Kornimate/medical-research-clean huggingface dataset:
molecular profiling of exosomes in tumor-draining vein of early-staged lung cancer

Conditions: Lung Cancer; Exosomes; Non Small Cell Lung Cancer

Summary: this is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. the main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.

surgical resection remains the best chance for cure in patients with early-stage non-small-cell lung cancer (nsclc). unfortunately, approximately 30-50% of patients will relapse within 5-year of curative surgery despite early tnm-stage. the identification of prognostic biomarkers of relapse is a necessity. among them, extracellular vesicles (exosomes) study seems promising in early stage cancers and samples directly in tumor-draining vein to. the pulmonary vein is draining blood directly from the lungs and sampling at this location could provide a higher yield for oncosome. the litterature reports that navarro et al. are the only team to have link exosome characteristics to oncological outcomes following surgery. the investigators propose to analyze the molecular profiling mediated by these extracellular vesicles in the tumor-draining vein of operated patients. a peripheral blood sample is recolted before surgery (d-1 or d0). during oncological lung surgery, the pulmonary tumor-drainage vein is first exposed and punctured with a needle prior to subsequent surgical manipulation for resection (d0). a piece of resected tumor will be analyzed for the study (d0). quantification and size distribution of exosome and molecular cargo of exosome in blood samples (peripheral and pulmonary vein) and tumor are analyzed (dna sequencing). standard clinical and radiological follow-up is then performed and 2-year overall survival and 2-year disease free-survival are checked.

Eligibility criteria:
inclusion criteria: - surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on ct-scan exclusion criteria: * pure ground glass nodule, * neoadjuvant therapy, * second cancer or cancer in the 5 years, * pregnancy, * patients \<18 years-old, * tutorship
assessment of knee arthrosis after bariatric surgery

Conditions: Bariatric Surgery Candidate

Summary: impact of loss of weight on knee arthrosis has not been thoroughly studied. the primary goal of this study is to compare the mri parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery. knee mri is not currently part of the investigations preceding bariatric surgery.

assessment of knee arthrosis in severely obese patients after bariatric surgery. impact of loss of weight on knee arthrosis has not been thoroughly studied. the primary goal of this study is to compare the mri parameters (aspect of cartilage and oedema of spongious sub-chondral bone) before and one year after bariatric surgery.

Eligibility criteria:
inclusion criteria: * bariatric surgery * imc \>= 35 exclusion criteria: * those of bariatric surgery * contra-indication to mri * pregnancy

Keywords: knee arthrosis obesity mri bariatric surgery
intensive combination approach to rollback the hiv epidemic in nigerian youth (icare) plus effectiveness/implementation hybrid study

Conditions: Adolescent HIV Infection

Summary: two combination interventions (hiv case finding intervention and hiv treatment intervention), each with mhealth and peer navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in nigeria.

two combination interventions, each with mhealth and peer navigation components, will be evaluated in two 48-week parallel hybrid effectiveness/implementation trials among youth aged 15-24 in nigeria: 1. hiv case finding intervention: single arm trial of an hiv case finding and linkage to care intervention targeting young men at risk of hiv infection (n = 6000), particularly young men who have sex with men (ymsm) in akwa ibom, benue, enugu, kano, taraba, and lagos states who complete hiv testing. objectives: to determine the effectiveness of the intervention to: * identify youth living with hiv, particularly ymsm and * link those who test hiv-positive to hiv care * pre-exposure prophylaxis (prep) initiation (uptake) among those who test hiv-negative. 2. hiv treatment intervention: randomized controlled trial of a medication adherence and viral suppression intervention among youth newly diagnosed with hiv and initiating antiretroviral therapy (art) for the first time (n = 600) at the participating clinical sites. objectives: to determine the effectiveness of the intervention on * viral suppression and * adherence to art * success of implementation in the target populations

Eligibility criteria:
inclusion criteria: hiv case finding intervention: * aged 15 to 24 * male birth sex of any current gender identity * understand basic english, yoruba, hausa, igbo or pidgin english for the prep component, must also be hiv-negative hiv treatment intervention: * aged 15 to 24 * hiv seropositive * initiating art for the first time at a clinical research performance site (crps) clinic or satellite clinic * understand basic english, yoruba, hausa, igbo or pidgin english * intention to remain a crps patient during follow-up exclusion criteria: * unable to provide consent * no parental permission if aged 15 and not emancipated

