Kornimate/medical-research-clean huggingface dataset:
profiling of circulating immune cells to uncover response signatures to anti-pd1 immunotherapy in melanoma patients

Conditions: Melanoma

Summary: despite being standard of care, there are still many medical requirements related to immune checkpoint blocker based therapies such as identify patients susceptible to respond with the less adverse events, evaluate the clinical benefit of adjuvant treatment /risk of relapse and design new strategies for non-responder patients. thus, this project aims at understanding the impact of anti-pd1 on the immune system through investigation of the phenotypic, functional, metabolic and transcriptomic profiles of circulating dc subsets and effectors in response to anti-pd1 therapy in melanoma patients. the primary objective of the study is to identify the biomarkers of response to anti-pd1 according to the type of patient before the start of the treatment.


Eligibility criteria:
inclusion criteria: * patient with histologically confirmed melanoma (stage i, ii, iii or iv based on ajcc classification) * able to sign the informed collection consent for the retrospective part or to express their non-opposition to the research for the prospective part of the study exclusion criteria: * subject under guardianship or subject deprived of freedom * persons benefiting from special protection (as defined in articles l1121-5 and l1121-8 of the public health code): minors, pregnant or breastfeeding women, adults protected by law (under guardianship, curatorship or deprived of liberty) and persons hospitalized without their consent (as defined in articles l3212-1 and l3212-3 of the public health code). * ocular melanoma
comparison of endoscopic band ligation plus 24-hour versus 72-hour terlipressin therapy

Conditions: Esophageal and Gastric Varices

Summary: in the western world, liver cirrhosis is a significant issue. acute variceal bleeding (avb) is a considerable complication of cirrhosis associated with high mortality. still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. this therapy with terlipressin usually was used for 72 hours. however, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.

in the western world, liver cirrhosis is a significant issue. acute variceal bleeding (avb) is a considerable complication of cirrhosis associated with high mortality. still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. this therapy with terlipressin usually was used for 72 hours. however, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects. objective: to compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.

Eligibility criteria:
inclusion criteria: * patients of 18 years and older * both genders, * diagnosis of liver cirrhosis with a child-pugh score ≤ 11 (class b or c) * acute variceal bleeding were included exclusion criteria: * patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases), * presence of sepsis, * multi-organ failure, * the requirement of continuous ionotropic or ventilatory support, * bleeding disorders, * hepatocellular carcinoma or other extrahepatic malignanc.

Keywords: terlipressin liver cirrhosis esophageal and gastric varices, collateral circulations
memantine for the treatment of cognitive impairment in systemic lupus erythematosus

Conditions: Lupus Erythematosus, Systemic

Summary: a phenome-wide association study (phewas) identified an association between a variant in the human gene for the n2a subunit of the n-methyl-d-aspartate (nmda) receptor, grin2a, and systemic lupus erythematosus (sle). a single nucleotide polymorphism (snp) in this gene encodes for increased nmda receptor activity. based on the potential function of the associated snp and published literature, alterations in snp function signaling may underlie a cluster of symptoms. the objective of this study is to evaluate the safety, tolerability and efficacy of memantine, an nmda receptor antagonist, in a precise patient subset with sle. participants will complete a full 14-week clinical trial, receiving either memantine or a placebo. participants' blood will be drawn to test for various antibodies as well as organ function. patients' urine will also be collected to assess organ function and pregnancy for females at a number of specific time points. the overall goal is to develop a safe and inexpensive therapeutic approach to reduce debilitating cognitive symptoms in a precisely selected sle sub-population.


Eligibility criteria:
inclusion criteria: 1. meet american college of rheumatology (acr) criteria for sle 2. report npsle symptoms on the screening survey recommended by eular guideline but limited to the psychiatric manifestations questions 3. score ≤ 85 on the rbans total index (≤ 1 sd below the normative mean of 100) exclusion criteria: 1. male and female subjects \ 60 years 2. change in medication that may affect mood or cognition including prednisone, antidepressant medications, or stimulants within the last 4 weeks 3. regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use 4. metabolic derangement defined as liver function tests \>3x upper limit of normal or severe renal disease defined as calculated creatinine clearance \<30 ml 5. severe psychiatric disease including schizophrenia, psychosis, suicidal depression 6. other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history)\* or prevent the participant from completing the protocol (poor compliance or unpredictable schedule) 7. inability or refusal to give informed consent for any reason including a diagnosis of dementia or significant cognitive impairment\*\* 8. patients who are pregnant 9. patients who are enrolled in other investigational drug studies

