Kornimate/medical-research-clean huggingface dataset:
pharmacogenomics of antiplatelet response - ii (pares-ii)

Conditions: Atherothrombosis

Summary: this clinical trial is examining the effect of 4-week aspirin therapy on platelet transcriptome in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.

platelet aggregation can initiate thrombosis on ulcerated arterial plaques resulting in acute coronary syndrome (acs). there is large variation in platelet aggregation between individuals. as the genetic message to the cell machinery is conveyed through its transcriptome, we hypothesize that much of the variability in platelet function can be explained by transcriptome changes including differences in gene or isoform expression, altered splicing events, or allele-specific expression. moreover, aspirin modifies gene expression in several cells, but whether it also affects platelet transcriptome has not yet been studied. our goal is to characterize the platelet transcriptome and identify genes that are up- or down-regulated after 4-week aspirin therapy. a major strength of our study is that it enrolls individuals from european americans and african americans and thus will have the ability to study similarities and differences between the two. the study will produce innovative comparative genomic/platelet phenotype data and will provide a potential pharmacogenomic and diagnostic template for the future discovery of novel antiplatelet regimens to prevent thrombosis-related cardiovascular disease events.

Eligibility criteria:
inclusion criteria: * participants from the genestar cohort * unaffected with no overt coronary artery disease or serious vascular event (stroke or peripheral vascular disease diagnosis * women who are postmenopausal. * women who use a reliable contraceptive method; a reliable contraceptive method will be defined as personal history of tubal ligation, ongoing use of intra-uterine device, or ongoing use of oral contraceptive pills. exclusion criteria: * presence of any cad or stroke, transient ischemic attacks, peripheral arterial disease * persons taking aspirin, nsaids, or any anti-coagulants who are medically unable to stop them for a two week pre-trial * a history of allergy to aspirin or clopidogrel * weight \< 60kg * age \ 75 years of age * a history of recent or any active bleeding * serious or current co-morbidity (aids, cancer) * pregnant women as determined by urine dipstick pregnancy test * any aneurysms on cranial magnetic resonance imaging/magnetic resonance angiography (obtained recently in the genestar participants) * blood pressure above \>=159/95mmhg * history of a gastric or duodenal ulcer, or significant gastrointestinal disease, like regional enteritis * mental incompetence to make a decision to participate (developmentally disabled, and persons with diagnosed psychiatric disorders-documented in primary care records).

Keywords: platelet transcriptome coronary artery disease myocardial ischemia coronary disease heart diseases cardiovascular diseases arteriosclerosis arterial occlusive diseases vascular diseases aspirin
s095029 as monotherapy and in combination with sym021 in patients with advanced solid tumor malignancies followed by an expansion part with triple combinations in patients with metastatic gastric or colorectal cancers

Conditions: Solid Tumor

Summary: the purpose of the study is to investigate the safety, tolerability, and preliminary anti-neoplastic activity of s095029 alone and in combination with sym021 in patients with advanced solid tumor malignancies followed by an expansion phase of triple combinations. \*the study sponsor has made the decision not to move forward to the expansion part of the study due to strategic considerations, unrelated to any safety issues or concerns. the study will be stopped after completion of dose escalation parts 1a and 1b of the study.


Eligibility criteria:
dose escalation part: inclusion criteria: * histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumor malignancies * patients with a malignancy not amenable to surgical intervention * patients with measurable disease and progression radiologically assessed * patients with disease progression after treatment with available standard of care therapies that are known to confer clinical benefit or who are intolerant to treatment. * patients with available archived tumor biopsy specimens or agree to mandatory biopsy * estimated life expectancy ≥ 12 weeks * adequate haematological function * adequate renal function * adequate hepatic function exclusion criteria: * pregnant and lactating women * major surgery within 4 weeks prior to the first imp administration or not recovered from the surgery * patients with serious/active/uncontrolled infection or infection requiring parenteral antibiotics, within 2 weeks prior to first imp administration * active hepatitis b virus infection * carriers of hiv antibodies * patients with active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to first imp administration * history of organ transplantation * history of gastrointestinal perforation, or intra-abdominal abscess within 28 days of inclusion * history of cirrhosis * history of pulmonary fibrosis or relevant uncontrolled chronic pulmonary condition * treatment with systemic immunosuppressive therapy * active autoimmune disease * administration of a live vaccine within 28 days prior to inclusion

Keywords: adults advanced solid tumors sym21 futuximab/modotuximab triplet combination anti-egfr anti-her2
evaluation of conventional and long pulse widths during a temporary spinal cord stimulation trial