Keywords: adolescents, hiv testing, hiv treatment
the effects of homogenized and unhomogenized milk on postprandial metabolism in healthy overweight men

Conditions: Hyperlipidemias; Inflammation; Atherosclerosis

Summary: the purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men


Eligibility criteria:
inclusion criteria: * men * aged between 18 and 70 years * quetelet index between 25 - 30 kg/m2 * mean serum triacylglycerol (≤1.7 mmol/l (31)) exclusion criteria: * women * indication for treatment with cholesterol-lowering drugs according to the dutch cholesterol consensus (32) * lactose intolerance * current smoker * familial hypercholesterolemia * abuse of drugs * more than 21 alcoholic consumptions per week * no stable body weight (weight gain or loss \< 3 kg in the past three months) * use of medication or a diet known to affect serum lipid or glucose metabolism * severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis. * active cardiovascular disease like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebro vascular accident) * use of an investigational product within the previous 1 month * not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study * not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study * difficult venipuncture as evidenced during the screening visits

Keywords: milk homogenization postprandial hyperlipidemia postprandial inflammation overweight
perioperative enfortumab vedotin (ev) plus pembrolizumab (mk-3475) versus neoadjuvant chemotherapy for cisplatin-eligible muscle invasive bladder cancer (mibc) (mk-3475-b15/ keynote-b15 / ev-304)

Conditions: Bladder Cancer

Summary: the purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (ev) plus pembrolizumab and radical cystectomy (rc) + pelvic lymph node dissection (plnd) compared with the current standard of care (neoadjuvant chemotherapy \[gemcitabine plus cisplatin\] and rc + plnd) for participants with mibc who are cisplatin-eligible. the primary hypothesis is perioperative ev and pembrolizumab and rc + plnd (arm a) will achieve superior event free survival (efs) compared with neoadjuvant gemcitabine + cisplatin and rc + plnd (arm b).


Eligibility criteria:
inclusion criteria: * have a histologically confirmed diagnosis of urothelial carcinoma (uc) / muscle invasive bladder cancer (mibc) (t2-t4an0m0 or t1-t4an1m0) with predominant (≥50%) urothelial histology. * have clinically non-metastatic bladder cancer (n≤1 m0) determined by imaging (computed tomography (ct) or magnetic resonance imaging (mri) of the chest/abdomen/pelvis * be deemed eligible for radical cystectomy (rc) + pelvic lymph node dissection (plnd) * have eastern cooperative oncology group (ecog) performance status of 0 or 1 * have adequate organ function. exclusion criteria: * has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions * has received any prior systemic treatment for mibc or non-invasive muscle bladder cancer (nmibc - prior treatment for nmibc with intravesical bcg/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (pd-1), anti-programmed cell death ligand 1/ ligand 2 (pd-l1/l2), or anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4) * has ≥n2 disease or metastatic disease (m1) as identified by imaging * is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol * has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder * has undergone partial cystectomy of the bladder to remove any nmibc or mibc * has received a live or live attenuated vaccine within 30 days before the first dose of study intervention * has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (hiv) infection. hepatitis b infection or known active hepatitis c infection * has a known psychiatric or substance abuse disorder * has had an allogenic tissue/solid organ transplant * has ongoing sensory or motor neuropathy grade 2 or higher * has active keratitis (superficial punctate keratitis) or corneal ulcerations * has a history of uncontrolled diabetes defined as hemoglobin a1c (hba1c) ≥8% or hba1c 7% to \<8% with associated diabetes symptoms

Keywords: programmed cell death 1 (pd-1) programmed death-ligand 1 (pd-l1) programmed death-ligand 2 (pd-l2) pelvic lymph node dissection (plnd) radical cystectomy (rc)
gem 1.5 mg b.i.d. to 4.5 mg b.i.d. versus lorazepam in gad (0777-026)

Conditions: Anxiety Disorder

Summary: this study will determine the effectiveness of mk0777 gem versus lorazepam in the treatment of patients with generalized anxiety disorder. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * have been diagnosed with generalized anxiety disorder * women of childbearing potential must use a double-barrier methods of contraception and must have a negative blood pregnancy test at the beginning of the study exclusion criteria: * history of drug or alcohol abuse * have previously participated in another study using mk0777
pseudophakic astigmatic reduction with verion-lensx arcuate incisions

Conditions: Astigmatism

Summary: to assess the effectiveness of the verion-lensx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

the purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. the procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