Keywords: cognitive dysfunction memantine lupus
deciphering the vitiligo transcriptomic signature between repigmented and non repigmented lesions

Conditions: Vitiligo

Summary: the purpose of this study is to perform an in-depth analysis of the molecular pathways involved in lesions responding to current treatment and lesions not responding to current treatment

treatment strategy: combination of oral mini-pulse of methylprednisolone 16mg twice a week + phototherapy ultraviolet b (uvb) tl01, 2 times a week. one skin biopsy will be performed at baseline and two skin biopsies at month 3 and month 6 on the same area forearms (excluding skin folds) blood samples will be taken (30 ml) at week 0, week 12, week 24 for the measurement of pro-inflammatory cytokines and chemokines ligands in blood sera. principal objective: the aim of this study is to perform an in-depth analysis of vitiligo skin and blood samples taken during the course of a standard therapy to identify pathways involved in the repigmentation. secondary objectives: * evolution of vitiligo disease in relation of patient profile * evolution of the activity of vitiligo in relation of patient profile the statistical and bioinformatics analyzes will be carried out on the data resulting from research with correlation to clinical data.

Eligibility criteria:
inclusion criteria: * subject: male or female aged ≥ 18 years and ≤ 65 years * diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved \>5% excluding hands and feet, with lesions located on arms * active non-segmental vitiligo is defined by: * non-segmental vitiligo with new patches or extension of old lesions during the last 6 months and * presence of hypochromic aspect under wood's lamp examination and/or perifollicular hypopigmentation under wood's lamp examination. * able to read, understand, and give documented informed consent * registered in the french social security * patients that could receive the combination of oral steroids and phototherapy according the recommendation * signed informed consent form exclusion criteria: * segmental or mixed vitiligo * are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures. * are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
optimizing care for older adults through thyroid hormone deprescribing

Conditions: Hypothyroidism

Summary: the proposed study focuses on testing a novel adapted evidence-based multilevel intervention, deprescribing thyroid hormone in older adults (d-thio), to support thyroid hormone deprescribing (dose de-escalation and/or discontinuation) in older adults with thyroid hormone overtreatment and/or misuse and reduce patient harm. findings from this study will lay the groundwork for broad implementation of d-thio and serve as a model for deprescribing inappropriate medications for other endocrine conditions and conditions with biochemical monitoring.

the proposed study is the first multi-site trial to evaluate a novel evidence-based adapted multilevel intervention, d-thio (deprescribing thyroid hormone in older adults), consisting of evidence-based pharmaceutical opinion to providers, education brochures to patients and facilitated by clinical champions, to support thyroid hormone deprescribing in older adults. we will conduct a type 1 hybrid effectiveness-implementation trial of d-thio vs. enhanced usual care (american thyroid association \[ata\] provider abbreviated guidelines, ata patient brochure) at 3 sites (university of michigan, henry ford, university of california san francisco) in 150 providers (primary care, endocrinologists, geriatricians, advance practice providers) and 750 of their patients 65 years and older who are overtreated with thyroid hormone. we will randomize 1:1 at the provider level within each site. the aims of the study are: 1) to assess the effectiveness of d-thio on thyroid hormone deprescribing by providers and on reducing overtreatment and misuse with thyroid hormone via emr, 2) to assess the effectiveness of d-thio on provider and patient knowledge and attitudes regarding thyroid hormone deprescribing via surveys, and 3) to identify factors related to the implementation of d-thio across diverse general care settings via post-trial interviews with key stakeholders.

Eligibility criteria:
patient eligibility: inclusion criteria: 1. age 65 years and older 2. on thyroid hormone therapy and have a serum thyroid-stimulating hormone (tsh) \<0.5 miu/l or are on thyroid hormone therapy for an inappropriate indication 3. english speaking 4. without cognitive impairment exclusion criteria: 1) patients with a diagnosis of thyroid cancer, secondary hypothyroidism, history of total thyroidectomy or hospitalization in the past 3 months will be excluded. provider eligibility: inclusion: primary care physicians, endocrinologists, geriatricians, and advanced practice providers (apps) who practice at university of michigan, henry ford health system or university of california san fransico (ucsf) and who prescribe thyroid hormone for eligible patients identified above will be eligible for study participation. exclusion: providers who don't prescribe thyroid hormone.