Conditions: Spinal Cord Stimulation; Pain, Back; Pain

Summary: the purpose of this study is to evaluate the effect of pulse widths \ 1000 µs on clinical outcomes during a temporary scs trial.

the proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at the ohio pain clinic. the study will enroll up to 15 subjects in order to include up to 10 subjects in the study. subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for scs and have agreed to undergo a temporary scs trial using the algostim system with percutaneous leads. each subject will be followed during the trial period of approximately 7 days. the study will end when the last subject has completed the trial period. exited. the expected enrollment period for this study is approximately three months. after exit from the clinical study, subjects will continue to be followed by their physician per usual care. all device and procedure-related aes will be collected and reported per the study protocol.

Eligibility criteria:
inclusion criteria: * subject is eligible for scs therapy according to the algovita scs system indications for use statement * study candidate is undergoing a scs trial using nuvectra algostim system * subject signed a valid, institutional review board (irb)-approved informed consent form. * subject is 18 years of age or older when written informed consent is obtained exclusion criteria: * subject is contraindicated for an algovita scs system * subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments * subject has a life expectancy of less than 2 years * subject is participating in another clinical study that would confound data analysis * subject has a coexisting pain condition that might confound pain ratings * subject has a significant psychiatric disorder
molecular characterization of ctcs and ctdna in blood and plasma samples from patients with metastatic and/or hormone-resistant prostate cancer

Conditions: Hormone-Resistant Prostate Cancer; Metastatic Prostate Carcinoma

Summary: this research trial studies molecular characterization of circulating tumor cells (ctcs) and circulating tumor (ct) deoxyribonucleic acid (dna) in blood and plasma samples from patients with prostate cancer that has spread to other places in the body and/or has not responded to previous treatment with hormones. studying samples of blood and plasma collected from patients with prostate cancer before, during, and/or after treatment in the laboratory may help doctors learn more about changes that occur in dna and identify the development of drug resistance.

primary objectives: i. perform molecular analysis of plasma samples from 25 patients with metastatic prostate cancer collected before and during treatment of the disease with abiraterone acetate (zytiga) or enzalutamide (xtandi). ii. perform molecular characterization of circulating tumor cells (ctcs) and plasma collected from 75 patients with progressing advanced metastatic prostate cancer. outline: patients are assigned to 1 of 2 groups based on the timing of specimen collection. group i: previously collected plasma samples are analyzed for ctdna via polymerase chain reaction (pcr) and next generation sequencing (nsg). group ii: patients undergo collection of blood samples before and following systemic therapy for analysis of ctc enumeration, ribonucleic acid (rna) expression, and ctdna via pcr and nsg.

Eligibility criteria:
inclusion criteria: * group i: samples for group i will be selected from existing sample sets obtained from concluded studies (usc irb #'s 10-00006 and 11-00450) * group i: excess plasma collected and stored in these trials from patients treated with abiraterone or enzalutamide will be used for the molecular analysis of the current protocol * group ii: the second group of samples (group 2) will involve prospective collection of peripheral blood from patients with advanced, treatment-resistant metastatic prostate cancer * group ii: histologic documentation of prostate cancer * group ii: metastatic cancer diagnosed by imaging and other clinical criteria * group ii: treatment-resistance determined by at least one of the following factors: increase in prostate-specific antigen (psa) value over a baseline measurement; increase in size or number of metastatic deposits determined on imaging; and/or progression in cancer related symptoms
clinical trial to compare treatment with gp2017 and humira® in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: clinical trial to compare treatment with gp2017 and humira® in patients with rheumatoid arthritis

the purpose of this study is to demonstrate similar efficacy and safety of gp2017 and us-licensed humira® in patients with moderate to severe rheumatoid arthritis (ra) with inadequate response to disease modifying anti-rheumatic drugs (dmards), including methotrexate (mtx).