Eligibility criteria:
inclusion criteria: * age 40 or older * willing and able to provide informed consent for participation in the study. exclusion criteria: -

Keywords: pseudophakic
dietary modifications effect on continuous lcig infusion outcomes in patients with advanced parkinson&apos;s disease

Conditions: Parkinson Disease

Summary: to evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with pd treated with duodopa®. this is in search for an optimal diet that will accompany duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.

a prospective single-blind-crossover study in patients with pd regularly treated with duodopa® (licg) in which three different diets will be given. diet a: low fat western diet - traditional low-fat western diet; a normal diet according to the recommendations of health organizations in which proteins consumed throughout the day, high-protein meal at noon and in the evening. diet b: equal protein redistribution diet (eprd) - proteins consumption is controlled and equally distributed over six meals throughout the day to minimize motor fluctuations. diet c: protein redistribution diet (prd) in which proteins are consumed in the morning prior to connection to the pump and in the evening after disconnecting from the . carbohydrates and fats will be consumed during the day. following recruitment and study initiation patients will consume diet a for 3 weeks. patients will then be randomized into either diet b or diet c for 3 additional weeks. at completion of this period patients will consume diet a for 2 weeks ("wash-out" period) and will then be "crosseovered" to get the third diet (b or c).

Eligibility criteria:
inclusion criteria: * patients treated with duodopa at least three months and are stable on medical therapy * patients should be not demented, able to fill diaries and to sign an informed consent exclusion criteria: * severe dementia * inability to fill out diaries * unstable mediated condition * chronic renal failure

Keywords: parkinson duodopa diet proteins amino acids
improving safety of lead extraction procedures by traction force sensing

Conditions: Cardiac Implantable Electronic Device Infection; Cardiovascular Infections

Summary: death and vascular tears occur in up to 1% of the patients undergoing lead extraction procedures. these complications are due to abnormal force vectors during the procedure. the investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital force gauge is associated with minimal lead displacement compared to conventional lead extraction. lead displacement is an indirect risk factor for potentially fatal lead extraction complications

use of force no greater than 8 pounds of tension will improve lead extraction and minimize lead displacement compared to current standard of care methods which do not limit the force applied. among subjects undergoing lead extraction procedures for cied infection, bidirectional rail (superior and inferior) and traction force objective feedback using force gauge is associated with minimal displacement (\<1cm) of the leads (surrogate marker) on fluoroscopy compared to conventional lead extraction. • the research nature of the protocol is explicitly explained to the patient and an informed consent is explained obtained from the patient prior to the procedure. only patients with cied infections requiring lead extraction are enrolled in the study. patients are risk stratified based on our current risk stratifications scheme. multiple superior and inferior venous accesses are obtained during the procedure. the leads are prepared using locking stylets. baseline fluoroscopic image of the position of the leads is stored. a deflectable sheath and traction forceps are deployed from the groin to provide downward rail in the force feedback arm. locking stylet from the lead is in turn attached to a force gauge (mcmaster-carr santa fe springs, ca). the procedure is performed using continuous fluoroscopic image save tool during the procedure for post procedural viewing and analysis. the patients are randomized to the active arm (to keep force around 8 lb) or the control arm (tactile force discretion based on the operator. the investigator is blinded to the force gauge reading for half of the patients enrolled in the study. for the other half of the patients, the operator optimizes the force to prevent overexertion (\<8-9 pounds). three point along the lead course evaluated during the study. position of downward turn of the lead in the svc, heel of the lead (only in case of rv lead) and the lead tip positions are evaluated. the investigators postulate that there will be at least 5 cine-fluoroscopic views per every lead. the investigators hypothesize that use of bidirectional rail and force feedback is associated with minimal displacement of the lead on fluoroscopy.

Eligibility criteria:
inclusion criteria: • patients with cied infection requiring extraction exclusion criteria: * age \<18 years * noninfectious reasons for extraction * patients with cognitive impairment, who are unable to consent.