Keywords: thyroid hormone overtreatment and misuse older adults deprescribing
vascular abnormalities and bleeding diathesis

Conditions: Bleeding Diathesis

Summary: inherited bleeding disorders (ibd) consist of a heterogeneous group of diseases including coagulation and/or platelets defects and more rarely vascular dysfunctions. a family of four patients suffering from unexplained excessive bleeding has been followed clinically in france for many years. recently, whole exome sequencing (wes) of dna allowed the identification of a heterozygous genetic variant which segregated to family members with bleeding diathesis. the aim of the study was to better characterize the phenotype by studying vwf and platelets in affected family members ultimately contributing to the pathogenesis of a bleeding diathesis.

as explained in the brief summary, whole exome sequencing (wes) of dna was performed in a family of four patients suffering from unexplained excessive bleeding. it allowed the identification of a variant which segregated to family members with bleeding diathesis. firstly, in vitro, functional analyses were performed in primary human endothelial cells. then, in-vivo analysis have to be performed on affected patients. the four related patients suffering from excessive bleeding have been followed clinically in france for many years. during the follow-up of three of these affected patients, biological studies are planned. biological assays include: * conventional assessment of primary haemostasis: platelet count, platelet aggregation, functional and antigen measurement of von willebrand factor. * specific testing: von willebrand factor multimeric profile, immunolabeling of platelets. conventional assessment is part of the conventional follow-up of patients with inherited bleeding disorder. it will not require any additional blood sample. for specific testing and after informed consent, fresh blood samples of patients will be collected in 1/10 volume of acid-citrate-dextrose and centrifuged for 10 min at 200 g to obtain platelet-rich plasma (prp) for functional analysis of platelets and platelet-poor plasma for the multimerization state of von willebrand factor. then, the results will be compared to the in-vitro findings.

Eligibility criteria:
inclusion criteria: - members of the family exclusion criteria: - patient who refused to participate

Keywords: mucocutaneous bleeding surgery bleeding outcomes
lutonix® drug coated balloon vs. standard balloon angioplasty for treatment of femoropopliteal in-stent restenosis

Conditions: Femoral Artery Stenosis; Femoral Artery Occlusion; Restenosis

Summary: to assess the safety and efficacy of the lutonix drug coated balloon for treatment of femoropopliteal artery (sfa) in-stent restenosis (isr).


Eligibility criteria:
key inclusion criteria: 1. male or non-pregnant female ≥18 years of age 2. rutherford clinical category 2-4 3. significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery 4. lesion measures between 4 and 18 cm 5. target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix 6. a patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography 7. successful crossing and predilatation of the target lesion with a guidewire 8. at least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized 9. no other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment key exclusion criteria: 1. life expectancy of \<1 year 2. patient is currently participating in an investigational drug or other device study or previously enrolled in this study note: enrollment in another drug or device clinical trial during the follow up period is not allowed 3. history of stroke within 3 months 4. history of mi, thrombolysis or angina within 2 weeks of enrollment 5. prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion 6. target lesion involves a previously placed covered stent or drug-eluting stent 7. grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent 8. inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication 9. known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion 10. intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)
the prevalence of metabolic syndrome and its associated factors in an urban city

Conditions: Prediabetes

Summary: the secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria.

up to now, there has been to uniform case definition for the metabolic syndrome. the world health organization and the third report of the national cholesterol education program's adult treatment panel (atp iii), and bureau of health promotion, taiwan proposed different criteria for the metabolic syndrome. therefore, the secondary objective is to evaluate the agreement between these criteria and the prevalence of concordant and discordant according to different criteria. three thousand persons will be randomly selected from resident of taichung city. all the participants will fulfill a structured questionnaire. blood pressure, anthropometric variables are measured. biochemical markers are analyzed by a biochemical autoanalyzer. kappa will be used to estimate the agreement between different criteria.

Eligibility criteria:
inclusion criteria: residents aged 40 and over of taichung city, taiwan in october, 2004. exclusion criteria: -
new medication treatment for stimulant dependence

Conditions: Cocaine Dependence

Summary: this study will evaluate the efficacy of ondansetron compared with placebo in the treatment of cocaine dependence.

we propose to conduct a 9 week randomized, controlled clinical trial to evaluate the efficacy of ondansetron 4 mg twice daily compared with placebo (total n = 100/group × 2 groups = 200 individuals randomized, 400 total subjects will be consented), provided as an adjunct to manual-driven, structured cbt + bbcet in the treatment of cocaine dependence.