Eligibility criteria:
inclusion criteria: 1. patients must have been diagnosed with ra ≥ 6 months prior to screening 2. patients must have active disease, defined as das28-crp ≥ 3.2 at the time of screening 3. patients must have crp levels above 5mg/l or esr levels above the upper limits of normal 4. patients must have had inadequate clinical response to mtx 10 - 25 mg/week exclusion criteria: 1. previous treatment with adalimumab, other anti-tnfα therapies or cell depleting agents, e.g. anti-cd20 therapy 2. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment 3. nursing (lactating) or pregnant women 4. history of or ongoing inflammatory or autoimmune diseases other than ra, e.g. mixed connective tissue disease, systemic lupus erythematosus etc. 5. systemic corticosteroids \> 7.5mg/day within 4 weeks prior to baseline 6. history or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence 7. history of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (new york heart association iii-iv), active peptic ulcer disease, recent stroke (within 3 months) 8. subject known to have immune deficiency, history of positive human immunodeficiency virus (hiv) status or immunocompromised for other reasons 9. history of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis) 10. history of persistent chronic infection; recurrent infection or active infections 11. history of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest x-ray, chest computerized tomography(ct) scan, magnetic resonance imaging (mri)) and/ or positive quantiferon-tb gold test (qft) 12. history or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis 13. positive serology hepatitis b (either hbsag or anti-hbc) or hepatitis c (positive hcv-ab or hcv-rna) indicative of previous or current infections
yatep - the impact of horse assisted therapy (hat) on treatment outcomes

Conditions: Addiction

Summary: the objective of the study is to assess the impact of horse assisted therapy (hat) on: * addiction treatment outcomes (its effectiveness as an alternative therapy) * addiction treatment dropout \& addiction relapse (its efficacy in preventing dropout). hypothesis: hat will correlate with: * beneficial treatment outcomes of depression, anxiety, aggression * with improved self esteem \& motivation * lower treatment dropout \& addiction relapse.

background inclusion of horses in therapeutic settings is a scientific issue with significant social and health implications in norway. challenges include increasing provision of horse assisted therapy of variable quality to vulnerable population groups with little substantiating evidence of associated benefit(s) due to lack of research, design issues, mainstream clinicians'/scientists' scepticism of "alternative therapy" and associated difficulties in attracting top researchers and funding. extensive review of literature found a growing volume of studies but as indicated in the most recent systematic review, there are few studies with adequate research design. oslo university hospital's dept of addiction treatment - youth (aua) presents a unique research/evaluation potential to study hat. it will treat approximately 100 patients per year aged 16 to 26 years with a primary diagnosis of addiction. horse assisted therapy (using aua's residential herd) is an integral part of the addiction therapeutic program. furthermore, aua's strong emphasis on research and its youth addiction treatment evaluation project (yatep) data base will provide an evidence base needed for sound study in an emerging area of science and psychotherapy. patient drop out from addiction therapy is high, often exceeding 50% (stark 1992). many aua patients claim that they remain in treatment because of the horses. the study is a randomised controlled trial of in-patients undergoing treatment. the participant group has treatment as usual plus hat; the control group treatment as usual. participant and control groups are drawn from aua patients (aged 16 to 26 years of age with a primary diagnosis of addiction international classification of diseases (icd f10-f19), admitted between 2013 and 2014 to aua's in-patient unit and who have consented to participate in research. hat is a structured program of 12 x 90 minute therapeutic sessions with horses, including horse care, ground and mounted work, conducted by two clinically qualified therapists who are also level i riding instructors.

Eligibility criteria:
inclusion criteria: * primary diagnosis of addictioninternational classification of diseases icd f10-f19, admitted in 2011-2014 for treatment at aua's in-patient unit exclusion criteria: * ongoing psychoses

Keywords: horse assisted therapy (hat) equine assisted psychotherapy (eap) clinical trial randomised controlled trial (rct) psychotherapy
functional and performance determinants in climbers: examining the role of mobility, stability, and fatigue across proficiency levels

Conditions: Fatigue; Joint Hypermobility Syndrome; Climbing Injuries; Cognitive Fatigue

Summary: the primary objective is to understand how motor skills and fatigue affect climbing performance in indoor and outdoor climbers, also comparing elite and amateur climbers. aims: * assess differences in selected joint range of motion, isometric strength, and dynamic stability between elite and intermediate climbers. * evaluate the impact of the fatigue protocol on functional performance and cognitive outcomes across climbers of varying skill levels (intermediate vs. advanced). * examine the impact of general joint hypermobility, as indicated by beighton scores, on functional climbing performance. * association between cognitive factors (e.g., attention, memory) and motor skills. research questions: * do elite climbers have better joint mobility and balance than amateur climbers? * how does fatigue affect performance and reaction time and cognitive function? * does having flexible joints (joint hypermobility) make climbers better athletes * what are the performance differences between indoor and outdoor climbers? this study will help identify key skills and physical traits that improve climbing performance. it will also explore how fatigue and flexibility impact safety and performance in different climbing environments.

detailed description this study investigates the functional and performance determinants in indoor and outdoor climbers, focusing on mobility, stability, fatigue, and skill level. the protocol will compare elite and intermediate climbers through various physical and cognitive assessments conducted before and after a climbing-specific fatigue protocol. the goal is to identify key biomechanical, physiological, and cognitive factors that influence climbing performance and fatigue resistance in both climbing environments.