Keywords: infection pacemaker icd crt
quality of life of patients with acute myelogenous leukemia (aml) or myelodysplastic syndrome (mds)

Conditions: Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Summary: primary objectives: * to compare the neuropsychiatric (np) and neurocognitive (nc) symptoms and assess the quality of life (qol) in older patients (age \> 18) with acute myelogenous leukemia (aml) or high-risk myelodysplastic syndrome (mds) receiving different therapies, chemotherapy (clofarabine + ara-c) or targeted therapies (pkc412 + low-dose ara-c, or r115777 + low-dose ara-c, or decitabine, or sti + low-dose ara-c). * to determine whether there is a correlation between the number of packed red blood cell (prbc) transfusions and cognitive scores and/or qol.

you will participate in a series of neurocognitive tests. for these tests, you will be asked to complete certain tasks that require the use of your hands, eyes, and ears. the neurocognitive testing will take about 30 minutes. you will answer some questionnaires about disease symptoms and your quality of life. it will take about 30 minutes to complete the questionnaires. you will participate in these neurocognitive tests and fill out the questionnaires before you begin cancer therapy. your interval testing will coincide with your clinic visit evaluations, which will be approximately at 1 month, 3 months, and 6 months. if you do not receive therapy, you will be asked to complete the neurocognitive tests at baseline and then again on your follow up clinic visit evaluations, which will be approximately at 3 months and at 6 months. you may be asked to continue your participation in these neurocognitive tests and fill out questionnaires approximately every 3 months thereafter. this is an investigational study. about 306 patients will take part in this study. all will be enrolled at utmdacc.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed aml or mds. patients who fail an mds/aml therapy and receive other therapies may be asked to continue participation in this neurocognitive study. 2. patients who are 18 years of age or older. 3. patients who are seen in the mdacc adult leukemia clinic. patients who do not enroll onto therapy protocols are also eligible. 4. patients must sign the informed consent. exclusion criteria: 1) not applicable

Keywords: acute myelogenous leukemia myelodysplastic syndrome leukemia quality of life questionnaire survey neurocognitive function aml mds qol
study of the impact of cataract surgery on the corneal epithelium and ocular surface of diabetic patients

Conditions: Cataract Diabetic

Summary: diabetes is one of the most common fatal metabolic diseases in the world. diabetes-induced ocular surface alterations are poorly understood. indeed, it was once thought that the cornea, avascular, was immune to the effects of diabetes. a growing number of publications now demonstrate the opposite. these alterations affect up to 70% of diabetic patients at some point in the progression of their diabetes. another common complication of diabetes is the early development of a cataract, requiring surgery. diabetic patients are therefore more likely to require surgery at an early age than the general population. diabetes and cataract surgery both induce corneal changes. cataract surgery in diabetic patients is therefore at greater risk of corneal complications. diabetes induces dysfunction of the main lacrimal gland, corneal neuropathy, meibomian dysfunction and a decrease in conjunctival mucus cells. diabetic patients are therefore particularly at risk of exacerbation or appearance of alterations of the corneal epithelium and the ocular surface in postoperative cataract surgery. therefore, it seems necessary to evaluate the impact of cataract surgery on the ocular surface and corneal epithelium of diabetic patients, in order to improve their management.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years); * patient operated on for cataract at hus between january 2022 and january 2024; * patient who did not express his opposition to the reuse of his data for scientific research purposes; * patient who benefited from the measurement of the above-mentioned judgment criteria during his pre- and post-operative consultations. exclusion criteria: * presence in the medical file of the subject's opposition to the reuse of his data for scientific research purposes. * prolonged use of stored eye drops; * documented etiology of chronic alteration of the ocular surface (shingles, herpes, gougerot-sjogren syndrome, graft-versus-host disease); * minor patient or under guardianship or curatorship.

Keywords: cataract diabetes corneal epithelium lacrimal gland corneal neuropathy meibomian dysfunction
grappler® interference screw post-market clinical follow-up study

Conditions: Ankle Injuries; Syndesmotic Injuries; Ankle Inversion Sprain; Deltoid Ankle Sprain; Achilles Tendon Rupture; Flexor Hallucis Longus on the Left; Flexor Digitorum Longus on the Left; Ankle Sprains; Flexor Hallucis Longus on the Right; Flexor Digitorum Longus on the Right

Summary: ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the grappler(r) interference screw.

this is a ambispective, multi-surgeon, single site, consecutive case series. data collection will occur in two phases. retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the grappler® interference screw system. data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). the subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (pro's).

Eligibility criteria:
inclusion criteria: * the subject must have undergone a foot and/or ankle procedure involving soft tissue attachment to bone using the grappler® interference screw system and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques * the subject must have adequate radiographic and medical records for the minimum follow-up requirement of six months for the prospective data collection: - the subject is willing to provide written informed consent exclusion criteria: * none