Eligibility criteria:
inclusion criteria: * males and females who have given written informed consent. * ages 18 years and above and, must weigh at least 40 kg and no more than 140 kg. * good physical health as determined by a complete physical examination, an ekg within normal limits, and laboratory screening tests within acceptable parameters. * current dsm-iv diagnosis of cocaine dependence. * at least one positive urine drug screen for cocaine at screen or baseline prior to randomization. * the pregnancy test for females at intake must be negative. * literacy in english and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments. * answered an advertisement in the newspaper/radio/television, and expressing a wish to stop using cocaine. * willing to participate in behavioral treatments for cocaine dependence. exclusion criteria: please contact site for additional information

Keywords: cocaine dependence cocaine abuse cocaine crack
the role of genetics in weight loss

Conditions: Body Mass Index (BMI)

Summary: the prevalence of both overweight and obesity is increasing at an alarming rate worldwide. in fact, it is estimated that 2.16 billion adults (38%) will be overweight and 1.12 billion adults (20%) will be obese by 2030. among other risk factors (e.g., environmental, behavioral, and medical), genetics holds an important role. genome-wide association studies have discovered hundreds of loci associated with body mass index (bmi). polygenic scores (ps) are generated from a combination of millions of genetic variants that are associated with bmi. several diet intervention studies aimed at reducing body weight in overweight and obese individuals. however, the effect of genetic background on the effectiveness of diet interventions is largely unknown. to our knowledge, the diet intervention examining the factors interacting with treatment success (dietfits) trial is the only prospective study that has been designed to evaluate the effect of genotypes in modifying the impact of a healthy low-fat diet vs a healthy low-carbohydrate diet on weight change, but this study did not consider ps. the aim of our study is to determine whether bmi ps impacts the effectiveness of dietary intervention in reducing bmi among individuals with elevated bmi. to achieve this, the investigators will leverage the unique opportunity provided by the finnish biobanks research environment to re-contact 1200 individuals who have extreme genetic predisposition for high/low bmi as measured by a ps for bmi and evaluate how a randomized diet intervention effect varies between the two extreme groups. in brief, the investigators will invite overweight (25-35 bmi) individuals with very high (top 5%; n=600) and very low (bottom 5%; n=600) ps for bmi. half of the participants in each group will be subsequently randomized to enroll in a dietary/lifestyle coaching intervention program or the placebo group and not receive any dietary advice or information. all participants will be asked to answer an online questionnaire and provide a fasting blood sample at baseline and at the end of the study. this well-powered prospective study leverages the unique opportunity to re-contact individuals at the extremes of bmi ps from a large pool of individuals with already available genetic information. this study will determine whether bmi ps can be used to identify overweight and obese individuals who are more likely to succeed in a reduced-energy dietary intervention, which will assist our efforts in curbing the overweight and obesity epidemic.


Eligibility criteria:
inclusion criteria: * 30-65 years old * body mass index (bmi) of 25-35 * participants with genetic data available * participants with a valid recontacting informed consent to their biobank exclusion criteria: * diagnosis of type i and ii diabetes mellitus * history of bariatric surgery * diagnosis of schizophrenia and intellectual disability * diagnosis of dementia and parkinson's * diagnosis of visual impairment * diagnosis of multiple sclerosis * pregnancy or breastfeeding during enrollment screening
the role of a motion sensor with accompanying web application on step counts, energy balance, and metabolic markers in nurses

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases

Summary: the purpose of this prospective randomized controlled trial is to explore the role of a motion sensor with accompany web application on step counts, energy balance, and metabolic markers in nurses. additionally, eating behaviours, behavioural regulation in exercise, and mood states that may impact these parameters will also be examined.


Eligibility criteria:
inclusion criteria: * 1. participant must be a registered nurse with the university of ottawa heart institute; 2. participant must be 18 years of age or older; 3. participant must be able to walk unassisted; 4. participant is able and willing to provide informed consent. exclusion criteria: 1. participant is pregnant, lactating or planning to become pregnant during the study period; 2. participant is unable to read and understand english; 3. medical contraindications to exercise; 4. already using a motion sensor device to track physical activity. -

Keywords: cardiovascular disease motor activity woman workplace delivery of health care