 100 mmhg * had severe asthma or severe chronic obstructive pulmonary disease * had uncontrolled heart failure * had a serum aspartate aminotransferase or alanine aminotransferase concentration greater than four times the upper limit of normal
a dose finding study of remifentanil and propofol for lumbar punctures in children

Conditions: Hematologic Diseases; Neoplasms

Summary: this study will examine whether the combination of two anaesthetic medications, propofol and remifentanil, is suitable for short duration surgical procedures, providing a shorter recovery time and fewer side effects than either drug used alone.

propofol is the primary medication used by anesthesiologists at hsc to provide sedation for lumbar puncture. propofol provides amnesia, anxiolysis, and hypnosis, but because propofol has no analgestic properties patients often respond to the pain of lp needle insertion. to ensure patient immobility, the dose of propofol is often increased, resulting in a duration of action that is excessive for lumbar puncture. remifentanil is an ultra-short acting opioid which can be used to provide analgesia and sedation for short painful procedures with minimal residual pain. however, when used as the sole agent, remifentanil is associated with a high incidence of respiratory depression and/or arterial oxygen desaturation and does not provide amnesia or anxiolysis. the combination of propofol and remifentanil may be particularly suitable for short duration procedures, providing a shorter recovery time and fewer side effects than either drug used alone. the objective is to determine the minimum effective dose of remifentanil required to prevent movement for insertion of a lumbar puncture needle when co-administered with propofol. the results obtained from this study will be used in a future study of the recovery characteristics of propofol and remifentanil in children undergoing lumbar puncture.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a hemato-oncological disorder * scheduled to undergo a lumbar puncture * aged 4-11 years * male or female * unpremedicated * willing and able to provide informed consent (or informed consent by parents) exclusion criteria: * children who are known or suspected to be difficult to ventilate by face mask * children who are deemed medically unfit to receive either of the two study medications * children who are obese (weight for height \> 95th percentile, * children who do not have an indwelling intravenous line

Keywords: spinal puncture remifentanil propofol anesthesia dose finding pediatrics
a phase 1 study evaluating safety and tolerability of nvn1000 gel

Conditions: Acne Vulgaris

Summary: this is a 2 week phase 1 study of sb204 (nvn1000 gel) in healthy adult volunteers with elevated propionibacterium acnes (p. acnes) counts. subjects will apply nvn1000 4% gel or vehicle gel twice daily to their face. assessments will include cutaneous tolerability, safety, and p. acnes counts.

in this single-center, vehicle gel-controlled, evaluator and subject blinded study, approximately 30 otherwise healthy adult subjects with elevated p. acnes counts will be randomized 2:1 to nvn1000 4% gel or vehicle gel. the subjects will apply the test material twice daily to their face after washing. subjects will be seen daily at the skin study center during the week and will apply their evening and weekend dose at home. cutaneous tolerability will be assessed by the investigator at baseline, week 1, and week 2. safety assessments include collection of adverse events, laboratory results, and clinically significant changes in physical examination. p. acnes counts will be obtained at baseline, week 1 and week 2.

Eligibility criteria:
inclusion criteria: * healthy adult male or female volunteers * if a woman of child-bearing potential, agrees to use effective method of birth control during the study and for 30 days after the final study visit * agree to refrain from use of antimicrobial topical products during study exclusion criteria: * any skin disorders of acute or chronic nature including psoriasis, eczema, etc * female subjects who are pregnant, nursing, or planning to become pregnant * subjects who have used topical or systemic antibiotics, estrogens, drugs associated with methemoglobinemia, nitrate donors * subjects with baseline methemoglobin \> 2% * subjects with clinically significant anemia

Keywords: propionibacterium acnes acne