Eligibility criteria:
inclusion criteria: * primary sport discipline - climbing (bouldering/lead rock or other) * healthy (without injury, pain, or symptoms) at the time of the study * participation in climbing training (minimum 3 months) exclusion criteria: * pain or other symptoms related during study * rheumatological disease * neurological disease or balance disorders * orthopaedic disease * genetic disease * cardiovascular system disease * surgeries of upper and lower limb in the last year * surgeries of spine in the last year * a primary sport other than climbing. * taking medications that may affect balance. * use of orthopedic supplies during the study

Keywords: bouldering sports performance assessment climbing-specific performance hand grip strength indoor climbing outdoor climbing
connection to care: pilot study of a mobile health tool for patients with depression and anxiety

Conditions: Anxiety; Depression

Summary: this is a pilot feasibility study of a mobile health tool (smartphone app) for primary care patients receiving treatment for depression or anxiety delivered in an integrated primary care-based behavioral health program.

this research is a feasibility pilot study of a smartphone app using mixed methods. the research seeks to answer the question: "is a mobile health tool for patient self-management feasible, useful, appropriate, and acceptable for patients and care managers for patients with depression or anxiety treated in an integrated primary-care based behavioral health program?"

Eligibility criteria:
inclusion criteria: * be part of the behavioral health integration program for anxiety and/or depression; must have an iphone or android smartphone with a mobile voice calling plan with a us carrier; fluent in english exclusion criteria: * individual unable or unwilling to accept the terms of the ginger.io terms of use; actively suicidal as determined by a healthcare professional; score of 3 on the patient health questionnaire-9 item 9 (which assesses thoughts of self-harm); or documented history of 2 or more prior suicide attempts; working diagnosis of psychotic disorder, bipolar disorder, dementia, active substance dependence
comparing two-needle vs. surgery-guided arthrocentesis for tmj disorders

Conditions: Temporomandibular Joint Disorders

Summary: the goal of this clinical trial is to compare two methods of arthrocentesis in treating temporomandibular joint (tmj) disorders. the main questions it aims to answer are: is surgery-guided arthrocentesis more efficient in terms of operation time compared to traditional two-needle arthrocentesis? does the use of surgical guides lead to less postoperative pain and better patient comfort? participants will: undergo either the traditional two-needle arthrocentesis or the surgery-guided arthrocentesis. be monitored for operation time, postoperative pain, and overall patient comfort. researchers will compare the outcomes of patients who underwent traditional two-needle arthrocentesis with those who had surgery-guided arthrocentesis to see if the latter can shorten operation time and improve patient comfort.


Eligibility criteria:
inclusion criteria: * patients diagnosed with wilkes stage ii, iii, or iv temporomandibular joint (tmj) internal derangement. * presence of pain, sound, or both in the tmj. * limitation or locking in mouth opening, or both. * patients who have not responded to symptoms after a minimum of three months of splint therapy. exclusion criteria: * presence of infection in the puncture area. * presence of osteomyelitis in the neighboring region. * patients with uncontrolled coagulopathies. * patients experiencing limitation in maximum mouth opening without disk disorder. * patients with severe degenerative joint disease (e.g., deformed condylar contour, osteophyte findings in mri). * history of tmj surgery. * history of muscle-originated mandibular hypomobility.

Keywords: arthrocentesis,temporomandibular joint guided surgery
aromatherapy for stress and burnout among healthcare providers

Conditions: Stress; Burnout, Professional; Stress, Job

Summary: the purpose of this study is to evaluate the potential for inhalation of plant-based aromas to reduce stress and burnout among healthcare professionals and staff in hospitals and urgent care centers.

after being informed about the study and potential risks/benefits, participants will provide e-sign informed consent documents and be randomized to one of three groups in a 1:1:1 ratio. each participant will apply the assigned study oil to the jawline for inhalation three times daily for a total of 7 days.

Eligibility criteria:
inclusion criteria: * age 20-59 * lives in the united states * otherwise healthy * employed full time in a capacity that interacts with patients at a hospital, primary, or urgent care center that treats covid-19 patients. full time is defined as 35 hours or more each week. exclusion criteria: * positive covid-19 test within 60 days of the study period * covid vaccine of any type scheduled during the intervention period or the week prior to the start of the study * allergy to any of the ingredients * regular smokers in the home (daily or more often) * pregnant, trying to conceive, or breastfeeding * existing use of an aromatherapy blend for stress management

Keywords: aromatherapy essential oils